CopyCited 2 times | Published | Florida 1st District Court of Appeal
...utory and regulatory
framework governing trauma centers. The Florida Legislature has
found it necessary to establish an inclusive trauma system
“designed to meet the needs of all injured trauma victims who
require care in an acute-care setting.” § 395.40(2), Fla....
...To that end, the Legislature “place[s] primary
responsibility for the planning and establishment of a statewide
inclusive trauma system with the department” and requires the
Department to update the state’s trauma system plan at least
annually. § 395.40(3)-(6), Fla. Stat.; see also § 395.402(3), Fla.
Stat....
...t least one Level I or
Level II trauma center, “[t]he department shall allocate, by rule,
the number of trauma centers needed for each trauma service
area,” and “[t]here shall be no more than a total of 44 trauma
centers in the state.” § 395.402(4), Fla. Stat. Florida
Administrative Code Rule 64J-2.010 sets forth the criteria to be
used in allocating trauma centers among the TSAs and allocates
two trauma centers for TSA 9.
Section 395.4025, Florida Statutes (2016), governs the trauma
center application and selection process. First, the Department
“shall annually notify each acute care general hospital . . . that the
department is accepting letters of intent from hospitals that are
interested in becoming trauma centers.” § 395.4025(2)(a), Fla.
Stat....
...“By October 15, the department shall send to all hospitals
that submitted a letter of intent an application package that will
provide the hospitals with instructions for submitting information
to the department for selection as a trauma center.” §
395.4025(2)(b), Fla. Stat. “In order to be considered by the
department, applications . . . must be received by the department
no later than the close of business on April 1.” § 395.4025(2)(c),
Fla....
...s the
critical elements required for a trauma center.” Id. “After April
30, any hospital that submitted an application found acceptable by
the department based on provisional review shall be eligible to
operate as a provisional trauma center.” § 395.4025(3), Fla. Stat.
After a hospital is approved as a provisional trauma center,
“[b]etween May 1 and October 1, the department shall conduct an
in-depth evaluation of all applications found acceptable in the
provisional review.” § 395.4025(4), Fla. Stat. Finally, based on the
recommendations from a review team, the Department shall select
verified trauma centers by July 1 of the second year following the
filing of the letter of intent. § 395.4025(6), Fla....
...to make the final
selection(s). Upon final verification, a trauma center is granted
approval to operate for seven years, provided it continues to
maintain trauma center standards and acceptable patient
outcomes, and may thereafter apply for renewal. § 395.4025(6),
Fla....
...2d at 753, approved sub
nom. Naegele Outdoor Advert. Co., Inc. v. City of Jacksonville,
659
So. 2d 1046 (Fla. 1995); see also Heslop v. Moore,
716 So. 2d 276,
279 (Fla. 3d DCA 1998).
Bayfront argued, and the trial court ruled, that pursuant to
section
395.4025(5), the Department may not accept a LOI or
accept, review, and/or provisionally grant a trauma center
application when there is no need (i.e., an open slot) for a trauma
center in the TSA. This matter necessitates a brief review of the
statutory scheme. Section
395.4025(2) governs the submission of
a LOI and application and the ensuing provisional review of the
application, and in pertinent part it requires the Department to
notify each hospital that it is accepting LOIs, to send an
application pack...
...trauma center. The
provisions of subsection (2) do not confer discretion on the
Department and require it to invite and accept a LOI and to accept,
provisionally review, and provisionally grant an application
without regard to need. Notably, section 395.4025(2)(d)1.
9
authorizes the Department to grant an extension of time to an
applicant if the number of applicants in the TSA is equal to or less
than the service area allocation, not if the number of applicants is
equal to or less than the number of open slots, which further
evinces that the Legislature considers need irrelevant at the
provisional review stage of the application process. Section
395.4025(3) provides that after April 30, any hospital whose
application has been provisionally approved shall be eligible to
operate as a provisional trauma center. Section 395.4025(4)
governs the in-depth review of applications.
Section 395.4025(5), Florida Statutes, governs the onsite visit
by a review team of out-of-state experts and contains the following
provision, which is at the heart of the issue: “In addition, hospitals
being considered as provisional trauma center...
...that
sentence in interpreting the statute as prohibiting the Department
from processing and approving an application at the provisional
review stage when there is not an open trauma center slot in the
TSA.
The statutory context indicates that section 395.4025(5) is not
intended to make need a criteria at or before the provisional review
stage....
...a timely and complete application and have the critical elements
required for a trauma center. The Legislature’s definition of
“provisional trauma center” as “a hospital that has been verified
by the department to be in substantial compliance with the
requirements in s. 395.4025 and has been approved by the
department to operate as a provisional Level I trauma center,
Level II trauma center, or pediatric trauma center” supports this
10
interpretation. See § 395.4001(10), Fla....
...allow need to enter into consideration. See, e.g., Searcy, Denney,
Scarola, Barnhart & Shipley,
209 So. 3d at 1189 (explaining that
all parts of a statute must be given effect and must be read
together to achieve a consistent whole). For all these reasons,
section
395.4025 is clear and does not require or permit the
Department to consider need until the onsite review stage of the
application process.
Florida Administrative Code Rule 64J-2.012(1)(a) does not
compel a different conclusion as it req...
...As such, Bayfront
failed to demonstrate a substantial likelihood of success on the
merits of its claim relating to need.
Bayfront also argued, and the trial court found, that
Northside cannot begin operations as a provisional trauma center
until the conclusion of all administrative proceedings. Section
395.4025 provides that “[a]fter April 30, any hospital that
submitted an application found acceptable by the department
based on provisional review shall be eligible to operate as a
11
provisional trauma center.” § 395.4025(3), Fla. Stat.; see also Fla.
Admin. Code R. 64J-2.012(1)(g)1. (providing that the Department
shall notify each hospital that passed the provisional review
process that “the hospital shall operate as a Provisional trauma
center beginning May 1”). Section 395.4025(7), Florida Statutes,
provides that “[a]ny hospital that wishes to protest a decision made
by the department based on the department’s preliminary or in-
depth review of applications or on the recommendations of the site
visit re...
...ll proceed as
provided in chapter 120,” but it does not state what effect an
administrative challenge has on a provisional trauma center
beginning operation. The parties cited and we found no statute,
rule, or appellate decision directly on point. Section 395.4025 sets
forth a definite timeline for the trauma center application process
and requires a hospital to establish a trauma center prior to
submitting an application....
CopyCited 1 times | Published | Florida 1st District Court of Appeal
...The law governing the administration of the trauma
system is set forth in Part II of Chapter 395, Florida Statutes. In
order to provide timely access and uniformity in trauma care, the
state was divided into nineteen Trauma Service Areas (“TSAs”),
each of which should provide at least one Level I or II trauma
center, §§ 395.402(4)(a) & (b), Fla. Stat. (2016). However, the
Legislature determined there should be no more than a total of 44
trauma centers within the State. § 395.402(4)(c), Fla. Stat. (2016).
1 The appeals at issue were consolidated for travel and are
now consolidated for disposition.
2 The Legislature substantially amended the applicable
statutes in this case, in particular sections 395.402 and 395.4025,
after oral argument....
...Unless otherwise indicated, the statutory citations listed
here refer to the 2016 version of these statutes.
3
Beyond these statutory guidelines, the primary responsibility
for planning, establishing, and implementing the trauma system
was delegated to the Department. § 395.40(3), Fla. Stat. To ensure
an integrated trauma system across the state, the Department
conducted an annual assessment to determine how many trauma
centers were needed. § 395.402(2)(b), Fla. Stat. (2016). Based on
the results of this assessment, the Department “allocate[d], by
rule, the number of trauma centers needed for each [TSA].”
§ 395.402(4)(b), Fla....
...the proposed rules were not arbitrary or capricious, the rules
contravened the laws being implemented and vested unbridled
discretion in the Department.
MOOTNESS
After oral argument in this case, the Legislature substantially
amended sections 395.402 and 395.4025. Ch. 2018-66, Laws of
Florida. As stated above, under prior statutes the Department was
tasked with “allocat[ing], by rule, the number of trauma centers
needed for each trauma service area.” § 395.402(4)(b), Fla....
...d/b/a Orange Park Medical Center (“Orange Park”). JFK and
Public Health Trust submitted letters of intent to apply to operate
as a trauma center; Orange Park already operates a provisional
trauma center.
5
(2016). See also § 395.4025(1), Fla....
...(2016) (requiring that “the
department shall establish the approximate number of trauma
centers needed to ensure reasonable access to high-quality trauma
services”). However, under these statutes as revised in 2018, the
Legislature itself now provides the maximum number of trauma
centers for each service area. § 395.402(1)(c), Fla. Stat. (2018). No
longer does the Department have the authority to select or
establish the appropriate number of trauma centers. § 395.4025(1),
Fla. Stat. (2018). The new statutes prohibit the Department from
approving trauma centers—or even accepting letters of intent—for
service areas that have already met the new statutory maximums,
absent certain extenuating circumstances. § 395.4025(3) & (4), Fla.
Stat....
...3d at 654.
The ALJ determined that the Proposed Rules were an invalid
exercise of delegated legislative authority because (1) it would
render superfluous the requirement that trauma centers be
located in a TSA with a need under the prior version of section
395.4025(5) where all TSAs would always have a need; (2) the rule
minimums would implicitly supersede the statutory minimum
provided by the prior version of section 395.402(4); and (3) it vests
the Department with unbridled discretion to permit it to reserve
trauma center slots for TSAs that have not satisfied their rule
minimum....
...er subsection (5) are
wholly conditional. We find this distinction to be relevant here, so
that the request for fees under section
120.595(2) allows us to
decide this moot appeal.
7
First, the prior version of section
395.4025(5) provided that
provisional trauma centers “shall be located in a trauma service
area that has a need for such a trauma center.” (emphasis added).
The ALJ held that because the Department’s allocation of
minimum need would mean all TSAs would “always” have a need,
the Proposed Rules render the prior version of section
395.4025(5)
superfluous. The ALJ’s holding is not accurate under the statute
or the Proposed Rules.
There is nothing in the prior version of section
395.4025(5)
that bars multiple TSAs from having needs at the same time....
...sited
Aug. 9, 2018) (defining “need” as “a lack of something requisite,
desirable, or useful”).
Further, TSAs would not “always” have a need. Once the
former statewide cap of 44 trauma centers was met, no TSA would
have a need. See § 395.402(4)(c), Fla....
...would foreclose the opportunity for another TSA to meet its rule
minimum.
This is all within its authority, as the Department was tasked
with establishing “the approximate number of trauma centers
needed to ensure reasonable access to high-quality trauma
services.” See § 395.4025(1), Fla. Stat. (2016) (emphasis added).
The Legislature’s use of the words “approximate” and “reasonable”
makes unlikely that it intended “need” to refer to a defined and
limited maximum. The former section 395.4025(5) was not
rendered superfluous or contravened by the Proposed Rules.
Second, the prior version of section 395.402(4) provided both
a floor for the individual TSAs (one) and a ceiling for the state (44).
8
§ 395.402(4)(b) & (c), Fla. Stat. (2016). The ALJ held that the
Proposed Rules implicitly superseded the prior version of section
395.402(4), which already had established a minimum number of
trauma centers per TSA.
The statutory floor in the prior version of section 395.402(4)
provided a universal minimum without consideration of a TSA’s
actual or approximate need. Between the floor and the ceiling, the
Department was tasked with allocating (distributing or
designating) the remaining 25 available trauma centers slots
amongst the TSAs based upon their approximate need.
§§ 395.402(4)(b), 395.4025(1), Fla....
...provide each
TSA’s minimum need to support the purpose of the statute, which
is access. The Proposed Rules leave open the opportunity to
distribute all available trauma center slots, if needed. The Old
Rules actually rendered the prior version of section 395.402(4)
superfluous in providing for maximum of 27 trauma centers for the
state, prohibiting it from ever reaching the 44 total trauma centers
allowed.
Third, the ALJ held that the Proposed Rules vested the
Department with unbridled discretion insofar as it could reserve
trauma center slots under the statutory cap for TSAs that had one
trauma center—satisfying the statutory minimum under the prior
version of section 395.402(4)(b)—but that had not yet met their
rule minimum....
CopyCited 1 times | Published | Florida 1st District Court of Appeal
...and regulatory framework
governing the trauma center application and selection process. The Florida
Legislature has delegated the primary responsibility for the planning and
establishment of a statewide inclusive trauma system to the Department. § 395.40(3),
Fla....
...he state’s 19
trauma service areas (TSA), subject to the limitations that each TSA should have at
2
least one Level I or Level II trauma center and there may be no more than 44 trauma
centers statewide. § 395.402(4)(a)-(c), Fla....
...Application and Selection Process
The trauma center application and selection process is a lengthy, multistage
process that begins each year with the Department notifying acute care hospitals and
trauma agencies that it is accepting letters of intent from those hospitals interested
in becoming trauma centers. § 395.4025(2)(a), Fla. Stat. (2015). Letters of intent are
due by October 1, and the Department thereafter distributes an application package
to each hospital that timely submitted a letter of intent. § 395.4025(2)(a)-(b), Fla.
Stat. (2015). The completed application is due by April 1 of the following year. §
395.4025(2)(c), Fla....
...complete and that the hospital has the critical elements required for a trauma center.”
Id. If the Department finds the hospital’s application acceptable based on the
provisional review, the hospital is “eligible to operate as a provisional trauma
center.” § 395.4025(3), Fla. Stat. (2015).
3
Between May 1 and October 1, the process entails an “in-depth evaluation”
by the Department of all applications found acceptable in the provisional review. §
395.4025(4), Fla. Stat. (2015). And between October 1 and June 1, a review team of
out-of-state experts assembled by the Department conducts onsite visits of all
provisionally approved trauma centers. § 395.4025(5), Fla. Stat. (2015). Based on
the recommendations from the review team, the Department selects verified trauma
centers by July 1 of the second year following the filing of the letter of intent. §
395.4025(6), Fla....
...Admin. Code R. 64J-2.016(11). Upon final verification, the
trauma center is granted approval to operate for seven years, provided it continues
to maintain trauma center standards and acceptable patient outcomes, and may
thereafter apply for renewal. § 395.4025(6), Fla....
...Van Laningham entered an order rejecting the Department’s decision and
recommending that the Department enter a final order (1) deeming Jackson South’s
2015 Application acceptable, (2) verifying that Jackson South was in substantial
compliance with the requirements of section 395.4025, and (3) approving Jackson
South to operate as a provisional Level II trauma center until the 2014-2016
application cycle concluded for TSA 19....
...ile challenging the denial of
a previous application. The statutory scheme provides several points of entry for a
hospital to challenge an adverse decision made by the Department, including the
decision to deny an applicant a provisional license. § 395.4025(7), Fla....
...on may ultimately be
denied due to a lack of authorized need. Even if a hospital successfully completes
the rigorous application process to become a verified trauma center, there still must
be a need for a trauma center in the relevant TSA. 2 See § 395.4025(5), Fla....
CopyPublished | Florida 1st District Court of Appeal | 2013 WL 4859092
...for the state to subsidize trauma centers. The report noted that in 1990, the Legislature passed comprehensive legislation to regulate and partially subsidize trauma centers. Id. at 4; see also Ch. 90-284, Laws of Fla. In what was later codified as section 395.402, the Legislature created nineteen trauma service areas in the state; each service area would have at least one trauma center, with not more than forty-four centers statewide. See Ch. 90-284, § 5, Laws of Fla.; § 395.033, Fla. Stat. (1991) (renumbered as § 395.402 by ch. 92-289, Laws of Fla.). A related statute, later codified as section 395.4025, directed DOH’s predecessor to establish an “approximate number of state-sponsored trauma centers needed to ensure reasonable access to high quality services” within each trauma service area. See Ch. 90-284, § 6(1), Laws of Fla.; § 395.0335(1), Fla. Stat. (1991) (renumbered as § 395.4025 by ch....
...This section also set forth a list of some of the criteria to be considered in reviewing trauma center applications, including whether the hospital had sufficient facilities and personnel. See Ch. 90-284, § 6(2)(d), Laws of Fla.; § 395.0335(2)(d), Fla. Stat. (1991) (renumbered as § 395.4025 by ch....
...92-989, Laws of Fla.) (emphasis added). Further, this section required that new facilities “shall be located in a trauma service area which has a need for such a center.” Ch. 90-284, § 6(5), Laws of Fla.; § 395.0335(5), Fla. Stat. (1991) (renumbered as § 395.4025 by ch....
...ma centers without referencing any additional data or analysis. Rule Challenge Final Order at 16. ii. 2004- Statutory Revisions and Rule Challenge In 2004, the Legislature substantially amended the trauma care statutes. See Ch.2004-259, Laws of Fla. Section 395.402 was amended to state the “Legislature recognizes the need for a statewide, cohesive, uniform, and integrated trauma system.” § 395.402(1),' Fla....
...(g) Transportation capabilities, including ground and air transport. (h) Medically appropriate ground and air travel times. (i) Recommendations of the Regional Domestic Security Task Force. (j) The actual number of trauma victims currently being served by each trauma center. (k)Other appropriate criteria. §
395.402(2)-(3), Fla. Stat (2004) (emphasis added). This section also required that DOH “shall allocate, by rule, the number of trauma centers needed for each trauma service area.” §
395.402(4)(b), Fla. Stat. (2004) (emphasis added). Further, section
395.4015 required that rather than using the existing nineteen trauma service areas, DOH “shall establish trauma regions that cover all geographical areas of the state and have boundaries that are coterminous with the boundaries of the regional domestic security task forces established under s.
943.0312.” §
395.4015, Fla. Stat. (2004). Section
395.402(4) clarified that the existing nineteen service areas would remain in place until DOH completed the February 2005 assessment. Moreover, section
395.4025 was also amended in 2004 to state that “until [DOH] has conducted the review provided under s.
395.402, only hospitals located in trauma service areas where there is no existing trauma center may apply.” §
395.4025(14), Fla. Stat. (2004). Section
395.4025 also required that DOH “shall annually notify” existing trauma care centers “that [DOH] is accepting letters of intent from hospitals that are interested in becoming trauma centers.” §
395.4025(2)(a), Fla. Stat. (2004). Further, section
395.4025 continued to require, as it did in 1991, that applicant hospitals have sufficient facilities and personnel and “be located in a trauma service area that has a need for such a trauma center.” §
395.4025(2)(c), (5), Fla....
...rsuant to this section shall proceed as provided in chapter 120. Hearings held under this subsection shall be conducted in the same manner as provided in ss.
120.569 and
120.57. Cases filed under chapter 120 may combine all disputes between parties. §
395.4025(7), Fla....
...This court recently affirmed the ALJ’s determination that rule 64J-2.010 was invalid. Dep’t of Health v. Bayfront Med. Ctr., Inc., — So.3d -, 37 Fla. L. Weekly D2754 ,
2012 WL 5971201 (Fla. 1st DCA 2012). This court reasoned that although the rule purported to implement sections
395.401,
395.4015, and
395.402, the rule had not been changed since these statutes were “substantially amended.” Id....
...atutes. The ALJ found the approval of appellees’ new trauma centers would “result in an immediate reduction in trauma patient volumes as well as increased staffing challenges” for appellants’ centers which is the type of injury that sections 395.402 and 395.4025 were designed to protect. The ALJ reasoned section 395.402(2) required DOH to review the trauma system to determine the need for additional trauma centers by “taking into consideration specifically identified criteria and factors that directly involve and affect the substantial interests of...
...within a given region arising from the establishment of a new trauma center.” Id. Additionally, the ALJ found the Legislature expressly recognized that the substantial interests of hospitals may be affected by the granting of new trauma centers in section
395.4025(7), which states that “[a]ny hospital that wishes to protest a decision made by the department based on the department’s preliminary or in-depth review of applications” may do so through a chapter 120 hearing. Whether or not section
395.4025 provides an independent basis for standing by “provision of statute” as contemplated by section
120.52(13) we need not decide here. The ALJ was correct that appellants’ injuries of economic loss and shortage of available specialists and other *92 service providers are within the zone of interest protected by sections 895.402 and
395.4025....
...Appellees also argue the trauma statutes do not sufficiently identify economic interests as a protected interest. Instead, they argue the trauma statutes put first priority on the needs of the patients, not the needs of the existing trauma centers. They cite section 395.40(2), which states: *93 § 395.40(2), Fla....
...However, based on the injuries alleged by appellants, the existing trauma centers may not continue to have the financial resources or personnel to care for injured victims if additional trauma facilities are added where there is no need. Moreover, this language in section 395.40 does not nullify the extensive language in section 395.402 which requires DOH to consider factors which would affect existing facilities, including inventories of available trauma care resources and professional medical staff, and stakeholder recommendations. In fact, section 395.402 specifically requires DOH to take into consideration “the need to maintain effective trauma care in areas served by existing centers, with consideration for the volume of trauma patients served, and the amount of charity care provided.” § 395.402(2)(g), Fla....
...njured trauma victim is incorporated. The Legislature deems the benefits of trauma care provided within an inclusive trauma system to be of vital significance to the outcome of a trauma victim. *93 Further, at oral argument, appellee DOH argued that section 395.4025, which pertains to the submission and review of trauma center applications, did not permit DOH to consider need for additional trauma centers when it reviewed applications. Instead, DOH argued this section required it to grant any application that met the statutory criteria. However, section 395.4025(1) specifically requires DOH to “establish the approximate number of trauma centers needed to ensure reasonable access to high-quality trauma services.” § 395.4025(1), Fla....
CopyPublished | Florida 1st District Court of Appeal | 2012 Fla. App. LEXIS 20567, 2012 WL 5971201
...at the Department’s existing rule 64J-2.010, Florida Administrative Code constituted an invalid exercise of delegated legislative authority. The subject rule allocates trauma centers throughout the state of Florida. It purports to be authorized by section 395.405, Florida Statutes and to implement sections 395.401, 395.4015, 395.402, and 395.405....
...“[T]he authority to adopt an administrative rule must be based upon an explicit power or duty identified in the enabling statute. Otherwise, the rule is not a valid exercise of delegated legislative authority.” Id. In the Final Order, the judge found that, although the rule claims to implement sections 395.401, 395.4015 and 395.402, none of these statutes can serve as rule-making authority for rule 64J-2.010....
...As such, the rule continues to implement the outdated provisions of these statutes, without implementing any of the enumerated statutes. The Department has not updated the rule to conform to the 2004 amendments or the 2005 Assessment. The rule does not implement the 2004 amendment to section 395.4015, which governs state regional trauma planning and trauma regions....
...wever, the 2004 amendment requires that the trauma regions both “cover all geographical areas of the state and have boundaries that are coterminous with the boundaries of the regional domestic security task forces established under s.
943.0312.” §
395.4015(1), Fla. Stat. (2004). Because the rule continues to set forth *1020 nineteen trauma service areas that are not coterminous with the boundaries of the seven regional domestic security task forces, it does not implement the changes in the 2004 version of section
395.4015. Similarly, the rule fails to implement the 2004 amendments to section
395.402....
...But the rule has not been amended to reflect this recommendation. It still contains the original nineteen trauma service areas. Nor has the rule been amended to reflect the requirement in the 2004 amendment to the statute that the Department conduct a review of the trauma regions annually after 2005. See § 395.402(4), Fla. Stat. (2004). Finally, the rule also states that it implements section 395.405. That section merely provides, “The department shall adopt and enforce all rules necessary to administer ss. 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.404, and 395.4045.” This is no more than a general grant of authority to adopt and enforce necessary rules....