STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
BAYFRONT MEDICAL CENTER, INC., FLORIDA HEALTH SCIENCES )
CENTER, INC., d/b/a TAMPA )
GENERAL HOSPITAL; ST. )
JOSEPH’S HOSPITAL, INC., ) d/b/a ST. JOSEPH’S HOSPITAL; ) AND SHANDS JACKSONVILLE )
MEDICAL CENTER, INC., )
)
Petitioners, )
)
and )
) HCA HEALTH SERVICES OF FLORIDA, ) INC., d/b/a BLAKE MEDICAL ) CENTER AND HCA HEALTH SERVICES ) OF FLORIDA, INC., d/b/a ) REGIONAL MEDICAL CENTER BAYONET ) POINT, )
)
Intervenors, )
)
vs. )
)
DEPARTMENT OF HEALTH, )
)
Respondent. )
Case Nos. 11-2602RX
11-2603RX
11-2746RX
11-2796RX
)
FINAL ORDER
Pursuant to notice, a formal hearing was held in this case before W. David Watkins, Administrative Law Judge of the Division of Administrative Hearings, on June 27 through 30, 2011, and July 7, 2011, in Tallahassee, Florida.
APPEARANCES
For Petitioners: Jeffrey L. Frehn, Esquire
Donna Elizabeth Blanton, Esquire Radey, Thomas, Yon and Clark
301 South Bronough Street, Suite 200 Tallahassee, Florida 32301
(Bayfront and Tampa General Hospital)
Robert A. Weiss, Esquire Karen Ann Putnal, Esquire
Parker, Hudson, Rainer and Dobbs, LLP
118 North Gadsden Street, Suite 200 Tallahassee, Florida 32301
(St. Joseph’s Hospital)
Seann M. Frazier, Esquire Greenberg Traurig, P.A.
101 East College Avenue Tallahassee, Florida 32302-7742 (Shands Jacksonville)
For Respondents: Thomas Barnhart, Esquire
Michael T. Flury, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399 (Department of Health)
Nicholas W. Romanello, Esquire Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32299-1703
For Intervenors: Stephen A. Ecenia, Esquire
J. Stephen Menton, Esquire Rutledge, Ecenia and Purnell, P.A.
119 South Monroe Street, Suite 202 Post Office Box 551
Tallahassee, Florida 32302-0551 (Blake Medical Center and Regional
Medical Center Bayonet Point)
STATEMENT OF THE ISSUE
Whether Florida Administrative Code Rule 64J-2.010 enlarges, modifies or contravenes the specific provisions of law implemented, or is arbitrary or capricious, and thus constitutes an invalid exercise of delegated legislative authority.
PRELIMINARY STATEMENT
On May 23, 2011, Bayfront Medical Center, Inc. ("Bayfront") and Florida Health Sciences Center, Inc., d/b/a Tampa General Hospital ("TGH") each filed a Petition for Determination of Invalidity of Existing Rule to challenge the validity of rule 64J-2.010. The petitions were assigned DOAH Case Nos. 11-2602RX and 11-2603RX, respectively.
On May 25, 2011, St. Joseph's Hospital, Inc., d/b/a
St. Joseph's Hospital ("SJH") filed a Petition for Determination of Invalidity of Existing rule to challenge the validity of rule 64J-2.010. SJH's petition was assigned DOAH Case No. 11-2746RX.
On June 2, 2011, Shands Jacksonville Medical Center, Inc. ("Shands") filed a Petition for Determination of Invalidity of Existing rule, also seeking to challenge the validity of rule 64J-2.010. The Shands petition was assigned DOAH Case No.
11-2796RX. (Bayfront, TGH, SJH and Shands are collectively referred to herein as the "Petitioners.")
On May 31, 2011, HCA Health Services of Florida, Inc. d/b/a Blake Medical Center and HCA Services of Florida, Inc., d/b/a
Regional Medical Center Bayonet Point ("Intervenors") filed a Petition to Intervene in DOAH Case No. 11-2602RX. The Petition to Intervene was granted subject to proof of standing by Order dated June 8, 2011.
Petitioners' and Intervenors' cases were consolidated with the agreement of the parties by Orders dated June 1, 2011, and June 7, 2011.
This matter was set for hearing on June 22, 2011, with the agreement of the parties, by Order dated June 2, 2011. On
June 9, 2011, Respondent filed a Motion for Continuance of the final hearing to an unspecified date. Intervenors joined the Motion for Continuance. Petitioners opposed the motion. A hearing was held on the motion on June 13, 2011, and the final hearing in this matter was rescheduled to commence June 27, 2011.
On June 15, 2011, Intervenors filed a motion to dismiss Petitioners for lack of standing. On June 16, 2011, Respondents also filed a motion to dismiss Petitioners for lack of standing. Those motions were denied at the outset of the hearing subject to renewal in Respondent’s and Intervenors’ proposed final orders. Bayfront and TGH filed a response, which was joined in by Shands and SJH.
On June 17, 2011, Intervenors filed a Motion in Limine to exclude the introduction of certain evidence by Petitioners.
This motion was denied. Bayfront and TGH filed a response, which was joined by Shands and SJH.
On June 23, 2011, Intervenors filed a Motion to Bifurcate the Proceeding or in the Alternative to Continue the Final Hearing to an unspecified date in August 2011. Bayfront and Tampa General filed a response in opposition to the motion to bifurcate or in the alternative to continue the final hearing, which was joined by Shands and SJH. A hearing on the motion to bifurcate or continue the case was held on June 24, 2011, and the motion was denied by Order dated June 24, 2011.
On June 27, 2011, Intervenors filed motions for attorneys’ fees and costs against each of the Petitioners pursuant to section 120.595, Florida Statutes. On July 1, 2011, Respondents filed motions for attorneys’ fees and costs against each of the Petitioners, again pursuant to section 120.595. Bayfront, TGH, SJH and Shands all timely filed responses to the motions for attorneys’ fees and costs. At hearing, the motions were denied without prejudice to renew them in the proposed final orders.
The final hearing was held June 27-30, 2011, and July 7, 2011, in Tallahassee, Florida. At hearing, co-Petitioners Bayfront and TGH presented the testimony of Lewis Flint, M.D., accepted as an expert in trauma surgery and trauma system assessment; Susan McDevitt, RN, BSN, MBA, Director of the Department's Office of Trauma; and Mark Richardson, accepted as
an expert in health planning. TGH/Bayfront Exhibits numbered 1- 16, 18-23, 26-27, and 32-34 were admitted into evidence.
Petitioner St. Joseph's presented the testimony of Mark D. Vaaler, accepted as an expert in medical staff administration and Mark Richardson. St. Joseph's Exhibits numbered 1 and 3 were admitted into evidence.
Petitioner Shands Jacksonville presented the testimony of Mark Richardson and Joseph J. Tepas, III, M.D. Shands Jacksonville's Exhibits 1-5, 8-14, and 22-23 were admitted into evidence.
Respondent Department, for its case-in-chief, recalled the Director of the Department's Office of Trauma, Susan McDevitt, RN, BSN, MBA., who was accepted as an expert in trauma system planning, compliance and regulation. Respondent's Exhibits numbered 1-23, 28-30 and 35 were admitted into evidence.
Intervenors Blake and Bayonet Point presented the testimony of witnesses James Hurst, M.D.; Susan McDevitt, RN, BSN, MBA, and Gene Nelson, who was accepted as an expert in Health Planning, Health Policy, and Trauma Center Feasibility Analysis. Intervenor's Exhibits numbered 1-55 were admitted into evidence.
The final hearing Transcript, comprised of Volumes 1-10, was filed with the Division on July 26, 2011.
On August 2, 2011, the undersigned received correspondence regarding issues in this case from a private individual who appeared to be unaffiliated with any party in the case.
A Notice of Ex-parte Communication was issued on August 4, 2011. On August 4, 2011, with the agreement of all parties, Intervenors filed a motion to strike the ex-parte communication. The motion to strike was granted by Order dated August 15, 2011.
On August 12, 2011, a telephonic post-hearing conference was held during which the undersigned disclosed a personal matter that occurred post-hearing involving two hospitals related by ownership to two of the parties to this case (one of the Petitioners, and Intervenors). After this disclosure, the parties were requested to file any motions for disqualification by not later than August 17, 2011. No such motions were filed.
By agreement of the parties (and confirmed by Order dated August 9, 2011), proposed final orders were due on or before August 11, 2011. Each party timely filed a Proposed Final Order, all of which have been carefully considered in the preparation of this Final Order.
All citations are to Florida Statutes (2010), unless otherwise indicated.
FINDINGS OF FACT
The Parties
Bayfront is a 480-bed tertiary hospital located in St. Petersburg, Pinellas County, Florida. In addition to serving as a teaching hospital, Bayfront is designated as a
Level II trauma center pursuant to chapter 395, Part II, Florida Statutes.
Bayfront had a $3.6 million operating deficit in 2009 and a positive operating margin below one percent ($1.969 million) in 2010. Due to its financial strife in recent years, Bayfront has been forced to defer needed capital projects due to a poor liquidity position, inadequate borrowing capacity and insufficient cash flow.
Tampa General is a major tertiary hospital that is designated by the state as a Level I trauma center. TGH also serves as a teaching hospital for the University of South Florida, College of Medicine ("USF"). TGH is located in Tampa, Hillsborough County, Florida.
Like Bayfront, TGH has also experienced significant financial challenges in recent years. For fiscal year 2011, TGH's budget reflected only a $7 million (one percent) operating margin. However, due to subsequent events, including Medicaid cuts and flat utilization year-to-date, TGH now expects to do no better than break-even, and may even incur a $4 million
operating loss in FY 2011. This is significant because TGH has reached its borrowing capacity and must rely on its operating margin to build cash that will be used to fund needed capital projects and expenditures. Maintaining a positive and substantial operating margin is therefore critical to TGH's ability to replace equipment and infrastructure.
St. Joseph's Hospital has served the Tampa area for 75 years and has approximately 800 licensed acute care beds. SJH offers a broad array of acute care services, including tertiary health care, serves as a comprehensive regional stroke center, and has been repeatedly recognized as a Consumers Choice hospital.
SJH operates a Level II trauma center, and in 2010, treated approximately 2,700 trauma patients. SJH also has one of the busiest emergency departments in the state, with approximately 145,000 patient visits in 2010.
Shands Jacksonville is an existing Level I trauma center. It is one of only seven such Level I providers in the state of Florida. Located in Jacksonville (Duval County), Shands treats approximately 4,000 trauma victims every year.
Respondent Department of Health is the state agency authorized to verify and regulate trauma centers in the state of Florida pursuant to chapter 395, Part II, Florida Statutes and Florida Administrative Code Rule 64J-2.001 et seq. The Division
of Emergency Medical Operations, Office of Trauma, oversees the Department's responsibilities with respect to the statewide trauma system.
Intervenor Bayonet Point is a general acute-care hospital located in Pasco County, Florida. Bayonet Point is currently seeking to obtain designation as a trauma center. As of the date of the hearing in this matter, Bayonet Point's application for designation as a trauma center was not complete and Bayonet Point was in the process of developing the facilities and retaining the medical staff necessary to meet the standards and criteria required for its application to be deemed complete.
Intervenor Blake Medical Center is a general acute care hospital located in Manatee County, Florida. Blake is currently seeking to obtain designation as a trauma center. As of the date of the hearing in this matter, Blake's application for designation as a trauma center was not complete and Blake was in the process of developing the facilities and retaining the medical staff necessary to meet the standards and criteria required for its application to be deemed complete.
Although not a party to this case, HCA/Orange Park Medical Center ("Orange Park") is also currently in the process of applying for trauma center designation. Orange Park is
located in Clay County, immediately to the south of Duval County.
The Florida Trauma System
For purposes of organizing a statewide network of trauma services, the Florida Legislature directed the Department to "undertake the implementation of a statewide inclusive trauma system as funding is available." § 395.40(3), Fla. Stat. The statewide trauma network includes not just verified trauma centers, but all other acute care hospitals in the State, as well as ground and air emergency medical services providers, and "every health care provider or facility with resources to care for the injured trauma victim." § 395.40(2), Fla. Stat.
The network is premised on the basic principle that a trauma victim who is timely transported and triaged to receive specialized trauma care will have a better clinical outcome.
§ 395.40(2), Fla. Stat. A trauma victim's injuries are evaluated and assigned an Injury Severity Score ("ISS").
§ 395.4001(5), Fla. Stat. Patients with ISS scores of 9 or greater are considered trauma patients. § 395.402(1), Fla. Stat.
Trauma experts speak in terms of "a Golden Hour," a clinical rule of thumb that postulates no more than 60 minutes should elapse from the occurrence of an injury to the beginning of definitive treatment. There is, however, no current
consensus on what constitutes the "Golden Hour" for transport times. A 1990 Department study recommended travel time of 25-35 minutes as the outside range for optimal outcomes. A 1999 Department study favored a goal of 30 minutes transport time by ground, and a 50-mile radius by helicopter. By contrast, a 2005 study conducted for the Department used 85 minutes "total evacuation time" as "acceptable."
Because of the necessity for rapid transport, key components of the trauma network are ground and air EMS transportation. It is important to get the trauma victim to the nearest trauma center as rapidly as possible, because "you can't do surgery in the back of an ambulance." Each EMS provider operates pursuant to Uniform Trauma Transport Protocols and inter-facility guidelines which give guidance for how, where and when trauma patients should be transported.
Trauma centers are required to have numerous different kinds of physician specialists at the ready at all times. For instance, with respect to surgical services, a Level I trauma center must have "a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary (in-hospital) and backup trauma coverage 24 hours a day at the trauma center when summoned."
Further, in addition to having at least one "neurosurgeon to provide in-hospital trauma coverage 24 hours a day at the trauma center," a Level I provider must also have surgeons "available to arrive promptly at the trauma center" in
11 other specialties, including (but not limited to) hand surgery, oral/maxillofacial surgery, cardiac surgery, orthopedic surgery, otorhinolaryngologic surgery and plastic surgery.
Level II trauma centers must comply with similar physician specialist standards. Not surprisingly, it is a constant struggle for existing trauma centers to ensure the availability of qualified clinical staff, technicians, specialty physicians and other personnel and resources necessary to continually meet the rigorous programmatic requirements of a trauma center.
In general, trauma centers are not profitable due to the intensity of resources necessary to achieve an appropriately functioning trauma program, and the scarcity of such resources. The Challenged Rule
In 1992, the Department of Health and Rehabilitative Services ("HRS") adopted Florida Administrative Code Rule 64J- 2.010, (the "Rule"). Respondent Department of Health assumed administration of the Rule in 1996, when the Legislature split HRS into two new agencies, the Department of Health and the Department of Children and Families.
The Rule is a statement of need, sometimes referred to as "open slots" for a specific number of trauma centers allocated among 19 geographic service areas ("trauma service areas" or "TSAs") in the state.
The current version1/ of rule 64J-2.010, the subject of this rule challenge, reads in its entirety as follows:
The number and composition of TSAs shall be in accordance with section 395.402, F.S.
The number of trauma centers in each TSA shall be in accordance with the maximum number set forth in the table below. Each trauma service area shall have at least one Level I or Level II trauma center position.
The number of trauma center positions for each TSA is as follows:
TSA | Counties | Trauma Centers |
1 | Escambia; Okaloosa; Santa | 2 |
Rosa; Walton | ||
2 | Bay; Gulf; Holmes; Washington | 1 |
3 | Calhoun; Franklin; Gadsden; | 1 |
Jackson; Jefferson; Leon; | ||
Liberty; Madison; Taylor; | ||
Wakulla | ||
4 | Alachua; Bradford; Columbia; | 2 |
Dixie; Gilchrist; Hamilton; Lafayette; Levy; Putnam; Suwannee; Union
5 Baker; Clay; Duval; Nassau; St. | 2 |
Johns | |
6 Citrus; Hernando; Marion | 1 |
7 Flagler; Volusia | 2 |
8 Lake; Orange; Osceola; | 3 |
Seminole; Sumter | |
9 Pasco; Pinellas | 3 |
10 Hillsborough | 2 |
11 Hardee; Highlands; Polk | 3 |
12 Brevard; Indian River | 2 |
13 DeSoto; Manatee; Sarasota | 3 |
14 Martin; Okeechobee; St. Lucie | 1 |
15 Charlotte; Glades; Hendry; Lee | 2 |
16 Palm Beach | 2 |
17 Collier | 1 |
18 Broward | 3 |
19 Dade; Monroe | 6 |
TOTAL | 42 |
The trauma center will be assigned by the department according to section 395.402(4), F.S.
Specific Authority 395.405 FS. Law Implemented 395.401, 395.4015, 395.402, 395.405 FS. History–New 12-10-92, Formerly
10D-66.1075, Amended 6-9-05, 12-18-06, Formerly 64E-2.022.
A hospital seeking to establish a new trauma center must file an application with the Department. If a TSA has fewer trauma centers than the number allocated to the TSA in the Rule, the Department deems need to exist without reference to
any additional analysis or data. Accordingly, if a hospital's application to establish a new trauma center complies with trauma center programmatic requirements, the Department will approve the application. As will be discussed in greater detail infra, the Department believes it is bound by the determination of need set forth in the Rule and that it does not have authority to deny an application that meets programmatic requirements so long as there is an "open slot" for a new trauma center within a particular TSA. Indeed, the Department has never denied an application that met the programmatic requirements when need existed under the Rule.
History of the Rule
In 1989, the Legislature directed HRS (DOH's predecessor) to submit a report by February 1, 1990, (the "1990 Report"). The 1990 Report was to include a proposal for funding trauma centers that "will result in funding of the number of strategically placed trauma centers necessary to ensure adequate trauma care throughout the state." Ch. 89-275, § 6, Laws of Fla. The 1990 Report was to include "an estimation of . . . the approximate number and generalized location of state-sponsored trauma centers needed to ensure adequate trauma care throughout the state . . . ." Id.
The 1990 Report was prepared by the Committee on State-Sponsored Trauma Centers (the "1990 Committee"). Although
HRS timely submitted the Committee's report to the Legislature on February 1, 1990, HRS indicated that it did not "fully support all of the conclusions and recommendations contained in the task force report."
In its report, the 1990 Committee recommended the creation of 19 trauma service areas. The boundary of each TSA was drawn to include a "nucleus county" along with its sending (later referred to as "feeder") counties. A nucleus county was one that retained at least 90 percent of its resident trauma alert patients, but also included any county that had a retention rate greater than 75 percent (but less than 90 percent) if no contiguous county had the requisite 90 percent retention rate. Any county that retained less than 75 percent of its trauma alert patients was designated a feeder county. This feeder county was then grouped with the nucleus county that received a majority of the feeder county's outbound patients.
After reviewing 1988 patient flow data and applying the above rules, the 1990 Committee created and assigned counties to 19 trauma service areas. Under the 1990 Committee's methodology, a nucleus county was a candidate for a trauma center, but a feeder county was not.
Table 3.3 of the 1990 Report set forth the Committee's recommendation as to the number of trauma centers to be allocated to each of the 19 TSAs:
Table 3.3
Recommended Trauma Service Areas and Number of Trauma Centers
1988 Number Treated | 1988 Number Residing | Recommended No. Trauma Centers | |||||
Service Area | ISS Level 9+ | ISS Level 16+ | ISS Level 9+ | ISS Level 16+ | Min | Max | |
1 | 1332 | 275 | | | 1166 | 223 | 2 | 3 |
2 | 489 | 117 | | | 452 | 105 | 1 | 1 |
3 | 815 | 185 | | | 701 | 152 | 1 | 2 |
4 | 1183 | 269 | | | 1011 | 226 | 2 | 3 |
5 | 2268 | 662 | | | 2566 | 546 | 2 | 3 |
6 | 869 | 138 | | | 877 | 143 | 1 | 2 |
7 | 1376 | 225 | | | 1286 | 190 | 2 | 3 |
8 | 3756 | 698 | | | 3329 | 592 | 3 | 4 |
9 | 3978 | 626 | | | 3709 | 552 | 3 | 4 |
10 | 2458 | 604 | | | 2222 | 507 | 2 | 3 |
11 | 1834 | 302 | | | 1665 | 290 | 3 | 4 |
12 | 1487 | 220 | | | 1433 | 218 | 2 | 3 |
13 | 1900 | 264 | | | 1810 | 247 | 3 | 4 |
14 | 687 | 105 | | | 698 | 102 | 1 | 2 |
15 | 1455 | 243 | | | 1386 | 236 | 2 | 4 |
16 | 2310 | 365 | | | 2233 | 371 | 2 | 3 |
17 | 476 | 73 | | | 436 | 75 | 1 | 1 |
18 | 4238 | 670 | | | 4204 | 652 | 4 | 5 |
19 | 7346 | 1370 | | | 6633 | 1176 | 6 | 7 |
Total | 40857 | 7411 | | | 37817 | 6603 | 44 | 60 |
Table 3.3 indicates a total trauma center need ranging from 432/ to 60 trauma centers, although only 12 trauma centers were in existence at the time of the report. As the table reflects, the need estimate was apparently based on only one factor: the number of trauma patients residing and treated within each TSA in 1988. However, the 1990 Report indicates that members of the "number and location subcommittee" may have considered other factors in arriving at their recommendation:
The study design formulated by the CHSPA called for identification and analysis of trauma patient incidence and patient flow for a one-year period based on the HCCB detailed case mix data. This data analysis effort alone, however, would not specifically identify the number of trauma centers needed in the state, nor their generalized location. The patient incidence and flow information needs to be considered in relation to the following factors in order to reach sound recommendations: . . .
The injury severity level for which trauma center care is required;
the minimum number of cases which should be treated at a trauma center in order to maintain skill proficiencies consistent with high quality outcomes;
appropriate travel times from accident location to a trauma center; and,
the existing level of facility resources available in an area upon which one or more trauma centers could be built.
While information on certain of these points was available through trauma care literature and previous research, its applicability to Florida’s circumstances was not clear in all instances. Therefore, the Department sought recommendations on these issues from the committee and, especially, from the number and location subcommittee. The subcommittee’s recommendations, as ratified by the full committee, were integral to the development to the approximate number and generalized locations of state-sponsored trauma care throughout the state.
However, no methodology was provided within the Report to show how the number of trauma centers was allocated among the TSAs based upon the data considered by the committee. The committee also cautioned that their estimate did not take into
account other relevant factors or local conditions within each TSA that should be assessed before deciding how many trauma centers were in fact needed, including resource availability. As stated in the 1990 Report:
It was the full committee's feeling that the number of hospitals able to apply to be state-sponsored trauma centers would be limited by the lack of resources in the service area. For instance, the standards require that trauma centers have certain physician specialists committed to the facility for availability 24 hours a day, seven days a week. There are not enough specialists available in any area of the state to staff more than a few trauma centers. The reality of the situation lead the full committee to believe that there cannot be a proliferation of trauma centers. Dialogue between the state and local/regional agency would be essential to making the decision on the number of trauma centers needed.
The 1990 Report did not include data or analysis relating to factors such as the availability of physician specialists within geographic areas, existing trauma center patient volumes, patient outcomes, or the capacity and adequacy of existing trauma centers.
Following receipt of the 1990 Report, the Legislature amended the trauma statute by adopting the 19 trauma service areas proposed in the 1990 Report. Chapter 90-284, § 5, at
2188-89, Laws of Fla. However, the Legislature did not consider
the trauma service area boundaries to be permanent or static. Instead, the Legislature provided that:
[t]hese areas are subject to periodic revision by the Legislature based on recommendations made as part of local or regional trauma plans approved by the department . . . These areas shall, at a minimum, be reviewed by the Legislature prior to the next 7-year verification cycle of state sponsored trauma centers.
As part of the 1990 trauma statute amendment, the Legislature provided that, in addition to complying with the trauma center standards, a trauma center applicant must "be located in a trauma service area which has a need for such a center." Ch. 90-284, § 6, at 2191, Laws of Fla. In this regard, the Legislature directed HRS to "establish [within each service area] the approximate number of state-sponsored trauma centers needed to ensure reasonable access to high quality trauma services." Id. (emphasis added). This need determination, which must be promulgated via rule, was to be "based on the state trauma system plan and the [1990 Report]." Id.; § 395.402(3)(b) ("[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area").
However, the Legislature rejected the 1990 Report's recommended minimum of 43 and maximum of 60 trauma centers. Instead, the Legislature stipulated that there should be a
minimum of 19 trauma centers (i.e., one trauma center in each service area) and "no more than" 44 trauma centers. Ch. 90-284,
§ 5, at 2189-90, Laws of Fla.
In 1992, HRS promulgated rule 64J-2.010. The Rule adopted the column in Table 3.3 of the 1990 Report reflecting the "minimum" recommended number of trauma centers, and stated that "[t]he number of trauma centers in each TSA shall be in accordance with the minimum number set forth in the table.3/” The trauma center need allocated by rule 64J-2.010, which merely replicates Table 3.3, has remained unchanged since 1992 with the exception of TSA 18.
Subsequent Developments
In 1998, the Legislature directed DOH via a committee (the "1999 Committee") to prepare a report by February 1, 1999, (the "1999 Report") "on how best to ensure that patients requiring trauma care have timely access to a trauma center." In furtherance of this objective, the 1999 Committee was required to "study . . . the strategic geographical location of trauma centers . . . ." Id.
In its report, the 1999 Committee recommended that "[t]he goal for timely access to trauma centers should be to assure that every trauma victim can be delivered to a trauma center, either by emergency medical ground or air transport,
within 30 minutes of beginning transport." As stated in the 1999 Report:
There must be an adequate number of trauma centers distributed statewide in order to ensure timely access. . . [T]he ideal trauma system would assure that every trauma victim can be delivered to a trauma center within 30-minute air or ground transport.
The geographical locations of the 19 trauma centers either verified or provisional as of July 1998 are shown on Map 1 in Appendix F. The circles around each trauma center location illustrate a fifty-mile flight radius, which translates into an average 30- minutes transport time by helicopter for a trauma victim. Helicopter transport time is used for this illustration because air medical transport allows trauma victims to be transported further distances within the 30-minute timeframe.
The 1999 Committee found that some areas in Florida were not within a fifty-mile flight radius of one of the 19 existing trauma centers, which meant residents in these areas could not access a trauma center within 30 minutes. In fact, at that time, only 80 to 85 percent of Florida residents were within 30 minutes of a trauma center.4/ The committee therefore concluded "Florida does not have an adequate number of trauma centers distributed statewide to ensure timely access to appropriate trauma care."
As a result of its findings, the 1999 Committee "developed two additional criteria for use by the department:
1) the overall goal of 30-minute transport time to trauma centers, and; 2) its equivalent, 50 miles, for helicopter flight times." The committee stated that these access criteria "should be considered by [DOH] in developing administrative rules for the planning and development of additional trauma centers . . ."
The 1999 Committee made no attempt to quantify the number of additional trauma centers that were needed statewide, or within each TSA, to achieve the 30-minute goal.5/ Nor did the committee seek to update the Rule (i.e., Table 3.3) using the 1990 Report's methodology. However, the committee cautioned that:
[r]etaining the limit on the number of trauma centers was . . . essential in order to maintain a reasonable volume of patients who are trauma victims as well as to avoid conflicts between competing trauma centers for recruitment of key professional staff.
The 1999 Committee recommended giving DOH the "statutory authority to assign counties to trauma service areas" and that DOH "conduct a review of the regional structure of the
19 trauma service areas and the assignment of the counties between these areas and make changes, if found to be appropriate." The 1999 Report offered the following explanation for this recommendation:
The committee did recommend that authority to assign counties to trauma service areas should be given to the department. Current authority resides with the Legislature.
Shifting this authority to the department will allow flexibility in the system to more quickly respond to changing needs at the local level.
Consistent with the 1999 Committee's recommendation, the Legislature repealed the statutory provision that made the trauma service areas subject to periodic review and "revision by the Legislature." Ch. 99-397, § 195, at 164, Laws of Fla. This repealed provision was replaced with an amendment to section 395.402(3) that delegated to DOH the statutory duty to review and revise the TSA boundaries, which stated as follows:
Trauma service areas are to be used. The department shall periodically review the assignment of the 67 counties to trauma service areas. These assignments are made for the purpose of developing a system of trauma centers. Revisions made by the department should take into consideration the recommendations made as part of the regional trauma system plans approved by the department, as well as the recommendations made as part of the state trauma system plan. These areas must, at a minimum, be reviewed in the year 2000 and every 5 years thereafter. Until the department completes its initial review, the assignment of counties shall remain as established pursuant to chapter 90-284, Laws of Florida. Ch. 99-397, § 195, at 163-64, Laws of Fla. (Emphasis added).
In response to the Legislature's directive, DOH initiated a review of the service areas and prepared a draft report entitled “Trauma Service Area Study-Year 2000” (the "2000 Draft Study"). However, for reasons unknown in this record, DOH
apparently never finalized that study, and it was received in evidence in draft form only.
In the 2000 Draft Study, DOH noted that the "primary purpose" of the TSA review mandated by section 395.402(3) "is to determine if the 19 trauma service areas . . . continue to be rational service areas." Based on the 1990 Report's methodology, the draft study's tentative recommendation was not to change the trauma service areas, although DOH "should continue to study and review the trauma service areas . . . to determine if different county configurations might lead to more timely access . . . ." At the same time, after analyzing more recent data, the draft study recommended the allocation of a different number of trauma centers to TSAs 9, 10, 11, and 12 as compared to the Rule.6/ Additionally, the 2000 Draft Study made the following finding:
Because of the substantial financial commitment made by a hospital to be a trauma center, patient volume becomes an important factor for a hospital in terms of being financially viable and having enough work for trauma surgeons to maintain their skills. The old adage of practice makes perfect is particularly applicable to those treating the seriously injured trauma patient. . . To meet [the American College of Surgeons] caseload recommendations, locating trauma centers in areas where skill levels can be maintained by trauma surgeons is an important factor. Furthermore, to recruit and retain well-qualified surgeons to work in a trauma center, it is important
to have a sufficient number of patients to treat, especially to the surgeon.
Thus, the 2000 Study emphasized that trauma centers must see enough patients to be financially viable and for trauma surgeons to maintain their skills, and referenced the American College of Surgeons recommendation that Level I trauma centers treat 600 to 1000 patients annually and Level II trauma centers treat 350 to 600 patients annually.
The 2000 Study concluded:
-No change in trauma service areas should be made at this time. This study found that minimal change occurred in those counties identified as nucleus counties.
Furthermore, the relationship between nucleus counties and those identified as sending or "feeder" counties remains intact.
-The 19 trauma service areas should continue to serve as the geographical basis for the allocation of the 44 authorized trauma center slots.
-The 44 authorized trauma center slots in chapter 395.401 Florida Statutes [now section 395.402(4)(c) should remain as the maximum number required to meet trauma patient care demands.
2004 Amendments to the Trauma Statutes and the 2005 Assessment
In 2004, the Legislature made substantial revisions to the trauma statute. Chapter 2004-259, Section 6, Laws of Florida amended section 395.402 to direct the Department to complete a statewide assessment of the trauma system by
February 1, 2005 ("the 2005 Assessment"). § 395.402(2), Fla.
Stat. The scope of this assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. An appropriation of $300,000 was authorized for the Department to contract with a state university to perform the actions required under the amended statute. Ch. 2004-259, § 10, Laws of Florida.
One objective of the 2005 Assessment was to "[c]onsider aligning trauma service areas within [sic] the trauma region boundaries as established in" section 395.4015(1).
§395.402(2)(a), Fla. Stat. In a related 2004 amendment, the Legislature added a sunset provision that, upon completion of the 2005 Assessment, ended the statutory mandate to use the service areas created in 1990. See § 395.402(2) ("[t]rauma service areas as defined in this section are to be utilized until [DOH] completes" the 2005 Assessment) (emphasis added);
§ 395.402(4) ("[u]ntil the department completes the February 2005 Assessment, the assignment of counties shall remain as established in this section.")
The obvious intent of the above statutory change was for the section 395.402(4) service areas to be replaced by the service areas DOH established or adopted once it had the results of the 2005 Assessment. "Annually thereafter" (as opposed to every five years per the 1999 version of the statute) DOH was required to "review the assignment of the 67 counties to trauma
service areas . . . ." Ch. 2004-259, § 6, at 13, Laws of Florida (amending § 395.402(3)).
Another objective of the 2005 Assessment was to "establish criteria for determining the number and level of trauma centers needed to serve the population in a defined trauma service area or region." § 395.402(2)(c), Fla. Stat. Based on these criteria, DOH was then to "[r]eview the number and level of trauma centers needed for each trauma service area to provide a statewide integrated trauma system."
§ 395.402(2)(b), Fla. Stat. As part of this need assessment, DOH was required to consider the "[i]nventories of available trauma care resources, including professional medical staff," as well as the "[r]ecommendations of the Regional Domestic Security Task Force" and "the actual number of trauma victims currently being served by each trauma center." § 395.402(3), Fla. Stat.
However, unlike the situation with the 1990 Report, the Legislature did not intend for DOH to rely on the 2005 Assessment indefinitely. To avoid this, the Legislature therefore required DOH to update the 2005 Assessment by annually reviewing "the requirements of paragraphs (2)(b )-(g) and subsection (3)" of section 395.402. This meant that each annual review, like the initial 2005 Assessment, had to "[r]eview the number and level of trauma centers needed for each trauma service area or region" by, among other things, considering
"[i]nventories of available trauma care resources, including professional medical staff." §§ 395.402(2)(b) and (3)(e). The need determinations resulting from these annual reviews would then have to be codified in a rule per section 395.402(4)(b) ("[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area").
The 2004 Legislature clearly intended for DOH to rely on the updated need assessments required by section 395.402(4), rather than the need allocation in the 1990 Report (which was incorporated into the Rule). This is evident from the fact that the 2004 Legislature repealed the provision that previously required DOH to establish need based on the 1990 Report. See
chapter 2004-259, § 7, at page 14, Laws of Florida (amending section 395.4026(1)), which states in relevant part:
Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, and recommendations of the local or regional trauma agency, and the 1990 Report and Proposal for Funding State Sponsored Trauma Centers, the department shall establish the approximate number of state approved trauma centers needed to ensure reasonable access to high-quality trauma services. The Using the guidelines and procedures outlined in the 1990 report, except when in conflict with those prescribed in this section, the department shall select those hospitals that are to be recognized as state approved trauma centers . . .
[emphasis added]
By repealing the statutory reference to the 1990 Report, the Legislature expressly required the Department to discontinue any reliance on the 1990 Report as a basis for allocating trauma center need.
In addition, the 2004 Legislature imposed a moratorium on the submission of applications for new trauma centers in any TSA that already had one trauma center until the 2005 Assessment was complete, regardless of whether the Rule indicated a need for an additional trauma center within the TSA. § 395.4025(14), Fla. Stat. It is reasonable to infer that the imposition of a moratorium notwithstanding unmet need in several of the TSA's under the Rule indicates that the Legislature considered the Rule to be outdated and no longer valid. The moratorium therefore had the effect of maintaining the status quo until the Rule could be updated with a new assessment.
The Department timely submitted its 2005 Assessment to the Legislature on February 1, 2005. The assessment itself was conducted by a group of investigators from the University of South Florida and the University of Florida. This group was assisted by a National Steering Committee "composed of recognized experts in the fields of trauma care and trauma system analysis "
In its transmittal letter to the Legislature, DOH specifically noted that the assessment included a recommendation
regarding “the number and level of trauma centers needed to provide a statewide integrated trauma system. . . .” In contrast with HRS' contemporaneous objections to the 1990 Report, the DOH transmittal letter identified no areas of disagreement with the 2005 Assessment.
The 2005 Assessment included 5 "Recommendations", including:
(Emphasis added)
Thus, unlike the 1990 Report (and the Rule), the authors of the 2005 Assessment recommended that the availability of existing resources should be taken into account in determining the need for new trauma centers.
In evaluating need based on DSTF region, the 2005 Assessment identified an unmet need for only four more trauma centers in the state,8/ which "would provide access to a trauma center for 99 percent of the people in Florida." Given the 20
trauma centers in existence at the time, this meant that the total trauma center need was 24, which is substantially below the need established by the Rule of 42 trauma centers. This lower need determination was due in part to the fact that the 2005 Assessment took "trauma center capacity," and not just the number of patients served per trauma center, into account.
According to the 2005 Assessment, the recommended four new trauma centers were needed in DSTF Regions 1, 2, 3 and 5. However, the assessment concluded there was no need for another trauma center in DSTF Region 4 (Tampa Bay), which was found to have "adequate trauma center access at this time." This contrasts with the Rule, which purports to authorize five more trauma centers in the counties assigned to Region 4. In particular, under the Rule, there is a net need for two new trauma centers in Pasco County (TSA 9), two new trauma centers in Manatee County (TSA 13) and one new trauma center in either Citrus or Hernando County (TSA 6).
The only legislative response to the 2005 Assessment was an increase in funding to trauma centers. Likewise, the Department has not amended the Rule to implement the recommendations contained in the Assessment.
In 2008, the Department held rule development workshops in order for trauma system constituents to indicate whether trauma center allocations contained in the Rule should
be changed. Pursuant to stakeholder requests arising out of the workshops, the Department began consideration of an increase in the maximum number of trauma center positions allocated to TSA 1 (Escambia, Santa Rosa, Fort Walton and Okaloosa Counties).
Following numerous public workshops and hearings, the Department filed notice of its intent to amend the Rule to increase the allocation of trauma centers in TSA 1 from 2 to 3. However, the amendment did not become final due to matters unrelated to the determination itself and was withdrawn by the Department.9/
The January, 2011 TSA Report
In 2011, a study was completed for DOH entitled "Florida Trauma Service Area Analysis" (the "2011 TSA Report") that relied on the 1990 Report's patient flow methodology for assigning counties to trauma service areas. However, this study did not take into account all of the section 395.402(3) criteria. The 2011 TSA Report disclosed this deficiency, stating:
This study provides an analysis of TSAs and counties to assess retention of trauma alert patients within the county. Rules for designating counties as nucleus counties for trauma centers and counties for consideration for trauma centers were defined in analyses of TSAs conducted for the office of Trauma in 1990 and 2000.
* * *
This report analyzes hospital discharges by TSA from 2000 to 2009. Hospital
discharge data from [AHCA] is used to analyze the county of residence and
treating facility for all trauma patients with an Injury Severity Score (ISS) of 9 or greater, as deemed by statute . . . .
Other considerations required, by statute, in the assignment of counties to
TSAs include recommendations of regional trauma system plans, stakeholder recommendations, geographical composition to assure rapid access to trauma
care, inventories of available trauma care resources, transportation capabilities, medically appropriate travel times, recommendations by the Regional Domestic Security Task Force, and any appropriate criteria. These considerations are not integrated into this analysis of TSAs. (Emphasis added).
Although the 2011 TSA Study used the same methodology as the 1990 Report, the 2011 TSA Study supports a different TSA configuration than the one established in the 1990 Report because patient flow patterns have changed since 1990. For example, in the 1990 analysis, the primary treatment county for Manatee County was Sarasota County. Because Manatee served as a feeder county for Sarasota (a nucleus county), it was grouped in the 1990 Report with Sarasota County in TSA 13. However, the updated information in the 2011 TSA study shows that the primary treatment county for Manatee County residents is now Pinellas (TSA 9's nucleus county), which requires that Manatee County be reassigned to TSA 9 per the 1990 Report's methodology. A similar shift in patient flow also dictates the reassignment of Hernando County from TSA 6 to TSA 10 (Hillsborough County).
Indeed, it appears that all of the counties in TSA 6 would have to be merged with other trauma service areas since Marion County, which was designated as TSA 6's nucleus county in the 1990 Report, no longer qualifies as a nucleus county.
The Department maintains that its employees are continuously reviewing trauma volume, injury severity scores, population and other data and that this activity qualifies as the annual need and trauma service area reviews required by section 395.402(4). However, DOH has not established a need methodology by rule, policy or otherwise that it could apply to this data to quantify the number of trauma centers needed in each TSA. In the absence of an articulable need methodology, it is not possible to verify or replicate any assessment DOH may have done based on the data it claims to have reviewed.
More significantly, the Department has itself acknowledged the problem of not having a methodology or process in place for conducting regular assessments. In its "2011-2015 Florida Trauma System Strategic Plan" (the "2011 State Plan"), DOH identified as a "threat" to the achievement of Goal 8 (Regional Trauma System Evaluation) the "[l]ack of effective evaluation criteria, tools and a systematic and periodic process to evaluate trauma service areas and apportionment of trauma centers." In furtherance of Goal 8, DOH also recognized the need to "[c]onduct a statewide comprehensive assessment of the
Florida Trauma System access to care based on s. 395.402, F.S., the Western-Bazzoli criteria and other criteria to evaluate access to care and the effectiveness of the trauma service areas/regions." The specified timeline for this future assessment was "December 2011, with annual reviews thereafter as funding is available."
On May 19, 2011, the Department's State Surgeon General signed an "Issue Paper" approving a "Florida Trauma System Special Study." This study is intended to "assist the department in developing a process and evidence-based guidelines to be utilized by [DOH] in determining the need for trauma center locations throughout the state." According to the Department's witness, Susan McDevitt (former Director of the Office of Trauma), DOH intends to use this study to develop a formula or methodology for determining the need for new trauma centers in the state. DOH determined this study was needed because the "trauma network has matured and changed" since 2005 when the "last comprehensive assessment of the Florida trauma system" was done. However, December 2011 is the earliest anticipated date for completion of this study, and DOH has no timeline for when this study may result in any rule amendment.
As noted, the 1990 Report forms the basis for the configuration of the existing 19 TSA's as well as the need allocated to each of the TSA's within the Rule (with the
exception of the reduction in Broward County). However,
Dr. Lewis Flint, an expert in trauma surgery and trauma system assessment, credibly explained how Florida's trauma system has "matured and changed" since the 1990 Study was completed:
Q. Now, Doctor, can you describe what changes there have been in the trauma system since the 1990 study was completed?
A. Well, in 1990, there were fewer trauma centers than there currently are. I believe there were only about 12 designated centers in 1990. There are 22 now.
The availability and the efficiency and quality of pre-hospital care has changed in a major way since 1990. We have far more advanced life support staff on ambulances than we had in 1990.
We have far more plentiful air evacuation capability than we had in 1990, and the quality and efficiency of the existing trauma centers has changed in a major way as the centers have matured.
So that the combination of greatly improved pre-hospital care and significant improvements in efficiency and in-patient outcomes in the existing trauma centers has meant that this system has matured into a very effective trauma system.
It is not free of shortcomings, it is not an entire system yet. It has some holes in it, but the system as such has changed in a major way since 1990, such that it was our view at the close of the 2005 comprehensive assessment, that a decision about deployment of trauma centers that was based solely on distance and geography was not going to be an optimum method of determining how the system should be deployed.
Whether or not the 1990 Report was valid when issued, its recommended service area configurations and need allocations have been rendered obsolete by the passage of time, changes in patient flow patterns, and significant advances in the trauma care delivery system since the Rule was adopted. Reasonable health planning requires the use of the most recent data available and systematic evaluation of the multiplicity of factors that determine the appropriate number and location of trauma centers in the state. No doubt that is why the Legislature directed DOH to conduct assessments annually.
§ 395.402(4). Here, the 1990 Report's recommendations were predicated on 1988 information that is now more than two decades old.10/ It is inappropriate to rely on 1988 data to justify the service area configuration or need allocation in 2011, particularly given the major changes and maturation of the trauma system since 1988.
The 1990 Report (and rule) also fails to take into account criteria that must now be considered pursuant to the 2004 amendment to section 395.402. In particular, section 395.402(3) as amended, requires the DOH annual need and service area reviews to take into account Regional Domestic Security Task Force recommendations, transportation capabilities (including air transport), and inventories of available trauma care resources (including professional medical staff). The 1990
Report took none of these factors into account in making the need recommendations that were eventually incorporated into the Rule. Notably, had the availability of professional medical staff been factored into the analysis, need would likely have been reduced, as the 1990 Report itself observed, stating:
It was the full committee's feeling that the number of hospitals able to apply to be state-sponsored trauma centers would be limited by the lack of resources in the service area. For instance, the standards require that trauma centers have certain physician specialists committed to the facility for availability 24 hours a day, seven days a week. There are not enough specialists available in any area of the state to staff more than a few trauma centers. The reality of the situation lead the full committee to believe that there cannot be a proliferation of trauma centers.
(Emphasis added).
Standing
Petitioners TGH and SJH are located in TSA 10 (Hillsborough County). Petitioner Bayfront is located in Pinellas County in TSA 9 (Pinellas and Pasco Counties). Intervenor Bayonet Point is also located in TSA 9, but in Pasco County. Intervenor Blake is located in Manatee County, in TSA
13 (Manatee, Sarasota, and DeSoto Counties), adjacent to TSA 9.
Petitioner Shands is located in TSA 5 (Baker, Clay, Duval, Nassau, and St. Johns Counties). Trauma center applicant
Orange Park (a non-party) is located in TSA 5 but in a different county (Clay) from Petitioner Shands (Duval).
As noted earlier, because of the intensity of resources that must be devoted to a trauma center, hospitals generally lose money in their operation. Specifically, in FY 2010 Tampa General's Level I trauma center had a $15.7 million net loss, while Bayfront's Level II trauma center had a
$3 million net loss. Similarly, Shands lost approximately
$2.7 million and SJH lost $8.3 million from the operation of their trauma centers in FY 2010.
Of the 42 trauma center positions available statewide, the Rule allocates three to TSA 9 and three to TSA 13. Because TSA 9 currently has one designated trauma center (Bayfront) while TSA 13 has none, the Rule establishes a net need for two more trauma centers in TSA 9 and three more trauma centers in TSA 13.
The Intervenors' pending trauma center applications propose to establish Level II trauma centers at Regional Medical Center Bayonet Point in Pasco County, (TSA 9), and at Blake Medical Center in Manatee County (TSA 13).
The filing of the Intervenors' applications triggered the application review process set forth in section 395.4025(2). Pursuant to this statute, the deadline for submitting a trauma application is April 1 of each year. § 395.4025(2)(c). The
filing of an application triggers a 30-day provisional review period (which in this case is delayed until October 1, 2011, due to an 18-month extension request made by Intervenors). The limited purpose of this provisional review is to determine if the hospital's application is complete "and that the hospital has the critical elements required for a trauma center." Id.
The "critical element" portion of the review is based on the trauma center standards and includes a review of whether the hospital meets the equipment, facility, personnel and quality assurance standards. Id. Any hospital that (i) submitted an application found acceptable in the provisional review (i.e., meets the trauma center standards) and (ii) is located in a TSA that has a need for a trauma center may operate as a provisional trauma center after the 30-day provisional review period has concluded. §§ 395.4025(2)(d) and (5).
Based upon the facts of record, there is a reasonable probability that the Intervenor hospitals will achieve provisional trauma center status by October 30, 2011, (the end of the 30-day provisional review period that will start
October 1, 2011). First, Intervenors' witness James Hurst, M.D. (who is assisting Intervenors and Orange Park in recruiting trauma surgeons and in the application process) testified without contradiction that the HCA applications would be complete and in compliance with the applicable trauma center
standards by the extended October 1st application submission deadline. Second, both Intervenor hospitals are located in trauma service areas with a need as established by the Rule. As confirmed by Ms. McDevitt, if the applications meet the programmatic requirements as determined by the provisional review, and there is a need indicated by the Rule, DOH will approve the applications and award the Intervenor hospitals in TSA 9 and 13 provisional trauma center status. Likewise, it is reasonable to expect that the Orange Park application will be approved if it meets the programmatic requirements, given the available slot in TSA 5.
Upon receiving the provisional trauma center designation, the EMS providers will be required to treat Bayonet Point, Blake, and Orange Park as trauma centers. This means that the EMS providers will have to revise their protocols to redirect the transport of trauma alert patients from other existing trauma centers to the new centers. See, Fla. Admin. Code R. 64J-2.002(3)(g). A "trauma alert" patient is defined as a "person whose primary physical injury is a blunt, penetrating or burn injury, and who meets one or more of the adult trauma scorecard criteria . . . ." Fla. Admin. Code R. 64J-2.001(14). Pursuant to the DOH Trauma Transport Protocols Manual (which all EMS providers must follow), EMS providers must transport all trauma alert patients to the closest trauma center that is
"within 30 minutes by ground or air transport or within 50 miles by air transport." As a result, any trauma alert patient who is closest to Bayonet Point, Blake, or Orange Park will have to be transported to one of those hospitals once they are designated as provisional trauma centers.
A provisional trauma center at Bayonet Point would become the closest trauma center for Pasco, Hernando, and Citrus residents (the "northern Tampa Bay region"). Trauma alert patients from these counties would therefore have to be transported to Bayonet Point instead of to the existing trauma centers in Hillsborough (SJH and Tampa General) or Pinellas (Bayfront). Likewise, a provisional trauma center at Blake would become the closest trauma center to Manatee and Sarasota (the "southern Tampa Bay region") requiring transport of their trauma alert patients to Blake rather than to the Hillsborough or Pinellas trauma centers.
In 2010, 669 trauma alert patients (16 and over) were transported to Bayfront from the counties in the northern and southern regions of Tampa Bay. This represents 42 percent of all the trauma alert patients (16 and over) transported to Bayfront. From the same area and during the same time period,
120 trauma alert patients (16 and over) were transported to Tampa General. All of these trauma alert patients would be redirected away from Bayfront and Tampa General and transported
to the closer Intervenor trauma centers per the EMS transport protocols.
The redirection of these trauma alert patients to Bayonet Point and Blake would substantially and adversely affect both Bayfront and Tampa General. In Bayfront’s case, the lost contribution margin caused by the annual diversion of even 400 trauma patients would reduce Bayfront's total margin by at least
$2.3 million each year. Likewise, the yearly diversion of 120 trauma patients from Tampa General would result in an annual lost contribution margin and reduction in total margin in excess of $1 million. Notably, for both hospitals this represents the minimum potential loss of trauma patients and revenue as a result of the approval of the Intervenors' trauma centers.
Annual losses in excess of a million dollars would be material to both Bayfront and Tampa General given the financial challenges both hospitals are already facing.
Although physically located in TSA 10 (Hillsborough County) SJH now receives trauma patients from Hillsborough, Pasco, Citrus, Hernando, and Sumter counties. If approved, the trauma center at Bayonet Point would become the closest trauma center for Pasco, Hernando, and Citrus residents and would likely result in the immediate loss of between 149 and 307 from SJH's trauma program.
If the Orange Park trauma center is approved, it is reasonable to expect that all of Shands trauma patients originating from Clay County would instead be redirected to Orange Park. This would represent a loss of approximately 1,000 patients annually, or 25 percent of Shands current trauma volume. With fewer cases to absorb the high fixed costs of trauma preparedness, Shands expects that it would lose $3,400 per case, on a fully allocated basis, rather than the $665/case it now loses. Thus, whereas Shands' trauma center currently loses $2.7 million annually, that loss would increase to approximately $10 million per year. And on a contribution margin basis (where fixed costs are excluded) Shands will experience a decline in contribution margin of $6-7 million annually once the Orange Park trauma center becomes operational.
In addition to the direct loss of trauma patients and corresponding revenue, it is reasonable to anticipate that the approval of new trauma centers in relatively close proximity to existing centers will result in increased competition for scarce surgical subspecialists currently associated with the existing trauma programs. Specifically, the opening of new trauma centers in TSA's 5, 9, and 13 are likely to increase the difficulty and escalate the cost of ensuring adequate on-call specialty physician coverage for the Petitioner's hospitals and
to adversely affect their ability to retain highly skilled nurses, technicians, and other trauma program staff.
CONCLUSIONS OF LAW
Jurisdiction and Standing
The Division of Administrative Hearings has jurisdiction over the subject matter of this proceeding. See
§§ 120.56(1)(c), 120.569 and 120.57(1), Fla. Stat. Section 120.56(1)(a) provides:
Any person substantially affected by a rule or a proposed rule may seek an administrative determination of the invalidity of the rule on the ground that the Rule is an invalid exercise of delegated legislative authority.
Jurisdiction attaches when a person who is substantially affected by a rule claims that it is an invalid exercise of delegated legislative authority. The party challenging an existing agency rule has the burden to prove by a preponderance of the evidence that the Rule constitutes an invalid exercise of delegated legislative authority as to the objections raised. § 120.56(3)(a), Fla. Stat. Cortes v. State Bd. of Regents, 665 So. 2d 132 (Fla. 1st DCA 1995). The challenger's burden is a stringent one. Id.; Charity v. Fla. State Univ., 680 So. 2d 463 (Fla. 1st DCA 1996).
Substantial interest jurisdiction under section 120.569(1) does not require that a party prevail on the merits.
See Peace River/Manasota Reg'l Water Supply Auth. v. IMC Phosphates Co., 18 So. 3d 1079, 1082-85 (Fla. 2d DCA 2009); Palm Beach Cnty. Envt'l Coal. v. Dep't of Envt'l Prot., 14 So. 3d 1076 (Fla. 2009). If a party's substantial interests "could be affected" or "could reasonably be affected," then that is enough to establish the substantial interests needed to obtain standing. See Peace River, 18 So. 3d at 1084; Palm Beach Cnty. Envt'l Coal., 14 So. 3d at 1078. The standing requirement is a "forward-looking concept [that] cannot 'disappear' based upon the ultimate outcome of the proceeding." See Id., 18 So. 3d at 1083; 14 So. 3d at 1078.
Some of the Petitioners argue that the proper jurisdictional inquiry is whether the impact of the Rule on Petitioners is different than its impact on other Florida citizens, citing NAACP v. Fla. Bd. of Regents, 863 So. 2d 294,
299 (Fla. 2003). To be "substantially affected" does not require an "immediate and actual harm." See Id., 863 So. 2d at
300. In NAACP, it was not necessary for any rule challenger to demonstrate that he or she had been rejected for admission to a state university due to the adoption of rule eliminating affirmative action policies; prospective candidates were also substantially affected and could challenge the Rule.
As will be discussed in greater detail infra, Petitioners have demonstrated that the effect of the Rule is not
speculative or remote, and that compared to a typical citizen, the impact of the Rule on Petitioners presents a different kind of harm. Therefore, Petitioners meet the test for standing established in NAACP. However, since NAACP addressed the issue of associational standing, the more stringent test of standing established in Agrico Chemical Co. v. Dep’t of Envtl. Reg., 406 So. 2d 478 (Fla. 2d DCA 1981) must be applied.
Under the Agrico test, a party's substantial interests are determined if: 1) the party will suffer injury in fact which is of sufficient immediacy to entitle him to a section
120.57 hearing, and 2) the party's substantial injury is of a type or nature which the proceeding is designed to protect. Agrico, 406 So. 2d at 482. Thus, the first prong of this test deals with the degree of injury or "injury in fact," while the second deals with the nature of the injury. Respondent and Intervenors argue that none of the Petitioners have standing under this test because the injury alleged is not real and immediate but rather is hypothetical, conjectural and speculative, and is based on future events that may never happen.
The Department has stated that based on the determination of need set forth in the Rule, it intends to approve the pending applications for new trauma programs in TSAs 5, 9, and 13 upon satisfaction of programmatic criteria. The
approval of those new trauma programs is reasonably expected to result in an immediate reduction in trauma patient volumes as well as increased staffing challenges at the Petitioners' trauma centers. Given the pendency of those applications and their likelihood of approval, the adverse impacts feared by Petitioners are likely to occur with sufficient immediacy to confer standing to participate in this rule challenge proceeding.
Under the second prong of the Agrico test, the Petitioners' substantial injury is of the type which this proceeding is designed to protect. The Rule was promulgated pursuant to section 395.405 to implement the provisions of sections 395.401, 395.4015, and 395.402. Section 395.402 states in pertinent part:
The Legislature recognizes the need for a statewide, cohesive, uniform, and integrated trauma system. Within the trauma service areas, Level I and Level II trauma centers shall each be capable of annually treating a minimum of 1,000 and 500 patients, respectively, with an injury severity score (ISS) of 9 or greater. Level II trauma centers in counties with a population of more than 500,000 shall have the capacity to care for 1,000 patients per year.
Trauma service areas as defined in this section are to be utilized until the Department of Health completes an assessment
of the trauma system and reports its finding to the Governor, the President of
the Senate, the Speaker of the House of Representatives, and the substantive legislative committees.
The report shall be submitted by February 1, 2005. The department shall review the existing trauma system and determine whether it is effective in providing trauma care uniformly throughout the state.
The assessment shall:
Consider aligning trauma service areas within the trauma region boundaries as established in July 2004.
Review the number and level of trauma centers needed for each trauma service area to provide a statewide integrated trauma system.
Establish criteria for determining the number and level of trauma centers needed to serve the population in a defined trauma service area or region.
Consider including criteria within trauma center approval standards based upon the number of trauma victims served within a service area.
Review the Regional Domestic Security Task Force structure and determine whether integrating the trauma system planning with interagency regional emergency and disaster planning efforts is feasible and identify any duplication of efforts between the two entities.
Make recommendations regarding a continued revenue source which shall include a local participation requirement.
Make recommendations regarding a formula for the distribution of funds identified for trauma centers which shall
address incentives for new centers where needed and 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.
In conducting such assessment and subsequent annual reviews, the department shall consider:
The recommendations made as part of the regional trauma system plans submitted by regional trauma agencies.
Stakeholder recommendations.
The geographical composition of an area to ensure rapid access to trauma care by patients.
Historical patterns of patient referral and transfer in an area.
Inventories of available trauma care resources, including professional medical staff.
Population growth characteristics.
Transportation capabilities, including ground and air transport.
Medically appropriate ground and air travel times.
Recommendations of the Regional Domestic Security Task Force.
The actual number of trauma victims currently being served by each trauma center.
Other appropriate criteria. (Emphasis added)
The above statute directs the Department to determine the need for additional trauma centers in the state, taking into consideration specifically identified criteria and factors that directly involve and affect the substantial interests of the Petitioners, including but not limited to "historical patterns of patient referral and transfer in an area," "inventories of available trauma care resources, including professional medical staff," and "stakeholder recommendations." The statute's straightforward purpose is to assess and evaluate the state trauma system as a whole, which includes consideration of the capabilities of existing trauma centers, the availability of the resources needed to provide comprehensive trauma care, and the effect on the delivery of trauma care within a given region arising from the establishment of a new trauma center to serve the same region.
The Florida Legislature has expressly recognized that the substantial interests of hospitals (including those that operate designated trauma centers) may be determined by the Department's decision on a new trauma center application. Section 395.4025, provides in relevant part:
(7) Any 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 review team pursuant 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 §§ 120.569 and 120.57. Cases filed under chapter 120 may combine all disputes between parties.
(Emphasis added)
Petitioners have established that they are in imminent danger of suffering immediate and actual harm as a result of the Rule. Thus, Petitioners possess the standing necessary to maintain this action under Agrico, and the Division of Administrative Hearings has jurisdiction to hear their claims that the Rule is an invalid exercise of delegated legislative authority.
Invalid Exercise of Delegated Legislative Authority?
Petitioners brought this rule challenge pursuant to sections 120.56(1) and (3), Florida Statutes. Section 120.56(3)(a) provides:
A substantially affected person may seek an administrative determination of the invalidity of an existing rule at any time during the existence of the rule. The petitioner has the burden of proving by a preponderance of the evidence that the existing rule is an invalid exercise of delegated legislative authority as to the objections raised.
Florida Statutes define what constitutes an "invalid exercise of delegated legislative authority":
‘Invalid exercise of delegated legislative authority’ means action that goes beyond the powers, functions, and duties delegated by the Legislature. A proposed or existing rule is an invalid exercise of delegated
legislative authority if anyone of the following applies:
* * *
The agency has exceeded its grant of rulemaking authority, citation to which is required by section 120.54(3)(a)1.;
The rule enlarges, modifies, or contravenes the specific provisions of law implemented, citation to which is required by section 120.54(3)(a)1.;
The Rule is vague, fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency;
The Rule is arbitrary or capricious. A rule is arbitrary if it is not supported by logic or the necessary facts; a rule is capricious if it is adopted without thought or reason or is irrational;
* * *
A grant of rulemaking authority is necessary but not sufficient to allow an agency to adopt a rule; a specific law to be implemented is also required. An agency may adopt only rules that implement or interpret the specific powers and duties granted by the enabling statute. No agency shall have authority to adopt a rule only because it is reasonably related to the purpose of the enabling legislation and is not arbitrary and capricious or is within the agency's class of powers and duties, nor shall an agency have the authority to implement statutory provisions setting forth general legislative intent or policy. Statutory language granting rulemaking authority or generally describing the powers and functions of an agency shall be construed to extend no further than implementing or interpreting the specific powers and duties conferred by the enabling statute.
Added in 2008, section 120.52(17) provides:
‘Rulemaking authority’ means statutory language that explicitly authorizes or requires an agency to adopt, develop, establish, or otherwise create any statement coming within the definition of the term ‘rule.’
This definition does not add new restrictions to agency rulemaking authority, but it does emphasize the existing restrictions cited in the definition of an "invalid exercise of delegated legislative authority." See Fla. Elec. Comm'n v.
Blair, 52 So. 3d 9 (Fla. 151 DCA 2010). The term "law implemented" is also defined by Florida Statutes as "the language of the enabling statute being carried out or interpreted by an agency through rulemaking." See § 120.52(9), Fla. Stat.
The portion of the definition of an invalid exercise which is not found in Section 120.52(8)(a) - (e) is sometimes referred to as the "flush-left" portion of the definition. In SW. Fla. Water Mgmt. Dist. v. Save the Manatee Club, Inc., 773 So. 2d 594 (Fla. 1st DCA 2000), the First District Court of Appeal found that this language prohibited an agency from adopting rules except those "that implement or interpret the specific powers and duties granted by the enabling statute.
See Id., 773 So. 2d at 599. The court observed that, "[i]n the context of the entire sentence, it is clear that the 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.; see also Bd. of Trustees of Internal
Improvement Trust Fund v. Day Cruise Ass'n, 794 So. 2d 696 (Fla. 1st DCA 2001); clarified, rehearing denied, question certified, 798 So. 2d 847 (Fla. 1st DCA 2001); rev. denied, 823 So. 2d
123 (Fla. 2002).
Petitioners seek a determination that the Rule is an invalid exercise of delegated legislative authority because the Rule goes beyond the powers, functions and duties delegated by the Legislature; because the Rule exceeds any grant of rulemaking authority; because the Rule contravenes the specific provisions of law that it purports to implement; and because the Rule is arbitrary and capricious. See §§ 120.52(8), 120.52(8)(b), 120.52(8)(c) and 120.52(8)(d) and 120.52(8)(e), Fla. Stat.
Petitioners assert that the Rule is invalid for at least two reasons. First, if the Rule was ever valid, there is no longer statutory support for the Rule following the 2004 overhaul of trauma statutes. Second, the Rule is invalid because it is arbitrary and capricious. If the Rule ever had a rational basis when it was adopted in 1992, that basis can no longer be described as rational due to the occurrence of
significant events in the intervening twenty years. The evidence of record supports Petitioners' assertions on both counts.
99. Sections 395.401, 395.4015 and 395.402 are cited by the Rule as the statutory provisions being implemented.11/
Section 395.401 primarily addresses the activities of trauma agencies, rather than any particular trauma center operated at a hospital. Pursuant to section 395.4001(11), a "trauma agency" is an entity established by one or more counties for the purpose of administering an inclusive regional trauma system. As established at hearing, Florida has only four trauma agencies, and the majority of the State does not fall within the jurisdiction of these four trauma agencies. Section 395.401(1) and (3) primarily addresses these trauma agencies.12/ The challenged Rule does not address trauma agencies. Thus, section 395.401(1) and (3) cannot serve as rulemaking authority for the Rule.
Section 395.401(2) provides:
The department shall adopt, by rule, standards for verification of trauma centers based on national guidelines, including those established by the American College of Surgeons entitled "Hospital and Prehospital Resources for Optimal Care of the
Injured Patient" and published appendices thereto. Standards specific to pediatric trauma referral centers shall be developed in conjunction with Children's Medical
Services and adopted by rule of the department.
Thus, section 395.401(2) might serve as a basis for the Rule if the Rule attempted to implement national guidelines established by the American College of Surgeons entitled "Hospital and Prehospital Resources for Optimal Care of the Injured Patient." However, the Department provided no testimony that suggests that the challenged Rule was developed while using these guidelines. Accordingly, the Rule does not implement section 395.401(2), and that statute does not support the Rule.
Section 395.4015 more specifically requires the Department to establish a statewide trauma system plan. As part of that plan, the law requires the Department to establish trauma regions. The law provides:
(l) The department shall establish a state trauma system plan. As part of the state trauma system plan, the department 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 section 943.0312. These regions may serve as the basis for the development of department- approved local or regional trauma plans. However, the delivery of trauma services by or in coordination with a trauma agency established before July 1, 2004, may continue in accordance with public and private agreements and operational procedures entered into as provided in section 395.401.
The department shall consider the advice and recommendations of any affected local or regional trauma agency in developing the state trauma system plan.
The department shall use the state trauma system plan as the basis for establishing a statewide inclusive trauma system.
Petitioners argue that the above provision mandates that the Department transition from the use of TSAs to allocate need to "trauma regions" that have boundaries that are coterminous with the boundaries of the seven regional domestic security task force regions. However, reference to section
395.402 establishes that the Legislature did not necessarily intend the trauma regions to replace TSA's for purposes of allocating trauma center need. Indeed, the two are identified as separate, coexistent entities within section 395.402(4), Florida Statutes:
In cases where a trauma service area is located within the boundaries of more than one trauma region, the trauma service area’s needs, response capability, and system requirements shall be considered by each trauma region served by that trauma service area in its regional system plan.
However, by the same token neither can section 395.4015 form the basis for the Rule since need for trauma centers is not allocated by trauma region within the Rule.
The final statute cited by the Rule as a law it implements is Section 395.402. The first three subparts of the
statute are set forth at paragraph 91 above. Subpart 4 provides as follows:
Annually thereafter, the Department shall review the assignment of the 67 counties to trauma service areas, in addition to the requirements of paragraphs (2)(b)-(g) and subsection (3). County assignments are made for the purpose of developing a system of trauma centers. Revisions made by the department shall take into consideration the recommendations made as part of the regional trauma system plans approved by the department and the recommendations made as part of the State Trauma System Plan. In cases where a trauma service area is located within the boundaries of more than one trauma region, the trauma service area’s needs, response capability, and system requirements shall be considered by each trauma region served by that trauma service area in its regional system plan. Until the department completes the February 2005 assessment, the assignment of counties shall remain as established in this section.
The following trauma service areas are hereby established:
Trauma service area 1 shall consist of Escambia, Okaloosa, Santa Rosa, and Walton Counties.
Trauma service area 2 shall consist of Bay, Gulf, Holmes, and Washington Counties.
Trauma service area 3 shall consist of Calhoun, Franklin, Gadsden, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, and Wakulla Counties.
Trauma service area 4 shall consist of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, and Union Counties.
Trauma service area 5 shall consist of Baker, Clay, Duval, Nassau, and St. Johns Counties.
Trauma service area 6 shall consist of Citrus, Hernando, and Marion Counties.
Trauma service area 7 shall consist of Flagler and Volusia Counties.
Trauma service area 8 shall consist of Lake, Orange, Osceola, Seminole, and Sumter Counties.
Trauma service area 9 shall consist of Pasco and Pinellas Counties.
Trauma service area 10 shall consist of Hillsborough County.
Trauma service area 11 shall consist of Hardee, Highlands, and Polk Counties.
Trauma service area 12 shall consist of Brevard and Indian River Counties.
Trauma service area 13 shall consist of DeSoto, Manatee, and Sarasota Counties.
Trauma service area 14 shall consist of Martin, Okeechobee, and St. Lucie Counties.
Trauma service area 15 shall consist of Charlotte, Glades, Hendry, and Lee Counties.
Trauma service area 16 shall consist of Palm Beach County.
Trauma service area 17 shall consist of Collier County.
Trauma service area 18 shall consist of Broward County.
Trauma service area 19 shall consist of Miami-Dade and Monroe Counties.
Each trauma service area should have at least one Level I or Level II trauma center. The department shall allocate, by rule, the number of trauma centers needed for each trauma service area.
There shall be no more than a total of
44 trauma centers in the state. History.—ss. 5, 15, ch. 90-284; ss. 37, 98, ch. 92-289; s. 195, ch. 99-397; s. 26, ch. 2000-242; s. 6, ch. 2004-259; s. 100, ch. 2008-4.
Note.—Former s. 395.033.
In its Proposed Order, the Department explained that it does not believe it has the authority to reconfigure county assignments within the TSA's:
What the Department has not done, and cannot do, is make "[r]evisions" to these county assignments, as implied in the wording of this provision. §395.402(4), Fla. Stat.
Because the counties are assigned to TSAs by statute, the Department has no ability to change them in the absence of a legislative enactment repealing section 395.402(4)(a) and giving the Department such authority. (Respondents Proposed Final Order, para. 62)
The Respondent's position regarding this statutory limitation is rejected. Section 395.402, first adopted in 1990, established temporary guidelines for the establishment of trauma service areas. These temporary guidelines included the nineteen TSAs referenced in the Rule. However, in 2004, the law was amended to require the Department to complete an assessment of Florida's trauma system, and to provide a report to the Governor and legislature no later than February 1, 2005. The law
unequivocally states that the TSA county assignments were to be in effect only until the Department completed its February 2005 assessment. See, e.g., § 395.4015(4), Fla. Stat. ("Until the department completes the February 2005 assessment, the assignment of counties shall remain as established in this section.") (Emphasis added) The authority granted by section
395.402 for the use of the identified TSAs existed only until February 2005. After that time, the Department was required to consider the findings of the 2005 Assessment, as well as the recommendations made as part of the regional trauma system plans approved by the Department and the recommendations made as part of the state trauma system plan. Thus, section 395.402 can no longer serve as a valid basis for the Rule.13/
Moreover, the Department was required to "review the assignment of the 67 counties to trauma service areas," taking into consideration the factors set forth in paragraphs (2)(b)-
(g) and subsection (3) of section 395.402. Having done so, it was incumbent on the Department to amend its Rule to configure the TSA's and allocate the number of trauma centers determined to be needed within each through systematic evaluation and application of the statutory criteria. Thus, the continued use of the Rule by the Department contravenes the very statute it purports to implement.
The Rule is Arbitrary and Capricious
Petitioners assert that the Rule is an invalid exercise of delegated legislative authority because it is arbitrary and capricious. See § 120.52(8)(e), Fla. Stat. "A rule is arbitrary if it is not supported by logic or the
necessary facts; a rule is capricious if it is adopted without thought or reason or is irrational." See Id. The analysis for whether a rule is arbitrary and capricious is (1) whether the rule is supported by logic or the necessary facts; and (2) whether the rule was adopted without thought or is irrational. See id; Las Mercedes Home Care Corp v. Ag. for Health Care Admin., Case No. 10-0860RX (Fla. DOAH F.O. July 23, 2010).
The Department's representative testified that in her opinion, the Rule is a valid determination of current need for new trauma centers based on her knowledge of the Department's "internal" consideration of numerous factors and criteria relating to the issue of need. The Department’s representative conceded, however, that neither the factors nor the methodology used by the Department are contained in any rule or otherwise documented.14/ Thus the facts and logic that the Department contends support the validity of the Rule are unknown and unknowable. The Department did not present any rational explanation of how the Department determines current need for
additional trauma programs based on the 1988 data that gave rise to the Rule.
The Department's continued reliance on the Rule as a determination of current need, without explanation of how or why the Rule, which is based on obsolete data and an unknown methodology, is a valid reflection of current need, leaves the logic of such an approach within the mind or minds of Department employees, and thus obfuscates, rather than elaborates or implements the Rule's legislative purpose.
Structural changes to the trauma system since 1990 have rendered the 1990 Report (and accordingly the Rule) obsolete and unreliable. If the 2005 Assessment is too old to be used, as DOH acknowledged in concluding a new study was needed, then the 1990 Report must also be too old. Bonita Bay Properties, Inc. v. Dept. of Envtl. Prot., Case No. 95-2552RP (Fla. DOAH Dec. 12, 1995) ([t]he Department's use of 10-year-old aerial survey data in developing this proposed Rule, without considering the 1994-95 data being collected by it and without waiting for the conclusion of its current study and then analyzing that data, is itself arbitrary and capricious"). Regardless of whether the Rule was valid when adopted, it is no longer reasonably related to the purpose of the enabling legislation, and the Department's continued reliance on the Rule as a determination of need is irrational. As explained in
Agrico Chemical Company v. Dep’t of Envtl. Prot., 365 So. 2d 759 (Fla. 1st DCA 1979):
A capricious action is one which is taken without thought or reason and irrationally. An arbitrary decision is one not supported by facts or logic, or despotic.
Administrative discretion must be reasoned and based upon competent substantial evidence. Id. at 763.
The Rule also contravenes section 395.402. This statute as amended in 2004 established an annual assessment process for determining (and updating) need and the TSA boundaries. Because the Rule was promulgated before 2004, it was obviously not a product of this new statutory process. However, starting in 2005, DOH was required to (but did not) validate or update the Rule through the section 395.402 assessment process.15/
More importantly, the 2004 legislation established new criteria in section 395.402(3) that DOH was required to consider in assessing need and the TSA boundaries. The additional criteria included, but were not limited to, "[i]nventories of available trauma resources, including professional medical staff." § 395.402(3)(e). The record established that this and the other new criteria were not considered in the 1990 Report, which was (and still is) the basis for the Rule. Because the Rule fails to take into account
all of the statutory criteria mandated, it is in conflict with section 395.402(3).
The formerly wide discretion accorded agencies when exercising their rulemaking authority is not without constraints. Statutory changes to laws which authorize rulemaking have circumscribed the amount of discretion that agencies may employ. See, e.g., S.W. Fla. Water Mgmnt. Dist. v. Save the Manatee Club, Inc., 773 So. 2d 594 (Fla. 1st DCA 2000).
Based upon the competent substantial evidence of record, the challenged Rule is an invalid exercise of delegated legislative authority because it exceeds and contravenes the law implemented and because it is arbitrary and capricious.
Ruling on Motions for Attorneys Fees and Costs
Respondent and Intervenors filed motions for attorneys’ fees and costs against each of the Petitioners pursuant to section 120.595, Florida Statutes. The motions assert that each of the Petitioners participated in this proceeding for an improper purpose. Inasmuch as the challenged Rule has been declared invalid, and there is no evidence to conclude that any of the Petitioners participated in this proceeding for an improper purpose, both motions are denied.
In its Proposed Final Order, Shands requested that attorneys fees and costs be assessed against the Department, alleging the "Department's delay in implementing requirements
set forth by the 2004 Florida Legislature was not substantially justified."
Section 120.595(3) provides:
(3) CHALLENGES TO EXISTING AGENCY RULES PURSUANT TO SECTION 120.56(3) AND (5).—If the appellate court or administrative law judge declares a rule or portion of a rule invalid pursuant to section 120.56(3) or (5), a judgment or order shall be rendered against the agency for reasonable costs and reasonable attorney’s fees, unless the agency demonstrates that its actions were substantially justified or special circumstances exist which would make the award unjust. An agency’s actions are “substantially justified” if there was a reasonable basis in law and fact at the time the actions were taken by the agency. If the agency prevails in the proceedings, the appellate court or administrative law judge shall award reasonable costs and reasonable attorney’s fees against a party if the appellate court or administrative law judge determines that a party participated in the proceedings for an improper purpose as defined by paragraph (1)(e). No award of attorney’s fees as provided by this subsection shall exceed $50,000.
Based upon the facts of this record, the undersigned concludes that it would be inappropriate to assess attorneys' fees and costs against the Department. Specifically, although this Order rejects the Department's argument, the undersigned finds that the Department was "substantially justified" in defending the Rule based upon its belief that it lacked the statutory authority to reconfigure the 19 TSAs.
ORDER
Based on the foregoing Findings of Fact and Conclusions of Law, it is ORDERED that rule 64J-2.010 constitutes an invalid exercise of delegated legislative authority.
DONE AND ORDERED this 23rd day of September, 2011, in Tallahassee, Leon County, Florida.
S
W. DAVID WATKINS Administrative Law Judge
Division of Administrative Hearings The DeSoto Building
1230 Apalachee Parkway
Tallahassee, Florida 32399-3060
(850) 488-9675
Fax Filing (850) 921-6847 www.doah.state.fl.us
Filed with the Clerk of the Division of Administrative Hearings this 23rd day of September, 2011.
ENDNOTES
1/ At "constituent" (provider) request, rule 64J-2.010 was amended in 2006 to reduce the maximum number of trauma centers allocated to TSA 18 (consisting solely of Broward County) from 4 to 3. This rule amendment also clarified that the allocations for each TSA represented the "maximum" rather than the "minimum" number needed. Otherwise, the current version of the rule is identical to the original (1992) version.
2/ On its face, Table 3.3 states that the total "minimum" number of trauma centers needed is 44. However, this is a typographical error. When the numbers under the minimum column are summed, the total is 43, not 44.
3/ The rule initially used the phrase "minimum number" to reflect the fact that the rule had derived its need numbers from the "minimum" column in Table 3.3. However, as used in the rule, rather than being a minimum, these numbers actually reflected the maximum need in each TSA. To clarify this fact, DOH subsequently amended the rule by substituting the word "maximum" for "minimum."
4/ As noted in the "Florida Trauma Service Area Analysis: 2000 to 2009," discussed infra, 96.3 percent of Florida residents are now within 50 miles of a trauma center due to the approval of new providers since 1999.
5/ The Committee found that establishment of trauma centers in the eight unserved trauma service areas should be a priority.
6/ Notwithstanding the recommended changes to the allocations within these four TSA's, DOH did not initiate rulemaking to adopt those changes.
7/ With respect to its review of the trauma service areas, the 2005 Assessment appears to expressly reject the continued use of the 19 trauma service areas that were initially defined in the 1990 Report. Specifically, in "Appendix 9: Findings and Recommendations Relative to Goals," the 2005 Assessment stated: "Review the current boundaries of the trauma service areas and make recommendations to retain or modify current trauma service areas. This has been done and the recommendation was made that DSTF regions replace the current trauma service areas." This is consistent with Recommendation 4 of the 2005 Assessment that "[i]t is feasible for the existing trauma service areas to be modified to follow the seven Domestic Security Task Force (DSTF) regions to facilitate regional planning."
8/ Tallahassee, Bay County, Orlando and Jacksonville. Interestingly, the 2005 Assessment did not recommend a reduction in the number of trauma centers in TSA 18 (Broward County), yet in 2006 the Department adopted a rule amendment reducing the slots allocated to TSA 18 from four to three.
9/ Governor's Executive Order 11-01, January 4, 2011.
10/ By way of example, a Department witness noted that in comparing the 1988 and 2010 population data, Florida's population has grown by over 50% (more than 6 million residents). Similarly, during that same time period, the number
of trauma victims categorized as ISS 9+ has increased by 44%, to 58,828 patients.
11/ The existing Rule also cites section 395.405, Florida Statutes, as a law that it implements. However, that statute simply gives the Department rulemaking authority and does not offer any specific guidance. This provision falls within the scope of the final sentence of the "flush-left" language of section 120.52(8) as a general description of the powers and functions of the Department. This statutory provision is therefore of no particular value in determining the Department's rulemaking authority. See Fla. Dep't of High. Saf. & Motor Veh. v. JM Auto, Inc., 977 So. 2d 733, 734 (Fla. 1st DCA 2008).
12/ Section 395.401(l)(j) and (k) are the only subsections within 395.401 which even reference trauma centers rather than trauma agencies. Those provisions do not relate to the Rule. 395.401(1)(j) requires that "[a]ny hospital which is verified as a trauma center shall accept all trauma victims that are appropriate for the facility regardless of race, sex, creed, or ability to pay." 395.401(l)(k) makes it "unlawful for any hospital or other facility to hold itself out as a trauma center unless it has been so verified."
13/ Nor does section 395.4025(1) lend support for the Rule's continued use of nineteen service areas. That law provides:
(1) For purposes of developing a system of trauma centers, the department shall use the
19 trauma service areas established in section 395.402. Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, and recommendations of the local or regional trauma agency, the department shall establish the approximate number of trauma centers needed to ensure reasonable access to high-quality trauma services. The department shall select those hospitals that are to be recognized as trauma centers. ·
Thus, Respondent and Intervenors argue, section 395.4025 specifically recognizes and authorizes the use of the nineteen service areas identified in the Rule. However, section 395.4025 also recognizes the changes that were supposed to have occurred in 2005 following the assessment required by section
395.402. Section 395.4025(14) provides:
(14) Notwithstanding any other provisions of this section and rules adopted pursuant to this section, until the department has conducted the review provided under section 395.402, only hospitals located in trauma services areas where there is no existing trauma center may apply.
14/ Nor does the piecemeal evaluation of trauma center need within individual TSA's satisfy the statutory mandate of an annual statewide assessment.
15/ DOH not only failed to follow the statutory process, but the rule actually conflicts with the initial 2005 Assessment, which was the only assessment DOH conducted pursuant to section 395.402, as amended in 2004.
COPIES FURNISHED:
Jeffrey L. Frehn, Esquire
Donna Elizabeth Blanton, Esquire Radey, Thomas, Yon and Clark
301 South Bronough Street, Suite 200 Tallahassee, Florida 32301
Robert A. Weiss, Esquire Karen Ann Putnal, Esquire
Parker, Hudson, Rainer and Dobbs, LLP
118 North Gadsden Street, Suite 200 Tallahassee, Florida 32301
Seann M. Frazier, Esquire Greenberg Traurig, P.A.
101 East College Avenue Tallahassee, Florida 32302-7742
Thomas Barnhart, Esquire Michael T. Flury, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399
Stephen A. Ecenia, Esquire
J. Stephen Menton, Esquire Rutledge, Ecenia and Purnell, P.A.
119 South Monroe Street, Suite 202 Post Office Box 551
Tallahassee, Florida 32302-0551
Nicholas W. Romanello, Esquire Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32299
R. S. Power, Agency Clerk Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703
H. Frank Farmer, MD., Ph.D., Secretary State Surgeon General
Department of Health
4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1703
Liz Cloud, Program Administrator Administrative Code
Department of State
R. A. Gray Building, Suite 101 Tallahassee, Florida 32399
Jesslyn Krouskroup, Acting Coordinator Joint Administrative Procedures Committee Room 680, Pepper Building
111 West Madison Street Tallahassee, Florida 32399-1400
NOTICE OF RIGHT TO JUDICIAL REVIEW
A party who is adversely affected by this Final Order is entitled to judicial review pursuant to section 120.68, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing one copy of a Notice of Appeal with the agency clerk of the Division of Administrative Hearings and a second copy, accompanied by filing fees prescribed by law, with the District Court of Appeal, First District, or with the District Court of Appeal in the appellate district where the party resides. The Notice of Appeal must be filed within 30 days of rendition of the order to be reviewed.
| Issue Date | Document | Summary |
|---|---|---|
| Feb. 18, 2013 | Mandate | |
| Feb. 18, 2013 | Mandate | |
| Nov. 30, 2012 | Opinion | |
| Nov. 30, 2012 | Opinion | |
| Sep. 23, 2011 | DOAH Final Order | Rule 64J-2.010, which determines the statewide need for new trauma centers, is an invalid exercise of delegated legislative authority. |
