TITLE 31 HEALTH

Section 22. Clinical Laboratories, 31-22-1 through 31-22-13.

ARTICLE 3 OFFENSES

31-22-2. Licenses.

1. No clinical laboratory shall be operated without a license issued and in force pursuant to this chapter; provided, however, that the department may promulgate rules and regulations by which a facility or a part of a facility in which laboratory testing is done may qualify for exemption from licensure when only specific tests or techniques, designated by the department and used for screening and monitoring purposes only, are performed.
2. Application for licenses shall be made to the Department of Community Health on forms prescribed by it. The application shall indicate the categories of procedures to be performed and shall contain such additional information as the department may require. Each application shall be accompanied by a nonrefundable fee prescribed by the department.
3. The license applied for shall be issued if the department finds that all requirements are met or, in the case of a new clinical laboratory not yet in operation, that the owner is in a position to meet them. A license shall authorize the performance of one or more procedures or categories of procedures and shall be valid for one year from the date of issue unless sooner canceled, suspended, or revoked.
4. A clinical laboratory license may be denied, revoked, suspended, limited, or renewal thereof denied on the following grounds:
   1. Making false statements of material information on an application for clinical laboratory license or any other documents required by the department;
   2. Permitting unauthorized persons to perform technical procedures or to issue or sign reports;
   3. Demonstrating incompetence in the performance or reporting of clinical laboratory examinations and procedures;
   4. Performing a test for or rendering a report to a person not authorized by law to receive such services;
   5. Referring a specimen for examination to a clinical laboratory in this state which has not been licensed pursuant to this chapter unless such referral laboratory is exempted from coverage of this chapter;
   6. Making a report on clinical laboratory work actually performed in another clinical laboratory without designating the name of the director and the name and address of the clinical laboratory in which the test was performed;
   7. Lending the use of the name of the licensed clinical laboratory or its personnel to an unlicensed clinical laboratory;
   8. Violating or aiding in the violation of any provision of this chapter or the rules or regulations promulgated hereunder; or
   9. Violating any other provisions of law applicable to the proper operation of a clinical laboratory.
5. Each clinical laboratory shall have a licensed director. An individual shall be permitted to direct no more than three clinical laboratories. No individual shall function as a director of a clinical laboratory unless he is a physician licensed to practice medicine and surgery pursuant to Chapter 34 of Title 43; provided, however, that the director of a clinical laboratory restricting its practice to dental pathology may be either a physician licensed to practice medicine and surgery or a dentist licensed to practice dentistry; provided, further, that the board may promulgate rules and regulations which authorize persons who possess doctorate degrees in biology, microbiology, and related fields to be directors of clinical laboratories when the proper circumstances and qualifications are present.
6. A clinical laboratory license shall specify on the face thereof the names of the owner and director, procedures or categories of procedures authorized, the location at which such procedures are to be performed, and the period for which the license is valid. The license shall be displayed at all times in a prominent place where it may be viewed by the public.
7. Licenses issued pursuant to this chapter shall be subject to renewal in accordance with rules and regulations of the department.
8. The board shall fix and publish in print or electronically and from time to time revise schedules of fees for applications and renewals. Such fees for clinical laboratory licenses shall be in amounts calculated to defray the costs of necessary inspections, evaluations, and investigations related thereto.
9. The board shall promulgate rules and regulations which specify minimum standards for laboratory supervisors; provided, however, that nothing in this chapter shall be construed to affect any director, supervisor, technologist, or technician who is holding any such position on July 1, 1970.
10. For the purposes of licensure, specimen collection stations which have a parent clinical laboratory licensed by the State of Georgia may be considered by the department to be part of that laboratory.

(Ga. L. 1970, p. 531, § 4; Ga. L. 1975, p. 737, § 2; Ga. L. 1982, p. 1081, §§ 3, 4, 8, 9; Ga. L. 2009, p. 453, § 1-4/HB 228; Ga. L. 2010, p. 838, § 10/SB 388.)

The 2010 amendment, effective June 3, 2010, inserted "in print or electronically" in the first sentence of subsection (h).