381.00783 Grounds for discipline; administrative penalties.
381.00785 Criminal penalties.
381.00787 Tattooing prohibited; penalty.
381.00789 Rulemaking.
381.00791 Local laws and ordinances.
381.008 Definitions of terms used in ss. 381.008-381.00897.
381.0081 Permit required to operate a migrant labor camp or residential migrant housing; penalties for unlawful establishment or operation; allocation of proceeds.
381.0082 Application for permit to operate migrant labor camp or residential migrant housing.
381.0083 Permit for migrant labor camp or residential migrant housing.
381.0084 Application fees for migrant labor camps and residential migrant housing.
381.0085 Revocation of permit to operate migrant labor camp or residential migrant housing.
381.0086 Rules; variances; penalties.
381.0087 Enforcement; citations.
381.0088 Right of entry.
381.00893 Complaints by aggrieved parties.
381.00895 Prohibited acts; application.
381.00896 Nondiscrimination.
381.00897 Access to migrant labor camps and residential migrant housing.
381.009 Toilets required by department regulations; charge for use of prohibited.
381.0098 Biomedical waste.
381.0101 Environmental health professionals.
381.0201 Technical and support services.
381.0202 Laboratory services.
381.0203 Pharmacy services.
381.02035 Canadian Prescription Drug Importation Program.
381.0204 Vital statistics.
381.0205 Emergency medical services.
381.026 Florida Patient’s Bill of Rights and Responsibilities.
381.0261 Summary of patient’s bill of rights; distribution; penalty.
381.028 Adverse medical incidents.
381.0303 Special needs shelters.
381.0402 Area health education center network.
381.0405 Office of Rural Health.
381.0406 Rural health networks.
381.04065 Rural health network cooperative agreements.
381.0601 Self-derived and directed-donor blood programs.
381.06014 Blood establishments.
381.06015 Public Cord Blood Tissue Bank.
381.06016 Umbilical cord blood awareness.
381.4015 Florida health care innovation.
381.4018 Physician workforce assessment and development.
381.4019 Dental Student Loan Repayment Program.
381.40195 Donated Dental Services Program.
381.402 Florida Reimbursement Assistance for Medical Education Program.
381.887 Emergency treatment for suspected opioid overdose.
381.89 Regulation of tanning facilities.
381.895 Standards for compressed air used for recreational diving.
381.91 Jessie Trice Cancer Prevention Program.
381.911 Prostate Cancer Awareness Program.
381.915 Casey DeSantis Cancer Research Program.
381.922 William G. “Bill” Bankhead, Jr., and David Coley Cancer Research Program.
381.92201 Exemptions from public records and public meetings requirements; peer review panels.
381.925 Cancer Center of Excellence Award.
381.93 Breast and cervical cancer early detection program.
381.931 Annual report on Medicaid expenditures.
381.9312 Uterine fibroid research database; education and public awareness.
381.9315 Gynecologic and ovarian cancer education and awareness.
381.932 Breast cancer early detection and treatment referral program.
381.933 Mammography reports.
381.95 Medical facility information maintained for terrorism response purposes; confidentiality.
381.96 Pregnancy support and wellness services.
381.98 The Florida Public Health Institute, Inc.; establishment; purpose; mission; duties; board of directors.
381.981 Health awareness campaigns.
381.982 Short title.
381.983 Definitions.
381.984 Educational programs.
381.985 Screening program.
381.9855 Dr. and Mrs. Alfonse and Kathleen Cinotti Health Care Screening and Services Grant Program; portal.
381.986 Medical use of marijuana.
381.987 Public records exemption for personal identifying information relating to medical marijuana held by the department.
381.988 Medical marijuana testing laboratories; marijuana tests conducted by a certified laboratory.
381.989 Public education campaigns.
381.99 Rare Disease Advisory Council.
381.991 Andrew John Anderson Pediatric Rare Disease Grant Program.
381.001 Public health system.— The Department of Health is responsible for the state’s public health system which shall be designed to promote, protect, and improve the health of all people in the state. The department shall provide leadership for an active partnership working toward shared public health goals and involving federal, state, and local governments and the private sector. It is the intent of the Legislature that the department provide public health services through the 67 county health departments in partnership with county governments, as specified in part I of chapter 154, and in so doing make every attempt possible to solicit the support and involvement of private and not-for-profit health care agencies in fulfilling the public health mission.
381.0011 Duties and powers of the Department of Health.—It is the duty of the Department of Health to:
(1) Assess the public health status and needs of the state.
(2) Administer and enforce laws and rules relating to sanitation, control of communicable diseases, illnesses and hazards to health among humans and from animals to humans, and the general health of the people of the state.
(3) Coordinate with federal, state, and local officials for the prevention and suppression of communicable and other diseases, illnesses, injuries, and hazards to human health.
(4) Provide for a thorough investigation and study of the incidence, causes, modes of propagation and transmission, and means of prevention, control, and cure of diseases, illnesses, and hazards to human health.
(5) Provide for the dissemination of information to the public relative to the prevention, control, and cure of diseases, illnesses, and hazards to human health.
(6) Act as registrar of vital statistics.
(7) Manage and coordinate emergency preparedness and disaster response functions to: investigate and control the spread of disease; coordinate the availability and staffing of special needs shelters; support patient evacuation; ensure the safety of food and drugs; provide critical incident stress debriefing; and provide surveillance and control of radiological, chemical, biological, and other environmental hazards.
(1) The department may commence and maintain all proper and necessary actions and proceedings to enforce the rules adopted pursuant to this chapter and may defend all actions and proceedings involving the department’s powers and duties.
(2) The department may apply for an injunction to the proper circuit court, and the judge of that court upon hearing and for cause shown may grant a temporary or permanent injunction, or both, restraining any person from violating or continuing to violate any of the provisions of this chapter or from failing or refusing to comply with the requirements of this chapter. A permanent injunction may be issued without bond. However, a temporary injunction may not be issued without bond except after a hearing of which the respondent has been given not less than 7 days’ prior notice. A temporary injunction may not be issued without bond which limits or prevents operations of an industrial, manufacturing, or processing plant, unless at the hearing, it is shown by clear, certain, and convincing evidence that irreparable injury will result to the public from the failure to issue the temporary injunction. If a temporary injunction or restraining order is improperly or erroneously granted, the state is liable in damages and to the extent provided for in chapter 768.
(3) The department may commence and maintain all proper and necessary actions and proceedings to compel the performance of any act specifically required of any person, officer, or board by any law of this state relating to public health.
(4) The department may appear before any trial court judge empowered to issue warrants in criminal cases and request the issuance of a warrant. The trial court judge shall issue a warrant directed to any sheriff, deputy, or police officer to assist in any way to carry out the purpose and intent of this chapter.
(5) It shall be the duty of every state and county attorney, sheriff, police officer, and other appropriate city and county officials upon request to assist the department or any of its agents in enforcing the state health laws, rules, and orders adopted under this chapter.
381.0016 County and municipal regulations and ordinances.—Any county or municipality may enact, in a manner prescribed by law, health regulations and ordinances not inconsistent with state public health laws and rules adopted by the department.
History.—s. 2, ch. 29834, 1955; ss. 19, 35, ch. 69-106; s. 59, ch. 77-147; s. 8, ch. 91-297; s. 11, ch. 2012-184.
Note.—Former s. 381.101.
381.0018 Application for and acceptance of gifts or grants.—The department may apply for and accept any funds, grants, gifts, or services made available to it by any agency or department of the Federal Government or any other agency or private individual in aid of any present or future health program undertaken, maintained, or proposed. All moneys received under the provision of this section shall be deposited in the State Treasury and shall be disbursed in the same manner as other funds of the department.
History.—s. 2, ch. 29834, 1955; ss. 19, 35, ch. 69-106; s. 65, ch. 77-147; s. 10, ch. 91-297.
Note.—Former s. 381.201.
381.0019 Disposition of equipment and material; transfers to county health departments.—When the department purchases equipment and materials in furtherance of its public health programs from state or federal or state and federal funds for primary use and location in a county health department of this state, it is authorized to transfer title to such equipment and materials to the board of county commissioners of the county where the county health department is located, unless otherwise prohibited by federal or state law, rule, or regulation. All property so transferred shall be accounted for as provided in chapter 274.
History.—s. 2, ch. 29834, 1955; s. 2, ch. 61-46; ss. 19, 35, ch. 69-106; s. 127, ch. 77-104; s. 11, ch. 91-297; s. 30, ch. 97-101.
Note.—Former s. 381.211.
381.002 Grant of title to prescriptive medical personal property to client.—Legal title to prescriptive medical personal property purchased by the department for the use or benefit of a particular client of the department may, pursuant to rules adopted by the department, be granted to such client. Such property is not subject to the requirements of chapter 273.
381.0021 Client welfare accounts.—The Department of Health may establish one or more client welfare accounts in any bank, savings and loan association, or credit union. If one account is created, separate revenue and expense accounts shall be maintained in the department’s accounting system for each client, program, facility, or institution. Funds to be deposited in the account shall consist of client funds, private donations, and revenue from any auxiliary, canteen, or similar endeavor in a department program, facility, or institution. The interest or increment accruing on such funds shall be the property of the client when such funds are deposited on behalf of a client. Nonclient funds shall be used for the benefit, education, and general welfare of clients. The general welfare of clients includes, but is not limited to, the establishment of, maintenance of, employment of personnel for, and the purchase of items for resale at canteens or through vending machines maintained by a department program, facility, or institution and for programs and activities that benefit clients such as canteens; hobby shops; recreational, entertainment, or activity centers; or similar programs.
381.0022 Sharing confidential or exempt information.—
(1) Notwithstanding any other provision of law to the contrary, the Department of Health and the Department of Children and Families may share confidential information or information exempt from disclosure under chapter 119 on any individual who is or has been the subject of a program within the jurisdiction of each agency. Information so exchanged remains confidential or exempt as provided by law.
(2) Notwithstanding any other provision of law to the contrary, the Department of Health may share confidential information or information exempt from disclosure under chapter 119 on any individual who is or has been a Medicaid recipient and is or was the subject of a program within the jurisdiction of the Department of Health, for the purpose of requesting, receiving, or auditing payment for services. Information so exchanged remains confidential or exempt as provided by law.
381.003 Communicable disease and AIDS prevention and control.—
(1) The department shall conduct a communicable disease prevention and control program as part of fulfilling its public health mission. A communicable disease is any disease caused by transmission of a specific infectious agent, or its toxic products, from an infected person, an infected animal, or the environment to a susceptible host, either directly or indirectly. The communicable disease program must include, but need not be limited to:
(a) Programs for the prevention and control of tuberculosis in accordance with chapter 392.
(b) Programs for the prevention and control of human immunodeficiency virus infection and acquired immune deficiency syndrome in accordance with chapter 384 and this chapter.
(c) Programs for the prevention and control of sexually transmissible diseases in accordance with chapter 384.
(d) Programs for the prevention, control, and reporting of communicable diseases of public health significance as provided for in this chapter.
(e) Programs for the prevention and control of vaccine-preventable diseases, including programs to immunize school children as required by s. 1003.22(3)-(11) and the development of an automated, electronic, and centralized database and registry of immunizations. The department shall ensure that all children in this state are immunized against vaccine-preventable diseases. The immunization registry must allow the department to enhance current immunization activities for the purpose of improving the immunization of all children in this state.
1. Except as provided in subparagraph 2., the department shall include all children born in this state in the immunization registry by using the birth records from the Office of Vital Statistics. The department shall add other children to the registry as immunization services are provided.
2. The parent or guardian of a child may refuse to have the child included in the immunization registry by signing a form obtained from the department, or from the health care practitioner or entity that provides the immunization, which indicates that the parent or guardian does not wish to have the child included in the immunization registry. Each consent to treatment form provided by a health care practitioner or by an entity that administers vaccinations or causes vaccinations to be administered to children from birth through 17 years of age must contain a notice stating that the parent or guardian of a child may refuse to have his or her child included in the immunization registry. The parent or guardian must provide such opt-out form to the health care practitioner or entity upon administration of the vaccination. Such health care practitioner or entity shall submit the form to the department. A parent or guardian may submit the opt-out form directly to the department. Any records or identifying information pertaining to the child shall be removed from the registry, if the parent or guardian has refused to have his or her child included in the immunization registry.
3. A college or university student, from 18 years of age to 23 years of age, who obtains a vaccination from a college or university student health center or clinic in the state may refuse to be included in the immunization registry by signing a form obtained from the department, health center, or clinic which indicates that the student does not wish to be included in the immunization registry. The student must provide such opt-out form to the health center or clinic upon administration of the vaccination. Such health center or clinic shall submit the form to the department. A student may submit the opt-out form directly to the department. Any records or identifying information pertaining to the student shall be removed from the registry if the student has refused to be included in the immunization registry.
4. The immunization registry shall allow for immunization records to be electronically available to entities that are required by law to have such records, including, but not limited to, schools and licensed child care facilities.
5. A health care practitioner licensed under chapter 458, chapter 459, or chapter 464 in this state who administers vaccinations or causes vaccinations to be administered to children from birth through 17 years of age is required to report vaccination data to the immunization registry, unless a parent or guardian of a child has refused to have the child included in the immunization registry by meeting the requirements of subparagraph 2. A health care practitioner licensed under chapter 458, chapter 459, or chapter 464 in this state who administers vaccinations or causes vaccinations to be administered to college or university students from 18 years of age to 23 years of age at a college or university student health center or clinic is required to report vaccination data to the immunization registry, unless the student has refused to be included in the immunization registry by meeting the requirements of subparagraph 3. Vaccination data for students in other age ranges may be submitted to the immunization registry only if the student consents to inclusion in the immunization registry. The upload of data from existing automated systems is an acceptable method for updating immunization information in the immunization registry. The information in the immunization registry must include the child’s name, date of birth, address, and any other unique identifier necessary to correctly identify the child; the immunization record, including the date, type of administered vaccine, and vaccine lot number; and the presence or absence of any adverse reaction or contraindication related to the immunization. Information received by the department for the immunization registry retains its status as confidential medical information and the department must maintain the confidentiality of that information as otherwise required by law. A health care practitioner or other agency that obtains information from the immunization registry must maintain the confidentiality of any medical records in accordance with s. 456.057 or as otherwise required by law.
(2) The department may adopt rules pursuant to ss. 120.536(1) and 120.54 to implement this section.
381.0031 Epidemiological research; report of diseases of public health significance to department.—
(1) The department may conduct studies concerning the epidemiology of diseases of public health significance affecting people in Florida.
(2) Any practitioner licensed in this state to practice medicine, osteopathic medicine, chiropractic medicine, naturopathy, or veterinary medicine; any licensed pharmacist authorized under a protocol with a supervising physician under s. 465.1895, or a collaborative pharmacy practice agreement, as defined in s. 465.1865, to perform or order and evaluate laboratory and clinical tests; any hospital licensed under part I of chapter 395; or any laboratory appropriately certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments and the federal rules adopted thereunder which diagnoses or suspects the existence of a disease of public health significance shall immediately report the fact to the Department of Health.
(3) An animal control officer operating under s. 828.27, a wildlife officer operating under s. 379.3311, or an animal disease laboratory operating under s. 585.61 shall report knowledge of any animal bite, diagnosis of disease in an animal, or suspicion of a grouping or clustering of animals having similar disease, symptoms, or syndromes that may indicate the presence of a threat to humans.
(4) The department shall periodically issue a list of infectious or noninfectious diseases determined by it to be a threat to public health and therefore of significance to public health and shall furnish a copy of the list to the practitioners listed in subsection (2). The list shall be based on the diseases recommended to be nationally notifiable by the Council of State and Territorial Epidemiologists and the Centers for Disease Control and Prevention. The department may expand upon the list if a disease emerges for which regular, frequent, and timely information regarding individual cases is considered necessary for the prevention and control of a disease specific to Florida.
(5) Reports required by this section must be in accordance with methods specified by rule of the department.
(6) Information submitted in reports required by this section is confidential, exempt from the provisions of s. 119.07(1), and is to be made public only when necessary to public health. A report so submitted is not a violation of the confidential relationship between practitioner and patient.
(7) The department may obtain and inspect copies of medical records, records of laboratory tests, and other medical-related information for reported cases of diseases of public health significance described in subsection (4). The department shall examine the records of a person who has a disease of public health significance only for purposes of preventing and eliminating outbreaks of disease and making epidemiological investigations of reported cases of diseases of public health significance, notwithstanding any other law to the contrary. Health care practitioners, licensed health care facilities, and laboratories shall allow the department to inspect and obtain copies of such medical records and medical-related information, notwithstanding any other law to the contrary. Release of medical records and medical-related information to the department by a health care practitioner, licensed health care facility, or laboratory, or by an authorized employee or agent thereof, does not constitute a violation of the confidentiality of patient records. A health care practitioner, health care facility, or laboratory, or any employee or agent thereof, may not be held liable in any manner for damages and is not subject to criminal penalties for providing patient records to the department as authorized by this section.
(8) The department may adopt rules related to reporting diseases of significance to public health, which must specify the information to be included in the report, who is required to report, the method and time period for reporting, requirements for enforcement, and required followup activities by the department which are necessary to protect public health.
381.00315 Public health advisories; public health emergencies; isolation and quarantines.—The State Health Officer is responsible for declaring public health emergencies, issuing public health advisories, and ordering isolation or quarantines.
(1) As used in this section, the term:
(a) “Isolation” means the separation of an individual who is reasonably believed to be infected with a communicable disease from individuals who are not infected, to prevent the possible spread of the disease.
(b) “Public health advisory” means any warning or report giving information to the public about a potential public health threat. Before issuing any public health advisory, the State Health Officer must consult with any state or local agency regarding areas of responsibility which may be affected by such advisory. Upon determining that issuing a public health advisory is necessary to protect the public health and safety, and prior to issuing the advisory, the State Health Officer must notify each county health department within the area which is affected by the advisory of the State Health Officer’s intent to issue the advisory. The State Health Officer is authorized to take any action appropriate to enforce any public health advisory.
(c) “Public health emergency” means any occurrence, or threat thereof, whether natural or manmade, which results or may result in substantial injury or harm to the public health from infectious disease, chemical agents, nuclear agents, biological toxins, or situations involving mass casualties or natural disasters.
(d) “Quarantine” means the separation of an individual reasonably believed to have been exposed to a communicable disease, but who is not yet ill, from individuals who have not been so exposed, to prevent the possible spread of the disease.
(2)(a) The department shall prepare and maintain a state public health emergency management plan to serve as a comprehensive guide to public health emergency response in this state. The department shall develop the plan in collaboration with the Division of Emergency Management, other executive agencies with functions relevant to public health emergencies, district medical examiners, and national and state public health experts and ensure that it integrates and coordinates with the public health emergency management plans and programs of the Federal Government. The plan must address each element of public health emergency planning and incorporate public health and epidemiological best practices to ensure that the state is prepared for every foreseeable public health emergency. The plan must include an assessment of state and local public health infrastructure, including information systems, physical plant, commodities, and human resources, and an analysis of the infrastructure necessary to achieve the level of readiness proposed by the plan for short-term and long-term public emergencies. Beginning July 1, 2022, the department shall submit the plan to the Division of Emergency Management for inclusion in the state comprehensive emergency management plan pursuant to s. 252.35. The department shall review the plan after the declared end of each public health emergency, and, in any event, at least every 5 years, and update its terms as necessary to ensure continuous planning.
(b) Before declaring a public health emergency, the State Health Officer shall, to the extent possible, consult with the Governor and shall notify the Chief of Domestic Security. The declaration of a public health emergency shall continue until the State Health Officer finds that the threat or danger has been dealt with to the extent that the emergency conditions no longer exist and he or she terminates the declaration. However, a declaration of a public health emergency may not continue for longer than 60 days unless the Governor concurs in the renewal of the declaration.
(c) The State Health Officer, upon declaration of a public health emergency, shall establish by order the method and procedure for identifying and reporting cases and deaths involving the infectious disease or other occurrence identified as the basis for the declared public health emergency. The method and procedure must be consistent with any standards developed by the Federal Government specific to the declared emergency or, if federal standards do not exist, must be consistent with public health best practices as identified by the State Health Officer. During the pendency of a public health emergency, the department is the sole entity responsible for the collection and official reporting and publication of cases and deaths. The State Health Officer, by order or emergency rule, may ensure necessary assistance from licensed health care providers in carrying out this function and may request the assistance of district medical examiners in performing this function.
(d) The State Health Officer, upon declaration of a public health emergency, may take actions that are necessary to protect the public health. Such actions include, but are not limited to:
1. Directing manufacturers of prescription drugs or over-the-counter drugs who are permitted under chapter 499 and wholesalers of prescription drugs located in this state who are permitted under chapter 499 to give priority to the shipping of specified drugs to pharmacies and health care providers within geographic areas identified by the State Health Officer. The State Health Officer must identify the drugs to be shipped. Manufacturers and wholesalers located in the state must respond to the State Health Officer’s priority shipping directive before shipping the specified drugs.
2. Notwithstanding chapters 465 and 499 and rules adopted thereunder, directing pharmacists employed by the department to compound bulk prescription drugs and provide these bulk prescription drugs to physicians and nurses of county health departments or any qualified person authorized by the State Health Officer for administration to persons as part of a prophylactic or treatment regimen.
3. Notwithstanding s. 456.036, temporarily reactivating the inactive license of the following health care practitioners, when such practitioners are needed to respond to the public health emergency: physicians licensed under chapter 458 or chapter 459; physician assistants licensed under chapter 458 or chapter 459; licensed practical nurses, registered nurses, and advanced practice registered nurses licensed under part I of chapter 464; respiratory therapists licensed under part V of chapter 468; and emergency medical technicians and paramedics certified under part III of chapter 401. Only those health care practitioners specified in this paragraph who possess an unencumbered inactive license and who request that such license be reactivated are eligible for reactivation. An inactive license that is reactivated under this paragraph shall return to inactive status when the public health emergency ends or before the end of the public health emergency if the State Health Officer determines that the health care practitioner is no longer needed to provide services during the public health emergency. Such licenses may only be reactivated for a period not to exceed 90 days without meeting the requirements of s. 456.036 or chapter 401, as applicable.
4. Ordering an individual to be examined, tested, treated, isolated, or quarantined for communicable diseases that have significant morbidity or mortality and present a severe danger to public health. Individuals who are unable or unwilling to be examined, tested, or treated for reasons of health, religion, or conscience may be subjected to isolation or quarantine.
a. Examination, testing, or treatment may be performed by any qualified person authorized by the State Health Officer.
b. If the individual poses a danger to the public health, the State Health Officer may subject the individual to isolation or quarantine. If there is no practical method to isolate or quarantine the individual, the State Health Officer may use any means necessary to treat the individual.
c. Any order of the State Health Officer given to effectuate this paragraph is immediately enforceable by a law enforcement officer under s. 381.0012.
(e) Individuals who assist the State Health Officer at his or her request on a volunteer basis during a public health emergency are entitled to the benefits specified in s. 110.504(2), (3), (4), and (5).
(3) To facilitate effective emergency management, when the United States Department of Health and Human Services contracts for the manufacture and delivery of licensable products in response to a public health emergency and the terms of those contracts are made available to the states, the department shall accept funds provided by counties, municipalities, and other entities designated in the state emergency management plan required under s. 252.35(2)(a) for the purpose of participation in those contracts. The department shall deposit those funds in the Grants and Donations Trust Fund and expend those funds on behalf of the donor county, municipality, or other entity for the purchase of the licensable products made available under the contract.
(4) The department has the duty and the authority to declare, enforce, modify, and abolish the isolation and quarantine of persons, animals, and premises as the circumstances indicate for controlling communicable diseases or providing protection from unsafe conditions that pose a threat to public health, except as provided in ss. 384.28 and 392.545-392.60. Any order of the department issued pursuant to this subsection shall be immediately enforceable by a law enforcement officer under s. 381.0012.
(5) The department shall adopt rules to specify the conditions and procedures for imposing and releasing an isolation or a quarantine. The rules must include provisions related to:
(a) The closure of premises.
(b) The movement of persons or animals exposed to or infected with a communicable disease.
(c) The tests or treatment for communicable disease required before employment or admission to the premises or to comply with an isolation or a quarantine.
(d) Testing or destruction of animals with or suspected of having a disease transmissible to humans.
(e) Access by the department to isolated or quarantined premises.
(f) The disinfection of isolated or quarantined animals, persons, or premises.
(g) Methods of isolation or quarantine.
(6) The rules adopted under this section and actions taken by the department pursuant to a declared public health emergency, isolation, or quarantine shall supersede all rules enacted by other state departments, boards or commissions, and ordinances and regulations enacted by political subdivisions of the state. Any person who violates any rule adopted under this section, any isolation or quarantine, or any requirement adopted by the department pursuant to a declared public health emergency, commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
381.00316 Discrimination by governmental and business entities based on health care choices; prohibition.—
(1)(a) It is the intent of the Legislature that Floridians be free from mandated facial coverings, mandates of any kind relating to vaccines as provided in this section, and discrimination based on such vaccination status.
(b) The Legislature finds that society is harmed by discrimination based on vaccination status as provided in this section when healthy persons are prevented from participating in society and accessing employment opportunities. The Legislature further finds that remedies to prevent such discrimination are in the best interest of this state.
(2) As used in this section, the term:
(a) “Business entity” has the same meaning as in s. 606.03. The term also includes a charitable organization as defined in s. 496.404, a corporation not for profit as defined in s. 617.01401, or any other business operating in this state.
(b) “COVID-19” means the novel coronavirus identified as SARS-CoV-2; any disease caused by SARS-CoV-2, its viral fragments, or a virus mutating therefrom; and all conditions associated with the disease which are caused by SARS-CoV-2, its viral fragments, or a virus mutating therefrom.
(c) “COVID-19 vaccine” means a preparation designed to stimulate the human body’s immune response against COVID-19.
(d) “Department” means the Department of Legal Affairs.
(e) “Emergency use authorization vaccine” means any vaccine that is authorized for emergency use under 21 U.S.C. 360bbb–3(a)(1) and qualifies as an unapproved product under 21 U.S.C. 360bbb–3(a)(2)(A).
(f) “Governmental entity” means the state or any political subdivision thereof, including the executive, legislative, and judicial branches of government; the independent establishments of the state, counties, municipalities, districts, authorities, boards, or commissions; or any agencies that are subject to chapter 286. The term does not include an educational institution as defined in s. 381.00319.
1(g) “Messenger ribonucleic acid vaccine” means any vaccine that uses laboratory-produced messenger ribonucleic acid to trigger the human body’s immune system to generate an immune response.
(3)(a) A business entity may not require any person to provide any documentation certifying vaccination with any vaccine defined under subsection (2) or postinfection recovery from COVID-19, or require a COVID-19 test, to gain access to, entry upon, or service from the business operations in this state or as a condition of contracting, hiring, promotion, or continued employment with the business entity.
(b) A business entity may not discharge or refuse to hire a person; deprive or attempt to deprive a person of employment opportunities; adversely affect a person’s status as an employee or as an applicant for employment; or otherwise discriminate against a person based on knowledge or belief of the person’s status relating to vaccination with any vaccine defined under subsection (2) or COVID-19 postinfection recovery, or a person’s failure to take a COVID-19 test.
(c) For matters relating to vaccines other than those defined under subsection (2), a business entity shall provide for exemptions and reasonable accommodations for religious and medical reasons in accordance with federal law.
(d) A licensed facility as defined in s. 395.002 may not discriminate in providing health care to a patient based solely on that patient’s vaccination status with a COVID-19 vaccine.
(4)(a) A governmental entity may not require any person to provide any documentation certifying vaccination with any vaccine defined under subsection (2) or postinfection recovery from COVID-19, or require a COVID-19 test, to gain access to, entry upon, or service from the governmental entity’s operations in this state or as a condition of contracting, hiring, promotion, or continued employment with the governmental entity.
(b) A governmental entity may not discharge or refuse to hire a person; deprive or attempt to deprive a person of employment opportunities; adversely affect a person’s status as an employee; or otherwise discriminate against a person based on the knowledge or belief of the person’s status relating to vaccination with any vaccine defined under subsection (2) or a person’s failure to take a COVID-19 test.
(c) For matters relating to vaccines other than those defined under subsection (2), a governmental entity shall provide for exemptions and reasonable accommodations for religious and medical reasons in accordance with federal law.
(5)(a) A business entity or governmental entity may not require a person to wear a face mask, a face shield, or any other facial covering that covers the mouth and nose. A business entity or governmental entity may not deny any person access to, entry upon, service from, or admission to such entity or otherwise discriminate against a person based on such person’s refusal to wear a face mask, a face shield, or any other facial covering that covers the mouth and nose.
(b) Paragraph (a) does not apply to:
1. A health care provider or health care practitioner as those terms are defined in s. 408.824, provided that such health care provider or health care practitioner is in compliance with that section.
2. A business entity or governmental entity when a face mask, a face shield, or any other facial covering that covers the mouth and nose is required safety equipment consistent with occupational or laboratory safety requirements, in accordance with standards adopted by the Department of Health. The Department of Health shall adopt emergency rules to develop such standards. Emergency rules adopted under this subparagraph are exempt from s. 120.54(4)(c) and shall remain in effect until replaced by rules adopted under the nonemergency rulemaking procedures of the Administrative Procedure Act.
(6)(a) The department may impose an administrative fine not to exceed $5,000 for each individual and separate violation of this section.
(b) For purposes of conducting an investigation or a proceeding, the department may administer oaths; take depositions; make inspections when authorized by law; issue subpoenas supported by affidavit; serve subpoenas and other process; and compel the attendance of witnesses and the production of books, papers, documents, and other evidence. Challenges to and enforcement of subpoenas or orders shall be in accordance with s. 120.569.
(c) Fines collected pursuant to this section must be deposited into the General Revenue Fund.
(7) This section does not limit the right of the person aggrieved by a violation of this section to recover damages or other relief under any other applicable law.
(8) If a governmental entity fails to comply with subsection (4), an employee terminated based on such noncompliance may be eligible for reemployment assistance under chapter 443 in addition to any other remedy available to the employee for a violation of this section.
(9) The department may adopt rules pursuant to ss. 120.536 and 120.54 to implement this section.
1Note.—Repealed June 1, 2025, by s. 9, ch. 2023-43.
381.00318 Complaints and investigations regarding mandate prohibitions; public records exemption.—
(1) A complaint alleging a business entity’s, a governmental entity’s, or an educational institution’s violation of s. 381.00316 or s. 381.00319, and all information relating to an investigation of such complaint, held by the Department of Legal Affairs or the Department of Health is confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution until the investigation is completed or ceases to be active. For purposes of this section, an investigation is considered “active” while such investigation is being conducted by the Department of Legal Affairs or the Department of Health with a reasonable good faith belief that it may lead to a determination of whether there was a violation of s. 381.00316 or s. 381.00319. An investigation does not cease to be active if the Department of Legal Affairs or the Department of Health is proceeding with reasonable dispatch and there is a good faith belief that action may be initiated by the Department of Legal Affairs or the Department of Health.
(2) After an investigation is completed or ceases to be active, information in records relating to the investigation remains confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution if disclosure of that information would do any of the following:
(a) Jeopardize the integrity of another active investigation.
(b) Reveal medical information about an individual.
(c) Reveal information regarding an individual’s religious beliefs.
(3) Information made confidential and exempt under this section may be released to another business entity, governmental entity, or educational institution in the furtherance of that entity’s or institution’s lawful duties and responsibilities.
(4) This section does not prohibit the disclosure of information in an aggregated format.
(5) This section is subject to the Open Government Sunset Review Act in accordance with s. 119.15 and shall stand repealed on October 2, 2028, unless reviewed and saved from repeal through reenactment by the Legislature.
381.00319 Prohibition on mask mandates and vaccination and testing mandates for educational institutions.—
(1) For purposes of this section, the term:
(a) “COVID-19” has the same meaning as in s. 381.00316.
(b) “COVID-19 vaccine” has the same meaning as in s. 381.00316.
(c) “Educational institution” means a public or private school, including a preschool, elementary school, middle school, junior high school, secondary school, career center, or postsecondary school.
(d) “Emergency use authorization vaccine” has the same meaning as in s. 381.00316.
1(e) “Messenger ribonucleic acid vaccine” has the same meaning as in s. 381.00316.
(2)(a) An educational institution may not impose a mandate on any person requiring vaccination with any vaccine defined under subsection (1).
(b) An educational institution in this state may not require any person to provide any documentation certifying vaccination with any vaccine defined under subsection (1) or postinfection recovery from COVID-19, or require a COVID-19 test, to gain admission or access to, entry upon, or service from the educational institution or as a condition of contracting, hiring, promotion, or continued employment with the educational institution. An educational institution may not discharge or refuse to hire a person; deprive or attempt to deprive a person of employment opportunities; adversely affect a person’s status as an employee or as an applicant for employment; or otherwise discriminate against a person based on knowledge or belief of the person’s status relating to vaccination with any vaccine defined under subsection (1) or COVID-19 postinfection recovery, or a person’s failure to take a COVID-19 test.
(c) For matters relating to vaccines other than those defined under subsection (1), an educational institution shall provide for exemptions and reasonable accommodations for religious and medical reasons in accordance with federal law.
(3)(a) An educational institution may not require a person to wear a face mask, a face shield, or any other facial covering that covers the mouth and nose. An educational institution may not deny any person access to, entry upon, service from, or admission to such educational institution or otherwise discriminate against a person based on such person’s refusal to wear a face mask, a face shield, or any other facial covering that covers the mouth and nose.
(b) Paragraph (a) does not apply to:
1. A health care provider or health care practitioner as those terms are defined in s. 408.824, provided such health care provider or health care practitioner is in compliance with that section.
2. An educational institution when a face mask, a face shield, or any other facial covering that covers the mouth and nose is used as required safety equipment in a course of study consistent with occupational or laboratory safety requirements, in accordance with standards adopted by the Department of Health. The Department of Health shall adopt emergency rules to develop such standards. Emergency rules adopted under this subparagraph are exempt from s. 120.54(4)(c) and shall remain in effect until replaced by rules adopted under the nonemergency rulemaking procedures of the Administrative Procedure Act.
(4)(a) Notwithstanding s. 768.39, the Department of Health may impose an administrative fine not to exceed $5,000 for each individual and separate violation of this section.
(b) For the purpose of conducting an investigation or a proceeding, the Department of Health may administer oaths; take depositions; make inspections when authorized by law; issue subpoenas supported by affidavit; serve subpoenas and other process; and compel the attendance of witnesses and the production of books, papers, documents, and other evidence. Challenges to and enforcement of subpoenas or orders shall be in accordance with s. 120.569.
(c) Fines collected pursuant to this section must be deposited in the General Revenue Fund.
(5) This section does not limit the right of the person aggrieved by a violation of this section to recover damages or other relief under any other applicable law.
(6) The Department of Health may adopt rules to implement this section.
1Note.—Repealed June 1, 2025, by s. 9, ch. 2023-43.
381.00321 The right of medical conscience of health care providers and health care payors.—
(1) DEFINITIONS.—As used in this section, the term:
(a) “Adverse action” means the discharge, transfer, demotion, discipline, suspension, exclusion, revocation of privileges, withholding of bonuses, or reduction in salary or benefits; any action that may negatively impact the advancement or graduation of a student, including, but not limited to, the withholding of scholarship funds; or any other disciplinary or retaliatory action taken against a health care provider.
(b) “Conscience-based objection” means an objection based on a sincerely held religious, moral, or ethical belief. Conscience with respect to entities is determined by reference to the entities’ governing documents; any published ethical, moral, or religious guidelines or directives; mission statements; constitutions; articles of incorporation; bylaws; policies; or regulations.
(c) “Department” means the Department of Health.
(d) “Educational institution” means a public or private school, college, or university.
(e) “Health care payor” means a health insurer, an employer, a health care sharing organization, a health plan, a health maintenance organization, a management services organization, or any other entity that pays for, or arranges for the payment of, any health care service, whether such payment is in whole or in part.
(f) “Health care provider” means:
1. Any person or entity licensed under chapter 394; chapter 400; chapter 401; chapter 457; chapter 458; chapter 459; chapter 460; chapter 461; chapter 462; chapter 463; chapter 464; chapter 465; chapter 466; chapter 467; part I, part II, part III, part IV, part V, part X, part XIII, or part XIV of chapter 468; chapter 478; chapter 480; part I, part II, or part III of chapter 483; chapter 484; chapter 486; chapter 490; or chapter 491; or
2. Any provider as defined in s. 408.803, a continuing care facility licensed under chapter 651, or a pharmacy permitted under chapter 465.
This term includes any student enrolled in an educational institution who is seeking to become a health care provider.
(g) “Health care service” means medical research, medical procedures, or medical services, including, but not limited to, testing; diagnosis; referral; dispensing or administering any drug, medication, or device; psychological therapy or counseling; research; therapy; recordmaking procedures; set up or performance of a surgery or procedure; or any other care or services performed or provided by any health care provider.
(h) “Participate” or “participation” means to pay for or take part in any way in providing or facilitating any health care service or any part of such service.
(i) “Right of medical conscience” means the right of a health care provider or health care payor to abide by sincerely held religious, moral, or ethical beliefs. With respect to health care providers or payors that are entities, such beliefs are determined by reference to the entities’ governing documents; any published ethical, moral, or religious guidelines or directives; mission statements; constitutions; articles of incorporation; bylaws; policies; or regulations.
(2) RIGHT OF MEDICAL CONSCIENCE.—
(a) A health care provider or health care payor has the right to opt out of participation in or payment for any health care service on the basis of a conscience-based objection. A health care provider must, at the time of the conscience-based objection or as soon as practicable thereafter, provide written notice of his or her conscience-based objection to the health care provider’s supervisor or employer, if applicable, and document his or her conscience-based objection to a particular health care service in the patient’s medical file. Additionally, if a patient, or potential patient, when attempting to schedule an appointment with the provider indicates to the provider that he or she is seeking a specific health care service for which the provider has a conscience-based objection, the provider must notify the patient that he or she does not provide such service before scheduling the appointment. A health care provider who is a student must provide written notice of his or her conscience-based objection to the educational institution at the time the conscience-based objection is made or as soon as practicable thereafter.
(b) The exercise of the right of medical conscience is limited to conscience-based objections to a specific health care service. This section may not be construed to waive or modify any duty a health care provider or health care payor may have to provide or pay for other health care services that do not violate their right of medical conscience, to waive or modify any duty to provide any informed consent required by law, or to allow a health care provider or payor to opt out of providing health care services to any patient or potential patient because of that patient’s or potential patient’s race, color, religion, sex, or national origin. Additionally, a health care payor may not decline to pay for a health care service it is contractually obligated to cover during the plan year.
(c) A health care provider may not be discriminated against or suffer adverse action because the health care provider declined to participate in a health care service on the basis of a conscience-based objection.
(3) SPEECH AND WHISTLE-BLOWER PROTECTIONS.—
(a) A health care provider or health care payor may not be discriminated against or suffer any adverse action in any manner with respect to:
1. Providing or causing to be provided, or intending to provide or cause to be provided, information relating to any violation of or any act or omission the health care provider or health care payor reasonably believes to be a violation of any provision of this act to his or her employer, the Attorney General, the department, any other state agency charged with protecting the right of medical conscience, the United States Department of Health and Human Services, the Office of Civil Rights, or any other federal agency charged with protecting the right of medical conscience;
2. Testifying or intending to testify in a proceeding concerning such violation; or
3. Assisting or participating in or intending to assist or participate in such a proceeding.
(b) Unless the disclosure is specifically prohibited by law, a health care provider or health care payor may not be discriminated against in any manner for disclosing information that the health care provider or health care payor reasonably believes constitutes:
1. A violation of any law, rule, or regulation;
2. A violation of any ethical guidelines for the provision of any medical procedure or service; or
3. A practice or method of treatment that may put patient health at risk or present a substantial and specific danger to public health or safety.
(4) ENFORCEMENT.—A health care provider or health care payor may file a complaint with the Attorney General alleging any violation of this section. If the Attorney General determines there has been a violation of this section, the Attorney General may commence a civil action for damages, injunctive relief, or any other appropriate relief, including attorney fees. For the purpose of conducting an investigation, the Attorney General may administer oaths; take depositions; make inspections when authorized by law; issue subpoenas supported by affidavit; serve subpoenas and other process; and compel the attendance of witnesses and the production of books, papers, documents, and other evidence. The Department of Legal Affairs may adopt rules to implement this subsection.
(5) IMMUNITY FROM LIABILITY.—A health care provider or health care payor may not be held civilly liable solely for declining to participate in or pay for a health care service on the basis of a conscience-based objection. However, this section does not limit a person’s ability to recover damages or other relief under any other applicable law due to behavior that constitutes a violation of this section or that is not related to a conscience-based objection.
(6) REQUIREMENT TO PROVIDE EMERGENCY MEDICAL TREATMENT.—This section may not be construed to override any requirement to provide emergency medical treatment in accordance with state law or the Emergency Medical Treatment and Active Labor Act, 42 U.S.C. s. 1395dd.
381.00322 International health organization policies.—A governmental entity as defined in s. 381.00316 or an educational institution as defined in s. 381.00319 may not adopt, implement, or enforce an international health organization’s public health policies or guidelines unless authorized to do so under state law, rule, or executive order issued by the Governor under s. 252.36.
381.0034 Requirement for instruction on HIV and AIDS.—
(1) The Department of Health shall require each person licensed or certified under chapter 467, part IV of chapter 468, or chapter 483, as a condition of biennial relicensure, to complete an educational course approved by the department on the modes of transmission, infection control procedures, clinical management, and prevention of human immunodeficiency virus and acquired immune deficiency syndrome. Such course shall include information on current state law on acquired immune deficiency syndrome and its impact on testing, confidentiality of test results, and treatment of patients. Each such licensee or certificateholder shall submit confirmation of having completed the course, on a form provided by the department, when submitting fees or application for each biennial renewal.
(2) Failure to complete the requirements of this section shall be grounds for disciplinary action contained in the chapters specified in subsection (1). In addition to discipline by the department, the licensee or certificateholder shall be required to complete said course.
(3) The department shall require, as a condition of granting a license under chapter 467 or part I of chapter 483, that an applicant making initial application for licensure complete an educational course acceptable to the department on human immunodeficiency virus and acquired immune deficiency syndrome. Upon submission of an affidavit showing good cause, an applicant who has not taken a course at the time of licensure shall be allowed 6 months to complete this requirement.
(4) The department shall have the authority to adopt rules to carry out the provisions of this section.
(5) Any professional holding two or more licenses or certificates subject to the provisions of this section shall be permitted to show proof of having taken one department-approved course on human immunodeficiency virus and acquired immune deficiency syndrome, for purposes of relicensure or recertification for the additional licenses.
381.0035 Educational course on HIV and AIDS; employees and clients of certain health care facilities.—
(1) The Department of Health shall require all employees and clients of facilities licensed under chapter 393, chapter 394, or chapter 397 and employees of facilities licensed under chapter 395, part II, part III, or part IV of chapter 400, or part I of chapter 429 to complete a one-time educational course on the modes of transmission, infection control procedures, clinical management, and prevention of human immunodeficiency virus and acquired immune deficiency syndrome with an emphasis on appropriate behavior and attitude change. Such instruction shall include information on current Florida law and its impact on testing, confidentiality of test results, and treatment of patients and any protocols and procedures applicable to human immunodeficiency counseling and testing, reporting, the offering of HIV testing to pregnant women, and partner notification issues pursuant to ss. 381.004 and 384.25. An employee who has completed the educational course required in this subsection is not required to repeat the course upon changing employment to a different facility licensed under chapter 393, chapter 394, chapter 395, chapter 397, part II, part III, or part IV of chapter 400, or part I of chapter 429.
(2) Facilities licensed under chapter 393, chapter 394, chapter 395, or chapter 397, part II, part III, or part IV of chapter 400, or part I of chapter 429 shall maintain a record of employees and dates of attendance at human immunodeficiency virus and acquired immune deficiency syndrome educational courses.
(3) The department shall have the authority to review the records of each facility to determine compliance with the requirements of this section. The department may adopt rules to carry out the provisions of this section.
(4) This section does not apply to an employee who is subject to the requirements of s. 456.033.
381.0038 Education; sterile needle and syringe exchange programs.—The Department of Health shall establish a program to educate the public about the threat of acquired immune deficiency syndrome.
(1) The acquired immune deficiency syndrome education program shall:
(a) Be designed to reach all segments of Florida’s population;
(b) Contain special components designed to reach non-English-speaking and other minority groups within the state;
(c) Impart knowledge to the public about methods of transmission of acquired immune deficiency syndrome and methods of prevention;
(d) Educate the public about transmission risks in social, employment, and educational situations;
(e) Educate health care workers and health facility employees about methods of transmission and prevention in their unique workplace environments;
(f) Contain special components designed to reach persons who may frequently engage in behaviors placing them at a high risk for acquiring acquired immune deficiency syndrome;
(g) Provide information and consultation to state agencies to educate all state employees;
(h) Provide information and consultation to state and local agencies to educate law enforcement and correctional personnel and inmates;
(i) Provide information and consultation to local governments to educate local government employees;
(j) Make information available to private employers and encourage them to distribute this information to their employees;
(k) Contain special components which emphasize appropriate behavior and attitude change; and
(l) Contain components that include information about domestic violence and the risk factors associated with domestic violence and AIDS.
(2) The education program designed by the Department of Health shall use all forms of the media and shall place emphasis on the design of educational materials that can be used by businesses, schools, and health care providers in the regular course of their business.
(3) The department may contract with other persons in the design, development, and distribution of the components of the education program.
(4) A county commission may authorize a sterile needle and syringe exchange program to operate within its county boundaries. The program may operate at one or more fixed locations or through mobile health units. The program shall offer the free exchange of clean, unused needles and hypodermic syringes for used needles and hypodermic syringes as a means to prevent the transmission of HIV, AIDS, viral hepatitis, or other blood-borne diseases among intravenous drug users and their sexual partners and offspring. Prevention of disease transmission must be the goal of the program. For the purposes of this subsection, the term “exchange program” means a sterile needle and syringe exchange program established by a county commission under this subsection. A sterile needle and syringe exchange program may not operate unless it is authorized and approved by a county commission in accordance with this subsection.
(a) Before an exchange program may be established, a county commission must:
1. Authorize the program under the provisions of a county ordinance;
2. Enter into a letter of agreement with the department in which the county commission agrees that any exchange program authorized by the county commission will operate in accordance with this subsection;
3. Enlist the local county health department to provide ongoing advice, consultation, and recommendations for the operation of the program;
4. Contract with one of the following entities to operate the program:
a. A hospital licensed under chapter 395.
b. A health care clinic licensed under part X of chapter 400.
c. A medical school in this state accredited by the Liaison Committee on Medical Education or the Commission on Osteopathic College Accreditation.
d. A licensed addictions receiving facility as defined in s. 397.311(27)(a)1.
e. A s. 501(c)(3) HIV/AIDS service organization.
(b) An exchange program must:
1. Develop an oversight and accountability system to ensure the program’s compliance with statutory and contractual requirements. The system must include measurable objectives for meeting the goal of the program and must track the progress in achieving those objectives. The system must require the program operator to routinely report its progress in achieving the objectives and the goal of the program. The system must also incorporate mechanisms to track the program operator’s compliance or noncompliance with contractual obligations and to apply consequences for noncompliance. The program must receive the county commission’s approval of the oversight and accountability system before commencing operations.
2. Provide for maximum security of sites where needles and syringes are exchanged and of any equipment used under the program, including, at a minimum, an accounting of the number of needles and syringes in use, the number of needles and syringes in storage, safe disposal of returned needles, and any other measure that may be required to control the use and dispersal of sterile needles and syringes.
3. Operate a one-to-one exchange, whereby a participant shall receive one sterile needle and syringe unit in exchange for each used one.
4. Make available educational materials regarding the transmission of HIV, viral hepatitis, and other blood-borne diseases. The program operator must offer such materials to program participants whenever needles or syringes are exchanged.
5. Provide onsite counseling or referrals for drug abuse prevention, education, and treatment, and provide onsite HIV and viral hepatitis screening or referrals for such screening. If such services are offered solely by referral, they must be made available to participants within 72 hours. The county commission in a rural county may, under its contract with the program operator, adjust the 72-hour requirement if the commission finds that the availability of providers warrants an extended timeframe.
6. Provide kits containing an emergency opioid antagonist, as defined in s. 381.887, or provide referrals to a program that can provide such kits.
7. Collect data for annual reporting purposes. The data must include the number of participants served; the number of used needles and syringes received and the number of clean, unused needles and syringes distributed through exchange with participants; the demographic profiles of the participants served; the number of participants entering drug counseling or treatment; the number of participants receiving testing for HIV, AIDS, viral hepatitis, or other blood-borne diseases; and other data that may be required under department rule. However, a participant’s personal identifying information may not be collected for any purpose. Each exchange program shall submit a report to its county commission and to the department by August 1 annually. The department shall submit a compilation report encompassing data from all exchange programs annually by October 1 to the Governor, the President of the Senate, and the Speaker of the House of Representatives. The department may adopt rules to implement this subparagraph.
(c) The possession, distribution, or exchange of needles or syringes as part of an exchange program established under this subsection is not a violation of any part of chapter 893 or any other law.
(d) An exchange program staff member, volunteer, or participant is not immune from criminal prosecution for:
1. The possession of needles or syringes that are not a part of the exchange program; or
2. The redistribution of needles or syringes in any form, if acting outside the exchange program.
(e) A law enforcement officer acting in good faith who arrests or charges a person who is thereafter determined to be immune from prosecution under this section shall be immune from civil liability that might otherwise be incurred or imposed by reason of the officer’s actions.
(f) State, county, or municipal funds may not be used to operate an exchange program. Exchange programs shall be funded through grants and donations from private resources and funds.
381.0039 Oversight of AIDS education programs.—The Department of Education, the Department of Health, and the Department of Business and Professional Regulation are directed to establish an interagency agreement to oversee the quality and cost efficiency of acquired immune deficiency syndrome education programs being administered in the state pursuant to chapters 381, 456, 943, and 945. The interagency agreement shall also include development, where appropriate, of methods for coordinating educational programs for various professional groups.
(a) “Health care setting” means a setting devoted to the diagnosis and care of persons or the provision of medical services to persons, such as county health department clinics, hospitals, urgent care clinics, substance abuse treatment clinics, primary care settings, community clinics, blood banks, mobile medical clinics, and correctional health care facilities.
(b) “HIV test” means a test ordered after July 6, 1988, to determine the presence of the antibody or antigen to human immunodeficiency virus or the presence of human immunodeficiency virus infection.
(c) “HIV test result” means a laboratory report of a human immunodeficiency virus test result entered into a medical record on or after July 6, 1988, or any report or notation in a medical record of a laboratory report of a human immunodeficiency virus test. The term does not include test results reported to a health care provider by a patient.
(d) “Nonhealth care setting” means a site that conducts HIV testing for the sole purpose of identifying HIV infection. Such setting does not provide medical treatment but may include community-based organizations, outreach settings, county health department HIV testing programs, and mobile vans.
(e) “Preliminary HIV test” means an antibody or antibody-antigen screening test, such as the immunosorbent assays (IA), or a rapid test approved by the United States Food and Drug Administration.
(f) “Significant exposure” means:
1. Exposure to blood or body fluids through needlestick, instruments, or sharps;
2. Exposure of mucous membranes to visible blood or body fluids to which universal precautions apply according to the National Centers for Disease Control and Prevention, including, without limitations, the following body fluids:
a. Blood.
b. Semen.
c. Vaginal secretions.
d. Cerebrospinal fluid (CSF).
e. Synovial fluid.
f. Pleural fluid.
g. Peritoneal fluid.
h. Pericardial fluid.
i. Amniotic fluid.
j. Laboratory specimens that contain HIV (e.g., suspensions of concentrated virus); or
3. Exposure of skin to visible blood or body fluids, especially when the exposed skin is chapped, abraded, or afflicted with dermatitis or the contact is prolonged or involving an extensive area.
(g) “Test subject” or “subject of the test” means the person upon whom an HIV test is performed, or the person who has legal authority to make health care decisions for the test subject.
(2) HUMAN IMMUNODEFICIENCY VIRUS TESTING; INFORMED CONSENT; RESULTS; COUNSELING; CONFIDENTIALITY.—
(a) Before performing an HIV test:
1. In a health care setting, the person to be tested shall be notified orally or in writing that the test is planned and that he or she has the right to decline the test. If the person to be tested declines the test, such decision shall be documented in the medical record. A person who has signed a general consent form for medical care is not required to sign or otherwise provide a separate consent for an HIV test during the period in which the general consent form is in effect.
2. In a nonhealth care setting, a provider shall obtain the informed consent of the person upon whom the test is to be performed. Informed consent shall be preceded by an explanation of the right to confidential treatment of information identifying the subject of the test and the results of the test as provided by law. The provider shall also inform the test subject that a positive HIV test result will be reported to the county health department with sufficient information to identify the test subject and provide him or her with information on the availability and location of sites where anonymous testing is performed. As required in paragraph (3)(c), each county health department shall maintain a list of sites where anonymous testing is performed which includes site locations, telephone numbers, and hours of operation.
(b) Except as provided in paragraph (h), informed consent must be obtained from a legal guardian or other person authorized by law if the person:
1. Is not competent, is incapacitated, or is otherwise unable to make an informed judgment; or
2. Has not reached the age of majority, except as provided in s. 384.30.
(c) The person ordering the test or that person’s designee shall ensure that all reasonable efforts are made to notify the test subject of his or her test result. Notification of a person with a positive test result shall include information on the availability of appropriate medical and support services, on the importance of notifying partners who may have been exposed, and on preventing transmission of HIV. Notification of a person with a negative test result shall include, as appropriate, information on preventing the transmission of HIV. When testing occurs in a hospital emergency department, detention facility, or other facility and the test subject has been released before being notified of positive test results, informing the county health department for that department to notify the test subject fulfills this responsibility.
(d) A positive preliminary test result may not be revealed to any person except in the following situations:
1. Preliminary test results may be released to licensed physicians or the medical or nonmedical personnel subject to the significant exposure for purposes of subparagraphs (h)10., 11., and 12.
2. Preliminary test results may be released to health care providers and to the person tested when decisions about medical care or treatment of, or recommendation to, the person tested and, in the case of an intrapartum or postpartum woman, when care, treatment, or recommendations regarding her newborn, cannot await the results of confirmatory testing. Positive preliminary HIV test results may not be characterized to the patient as a diagnosis of HIV infection. Justification for the use of preliminary test results must be documented in the medical record by the health care provider who ordered the test.
3. The results of rapid testing technologies shall be considered preliminary and may be released in accordance with the manufacturer’s instructions as approved by the federal Food and Drug Administration.
4. Corroborating or confirmatory testing must be conducted as followup to a positive preliminary test. Results shall be communicated to the patient according to statute regardless of the outcome. Except as provided in this section, test results are confidential and exempt from the provisions of s. 119.07(1).
(e) Except as provided in this section, the identity of any person upon whom a test has been performed and test results are confidential and exempt from the provisions of s. 119.07(1). No person who has obtained or has knowledge of a test result pursuant to this section may disclose or be compelled to disclose the identity of any person upon whom a test is performed, or the results of such a test in a manner which permits identification of the subject of the test, except to the following persons:
1. The subject of the test or the subject’s legally authorized representative.
2. Any person, including third-party payors, designated in a legally effective release of the test results executed prior to or after the test by the subject of the test or the subject’s legally authorized representative. The test subject may in writing authorize the disclosure of the test subject’s HIV test results to third party payors, who need not be specifically identified, and to other persons to whom the test subject subsequently issues a general release of medical information. A general release without such prior written authorization is not sufficient to release HIV test results.
3. An authorized agent or employee of a health facility or health care provider if the health facility or health care provider itself is authorized to obtain the test results, the agent or employee participates in the administration or provision of patient care or handles or processes specimens of body fluids or tissues, and the agent or employee has a need to know such information. The department shall adopt a rule defining which persons have a need to know pursuant to this subparagraph.
4. Health care providers consulting between themselves or with health care facilities to determine diagnosis and treatment. For purposes of this subparagraph, health care providers shall include licensed health care professionals employed by or associated with state, county, or municipal detention facilities when such health care professionals are acting exclusively for the purpose of providing diagnoses or treatment of persons in the custody of such facilities.
5. The department, in accordance with rules for reporting and controlling the spread of disease, as otherwise provided by state law.
6. A health facility or health care provider which procures, processes, distributes, or uses:
a. A human body part from a deceased person, with respect to medical information regarding that person; or
b. Semen provided prior to July 6, 1988, for the purpose of artificial insemination.
7. Health facility staff committees, for the purposes of conducting program monitoring, program evaluation, or service reviews pursuant to chapters 395 and 766.
8. Authorized medical or epidemiological researchers who may not further disclose any identifying characteristics or information.
9. A person allowed access by a court order which is issued in compliance with the following provisions:
a. No court of this state shall issue such order unless the court finds that the person seeking the test results has demonstrated a compelling need for the test results which cannot be accommodated by other means. In assessing compelling need, the court shall weigh the need for disclosure against the privacy interest of the test subject and the public interest which may be disserved by disclosure which deters blood, organ, and semen donation and future human immunodeficiency virus-related testing or which may lead to discrimination. This paragraph shall not apply to blood bank donor records.
b. Pleadings pertaining to disclosure of test results shall substitute a pseudonym for the true name of the subject of the test. The disclosure to the parties of the subject’s true name shall be communicated confidentially in documents not filed with the court.
c. Before granting any such order, the court shall provide the individual whose test result is in question with notice and a reasonable opportunity to participate in the proceedings if he or she is not already a party.
d. Court proceedings as to disclosure of test results shall be conducted in camera, unless the subject of the test agrees to a hearing in open court or unless the court determines that a public hearing is necessary to the public interest and the proper administration of justice.
e. Upon the issuance of an order to disclose test results, the court shall impose appropriate safeguards against unauthorized disclosure which shall specify the persons who may have access to the information, the purposes for which the information shall be used, and appropriate prohibitions on future disclosure.
10. A person allowed access by order of a judge of compensation claims of the Division of Administrative Hearings. A judge of compensation claims shall not issue such order unless he or she finds that the person seeking the test results has demonstrated a compelling need for the test results which cannot be accommodated by other means.
11. Those employees of the department or of child-placing or child-caring agencies or of family foster homes, licensed pursuant to s. 409.175, who are directly involved in the placement, care, control, or custody of such test subject and who have a need to know such information; adoptive parents of such test subject; or any adult custodian, any adult relative, or any person responsible for the child’s welfare, if the test subject was not tested under subparagraph (b)2. and if a reasonable attempt has been made to locate and inform the legal guardian of a test result. The department shall adopt a rule to implement this subparagraph.
12. Those employees of residential facilities or of community-based care programs that care for developmentally disabled persons, pursuant to chapter 393, who are directly involved in the care, control, or custody of such test subject and who have a need to know such information.
13. A health care provider involved in the delivery of a child can note the mother’s HIV test results in the child’s medical record.
14. Medical personnel or nonmedical personnel who have been subject to a significant exposure during the course of medical practice or in the performance of professional duties, or individuals who are the subject of the significant exposure as provided in subparagraphs (h)10.-12.
15. The medical examiner shall disclose positive HIV test results to the department in accordance with rules for reporting and controlling the spread of disease.
(f) Except as provided in this section, the identity of a person upon whom a test has been performed is confidential and exempt from the provisions of s. 119.07(1). No person to whom the results of a test have been disclosed may disclose the test results to another person except as authorized by this subsection and by ss. 951.27 and 960.003. Whenever disclosure is made pursuant to this subsection, it shall be accompanied by a statement in writing which includes the following or substantially similar language: “This information has been disclosed to you from records whose confidentiality is protected by state law. State law prohibits you from making any further disclosure of such information without the specific written consent of the person to whom such information pertains, or as otherwise permitted by state law. A general authorization for the release of medical or other information is NOT sufficient for this purpose.” An oral disclosure shall be accompanied by oral notice and followed by a written notice within 10 days, except that this notice shall not be required for disclosures made pursuant to subparagraphs (e)3. and 4.
(g) Human immunodeficiency virus test results contained in the medical records of a hospital licensed under chapter 395 may be released in accordance with s. 395.3025 without being subject to subparagraph (e)2., subparagraph (e)9., or paragraph (f).
(h) Paragraph (a) does not apply:
1. When testing for sexually transmissible diseases is required by state or federal law, or by rule, including the following situations:
a. HIV testing pursuant to s. 796.08 of persons convicted of prostitution or of procuring another to commit prostitution.
b. HIV testing of inmates pursuant to s. 945.355 before their release from prison by reason of parole, accumulation of gain-time credits, or expiration of sentence.
c. Testing for HIV by a medical examiner in accordance with s. 406.11.
d. HIV testing of pregnant women pursuant to s. 384.31.
2. To those exceptions provided for blood, plasma, organs, skin, semen, or other human tissue pursuant to s. 381.0041.
3. For the performance of an HIV-related test by licensed medical personnel in bona fide medical emergencies if the test results are necessary for medical diagnostic purposes to provide appropriate emergency care or treatment to the person being tested and the patient is unable to consent, as supported by documentation in the medical record. Notification of test results in accordance with paragraph (c) is required.
4. For the performance of an HIV-related test by licensed medical personnel for medical diagnosis of acute illness where, in the opinion of the attending physician, providing notification would be detrimental to the patient, as supported by documentation in the medical record, and the test results are necessary for medical diagnostic purposes to provide appropriate care or treatment to the person being tested. Notification of test results in accordance with paragraph (c) is required if it would not be detrimental to the patient. This subparagraph does not authorize the routine testing of patients for HIV infection without notification.
5. If HIV testing is performed as part of an autopsy for which consent was obtained pursuant to s. 872.04.
6. For the performance of an HIV test upon a defendant pursuant to the victim’s request in a prosecution for any type of sexual battery where a blood sample is taken from the defendant voluntarily, pursuant to court order for any purpose, or pursuant to s. 775.0877, s. 951.27, or s. 960.003; however, the results of an HIV test performed shall be disclosed solely to the victim and the defendant, except as provided in ss. 775.0877, 951.27, and 960.003.
7. If an HIV test is mandated by court order.
8. For epidemiological research pursuant to s. 381.0031, for research consistent with institutional review boards created by 45 C.F.R. part 46, or for the performance of an HIV-related test for the purpose of research, if the testing is performed in a manner by which the identity of the test subject is not known and may not be retrieved by the researcher.
9. If human tissue is collected lawfully without the consent of the donor for corneal removal as authorized by s. 765.5185 or enucleation of the eyes as authorized by s. 765.519.
10. For the performance of an HIV test upon an individual who comes into contact with medical personnel in such a way that a significant exposure has occurred during the course of employment, within the scope of practice, or during the course of providing emergency medical assistance to the individual. The term “medical personnel” includes a licensed or certified health care professional; an employee of a health care professional or health care facility; employees of a laboratory licensed under chapter 483; personnel of a blood bank or plasma center; a medical student or other student who is receiving training as a health care professional at a health care facility; and a paramedic or emergency medical technician certified by the department to perform life-support procedures under s. 401.23.
a. The occurrence of a significant exposure shall be documented by medical personnel under the supervision of a licensed physician and recorded only in the personnel record of the medical personnel.
b. Costs of an HIV test shall be borne by the medical personnel or the employer of the medical personnel. However, costs of testing or treatment not directly related to the initial HIV tests or costs of subsequent testing or treatment may not be borne by the medical personnel or the employer of the medical personnel.
c. In order to use the provisions of this subparagraph, the medical personnel must be tested for HIV pursuant to this section or provide the results of an HIV test taken within 6 months before the significant exposure if such test results are negative.
d. A person who receives the results of an HIV test pursuant to this subparagraph shall maintain the confidentiality of the information received and of the persons tested. Such confidential information is exempt from s. 119.07(1).
e. If the source of the exposure is not available and will not voluntarily present himself or herself to a health facility to be tested for HIV, the medical personnel or the employer of such person acting on behalf of the employee may seek a court order directing the source of the exposure to submit to HIV testing. A sworn statement by a physician licensed under chapter 458 or chapter 459 that a significant exposure has occurred and that, in the physician’s medical judgment, testing is medically necessary to determine the course of treatment constitutes probable cause for the issuance of an order by the court. The results of the test shall be released to the source of the exposure and to the person who experienced the exposure.
11. For the performance of an HIV test upon an individual who comes into contact with nonmedical personnel in such a way that a significant exposure has occurred while the nonmedical personnel provides emergency medical assistance during a medical emergency. For the purposes of this subparagraph, a medical emergency means an emergency medical condition outside of a hospital or health care facility that provides physician care. The test may be performed only during the course of treatment for the medical emergency.
a. The occurrence of a significant exposure shall be documented by medical personnel under the supervision of a licensed physician and recorded in the medical record of the nonmedical personnel.
b. Costs of any HIV test shall be borne by the nonmedical personnel or the employer of the nonmedical personnel. However, costs of testing or treatment not directly related to the initial HIV tests or costs of subsequent testing or treatment may not be borne by the nonmedical personnel or the employer of the nonmedical personnel.
c. In order to use the provisions of this subparagraph, the nonmedical personnel shall be tested for HIV pursuant to this section or shall provide the results of an HIV test taken within 6 months before the significant exposure if such test results are negative.
d. A person who receives the results of an HIV test pursuant to this subparagraph shall maintain the confidentiality of the information received and of the persons tested. Such confidential information is exempt from s. 119.07(1).
e. If the source of the exposure is not available and will not voluntarily present himself or herself to a health facility to be tested for HIV, the nonmedical personnel or the employer of the nonmedical personnel acting on behalf of the employee may seek a court order directing the source of the exposure to submit to HIV testing. A sworn statement by a physician licensed under chapter 458 or chapter 459 that a significant exposure has occurred and that, in the physician’s medical judgment, testing is medically necessary to determine the course of treatment constitutes probable cause for the issuance of an order by the court. The results of the test shall be released to the source of the exposure and to the person who experienced the exposure.
12. For the performance of an HIV test by the medical examiner or attending physician upon an individual who expired or could not be resuscitated while receiving emergency medical assistance or care and who was the source of a significant exposure to medical or nonmedical personnel providing such assistance or care.
a. HIV testing may be conducted only after appropriate medical personnel under the supervision of a licensed physician documents in the medical record of the medical personnel or nonmedical personnel that there has been a significant exposure and that, in accordance with the written protocols based on the National Centers for Disease Control and Prevention guidelines on HIV postexposure prophylaxis and in the physician’s medical judgment, the information is medically necessary to determine the course of treatment for the medical personnel or nonmedical personnel.
b. Costs of an HIV test performed under this subparagraph may not be charged to the deceased or to the family of the deceased person.
c. For this subparagraph to be applicable, the medical personnel or nonmedical personnel must be tested for HIV under this section or must provide the results of an HIV test taken within 6 months before the significant exposure if such test results are negative.
d. A person who receives the results of an HIV test pursuant to this subparagraph shall comply with paragraph (e).
13. For the performance of an HIV-related test medically indicated by licensed medical personnel for medical diagnosis of a hospitalized infant as necessary to provide appropriate care and treatment of the infant if, after a reasonable attempt, a parent cannot be contacted to provide consent. The medical records of the infant must reflect the reason consent of the parent was not initially obtained. Test results shall be provided to the parent when the parent is located.
14. For the performance of HIV testing conducted to monitor the clinical progress of a patient previously diagnosed to be HIV positive.
15. For the performance of repeated HIV testing conducted to monitor possible conversion from a significant exposure.
(3) COUNTY HEALTH DEPARTMENT NETWORK OF VOLUNTARY HUMAN IMMUNODEFICIENCY VIRUS TESTING PROGRAMS.—
(a) The Department of Health shall establish a network of voluntary human immunodeficiency virus testing programs in every county in the state. These programs shall be conducted in each health department established under the provisions of part I of chapter 154. Additional programs may be contracted to other private providers to the extent that finances permit and local circumstances dictate.
(b) Each county health department shall have the ability to provide counseling and testing for human immunodeficiency virus to each patient who receives services and shall offer such testing on a voluntary basis to each patient who presents himself or herself for services in a public health program designated by the State Health Officer by rule.
(c) Each county health department shall provide a program of counseling and testing for human immunodeficiency virus infection, on both an anonymous and confidential basis. Counseling provided to a patient tested on both an anonymous and confidential basis shall include informing the patient of the availability of partner-notification services, the benefits of such services, and the confidentiality protections available as part of such services. The Department of Health or its designated agent shall continue to provide for anonymous testing through an alternative testing site program with sites throughout all areas of the state. Each county health department shall maintain a list of anonymous testing sites. The list shall include the locations, phone numbers, and hours of operation of the sites and shall be disseminated to all persons and programs offering human immunodeficiency virus testing within the service area of the county health department, including physicians licensed under chapter 458 or chapter 459. Except as provided in this section, the identity of a person upon whom a test has been performed and test results are confidential and exempt from the provisions of s. 119.07(1).
(d) The result of a serologic test conducted under the auspices of the Department of Health shall not be used to determine if a person may be insured for disability, health, or life insurance or to screen or determine suitability for, or to discharge a person from, employment. Any person who violates the provisions of this subsection is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(4) HUMAN IMMUNODEFICIENCY VIRUS TESTING REQUIREMENTS; REGISTRATION WITH THE DEPARTMENT OF HEALTH; EXEMPTIONS FROM REGISTRATION.—No county health department and no other person in this state shall conduct or hold themselves out to the public as conducting a testing program for acquired immune deficiency syndrome or human immunodeficiency virus status without first registering with the Department of Health, reregistering each year, complying with all other applicable provisions of state law, and meeting the following requirements:
(a) The program must be directed by a person with a minimum number of contact hours of experience in the counseling of persons with acquired immune deficiency syndrome or human immunodeficiency virus infection, as established by the Department of Health by rule.
(b) The program must have all medical care supervised by a physician licensed under the provisions of chapter 458 or chapter 459.
(c) The program shall have all laboratory procedures performed in a laboratory appropriately certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments and the federal rules adopted thereunder.
(d) The program must meet all of the requirements in subsection (2).
(e) The program must provide the opportunity for pretest counseling on the meaning of a test for human immunodeficiency virus, including medical indications for the test; the possibility of false positive or false negative results; the potential need for confirmatory testing; the potential social, medical, and economic consequences of a positive test result; and the need to eliminate high-risk behavior.
(f) The program must provide supplemental corroborative testing on all positive test results before the results of any positive test are provided to the patient. Except as provided in this section, the identity of any person upon whom a test has been performed and test results are confidential and exempt from the provisions of s. 119.07(1).
(g) The program must provide the opportunity for face-to-face posttest counseling on the meaning of the test results; the possible need for additional testing; the social, medical, and economic consequences of a positive test result; and the need to eliminate behavior which might spread the disease to others.
(h) Each person providing posttest counseling to a patient with a positive test result shall receive specialized training, to be specified by rule of the department, about the special needs of persons with positive results, including recognition of possible suicidal behavior, and shall refer the patient for further health and social services as appropriate.
(i) When services are provided for a charge during pretest counseling, testing, supplemental testing, and posttest counseling, the program must provide a complete list of all such charges to the patient and the Department of Health.
(j) Nothing in this subsection shall be construed to require a facility licensed under chapter 395 or chapter 483 or a person licensed under the provisions of chapter 457, chapter 458, chapter 459, chapter 460, chapter 461, chapter 466, or chapter 467 to register with the Department of Health and comply with the requirements of this subsection if the testing program is part of routine medical care or if the facility or person does not advertise to the general public that the facility or person conducts testing programs for human immunodeficiency virus infection or specializes in such testing.
(k) The department shall deny, suspend, or revoke the registration of any person or agency that violates this section, or any rule adopted under this section, constituting an emergency affecting the immediate health, safety, and welfare of a person receiving service.
(5) PENALTIES.—
(a) Any violation of this section by a facility or licensed health care provider shall be a ground for disciplinary action contained in the facility’s or professional’s respective licensing chapter.
(b) Any person who violates the confidentiality provisions of this section and s. 951.27 commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(c) Any person who obtains information that identifies an individual who has a sexually transmissible disease including human immunodeficiency virus or acquired immunodeficiency syndrome, who knew or should have known the nature of the information and maliciously, or for monetary gain, disseminates this information or otherwise makes this information known to any other person, except by providing it either to a physician or nurse employed by the department or to a law enforcement agency, commits a felony of the third degree, punishable as provided in s. 775.082 or s. 775.083.
(6) EXEMPTIONS.—Except as provided in paragraph (3)(d) and ss. 627.429 and 641.3007, insurers and others participating in activities related to the insurance application and underwriting process shall be exempt from this section.
(7) MODEL PROTOCOL FOR COUNSELING AND TESTING FOR HUMAN IMMUNODEFICIENCY VIRUS.—The Department of Health shall develop, by rule, a model protocol consistent with the provisions of this section for counseling and testing persons for the human immunodeficiency virus. The protocol shall include criteria for evaluating a patient’s risk for human immunodeficiency virus infection and for offering human immunodeficiency virus testing, on a voluntary basis, as a routine part of primary health care or admission to a health care facility. The Department of Health shall ensure that the protocols developed under this section are made available to health care providers.
(8) FEES.—
(a) Each person or private organization registered as an AIDS or HIV testing site shall pay the department a fee which shall be set by rule of the department.
(b) Fees established pursuant to paragraph (a) shall be an amount sufficient to meet all costs incurred by the department in carrying out its registration, data collection, complaint monitoring, and administrative responsibilities under this section, for all private AIDS or HIV testing sites, but shall not exceed $100.
(c) No other fees shall be charged by other governmental agencies for these purposes.
(9) RULES.—The Department of Health may adopt rules to implement this section, including definitions of terms, procedures for accessing confidential information, requirements for testing, and requirements for registered testing sites.
(10) TESTING AS A CONDITION OF TREATMENT OR ADMISSION.—
(a) It is unlawful for any facility the operation of which, or for any person engaged in an occupation the practice of which, requires a license by the Agency for Health Care Administration, the Department of Health, or the Department of Business and Professional Regulation, to require any person to take or submit to a human immunodeficiency virus-related test as a condition of admission to any such facility or as a condition of purchasing or obtaining any service or product for which the license is required. This subsection shall not be construed to prohibit any physician in good faith from declining to provide a particular treatment requested by a patient if the appropriateness of that treatment can only be determined through a human immunodeficiency virus-related test.
(b) The Agency for Health Care Administration, the Department of Health, and the Department of Business and Professional Regulation shall adopt rules implementing this subsection.
(c) Any violation of this subsection or the rules implementing it shall be punishable as provided in subsection (5).
381.0041 Donation and transfer of human tissue; testing requirements.—
(1) Every donation of blood, plasma, organs, skin, or other human tissue for transfusion or transplantation to another shall be tested prior to transfusion or other use for human immunodeficiency virus infection and other communicable diseases specified by rule of the Department of Health. Tests for the human immunodeficiency virus infection shall be performed only after obtaining written, informed consent from the potential donor or the donor’s legal representative. Such consent may be given by a minor pursuant to s. 743.06. Obtaining consent shall include a fair explanation of the procedures to be followed and the meaning and use of the test results. Such explanation shall include a description of the confidential nature of the test as described in s. 381.004(2). If consent for testing is not given, then the person shall not be accepted as a donor except as otherwise provided in subsection (3).
(2) Notwithstanding the provisions of subsection (1), written, informed consent to perform testing shall not be required:
(a) When the blood, plasma, organ, skin, or other human tissue is received for processing or testing from an out-of-state blood bank;
(b) When blood or tissue is received from a health care facility or health care provider for reference testing or processing and the results of such test are reported back to the facility or provider; or
(c) When an unrevoked anatomical gift has been made pursuant to s. 765.514, by will or other written instrument, and the donor is deceased or incompetent.
(3) No person shall collect any blood, organ, skin, or other human tissue from one human being and hold it for, or actually perform, any implantation, transplantation, transfusion, grafting, or any other method of transfer to another human being without first testing such tissue for the human immunodeficiency virus and other communicable diseases specified by rule of the Department of Health, or without performing another process approved by rule of the Department of Health capable of killing the causative agent of those diseases specified by rule. Such testing shall not be required:
(a) When there is insufficient time to perform testing because of a life-threatening emergency circumstance and the blood is transferred with the recipient’s informed consent.
(b) For a donation of semen made by the spouse of a recipient for the purposes of artificial insemination or other reproductive procedure.
(c) When there is insufficient time to obtain the results of a confirmatory test for any tissue or organ which is to be transplanted, notwithstanding the provisions of s. 381.004(2)(d). In such circumstances, the results of preliminary screening tests may be released to the potential recipient’s treating physician for use in determining organ or tissue suitability.
(4) All human blood, organs, skin, or other human tissue which is to be transfused or transplanted to another and is found positive for human immunodeficiency virus or other communicable disease specified by rule of the Department of Health shall be rendered noncommunicable by the person holding the tissue or shall be destroyed, unless the human tissue is specifically labeled to identify the human immunodeficiency virus and:
(a) Is used for research purposes; or
(b) Is used to save the life of another and is transferred with the recipient’s informed consent.
(5) Each person who collects human blood, organs, skin, or other human tissue who finds evidence after confirmatory testing of human immunodeficiency virus in the donor shall notify the donor of the presence of the virus. When notifying the donor pursuant to this requirement, the donor shall be provided the following information:
(a) The meaning of the test results;
(b) Measures for the prevention of the transmission of the human immunodeficiency virus;
(c) The availability in the geographic area of any appropriate health care services, including mental health care, and appropriate social and support services;
(d) The benefits of locating and counseling any individual by whom the infected individual may have been exposed to human immunodeficiency virus and any individual whom the infected individual may have exposed to the virus; and
(e) The availability, if any, of the services of public health authorities with respect to locating and counseling any individual described in paragraph (d).
(6) Human immunodeficiency virus tests performed pursuant to autologous blood donations which have not been confirmed as positive by confirmatory testing may be revealed to the donor’s treating physician when such test results may be necessary for the diagnosis, treatment, or care of the donor.
(7) Any blood donor who tests positive for human immunodeficiency virus based upon confirmatory testing shall be notified in the following manner:
(a) The donor shall be sent written notification by certified mail that abnormal test results exist with respect to his or her blood donation, and the blood bank shall offer the opportunity to discuss the nature and significance of the findings by telephone or in person.
(b) If the blood bank does not receive a response from the donor within 30 days, it shall send the actual test results and the information required by subsection (5) to the donor by certified mail.
(8) The Department of Health shall develop, in conjunction with persons who collect human tissue, a model protocol for providing the information required in subsection (5).
(9) All blood banks shall be governed by the confidentiality provisions of s. 381.004(2).
(10) The Department of Health is authorized to adopt rules to implement this section. In adopting rules pertaining to this section, the department shall consider the rules of the United States Food and Drug Administration and shall conform to those rules to the extent feasible without jeopardizing the public health.
(11)(a) Any person who fails to test blood, plasma, organs, skin, or other human tissue which is to be transfused or transplanted, or violates the confidentiality provisions required by this section, is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(b) Any person who has human immunodeficiency virus infection, who knows he or she is infected with human immunodeficiency virus, and who has been informed that he or she may communicate this disease by donating blood, plasma, organs, skin, or other human tissue who donates blood, plasma, organs, skin, or other human tissue is guilty of a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(12) Prior to the transplant of an organ or artificial insemination, the institution or physician responsible for overseeing the procedure must provide the prospective recipient a warning as to the risks of contracting human immunodeficiency virus.
(13) The department shall develop and publish on its website an educational pamphlet relating to the risks and benefits of human cell, tissue, and cellular and tissue-based product transplants. The department shall electronically notify physicians of the availability of the pamphlet. At a minimum, the pamphlet shall include:
(a) An overview of the risk of infectious disease transmission.
(b) An overview of the standards for donor testing and screening.
(c) An overview of processing methods intended to reduce the risk of disease or bacterial transmission in donated human cells, tissue, or cellular or tissue-based products.
(d) The importance of providing limited recipient transplant information to the supplier of the human cells, tissue, or cellular or tissue-based products.
(e) The generosity of the human donor who provided the human cells, tissue, or cellular or tissue-based products.
381.0042 Patient care for persons with HIV infection.—The department may establish human immunodeficiency virus patient care networks in each region of the state where the number of cases of human immunodeficiency virus transmission justifies the establishment of cost-effective regional patient care networks. Such networks shall be delineated by rule of the department which shall take into account natural trade areas and centers of medical excellence that specialize in the treatment of human immunodeficiency virus, as well as available federal, state, and other funds. Each patient care network shall include representation of persons with human immunodeficiency virus infection; health care providers; business interests; the department, including, but not limited to, county health departments; and local units of government. Each network shall plan for the care and treatment of persons with human immunodeficiency virus in a cost-effective, dignified manner that emphasizes outpatient and home care. Once per year, each network shall make its recommendations concerning the needs for patient care to the department.
(1) This section may be cited as the “Blood Donor Protection Act.”
(2) A blood bank, a subsidiary or affiliate of a blood bank, an employee or agent of a blood bank, or a subsidiary or affiliate of an agent or employee of a blood bank, may not be compelled to disclose the identity or any identifying characteristics of a person who donates blood or a blood component. This subsection does not apply if written consent to disclose the donor’s identity or any identifying characteristics is obtained from the person who donates the blood or blood component and does not preclude disclosure to a local, state, or federal governmental public health authority as required by law.
(1) This section may be cited as the “Targeted Outreach for Pregnant Women Act of 1998.”
(2) It is the purpose of this section to establish a targeted outreach program for high-risk pregnant women who may not seek proper prenatal care, who suffer from substance abuse or mental health problems, or who have acquired human immunodeficiency virus (HIV), and to provide these women with links to much-needed services and information.
(3) The department shall:
(a) Conduct outreach programs through contracts with, grants to, or other working relationships with persons or entities where the target population is likely to be found.
(b) Provide outreach that is peer-based, culturally sensitive, and performed in a nonjudgmental manner.
(c) Encourage high-risk pregnant women of unknown status to be tested for HIV and other sexually transmissible diseases as specified by department rule.
(d) Educate women not receiving prenatal care as to the benefits of such care.
(e) Provide pregnant women who have HIV with information on the need for antiretroviral medication for their newborns, their medication options, and how they can access the medication after their discharge from the hospital.
(f) Link women with substance abuse treatment and mental health services, when available, and act as a liaison with Healthy Start coalitions, children’s medical services, Ryan White-funded providers, and other services of the Department of Health.
(g) Educate pregnant women who have HIV on the importance of engaging in and continuing HIV care.
(h) Provide continued oversight of any newborn exposed to HIV to determine the newborn’s final HIV status and ensure continued linkage to care if the newborn is diagnosed with HIV.
(4) The types of entities the department is encouraged to contract with, provide grants to, or enter into other working relationships with may include, but are not limited to, faith-based organizations, academic institutions, religious organizations, nonprofit community centers, and other social-services-related entities.
381.0046 Statewide HIV and AIDS prevention campaign.—
(1) The Department of Health shall develop and implement a statewide HIV and AIDS prevention campaign that is directed towards minorities who are at risk of HIV infection. The campaign shall include television, radio, and outdoor advertising; public service announcements; and peer-to-peer outreach. Each campaign message and concept shall be evaluated with members of the target group to ensure its effectiveness. The campaign shall provide information on the risk of HIV and AIDS infection and strategies to follow for prevention, early detection, and treatment. The campaign shall use culturally sensitive literature and educational materials and promote the development of individual skills for behavior modification.
(2) The Department of Health shall establish dedicated positions within the department for HIV and AIDS regional minority coordinators and a statewide HIV and AIDS minority coordinator. The coordinators shall facilitate statewide efforts to implement and coordinate HIV and AIDS prevention and treatment programs.
(1) The department shall conduct a primary and preventive health care program as part of fulfilling its public health mission. This program shall include, but is not limited to:
(a) Acute and episodic care in accordance with chapter 154.
(b) Prenatal and postpartum care in accordance with chapters 154 and 383.
(c) Child health services in accordance with chapters 154 and 383.
(d) School health services in accordance with chapters 1003 and 1006.
(e) Dental health services in accordance with chapter 154 and this chapter.
(f) Nutrition services in accordance with chapter 154.
(g) Chronic diseases prevention in accordance with chapter 385.
(h) Family planning services in accordance with this chapter.
(i) Childhood immunizations.
(j) Health education and promotion.
(k) Regulation of the practice of midwifery.
(2) Between October 1, or earlier if the vaccination is available, and February 1 of each year, subject to the availability of an adequate supply of the necessary vaccine, each hospital licensed pursuant to chapter 395 shall implement a program to offer immunizations against the influenza virus and pneumococcal bacteria to all patients age 65 or older, in accordance with the recommendations of the Advisory Committee on Immunization Practices of the United States Centers for Disease Control and Prevention and subject to the clinical judgment of the responsible practitioner.
(3) The department may adopt, repeal, and amend rules related to the services discussed in this section.
(1) SHORT TITLE.—This section shall be known as the “Comprehensive Family Planning Act.”
(2) ACCESS TO SERVICES; PROHIBITIONS.—Except as otherwise provided in this section, no medical agency or institution of this state or unit of local government shall interfere with the right of any patient or physician to use medically acceptable contraceptive procedures, supplies, or information or to restrict the physician-patient relationship.
(3) AUTHORITY AND POWERS.—
(a) The Department of Health shall implement a comprehensive family planning program which shall be designed to include, but not be limited to, the following:
1. Comprehensive family planning education and counseling programs.
2. Prescription for and provision of all medically recognized methods of contraception.
3. Medical evaluation, including cytological examination and other appropriate laboratory studies.
4. Treatment of physical complications other than pregnancy resulting from the use of contraceptive methods.
5. Provision of services at locations and times readily available to the population served.
6. Emphasis and stress on service to postpartum mothers.
(b) Services shall be available to all persons desirous of such services, subject to the provisions of this section, at a cost based on a fee schedule prepared and published by the Department of Health. Fees shall be based on the cost of service and ability to pay.
(4) MINORS; PROVISION OF MATERNAL HEALTH AND CONTRACEPTIVE INFORMATION AND SERVICES.—
(a) Maternal health and contraceptive information and services of a nonsurgical nature may be rendered to any minor by persons licensed to practice medicine under the provisions of chapter 458 or chapter 459, as well as by the Department of Health through its family planning program, provided the minor:
1. Is married;
2. Is a parent;
3. Is pregnant;
4. Has the consent of a parent or legal guardian; or
5. May, in the opinion of the physician, suffer probable health hazards if such services are not provided.
(b) Application of nonpermanent internal contraceptive devices shall not be deemed a surgical procedure.
(5) REFUSAL FOR RELIGIOUS OR MEDICAL REASONS.—The provisions of this section shall not be interpreted so as to prevent a physician or other person from refusing to furnish any contraceptive or family planning service, supplies, or information for medical or religious reasons; and the physician or other person shall not be held liable for such refusal.
(6) RULES.—The Department of Health may adopt rules to implement this section, including rules regarding definitions of terms and requirements for eligibility, informed-consent services, revisits, temporary contraceptive methods, voluntary sterilization, and infertility services.
(1) This section shall be known as the “Public Health Dental Program Act.”
(2) It is the intent of the Legislature to make available dental preventive and educational services to the citizens of the state and treatment services to indigent persons.
(3) The department shall implement a comprehensive dental program which shall be designed to include, but not be limited to:
(a) Comprehensive preventive and educational programs.
(b) Comprehensive treatment services, including diagnostic, basic restorative, surgical, pulpal therapy, prophylaxis, and limited prosthetic services.
(4) Services shall be available to eligible persons in accordance with eligibility criteria developed by the department. Fees for treatment shall be determined by the department.
(1) It is the intent of the Legislature to make available nutrition information to promote health and prevent disease for the citizens of the state and to provide nutrition assessment and diet counseling services to improve the nutritional status of indigent persons.
(2) The department shall implement a comprehensive nutrition program which shall include, but not be limited to, the following:
(a) Nutritional assessment and diet counseling for persons with nutritional risk factors who are provided health services through public health programs.
(b) Nutrition education to promote optimum health of the citizens of the state.
(c) Consultative nutrition services to group care facilities that promote the provision of safe and nutritionally adequate diets.
(3) Services shall be available to eligible persons in accordance with eligibility criteria adopted by the department. Fees for services shall be developed by the department.
381.0055 Confidentiality and quality assurance activities.—
(1) All information which is confidential by operation of law and which is obtained by the Department of Health, a county health department, healthy start coalition, or certified rural health network, or a panel or committee assembled by the department, a county health department, healthy start coalition, or certified rural health network pursuant to this section, shall retain its confidential status and be exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(2) All information which is confidential by operation of law and which is obtained by a hospital or health care provider from the department, a county health department, healthy start coalition, or certified rural health network, or a panel or committee assembled by the department, a county health department, healthy start coalition, or certified rural health network pursuant to this section, shall retain its confidential status and be exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(3) Portions of meetings, proceedings, reports, and records of the department, a county health department, healthy start coalition, or certified rural health network, or a panel or committee assembled by the department, a county health department, healthy start coalition, or certified rural health network pursuant to this section, which relate solely to patient care quality assurance and where specific persons or incidents are discussed are confidential and exempt from the provisions of s. 286.011, and s. 24(b), Art. I of the State Constitution and are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution, respectively.
(1) This section may be cited as the “School Health Services Act.”
(2) As used in this section, the term:
(a) “Emergency health needs” means onsite evaluation, management, and aid for illness or injury pending the student’s return to the classroom or release to a parent, guardian, designated friend, law enforcement officer, or designated health care provider.
(b) “Entity” or “health care entity” means a unit of local government or a political subdivision of the state; a hospital licensed under chapter 395; a health maintenance organization certified under chapter 641; a health insurer authorized under the Florida Insurance Code; a community health center; a migrant health center; a federally qualified health center; an organization that meets the requirements for nonprofit status under s. 501(c)(3) of the Internal Revenue Code; a private industry or business; or a philanthropic foundation that agrees to participate in a public-private partnership with a county health department, local school district, or school in the delivery of school health services, and agrees to the terms and conditions for the delivery of such services as required by this section and as documented in the local school health services plan.
(c) “Invasive screening” means any screening procedure in which the skin or any body orifice is penetrated.
(d) “Physical examination” means a thorough evaluation of the health status of an individual.
(e) “School health services plan” means the document that describes the services to be provided, the responsibility for provision of the services, the anticipated expenditures to provide the services, and evidence of cooperative planning by local school districts and county health departments.
(f) “Screening” means presumptive identification of unknown or unrecognized diseases or defects by the application of tests that can be given with ease and rapidity to apparently healthy persons.
(3) The Department of Health shall have the responsibility, in cooperation with the Department of Education, to supervise the administration of the school health services program and perform periodic program reviews. However, the principal of each school shall have immediate supervisory authority over the health personnel working in the school.
(4)(a) Each county health department shall develop, jointly with the district school board and the local school health advisory committee, a school health services plan. The plan must include, at a minimum, provisions for all of the following:
1. Health appraisal;
2. Records review;
3. Nurse assessment;
4. Nutrition assessment;
5. A preventive dental program;
6. Vision screening;
7. Hearing screening;
8. Scoliosis screening;
9. Growth and development screening;
10. Health counseling;
11. Referral and followup of suspected or confirmed health problems by the local county health department;
12. Meeting emergency health needs in each school;
13. County health department personnel to assist school personnel in health education curriculum development;
14. Referral of students to appropriate health treatment, in cooperation with the private health community whenever possible;
15. Consultation with a student’s parent or guardian regarding the need for health attention by the family physician, dentist, or other specialist when definitive diagnosis or treatment is indicated;
16. Maintenance of records on incidents of health problems, corrective measures taken, and such other information as may be needed to plan and evaluate health programs; except, however, that provisions in the plan for maintenance of health records of individual students must be in accordance with s. 1002.22;
17. Health information which will be provided by the school health nurses, when necessary, regarding the placement of students in exceptional student programs and the reevaluation at periodic intervals of students placed in such programs;
18. Notification to the local nonpublic schools of the school health services program and the opportunity for representatives of the local nonpublic schools to participate in the development of the cooperative health services plan; and
19. A reasonable attempt to notify a student’s parent, guardian, or caregiver before the student is removed from school, school transportation, or a school-sponsored activity to be taken to a receiving facility for an involuntary examination pursuant to s. 394.463, including and subject to the requirements and exceptions established under ss. 1002.20(3) and 1002.33(9), as applicable. For purposes of this subparagraph, “a reasonable attempt to notify” means the exercise of reasonable diligence and care by the principal or the principal’s designee to make contact with the student’s parent, guardian, or other known emergency contact whom the student’s parent or guardian has authorized to receive notification of an involuntary examination. At a minimum, the principal or the principal’s designee must take the following actions:
a. Use available methods of communication to contact the student’s parent, guardian, or other known emergency contact, including but not limited to, telephone calls, text messages, e-mails, and voice mail messages following the decision to initiate an involuntary examination of the student.
b. Document the method and number of attempts made to contact the student’s parent, guardian, or other known emergency contact, and the outcome of each attempt.
A principal or his or her designee who successfully notifies any other known emergency contact may share only the information necessary to alert such contact that the parent or caregiver must be contacted. All such information must be in compliance with federal and state law.
(b) Each school health advisory committee must, at a minimum, include members who represent the eight component areas of the Coordinated School Health model as defined by the Centers for Disease Control and Prevention. School health advisory committees are encouraged to address the eight components of the Coordinated School Health model in the school district’s school wellness policy pursuant to s. 1003.453.
(5) A nonpublic school may request to participate in the school health services program. A nonpublic school voluntarily participating in the school health services program shall:
(a) Cooperate with the county health department and district school board in the development of the cooperative health services plan;
(b) Make available adequate physical facilities for health services;
(c) Provide inservice health training to school personnel;
(d) Cooperate with public health personnel in the implementation of the school health services plan;
(e) Be subject to health service program reviews by the Department of Health and the Department of Education;
(f) At the beginning of each school year, provide parents and guardians with information concerning ways that they can help their children to be physically active and to eat healthful foods; and
(g) At the beginning of each school year, inform parents or guardians in writing that their children who are students in the school will receive specified health services as provided for in the district health services plan. A student will be exempt from any of these services if his or her parent or guardian requests such exemption in writing. This paragraph shall not be construed to authorize invasive screening; if there is a need for such procedure, the consent of the student’s parent or guardian shall be obtained in writing prior to performing the screening. However, the laws and rules relating to contagious or communicable diseases and sanitary matters shall not be violated.
(6) The district school board shall:
(a) Include health services and health education as part of the comprehensive plan for the school district;
(b) Provide inservice health training for school personnel;
(c) Make available adequate physical facilities for health services;
(d) At the beginning of each school year, provide parents and guardians with information concerning ways that they can help their children to be physically active and to eat healthful foods; and
(e) At the beginning of each school year, inform parents or guardians in writing that their children who are students in the district schools will receive specified health services as provided for in the district health services plan. A student will be exempt from any of these services if his or her parent or guardian requests such exemption in writing. This paragraph shall not be construed to authorize invasive screening; if there is a need for such procedure, the consent of the student’s parent or guardian shall be obtained in writing prior to performing the screening. However, the laws and rules relating to contagious or communicable diseases and sanitary matters shall not be violated.
(7) The Department of Health, in cooperation with the Department of Education, may adopt rules necessary to implement this section. The rules may include standards and requirements for developing school health services plans, conducting school health screening, meeting emergency health needs, maintaining school health records, and coordinating with education programs for exceptional students.
(8) In the absence of negligence, no person shall be liable for any injury caused by an act or omission in the administration of school health services.
(9) Any health care entity that provides school health services under contract with the department pursuant to a school health services plan developed under this section, and as part of a school nurse services public-private partnership, is deemed to be a corporation acting primarily as an instrumentality of the state solely for the purpose of limiting liability pursuant to s. 768.28(5). The limitations on tort actions contained in s. 768.28(5) shall apply to any action against the entity with respect to the provision of school health services, if the entity is acting within the scope of and pursuant to guidelines established in the contract or by rule of the department. The contract must require the entity, or the partnership on behalf of the entity, to obtain general liability insurance coverage, with any additional endorsement necessary to insure the entity for liability assumed by its contract with the department. The Legislature intends that insurance be purchased by entities, or by partnerships on behalf of the entity, to cover all liability claims, and under no circumstances shall the state or the department be responsible for payment of any claims or defense costs for claims brought against the entity or its subcontractor for services performed under the contract with the department. This subsection does not preclude consideration by the Legislature for payment by the state of any claims bill involving an entity contracting with the department pursuant to this section.
(1) The State Surgeon General, or his or her designee, in cooperation with the Commissioner of Education, or his or her designee, shall publicize the availability of funds, targeting those school districts or schools which have a high incidence of medically underserved high-risk children, low birthweight babies, infant mortality, or teenage pregnancy.
(2) The State Surgeon General, or his or her designees, in cooperation with the Commissioner of Education, or his or her designees, in equal representation, shall form a joint committee to evaluate and select the school districts or schools to be funded.
(3) Any school district, school, or laboratory school which desires to receive state funding under the provisions of this section shall submit a proposal to the joint committee established in subsection (2). The proposal shall state the goals of the program, provide specific plans for reducing teenage pregnancy, and describe all of the health services to be available to students with funds provided pursuant to this section, including a combination of initiatives such as health education, counseling, extracurricular, and self-esteem components. School health services shall not promote elective termination of pregnancy as a part of counseling services. Only those program proposals which have been developed jointly by county health departments and local school districts or schools, and which have community and parental support, shall be eligible for funding. Funding shall be available specifically for implementation of one of the following programs:
(a) School health improvement pilot project.—The program shall include basic health care to an elementary school, middle school, and high school feeder system. Program services shall include, but not be limited to:
1. Planning, implementing, and evaluating school health services. Staffing shall include a full-time, trained school health aide in each elementary, middle, and high school; one full-time nurse to supervise the aides in the elementary and middle schools; and one full-time nurse in each high school.
2. Providing student health appraisals and identification of actual or potential health problems by screenings, nursing assessments, and record reviews.
3. Expanding screening activities.
4. Improving the student utilization of school health services.
5. Coordinating health services for students with parents or guardians and other agencies in the community.
(b) Student support services team program.—The program shall include a multidisciplinary team composed of a psychologist, social worker, and nurse whose responsibilities are to provide basic support services and to assist, in the school setting, children who exhibit mild to severely complex health, behavioral, or learning problems affecting their school performance. Support services shall include, but not be limited to: evaluation and treatment for minor illnesses and injuries, referral and followup for serious illnesses and emergencies, onsite care and consultation, referral to a physician, and followup care for pregnancy or chronic diseases and disorders as well as emotional or mental problems. Services also shall include referral care for drug and alcohol abuse and sexually transmitted diseases, sports and employment physicals, immunizations, and in addition, effective preventive services aimed at delaying early sexual involvement and aimed at pregnancy, acquired immune deficiency syndrome, sexually transmitted diseases, and destructive lifestyle conditions, such as alcohol and drug abuse. Moneys for this program shall be used to fund three teams, each consisting of one half-time psychologist, one full-time nurse, and one full-time social worker. Each team shall provide student support services to an elementary school, middle school, and high school that are a part of one feeder school system and shall coordinate all activities with the school administrator and certified school counselor at each school. A program that places all three teams in middle schools or high schools may also be proposed.
(c) Full service schools.—The full-service schools shall integrate the services of the Department of Health that are critical to the continuity-of-care process. The department shall provide services to students on the school grounds. Department personnel shall provide their specialized services as an extension of the educational environment. Such services may include nutritional services, medical services, aid to dependent children, parenting skills, counseling for abused children, and education for the students’ parents or guardians.
Funding may also be available for any other program that is comparable to a program described in this subsection but is designed to meet the particular needs of the community.
(4) In addition to the merits of a proposal, selection shall be based on those school districts or schools that most closely meet the following criteria:
(a) Have evidence of a comprehensive inservice staff development plan to ensure delivery of appropriate curriculum.
(b) Have evidence of a cooperative working relationship between the county health department and the school district or school and have community as well as parental support.
(c) Have a high percentage of subsidized school lunches.
(d) Have a high incidence of medically underserved high-risk children, low birthweight babies, infant mortality, or teenage pregnancy.
(5) Each school district or school program that is funded through the provisions of this section shall provide a mechanism through which a parent may, by written request, exempt a child from all or certain services provided by a school health services program described in subsection (3).
(6) The services provided by a comprehensive school health program must focus attention on promoting the health of students, reducing risk-taking behavior, and reducing teen pregnancy. Services provided under this section are in addition to the services provided under s. 381.0056 and are intended to supplement, rather than supplant, those services.
381.0059 Background screening requirements for school health services personnel.—
(1) Pursuant to the provisions of chapter 435, any person who provides services under a school health services plan pursuant to s. 381.0056 must meet level 2 screening requirements as described in s. 435.04. A person may satisfy the requirements of this subsection by submitting proof of compliance with the requirements of level 2 screening conducted within 12 months before the date that person initially provides services under a school health services plan.
(2) A person may provide services under a school health services plan pursuant to s. 381.0056 prior to the completion of level 2 screening. However, pending the results of the screening, such person may not be alone with a minor.
(3) As provided in s. 435.07, the Department of Health may grant an exemption from disqualification to provide services under a school health services plan pursuant to s. 381.0056.
(4) Under penalty of perjury, each person who provides services under a school health plan pursuant to s. 381.0056 must attest to meeting the level 2 screening requirements for participation under the plan and agree to inform his or her employer immediately if convicted of any disqualifying offense while providing services under a plan.
(5) As used in this section, the term “person who provides services under a school health services plan” includes unpaid volunteers, except for an unpaid volunteer who lectures students in group settings on health education topics.
381.00591 Department of Health; National Environmental Laboratory accreditation; application.—The Department of Health may apply for and become a National Environmental Laboratory Accreditation Program accreditation body.
381.00593 Public school volunteer health care practitioner program.—
(1) This section may be cited as the “Public School Volunteer Health Care Practitioner Act.”
(2) The purpose of this section is to establish a public school volunteer health care practitioner program with incentives and coordinate the program with the “School Health Services Act,” pursuant to s. 381.0056, in order to encourage health care practitioners to provide their services, without compensation, in the public schools; and such program is intended to complement other programs designed to provide health services or increase the level of health care in the public schools.
(3) For purposes of this section, the term “health care practitioner” means a physician licensed under chapter 458; an osteopathic physician licensed under chapter 459; a chiropractic physician licensed under chapter 460; a podiatric physician licensed under chapter 461; an optometrist licensed under chapter 463; an advanced practice registered nurse, registered nurse, or licensed practical nurse licensed under part I of chapter 464; a pharmacist licensed under chapter 465; a dentist or dental hygienist licensed under chapter 466; a midwife licensed under chapter 467; a speech-language pathologist or audiologist licensed under part I of chapter 468; a dietitian/nutritionist licensed under part X of chapter 468; or a physical therapist licensed under chapter 486.
(4)(a) Notwithstanding any provision of chapter 458, chapter 459, chapter 460, chapter 461, chapter 463, part I of chapter 464, chapter 465, chapter 466, chapter 467, parts I and X of chapter 468, or chapter 486 to the contrary, any health care practitioner who participates in the program established in this section and thereby agrees to provide his or her services, without compensation, in a public school for at least 80 hours a year for each school year during the biennial licensure period, or, if the health care practitioner is retired, for at least 400 hours a year for each school year during the licensure period, upon providing sufficient proof from the applicable school district that the health care practitioner has completed such hours at the time of license renewal under procedures specified by the Department of Health, shall be eligible for the following:
1. Waiver of the biennial license renewal fee for an active license; and
2. Fulfillment of a maximum of 25 percent of the continuing education hours required for license renewal under s. 456.013(9).
The school district may establish a schedule for health care practitioners who participate in the program.
(b) A health care practitioner must complete all forms and procedures for participation in the program prior to the applicable license renewal date.
(5) To participate in the program, a health care practitioner must:
(a) Have a valid, active license to practice his or her profession in this state.
(b) Submit fingerprints and have a background screening in accordance with the requirements of s. 381.0059, unless already provided and completed for practitioner licensing, profiling, or credentialing purposes.
(6) The school district, through its self-insurance program, shall bear the cost of any increase in premiums for liability protection for health care practitioners participating in the program other than those employed by the school or school district.
(7)(a) The Department of Health shall have the responsibility to supervise the program and perform periodic program reviews as provided in s. 381.0056(3).
(b) The Department of Health, in cooperation with the Department of Education, shall publicize the availability of the program and its benefits.
(8) The provisions of this section shall be implemented to the extent of specific appropriations contained in the annual General Appropriations Act for such purpose.
381.006 Environmental health.—The department shall conduct an environmental health program as part of fulfilling the state’s public health mission. The purpose of this program is to detect and prevent disease caused by natural and manmade factors in the environment. The environmental health program shall include, but not be limited to:
(1) A drinking water function.
(2) An environmental health surveillance function which shall collect, compile, and correlate information on public health and exposure to hazardous substances through sampling and testing of water, air, or foods. Environmental health surveillance shall include a comprehensive assessment of drinking water under the department’s supervision and an indoor air quality testing and monitoring program to assess health risks from exposure to chemical, physical, and biological agents in the indoor environment.
(3) A toxicology and hazard assessment function which shall conduct toxicological and human health risk assessments of exposure to toxic agents, for the purposes of:
(a) Supporting determinations by the State Health Officer of safe levels of contaminants in water, air, or food if applicable standards or criteria have not been adopted. These determinations shall include issuance of health advisories to protect the health and safety of the public at risk from exposure to toxic agents.
(b) Provision of human toxicological health risk assessments to the public and other governmental agencies to characterize the risks to the public from exposure to contaminants in air, water, or food.
(c) Consultation and technical assistance to the Department of Environmental Protection and other governmental agencies on actions necessary to ameliorate exposure to toxic agents, including the emergency provision by the Department of Environmental Protection of drinking water in cases of drinking water contamination that present an imminent and substantial threat to the public’s health, as required by s. 376.30(3)(c)1.a.
(d) Monitoring and reporting the body burden of toxic agents to estimate past exposure to these toxic agents, predict future health effects, and decrease the incidence of poisoning by identifying and eliminating exposure.
(4) A sanitary nuisance function, as that term is defined in chapter 386.
(5) A migrant labor function.
(6) A public facilities function, including sanitary practices relating to state, county, municipal, and private institutions serving the public; jointly with the Department of Education, publicly and privately owned schools; all places used for the incarceration of prisoners and inmates of state institutions for the mentally ill; toilets and washrooms in all public places and places of employment; any other condition, place, or establishment necessary for the control of disease or the protection and safety of public health.
(7) A biohazardous waste control function.
(8) A function to control diseases transmitted from animals to humans, including the segregation, quarantine, and destruction of domestic pets and wild animals having or suspected of having such diseases.
(9) An environmental epidemiology function which shall investigate food-borne disease, waterborne disease, and other diseases of environmental causation, whether of chemical, radiological, or microbiological origin. A $10 surcharge for this function shall be assessed upon all persons permitted under chapter 500. This function shall include an educational program for physicians and health professionals designed to promote surveillance and reporting of environmental diseases, and to further the dissemination of knowledge about the relationship between toxic substances and human health which will be useful in the formulation of public policy and will be a source of information for the public.
(10) Mosquito and pest control functions as provided in chapters 388 and 482.
(11) A radiation control function as provided in chapter 404 and part IV of chapter 468.
(12) A public swimming and bathing facilities function as provided in chapter 514.
(13) A mobile home park, lodging park, recreational vehicle park, and recreational camp function as provided in chapter 513.
(14) A sanitary facilities function, which shall include minimum standards for the maintenance and sanitation of sanitary facilities; public access to sanitary facilities; and fixture ratios for special or temporary events and for homeless shelters.
(15) A group-care-facilities function. As used in this subsection, the term “group care facility” means any public or private school, assisted living facility, adult family-care home, adult day care center, short-term residential treatment center, residential treatment facility, home for special services, transitional living facility, crisis stabilization unit, hospice, prescribed pediatric extended care center, intermediate care facility for persons with developmental disabilities, or boarding school. The department may adopt rules necessary to protect the health and safety of residents, staff, and patrons of group care facilities. Rules related to public and private schools shall be developed by the Department of Education in consultation with the department. Rules adopted under this subsection may include definitions of terms; provisions relating to operation and maintenance of facilities, buildings, grounds, equipment, furnishings, and occupant-space requirements; lighting; heating, cooling, and ventilation; food service; water supply and plumbing; sewage; sanitary facilities; insect and rodent control; garbage; safety; personnel health, hygiene, and work practices; and other matters the department finds are appropriate or necessary to protect the safety and health of the residents, staff, students, faculty, or patrons. The department may not adopt rules that conflict with rules adopted by the licensing or certifying agency. The department may enter and inspect at reasonable hours to determine compliance with applicable statutes or rules. In addition to any sanctions that the department may impose for violations of rules adopted under this section, the department shall also report such violations to any agency responsible for licensing or certifying the group care facility. The licensing or certifying agency may also impose any sanction based solely on the findings of the department.
(16) A function for investigating elevated levels of lead in blood. Each participating county health department may expend funds for federally mandated certification or recertification fees related to conducting investigations of elevated levels of lead in blood.
(17) A food service inspection function for domestic violence centers that are certified and monitored by the Department of Children and Families under part XII of chapter 39 and group care homes as described in subsection (15), which shall be conducted annually and be limited to the requirements in department rule applicable to community-based residential facilities with five or fewer residents.
The department may adopt rules to carry out the provisions of this section.
(1) In addition to any administrative action authorized by chapter 120 or by other law, the department may impose a fine, which may not exceed $500 for each violation, for a violation of s. 381.006(15) or s. 381.0072, for a violation of any rule adopted by the department under this chapter, or for a violation of chapter 386 not involving onsite sewage treatment and disposal systems. The department shall give an alleged violator a notice of intent to impose such fine. Each day that a violation continues may constitute a separate violation.
(2) In determining the amount of fine to be imposed, if any, for a violation, the following factors shall be considered:
(a) The gravity of the violation, including the probability that death or serious physical or emotional harm to any person will result or has resulted, the severity of the actual or potential harm, and the extent to which the provisions of the applicable statutes or rules were violated.
(b) Actions taken by the owner or operator to correct violations.
(c) Any previous violations.
(3) All amounts collected under this section shall be deposited into an appropriate trust fund of the department.
381.0062 Supervision; private and certain public water systems.—
(1) DEFINITIONS.—As used in this section:
(a) “Contaminant” means any physical, biological, chemical, or radiological substance or matter in water.
(b) “Department” means the Department of Health, including the county health departments.
(c) “Florida Safe Drinking Water Act” means part VI of chapter 403.
(d) “Health hazard” means any condition, contaminant, device, or practice in a water system or its operation which will create or has the potential to create an acute or chronic threat to the health and well-being of the water consumer.
(e) “Limited use commercial public water system” means a public water system not covered or included in the Florida Safe Drinking Water Act, which serves one or more nonresidential establishments and provides piped water.
(f) “Limited use community public water system” means a public water system not covered or included in the Florida Safe Drinking Water Act, which serves five or more residences or two or more rental residences, and provides piped water.
(g) “Maximum contaminant level” means the maximum permissible level of a contaminant in potable water delivered to consumers.
(h) “Multifamily water system” means a water system that provides piped water to three or four residences, one of which may be a rental residence.
(i) “Person” means an individual, public or private corporation, company, association, partnership, municipality, agency of the state, district, federal, or any other legal entity, or its legal representative, agent, or assignee.
(j) “Potable water” means water that is satisfactory for human consumption, dermal contact, culinary purposes, or dishwashing as approved by the department.
(k) “Private water system” means a water system that provides piped water for one or two residences, one of which may be a rental residence.
(l) “Public consumption” means oral ingestion or physical contact with water by a person for any purpose other than cleaning work areas or simple handwashing. Examples of public consumption include, when making food or beverages available to the general public, water used for washing food, cooking utensils, or food service areas and water used for preparing food or beverages; washing surfaces accessed by children as in a child care center or similar setting; washing medical instruments or surfaces accessed by a patient; any water usage in health care facilities; emergency washing devices such as eye washing sinks; washing in food processing plants or establishments like slaughterhouses and packinghouses; and water used in schools.
(m) “Public water system” means a water system that is not included or covered under the Florida Safe Drinking Water Act, provides piped water to the public, and is not a private or multifamily water system. For purposes of this section, public water systems are classified as limited use community or limited use commercial.
(n) “Supplier of water” means the person, company, or corporation that owns or operates a limited use community or limited use commercial public water system, a multifamily water system, or a private water system.
(o) “Variance” means a sanction from the department affording a supplier of water an extended time to correct a maximum contaminant level violation caused by the raw water or to deviate from construction standards established by rule of the department.
(2) SUPERVISION.—The department and its agents shall have general supervision and control over all private water systems, multifamily water systems, and public water systems not covered or included in the Florida Safe Drinking Water Act (part VI of chapter 403), and over those aspects of the public water supply program for which it has the duties and responsibilities provided for in part VI of chapter 403. The department shall:
(a) Administer and enforce the provisions of this section and all rules and orders adopted or issued under this section, including water quality and monitoring standards.
(b) Require any person wishing to construct, modify, or operate a limited use community or limited use commercial public water system or a multifamily water system to first make application to and obtain approval from the department on forms adopted by rule of the department.
(c) Review and act upon any application for the construction, modification, operation, or change of ownership of, and conduct surveillance, enforcement, and compliance investigations of, limited use community and limited use commercial public water systems, and multifamily water systems.
(d) Require a fee from the supplier of water in an amount sufficient to cover the costs of reviewing and acting upon any application for the construction, modification, or operation of a limited use community and limited use commercial public water system, of not less than $10 or more than $90 annually.
(e) Require a fee from the supplier of water in an amount sufficient to cover the costs of reviewing and acting upon any application for the construction or change of ownership of a multifamily water system, of not less than $10 or more than $90.
(f) Require a fee from the supplier of water in an amount sufficient to cover the costs of sample collection, review of analytical results, health-risk interpretations, and coordination with other agencies when such work is not included in paragraphs (b) and (c) and is requested by the supplier of water, of not less than $10 or more than $90.
(g) Require suppliers of water to collect samples of water, to submit such samples to a department-certified drinking water laboratory for contaminant analysis, and to keep sampling records as required by rule of the department.
(h) Require all fees collected by the department in accordance with the provisions of this section to be deposited in an appropriate trust fund of the department, and used exclusively for the payment of costs incurred in the administration of this section.
(i) Prohibit any supplier of water from, intentionally or otherwise, introducing any contaminant which poses a health hazard into a drinking water system.
(j) Require suppliers of water to give public notice of water problems and corrective measures under the conditions specified by rule of the department.
(k) Require a fee to cover the cost of reinspection of any system regulated under this section, which may not be less than $25 or more than $40.
(3) RIGHT OF ENTRY.—For purposes of this section, department personnel may enter, at any reasonable time and if they have reasonable cause to believe a violation of this section is occurring or about to occur, upon any and all parts of the premises of such limited use public and multifamily drinking water systems, to make an examination and investigation to determine the sanitary and safety conditions of such systems.
(4) ENFORCEMENT AND PENALTIES.—
(a) Any person who constructs, modifies, or operates a limited use community or limited use commercial public water system, a multifamily water system, or a private water system, without first complying with the requirements of this section, who operates a water system in violation of department order, or who maintains or operates a water system after revocation of the permit is guilty of a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
(b) This section and rules adopted pursuant to this section may be enforced by injunction or restraining order granted by a circuit court as provided in s. 381.0012(2).
(c) Additional remedies available to county health department staff through any county or municipal ordinance may be applied, over and above the penalties set forth in this section, to any violation of this section or the rules adopted pursuant to this section.
(5) VARIANCES AND EXEMPTIONS.—
(a) The department may grant variances and exemptions from the rules adopted under this section through procedures set forth by the rule of the department.
(b) Any establishment with a limited use commercial public water system which does not make tap water available for public consumption and meets the water quality standards and installation requirements established by the department shall be exempt from obtaining an annual operating permit from the department, if the supplier of water:
1. Registers with the department; if the establishment changes ownership or business activity, it must register; and pay a $15 registration fee; and
2. Performs an initial water quality clearance of the water supply system.
A system exempt under this subsection may, in order to retain potable water status, conduct annual testing for bacteria in the form of one satisfactory microbiological sample per calendar year.
381.0063 Drinking water funds.—All fees and penalties received from suppliers of water pursuant to ss. 403.860(5) and 403.861(7)(a) shall be deposited in the appropriate County Health Department Trust Fund to be used by the department to pay the costs of expenditures required pursuant to ss. 381.0062 and 403.862(1)(c).
381.0064 Continuing education program for installation and use of onsite sewage treatment and disposal systems.—
(1) The Department of Environmental Protection shall establish a program for continuing education which meets the purposes of ss. 381.0101 and 489.554 regarding the public health and environmental effects of onsite sewage treatment and disposal systems and any other matters the department determines desirable for the safe installation and use of onsite sewage treatment and disposal systems. The department may charge a fee to cover the cost of such program.
(2) The department shall by rule establish criteria for the approval of continuing education courses and providers, including requirements relating to the content of courses and standards for approval of providers, and may by rule establish criteria for accepting alternative nonclassroom continuing education on an hour-for-hour basis.
(3) Septic tank contractors and master septic tank contractors registered under part III of chapter 489 shall meet the continuing education requirements set forth in s. 489.554.
1381.0065 Onsite sewage treatment and disposal systems; regulation.—
(1) LEGISLATIVE INTENT.—
(a) It is the intent of the Legislature that proper management of onsite sewage treatment and disposal systems is paramount to the health, safety, and welfare of the public.
(b) It is the intent of the Legislature that where a publicly owned or investor-owned sewerage system is not available, the department shall issue permits for the construction, installation, modification, abandonment, or repair of onsite sewage treatment and disposal systems under conditions as described in this section and rules adopted under this section. It is further the intent of the Legislature that the installation and use of onsite sewage treatment and disposal systems not adversely affect the public health or significantly degrade the groundwater or surface water.
(2) DEFINITIONS.—As used in ss. 381.0065-381.0067, the term:
(a) “Available,” as applied to a publicly owned or investor-owned sewerage system, means that the publicly owned or investor-owned sewerage system is capable of being connected to the plumbing of an establishment or residence, is not under a Department of Environmental Protection moratorium, and has adequate permitted capacity to accept the sewage to be generated by the establishment or residence; and:
1. For a residential subdivision lot, a single-family residence, or an establishment, any of which has an estimated sewage flow of 1,000 gallons per day or less, a gravity sewer line to maintain gravity flow from the property’s drain to the sewer line, or a low pressure or vacuum sewage collection line in those areas approved for low pressure or vacuum sewage collection, exists in a public easement or right-of-way that abuts the property line of the lot, residence, or establishment.
2. For an establishment with an estimated sewage flow exceeding 1,000 gallons per day, a sewer line, force main, or lift station exists in a public easement or right-of-way that abuts the property of the establishment or is within 50 feet of the property line of the establishment as accessed via existing rights-of-way or easements.
3. For proposed residential subdivisions with more than 50 lots, for proposed commercial subdivisions with more than 5 lots, and for areas zoned or used for an industrial or manufacturing purpose or its equivalent, a sewerage system exists within one-fourth mile of the development as measured and accessed via existing easements or rights-of-way.
4. For repairs or modifications within areas zoned or used for an industrial or manufacturing purpose or its equivalent, a sewerage system exists within 500 feet of an establishment’s or residence’s sewer stub-out as measured and accessed via existing rights-of-way or easements.
(b)1. “Bedroom” means a room that can be used for sleeping and that:
a. For site-built dwellings, has a minimum of 70 square feet of conditioned space;
b. For manufactured homes, is constructed according to the standards of the United States Department of Housing and Urban Development and has a minimum of 50 square feet of floor area;
c. Is located along an exterior wall;
d. Has a closet and a door or an entrance where a door could be reasonably installed; and
e. Has an emergency means of escape and rescue opening to the outside in accordance with the Florida Building Code.
2. A room may not be considered a bedroom if it is used to access another room except a bathroom or closet.
3. “Bedroom” does not include a hallway, bathroom, kitchen, living room, family room, dining room, den, breakfast nook, pantry, laundry room, sunroom, recreation room, media/video room, or exercise room.
(c) “Blackwater” means that part of domestic sewage carried off by toilets, urinals, and kitchen drains.
(d) “Department” means the Department of Environmental Protection.
(e) “Domestic sewage” means human body waste and wastewater, including bath and toilet waste, residential laundry waste, residential kitchen waste, and other similar waste from appurtenances at a residence or establishment.
(f) “Enhanced nutrient-reducing onsite sewage treatment and disposal system” means an onsite sewage treatment and disposal system approved by the department as capable of meeting or exceeding a 50 percent total nitrogen reduction before disposal of wastewater in the drainfield, or at least 65 percent total nitrogen reduction combined from the onsite sewage tank or tanks and drainfield.
(g) “Graywater” means that part of domestic sewage that is not blackwater, including waste from the bath, lavatory, laundry, and sink, except kitchen sink waste.
(h) “Florida Keys” means those islands of the state located within the boundaries of Monroe County.
(i) “Injection well” means an open vertical hole at least 90 feet in depth, cased and grouted to at least 60 feet in depth which is used to dispose of effluent from an onsite sewage treatment and disposal system.
(j) “Innovative system” means an onsite sewage treatment and disposal system that, in whole or in part, employs materials, devices, or techniques that are novel or unique and that have not been successfully field-tested under sound scientific and engineering principles under climatic and soil conditions found in this state.
(k) “Lot” means a parcel or tract of land described by reference to recorded plats or by metes and bounds, or the least fractional part of subdivided lands having limited fixed boundaries or an assigned number, letter, or any other legal description by which it can be identified.
(l) “Mean annual flood line” means the elevation determined by calculating the arithmetic mean of the elevations of the highest yearly flood stage or discharge for the period of record, to include at least the most recent 10-year period. If at least 10 years of data is not available, the mean annual flood line shall be as determined based upon the data available and field verification conducted by a certified professional surveyor and mapper with experience in the determination of flood water elevation lines or, at the option of the applicant, by department personnel. Field verification of the mean annual flood line shall be performed using a combination of those indicators listed in subparagraphs 1.-7. that are present on the site, and that reflect flooding that recurs on an annual basis. In those situations where any one or more of these indicators reflect a rare or aberrant event, such indicator or indicators shall not be utilized in determining the mean annual flood line. The indicators that may be considered are:
1. Water stains on the ground surface, trees, and other fixed objects;
2. Hydric adventitious roots;
3. Drift lines;
4. Rafted debris;
5. Aquatic mosses and liverworts;
6. Moss collars; and
7. Lichen lines.
(m) “Onsite sewage treatment and disposal system” means a system that contains a standard subsurface, filled, or mound drainfield system; an aerobic treatment unit; a graywater system tank; a laundry wastewater system tank; a septic tank; a grease interceptor; a pump tank; a solids or effluent pump; a waterless, incinerating, or organic waste-composting toilet; or a sanitary pit privy that is installed or proposed to be installed beyond the building sewer on land of the owner or on other land to which the owner has the legal right to install a system. The term includes any item placed within, or intended to be used as a part of or in conjunction with, the system. This term does not include package sewage treatment facilities and other treatment works regulated under chapter 403.
(n) “Permanent nontidal surface water body” means a perennial stream, a perennial river, an intermittent stream, a perennial lake, a submerged marsh or swamp, a submerged wooded marsh or swamp, a spring, or a seep, as identified on the most recent quadrangle map, 7.5 minute series (topographic), produced by the United States Geological Survey, or products derived from that series. “Permanent nontidal surface water body” shall also mean an artificial surface water body that does not have an impermeable bottom and side and that is designed to hold, or does hold, visible standing water for at least 180 days of the year. However, a nontidal surface water body that is drained, either naturally or artificially, where the intent or the result is that such drainage be temporary, shall be considered a permanent nontidal surface water body. A nontidal surface water body that is drained of all visible surface water, where the lawful intent or the result of such drainage is that such drainage will be permanent, shall not be considered a permanent nontidal surface water body. The boundary of a permanent nontidal surface water body shall be the mean annual flood line.
(o) “Potable water line” means any water line that is connected to a potable water supply source, but the term does not include an irrigation line with any of the following types of backflow devices:
1. For irrigation systems into which chemicals are not injected, any atmospheric or pressure vacuum breaker or double check valve or any detector check assembly.
2. For irrigation systems into which chemicals such as fertilizers, pesticides, or herbicides are injected, any reduced pressure backflow preventer.
(p) “Septage” means a mixture of sludge, fatty materials, human feces, and wastewater removed during the pumping of an onsite sewage treatment and disposal system.
(q) “Subdivision” means, for residential use, any tract or plot of land divided into two or more lots or parcels of which at least one is 1 acre or less in size for sale, lease, or rent. A subdivision for commercial or industrial use is any tract or plot of land divided into two or more lots or parcels of which at least one is 5 acres or less in size and which is for sale, lease, or rent. A subdivision shall be deemed to be proposed until such time as an application is submitted to the local government for subdivision approval or, in those areas where no local government subdivision approval is required, until such time as a plat of the subdivision is recorded.
(r) “Tidally influenced surface water body” means a body of water that is subject to the ebb and flow of the tides and has as its boundary a mean high-water line as defined by s. 177.27(15).
(s) “Toxic or hazardous chemical” means a substance that poses a serious danger to human health or the environment.
(3) DUTIES AND POWERS OF THE DEPARTMENT OF ENVIRONMENTAL PROTECTION.—The department shall:
(a) Adopt rules to administer ss. 381.0065-381.0067, including definitions that are consistent with the definitions in this section, increases for the lot-flow allowance for performance-based systems, requirements for separation from water table elevation during the wettest season, requirements for the design and construction of any component part of an onsite sewage treatment and disposal system, application and permit requirements for persons who maintain an onsite sewage treatment and disposal system, requirements for maintenance and service agreements for aerobic treatment units and performance-based treatment systems, and recommended standards, including disclosure requirements, for voluntary system inspections to be performed by individuals who are authorized by law to perform such inspections and who shall inform a person having ownership, control, or use of an onsite sewage treatment and disposal system of the inspection standards and of that person’s authority to request an inspection based on all or part of the standards.
(b) Perform application reviews and site evaluations, issue permits, and conduct inspections and complaint investigations associated with the construction, installation, maintenance, modification, abandonment, operation, use, or repair of an onsite sewage treatment and disposal system for a residence or establishment with an estimated domestic sewage flow of 10,000 gallons or less per day, or an estimated commercial sewage flow of 5,000 gallons or less per day, which is not currently regulated under chapter 403.
(c) Develop a comprehensive program to ensure that onsite sewage treatment and disposal systems regulated by the department are sized, designed, constructed, installed, sited, repaired, modified, abandoned, used, operated, and maintained in compliance with this section and rules adopted under this section to prevent groundwater contamination, including impacts from nutrient pollution, and surface water contamination and to preserve the public health. The department is the final administrative interpretive authority regarding rule interpretation. In the event of a conflict regarding rule interpretation, the Secretary of Environmental Protection, or his or her designee, shall timely assign a staff person to resolve the dispute.
(d) Grant variances in hardship cases under the conditions prescribed in this section and rules adopted under this section.
(e) Permit the use of a limited number of innovative systems for a specific period of time, when there is compelling evidence that the system will function properly and reliably to meet the requirements of this section and rules adopted under this section.
(f) Issue annual operating permits under this section.
(g) Establish and collect fees as established under s. 381.0066 for services provided with respect to onsite sewage treatment and disposal systems.
(h) Conduct enforcement activities in accordance with part I of chapter 403, for violations of this section, part I of chapter 386, or part III of chapter 489 or for a violation of any rule adopted by the department under this section, part I of chapter 386, or part III of chapter 489. All references to part I of chapter 386 in this section relate solely to nuisances involving improperly built or maintained septic tanks or other onsite sewage treatment and disposal systems, and untreated or improperly treated or transported waste from onsite sewage treatment and disposal systems. The department shall have all the duties and authorities of the Department of Health in part I of chapter 386 for nuisances involving onsite sewage treatment and disposal systems. The department’s authority under part I of chapter 386 is in addition to and may be pursued independently of or simultaneously with the enforcement remedies provided under this section and chapter 403.
(i) Provide or conduct education and training of department personnel, service providers, and the public regarding onsite sewage treatment and disposal systems.
(j) Supervise research on, demonstration of, and training on the performance, environmental impact, and public health impact of onsite sewage treatment and disposal systems within this state. Research fees collected under s. 381.0066(2)(k) must be used to develop and fund hands-on training centers designed to provide practical information about onsite sewage treatment and disposal systems to septic tank contractors, master septic tank contractors, contractors, inspectors, engineers, and the public and must also be used to fund research projects which focus on improvements of onsite sewage treatment and disposal systems, including use of performance-based standards and reduction of environmental impact. Research projects shall be applicable to and reflect the soil conditions specific to this state. Such projects shall be awarded through competitive negotiation, using the procedures provided in s. 287.055, to public or private entities that have experience in onsite sewage treatment and disposal systems in this state and that are principally located in this state.
(k) Approve the installation of individual graywater disposal systems in which blackwater is treated by a central sewerage system.
(l) Regulate and permit the sanitation, handling, treatment, storage, reuse, and disposal of byproducts from any system regulated under this chapter.
(m) Permit and inspect portable or temporary toilet services and holding tanks. The department shall review applications, perform site evaluations, and issue permits for the temporary use of holding tanks, privies, portable toilet services, or any other toilet facility that is intended for use on a permanent or nonpermanent basis, including facilities placed on construction sites when workers are present. The department may specify standards for the construction, maintenance, use, and operation of any such facility for temporary use.
(n) Regulate and permit maintenance entities for performance-based treatment systems and aerobic treatment unit systems. To ensure systems are maintained and operated according to manufacturer’s specifications and designs, the department shall establish by rule minimum qualifying criteria for maintenance entities. The criteria shall include training, access to approved spare parts and components, access to manufacturer’s maintenance and operation manuals, and service response time. The maintenance entity shall employ a contractor licensed under s. 489.105(3)(m), or part III of chapter 489, or a state-licensed wastewater plant operator, who is responsible for maintenance and repair of all systems under contract.
(o) Adopt rules establishing and implementing a program of general permits for this section for projects, or categories of projects, which have, individually or cumulatively, a minimal adverse impact on public health or the environment. Such rules must:
1. Specify design or performance criteria which, if applied, would result in compliance with appropriate standards; and
2. Authorize a person who complies with the general permit eligibility requirements to use the permit 30 days after giving notice to the department without any agency action by the department. Within the 30-day notice period, the department shall determine whether the activity qualifies for a general permit. If the activity does not qualify or the notice does not contain all the required information, the department must notify the person.
(4) PERMITS; INSTALLATION; CONDITIONS.—A person may not construct, repair, modify, abandon, or operate an onsite sewage treatment and disposal system without first obtaining a permit approved by the department. The department may issue permits to carry out this section, except that the issuance of a permit for work seaward of the coastal construction control line established under s. 161.053 shall be contingent upon receipt of any required coastal construction control line permit from the department. A construction permit is valid for 18 months after the date of issuance and may be extended by the department for one 90-day period under rules adopted by the department. A repair permit is valid for 90 days after the date of issuance. An operating permit must be obtained before the use of any aerobic treatment unit or if the establishment generates commercial waste. Buildings or establishments that use an aerobic treatment unit or generate commercial waste shall be inspected by the department at least annually to assure compliance with the terms of the operating permit. The operating permit for a commercial wastewater system is valid for 1 year after the date of issuance and must be renewed annually. The operating permit for an aerobic treatment unit is valid for 2 years after the date of issuance and must be renewed every 2 years. If all information pertaining to the siting, location, and installation conditions or repair of an onsite sewage treatment and disposal system remains the same, a construction or repair permit for the onsite sewage treatment and disposal system may be transferred to another person, if the transferee files, within 60 days after the transfer of ownership, an amended application providing all corrected information and proof of ownership of the property. A fee is not associated with the processing of this supplemental information. A person may not contract to construct, modify, alter, repair, service, abandon, or maintain any portion of an onsite sewage treatment and disposal system without being registered under part III of chapter 489. A property owner who personally performs construction, maintenance, or repairs to a system serving his or her own owner-occupied single-family residence is exempt from registration requirements for performing such construction, maintenance, or repairs on that residence, but is subject to all permitting requirements. A municipality or political subdivision of the state may not issue a building or plumbing permit for any building that requires the use of an onsite sewage treatment and disposal system unless the owner or builder has received a construction permit for such system from the department. A building or structure may not be occupied and a municipality, political subdivision, or any state or federal agency may not authorize occupancy until the department approves the final installation of the onsite sewage treatment and disposal system. A municipality or political subdivision of the state may not approve any change in occupancy or tenancy of a building that uses an onsite sewage treatment and disposal system until the department has reviewed the use of the system with the proposed change, approved the change, and amended the operating permit.
(a) Subdivisions and lots in which each lot has a minimum area of at least one-half acre and either a minimum dimension of 100 feet or a mean of at least 100 feet of the side bordering the street and the distance formed by a line parallel to the side bordering the street drawn between the two most distant points of the remainder of the lot may be developed with a water system regulated under s. 381.0062 and onsite sewage treatment and disposal systems, provided the projected daily sewage flow does not exceed an average of 1,500 gallons per acre per day, and provided satisfactory drinking water can be obtained and all distance and setback, soil condition, water table elevation, and other related requirements of this section and rules adopted under this section can be met.
(b) Subdivisions and lots using a public water system as defined in s. 403.852 may use onsite sewage treatment and disposal systems, provided there are no more than four lots per acre, provided the projected daily sewage flow does not exceed an average of 2,500 gallons per acre per day, and provided that all distance and setback, soil condition, water table elevation, and other related requirements that are generally applicable to the use of onsite sewage treatment and disposal systems are met.
(c) Notwithstanding paragraphs (a) and (b), for subdivisions platted of record on or before October 1, 1991, when a developer or other appropriate entity has previously made or makes provisions, including financial assurances or other commitments, acceptable to the department, that a central water system will be installed by a regulated public utility based on a density formula, private potable wells may be used with onsite sewage treatment and disposal systems until the agreed-upon densities are reached. In a subdivision regulated by this paragraph, the average daily sewage flow may not exceed 2,500 gallons per acre per day. This section does not affect the validity of existing prior agreements. After October 1, 1991, the exception provided under this paragraph is not available to a developer or other appropriate entity.
(d) Paragraphs (a) and (b) do not apply to any proposed residential subdivision with more than 50 lots or to any proposed commercial subdivision with more than 5 lots where a publicly owned or investor-owned sewage treatment system is available. This paragraph does not allow development of additional proposed subdivisions in order to evade the requirements of this paragraph.
(e) The department shall adopt rules relating to the location of onsite sewage treatment and disposal systems, including establishing setback distances, to prevent groundwater contamination and surface water contamination and to preserve the public health. The rules must consider conventional and enhanced nutrient-reducing onsite sewage treatment and disposal system designs, impaired or degraded water bodies, domestic wastewater and drinking water infrastructure, potable water sources, nonpotable wells, stormwater infrastructure, the onsite sewage treatment and disposal system remediation plans developed pursuant to s. 403.067(7)(a)9.b., nutrient pollution, and the recommendations of the onsite sewage treatment and disposal systems technical advisory committee established pursuant to former s. 381.00652. The rules must also allow a person to apply for and receive a variance from a rule requirement upon demonstration that the requirement would cause an undue hardship and granting the variance would not cause or contribute to the exceedance of a total maximum daily load.
(f) Onsite sewage treatment and disposal systems that are permitted before June 21, 2022, may not be placed closer than:
1. Seventy-five feet from a private potable well.
2. Two hundred feet from a public potable well serving a residential or nonresidential establishment having a total sewage flow of greater than 2,000 gallons per day.
3. One hundred feet from a public potable well serving a residential or nonresidential establishment having a total sewage flow of less than or equal to 2,000 gallons per day.
4. Fifty feet from any nonpotable well.
5. Ten feet from any storm sewer pipe, to the maximum extent possible, but in no instance shall the setback be less than 5 feet.
6. Seventy-five feet from the mean high-water line of a tidally influenced surface water body.
7. Seventy-five feet from the mean annual flood line of a permanent nontidal surface water body.
8. Fifteen feet from the design high-water line of retention areas, detention areas, or swales designed to contain standing or flowing water for less than 72 hours after a rainfall or the design high-water level of normally dry drainage ditches or normally dry individual lot stormwater retention areas.
(g) This section and rules adopted under this section relating to soil condition, water table elevation, distance, and other setback requirements must be equally applied to all lots, with the following exceptions:
1. Any residential lot that was platted and recorded on or after January 1, 1972, or that is part of a residential subdivision that was approved by the appropriate permitting agency on or after January 1, 1972, and that was eligible for an onsite sewage treatment and disposal system construction permit on the date of such platting and recording or approval shall be eligible for an onsite sewage treatment and disposal system construction permit, regardless of when the application for a permit is made. If rules in effect at the time the permit application is filed cannot be met, residential lots platted and recorded or approved on or after January 1, 1972, shall, to the maximum extent possible, comply with the rules in effect at the time the permit application is filed. At a minimum, however, those residential lots platted and recorded or approved on or after January 1, 1972, but before January 1, 1983, shall comply with those rules in effect on January 1, 1983, and those residential lots platted and recorded or approved on or after January 1, 1983, shall comply with those rules in effect at the time of such platting and recording or approval. In determining the maximum extent of compliance with current rules that is possible, the department shall allow structures and appurtenances thereto which were authorized at the time such lots were platted and recorded or approved.
2. Lots platted before 1972 are subject to a 50-foot minimum surface water setback and are not subject to lot size requirements. The projected daily flow for onsite sewage treatment and disposal systems for lots platted before 1972 may not exceed:
a. Two thousand five hundred gallons per acre per day for lots served by public water systems as defined in s. 403.852.
b. One thousand five hundred gallons per acre per day for lots served by water systems regulated under s. 381.0062.
(h)1. The department may grant variances in hardship cases which may be less restrictive than the provisions specified in this section. If a variance is granted and the onsite sewage treatment and disposal system construction permit has been issued, the variance may be transferred with the system construction permit, if the transferee files, within 60 days after the transfer of ownership, an amended construction permit application providing all corrected information and proof of ownership of the property and if the same variance would have been required for the new owner of the property as was originally granted to the original applicant for the variance. A fee is not associated with the processing of this supplemental information. A variance may not be granted under this section until the department is satisfied that:
a. The hardship was not caused intentionally by the action of the applicant;
b. A reasonable alternative, taking into consideration factors such as cost, does not exist for the treatment of the sewage; and
c. The discharge from the onsite sewage treatment and disposal system will not adversely affect the health of the applicant or the public or significantly degrade the groundwater or surface waters.
Where soil conditions, water table elevation, and setback provisions are determined by the department to be satisfactory, special consideration must be given to those lots platted before 1972.
2. The department shall appoint and staff a variance review and advisory committee, which shall meet monthly to recommend agency action on variance requests. The committee shall make its recommendations on variance requests at the meeting in which the application is scheduled for consideration, except for an extraordinary change in circumstances, the receipt of new information that raises new issues, or when the applicant requests an extension. The committee shall consider the criteria in subparagraph 1. in its recommended agency action on variance requests and shall also strive to allow property owners the full use of their land where possible.
a. The committee is composed of the following:
(I) The Secretary of Environmental Protection or his or her designee.
(II) A representative from the county health departments.
(III) A representative from the home building industry recommended by the Florida Home Builders Association.
(IV) A representative from the septic tank industry recommended by the Florida Onsite Wastewater Association.
(V) A representative from the Department of Health.
(VI) A representative from the real estate industry who is also a developer in this state who develops lots using onsite sewage treatment and disposal systems, recommended by the Florida Association of Realtors.
(VII) A representative from the engineering profession recommended by the Florida Engineering Society.
b. Members shall be appointed for a term of 3 years, with such appointments being staggered so that the terms of no more than two members expire in any one year. Members shall serve without remuneration, but if requested, shall be reimbursed for per diem and travel expenses as provided in s. 112.061.
3. The variance review and advisory committee is not responsible for reviewing water well permitting. However, the committee shall consider all requirements of law related to onsite sewage treatment and disposal systems when making recommendations on variance requests for onsite sewage treatment and disposal system permits.
(i) A construction permit may not be issued for an onsite sewage treatment and disposal system in any area zoned or used for industrial or manufacturing purposes, or its equivalent, where a publicly owned or investor-owned sewage treatment system is available, or where a likelihood exists that the system will receive toxic, hazardous, or industrial waste. An existing onsite sewage treatment and disposal system may be repaired if a publicly owned or investor-owned sewage treatment system is not available within 500 feet of the building sewer stub-out and if system construction and operation standards can be met. This paragraph does not require publicly owned or investor-owned sewage treatment systems to accept anything other than domestic wastewater.
1. A building located in an area zoned or used for industrial or manufacturing purposes, or its equivalent, when such building is served by an onsite sewage treatment and disposal system, must not be occupied until the owner or tenant has obtained written approval from the department. The department may not grant approval when the proposed use of the system is to dispose of toxic, hazardous, or industrial wastewater or toxic or hazardous chemicals.
2. Each person who owns or operates a business or facility in an area zoned or used for industrial or manufacturing purposes, or its equivalent, or who owns or operates a business that has the potential to generate toxic, hazardous, or industrial wastewater or toxic or hazardous chemicals, and uses an onsite sewage treatment and disposal system that is installed on or after July 5, 1989, must obtain an annual system operating permit from the department. A person who owns or operates a business that uses an onsite sewage treatment and disposal system that was installed and approved before July 5, 1989, does not need to obtain a system operating permit. However, upon change of ownership or tenancy, the new owner or operator must notify the department of the change, and the new owner or operator must obtain an annual system operating permit, regardless of the date that the system was installed or approved.
3. The department shall periodically review and evaluate the continued use of onsite sewage treatment and disposal systems in areas zoned or used for industrial or manufacturing purposes, or its equivalent, and may require the collection and analyses of samples from within and around such systems. If the department finds that toxic or hazardous chemicals or toxic, hazardous, or industrial wastewater have been or are being disposed of through an onsite sewage treatment and disposal system, the department shall initiate enforcement actions against the owner or tenant to ensure adequate cleanup, treatment, and disposal.
(j) An onsite sewage treatment and disposal system designed by a professional engineer registered in the state and certified by such engineer as complying with performance criteria adopted by the department must be approved by the department subject to the following:
1. The performance criteria applicable to engineer-designed systems must be limited to those necessary to ensure that such systems do not adversely affect the public health or significantly degrade the groundwater or surface water. Such performance criteria shall include consideration of the quality of system effluent, the proposed total sewage flow per acre, wastewater treatment capabilities of the natural or replaced soil, water quality classification of the potential surface-water-receiving body, and the structural and maintenance viability of the system for the treatment of domestic wastewater. However, performance criteria shall address only the performance of a system and not a system’s design.
2. A person electing to use an engineer-designed system shall, upon completion of the system design, submit such design, certified by a registered professional engineer, to the county health department. The county health department may use an outside consultant to review the engineer-designed system, with the actual cost of such review to be borne by the applicant. Within 5 working days after receiving an engineer-designed system permit application, the county health department shall request additional information if the application is not complete. Within 15 working days after receiving a complete application for an engineer-designed system, the county health department shall issue the permit or, if it determines that the system does not comply with the performance criteria, shall notify the applicant of that determination and refer the application to the department for a determination as to whether the system should be approved, disapproved, or approved with modification. The department engineer’s determination shall prevail over the action of the county health department. The applicant shall be notified in writing of the department’s determination and of the applicant’s rights to pursue a variance or seek review under the provisions of chapter 120.
3. The owner of an engineer-designed performance-based system must maintain a current maintenance service agreement with a maintenance entity permitted by the department. The maintenance entity shall inspect each system at least twice each year and shall report quarterly to the department on the number of systems inspected and serviced. The reports may be submitted electronically.
4. The property owner of an owner-occupied, single-family residence may be approved and permitted by the department as a maintenance entity for his or her own performance-based treatment system upon written certification from the system manufacturer’s approved representative that the property owner has received training on the proper installation and service of the system. The maintenance service agreement must conspicuously disclose that the property owner has the right to maintain his or her own system and is exempt from contractor registration requirements for performing construction, maintenance, or repairs on the system but is subject to all permitting requirements.
5. The property owner shall obtain a biennial system operating permit from the department for each system. The department shall inspect the system at least annually, or on such periodic basis as the fee collected permits, and may collect system-effluent samples if appropriate to determine compliance with the performance criteria. The fee for the biennial operating permit shall be collected beginning with the second year of system operation.
6. If an engineer-designed system fails to properly function or fails to meet performance standards, the system shall be re-engineered, if necessary, to bring the system into compliance with the provisions of this section.
(k) An innovative system may be approved in conjunction with an engineer-designed site-specific system that is certified by the engineer to meet the performance-based criteria adopted by the department.
(l) For the Florida Keys, the department shall adopt a special rule for the construction, installation, modification, operation, repair, maintenance, and performance of onsite sewage treatment and disposal systems which considers the unique soil conditions and water table elevations, densities, and setback requirements. On lots where a setback distance of 75 feet from surface waters, saltmarsh, and buttonwood association habitat areas cannot be met, an injection well, approved and permitted by the department, may be used for disposal of effluent from onsite sewage treatment and disposal systems. The following additional requirements apply to onsite sewage treatment and disposal systems in Monroe County:
1. The county, each municipality, and those special districts established for the purpose of the collection, transmission, treatment, or disposal of sewage shall ensure, in accordance with the specific schedules adopted by the Administration Commission under s. 380.0552, the completion of onsite sewage treatment and disposal system upgrades to meet the requirements of this paragraph.
2. Onsite sewage treatment and disposal systems must cease discharge by December 31, 2015, or must comply with department rules and provide the level of treatment which, on a permitted annual average basis, produces an effluent that contains no more than the following concentrations:
a. Biochemical Oxygen Demand (CBOD5) of 10 mg/l.
b. Suspended Solids of 10 mg/l.
c. Total Nitrogen, expressed as N, of 10 mg/l or a reduction in nitrogen of at least 70 percent. A system that has been tested and certified to reduce nitrogen concentrations by at least 70 percent shall be deemed to be in compliance with this standard.
d. Total Phosphorus, expressed as P, of 1 mg/l.
In addition, onsite sewage treatment and disposal systems discharging to an injection well must provide basic disinfection as defined by department rule.
3. In areas not scheduled to be served by a central sewerage system, onsite sewage treatment and disposal systems must, by December 31, 2015, comply with department rules and provide the level of treatment described in subparagraph 2.
4. In areas scheduled to be served by a central sewerage system by December 31, 2015, if the property owner has paid a connection fee or assessment for connection to the central sewerage system, the property owner may install a holding tank with a high water alarm or an onsite sewage treatment and disposal system that meets the following minimum standards:
a. The existing tanks must be pumped and inspected and certified as being watertight and free of defects in accordance with department rule; and
b. A sand-lined drainfield or injection well in accordance with department rule must be installed.
5. Onsite sewage treatment and disposal systems must be monitored for total nitrogen and total phosphorus concentrations as required by department rule.
6. The department shall enforce proper installation, operation, and maintenance of onsite sewage treatment and disposal systems pursuant to this chapter, including ensuring that the appropriate level of treatment described in subparagraph 2. is met.
7. The authority of a local government, including a special district, to mandate connection of an onsite sewage treatment and disposal system is governed by s. 4, chapter 99-395, Laws of Florida.
8. Notwithstanding any other law, an onsite sewage treatment and disposal system installed after July 1, 2010, in unincorporated Monroe County, excluding special wastewater districts, that complies with the standards in subparagraph 2. is not required to connect to a central sewerage system until December 31, 2020.
(m) A product sold in the state for use in onsite sewage treatment and disposal systems may not contain any substance in concentrations or amounts that would interfere with or prevent the successful operation of such system, or that would cause discharges from such systems to violate applicable water quality standards. The department shall publish criteria for products known or expected to meet the conditions of this paragraph. If a product does not meet such criteria, such product may be sold if the manufacturer satisfactorily demonstrates to the department that the conditions of this paragraph are met.
(n) Evaluations for determining the seasonal high-water table elevations or the suitability of soils for the use of a new onsite sewage treatment and disposal system shall be performed by department personnel, professional engineers registered in the state, or such other persons with expertise, as defined by rule, in making such evaluations. Evaluations for determining mean annual flood lines shall be performed by those persons identified in paragraph (2)(l). The department shall accept evaluations submitted by professional engineers and such other persons as meet the expertise established by this section or by rule unless the department has a reasonable scientific basis for questioning the accuracy or completeness of the evaluation.
(o) An application for an onsite sewage treatment and disposal system permit shall be completed in full, signed by the owner or the owner’s authorized representative, or by a contractor licensed under chapter 489, and shall be accompanied by all required exhibits and fees. Specific documentation of property ownership is not required as a prerequisite to the review of an application or the issuance of a permit. The issuance of a permit does not constitute determination by the department of property ownership.
(p) The department may not require any form of subdivision analysis of property by an owner, developer, or subdivider before submission of an application for an onsite sewage treatment and disposal system.
(q) This section does not limit the power of a municipality or county to enforce other laws for the protection of the public health and safety.
(r) In the siting of onsite sewage treatment and disposal systems, including drainfields, shoulders, and slopes, guttering may not be required on single-family residential dwelling units for systems located greater than 5 feet from the roof drip line of the house. If guttering is used on residential dwelling units, the downspouts shall be directed away from the drainfield.
(s) Notwithstanding subparagraph (g)1., onsite sewage treatment and disposal systems located in floodways of the Suwannee and Aucilla Rivers must adhere to the following requirements:
1. The absorption surface of the drainfield may not be subject to flooding based on 10-year flood elevations. Provided, however, for lots or parcels created by the subdivision of land in accordance with applicable local government regulations before January 17, 1990, if an applicant cannot construct a drainfield system with the absorption surface of the drainfield at an elevation equal to or above 10-year flood elevation, the department shall issue a permit for an onsite sewage treatment and disposal system within the 10-year floodplain of rivers, streams, and other bodies of flowing water if all of the following criteria are met:
a. The lot is at least one-half acre in size;
b. The bottom of the drainfield is at least 36 inches above the 2-year flood elevation; and
c. The applicant installs a waterless, incinerating, or organic waste composting toilet and a graywater system and drainfield in accordance with department rules; an aerobic treatment unit and drainfield in accordance with department rules; a system that is capable of reducing effluent nitrate by at least 50 percent in accordance with department rules; or a system other than a system using alternative drainfield materials in accordance with department rules. The United States Department of Agriculture Soil Conservation Service soil maps, State of Florida Water Management District data, and Federal Emergency Management Agency Flood Insurance maps are resources that shall be used to identify flood-prone areas.
2. The use of fill or mounding to elevate a drainfield system out of the 10-year floodplain of rivers, streams, or other bodies of flowing water may not be permitted if such a system lies within a regulatory floodway of the Suwannee and Aucilla Rivers. In cases where the 10-year flood elevation does not coincide with the boundaries of the regulatory floodway, the regulatory floodway will be considered for the purposes of this subsection to extend at a minimum to the 10-year flood elevation.
(t)1. The owner of an aerobic treatment unit system shall maintain a current maintenance service agreement with an aerobic treatment unit maintenance entity permitted by the department. The maintenance entity shall inspect each aerobic treatment unit system at least twice each year and shall report quarterly to the department on the number of aerobic treatment unit systems inspected and serviced. The reports may be submitted electronically.
2. The property owner of an owner-occupied, single-family residence may be approved and permitted by the department as a maintenance entity for his or her own aerobic treatment unit system upon written certification from the system manufacturer’s approved representative that the property owner has received training on the proper installation and service of the system. The maintenance entity service agreement must conspicuously disclose that the property owner has the right to maintain his or her own system and is exempt from contractor registration requirements for performing construction, maintenance, or repairs on the system but is subject to all permitting requirements.
3. A septic tank contractor licensed under part III of chapter 489, if approved by the manufacturer, may not be denied access by the manufacturer to aerobic treatment unit system training or spare parts for maintenance entities. After the original warranty period, component parts for an aerobic treatment unit system may be replaced with parts that meet manufacturer’s specifications but are manufactured by others. The maintenance entity shall maintain documentation of the substitute part’s equivalency for 2 years and shall provide such documentation to the department upon request.
4. The owner of an aerobic treatment unit system shall obtain a system operating permit from the department and allow the department to inspect during reasonable hours each aerobic treatment unit system at least annually, and such inspection may include collection and analysis of system-effluent samples for performance criteria established by rule of the department.
(u) The department may require the submission of detailed system construction plans that are prepared by a professional engineer registered in this state. The department shall establish by rule criteria for determining when such a submission is required.
(v) Any permit issued and approved by the department for the installation, modification, or repair of an onsite sewage treatment and disposal system shall transfer with the title to the property in a real estate transaction. A title may not be encumbered at the time of transfer by new permit requirements by a governmental entity for an onsite sewage treatment and disposal system which differ from the permitting requirements in effect at the time the system was permitted, modified, or repaired. An inspection of a system may not be mandated by a governmental entity at the point of sale in a real estate transaction. This paragraph does not affect a septic tank phase-out deferral program implemented by a consolidated government as defined in s. 9, Art. VIII of the State Constitution of 1885.
(w) A governmental entity, including a municipality, county, or statutorily created commission, may not require an engineer-designed performance-based treatment system, excluding a passive engineer-designed performance-based treatment system, before the completion of the Florida Onsite Sewage Nitrogen Reduction Strategies Project. This paragraph does not apply to a governmental entity, including a municipality, county, or statutorily created commission, which adopted a local law, ordinance, or regulation on or before January 31, 2012. Notwithstanding this paragraph, an engineer-designed performance-based treatment system may be used to meet the requirements of the variance review and advisory committee recommendations.
(x)1. An onsite sewage treatment and disposal system is not considered abandoned if the system is disconnected from a structure that was made unusable or destroyed following a disaster and if the system was properly functioning at the time of disconnection and was not adversely affected by the disaster. The onsite sewage treatment and disposal system may be reconnected to a rebuilt structure if:
a. The reconnection of the system is to the same type of structure which contains the same number of bedrooms or fewer, if the square footage of the structure is less than or equal to 110 percent of the original square footage of the structure that existed before the disaster;
b. The system is not a sanitary nuisance; and
c. The system has not been altered without prior authorization.
2. An onsite sewage treatment and disposal system that serves a property that is foreclosed upon is not considered abandoned.
(y) If an onsite sewage treatment and disposal system permittee receives, relies upon, and undertakes construction of a system based upon a validly issued construction permit under rules applicable at the time of construction but a change to a rule occurs within 5 years after the approval of the system for construction but before the final approval of the system, the rules applicable and in effect at the time of construction approval apply at the time of final approval if fundamental site conditions have not changed between the time of construction approval and final approval.
(z) An existing-system inspection or evaluation and assessment, or a modification, replacement, or upgrade of an onsite sewage treatment and disposal system is not required for a remodeling addition or modification to a single-family home if a bedroom is not added. However, a remodeling addition or modification to a single-family home may not cover any part of the existing system or encroach upon a required setback or the unobstructed area. To determine if a setback or the unobstructed area is impacted, the local health department shall review and verify a floor plan and site plan of the proposed remodeling addition or modification to the home submitted by a remodeler which shows the location of the system, including the distance of the remodeling addition or modification to the home from the onsite sewage treatment and disposal system. The local health department may visit the site or otherwise determine the best means of verifying the information submitted. A verification of the location of a system is not an inspection or evaluation and assessment of the system. The review and verification must be completed within 7 business days after receipt by the local health department of a floor plan and site plan. If the review and verification is not completed within such time, the remodeling addition or modification to the single-family home, for the purposes of this paragraph, is approved.
(5) ENFORCEMENT; RIGHT OF ENTRY.—
(a) Department personnel who have reason to believe noncompliance exists, may at any reasonable time, enter the premises permitted under ss. 381.0065-381.0066, or the business premises of any septic tank contractor or master septic tank contractor registered under part III of chapter 489, or any premises that the department has reason to believe is being operated or maintained not in compliance, to determine compliance with the provisions of this section, part I of chapter 386, or part III of chapter 489 or rules or standards adopted under ss. 381.0065-381.0067, part I of chapter 386, or part III of chapter 489. As used in this paragraph, the term “premises” does not include a residence or private building. To gain entry to a residence or private building, the department must obtain permission from the owner or occupant or secure an inspection warrant from a court of competent jurisdiction pursuant to the procedures of s. 403.091.
(b) The department has all of the judicial and administrative remedies available to it pursuant to part I of chapter 403 for violations of ss. 381.0065-381.0067, part I of chapter 386, or part III of chapter 489 or the rules adopted by the department. The department, pursuant to ss. 381.0065-381.0067, part I of chapter 386, or part III of chapter 489, shall deposit any damages, costs, or penalties it collects pursuant to this section and part I of chapter 403 in the Water Quality Assurance Trust Fund.
(6) LAND APPLICATION OF SEPTAGE PROHIBITED.—Effective January 1, 2016, the land application of septage from onsite sewage treatment and disposal systems is prohibited.
(7) USE OF ENHANCED NUTRIENT-REDUCING ONSITE SEWAGE TREATMENT AND DISPOSAL SYSTEMS.—To meet the requirements of a total maximum daily load, the department shall implement a fast-track approval process of no longer than 6 months for the determination of the use of American National Standards Institute 245 systems approved by NSF International before July 1, 2020. The department shall also establish an enhanced nutrient-reducing onsite sewage treatment and disposal system approval program that will expeditiously evaluate and approve such systems for use in this state to comply with ss. 403.067(7)(a)10. and 373.469(3)(d).
(8) PRIVATE PROVIDER INSPECTIONS.—
(a) Notwithstanding any other law, ordinance, or policy, the owner of an onsite sewage treatment and disposal system or a contractor upon the owner’s written authorization may hire a private provider to perform an inspection that follows applicable regulatory requirements of the onsite sewage treatment and disposal system.
(b) An inspection of an onsite sewage treatment and disposal system required under this section may not be conducted by the private provider or authorized representative of the private provider that installed the onsite sewage treatment and disposal system.
(c) A private provider or an authorized representative of a private provider may perform onsite sewage treatment and disposal system inspections if they are:
1. An environmental health professional certified under s. 381.0101;
2. A master septic tank contractor registered under part III of chapter 489;
3. A professional engineer licensed under chapter 471 and have passed all parts of the Onsite Sewage Treatment and Disposal System Accelerated Certification Training; or
4. Working under the supervision of a licensed professional engineer and have passed all parts of the Onsite Sewage Treatment and Disposal System Accelerated Certification Training.
(d) An owner or authorized contractor using a private provider for an onsite sewage treatment and disposal system inspection must provide notice to the department at the time of permit application or by 2 p.m. local time, 2 business days before the first scheduled inspection by the department. The notice must include all of the following information:
1. For each private provider or authorized representative performing the inspection:
a. Name and firm name, address, telephone number, and e-mail address.
b. Professional license or certification number.
c. Qualification statement or résumé.
2. An acknowledgment from the owner in substantially the following form:
I HAVE ELECTED TO USE ONE OR MORE PRIVATE PROVIDERS TO PERFORM AN ONSITE SEWAGE TREATMENT AND DISPOSAL SYSTEM INSPECTION THAT IS THE SUBJECT OF THE ENCLOSED PERMIT APPLICATION. I UNDERSTAND THAT THE DEPARTMENT OF ENVIRONMENTAL PROTECTION MAY NOT PERFORM THE REQUIRED ONSITE SEWAGE TREATMENT AND DISPOSAL SYSTEM INSPECTION TO DETERMINE COMPLIANCE WITH THE APPLICABLE CODES, EXCEPT TO THE EXTENT AUTHORIZED BY LAW. INSTEAD, THE INSPECTION WILL BE PERFORMED BY THE LICENSED OR CERTIFIED PRIVATE PROVIDER IDENTIFIED IN THE APPLICATION. BY EXECUTING THIS FORM, I ACKNOWLEDGE THAT I HAVE MADE INQUIRY REGARDING THE COMPETENCE OF THE LICENSED OR CERTIFIED PRIVATE PROVIDER AND AM SATISFIED THAT MY INTERESTS ARE ADEQUATELY PROTECTED. I AGREE TO INDEMNIFY, DEFEND, AND HOLD HARMLESS THE DEPARTMENT FROM ANY CLAIMS ARISING FROM MY USE OF THE LICENSED OR CERTIFIED PRIVATE PROVIDER IDENTIFIED IN THE APPLICATION TO PERFORM THE ONSITE SEWAGE TREATMENT AND DISPOSAL SYSTEM INSPECTION THAT IS THE SUBJECT OF THE ENCLOSED PERMIT APPLICATION. ADDITIONALLY, I UNDERSTAND THAT IN THE EVENT THE ONSITE SEWAGE TREATMENT AND DISPOSAL SYSTEM DOES NOT COMPLY WITH APPLICABLE RULES AND LAW, I WILL BE RESPONSIBLE FOR REMEDIATING THE SYSTEM IN ACCORDANCE WITH EXISTING LAW.
If an owner or authorized contractor makes any changes to the listed private provider or the service to be performed by the private provider, the owner or the authorized contractor must update the notice to reflect the change within 1 business day after the change. The change of an authorized representative identified in the permit application does not require a revision of the permit, and the department may not charge a fee for making such change.
(e) The department may audit up to 25 percent of private providers each year to ensure the accurate performance of onsite sewage treatment and disposal system inspections. Work on an onsite sewage treatment and disposal system may proceed after inspection and approval by a private provider if the owner or authorized contractor has given notice of the inspection pursuant to paragraph (d), and, subsequent to such inspection and approval, such work may not be delayed for completion of an inspection audit by the department unless deficiencies are found in the audit.
(f) This subsection does not prevent the department from investigating complaints.
(g) By October 1, 2023, the department shall submit a report to the President of the Senate and the Speaker of the House of Representatives reviewing the use of private providers to perform onsite sewage treatment and disposal system inspections as authorized by this subsection. The report must include, at a minimum, the number of such inspections performed by private providers.
(h) The department shall adopt rules to implement this subsection and must initiate such rulemaking by August 31, 2022.
(9) CONTRACT OR DELEGATION AUTHORITY.—The department may contract with or delegate its powers and duties under this section to a county as provided in s. 403.061 or s. 403.182.
“The Legislature intends that the transfer of the regulation of the Onsite Sewage Program from the Department of Health to the Department of Environmental Protection, as required by the Clean Waterways Act, chapter 2020-150, Laws of Florida, be completed in a phased approach.
“(1) Before the phased transfer, the Department of Environmental Protection shall coordinate with the Department of Health to identify equipment and vehicles that were previously used to carry out the program in each county and that are no longer needed for such purpose. The Department of Health shall transfer the agreed-upon equipment and vehicles to the Department of Environmental Protection, to the extent that each county agrees to relinquish ownership of such equipment and vehicles to the Department of Health.
“(2) When the Department of Environmental Protection begins implementing the program within a county, the Department of Health may no longer implement or collect fees for the program unless specified by separate delegation or contract with the Department of Environmental Protection.”
Note.—Former s. 381.272.
381.00651 Periodic evaluation and assessment of onsite sewage treatment and disposal systems.—
(1) For the purposes of this section, the term “first magnitude spring” means a spring that has a median water discharge of greater than or equal to 100 cubic feet per second for the period of record, as determined by the Department of Environmental Protection.
(2) A county or municipality that contains a first magnitude spring shall, by no later than January 1, 2013, develop and adopt by local ordinance an onsite sewage treatment and disposal system evaluation and assessment program that meets the requirements of this section. The ordinance may apply within all or part of its geographic area. Those counties or municipalities containing a first magnitude spring which have already adopted an onsite sewage treatment and disposal system evaluation and assessment program and which meet the grandfathering requirements contained in this section, or have chosen to opt out of this section in the manner provided herein, are exempt from the requirement to adopt an ordinance implementing an evaluation and assessment program. The governing body of a local government that chooses to opt out of this section, by a 60 percent vote of the voting members of the governing board, shall do so by adopting a resolution that indicates an intent on the part of such local government not to adopt an onsite sewage treatment and disposal system evaluation and assessment program. Such resolution shall be addressed and transmitted to the Secretary of State. Absent an interlocal agreement or county charter provision to the contrary, a municipality may elect to opt out of the requirements of this section, by a 60 percent vote of the voting members of the governing board, notwithstanding a contrary decision of the governing body of a county. Any local government that has properly opted out of this section but subsequently chooses to adopt an evaluation and assessment program may do so only pursuant to the requirements of this section and may not deviate from such requirements.
(3) Any county or municipality that does not contain a first magnitude spring may at any time develop and adopt by local ordinance an onsite sewage treatment and disposal system evaluation and assessment program, provided such program meets and does not deviate from the requirements of this section.
(4) Notwithstanding any other provision in this section, a county or municipality that has adopted a program before July 1, 2011, may continue to enforce its current program without having to meet the requirements of this section, provided such program does not require an evaluation at the point of sale in a real estate transaction.
(5) Any county or municipality may repeal an ordinance adopted pursuant to this section only if the county or municipality notifies the Secretary of State by letter of the repeal. No county or municipality may adopt an onsite sewage treatment and disposal system evaluation and assessment program except pursuant to this section.
(6) The requirements for an onsite sewage treatment and disposal system evaluation and assessment program are as follows:
(a) Evaluations.—An evaluation of each onsite sewage treatment and disposal system within all or part of the county’s or municipality’s jurisdiction must take place once every 5 years to assess the fundamental operational condition of the system and to identify system failures. The ordinance may not mandate an evaluation at the point of sale in a real estate transaction and may not require a soil examination. The location of the system shall be identified. A tank and drainfield evaluation and a written assessment of the overall condition of the system pursuant to the assessment procedure prescribed in subsection (7) are required.
(b) Qualified contractors.—Each evaluation required under this subsection must be performed by a qualified contractor, who may be a septic tank contractor or master septic tank contractor registered under part III of chapter 489, a professional engineer having wastewater treatment system experience and licensed under chapter 471, or an environmental health professional certified under this chapter in the area of onsite sewage treatment and disposal system evaluation. Evaluations and pump-outs may also be performed by an authorized employee working under the supervision of an individual listed in this paragraph; however, all evaluation forms must be signed by a qualified contractor in writing or by electronic signature.
(c) Repair of systems.—The local ordinance may not require a repair, modification, or replacement of a system as a result of an evaluation unless the evaluation identifies a system failure. For purposes of this subsection, the term “system failure” means a condition existing within an onsite sewage treatment and disposal system which results in the discharge of untreated or partially treated wastewater onto the ground surface or into surface water or that results in the failure of building plumbing to discharge properly and presents a sanitary nuisance. A system is not in failure if the system does not have a minimum separation distance between the drainfield and the wettest season water table or if an obstruction in a sanitary line or an effluent screen or filter prevents effluent from flowing into a drainfield. If a system failure is identified and several allowable remedial measures are available to resolve the failure, the system owner may choose the least costly allowable remedial measure to fix the system. There may be instances in which a pump-out is sufficient to resolve a system failure. Allowable remedial measures to resolve a system failure are limited to what is necessary to resolve the failure and must meet, to the maximum extent practicable, the requirements of the repair code in effect when the repair is made, subject to the exceptions specified in s. 381.0065(4)(g). An engineer-designed performance-based treatment system to reduce nutrients may not be required as an alternative remediation measure to resolve the failure of a conventional system.
(d) Exemptions.—
1. The local ordinance shall exempt from the evaluation requirements any system that is required to obtain an operating permit pursuant to state law or that is inspected by the department pursuant to the annual permit inspection requirements of chapter 513.
2. The local ordinance may provide for an exemption or an extension of time to obtain an evaluation and assessment if connection to a sewer system is available, connection to the sewer system is imminent, and written arrangements for payment of any utility assessments or connection fees have been made by the system owner.
3. An onsite sewage treatment and disposal system serving a residential dwelling unit on a lot with a ratio of one bedroom per acre or greater is exempt from the requirements of this section and may not be included in any onsite sewage treatment and disposal system inspection program.
(7) The following procedures shall be used for conducting evaluations:
(a) Tank evaluation.—The tank evaluation shall assess the apparent structural condition and watertightness of the tank and shall estimate the size of the tank. The evaluation must include a pump-out. However, an ordinance may not require a pump-out if there is documentation indicating that a tank pump-out or a permitted new installation, repair, or modification of the system has occurred within the previous 5 years, identifying the capacity of the tank, and indicating that the condition of the tank is structurally sound and watertight. Visual inspection of the tank must be made when the tank is empty to detect cracks, leaks, or other defects. Baffles or tees must be checked to ensure that they are intact and secure. The evaluation shall note the presence and condition of outlet devices, effluent filters, and compartment walls; any structural defect in the tank; the condition and fit of the tank lid, including manholes; whether surface water can infiltrate the tank; and whether the tank was pumped out. If the tank, in the opinion of the qualified contractor, is in danger of being damaged by leaving the tank empty after inspection, the tank shall be refilled before concluding the inspection. Broken or damaged lids or manholes shall be replaced without obtaining a repair permit.
(b) Drainfield evaluation.—The drainfield evaluation must include a determination of the approximate size and location of the drainfield. The evaluation shall state whether there is any sewage or effluent visible on the ground or discharging to a ditch or other water body and the location of any downspout or other source of water near or in the vicinity of the drainfield.
(c) Special circumstances.—If the system contains pumps, siphons, or alarms, the following information may be provided at the request of the homeowner:
1. An assessment of dosing tank integrity, including the approximate volume and the type of material used in the tank’s construction;
2. Whether the pump is elevated off the bottom of the chamber and its operational status;
3. Whether the system has a check valve and purge hole; and
4. Whether the system has a high-water alarm, and if so whether the alarm is audio or visual or both, the location and operational condition of the alarm, and whether the electrical connections to the alarm appear satisfactory.
If the homeowner does not request this information, the qualified contractor and its employee are not liable for any damages directly relating from a failure of the system’s pumps, siphons, or alarms. This exclusion of liability must be stated on the front cover of the report required under paragraph (d).
(d) Assessment procedure.—All evaluation procedures used by a qualified contractor shall be documented in the environmental health database of the Department of Environmental Protection. The qualified contractor shall provide a copy of a written, signed evaluation report to the property owner upon completion of the evaluation and to the county health department within 30 days after the evaluation. The report must contain the name and license number of the company providing the report. A copy of the evaluation report shall be retained by the local county health department for a minimum of 5 years and until a subsequent inspection report is filed. The front cover of the report must identify any system failure and include a clear and conspicuous notice to the owner that the owner has a right to have any remediation of the failure performed by a qualified contractor other than the contractor performing the evaluation. The report must further identify any crack, leak, improper fit, or other defect in the tank, manhole, or lid, and any other damaged or missing component; any sewage or effluent visible on the ground or discharging to a ditch or other surface water body; any downspout, stormwater, or other source of water directed onto or toward the system; and any other maintenance need or condition of the system at the time of the evaluation which, in the opinion of the qualified contractor, would possibly interfere with or restrict any future repair or modification to the existing system. The report shall conclude with an overall assessment of the fundamental operational condition of the system.
(8) The county health department, in coordination with the department, shall administer any evaluation program on behalf of a county, or a municipality within the county, that has adopted an evaluation program pursuant to this section. In order to administer the evaluation program, the county or municipality, in consultation with the county health department, may develop a reasonable fee schedule to be used solely to pay for the costs of administering the evaluation program. Such a fee schedule shall be identified in the ordinance that adopts the evaluation program. When arriving at a reasonable fee schedule, the estimated annual revenues to be derived from fees may not exceed reasonable estimated annual costs of the program. Fees shall be assessed to the system owner during an inspection and separately identified on the invoice of the qualified contractor. Fees shall be remitted by the qualified contractor to the county health department. The county health department’s administrative responsibilities include the following:
(a) Providing a notice to the system owner at least 60 days before the system is due for an evaluation. The notice may include information on the proper maintenance of onsite sewage treatment and disposal systems.
(b) In consultation with the department, providing uniform disciplinary procedures and penalties for qualified contractors who do not comply with the requirements of the adopted ordinance, including, but not limited to, failure to provide the evaluation report as required in this subsection to the system owner and the county health department. Only the county health department may assess penalties against system owners for failure to comply with the adopted ordinance, consistent with existing requirements of law.
(9)(a) A county or municipality that adopts an onsite sewage treatment and disposal system evaluation and assessment program pursuant to this section shall notify the Secretary of Environmental Protection, the Department of Health, and the applicable county health department upon the adoption of its ordinance establishing the program.
(b) Upon receipt of the notice under paragraph (a), the department shall, within existing resources, notify the county or municipality of the potential use of, and access to, program funds under the Clean Water State Revolving Fund or s. 319 of the Clean Water Act, provide guidance in the application process to receive such moneys, and provide advice and technical assistance to the county or municipality on how to establish a low-interest revolving loan program or how to model a revolving loan program after the low-interest loan program of the Clean Water State Revolving Fund. This paragraph does not obligate the department to provide any county or municipality with money to fund such programs.
(c) The department may not adopt any rule that alters this section.
(d) The department must allow county health departments and qualified contractors access to the environmental health database to track relevant information and assimilate data from assessment and evaluation reports of the overall condition of onsite sewage treatment and disposal systems. The environmental health database must be used by contractors to report each service and evaluation event and by a county health department to notify owners of onsite sewage treatment and disposal systems when evaluations are due. Data and information must be recorded and updated as service and evaluations are conducted and reported.
(10) This section does not:
(a) Limit county and municipal home rule authority to act outside the scope of the evaluation and assessment program set forth in this section;
(b) Repeal or affect any other law relating to the subject matter of onsite sewage treatment and disposal systems; or
(c) Prohibit a county or municipality from:
1. Enforcing existing ordinances or adopting new ordinances relating to onsite sewage treatment facilities to address public health and safety if such ordinances do not repeal, suspend, or alter the requirements or limitations of this section.
2. Adopting local environmental and pollution abatement ordinances for water quality improvement as provided for by law if such ordinances do not repeal, suspend, or alter the requirements or limitations of this section.
3. Exercising its independent and existing authority to meet the requirements of s. 381.0065.
381.00655 Connection of existing onsite sewage treatment and disposal systems to central sewerage system; requirements.—
(1)(a) The owner of a properly functioning onsite sewage treatment and disposal system, excluding an approved onsite graywater system, must connect the system or the building’s plumbing to an available publicly owned or investor-owned sewerage system within 365 days after written notification by the owner of the publicly owned or investor-owned sewerage system that the system is available for connection. The publicly owned or investor-owned sewerage system must notify the owner of the onsite sewage treatment and disposal system of the availability of the central sewerage system. No less than 1 year prior to the date the sewerage system will become available, the publicly owned or investor-owned sewerage system shall notify the affected owner of the onsite sewage treatment and disposal system of the anticipated availability of the sewerage system and shall also notify the owner that the owner will be required to connect to the sewerage system within 1 year of the actual availability. The owner shall have the option of prepaying the amortized value of required connection charges in equal monthly installments over a period not to exceed 2 years from the date of the initial notification of anticipated availability. Nothing in this section shall operate to impair contracts or other binding obligations relating to payment schedules in existence as of October 1, 1993. Nothing in this paragraph limits the power of a municipality or county to enforce other laws for the protection of the public health and safety.
(b) The owner of an onsite sewage treatment and disposal system that needs repair or modification to function in a sanitary manner or to comply with the requirements of ss. 381.0065-381.0067 or rules adopted under those sections must connect to an available publicly owned or investor-owned sewerage system within 90 days after written notification from the department. In hardship cases, upon request of the owner, the department may approve an extension of not more than 90 days for sewerage connection. The department may approve only one extension. This paragraph does not authorize the owner of the onsite sewage treatment and disposal system to create or maintain a sanitary nuisance.
(2) The provisions of subsection (1) or any other provision of law to the contrary notwithstanding:
(a) The local governing body of the jurisdiction in which the owner of the onsite sewage treatment and disposal system resides may provide that any connection fee charged under this section by an investor-owned sewerage system may be paid without interest in monthly installments, over a period of time not to exceed 5 years from the date the sewerage system becomes available if it determines that the owner has demonstrated a financial hardship. The local governing body shall establish criteria for making this determination which take into account the owner’s net worth, income, and financial needs.
(b) A publicly owned or investor-owned sewerage system may, with the approval of the department, waive the requirement of mandatory onsite sewage disposal connection if it determines that such connection is not required in the public interest due to public health considerations.
(c) A local government or water and sewer district responsible for the operation of a centralized sewer system under s. 153.62 may grant a variance to an owner of a performance-based onsite sewage treatment and disposal system permitted by the department as long as the onsite system is functioning properly and satisfying the conditions of the operating permit. Nothing in this paragraph shall be construed to require a local government or water and sewer district to issue a variance under any circumstance. Nothing in this paragraph shall be construed as limiting local government authority to enact ordinances under s. 4, chapter 99-395, Laws of Florida. A local government or water and sewer district located in any of the following areas shall not be required to issue a variance under any circumstance:
1. An area of critical state concern.
2. An area that was designated as an area of critical state concern for at least 20 consecutive years prior to removal of the designation.
3. An area in the South Florida Water Management District west C-11 basin that discharges through the S-9 pump into the Everglades.
4. An area designated by the Lake Okeechobee Protection Act.
(3) Local governmental agencies, as defined in s. 403.1835(2), that receive grants or loans from the department to offset the cost of connecting onsite sewage treatment and disposal systems to publicly owned or investor-owned sewerage systems are encouraged to do all of the following while such funds remain available:
(a) Identify the owners of onsite sewage treatment and disposal systems within the jurisdiction of the respective local governmental agency who are eligible to apply for the grant or loan funds and notify such owners of the funding availability.
(b) Maintain a publicly available website with information relating to the availability of the grant or loan funds, including the amount of funds available and information on how the owner of an onsite sewage treatment and disposal system may apply for such funds.
381.0066 Onsite sewage treatment and disposal systems; fees.—
(1) The department may collect fees for services provided with respect to onsite sewage treatment and disposal systems. The total fees assessed under this section must be sufficient to meet the cost of administering this section and ss. 381.0065 and 381.00655.
(2) The minimum fees in the following fee schedule apply until changed by rule by the department within the following limits:
(a) Application review, permit issuance, or system inspection, when performed by the department or a private provider inspector, including repair of a subsurface, mound, filled, or other alternative system or permitting of an abandoned system: a fee of not less than $25, or more than $125.
(b) Site evaluation, site reevaluation, evaluation of a system previously in use, or a per annum septage disposal site evaluation: a fee of not less than $40, or more than $115.
(c) Biennial operating permit for aerobic treatment units or performance-based treatment systems: a fee of not more than $100.
(d) Annual operating permit for systems located in areas zoned for industrial manufacturing or equivalent uses or where the system is expected to receive wastewater which is not domestic in nature: a fee of not less than $150, or more than $300.
(e) Innovative technology: a fee not to exceed $25,000.
(f) Septage disposal service, septage stabilization facility, portable or temporary toilet service, tank manufacturer inspection: a fee of not less than $25, or more than $200, per year.
(g) Application for variance: a fee of not less than $150, or more than $300.
(h) Annual operating permit for waterless, incinerating, or organic waste composting toilets: a fee of not less than $15, or more than $30.
(i) Aerobic treatment unit or performance-based treatment system maintenance entity permit: a fee of not less than $25, or more than $150, per year.
(j) Reinspection fee per visit for site inspection after system construction approval or for noncompliant system installation per site visit: a fee of not less than $25, or more than $100.
(k) Research: An additional $5 fee shall be added to each new system construction permit issued to be used to fund onsite sewage treatment and disposal system research, demonstration, and training projects. Five dollars from any repair permit fee collected under this section shall be used for funding the hands-on training centers described in s. 381.0065(3)(j).
(l) Annual operating permit, including annual inspection and any required sampling and laboratory analysis of effluent, for an engineer-designed performance-based system: a fee of not less than $150, or more than $300.
The funds collected pursuant to this subsection for the implementation of onsite sewage treatment and disposal system regulation and for the purposes of ss. 381.00655 and 381.0067, subsequent to any phased transfer of implementation from the Department of Health to the department within any county pursuant to s. 381.0065, must be deposited in the Florida Permit Fee Trust Fund under s. 403.0871, to be administered by the department.
381.0067 Corrective orders; private and certain public water systems and onsite sewage treatment and disposal systems.—When the department or its agents, through investigation, find that any private water system, public water system not covered or included in the Florida Safe Drinking Water Act (part VI of chapter 403), or onsite sewage treatment and disposal system constitutes a nuisance or menace to the public health or significantly degrades the groundwater or surface water, the department or its agents may issue an order requiring the owner to correct the improper condition. If the improper condition relates to the drainfield of an onsite sewage treatment and disposal system, the department or its agents may issue an order requiring the owner to repair or replace the drainfield. If an onsite sewage treatment and disposal system has failed, the department or its agents shall issue an order requiring the owner to replace the system. For purposes of this section, an onsite sewage treatment and disposal system has failed if the operation of the system constitutes a nuisance or menace to the public health or significantly degrades the groundwater or surface water and the system cannot be repaired.
History.—s. 2, ch. 29834, 1955; ss. 19, 35, ch. 69-106; s. 74, ch. 77-147; s. 17, ch. 77-337; s. 28, ch. 91-297; s. 6, ch. 93-151; s. 6, ch. 2006-252.
Note.—Former s. 381.291.
381.0072 Food service protection.—
(1) DEPARTMENT OF HEALTH; SANITATION RULES.—
(a) It shall be the duty of the Department of Health to adopt and enforce sanitation rules consistent with law to ensure the protection of the public from food-borne illness. These rules shall provide the standards and requirements for the storage, preparation, serving, or display of food in food service establishments as defined in this section.
(b) A food service establishment is subject to the sanitation rules adopted and enforced by the department. This section does not apply to a food service establishment permitted or licensed under chapter 500 or a public food service establishment licensed under chapter 509 unless the public food service establishment is a culinary education program licensed under chapter 509.
(2) DEFINITIONS.—As used in this section, the term:
(a) “Culinary education program” means a program that:
1. Educates enrolled students in the culinary arts, including the preparation, cooking, and presentation of food, or provides education and experience in culinary arts-related businesses;
2. Is provided by:
a. A state university as defined in s. 1000.21;
b. A Florida College System institution as defined in s. 1000.21;
c. A career center as defined in s. 1001.44;
d. A charter technical career center as defined in s. 1002.34;
e. A nonprofit independent college or university that is located and chartered in this state and accredited by the Commission on Colleges of the Southern Association of Colleges and Schools to grant baccalaureate degrees, that is under the jurisdiction of the Department of Education, and that is eligible to participate in the William L. Boyd, IV, Effective Access to Student Education Grant Program; or
f. A nonpublic postsecondary educational institution licensed pursuant to part III of chapter 1005; and
3. Is inspected by any state agency or agencies for compliance with sanitation standards.
(b) “Department” means the Department of Health or its representative county health department.
(c) “Food service establishment” means detention facilities, public or private schools, migrant labor camps, assisted living facilities, facilities participating in the United States Department of Agriculture Afterschool Meal Program that are located at a facility or site that is not inspected by another state agency for compliance with sanitation standards, adult family-care homes, adult day care centers, short-term residential treatment centers, residential treatment facilities, homes for special services, transitional living facilities, crisis stabilization units, hospices, prescribed pediatric extended care centers, intermediate care facilities for persons with developmental disabilities, boarding schools, civic or fraternal organizations, bars and lounges, vending machines that dispense potentially hazardous foods at facilities expressly named in this paragraph, and facilities used as temporary food events or mobile food units at any facility expressly named in this paragraph, where food is prepared and intended for individual portion service, including the site at which individual portions are provided, regardless of whether consumption is on or off the premises and regardless of whether there is a charge for the food. The term includes a culinary education program where food is prepared and intended for individual portion service, regardless of whether there is a charge for the food or whether the program is inspected by another state agency for compliance with sanitation standards. The term does not include any entity not expressly named in this paragraph; nor does the term include a domestic violence center certified and monitored by the Department of Children and Families under part XII of chapter 39 if the center does not prepare and serve food to its residents and does not advertise food or drink for public consumption.
(d) “Operator” means the owner, operator, keeper, proprietor, lessee, manager, assistant manager, agent, or employee of a food service establishment.
(3) DUTIES.—
(a) The department may advise and consult with the Agency for Health Care Administration, the Department of Business and Professional Regulation, the Department of Agriculture and Consumer Services, and the Department of Children and Families concerning procedures related to the storage, preparation, serving, or display of food at any building, structure, or facility not expressly included in this section that is inspected, licensed, or regulated by those agencies.
(b) The department shall adopt rules, including definitions of terms which are consistent with law prescribing minimum sanitation standards and manager certification requirements as prescribed in s. 509.039, and which shall be enforced in food service establishments as defined in this section. The sanitation standards must address the construction, operation, and maintenance of the establishment; lighting, ventilation, laundry rooms, lockers, use and storage of toxic materials and cleaning compounds, and first-aid supplies; plan review; design, construction, installation, location, maintenance, sanitation, and storage of food equipment and utensils; employee training, health, hygiene, and work practices; food supplies, preparation, storage, transportation, and service, including access to the areas where food is stored or prepared; and sanitary facilities and controls, including water supply and sewage disposal; plumbing and toilet facilities; garbage and refuse collection, storage, and disposal; and vermin control. Public and private schools, if the food service is operated by school employees, bars and lounges, civic organizations, and any other facility that is not regulated under this section are exempt from the rules developed for manager certification. The department shall administer a comprehensive inspection, monitoring, and sampling program to ensure such standards are maintained. With respect to food service establishments permitted or licensed under chapter 500 or chapter 509, the department shall assist the Division of Hotels and Restaurants of the Department of Business and Professional Regulation and the Department of Agriculture and Consumer Services with rulemaking by providing technical information.
(c) The department shall carry out all provisions of this chapter and all other applicable laws and rules relating to the inspection or regulation of food service establishments as defined in this section, for the purpose of safeguarding the public’s health, safety, and welfare.
(d) The department shall inspect each food service establishment as often as necessary to ensure compliance with applicable laws and rules. The department shall have the right of entry and access to these food service establishments at any reasonable time. In inspecting food service establishments under this section, the department shall provide each inspected establishment with the food recovery brochure developed under s. 595.420.
(e) The department or other appropriate regulatory entity may inspect theaters to ensure compliance with applicable laws and rules pertaining to minimum sanitation standards. A fee for inspection shall be prescribed by rule, but the aggregate amount charged per year per theater establishment shall not exceed $300, regardless of the entity providing the inspection.
(4) LICENSES REQUIRED.—
(a) Licenses; annual renewals.—Each food service establishment regulated under this section shall obtain a license from the department annually. Food service establishment licenses shall expire annually and are not transferable from one place or individual to another. However, those facilities licensed by the department’s Office of Licensure and Certification, the Child Care Services Program Office, or the Agency for Persons with Disabilities are exempt from this subsection. It shall be a misdemeanor of the second degree, punishable as provided in s. 381.0061, s. 775.082, or s. 775.083, for such an establishment to operate without this license. The department may refuse a license, or a renewal thereof, to any establishment that is not constructed or maintained in accordance with law and with the rules of the department. Annual application for renewal is not required.
(b) Application for license.—Each person who plans to open a food service establishment regulated under this section and not regulated under chapter 500 or chapter 509 shall apply for and receive a license prior to the commencement of operation.
(5) LICENSE; INSPECTION; FEES.—
(a) The department is authorized to collect fees from establishments licensed under this section and from those facilities exempted from licensure under paragraph (4)(a). It is the intent of the Legislature that the total fees assessed under this section be in an amount sufficient to meet the cost of carrying out the provisions of this section.
(b) The fee schedule for food service establishments licensed under this section shall be prescribed by rule, but the aggregate license fee per establishment shall not exceed $300.
(c) The license fees shall be prorated on a quarterly basis. Annual licenses shall be renewed as prescribed by rule.
(6) FINES; SUSPENSION OR REVOCATION OF LICENSES; PROCEDURE.—
(a) The department may impose fines against the establishment or operator regulated under this section for violations of sanitary standards, in accordance with s. 381.0061. All amounts collected shall be deposited to the credit of the County Health Department Trust Fund administered by the department.
(b) The department may suspend or revoke the license of any food service establishment licensed under this section that has operated or is operating in violation of any of the provisions of this section or the rules adopted under this section. Such food service establishment shall remain closed when its license is suspended or revoked.
(c) The department may suspend or revoke the license of any food service establishment licensed under this section when such establishment has been deemed by the department to be an imminent danger to the public’s health for failure to meet sanitation standards or other applicable regulatory standards.
(d) No license shall be suspended under this section for a period of more than 12 months. At the end of such period of suspension, the establishment may apply for reinstatement or renewal of the license. A food service establishment which has had its license revoked may not apply for another license for that location prior to the date on which the revoked license would have expired.
(7) IMMINENT DANGERS; STOP-SALE ORDERS.—
(a) In the course of epidemiological investigations or for those establishments regulated by the department under this chapter, the department, to protect the public from food that is unwholesome or otherwise unfit for human consumption, may examine, sample, seize, and stop the sale or use of food to determine its condition. The department may stop the sale and supervise the proper destruction of food when the State Health Officer or his or her designee determines that such food represents a threat to the public health.
(b) The department may determine that a food service establishment regulated under this section is an imminent danger to the public health and require its immediate closure when such establishment fails to comply with applicable sanitary and safety standards and, because of such failure, presents an imminent threat to the public’s health, safety, and welfare. The department may accept inspection results from state and local building and firesafety officials and other regulatory agencies as justification for such actions. Any facility so deemed and closed shall remain closed until allowed by the department or by judicial order to reopen.
(8) MISREPRESENTING FOOD OR FOOD PRODUCTS.—No operator of any food service establishment regulated under this section shall knowingly and willfully misrepresent the identity of any food or food product to any of the patrons of such establishment. Food used by food establishments shall be identified, labeled, and advertised in accordance with the provisions of chapter 500.
(1) LEGISLATIVE INTENT.—It is the intent of the Legislature to protect the health, safety, and welfare of the public from the spread of infectious diseases from practices that prick, pierce, or scar the skin and therefore, to that end, to regulate body-piercing salons.
(2) DEFINITIONS.—As used in this section:
(a) “Body piercing” means for commercial purposes the act of penetrating the skin to make, generally permanent in nature, a hole, mark, or scar. “Body piercing” does not include the use of a mechanized, presterilized ear-piercing system that penetrates the outer perimeter or lobe of the ear or both.
(b) “Body-piercing salon” means a place where body piercing occurs.
(c) “Department” means the Department of Health.
(d) “Establishment” means a body-piercing salon as defined in this section.
(e) “Jewelry” means any personal ornament inserted into a pierced area other than the outer perimeter or lobe of the ear.
(f) “Licensee” means any person licensed under this section who is responsible for compliance with this section and the rules adopted under this section.
(g) “Operator” means an individual designated by a licensee to control the operation of an establishment.
(h) “Person” means any individual, partnership, corporation, or association.
(i) “Safe level” means not more than 50 colonies of microorganisms per 4 square inches of equipment or device surface.
(j) “Sanitization” means the effective bactericidal treatment of surfaces of equipment and devices by a product registered by the United States Environmental Protection Agency which provides a sufficient concentration of chemicals and enough time to reduce the bacterial count, including pathogens, to a safe level.
(k) “Sterilization” means the use of procedures that destroy all microbial life, including viruses, on the equipment or device.
(l) “Stop-use order” means a written notice from the department to a licensee requiring the licensee to remove a piece of equipment or cease conducting a particular procedure because the equipment is not being operated or the procedure conducted in accordance with the requirements of this section or any rule adopted pursuant thereto.
(m) “Temporary establishment” means a body-piercing establishment that operates at a fixed location for a period of time of not more than 14 consecutive days in conjunction with a single event or celebration.
(3) EXEMPTIONS.—This section does not apply to the practice of any licensed health care professional under the regulatory jurisdiction of the department as long as the person does not hold himself or herself out as a body-piercing establishment.
(4) LICENSE REQUIRED.—
(a) A person may not operate an establishment unless it is licensed under this section.
(b) Any person operating an establishment must obtain a license from the department annually.
(c) A license for an establishment is not transferable from one place or person to another.
(d) A license automatically expires on September 30 of each year unless renewed by the department upon the request of the licensee.
(e) A current license must be displayed in a public area of the establishment.
(f) A person operating a temporary establishment must receive a temporary license from the department prior to operation. The department must be contacted at least 7 days prior to commencement of operation of the establishment and must conduct an inspection of the establishment to ensure compliance with licensing requirements prior to issuing the temporary license.
(5) LICENSE APPLICATION.—
(a) A person must apply to the department for an establishment license prior to commencement of operation and must apply for annual renewal of the license in order to continue operation.
(b) Application for an initial license or the renewal of a license must be on a form provided by the department and must be accompanied by the annual or prorated fee required in this section.
(c) The licensee must report any change in the application information to the department before the change may be put into operation.
(6) FEES.—
(a) Fees assessed under this section shall be reasonably calculated to cover the cost of regulation under this section, may be used only to meet the costs of carrying out the requirements of this section, and are nonrefundable.
(b) A person applying for initial licensure or reactivation of an expired license at the beginning of the licensing period or for renewal of a license shall pay the full fee. All other applicants, whether for initial licensure or reactivation of an expired license, shall pay a prorated fee based on the number of quarters left until September 30.
(c) Fees must be received by the department within 30 days after receipt of written notification from the department that a fee is due. Failure to pay timely will result in the assessment of a late fee. Fees are payable to the county health department in the county where the establishment is located.
(d) The fees assessed under this section are, unless prorated, as follows:
1. The annual license fee, or license renewal fee, for a body-piercing salon is $150.
2. Each late fee is $100.
3. The fee for a temporary establishment license is $75.
(7) MINORS.—A person may not perform body piercing on a minor without the written notarized consent of the minor’s parent or legal guardian, and an establishment may not perform body piercing on a minor under the age of 16 unless the minor is accompanied by a parent or legal guardian.
(8) PROHIBITED ACTS; PENALTIES; INJUNCTION.—
(a) Each of the following acts constitutes a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084:
1. Owning, operating, or soliciting business as an establishment in this state without first procuring a license from the department, unless specifically exempted by this section.
2. Obtaining or attempting to obtain a license to operate an establishment by means of fraud, misrepresentation, or concealment.
(b) Each of the following acts constitutes a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083:
1. Failing to maintain the records required by this section or knowingly making false entries in such records.
2. Failing to comply with the requirements regarding minors set forth in subsection (7).
(c) In addition to any other punishment provided for, the court may suspend or revoke the license of any licensee under this section who has been found guilty of any violation of paragraph (a) or paragraph (b).
(d) If the department or any state attorney has probable cause to believe that an establishment or person has violated any provision of paragraph (a), an action may be brought by the department or the state attorney to enjoin such establishment or person from continuing such violation, or engaging therein or doing any acts in furtherance thereof, and the court may provide any other relief it deems appropriate.
(9) ENFORCEMENT.—
(a) The department shall inspect or investigate an establishment as necessary, but at least annually, to ensure compliance with this section. Department personnel may, at any reasonable time, enter any establishment licensed under this section or any premises the department has reason to believe is being operated or maintained in violation of this section, to determine compliance with this section or any rule adopted under this section.
(b) The department may impose an administrative fine, not to exceed $1,000 per violation per day, for the violation of any provision of this section, any rule adopted under this section, or any term or condition of any license issued under this section by the department.
(c) In determining the amount of fine to be levied for a violation, as provided in paragraph (b), the following factors shall be considered:
1. The severity of the violation and the extent to which the provisions of this section, the rules adopted under this section, or any terms or conditions of any license issued under this section were violated.
2. Actions taken by the licensee to correct the violation.
3. Any previous violations by the licensee.
(d) The department may issue a stop-use order, or institute legal action for injunctive or other relief, to enforce any provision of this section.
(e) The department may cancel, revoke, or suspend a license to operate an establishment if the licensee:
1. Fails to pay any fee required by this section;
2. Obtains or attempts to obtain a license under this section by fraud, misrepresentation, or concealment; or
3. Violates any provision of this section or any rule adopted under this section.
(f)1. The department may issue a citation that contains an order of correction or an order to pay a fine, or both, for any violation of this section or the rules adopted under this section, when the violation of the section or rule is enforceable by an administrative or civil remedy or when the violation of the section or rule is a misdemeanor of the second degree. A citation constitutes a notice of proposed agency action.
2. A citation must be in writing and must describe the particular nature of the violation, including specific reference to the provision of law or rule allegedly violated.
3. The fines imposed by a citation may not exceed $1,000 for each violation. Each day the violation exists constitutes a separate violation for which a citation may be issued.
4. The department shall inform the recipient of a citation, by written notice pursuant to ss. 120.569 and 120.57, of the right to an administrative hearing to contest the citation within 21 days after the date the citation is received. The citation must contain a conspicuous statement that if the recipient fails to pay any fine levied against the recipient within the time allowed or fails to appear to contest the citation after having requested a hearing, the recipient has waived the recipient’s right to contest the citation and must pay the maximum fine.
5. The department may reduce or waive any fine imposed by a citation. In determining whether to reduce or waive a fine, the department must consider the gravity of the violation, the person’s attempts at correcting the violation, and the person’s history of previous violations for which enforcement actions were taken under this section.
6. Any person who willingly refuses to sign and accept a citation issued by the department commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
7. This paragraph provides an alternative means of enforcing this section, but does not prohibit the department from enforcing this section or the rules adopted under this section by any other means. However, the department may use only a single method of enforcement for each violation.
(g) The department shall deposit all fines it collects under this section in the County Health Department Trust Fund for use in providing services specified in this section.
(10) RULES.—The department has authority to adopt rules to implement this section. Such rules may include sanitation practices, sterilization requirements and procedures, patient record content requirements, personnel record retention requirements, patient notification requirements and procedures, physical plant requirements, light requirements, and enforcement procedures.
(11) BODY-PIERCING SALONS; SPECIFIC REQUIREMENTS.—
(a) A body-piercing salon must:
1. Properly sterilize all instruments that pierce the skin, directly aid in piercing the skin, or may come in contact with instruments that pierce the skin, through such means as storage in trays with other instruments or contact with forceps, in accordance with the sterilization procedures in this section.
2. Sanitize all equipment indirectly used in body piercing, including any beds, tables, headrests, armrests, legrests, or handrails.
3. Use protective infection barriers such as gloves and masks when serving a customer. If the protective barriers are contaminated, they must be properly disposed of immediately. Protective barriers may only be used once and only for one customer.
4. To the degree possible, thoroughly cleanse the area to be pierced with an antiseptic solution before and after the piercing.
5. Use only jewelry that is made of implant grade high-quality stainless steel, solid gold of at least 14K weight, niobium, titanium, platinum, a dense, low-porosity plastic, or silver and that is free of nicks, scratches, or irregular surfaces.
6. Provide each customer with written instructions on the proper care of the pierced area so as to prevent infection.
7. Maintain a record of each customer’s visit for a period of not less than 2 years, including, but not limited to, the customer’s name, date of visit, and area pierced and the name of the person performing the piercing.
8. Report any injury or any complaint of injury to the department on forms prescribed by the department and provide a copy of the report to the complainant.
(b) Sterilization procedures must include the following:
1. Proper autoclaving must be done according to the autoclave manufacturer’s instructions.
2. There must be a sterilization indicator in each autoclaving to monitor the sterilization procedure. The indicator must indicate exposure to steam and 250° Fahrenheit.
3. Contaminated instruments must be sterilized in the following manner:
a. The contaminated instruments must be thoroughly cleansed with an antiseptic solution, according to the instructions for the antiseptic solution, and hot water.
b. The contaminated instruments and all other instruments, must be packaged properly and loaded correctly into the autoclave.
c. The contaminated instruments must be sterilized by autoclave.
4. All sterilized instruments must be stored and handled in a manner that maintains sterility.
5. Autoclaves must be cleaned regularly and serviced at least once a year.
6. Each body-piercing salon utilizing autoclave sterilization techniques must post the sterilization procedures and ensure that personnel responsible for performing the sterilization procedures are adequately trained.
7. All staff must be trained in proper infection-control procedures.
8. Presterilized, prewrapped, disposable instruments may be used, but must be used in accordance with the manufacturer’s instructions.
(c) The body-piercing salon must be in compliance with s. 381.0098.
381.00771 Definitions of terms used in ss. 381.00771-381.00791.—As used in ss. 381.00771-381.00791, the term:
(1) “Active license or registration” means a current license or registration issued by the department that is not suspended or revoked.
(2) “Department” means the Department of Health.
(3) “Guest tattoo artist” means a person who is licensed, registered, or certified to practice tattooing in a jurisdiction outside of this state who is registered with the department to practice tattooing in this state.
(4) “Operator” means a person designated by a tattoo establishment or temporary establishment to control the operation of the establishment.
(5) “Stop-use order” means a written notice from the department to a licensee or registrant requiring him or her to remove any tattooing equipment or supplies, or cease conducting any particular procedures, because the equipment or supplies are not being used or the procedures are not being conducted in accordance with ss. 381.00771-381.00791 or any rule adopted under those sections.
(6) “Tattoo” means a mark or design made on or under the skin of a human being by a process of piercing and ingraining a pigment, dye, or ink in the skin.
(7) “Tattoo artist” means a person licensed under ss. 381.00771-381.00791 to practice tattooing.
(8) “Tattoo establishment” means any permanent location, place, area, structure, or business where tattooing is performed.
(9) “Temporary establishment” means any location, place, area, or structure where tattooing is performed during, and in conjunction with, a convention or other similar event that does not exceed 14 consecutive days.
381.00773 Application of ss. 381.00771-381.00791; exemption.—
(1) Except for s. 381.00787, which applies to all persons, ss. 381.00771-381.00791 do not apply to a person licensed to practice medicine or dentistry under chapter 458, chapter 459, or chapter 466 who performs tattooing exclusively for medical or dental purposes.
(2) Sections 381.00771-381.00791 apply exclusively to the tattooing of human beings and do not apply to the tattooing of any animal.
381.00775 Tattoo artists; licensure; registration of guest tattoo artists.—
(1) Except as provided in s. 381.00773, a person may not tattoo the body of any human being in this state unless the person is licensed as a tattoo artist or registered as a guest tattoo artist under this section.
(2)(a) A person seeking licensure as a tattoo artist must apply to the department in the format prescribed by the department. An application must include:
1. The name and residence address of the applicant.
2. The name and street address of each tattoo establishment and temporary establishment at which the applicant intends to practice tattooing in this state.
(b) The department shall issue a license to an applicant who:
1. Is 18 years of age or older.
2. Submits a completed application.
3. Pays the applicable license fee established in s. 381.00781.
4. Submits proof of successful completion of an education course approved by the department on blood-borne pathogens and communicable diseases.
5. Submits proof of passage of an examination approved by the department on the material presented in the education course.
(c) The department shall approve one or more education courses and examinations that allows a person to complete the requirements of subparagraphs (b)4. and 5. in person or through an Internet website.
(d) A tattoo artist must, within 30 days after a change, notify the department of any change in the following information disclosed in his or her most recent application for issuance or renewal of his or her tattoo artist license in the format prescribed by the department:
1. The name and residence address of the tattoo artist.
2. The name and street address of each tattoo establishment in this state at which the tattoo artist has practiced tattooing for more than 14 days since the most recent renewal of his or her tattoo artist license or, if the license has not been renewed, since the license was issued.
(3)(a) A person seeking registration as a guest tattoo artist must apply to the department in the format prescribed by the department. An application must include:
1. The name and residence address of the applicant.
2. The name and street address of each tattoo establishment and temporary establishment at which the applicant will practice under the guest tattoo artist registration.
(b) The department shall issue a guest tattoo artist registration to an applicant who:
1. Is 18 years of age or older.
2. Submits a completed application.
3. Pays the applicable registration fee established in s. 381.00781.
4. Holds an active license, registration, or certification issued by a jurisdiction outside this state, whether by another state, the District of Columbia, any possession or territory of the United States, or any foreign jurisdiction, if:
a. The education and examination requirements of the license, registration, or certification substantially meet or exceed the requirements of subparagraphs (2)(b)4. and 5.; or
b. The applicant submits proof of successful completion of an education course approved by the department under subparagraph (2)(b)4. and proof of passage of an examination approved by the department under subparagraph (2)(b)5.
(4)(a) A tattoo artist license is valid for 1 year and must be renewed annually.
(b) A guest tattoo artist registration is valid for 14 days. A guest tattoo artist may apply for reregistration before or after expiration of his or her current registration.
(5) A license or registration issued by the department under this section is not transferable.
(1)(a) Except as provided in s. 381.00773, a person may not tattoo the body of any human being in this state except at a tattoo establishment or temporary establishment licensed under this section.
(b) A person may not operate a tattoo establishment or temporary establishment in this state unless the establishment is licensed under this section.
(2) A person seeking licensure of a tattoo establishment must apply to the department in the format prescribed by the department. An application must include:
(a) The registered business name, including any fictitious names under which the tattoo establishment conducts business in the state.
(b) The street address and telephone number of the tattoo establishment.
(c) The name, mailing address, and telephone number of the tattoo establishment’s operator.
(d) The name and address of the tattoo establishment’s registered agent for service of process in the state.
(3) The department shall issue a tattoo establishment license to an applicant, if:
(a) The applicant submits a completed application.
(b) The applicant pays the applicable license fee established in s. 381.00781.
(c) The establishment complies with all applicable local building, occupational, zoning, and health codes.
(4) A temporary establishment must meet the same requirements for licensure as a permanent tattoo establishment.
(5)(a) A license is valid only for the location listed on the license. A tattoo establishment must notify the department in the format prescribed by the department before any change of the licensed location. A tattoo establishment with more than one location must obtain a separate license for each location.
(b) A tattoo establishment license is valid for 1 year and must be renewed annually.
(c) A temporary establishment license is valid for the duration of a convention or other similar event for which the license is issued not to exceed 14 consecutive days.
(6) A license issued by the department under this section is not transferable.
(1) A tattoo establishment or temporary establishment must:
(a) Display an active license for the establishment in a manner that is easily visible to the public at all times while tattooing is performed at the establishment.
(b) Ensure that each tattoo artist and guest tattoo artist, while practicing tattooing at the establishment, meets all applicable requirements of ss. 381.00771-381.00791.
(c) Maintain sanitary conditions of the establishment at all times.
(d) Comply with all state and local health codes and ordinances.
(e) Allow the department to inspect the establishment pursuant to subsection (4).
(f) Comply with s. 381.0098 and rules adopted under that section.
(2) A tattoo artist or guest tattoo artist must:
(a) Display his or her active license in a manner that is easily visible to the public at all times while practicing tattooing.
(b) Practice tattooing exclusively at an establishment licensed under ss. 381.00771-381.00791.
(c) Maintain sanitary conditions of the establishment at all times.
(d) Comply with all state and local health codes and ordinances.
(3) A tattoo artist or guest tattoo artist may tattoo the body of a minor child only to the extent authorized in s. 381.00787. A tattoo establishment or temporary establishment must keep, for the period prescribed by the department, each written notarized consent submitted under s. 381.00787(2)(c) by the parent or legal guardian of a minor child who is tattooed at the establishment.
(4) The department may inspect and investigate each tattoo establishment and temporary establishment as necessary to ensure compliance with ss. 381.00771-381.00791. However, the department shall inspect each tattoo establishment at least annually and shall inspect each temporary establishment before and, as necessary, during a convention or similar event with which the establishment is connected.
381.00781 Fees; disposition.—The department shall establish by rule the following fees:
(1) For the initial licensure of a tattoo establishment and the renewal of such license, a fee not to exceed $250 per year.
(2) For licensure of a temporary establishment, a fee not to exceed $250.
(3) For the initial licensure of a tattoo artist and the renewal of such license, a fee not to exceed $150 per year.
(4) For registration or reregistration of a guest tattoo artist, a fee not to exceed $45.
(5) For reactivation of an inactive tattoo establishment license or tattoo artist license. A license becomes inactive if it is not renewed before the expiration of the current license.
381.00783 Grounds for discipline; administrative penalties.—
(1) The following acts constitute grounds for which disciplinary action specified in subsection (2) may be taken by the department against any tattoo establishment, temporary establishment, tattoo artist, guest tattoo artist, operator of a tattoo establishment, or unlicensed person engaged in activities regulated under ss. 381.00771-381.00791:
(a) Providing false information on an application for licensure or registration.
(b) Violating a state or local health code or ordinance.
(c) Violating any provision of ss. 381.00771-381.00791, rule adopted under those sections, or lawful order of the department.
(d) Being found guilty of or pleading nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of tattooing or the operation of a tattoo establishment or temporary establishment.
(e) Committing fraud, deceit, negligence, or misconduct in the practice of tattooing or the operation of a tattoo establishment or temporary establishment.
(f) Aiding, procuring, or assisting a person to unlawfully practice tattooing or unlawfully operate a tattoo establishment or temporary establishment.
(g) Failing to keep the written notarized consent of the parent or legal guardian of a minor child who is tattooed at a tattoo establishment or temporary establishment for the period specified pursuant to s. 381.00779(3) or knowingly making false entries in a parent’s or legal guardian’s written notarized consent.
(2) When the department determines that a person commits any of the acts set forth in subsection (1), the department may enter an order imposing one or more of the following penalties:
(a) Refusal to issue a license or registration or renew a license.
(b) Suspension or revocation of a license or registration.
(c) Imposition of an administrative fine not to exceed $1,500 for each count or separate violation.
(d) Issuance of a reprimand.
(e) Placement of the licensee or registrant on probation for a specified period and subject to the conditions that the department may specify.
(f) Issuance of a stop-use order.
(g) Corrective action.
(3) The department shall impose stricter penalties for the repetition of violations and as the severity of violations escalate, distinguishing lesser violations from those that endanger the public health.
(4) Disciplinary proceedings shall be conducted as provided in chapter 120.
(1) A person may not tattoo the body of a minor child younger than 16 years of age unless the tattooing is performed for medical or dental purposes by a person licensed to practice medicine or dentistry under chapter 458, chapter 459, or chapter 466.
(2) A person may not tattoo the body of a minor child who is at least 16 years of age, but younger than 18 years of age, unless:
(a) The minor child is accompanied by his or her parent or legal guardian;
(b) The minor child and his or her parent or legal guardian each submit proof of his or her identity by producing a government-issued photo identification;
(c) The parent or legal guardian submits his or her written notarized consent in the format prescribed by the department;
(d) The parent or legal guardian submits proof that he or she is the parent or legal guardian of the minor child; and
(e) The tattooing is performed by a tattoo artist or guest tattoo artist licensed under ss. 381.00771-381.00791 or a person licensed to practice medicine or dentistry under chapter 458, chapter 459, or chapter 466.
(3) A person who violates this section commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083. However, a person who tattoos the body of a minor child younger than 18 years of age does not violate this section, if:
(a) The person carefully inspects what appears to be a government-issued photo identification that represents that the minor child is 18 years of age or older.
(b) The minor child falsely represents himself or herself as being 18 years of age or older and presents a fraudulent identification.
(c) A reasonable person of average intelligence would believe that the minor child is 18 years of age or older and that the photo identification is genuine, was issued to the minor child, and truthfully represents the minor child’s age.
381.00789 Rulemaking.—The department shall adopt rules to administer ss. 381.00771-381.00791. Such rules may include, but are not limited to, rules defining terms; prescribing educational requirements for tattoo artists and guest tattoo artists, health and safety requirements, sanitation practices, and sterilization requirements and procedures; and providing requirements for tattoo equipment, customer notification, the contents of customer records, the retention of records, and physical plants. The department shall consult with representatives of the tattooing industry in this state during the development of such rules.
381.00791 Local laws and ordinances.—Sections 381.00771-381.00791 do not preempt any local law or ordinance of a county or municipality that imposes regulations on tattoo establishments, temporary establishments, tattoo artists, or the practice of tattooing which are in addition to those sections.
381.008 Definitions of terms used in ss. 381.008-381.00897.—As used in ss. 381.008-381.00897, the following words and phrases mean:
(1) “Common areas”—That portion of a migrant labor camp or residential migrant housing not included within private living quarters and where migrant labor camp or residential migrant housing residents generally congregate.
(2) “Department”—The Department of Health and its representative county health departments.
(3) “Invited guest”—Any person who is invited by a resident to a migrant labor camp or residential migrant housing to visit that resident.
(4) “Migrant farmworker”—A person who is or has been employed in hand labor operations in planting, cultivating, or harvesting agricultural crops within the last 12 months and who has changed residence for purposes of employment in agriculture within the last 12 months.
(5) “Migrant labor camp”—One or more buildings, structures, barracks, or dormitories, and the land appertaining thereto, constructed, established, operated, or furnished as an incident of employment as living quarters for seasonal or migrant farmworkers whether or not rent is paid or reserved in connection with the use or occupancy of such premises. The term does not include a single-family residence that is occupied by a single family.
(6) “Other authorized visitors”—Any person, other than an invited guest, who is:
(a) A federal, state, or county government official;
(b) A physician or other health care provider whose sole purpose is to provide medical care or medical information;
(c) A representative of a bona fide religious organization who, during the visit, is engaged in the vocation or occupation of a religious professional or worker such as a minister, priest, or nun;
(d) A representative of a nonprofit legal services organization, who must comply with the Code of Professional Conduct of The Florida Bar; or
(e) Any other person who provides services for farmworkers which are funded in whole or in part by local, state, or federal funds but who does not conduct or attempt to conduct solicitations.
(7) “Private living quarters”—A building or portion of a building, dormitory, or barracks, including its bathroom facilities, or a similar type of sleeping and bathroom area, which is a home, residence, or sleeping place for a resident of a migrant labor camp. The term includes residential migrant housing.
(8) “Residential migrant housing”—A building, structure, mobile home, barracks, or dormitory, and any combination thereof on adjacent property which is under the same ownership, management, or control, and the land appertaining thereto, that is rented or reserved for occupancy by five or more seasonal or migrant farmworkers, except:
(a) Housing furnished as an incident of employment.
(b) A single-family residence or mobile home dwelling unit that is occupied only by a single family and that is not under the same ownership, management, or control as other farmworker housing to which it is adjacent or contiguous.
(c) A hotel or motel, as described in chapter 509, that is furnished for transient occupancy.
(d) Any housing owned or operated by a public housing authority except for housing which is specifically provided for persons whose principal income is derived from agriculture.
(9) “Personal hygiene facilities”—Adequate facilities for providing hot water at a minimum of 110 degrees Fahrenheit for bathing and dishwashing purposes, and an adequate and convenient approved supply of potable water available at all times in each migrant labor camp and residential migrant housing for drinking, culinary, bathing, dishwashing, and laundry purposes.
(10) “Lighting”—At least one ceiling-type light fixture capable of providing 20 foot-candles of light at a point 30 inches from the floor, and at least one separate double electric wall outlet in each habitable room in a migrant labor camp or residential migrant housing.
(11) “Sewage disposal”—Approved facilities for satisfactory disposal and treatment of human excreta and liquid waste.
(12) “Garbage disposal”—Watertight receptacles of impervious material which are provided with tight-fitting covers suitable to protect the contents from flies, insects, rodents, and other animals.
381.0081 Permit required to operate a migrant labor camp or residential migrant housing; penalties for unlawful establishment or operation; allocation of proceeds.—
(1) MIGRANT LABOR CAMP; PERMIT REQUIREMENT.—A person who establishes, maintains, or operates a migrant labor camp in this state without first having obtained a permit from the department and who fails to post such permit and keep such permit posted in the camp to which it applies at all times during maintenance or operation of the camp commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(2) RESIDENTIAL MIGRANT HOUSING; PERMIT REQUIREMENT.—A person who establishes, maintains, or operates any residential migrant housing in this state without first having obtained a permit from the department commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(3) RESIDENTIAL MIGRANT HOUSING; HEALTH AND SANITATION.—A person who establishes, maintains, or operates any residential migrant housing or migrant labor camp in this state without providing adequate personal hygiene facilities, lighting, sewage disposal, and garbage disposal, and without first having obtained the required permit from the department, commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(4) FINE.—The department may impose a fine of up to $1,000 for each violation of this section. If the owner of land on which a violation of this section occurs is other than the person committing the violation and the owner knew or should have known upon reasonable inquiry that this section was being violated on the land, the fine may be applied against such owner. In determining the amount of the fine to be imposed, the department shall consider any corrective actions taken by the violator and any previous violations.
(5) SEIZURE.—
(a) In addition to other penalties provided by this section, the buildings, personal property, and land used in connection with a felony violation of this section may be seized and forfeited pursuant to the Contraband Forfeiture Act.
(b) After satisfying any liens on the property, the remaining proceeds from the sale of the property seized under this section shall be allocated as follows if the department participated in the inspection or investigation leading to seizure and forfeiture under this section:
1. One-third of the proceeds shall be allocated to the law enforcement agency involved in the seizure, to be used as provided in s. 932.7055.
2. One-third of the proceeds shall be allocated to the department, to be used for purposes of enforcing the provisions of this section.
3. One-third of the proceeds shall be deposited in the State Apartment Incentive Loan Fund, to be used for the purpose of providing funds to sponsors who provide housing for farmworkers.
(c) After satisfying any liens on the property, the remaining proceeds from the sale of the property seized under this section shall be allocated equally between the law enforcement agency involved in the seizure and the State Apartment Incentive Loan Fund if the department did not participate in the inspection or investigation leading to seizure and forfeiture.
381.0082 Application for permit to operate migrant labor camp or residential migrant housing.—Application for a permit to establish, operate, or maintain a migrant labor camp or residential migrant housing must be made to the department in writing on a form and under rules prescribed by the department. The application must state the location of the existing or proposed migrant labor camp or residential migrant housing; the approximate number of persons to be accommodated; the probable duration of use, and any other information the department requires.
381.0083 Permit for migrant labor camp or residential migrant housing.—Any person who is planning to construct, enlarge, remodel, use, or occupy a migrant labor camp or residential migrant housing or convert property for use as a migrant labor camp or residential migrant housing must give written notice to the department of the intent to do so at least 45 days before beginning such construction, enlargement, or renovation. If the department is satisfied, after causing an inspection to be made, that the camp or the residential migrant housing meets the minimum standards of construction, sanitation, equipment, and operation required by rules issued under s. 381.0086 and that the applicant has paid the application fees required by s. 381.0084, it shall issue in the name of the department the necessary permit in writing on a form to be prescribed by the department. The permit, unless sooner revoked, shall expire on September 30 next after the date of issuance, and it shall not be transferable. An application for a permit shall be filed with the department 30 days prior to operation. When there is a change in ownership of a currently permitted migrant labor camp or residential migrant housing, the new owner must file an application with the department at least 15 days before the change. In the case of a facility owned or operated by a public housing authority, an annual satisfactory sanitation inspection of the living units by the Farmers Home Administration or the Department of Housing and Urban Development shall substitute for the pre-permitting inspection required by the department.
381.0084 Application fees for migrant labor camps and residential migrant housing.—
(1) Each migrant labor camp operator or owner of residential migrant housing who is subject to s. 381.0081 shall pay to the department the following annual application fees:
(a) Camps or residential migrant housing that have capacity for 5 to 50 occupants: $125.
(b) Camps or residential migrant housing that have capacity for 51 to 100 occupants: $225.
(c) Camps or residential migrant housing that have capacity for 101 or more occupants: $500.
(2) The department shall deposit fees collected under this section in the County Health Department Trust Fund for use in the migrant labor camp program and shall use those fees solely for actual costs incurred in enforcing ss. 381.008-381.00895.
(3) Any existing migrant labor camp or residential migrant housing that is substantially renovated or newly constructed is exempt from the annual application fee described in this section for the next annual permit after the renovations or construction occurred.
(4) Any existing migrant labor camp or residential migrant housing that, during any permit year, has no major deficiencies cited by the department, no uncorrected deficiencies, and no administrative action taken against it is exempt from the annual application fee described in this section for the next annual permit period.
381.0085 Revocation of permit to operate migrant labor camp or residential migrant housing.—The department may revoke a permit authorizing the operation of a migrant labor camp or residential migrant housing if it finds the holder has failed to comply with any provision of this law or any rule adopted hereunder. To reinstate a permit for migrant labor camp or residential migrant housing from which a permit has been revoked, the operator shall submit another application with the appropriate fee and satisfy the department that he or she is in compliance with all applicable rules.
(1) The department shall adopt rules necessary to protect the health and safety of migrant farmworkers and other migrant labor camp or residential migrant housing occupants, including rules governing field sanitation facilities. These rules must include definitions of terms; a process for plan review of the construction of new, expanded, or remodeled camps or residential migrant housing, sites, buildings, and structures; and standards for personal hygiene facilities, lighting, sewage disposal, safety, minimum living space per occupant, bedding, food equipment, food storage and preparation, insect and rodent control, garbage, heating equipment, water supply, maintenance and operation of the camp, housing, or roads, and such other matters as the department finds to be appropriate or necessary to protect the life and health of the occupants. Housing operated by a public housing authority is exempt from the provisions of any administrative rule that conflicts with or is more stringent than the federal standards applicable to the housing.
(2) Except when prohibited as specified in subsection (6), an owner or operator may apply for a permanent structural variance from the department’s rules by filing a written application and paying a fee set by the department, not to exceed $100. This application must:
(a) Clearly specify the standard from which the variance is desired.
(b) Provide adequate justification that the variance is necessary to obtain a beneficial use of an existing facility and to prevent a practical difficulty or unnecessary hardship.
(c) Clearly set forth the specific alternative measures that the owner or operator has taken to protect the health and safety of occupants and adequately show that the alternative measures have achieved the same result as the standard from which the variance is sought.
(3) Any variance granted by the department must be in writing, must state the standard involved, and must state as conditions of the variance the specific alternative measures taken to protect the health and safety of the occupants. In denying the request, the department must provide written notice under ss. 120.569 and 120.57 of the applicant’s right to an administrative hearing to contest the denial within 21 days after the date of receipt of the notice.
(4) A person who violates any provision of ss. 381.008-381.00895 or rules adopted under such sections is subject either to the penalties provided in ss. 381.0012 and 381.0061 or to the penalties provided in s. 381.0087.
(5) Notwithstanding any other provision of this chapter, any housing that is furnished as a condition of employment so as to subject it to the requirements of the Occupational Health and Safety Act of 1970, 29 U.S.C. s. 655, shall only be inspected under the temporary labor camp standards at 42 C.F.R. s. 1910.142.
(6) For the purposes of filing an interstate clearance order with the Department of Commerce, if the housing is covered by 20 C.F.R. part 654, subpart E, no permanent structural variance referred to in subsection (2) is allowed.
(1) Department personnel may issue citations that contain an order of correction or an order to pay a fine, or both, for violations of ss. 381.008-381.00895 or the field sanitation facility rules adopted by the department when a violation of those sections or rules is enforceable by an administrative or civil remedy, or when a violation of those sections or rules is a misdemeanor of the second degree. A citation issued under this section constitutes a notice of proposed agency action. The recipient of a citation for a major deficiency, as defined by rule of the department, will be given a maximum of 48 hours to make satisfactory correction or demonstrate that provisions for correction are satisfactory.
(2) Citations must be in writing and must describe the particular nature of the violation, including specific reference to the provision of statute or rule allegedly violated. Continual or repeat violations of the same requirement will result in the issuance of a citation.
(3) The fines imposed by a citation issued by the department may not exceed $500 for each violation. Each day the violation exists constitutes a separate violation for which a citation may be issued.
(4) The citing official shall inform the recipient, by written notice pursuant to ss. 120.569 and 120.57, of the right to an administrative hearing to contest the citation of the agency within 21 days after the date of receipt of the citation. The citation must contain a conspicuous statement that if the citation recipient fails to pay the fine within the time allowed, or fails to appear to contest the citation after having requested a hearing, the recipient is deemed to have waived the right to contest the citation and must pay an amount up to the maximum fine or penalty.
(5) The department may reduce or waive the fine imposed by the citation. In determining whether to reduce or waive the fine, the department must give due consideration to such factors as the gravity of the violation, the good faith of the person who has allegedly committed the violation, and the person’s history of previous violations, including violations for which enforcement actions were taken under this section or other provisions of state law.
(6) Any person who willfully refuses to sign and accept a citation issued by the department commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
(7) The department shall deposit all fines collected under ss. 381.008-381.00895 in the County Health Department Trust Fund for use of the migrant labor camp inspection program and shall use such fines to improve migrant labor camp and residential migrant housing as described in s. 381.0086.
(8) The provisions of this section are an alternative means of enforcing ss. 381.008-381.00895 and the field sanitation facility rules. This section does not prohibit the department from enforcing those sections or rules by any other means. However, the agency shall elect to use only the procedure for enforcement under this section or another method of civil or administrative enforcement for a single violation.
(9) When the department suspects that a law has been violated, it shall notify the entity that enforces the law.
381.0088 Right of entry.—The department or its inspectors may enter and inspect migrant labor camps or residential migrant housing at reasonable hours and investigate such facts, conditions, and practices or matters, as are necessary or appropriate to determine whether any person has violated any provisions of applicable statutes or rules adopted pursuant thereto by the department. The right of entry extends to any premises that the department has reason to believe is being established, maintained, or operated as a migrant labor camp or residential migrant housing without a permit, but such entry may not be made without the permission of the owner, person in charge, or resident thereof, unless an inspection warrant is first obtained from the circuit court authorizing the entry. Any application for a permit made under s. 381.0082 constitutes permission for, and complete acquiescence in, any entry or inspection of the premises for which the permit is sought, to verify the information submitted on or in connection with the application; to discover, investigate, and determine the existence of any violation of ss. 381.008-381.00895 or rules adopted thereunder; or to elicit, receive, respond to, and resolve complaints. Any current valid permit constitutes unconditional permission for, and complete acquiescence in, any entry or inspection of the premises by authorized personnel. The department may from time to time publish the reports of such inspections.
381.00893 Complaints by aggrieved parties.—Any person who believes that the housing violates any provision of ss. 381.008-381.00895 or rules adopted thereunder may file a complaint with the department. Upon receipt of the complaint, if the department finds there are reasonable grounds to believe that a violation exists and that the nature of the alleged violation could pose a serious and immediate threat to public health, the department shall conduct an inspection as soon as practicable. In all other cases where the department finds there are reasonable grounds to believe that a violation exists, the department shall notify the owner and the operator of the housing that a complaint has been received and the nature of the complaint. The department shall also advise the owner and the operator that the alleged violation must be remedied within 3 business days. The department shall conduct an inspection as soon as practicable following such 3-day period. The department shall notify the owner or the operator of the housing and the complainant in writing of the results of the inspection and the action taken. Upon request of the complainant, the department shall conduct the inspection so as to protect the confidentiality of the complainant. The department shall adopt rules by January 1, 1994, to implement this section.
(1) An owner or operator of housing subject to the provisions of ss. 381.008-381.00897 may not, for the purpose of retaliating against a resident of that housing, discriminatorily terminate or discriminatorily modify a tenancy by increasing the resident’s rent; decreasing services to the resident; bringing or threatening to bring against the resident an action for eviction or possession or another civil action; refusing to renew the resident’s tenancy; or intimidating, threatening, restraining, coercing, blacklisting, or discharging the resident. Examples of conduct for which the owner or operator may not retaliate include, but are not limited to, situations in which:
(a) The resident has complained in good faith, orally or in writing, to the owner or operator of the housing, the employer, or any government agency charged with the responsibility of enforcing the provisions of ss. 381.008-381.00897.
(b) The resident has exercised any legal right provided in this chapter with respect to the housing.
(2) A resident who brings an action for or raises a defense of retaliatory conduct must have acted in good faith.
(3) This section does not apply if the owner or operator of housing proves that the eviction or other action is for good cause, including, without limitation, a good faith action for nonpayment of rent, a violation of the resident’s rental or employment agreement, a violation of reasonable rules of the owner or operator of the housing or of the employer, or a violation of this chapter or the Florida Residential Landlord and Tenant Act.
(1) The Legislature declares that it is the policy of this state that each county and municipality must permit and encourage the development and use of a sufficient number and sufficient types of farmworker housing facilities to meet local needs. The Legislature further finds that discriminatory practices that inhibit the development of farmworker housing are a matter of state concern.
(2) Any owner or developer of farmworker housing which has qualified for a permit to operate, or who would qualify for a permit based upon plans submitted to the department, or the residents or intended residents of such housing may invoke the provisions of this section.
(3) A municipality or county may not enact or administer local land use ordinances to prohibit or discriminate against the development and use of farmworker housing facilities because of the occupation, race, sex, color, religion, national origin, or income of the intended residents.
(4) This section does not prohibit the imposition of local property taxes, water service and garbage collection fees, normal inspection fees, local bond assessments, or other fees, charges, or assessments to which other dwellings of the same type in the same zone are subject.
(5) This section does not prohibit a municipality or county from extending preferential treatment to farmworker housing, including, without limitation, fee reductions or waivers or changes in architectural requirements, site development or property line requirements, or vehicle parking requirements that reduce the development costs of farmworker housing.
381.00897 Access to migrant labor camps and residential migrant housing.—
(1) RIGHT OF ACCESS OF INVITED GUEST.—A resident of a migrant labor camp or residential migrant housing may decide who may visit him or her in the resident’s private living quarters. A person may not prohibit or attempt to prohibit an invited guest access to or egress from the private living quarters of the resident who invited the guest by the erection or maintenance of any physical barrier, by physical force or violence, by threat of force or violence, or by any verbal order or notice given in any manner. Any invited guest must leave the private living quarters upon the reasonable request of a resident residing within the same private living quarters.
(2) RIGHT OF ACCESS OF OTHERS.—Other authorized visitors have a right of access to or egress from the common areas of a migrant labor camp or residential migrant housing as provided in this subsection. A person may not prohibit or attempt to prohibit other visitors access to or egress from the common areas of a migrant labor camp or residential migrant housing by the erection or maintenance of any physical barrier, by physical force or violence, by threat of force or violence, or by any verbal order or notice given in any manner, except as provided in this section. Owners or operators of migrant labor camps or residential migrant housing may adopt reasonable rules regulating hours of access to housing, if such rules permit at least 4 hours of access each day during nonworking hours Monday through Saturday and between the hours of 12 noon and 8 p.m. on Sunday. Any other authorized visitor must leave the private living quarters upon the reasonable request of a person who resides in the same private living quarters.
(3) CIVIL ACTION.—Any person prevented from exercising rights guaranteed by this section may bring an action in the appropriate court of the county in which the alleged infringement occurred; and, upon favorable adjudication, the court shall enjoin the enforcement of any rule, practice, or conduct that operates to deprive the person of such rights.
(4) CIVIL LIABILITY.—Other visitors are licensees, not guests or invitees, for purposes of any premises liability.
(5) OTHER RULES.—The housing owner or operator may require invited guests and other visitors to check in before entry and to present picture identification. Migrant labor camp and residential migrant housing owners or operators may adopt other rules regulating access to a camp only if the rules are reasonably related to the purpose of promoting the safety, welfare, or security of residents, visitors, farmworkers, or the owner’s or operator’s business.
(6) POSTING REQUIRED.—Rules relating to access are unenforceable unless they have been conspicuously posted in the migrant labor camp or migrant residential housing and a copy has been furnished to the department.
(7) LIMITATIONS.—This section does not create a general right of solicitation in migrant labor camps or residential migrant housing. This section does not prohibit the erection or maintenance of a fence around a migrant labor camp or residential migrant housing if one or more unlocked gates or gateways in the fence are provided; nor does this section prohibit posting the land adjacent to a migrant labor camp or residential migrant housing if access to the camp is clearly marked; nor does this section restrict migrant workers residing within the same living quarters from imposing reasonable restrictions on their fellow residents to accommodate reasonable privacy and other concerns of the residents.
381.009 Toilets required by department regulations; charge for use of prohibited.—No place of employment or place serving the public shall make a charge for the use of any toilet which is required to be provided by regulation of the Department of Health. Any place of employment or place serving the public which violates this act is guilty of a misdemeanor of the second degree, punishable as provided in s. 775.083.
(1) LEGISLATIVE INTENT.—Except as otherwise provided herein, the Department of Health shall regulate the packaging, transport, storage, and treatment of biomedical waste. The Department of Environmental Protection shall regulate onsite and offsite incineration and disposal of biomedical waste. Consistent with the foregoing, the Department of Health shall have the exclusive authority to establish treatment efficacy standards for biomedical waste and the Department of Environmental Protection shall have the exclusive authority to establish statewide standards relating to environmental impacts, if any, of treatment and disposal including, but not limited to, water discharges and air emissions. An interagency agreement between the Department of Environmental Protection and the Department of Health shall be developed to ensure maximum efficiency in coordinating, administering, and regulating biomedical wastes.
(2) DEFINITIONS.—As used in this section, the term:
(a) “Biomedical waste” means any solid or liquid waste which may present a threat of infection to humans. The term includes, but is not limited to, nonliquid human tissue and body parts; laboratory and veterinary waste which contains human-disease-causing agents; discarded disposable sharps; human blood, blood products, and body fluids; and other materials which in the opinion of the department represent a significant risk of infection to persons outside the generating facility. The term does not include human remains that are disposed of by persons licensed under chapter 497.
(b) “Biomedical waste generator” means a facility or person that produces or generates biomedical waste. The term includes, but is not limited to, hospitals, skilled nursing or convalescent hospitals, intermediate care facilities, clinics, dialysis clinics, dental offices, health maintenance organizations, surgical clinics, medical buildings, physicians’ offices, laboratories, veterinary clinics, and funeral homes where embalming procedures are performed.
(c) “Department” means the Department of Health.
(d) “Sharps” mean those biomedical wastes which as a result of their physical characteristics are capable of puncturing, lacerating, or otherwise breaking the skin when handled.
(e) “Treatment” means any process, including steam treatment, chemical treatment, and microwave shredding, which changes the character or composition of biomedical waste so as to render it noninfectious. For the purposes of this section, treatment does not include the incineration of biomedical waste.
(3) OPERATING STANDARDS.—The department shall adopt rules necessary to protect the health, safety, and welfare of the public and to carry out the purpose of this section. Such rules shall address, but need not be limited to, definitions of terms, the packaging of biomedical waste, including specific requirements for the segregation of the waste at the point of generation; the safe packaging of sharps; the placement of the waste in containers that will protect waste handlers and the public from exposure; the appropriate labeling of containers of waste; written operating plans for managing biomedical waste; and the transport, storage, and treatment of biomedical wastes.
(4) PERMITS AND FEES.—
(a) All persons who generate, store, or treat biomedical waste shall obtain a permit from the department prior to commencing operation, except that a biomedical waste generator generating less than 25 pounds of biomedical waste in each 30-day period shall be exempt from the registration and fee requirements of this subsection. A biomedical waste generator need not obtain a separate permit if such generator works less than 6 hours in a 7-day period at a location different than the location specified on the permit. The department may issue combined permits for generation, storage, and treatment as appropriate to streamline permitting procedures. Application for such permit shall be made on an application form provided by the department and within the timeframes and in the manner prescribed by department rule.
(b) Once the department determines that the person generating, storing, or treating biomedical waste is capable of constructing a facility or operating in compliance with this section and the rules adopted under this section, the department shall grant the permit.
(c) If the department determines that the person generating, storing, or treating biomedical waste does not meet the provisions outlined in this section or the rules adopted under this section, the department shall deny the application for the permit pursuant to provisions of chapter 120. Such denial shall be in writing and shall list the circumstances for denial. Upon correction of such circumstances, the permit shall be issued.
(d) The permit for a biomedical waste facility may not be transferred. When the ownership, control, or name of a biomedical waste facility is changed and continues to operate, the new owner shall apply to the department, upon forms provided by the department, for issuance of a permit in the timeframe and manner prescribed by rule of the department.
(e) The department shall establish a schedule of fees for such permits. Fees assessed under this section shall be in an amount sufficient to meet the costs of carrying out the provisions of this section and rules adopted under this section. The fee schedule shall not be less than $50 or more than $400 for each year the permit is valid. Fees may be prorated on a quarterly basis when a facility will be in operation for 6 months or less before the annual renewal date. The department shall assess the minimum fees provided in this subsection until a fee schedule is adopted by rule of the department. Facilities owned and operated by the state shall be exempt from the payment of any fees.
(f) Fees collected by the department in accordance with provisions of this section and the rules adopted under this section shall be deposited into a trust fund administered by the department for the payment of costs incurred in the administration of this section.
(g) Permits issued by the department shall be valid for no more than 5 years. However, upon expiration, a new permit may be issued by the department in accordance with this section and the rules of the department.
(h) The department may develop a streamlined process for permitting biomedical waste storage facilities that accept and store only sharps collected from the public, which may include the issuance of a single permit for each applicant that develops or sponsors a sharps collection program.
(5) TRANSPORTERS.—Any person who transports biomedical waste within the state must register with the department prior to engaging in the transport of biomedical waste in accordance with rules adopted by the department. A registration may not be transferred from one biomedical waste transporter to another. If the ownership or name of a biomedical waste transporter is changed and the owner intends to continue operation of the transporter, the owner must apply to the department on departmental forms within the timeframes and in the manner prescribed by department rule. The department may charge registration fees in the same manner as is provided in paragraphs (4)(e) and (f). The department may exempt from this requirement any person who, or facility that, transports less than 25 pounds of such waste on any single occasion.
(6) TRACKING SYSTEM.—The department shall adopt rules for a system of tracking biomedical waste.
(a) Such system shall, at a minimum, provide for tracking of the transportation of the waste from the generator to the treatment or incineration facility, including a means for providing the generator of the waste assurance that the waste is received by the treatment or incineration facility, and shall include the identification of the entity transporting the waste on the container.
(b) Inspections may be conducted for purposes of compliance with this section. Any such inspection shall be commenced and completed with reasonable promptness. If the officer, employee, or representative of the department obtains any samples, prior to leaving the premises he or she shall give the owner, operator, or agent in charge a receipt describing the sample obtained.
(c) Any person who fails to comply with the provisions of this subsection commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
(7) ENFORCEMENT AND PENALTIES.—Any person or public body in violation of this section or rules adopted under this section is subject to penalties provided in ss. 381.0012 and 381.0061. However, an administrative fine not to exceed $2,500 may be imposed for each day such person or public body is in violation of this section. The department may deny, suspend, or revoke any biomedical waste permit or registration if the permittee violates this section, any rule adopted under this section, or any lawful order of the department.
(8) PREEMPTION OF AUTHORITY TO REGULATE.—The regulation and inspection of biomedical waste generators is hereby preempted by the state. Nothing in this chapter shall be construed to affect a local government’s zoning and land use authority over biomedical waste generators. Acute care hospitals, licensed under chapter 395, which utilize a certified onsite treatment process involving grinding and treatment, may dispose of such treated biomedical waste in the normal municipal solid waste stream upon notifying the local governments that are responsible for solid waste collection and disposal.
(1) DEFINITIONS.—As used in this section, the term:
(a) “Board” means the Environmental Health Professionals Advisory Board.
(b) “Certified” means a person who has displayed competency to perform evaluations of environmental or sanitary conditions through examination.
(c) “Department” means the Department of Health.
(d) “Environmental health” means that segment of public health work which deals with the examination of those factors in the human environment which may impact adversely on the health status of an individual or the public.
(e) “Environmental health professional” means a person who is employed or assigned the responsibility for assessing the environmental health or sanitary conditions, as defined by the department, within a building, on an individual’s property, or within the community at large, and who has the knowledge, skills, and abilities to carry out these tasks. Environmental health professionals may be either field, supervisory, or administrative staff members.
(f) “Environmental health technician” means a person who is employed or assigned the responsibility for conducting septic inspections under the supervision of a certified environmental health professional. An environmental health technician must have completed training approved by the department and have the knowledge, skills, and abilities to carry out these tasks.
(g) “Primary environmental health program” means those programs determined by the department to be essential for providing basic environmental and sanitary protection to the public. At a minimum, these programs shall include food protection program work.
(h) “Registered sanitarian,” “R.S.,” “Registered Environmental Health Specialist,” or “R.E.H.S.” means a person who has been certified by either the National Environmental Health Association or the Florida Environmental Health Association as knowledgeable in the environmental health profession.
(2) CERTIFICATION; EXEMPTIONS.—A person may not perform environmental health or sanitary evaluations in any primary program area of environmental health without being certified by the department as competent to perform such evaluations. This section does not apply to any of the following:
(a) Persons performing inspections of public food service establishments licensed under chapter 509.
(b) Persons performing site evaluations in order to determine proper placement and installation of onsite wastewater treatment and disposal systems who have successfully completed a department-approved soils morphology course and who are working under the direct responsible charge of an engineer licensed under chapter 471.
(c) Environmental health technicians employed by a department as defined in s. 20.03 who are assigned the responsibility for conducting septic tank inspections under the supervision of an environmental health professional certified in onsite sewage treatment and disposal.
(3) ENVIRONMENTAL HEALTH PROFESSIONALS ADVISORY BOARD.—The State Health Officer shall appoint an advisory board to assist the department in the promulgation of rules for certification, testing, establishing standards, and seeking enforcement actions against certified professionals.
(a) The board shall be comprised of the State Surgeon General or his or her designee, one individual who will be certified under this section, one individual not employed in a governmental capacity who will or does employ a certified environmental health professional, one individual whose business is or will be evaluated by a certified environmental health professional, and a citizen of the state who neither employs nor is routinely evaluated by a person certified under this section.
(b) The board shall advise the department as to the minimum disciplinary guidelines and standards of competency and proficiency necessary to obtain certification in a primary area of environmental health practice.
1. The board shall recommend primary areas of environmental health practice in which environmental health professionals should be required to obtain certification.
2. The board shall recommend minimum standards of practice which the department shall incorporate into rule.
3. The board shall evaluate and recommend to the department existing registrations and certifications which meet or exceed minimum department standards and should, therefore, exempt holders of such certificates or registrations from compliance with this section.
4. The board shall hear appeals of certificate denials, revocation, or suspension and shall advise the department as to the disposition of such an appeal.
5. The board shall meet as often as necessary, but no less than semiannually, handle appeals to the department, and conduct other duties of the board.
6. Members of the board shall receive no compensation but are entitled to reimbursement for per diem and travel expenses in accordance with s. 112.061.
(4) STANDARDS FOR CERTIFICATION.—The department shall adopt rules that establish definitions of terms and minimum standards of education, training, or experience for those persons subject to this subsection. The rules must also address the process for application, examination, issuance, expiration, and renewal of certification and ethical standards of practice for the profession.
(a) Persons employed as environmental health professionals shall exhibit a knowledge of rules and principles of environmental and public health law in Florida through examination. A person may not conduct environmental health evaluations in a primary program area unless he or she is currently certified in that program area or works under the direct supervision of a certified environmental health professional.
1. All persons who begin employment in a primary environmental health program on or after September 21, 1994, must be certified in that program within 6 months after employment.
2. Persons employed in the primary environmental health program of a food protection program or an onsite sewage treatment and disposal system prior to September 21, 1994, shall be considered certified while employed in that position and shall be required to adhere to any professional standards established by the department pursuant to paragraph (b), complete any continuing education requirements imposed under paragraph (d), and pay the certificate renewal fee imposed under subsection (7).
3. Persons employed in the primary environmental health program of a food protection program or an onsite sewage treatment and disposal system prior to September 21, 1994, who change positions or program areas and transfer into another primary environmental health program area on or after September 21, 1994, must be certified in that program within 6 months after such transfer, except that they will not be required to possess the college degree required under paragraph (e).
4. Registered sanitarians shall be considered certified and shall be required to adhere to any professional standards established by the department pursuant to paragraph (b).
(b) At a minimum, the department shall establish standards for professionals in the areas of food hygiene and onsite sewage treatment and disposal.
(c) Those persons conducting primary environmental health evaluations shall be certified by examination to be knowledgeable in any primary area of environmental health in which they are routinely assigned duties.
(d) Persons who are certified shall renew their certification biennially by completing not less than 24 contact hours of continuing education for each program area in which they maintain certification, subject to a maximum of 48 hours for multiprogram certification.
(e) Applicants for certification shall have graduated from an accredited 4-year college or university with a degree or major coursework in public health, environmental health, environmental science, or a physical or biological science.
(f) A certificateholder shall notify the department within 60 days after any change of name or address from that which appears on the current certificate.
(5) STANDARDS FOR ENVIRONMENTAL HEALTH TECHNICIAN CERTIFICATION.—The department, in conjunction with the Department of Environmental Protection, shall adopt rules that establish definitions of terms and minimum standards of education, training, and experience for those persons subject to this subsection. The rules must also address the process for application, examination, issuance, expiration, and renewal of certification, and ethical standards of practice for the profession.
(a) At a minimum, the department shall establish standards for technicians in the areas of onsite sewage treatment and disposal.
(b) A person conducting septic inspections must be certified by examination to be knowledgeable in the area of onsite sewage treatment and disposal.
(c) An applicant for certification as an environmental health technician must, at a minimum, have received a high school diploma or its equivalent.
(d) An applicant for certification as an environmental health technician must be employed by a department as defined in s. 20.30.
(e) An applicant for certification as an environmental health technician must complete supervised field inspection work as prescribed by department rule before examination.
(f) A certified environmental health technician must renew his or her certification biennially by completing at least 24 contact hours of continuing education for each program area in which he or she maintains certification, subject to a maximum of 48 hours for multiprogram certification.
(g) A certified environmental health technician shall notify the department within 60 days after any change of name or address from that which appears on the current certificate.
(6) EXEMPTIONS.—A person who conducts primary environmental evaluation activities and maintains a current registration or certification from another state agency which examined the person’s knowledge of the primary program area and requires comparable continuing education to maintain the certificate shall not be required to be certified by this section.
(7) FEES.—The department shall charge fees in amounts necessary to meet the cost of providing environmental health professional certification. Fees for certification shall be not less than $10 or more than $300 and shall be set by rule. Application, examination, and certification costs shall be included in this fee. Fees for renewal of a certificate shall be no less than $25 nor more than $150 per biennium.
(8) PENALTIES.—The department may deny, suspend, or revoke a certificate or impose an administrative fine of up to $500 for each violation of this section or a rule adopted under this section or may pursue any other enforcement action authorized by law. Any person who has had a certificate revoked may not conduct environmental health evaluations in a primary program area for a minimum of 5 years from the date of revocation.
381.0201 Technical and support services.—The department shall establish certain technical and support programs to enable the county health departments and other public or private agencies to carry out the public health mission. These programs shall include, but not be limited to, laboratory, pharmacy, vital statistics, and emergency medical services.
(1) The department shall establish and maintain, in suitable and convenient places in the state, laboratories for microbiological and chemical analyses and any other purposes it determines necessary for the protection of the public health.
(2) The department may contract or agree with any person or public or private agency to provide laboratory services relating to or having potential impact on the public health or relating to the health of clients directly under the care of the state.
(3) The department is authorized to establish and collect reasonable fees and charges for laboratory services provided. Such fees and charges shall be deposited in a trust fund administered by the department and shall be used solely for this purpose.
(4) The department may perform laboratory testing related to public health for other states on a fee-for-service basis.
(1) The department may contract on a statewide basis for the purchase of drugs, as defined in s. 499.003, to be used by state agencies and political subdivisions, and may adopt rules to administer this section.
(2) The department shall establish and maintain a pharmacy services program, including, but not limited to:
(a) A central pharmacy to support pharmaceutical services provided by the county health departments, including pharmaceutical repackaging, dispensing, and the purchase and distribution of immunizations and other pharmaceuticals.
(b) Consultation to county health departments as required by s. 154.04(1)(c).
381.02035 Canadian Prescription Drug Importation Program.—
(1) PROGRAM ESTABLISHED.—The Agency for Health Care Administration shall establish the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the state.
(2) DEFINITIONS.—As used in this section, the term:
(a) “Agency” means the Agency for Health Care Administration.
(b) “Canadian supplier” means a manufacturer, wholesale distributor, or pharmacy appropriately licensed or permitted under Canadian law to manufacture, distribute, or dispense prescription drugs.
(c) “County health department” means a health care facility established under part I of chapter 154.
(d) “Department” means the Department of Health.
(e) “Drug” or “prescription drug” has the same meaning as “prescription drug” in s. 499.003, but is limited to drugs intended for human use.
(f) “Federal act” means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq. as amended by the Drug Quality and Security Act, 21 U.S.C. ss. 351 et seq.
(g) “Free clinic” means a clinic that delivers only medical diagnostic services or nonsurgical medical treatment free of charge to low-income recipients.
(h) “Medicaid pharmacy” means a pharmacy licensed under chapter 465 that has a Medicaid provider agreement in effect with the agency and is in good standing with the agency.
(i) “Pharmacist” means a person who holds an active and unencumbered license to practice pharmacy pursuant to chapter 465.
(j) “Program” means the Canadian Prescription Drug Importation Program.
(k) “Track-and-trace” means the product-tracing process for the components of the pharmaceutical distribution supply chain as described in Title II of the Drug Quality and Security Act, Drug Supply Chain Security Act, 21 U.S.C. ss. 351 et seq.
(l) “Vendor” means the entity contracted by the agency to manage specified functions of the program.
(3) IMPORTATION PROCESS.—
(a) The agency shall contract with a vendor to provide services under the program.
(b) By December 1, 2019, and each year thereafter, the vendor shall develop a Wholesale Prescription Drug Importation List identifying the prescription drugs that have the highest potential for cost savings to the state. In developing the list, the vendor shall consider, at a minimum, which prescription drugs will provide the greatest cost savings to state programs, including prescription drugs for which there are shortages, specialty prescription drugs, and high volume prescription drugs. The agency, in consultation with the department, shall review the Wholesale Prescription Drug Importation List every 3 months to ensure that it continues to meet the requirements of the programs and may direct the vendor to revise the list, as necessary.
(c) The vendor shall identify Canadian suppliers that are in full compliance with relevant Canadian federal and provincial laws and regulations and the federal act and who have agreed to export drugs identified on the list at prices that will provide cost savings to the state. The vendor must verify that such Canadian suppliers meet all of the requirements of the program, while meeting or exceeding the federal and state track-and-trace laws and regulations.
(d) The vendor shall contract with such eligible Canadian suppliers, or facilitate contracts between eligible importers and Canadian suppliers, to import drugs under the program.
(e) The vendor shall maintain a list of all registered importers that participate in the program.
(f) The vendor shall ensure compliance with Title II of the federal Drug Quality and Security Act, Pub. L. No. 113-54, by all suppliers, importers and other distributors, and participants in the program.
(g) The vendor shall assist the agency in the preparation of the annual report required by subsection (12), including the timely provision of any information requested by the agency.
(h) The vendor shall provide an annual financial audit of its operations to the agency as required by the agency. The vendor shall also provide quarterly financial reports specific to the program and shall include information on the performance of its subcontractors and vendors. The agency shall determine the format and contents of the reports.
(4) BOND REQUIREMENT.—The agency shall require a bond from the vendor to mitigate the financial consequences of potential acts of malfeasance or misfeasance or fraudulent or dishonest acts committed by the vendor, any employees of the vendor, or its subcontractors.
(5) ELIGIBLE PRESCRIPTION DRUGS.—Eligible importers, as described in subsection (7), may import a drug from an eligible Canadian supplier, as described in subsection (6), if:
(a) The drug meets the United States Food and Drug Administration’s standards related to safety, effectiveness, misbranding, and adulteration;
(b) Importing the drug would not violate federal patent laws;
(c) Importing the drug is expected to generate cost savings; and
(d) The drug is not:
1. A controlled substance as defined in 21 U.S.C. s. 802;
2. A biological product as defined in 42 U.S.C. s. 262;
3. An infused drug;
4. An intravenously injected drug;
5. A drug that is inhaled during surgery; or
6. A drug that is a parenteral drug, the importation of which is determined by the United States Secretary of Health and Human Services to pose a threat to the public health.
(6) ELIGIBLE CANADIAN SUPPLIERS.—A Canadian supplier may export prescription drugs into this state under the program if the supplier:
(a) Is in full compliance with relevant Canadian federal and provincial laws and regulations;
(b) Is identified by the vendor as eligible to participate in the program; and
(c) Submits an attestation that the supplier has a registered agent in the United States, including the name and United States address of the registered agent.
(7) ELIGIBLE IMPORTERS.—The following entities may import prescription drugs from an eligible Canadian supplier under the program:
(a) A pharmacist or wholesaler employed by or under contract with the department’s central pharmacy, for distribution to a county health department or free clinic for dispensing to clients treated in such department or clinic.
(b) A pharmacist or wholesaler employed by or under contract with a Medicaid pharmacy, for dispensing to the pharmacy’s Medicaid recipients.
(c) A pharmacist or wholesaler employed by or under contract with the Department of Corrections, for dispensing to inmates in the custody of the Department of Corrections.
(d) A pharmacist or wholesaler employed by or under contract with a developmental disabilities center, as defined in s. 393.063, for dispensing to clients treated in such center.
(e) A pharmacist or wholesaler employed by or under contract with a treatment facility, as defined in s. 394.455, for dispensing to patients treated in such facility.
(f) A pharmacist or wholesaler employed by or under contract with a forensic facility, as defined in s. 916.106, that is managed by the Agency for Persons with Disabilities, for dispensing to clients treated in such facility.
(8) DISTRIBUTION REQUIREMENTS.—Eligible Canadian suppliers and eligible importers participating under the program:
(a) Must comply with the tracking and tracing requirements of 21 U.S.C. ss. 360eee et seq.
(b) May not distribute, dispense, or sell prescription drugs imported under the program outside of the state.
(9) FEDERAL APPROVAL.—By July 1, 2020, the agency shall submit a request to the United States Secretary of Health and Human Services for approval of the program under 21 U.S.C. s. 384(l). The agency shall begin operating the program within 6 months after receiving such approval. The request must, at a minimum:
(a) Describe the agency’s plan for operating the program.
(b) Demonstrate how the prescription drugs imported into this state under the program will meet the applicable federal and state standards for safety and effectiveness.
(c) Demonstrate how the drugs imported into this state under the program will comply with federal tracing procedures.
(d) Include a list of proposed prescription drugs that have the highest potential for cost savings to the state through importation at the time that the request is submitted.
(e) Estimate the total cost savings attributable to the program.
(f) Provide the costs of program implementation to the state.
(g) Include a list of potential Canadian suppliers from which the state would import drugs and demonstrate that the suppliers are in full compliance with relevant Canadian federal and provincial laws and regulations as well as all applicable federal and state laws and regulations.
(10) PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.—
(a) The vendor shall ensure the safety and quality of drugs imported under the program. The vendor shall:
1. For an initial imported shipment of a specific drug by an importer, ensure that each batch of the drug in the shipment is statistically sampled and tested for authenticity and degradation in a manner consistent with the federal act.
2. For every subsequent imported shipment of that drug by that importer, ensure that a statistically valid sample of the shipment is tested for authenticity and degradation in a manner consistent with the federal act.
3. Certify that the drug:
a. Is approved for marketing in the United States and is not adulterated or misbranded; and
b. Meets all of the labeling requirements under 21 U.S.C. s. 352.
4. Maintain qualified laboratory records, including complete data derived from all tests necessary to ensure that the drug is in compliance with the requirements of this section.
5. Maintain documentation demonstrating that the testing required by this section was conducted at a qualified laboratory in accordance with the federal act and any other applicable federal and state laws and regulations governing laboratory qualifications.
(b) All testing required by this section must be conducted in a qualified laboratory that meets the standards under the federal act and any other applicable federal and state laws and regulations governing laboratory qualifications for drug testing.
(c) The vendor shall maintain information and documentation submitted under this section for a period of at least 7 years.
(d) A participating importer must submit all of the following information to the vendor:
1. The name and quantity of the active ingredient of the drug.
2. A description of the dosage form of the drug.
3. The date on which the drug is received.
4. The quantity of the drug that is received.
5. The point of origin and destination of the drug.
6. The price paid by the importer for the drug.
(e) A participating Canadian supplier must submit the following information and documentation to the vendor specifying all of the following:
1. The original source of the drug, including:
a. The name of the manufacturer of the drug.
b. The date on which the drug was manufactured.
c. The location (country, state or province, and city) where the drug was manufactured.
2. The date on which the drug is shipped.
3. The quantity of the drug that is shipped.
4. The quantity of each lot of the drug originally received and the source of the lot.
5. The lot or control number and the batch number assigned to the drug by the manufacturer.
(f) The agency may require that the vendor collect any other information necessary to ensure the protection of the public health.
(11) IMMEDIATE SUSPENSION.—The agency shall immediately suspend the importation of a specific drug or the importation of drugs by a specific importer if it discovers that any drug or activity is in violation of this section or any federal or state law or regulation. The agency may revoke the suspension if, after conducting an investigation, it determines that the public is adequately protected from counterfeit or unsafe drugs being imported into this state.
(12) ANNUAL REPORT.—By December 1 of each year, the agency shall submit a report to the Governor, the President of the Senate, and the Speaker of the House of Representatives on the operation of the program during the previous fiscal year. The report must include, at a minimum:
(a) A list of the prescription drugs that were imported under the program;
(b) The number of participating entities;
(c) The number of prescriptions dispensed through the program;
(d) The estimated cost savings during the previous fiscal year and to date attributable to the program;
(e) A description of the methodology used to determine which drugs should be included on the Wholesale Prescription Drug Importation List; and
(f) Documentation as to how the program ensures the following:
1. That Canadian suppliers participating in the program are of high quality, high performance, and in full compliance with relevant Canadian federal and provincial laws and regulations as well as all federal laws and regulations and state laws and rules;
2. That prescription drugs imported under the program are not shipped, sold, or dispensed outside of this state once in the possession of the importer;
3. That prescription drugs imported under the program are pure, unadulterated, potent, and safe;
4. That the program does not put consumers at a higher health and safety risk than if the consumer did not participate; and
5. That the program provides cost savings to the state on imported prescription drugs.
(13) NOTIFICATION OF FEDERAL APPROVAL.—Upon receipt of federal approval of the program, the agency shall notify the President of the Senate, the Speaker of the House of Representatives, and the relevant committees of the Senate and the House of Representatives. After approval is received and before the start of the next regular session of the Legislature in which the proposal could be funded, the agency shall submit to all parties a proposal for program implementation and program funding.
(14) RULEMAKING.—The agency shall adopt rules necessary to implement this section.
381.026 Florida Patient’s Bill of Rights and Responsibilities.—
(1) SHORT TITLE.—This section may be cited as the “Florida Patient’s Bill of Rights and Responsibilities.”
(2) DEFINITIONS.—As used in this section and s. 381.0261, the term:
(a) “Department” means the Department of Health.
(b) “Health care facility” means a facility licensed under chapter 395.
(c) “Health care provider” means a physician licensed under chapter 458, an osteopathic physician licensed under chapter 459, a podiatric physician licensed under chapter 461, or an advanced practice registered nurse registered under s. 464.0123.
(d) “Primary care provider” means a health care provider licensed under chapter 458, chapter 459, or chapter 464 who provides medical services to patients which are commonly provided without referral from another health care provider, including family and general practice, general pediatrics, and general internal medicine.
(e) “Responsible provider” means a health care provider who is primarily responsible for patient care in a health care facility or provider’s office.
(3) PURPOSE.—It is the purpose of this section to promote the interests and well-being of the patients of health care providers and health care facilities and to promote better communication between the patient and the health care provider. It is the intent of the Legislature that health care providers understand their responsibility to give their patients a general understanding of the procedures to be performed on them and to provide information pertaining to their health care so that they may make decisions in an informed manner after considering the information relating to their condition, the available treatment alternatives, and substantial risks and hazards inherent in the treatments. It is the intent of the Legislature that patients have a general understanding of their responsibilities toward health care providers and health care facilities. It is the intent of the Legislature that the provision of such information to a patient eliminate potential misunderstandings between patients and health care providers. It is a public policy of the state that the interests of patients be recognized in a patient’s bill of rights and responsibilities and that a health care facility or health care provider may not require a patient to waive his or her rights as a condition of treatment. This section shall not be used for any purpose in any civil or administrative action and neither expands nor limits any rights or remedies provided under any other law.
(4) RIGHTS OF PATIENTS.—Each health care facility or provider shall observe the following standards:
(a) Individual dignity.—
1. The individual dignity of a patient must be respected at all times and upon all occasions.
2. Every patient who is provided health care services retains certain rights to privacy, which must be respected without regard to the patient’s economic status or source of payment for his or her care. The patient’s rights to privacy must be respected to the extent consistent with providing adequate medical care to the patient and with the efficient administration of the health care facility or provider’s office. However, this subparagraph does not preclude necessary and discreet discussion of a patient’s case or examination by appropriate medical personnel.
3. A patient has the right to a prompt and reasonable response to a question or request. A health care facility shall respond in a reasonable manner to the request of a patient’s health care provider for medical services to the patient. The health care facility shall also respond in a reasonable manner to the patient’s request for other services customarily rendered by the health care facility to the extent such services do not require the approval of the patient’s health care provider or are not inconsistent with the patient’s treatment.
4. A patient in a health care facility has the right to retain and use personal clothing or possessions as space permits, unless for him or her to do so would infringe upon the right of another patient or is medically or programmatically contraindicated for documented medical, safety, or programmatic reasons.
5. A patient receiving care in a health care facility or in a provider’s office has the right to bring any person of his or her choosing to the patient-accessible areas of the health care facility or provider’s office to accompany the patient while the patient is receiving inpatient or outpatient treatment or is consulting with his or her health care provider, unless doing so would risk the safety or health of the patient, other patients, or staff of the facility or office or cannot be reasonably accommodated by the facility or provider.
(b) Information.—
1. A patient has the right to know the name, function, and qualifications of each health care provider who is providing medical services to the patient. A patient may request such information from his or her responsible provider or the health care facility in which he or she is receiving medical services.
2. A patient in a health care facility has the right to know what patient support services are available in the facility.
3. A patient has the right to be given by his or her health care provider information concerning diagnosis, planned course of treatment, alternatives, risks, and prognosis, unless it is medically inadvisable or impossible to give this information to the patient, in which case the information must be given to the patient’s guardian or a person designated as the patient’s representative. A patient has the right to refuse this information.
4. A patient has the right to refuse any treatment based on information required by this paragraph, except as otherwise provided by law. The responsible provider shall document any such refusal.
5. A patient in a health care facility has the right to know what facility rules and regulations apply to patient conduct.
6. A patient has the right to express grievances to a health care provider, a health care facility, or the appropriate state licensing agency regarding alleged violations of patients’ rights. A patient has the right to know the health care provider’s or health care facility’s procedures for expressing a grievance.
7. A patient in a health care facility who does not speak English has the right to be provided an interpreter when receiving medical services if the facility has a person readily available who can interpret on behalf of the patient.
8. A health care provider or health care facility shall respect a patient’s right to privacy and should refrain from making a written inquiry or asking questions concerning the ownership of a firearm or ammunition by the patient or by a family member of the patient, or the presence of a firearm in a private home or other domicile of the patient or a family member of the patient. Notwithstanding this provision, a health care provider or health care facility that in good faith believes that this information is relevant to the patient’s medical care or safety, or safety of others, may make such a verbal or written inquiry.
9. A patient may decline to answer or provide any information regarding ownership of a firearm by the patient or a family member of the patient, or the presence of a firearm in the domicile of the patient or a family member of the patient. A patient’s decision not to answer a question relating to the presence or ownership of a firearm does not alter existing law regarding a physician’s authorization to choose his or her patients.
10. A health care provider or health care facility may not discriminate against a patient based solely upon the patient’s exercise of the constitutional right to own and possess firearms or ammunition.
11. A health care provider or health care facility shall respect a patient’s legal right to own or possess a firearm and should refrain from unnecessarily harassing a patient about firearm ownership during an examination.
(c) Financial information and disclosure.—
1. A patient has the right to be given, upon request, by the responsible provider, his or her designee, or a representative of the health care facility full information and necessary counseling on the availability of known financial resources for the patient’s health care.
2. A health care provider or a health care facility shall, upon request, disclose to each patient who is eligible for Medicare, before treatment, whether the health care provider or the health care facility in which the patient is receiving medical services accepts assignment under Medicare reimbursement as payment in full for medical services and treatment rendered in the health care provider’s office or health care facility.
3. A primary care provider may publish a schedule of charges for the medical services that the provider offers to patients. The schedule must include the prices charged to an uninsured person paying for such services by cash, check, credit card, or debit card. The schedule must be posted in a conspicuous place in the reception area of the provider’s office and must include, but is not limited to, the 50 services most frequently provided by the primary care provider. The schedule may group services by three price levels, listing services in each price level. The posting must be at least 15 square feet in size. A primary care provider who publishes and maintains a schedule of charges for medical services is exempt from the license fee requirements for a single period of renewal of a professional license under chapter 456 for that licensure term and is exempt from the continuing education requirements of chapter 456 and the rules implementing those requirements for a single 2-year period.
4. If a primary care provider publishes a schedule of charges pursuant to subparagraph 3., he or she must continually post it at all times for the duration of active licensure in this state when primary care services are provided to patients. If a primary care provider fails to post the schedule of charges in accordance with this subparagraph, the provider shall be required to pay any license fee and comply with any continuing education requirements for which an exemption was received.
5. A health care provider or a health care facility shall, upon request, furnish a person, before the provision of medical services, a reasonable estimate of charges for such services. The health care provider or the health care facility shall provide an uninsured person, before the provision of a planned nonemergency medical service, a reasonable estimate of charges for such service and information regarding the provider’s or facility’s discount or charity policies for which the uninsured person may be eligible. Such estimates by a primary care provider must be consistent with the schedule posted under subparagraph 3. Estimates shall, to the extent possible, be written in language comprehensible to an ordinary layperson. Such reasonable estimate does not preclude the health care provider or health care facility from exceeding the estimate or making additional charges based on changes in the patient’s condition or treatment needs.
6. Each licensed facility, except a facility operating exclusively as a state facility, shall make available to the public on its website or by other electronic means a description of and a hyperlink to the health information that is disseminated by the agency pursuant to s. 408.05(3). The facility shall place a notice in the reception area that such information is available electronically and the website address. The licensed facility may indicate that the pricing information is based on a compilation of charges for the average patient and that each patient’s statement or bill may vary from the average depending upon the severity of illness and individual resources consumed. The licensed facility may also indicate that the price of service is negotiable for eligible patients based upon the patient’s ability to pay.
7. A patient has the right to receive a copy of an itemized statement or bill upon request. A patient has a right to be given an explanation of charges upon request.
(d) Access to health care.—
1. A patient has the right to impartial access to medical treatment or accommodations, regardless of race, national origin, religion, handicap, or source of payment.
2. A patient has the right to treatment for any emergency medical condition that will deteriorate from failure to provide such treatment.
3. A patient has the right to access any mode of treatment that is, in his or her own judgment and the judgment of his or her health care practitioner, in the best interests of the patient, including complementary or alternative health care treatments, in accordance with the provisions of s. 456.41.
(e) Experimental research.—In addition to the provisions of s. 766.103, a patient has the right to know if medical treatment is for purposes of experimental research and to consent prior to participation in such experimental research. For any patient, regardless of ability to pay or source of payment for his or her care, participation must be a voluntary matter; and a patient has the right to refuse to participate. The patient’s consent or refusal must be documented in the patient’s care record.
(f) Patient’s knowledge of rights and responsibilities.—In receiving health care, patients have the right to know what their rights and responsibilities are.
(5) RESPONSIBILITIES OF PATIENTS.—Each patient of a health care provider or health care facility shall respect the health care provider’s and health care facility’s right to expect behavior on the part of patients which, considering the nature of their illness, is reasonable and responsible. Each patient shall observe the responsibilities described in the following summary.
(6) SUMMARY OF RIGHTS AND RESPONSIBILITIES.—Any health care provider who treats a patient in an office or any health care facility licensed under chapter 395 that provides emergency services and care or outpatient services and care to a patient, or admits and treats a patient, shall adopt and make available to the patient, in writing, a statement of the rights and responsibilities of patients, including the following:
SUMMARY OF THE FLORIDA PATIENT’S BILL OF RIGHTS AND RESPONSIBILITIES
Florida law requires that your health care provider or health care facility recognize your rights while you are receiving medical care and that you respect the health care provider’s or health care facility’s right to expect certain behavior on the part of patients. You may request a copy of the full text of this law from your health care provider or health care facility. A summary of your rights and responsibilities follows:
A patient has the right to be treated with courtesy and respect, with appreciation of his or her individual dignity, and with protection of his or her need for privacy.
A patient has the right to a prompt and reasonable response to questions and requests.
A patient has the right to know who is providing medical services and who is responsible for his or her care.
A patient has the right to know what patient support services are available, including whether an interpreter is available if he or she does not speak English.
A patient has the right to bring any person of his or her choosing to the patient-accessible areas of the health care facility or provider’s office to accompany the patient while the patient is receiving inpatient or outpatient treatment or is consulting with his or her health care provider, unless doing so would risk the safety or health of the patient, other patients, or staff of the facility or office or cannot be reasonably accommodated by the facility or provider.
A patient has the right to know what rules and regulations apply to his or her conduct.
A patient has the right to be given by the health care provider information concerning diagnosis, planned course of treatment, alternatives, risks, and prognosis.
A patient has the right to refuse any treatment, except as otherwise provided by law.
A patient has the right to be given, upon request, full information and necessary counseling on the availability of known financial resources for his or her care.
A patient who is eligible for Medicare has the right to know, upon request and in advance of treatment, whether the health care provider or health care facility accepts the Medicare assignment rate.
A patient has the right to receive, upon request, prior to treatment, a reasonable estimate of charges for medical care.
A patient has the right to receive a copy of a reasonably clear and understandable, itemized bill and, upon request, to have the charges explained.
A patient has the right to impartial access to medical treatment or accommodations, regardless of race, national origin, religion, handicap, or source of payment.
A patient has the right to treatment for any emergency medical condition that will deteriorate from failure to provide treatment.
A patient has the right to know if medical treatment is for purposes of experimental research and to give his or her consent or refusal to participate in such experimental research.
A patient has the right to express grievances regarding any violation of his or her rights, as stated in Florida law, through the grievance procedure of the health care provider or health care facility which served him or her and to the appropriate state licensing agency.
A patient is responsible for providing to the health care provider, to the best of his or her knowledge, accurate and complete information about present complaints, past illnesses, hospitalizations, medications, and other matters relating to his or her health.
A patient is responsible for reporting unexpected changes in his or her condition to the health care provider.
A patient is responsible for reporting to the health care provider whether he or she comprehends a contemplated course of action and what is expected of him or her.
A patient is responsible for following the treatment plan recommended by the health care provider.
A patient is responsible for keeping appointments and, when he or she is unable to do so for any reason, for notifying the health care provider or health care facility.
A patient is responsible for his or her actions if he or she refuses treatment or does not follow the health care provider’s instructions.
A patient is responsible for assuring that the financial obligations of his or her health care are fulfilled as promptly as possible.
A patient is responsible for following health care facility rules and regulations affecting patient care and conduct.
381.0261 Summary of patient’s bill of rights; distribution; penalty.—
(1) The Department of Health shall publish on its Internet website a summary of the Florida Patient’s Bill of Rights and Responsibilities. In adopting and making available to patients the summary of the Florida Patient’s Bill of Rights and Responsibilities, health care providers and health care facilities are not limited to the format in which the department publishes the summary.
(2) Health care providers and health care facilities, if requested, shall inform patients of the address and telephone number of each state agency responsible for responding to patient complaints about a health care provider or health care facility’s alleged noncompliance with state licensing requirements established pursuant to law.
(3) Health care facilities shall adopt policies and procedures to ensure that inpatients are provided the opportunity during the course of admission to receive information regarding their rights and how to file complaints with the facility and appropriate state agencies.
(4)(a) An administrative fine may be imposed by the Agency for Health Care Administration when any health care facility fails to make available to patients a summary of their rights, pursuant to s. 381.026 and this section. Initial nonwillful violations shall be subject to corrective action and shall not be subject to an administrative fine. The Agency for Health Care Administration may levy a fine against a health care facility of up to $5,000 for nonwillful violations and up to $25,000 for intentional and willful violations. Each intentional and willful violation constitutes a separate violation and is subject to a separate fine.
(b) An administrative fine may be imposed by the appropriate regulatory board, or the department if there is no board, when any health care provider fails to make available to patients a summary of their rights, pursuant to s. 381.026 and this section. Initial nonwillful violations shall be subject to corrective action and shall not be subject to an administrative fine. The appropriate regulatory board or department may levy a fine against a health care provider of up to $100 for nonwillful violations and up to $500 for willful violations. Each intentional and willful violation constitutes a separate violation and is subject to a separate fine.
(5) In determining the amount of fine to be levied for a violation, as provided in subsection (4), the following factors shall be considered:
(a) The scope and severity of the violation, including the number of patients found to not have received notice of patient rights, and whether the failure to provide notice to patients was willful.
(b) Actions taken by the health care provider or health care facility to correct the violations or to remedy complaints.
(c) Any previous violations of this section by the health care provider or health care facility.
(1) SHORT TITLE.—This section may be cited as the “Patients’ Right-to-Know About Adverse Medical Incidents Act.”
(2) PURPOSE.—It is the purpose of this act to implement s. 25, Art. X of the State Constitution. The Legislature finds that this section of the State Constitution is intended to grant patient access to records of adverse medical incidents, which records were made or received in the course of business by a health care facility or provider, and not to repeal or otherwise modify existing laws governing the use of these records and the information contained therein. The Legislature further finds that all existing laws extending criminal and civil immunity to persons providing information to quality-of-care committees or organizations and all existing laws concerning the discoverability or admissibility into evidence of records of an adverse medical incident in any judicial or administrative proceeding remain in full force and effect.
(3) DEFINITIONS.—As used in s. 25, Art. X of the State Constitution and this act, the term:
(a) “Agency” means the Agency for Health Care Administration.
(b) “Adverse medical incident” means medical negligence, intentional misconduct, and any other act, neglect, or default of a health care facility or health care provider which caused or could have caused injury to or the death of a patient, including, but not limited to, those incidents that are required by state or federal law to be reported to any governmental agency or body, incidents that are reported to any governmental agency or body, and incidents that are reported to or reviewed by any health care facility peer review, risk management, quality assurance, credentials, or similar committee or any representative of any such committee.
(c) “Department” means the Department of Health.
(d) “Have access to any records” means, in addition to any other procedure for producing the records provided by general law, making the records available for inspection and copying upon formal or informal request by the patient or a representative of the patient, provided that current records that have been made publicly available by publication or on the Internet may be provided by reference to the location at which the records are publicly available.
(e) “Health care provider” means a physician licensed under chapter 458, chapter 459, or chapter 461.
(f) “Health care facility” means a facility licensed under chapter 395.
(g) “Identity” means any “individually identifiable health information” as defined by the Health Insurance Portability and Accountability Act of 1996 or its implementing regulations.
(h) “Patient” means an individual who has sought, is seeking, is undergoing, or has undergone care or treatment in a health care facility or by a health care provider.
(i) “Privacy restrictions imposed by federal law” means the provisions relating to the disclosure of patient privacy information under federal law, including, but not limited to, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Pub. L. No. 104-191, and its implementing regulations, the Federal Privacy Act, 5 U.S.C. s. 552(a), and its implementing regulations, and any other federal law, including, but not limited to, federal common law and decisional law, that would prohibit the disclosure of patient privacy information.
(j) “Records” means the final report of any adverse medical incident. Medical records that are not the final report of any adverse medical incident, including drafts or other nonfinal versions; notes; and any documents or portions thereof which constitute, contain, or reflect any attorney-client communications or any attorney-client work product may not be considered “records” for purposes of s. 25, Art. X of the State Constitution and this act.
(k) “Representative of the patient” means a parent of a minor patient, a court-appointed guardian for the patient, a health care surrogate, or a person holding a power of attorney or notarized consent appropriately executed by the patient granting permission to a health care facility or health care provider to disclose the patient’s health care information to that person. In the case of a deceased patient, the term also means the personal representative of the estate of the deceased patient; the deceased patient’s surviving spouse, surviving parent, or surviving adult child; the parent or guardian of a surviving minor child of the deceased patient; or the attorney for any such person.
(4) PATIENTS’ RIGHT OF ACCESS.—Patients have a right to have access to any records made or received in the course of business by a health care facility or health care provider relating to any adverse medical incident. In providing access to these records, the health care facility or health care provider may not disclose the identity of patients involved in the incidents and shall maintain any privacy restrictions imposed by federal law.
(5) APPLICABILITY.—Section 25, Art. X of the State Constitution applies to records created, incidents occurring, and actions pending on or after November 2, 2004. Section 25, Art. X of the State Constitution does not apply to records created, incidents occurring, or actions pending before November 2, 2004. A patient requesting records on or after November 2, 2008, shall be eligible to receive records created within 4 years before the date of the request.
(6) USE OF RECORDS.—
(a) This section does not repeal or otherwise alter any existing restrictions on the discoverability or admissibility of records relating to adverse medical incidents otherwise provided by law, including, but not limited to, those contained in ss. 395.0191, 395.0193, 395.0197, 766.101, and 766.1016, or repeal or otherwise alter any immunity provided to, or prohibition against compelling testimony by, persons providing information or participating in any peer review panel, medical review committee, hospital committee, or other hospital board otherwise provided by law, including, but not limited to, ss. 395.0191, 395.0193, 766.101, and 766.1016.
(b) Except as otherwise provided by act of the Legislature, records of adverse medical incidents, including any information contained therein, obtained under s. 25, Art. X of the State Constitution, are not discoverable or admissible into evidence and may not be used for any purpose, including impeachment, in any civil or administrative action against a health care facility or health care provider. This includes information relating to performance or quality improvement initiatives and information relating to the identity of reviewers, complainants, or any person providing information contained in or used in, or any person participating in the creation of the records of adverse medical incidents.
(7) PRODUCTION OF RECORDS.—
(a) Pursuant to s. 25, Art. X of the State Constitution, the adverse medical incident records to which a patient is granted access are those of the facility or provider of which he or she is a patient and which pertain to any adverse medical incident affecting the patient or any other patient which involves the same or substantially similar condition, treatment, or diagnosis as that of the patient requesting access.
(b)1. Using the process provided in s. 395.0197, the health care facility shall be responsible for identifying records as records of an adverse medical incident, as defined in s. 25, Art. X of the State Constitution.
2. Using the process provided in s. 458.351, the health care provider shall be responsible for identifying records as records of an adverse medical incident, as defined in s. 25, Art. X of the State Constitution, occurring in an office setting.
(c)1. Fees charged by a health care facility for copies of records requested by a patient under s. 25, Art. X of the State Constitution may not exceed the reasonable and actual cost of complying with the request, including a reasonable charge for the staff time necessary to search for records and prevent the disclosure of the identity of any patient involved in the adverse medical incident through redaction or other means as required by the Health Insurance Portability and Accountability Act of 1996 or its implementing regulations. The health care facility may require payment, in full or in part, before acting on the records request.
2. Fees charged by a health care provider for copies of records requested by a patient under s. 25, Art. X of the State Constitution may not exceed the amount established under s. 456.057(17), which may include a reasonable charge for the staff time necessary to prevent the disclosure of the identity of any patient involved in the adverse medical incident through redaction or other means as required by the Health Insurance Portability and Accountability Act of 1996 or its implementing regulations. The health care provider may require payment, in full or in part, before acting on the records request.
(d)1. Requests for production of adverse medical incident records shall be processed by the health care facility or health care provider in a timely manner, after having a reasonable opportunity to determine whether or not the requested record is a record subject to disclosure and to prevent the disclosure of the identity of any patient involved in the adverse medical incident through redaction or other means.
2. A request for production of records must be submitted in writing and must identify the patient requesting access to the records by name, address, and the last four digits of the patient’s social security number; describe the patient’s condition, treatment, or diagnosis; and provide the name of the health care providers whose records are being sought.
(1) PURPOSE.—The purpose of this section is to provide for the operation and closure of special needs shelters and to designate the Department of Health, through its county health departments, as the lead agency for coordination of the recruitment of health care practitioners, as defined in s. 456.001(4), to staff special needs shelters in times of emergency or disaster and to provide resources to the department to carry out this responsibility. However, nothing in this section prohibits a county health department from entering into an agreement with a local emergency management agency to assume the lead responsibility for recruiting health care practitioners.
(2) SPECIAL NEEDS SHELTER PLAN; STAFFING; STATE AGENCY ASSISTANCE.—If funds have been appropriated to support disaster coordinator positions in county health departments:
(a) The department shall assume lead responsibility for the coordination of local medical and health care providers, the American Red Cross, and other interested parties in developing a plan for the staffing and medical management of special needs shelters and pediatric special needs shelters. Plans must conform to the local comprehensive emergency management plan.
(b) County health departments shall, in conjunction with the local emergency management agencies, have the lead responsibility for coordination of the recruitment of health care practitioners to staff local special needs shelters. County health departments shall assign their employees to work in special needs shelters when those employees are needed to protect the health and safety of persons with special needs. County governments shall assist the department with nonmedical staffing and the operation of special needs shelters. The local health department and emergency management agency shall coordinate these efforts to ensure appropriate staffing in special needs shelters, including a staff member who is familiar with the needs of persons with Alzheimer’s disease.
(c) The appropriate county health department and local emergency management agency shall jointly decide who has responsibility for medical supervision in each special needs shelter.
(d) Local emergency management agencies shall be responsible for the designation and operation of special needs shelters during times of emergency or disaster and the closure of the facilities following an emergency or disaster. The local health department and emergency management agency shall coordinate these efforts to ensure the appropriate designation and operation of special needs shelters. County health departments shall assist the local emergency management agency with regard to the management of medical services in special needs shelters.
(e) The Secretary of Elderly Affairs, or his or her designee, shall convene, at any time that he or she deems appropriate and necessary, a multiagency special needs shelter discharge planning team to assist local areas that are severely impacted by a natural or manmade disaster that requires the use of special needs shelters. Multiagency special needs shelter discharge planning teams shall provide assistance to local emergency management agencies with the continued operation or closure of the shelters, as well as with the discharge of special needs clients to alternate facilities if necessary. Local emergency management agencies may request the assistance of a multiagency special needs shelter discharge planning team by alerting statewide emergency management officials of the necessity for additional assistance in their area. The Secretary of Elderly Affairs is encouraged to proactively work with other state agencies prior to any natural disasters for which warnings are provided to ensure that multiagency special needs shelter discharge planning teams are ready to assemble and deploy rapidly upon a determination by state emergency management officials that a disaster area requires additional assistance. The Secretary of Elderly Affairs may call upon any state agency or office to provide staff to assist a multiagency special needs shelter discharge planning team. Unless the secretary determines that the nature or circumstances surrounding the disaster do not warrant participation from a particular agency’s staff, each multiagency special needs shelter discharge planning team shall include at least one representative from each of the following state agencies:
1. Department of Elderly Affairs.
2. Department of Health.
3. Department of Children and Families.
4. Department of Veterans’ Affairs.
5. Division of Emergency Management.
6. Agency for Health Care Administration.
7. Agency for Persons with Disabilities.
(3) SPECIAL CARE FOR PERSONS WITH ALZHEIMER’S DISEASE OR RELATED FORMS OF DEMENTIA.—All special needs shelters must establish designated shelter areas for persons with Alzheimer’s disease or related forms of dementia to enable those persons to maintain their normal habits and routines to the greatest extent possible.
(4) REIMBURSEMENT TO HEALTH CARE PRACTITIONERS AND FACILITIES.—
(a) The department shall, upon request, reimburse in accordance with paragraph (b):
1. Health care practitioners, as defined in s. 456.001, provided the practitioner is not providing care to a patient under an existing contract, and emergency medical technicians and paramedics licensed under chapter 401 for medical care provided at the request of the department in special needs shelters or at other locations during times of emergency or a declared disaster. Reimbursement for health care practitioners, except for physicians licensed under chapter 458 or chapter 459, shall be based on the average hourly rate that such practitioners were paid according to the most recent survey of Florida hospitals conducted by the Florida Hospital Association or other nationally recognized or state-recognized data source.
2. Health care facilities, such as hospitals, nursing homes, assisted living facilities, and community residential homes, if, upon closure of a special needs shelter, a multiagency special needs shelter discharge planning team determines that it is necessary to discharge persons with special needs to other health care facilities. The receiving facilities are eligible for reimbursement for services provided to the individuals for up to 90 days. A facility must show proof of a written request from a representative of an agency serving on the multiagency special needs shelter discharge planning team that the individual for whom the facility is seeking reimbursement for services rendered was referred to that facility from a special needs shelter. The department shall specify by rule which expenses are reimbursable and the rate of reimbursement for each service.
(b) Reimbursement is subject to the availability of federal funds and shall be requested on forms prepared by the department. If a Presidential Disaster Declaration has been issued, the department shall request federal reimbursement of eligible expenditures. The department may not provide reimbursement to facilities under this subsection for services provided to a person with special needs if, during the period of time in which the services were provided, the individual was enrolled in another state-funded program, such as Medicaid or another similar program, was covered under a policy of health insurance as defined in s. 624.603, or was a member of a health maintenance organization or prepaid health clinic as defined in chapter 641, which would otherwise pay for the same services. Travel expense and per diem costs shall be reimbursed pursuant to s. 112.061.
(5) HEALTH CARE PRACTITIONER REGISTRY.—The department may use the registries established in ss. 401.273 and 456.38 when health care practitioners are needed to staff special needs shelters or to assist with other disaster-related activities.
(6) SPECIAL NEEDS SHELTER INTERAGENCY COMMITTEE.—The State Surgeon General may establish a special needs shelter interagency committee and serve as, or appoint a designee to serve as, the committee’s chair. The department shall provide any necessary staff and resources to support the committee in the performance of its duties. The committee shall address and resolve problems related to special needs shelters not addressed in the state comprehensive emergency medical plan and shall consult on the planning and operation of special needs shelters.
(a) The committee shall develop, negotiate, and regularly review any necessary interagency agreements, and undertake other such activities as the department deems necessary to facilitate the implementation of this section.
(b) The special needs shelter interagency committee shall be composed of representatives of emergency management, health, medical, and social services organizations. Membership shall include, but shall not be limited to, representatives of the Departments of Health, Children and Families, Elderly Affairs, and Education; the Agency for Health Care Administration; the Division of Emergency Management; the Florida Medical Association; the Florida Osteopathic Medical Association; Associated Home Health Industries of Florida, Inc.; the Florida Nurses Association; the Florida Health Care Association; the Florida Assisted Living Affiliation; the Florida Hospital Association; the Florida Statutory Teaching Hospital Council; the Florida Association of Homes for the Aging; the Florida Emergency Preparedness Association; the American Red Cross; Florida Hospices and Palliative Care, Inc.; the Association of Community Hospitals and Health Systems; the Florida Association of Health Maintenance Organizations; the Florida League of Health Systems; the Private Care Association; the Salvation Army; the Florida Association of Aging Services Providers; the AARP; and the Florida Renal Coalition.
(c) Meetings of the committee shall be held in Tallahassee, and members of the committee shall serve at the expense of the agencies or organizations they represent. The committee shall make every effort to use teleconference or video conference capabilities in order to ensure statewide input and participation.
(7) RULES.—The department, in coordination with the Division of Emergency Management, has the authority to adopt rules necessary to implement this section. Rules shall include:
(a) The definition of a “person with special needs,” including eligibility criteria for individuals with physical, mental, cognitive impairment, or sensory disabilities and the services a person with special needs can expect to receive in a special needs shelter.
(b) The process for special needs shelter health care practitioners and facility reimbursement for services provided in a disaster.
(c) Guidelines for special needs shelter staffing levels to provide services.
(d) The definition of and standards for special needs shelter supplies and equipment, including durable medical equipment.
(e) Standards for the special needs shelter registration program, including all necessary forms and guidelines for addressing the needs of unregistered persons in need of a special needs shelter.
(f) Standards for addressing the needs of families where only one dependent is eligible for admission to a special needs shelter and the needs of adults with special needs who are caregivers for individuals without special needs.
(g) The requirement of the county health departments to seek the participation of hospitals, nursing homes, assisted living facilities, home health agencies, hospice providers, nurse registries, home medical equipment providers, dialysis centers, and other health and medical emergency preparedness stakeholders in pre-event planning activities.
(8) EMERGENCY MANAGEMENT PLANS.—The submission of emergency management plans to county health departments by home health agencies, nurse registries, hospice programs, and home medical equipment providers is conditional upon receipt of an appropriation by the department to establish disaster coordinator positions in county health departments unless the State Surgeon General and a local county commission jointly determine to require that such plans be submitted based on a determination that there is a special need to protect public health in the local area during an emergency.
381.0402 Area health education center network.—The department, in cooperation with the state-approved medical schools in this state, shall organize an area health education center network based on earlier medically indigent demonstration projects and shall evaluate the impact of each network on improving access to services by persons who are medically underserved. The network shall be a catalyst for the primary care training of health professionals through increased opportunities for training in medically underserved areas.
(1) The department shall contract to assist in funding an area health education center network which links the provision of primary care services to low-income persons with the education of medical students, interns, and residents. The network shall:
(a) Be coordinated with and under contract with the state-approved medical schools, which shall be responsible for the clinical training and supervision.
(b) Divide the state into service areas with each state-approved medical school coordinating the recruiting, training, and retention of medical students within its assigned area.
(c) Use a multidisciplinary approach with appropriate medical supervision.
(d) Use current community resources such as county health departments, federally funded primary care centers, or other primary health care providers as community-based sites for training medical students, interns, and residents.
(2) The department shall establish criteria and procedures for quality assurance, performance evaluations, periodic audits, and other appropriate safeguards for the network.
(3) The department shall make every effort to assure that participating medical schools do not discriminate among enrollees with respect to age, race, sex, or health status. However, such schools may target high-risk medically needy population groups.
(4) The department may use no more than 5 percent of the annual appropriation for administering and evaluating the network.
(1) ESTABLISHMENT.—The Department of Health shall establish an Office of Rural Health. The Office of Rural Health shall coordinate its activities with the area health education center network established pursuant to s. 381.0402 and with any appropriate research and policy development centers within universities that have state-approved medical schools. The Office of Rural Health may enter into a formal relationship with any center that designates the office as an affiliate of the center.
(2) PURPOSE.—The Office of Rural Health shall actively foster the provision of health care services in rural areas and serve as a catalyst for improved health services to citizens in rural areas of the state.
(3) GENERAL FUNCTIONS.—The office shall:
(a) Integrate policies related to physician workforce, hospitals, public health, and state regulatory functions.
(b) Propose solutions to problems affecting health care delivery in rural areas.
(c) Seek grant funds from foundations and the Federal Government.
(4) COORDINATION.—The office shall:
(a) Identify federal and state rural health programs and provide technical assistance to rural providers regarding participation in such programs.
(b) Act as a clearinghouse for collecting and disseminating information on rural health care issues, research findings on rural health care, and innovative approaches to the delivery of health care in rural areas.
(c) Foster the creation of regional health care systems that promote cooperation, rather than competition.
(d) Coordinate the department’s rural health care activities, programs, and policies.
(e) Design initiatives to improve access to emergency medical services in rural areas.
(f) Assume responsibility for state coordination of the Rural Hospital Transition Grant Program and other federal rural health care programs.
(5) TECHNICAL ASSISTANCE.—The office shall:
(a) Help rural health care providers obtain health care practitioners by promoting the location and relocation of health care practitioners in rural areas.
(b) Provide technical assistance to hospitals, community and migrant health centers, and other health care providers.
(c) Design strategies to improve health care workforce recruitment and placement programs.
(6) RESEARCH PUBLICATIONS AND SPECIAL STUDIES.—The office shall:
(a) Conduct policy and research studies.
(b) Conduct health status studies of rural residents.
(c) Collect relevant data on rural health care issues for use in department policy development.
(a) The Legislature finds that, in rural areas, access to health care is limited and the quality of health care is negatively affected by inadequate financing, difficulty in recruiting and retaining skilled health professionals, and because of a migration of patients to urban areas for general acute care and specialty services.
(b) The Legislature further finds that the efficient and effective delivery of health care services in rural areas requires the integration of public and private resources and the coordination of health care providers.
(c) The Legislature further finds that the availability of a continuum of quality health care services, including preventive, primary, secondary, tertiary, and long-term care, is essential to the economic and social vitality of rural communities.
(d) The Legislature further finds that the creation of rural health networks can help to alleviate these problems. Rural health networks shall act in the broad public interest and, to the extent possible, be structured to provide a continuum of quality health care services for rural residents through the cooperative efforts of rural health network members.
(e) The Legislature further finds that rural health networks shall have the goal of increasing the utilization of statutory rural hospitals for appropriate health care services whenever feasible, which shall help to ensure their survival and thereby support the economy and protect the health and safety of rural residents.
(f) Finally, the Legislature finds that rural health networks may serve as “laboratories” to determine the best way of organizing rural health services, to move the state closer to ensuring that everyone has access to health care, and to promote cost containment efforts. The ultimate goal of rural health networks shall be to ensure that quality health care is available and efficiently delivered to all persons in rural areas.
(2) DEFINITIONS.—
(a) “Rural” means an area with a population density of less than 100 individuals per square mile or an area defined by the most recent United States Census as rural.
(b) “Health care provider” means any individual, group, or entity, public or private, that provides health care, including: preventive health care, primary health care, secondary and tertiary health care, in-hospital health care, public health care, and health promotion and education.
(c) “Rural health network” or “network” means a nonprofit legal entity, consisting of rural and urban health care providers and others, that is organized to plan and deliver health care services on a cooperative basis in a rural area, except for some secondary and tertiary care services.
(3) Health care provider membership may vary, but all networks shall include members that provide public health, comprehensive primary care, emergency medical care, and acute inpatient care.
(4) Network membership shall be available to all health care providers, provided that they render care to all patients referred to them from other network members, comply with network quality assurance and risk management requirements, abide by the terms and conditions of network provider agreements in paragraph (11)(c), and provide services at a rate or price equal to the rate or price negotiated by the network.
(5) Network areas do not need to conform to local political boundaries or state administrative district boundaries. The geographic area of one rural health network, however, may not overlap the territory of any other rural health network.
(6) Networks shall develop provisions for referral to tertiary inpatient care and to other services that are not available in rural areas.
(7) Networks shall make available health promotion, disease prevention, and primary care services to improve the health status of rural residents and to contain health care costs.
(8) Networks may have multiple points of entry, such as through private physicians, community health centers, county health departments, certified rural health clinics, hospitals, or other providers; or they may have a single point of entry.
(9) Networks shall establish standard protocols, coordinate and share patient records, and develop patient information exchange systems.
(10) Networks shall develop risk management and quality assurance programs for network providers.
(11) NETWORK GOVERNANCE AND ORGANIZATION.—
(a) Networks shall be incorporated under the laws of the state.
(b) Networks shall have a board of directors that derives membership from local government, health care providers, businesses, consumers, and others.
(c) Network boards of directors shall have the responsibility of determining the content of health care provider agreements that link network members. The agreements shall specify:
1. Who provides what services.
2. The extent to which the health care provider provides care to persons who lack health insurance or are otherwise unable to pay for care.
3. The procedures for transfer of medical records.
4. The method used for the transportation of patients between providers.
5. Referral and patient flow including appointments and scheduling.
6. Payment arrangements for the transfer or referral of patients.
(d) There shall be no liability on the part of, and no cause of action of any nature shall arise against, any member of a network board of directors, or its employees or agents, for any lawful action taken by them in the performance of their administrative powers and duties under this subsection.
(12) NETWORK SERVICES.—
(a) Networks, to the extent feasible, shall provide for a continuum of care for all patients served by the network. Each network shall include the following core services: disease prevention, health promotion, comprehensive primary care, emergency medical care, and acute inpatient care. Each network shall ensure the availability of comprehensive maternity care, including prenatal, delivery, and postpartum care for uncomplicated pregnancies, either directly, by contract, or through referral agreements. Networks shall, to the extent feasible, also ensure the availability of the following services within the specified timeframes, either directly, by contract, or through referral agreements:
1. Services available in the home.
a. Home health care.
b. Hospice care.
2. Services accessible within 30 minutes travel time or less.
a. Emergency medical services, including advanced life support, ambulance, and basic emergency room services.
b. Primary care.
c. Prenatal and postpartum care for uncomplicated pregnancies.
d. Community-based services for elders, such as adult day care and assistance with activities of daily living.
e. Public health services, including communicable disease control, disease prevention, health education, and health promotion.
f. Outpatient psychiatric and substance abuse services.
3. Services accessible within 45 minutes travel time or less.
a. Hospital acute inpatient care for persons whose illnesses or medical problems are not severe.
b. Level I obstetrical care, which is labor and delivery for low-risk patients.
c. Skilled nursing services, long-term care, including nursing home care.
d. Dialysis.
e. Osteopathic and chiropractic manipulative therapy.
4. Services accessible within 2 hours travel time or less.
a. Specialist physician care.
b. Hospital acute inpatient care for severe illnesses and medical problems.
c. Level II and III obstetrical care, which is labor and delivery care for high-risk patients and neonatal intensive care.
d. Comprehensive medical rehabilitation.
e. Inpatient psychiatric and substance abuse services.
f. Magnetic resonance imaging, lithotripter treatment, advanced radiology, and other technologically advanced services.
g. Subacute care.
(b) Networks shall actively participate with area health education center programs, whenever feasible, in developing and implementing recruitment, training, and retention programs directed at positively influencing the supply and distribution of health care professionals serving in, or receiving training in, network areas.
(c) As funds become available, networks shall emphasize community care alternatives for elders who would otherwise be placed in nursing homes.
(d) To promote the most efficient use of resources, networks shall emphasize disease prevention, early diagnosis and treatment of medical problems, and community care alternatives for persons with mental health and substance abuse disorders who are at risk to be institutionalized.
(13) TRAUMA SERVICES.—In those network areas which have an established trauma agency approved by the Department of Health, that trauma agency must be a participant in the network. Trauma services provided within the network area must comply with s. 395.405.
(14) NETWORK FINANCING.—Networks may use all sources of public and private funds to support network activities. Nothing in this section prohibits networks from becoming managed care providers.
(15) NETWORK IMPLEMENTATION.—As funds become available, networks shall be developed and implemented in two phases.
(a) Phase I shall consist of a network planning and development grant program. Planning grants shall be used to organize networks, incorporate network boards, and develop formal provider agreements as provided for in this section. The Department of Health shall develop a request-for-proposal process to solicit grant applications.
(b) Phase II shall consist of network operations. As funds become available, certified networks shall be eligible to receive grant funds to be used to help defray the costs of network infrastructure development, patient care, and network administration. Infrastructure development includes, but is not limited to: recruitment and retention of primary care practitioners; development of preventive health care programs; linkage of urban and rural health care systems; design and implementation of automated patient records, outcome measurement, quality assurance, and risk management systems; establishment of one-stop service delivery sites; upgrading of medical technology available to network providers; enhancement of emergency medical systems; enhancement of medical transportation; and development of telecommunication capabilities. A Phase II award may occur in the same fiscal year as a Phase I award.
(16) CERTIFICATION.—For the purpose of certifying networks that are eligible for Phase II funding, the Department of Health shall certify networks that meet the criteria delineated in this section and the rules governing rural health networks.
(17) RULES.—The Department of Health shall establish rules that govern the creation and certification of networks, including establishing outcome measures for networks.
381.04065 Rural health network cooperative agreements.—
(1) INTENT.—It is the Legislature’s intent that, to the extent necessary to foster the development of rural health networks as provided for in s. 381.0406, competitive market forces shall be replaced with state regulation, as provided for in this section. It is also the intent of the Legislature that consolidation of network hospital services or technologies undertaken pursuant to this section, and cooperative agreements between members of rural health networks, shall not violate the state’s antitrust laws when such arrangements improve the quality of health care, moderate cost increases, and are made between members of rural health networks as defined in s. 381.0406. It is also the intent of the Legislature that such arrangements be protected from federal antitrust laws, subject to the approval and supervision of the Department of Health. Such intent is within the public policy of the state to facilitate the provision of quality, cost-efficient medical care to rural patients.
(2) DEPARTMENT APPROVAL.—Providers who are members of certified rural health networks who seek to consolidate services or technologies or enter into cooperative agreements shall seek approval from the Department of Health, which may consult with the Department of Legal Affairs. The department shall determine that the likely benefits resulting from the agreement outweigh any disadvantages attributable to any potential reduction in competition resulting from the agreement and issue a letter of approval if, in its determination, the agreement reduces or moderates costs and meets any of the following criteria:
(a) Consolidates services or facilities in a market area used by rural health network patients to avoid duplication;
(b) Promotes cooperation between rural health network members in the market area;
(c) Encourages cost sharing among rural health network facilities;
(d) Enhances the quality of rural health care; or
(e) Improves utilization of rural health resources and equipment.
(3) STATE OVERSIGHT.—The Department of Health shall review each agreement approved under this section at least every 2 years. If the department determines that the likely benefits resulting from its state action approval no longer outweigh any disadvantages attributable to any potential reduction in competition resulting from the agreement, the department shall initiate proceedings to terminate its state action approval governing the agreement. Such termination proceeding shall be governed by chapter 120.
(4) JUDICIAL REVIEW.—Any applicant aggrieved by a decision of the Department of Health shall be entitled to both administrative and judicial review thereof in accordance with chapter 120. In such review, the decision of the department shall be affirmed unless it is arbitrary, capricious, or it is not in compliance with this section.
(5) RULEMAKING.—The Department of Health, in consultation with the Office of the Attorney General, shall establish rules necessary to implement this section.
381.0601 Self-derived and directed-donor blood programs.—
(1) Any person residing in this state shall be entitled and allowed to participate in a program to donate his or her own blood, in order to have such blood available for autologous, or self-derived, transfusion at the time of a planned medical need.
(2) Any person residing in this state shall be entitled and allowed to participate in a directed-donor blood program to donate the blood of specific donors for use by a designated recipient, in order to have such blood available for blood transfusions at the time of a planned medical need.
(3) Such blood shall not be administered to any other individual until such time as the designated recipient no longer has a need for the blood, after which time the blood shall revert to the blood bank’s general account, except that in the event of a medical emergency, such blood from a designated donor may be used to meet the emergency need.
(a) “Blood establishment” means any person, entity, or organization, operating within the state, which examines an individual for the purpose of blood donation or which collects, processes, stores, tests, or distributes blood or blood components collected from the human body for the purpose of transfusion, for any other medical purpose, or for the production of any biological product. A person, entity, or organization that uses a mobile unit to conduct such activities within the state is also a blood establishment.
(b) “Volunteer donor” means a person who does not receive remuneration, other than an incentive, for a blood donation intended for transfusion, and the product container of the donation from the person qualifies for labeling with the statement “volunteer donor” under 21 C.F.R. s. 606.121.
(2) Any blood establishment operating in the state may not conduct any activity defined in paragraph (1)(a) unless that blood establishment is operated in a manner consistent with the provisions of 21 C.F.R. parts 211 and 600-640.
(3) Any blood establishment determined to be operating in the state in a manner not consistent with the provisions of 21 C.F.R. parts 211 and 600-640 and in a manner that constitutes a danger to the health or well-being of donors or recipients as evidenced by the federal Food and Drug Administration’s inspection reports and the revocation of the blood establishment’s license or registration is in violation of this chapter and must immediately cease all operations in the state.
(4) The operation of a blood establishment in a manner not consistent with the provisions of 21 C.F.R. parts 211 and 600-640 and in a manner that constitutes a danger to the health or well-being of blood donors or recipients as evidenced by the federal Food and Drug Administration’s inspection process is declared a nuisance and inimical to the public health, welfare, and safety. The Agency for Health Care Administration or any state attorney may bring an action for an injunction to restrain such operations or enjoin the future operation of the blood establishment.
(5) A local government may not restrict the access to or use of any public facility or infrastructure for the collection of blood or blood components from volunteer donors based on whether the blood establishment is operating as a for-profit organization or not-for-profit organization.
(6) In determining the service fee of blood or blood components received from volunteer donors and sold to hospitals or other health care providers, a blood establishment may not base the service fee of the blood or blood component solely on whether the purchasing entity is a for-profit organization or not-for-profit organization.
(7) A blood establishment that collects blood or blood components from volunteer donors must disclose on the Internet the information required under this subsection to educate and inform donors and the public about the blood establishment’s activities. A hospital that collects blood or blood components to be used only by that hospital’s licensed facilities or by a health care provider that is a part of the hospital’s business entity is exempt from the disclosure requirements in this subsection. The information required to be disclosed under this subsection may be cumulative for all blood establishments within a business entity. A blood establishment must disclose on its website all of the following information:
(a) A description of the steps involved in collecting, processing, and distributing volunteer donations.
(b) By March 1 of each year, the number of units of blood components which were:
1. Produced by the blood establishment during the preceding calendar year;
2. Obtained from other sources during the preceding calendar year;
3. Distributed during the preceding calendar year to health care providers located outside this state. However, if the blood establishment collects donations in a county outside this state, distributions to health care providers in that county shall be excluded. Such information shall be reported in the aggregate for health care providers located within the United States and its territories or outside the United States and its territories; and
4. Distributed during the preceding calendar year to entities that are not health care providers. Such information shall be reported in the aggregate for purchasers located within the United States and its territories or outside the United States and its territories.
(c) The blood establishment’s conflict-of-interest policy, policy concerning related-party transactions, whistleblower policy, and policy for determining executive compensation. If a change occurs to any of these documents, the revised document must be available on the blood establishment’s website by the following March 1.
(d) Except for a hospital that collects blood or blood components from volunteer donors:
1. The most recent 3 years of the Return of Organization Exempt from Income Tax, Internal Revenue Service Form 990, if the business entity for the blood establishment is eligible to file such return. The Form 990 must be available on the blood establishment’s website within 60 calendar days after it is filed with the Internal Revenue Service; or
2. If the business entity for the blood establishment is not eligible to file the Form 990 return, a balance sheet, income statement, and statement of changes in cash flow, along with the expression of an opinion thereon by an independent certified public accountant who audited or reviewed such financial statements. Such documents must be available on the blood establishment’s website within 120 days after the end of the blood establishment’s fiscal year and must remain on the blood establishment’s website for at least 36 months.
(8) A blood establishment is liable for a civil penalty for failing to make the disclosures required under subsection (7). The Department of Legal Affairs may assess the civil penalty against the blood establishment for each day that it fails to make such required disclosures, but the penalty may not exceed $10,000 per year. If multiple blood establishments operated by a single business entity fail to meet such disclosure requirements, the civil penalty may be assessed against only one of the business entity’s blood establishments. The Department of Legal Affairs may terminate an action if the blood establishment agrees to pay a stipulated civil penalty. A civil penalty so collected accrues to the state and shall be deposited as received into the General Revenue Fund unallocated. The Department of Legal Affairs may terminate the action and waive the civil penalty upon a showing of good cause by the blood establishment as to why the required disclosures were not made.
(1) There is established a statewide consortium to be known as the Public Cord Blood Tissue Bank. The Public Cord Blood Tissue Bank is established as a nonprofit legal entity to collect, screen for infectious and genetic diseases, perform tissue typing, cryopreserve, and store umbilical cord blood as a resource to the public. The University of Florida, the University of South Florida, the University of Miami, and the Mayo Clinic, Jacksonville shall jointly form the collaborative consortium, each working with community resources such as regional blood banks, hospitals, and other health care providers to develop local and regional coalitions for the purposes set forth in this act. The consortium participants shall align their outreach programs and activities to all geographic areas of the state, covering the entire state. The consortium is encouraged to conduct outreach and research for Hispanics, African Americans, Native Americans, and other ethnic and racial minorities.
(2) The Agency for Health Care Administration and the Department of Health shall encourage health care providers, including, but not limited to, hospitals, birthing facilities, county health departments, physicians, midwives, and nurses, to disseminate information about the Public Cord Blood Tissue Bank.
(3) Nothing in this section creates a requirement of any health care or services program that is directly affiliated with a bona fide religious denomination that includes as an integral part of its beliefs and practices the tenet that blood transfer is contrary to the moral principles the denomination considers to be an essential part of its beliefs.
(4) Any health care facility or health care provider receiving financial remuneration for the collection of umbilical cord blood shall provide written disclosure of this information to any woman postpartum or parent of a newborn from whom the umbilical cord blood is collected prior to the harvesting of the umbilical cord blood.
(5) A woman admitted to a hospital or birthing facility for obstetrical services may be offered the opportunity to donate umbilical cord blood to the Public Cord Blood Tissue Bank. A woman may not be required to make such a donation.
(6) The consortium may charge reasonable rates and fees to recipients of cord blood tissue bank products.
(1) The Department of Health shall make publicly available, by posting on its Internet website, resources and an Internet website link to materials relating to umbilical cord blood which have been developed by the Parent’s Guide to Cord Blood Foundation, Inc., including:
(a) An explanation of the potential value and uses of umbilical cord blood, including cord blood cells and stem cells, for individuals who are, as well as individuals who are not, biologically related to a mother or her newborn child.
(b) An explanation of the differences between using one’s own cord blood cells and using biologically related or biologically unrelated cord blood stem cells in the treatment of disease.
(c) An explanation of the differences between public and private umbilical cord blood banking.
(d) The options available to a mother relating to stem cells that are contained in the umbilical cord blood after the delivery of her newborn, including:
1. Donating the stem cells to a public umbilical cord blood bank where facilities are available;
2. Storing the stem cells in a private family umbilical cord blood bank for use by immediate and extended family members;
3. Storing the stem cells for use by family members through a family or sibling donor banking program that provides free collection, processing, and storage if there is an existing medical need; and
4. Discarding the stem cells.
(e) The medical processes involved in the collection of cord blood.
(f) Criteria for medical or family history that can impact a family’s consideration of umbilical cord blood banking, including the likelihood of using a baby’s cord blood to serve as a match for a family member who has a medical condition.
(g) Options for ownership and future use of donated umbilical cord blood.
(h) The average cost of public and private umbilical cord blood banking.
(i) The availability of public and private cord blood banks to residents of this state, including:
1. A list of public cord blood banks and the hospitals served by such blood banks;
2. A list of private cord blood banks that are available; and
3. The availability of free family banking and sibling donor programs if there is an existing medical need by a family member.
(j) An explanation of which racial and ethnic groups are in particular need of publicly donated cord blood samples based upon medical data developed by the Health Resources and Services Administration of the United States Department of Health and Human Services.
(2) The Department of Health shall encourage health care providers who provide health care services that are directly related to a woman’s pregnancy to make available to a pregnant patient before her third trimester of pregnancy, or, if later, at the first visit of such patient to the provider, information listed under subsection (1) which relates to the patient’s options regarding umbilical cord blood banking.
(3) A health care provider or a health care facility, or any employee or agent thereof, is not liable for damages in a civil action, subject to prosecution in a criminal proceeding, or subject to disciplinary action by the appropriate regulatory board for acting in good faith to comply with the provisions of this section.
(1) DEFINITIONS.—As used in this section, the term:
(a) “Council” means the Health Care Innovation Council.
(b) “Department” means the Department of Health.
(c) “Health care provider” means any person or entity licensed, certified, registered, or otherwise authorized by law to provide health care services in this state.
(2) LEGISLATIVE INTENT.—The Legislature intends to harness the innovation and creativity of entrepreneurs and businesses, together with the state’s health care system and stakeholders, to lead the discussion and highlight advances and innovations that will address challenges in the health care system as they develop in real time and transform the delivery and strengthen the quality of health care in Florida. Innovative technologies, workforce pathways, service delivery models, or other solutions that improve the quality of care in measurable and sustainable ways, that can be replicated, and that will lower costs and allow that value to be passed on to health care consumers shall be highlighted for adoption across all neighborhoods and communities in this state.
(3) HEALTH CARE INNOVATION COUNCIL.—The Health Care Innovation Council, a council as defined in s. 20.03, is created within the department to tap into the best knowledge and experience available by regularly bringing together subject matter experts in a public forum to explore and discuss innovations in technology, workforce, and service delivery models that can be exhibited as best practices, implemented, or scaled in order to improve the quality and delivery of health care in this state in measurable, sustainable, and reproducible ways.
(a) Membership.—
1. The Lieutenant Governor shall serve as an ex officio, nonvoting member and shall act as the council chair.
2. The council shall be composed of the following voting members, to be appointed by July 1, 2024:
a. One member appointed by the President of the Senate and one member appointed by the Speaker of the House of Representatives. The appointing officers shall make appointments prioritizing members who have the following experience:
(I) A representative of the health care sector who has senior-level experience in reducing inefficiencies in health care delivery systems;
(II) A representative of the private sector who has senior-level experience in cybersecurity or software engineering in the health care sector;
(III) A representative who has expertise in emerging technology that can be used in the delivery of health care; or
(IV) A representative who has experience in finance or investment or in management and operation of early stage companies.
b. A physician licensed under chapter 458 or chapter 459, appointed by the Governor.
c. A nurse licensed under chapter 464, appointed by the Governor.
d. An employee of a hospital licensed under chapter 395 who has executive-level experience, appointed by the Governor.
e. A representative of the long-term care facility industry, appointed by the Governor.
f. An employee of a health insurer or health maintenance organization who has executive-level experience, appointed by the Governor.
g. A resident of this state who can represent the interest of health care patients in this state, appointed by the Governor.
3. The chair of the Council of Florida Medical School Deans shall serve as a voting member of the council.
4. The council shall be composed of the following ex officio, nonvoting members:
a. The State Surgeon General.
b. The Secretary of Health Care Administration.
c. The Secretary of Children and Families.
d. The director of the Agency for Persons with Disabilities.
e. The Secretary of Elderly Affairs.
5. Except for ex officio members, the term of all appointees shall be for 2 years unless otherwise specified. However, to achieve staggered terms, the appointees in sub-subparagraphs 2.a.-c. shall serve initial terms of 3 years. The appointees may be reappointed for no more than four consecutive terms.
6. Any vacancy occurring on the council must be filled in the same manner as the original appointment. Any member who is appointed to fill a vacancy occurring because of death, resignation, or ineligibility for membership shall serve only for the unexpired term of the member’s predecessor.
7. Members whose terms have expired may continue to serve until replaced or reappointed. However, members whose terms have expired may not serve longer than 6 months after the expiration of their terms.
8. Members shall serve without compensation but are entitled to reimbursement for per diem and travel expenses pursuant to s. 112.061.
9. Members may be removed for cause by the appointing entity.
10. Each member of the council who is not otherwise required to file a financial disclosure statement pursuant to s. 8, Art. II of the State Constitution or s. 112.3144 must file a disclosure of financial interests pursuant to s. 112.3145.
(b) Meetings.—The council shall convene its first organizational meeting by September 1, 2024. Thereafter, the council shall meet as necessary, but at least quarterly, at the call of the chair. In order to provide an opportunity for the broadest public input, the chair shall ensure that a majority of the meetings held in a year are geographically dispersed within this state. As feasible, meetings are encouraged to provide an opportunity for presentation or demonstration of innovative solutions in person. A majority of the members of the council constitutes a quorum, and a meeting may not be held with less than a quorum present. In order to establish a quorum, the council may conduct its meetings through teleconference or other electronic means. The affirmative vote of a majority of the members of the council present is necessary for any official action by the council.
(c) Conflicts of interest.—
1. A council member may not vote on any matter that would provide:
a. Direct financial benefit to the member;
b. Financial benefit to a relative of the member, including an entity of which a relative is an officer, partner, director, or proprietor or in which the relative has a material interest; or
c. Financial benefit to a person or entity with whom the member has a business relationship.
2. With respect to the revolving loan program established in subsection (7):
a. Council members may not receive loans under the program; and
b. A person or entity that has a conflict-of-interest relationship with a council member as described in sub-subparagraph 1.b. or sub-subparagraph 1.c. may not receive a loan under the program unless that council member recused himself or herself from consideration of the person’s or entity’s application.
3. For purposes of this paragraph, the term:
a. “Business relationship” means an ownership or controlling interest, an affiliate or subsidiary relationship, a common parent company, or any mutual interest in any limited partnership, limited liability partnership, limited liability company, or other entity or business association.
b. “Relative” means a father, mother, son, daughter, husband, wife, brother, sister, grandparent, father-in-law, mother-in-law, son-in-law, or daughter-in-law of a person.
(d) Public meetings and records.—The council and any subcommittees it forms are subject to the provisions of chapter 119 relating to public records and the provisions of chapter 286 relating to public meetings.
(4) HEALTH CARE INNOVATION COUNCIL DUTIES.—In order to facilitate and implement this section, the council shall:
(a) By February 1, 2025, adopt and update as necessary a document that sets forth and describes a mission statement, goals, and objectives for the council to function and meet the purposes of this section.
(b) Facilitate public meetings across this state at which innovators, developers, and implementers of technologies, workforce pathways, service delivery models, and other solutions may present information and lead discussions on concepts that address challenges to the health care system as they develop in real time and advance the delivery of health care in this state through technology and innovation.
1. Consideration must be given to how such concepts increase efficiency in the health care system in this state, reduce strain on the state’s health care workforce, improve patient outcomes, expand public access to health care services in this state, or reduce costs for patients and the state without reducing the quality of patient care.
2. Exploration and discussion of concepts may include how concepts can be supported, cross-functional, or scaled to meet the needs of health care consumers, including employers, payors, patients, and the state.
3. The council may coordinate with the Small Business Development Center Network, the Florida Opportunity Fund, the Institute for Commercialization of Florida Technology, and other business incubators, development organizations, or institutions of higher education to include emerging and early stage innovators, developers, and implementers of technology, models, or solutions in health care in the exploration and discussion of concepts and breakthrough innovations.
4. To support adoption and implementation of innovations and advancements, specific meetings may be held which bring together technical experts, such as those in system integration, cloud computing, artificial intelligence, and cybersecurity, to lead discussions on recommended structures and integrations of information technology products and services and propose solutions that can make adoption and implementation efficient, effective, and economical.
5. The council may also highlight broad community or statewide issues or needs of providers and users of health care delivery and may facilitate public forums in order to explore and discuss the range of effective, efficient, and economical technology and innovative solutions that can be implemented.
(c) Annually distinguish the most impactful concepts by recognizing the innovators, developers, and implementers whose work is helping Floridians to live brighter and healthier lives. In seeking out projects, initiatives, and concepts that are having a positive impact in Florida, have huge potential to scale that impact throughout this state through growth or replication, or are cutting-edge advancements, programs, or other innovations that have the capability to accelerate transformation of health care in this state, the council may issue awards to recognize these strategic and innovative thinkers who are helping Floridians live brighter and healthier lives. The council may develop a logo for the award for use by awardees to advertise their achievements and recognition.
(d) Consult with and solicit input from health care experts, health care providers, and technology and manufacturing experts in the health care or related fields, users of such innovations or systems, and the public to develop and update:
1. Best practice recommendations that will lead to the continuous modernization of the health care system in this state and make the Florida system a nationwide leader in innovation, technology, and service. At a minimum, recommendations must be made for how to explore implementation of innovations, how to implement new technologies and strategies, and health care service delivery models. As applicable, best practices must be distinguished by practice setting and with an emphasis on increasing efficiency in the delivery of health care, reducing strain on the health care workforce, increasing public access to health care, improving patient outcomes, reducing unnecessary emergency room visits, and reducing costs for patients and the state without reducing the quality of patient care. Specifically for information technology, best practices must also recommend actions to guide the selection of technologies and innovations, which may include, but need not be limited to, considerations for system-to-system integration, consistent user experiences for health care workers and patients, and patient education and practitioner training.
2. A list of focus areas in which to advance the delivery of health care in this state through innovative technologies, workforce pathways, or service delivery models. The focus areas may be broad or specific, but must, at a minimum, consider all of the following topics:
a. The health care workforce. This topic includes, but is not limited to, all of the following:
(I) Approaches to cultivate interest and growth in the workforce, including concepts resulting in increases in the number of providers.
(II) Efforts to improve the use of the workforce, whether through techniques, training, or devices to increase effectiveness or efficiency.
(III) Educational pathways that connect students with employers or result in attainment of cost-efficient and timely degrees or credentials.
(IV) Use of technology to reduce the burden on the workforce during decisionmaking processes such as triage, but which leaves all final decisions to the health care practitioner.
b. The provision of patient care in the most appropriate setting and reduction of unnecessary emergency room visits. These topics include, but are not limited to, all of the following:
(I) Use of advanced technologies to improve patient outcomes, provide patient care, or improve patient quality of life.
(II) The use of early detection devices, including remote communications devices and diagnostic tools engineered for early detection and patient engagement.
(III) At-home patient monitoring devices and measures.
(IV) Advanced at-home health care.
(V) Advanced adaptive equipment.
c. The delivery of primary care through methods, practices, or procedures that increase efficiencies.
d. The technical aspects of the provision of health care. These aspects include, but are not limited to, all of the following:
(I) Interoperability of electronic health records systems and the impact on patient care coordination and administrative costs for health care systems.
(II) Cybersecurity and the protection of health care data and systems.
(e) Identify and recommend any changes to Florida law or changes that can be implemented without legislative action which are necessary to:
1. Advance, transform, or innovate in the delivery and strengthen the quality of health care in Florida, including removal or update of any regulatory barriers or governmental inefficiencies.
2. Implement the council’s duties or recommendations.
(f) Recommend criteria for awarding loans as provided in subsection (7) to the department and review loan applications.
(g) Annually submit by December 1 a report of council activities and recommendations to the Governor, the President of the Senate, and the Speaker of the House of Representatives. At a minimum, the report must include an update on the status of the delivery of health care in this state; information on implementation of best practices by health care industry stakeholders in this state; and highlights of exploration, development, or implementation of innovative technologies, workforce pathways, service delivery models, or other solutions by health care industry stakeholders in this state.
(5) AGENCY COOPERATION.—All state agencies and statutorily created state entities shall assist and cooperate with the council as requested.
(6) DEPARTMENT DUTIES.—The department shall, at a minimum, do all of the following to facilitate implementation of this section:
(a) Provide reasonable and necessary support staff and materials to assist the council in the performance of its duties.
(b) Maintain on the homepage of the department a link to a website dedicated to the council on which the department shall post information related to the council, including the outcomes of the duties of the council and annual reports as described in subsection (4).
(c) Identify and publish on its website a list of any sources of federal, state, or private funding available for implementation of innovative technologies and service delivery models in health care, including the details and eligibility requirements for each funding opportunity. Upon request, the department shall provide technical assistance to any person wanting to apply for such funding. If the entity with oversight of the funding opportunity provides technical assistance, the department may foster working relationships that allow the department to refer the person seeking funding to the appropriate contact for such assistance.
(d) Incorporate recommendations of the council into the department’s duties or as part of the administration of this section, or update administrative rules or procedures as appropriate based upon council recommendations.
(7) REVOLVING LOAN PROGRAM.—The department shall administer a revolving loan program for applicants seeking to implement innovative solutions in this state.
(a) Administration.—The council may make recommendations to the department for the administration of the loans. The department shall adopt rules:
1. Establishing an application process to submit and review funding proposals for loans. Such rules must also include the process for the council to review applications to ensure compliance with applicable laws, including those related to discrimination and conflicts of interest. If a council member participated in the vote of the council recommending an award for a proposal with which the council member has a conflict of interest, the division may not award the loan to that entity.
2. Establishing eligibility criteria to be applied by the council in recommending applications for the award of loans which:
a. Incorporate the recommendations of the council. The council shall recommend to the department criteria based upon input received and the focus areas developed. The council may recommend updated criteria as necessary, based upon the most recent input, best practice recommendations, or focus areas list.
b. Determine which proposals are likely to provide the greatest return to the state if funded, taking into consideration, at a minimum, the degree to which the proposal would increase efficiency in the health care system in this state, reduce strain on the state’s health care workforce, improve patient outcomes, increase public access to health care in this state, or provide cost savings to patients or the state without reducing the quality of patient care.
3. It deems necessary to administer the program, including, but not limited to, rules for application requirements, the ability of the applicant to properly administer funds, the professional excellence of the applicant, the fiscal stability of the applicant, the state or regional impact of the proposal, matching requirements for the proposal, and other requirements to further the purposes of the program.
(b) Eligibility.—
1. The following entities may apply for a revolving loan:
a. Entities licensed, registered, or certified by the Agency for Health Care Administration as provided under s. 408.802, except for those specified in s. 408.802(1), (3), (13), (23), or (25).
b. An education or clinical training provider in partnership with an entity under sub-subparagraph a.
2.a. Council members may not receive loans under the program.
b. An entity that has a conflict-of-interest relationship with a council member as described in sub-subparagraph (3)(c)1.b. or sub-subparagraph (3)(c)1.c. may not receive a loan under the program unless that council member recused himself or herself from consideration of the entity’s application.
3. Priority must be given to applicants located in a rural or medically underserved area as designated by the department which are:
a. Rural hospitals as defined in s. 395.602(2).
b. Nonprofit entities that accept Medicaid patients.
4. The department may award a loan for up to 50 percent of the total projected implementation costs, or up to 80 percent of total projected implementation costs for an applicant under subparagraph 3. The applicant must demonstrate the source of funding it will use to cover the remainder of the total projected implementation costs, which funding must be from nonstate sources.
(c) Applications.—
1. The department shall set application periods to apply for loans. The department may set multiple application periods in a fiscal year, with up to four periods per year. The department shall coordinate with the council when establishing application periods to establish separate priority, in addition to eligibility, within the loan applications for defined categories based on the current focus area list. The department shall publicize the availability of loans under the program to stakeholders, education or training providers, and others.
2. Upon receipt of an application, the department shall determine whether the application is complete and the applicant has demonstrated the ability to repay the loan. Within 30 days after the close of the application period, the department shall forward all completed applications to the council for consideration.
3. The council shall review applications for loans under the criteria and pursuant to the processes and format adopted by the department. The council shall submit to the department for approval lists of applicants that it recommends for funding, arranged in order of priority and as required for the application period.
4. A loan applicant must demonstrate plans to use the funds to implement one or more innovative technologies, workforce pathways, service delivery models, or other solutions in order to fill a demonstrated need; obtain or upgrade necessary equipment, hardware, and materials; adopt new technologies or systems; or a combination thereof which will improve the quality and delivery of health care in measurable and sustainable ways and which will lower costs and allow savings to be passed on to health care consumers.
(d) Awards.—
1. The amount of each loan must be based upon demonstrated need and availability of funds. The department may not award more than 10 percent of the total allocated funds for the fiscal year to a single loan applicant.
2. The interest rate for each loan may not exceed 1 percent.
3. The term of each loan is up to 10 years.
4. In order to equitably distribute limited state funding, applicants may apply for and be awarded only one loan per fiscal year. If a loan recipient has one or more outstanding loans at any time, the recipient may apply for funding for a new loan if the current loans are in good standing.
(e) Written agreement.—
1. Each loan recipient must enter into a written agreement with the department to receive the loan. At a minimum, the agreement with the applicant must specify all of the following:
a. The total amount of the award.
b. The performance conditions that must be met, based upon the submitted proposal and the defined category or focus area, as applicable.
c. The information to be reported on actual implementation costs, including the share from nonstate resources.
d. The schedule for payment.
e. The data and progress reporting requirements and schedule.
f. Any sanctions that would apply for failure to meet performance conditions.
2. The department shall develop uniform data reporting requirements for loan recipients to evaluate the performance of the implemented proposals. Such data must be shared with the council.
3. If requested, the department shall provide technical assistance to loan recipients under the program.
(f) Loan repayment.—Loans become due and payable in accordance with the terms of the written agreement. All repayments of principal received by the department in a fiscal year shall be returned to the revolving loan fund and made available for loans to other applicants.
(g) Revolving loan fund.—The department shall create and maintain a separate account in the Grants and Donations Trust Fund within the department as a fund for the program. All repayments of principal must be returned to the revolving loan fund and made available as provided in this section. Notwithstanding s. 216.301, funds appropriated for the revolving loan program are not subject to reversion. The department may contract with a third-party administrator to administer the program, including loan servicing, and manage the revolving loan fund. A contract for a third-party administrator which includes management of the revolving loan fund must, at a minimum, require maintenance of the revolving loan fund to ensure that the program may operate in a revolving manner.
(8) REPORTING.—The department shall publish on its website information related to loan recipients, including the written agreements, performance conditions and their status, and the total amount of loan funds disbursed to date. The department shall update the information annually on the award date. The department shall, beginning on September 1, 2025, and annually thereafter, post on its website a report on this section for the previous fiscal year which must include all of the following information:
(a) A summary of the adoption and implementation of recommendations of the council during the previous fiscal year.
(b) An evaluation of actions and related activities to meet the purposes set forth in this section.
(c) Consolidated data based upon the uniform data reporting by funding recipients and an evaluation of how the provision of the loans has met the purposes set forth in this section.
(d) The number of applications for loans, the types of proposals received, and an analysis on the relationship between the proposals and the purposes of this section.
(e) The amount of funds allocated and awarded for each loan application period, as well as any funds not awarded in that period.
(f) The amount of funds paid out during the fiscal year and any funds repaid or unused.
(g) The number of persons assisted and outcomes of any technical assistance requested for loans and any federal, state, or private funding opportunities.
(9) EVALUATION.—
(a) Beginning October 1, 2029, and every 5 years thereafter, the Office of Economic and Demographic Research (EDR) shall develop and present to the Governor, the President of the Senate, and the Speaker of the House of Representatives a comprehensive financial and economic evaluation of the innovative solutions undertaken by the revolving loan program administered under this section. The evaluation must include, but need not be limited to, separate calculations of the state’s return and the economic value to residents of this state, as well as the identification of any cost savings to patients or the state and the impact on the state’s health care workforce.
(b) Beginning October 1, 2030, and every 5 years thereafter, the Office of Program Policy Analysis and Government Accountability (OPPAGA) shall develop and present to the Governor, the President of the Senate, and the Speaker of the House of Representatives an evaluation of the administration and efficiency of the revolving loan program administered under this section. The evaluation must include, but need not be limited to, the degree to which the collective proposals increased efficiency in the health care system in this state, improved patient outcomes, increased public access to health care, and achieved the cost savings identified in paragraph (a) without reducing the quality of patient care.
(c) Both the EDR and OPPAGA shall include recommendations for consideration by the Legislature. The EDR and OPPAGA must be given access to all data necessary to complete the evaluation, including any confidential data. The offices may collaborate on data collection and analysis.
(10) RULES.—The department shall adopt rules to implement this section.
(11) EXPIRATION.—This section expires July 1, 2043.
A. Section 2, ch. 2024-16, provides that “[t]he Department of Health shall, and all conditions are deemed met to, adopt emergency rules pursuant to s. 120.54(4), Florida Statutes, for the purpose of implementing s. 381.4015, Florida Statutes. Notwithstanding any other law, emergency rules adopted pursuant to this section are effective for 6 months after adoption and may be renewed during the pendency of the procedure to adopt permanent rules addressing the subject of the emergency rules.”
B. Section 3(3), ch. 2024-16, provides that “[b]y August 1 of each year, beginning in the 2024-2025 fiscal year through the 2033-2034 fiscal year, the Chief Financial Officer shall transfer $50 million in nonrecurring funds from the General Revenue Fund to the Grants and Donations Trust Fund within the Department of Health. Each year, beginning in the 2024-2025 fiscal year through the 2033-2034 fiscal year, the nonrecurring sum of $50 million is appropriated from the Grants and Donations Trust Fund to the Department of Health for the revolving loan fund created in s. 381.4015, Florida Statutes. The department may use up to 3 percent of the appropriated funds for administrative costs to implement the revolving loan program.”
381.4018 Physician workforce assessment and development.—
(1) DEFINITIONS.—As used in this section, the term:
(a) “Consortium” or “consortia” means a combination of statutory teaching hospitals, specialty children’s hospitals, statutory rural hospitals, other hospitals, accredited medical schools, clinics operated by the Department of Health, clinics operated by the Department of Veterans’ Affairs, area health education centers, community health centers, federally qualified health centers, prison clinics, local community clinics, or other programs. At least one member of the consortium shall be a sponsoring institution accredited or currently seeking accreditation by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association.
(b) “Council” means the Physician Workforce Advisory Council.
(c) “Department” means the Department of Health.
(d) “Graduate medical education program” means a program accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association.
(e) “Primary care specialty” means emergency medicine, family practice, internal medicine, pediatrics, psychiatry, geriatrics, general surgery, obstetrics and gynecology, and combined pediatrics and internal medicine and other specialties as determined by the Physician Workforce Advisory Council or the Department of Health.
(2) PURPOSE.—The department shall serve as a coordinating and strategic planning body to actively assess the state’s current and future physician workforce needs and work with multiple stakeholders to develop strategies and alternatives to address current and projected physician workforce needs.
(3) GENERAL FUNCTIONS.—The department shall maximize the use of existing programs under the jurisdiction of the department and other state agencies and coordinate governmental and nongovernmental stakeholders and resources in order to develop a state strategic plan and assess the implementation of such strategic plan. In developing the state strategic plan, the department shall:
(a) Monitor, evaluate, and report on the supply and distribution of physicians licensed under chapter 458 or chapter 459. The department shall maintain a database to serve as a statewide source of data concerning the physician workforce.
(b) Develop a model and quantify, on an ongoing basis, the adequacy of the state’s current and future physician workforce as reliable data becomes available. Such model must take into account demographics, physician practice status, place of education and training, generational changes, population growth, economic indicators, and issues concerning the “pipeline” into medical education.
(c) Develop and recommend strategies to determine whether the number of qualified medical school applicants who might become competent, practicing physicians in this state will be sufficient to meet the capacity of the state’s medical schools. If appropriate, the department shall, working with representatives of appropriate governmental and nongovernmental entities, develop strategies and recommendations and identify best practice programs that introduce health care as a profession and strengthen skills needed for medical school admission for elementary, middle, and high school students, and improve premedical education at the precollege and college level in order to increase this state’s potential pool of medical students.
(d) Develop strategies to ensure that the number of graduates from the state’s public and private allopathic and osteopathic medical schools is adequate to meet physician workforce needs, based on the analysis of the physician workforce data, so as to provide a high-quality medical education to students in a manner that recognizes the uniqueness of each new and existing medical school in this state.
(e) Pursue strategies and policies to create, expand, and maintain graduate medical education positions in the state based on the analysis of the physician workforce data. Such strategies and policies must take into account the effect of federal funding limitations on the expansion and creation of positions in graduate medical education. The department shall develop options to address such federal funding limitations. The department shall consider options to provide direct state funding for graduate medical education positions in a manner that addresses requirements and needs relative to accreditation of graduate medical education programs. The department shall consider funding residency positions as a means of addressing needed physician specialty areas, rural areas having a shortage of physicians, and areas of ongoing critical need, and as a means of addressing the state’s physician workforce needs based on an ongoing analysis of physician workforce data.
(f) Develop strategies to maximize federal and state programs that provide for the use of incentives to attract physicians to this state or retain physicians within the state. Such strategies should explore and maximize federal-state partnerships that provide incentives for physicians to practice in federally designated shortage areas, in otherwise medically underserved areas, or in rural areas. Strategies shall also consider the use of state programs, such as the Medical Education Reimbursement and Loan Repayment Program pursuant to s. 381.402, which provide for education loan repayment or loan forgiveness and provide monetary incentives for physicians to relocate to underserved areas of the state.
(g) Coordinate and enhance activities relative to physician workforce needs, undergraduate medical education, graduate medical education, and reentry of retired military and other physicians into the physician workforce provided by the Division of Medical Quality Assurance, area health education center networks established pursuant to s. 381.0402, and other offices and programs within the department as designated by the State Surgeon General.
(h) Work in conjunction with and act as a coordinating body for governmental and nongovernmental stakeholders to address matters relating to the state’s physician workforce assessment and development for the purpose of ensuring an adequate supply of well-trained physicians to meet the state’s future needs. Such governmental stakeholders shall include, but need not be limited to, the State Surgeon General or his or her designee, the Commissioner of Education or his or her designee, the Secretary of Health Care Administration or his or her designee, and the Chancellor of the State University System or his or her designee, and, at the discretion of the department, other representatives of state and local agencies that are involved in assessing, educating, or training the state’s current or future physicians. Other stakeholders shall include, but need not be limited to, organizations representing the state’s public and private allopathic and osteopathic medical schools; organizations representing hospitals and other institutions providing health care, particularly those that currently provide or have an interest in providing accredited medical education and graduate medical education to medical students and medical residents; organizations representing allopathic and osteopathic practicing physicians; and, at the discretion of the department, representatives of other organizations or entities involved in assessing, educating, or training the state’s current or future physicians.
(i) Serve as a liaison with other states and federal agencies and programs in order to enhance resources available to the state’s physician workforce and medical education continuum.
(j) Act as a clearinghouse for collecting and disseminating information concerning the physician workforce and medical education continuum in this state.
The department may adopt rules to implement this subsection, including rules that establish guidelines to implement the federal Conrad 30 Waiver Program created under s. 214(l) of the Immigration and Nationality Act.
(4) PHYSICIAN WORKFORCE ADVISORY COUNCIL.—There is created in the department the Physician Workforce Advisory Council, an advisory council as defined in s. 20.03. The council shall comply with the requirements of s. 20.052, except as otherwise provided in this section.
(a) The council shall consist of 19 members. Members appointed by the State Surgeon General shall include:
1. A designee from the department who is a physician licensed under chapter 458 or chapter 459 and recommended by the State Surgeon General.
2. An individual who is affiliated with the Science Students Together Reaching Instructional Diversity and Excellence program and recommended by the area health education center network.
3. Two individuals recommended by the Council of Florida Medical School Deans, one representing a college of allopathic medicine and one representing a college of osteopathic medicine.
4. One individual recommended by the Florida Hospital Association, representing a hospital that is licensed under chapter 395, has an accredited graduate medical education program, and is not a statutory teaching hospital.
5. One individual representing a statutory teaching hospital as defined in s. 408.07 and recommended by the Safety Net Hospital Alliance.
6. One individual representing a family practice teaching hospital as defined in s. 395.805 and recommended by the Council of Family Medicine and Community Teaching Hospitals.
7. Two individuals recommended by the Florida Medical Association, one representing a primary care specialty and one representing a nonprimary care specialty.
8. Two individuals recommended by the Florida Osteopathic Medical Association, one representing a primary care specialty and one representing a nonprimary care specialty.
9. Two individuals who are program directors of accredited graduate medical education programs, one representing a program that is accredited by the Accreditation Council for Graduate Medical Education and one representing a program that is accredited by the American Osteopathic Association.
10. An individual recommended by the Florida Association of Community Health Centers representing a federally qualified health center located in a rural area as defined in s. 381.0406(2)(a).
11. An individual recommended by the Florida Academy of Family Physicians.
12. An individual recommended by the Florida Alliance for Health Professions Diversity.
13. The Chancellor of the State University System or his or her designee.
14. A layperson member as determined by the State Surgeon General.
Appointments to the council shall be made by the State Surgeon General. Each entity authorized to make recommendations under this subsection shall make at least two recommendations to the State Surgeon General for each appointment to the council. The State Surgeon General shall name one appointee for each position from the recommendations made by each authorized entity.
(b) Each council member shall be appointed to a 4-year term. An individual may not serve more than two terms. Any council member may be removed from office for malfeasance; misfeasance; neglect of duty; incompetence; permanent inability to perform official duties; or pleading guilty or nolo contendere to, or being found guilty of, a felony. Any council member who meets the criteria for removal, or who is otherwise unwilling or unable to properly fulfill the duties of the office, shall be succeeded by an individual chosen by the State Surgeon General to serve out the remainder of the council member’s term. If the remainder of the replaced council member’s term is less than 18 months, notwithstanding the provisions of this paragraph, the succeeding council member may be reappointed twice by the State Surgeon General.
(c) The chair of the council is the State Surgeon General, who shall designate a vice chair from the membership of the council to serve in the absence of the State Surgeon General. A vacancy shall be filled for the remainder of the unexpired term in the same manner as the original appointment.
(d) Council members are not entitled to receive compensation or reimbursement for per diem or travel expenses.
(e) The council shall meet at least twice a year in person or by teleconference.
(f) The council shall:
1. Advise the State Surgeon General and the department on matters concerning current and future physician workforce needs in this state;
2. Review survey materials and the compilation of survey information;
3. Annually review the number, location, cost, and reimbursement of graduate medical education programs and positions;
4. Provide recommendations to the department regarding the survey completed by physicians licensed under chapter 458 or chapter 459;
5. Assist the department in preparing the annual report to the Legislature pursuant to ss. 458.3192 and 459.0082;
6. Assist the department in preparing an initial strategic plan, conduct ongoing strategic planning in accordance with this section, and provide ongoing advice on implementing the recommendations;
7. Monitor and provide recommendations regarding the need for an increased number of primary care or other physician specialties to provide the necessary current and projected health and medical services for the state; and
8. Monitor and make recommendations regarding the status of the needs relating to graduate medical education in this state.
381.4019 Dental Student Loan Repayment Program.—The Dental Student Loan Repayment Program is established to support the state Medicaid program and promote access to dental care by supporting qualified dentists and dental hygienists who treat medically underserved populations in dental health professional shortage areas or medically underserved areas.
(1) As used in this section, the term:
(a) “Dental health professional shortage area” means a geographic area designated as such by the Health Resources and Services Administration of the United States Department of Health and Human Services.
(b) “Department” means the Department of Health.
(c) “Free clinic” means a provider that meets the description of a clinic specified in s. 766.1115(3)(d)14.
(d) “Loan program” means the Dental Student Loan Repayment Program.
(e) “Medically underserved area” means a geographic area, an area having a special population, or a facility which is designated by department rule as a health professional shortage area as defined by federal regulation and which has a shortage of dental health professionals who serve Medicaid recipients and other low-income patients.
(f) “Public health program” means a county health department, the Children’s Medical Services program, a federally funded community health center, a federally funded migrant health center, or other publicly funded or nonprofit health care program designated by the department.
(2) The department shall establish a dental student loan repayment program to benefit Florida-licensed dentists and dental hygienists who:
(a) Demonstrate, as required by department rule, active employment in a public health program or private practice that serves Medicaid recipients and other low-income patients and is located in a dental health professional shortage area or a medically underserved area; and
(b) Volunteer 25 hours per year providing dental services in a free clinic that is located in a dental health professional shortage area or a medically underserved area, through another volunteer program operated by the state pursuant to part IV of chapter 110, or through a pro bono program approved by the Board of Dentistry. In order to meet the requirements of this paragraph, the volunteer hours must be verifiable in a manner determined by the department.
(3) The department shall award funds from the loan program to repay the student loans of a dentist or dental hygienist who meets the requirements of subsection (2).
(a) An award shall be 20 percent of a dentist’s or dental hygienist’s principal loan amount at the time he or she applied for the program but may not exceed $50,000 per year per eligible dentist or $7,500 per year per eligible dental hygienist.
(b) Only loans to pay the costs of tuition, books, dental equipment and supplies, uniforms, and living expenses may be covered.
(c) All repayments are contingent upon continued proof of eligibility and must be made directly to the holder of the loan. The state bears no responsibility for the collection of any interest charges or other remaining balances.
(d) A dentist or dental hygienist may receive up to a maximum of 5 awards pursuant to paragraph (a), one award for each year he or she maintains eligibility for the program for the entire year. Such awards are not required to be awarded in consecutive years, and, if a dentist or dental hygienist loses eligibility pursuant to subsection (4) for the current year, he or she may reapply for the program in a future year once he or she has regained eligibility.
(4) A dentist or dental hygienist is not eligible to receive funds under the loan program if the dentist or dental hygienist:
(a) Is no longer employed by a public health program or private practice that meets the requirements of subsection (2) or does not verify, in a manner determined by the department, that he or she has volunteered his or her dental services for the required number of hours.
(b) Ceases to participate in the Florida Medicaid program.
(c) Has disciplinary action taken against his or her license by the Board of Dentistry for a violation of s. 466.028.
(5) A dentist or dental hygienist who receives payment under the program shall furnish information requested by the department for the purpose of the department’s duties under s. 381.4021.
(6) The department shall adopt rules to administer the loan program.
(7) Implementation of the loan program is subject to legislative appropriation.
(8) The Agency for Health Care Administration shall seek federal authority to use Title XIX matching funds for this program.
(9) Any payments made under this section and subsequently returned by a financial institution to the department may be deposited into the Grants and Donations Trust Fund to be used for the same purpose. Notwithstanding ss. 216.181 and 216.292, the department may submit budget amendments, subject to the notice, review, and objection procedures of s. 216.177, to increase budget authority to make payments under this section.
(1) This act may be cited as the “Donated Dental Services Act.”
(2) As used in this section, the term:
(a) “Department” means the Department of Health.
(b) “Program” means the Donated Dental Services Program as established pursuant to subsection (3).
(3) The department shall establish the Donated Dental Services Program for the purpose of providing comprehensive dental care through a network of volunteer dentists and other dental providers to needy, disabled, elderly, and medically compromised individuals who cannot afford necessary treatment but are ineligible for public assistance. An eligible individual may receive treatment in a volunteer dentist’s or participating dental provider’s private office or at any other suitable location. An eligible individual is not required to pay any fee or cost associated with the treatment he or she receives.
(4) The department shall establish the program. The department shall contract with a nonprofit organization that has experience in providing similar services or administering similar programs. The contract must specify the responsibilities of the nonprofit organization, which may include, but are not limited to:
(a) Maintaining a network of volunteer dentists and other dental providers, including, but not limited to, dental specialists and dental laboratories, to provide comprehensive dental services to eligible individuals.
(b) Maintaining a system to refer eligible individuals to the appropriate volunteer dentist or participating dental provider.
(c) Developing a public awareness and marketing campaign to promote the program and educate eligible individuals about its availability and services.
(d) Providing the necessary administrative and technical support to administer the program.
(e) Submitting an annual report to the department which must include, at a minimum:
1. Financial data relating to administering the program.
2. Demographic data and other information relating to the eligible individuals who are referred to and receive treatment through the program.
3. Demographic data and other information relating to the volunteer dentists and participating dental providers who provide dental services through the program.
4. Any other data or information that the department may require.
(f) Performing any other program-related duties and responsibilities as required by the department.
(5) The department shall adopt rules to administer the program.
(6) Implementation of the program is subject to legislative appropriation.
381.402 Florida Reimbursement Assistance for Medical Education Program.—
(1) To support the state Medicaid program and to encourage qualified medical professionals to practice in underserved locations where there are shortages of such personnel, there is established the Florida Reimbursement Assistance for Medical Education Program. The function of the program is to make payments that offset loans and educational expenses incurred by students for studies leading to a medical or nursing degree, medical or nursing licensure, or advanced practice registered nurse licensure or physician assistant licensure.
(2) The following licensed or certified health care practitioners are eligible to participate in the program:
(a) Medical doctors with primary care specialties.
(b) Doctors of osteopathic medicine with primary care specialties.
(c) Advanced practice registered nurses registered to engage in autonomous practice under s. 464.0123.
(d) Advanced practice registered nurses.
(e) Physician assistants.
(f) Mental health professionals, including licensed clinical social workers, licensed marriage and family therapists, licensed mental health counselors, and licensed psychologists.
(g) Licensed practical nurses and registered nurses.
Primary care medical specialties for physicians include obstetrics, gynecology, general and family practice, geriatrics, internal medicine, pediatrics, psychiatry, and other specialties which may be identified by the Department of Health.
(3) From the funds available, the Department of Health shall make payments as follows:
(a) For a 4-year period of continued proof of practice in an area specified in paragraph (b), up to $150,000 for physicians, up to $90,000 for advanced practice registered nurses registered to engage in autonomous practice under s. 464.0123 and practicing autonomously, up to $75,000 for advanced practice registered nurses and physician assistants, up to $75,000 for mental health professionals, and up to $45,000 for licensed practical nurses and registered nurses. Each practitioner is eligible to receive an award for only one 4-year period of continued proof of practice; however, the 4 years of practice are not required to be consecutive. At the end of each year that a practitioner participates in the program, the department shall award 25 percent of a practitioner’s principal loan amount at the time he or she applied for the program. Penalties for noncompliance are the same as those in the National Health Services Corps Loan Repayment Program. Educational expenses include costs for tuition, matriculation, registration, books, laboratory and other fees, other educational costs, and reasonable living expenses as determined by the Department of Health.
(b) All payments are contingent on continued proof of:
1.a. Primary care practice in a rural hospital as defined in s. 395.602(2)(b) or an underserved area designated by the Department of Health, provided the practitioner accepts Medicaid reimbursement if eligible for such reimbursement; or
b. For practitioners other than physicians, practice in other settings, including, but not limited to, a nursing home facility as defined in s. 400.021, a home health agency as defined in s. 400.462, or an intermediate care facility for the developmentally disabled as defined in s. 400.960. Any such setting must be located in, or serve residents or patients in, an underserved area designated by the Department of Health and must provide services to Medicaid patients.
2. Providing 25 hours annually of volunteer primary care services in a free clinic as specified in s. 766.1115(3)(d)14. or through another volunteer program operated by the state pursuant to part IV of chapter 110. In order to meet the requirements of this subparagraph, the volunteer hours must be verifiable in a manner determined by the department.
(c) Correctional facilities, state hospitals, and other state institutions that employ medical personnel must be designated by the Department of Health as underserved locations. Locations with high incidences of infant mortality, high morbidity, or low Medicaid participation by health care professionals may be designated as underserved.
(4) The Department of Health may use funds appropriated for the program as matching funds for federal loan repayment programs such as the National Health Service Corps State Loan Repayment Program.
(5) A health care practitioner who receives payment under the program shall furnish information requested by the department for the purpose of the department’s duties under s. 381.4021.
(6) The Department of Health may adopt rules for the administration of the program. The department may also solicit technical advice regarding conduct of the program from the Department of Education and Florida universities and Florida College System institutions. The Department of Health shall submit a budget request for an amount sufficient to fund medical education reimbursement, loan repayments, and program administration.
(7) The Agency for Health Care Administration shall seek federal authority to use Title XIX matching funds for this program.
(8) Any payments made under this section and subsequently returned by a financial institution to the Department of Health may be deposited into the Grants and Donations Trust Fund to be used for the same purpose. Notwithstanding ss. 216.181 and 216.292, the department may submit budget amendments, subject to the notice, review, and objection procedures of s. 216.177, to increase budget authority to make payments under this section.
(1) For the student loan repayment programs established in ss. 381.4019 and 381.402, the department shall annually provide a report, beginning July 1, 2024, to the Governor, the President of the Senate, and the Speaker of the House of Representatives which, at a minimum, details all of the following:
(a) The number of applicants for loan repayment.
(b) The number of loan payments made under each program.
(c) The amounts for each loan payment made.
(d) The type of practitioner to whom each loan payment was made.
(e) The number of loan payments each practitioner has received under either program.
(f) The practice setting in which each practitioner who received a loan payment practices.
(2)(a) The department shall contract with an independent third party to develop and conduct a design study to evaluate the impact of the student loan repayment programs established in ss. 381.4019 and 381.402, including, but not limited to, the effectiveness of the programs in recruiting and retaining health care professionals in geographic and practice areas experiencing shortages. The department shall begin collecting data for the study by January 1, 2025, and shall submit the results of the study to the Governor, the President of the Senate, and the Speaker of the House of Representatives by January 1, 2030.
(b) The department shall participate in a provider retention and information system management multistate collaborative that collects data to measure outcomes of education debt support-for-service programs.
381.735 Office of Minority Health and Health Equity.—
(1) The Office of Minority Health and Health Equity established under s. 20.43(9) shall develop and promote the statewide implementation of policies, programs, and practices that increase health equity in this state, including, but not limited to, increased access to and quality of health care services for racial and ethnic minority populations. One representative from each county health department shall serve as a minority health liaison to assist the office in implementing this section. The office shall use all available resources and pursue opportunities for increased funding to achieve the purpose of this section.
(2) The office shall coordinate with agencies, organizations, and providers across this state to do all of the following:
(a) Gather and analyze data regarding disparities in health status, health outcomes, quality of health care, and access to health care services for racial and ethnic minority populations in this state.
(b) Develop mechanisms that support better information dissemination and education about health disparities which lead to improved access to and delivery of health care services to racial and ethnic minority populations in this state.
(c) Support minority health liaisons by facilitating access to and the exchange of information related to health promotion, preventive health services, and education in the appropriate use of care.
(d) Develop and promote synergistic initiatives between programs, including, but not limited to, programs related to maternal and child health and human immunodeficiency virus and acquired immune deficiency syndrome, to mitigate health disparities for racial and ethnic minority populations in this state.
(e) Promote evaluations of demonstration projects and disseminate the evaluation findings to enhance the success and sustainability of policies, programs, and practices that increase health equity in this state.
(f) Promote the use of community health workers to improve the cultural competency of services and build individual and community self-sufficiency.
(g) Promote the development of programs that improve access to health care services for individuals with limited proficiency in the English language, including individuals with disabilities.
(3) The Department of Health shall maintain all of the following on its website, updated at least annually:
(a) Current data on health disparities and issues affecting racial and ethnic minority populations in this state.
(b) Information about and links to resources available to racial and ethnic minority populations in this state.
(c) Resources for providers who wish to improve cultural competency, understand health disparities, and increase the quality of and access to health care services for racial and ethnic minority populations in this state. These resources must include, but need not be limited to, minority health literature, research, and referrals; capacity-building and technical assistance services; and training materials for implementing nationally recognized evidence-based practices for culturally and linguistically appropriate health care services.
(d) Contact information for local minority health liaisons.
(4) The office shall serve as a liaison to and assist the federal Offices of Minority Health and Regional Health Operations, as appropriate.
(5) The department may adopt rules to implement this section.
381.7351 Short title; Closing the Gap Act.—Sections 381.7351-381.7356 may be cited as the “Reducing Racial and Ethnic Health Disparities: Closing the Gap Act.”
381.7352 Legislative intent.—It is the intent of the Legislature to provide funds within Florida counties and Front Porch Florida Communities, in the form of Reducing Racial and Ethnic Health Disparities: Closing the Gap grants, to stimulate the development of community-based and neighborhood-based projects which will improve the health outcomes of racial and ethnic populations. Further, it is the intent of the Legislature that these programs foster the development of coordinated, collaborative, and broad-based participation by public and private entities, and faith-based organizations. Finally, it is the intent of the Legislature that the grant program function as a partnership between state and local governments, faith-based organizations, and private sector health care providers, including managed care, voluntary health care resources, social service providers, and nontraditional partners.
381.7353 Reducing Racial and Ethnic Health Disparities: Closing the Gap grant program; administration; department duties.—
(1) The Reducing Racial and Ethnic Health Disparities: Closing the Gap grant program shall be administered by the Department of Health.
(2) The department shall:
(a) Publicize the availability of funds and establish an application process for submitting a grant proposal.
(b) Provide technical assistance and training, including a statewide meeting promoting best practice programs, as requested, to grant recipients.
(c) Develop uniform data reporting requirements for the purpose of evaluating the performance of the grant recipients and demonstrating improved health outcomes.
(d) Develop a monitoring process to evaluate progress toward meeting grant objectives.
(e) Coordinate with existing community-based programs, such as chronic disease community intervention programs, cancer prevention and control programs, diabetes control programs, the Healthy Start program, the Florida Kidcare Program, the HIV/AIDS program, immunization programs, maternal health programs, and other related programs at the state and local levels, to avoid duplication of effort and promote consistency.
(1) Any person, entity, or organization within a county may apply for a Closing the Gap grant and may serve as the lead agency to administer and coordinate project activities within the county and develop community partnerships necessary to implement the grant.
(2) Persons, entities, or organizations within adjoining counties with populations of less than 100,000, based on the annual estimates produced by the Population Program of the University of Florida Bureau of Economic and Business Research, may jointly submit a multicounty Closing the Gap grant proposal. However, the proposal must clearly identify a single lead agency with respect to program accountability and administration.
(3) Nothing in ss. 381.7351-381.7356 shall prevent a person, entity, or organization within a county or group of counties from separately contracting for the provision of racial and ethnic health promotion, health awareness, and disease prevention services.
(1) Closing the Gap grant proposals shall be submitted to the Department of Health for review.
(2) A proposal must include each of the following elements:
(a) The purpose and objectives of the proposal, including identification of the particular racial or ethnic disparity the project will address. The proposal must address one or more of the following priority areas:
1. Decreasing racial and ethnic disparities in maternal and infant mortality rates.
2. Decreasing racial and ethnic disparities in severe maternal morbidity rates and other maternal health outcomes.
3. Decreasing racial and ethnic disparities in morbidity and mortality rates relating to cancer.
4. Decreasing racial and ethnic disparities in morbidity and mortality rates relating to HIV/AIDS.
5. Decreasing racial and ethnic disparities in morbidity and mortality rates relating to cardiovascular disease.
6. Decreasing racial and ethnic disparities in morbidity and mortality rates relating to diabetes.
7. Increasing adult and child immunization rates in certain racial and ethnic populations.
8. Decreasing racial and ethnic disparities in oral health care.
9. Decreasing racial and ethnic disparities in morbidity and mortality rates relating to sickle cell disease.
10. Decreasing racial and ethnic disparities in morbidity and mortality rates relating to Lupus.
11. Decreasing racial and ethnic disparities in morbidity and mortality rates relating to Alzheimer’s disease and dementia.
12. Improving neighborhood social determinants of health, such as transportation, safety, and food access, as outlined by the Centers for Disease Control and Prevention’s “Tools for Putting Social Determinants of Health into Action.”
(b) Identification and relevance of the target population.
(c) Methods for obtaining baseline health status data and assessment of community health needs.
(d) Mechanisms for mobilizing community resources and gaining local commitment.
(e) Development and implementation of health promotion and disease prevention interventions.
(f) Mechanisms and strategies for evaluating the project’s objectives, procedures, and outcomes.
(g) A proposed work plan, including a timeline for implementing the project.
(h) Likelihood that project activities will occur and continue in the absence of funding.
(3) Priority shall be given to proposals that:
(a) Represent areas with the greatest documented racial and ethnic health status disparities.
(b) Exceed the minimum local contribution requirements specified in s. 381.7356.
(c) Demonstrate broad-based local support and commitment from entities representing racial and ethnic populations, including non-Hispanic whites. Indicators of support and commitment may include agreements to participate in the program, letters of endorsement, letters of commitment, interagency agreements, or other forms of support.
(d) Demonstrate a high degree of participation by the health care community in clinical preventive service activities and community-based health promotion and disease prevention interventions.
(e) Have been submitted from counties with a high proportion of residents living in poverty and with poor health status indicators.
(f) Demonstrate a coordinated community approach to addressing racial and ethnic health issues within existing publicly financed health care programs.
(g) Incorporate intervention mechanisms which have a high probability of improving the targeted population’s health status.
(h) Demonstrate a commitment to quality management in all aspects of project administration and implementation.
(i) Incorporate policy approaches to achieve sustainable long-term improvement.
(1) One or more Closing the Gap grants may be awarded in a county, or in a group of adjoining counties from which a multicounty application is submitted.
(2) Closing the Gap grants shall be awarded on a matching basis. One dollar in local matching funds must be provided for each $3 grant payment made by the state, except that:
(a) In counties with populations greater than 50,000, up to 50 percent of the local match may be in kind in the form of free services or human resources. Fifty percent of the local match must be in the form of cash.
(b) In counties with populations of 50,000 or less, the required local matching funds may be provided entirely through in-kind contributions.
(c) Grant awards to Front Porch Florida Communities shall not be required to have a matching requirement.
(3) The amount of the grant award shall be based on the county or neighborhood’s population, or on the combined population in a group of adjoining counties from which a multicounty application is submitted, and on other factors, as determined by the department.
(4) The department may not establish a minimum amount or a maximum amount for grants and shall determine the amount of each award based on the merits of the application. The department shall ensure that grants are awarded to applicants in various regions of this state.
(5) In addition to the requirements provided in s. 381.7353, and subject to the availability of state and federal funds in the HIV/AIDS program, the department shall promote synergistic initiatives between the Closing the Gap grant program and the HIV/AIDS program to leverage the expertise of the Closing the Gap grant program. These initiatives may include the establishment of a supplemental grant program whereby persons, entities, or organizations eligible for a Closing the Gap grant under s. 381.7354 may submit to the department a grant proposal, pursuant to the application process established under s. 381.7355, for funding to further the purposes listed in s. 381.7355(2)(a) and to promote innovative prevention, treatment, and awareness initiatives for minority populations in metropolitan areas which have a higher prevalence of HIV/AIDS for the purposes of reducing the incidence of the HIV infection in such communities and prioritizing the identification of individuals, in a manner consistent with the clinical guidelines of the federal Health Resources and Services Administration, who are not yet aware of their HIV status.
(6) A Closing the Gap grant shall be funded for 1 year and may be renewed annually upon application to and approval by the department, subject to the achievement of quality standards, objectives, and outcomes and to the availability of funds.
(7) Implementation of the Reducing Racial and Ethnic Health Disparities: Closing the Gap grant program shall be subject to a specific appropriation provided in the General Appropriations Act.
381.739 Short title; Charlie Mack Overstreet Brain or Spinal Cord Injuries Act.—Sections 381.739-381.79 may be cited as the “Charlie Mack Overstreet Brain or Spinal Cord Injuries Act.”
381.7395 Legislative intent.—It is the intent of the Legislature to ensure the referral of individuals who have moderate-to-severe brain or spinal cord injuries to the brain and spinal cord injury program, a coordinated rehabilitation program administered by the department. The program shall provide eligible persons, as defined in s. 381.76, the opportunity to obtain the necessary rehabilitative services enabling them to be referred to a vocational rehabilitation program or to return to an appropriate level of functioning in their community. Further, it is intended that permanent disability be avoided, whenever possible, through prevention, early identification, emergency medical services and transport, and proper medical and rehabilitative treatment.
381.74 Establishment and maintenance of a central registry.—The department shall establish and maintain a central registry of persons who have moderate-to-severe brain or spinal cord injuries.
(1) Every public health agency, private health agency, public social agency, private social agency, and attending physician shall report to the division within 5 days after identification or diagnosis of any person who has a moderate-to-severe brain or spinal cord injury. The consent of such person shall not be required.
(2) The report shall contain the name, age, residence, and type of disability of the individual and such additional information as may be deemed necessary by the department.
381.745 Definitions; ss. 381.739-381.79.—As used in ss. 381.739-381.79, the term:
(1) “Activity of daily living” means an activity required on a frequent basis which permits an individual to secure or maintain independence. Such activities include, but are not limited to, personal home care, transportation, personal assistance services, housekeeping, shopping, attending school, communication, and employment.
(2) “Brain or spinal cord injury” means:
(a) A lesion to the spinal cord or cauda equina, resulting from external trauma, with evidence of significant involvement of two of the following deficits or dysfunctions:
1. Motor deficit.
2. Sensory deficit.
3. Bowel and bladder dysfunction.
(b) An insult to the skull, brain, or its covering, resulting from external trauma that produces an altered state of consciousness or anatomic motor, sensory, cognitive, or behavioral deficits.
(3) “Emergency medical evacuation system” means a department-approved transportation system that provides timely and skilled emergency care and movement of individuals believed to have sustained a brain or spinal cord injury.
(4) “Personal assistance services” means a range of services, provided by one or more individuals, which are designed to assist an individual who has a disability to perform activities of daily living.
(5) “Funded services” means services paid for through the brain and spinal cord injury program.
(6) “Designated facility” means a facility approved by the brain and spinal cord injury program which meets the criteria and standards of care of the brain and spinal cord injury program for individuals who have sustained a brain or spinal cord injury.
(7) “Third-party coverage” means any claim for, right to receive payment for, or any coverage for the payment of any services under the brain and spinal cord injury program.
(8) “Third-party payment” means any and all payments received or due as a result of any third-party obligation created by gift, coverage or other contract, settlement or judicial decision, or action of law.
(9) “Transitional living facility” means a state-approved facility as defined and licensed under chapter 400.
(10) “Trauma center” means a department-approved acute care facility that provides diagnosis and treatment of individuals who have sustained a brain or spinal cord injury.
381.75 Duties and responsibilities of the department.—Consistent with the mandate of s. 381.7395, the department shall develop and administer a multilevel treatment program for individuals who sustain brain or spinal cord injuries and who are referred to the brain and spinal cord injury program.
(1) Within 15 days after any report of an individual who has sustained a brain or spinal cord injury, the department shall notify the individual or the most immediate available family members of their right to assistance from the state, the services available, and the eligibility requirements.
(2) The department shall refer individuals who have brain or spinal cord injuries to other state agencies to ensure that rehabilitative services, if desired, are obtained by that individual.
(3) The department, in consultation with emergency medical service, shall develop standards for an emergency medical evacuation system that will ensure that all individuals who sustain traumatic brain or spinal cord injuries are transported to a department-approved trauma center that meets the standards and criteria established by the emergency medical service and the acute-care standards of the brain and spinal cord injury program.
(4) The department shall develop standards for designation of rehabilitation centers to provide rehabilitation services for individuals who have brain or spinal cord injuries.
(5) The department shall determine the appropriate number of designated acute-care facilities, inpatient rehabilitation centers, and outpatient rehabilitation centers needed based on incidence, volume of admissions, and other appropriate criteria.
(6) The department shall develop standards for designation of transitional living facilities to provide transitional living services for individuals who participate in the brain and spinal cord injury program.
381.755 Benefits not assignable.—The right of an eligible individual to any services provided by the brain and spinal cord injury program is not transferable or assignable, and any benefits, including money, goods, or chattels, received as services under the brain and spinal cord injury program are exempt from all state, county, and municipal taxes and from sale under the process of any court, except for obligations contracted for the purchase of such property.
381.76 Eligibility for the brain and spinal cord injury program.—
(1) An individual shall be accepted as eligible for the brain and spinal cord injury program following certification by the department that the individual:
(a) Has been referred to the central registry pursuant to s. 381.74;
(b) Is a legal resident of this state at the time of application for services;
(c) Has sustained a brain or spinal cord injury;
(d) Is medically stable; and
(e) Is reasonably expected to achieve reintegration into the community through services provided by the brain and spinal cord injury program.
(2) If the department is unable to provide services to all eligible individuals, the department may establish an order of selection.
381.765 Retention of title to and disposal of equipment.—
(1) The department may retain title to any property, tools, instruments, training supplies, equipment, or other items of value acquired for services provided under the brain and spinal cord injury program or for personnel employed in operating the brain and spinal cord injury program, and may repossess or transfer such property, tools, instruments, supplies, equipment, or other items of value.
(2) The department may offer for sale any surplus items acquired in operating the brain and spinal cord injury program when they are no longer necessary or exchange them for necessary items that may be used to greater advantage. When any such surplus equipment is sold or exchanged, a receipt for the equipment shall be taken from the purchaser showing the consideration given for such equipment and forwarded to the Chief Financial Officer, and any funds received by the brain and spinal cord injury program pursuant to any such transaction shall be deposited in the Brain and Spinal Cord Injury Program Trust Fund and shall be available for expenditure for any purpose consistent with ss. 381.739-381.79.
381.775 Applicant and recipient records; confidential and privileged.—
(1) All oral and written records, information, letters, and reports received, made, or maintained by the department relative to any applicant for or recipient of services under the brain and spinal cord injury program are privileged, confidential, and exempt from s. 119.07(1). Any person who discloses or releases such records, information, or communications in violation of this section commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083. Such records may not be released, except that:
(a) Records may be released to the applicant or recipient, or his or her representative, upon receipt of a written waiver from the applicant or recipient. Medical, psychological, or other information that the department believes may be harmful to an applicant or recipient may not be released directly to him or her, but must be provided through a licensed health care professional designated by the applicant or recipient.
(b) Records that do not identify applicants or recipients may be released for the purpose of research, when the research is approved by the department.
(c) Records used in administering the brain and spinal cord injury program may be released as required to administer the program or as required by an agency or political subdivision of the state in the performance of its duties. Any agency or political subdivision to which records are released under this paragraph may not disclose the records to third parties.
(d) Records may be released upon the order of an administrative law judge, a hearing officer, a judge of compensation claims, an agency head exercising quasi-judicial authority, or a judge of a court of competent jurisdiction following a finding in an in camera proceeding that the records are relevant to the inquiry before the court and should be released. The in camera proceeding and all records relating thereto are confidential and exempt from s. 119.07(1).
(e) Whenever an applicant for or recipient of services under the brain and spinal cord injury program has declared any intention to harm other persons or property, such declaration may be disclosed.
(f) The department may release personal information about an applicant for or recipient of services under the brain and spinal cord injury program in order to protect him or her or others when the applicant or recipient poses a threat to his or her own safety or to the safety of others and shall, upon official request, release such information to law enforcement agencies investigating the commission of a crime.
(2) Records that come into the possession of the department relative to any applicant for or receipt of services under the brain and spinal cord injury program and that are confidential by other provisions of law are confidential and exempt from s. 119.07(1), and may not be released by the department, except as provided in this section.
381.78 Advisory council on brain and spinal cord injuries.—
(1) There is created within the department an 18-member advisory council on brain and spinal cord injuries. The council shall be composed of a minimum of four individuals who have brain injuries or are family members of individuals who have brain injuries, a minimum of four individuals who have spinal cord injuries or are family members of individuals who have spinal cord injuries, and a minimum of two individuals who represent the special needs of children who have brain or spinal cord injuries. The balance of the council members shall be physicians, other allied health professionals, administrators of brain and spinal cord injury programs, and representatives from support groups that have expertise in areas related to the rehabilitation of individuals who have brain or spinal cord injuries. Additionally, the council must include two veterans who have or have had a traumatic brain injury, chronic traumatic encephalopathy, or subconcussive impacts due to military service, or include the family members of such veterans.
(2) Members of the council shall be appointed to serve by the State Surgeon General. All members’ terms shall be for 4 years. An individual may not serve more than two terms. Any council member who is unwilling or unable to properly fulfill the duties of the office shall be succeeded by an individual chosen by the State Surgeon General to serve out the unexpired balance of the replaced council member’s term. If the unexpired balance of the replaced council member’s term is less than 18 months, then, notwithstanding the provisions of this subsection, the succeeding council member may be reappointed by the State Surgeon General twice.
(3) The council shall meet at least two times annually.
(4) The council shall provide advice and expertise to the department in the preparation, implementation, and periodic review of the brain and spinal cord injury program.
(5) Members of the advisory council are entitled to reimbursement for per diem and travel expenses for required attendance at council meetings in accordance with s. 112.061. Reasonable expenses for personal assistance services and interpreters needed by members during required attendance at council meetings shall be reimbursed. A member may not receive any compensation for performing duties specified in, or arising out of, her or his duties as a council member under ss. 381.739-381.79, except as otherwise specified in ss. 381.739-381.79.
(6) A member of the advisory council may not cast a vote on any matter that would provide direct financial benefit to the member or create a conflict of interest under state law.
(7) A member of the advisory council may be removed from office by the State Surgeon General for malfeasance, misfeasance, neglect of duty, incompetence, or permanent inability to perform official duties or for pleading nolo contendere to, or being found guilty of, a crime. Malfeasance includes, but is not limited to, a violation of any specific prohibition within ss. 381.739-381.79.
381.785 Recovery of third-party payments for funded services.—
(1) Third-party coverage for funded services constitutes primary coverage.
(2) An applicant for or recipient of services funded under the brain and spinal cord injury program must inform the brain and spinal cord injury program of any rights she or he has to third-party payments for such services, and the brain and spinal cord injury program shall be subrogated to her or his rights to such third-party payments. The brain and spinal cord injury program may recover directly from:
(a) Any third party that is liable to make a benefit payment to the provider of the recipient’s funded services or to the recipient under the terms of any contract, settlement, or award;
(b) The recipient, if she or he has received a third-party payment for funded services provided to her or him; or
(c) The provider of the recipient’s funded services, if third-party payment for such services has been recovered by the provider.
(3) An applicant for or a recipient of funded services is deemed to have assigned to the brain and spinal cord injury program her or his rights to any payments for such services from a third party and to have authorized the brain and spinal cord injury program to release information with respect to such services for the sole purpose of obtaining reimbursement.
(4) The brain and spinal cord injury program may, in order to enforce its rights under this section, institute, intervene in, or join any legal proceeding against a third party against whom recovery rights arise. Action taken by the brain and spinal cord injury program does not preclude the recipient’s recovery for that portion of her or his damages not subrogated to the brain and spinal cord injury program, and action taken by the recipient does not prejudice the rights of the brain and spinal cord injury program.
(5) When the brain and spinal cord injury program provides, pays for, or becomes liable for funded services, it has a lien for the amount of such services upon all causes of action that accrue to the recipient or to her or his legal representatives as a result of sickness, injury, disease, disability, or death due to the liability of a third party which necessitated funded services. To perfect such lien, a notice of lien must be filed with the clerk of the circuit court in the recipient’s county of residence. The notice of lien must contain the name and address of the person to whom services were furnished and the name, address, and telephone number of a person at the brain and spinal cord injury program from whom information regarding the lien can be obtained. Failure of the brain and spinal cord injury program to file a notice of lien does not affect the program’s other rights provided in this section. Any notice of lien filed as provided under this subsection is valid for 5 years after filing, and may be extended for an additional 5-year period by filing a new notice of lien at any time prior to the expiration of the original notice of lien.
(6) In recovering any payments in accordance with this section, the brain and spinal cord injury program may make appropriate settlements.
(7) Notwithstanding any other law to the contrary, payments made for funded services are neither collateral payments nor collateral sources within the meaning of chapter 86-160, Laws of Florida, or chapter 88-1, Laws of Florida.
(8) Notwithstanding any other law to the contrary, the brain and spinal cord injury program retains all rights and remedies granted under this section as against moneys paid under chapter 440.
(9) The department shall adopt rules to administer this section.
381.79 Brain and Spinal Cord Injury Program Trust Fund.—
(1) There is created in the State Treasury the Brain and Spinal Cord Injury Program Trust Fund. Moneys in the fund shall be appropriated to the department for the purpose of providing the cost of care for brain or spinal cord injuries as a payor of last resort to residents of this state, for multilevel programs of care established pursuant to s. 381.75.
(a) Authorization of expenditures for brain or spinal cord injury care shall be made only by the department.
(b) Authorized expenditures include acute care, rehabilitation, transitional living, equipment and supplies necessary for activities of daily living, public information, prevention, education, and research. In addition, the department may provide matching funds for public or private assistance provided under the brain and spinal cord injury program and may provide funds for any approved expansion of services for treating individuals who have sustained a brain or spinal cord injury.
(2) The department shall issue a report to the President of the Senate and the Speaker of the House of Representatives by March 1 of each year, summarizing the activities supported by the trust fund.
(3) Annually, 5 percent of the revenues deposited monthly in the fund pursuant to s. 318.21(2)(d) shall be appropriated to the University of Florida and 5 percent to the University of Miami for spinal cord injury and brain injury research. The amount to be distributed to the universities shall be calculated based on the deposits into the fund for each quarter in the fiscal year, but may not exceed $500,000 per university per year. Funds distributed under this subsection shall be made in quarterly payments at the end of each quarter during the fiscal year.
(4) The Board of Governors of the State University System shall establish a program administration process which shall include: an annual prospective program plan with goals, research design, proposed outcomes, a proposed budget, an annual report of research activities and findings, and an annual end-of-year financial statement. Prospective program plans shall be submitted to the Board of Governors, and funds shall be released upon acceptance of the proposed program plans. The annual report of research activities and findings shall be submitted to the Board of Governors, with the executive summaries submitted to the President of the Senate, the Speaker of the House of Representatives, and the State Surgeon General.
(5) Moneys received under s. 381.785 shall be deposited into the trust fund and used for the purposes specified in subsection (1).
(6) The department may accept, deposit into the trust fund, and use for carrying out the purposes of ss. 381.739-381.79 gifts made unconditionally by will or otherwise. Any gift made under conditions that, in the judgment of the department, are proper and consistent with this section, the laws of the United States, and the laws of this state may be accepted and shall be held, invested, reinvested, and used in accordance with the conditions of the gift.
381.814 Sickle Cell Disease Research and Treatment Grant Program.—The Sickle Cell Disease Research and Treatment Grant Program is created within the Department of Health.
(1) As used in this section, the term:
(a) “Center of excellence” means a health care facility dedicated to the treatment of patients with sickle cell disease which provides evidence-based, comprehensive, patient-centered coordinated care.
(b) “Department” means the Department of Health.
(c) “Health care practitioner” has the same meaning as provided in s. 456.001.
(d) “Program” means the Sickle Cell Disease Research and Treatment Grant Program.
(e) “Sickle cell disease” means the group of hereditary blood disorders caused by an abnormal type of hemoglobin resulting in malformed red blood cells with impaired function. The term includes both symptomatic manifestations of sickle cell disease and asymptomatic sickle cell trait.
(2) The purpose of the program is to fund projects that improve the quality and accessibility of health care services available for persons living with sickle cell disease in this state as well as to advance the collection and analysis of comprehensive data to support research of sickle cell disease. The long-term goals of the program are to:
(a) Improve the health outcomes and quality of life for Floridians with sickle cell disease.
(b) Expand access to high-quality, specialized care for sickle cell disease.
(c) Improve awareness and understanding among health care practitioners of current best practices for the treatment and management of sickle cell disease.
(3) Funds appropriated to the program shall be awarded by the Office of Minority Health and Health Equity, within the department, to community-based sickle cell disease medical treatment and research centers operating in this state.
(4) The Office of Minority Health and Health Equity shall award grants under the program to community-based sickle cell disease medical treatment and research centers to fund projects specific to sickle cell disease in the following project areas:
(a) Sickle cell disease workforce development and education.—Such projects shall include, but need not be limited to, facility-based education programs, continuing education curriculum development, and outreach and education activities with the local health care practitioner community. Workforce development and education projects must be based on current evidence-based clinical practice guidelines for sickle cell disease.
(b) Sickle Cell Disease Treatment Centers of Excellence.—Such projects shall include, but need not be limited to, operational support for existing centers of excellence, facility enhancement of existing centers of excellence, and the establishment of new centers of excellence.
(5) The department shall:
(a) By July 15, 2024, publicize the availability of funds, establish an application process for submitting a grant proposal, and initiate a call for applications.
(b) Develop uniform data reporting requirements for the purpose of evaluating the performance of the grant recipients and demonstrating improved health outcomes.
(c) Develop a monitoring process to evaluate progress towards meeting grant objectives.
(6) The department shall submit an annual report to the Governor, the President of the Senate, the Speaker of the House of Representatives, and the State Surgeon General by March 1 and publish the report on the department’s website. The report shall include the status and progress for each project supported by the program during the previous calendar year. The report shall include, at a minimum, recommendations for improving the program and the following components for each project supported by the program:
(a) A summary of the project and the project outcomes or expected project outcomes.
(b) The status of the project, including whether it is completed or the estimated date of completion.
(c) The amount of the grant awarded and the estimated or actual cost of the project.
(d) The source and amount of any federal, state, or local government grants or donations or private grants or donations funding the project.
(e) A list of all entities involved in the project.
(7) The department may adopt rules as necessary to implement the provisions of this section.
(8) The recipient of a grant awarded under the program may not use more than 5 percent of grant funds for administrative expenses. Notwithstanding s. 216.301 and pursuant to s. 216.351, the balance of any appropriation from the General Revenue Fund for the program which is not disbursed but which is obligated pursuant to contract or committed to be expended by June 30 of the fiscal year in which the funds are appropriated may be carried forward for up to 5 years after the effective date of the original appropriation.
381.815 Sickle-cell program.—The Department of Health shall, to the extent that resources are available:
(1) Provide education to the citizens of Florida about sickle-cell disease.
(2) Work cooperatively with not-for-profit centers to provide community-based education, patient teaching, and counseling and to encourage diagnostic screening.
(3) Make grants or enter into contracts with not-for-profit centers.
381.82 Ed and Ethel Moore Alzheimer’s Disease Research Program.—
(1) The Ed and Ethel Moore Alzheimer’s Disease Research Program is created within the Department of Health. The purpose of the program is to fund research leading to prevention of or a cure for Alzheimer’s disease. The long-term goals of the program are to:
(a) Improve the health of Floridians by researching better prevention and diagnoses of and treatments and cures for Alzheimer’s disease.
(b) Expand the foundation of knowledge relating to the prevention, diagnosis, treatment, and cure of Alzheimer’s disease.
(c) Stimulate economic activity in the state in areas related to Alzheimer’s disease research.
(2)(a) Funds appropriated for the Ed and Ethel Moore Alzheimer’s Disease Research Program shall be used exclusively for the award of grants and fellowships through a competitive process for research relating to the prevention, diagnosis, treatment, and cure of Alzheimer’s disease and for expenses incurred in the administration of this section. Priority shall be granted to research designed to prevent or cure Alzheimer’s disease.
(b) Applications for Alzheimer’s disease research funding under the program may be submitted from any university or established research institute in the state. All qualified investigators in the state, regardless of institution affiliation, shall have equal access and opportunity to compete for research funding. The following types of applications may be considered for funding:
1. Investigator-initiated research grants.
2. Institutional research grants.
3. Predoctoral and postdoctoral research fellowships.
4. Collaborative research grants, including those that advance the finding of cures through basic or applied research.
(3) There is created within the Department of Health the Alzheimer’s Disease Research Grant Advisory Board.
(a) The board shall consist of 11 members appointed by the State Surgeon General. The board shall be composed of two gerontologists, two geriatric psychiatrists, two geriatricians, two neuroscientists, and three neurologists. Initial appointments to the board shall be made by October 1, 2014. The board members shall serve 4-year terms, except that, to provide for staggered terms, five of the initial appointees shall serve 2-year terms and six shall serve 4-year terms. All subsequent appointments shall be for 4-year terms. The chair of the board shall be elected from the membership of the board and shall serve as chair for 2 years. An appointed member may not serve more than two consecutive terms. Appointed members must have experience in Alzheimer’s disease or related biomedical research. The board shall adopt internal organizational procedures as necessary for its efficient organization. The board shall establish and follow rigorous guidelines for ethical conduct and adhere to a strict policy with regard to conflicts of interest. A member of the board may not participate in any discussion or decision of the board or a panel with respect to a research proposal by any firm, entity, or agency with which the member is associated as a member of the governing body or as an employee or with which the member has entered into a contractual arrangement.
(b) The department shall provide such staff, information, and other assistance as is reasonably necessary to assist the board in carrying out its responsibilities. Members of the board shall serve without compensation and may not receive reimbursement for per diem or travel expenses.
(c) The board shall advise the State Surgeon General as to the scope of the research program and shall submit its recommendations for proposals to be funded to the State Surgeon General by December 15 of each year. Grants and fellowships shall be awarded by the State Surgeon General, after consultation with the board, on the basis of scientific merit. Other responsibilities of the board may include, but are not limited to, providing advice on program priorities and emphases; assisting in the development of appropriate linkages to nonacademic entities, such as voluntary organizations, health care delivery institutions, industry, government agencies, and public officials; and developing and providing oversight regarding mechanisms for the dissemination of research results.
(d)1. Applications provided to the board for Alzheimer’s disease research grants under this section, and any records generated by the board relating to review of such applications, except final recommendations, are confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
2. Those portions of a meeting of the board during which applications for Alzheimer’s disease research grants under this section are discussed are exempt from s. 286.011 and s. 24(b), Art. I of the State Constitution. The closed portion of a meeting must be recorded. The recording shall be maintained by the board and shall be subject to disclosure in accordance with subparagraph 3.
3. Information that is held confidential and exempt under this paragraph may be disclosed with the express written consent of the individual to whom the information pertains or the individual’s legally authorized representative, or by court order upon a showing of good cause.
(4) The board shall submit a fiscal-year progress report on the programs under its purview annually to the Governor, the President of the Senate, the Speaker of the House of Representatives, and the State Surgeon General by February 15. The report must include:
(a) For each research project supported by grants or fellowships awarded under the program:
1. A summary of the research project and results or expected results of the research.
2. The status of the research project, including whether it has concluded or the estimated date of completion.
3. The amount of the grant or fellowship awarded and the estimated or actual cost of the research project.
4. A list of principal investigators under the research project.
5. The title, citation, and summary of findings of a publication in a peer-reviewed journal resulting from the research.
6. The source and amount of any federal, state, or local government grants or donations or private grants or donations generated as a result of the research project.
7. The status of a patent, if any, generated from the research project and an economic analysis of the impact of the resulting patent.
8. A list of postsecondary educational institutions involved in the research project, a description of each postsecondary educational institution’s involvement in the research project, and the number of students receiving training or performing research under the research project.
(b) The state ranking and total amount of Alzheimer’s disease research funding currently flowing into the state from the National Institutes of Health.
(c) Progress toward programmatic goals, particularly in the prevention, diagnosis, treatment, and cure of Alzheimer’s disease.
(d) Recommendations to further the mission of the program.
(5) The activities of the board provided in subsection (3) are exempt from chapter 120.
(6) The department may adopt rules as necessary to implement the provisions of this section.
(7) Implementation of the Ed and Ethel Moore Alzheimer’s Disease Research Program is subject to legislative appropriation.
(8) Notwithstanding s. 216.301 and pursuant to s. 216.351, the balance of any appropriation from the General Revenue Fund for the Ed and Ethel Moore Alzheimer’s Disease Research Program which is not disbursed but which is obligated pursuant to contract or committed to be expended by June 30 of the fiscal year in which the funds are appropriated may be carried forward for up to 5 years after the effective date of the original appropriation.
381.825 Education and public awareness relating to Alzheimer’s disease and related forms of dementia.—
(1) This section may be cited as the “Ramping up Education of Alzheimer’s Disease and Dementia for You (READY) Act.”
(2) The Department of Health shall, through existing, relevant public health and community outreach programs, educate health care practitioners licensed under chapters 458, 459, and 464 on all of the following:
(a) The importance of early detection and timely diagnosis of Alzheimer’s disease and related forms of dementia.
(b) Using a validated cognitive assessment tool.
(c) The value and effectiveness of the Medicare annual wellness visit in detecting Alzheimer’s disease and related forms of dementia.
(d) Using Medicare advance care planning billing codes for persons with Alzheimer’s disease and related forms of dementia.
(e) Reducing the risk of cognitive decline, particularly among persons in diverse communities who are at greater risk of developing Alzheimer’s disease and related forms of dementia.
381.84 Comprehensive Statewide Tobacco Education and Use Prevention Program.—
(1) DEFINITIONS.—As used in this section and for purposes of the provisions of s. 27, Art. X of the State Constitution, the term:
(a) “AHEC network” means an area health education center network established under s. 381.0402.
(b) “CDC” means the United States Centers for Disease Control and Prevention.
(c) “Council” means the Tobacco Education and Use Prevention Advisory Council.
(d) “Department” means the Department of Health.
(e) “Tobacco” means, without limitation, tobacco itself and tobacco products that include tobacco and are intended or expected for human use or consumption, including, but not limited to, cigarettes, cigars, pipe tobacco, and smokeless tobacco.
(f) “Youth” means minors and young adults.
(2) PURPOSE, FINDINGS, AND INTENT.—It is the purpose of this section to implement s. 27, Art. X of the State Constitution. The Legislature finds that s. 27, Art. X of the State Constitution requires the funding of a statewide tobacco education and use prevention program that focuses on tobacco use by youth. The Legislature further finds that the primary goals of the program are to reduce the prevalence of tobacco use among youth, adults, pregnant women, and women who may become pregnant; reduce per capita tobacco consumption; and reduce exposure to environmental tobacco smoke. Further, it is the intent of the Legislature to base increases in funding for individual components of the program on the results of assessments and evaluations. Recognizing that some components will need to grow faster than inflation, it is the intent of the Legislature to fund portions of the program on a nonrecurring basis in the early years so that those components that are most effective can be supported as the program matures.
(3) PROGRAM COMPONENTS AND REQUIREMENTS.—The department shall conduct a comprehensive, statewide tobacco education and use prevention program consistent with the recommendations for effective program components contained in the 1999 Best Practices for Comprehensive Tobacco Control Programs of the CDC, as amended by the CDC. The program shall include the following components, each of which shall focus on educating people, particularly pregnant women, women who may become pregnant, and youth and their parents, about the health hazards of tobacco and discouraging the use of tobacco:
(a) Counter-marketing and advertising; Internet resource center.—The counter-marketing and advertising campaign shall include, at a minimum, Internet, print, radio, and television advertising and shall be funded with a minimum of one-third of the total annual appropriation required by s. 27, Art. X of the State Constitution.
1. The campaign shall include an Internet resource center for copyrighted materials and information concerning tobacco education and use prevention, including cessation. The Internet resource center must be accessible to the public, including parents, teachers, and students, at each level of public and private schools, universities, and colleges in the state and shall provide links to other relevant resources. The Internet address for the resource center must be incorporated in all advertising. The information maintained in the resource center shall be used by the other components of the program.
2. The campaign shall use innovative communication strategies, such as targeting specific audiences who use personal communication devices and frequent social networking websites.
(b) Cessation programs, counseling, and treatment.—This program component shall include two subcomponents:
1. A statewide toll-free cessation service, which may include counseling, referrals to other local resources and support services, and treatment to the extent funds are available for treatment services; and
2. A local community-based program to disseminate information about tobacco-use cessation, how tobacco-use cessation relates to prenatal care and obesity prevention, and other chronic tobacco-related diseases.
(c) Surveillance and evaluation.—The program shall conduct ongoing epidemiological surveillance and shall contract for annual independent evaluations of the effectiveness of the various components of the program in meeting the goals as set forth in subsection (2).
(d) Youth school programs.—School and after-school programs shall use current evidence-based curricula and programs that involve youth to educate youth about the health hazards of tobacco, help youth develop skills to refuse tobacco, and demonstrate to youth how to stop using tobacco.
(e) Community programs and chronic disease prevention.—The department shall promote and support local community-based partnerships that emphasize programs involving youth, pregnant women, and women who may become pregnant, including programs for the prevention, detection, and early intervention of tobacco-related chronic diseases.
(f) Training.—The program shall include the training of health care practitioners, tobacco-use cessation counselors, and teachers by health professional students and other tobacco-use prevention specialists who are trained in preventing tobacco use and health education. Tobacco-use cessation counselors shall be trained by specialists who are certified in tobacco-use cessation.
(g) Administration and management, statewide programs, and county health departments.—The department shall administer the program within the expenditure limit established in subsection (8). Each county health department is eligible to receive a portion of the annual appropriation, on a per capita basis, for coordinating tobacco education and use prevention programs within that county. Appropriated funds may be used to improve the infrastructure of the county health department to implement the comprehensive, statewide tobacco education and use prevention program. Each county health department shall prominently display in all treatment rooms and waiting rooms counter-marketing and advertisement materials in the form of wall posters, brochures, television advertising if televisions are used in the lobby or waiting room, and screensavers and Internet advertising if computer kiosks are available for use or viewing by people at the county health department.
(h) Enforcement and awareness of related laws.—In coordination with the Department of Business and Professional Regulation, the program shall monitor the enforcement of laws, rules, and policies prohibiting the sale or other provision of tobacco to minors, as well as the continued enforcement of the Florida Clean Air Act prescribed in chapter 386. The advertisements produced in accordance with paragraph (a) may also include information designed to make the public aware of these related laws and rules. The departments may enter into interagency agreements to carry out this program component.
(i) AHEC tobacco-use cessation initiative.—The AHEC network may administer the AHEC tobacco-use cessation initiative in each county within the state and perform other activities as determined by the department.
(4) ADVISORY COUNCIL; MEMBERS, APPOINTMENTS, AND MEETINGS.—The Tobacco Education and Use Prevention Advisory Council is created within the department.
(a) The council shall consist of 23 members, including:
1. The State Surgeon General, who shall serve as the chairperson.
2. One county health department director, appointed by the State Surgeon General.
3. Two members appointed by the Commissioner of Education, of whom one must be a school district superintendent.
4. The chief executive officer of the Florida Division of the American Cancer Society, or his or her designee.
5. The chief executive officer of the Greater Southeast Affiliate of the American Heart Association, or his or her designee.
6. The chief executive officer of the American Lung Association of Florida, or his or her designee.
7. The dean of the University of Miami School of Medicine, or his or her designee.
8. The dean of the University of Florida College of Medicine, or his or her designee.
9. The dean of the University of South Florida College of Medicine, or his or her designee.
10. The dean of the Florida State University College of Medicine, or his or her designee.
11. The dean of Nova Southeastern College of Osteopathic Medicine, or his or her designee.
12. The dean of the Lake Erie College of Osteopathic Medicine in Bradenton, Florida, or his or her designee.
13. The chief executive officer of the Campaign for Tobacco Free Kids, or his or her designee.
14. The chief executive officer of the Legacy Foundation, or his or her designee.
15. Four members appointed by the Governor, of whom two must have expertise in the field of tobacco-use prevention and education or tobacco-use cessation and one individual who shall be between the ages of 16 and 21 at the time of his or her appointment.
16. Two members appointed by the President of the Senate, of whom one must have expertise in the field of tobacco-use prevention and education or tobacco-use cessation.
17. Two members appointed by the Speaker of the House of Representatives, of whom one must have expertise in the field of tobacco-use prevention and education or tobacco-use cessation.
(b) The appointments shall be for 3-year terms and shall reflect the diversity of the state’s population. A vacancy shall be filled by appointment by the original appointing authority for the unexpired portion of the term.
(c) An appointed member may not serve more than two consecutive terms.
(d) The council shall meet at least quarterly and upon the call of the chairperson. Meetings may be held via teleconference or other electronic means.
(e) Members of the council shall serve without compensation, but are entitled to reimbursement for per diem and travel expenses pursuant to s. 112.061. Members who are state officers or employees or who are appointed by state officers or employees shall be reimbursed for per diem and travel expenses pursuant to s. 112.061 from the state agency through which they serve.
(f) The department shall provide council members with information and other assistance as is reasonably necessary to assist the council in carrying out its responsibilities.
(5) COUNCIL DUTIES AND RESPONSIBILITIES.—The council shall advise the State Surgeon General as to the direction and scope of the Comprehensive Statewide Tobacco Education and Use Prevention Program. The responsibilities of the council include, but are not limited to:
(a) Providing advice on program priorities and emphases.
(b) Providing advice on the overall program budget.
(c) Providing advice on copyrighted material, trademark, and future transactions as they pertain to the tobacco education and use prevention program.
(d) Reviewing broadcast material prepared for the Internet, portable media players, radio, and television as it relates to the advertising component of the tobacco education and use prevention program.
(e) Participating in periodic program evaluation.
(f) Assisting in the development of guidelines to ensure fairness, neutrality, and adherence to the principles of merit and quality in the conduct of the program.
(g) Assisting in the development of administrative procedures relating to solicitation, review, and award of contracts and grants in order to ensure an impartial, high-quality peer review system.
(h) Assisting in the development and supervision of peer review panels.
(i) Reviewing reports of peer review panels and making recommendations for contracts and grants.
(j) Reviewing the activities and evaluating the performance of the AHEC network to avoid duplicative efforts using state funds.
(k) Recommending meaningful outcome measures through a regular review of tobacco-use prevention and education strategies and programs of other states and the Federal Government.
(l) Recommending policies to encourage a coordinated response to tobacco use in this state, focusing specifically on creating partnerships within and between the public and private sectors.
(6) CONTRACT REQUIREMENTS.—Contracts or grants for the program components or subcomponents described in paragraphs (3)(a)-(f) shall be awarded by the State Surgeon General, after consultation with the council, on the basis of merit, as determined by an open, competitive, peer-reviewed process that ensures objectivity, consistency, and high quality. The department shall award such grants or contracts no later than October 1 for each fiscal year. A recipient of a contract or grant for the program component described in paragraph (3)(c) is not eligible for a contract or grant award for any other program component described in subsection (3) in the same state fiscal year. A school or college of medicine that is represented on the council is not eligible to receive a contract or grant under this section. The department shall award a contract or grant in the amount of $10 million to the AHEC network for the purpose of developing the components described in paragraph (3)(i). The AHEC network may apply for competitive contracts or grants.
(a) In order to ensure that all proposals for funding are appropriate and are evaluated fairly on the basis of merit, the State Surgeon General, in consultation with the council, shall appoint a peer review panel of independent, qualified experts in the field of tobacco control to review the content of each proposal and establish its priority score. The priority scores shall be forwarded to the council and must be considered in determining which proposals will be recommended for funding.
(b) The council and the peer review panel shall establish and follow rigorous guidelines for ethical conduct and adhere to a strict policy with regard to conflicts of interest. A member of the council or panel may not participate in any discussion or decision with respect to a research proposal by any firm, entity, or agency with which the member is associated as a member of the governing body or as an employee or with which the member has entered into a contractual arrangement. Meetings of the council and the peer review panels are subject to chapter 119, s. 286.011, and s. 24, Art. I of the State Constitution.
(c) In each contract or grant agreement, the department shall limit the use of food and promotional items to no more than 2.5 percent of the total amount of the contract or grant and limit overhead or indirect costs to no more than 7.5 percent of the total amount of the contract or grant. The department, in consultation with the Department of Financial Services, shall publish guidelines for appropriate food and promotional items.
(d) In each advertising contract, the department shall limit the total of production fees, buyer commissions, and related costs to no more than 10 percent of the total contract amount.
(e) Notwithstanding the competitive process for contracts prescribed in this subsection, each county health department is eligible for core funding, on a per capita basis, to implement tobacco education and use prevention activities within that county.
(7) ANNUAL REPORT REQUIRED.—By January 31 of each year, the department shall provide to the Governor, the President of the Senate, and the Speaker of the House of Representatives a report that evaluates the program’s effectiveness in reducing and preventing tobacco use and that recommends improvements to enhance the program’s effectiveness. The report must contain, at a minimum, an annual survey of youth attitudes and behavior toward tobacco, as well as a description of the progress in reducing the prevalence of tobacco use among youth, adults, pregnant women, and women who may become pregnant; reducing per capita tobacco consumption; and reducing exposure to environmental tobacco smoke.
(8) LIMITATION ON ADMINISTRATIVE EXPENSES.—From the total funds appropriated for the Comprehensive Statewide Tobacco Education and Use Prevention Program in the General Appropriations Act, an amount of up to 5 percent may be used by the department for administrative expenses.
(9) RULEMAKING AUTHORIZED.—The department shall adopt rules pursuant to ss. 120.536(1) and 120.54 to administer this section.
(1) It is the intent of the Legislature to establish a coordinated effort among the state’s public and private universities and hospitals and the biomedical industry to discover brain tumor cures and develop brain tumor treatment modalities. Moreover, it is the intent of the Legislature to expand the state’s economy by attracting biomedical researchers and research companies to the state.
(2) The Evelyn F. and William L. McKnight Brain Institute of the University of Florida shall work with other institutions and organizations to develop and maintain a brain tumor registry that is an automated, electronic, and centralized database of individuals with brain tumors. The individual, or the parent or guardian of the individual if the individual is a minor, may refuse to participate in the brain tumor registry by signing a form obtained from the department or from the health care practitioner or entity that provides brain tumor care or treatment which indicates that the individual does not wish to be included in the registry. The decision to not participate in the registry must be noted in the registry.
(3) The Florida Center for Brain Tumor Research is established within the Evelyn F. and William L. McKnight Brain Institute of the University of Florida.
(a) The purpose of the center is to foster collaboration with brain cancer research organizations and other institutions, provide a central repository for brain tumor biopsies from individuals throughout the state, improve and monitor brain tumor biomedical research programs within the state, facilitate funding opportunities, and foster improved technology transfer of brain tumor research findings into clinical trials and widespread public use.
(b) The goal of the center is to find cures for brain tumors.
(c) Funds specifically appropriated by the Legislature for peer-reviewed brain tumor research shall be awarded using a competitive grant process developed by the center.
(d) The center shall hold an annual brain tumor biomedical technology summit in the state to which scientists conducting basic peer-reviewed scientific research from the state’s public and private universities, teaching hospitals, and for-profit and nonprofit institutions are invited to share biomedical research findings in order to expedite the discovery of cures. Summit attendees shall cover the costs of such attendance or obtain sponsorship for such attendance.
(e) The center shall encourage clinical trials in the state on research that holds the promise of curing brain tumors. The center shall facilitate the formation of partnerships between researchers, physicians, clinicians, and hospitals for the purpose of sharing new techniques and new research findings and coordinating the voluntary donation of brain tumor biopsies.
(f) The center shall submit an annual report to the Governor, the President of the Senate, the Speaker of the House of Representatives, and the State Surgeon General no later than January 15 that contains recommendations for legislative changes necessary to foster a positive climate for the pursuit of brain tumor research and the development of treatment modalities in the state.
(g) The center shall be funded through private, state, and federal sources.
(4) There is established within the center a scientific advisory council that includes biomedical researchers, physicians, clinicians, and representatives from public and private universities and hospitals. The council shall meet at least annually.
(a) The council shall consist of:
1. Two members from the Florida Center for Brain Tumor Research within the Evelyn F. and William L. McKnight Brain Institute of the University of Florida appointed by the Governor.
2. Two members from The Scripps Research Institute, one of whom must have expertise in basic brain tumor research, appointed by the Speaker of the House of Representatives.
3. Two members from other public and private universities and institutions directly involved in brain tumor research appointed by the President of the Senate.
4. One member from the Mayo Clinic in Jacksonville who is directly involved in the treatment of brain tumor patients or who has expertise in basic brain tumor research appointed by the State Surgeon General.
5. Two members from the Cleveland Clinic in Florida who are directly involved in basic brain tumor research appointed by the Governor.
6. One member from the H. Lee Moffitt Cancer Center and Research Institute who is directly involved in the treatment of brain tumor patients or who has expertise in basic brain tumor research appointed by the Speaker of the House of Representatives.
7. One member from the M. D. Anderson Cancer Center Orlando who is directly involved in the treatment of brain tumor patients or who has expertise in basic brain tumor research appointed by the President of the Senate.
(b) Council members shall serve staggered 4-year terms.
(c) Council members shall serve without compensation, and each organization represented shall cover all expenses of its representative.
381.8531 Florida Center for Brain Tumor Research; public records exemption.—
(1) The following information held by the Florida Center for Brain Tumor Research before, on, or after July 1, 2011, is confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution:
(a) Personal identifying information of a donor to the central repository for brain tumor biopsies or the brain tumor registry.
(b) Any information received from an individual from another state or nation or the Federal Government that is otherwise confidential or exempt pursuant to the laws of that state or nation or pursuant to federal law.
(2) Such information may be disclosed to a person engaged in bona fide research if that person agrees to:
(a) Submit to the Florida Center for Brain Tumor Research a research plan that has been approved by an institutional review board and that specifies the exact nature of the information requested, the intended use of the information, and the reason that the research could not practicably be conducted without the information;
(b) Sign a confidentiality agreement with the Florida Center for Brain Tumor Research;
(c) Maintain the confidentiality of the information received; and
(d) To the extent permitted by law and after the research has concluded, destroy any confidential information obtained.
(1) The Institutional Review Board is created within the Department of Health in order to satisfy federal requirements under 45 C.F.R. part 46 and 21 C.F.R. parts 50 and 56 that an institutional review board review all biomedical and behavioral research on human subjects which is funded or supported in any manner by the department.
(2) Consistent with federal requirements, the State Surgeon General shall determine and appoint the membership of the board and designate its chair.
(3) The department’s Institutional Review Board may serve as an institutional review board for other agencies at the discretion of the State Surgeon General.
(4) Each board member is entitled to reimbursement for per diem and travel expenses as provided in s. 112.061 while carrying out the official business of the board.
(5) The department shall charge for costs it incurs for the research oversight it provides according to a fee schedule, except that fees shall be waived for any student who is a candidate for a degree at a university located in this state. The fee schedule shall provide fees for initial review, amendments, and continuing review. The department may adopt any rules necessary to comply with federal requirements and this section. The rules must also prescribe procedures for submitting an application for the Institutional Review Board’s review.
381.875 Enhanced potential pandemic pathogen research prohibited.—
(1) As used in this section, the term:
(a) “Enhanced potential pandemic pathogen” means a potential pandemic pathogen that results from enhancing the transmissibility or virulence of a pathogen. The term does not include naturally occurring pathogens circulating in or recovered from nature, regardless of their pandemic potential.
(b) “Enhanced potential pandemic pathogen research” means research that may be reasonably anticipated to create, transfer, or use potential pandemic pathogens that result from enhancing a pathogen’s transmissibility or virulence in humans.
(c) “Potential pandemic pathogen” means a bacterium, virus, or other microorganism that is likely to be both:
1. Highly transmissible and capable of wide, uncontrollable spread in human populations; and
2. Highly virulent, making it likely to cause significant morbidity or mortality in humans.
(2) Any research that is reasonably likely to create an enhanced potential pandemic pathogen or that has been determined by the United States Department of Health and Human Services, another federal agency, or a state agency as defined in s. 11.45 to create such a pathogen is prohibited in this state.
(3) Any researcher applying for state or local funding to conduct research in this state must disclose in the application to the funding source whether the research meets the definition of enhanced potential pandemic pathogen research.
(4) The Department of Health shall exercise its authority under s. 381.0012 to enjoin violations of this section.
(5) This section does not affect research funded or conducted before May 11, 2023.
(1) This section and s. 381.885 may be cited as the “Emergency Allergy Treatment Act.”
(2) As used in this section and s. 381.885, the term:
(a) “Administer” means to directly apply an epinephrine auto-injector to the body of an individual.
(b) “Authorized entity” means an entity or organization at or in connection with which allergens capable of causing a severe allergic reaction may be present. The term includes, but is not limited to, restaurants, recreation camps, youth sports leagues, theme parks and resorts, and sports arenas. However, a school as described in s. 1002.20(3)(i) or s. 1002.42(17)(b) is an authorized entity for the purposes of s. 381.885(4) and (5) only.
(c) “Authorized health care practitioner” means a licensed practitioner authorized by the laws of the state to prescribe drugs or certified as an emergency medical technician, trained in accordance with applicable certification requirements, and currently employed by an organized first-response agency or a licensed ambulance service.
(d) “Department” means the Department of Health.
(e) “Epinephrine auto-injector” means a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body.
(f) “Self-administration” means an individual’s discretionary administration of an epinephrine auto-injector on herself or himself.
(3) The purpose of this section is to provide for the certification of persons who administer lifesaving treatment to persons who have severe allergic reactions when a physician is not immediately available.
(4) The department may:
(a) Adopt rules necessary to administer this section.
(b) Conduct educational training programs as described in subsection (5) and approve programs conducted by other persons or governmental agencies.
(c) Issue and renew certificates of training to persons who have complied with this section and the rules adopted by the department.
(d) Collect fees necessary to administer this section.
(5) Educational training programs required by this section must be conducted by a nationally recognized organization experienced in training laypersons in emergency health treatment or an entity or individual approved by the department. The curriculum must include at a minimum:
(a) Recognition of the symptoms of systemic reactions to food, insect stings, and other allergens; and
(b) The proper administration of an epinephrine auto-injector.
(6) A certificate of training may be given to a person who:
(a) Is 18 years of age or older;
(b) Has, or reasonably expects to have, responsibility for or contact with at least one other person as a result of his or her occupational or volunteer status, including, but not limited to, a camp counselor, scout leader, school teacher, forest ranger, tour guide, or chaperone; and
(c) Has successfully completed an educational training program as described in subsection (5) or holds a current state emergency medical technician certification with evidence of training in the recognition of a severe allergic reaction and the administration of an epinephrine auto-injector.
(7) A person who successfully completes an educational training program may obtain a certificate upon payment of an application fee of $25.
(8) A certificate issued pursuant to this section authorizes the holder to receive, upon presentment of the certificate, a prescription for epinephrine auto-injectors from an authorized health care practitioner or the department. The certificate also authorizes the holder, in an emergency situation when a physician is not immediately available, to possess and administer a prescribed epinephrine auto-injector to a person experiencing a severe allergic reaction.
(1) PRESCRIBING TO AN AUTHORIZED ENTITY.—An authorized health care practitioner may prescribe epinephrine auto-injectors in the name of an authorized entity for use in accordance with this section, and pharmacists may dispense epinephrine auto-injectors pursuant to a prescription issued in the name of an authorized entity.
(2) MAINTENANCE OF SUPPLY.—An authorized entity may acquire and stock a supply of epinephrine auto-injectors pursuant to a prescription issued in accordance with this section. Such epinephrine auto-injectors must be stored in accordance with the epinephrine auto-injector’s instructions for use and with any additional requirements that may be established by the department. An authorized entity shall designate employees or agents who hold a certificate issued pursuant to s. 381.88 to be responsible for the storage, maintenance, and general oversight of epinephrine auto-injectors acquired by the authorized entity.
(3) USE OF EPINEPHRINE AUTO-INJECTORS.—An individual who holds a certificate issued pursuant to s. 381.88 may, on the premises of or in connection with the authorized entity, use epinephrine auto-injectors prescribed pursuant to subsection (1) to:
(a) Provide an epinephrine auto-injector to a person who the certified individual in good faith believes is experiencing a severe allergic reaction for that person’s immediate self-administration, regardless of whether the person has a prescription for an epinephrine auto-injector or has previously been diagnosed with an allergy.
(b) Administer an epinephrine auto-injector to a person who the certified individual in good faith believes is experiencing a severe allergic reaction, regardless of whether the person has a prescription for an epinephrine auto-injector or has previously been diagnosed with an allergy.
(4) EXPANDED AVAILABILITY.—An authorized entity that acquires a stock supply of epinephrine auto-injectors pursuant to a prescription issued by an authorized health care practitioner in accordance with this section may make the auto-injectors available to individuals other than certified individuals identified in subsection (3) who may administer the auto-injector to a person believed in good faith to be experiencing a severe allergic reaction if the epinephrine auto-injectors are stored in a locked, secure container and are made available only upon remote authorization by an authorized health care practitioner after consultation with the authorized health care practitioner by audio, televideo, or other similar means of electronic communication. Consultation with an authorized health care practitioner for this purpose is not considered the practice of telemedicine or otherwise construed as violating any law or rule regulating the authorized health care practitioner’s professional practice.
(5) IMMUNITY FROM LIABILITY.—Any person, as defined under s. 1.01, including an authorized health care practitioner, a dispensing health care practitioner or pharmacist, an individual trainer under s. 381.88(5), and a person certified pursuant to s. 381.88(7), who possesses, administers, or stores an epinephrine auto-injector in compliance with this act, and an uncertified person who administers an epinephrine auto-injector as authorized under subsection (4) in compliance with this act, is afforded the civil liability immunity protections provided under s. 768.13.
381.887 Emergency treatment for suspected opioid overdose.—
(1) As used in this section, the term:
(a) “Administer” or “administration” means to introduce an emergency opioid antagonist into the body of a person.
(b) “Authorized health care practitioner” means a licensed practitioner authorized by the laws of this state to prescribe or dispense drugs.
(c) “Caregiver” means a family member, friend, or person in a position to have contact with a person at risk of experiencing an opioid overdose.
(d) “Emergency opioid antagonist” means naloxone hydrochloride or any similarly acting drug that blocks the effects of opioids administered from outside the body and that is approved by the United States Food and Drug Administration for the treatment of an opioid overdose.
(e) “Patient” means a person at risk of experiencing an opioid overdose.
(2) The purpose of this section is to provide for the prescribing, ordering, and dispensing of emergency opioid antagonists to patients and caregivers and to encourage the prescribing, ordering, and dispensing of emergency opioid antagonists by authorized health care practitioners.
(3)(a) An authorized health care practitioner may prescribe and dispense an emergency opioid antagonist to, and a pharmacist may order an emergency opioid antagonist with an autoinjection delivery system, a prefilled injection device delivery system, or an intranasal application delivery system for, a patient or caregiver for use in accordance with this section.
(b) A pharmacist may dispense an emergency opioid antagonist pursuant to a prescription by an authorized health care practitioner. A pharmacist may dispense an emergency opioid antagonist with an autoinjection delivery system, a prefilled injection device delivery system, or an intranasal application delivery system, which must be appropriately labeled with instructions for use, pursuant to a pharmacist’s order or pursuant to a nonpatient-specific standing order.
(c) A patient or caregiver is authorized to store and possess approved emergency opioid antagonists and, in an emergency situation when a physician is not immediately available, administer the emergency opioid antagonist to a person believed in good faith to be experiencing an opioid overdose, regardless of whether that person has a prescription for an emergency opioid antagonist.
(4) The following persons are authorized to possess, store, and administer emergency opioid antagonists as clinically indicated and are immune from any civil liability or criminal liability as a result of administering an emergency opioid antagonist:
(a) Emergency responders, including, but not limited to, law enforcement officers, paramedics, and emergency medical technicians.
(b) Crime laboratory personnel for the statewide criminal analysis laboratory system as described in s. 943.32, including, but not limited to, analysts, evidence intake personnel, and their supervisors.
(c) Personnel of a law enforcement agency or an other agency, including, but not limited to, correctional probation officers and child protective investigators who, while acting within the scope or course of employment, come into contact with a controlled substance or persons at risk of experiencing an opioid overdose.
(d) Personnel of the Department of Juvenile Justice and of any contracted provider with direct contact with youth authorized under chapters 984 and 985.
(5) A person, including, but not limited to, an authorized health care practitioner, a dispensing health care practitioner, or a pharmacist, who possesses, administers, prescribes, dispenses, or stores an approved emergency opioid antagonist in compliance with this section and s. 768.13 is afforded the civil liability immunity protections provided under s. 768.13.
(6)(a) An authorized health care practitioner, acting in good faith and exercising reasonable care, is not subject to discipline or other adverse action under any professional licensure statute or rule and is immune from any civil or criminal liability as a result of prescribing an emergency opioid antagonist in accordance with this section.
(b) A dispensing health care practitioner or pharmacist, acting in good faith and exercising reasonable care, is not subject to discipline or other adverse action under any professional licensure statute or rule and is immune from any civil or criminal liability as a result of dispensing an emergency opioid antagonist in accordance with this section.
(7) This section does not limit any existing immunities for emergency responders or other persons which are provided under this chapter or any other applicable provision of law. This section does not create a duty or standard of care for a person to prescribe or administer an emergency opioid antagonist.
(a) “Tanning facility” means a place of business which provides access to a tanning device by customers.
(b) “Department” means the Department of Health.
(c) “Tanning device” means equipment that emits electromagnetic radiation of wavelengths between 200 and 400 nanometers and that is used for tanning the skin, including a sunlamp, tanning booth, or tanning bed or any accompanying equipment.
(2) This section does not apply to a tanning facility that uses only phototherapy devices that emit ultraviolet radiation which are used only by or under the direct supervision of a physician licensed under chapter 458 or an osteopathic physician licensed under chapter 459.
(3)(a) A person may not operate a tanning facility unless it is licensed under this section.
(b) The department shall establish procedures for the issuance and annual renewal of licenses and shall establish annual license and renewal fees and late-payment fees in an amount necessary to cover the expenses of administering this section. Annual license and renewal fees may not be more than $250 per tanning device, and a maximum total fee per individual tanning facility may be set by rule.
(c) The department may adopt a system under which licenses expire on staggered dates and the annual renewal fees are prorated quarterly to reflect the actual number of months the license is valid.
(d) The department may cancel, revoke, or suspend a license to operate a tanning facility if the licensee:
1. Fails to pay any fee required by this section;
2. Obtains or attempts to obtain a license by fraud; or
3. Violates a provision of this section.
(4)(a) A tanning facility must give each customer a written warning that states that:
1. Not wearing the provided eye protection can cause damage to the eyes.
2. Overexposure causes burns.
3. Repeated exposure can cause premature aging of the skin or skin cancer.
4. Abnormal skin sensitivity or burning may be caused by certain foods, cosmetics, or medications, including, without limitation, tranquilizers, diuretics, antibiotics, high blood pressure medicines, or birth control pills.
5. Any person who takes a prescription or over-the-counter medication should consult a physician before using a tanning device.
6. It does not carry liability insurance for injuries caused by tanning devices or states the limits of any liability insurance it carries.
(b) A tanning facility must have a copy of the facility’s most recent inspection report available to the public and must post a warning sign in any area where a tanning device is used. Posting this sign does not absolve the facility of any liability. The sign must state:
DANGER, ULTRAVIOLET RADIATION
Follow these instructions:
1. Avoid frequent or lengthy exposure. As with natural sunlight, exposure can cause eye and skin injury or allergic reactions. Repeated exposure can cause chronic sun damage characterized by wrinkling, dryness, fragility and bruising of the skin or skin cancer.
2. Wear protective eyewear. FAILURE TO USE PROTECTIVE EYEWEAR CAN RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES.
3. Ultraviolet radiation from sunlamps will aggravate the effects of the sun. Therefore, do not sunbathe before or after exposure to ultraviolet radiation.
4. Using medications or cosmetics can increase your sensitivity to ultraviolet radiation. Consult a physician before using a sunlamp if you are using medications, have a history of skin problems, or believe you are especially sensitive to sunlight. Women who are pregnant or on birth control who use this product can develop discolored skin. IF YOU DO NOT TAN IN THE SUN YOU WILL NOT TAN BY USING THIS DEVICE.
(5) A tanning facility may not claim or distribute promotional materials that claim a tanning device is safe or free from risk.
(6) A tanning facility must:
(a) During operating hours, have an operator present who is sufficiently knowledgeable and trained in accordance with rules of the department in the correct operation of the tanning devices to inform and assist each customer in the proper use of the devices.
(b) Before each use of a tanning device:
1. Properly sanitize that tanning device equipment, including, without limitation, handrails, headrests, and bed surfaces; and
2. Provide a customer with properly sanitized protective eyewear that protects the eye from ultraviolet radiation and allows adequate vision to maintain balance.
(c) Show each customer how to use suitable physical aids, such as handrails and floor markings, to maintain proper exposure distances recommended by the manufacturer.
(d) Use a timer on each tanning device which is accurate for any selected time interval to plus or minus 10 percent.
(e) Limit each customer to the maximum exposure time recommended by the manufacturer of the tanning device.
(f) Maintain the interior temperature of the tanning facility below 100 °F.
(g) Each time a person uses a tanning facility or executes or renews a contract to use a tanning facility, have the person sign a written statement acknowledging that he or she has read and understands the warnings before using the device and that he or she agrees to use the protective eyewear.
(h) Display its license in a public area of the tanning facility.
(i) Report any injury or any complaint of injury to the department on forms prescribed by the department and provide a copy of the report to the complainant. The department shall send to the federal Food and Drug Administration a copy of any report of an injury occurring in a tanning facility.
(j) Keep a record, for a period of not less than 4 years, of each customer’s use of a tanning device.
(7) A tanning facility may not allow a minor between the ages of 14 and 18 to use a tanning device unless it has on file a statement signed by the minor’s parent or legal guardian stating that the parent or legal guardian has read and understands the warnings given by the tanning facility, consents to the minor’s use of a tanning device, and agrees that the minor will use the provided protective eyewear.
(8) A minor under the age of 14 must be accompanied by a parent or legal guardian when using a tanning device.
(9) The department shall inspect or investigate a tanning facility as necessary but at least annually.
(10) PENALTIES.—
(a) Each of the following acts constitutes a felony of the third degree, punishable as provided in s. 775.082 or s. 775.083:
1. Owning or operating, or soliciting business as, a tanning facility in this state without first procuring a license from the department, unless specifically exempted by this section.
2. Obtaining or attempting to obtain a license by means of fraud, misrepresentation, or concealment.
(b) Each of the following acts constitutes a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083:
1. Failing to maintain the records required by this section or knowingly making false entries in such records.
2. Failing to comply with subsection (7) or subsection (8).
(c) The court may, in addition to other punishment provided for, suspend or revoke the license of any licensee under this section who has been found guilty of any violation listed in paragraph (a) or paragraph (b).
(d) In the event the department or any state attorney shall have probable cause to believe that a tanning facility or other person has violated any provision of paragraph (a), an action may be brought by the department or any state attorney to enjoin such tanning facility or any person from continuing such violation, or engaging therein or doing any acts in furtherance thereof, and for such other relief as to the court seems appropriate.
(11)(a) The department may impose an administrative fine not to exceed $1,000 per violation per day, for the violation of any provision of this section, rule adopted under this section, or term or condition of any license issued by the department.
(b) In determining the amount of fine to be levied for a violation, as provided in paragraph (a), the following factors shall be considered:
1. The severity of the violation and the extent to which the provisions of this act, the rules adopted under this act, or any terms or conditions of any license were violated.
2. Actions taken by the licensee to correct the violation.
3. Any previous violations by the licensee.
(12) The department may institute legal action for injunctive or other relief to enforce this section. If a tanning facility or other person violates this section or any rule adopted under this section, the department may issue a stop-use order, as prescribed by rule, to remove a tanning device from service.
(13) The department shall adopt rules to administer this section. The rules may include, but need not be limited to, requirements for training tanning facility operators and employees; definitions of terms; the approval of training courses; safety; plan review; and the design, construction, operation, maintenance, and cleanliness of tanning facilities and tanning devices.
381.895 Standards for compressed air used for recreational diving.—
(1) The Department of Health shall establish maximum allowable levels for contaminants in compressed air used for recreational sport diving in this state. In developing the standards, the department must take into consideration the levels of contaminants allowed by the Grade “E” Recreational Diving Standards of the Compressed Gas Association.
(2) The standards prescribed under this section do not apply to:
(a) Any person providing compressed air for his or her own use.
(b) Any governmental entity using a governmentally owned compressed air source for work related to the governmental entity.
(c) Foreign registered vessels upon which a compressor is used to provide compressed air for work related to the operation of the vessel.
(3) A person or entity that, for compensation, provides compressed air for recreational sport diving in this state, including compressed air provided as part of a dive package of equipment rental, dive boat rental, or dive boat charter, must ensure that the compressed air is tested quarterly by a laboratory that is accredited by either the American Industrial Hygiene Association or the American Association for Laboratory Accreditation and that the results of such tests are provided quarterly to the Department of Health. In addition, the person or entity must post the certificate issued by the laboratory accredited by the American Industrial Hygiene Association or the American Association for Laboratory Accreditation in a conspicuous location where it can readily be seen by any person purchasing compressed air.
(4) The Department of Health shall maintain a record of all quarterly test results provided under this section.
(5) It is a misdemeanor of the second degree for any person or entity to provide, for compensation, compressed air for recreational sport diving in this state, including compressed air provided as part of a dive package of equipment rental, dive boat rental, or dive boat charter, without:
(a) Having received a valid certificate issued by a laboratory accredited by the American Industrial Hygiene Association or the American Association for Laboratory Accreditation which certifies that the compressed air meets the standards for contaminant levels established by the Department of Health.
(b) Posting the certificate issued by a laboratory accredited by the American Industrial Hygiene Association or the American Association for Laboratory Accreditation in a conspicuous location where it can readily be seen by persons purchasing compressed air.
(6) The department shall adopt rules necessary to carry out the provisions of this section, which must include:
(a) Maximum allowable levels of contaminants in compressed air used for sport diving.
(b) Procedures for the submission of test results to the department.
(1) It is the intent of the Legislature to create a community faith-based disease-prevention program in conjunction with the Health Choice Network and other community health centers to build upon the natural referral and education networks in place within minority communities and to increase access to health service delivery in Florida and establish a funding source to build upon local private participation to sustain the operation of the program.
(2)(a) There is created the Jessie Trice Cancer Prevention Program, to be located, for administrative purposes, within the Department of Health, and operated from the community health centers within the Health Choice Network in Florida.
(b) Funding may be provided to develop contracts with community health centers and local community faith-based education programs to provide cancer screening, diagnosis, education, and treatment services to low-income populations throughout the state.
(1) The purpose of this program is to provide statewide outreach, promote prostate cancer awareness, communicate the advantages of early detection, report recent progress in prostate cancer research and the availability of clinical trials, minimize health disparities through outreach and education, communicate best practices principles to physicians involved in the care of prostate cancer patients, and establish a communication platform for patients and their advocates.
(2) For purposes of implementing the program, the University of Florida Prostate Disease Center may work with other agencies, organizations, and institutions to create a systematic approach to community education and increase public awareness regarding prostate cancer by:
(a) Conducting activities directly or entering into a contract with qualified nonprofit community education entities.
(b) Seeking any available gifts, private grants, or funds from the Federal Government, philanthropic foundations, and industry or business groups.
(3) The University of Florida Prostate Disease Center (UFPDC) shall establish the UFPDC Prostate Cancer Advisory Council and lead the advisory council in developing and implementing strategies to improve outreach and education and thereby reduce the number of patients who develop prostate cancer.
(a) The executive director of the University of Florida Prostate Disease Center shall appoint, in consultation with the Department of Health’s Comprehensive Cancer Control Program and the State Surgeon General, a geographically and institutionally diverse advisory council, which shall consist of:
1. Two persons from prostate cancer survivor groups or cancer-related advocacy groups.
2. Four persons, one of whom is a physician licensed under chapter 458, one of whom is a physician licensed under chapter 459, one of whom is a scientist, and one of whom is the executive director of the University of Florida Prostate Disease Center or a designee.
3. Three persons who are engaged in the practice of a cancer-related medical specialty from health organizations committed to cancer research and control.
(b) Members shall serve as volunteers without compensation.
(c) Each member of the advisory council shall be appointed to a 4-year term; however, for the purpose of providing staggered terms, of the initial appointments, four members shall be appointed to 2-year terms and four members shall be appointed to 4-year terms. The remaining seat shall be filled by the executive director of the University of Florida Prostate Disease Center or a designee.
(d) The advisory council shall meet annually and at other times at the call of the executive director of the University of Florida Prostate Disease Center or by a majority vote of the members of the advisory council.
(e) Five of the members of the advisory council constitute a quorum, and an affirmative vote of a majority of the members present is required for final action.
(f) The advisory council shall:
1. Present prostate-cancer-related policy recommendations to the Department of Health and other appropriate governmental entities.
2. Assess the accuracy of prostate cancer information disseminated to the public.
3. Develop effective communication channels among all private and public entities in the state involved in prostate cancer education, research, treatment, and patient advocacy.
4. Plan, develop, and implement activities designed to heighten awareness and educate residents of the state, especially those in underserved areas, regarding the importance of prostate cancer awareness.
5. Disseminate information about recent progress in prostate cancer research and the availability of clinical trials.
6. Minimize health disparities through outreach and education.
7. Communicate best practices principles to physicians involved in the care of patients with prostate cancer.
8. Establish a communication platform for patients and their advocates.
9. Solicit private grants or philanthropic funding to conduct an annual prostate cancer symposium that brings physicians, researchers, community leaders, prostate cancer survivors, and prostate cancer advocates together to highlight recent advances in prostate cancer research, clinical trials, and best practices used for the prevention of prostate cancer and to promote strategies for successful rural and urban outreach, community education, and increased awareness.
10. Submit and present an annual report to the Governor, the President of the Senate, the Speaker of the House of Representatives, and the State Surgeon General by January 15 of each year, which contains recommendations for legislative changes necessary to decrease the incidence of prostate cancer, decrease racial and ethnic disparities among persons diagnosed with prostate cancer, and promote increased community education and awareness regarding this disease.
(4) The University of Florida Prostate Disease Center (UFPDC) and the UFPDC Prostate Cancer Advisory Council shall be funded within existing resources of the university.
(1) This section may be cited as the “Casey DeSantis Cancer Research Act.”
(2) The Casey DeSantis Cancer Research Program is established to enhance the quality and competitiveness of cancer care in this state, further a statewide biomedical research strategy directly responsive to the health needs of Florida’s citizens, capitalize on the potential educational opportunities available to its students, and promote the provision of high-quality, innovative health care for persons undergoing cancer treatment in this state. The department shall:
(a) Make payments to cancer centers recognized by the National Cancer Institute (NCI) at the National Institutes of Health as NCI-designated cancer centers or NCI-designated comprehensive cancer centers, and cancer centers working toward achieving NCI designation. The department shall distribute funds to participating cancer centers on a quarterly basis during each fiscal year for which an appropriation is made.
(b) Make cancer innovation grant funding available through the Cancer Innovation Fund under subsection (9) to health care providers and facilities that demonstrate excellence in patient-centered cancer treatment or research.
(3) On or before September 15 of each year, the department shall calculate an allocation fraction to be used for distributing funds to participating cancer centers. On or before the final business day of each quarter of the state fiscal year, the department shall distribute to each participating cancer center one-fourth of that cancer center’s annual allocation calculated under subsection (6). The allocation fraction for each participating cancer center is based on the cancer center’s tier-designated weight under subsection (4) multiplied by each of the following allocation factors based on activities in this state: number of reportable cases, peer-review costs, and biomedical education and training. As used in this section, the term:
(a) “Biomedical education and training” means instruction that is offered to a student who is enrolled in a biomedical research program at an affiliated university as a medical student or a student in a master’s or doctoral degree program, or who is a resident physician trainee or postdoctoral trainee in such program. An affiliated university biomedical research program must be accredited or approved by a nationally recognized agency and offered through an institution accredited by an accrediting agency or association recognized by the database created and maintained by the United States Department of Education. Full-time equivalency for trainees shall be prorated for training received in oncologic sciences and oncologic medicine.
(b) “Cancer center” means a comprehensive center with at least one geographic site in the state, a freestanding center located in the state, a center situated within an academic institution, or a Florida-based formal research-based consortium under centralized leadership that has achieved NCI designation or is prepared to achieve NCI designation by June 30, 2024.
(c) “Florida-based” means that a cancer center’s actual or sought designated status is or would be recognized by the NCI as primarily located in Florida and not in another state.
(d) “Peer-review costs” means the total annual direct costs for peer-reviewed cancer-related research projects, consistent with reporting guidelines provided by the NCI, for the most recent annual reporting period available.
(e) “Reportable cases” means cases of cancer in which a cancer center is involved in the diagnosis, evaluation of the diagnosis, evaluation of the extent of cancer spread at the time of diagnosis, or administration of all or any part of the first course of therapy for the most recent annual reporting period available. Cases relating to patients enrolled in institutional or investigator-initiated interventional clinical trials shall be weighted at 1.2 relative to other cases weighted at 1.0. Determination of institutional or investigator-initiated interventional clinical trials must be consistent with reporting guidelines provided by the NCI.
(4) Tier designations and corresponding weights within the Casey DeSantis Cancer Research Program are as follows:
(a) Tier 1: NCI-designated comprehensive cancer centers, which shall be weighted at 1.5.
(b) Tier 2: NCI-designated cancer centers, which shall be weighted at 1.25.
(c) Tier 3: Cancer centers seeking designation as either a NCI-designated cancer center or NCI-designated comprehensive cancer center, which shall be weighted at 1.0.
1. A cancer center shall meet the following minimum criteria to be considered eligible for Tier 3 designation in any given fiscal year:
a. Conducting cancer-related basic scientific research and cancer-related population scientific research;
b. Offering and providing the full range of diagnostic and treatment services on site, as determined by the Commission on Cancer of the American College of Surgeons;
c. Hosting or conducting cancer-related interventional clinical trials that are registered with the NCI’s Clinical Trials Reporting Program;
d. Offering degree-granting programs or affiliating with universities through degree-granting programs accredited or approved by a nationally recognized agency and offered through the center or through the center in conjunction with another institution accredited by an accrediting agency or association recognized by the database created and maintained by the United States Department of Education;
e. Providing training to clinical trainees, medical trainees accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association, and postdoctoral fellows recently awarded a doctorate degree; and
f. Having more than $5 million in annual direct costs associated with their total NCI peer-reviewed grant funding.
2. The General Appropriations Act or accompanying legislation may limit the number of cancer centers which shall receive Tier 3 designations or provide additional criteria for such designation.
3. A cancer center’s participation in Tier 3 may not extend beyond June 30, 2024.
4. A cancer center that qualifies as a designated Tier 3 center under the criteria provided in subparagraph 1. by July 1, 2014, is authorized to pursue NCI designation as a cancer center or a comprehensive cancer center until June 30, 2024.
(5) The department shall use the following formula to calculate a participating cancer center’s allocation fraction:
CAF = [0.4 x (CRC÷TCRC)]+[0.3 x (CPC÷TCPC)]+[0.3 x (CBE÷TCBE)]
Where:
CAF = A cancer center’s allocation fraction.
CRC = A cancer center’s tier-weighted reportable cases.
TCRC = The total tier-weighted reportable cases for all cancer centers.
CPC = A cancer center’s tier-weighted peer-review costs.
TCPC = The total tier-weighted peer-review costs for all cancer centers.
CBE = A cancer center’s tier-weighted biomedical education and training.
TCBE = The total tier-weighted biomedical education and training for all cancer centers.
(6) A cancer center’s annual allocation shall be calculated by multiplying the funds appropriated for the Casey DeSantis Cancer Research Program in the General Appropriations Act by that cancer center’s allocation fraction. If the calculation results in an annual allocation that is less than $16 million, that cancer center’s annual allocation shall be increased to a sum equaling $16 million, with the additional funds being provided proportionally from the annual allocations calculated for the other participating cancer centers.
(7) The amount of $37,771,257 from the total funds appropriated in the General Appropriations Act for the Casey DeSantis Cancer Research Program shall be excluded from the annual allocation fraction calculation under subsection (5). The excluded amount shall be distributed to participating cancer centers in the same proportion as determined by the allocation fraction calculation.
(8) The Cancer Connect Collaborative, a council as defined in s. 20.03, is created within the department to advise the department and the Legislature on developing a holistic approach to the state’s efforts to fund cancer research, cancer facilities, and treatments for cancer patients. The collaborative may make recommendations on proposed legislation, proposed rules, best practices, data collection and reporting, issuance of grant funds, and other proposals for state policy relating to cancer research or treatment.
(a) The Surgeon General shall serve as an ex officio, nonvoting member and shall serve as the chair.
(b) The collaborative shall be composed of the following voting members, to be appointed by September 1, 2024:
1. Two members appointed by the Governor, one member appointed by the President of the Senate, and one member appointed by the Speaker of the House of Representatives, based on the criteria of this subparagraph. The appointing officers shall make their appointments prioritizing members who have the following experience or expertise:
a. The practice of a health care profession specializing in oncology clinical care or research;
b. The development of preventive and therapeutic treatments to control cancer;
c. The development of innovative research into the causes of cancer, the development of effective treatments for persons with cancer, or cures for cancer; or
d. Management-level experience with a cancer center licensed under chapter 395.
2. One member who is a resident of this state who can represent the interests of cancer patients in this state, appointed by the Governor.
(c) The terms of appointees under paragraph (b) shall be for 2 years unless otherwise specified. However, to achieve staggered terms, the initial appointees under that paragraph shall serve 3 years for their first term. These appointees may be reappointed for no more than four consecutive terms.
(d) Any vacancy occurring on the collaborative must be filled in the same manner as the original appointment. Any member who is appointed to fill a vacancy occurring because of death, resignation, or ineligibility for membership shall serve only for the unexpired term of the member’s predecessor.
(e) Members whose terms have expired may continue to serve until replaced or reappointed, but for no more than 6 months after the expiration of their terms.
(f) Members shall serve without compensation but are entitled to reimbursement for per diem and travel expenses pursuant to s. 112.061.
(g) The collaborative shall meet as necessary, but at least quarterly, at the call of the chair. A majority of the members of the collaborative constitutes a quorum, and a meeting may not be held with less than a quorum present. In order to establish a quorum, the collaborative may conduct its meetings through teleconference or other electronic means. The affirmative vote of a majority of the members of the collaborative present is necessary for any official action by the collaborative.
(h) The collaborative shall develop a long-range comprehensive plan for the Casey DeSantis Cancer Research Program. In the development of the plan, the collaborative must solicit input from cancer centers, research institutions, biomedical education institutions, hospitals, and medical providers. The collaborative shall submit the plan to the Governor, the President of the Senate, and the Speaker of the House of Representatives no later than December 1, 2024. The plan must include, but need not be limited to, all of the following components:
1. Expansion of grant fund opportunities to include a broader pool of Florida-based cancer centers, research institutions, biomedical education institutions, hospitals, and medical providers to receive funding through the Cancer Innovation Fund.
2. An evaluation to determine metrics that focus on patient outcomes, quality of care, and efficacy of treatment.
3. A compilation of best practices relating to cancer research or treatment.
(i) The department shall provide reasonable and necessary support staff and materials to assist the collaborative in the performance of its duties.
(j)1. As used in this paragraph, the term “proprietary business information” means information that:
a. Is owned or controlled by the applicant;
b. Is intended to be private and is treated by the applicant as private;
c. Has not been disclosed except as required by law or a private agreement that provides that the information will not be released to the public;
d. Is not readily available or ascertainable through proper means from another source in the same configuration as received by the collaborative;
e. Affects competitive interests, and the disclosure of such information would impair the competitive advantage of the applicant; and
f. Is explicitly identified or clearly marked as proprietary business information.
2. Proprietary business information held by the department or the collaborative is confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution. This exemption does not apply to information contained in final recommendations of the collaborative.
3. Portions of a meeting of the collaborative during which confidential and exempt proprietary business information is discussed are exempt from s. 286.011 and s. 24(b), Art. I of the State Constitution. The closed portion of a meeting must be recorded, and the recording must be maintained by the collaborative. The recording is confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
4.a. Proprietary business information made confidential and exempt under subparagraph 2. may be disclosed with the express written consent of the applicant to whom the information pertains, or the applicant’s legally authorized representative, or pursuant to a court order upon a showing of good cause.
b. Recordings of those portions of exempt meetings which are made confidential and exempt under subparagraph 3. may be disclosed to the department or pursuant to a court order upon a showing of good cause.
5. This paragraph is subject to the Open Government Sunset Review Act in accordance with s. 119.15 and shall stand repealed on October 2, 2029, unless reviewed and saved from repeal through reenactment by the Legislature.
(9) The collaborative shall advise the department on the awarding of grants issued through the Cancer Innovation Fund. During any fiscal year for which funds are appropriated to the fund, the collaborative shall review all submitted grant applications and make recommendations to the department for awarding grants to support innovative cancer research and treatment models, including emerging research and treatment trends and promising treatments that may serve as catalysts for further research and treatments. The department shall make the final grant allocation awards. The collaborative shall give priority to applications seeking to expand the reach of innovative cancer treatment models into underserved areas of this state.
(10) Beginning July 1, 2025, and each year thereafter, the department, in conjunction with participating cancer centers, shall submit a report to the Cancer Control and Research Advisory Council and the collaborative on specific metrics relating to cancer mortality and external funding for cancer-related research in this state. If a cancer center does not endorse this report or produce an equivalent independent report, the cancer center is ineligible to receive program funding for 1 year. The department must submit this annual report, and any equivalent independent reports, to the Governor, the President of the Senate, and the Speaker of the House of Representatives no later than September 15 of each year the report or reports are submitted by the department. The report must include:
(a) An analysis of trending age-adjusted cancer mortality rates in the state, which must include, at a minimum, overall age-adjusted mortality rates for cancer statewide and age-adjusted mortality rates by age group, geographic region, and type of cancer, which must include, at a minimum:
1. Lung cancer.
2. Pancreatic cancer.
3. Sarcoma.
4. Melanoma.
5. Leukemia and myelodysplastic syndromes.
6. Brain cancer.
7. Breast cancer.
(b) Identification of trends in overall federal funding, broken down by institutional source, for cancer-related research in the state.
(c) A list and narrative description of interinstitutional collaboration among participating cancer centers, which may include grants received by participating cancer centers in collaboration, a comparison of such grants in proportion to the grant totals for each cancer center, a catalog of retreats and progress seed grants using state funds, and targets for collaboration in the future and reports on progress regarding such targets where appropriate.
(11) Beginning July 1, 2024, each allocation agreement issued by the department relating to cancer center payments under subsection (2) must include all of the following:
(a) A line-item budget narrative documenting the annual allocation of funds to a cancer center.
(b) A cap on the annual award of 15 percent for administrative expenses.
(c) A requirement for the cancer center to submit quarterly reports of all expenditures made by the cancer center with funds received through the Casey DeSantis Cancer Research Program.
(d) A provision to allow the department and other state auditing bodies to audit all financial records, supporting documents, statistical records, and any other documents pertinent to the allocation agreement.
(e) A provision requiring the annual reporting of outcome data and protocols used in achieving those outcomes.
(12) This section is subject to annual appropriation by the Legislature.
(13) The department may adopt rules to administer this section.
381.922 William G. “Bill” Bankhead, Jr., and David Coley Cancer Research Program.—
(1) The William G. “Bill” Bankhead, Jr., and David Coley Cancer Research Program, which may be otherwise cited as the “Bankhead-Coley Program,” is created within the Department of Health. The purpose of the program shall be to advance progress towards cures for cancer through grants awarded through a peer-reviewed, competitive process.
(2) The program shall provide grants for cancer research to further the search for cures for cancer.
(a) Emphasis shall be given to the following goals, as those goals support the advancement of such cures:
1. Efforts to significantly expand cancer research capacity in the state by:
a. Identifying ways to attract new research talent and attendant national grant-producing researchers to cancer research facilities in this state;
b. Implementing a peer-reviewed, competitive process to identify and fund the best proposals to expand cancer research institutes in this state;
c. Funding through available resources for those proposals that demonstrate the greatest opportunity to attract federal research grants and private financial support;
d. Encouraging the employment of bioinformatics in order to create a cancer informatics infrastructure that enhances information and resource exchange and integration through researchers working in diverse disciplines, to facilitate the full spectrum of cancer investigations;
e. Facilitating the technical coordination, business development, and support of intellectual property as it relates to the advancement of cancer research; and
f. Aiding in other multidisciplinary research-support activities as they inure to the advancement of cancer research.
2. Efforts to improve both research and treatment through greater participation in clinical trials networks by:
a. Identifying ways to increase pediatric and adult enrollment in cancer clinical trials;
b. Supporting public and private professional education programs designed to increase the awareness and knowledge about cancer clinical trials;
c. Providing tools to cancer patients and community-based oncologists to aid in the identification of cancer clinical trials available in the state; and
d. Creating opportunities for the state’s academic cancer centers to collaborate with community-based oncologists in cancer clinical trials networks.
3. Efforts to reduce the impact of cancer on disparate groups by:
a. Identifying those cancers that disproportionately impact certain demographic groups; and
b. Building collaborations designed to reduce health disparities as they relate to cancer.
(b) Preference may be given to grant proposals that foster collaborations among institutions, researchers, and community practitioners, as such proposals support the advancement of cures through basic or applied research, including clinical trials involving cancer patients and related networks.
(c) There is established within the program the Live Like Bella Initiative. The purpose of the initiative is to advance progress toward curing pediatric cancer by awarding grants through the peer-reviewed, competitive process established under subsection (3). This paragraph is subject to the annual appropriation of funds by the Legislature.
(3)(a) Applications for funding for cancer research may be submitted by any university or established research institute in the state. All qualified investigators in the state, regardless of institutional affiliation, shall have equal access and opportunity to compete for the research funding. Collaborative proposals, including those that advance the program’s goals enumerated in subsection (2), may be given preference. Grants shall be awarded by the department, after consultation with the Biomedical Research Advisory Council, on the basis of scientific merit, as determined by the competitively open peer-reviewed process to ensure objectivity, consistency, and high quality. The following types of applications may be considered for funding:
1. Investigator-initiated research grants.
2. Institutional research grants.
3. Collaborative research grants, including those that advance the finding of cures through basic or applied research.
(b) To ensure that all proposals for research funding are appropriate and are evaluated fairly on the basis of scientific merit, the department shall appoint peer review panels of independent, scientifically qualified individuals to review the scientific merit of each proposal and establish its priority score. The priority scores shall be forwarded to the council and must be considered in determining which proposals shall be recommended for funding.
(c) The council and the peer review panels shall establish and follow rigorous guidelines for ethical conduct and adhere to a strict policy with regard to conflicts of interest. A member of the council or panel may not participate in any discussion or decision of the council or a panel with respect to a research proposal by any firm, entity, or agency with which the member is associated as a member of the governing body or as an employee or with which the member has entered into a contractual arrangement.
(4) The William G. “Bill” Bankhead, Jr., and David Coley Cancer Research Program is funded pursuant to s. 215.5602(12). Funds appropriated for the William G. “Bill” Bankhead, Jr., and David Coley Cancer Research Program shall be distributed pursuant to this section to provide grants to researchers seeking cures for cancer and cancer-related illnesses, with emphasis given to the goals enumerated in this section. From the total funds appropriated, an amount of up to 10 percent may be used for administrative expenses.
(5) The Biomedical Research Advisory Council shall submit a report relating to grants awarded under the program to the Governor, the President of the Senate, and the Speaker of the House of Representatives by December 15 each year. The report must include:
(a) For each research project supported by grants or fellowships awarded under the program:
1. A summary of the research project and results or expected results of the research.
2. The status of the research project, including whether it has concluded or the estimated date of completion.
3. The amount of the grant or fellowship awarded and the estimated or actual cost of the research project.
4. A list of principal investigators under the research project.
5. The title, citation, and summary of findings of a publication in a peer-reviewed journal resulting from the research.
6. The source and amount of any federal, state, or local government grants or donations or private grants or donations generated as a result of the research project.
7. The status of a patent, if any, generated from the research project and an economic analysis of the impact of the resulting patent.
8. A list of postsecondary educational institutions involved in the research project, a description of each postsecondary educational institution’s involvement in the research project, and the number of students receiving training or performing research under the research project.
(b) The state ranking and total amount of cancer research funding currently flowing into the state from the National Institutes of Health.
(c) Progress toward programmatic goals, particularly in the prevention, diagnosis, treatment, and cure of cancer.
(d) Recommendations to further the mission of the program.
Note.—Subparagraphs (2)(a)1.-3. former s. 381.921.
1381.92201 Exemptions from public records and public meetings requirements; peer review panels.—
(1) That portion of a meeting of a peer review panel in which applications for biomedical research grants under s. 215.5602 or s. 381.922 are discussed is exempt from s. 286.011 and s. 24(b), Art. I of the State Constitution.
(2) Any records generated by the peer review panel relating to review of applications for biomedical research grants, except final recommendations, are confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(3) Research grant applications provided to the peer review panel are confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(4) Information that is held confidential and exempt under this section may be disclosed with the express written consent of the individual to whom the information pertains or the individual’s legally authorized representative, or by court order upon showing good cause.
(1) The Legislature intends to recognize hospitals, treatment centers, and other providers in this state which demonstrate excellence in patient-centered coordinated care for persons undergoing cancer treatment and therapy in this state. The goal of this program is to encourage excellence in cancer care in this state, attract and retain the best cancer care providers to the state, and help Florida providers be recognized nationally as a preferred destination for quality cancer care. The Cancer Center of Excellence Award will recognize providers that exceed service standards and excel in providing quality, comprehensive, and patient-centered coordinated care.
(2) The Florida Cancer Control and Research Advisory Council, established in s. 1004.435, and the Biomedical Research Advisory Council, established in s. 215.5602, shall select seven members and six members, respectively, to form a joint committee.
(a) The joint committee, consisting of 13 members, shall:
1. By January 1, 2014, develop rigorous performance measures, a rating system, and a rating standard that must be achieved to document and distinguish a cancer center that excels in providing quality, comprehensive, and patient-centered coordinated care.
2. Review at least every 3 years and revise, if applicable, the performance measures, rating system, and rating standard to ensure providers are continually enhancing their programs to reflect best practices and advances in cancer treatment and care from the perspective of quality, comprehensive, and patient-centered coordinated care.
3. Submit its proposed performance measures, rating system, and rating standard to the Florida Cancer Control and Research Advisory Council and the Biomedical Research Advisory Council to be approved by both councils prior to the evaluation of any provider under such criteria.
(b) The criteria established by the joint committee must require, at a minimum, that each hospital, treatment center, or other provider:
1. Maintain a license in good standing in this state which authorizes health care services to be provided.
2. Be accredited by the Commission on Cancer of the American College of Surgeons.
3. Actively participate in at least one regional cancer control collaborative that is operating pursuant to the Florida Comprehensive Cancer Control Program’s cooperative agreement with the Centers for Disease Control and Prevention’s National Comprehensive Cancer Control Program.
4. Demonstrate excellence in and dissemination of scientifically rigorous cancer research.
5. Integrate training and education of biomedical researchers and health care professionals.
6. Meet enhanced cancer care coordination standards which, at a minimum, focus on:
a. Coordination of care by cancer specialists and nursing and allied health professionals.
b. Psychosocial assessment and services.
c. Suitable and timely referrals and followup.
d. Providing accurate and complete information on treatment options, including clinical trials, which consider each person’s needs, preferences, and resources, whether provided by that center or available through other health care providers.
e. Participation in a comprehensive network of cancer specialists of multiple disciplines, which enables the patient to consult with a variety of experts to examine treatment alternatives.
f. Family services and support.
g. Aftercare and survivor services.
h. Patient and family satisfaction survey results.
(c) The members of the joint committee shall serve without compensation but may receive reimbursement as provided in s. 112.061 for travel and other necessary expenses incurred in the performance of their official duties.
(d) The Department of Health shall provide such staff, information, and other assistance as is reasonably necessary to assist the joint committee in carrying out its responsibilities.
(3)(a) A provider may apply to the Department of Health for a Cancer Center of Excellence Award. The joint committee must develop an application form to be used by the Department of Health that requires, among other things, submission of documentation by the provider which demonstrates that the criteria in subsection (2) have been met.
(b) After January 1, 2014, the Department of Health shall annually conduct two application cycles. The applications are not applications for licensure; the grant of the award by the State Surgeon General is not final agency action; and the Cancer Center of Excellence Award program is not subject to the provisions of chapter 120.
(4)(a) The State Surgeon General shall appoint a team of independent evaluators to assess applicants to determine eligibility for the award. An application is to be evaluated independently of any other application. The team shall consist of five evaluators to be selected, in any combination, from the following:
1. No more than five health care practitioners or health care facilities not licensed in this state which provide health care services involving cancer diagnoses or treatment;
2. No more than three members from the Florida Cancer Control and Research Advisory Council;
3. No more than two members from the Biomedical Research and Advisory Council; and
4. No more than one layperson who has experience as a cancer patient or as a family member of a cancer patient if that person or his or her family member did not receive care from the applicant or providers being evaluated.
(b) Each evaluator must be independent and free of any conflict of interest with respect to a health care provider or facility licensed in this state. Each person selected to participate on the evaluation team must sign a conflict of interest attestation before being appointed to the evaluation team.
(5)(a) Two evaluation team members may, as necessary, conduct an onsite evaluation to verify submitted application documentation.
(b) Each member on the evaluation team shall report to the State Surgeon General those applicants that achieved or exceeded the required score based on the rating system developed in subsection (2) which demonstrates the cancer center excels in providing quality, comprehensive, and patient-centered coordinated care.
(6) The State Surgeon General shall notify the Governor regarding the providers that are eligible to receive the Cancer Center of Excellence Award.
(7) The award shall be recognized for a period of 3 years after the date of the award. A provider may reapply for subsequent awards.
(8) A provider that receives a Cancer Center of Excellence Award may use the designation in its advertising and marketing for up to 3 years after the date of the award. In addition, a provider that receives a Cancer Center of Excellence Award may be granted, for 3 years after the date of the award, a preference in competitive solicitations related to cancer care or research undertaken by a state agency or state university.
(9) The State Surgeon General shall report to the President of the Senate and the Speaker of the House of Representatives by December 15 of each year, the number of applications received, the number of award recipients by application cycle, a list of award recipients, and recommendations to strengthen the Cancer Center of Excellence Award program.
(10) The Department of Health shall adopt necessary rules related to the application cycles and submission of the application form.
381.93 Breast and cervical cancer early detection program.—This section may be cited as the “Mary Brogan Breast and Cervical Cancer Early Detection Program Act.”
(1) It is the intent of the Legislature to reduce the rates of death due to breast and cervical cancer through early diagnosis and increased access to early screening, diagnosis, and treatment programs.
(2) The Department of Health, using available federal funds and state funds appropriated for that purpose, is authorized to establish the Mary Brogan Breast and Cervical Cancer Screening and Early Detection Program to provide screening, diagnosis, evaluation, treatment, case management, and followup and referral to the Agency for Health Care Administration for coverage of treatment services.
(3) The Mary Brogan Breast and Cervical Cancer Early Detection Program shall be funded through grants for such screening and early detection purposes from the federal Centers for Disease Control and Prevention under Title XV of the Public Health Service Act, 42 U.S.C. ss. 300k et seq.
(4) The department shall limit enrollment in the program to persons with incomes up to and including 200 percent of the federal poverty level. The department shall establish an eligibility process that includes an income-verification process to ensure that persons served under the program meet income guidelines.
(5) The department may provide other breast and cervical cancer screening and diagnostic services; however, such services shall be funded separately through other sources than this act.
381.931 Annual report on Medicaid expenditures.—The Department of Health and the Agency for Health Care Administration shall monitor the total Medicaid expenditures for services made under this act. If Medicaid expenditures are projected to exceed the amount appropriated by the Legislature, the Department of Health shall limit the number of screenings to ensure Medicaid expenditures do not exceed the amount appropriated.
381.9312 Uterine fibroid research database; education and public awareness.—
(1) DEFINITIONS.—As used in this section, the term:
(a) “Department” means the Department of Health.
(b) “Health care provider” means a physician or physician assistant licensed under chapter 458 or chapter 459 or an advanced practice registered nurse licensed under chapter 464.
(c) “Uterine fibroid” means a noncancerous growth of the uterus that often appears during a woman’s childbearing years.
(2) UTERINE FIBROID RESEARCH DATABASE.—
(a) The department shall develop and maintain an electronic database consisting of information related to uterine fibroids. The purpose of the database is to encourage research relating to the diagnosis and treatment of uterine fibroids and to ensure that women are provided with the relevant information and health care necessary to prevent and treat uterine fibroids. The database must include, but need not be limited to, all of the following information:
1. Incidence and prevalence of women diagnosed with uterine fibroids in the state.
2. Demographic attributes of women diagnosed with uterine fibroids in the state.
3. Treatments and procedures for uterine fibroids used by health care providers in the state.
(b) A health care provider who diagnoses or treats a woman with uterine fibroids shall submit information relating to such diagnosis or treatment to the department in a form and manner prescribed by department rule for inclusion in the database. Such information may be submitted along with any reports or other information that the health care provider is required to submit to the department pursuant to state law.
(c) The database may not include any personal identifying information of women diagnosed with or treated for uterine fibroids.
(3) UTERINE FIBROID EDUCATION OUTREACH AND PUBLIC AWARENESS.—The department shall develop and include information related to uterine fibroids in its women’s health care educational materials currently made available to the public. The information must include, but need not be limited to, the following:
(a) Possible risk factors for developing uterine fibroids.
(b) Range of available treatment options that are considered alternatives to hysterectomy.
381.9315 Gynecologic and ovarian cancer education and awareness.—
(1) This section may be cited as the “Kelly Smith Gynecologic and Ovarian Cancer Education and Awareness Act.”
(2) The department shall encourage health care providers, including, but not limited to, hospitals, birthing facilities, county health departments, physicians, midwives, and nurses, to disseminate and display information about gynecologic cancers, including the signs and symptoms, risk factors, benefits of early detection through appropriate diagnostic testing, and treatment options.
(3) The department shall encourage women to discuss the risks of gynecologic cancers with their health care providers.
(4) The State Surgeon General shall make publicly available, by posting on the Internet website of the Department of Health, resources and an Internet website link to the federal Centers for Disease Control and Prevention website for gynecologic cancer information.
(5) The department is encouraged to seek any available grants from private or federal sources to promote gynecologic cancer awareness, including, but not limited to, early warning signs and risk factors associated with gynecologic cancers.
(6) The department is encouraged to collaborate with other agencies, organizations, and institutions to create a systematic approach to increasing public awareness regarding gynecologic cancers.
381.932 Breast cancer early detection and treatment referral program.—
(1) For purposes of this section, the term:
(a) “Breast cancer screening and referral services” means necessary breast cancer screening and referral services for a procedure intended to treat cancer of the human breast, including, but not limited to, surgery, radiation therapy, chemotherapy, hormonal therapy, and related medical followup services.
(b) “Unserved or underserved populations” means women who are:
1. At or below 200 percent of the federal poverty level for individuals;
2. Without health insurance that covers breast cancer screenings; and
3. Nineteen to 64 years of age, inclusive.
(2) There is established, within existing or specific appropriations, a breast cancer early detection and treatment referral program within the Department of Health. The purposes of the program are to:
(a) Promote referrals for the screening, detection, and treatment of breast cancer among unserved or underserved populations.
(b) Educate the public regarding breast cancer and the benefits of early detection.
(c) Provide referral services for persons seeking treatment.
(3) The program shall include, but not be limited to, the:
(a) Establishment of a public education and outreach initiative to publicize breast cancer early detection services, the benefits of early detection of breast cancer, and the recommended frequency for receiving screening services, including clinical breast examinations and mammography guidelines established by the United States Preventive Services Task Force.
(b) Development of professional education programs that include information regarding the benefits of the early detection of breast cancer and the recommended frequency for receiving a mammogram, as recommended in the most current breast cancer screening guidelines established by the United States Preventive Services Task Force.
(c) Establishment of a system to track and monitor all women screened for breast cancer in the program. The system shall include, but not be limited to, monitoring abnormal screening tests, referring women for treatment when needed, and tracking women to be screened at recommended screening intervals.
(4) The State Surgeon General shall submit an annual report to the appropriate substantive committees of the Legislature. The report shall include, but not be limited to, a description of the rate of breast cancer morbidity and mortality in the state and the extent to which women are participating in breast cancer screening as reported by the Behavioral Risk Factor Surveillance System.
(1) DEFINITIONS.—As used in this section, the term:
(a) “Facility” has the same meaning as in 21 C.F.R. s. 900.2(q).
(b) “Mammography” has the same meaning as in 21 C.F.R. s. 900.2(aa).
(c) “Mammography report” has the same meaning as in 21 C.F.R. s. 900.12(c).
(2) MAMMOGRAPHY REPORTS; RESULTS.—A facility that performs mammography shall send a summary of a patient’s mammography report to each patient in accordance with 21 C.F.R. s. 900.12(c). If a facility determines that a patient has heterogeneously or extremely dense breasts, the summary must include the following notice:
“Your mammogram shows that your breast tissue is dense. Dense breast tissue is relatively common and is found in approximately 50 percent of women. The presence of dense breast tissue can make it more difficult to detect some abnormalities in the breast and may also be associated with an increased risk of breast cancer. This information about the results of your mammogram is given to you to raise your awareness. A report of your results was sent to your health care provider. Further recommendations may be added at the discretion of the interpreting radiologist. Please be aware that additional screening studies may not be covered by your insurance.”
(a) This subsection does not create a duty, standard of care, or other legal obligation beyond the duty to provide notice as set forth in this subsection.
(b) This subsection does not require a notice that is inconsistent with the federal Mammography Quality Standards Act or any regulation promulgated pursuant to that act.
(3) REPEAL.—This section is repealed September 10, 2024.
381.95 Medical facility information maintained for terrorism response purposes; confidentiality.—
(1) Any information identifying or describing the name, location, pharmaceutical cache, contents, capacity, equipment, physical features, or capabilities of individual medical facilities, storage facilities, or laboratories established, maintained, or regulated by the Department of Health as part of the state’s plan to defend against an act of terrorism as defined in s. 775.30 is exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution. This exemption is remedial in nature, and it is the intent of the Legislature that this exemption apply to information held by the Department of Health before, on, or after the effective date of this section.
(2) Information made exempt by this section may be disclosed by the custodial agency to another state or federal agency in order to prevent, detect, guard against, respond to, investigate, or manage the consequences of any attempted or actual act of terrorism, or to prosecute those responsible for such attempts or acts.
(3) The certification by the Governor of the sufficiency of any location, pharmaceutical cache, contents, capacity, equipment, physical features, or capabilities of individual medical facilities, storage facilities, or laboratories established, maintained, or regulated by the Department of Health as part of the state’s plan to defend against an act of terrorism is a public record.
(1) DEFINITIONS.—As used in this section, the term:
(a) “Department” means the Department of Health.
(b) “Eligible client” means any of the following:
1. A pregnant woman or a woman who suspects she is pregnant, and the family of such woman, who voluntarily seeks pregnancy support services and any woman who voluntarily seeks wellness services.
2. A woman who has given birth in the previous 12 months and her family.
3. A parent or parents or a legal guardian or legal guardians, and the families of such parents and legal guardians, for up to 12 months after the birth of a child or the adoption of a child younger than 3 years of age.
(c) “Florida Pregnancy Care Network, Inc.,” or “network” means the not-for-profit statewide alliance of pregnancy support organizations that provide pregnancy support and wellness services through a comprehensive system of care to women and their families.
(d) “Pregnancy and parenting support services” means services that promote and encourage childbirth, including, but not limited to:
1. Direct client services, such as pregnancy testing, counseling, referral, training, and education for pregnant women and their families.
2. Nonmedical material assistance that improves the pregnancy or parenting situation of families, including, but not limited to, clothing, car seats, cribs, formula, and diapers.
3. Counseling or mentoring, education materials, and classes regarding pregnancy, parenting, adoption, life skills, and employment readiness.
4. Network awareness activities, including a promotional campaign to educate the public about the pregnancy support services offered by the network and a website that provides information on the location of providers in the user’s area and other available community resources.
5. Communication activities, including the operation and maintenance of a hotline or call center with a single statewide toll-free number that is available 24 hours a day for an eligible client to obtain the location and contact information for a pregnancy center located in the client’s area.
(e) “Wellness services” means services or activities intended to maintain and improve health or prevent illness and injury, including, but not limited to, high blood pressure screening, anemia testing, thyroid screening, cholesterol screening, diabetes screening, and assistance with smoking cessation.
(2) DEPARTMENT DUTIES.—The department shall contract with the network for the management and delivery of pregnancy and parenting support services and wellness services to eligible clients.
(3) CONTRACT REQUIREMENTS.—The department contract shall specify the contract deliverables, including financial reports and other reports due to the department, timeframes for achieving contractual obligations, and any other requirements the department determines are necessary, such as staffing and location requirements. The contract shall require the network to:
(a) Establish, implement, and monitor a comprehensive system of care through subcontractors to meet the pregnancy and parenting support and wellness needs of eligible clients.
(b) Establish and manage subcontracts with a sufficient number of providers to ensure the availability of pregnancy and parenting support services and wellness services for eligible clients, and maintain and manage the delivery of such services throughout the contract period.
(c) Spend at least 85 percent of the contract funds on pregnancy and parenting support services, excluding services specified in subparagraph (1)(d)4., and wellness services.
(d) Offer wellness services through vouchers or other appropriate arrangements that allow the purchase of services from qualified health care providers.
(e) Require a background screening under s. 943.0542 for all paid staff and volunteers of a subcontractor if such staff or volunteers provide direct client services to an eligible client who is a minor or an elderly person or who has a disability.
(f) Annually monitor its subcontractors and specify the sanctions that shall be imposed for noncompliance with the terms of a subcontract.
(g) Subcontract only with providers that exclusively promote and support childbirth.
(h) Ensure that informational materials provided to an eligible client by a provider are current and accurate and cite the reference source of any medical statement included in such materials.
(i) Ensure that the department is provided with all information necessary for the report required under subsection (5).
(4) SERVICES.—Services provided pursuant to this section must be provided in a noncoercive manner and may not include any religious content.
(5) REPORT.—By July 1, 2024, and each year thereafter, the department shall report to the Governor, the President of the Senate, and the Speaker of the House of Representatives on the amount and types of services provided by the network; the expenditures for such services; and the number of, and demographic information for, women, parents, and families served by the network.
381.98 The Florida Public Health Institute, Inc.; establishment; purpose; mission; duties; board of directors.—
(1) The Florida Public Health Institute, Inc., referred to in this section as “the corporation,” is established for the purpose of advancing the knowledge and practice of public health, including promoting health awareness in this state.
(2) The purpose and objective of the corporation shall be to operate exclusively for charitable, scientific, and educational purposes; to protect and improve the health and well-being of Florida’s people and environment through partnerships committed to program innovation, education, applied research, and policy development; and to engage in charitable programs dedicated to improving the health of Floridians.
(3) The corporation shall be established as a not-for-profit entity qualifying under s. 501(c)(3) of the Internal Revenue Code. The corporation may receive, hold, invest, and administer property and any moneys acquired from private, local, state, and federal sources, as well as technical and professional income generated or derived from the mission-related activities of the corporation. The corporation shall have all of the powers conferred upon corporations organized under chapter 617.
(4) The corporation’s duties include procuring funds necessary for accomplishing the purpose and mission of the corporation. The corporation shall strive to complement, supplement, and enhance the missions of the various organizations, entities, and departments that provide public health initiatives by serving as the lead corporation in the state for promoting public health awareness.
(5) The affairs of the corporation shall be managed by an executive director appointed by a board of directors.
(6)(a) The board of directors shall be elected in accordance with the bylaws of the corporation and shall include, but not be limited to, the following:
1. The State Surgeon General or his or her designee.
2. A representative of the Florida Public Health Association.
3. Representatives of local health departments, with at least one representative each from the southern, central, and northern geographic areas of the state.
4. Representatives of institutions of higher learning.
5. Representatives of the private health care provider sector, industry or business groups, or philanthropic foundations.
(b) The majority of board members may not be state employees.
(7) The corporation and the Department of Health shall enter into partnerships with providers of continuing education for health care practitioners, including, but not limited to, hospitals and state and local medical organizations, to ensure that practitioners are aware of the most recent and complete diagnostic and treatment tools.
(8) The corporation may provide personnel to the Department of Health for the purpose of performing duties and responsibilities outlined in private and public grants received by the Department of Health. These personnel are not state employees and are not entitled to retirement credit and other benefits provided to state employees under chapters 110 and 112. These personnel shall perform services pursuant to an agreement between the corporation and the Department of Health.
(9) The corporation may purchase goods, services, and property for use by the Department of Health. These purchases are not subject to the provisions of chapters 253, 255, and 287, nor to the control or direction of the Department of Environmental Protection or the Department of Management Services.
(10) The corporation shall provide an annual report concerning its activities to the President of the Senate and the Speaker of the House of Representatives.
(1) The Florida Public Health Institute, Inc., in consultation with the Department of Health, shall coordinate monthly health awareness campaigns with national, state, and local health care organizations and government entities targeting a wide range of the public, including: parents; teachers and other school employees; students in 4th through 12th grades, colleges, and universities; state agency employees; county and local government employees; patients of county health departments; Medicaid recipients; health care professionals and providers; and the public in general.
(2) The awareness campaigns shall include the provision of educational information about preventing, detecting, treating, and curing the following diseases or conditions. Additional diseases and conditions that impact the public health may be added by the board of directors of the Florida Public Health Institute, Inc.; however, each of the following diseases or conditions must be included in an awareness campaign during at least 1 month in any 24-month period:
(a) Cancer, including breast, prostate, cervical, ovarian, colorectal, and skin cancer and leukemia.
(b) Heart disease.
(c) Stroke.
(d) Lung disease, including asthma and smoking-relating disease.
(e) Neurological disorders and disease, including Alzheimer’s disease, Parkinson’s disease, and epilepsy.
(f) Gastrointestinal disease.
(g) Kidney disease.
(h) Diabetes.
(i) Liver disease.
(j) Autoimmune disorders.
(k) Birth defects and prenatal care.
(l) Obesity and malnutrition.
(m) Sexually transmissible disease.
(n) Hepatitis A, hepatitis B, and hepatitis C.
(o) Arthritis.
(p) Vaccine-preventable diseases.
(q) Infectious diseases, including HIV/AIDS.
(r) Substance abuse, including, but not limited to, emergency opioid antagonists.
(s) Mental illness.
(t) Lupus.
(u) Osteoporosis.
(3) The health awareness campaigns shall be funded by the Florida Public Health Institute, Inc., and the Department of Health to the extent that funds are available from public and private sources.
(4) Health awareness information shall be disseminated through all available methods, including print, audio, visual, and electronic media.
381.983 Definitions.—As used in this act, the term:
(1) “Affected property” means a room or group of rooms within a property constructed before January 1, 1960, or within a property constructed between January 1, 1960, and January 1, 1978, where the owner has actual knowledge of the presence of lead-based paint, that form a single independent habitable dwelling unit for occupation by one or more individuals and that has living facilities with permanent provisions for living, sleeping, eating, cooking, and sanitation. Affected property does not include:
(a) An area not used for living, sleeping, eating, cooking, or sanitation, such as an unfinished basement;
(b) A unit within a hotel, motel, or similar seasonal or transient facility, unless such unit is occupied by one or more persons at risk for a period exceeding 30 days;
(c) An area that is secured and inaccessible to occupants; or
(d) A unit that is not offered for rent.
(2) “Dust-lead hazard” means surface dust in a residential dwelling or a facility occupied by a person at risk which contains a mass-per-area concentration of lead equal to or exceeding 40 ug/ft2 on floors or 250 ug/ft2 on interior windowsills based on wipe samples.
(3) “Elevated blood-lead level” means a quantity of lead in the blood, measured from a venous or capillary draw, which exceeds the cutpoint specified in department rule. The determination of elevated blood-lead level must be based on national recommendations developed by the Council of State and Territorial Epidemiologists and the Centers for Disease Control and Prevention.
(4) “Lead-based paint” means paint or other surface coatings that contain lead equal to or exceeding 1.0 milligram per square centimeter, 0.5 percent by weight, or 5,000 parts per million (ppm) by weight.
(5) “Lead-based-paint hazard” means paint-lead hazards and dust-lead hazards.
(6) “Owner” means a person, firm, corporation, nonprofit organization, partnership, government, guardian, conservator, receiver, trustee, executor, or other judicial officer, or other entity which, alone or with others, owns, holds, or controls the freehold or leasehold title or part of the title to property, with or without actually possessing it. The definition includes a vendee who possesses the title, but does not include a mortgagee or an owner of a reversionary interest under a ground rent lease. The term includes any authorized agent of the owner, including a property manager or leasing agent.
(7) “Paint-lead hazard” means any one of the following:
(a) Any lead-based paint on a friction surface that is subject to abrasion and where the dust-lead levels on the nearest horizontal surface underneath the friction surface, such as the windowsill or floor, are equal to or greater than the dust-lead-hazard levels defined in subsection (2);
(b) Any damaged or otherwise deteriorated lead-based paint on an impact surface that is caused by impact from a related building material, such as a door knob that knocks into a wall or a door that knocks against its door frame;
(c) Any chewable lead-based painted surface on which there is evidence of teeth marks; or
(d) Any other deteriorated lead-based paint in or on the exterior of any residential building or any facility occupied by a person at risk.
(8) “Person at risk” means a child under the age of 6 years or a pregnant woman who resides or regularly spends at least 24 hours per week in an affected property.
(9) “Tenant” means the individual named as the lessee in a lease, rental agreement, or occupancy agreement for a dwelling unit.
(1) LEAD POISONING PREVENTION EDUCATIONAL PROGRAM ESTABLISHED.—In order to achieve the purposes of this act, a statewide, multifaceted, ongoing educational program designed to meet the needs of tenants, property owners, health care providers, early childhood educators, care providers, and realtors is established.
(2) PUBLIC INFORMATION INITIATIVE.—The Governor, in conjunction with the State Surgeon General or his or her designee, shall sponsor a series of public service announcements on radio, on television, on the Internet, or in print media about the nature of lead-based-paint hazards, the importance of standards for lead poisoning prevention in properties, and the purposes and responsibilities set forth in this act. In developing and coordinating this public information initiative, the sponsors shall seek the participation and involvement of private industry organizations, including those involved in real estate, insurance, mortgage banking, or pediatrics.
(3) DISTRIBUTION OF INFORMATION ABOUT CHILDHOOD LEAD POISONING.—The State Surgeon General or his or her designee shall develop culturally and linguistically appropriate information and distribution methods regarding childhood lead poisoning, the importance of testing for elevated blood-lead levels, prevention of childhood lead poisoning, treatment of childhood lead poisoning, and, as appropriate, the requirements of this act. This information shall be distributed to parents or legal guardians of children 6 years of age or younger on the following occasions:
(a) By a health care provider at the time of a child’s birth and at the time of any childhood immunization or vaccination unless it is established that such information has been provided to the parent or legal guardian by the health care provider within the prior 12 months.
(b) By the owner or operator of any child care facility or preschool or kindergarten class on or before each October 15.
(1) The State Surgeon General shall establish guidelines for early identification of persons at risk of having elevated blood-lead levels and for the systematic screening of children under 6 years of age in the target populations identified in subsection (2) for the presence of elevated blood-lead levels. Children within the specified target populations shall be screened with a blood-lead test at age 12 months and age 24 months, or between the ages of 36 months and 72 months if they have not previously been screened. The State Surgeon General shall, after consultation with recognized professional medical groups and such other sources as the State Surgeon General deems appropriate, adopt rules to follow established national guidelines or recommendations such as those issued by the Council of State and Territorial Epidemiologists and the Centers for Disease Control and Prevention related to reporting elevated blood-lead levels and screening results to the department pursuant to this section.
(2) In developing screening programs to identify persons at risk with elevated blood-lead levels, priority shall be given to persons within the following categories:
(a) All children enrolled in the Medicaid program at ages 12 months and 24 months, or between the ages of 36 months and 72 months if they have not previously been screened.
(b) Children under the age of 6 years exhibiting delayed cognitive development or other symptoms of childhood lead poisoning.
(c) Persons at risk residing in the same household, or recently residing in the same household, as another person at risk with an elevated blood-lead level.
(d) Persons at risk residing, or who have recently resided, in buildings or geographical areas in which significant numbers of cases of lead poisoning or elevated blood-lead levels have recently been reported.
(e) Persons at risk residing, or who have recently resided, in an affected property contained in a building that during the preceding 3 years has been subject to enforcement for violations of lead-poisoning-prevention statutes, ordinances, rules, or regulations.
(f) Persons at risk residing, or who have recently resided, in a room or group of rooms contained in a building whose owner also owns a building containing affected properties which, during the preceding 3 years, has been subject to an enforcement action for a violation of lead-poisoning-prevention statutes, ordinances, rules, or regulations.
(g) Persons at risk residing in other buildings or geographical areas in which the State Surgeon General reasonably determines there is a significant risk of affected individuals having an elevated blood-lead level.
(3) The department shall maintain comprehensive records of all screenings indicating an elevated blood-lead level.
(4) The results of screenings conducted pursuant to this section shall be reported by the health care provider who conducted or ordered the screening to the individual who was screened, or to the individual’s parent or legal guardian if he or she is a minor.
381.9855 Dr. and Mrs. Alfonse and Kathleen Cinotti Health Care Screening and Services Grant Program; portal.—
(1)(a) The Department of Health shall implement the Dr. and Mrs. Alfonse and Kathleen Cinotti Health Care Screening and Services Grant Program. The purpose of the program is to expand access to no-cost health care screenings or services for the general public facilitated by nonprofit entities. The department shall do all of the following:
1. Publicize the availability of funds and enlist the aid of county health departments for outreach to potential applicants at the local level.
2. Establish an application process for submitting a grant proposal and criteria an applicant must meet to be eligible.
3. Develop guidelines a grant recipient must follow for the expenditure of grant funds and uniform data reporting requirements for the purpose of evaluating the performance of grant recipients. The guidelines must require grant funds to be spent on screenings, including referrals for treatment, if appropriate, or related services for one or more of the following:
a. Hearing.
b. Vision.
c. Dental.
d. Cancer.
e. Diabetes.
f. Renal disease.
g. Chronic obstructive pulmonary disease.
h. Hypertension.
i. Heart disease.
j. Stroke.
k. Scoliosis.
(b) A nonprofit entity may apply for grant funds in order to implement new health care screening or services programs that the entity has not previously implemented.
(c) A nonprofit entity that has previously implemented a specific health care screening or services program at one or more specific locations may apply for grant funds in order to provide the same or similar screenings or services at new locations or through a mobile health clinic or mobile unit in order to expand the program’s delivery capabilities.
(d) An entity that receives a grant under this section must:
1. Follow Department of Health guidelines for reporting on expenditure of grant funds and measures to evaluate the effectiveness of the entity’s health care screening or services program.
2. Publicize to the general public and encourage the use of the health care screening portal created under subsection (2).
(e) The Department of Health may adopt rules for the implementation of this subsection.
(2)(a) The Department of Health shall create and maintain an Internet-based portal to direct the general public to events, organizations, and venues in this state from which health screenings or services may be obtained at no cost or at a reduced cost and for the purpose of directing licensed health care practitioners to opportunities for volunteering their services to conduct, administer, or facilitate such health screenings or services. The department may contract with a third-party vendor for the creation or maintenance of the portal.
(b) The portal must be easily accessible by the public, not require a sign-up or login, and include the ability for a member of the public to enter his or her address and obtain localized and current data on opportunities for screenings and services and volunteer opportunities for health care practitioners. The portal must include, but need not be limited to, all statutorily created screening programs, other than newborn screenings established under chapter 383, which are funded and operational under the department’s authority. The department shall coordinate with county health departments so that the portal includes information on such health screenings and services provided by county health departments or by nonprofit entities in partnership with county health departments.
(c) The department shall include a clear and conspicuous link to the portal on the homepage of its website. The department shall publicize the portal to, and encourage the use of the portal by, the general public and shall enlist the aid of county health departments for such outreach.
(1) DEFINITIONS.—As used in this section, the term:
(a) “Attractive to children” means the use of any image or words designed or likely to appeal to persons younger than 18 years of age, including, but not limited to, cartoons, toys, animals, food, or depictions of persons younger than 18 years of age; any other likeness to images, characters, or phrases that are popularly used to advertise to persons younger than 18 years of age; or any reasonable likeness to commercially available candy.
(b) “Caregiver” means a resident of this state who has agreed to assist with a qualified patient’s medical use of marijuana, has a caregiver identification card, and meets the requirements of subsection (6).
(c) “Chronic nonmalignant pain” means pain that is caused by a qualifying medical condition or that originates from a qualifying medical condition and persists beyond the usual course of that qualifying medical condition.
(d) “Close relative” means a spouse, parent, sibling, grandparent, child, or grandchild, whether related by whole or half blood, by marriage, or by adoption.
(e) “Edibles” means commercially produced food items made with marijuana oil, but no other form of marijuana, that are produced and dispensed by a medical marijuana treatment center.
(f) “Low-THC cannabis” means a plant of the genus Cannabis, the dried flowers of which contain 0.8 percent or less of tetrahydrocannabinol and more than 10 percent of cannabidiol weight for weight; the seeds thereof; the resin extracted from any part of such plant; or any compound, manufacture, salt, derivative, mixture, or preparation of such plant or its seeds or resin that is dispensed from a medical marijuana treatment center.
(g) “Marijuana” means all parts of any plant of the genus Cannabis, whether growing or not; the seeds thereof; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant or its seeds or resin, including low-THC cannabis, which are dispensed from a medical marijuana treatment center for medical use by a qualified patient.
(h) “Marijuana delivery device” means an object used, intended for use, or designed for use in preparing, storing, ingesting, inhaling, or otherwise introducing marijuana into the human body, and which is dispensed from a medical marijuana treatment center for medical use by a qualified patient, except that delivery devices intended for the medical use of marijuana by smoking need not be dispensed from a medical marijuana treatment center in order to qualify as marijuana delivery devices.
(i) “Marijuana testing laboratory” means a facility that collects and analyzes marijuana samples from a medical marijuana treatment center and has been certified by the department pursuant to s. 381.988.
(j) “Medical director” means a person who holds an active, unrestricted license as an allopathic physician under chapter 458 or osteopathic physician under chapter 459 and is in compliance with the requirements of paragraph (3)(c).
(k) “Medical use” means the acquisition, possession, use, delivery, transfer, or administration of marijuana authorized by a physician certification. The term does not include:
1. Possession, use, or administration of marijuana that was not purchased or acquired from a medical marijuana treatment center.
2. Possession, use, or administration of marijuana in the form of commercially produced food items other than edibles or of marijuana seeds.
3. Use or administration of any form or amount of marijuana in a manner that is inconsistent with the qualified physician’s directions or physician certification.
4. Transfer of marijuana to a person other than the qualified patient for whom it was authorized or the qualified patient’s caregiver on behalf of the qualified patient.
5. Use or administration of marijuana in the following locations:
a. On any form of public transportation, except for low-THC cannabis not in a form for smoking.
b. In any public place, except for low-THC cannabis not in a form for smoking.
c. In a qualified patient’s place of employment, except when permitted by his or her employer.
d. In a state correctional institution, as defined in s. 944.02, or a correctional institution, as defined in s. 944.241.
e. On the grounds of a preschool, primary school, or secondary school, except as provided in s. 1006.062.
f. In a school bus, a vehicle, an aircraft, or a motorboat, except for low-THC cannabis not in a form for smoking.
6. The smoking of marijuana in an enclosed indoor workplace as defined in s. 386.203(5).
(l) “Physician certification” means a qualified physician’s authorization for a qualified patient to receive marijuana and a marijuana delivery device from a medical marijuana treatment center.
(m) “Qualified patient” means a resident of this state who has been added to the medical marijuana use registry by a qualified physician to receive marijuana or a marijuana delivery device for a medical use and who has a qualified patient identification card.
(n) “Qualified physician” means a person who holds an active, unrestricted license as an allopathic physician under chapter 458 or as an osteopathic physician under chapter 459 and is in compliance with the physician education requirements of subsection (3).
(o) “Smoking” means burning or igniting a substance and inhaling the smoke.
(p) “Terminal condition” means a progressive disease or medical or surgical condition that causes significant functional impairment, is not considered by a treating physician to be reversible without the administration of life-sustaining procedures, and will result in death within 1 year after diagnosis if the condition runs its normal course.
(2) QUALIFYING MEDICAL CONDITIONS.—A patient must be diagnosed with at least one of the following conditions to qualify to receive marijuana or a marijuana delivery device:
(a) Cancer.
(b) Epilepsy.
(c) Glaucoma.
(d) Positive status for human immunodeficiency virus.
(e) Acquired immune deficiency syndrome.
(f) Posttraumatic stress disorder.
(g) Amyotrophic lateral sclerosis.
(h) Crohn’s disease.
(i) Parkinson’s disease.
(j) Multiple sclerosis.
(k) Medical conditions of the same kind or class as or comparable to those enumerated in paragraphs (a)-(j).
(l) A terminal condition diagnosed by a physician other than the qualified physician issuing the physician certification.
(m) Chronic nonmalignant pain.
(3) QUALIFIED PHYSICIANS AND MEDICAL DIRECTORS.—
(a) Before being approved as a qualified physician and before each license renewal, a physician must successfully complete a 2-hour course and subsequent examination offered by the Florida Medical Association or the Florida Osteopathic Medical Association which encompass the requirements of this section and any rules adopted hereunder. The course and examination must be administered at least annually and may be offered in a distance learning format, including an electronic, online format that is available upon request. The price of the course may not exceed $500.
(b) A qualified physician may not be employed by, or have any direct or indirect economic interest in, a medical marijuana treatment center or marijuana testing laboratory.
(c) Before being employed as a medical director and before each license renewal, a medical director must successfully complete a 2-hour course and subsequent examination offered by the Florida Medical Association or the Florida Osteopathic Medical Association which encompass the requirements of this section and any rules adopted hereunder. The course and examination must be administered at least annually and may be offered in a distance learning format, including an electronic, online format that is available upon request. The price of the course may not exceed $500.
(4) PHYSICIAN CERTIFICATION.—
(a) A qualified physician may issue a physician certification only if the qualified physician:
1. Conducted an examination of the patient and a full assessment of the medical history of the patient. Before issuing an initial certification to a patient, the qualified physician must conduct an in-person physical examination of the patient. For certification renewals, a qualified physician who has issued a certification to a patient after conducting an in-person physical examination may conduct subsequent examinations of that patient through telehealth as defined in s. 456.47. For the purposes of this subparagraph, the term “in-person physical examination” means an examination conducted by a qualified physician while the physician is physically present in the same room as the patient.
2. Diagnosed the patient with at least one qualifying medical condition.
3. Determined that the medical use of marijuana would likely outweigh the potential health risks for the patient, and such determination must be documented in the patient’s medical record. If a patient is younger than 18 years of age, a second physician must concur with this determination, and such concurrence must be documented in the patient’s medical record.
4. Determined whether the patient is pregnant and documented such determination in the patient’s medical record. A physician may not issue a physician certification, except for low-THC cannabis, to a patient who is pregnant.
5. Reviewed the patient’s controlled drug prescription history in the prescription drug monitoring program database established pursuant to s. 893.055.
6. Reviews the medical marijuana use registry and confirmed that the patient does not have an active physician certification from another qualified physician.
7. Registers as the issuer of the physician certification for the named qualified patient on the medical marijuana use registry in an electronic manner determined by the department, and:
a. Enters into the registry the contents of the physician certification, including the patient’s qualifying condition and the dosage not to exceed the daily dose amount determined by the department, the amount and forms of marijuana authorized for the patient, and any types of marijuana delivery devices needed by the patient for the medical use of marijuana.
b. Updates the registry within 7 days after any change is made to the original physician certification to reflect such change.
c. Deactivates the registration of the qualified patient and the patient’s caregiver when the physician no longer recommends the medical use of marijuana for the patient.
8. Obtains the voluntary and informed written consent of the patient for medical use of marijuana each time the qualified physician issues a physician certification for the patient, which shall be maintained in the patient’s medical record. The patient, or the patient’s parent or legal guardian if the patient is a minor, must sign the informed consent acknowledging that the qualified physician has sufficiently explained its content. The qualified physician must use a standardized informed consent form adopted in rule by the Board of Medicine and the Board of Osteopathic Medicine, which must include, at a minimum, information related to:
a. The Federal Government’s classification of marijuana as a Schedule I controlled substance.
b. The approval and oversight status of marijuana by the Food and Drug Administration.
c. The current state of research on the efficacy of marijuana to treat the qualifying conditions set forth in this section.
d. The potential for addiction.
e. The potential effect that marijuana may have on a patient’s coordination, motor skills, and cognition, including a warning against operating heavy machinery, operating a motor vehicle, or engaging in activities that require a person to be alert or respond quickly.
f. The potential side effects of marijuana use, including the negative health risks associated with smoking marijuana.
g. The risks, benefits, and drug interactions of marijuana.
h. That the patient’s deidentified health information contained in the physician certification and medical marijuana use registry may be used for research purposes.
(b) If a qualified physician issues a physician certification for a qualified patient diagnosed with a qualifying medical condition pursuant to paragraph (2)(k), the physician must submit the following to the applicable board within 14 days after issuing the physician certification:
1. Documentation supporting the qualified physician’s opinion that the medical condition is of the same kind or class as the conditions in paragraphs (2)(a)-(j).
2. Documentation that establishes the efficacy of marijuana as treatment for the condition.
3. Documentation supporting the qualified physician’s opinion that the benefits of medical use of marijuana would likely outweigh the potential health risks for the patient.
4. Any other documentation as required by board rule.
The department must submit such documentation to the Consortium for Medical Marijuana Clinical Outcomes Research established pursuant to s. 1004.4351.
(c) If a qualified physician determines that smoking is an appropriate route of administration for a qualified patient, other than a patient diagnosed with a terminal condition, the qualified physician must submit the following documentation to the applicable board:
1. A list of other routes of administration, if any, certified by a qualified physician that the patient has tried, the length of time the patient used such routes of administration, and an assessment of the effectiveness of those routes of administration in treating the qualified patient’s qualifying condition.
2. Research documenting the effectiveness of smoking as a route of administration to treat similarly situated patients with the same qualifying condition as the qualified patient.
3. A statement signed by the qualified physician documenting the qualified physician’s opinion that the benefits of smoking marijuana for medical use outweigh the risks for the qualified patient.
(d) A qualified physician may not issue a physician certification for marijuana in a form for smoking to a patient under 18 years of age unless the patient is diagnosed with a terminal condition, the qualified physician determines that smoking is the most effective route of administration for the patient, and a second physician who is a board-certified pediatrician concurs with such determination. Such determination and concurrence must be documented in the patient’s medical record and in the medical marijuana use registry. The certifying physician must obtain the written informed consent of such patient’s parent or legal guardian before issuing a physician certification to the patient for marijuana in a form for smoking. The qualified physician must use a standardized informed consent form adopted in rule by the Board of Medicine and the Board of Osteopathic Medicine which must include information concerning the negative health effects of smoking marijuana on persons under 18 years of age and an acknowledgment that the qualified physician has sufficiently explained the contents of the form.
(e) The Board of Medicine and the Board of Osteopathic Medicine shall review the documentation submitted pursuant to paragraph (c) and shall each, by July 1, 2021, adopt by rule practice standards for the certification of smoking as a route of administration.
(f) A qualified physician may not issue a physician certification for more than three 70-day supply limits of marijuana or more than six 35-day supply limits of marijuana in a form for smoking. The department shall quantify by rule a daily dose amount with equivalent dose amounts for each allowable form of marijuana dispensed by a medical marijuana treatment center. The department shall use the daily dose amount to calculate a 70-day supply.
1. A qualified physician may request an exception to the daily dose amount limit, the 35-day supply limit of marijuana in a form for smoking, and the 4-ounce possession limit of marijuana in a form for smoking established in paragraph (14)(a). The request shall be made electronically on a form adopted by the department in rule and must include, at a minimum:
a. The qualified patient’s qualifying medical condition.
b. The dosage and route of administration that was insufficient to provide relief to the qualified patient.
c. A description of how the patient will benefit from an increased amount.
d. The minimum daily dose amount of marijuana that would be sufficient for the treatment of the qualified patient’s qualifying medical condition.
2. A qualified physician must provide the qualified patient’s records upon the request of the department.
3. The department shall approve or disapprove the request within 14 days after receipt of the complete documentation required by this paragraph. The request shall be deemed approved if the department fails to act within this time period.
(g) A qualified physician must evaluate an existing qualified patient at least once every 30 weeks before issuing a new physician certification. A qualified physician who has issued a certification to the patient after conducting an in-person physical examination as defined in subparagraph (a)1. may conduct the evaluation through telehealth as defined in s. 456.47. A physician must:
1. Determine if the patient still meets the requirements to be issued a physician certification under paragraph (a).
2. Identify and document in the qualified patient’s medical records whether the qualified patient experienced either of the following related to the medical use of marijuana:
a. An adverse drug interaction with any prescription or nonprescription medication; or
b. A reduction in the use of, or dependence on, other types of controlled substances as defined in s. 893.02.
3. Submit a report with the findings required pursuant to subparagraph 2. to the department. The department shall submit such reports to the Consortium for Medical Marijuana Clinical Outcomes Research established pursuant to s. 1004.4351.
(h) An active order for low-THC cannabis or medical cannabis issued pursuant to former s. 381.986, Florida Statutes 2016, and registered with the compassionate use registry before June 23, 2017, is deemed a physician certification, and all patients possessing such orders are deemed qualified patients until the department begins issuing medical marijuana use registry identification cards.
(i) The department shall monitor physician registration in the medical marijuana use registry and the issuance of physician certifications for practices that could facilitate unlawful diversion or misuse of marijuana or a marijuana delivery device and shall take disciplinary action as appropriate. The department may suspend the registration of a qualified physician in the medical marijuana use registry for a period of up to 2 years if the qualified physician:
1. Fails to comply with this section; or
2. Provides, advertises, or markets telehealth services before July 1, 2023.
(j) The Board of Medicine and the Board of Osteopathic Medicine shall jointly create a physician certification pattern review panel that shall review all physician certifications submitted to the medical marijuana use registry. The panel shall track and report the number of physician certifications and the qualifying medical conditions, dosage, supply amount, and form of marijuana certified. The panel shall report the data both by individual qualified physician and in the aggregate, by county, and statewide. The physician certification pattern review panel shall, beginning January 1, 2018, submit an annual report of its findings and recommendations to the Governor, the President of the Senate, and the Speaker of the House of Representatives.
(k) The department, the Board of Medicine, and the Board of Osteopathic Medicine may adopt rules pursuant to ss. 120.536(1) and 120.54 to implement this subsection.
(5) MEDICAL MARIJUANA USE REGISTRY.—
(a) The department shall create and maintain a secure, electronic, and online medical marijuana use registry for physicians, patients, and caregivers as provided under this section. The medical marijuana use registry must be accessible to law enforcement agencies, qualified physicians, and medical marijuana treatment centers to verify the authorization of a qualified patient or a caregiver to possess marijuana or a marijuana delivery device and record the marijuana or marijuana delivery device dispensed. The medical marijuana use registry must also be accessible to practitioners licensed to prescribe prescription drugs to ensure proper care for patients before medications that may interact with the medical use of marijuana are prescribed. The medical marijuana use registry must prevent an active registration of a qualified patient by multiple physicians.
(b) The department shall determine whether an individual is a resident of this state for the purpose of registration of qualified patients and caregivers in the medical marijuana use registry. To prove residency:
1. An adult resident must provide the department with a copy of his or her valid Florida driver license issued under s. 322.18 or a copy of a valid Florida identification card issued under s. 322.051.
2. An adult seasonal resident who cannot meet the requirements of subparagraph 1. may provide the department with a copy of two of the following that show proof of residential address:
a. A deed, mortgage, monthly mortgage statement, mortgage payment booklet or residential rental or lease agreement.
b. One proof of residential address from the seasonal resident’s parent, step-parent, legal guardian or other person with whom the seasonal resident resides and a statement from the person with whom the seasonal resident resides stating that the seasonal resident does reside with him or her.
c. A utility hookup or work order dated within 60 days before registration in the medical use registry.
d. A utility bill, not more than 2 months old.
e. Mail from a financial institution, including checking, savings, or investment account statements, not more than 2 months old.
f. Mail from a federal, state, county, or municipal government agency, not more than 2 months old.
g. Any other documentation that provides proof of residential address as determined by department rule.
3. A minor must provide the department with a certified copy of a birth certificate or a current record of registration from a Florida K-12 school and must have a parent or legal guardian who meets the requirements of subparagraph 1.
For the purposes of this paragraph, the term “seasonal resident” means any person who temporarily resides in this state for a period of at least 31 consecutive days in each calendar year, maintains a temporary residence in this state, returns to the state or jurisdiction of his or her residence at least one time during each calendar year, and is registered to vote or pays income tax in another state or jurisdiction.
(c) The department may suspend or revoke the registration of a qualified patient or caregiver if the qualified patient or caregiver:
1. Provides misleading, incorrect, false, or fraudulent information to the department;
2. Obtains a supply of marijuana in an amount greater than the amount authorized by the physician certification;
3. Falsifies, alters, or otherwise modifies an identification card;
4. Fails to timely notify the department of any changes to his or her qualified patient status; or
5. Violates the requirements of this section or any rule adopted under this section.
(d) The department shall immediately suspend the registration of a qualified patient charged with a violation of chapter 893 until final disposition of any alleged offense. Thereafter, the department may extend the suspension, revoke the registration, or reinstate the registration.
(e) The department shall immediately suspend the registration of any caregiver charged with a violation of chapter 893 until final disposition of any alleged offense. The department shall revoke a caregiver registration if the caregiver does not meet the requirements of subparagraph (6)(b)6.
(f) The department may revoke the registration of a qualified patient or caregiver who cultivates marijuana or who acquires, possesses, or delivers marijuana from any person or entity other than a medical marijuana treatment center.
(g) The department shall revoke the registration of a qualified patient, and the patient’s associated caregiver, upon notification that the patient no longer meets the criteria of a qualified patient.
(h) The department may adopt rules pursuant to ss. 120.536(1) and 120.54 to implement this subsection.
(6) CAREGIVERS.—
(a) The department must register an individual as a caregiver on the medical marijuana use registry and issue a caregiver identification card if an individual designated by a qualified patient meets all of the requirements of this subsection and department rule.
(b) A caregiver must:
1. Not be a qualified physician and not be employed by or have an economic interest in a medical marijuana treatment center or a marijuana testing laboratory.
2. Be 21 years of age or older and a resident of this state.
3. Agree in writing to assist with the qualified patient’s medical use of marijuana.
4. Be registered in the medical marijuana use registry as a caregiver for no more than one qualified patient, except as provided in this paragraph.
5. Successfully complete a caregiver certification course developed and administered by the department or its designee, which must be renewed biennially. The price of the course may not exceed $100.
6. Pass a background screening pursuant to subsection (9), unless the patient is a close relative of the caregiver.
(c) A qualified patient may designate no more than one caregiver to assist with the qualified patient’s medical use of marijuana, unless:
1. The qualified patient is a minor and the designated caregivers are parents or legal guardians of the qualified patient;
2. The qualified patient is an adult who has an intellectual or developmental disability that prevents the patient from being able to protect or care for himself or herself without assistance or supervision and the designated caregivers are the parents or legal guardians of the qualified patient;
3. The qualified patient is admitted to a hospice program; or
4. The qualified patient is participating in a research program in a teaching nursing home pursuant to s. 1004.4351.
(d) A caregiver may be registered in the medical marijuana use registry as a designated caregiver for no more than one qualified patient, unless:
1. The caregiver is a parent or legal guardian of more than one minor who is a qualified patient;
2. The caregiver is a parent or legal guardian of more than one adult who is a qualified patient and who has an intellectual or developmental disability that prevents the patient from being able to protect or care for himself or herself without assistance or supervision;
3. All qualified patients the caregiver has agreed to assist are admitted to a hospice program and have requested the assistance of that caregiver with the medical use of marijuana; the caregiver is an employee of the hospice; and the caregiver provides personal care or other services directly to clients of the hospice in the scope of that employment; or
4. All qualified patients the caregiver has agreed to assist are participating in a research program in a teaching nursing home pursuant to s. 1004.4351.
(e) A caregiver may not receive compensation, other than actual expenses incurred, for any services provided to the qualified patient.
(f) If a qualified patient is younger than 18 years of age, only a caregiver may purchase or administer marijuana for medical use by the qualified patient. The qualified patient may not purchase marijuana.
(g) A caregiver must be in immediate possession of his or her medical marijuana use registry identification card at all times when in possession of marijuana or a marijuana delivery device and must present his or her medical marijuana use registry identification card upon the request of a law enforcement officer.
(h) The department may adopt rules pursuant to ss. 120.536(1) and 120.54 to implement this subsection.
(7) IDENTIFICATION CARDS.—
(a) The department shall issue medical marijuana use registry identification cards for qualified patients and caregivers who are residents of this state, which must be renewed annually. The identification cards must be resistant to counterfeiting and tampering and must include, at a minimum, the following:
1. The name, address, and date of birth of the qualified patient or caregiver.
2. A full-face, passport-type, color photograph of the qualified patient or caregiver taken within the 90 days immediately preceding registration or the Florida driver license or Florida identification card photograph of the qualified patient or caregiver obtained directly from the Department of Highway Safety and Motor Vehicles.
3. Identification as a qualified patient or a caregiver.
4. The unique numeric identifier used for the qualified patient in the medical marijuana use registry.
5. For a caregiver, the name and unique numeric identifier of the caregiver and the qualified patient or patients that the caregiver is assisting.
6. The expiration date of the identification card.
(b) The department must receive written consent from a qualified patient’s parent or legal guardian before it may issue an identification card to a qualified patient who is a minor.
(c) The department shall adopt rules pursuant to ss. 120.536(1) and 120.54 establishing procedures for the issuance, renewal, suspension, replacement, surrender, and revocation of medical marijuana use registry identification cards pursuant to this section and shall begin issuing qualified patient identification cards by October 3, 2017.
(d) Applications for identification cards must be submitted on a form prescribed by the department. The department may charge a reasonable fee associated with the issuance, replacement, and renewal of identification cards. The department shall allocate $10 of the identification card fee to the Division of Research at Florida Agricultural and Mechanical University for the purpose of educating minorities about marijuana for medical use and the impact of the unlawful use of marijuana on minority communities. The department shall contract with a third-party vendor to issue identification cards. The vendor selected by the department must have experience performing similar functions for other state agencies.
(e) A qualified patient or caregiver shall return his or her identification card to the department within 5 business days after revocation.
(8) MEDICAL MARIJUANA TREATMENT CENTERS.—
(a) The department shall license medical marijuana treatment centers to ensure reasonable statewide accessibility and availability as necessary for qualified patients registered in the medical marijuana use registry and who are issued a physician certification under this section.
1. As soon as practicable, but no later than July 3, 2017, the department shall license as a medical marijuana treatment center any entity that holds an active, unrestricted license to cultivate, process, transport, and dispense low-THC cannabis, medical cannabis, and cannabis delivery devices, under former s. 381.986, Florida Statutes 2016, before July 1, 2017, and which meets the requirements of this section. In addition to the authority granted under this section, these entities are authorized to dispense low-THC cannabis, medical cannabis, and cannabis delivery devices ordered pursuant to former s. 381.986, Florida Statutes 2016, which were entered into the compassionate use registry before July 1, 2017, and are authorized to begin dispensing marijuana under this section on July 3, 2017. The department may grant variances from the representations made in such an entity’s original application for approval under former s. 381.986, Florida Statutes 2014, pursuant to paragraph (e).
2. The department shall license as medical marijuana treatment centers 10 applicants that meet the requirements of this section, under the following parameters:
a. As soon as practicable, but no later than August 1, 2017, the department shall license any applicant whose application was reviewed, evaluated, and scored by the department and which was denied a dispensing organization license by the department under former s. 381.986, Florida Statutes 2014; which had one or more administrative or judicial challenges pending as of January 1, 2017, or had a final ranking within one point of the highest final ranking in its region under former s. 381.986, Florida Statutes 2014; which meets the requirements of this section; and which provides documentation to the department that it has the existing infrastructure and technical and technological ability to begin cultivating marijuana within 30 days after registration as a medical marijuana treatment center.
b. As soon as practicable, the department shall license one applicant that is a recognized class member of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers Litig., 856 F. Supp. 2d 1 (D.D.C. 2011). An applicant licensed under this sub-subparagraph is exempt from the requirement of subparagraph (b)2. An applicant that applies for licensure under this sub-subparagraph, pays its initial application fee, is determined by the department through the application process to qualify as a recognized class member, and is not awarded a license under this sub-subparagraph may transfer its initial application fee to one subsequent opportunity to apply for licensure under subparagraph 4.
c. As soon as practicable, but no later than October 3, 2017, the department shall license applicants that meet the requirements of this section in sufficient numbers to result in 10 total licenses issued under this subparagraph, while accounting for the number of licenses issued under sub-subparagraphs a. and b.
3. For up to two of the licenses issued under subparagraph 2., the department shall give preference to applicants that demonstrate in their applications that they own one or more facilities that are, or were, used for the canning, concentrating, or otherwise processing of citrus fruit or citrus molasses and will use or convert the facility or facilities for the processing of marijuana.
4. Within 6 months after the registration of 100,000 active qualified patients in the medical marijuana use registry, the department shall license four additional medical marijuana treatment centers that meet the requirements of this section. Thereafter, the department shall license four medical marijuana treatment centers within 6 months after the registration of each additional 100,000 active qualified patients in the medical marijuana use registry that meet the requirements of this section.
(b) An applicant for licensure as a medical marijuana treatment center shall apply to the department on a form prescribed by the department and adopted in rule. The department shall adopt rules pursuant to ss. 120.536(1) and 120.54 establishing a procedure for the issuance and biennial renewal of licenses, including initial application and biennial renewal fees sufficient to cover the costs of implementing and administering this section, and establishing supplemental licensure fees for payment beginning May 1, 2018, sufficient to cover the costs of administering ss. 381.989 and 1004.4351. The department shall identify applicants with strong diversity plans reflecting this state’s commitment to diversity and implement training programs and other educational programs to enable minority persons and minority business enterprises, as defined in s. 288.703, and veteran business enterprises, as defined in s. 295.187, to compete for medical marijuana treatment center licensure and contracts. Subject to the requirements in subparagraphs (a)2.-4., the department shall issue a license to an applicant if the applicant meets the requirements of this section and pays the initial application fee. The department shall renew the licensure of a medical marijuana treatment center biennially if the licensee meets the requirements of this section and pays the biennial renewal fee. However, the department may not renew the license of a medical marijuana treatment center that has not begun to cultivate, process, and dispense marijuana by the date that the medical marijuana treatment center is required to renew its license. An individual may not be an applicant, owner, officer, board member, or manager on more than one application for licensure as a medical marijuana treatment center. An individual or entity may not be awarded more than one license as a medical marijuana treatment center. An applicant for licensure as a medical marijuana treatment center must demonstrate:
1. That, for the 5 consecutive years before submitting the application, the applicant has been registered to do business in the state.
2. Possession of a valid certificate of registration issued by the Department of Agriculture and Consumer Services pursuant to s. 581.131.
3. The technical and technological ability to cultivate and produce marijuana, including, but not limited to, low-THC cannabis.
4. The ability to secure the premises, resources, and personnel necessary to operate as a medical marijuana treatment center.
5. The ability to maintain accountability of all raw materials, finished products, and any byproducts to prevent diversion or unlawful access to or possession of these substances.
6. An infrastructure reasonably located to dispense marijuana to registered qualified patients statewide or regionally as determined by the department.
7. The financial ability to maintain operations for the duration of the 2-year approval cycle, including the provision of certified financial statements to the department.
a. Upon approval, the applicant must post a $5 million performance bond issued by an authorized surety insurance company rated in one of the three highest rating categories by a nationally recognized rating service. However, a medical marijuana treatment center serving at least 1,000 qualified patients is only required to maintain a $2 million performance bond.
b. In lieu of the performance bond required under sub-subparagraph a., the applicant may provide an irrevocable letter of credit payable to the department or provide cash to the department. If provided with cash under this sub-subparagraph, the department shall deposit the cash in the Grants and Donations Trust Fund within the Department of Health, subject to the same conditions as the bond regarding requirements for the applicant to forfeit ownership of the funds. If the funds deposited under this sub-subparagraph generate interest, the amount of that interest shall be used by the department for the administration of this section.
8. That all owners, officers, board members, and managers have passed a background screening pursuant to subsection (9).
9. The employment of a medical director to supervise the activities of the medical marijuana treatment center.
10. A diversity plan that promotes and ensures the involvement of minority persons and minority business enterprises, as defined in s. 288.703, or veteran business enterprises, as defined in s. 295.187, in ownership, management, and employment. An applicant for licensure renewal must show the effectiveness of the diversity plan by including the following with his or her application for renewal:
a. Representation of minority persons and veterans in the medical marijuana treatment center’s workforce;
b. Efforts to recruit minority persons and veterans for employment; and
c. A record of contracts for services with minority business enterprises and veteran business enterprises.
(c) A medical marijuana treatment center may not make a wholesale purchase of marijuana from, or a distribution of marijuana to, another medical marijuana treatment center, unless the medical marijuana treatment center seeking to make a wholesale purchase of marijuana submits proof of harvest failure to the department.
(d) The department shall establish, maintain, and control a computer software tracking system that traces marijuana from seed to sale and allows real-time, 24-hour access by the department to data from all medical marijuana treatment centers and marijuana testing laboratories. The tracking system must allow for integration of other seed-to-sale systems and, at a minimum, include notification of when marijuana seeds are planted, when marijuana plants are harvested and destroyed, and when marijuana is transported, sold, stolen, diverted, or lost. Each medical marijuana treatment center shall use the seed-to-sale tracking system established by the department or integrate its own seed-to-sale tracking system with the seed-to-sale tracking system established by the department. Each medical marijuana treatment center may use its own seed-to-sale system until the department establishes a seed-to-sale tracking system. The department may contract with a vendor to establish the seed-to-sale tracking system. The vendor selected by the department may not have a contractual relationship with the department to perform any services pursuant to this section other than the seed-to-sale tracking system. The vendor may not have a direct or indirect financial interest in a medical marijuana treatment center or a marijuana testing laboratory.
(e) A licensed medical marijuana treatment center shall cultivate, process, transport, and dispense marijuana for medical use. A licensed medical marijuana treatment center may not contract for services directly related to the cultivation, processing, and dispensing of marijuana or marijuana delivery devices, except that a medical marijuana treatment center licensed pursuant to subparagraph (a)1. may contract with a single entity for the cultivation, processing, transporting, and dispensing of marijuana and marijuana delivery devices. A licensed medical marijuana treatment center must, at all times, maintain compliance with the criteria demonstrated and representations made in the initial application and the criteria established in this subsection. Upon request, the department may grant a medical marijuana treatment center a variance from the representations made in the initial application. Consideration of such a request shall be based upon the individual facts and circumstances surrounding the request. A variance may not be granted unless the requesting medical marijuana treatment center can demonstrate to the department that it has a proposed alternative to the specific representation made in its application which fulfills the same or a similar purpose as the specific representation in a way that the department can reasonably determine will not be a lower standard than the specific representation in the application. A variance may not be granted from the requirements in subparagraph 2. and subparagraphs (b)1. and 2.
1. A licensed medical marijuana treatment center may transfer ownership to an individual or entity who meets the requirements of this section. A publicly traded corporation or publicly traded company that meets the requirements of this section is not precluded from ownership of a medical marijuana treatment center. To accommodate a change in ownership:
a. The licensed medical marijuana treatment center shall notify the department in writing at least 60 days before the anticipated date of the change of ownership.
b. The individual or entity applying for initial licensure due to a change of ownership must submit an application that must be received by the department at least 60 days before the date of change of ownership.
c. Upon receipt of an application for a license, the department shall examine the application and, within 30 days after receipt, notify the applicant in writing of any apparent errors or omissions and request any additional information required.
d. Requested information omitted from an application for licensure must be filed with the department within 21 days after the department’s request for omitted information or the application shall be deemed incomplete and shall be withdrawn from further consideration and the fees shall be forfeited.
e. Within 30 days after the receipt of a complete application, the department shall approve or deny the application.
2. A medical marijuana treatment center, and any individual or entity who directly or indirectly owns, controls, or holds with power to vote 5 percent or more of the voting shares of a medical marijuana treatment center, may not acquire direct or indirect ownership or control of any voting shares or other form of ownership of any other medical marijuana treatment center.
3. A medical marijuana treatment center may not enter into any form of profit-sharing arrangement with the property owner or lessor of any of its facilities where cultivation, processing, storing, or dispensing of marijuana and marijuana delivery devices occurs.
4. All employees of a medical marijuana treatment center must be 21 years of age or older and have passed a background screening pursuant to subsection (9).
5. Each medical marijuana treatment center must adopt and enforce policies and procedures to ensure employees and volunteers receive training on the legal requirements to dispense marijuana to qualified patients.
6. When growing marijuana, a medical marijuana treatment center:
a. May use pesticides determined by the department, after consultation with the Department of Agriculture and Consumer Services, to be safely applied to plants intended for human consumption, but may not use pesticides designated as restricted-use pesticides pursuant to s. 487.042.
b. Must grow marijuana within an enclosed structure and in a room separate from any other plant.
c. Must inspect seeds and growing plants for plant pests that endanger or threaten the horticultural and agricultural interests of the state in accordance with chapter 581 and any rules adopted thereunder.
d. Must perform fumigation or treatment of plants, or remove and destroy infested or infected plants, in accordance with chapter 581 and any rules adopted thereunder.
7. Each medical marijuana treatment center must produce and make available for purchase at least one low-THC cannabis product.
8. A medical marijuana treatment center that produces edibles must hold a permit to operate as a food establishment pursuant to chapter 500, the Florida Food Safety Act, and must comply with all the requirements for food establishments pursuant to chapter 500 and any rules adopted thereunder. Edibles may not contain more than 200 milligrams of tetrahydrocannabinol, and a single serving portion of an edible may not exceed 10 milligrams of tetrahydrocannabinol. Edibles may have a potency variance of no greater than 15 percent. Marijuana products, including edibles, may not be attractive to children; be manufactured in the shape of humans, cartoons, or animals; be manufactured in a form that bears any reasonable resemblance to products available for consumption as commercially available candy; or contain any color additives. To discourage consumption of edibles by children, the department shall determine by rule any shapes, forms, and ingredients allowed and prohibited for edibles. Medical marijuana treatment centers may not begin processing or dispensing edibles until after the effective date of the rule. The department shall also adopt sanitation rules providing the standards and requirements for the storage, display, or dispensing of edibles.
9. Within 12 months after licensure, a medical marijuana treatment center must demonstrate to the department that all of its processing facilities have passed a Food Safety Good Manufacturing Practices, such as Global Food Safety Initiative or equivalent, inspection by a nationally accredited certifying body. A medical marijuana treatment center must immediately stop processing at any facility which fails to pass this inspection until it demonstrates to the department that such facility has met this requirement.
10. A medical marijuana treatment center that produces prerolled marijuana cigarettes may not use wrapping paper made with tobacco or hemp.
11. When processing marijuana, a medical marijuana treatment center must:
a. Process the marijuana within an enclosed structure and in a room separate from other plants or products.
b. Comply with department rules when processing marijuana with hydrocarbon solvents or other solvents or gases exhibiting potential toxicity to humans. The department shall determine by rule the requirements for medical marijuana treatment centers to use such solvents or gases exhibiting potential toxicity to humans.
c. Comply with federal and state laws and regulations and department rules for solid and liquid wastes. The department shall determine by rule procedures for the storage, handling, transportation, management, and disposal of solid and liquid waste generated during marijuana production and processing. The Department of Environmental Protection shall assist the department in developing such rules.
d. Test the processed marijuana using a medical marijuana testing laboratory before it is dispensed. Results must be verified and signed by two medical marijuana treatment center employees. Before dispensing, the medical marijuana treatment center must determine that the test results indicate that low-THC cannabis meets the definition of low-THC cannabis, the concentration of tetrahydrocannabinol meets the potency requirements of this section, the labeling of the concentration of tetrahydrocannabinol and cannabidiol is accurate, and all marijuana is safe for human consumption and free from contaminants that are unsafe for human consumption. The department shall determine by rule which contaminants must be tested for and the maximum levels of each contaminant which are safe for human consumption. The Department of Agriculture and Consumer Services shall assist the department in developing the testing requirements for contaminants that are unsafe for human consumption in edibles. The department shall also determine by rule the procedures for the treatment of marijuana that fails to meet the testing requirements of this section, s. 381.988, or department rule. The department may select samples of marijuana from a medical marijuana treatment center facility which shall be tested by the department to determine whether the marijuana meets the potency requirements of this section, is safe for human consumption, and is accurately labeled with the tetrahydrocannabinol and cannabidiol concentration or to verify the result of marijuana testing conducted by a marijuana testing laboratory. The department may also select samples of marijuana delivery devices from a medical marijuana treatment center to determine whether the marijuana delivery device is safe for use by qualified patients. A medical marijuana treatment center may not require payment from the department for the sample. A medical marijuana treatment center must recall marijuana, including all marijuana and marijuana products made from the same batch of marijuana, that fails to meet the potency requirements of this section, that is unsafe for human consumption, or for which the labeling of the tetrahydrocannabinol and cannabidiol concentration is inaccurate. The department shall adopt rules to establish marijuana potency variations of no greater than 15 percent using negotiated rulemaking pursuant to s. 120.54(2)(d) which accounts for, but is not limited to, time lapses between testing, testing methods, testing instruments, and types of marijuana sampled for testing. The department may not issue any recalls for product potency as it relates to product labeling before issuing a rule relating to potency variation standards. A medical marijuana treatment center must also recall all marijuana delivery devices determined to be unsafe for use by qualified patients. The medical marijuana treatment center must retain records of all testing and samples of each homogeneous batch of marijuana for at least 9 months. The medical marijuana treatment center must contract with a marijuana testing laboratory to perform audits on the medical marijuana treatment center’s standard operating procedures, testing records, and samples and provide the results to the department to confirm that the marijuana or low-THC cannabis meets the requirements of this section and that the marijuana or low-THC cannabis is safe for human consumption. A medical marijuana treatment center shall reserve two processed samples from each batch and retain such samples for at least 9 months for the purpose of such audits. A medical marijuana treatment center may use a laboratory that has not been certified by the department under s. 381.988 until such time as at least one laboratory holds the required certification, but in no event later than July 1, 2018.
e. Package the marijuana in compliance with the United States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
f. Package the marijuana in a receptacle that has a firmly affixed and legible label stating the following information:
(I) The marijuana or low-THC cannabis meets the requirements of sub-subparagraph d.
(II) The name of the medical marijuana treatment center from which the marijuana originates.
(III) The batch number and harvest number from which the marijuana originates and the date dispensed.
(IV) The name of the physician who issued the physician certification.
(V) The name of the patient.
(VI) The product name, if applicable, and dosage form, including concentration of tetrahydrocannabinol and cannabidiol. The product name may not contain wording commonly associated with products that are attractive to children or which promote the recreational use of marijuana.
(VII) The recommended dose.
(VIII) A warning that it is illegal to transfer medical marijuana to another person.
(IX) A marijuana universal symbol developed by the department.
12. The medical marijuana treatment center shall include in each package a patient package insert with information on the specific product dispensed related to:
a. Clinical pharmacology.
b. Indications and use.
c. Dosage and administration.
d. Dosage forms and strengths.
e. Contraindications.
f. Warnings and precautions.
g. Adverse reactions.
13. In addition to the packaging and labeling requirements specified in subparagraphs 11. and 12., marijuana in a form for smoking must be packaged in a sealed receptacle with a legible and prominent warning to keep away from children and a warning that states marijuana smoke contains carcinogens and may negatively affect health. Such receptacles for marijuana in a form for smoking must be plain, opaque, and white without depictions of the product or images other than the medical marijuana treatment center’s department-approved logo and the marijuana universal symbol.
14. The department shall adopt rules to regulate the types, appearance, and labeling of marijuana delivery devices dispensed from a medical marijuana treatment center. The rules must require marijuana delivery devices to have an appearance consistent with medical use.
15. Each edible must be individually sealed in plain, opaque wrapping marked only with the marijuana universal symbol. Where practical, each edible must be marked with the marijuana universal symbol. In addition to the packaging and labeling requirements in subparagraphs 11. and 12., edible receptacles must be plain, opaque, and white without depictions of the product or images other than the medical marijuana treatment center’s department-approved logo and the marijuana universal symbol. The receptacle must also include a list of all the edible’s ingredients, storage instructions, an expiration date, a legible and prominent warning to keep away from children and pets, and a warning that the edible has not been produced or inspected pursuant to federal food safety laws.
16. When dispensing marijuana or a marijuana delivery device, a medical marijuana treatment center:
a. May dispense any active, valid order for low-THC cannabis, medical cannabis and cannabis delivery devices issued pursuant to former s. 381.986, Florida Statutes 2016, which was entered into the medical marijuana use registry before July 1, 2017.
b. May not dispense more than a 70-day supply of marijuana within any 70-day period to a qualified patient or caregiver. May not dispense more than one 35-day supply of marijuana in a form for smoking within any 35-day period to a qualified patient or caregiver. A 35-day supply of marijuana in a form for smoking may not exceed 2.5 ounces unless an exception to this amount is approved by the department pursuant to paragraph (4)(f).
c. Must have the medical marijuana treatment center’s employee who dispenses the marijuana or a marijuana delivery device enter into the medical marijuana use registry his or her name or unique employee identifier.
d. Must verify that the qualified patient and the caregiver, if applicable, each have an active registration in the medical marijuana use registry and an active and valid medical marijuana use registry identification card, the amount and type of marijuana dispensed matches the physician certification in the medical marijuana use registry for that qualified patient, and the physician certification has not already been filled.
e. May not dispense marijuana to a qualified patient who is younger than 18 years of age. If the qualified patient is younger than 18 years of age, marijuana may only be dispensed to the qualified patient’s caregiver.
f. May not dispense or sell any other type of cannabis, alcohol, or illicit drug-related product, including pipes or wrapping papers made with tobacco or hemp, other than a marijuana delivery device required for the medical use of marijuana and which is specified in a physician certification.
g. Must, upon dispensing the marijuana or marijuana delivery device, record in the registry the date, time, quantity, and form of marijuana dispensed; the type of marijuana delivery device dispensed; and the name and medical marijuana use registry identification number of the qualified patient or caregiver to whom the marijuana delivery device was dispensed.
h. Must ensure that patient records are not visible to anyone other than the qualified patient, his or her caregiver, and authorized medical marijuana treatment center employees.
(f) To ensure the safety and security of premises where the cultivation, processing, storing, or dispensing of marijuana occurs, and to maintain adequate controls against the diversion, theft, and loss of marijuana or marijuana delivery devices, a medical marijuana treatment center shall:
1.a. Maintain a fully operational security alarm system that secures all entry points and perimeter windows and is equipped with motion detectors; pressure switches; and duress, panic, and hold-up alarms; and
b. Maintain a video surveillance system that records continuously 24 hours a day and meets the following criteria:
(I) Cameras are fixed in a place that allows for the clear identification of persons and activities in controlled areas of the premises. Controlled areas include grow rooms, processing rooms, storage rooms, disposal rooms or areas, and point-of-sale rooms.
(II) Cameras are fixed in entrances and exits to the premises, which shall record from both indoor and outdoor, or ingress and egress, vantage points.
(III) Recorded images must clearly and accurately display the time and date.
(IV) Retain video surveillance recordings for at least 45 days or longer upon the request of a law enforcement agency.
2. Ensure that the medical marijuana treatment center’s outdoor premises have sufficient lighting from dusk until dawn.
3. Ensure that the indoor premises where dispensing occurs includes a waiting area with sufficient space and seating to accommodate qualified patients and caregivers and at least one private consultation area that is isolated from the waiting area and area where dispensing occurs. A medical marijuana treatment center may not display products or dispense marijuana or marijuana delivery devices in the waiting area.
4. Not dispense from its premises marijuana or a marijuana delivery device between the hours of 9 p.m. and 7 a.m., but may perform all other operations and deliver marijuana to qualified patients 24 hours a day.
5. Store marijuana in a secured, locked room or a vault.
6. Require at least two of its employees, or two employees of a security agency with whom it contracts, to be on the premises at all times where cultivation, processing, or storing of marijuana occurs.
7. Require each employee or contractor to wear a photo identification badge at all times while on the premises.
8. Require each visitor to wear a visitor pass at all times while on the premises.
9. Implement an alcohol and drug-free workplace policy.
10. Report to local law enforcement within 24 hours after the medical marijuana treatment center is notified or becomes aware of the theft, diversion, or loss of marijuana.
(g) To ensure the safe transport of marijuana and marijuana delivery devices to medical marijuana treatment centers, marijuana testing laboratories, or qualified patients, a medical marijuana treatment center must:
1. Maintain a marijuana transportation manifest in any vehicle transporting marijuana. The marijuana transportation manifest must be generated from a medical marijuana treatment center’s seed-to-sale tracking system and include the:
a. Departure date and approximate time of departure.
b. Name, location address, and license number of the originating medical marijuana treatment center.
c. Name and address of the recipient of the delivery.
d. Quantity and form of any marijuana or marijuana delivery device being transported.
e. Arrival date and estimated time of arrival.
f. Delivery vehicle make and model and license plate number.
g. Name and signature of the medical marijuana treatment center employees delivering the product.
(I) A copy of the marijuana transportation manifest must be provided to each individual, medical marijuana treatment center, or marijuana testing laboratory that receives a delivery. The individual, or a representative of the center or laboratory, must sign a copy of the marijuana transportation manifest acknowledging receipt.
(II) An individual transporting marijuana or a marijuana delivery device must present a copy of the relevant marijuana transportation manifest and his or her employee identification card to a law enforcement officer upon request.
(III) Medical marijuana treatment centers and marijuana testing laboratories must retain copies of all marijuana transportation manifests for at least 3 years.
2. Ensure only vehicles in good working order are used to transport marijuana.
3. Lock marijuana and marijuana delivery devices in a separate compartment or container within the vehicle.
4. Require employees to have possession of their employee identification card at all times when transporting marijuana or marijuana delivery devices.
5. Require at least two persons to be in a vehicle transporting marijuana or marijuana delivery devices, and require at least one person to remain in the vehicle while the marijuana or marijuana delivery device is being delivered.
6. Provide specific safety and security training to employees transporting or delivering marijuana and marijuana delivery devices.
(h) A medical marijuana treatment center may not engage in advertising that is visible to members of the public from any street, sidewalk, park, or other public place, except:
1. The dispensing location of a medical marijuana treatment center may have a sign that is affixed to the outside or hanging in the window of the premises which identifies the dispensary by the licensee’s business name, a department-approved trade name, or a department-approved logo. A medical marijuana treatment center’s trade name and logo may not contain wording or images that are attractive to children or which promote recreational use of marijuana.
2. A medical marijuana treatment center may engage in Internet advertising and marketing under the following conditions:
a. All advertisements must be approved by the department.
b. An advertisement may not have any content that is attractive to children or which promotes the recreational use of marijuana.
c. An advertisement may not be an unsolicited pop-up advertisement.
d. Opt-in marketing must include an easy and permanent opt-out feature.
(i) Each medical marijuana treatment center that dispenses marijuana and marijuana delivery devices shall make available to the public on its website:
1. Each marijuana and low-THC product available for purchase, including the form, strain of marijuana from which it was extracted, cannabidiol content, tetrahydrocannabinol content, dose unit, total number of doses available, and the ratio of cannabidiol to tetrahydrocannabinol for each product.
2. The price for a 30-day, 50-day, and 70-day supply at a standard dose for each marijuana and low-THC product available for purchase.
3. The price for each marijuana delivery device available for purchase.
4. If applicable, any discount policies and eligibility criteria for such discounts.
(j) Medical marijuana treatment centers are the sole source from which a qualified patient may legally obtain marijuana.
(k) The department may adopt rules pursuant to ss. 120.536(1) and 120.54 to implement this subsection.
(9) BACKGROUND SCREENING.—An individual required to undergo a background screening pursuant to this section must pass a level 2 background screening as provided under chapter 435, which, in addition to the disqualifying offenses provided in s. 435.04, shall exclude an individual who has an arrest awaiting final disposition for, has been found guilty of, regardless of adjudication, or has entered a plea of nolo contendere or guilty to an offense under chapter 837, chapter 895, or chapter 896 or similar law of another jurisdiction. Exemptions from disqualification as provided under s. 435.07 do not apply to this subsection.
(a) Such individual must submit a full set of fingerprints to the department or to a vendor, entity, or agency authorized by s. 943.053(13). The department, vendor, entity, or agency shall forward the fingerprints to the Department of Law Enforcement for state processing, and the Department of Law Enforcement shall forward the fingerprints to the Federal Bureau of Investigation for national processing.
(b) Fees for state and federal fingerprint processing and retention shall be borne by the medical marijuana treatment center or caregiver, as applicable. The state cost for fingerprint processing shall be as provided in s. 943.053(3)(e) for records provided to persons or entities other than those specified as exceptions therein.
(c) Fingerprints submitted to the Department of Law Enforcement pursuant to this subsection shall be retained by the Department of Law Enforcement as provided in s. 943.05(2)(g) and (h) and, when the Department of Law Enforcement begins participation in the program, enrolled in the Federal Bureau of Investigation’s national retained print arrest notification program. Any arrest record identified shall be reported to the department.
(10) MEDICAL MARIJUANA TREATMENT CENTER INSPECTIONS; ADMINISTRATIVE ACTIONS.—
(a) The department shall conduct announced or unannounced inspections of medical marijuana treatment centers to determine compliance with this section or rules adopted pursuant to this section.
(b) The department shall inspect a medical marijuana treatment center upon receiving a complaint or notice that the medical marijuana treatment center has dispensed marijuana containing mold, bacteria, or other contaminant that may cause or has caused an adverse effect to human health or the environment.
(c) The department shall conduct at least a biennial inspection of each medical marijuana treatment center to evaluate the medical marijuana treatment center’s records, personnel, equipment, processes, security measures, sanitation practices, and quality assurance practices.
(d) The Department of Agriculture and Consumer Services and the department shall enter into an interagency agreement to ensure cooperation and coordination in the performance of their obligations under this section and their respective regulatory and authorizing laws. The department, the Department of Highway Safety and Motor Vehicles, and the Department of Law Enforcement may enter into interagency agreements for the purposes specified in this subsection or subsection (7).
(e) The department shall publish a list of all approved medical marijuana treatment centers, medical directors, and qualified physicians on its website.
(f) The department may impose reasonable fines not to exceed $10,000 on a medical marijuana treatment center for any of the following violations:
1. Violating this section or department rule.
2. Failing to maintain qualifications for approval.
3. Endangering the health, safety, or security of a qualified patient.
4. Improperly disclosing personal and confidential information of the qualified patient.
5. Attempting to procure medical marijuana treatment center approval by bribery, fraudulent misrepresentation, or extortion.
6. Being convicted or found guilty of, or entering a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which directly relates to the business of a medical marijuana treatment center.
7. Making or filing a report or record that the medical marijuana treatment center knows to be false.
8. Willfully failing to maintain a record required by this section or department rule.
9. Willfully impeding or obstructing an employee or agent of the department in the furtherance of his or her official duties.
10. Engaging in fraud or deceit, negligence, incompetence, or misconduct in the business practices of a medical marijuana treatment center.
11. Making misleading, deceptive, or fraudulent representations in or related to the business practices of a medical marijuana treatment center.
12. Having a license or the authority to engage in any regulated profession, occupation, or business that is related to the business practices of a medical marijuana treatment center suspended, revoked, or otherwise acted against by the licensing authority of any jurisdiction, including its agencies or subdivisions, for a violation that would constitute a violation under Florida law.
13. Violating a lawful order of the department or an agency of the state, or failing to comply with a lawfully issued subpoena of the department or an agency of the state.
(g) The department may suspend, revoke, or refuse to renew a medical marijuana treatment center license if the medical marijuana treatment center commits any of the violations in paragraph (f).
(h) The department may adopt rules pursuant to ss. 120.536(1) and 120.54 to implement this subsection.
(11) PREEMPTION.—Regulation of cultivation, processing, and delivery of marijuana by medical marijuana treatment centers is preempted to the state except as provided in this subsection.
(a) A medical marijuana treatment center cultivating or processing facility may not be located within 500 feet of the real property that comprises a public or private elementary school, middle school, or secondary school.
(b)1. A county or municipality may, by ordinance, ban medical marijuana treatment center dispensing facilities from being located within the boundaries of that county or municipality. A county or municipality that does not ban dispensing facilities under this subparagraph may not place specific limits, by ordinance, on the number of dispensing facilities that may locate within that county or municipality.
2. A municipality may determine by ordinance the criteria for the location of, and other permitting requirements that do not conflict with state law or department rule for, medical marijuana treatment center dispensing facilities located within the boundaries of that municipality. A county may determine by ordinance the criteria for the location of, and other permitting requirements that do not conflict with state law or department rule for, all such dispensing facilities located within the unincorporated areas of that county. Except as provided in paragraph (c), a county or municipality may not enact ordinances for permitting or for determining the location of dispensing facilities which are more restrictive than its ordinances permitting or determining the locations for pharmacies licensed under chapter 465. A municipality or county may not charge a medical marijuana treatment center a license or permit fee in an amount greater than the fee charged by such municipality or county to pharmacies. A dispensing facility location approved by a municipality or county pursuant to former s. 381.986(8)(b), Florida Statutes 2016, is not subject to the location requirements of this subsection.
(c) A medical marijuana treatment center dispensing facility may not be located within 500 feet of the real property that comprises a public or private elementary school, middle school, or secondary school unless the county or municipality approves the location through a formal proceeding open to the public at which the county or municipality determines that the location promotes the public health, safety, and general welfare of the community.
(d) This subsection does not prohibit any local jurisdiction from ensuring medical marijuana treatment center facilities comply with the Florida Building Code, the Florida Fire Prevention Code, or any local amendments to the Florida Building Code or the Florida Fire Prevention Code.
(12) PENALTIES.—
(a) A qualified physician commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, if the qualified physician issues a physician certification for the medical use of marijuana for a patient without a reasonable belief that the patient is suffering from a qualifying medical condition.
(b) A person who fraudulently represents that he or she has a qualifying medical condition to a qualified physician for the purpose of being issued a physician certification commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(c) A qualified patient who uses marijuana, not including low-THC cannabis, or a caregiver who administers marijuana, not including low-THC cannabis, in plain view of or in a place open to the general public; in a school bus, a vehicle, an aircraft, or a boat; or on the grounds of a school except as provided in s. 1006.062, commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(d) A qualified patient or caregiver who cultivates marijuana or who purchases or acquires marijuana from any person or entity other than a medical marijuana treatment center violates s. 893.13 and is subject to the penalties provided therein.
(e)1. A qualified patient or caregiver in possession of marijuana or a marijuana delivery device who fails or refuses to present his or her marijuana use registry identification card upon the request of a law enforcement officer commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083, unless it can be determined through the medical marijuana use registry that the person is authorized to be in possession of that marijuana or marijuana delivery device.
2. A person charged with a violation of this paragraph may not be convicted if, before or at the time of his or her court or hearing appearance, the person produces in court or to the clerk of the court in which the charge is pending a medical marijuana use registry identification card issued to him or her which is valid at the time of his or her arrest. The clerk of the court is authorized to dismiss such case at any time before the defendant’s appearance in court. The clerk of the court may assess a fee of $5 for dismissing the case under this paragraph.
(f) A caregiver who violates any of the applicable provisions of this section or applicable department rules, for the first offense, commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083 and, for a second or subsequent offense, commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(g) A qualified physician who issues a physician certification for marijuana or a marijuana delivery device and receives compensation from a medical marijuana treatment center related to the issuance of a physician certification for marijuana or a marijuana delivery device is subject to disciplinary action under the applicable practice act and s. 456.072(1)(n).
(h) A person transporting marijuana or marijuana delivery devices on behalf of a medical marijuana treatment center or marijuana testing laboratory who fails or refuses to present a transportation manifest upon the request of a law enforcement officer commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
(i) Persons and entities conducting activities authorized and governed by this section and s. 381.988 are subject to ss. 456.053, 456.054, and 817.505, as applicable.
(j) A person or entity that cultivates, processes, distributes, sells, or dispenses marijuana, as defined in s. 29(b)(4), Art. X of the State Constitution, and is not licensed as a medical marijuana treatment center violates s. 893.13 and is subject to the penalties provided therein.
(k) A person who manufactures, distributes, sells, gives, or possesses with the intent to manufacture, distribute, sell, or give marijuana or a marijuana delivery device that he or she holds out to have originated from a licensed medical marijuana treatment center but that is counterfeit commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084. For the purposes of this paragraph, the term “counterfeit” means marijuana; a marijuana delivery device; or a marijuana or marijuana delivery device container, seal, or label which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a licensed medical marijuana treatment center and which thereby falsely purports or is represented to be the product of, or to have been distributed by, that licensed medical marijuana treatment facility.
(l) Any person who possesses or manufactures a blank, forged, stolen, fictitious, fraudulent, counterfeit, or otherwise unlawfully issued medical marijuana use registry identification card commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(13) UNLICENSED ACTIVITY.—
(a) If the department has probable cause to believe that a person or entity that is not registered or licensed with the department has violated this section, s. 381.988, or any rule adopted pursuant to this section, the department may issue and deliver to such person or entity a notice to cease and desist from such violation. The department also may issue and deliver a notice to cease and desist to any person or entity who aids and abets such unlicensed activity. The issuance of a notice to cease and desist does not constitute agency action for which a hearing under s. 120.569 or s. 120.57 may be sought. For the purpose of enforcing a cease and desist order, the department may file a proceeding in the name of the state seeking issuance of an injunction or a writ of mandamus against any person or entity who violates any provisions of such order.
(b) In addition to the remedies under paragraph (a), the department may impose by citation an administrative penalty not to exceed $5,000 per incident. The citation shall be issued to the subject and must contain the subject’s name and any other information the department determines to be necessary to identify the subject, a brief factual statement, the sections of the law allegedly violated, and the penalty imposed. If the subject does not dispute the matter in the citation with the department within 30 days after the citation is served, the citation shall become a final order of the department. The department may adopt rules pursuant to ss. 120.536(1) and 120.54 to implement this section. Each day that the unlicensed activity continues after issuance of a notice to cease and desist constitutes a separate violation. The department shall be entitled to recover the costs of investigation and prosecution in addition to the fine levied pursuant to the citation. Service of a citation may be made by personal service or by mail to the subject at the subject’s last known address or place of practice. If the department is required to seek enforcement of the cease and desist or agency order, it shall be entitled to collect attorney fees and costs.
(c) In addition to or in lieu of any other administrative remedy, the department may seek the imposition of a civil penalty through the circuit court for any violation for which the department may issue a notice to cease and desist. The civil penalty shall be no less than $5,000 and no more than $10,000 for each offense. The court may also award to the prevailing party court costs and reasonable attorney fees and, in the event the department prevails, may also award reasonable costs of investigation and prosecution.
(d) In addition to the other remedies provided in this section, the department or any state attorney may bring an action for an injunction to restrain any unlicensed activity or to enjoin the future operation or maintenance of the unlicensed activity or the performance of any service in violation of this section.
(e) The department must notify local law enforcement of such unlicensed activity for a determination of any criminal violation of chapter 893.
(14) EXCEPTIONS TO OTHER LAWS.—
(a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or any other provision of law, but subject to the requirements of this section, a qualified patient and the qualified patient’s caregiver may purchase from a medical marijuana treatment center for the patient’s medical use a marijuana delivery device and up to the amount of marijuana authorized in the physician certification, but may not possess more than a 70-day supply of marijuana, or the greater of 4 ounces of marijuana in a form for smoking or an amount of marijuana in a form for smoking approved by the department pursuant to paragraph (4)(f), at any given time and all marijuana purchased must remain in its original packaging.
(b) Notwithstanding paragraph (a), s. 893.13, s. 893.135, s. 893.147, or any other provision of law, a qualified patient and the qualified patient’s caregiver may purchase and possess a marijuana delivery device intended for the medical use of marijuana by smoking from a vendor other than a medical marijuana treatment center.
(c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or any other provision of law, but subject to the requirements of this section, an approved medical marijuana treatment center and its owners, managers, and employees may manufacture, possess, sell, deliver, distribute, dispense, and lawfully dispose of marijuana or a marijuana delivery device as provided in this section, s. 381.988, and by department rule. For the purposes of this subsection, the terms “manufacture,” “possession,” “deliver,” “distribute,” and “dispense” have the same meanings as provided in s. 893.02.
(d) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or any other provision of law, but subject to the requirements of this section, a certified marijuana testing laboratory, including an employee of a certified marijuana testing laboratory acting within the scope of his or her employment, may acquire, possess, test, transport, and lawfully dispose of marijuana as provided in this section, in s. 381.988, and by department rule.
(e) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or any other law, but subject to the requirements of this section, the department, including an employee of the department acting within the scope of his or her employment, may acquire, possess, test, transport, and lawfully dispose of marijuana and marijuana delivery devices as provided in this section, in s. 381.988, and by department rule.
(f) A licensed medical marijuana treatment center and its owners, managers, and employees are not subject to licensure or regulation under chapter 465 or chapter 499 for manufacturing, possessing, selling, delivering, distributing, dispensing, or lawfully disposing of marijuana or a marijuana delivery device, as provided in this section, in s. 381.988, and by department rule.
(g) This subsection does not exempt a person from prosecution for a criminal offense related to impairment or intoxication resulting from the medical use of marijuana or relieve a person from any requirement under law to submit to a breath, blood, urine, or other test to detect the presence of a controlled substance.
(h) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or any other provision of law, but subject to the requirements of this section and pursuant to policies and procedures established pursuant to s. 1006.062(8), school personnel may possess marijuana that is obtained for medical use pursuant to this section by a student who is a qualified patient.
(i) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or any other provision of law, but subject to the requirements of this section, a research institute established by a public postsecondary educational institution, such as the H. Lee Moffitt Cancer Center and Research Institute, Inc., established under s. 1004.43, or a state university that has achieved the preeminent state research university designation under s. 1001.7065 may possess, test, transport, and lawfully dispose of marijuana for research purposes as provided by this section.
(15) APPLICABILITY.—
(a) This section does not limit the ability of an employer to establish, continue, or enforce a drug-free workplace program or policy.
(b) This section does not require an employer to accommodate the medical use of marijuana in any workplace or any employee working while under the influence of marijuana.
(c) This section does not create a cause of action against an employer for wrongful discharge or discrimination.
(d) This section does not impair the ability of any party to restrict or limit smoking or vaping marijuana on his or her private property.
(e) This section does not prohibit the medical use of marijuana or a caregiver assisting with the medical use of marijuana in a nursing home facility licensed under part II of chapter 400, a hospice facility licensed under part IV of chapter 400, or an assisted living facility licensed under part I of chapter 429, if the medical use of marijuana is not prohibited in the facility’s policies.
(f) Marijuana, as defined in this section, is not reimbursable under chapter 440.
(16) FINES AND FEES.—Fines and fees collected by the department under this section shall be deposited in the Grants and Donations Trust Fund within the Department of Health.
2(17) Rules adopted pursuant to this section before July 1, 2025, are not subject to ss. 120.54(3)(b) and 120.541. This subsection expires July 1, 2025.
A. Section 1, ch. 2017-232, provides that “[i]t is the intent of the Legislature to implement s. 29, Article X of the State Constitution by creating a unified regulatory structure. If s. 29, Article X of the State Constitution is amended or a constitutional amendment related to cannabis or marijuana is adopted, this act shall expire 6 months after the effective date of such amendment.” If such amendment or adoption takes place, s. 381.986, as amended by s. 1, ch. 2017-232, will read:
381.986 Compassionate use of low-THC and medical cannabis.—
(1) DEFINITIONS.—As used in this section, the term:
(a) “Cannabis delivery device” means an object used, intended for use, or designed for use in preparing, storing, ingesting, inhaling, or otherwise introducing low-THC cannabis or medical cannabis into the human body.
(b) “Dispensing organization” means an organization approved by the department to cultivate, process, transport, and dispense low-THC cannabis or medical cannabis pursuant to this section.
(c) “Independent testing laboratory” means a laboratory, including the managers, employees, or contractors of the laboratory, which has no direct or indirect interest in a dispensing organization.
(d) “Legal representative” means the qualified patient’s parent, legal guardian acting pursuant to a court’s authorization as required under s. 744.3215(4), health care surrogate acting pursuant to the qualified patient’s written consent or a court’s authorization as required under s. 765.113, or an individual who is authorized under a power of attorney to make health care decisions on behalf of the qualified patient.
(e) “Low-THC cannabis” means a plant of the genus Cannabis, the dried flowers of which contain 0.8 percent or less of tetrahydrocannabinol and more than 10 percent of cannabidiol weight for weight; the seeds thereof; the resin extracted from any part of such plant; or any compound, manufacture, salt, derivative, mixture, or preparation of such plant or its seeds or resin that is dispensed only from a dispensing organization.
(f) “Medical cannabis” means all parts of any plant of the genus Cannabis, whether growing or not; the seeds thereof; the resin extracted from any part of the plant; and every compound, manufacture, sale, derivative, mixture, or preparation of the plant or its seeds or resin that is dispensed only from a dispensing organization for medical use by an eligible patient as defined in s. 499.0295.
(g) “Medical use” means administration of the ordered amount of low-THC cannabis or medical cannabis. The term does not include the:
1. Possession, use, or administration of low-THC cannabis or medical cannabis by smoking.
2. Transfer of low-THC cannabis or medical cannabis to a person other than the qualified patient for whom it was ordered or the qualified patient’s legal representative on behalf of the qualified patient.
3. Use or administration of low-THC cannabis or medical cannabis:
a. On any form of public transportation.
b. In any public place.
c. In a qualified patient’s place of employment, if restricted by his or her employer.
d. In a state correctional institution as defined in s. 944.02 or a correctional institution as defined in s. 944.241.
e. On the grounds of a preschool, primary school, or secondary school.
f. On a school bus or in a vehicle, aircraft, or motorboat.
(h) “Qualified patient” means a resident of this state who has been added to the compassionate use registry by a physician licensed under chapter 458 or chapter 459 to receive low-THC cannabis or medical cannabis from a dispensing organization.
(i) “Smoking” means burning or igniting a substance and inhaling the smoke. Smoking does not include the use of a vaporizer.
(2) PHYSICIAN ORDERING.—A physician is authorized to order low-THC cannabis to treat a qualified patient suffering from cancer or a physical medical condition that chronically produces symptoms of seizures or severe and persistent muscle spasms; order low-THC cannabis to alleviate symptoms of such disease, disorder, or condition, if no other satisfactory alternative treatment options exist for the qualified patient; order medical cannabis to treat an eligible patient as defined in s. 499.0295; or order a cannabis delivery device for the medical use of low-THC cannabis or medical cannabis, only if the physician:
(a) Holds an active, unrestricted license as a physician under chapter 458 or an osteopathic physician under chapter 459;
(b) Has treated the patient for at least 3 months immediately preceding the patient’s registration in the compassionate use registry;
(c) Has successfully completed the course and examination required under paragraph (4)(a);
(d) Has determined that the risks of treating the patient with low-THC cannabis or medical cannabis are reasonable in light of the potential benefit to the patient. If a patient is younger than 18 years of age, a second physician must concur with this determination, and such determination must be documented in the patient’s medical record;
(e) Registers as the orderer of low-THC cannabis or medical cannabis for the named patient on the compassionate use registry maintained by the department and updates the registry to reflect the contents of the order, including the amount of low-THC cannabis or medical cannabis that will provide the patient with not more than a 45-day supply and a cannabis delivery device needed by the patient for the medical use of low-THC cannabis or medical cannabis. The physician must also update the registry within 7 days after any change is made to the original order to reflect the change. The physician shall deactivate the registration of the patient and the patient’s legal representative when treatment is discontinued;
(f) Maintains a patient treatment plan that includes the dose, route of administration, planned duration, and monitoring of the patient’s symptoms and other indicators of tolerance or reaction to the low-THC cannabis or medical cannabis;
(g) Submits the patient treatment plan quarterly to the University of Florida College of Pharmacy for research on the safety and efficacy of low-THC cannabis and medical cannabis on patients;
(h) Obtains the voluntary written informed consent of the patient or the patient’s legal representative to treatment with low-THC cannabis after sufficiently explaining the current state of knowledge in the medical community of the effectiveness of treatment of the patient’s condition with low-THC cannabis, the medically acceptable alternatives, and the potential risks and side effects;
(i) Obtains written informed consent as defined in and required under s. 499.0295, if the physician is ordering medical cannabis for an eligible patient pursuant to that section; and
(j) Is not a medical director employed by a dispensing organization.
(3) PENALTIES.—
(a) A physician commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, if the physician orders low-THC cannabis for a patient without a reasonable belief that the patient is suffering from:
1. Cancer or a physical medical condition that chronically produces symptoms of seizures or severe and persistent muscle spasms that can be treated with low-THC cannabis; or
2. Symptoms of cancer or a physical medical condition that chronically produces symptoms of seizures or severe and persistent muscle spasms that can be alleviated with low-THC cannabis.
(b) A physician commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, if the physician orders medical cannabis for a patient without a reasonable belief that the patient has a terminal condition as defined in s. 499.0295.
(c) A person who fraudulently represents that he or she has cancer, a physical medical condition that chronically produces symptoms of seizures or severe and persistent muscle spasms, or a terminal condition to a physician for the purpose of being ordered low-THC cannabis, medical cannabis, or a cannabis delivery device by such physician commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(d) An eligible patient as defined in s. 499.0295 who uses medical cannabis, and such patient’s legal representative who administers medical cannabis, in plain view of or in a place open to the general public, on the grounds of a school, or in a school bus, vehicle, aircraft, or motorboat, commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(e) A physician who orders low-THC cannabis, medical cannabis, or a cannabis delivery device and receives compensation from a dispensing organization related to the ordering of low-THC cannabis, medical cannabis, or a cannabis delivery device is subject to disciplinary action under the applicable practice act and s. 456.072(1)(n).
(4) PHYSICIAN EDUCATION.—
(a) Before ordering low-THC cannabis, medical cannabis, or a cannabis delivery device for medical use by a patient in this state, the appropriate board shall require the ordering physician to successfully complete an 8-hour course and subsequent examination offered by the Florida Medical Association or the Florida Osteopathic Medical Association that encompasses the clinical indications for the appropriate use of low-THC cannabis and medical cannabis, the appropriate cannabis delivery devices, the contraindications for such use, and the relevant state and federal laws governing the ordering, dispensing, and possessing of these substances and devices. The course and examination shall be administered at least annually. Successful completion of the course may be used by a physician to satisfy 8 hours of the continuing medical education requirements required by his or her respective board for licensure renewal. This course may be offered in a distance learning format.
(b) The appropriate board shall require the medical director of each dispensing organization to hold an active, unrestricted license as a physician under chapter 458 or as an osteopathic physician under chapter 459 and successfully complete a 2-hour course and subsequent examination offered by the Florida Medical Association or the Florida Osteopathic Medical Association that encompasses appropriate safety procedures and knowledge of low-THC cannabis, medical cannabis, and cannabis delivery devices.
(c) Successful completion of the course and examination specified in paragraph (a) is required for every physician who orders low-THC cannabis, medical cannabis, or a cannabis delivery device each time such physician renews his or her license. In addition, successful completion of the course and examination specified in paragraph (b) is required for the medical director of each dispensing organization each time such physician renews his or her license.
(d) A physician who fails to comply with this subsection and who orders low-THC cannabis, medical cannabis, or a cannabis delivery device may be subject to disciplinary action under the applicable practice act and under s. 456.072(1)(k).
(5) DUTIES OF THE DEPARTMENT.—The department shall:
(a) Create and maintain a secure, electronic, and online compassionate use registry for the registration of physicians, patients, and the legal representatives of patients as provided under this section. The registry must be accessible to law enforcement agencies and to a dispensing organization to verify the authorization of a patient or a patient’s legal representative to possess low-THC cannabis, medical cannabis, or a cannabis delivery device and record the low-THC cannabis, medical cannabis, or cannabis delivery device dispensed. The registry must prevent an active registration of a patient by multiple physicians.
(b) Authorize the establishment of five dispensing organizations to ensure reasonable statewide accessibility and availability as necessary for patients registered in the compassionate use registry and who are ordered low-THC cannabis, medical cannabis, or a cannabis delivery device under this section, one in each of the following regions: northwest Florida, northeast Florida, central Florida, southeast Florida, and southwest Florida. The department shall develop an application form and impose an initial application and biennial renewal fee that is sufficient to cover the costs of administering this section. An applicant for approval as a dispensing organization must be able to demonstrate:
1. The technical and technological ability to cultivate and produce low-THC cannabis. The applicant must possess a valid certificate of registration issued by the Department of Agriculture and Consumer Services pursuant to s. 581.131 that is issued for the cultivation of more than 400,000 plants, be operated by a nurseryman as defined in s. 581.011, and have been operated as a registered nursery in this state for at least 30 continuous years.
2. The ability to secure the premises, resources, and personnel necessary to operate as a dispensing organization.
3. The ability to maintain accountability of all raw materials, finished products, and any byproducts to prevent diversion or unlawful access to or possession of these substances.
4. An infrastructure reasonably located to dispense low-THC cannabis to registered patients statewide or regionally as determined by the department.
5. The financial ability to maintain operations for the duration of the 2-year approval cycle, including the provision of certified financials to the department. Upon approval, the applicant must post a $5 million performance bond. However, upon a dispensing organization’s serving at least 1,000 qualified patients, the dispensing organization is only required to maintain a $2 million performance bond.
6. That all owners and managers have been fingerprinted and have successfully passed a level 2 background screening pursuant to s. 435.04.
7. The employment of a medical director to supervise the activities of the dispensing organization.
(c) Upon the registration of 250,000 active qualified patients in the compassionate use registry, approve three dispensing organizations, including, but not limited to, an applicant that is a recognized class member of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the Black Farmers and Agriculturalists Association, which must meet the requirements of subparagraphs (b)2.-7. and demonstrate the technical and technological ability to cultivate and produce low-THC cannabis.
(d) Allow a dispensing organization to make a wholesale purchase of low-THC cannabis or medical cannabis from, or a distribution of low-THC cannabis or medical cannabis to, another dispensing organization.
(e) Monitor physician registration and ordering of low-THC cannabis, medical cannabis, or a cannabis delivery device for ordering practices that could facilitate unlawful diversion or misuse of low-THC cannabis, medical cannabis, or a cannabis delivery device and take disciplinary action as indicated.
(6) DISPENSING ORGANIZATION.—An approved dispensing organization must, at all times, maintain compliance with the criteria demonstrated for selection and approval as a dispensing organization under subsection (5) and the criteria required in this subsection.
(a) When growing low-THC cannabis or medical cannabis, a dispensing organization:
1. May use pesticides determined by the department, after consultation with the Department of Agriculture and Consumer Services, to be safely applied to plants intended for human consumption, but may not use pesticides designated as restricted-use pesticides pursuant to s. 487.042.
2. Must grow low-THC cannabis or medical cannabis within an enclosed structure and in a room separate from any other plant.
3. Must inspect seeds and growing plants for plant pests that endanger or threaten the horticultural and agricultural interests of the state, notify the Department of Agriculture and Consumer Services within 10 calendar days after a determination that a plant is infested or infected by such plant pest, and implement and maintain phytosanitary policies and procedures.
4. Must perform fumigation or treatment of plants, or the removal and destruction of infested or infected plants, in accordance with chapter 581 and any rules adopted thereunder.
(b) When processing low-THC cannabis or medical cannabis, a dispensing organization must:
1. Process the low-THC cannabis or medical cannabis within an enclosed structure and in a room separate from other plants or products.
2. Test the processed low-THC cannabis and medical cannabis before they are dispensed. Results must be verified and signed by two dispensing organization employees. Before dispensing low-THC cannabis, the dispensing organization must determine that the test results indicate that the low-THC cannabis meets the definition of low-THC cannabis and, for medical cannabis and low-THC cannabis, that all medical cannabis and low-THC cannabis is safe for human consumption and free from contaminants that are unsafe for human consumption. The dispensing organization must retain records of all testing and samples of each homogenous batch of cannabis and low-THC cannabis for at least 9 months. The dispensing organization must contract with an independent testing laboratory to perform audits on the dispensing organization’s standard operating procedures, testing records, and samples and provide the results to the department to confirm that the low-THC cannabis or medical cannabis meets the requirements of this section and that the medical cannabis and low-THC cannabis is safe for human consumption.
3. Package the low-THC cannabis or medical cannabis in compliance with the United States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
4. Package the low-THC cannabis or medical cannabis in a receptacle that has a firmly affixed and legible label stating the following information:
a. A statement that the low-THC cannabis or medical cannabis meets the requirements of subparagraph 2.;
b. The name of the dispensing organization from which the medical cannabis or low-THC cannabis originates; and
c. The batch number and harvest number from which the medical cannabis or low-THC cannabis originates.
5. Reserve two processed samples from each batch and retain such samples for at least 9 months for the purpose of testing pursuant to the audit required under subparagraph 2.
(c) When dispensing low-THC cannabis, medical cannabis, or a cannabis delivery device, a dispensing organization:
1. May not dispense more than a 45-day supply of low-THC cannabis or medical cannabis to a patient or the patient’s legal representative.
2. Must have the dispensing organization’s employee who dispenses the low-THC cannabis, medical cannabis, or a cannabis delivery device enter into the compassionate use registry his or her name or unique employee identifier.
3. Must verify in the compassionate use registry that a physician has ordered the low-THC cannabis, medical cannabis, or a specific type of a cannabis delivery device for the patient.
4. May not dispense or sell any other type of cannabis, alcohol, or illicit drug-related product, including pipes, bongs, or wrapping papers, other than a physician-ordered cannabis delivery device required for the medical use of low-THC cannabis or medical cannabis, while dispensing low-THC cannabis or medical cannabis.
5. Must verify that the patient has an active registration in the compassionate use registry, the patient or patient’s legal representative holds a valid and active registration card, the order presented matches the order contents as recorded in the registry, and the order has not already been filled.
6. Must, upon dispensing the low-THC cannabis, medical cannabis, or cannabis delivery device, record in the registry the date, time, quantity, and form of low-THC cannabis or medical cannabis dispensed and the type of cannabis delivery device dispensed.
(d) To ensure the safety and security of its premises and any off-site storage facilities, and to maintain adequate controls against the diversion, theft, and loss of low-THC cannabis, medical cannabis, or cannabis delivery devices, a dispensing organization shall:
1.a. Maintain a fully operational security alarm system that secures all entry points and perimeter windows and is equipped with motion detectors; pressure switches; and duress, panic, and hold-up alarms; or
b. Maintain a video surveillance system that records continuously 24 hours each day and meets at least one of the following criteria:
(I) Cameras are fixed in a place that allows for the clear identification of persons and activities in controlled areas of the premises. Controlled areas include grow rooms, processing rooms, storage rooms, disposal rooms or areas, and point-of-sale rooms;
(II) Cameras are fixed in entrances and exits to the premises, which shall record from both indoor and outdoor, or ingress and egress, vantage points;
(III) Recorded images must clearly and accurately display the time and date; or
(IV) Retain video surveillance recordings for a minimum of 45 days or longer upon the request of a law enforcement agency.
2. Ensure that the organization’s outdoor premises have sufficient lighting from dusk until dawn.
3. Establish and maintain a tracking system approved by the department that traces the low-THC cannabis or medical cannabis from seed to sale. The tracking system shall include notification of key events as determined by the department, including when cannabis seeds are planted, when cannabis plants are harvested and destroyed, and when low-THC cannabis or medical cannabis is transported, sold, stolen, diverted, or lost.
4. Not dispense from its premises low-THC cannabis, medical cannabis, or a cannabis delivery device between the hours of 9 p.m. and 7 a.m., but may perform all other operations and deliver low-THC cannabis and medical cannabis to qualified patients 24 hours each day.
5. Store low-THC cannabis or medical cannabis in a secured, locked room or a vault.
6. Require at least two of its employees, or two employees of a security agency with whom it contracts, to be on the premises at all times.
7. Require each employee to wear a photo identification badge at all times while on the premises.
8. Require each visitor to wear a visitor’s pass at all times while on the premises.
9. Implement an alcohol and drug-free workplace policy.
10. Report to local law enforcement within 24 hours after it is notified or becomes aware of the theft, diversion, or loss of low-THC cannabis or medical cannabis.
(e) To ensure the safe transport of low-THC cannabis or medical cannabis to dispensing organization facilities, independent testing laboratories, or patients, the dispensing organization must:
1. Maintain a transportation manifest, which must be retained for at least 1 year.
2. Ensure only vehicles in good working order are used to transport low-THC cannabis or medical cannabis.
3. Lock low-THC cannabis or medical cannabis in a separate compartment or container within the vehicle.
4. Require at least two persons to be in a vehicle transporting low-THC cannabis or medical cannabis, and require at least one person to remain in the vehicle while the low-THC cannabis or medical cannabis is being delivered.
5. Provide specific safety and security training to employees transporting or delivering low-THC cannabis or medical cannabis.
(7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
(a) The department may conduct announced or unannounced inspections of dispensing organizations to determine compliance with this section or rules adopted pursuant to this section.
(b) The department shall inspect a dispensing organization upon complaint or notice provided to the department that the dispensing organization has dispensed low-THC cannabis or medical cannabis containing any mold, bacteria, or other contaminant that may cause or has caused an adverse effect to human health or the environment.
(c) The department shall conduct at least a biennial inspection of each dispensing organization to evaluate the dispensing organization’s records, personnel, equipment, processes, security measures, sanitation practices, and quality assurance practices.
(d) The department may enter into interagency agreements with the Department of Agriculture and Consumer Services, the Department of Business and Professional Regulation, the Department of Transportation, the Department of Highway Safety and Motor Vehicles, and the Agency for Health Care Administration, and such agencies are authorized to enter into an interagency agreement with the department, to conduct inspections or perform other responsibilities assigned to the department under this section.
(e) The department must make a list of all approved dispensing organizations and qualified ordering physicians and medical directors publicly available on its website.
(f) The department may establish a system for issuing and renewing registration cards for patients and their legal representatives, establish the circumstances under which the cards may be revoked by or must be returned to the department, and establish fees to implement such system. The department must require, at a minimum, the registration cards to:
1. Provide the name, address, and date of birth of the patient or legal representative.
2. Have a full-face, passport-type, color photograph of the patient or legal representative taken within the 90 days immediately preceding registration.
3. Identify whether the cardholder is a patient or legal representative.
4. List a unique numeric identifier for the patient or legal representative that is matched to the identifier used for such person in the department’s compassionate use registry.
5. Provide the expiration date, which shall be 1 year after the date of the physician’s initial order of low-THC cannabis or medical cannabis.
6. For the legal representative, provide the name and unique numeric identifier of the patient that the legal representative is assisting.
7. Be resistant to counterfeiting or tampering.
(g) The department may impose reasonable fines not to exceed $10,000 on a dispensing organization for any of the following violations:
1. Violating this section, s. 499.0295, or department rule.
2. Failing to maintain qualifications for approval.
3. Endangering the health, safety, or security of a qualified patient.
4. Improperly disclosing personal and confidential information of the qualified patient.
5. Attempting to procure dispensing organization approval by bribery, fraudulent misrepresentation, or extortion.
6. Being convicted or found guilty of, or entering a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which directly relates to the business of a dispensing organization.
7. Making or filing a report or record that the dispensing organization knows to be false.
8. Willfully failing to maintain a record required by this section or department rule.
9. Willfully impeding or obstructing an employee or agent of the department in the furtherance of his or her official duties.
10. Engaging in fraud or deceit, negligence, incompetence, or misconduct in the business practices of a dispensing organization.
11. Making misleading, deceptive, or fraudulent representations in or related to the business practices of a dispensing organization.
12. Having a license or the authority to engage in any regulated profession, occupation, or business that is related to the business practices of a dispensing organization suspended, revoked, or otherwise acted against by the licensing authority of any jurisdiction, including its agencies or subdivisions, for a violation that would constitute a violation under Florida law.
13. Violating a lawful order of the department or an agency of the state, or failing to comply with a lawfully issued subpoena of the department or an agency of the state.
(h) The department may suspend, revoke, or refuse to renew a dispensing organization’s approval if a dispensing organization commits any of the violations in paragraph (g).
(i) The department shall renew the approval of a dispensing organization biennially if the dispensing organization meets the requirements of this section and pays the biennial renewal fee.
(j) The department may adopt rules necessary to implement this section.
(8) PREEMPTION.—
(a) All matters regarding the regulation of the cultivation and processing of medical cannabis or low-THC cannabis by dispensing organizations are preempted to the state.
(b) A municipality may determine by ordinance the criteria for the number and location of, and other permitting requirements that do not conflict with state law or department rule for, dispensing facilities of dispensing organizations located within its municipal boundaries. A county may determine by ordinance the criteria for the number, location, and other permitting requirements that do not conflict with state law or department rule for all dispensing facilities of dispensing organizations located within the unincorporated areas of that county.
(9) EXCEPTIONS TO OTHER LAWS.—
(a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or any other provision of law, but subject to the requirements of this section, a qualified patient and the qualified patient’s legal representative may purchase and possess for the patient’s medical use up to the amount of low-THC cannabis or medical cannabis ordered for the patient, but not more than a 45-day supply, and a cannabis delivery device ordered for the patient.
(b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or any other provision of law, but subject to the requirements of this section, an approved dispensing organization and its owners, managers, and employees may manufacture, possess, sell, deliver, distribute, dispense, and lawfully dispose of reasonable quantities, as established by department rule, of low-THC cannabis, medical cannabis, or a cannabis delivery device. For purposes of this subsection, the terms “manufacture,” “possession,” “deliver,” “distribute,” and “dispense” have the same meanings as provided in s. 893.02.
(c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or any other provision of law, but subject to the requirements of this section, an approved independent testing laboratory may possess, test, transport, and lawfully dispose of low-THC cannabis or medical cannabis as provided by department rule.
(d) An approved dispensing organization and its owners, managers, and employees are not subject to licensure or regulation under chapter 465 or chapter 499 for manufacturing, possessing, selling, delivering, distributing, dispensing, or lawfully disposing of reasonable quantities, as established by department rule, of low-THC cannabis, medical cannabis, or a cannabis delivery device.
(e) An approved dispensing organization that continues to meet the requirements for approval is presumed to be registered with the department and to meet the regulations adopted by the department or its successor agency for the purpose of dispensing medical cannabis or low-THC cannabis under Florida law. Additionally, the authority provided to a dispensing organization in s. 499.0295 does not impair the approval of a dispensing organization.
(f) This subsection does not exempt a person from prosecution for a criminal offense related to impairment or intoxication resulting from the medical use of low-THC cannabis or medical cannabis or relieve a person from any requirement under law to submit to a breath, blood, urine, or other test to detect the presence of a controlled substance.
B. Section 14(1), ch. 2017-232, as amended by s. 10, ch. 2024-228, “in order to implement Specific Appropriations 484 through 492 of the 2024-2025 General Appropriations Act,” provides:
“(1) EMERGENCY RULEMAKING.—
“(a) The Department of Health and the applicable boards shall adopt emergency rules pursuant to s. 120.54(4), Florida Statutes, and this section necessary to implement s. 381.986, Florida Statutes. If an emergency rule adopted under this section is held to be unconstitutional or an invalid exercise of delegated legislative authority, and becomes void, the department or the applicable boards may adopt an emergency rule pursuant to this section to replace the rule that has become void. If the emergency rule adopted to replace the void emergency rule is also held to be unconstitutional or an invalid exercise of delegated legislative authority and becomes void, the department and the applicable boards must follow the nonemergency rulemaking procedures of the Administrative Procedures Act to replace the rule that has become void.
“(b) For emergency rules adopted under this section, the department and the applicable boards need not make the findings required by s. 120.54(4)(a), Florida Statutes. Emergency rules adopted under this section are exempt from ss. 120.54(3)(b) and 120.541, Florida Statutes. The department and the applicable boards shall meet the procedural requirements in s. 120.54(4)(a), Florida Statutes, if the department or the applicable boards have, before July 1, 2019, held any public workshops or hearings on the subject matter of the emergency rules adopted under this subsection. Challenges to emergency rules adopted under this subsection are subject to the time schedules provided in s. 120.56(5), Florida Statutes.
“(c) Emergency rules adopted under this section are exempt from s. 120.54(4)(c), Florida Statutes, and shall remain in effect until replaced by rules adopted under the nonemergency rulemaking procedures of the Administrative Procedures Act. Rules adopted under the nonemergency rulemaking procedures of the Administrative Procedures Act to replace emergency rules adopted under this section are exempt from ss. 120.54(3)(b) and 120.541, Florida Statutes. By July 1, 2025, the department and the applicable boards shall initiate nonemergency rulemaking pursuant to the Administrative Procedures Act to replace all emergency rules adopted under this section by publishing a notice of rule development in the Florida Administrative Register. Except as provided in paragraph (a), after July 1, 2025, the department and applicable boards may not adopt rules pursuant to the emergency rulemaking procedures provided in this section.”
C. Section 11, ch. 2024-228, provides that “[t]he amendments to subsection (1) of section 14 of chapter 2017-232, Laws of Florida, made by this act expire July 1, 2025, and the text of that subsection shall revert to that in existence on June 30, 2019, except that any amendments to such text enacted other than by this act shall be preserved and continue to operate to the extent that such amendments are not dependent upon the portions of text which expire pursuant to this section.” Effective July 1, 2025, s. 14(1), ch. 2017-232, as amended by s. 11, ch. 2024-228, will read:
“(1) EMERGENCY RULEMAKING.—
“(a) The Department of Health and the applicable boards shall adopt emergency rules pursuant to s. 120.54(4), Florida Statutes, and this section necessary to implement ss. 381.986 and 381.988, Florida Statutes. If an emergency rule adopted under this section is held to be unconstitutional or an invalid exercise of delegated legislative authority, and becomes void, the department or the applicable boards may adopt an emergency rule pursuant to this section to replace the rule that has become void. If the emergency rule adopted to replace the void emergency rule is also held to be unconstitutional or an invalid exercise of delegated legislative authority and becomes void, the department and the applicable boards must follow the nonemergency rulemaking procedures of the Administrative Procedures Act to replace the rule that has become void.
“(b) For emergency rules adopted under this section, the department and the applicable boards need not make the findings required by s. 120.54(4)(a), Florida Statutes. Emergency rules adopted under this section are exempt from ss. 120.54(3)(b) and 120.541, Florida Statutes. The department and the applicable boards shall meet the procedural requirements in s. 120.54(a), Florida Statutes, if the department or the applicable boards have, before [June 23, 2017], held any public workshops or hearings on the subject matter of the emergency rules adopted under this subsection. Challenges to emergency rules adopted under this subsection are subject to the time schedules provided in s. 120.56(5), Florida Statutes.
“(c) Emergency rules adopted under this section are exempt from s. 120.54(4)(c), Florida Statutes, and shall remain in effect until replaced by rules adopted under the nonemergency rulemaking procedures of the Administrative Procedures Act. By January 1, 2018, the department and the applicable boards shall initiate nonemergency rulemaking pursuant to the Administrative Procedures Act to replace all emergency rules adopted under this section by publishing a notice of rule development in the Florida Administrative Register. Except as provided in paragraph (a), after January 1, 2018, the department and applicable boards may not adopt rules pursuant to the emergency rulemaking procedures provided in this section.”
2Note.—Section 9, ch. 2024-228, amended subsection (17) “[i]n order to implement Specific Appropriations 484 through 492 of the 2024-2025 General Appropriations Act.”
381.987 Public records exemption for personal identifying information relating to medical marijuana held by the department.—
(1) The following information held by the department is confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution:
(a) A patient’s or caregiver’s personal identifying information in the medical marijuana use registry established under s. 381.986.
(b) All personal identifying information collected for the purpose of issuing a patient’s or caregiver’s medical marijuana use registry identification card described in s. 381.986.
(c) All personal identifying information pertaining to the physician certification for marijuana and the dispensing thereof.
(d) A qualified physician’s Drug Enforcement Administration number, residential address, and government-issued identification card.
(2) The department shall allow access to the confidential and exempt information in the medical marijuana use registry to:
(a) A law enforcement agency that is investigating a violation of law regarding marijuana in which the subject of the investigation claims an exception established under s. 381.986, except for information related to the patient’s diagnosis.
(b) A medical marijuana treatment center approved by the department pursuant to s. 381.986 which is attempting to verify the authenticity of a physician certification for marijuana, including whether the certification had been previously filled and whether the certification was issued for the person attempting to have it filled, except for information related to the patient’s diagnosis.
(c) A physician who has issued a certification for marijuana for the purpose of monitoring the patient’s use of such marijuana or for the purpose of determining, before issuing a certification for marijuana, whether another physician has issued a certification for the patient’s use of marijuana. The physician may access the confidential and exempt information only for the patient for whom he or she has issued a certification or is determining whether to issue a certification for the use of marijuana pursuant to s. 381.986.
(d) A practitioner licensed to prescribe prescription medications to ensure proper care of a patient before prescribing medication to that patient which may interact with marijuana.
(e) An employee of the department for the purposes of maintaining the registry and periodic reporting or disclosure of information that has been redacted to exclude personal identifying information.
(f) An employee of the department for the purposes of reviewing physician registration and the issuance of physician certifications to monitor practices that could facilitate unlawful diversion or the misuse of marijuana or a marijuana delivery device.
(g) The department’s relevant health care regulatory boards responsible for the licensure, regulation, or discipline of a physician if he or she is involved in a specific investigation of a violation of s. 381.986. If a health care regulatory board’s investigation reveals potential criminal activity, the board may provide any relevant information to the appropriate law enforcement agency.
(h) The Consortium for Medical Marijuana Clinical Outcomes Research established in s. 1004.4351(4).
(i) A person engaged in bona fide research if the person agrees:
1. To submit a research plan to the department which specifies the exact nature of the information requested and the intended use of the information;
2. To maintain the confidentiality of the records or information if personal identifying information is made available to the researcher;
3. To destroy any confidential and exempt records or information obtained after the research is concluded; and
4. Not to contact, directly or indirectly, for any purpose, a patient or physician whose information is in the registry.
(3) The department shall allow access to the confidential and exempt information pertaining to the physician certification for marijuana and the dispensing thereof, whether in the registry or otherwise held by the department, to:
(a) An employee of the department for the purpose of approving or disapproving a request for an exception to the daily dose amount limit for a qualified patient; and
(b) The Consortium for Medical Marijuana Clinical Outcomes Research pursuant to s. 381.986 for the purpose of conducting research regarding the medical use of marijuana.
(4) All information released by the department under subsections (2) and (3) remains confidential and exempt, and a person who receives access to such information must maintain the confidential and exempt status of the information received.
(5) A person who willfully and knowingly violates this section commits a felony of the third degree, punishable as provided in s. 775.082 or s. 775.083.
1381.988 Medical marijuana testing laboratories; marijuana tests conducted by a certified laboratory.—
(1) A person or entity seeking to be a certified marijuana testing laboratory must:
(a) Not be owned or controlled by a medical marijuana treatment center.
(b) Submit a completed application accompanied by an application fee, as established by department rule.
(c) Submit proof of an accreditation or a certification approved by the department issued by an accreditation or a certification organization approved by the department. The department shall adopt by rule a list of approved laboratory accreditations or certifications and accreditation or certification organizations.
(d) Require all employees, owners, and managers to submit to and pass a level 2 background screening pursuant to chapter 435. The department shall deny certification if the person or entity seeking certification has a disqualifying offense as provided in s. 435.04 or has an arrest awaiting final disposition for, has been found guilty of, or has entered a plea of guilty or nolo contendere to, regardless of adjudication, any offense listed in chapter 837, chapter 895, or chapter 896 or similar law of another jurisdiction. Exemptions from disqualification as provided under s. 435.07 do not apply to this paragraph.
1. Such employees, owners, and managers must submit a full set of fingerprints to the department or to a vendor, entity, or agency authorized by s. 943.053(13). The department, vendor, entity, or agency shall forward the fingerprints to the Department of Law Enforcement for state processing, and the Department of Law Enforcement shall forward the fingerprints to the Federal Bureau of Investigation for national processing.
2. Fees for state and federal fingerprint processing and retention shall be borne by the certified marijuana testing laboratory. The state cost for fingerprint processing shall be as provided in s. 943.053(3)(e) for records provided to persons or entities other than those specified as exceptions therein.
3. Fingerprints submitted to the Department of Law Enforcement pursuant to this paragraph shall be retained by the Department of Law Enforcement as provided in s. 943.05(2)(g) and (h) and, when the Department of Law Enforcement begins participation in the program, enrolled in the Federal Bureau of Investigation’s national retained print arrest notification program. Any arrest record identified shall be reported to the department.
(e) Demonstrate to the department the capability of meeting the standards for certification required by this subsection, and the testing requirements of s. 381.986 and this section and rules adopted thereunder.
(2) The department shall adopt rules pursuant to ss. 120.536(1) and 120.54 establishing a procedure for initial certification and biennial renewal, including initial application and biennial renewal fees sufficient to cover the costs of administering this certification program. The department shall renew the certification biennially if the laboratory meets the requirements of this section and pays the biennial renewal fee.
(3) The department shall adopt rules pursuant to ss. 120.536(1) and 120.54 establishing the standards for certification of marijuana testing laboratories under this section. The Department of Agriculture and Consumer Services and the Department of Environmental Protection shall assist the department in developing the rule, which must include, but is not limited to:
(a) Security standards.
(b) Minimum standards for personnel.
(c) Sample collection method and process standards.
(d) Proficiency testing for tetrahydrocannabinol potency, concentration of cannabidiol, and contaminants unsafe for human consumption, as determined by department rule.
(e) Reporting content, format, and frequency.
(f) Audits and onsite inspections.
(g) Quality assurance.
(h) Equipment and methodology.
(i) Chain of custody.
(j) Any other standard the department deems necessary to ensure the health and safety of the public.
(4) A marijuana testing laboratory may acquire marijuana only from a medical marijuana treatment center. A marijuana testing laboratory is prohibited from selling, distributing, or transferring marijuana received from a marijuana treatment center, except that a marijuana testing laboratory may transfer a sample to another marijuana testing laboratory in this state.
(5) A marijuana testing laboratory must properly dispose of all samples it receives, unless transferred to another marijuana testing laboratory, after all necessary tests have been conducted and any required period of storage has elapsed, as established by department rule.
(6) A marijuana testing laboratory shall use the computer software tracking system selected by the department under s. 381.986.
(7) The following acts constitute grounds for which disciplinary action specified in subsection (8) may be taken against a certified marijuana testing laboratory:
(a) Permitting unauthorized persons to perform technical procedures or issue reports.
(b) Demonstrating incompetence or making consistent errors in the performance of testing or erroneous reporting.
(c) Performing a test and rendering a report thereon to a person or entity not authorized by law to receive such services.
(d) Failing to file any report required under this section or s. 381.986 or the rules adopted thereunder.
(e) Reporting a test result if the test was not performed.
(f) Failing to correct deficiencies within the time required by the department.
(g) Violating or aiding and abetting in the violation of any provision of s. 381.986 or this section or any rules adopted thereunder.
(8) The department may refuse to issue or renew, or may suspend or revoke, the certification of a marijuana testing laboratory that is found to be in violation of this section or any rules adopted hereunder. The department may impose fines for violations of this section or rules adopted thereunder, based on a schedule adopted in rule. In determining the administrative action to be imposed for a violation, the department must consider the following factors:
(a) The severity of the violation, including the probability of death or serious harm to the health or safety of any person that may result or has resulted; the severity or potential harm; and the extent to which s. 381.986 or this section was violated.
(b) The actions taken by the marijuana testing laboratory to correct the violation or to remedy the complaint.
(c) Any previous violation by the marijuana testing laboratory.
(d) The financial benefit to the marijuana testing laboratory of committing or continuing the violation.
(9) The department may adopt rules pursuant to ss. 120.536(1) and 120.54 to implement this section.
(10) Fees collected by the department under this section shall be deposited in the Grants and Donations Trust Fund within the Department of Health.
A. Section 1, ch. 2017-232, provides that “[i]t is the intent of the Legislature to implement s. 29, Article X of the State Constitution by creating a unified regulatory structure. If s. 29, Article X of the State Constitution is amended or a constitutional amendment related to cannabis or marijuana is adopted, this act shall expire 6 months after the effective date of such amendment.” If such amendment or adoption takes place, s. 381.988, as created by s. 6, ch. 2017-232, is repealed.
B. Section 14(1), ch. 2017-232, as amended by s. 10, ch. 2024-228, “in order to implement Specific Appropriations 484 through 492 of the 2024-2025 General Appropriations Act,” provides:
“(1) EMERGENCY RULEMAKING.—
“(a) The Department of Health and the applicable boards shall adopt emergency rules pursuant to s. 120.54(4), Florida Statutes, and this section necessary to implement s. 381.986, Florida Statutes. If an emergency rule adopted under this section is held to be unconstitutional or an invalid exercise of delegated legislative authority, and becomes void, the department or the applicable boards may adopt an emergency rule pursuant to this section to replace the rule that has become void. If the emergency rule adopted to replace the void emergency rule is also held to be unconstitutional or an invalid exercise of delegated legislative authority and becomes void, the department and the applicable boards must follow the nonemergency rulemaking procedures of the Administrative Procedures Act to replace the rule that has become void.
“(b) For emergency rules adopted under this section, the department and the applicable boards need not make the findings required by s. 120.54(4)(a), Florida Statutes. Emergency rules adopted under this section are exempt from ss. 120.54(3)(b) and 120.541, Florida Statutes. The department and the applicable boards shall meet the procedural requirements in s. 120.54(4)(a), Florida Statutes, if the department or the applicable boards have, before July 1, 2019, held any public workshops or hearings on the subject matter of the emergency rules adopted under this subsection. Challenges to emergency rules adopted under this subsection are subject to the time schedules provided in s. 120.56(5), Florida Statutes.
“(c) Emergency rules adopted under this section are exempt from s. 120.54(4)(c), Florida Statutes, and shall remain in effect until replaced by rules adopted under the nonemergency rulemaking procedures of the Administrative Procedures Act. Rules adopted under the nonemergency rulemaking procedures of the Administrative Procedures Act to replace emergency rules adopted under this section are exempt from ss. 120.54(3)(b) and 120.541, Florida Statutes. By July 1, 2025, the department and the applicable boards shall initiate nonemergency rulemaking pursuant to the Administrative Procedures Act to replace all emergency rules adopted under this section by publishing a notice of rule development in the Florida Administrative Register. Except as provided in paragraph (a), after July 1, 2025, the department and applicable boards may not adopt rules pursuant to the emergency rulemaking procedures provided in this section.”
C. Section 11, ch. 2024-228, provides that “[t]he amendments to subsection (1) of section 14 of chapter 2017-232, Laws of Florida, made by this act expire July 1, 2025, and the text of that subsection shall revert to that in existence on June 30, 2019, except that any amendments to such text enacted other than by this act shall be preserved and continue to operate to the extent that such amendments are not dependent upon the portions of text which expire pursuant to this section.” Effective July 1, 2025, s. 14(1), ch. 2017-232, as amended by s. 11, ch. 2024-228, will read:
“(1) EMERGENCY RULEMAKING.—
“(a) The Department of Health and the applicable boards shall adopt emergency rules pursuant to s. 120.54(4), Florida Statutes, and this section necessary to implement ss. 381.986 and 381.988, Florida Statutes. If an emergency rule adopted under this section is held to be unconstitutional or an invalid exercise of delegated legislative authority, and becomes void, the department or the applicable boards may adopt an emergency rule pursuant to this section to replace the rule that has become void. If the emergency rule adopted to replace the void emergency rule is also held to be unconstitutional or an invalid exercise of delegated legislative authority and becomes void, the department and the applicable boards must follow the nonemergency rulemaking procedures of the Administrative Procedures Act to replace the rule that has become void.
“(b) For emergency rules adopted under this section, the department and the applicable boards need not make the findings required by s. 120.54(4)(a), Florida Statutes. Emergency rules adopted under this section are exempt from ss. 120.54(3)(b) and 120.541, Florida Statutes. The department and the applicable boards shall meet the procedural requirements in s. 120.54(a), Florida Statutes, if the department or the applicable boards have, before [June 23, 2017], held any public workshops or hearings on the subject matter of the emergency rules adopted under this subsection. Challenges to emergency rules adopted under this subsection are subject to the time schedules provided in s. 120.56(5), Florida Statutes.
“(c) Emergency rules adopted under this section are exempt from s. 120.54(4)(c), Florida Statutes, and shall remain in effect until replaced by rules adopted under the nonemergency rulemaking procedures of the Administrative Procedures Act. By January 1, 2018, the department and the applicable boards shall initiate nonemergency rulemaking pursuant to the Administrative Procedures Act to replace all emergency rules adopted under this section by publishing a notice of rule development in the Florida Administrative Register. Except as provided in paragraph (a), after January 1, 2018, the department and applicable boards may not adopt rules pursuant to the emergency rulemaking procedures provided in this section.”
(1) DEFINITIONS.—As used in this section, the term:
(a) “Cannabis” has the same meaning as in s. 893.02.
(b) “Department” means the Department of Health.
(c) “Marijuana” has the same meaning as in s. 381.986.
(2) STATEWIDE CANNABIS AND MARIJUANA EDUCATION AND ILLICIT USE PREVENTION CAMPAIGN.—
(a) The department shall implement a statewide cannabis and marijuana education and illicit use prevention campaign to publicize accurate information regarding:
1. The legal requirements for licit use and possession of marijuana in this state.
2. Safe use of marijuana, including preventing access by persons other than qualified patients as defined in s. 381.986, particularly children.
3. The short-term and long-term health effects of cannabis and marijuana use, particularly on minors and young adults.
4. Other cannabis-related and marijuana-related education determined by the department to be necessary to the public health and safety.
(b) The department shall provide educational materials regarding the eligibility for medical use of marijuana by individuals diagnosed with a terminal condition to individuals that provide palliative care or hospice services.
(c) The department may use television messaging, radio broadcasts, print media, digital strategies, social media, and any other form of messaging deemed necessary and appropriate by the department to implement the campaign. The department may work with school districts, community organizations, and businesses and business organizations and other entities to provide training and programming.
(d) The department may contract with one or more vendors to implement the campaign.
(e) The department shall contract with an independent entity to conduct annual evaluations of the campaign. The evaluations shall assess the reach and impact of the campaign, success in educating the citizens of the state regarding the legal parameters for marijuana use, success in preventing illicit access by adults and youth, and success in preventing negative health impacts from the legalization of marijuana. The first year of the program, the evaluator shall conduct surveys to establish baseline data on youth and adult cannabis use, the attitudes of youth and the general public toward cannabis and marijuana, and any other data deemed necessary for long-term analysis. By January 31 of each year, the department shall submit to the Governor, the President of the Senate, and the Speaker of the House of Representatives the annual evaluation of the campaign.
(a) The Department of Highway Safety and Motor Vehicles shall implement a statewide impaired driving education campaign to raise awareness and prevent marijuana-related and cannabis-related impaired driving and may contract with one or more vendors to implement the campaign. The Department of Highway Safety and Motor Vehicles may use television messaging, radio broadcasts, print media, digital strategies, social media, and any other form of messaging deemed necessary and appropriate by the department to implement the campaign.
(b) At a minimum, the Department of Highway Safety and Motor Vehicles or a contracted vendor shall establish baseline data on the number of marijuana-related citations for driving under the influence, marijuana-related traffic arrests, marijuana-related traffic accidents, and marijuana-related traffic fatalities, and shall track these measures annually thereafter. The Department of Highway Safety and Motor Vehicles or a contracted vendor shall annually evaluate and compile a report on the efficacy of the campaign based on those measures and other measures established by the Department of Highway Safety and Motor Vehicles. By January 31 of each year, the Department of Highway Safety and Motor Vehicles shall submit the report on the evaluation of the campaign to the Governor, the President of the Senate, and the Speaker of the House of Representatives.
1Note.—Section 1, ch. 2017-232, provides that “[i]t is the intent of the Legislature to implement s. 29, Article X of the State Constitution by creating a unified regulatory structure. If s. 29, Article X of the State Constitution is amended or a constitutional amendment related to cannabis or marijuana is adopted, this act shall expire 6 months after the effective date of such amendment.” If such amendment or adoption takes place, s. 381.989, as created by s. 7, ch. 2017-232, is repealed.
381.99 Rare Disease Advisory Council.—
(1) The Rare Disease Advisory Council, an advisory council as defined in s. 20.03(7), is created adjunct to the Department of Health for the purpose of providing recommendations on ways to improve health outcomes for individuals residing in this state who have a rare disease. The department shall provide staff and administrative support for the advisory council in the carrying out of its duties and responsibilities. For purposes of this section, the term “rare disease” means a condition that affects fewer than 200,000 people in the United States. Except as otherwise provided in this section, the advisory council shall operate in a manner consistent with s. 20.052.
(2) The advisory council is composed of the following members:
(a) As appointed by the Governor:
1. A representative of the Department of Health.
2. A representative of the Agency for Health Care Administration.
3. A representative of the Office of Insurance Regulation.
4. A representative of the Department of Education.
5. One geneticist practicing in this state.
6. One registered nurse or advanced practice registered nurse who is licensed and practicing in this state with experience in treating rare diseases.
7. One hospital administrator from a hospital in this state which provides care to individuals diagnosed with rare diseases.
8. A pharmacist who is licensed and practicing in this state who has experience with drugs that are used in the treatment of rare diseases.
9. A representative of the biotechnology industry.
10. A representative of health insurance companies.
(b) As appointed by the President of the Senate:
1. A representative from an academic research institution in this state which receives grant funding for research regarding rare diseases.
2. A physician who is licensed under chapter 458 or chapter 459 and practicing in this state with experience in treating rare diseases.
3. An individual who is 18 years of age or older who has a rare disease.
4. Two individuals who are, or were previously, caregivers for individuals with a rare disease.
5. A representative of an organization operating in this state which provides care or other support to individuals with rare diseases.
(c) As appointed by the Speaker of the House of Representatives:
1. A representative from an academic research institution in this state which receives grant funding for research regarding rare diseases.
2. A physician who is licensed under chapter 458 or chapter 459 and practicing in this state with experience in treating rare diseases.
3. An individual who is 18 years of age or older who has a rare disease.
4. Two individuals who are, or were previously, caregivers for individuals with a rare disease.
5. A representative of organizations in this state which provide care or other support to individuals with rare diseases.
Any vacancy on the advisory council must be filled in the same manner as the original appointment.
(3) The initial members of the advisory council must be appointed by September 1, 2021. Each member must be appointed to a 4-year term of office. However, in order to achieve staggered terms, each of the initial members appointed pursuant to paragraph (2)(a) must be appointed to a 2-year term. The Governor shall designate a chair and vice chair of the advisory council from among its membership. The advisory council shall meet for its initial meeting by October 1, 2021. Thereafter, the advisory council may meet upon the call of the chair or upon the request of a majority of its members. The advisory council may meet via teleconferencing or other electronic means. Notices for any scheduled meetings of the advisory council must be published in advance on the department’s website.
(4) The advisory council shall:
(a) Consult with experts on rare diseases and solicit public comment to assist in developing recommendations on improving the treatment of rare diseases in this state.
(b) Develop recommended strategies for academic research institutions in this state to facilitate continued research on rare diseases.
(c) Develop recommended strategies for health care providers to be informed on how to more efficiently recognize and diagnose rare diseases in order to effectively treat patients. The advisory council shall provide such strategies to the Department of Health for publication on the department’s website.
(d) Provide input and feedback in writing to the department, the Medicaid program, and other state agencies on matters that affect people who have been diagnosed with rare diseases, including, but not limited to, pandemic or natural disaster preparedness and response.
(e) By July 1 of each year, beginning in 2022, submit a report to the Governor and the State Surgeon General which describes the activities of the advisory council in the past year and its findings and recommendations regarding rare disease research and care. Additionally, the report must be made available on the department’s website.
381.991 Andrew John Anderson Pediatric Rare Disease Grant Program.—
(1)(a) There is created within the Department of Health the Andrew John Anderson Pediatric Rare Disease Grant Program. The purpose of the program is to advance the progress of research and cures for pediatric rare diseases by awarding grants through a competitive, peer-reviewed process.
(b) Subject to an annual appropriation by the Legislature, the program shall award grants for scientific and clinical research to further the search for new diagnostics, treatments, and cures for pediatric rare diseases.
(2)(a) Applications for grants for pediatric rare disease research may be submitted by any university or established research institute in the state. All qualified investigators in the state, regardless of institutional affiliation, shall have equal access and opportunity to compete for the research funding. Preference may be given to grant proposals that foster collaboration among institutions, researchers, and community practitioners, as such proposals support the advancement of treatments and cures of pediatric rare diseases through basic or applied research. Grants shall be awarded by the department, after consultation with the Rare Disease Advisory Council, pursuant to s. 381.99, on the basis of scientific merit, as determined by the competitive, peer-reviewed process to ensure objectivity, consistency, and high quality. The following types of applications may be considered for funding:
1. Investigator-initiated research grants.
2. Institutional research grants.
3. Collaborative research grants, including those that advance the finding of treatment and cures through basic or applied research.
(b) To ensure appropriate and fair evaluation of grant applications based on scientific merit, the department shall appoint peer review panels of independent, scientifically qualified individuals to review the scientific merit of each proposal and establish its priority score. The priority scores shall be forwarded to the council and must be considered in determining which proposals shall be recommended for funding.
(c) The council and the peer review panels shall establish and follow rigorous guidelines for ethical conduct and adhere to a strict policy with regard to conflicts of interest. A member of the council or panel may not participate in any discussion or decision of the council or panel with respect to a research proposal by any firm, entity, or agency that the member is associated with as a member of the governing body or as an employee or with which the member has entered into a contractual arrangement.
(d) Notwithstanding s. 216.301 and pursuant to s. 216.351, the balance of any appropriation from the General Revenue Fund for the Andrew John Anderson Pediatric Rare Disease Grant Program that is not disbursed but that is obligated pursuant to contract or committed to be expended by June 30 of the fiscal year in which the funds are appropriated may be carried forward for up to 5 years after the effective date of the original appropriation.
