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.
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: 64J-2.010 Apportionment of Trauma Centers within a Trauma Service Area (TSA). 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: 3. Designation of additional trauma centers should be based on the need as determined by trauma region.7/ Deployment of additional trauma centers should take place based not only on the number of patients served per trauma center, but according to a concept of “trauma center capacity,” which would be determined by the staffing levels of medical specialists and other healthcare professionals. An annual regional assessment is also recommended to analyze pre-hospital resources, ICU beds, capacity, trauma center performance including trauma registry data, and other medical resources based on per population estimates to plan for response and improvements. (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.
The Issue Whether proposed rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J-2.016 of the Florida Administrative Code (“the Proposed Rules”) are an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes (2016).1/
Findings Of Fact Background on Trauma Centers A “trauma center” is “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or [a] pediatric trauma center ” § 395.4001(14), Fla. Stat. Trauma centers must have a wide array of resources at their disposal at all times. For example, a trauma center must have approximately 30 specialists such as trauma surgeons, neurosurgeons, orthopedic surgeons, and anesthesiologists. A trauma center must also have specially trained nurses, advanced imaging and diagnostic equipment, dedicated operating rooms, a blood bank, specialized nursing units, and a helipad. Many of the personnel working in trauma centers have special training. Trauma surgeons have one or two additional years of critical care training followed by another year of training in emergency surgery or acute care surgery. Trauma center nurses typically have three additional years of training/education. In short, a trauma center is a hospital that has made a substantial investment in order to have the resources and personnel capable of caring for trauma patients. Florida Administrative Code Rule 64J-2.001(15) defines a “trauma patient” as “any person who has incurred a physical injury or wound caused by trauma and who has accessed an emergency medical services system.” Trauma injuries commonly occur as a result of motor vehicle accidents, falls from height, gunshot wounds, and stab wounds. See § 395.4001(18), Fla. Stat. (defining a “trauma victim” as “any person who has incurred a single or multisystem injury due to blunt or penetrating means or burns and who requires immediate medical intervention or treatment.”); Fla. Admin. Code R. 64J-2.001(12) (defining “trauma” as “a blunt, penetrating or burn injury caused by external force or violence.”). Trauma injuries are a leading cause of death for those ranging in age from 1 to 45. Hospitals with emergency departments (i.e., acute care hospitals) are capable of treating patients on an emergency basis. However, they would not necessarily have constant access to all of the resources mentioned above. In addition, acute care hospitals have not gone through the statutory process of being approved by the Department to operate as a trauma center. § 395.4001(14), Fla. Stat. (defining a “trauma center” as “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or pediatric trauma center, or is designated by the department as a Level II trauma center pursuant to s. 395.4025(14).”). See also § 395.401(1)(k), Fla. Stat. (mandating that “[i]t is unlawful for any hospital or other facility to hold itself out as a trauma center unless it has been so verified or designated pursuant to s. 395.4025(14).”).3/ In general, a patient in danger of imminent death from a trauma injury is likely to have a better chance of survival if he or she is treated in a trauma center as opposed to an acute care hospital. The Parties The Department is the state agency charged with implementing the laws governing the regulation of trauma centers. See § 395.40(3), Fla. Stat. (noting “[i]t is the intent of the Legislature to place primary responsibility for the planning and establishment of a statewide inclusive trauma system with the department. The department shall undertake the implementation of a statewide inclusive trauma system as funding is available.”); § 395.401(2), Fla. Stat. (mandating that “[t]he department shall adopt by rule, standards for verification of trauma centers based on national guidelines . . . .”); § 395.4015(1), Fla. Stat. (mandating that “[t]he department shall establish a state trauma system plan.”); § 395.402(2), Fla. Stat. (mandating that “[t]he department shall review the existing trauma system and determine whether it is effective in providing trauma care uniformly throughout the state.”). Of particular relevance to the instant case is the legislative mandate that the Department shall adopt rules governing the number of trauma centers that can be operated in Florida. See § 395.402(4)(b), Fla. Stat. (mandating that “[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area.”). Those rules (see, e.g., rule 64J-2.010) determine how many trauma centers can be in a particular trauma service area (“TSA”). The Legislature has assigned each county in Florida to a TSA, and there are currently 19 TSAs in Florida. See § 395.402(4), Fla. Stat. With regard to Petitioners, Shands Jacksonville operates a Level I trauma center in TSA 5, which consists of Baker, Clay, Duval, Nassau, and St. Johns Counties. Tampa General operates a Level I trauma center in TSA 10, which consists of Hillsborough County. Lee Memorial operates a Level II trauma center in TSA 15, which consists of Charlotte, Glades, Hendry, and Lee Counties. Bayfront Health operates a Level II trauma center in TSA 9, which consists of Pinellas and Pasco Counties. St. Joseph’s Hospital operates a Level II trauma center and a pediatric trauma center in TSA 10, which consists of Hillsborough County. As for the intervenors, JFK Medical Center is a licensed acute care hospital that has submitted a letter of intent to the Department so that it can apply to operate a Level II trauma center in TSA 17, which consists of Palm Beach County. Orange Park operates a provisional Level II trauma center in TSA 5, and Jackson South operates a provisional Level II trauma center in TSA 19, which consists of Miami-Dade and Monroe Counties. The meaning of the term “provisional trauma center” will be explained below. The Statutory Scheme Governing Trauma Centers As noted above, each of Florida’s 67 counties has been assigned to one of 19 TSAs, and the 19 TSAs play an important role in the location of trauma centers throughout the state. See § 395.4025(1), Fla. Stat. (providing that “[f]or purposes of developing a system of trauma centers, the department shall use the 19 trauma service areas established in s. 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.”); § 395.402(4)(b), Fla. Stat. (providing that the Department “shall allocate, by rule, the number of trauma centers needed for each [TSA].”). The Florida Legislature has mandated that every TSA “should have at least one Level I or Level II trauma center.” § 395.402(4)(b), Fla. Stat. However, there is a state-wide, statutory cap of 44 trauma centers. § 395.402(4)(c), Fla. Stat. (mandating that “[t]here shall be no more than a total of 44 trauma centers in the state.”). Hospitals seeking approval to operate trauma centers must complete a rigorous review process, and that process begins with a potential applicant submitting a letter of intent to the Department by October 1 of a particular year. See § 395.4025(2)(a), Fla. Stat. (providing that “[t]he department shall annually notify each acute care general hospital and each local and each regional trauma agency in the state that the department is accepting letters of intent from hospitals that are interested in becoming trauma centers. In order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists. Letters of intent must be postmarked no later than midnight October 1.”). By submitting a letter of intent, a hospital does not become obligated to subsequently file a fully fledged trauma center application. Fla. Admin. Code R. 64J-2.012(1)(a) (providing that “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if an available position, as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.”). “By October 15, the department shall send to all hospitals that submitted a letter of intent an application package that will provide the hospitals with instructions for submitting information to the department for selection as a trauma center.” § 395.4025(2)(c), Fla. Stat. Applications from hospitals seeking to operate trauma centers must be received by the Department by the close of business on April 1 of the following year. Once the Department receives a trauma center application, it conducts “a provisional review of each application for the purpose of determining that the hospital’s application is complete and that the hospital has the critical elements required for a trauma center.” § 395.4025(2)(c), Fla. Stat. The Department’s provisional review includes, but is not limited to, an examination of whether an applicant has: the equipment and facilities necessary to provide trauma services; (b) personnel in sufficient numbers and with proper qualifications to provide trauma services; and (c) an effective quality assurance process. See § 395.4025(2)(c), Fla. Stat. “After April 30, any hospital that submitted an application found acceptable by the department based on provisional review shall be eligible to operate as a provisional trauma center.” § 395.4025(3), Fla. Stat. A hospital that has been approved to operate as a provisional trauma center can immediately begin providing care to trauma victims. From an operational perspective, there is no difference between a provisional trauma center and one that is fully verified. Between May 1 and October 1 of the year following the filing of the letter of intent, the Department conducts an in- depth evaluation of all the applicants that were deemed eligible to operate as provisional trauma centers. § 395.4025(4), Fla. Stat. Then, between October 1 of the year following the filing of the letter of intent and June 1 of the next year, a review team of out-of-state experts assembled by the Department makes “onsite visits to all provisional trauma centers.” The out-of-state experts utilize a survey instrument developed by the Department that includes “objective criteria and guidelines for reviewers based on existing trauma center standards such that all trauma centers are assessed equally.” § 395.4025(5), Fla. Stat. That survey instrument also includes “a uniform rating system that will be used by reviewers to indicate the degree of compliance of each trauma center with specific standards, and to indicate the quality of care provided by each trauma center as determined through an audit of patient charts.” § 395.4025(5), Fla. Stat. Even if a hospital satisfies all of the requirements to operate a trauma center, there must be a need for a trauma center in the relevant TSA. See § 395.4025(5), Fla. Stat. (providing that “hospitals being considered as provisional trauma centers shall meet all the requirements of a trauma center and shall be located in a trauma service area that has a need for such a trauma center.”). (emphasis added). The Department, based on recommendations from the review team, selects trauma centers by July 1 of the second year following the filing of the letter of intent. § 395.4025(6), Fla. Stat. Following this initial approval, “[e]ach trauma center shall be granted a 7-year approval period during which time it must continue to maintain trauma center standards and acceptable patient outcomes as determined by department rule.” Id. An approval, “unless sooner suspended or revoked, automatically expires 7 years after the date of issuance and is renewable upon application for renewal as prescribed by rule of the department.” Id. Also, “[n]otwithstanding any provision of chapter 381, a hospital licensed under ss. 395.001-395.3025 that operates a trauma center may not terminate or substantially reduce the availability of trauma service without providing at least 180 days’ notice [to the Department] of its intent to terminate such services.” § 395.4025(8), Fla. Stat. There are currently 33 approved trauma centers in Florida. Unless the statewide cap of 44 in section 395.402(4)(c) is amended or removed, the Department can only approve 11 more trauma center applicants. Assessment of Need for Trauma Centers under the Current Rules The Department must annually assess Florida’s trauma system, including the number and level of trauma centers needed for each trauma service area. See § 395.402(2)(b), Fla. Stat. (requiring the Department 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(3), Fla. Stat. (mandating that the Department must consider the following during its annual reviews: recommendations of regional trauma agencies; stakeholder recommendations; the geographic composition of an area; historical patterns of patient referral and transfer in an area; inventories of available trauma care resources; population growth characteristics; transportation capabilities; 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; and other appropriate criteria). As noted above, the Legislature has empowered the Department to adopt rules governing the procedures and process by which it will determine which applicants will be selected for designation as trauma centers. See § 395.4025(13), Fla. Stat. (providing that “[t]he department may adopt, by rule, the procedures and process by which it will select trauma centers. Such procedures and process must be used in annually selecting trauma centers and must be consistent with subsections (1)-(8) except in those situations in which it is in the best interest of, and mutually agreed to by, all applicants within a service area and the department to reduce the timeframes.”). The rules governing trauma centers are set forth in Florida Administrative Code Chapter 64J-2 (collectively referred to as “the Current Rules”). With regard to the instant case, rule 64J-2.010 is particularly relevant and details how Level I and Level II trauma centers will be allocated among the 19 TSAs. On an annual basis beginning on or before August 30, the Department implements the process set forth in rule 64J- 2.010 by conducting the annual assessment mentioned above and assigning a score to each TSA. The process in rule 64J-2.010 begins by evaluating each TSA pursuant to the following criteria: (a) population; median transport times; (c) community support; (d) severely injured patients discharged from acute care hospitals; (e) Level I trauma centers; and (f) number of severely injured patients. For each of the aforementioned criteria, points are assigned to each TSA based on data from the annual assessment. The point scales associated with each criterion are designed to measure the need in each TSA for trauma center services. For example, a TSA with a population of less than 600,000 would receive 2 points, and a TSA with a population of greater than 2,400,000 would receive 10 points. TSAs with populations between those two extremes would receive 4, 6, or 8 points. See Fla. Admin. Code R. 64J-2.010(1)(a)1. As for median transport time, a TSA with a median transport time of less than 10 minutes would receive 0 points. In contrast, if the median transport time in a TSA was greater than 41 minutes, then that TSA would receive 4 points. TSAs with median transport times between those two extremes would receive 1, 2, or 3 points. See Fla. Admin. Code R. 64J- 2.010(1)(a)2. After a TSA’s total score is determined, the Department compares that score to the scale in rule 64J- 2.010(1)(b) which provides that: The following scoring system shall be used to allocate trauma centers within the TSAs: TSAs with a score of 5 points or less shall be allocated 1 trauma center. TSAs with a score of 6 to 10 points shall be allocated 2 trauma centers. TSAs with a score of 11 to 15 points shall be allocated 3 trauma centers. TSAs with a score of more than 15 points shall be allocated 4 trauma centers. In the Current Rules, rule 64J-2.010(3) contains a table setting forth the results based upon the March 24, 2014, Amended Trauma Service Area Assessment. For example, the table in rule 64J-2.010(3) indicates that TSA 1 consisting of Escambia, Okaloosa, Santa Rosa, and Walton Counties has a need for one trauma center. In contrast, the table indicates that TSA 19 consisting of Dade and Monroe Counties has a need for three trauma centers. The Department Changes Its Interpretation of “Need” In October of 2014, Orange Park filed a letter of intent indicating its desire to operate a trauma center in TSA 5. Because the Current Rules indicated that there was no need for an additional trauma center in TSA 5, the Department rejected Orange Park’s letter of intent. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the maximum number of trauma centers that are needed in a particular TSA. In 2015, Orange Park submitted another letter of intent to operate a trauma center in TSA 5. The Department accepted that letter of intent even though the numeric “need” derived from rule 64J-2.010 for TSA 5 had not changed. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the minimum number of trauma centers that are needed in a particular TSA. After the Department approved Orange Park’s application to operate as a provisional Level II trauma center in TSA 5, Shands Jacksonville challenged that decision, and Administrative Law Judge W. David Watkins issued a Recommended Order on January 27, 2017, concluding that Orange Park’s application must be denied. In the process of doing so, ALJ Watkins also concluded that “[t]he Department’s policy of accepting letters of intent and trauma center applications irrespective of need as established in rule 64J-2.010, constitutes an unadopted rule and is contrary to its validly adopted rules and statute.” Shands Jacksonville Med. Ctr., Inc., d/b/a UF Health Jacksonville v. Dep’t of Health and Orange Park Med. Ctr., Inc., DOAH Case No. 16-3369 (Recommended Order Jan. 27, 2017). Through the Proposed Rules, the Department is seeking to formalize its new interpretation of the term “need” as meaning the minimum number of trauma centers needed in a particular TSA. Assessment of Need under the Proposed Rules During the final hearing in this matter, Department employees described the Department’s impetus for changing its determination of how the term “need” as that term is used in chapter 395, part II, should be interpreted. For instance, the Department’s mission is to promote, protect, and improve the health of those living and visiting Florida. Because approximately 31 percent of severely injured patients were treated at acute care hospitals rather than trauma centers in 2013, the Department believes that there are an insufficient number of trauma centers in Florida. Also, as one or more trauma centers are added to a particular TSA, the Department observed that the number of trauma centers “needed” in that TSA under rule 64J-2.010 would decrease. This decrease would occur because median transport times and the number of severely injured patients discharged from acute care hospitals would decrease with the addition of trauma centers to that TSA. Accordingly, the Department deems the formula in rule 64J-2.010 to be a “diminishing” formula. As explained by Sue Dick, the Department’s Interim Division Director for the Division of Emergency Preparedness and Community Support (and former Chief of the Tallahassee, Florida Fire Department): [W]e saw the numbers required in a certain trauma service area diminishing because care was better. That’s what led us to go, wait a minute, that can’t be a maximum number because we are going to end up at a point where we say a maximum number is zero. So that’s when we started to look at the allocation and say, what we are really determining is how many more should they have to ensure that all patients are reaching median transport time in less than 10 minutes and very few patients are being discharged from acute care hospitals. That’s what led to the logic behind revisiting this rule and this formula. On September 1, 2016, the Department proposed a series of amendments to rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J- 2.016. The Proposed Rules would implement the Department’s new policy of deeming the calculations pursuant to rule 64J- 2.010(1)(b) to represent the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA. For instance, the Proposed Rules’ version of rule 64J- 2.010(1)(b) would amend the current version of rule 64J- 2.010(1)(b) to read as follows: “[t]he following scoring system shall be used to determine the minimum number of allocate trauma centers needed within the TSAs. Also, the Proposed Rules would add a subsection (4) to rule 64J-2.010, which would state that “[t]he allocation of trauma centers, as described in subsections (1) through (3) of this rule, is the minimum allocation needed and shall not affect existing verified trauma centers seeking renewal of their verification status pursuant to subsection 395.4025(6), F.S., . . . .” (emphasis added). The Proposed Rules would amend rule 64J-2.012(1)(a) to read as follows: “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if, subject to the trauma center limit in paragraph 395.402(4)(c), F.S., an available position, is open as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.” As a result, there would no longer be TSA-specific caps in rule 64J-2.010, and the statewide cap of 44 trauma centers in section 395.402(4)(c) would be the only numeric cap on trauma centers. The same result would flow from the Proposed Rules’ amendment to rule 64J-2.013(7): The department shall make a final determination on whether to approve or deny a hospital’s extension request only after the provisional review of all other trauma center applications in the hospital’s TSA are completed, and it has been determined that the number of trauma centers and Provisional Ttrauma Ccenters, in the hospital’s TSA is less than or equal to the allocated number of trauma centers allowed by paragraph 395.402(4)(c), F.S. positions available for that TSA. Finally, subsection (12) of rule 64J-2.013 would become subsection (11) and be amended as follows: A hospital receiving an extension greater than 12 months shall have its extension denied or terminated if the number of trauma centers and or Provisional Ttrauma Ccenters in the hospital’s TSA equals or is greater than the number of trauma centers provided in paragraph 395.402(4)(c), F.S available positions allocated to the TSA, resulting in the denial of its application and the department will inform the applicant of its right to a Section 120.57, F.S., hearing regarding this denial. Because the Proposed Rules would result in the calculations pursuant to rule 64J-2.010(1)(b) representing the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA, the Department could conceivably approve every applicant in that TSA so long as the statutory cap of 44 trauma centers in section 395.402(4)(c) would not be exceeded. The Proposed Rules also establish a tie-breaker system if the sum of provisional trauma centers found eligible for selection by the Department and the number of existing trauma centers would exceed the statutory limit established in section 395.402(4)(c). The tie-breaking criteria would consider the following: (a) whether the TSA in question already has a Level I or Level II trauma center; (b) the level of service that the applicants propose to provide; (c) the number of severely injured patients treated by the applicants; and (d) approval by a Department-approved trauma agency plan. Chief Dick testified that the Department would exercise discretion to ensure that a TSA that already had the minimum number of trauma centers under the Proposed Rules would not receive an additional trauma center if the statutory cap of 44 would be met or exceeded and another TSA lacked the statutory minimum of one: Q: Now, I want to explore a little bit one of the answers that you gave to Mr. Reynolds regarding how the [Proposed Rules] would work in conjunction with the statutory cap of 44 and the requirement for assignment of a trauma center to each TSA. Let me ask you a hypothetical. If there [are] 43, when you get to the point when there [are] 43 trauma centers that are opened around the state but there is still not one in Collier County, how does it work at that point as a potential new applicant comes in? A: If they are not in Collier County, they won’t be verified. We have a statutory obligation to meet the minimum of one per TSA, so – at a statutory cap of 44. So logic would state then as part of that 44, it includes one per TSA. So if there are 43 and there are none in TSA 17, we would have to reserve that spot until such point as there is one at a minimum in TSA 17, which is Collier, I believe. Q: Would that likewise be the approach if you have a TSA where the methodology calculates there is a need for four, but there [are] only three that are opened, how would it work then? A: I think it would be responsible of the Department, as we view the results of this allocation methodology as setting a minimum need to ensure reasonable access to care, that we would withhold spots until such point as that minimum is met per TSA. So if we are at 42 and there is still not one in TSA 17, which we just spoke to, but in addition there is another TSA that has one but through our methodology, we really think they need a minimum of two, I believe it’s within the Department’s authority to withhold that second one as well. However, Chief Dick acknowledged in subsequent testimony that the discretion she relies upon does not originate from a statute or a rule: Q: I think we had put forth that there’s been some testimony concerning the hypothetical, the what if there’s more applications received by the Department in a cycle than there are statewide slots? So in other words, you’ve got enough applications that its’s going to pop you over the [statutory cap of] 44. Do you understand my hypothetical? ALJ: We are still talking about the [Current Rules]? Q: Under [the Proposed Rules]. ALJ: [Proposed Rules]. Okay. Q: Thank you. A: I understand what you are saying. Q: And would you agree that there’s nothing in the [Proposed Rules] that tells you what happens in that circumstance, if the number received in all of the TSAs will put you over the statewide number? A: There’s nothing in the proposed rule that states that if we receive more applications than there are available spots statewide, what we will do. Q: Correct. There’s no criteria or standards? A: No, those procedures are not outlined in the rule, no. Q: Similarly, there’s nothing in [the Proposed Rules] that would preclude that all of the open positions statewide could be in one TSA or two TSAs to the exclusion of others; there’s nothing that prevents that from occurring? A: Well, I think there is something that prevents that from occurring, and the first thing being that – the first thing we would look at is to ensure there is at least one trauma center in each TSA so we would be able to reserve that. And the other thing I think is where it speaks to a trauma service area, trauma service area that has a need, we would interpret that to mean a minimum need as determined by our allocation methodology. So I would say that if there are – if it were an issue of we were going to go over the 44 and there was a TSA that still did not meet their minimum as we’ve outlined in our proposed rule, that it would be within our prerogative of the Department to hold a spot for that TSA to meet that minimum. Q: When you say it would be within your prerogative, there is nothing in the statute that outlines that procedure you just discussed, that you would hold one in your back pocket and say, I need that one for Collier County? A: No. Q: There’s nothing in [the Proposed Rules] that says that? A: No, there’s been a number of hypotheticals presented, and I just don’t think you can craft a rule that would address every hypothetical. So, no, there’s nothing that speaks specifically to that, what our specific process would be under those specific circumstances. * * * Q: I understand. [The Proposed Rules set] a minimum and all – my only question is, there [are] no standards or criteria in [the Proposed Rules] that would identify how many above the minimum should be approved; the Department’s position is it would approve as many as are applied for, if they meet all the standards? A: And have the endorsement of the regional trauma agency, yes. The Potential Utility Associated with Adopting the Proposed Rules All parties have proceeded under the reasonable assumption that adoption of the Proposed Rules would lead to more trauma centers in Florida. The Department and Intervenors’ primary argument in support of the Proposed Rules is that more trauma centers will result in: (a) increased access to the specialized care available at trauma centers; and (b) less time needed to transport trauma patients to trauma centers. Undertriage occurs when a severely injured patient in need of trauma care is treated by an acute care hospital. In that circumstance, the patient does not receive the benefit of being admitted to a facility dedicated to treating severely injured patients. The January 6, 2016, Amended Trauma Service Area Assessment by the Department indicates that approximately 31 percent of severely injured patients in Florida received care in an acute care hospital rather than a trauma center in 2013. Dr. Mark McKenney, an expert in surgical care and trauma care, characterized undertriage as an access to care problem that could threaten one’s life: I don’t think that any of us would feel good to have a third of us, when we have a life- threatening injury, end up in a hospital that doesn’t have a trauma team, doesn’t have trauma nurses, doesn’t have a trauma intensive care unit, doesn’t have an operating room immediately available, doesn’t have a surgeon in the hospital 24/7 who can take care of this, and doesn’t have subspecialists who routinely take care of the traumatically injured patients. A third is just too high a number. With regard to transport times, trauma care professionals refer to a generally accepted clinical principle for rendering treatment known as “the Golden Hour.” Within one hour after a person is injured, all of the following should occur: (a) emergency personnel are notified, arrive at the injury scene, evaluate the patient, and transport the patient to a trauma center; and (b) the trauma center starts resuscitation; conducts another evaluation of the patient; and performs a life-saving procedure. According to the Department and Intervenors, the increased access to trauma centers and the decreased transport times associated with adoption of the Proposed Rules will save lives.4/ Petitioners’ response to that line of reasoning is that an increase in the number of trauma centers will lead to a decrease in the quality of care rendered to trauma patients. A trauma center needs to treat a certain number of severely injured patients in order for its personnel to remain proficient and for the trauma center’s quality of care to remain high. During the final hearing, Petitioners presented persuasive testimony that “practice makes perfect” with regard to the treatment of trauma patients. For instance, Dr. Steven Epstein, an expert in trauma surgery, credibly testified that trauma injuries require a different level of expertise and that experience acquired through treating less severe injuries does not necessarily translate to the treatment of trauma patients: If you have a set number of patients and you put another trauma center geographically close, what happens is that you will cut the number of patients going to each place, each trauma center. And expertise in the general surgery world, as well as the trauma world, is based on volume. Let me start with the general surgery world and then move toward trauma. We know that in general surgery, residencies right now, they are focusing on different areas of surgery: breast surgery, colorectal surgery, laparoscopic surgery, so that people become experts in these areas. The idea of the general surgeon is going away. The same thing occurs with trauma surgery. Only the expertise there is learned during a fellowship and then with practice. If you take, for instance, a gunshot, the anatomy, any general surgeon can take out a gallbladder, but not any general surgeon can handle a gunshot to the abdomen. The anatomy changes. It’s a much different case. So people who have done this on a regular basis have some idea how to do this. The – what I call the voyeur, you bring in a general surgeon to do some trauma because we don’t have enough trauma surgeons, doesn’t have this same expertise. And you wind up as really – it’s a patient problem. We are talking about it as a problem with hospitals, but this is a patient problem. If the doctor doesn’t know how to treat the patient, then the patient suffers. And I think in the end, that’s what happens when you dilute an expertise. And trauma, with the addition of all these hospitals, winds up diluting an expertise. * * * We, meaning the doctors at our hospital and several other hospitals, have always made an assumption we practice, we practice, we practice, and we get better. If you don’t have the patients – because they call it the practice of medicine. If you don’t have the patients to practice with, you are not going to maintain your expertise. And I use the example, for instance, of a gunshot. But we do blunt trauma where people are in auto accidents, they are in shock, how to get them out of shock. There’s this whole sequence of events that takes place. Nursing, how to take care of these patients. It’s quite complex and I firmly believe that dilution of this knowledge is very detrimental in the end to the patient.5/ In addition, an increase in trauma centers would make it more difficult for a trauma center to acquire and retain the trauma center personnel that must be constantly on site. Dr. Epstein testified that trauma surgeons are already a scarce resource, and that scarcity will only be exacerbated with the addition of more trauma centers. Also, Mark Valler, an expert in trauma center and acute care medical staff administration, credibly testified about how the addition of 10 or 11 trauma centers in Florida would impact an existing trauma center’s ability to retain its staff: But I am concerned that 10 or 11 opening statewide, there are going to be advertisements for trauma surgeons, for neurosurgeons, for trauma orthopedic doctors all over the place. People are going to be recruiting like crazy, and they are going to be recruiting in the state of Florida because the physicians already have a Florida state license, so there is going to be a huge, huge recruiting effort if all those centers actually get approved at one time. However, there was no persuasive evidence presented during the final hearing indicating that any recent openings of new trauma centers have resulted in existing trauma centers experiencing declines in patient volume that would negatively impact quality of care. Accordingly, Chief Dick testified that it would be irresponsible for the Department to not facilitate better access to trauma care when the Department has received no evidence that quality of care had suffered. During the final hearing, Petitioners frequently mentioned the theoretical possibility that adoption of the Proposed Rules could lead to an inordinate number of trauma centers opening in a single TSA. Given the substantial amount of resources needed to open and maintain a trauma center, it is unlikely that a rational hospital administrator would seek to open a trauma center in a particular TSA unless the volume of trauma patients would enable it to operate profitably. Nevertheless, the testimony and the evidence leads to an inference that adoption of the Proposed Rules would likely lead to more trauma centers in well-served TSAs and no increase for TSAs in need of more trauma care. The following testimony from Mark Richardson, an expert in healthcare facility and services planning, illustrates this point: Q: There’s been some suggestion, I think you may have heard this during your deposition, that there may be free market forces that would operate to prevent some of these adverse results that you are describing. Do you have an opinion as to whether free market factors would help to prevent the maldistribution or other issues that you described as being bad consequences? A: I do have an opinion. I think if you look in terms of the folks, whoever have applied via a letter of intent for the development of the additional trauma centers, those centers are not located in areas where there currently are longer transport times. Those centers basically are located in basically metropolitan areas where there are already appears to be good reasonable access to care. Basically it’s adding new programs where there’s already a pretty good network of care provided. * * * My point here is that if you look in terms of where these folks are, they are basically in the Jacksonville area; they are basically in the Miami-Dade, south Florida area; they are in the Orlando area; or they are in the Palm Beach and Broward area, where there already are a number of existing transplant programs, where, for example, specific to the median transport time, there’s no problem in those areas. This is not the Panhandle where there is a problem in terms of transport times. This is not north Florida in terms of north Florida area where portions of the area may have some problems. This is basically adding incremental trauma center capacity to locales where there already is adequate care. It is certainly possible that Petitioners’ fears about lower quality of care could be realized if there is nothing other than the statutory cap to prevent hospitals from opening an unlimited number of trauma centers in TSAs encompassing large metropolitan areas. After considering all of the evidence and testimony, the undersigned is of the opinion that it would be impossible to draft a set of rules that would satisfy the concerns/interests of all the relevant stakeholders.6/ The disagreement over the merit of the Proposed Rules boils down to striking a balance between “practice makes perfect” and providing the earliest opportunity for definitive care. In relation to each other, the Current Rules put more emphasis on “practice makes perfect,” and the Proposed Rules emphasize providing more access to care.
Conclusions Competent substantial evidence supports the conclusion that Adrian Fuentes disabilities are the result of the failure to deliver him before his mother loss amniotic fluid, or up to an estimated 12 hours earlier. An earlier delivery was the standard of care expected in a case of IUGR. His permanent and severe disabilities were directly and proximately caused by the failure of SBHD employees to handle an ultrasound report expeditiously as directed and as their policy provided. ATTORNEYS’ FEES AND LOBBYISTS’ FEES: In compliance with s. 768.28(8), F.S., but not with Section 3 of this claim bill, Claimant's attorneys' fees are set at 25 percent. There is no lobbyist for the bill at this time. As of October 9, 2007, the attorneys reported having incurred costs of $115,246.02 for representing the Claimant. The Claimants entered into an agreement to pay attorneys’ fees and costs. RECOMMENDATIONS: For the reasons set forth in this report, I recommend that Senate Bill 60 (2008) be reported FAVORABLY. Respectfully submitted, Eleanor M. Hunter Senate Special Master cc: Senator Jeremy Ring Representative Evan Jenne Faye Blanton, Secretary of the Senate House Committee on Constitution and Civil Law Tom Thomas, House Special Master Counsel of Record
The Issue Whether a letter of the Department of Health dated January 15, 2002, violates Section 120.54(1)(a), Florida Statutes?
Findings Of Fact Westside (Petitioner) is an acute care general hospital licensed by the State of Florida, Agency for Health Care Administration, pursuant to Part I of Chapter 395, Florida Statutes. Westside is located at 8201 West Broward Boulevard, Plantation, Florida. Westside's location is in Trauma Service Area ("TSA") 18 comprised exclusively of Broward County as established by Section 395.402(3)(a)18., Florida Statutes. The Department, created pursuant to Section 20.43, Florida Statutes, is the state agency charged with primary responsibility for the planning and establishment of a statewide inclusive trauma system. See Section 395.40(3), Florida Statutes (2001). See also Rule 64E-2.021, Florida Administrative Code. "'Trauma agency' means a department-approved agency established and operated by one or more counties . . . for the purpose of administering an inclusive regional trauma system." Section 395.4001(10), Florida Statutes. The Broward County Trauma Agency ("BCTA") is the local trauma agency established by processes and procedures established, in turn, by rule of the Department. Section 395.401, Florida Statutes. It is the Department-approved trauma agency in TSA 18. Each local trauma agency, such as the BCTA, is directed by Section 395.401(1)(b), Florida Statutes, to "develop and submit to the department plans for local and regional trauma service systems." The plans must include certain components outlined in the statute. Among them are "the number and location of needed state approved trauma centers based on local needs, population, and location and distribution of resources." Section 395.401(1)(b)4., Florida Statutes. The statute also calls for periodic updates of the plans: After the submission of the initial trauma system plan, each trauma agency shall, every 5th year, submit to the department for approval an updated plan that identifies the changes, if any, to be made in the regional trauma system. Section 395.401(1)(n), Florida Statutes. The Broward County Trauma Agency Plan that had been in effect "a little bit longer" than since 1995 or 1996, was updated and submitted for approval to the state in 2001. (Deposition of Danz, p. 6.) Although it may have been somewhat delayed (the record is not clear about the precise amount of time between the approval of the plan in effect prior to the update and the update's approval), the timing of the submission was intended to accord with the statutory requirement that updates be reviewed by the BCTA and submitted for approval "every five years." (Id.) The plan in effect at the time of an update approval process that took place largely in the year 2001 stated: State trauma center planning has resulted in an estimated need for four (4) trauma centers in Broward County. For the purposes of network development this plan envisions the initial establishment of three (3) Level II facilities with additional facilities being placed on line as need and funding requires. Each center will act as the primary receiving facility for a designated geographical catchment area (see maps d1 and d2). (Exhibit 20, Part D, p. 4.) The updated plan, denominated Broward County Trauma Plan 2001 (also referred to as the "2001 Plan" or the "Plan"), made a change to the above language. The 2001 Plan states: The establishment of three (3) facilities (two Level I Adult and Pediatric Centers and one Level II Adult Center) each as the primary receiving facility for a designated geographical catchment area, has been determined to be the correct compliment for the County's current need. (Exhibit 6, p. 50.) George Danz is the chief of operations for the Broward County Medical Examiner's Office. He is also the Director of the BCTA. Director Danz outlined "[i]n a nutshell" (Deposition of Danz, p. 7), the process for approval of the updated trauma plan for TSA 18, Broward County Trauma Plan 2001, as follows: (Id.) The process is fairly lengthy. First of all, the [BCTA] goes through the plan and looks at what areas we need to make revisions and changes to and so forth. We make those changes. We then have a Trauma Advisory Committee. We take those changes to the Trauma Advisory Committee for their recommendations and approval. We then are required by state law to notify all of the hospitals and EMS providers in Broward County that revisions are being drafted. We have to provide public notice, advertise that the changes are being made. We have to have a formal public hearing before the Broward County Commissioners. We have that hearing, and if it's approved by the Board of County Commissioners, we then submit the plan to the State of Florida. The State reviews the plan. If they have any changes that they want us to make to the plan, they let us know. They make the change that the state requires and then the state finally provides us with an approval or denial of the plan. In keeping with the process outlined by him, Director Danz sent a memorandum to "Broward County Hospital Administrators" and "Trauma Care Providers" on January 26, 2001. (Exhibit 1.) The memorandum informed the administrators and providers of trauma care that the BCTA with the aid of the Trauma Advisory Committee and the Regional Health Planning Council, Inc., had updated the Broward County Trauma Plan in accordance with law. The memorandum further advised that the Broward County Commission had directed that notice be given that the updates to the plan would be considered at a public hearing to be held on February 27, 2001. In the meantime, the Broward County Trauma Advisory Committee on February 14, 2001, approved an updated trauma plan for TSA 18. Less than two weeks later, as announced in Director Danz's earlier memorandum to hospital administrators and trauma providers, the 2001 Plan was presented to the Broward County Commission at a public hearing. The Commission voted unanimously at the hearing held as scheduled February 27, 2001, to approve the 2001 Plan. On April 30, 2001, Director Danz submitted the 2001 Plan to the Department. In response, the Department, on May 24, 2001, wrote to Director Danz announcing the conclusion of its "review for completeness of the Broward County Trauma Agency Plan Update that was received May 2, 2001." (Exhibit 3.) Although the Department found the 2001 Plan to include a majority of required elements, it found six "to be missing or incomplete." (Id.) These six elements were listed in the May 24, 2001, letter from the Department to the BCTA Director. On June 26, 2001, Director Danz sent a letter to Program Administrator Frederick A. Williams at the Department's Bureau of Emergency Medical Services. The letter outlined how each of the six deficient elements had been addressed by BCTA. The letter was received June 29, 2001, by the Department. Twelve days later, on July 11, 2001, Bureau of Emergency Medical Services Chief Charles Bement wrote Director Danz: We have completed the review of the Broward County Trauma Agency Plan Update submitted to this office on May 2, 2001, with the changes and additions we had requested in our letter to you May 24, 2001. We are pleased to inform you that your plan update is approved effective as of the date of this letter. (Exhibit 5.) Although the 2001 Plan provided for only three trauma centers in Broward County, and there were already three existing centers, with the plan having been approved for more than two months, on September 26, 2001, Michael Joseph, the Chief Executive Officer of Westside executed a "STATE-APPROVED TRAUMA CENTER LETTER OF INTENT." (Exhibit 17). The letter expressed Westside's "interest in becoming a State-Approved Trauma Center (SATC) or State-Approved Pediatric Trauma Referral Center (SAPTRC), or in upgrading the trauma care services already being provided." (Id.) CEO Joseph's letter was not out of step with the latest thinking of the Department. It crossed in the mail with a letter from the Department dated September 28, 2001. This letter, under signature of Bureau Chief Bement to Director Danz and the BCTA reflected the Department's conclusion that the Broward County Trauma Plan 2001 (although previously approved by the Department) conflicted with a rule of the Department of Health. Accordingly, the letter announced Department action: amendment of the 2001 Plan to bring it into compliance with the rule. The letter stated: It has recently come to my attention that the trauma services system plan approved by the Bureau for the Broward County Trauma Agency conflicts with the provisions of Fla. Admin. Code R. 64E-2.022(3). The plan recommends three state approved trauma centers or pediatric trauma referral centers for trauma service area 18 while the Administrative Code provides for four. The Legislature has assigned responsibility for determining the number of trauma centers allocated to each trauma service area to the Department of Health. See [s.] 395.402(3)(b), Fla. Stat. The Department has allocated, by rule, four centers for your area (sic) therefore, the trauma services systems plan for Broward County Trauma Agency is amended in accordance with the law to provide for four centers. (Exhibit 7, emphasis supplied.) On the same day of the Department's letter announcing the amendment of the 2001 Plan, a memorandum was issued by M. Susan McDivitt, R.N., the Department's Executive Community Health Nursing Director. Bearing a subject line of "Letter of Intent for State Approved Trauma Centers," and dated September 28, 2001, the memorandum informed specific parties of the notice of amendment to the Broward County Trauma Plan. Ms. McDivitt's memo refers to the amendment as one that "provides for four state approved trauma centers or state approved pediatric trauma referral centers for Broward County, as outlined in the [rule]." Exhibit 16. The memorandum goes on, As you may know, [s.] 395.4025(2), Florida Statutes, provides that in order to be considered for approval as a trauma center an applicant must certify that its operation would be consistent with the trauma agency plan. Prior to this amendment, no acute care general hospital in Broward County could make that certification as the trauma agency plan only provided for three centers and Broward County has three centers. The above- referenced notification [by amending the 2001 Plan to provide for four trauma centers] has addressed that situation. (Id.) The following Monday, the Bureau of Emergency Medical Services stamped as received on October 1, 2001, Westside's letter of intent. Two weeks later, on October 15, 2001, the Office of the County Attorney for Broward County responded to the September 28, 2001, letter in writing. This written communication requested reconsideration of the action reflected in the Department's September 28 letter, that is, the amendment of the 2001 Plan to provide for four state-approved trauma centers rather than three. As part of the basis for reconsideration, the County Attorney's office wrote: [s.] 395.401(1)(c), Florida Statutes, provides that the Department must approve or disapprove a trauma plan within one hundred twenty (120) days of submission. Here, the Department approved the plan (which was submitted May 2, 2001) on July 11, 2001. There does not appear to be any statutory authority for the Department of Health to unilaterally "amend" a trauma plan once approved. Moreover, the Department's action here was taken after the 120 day window of consideration had closed, and more importantly, after the Department had already determined that the plan was consistent with Rule 64E-2.-22(3). (Exhibit 8.) On October 23, 2001, Bureau Chief Bement issued a memorandum to Nursing Director McDivitt. It details reasons "[t]here should be three trauma centers in Broward County. " (Exhibit 9.) By letter dated November 5, 2001, Art Clawson, Director of the Division of Emergency Medical Services and Community Health Resources in the Department, notified the Broward County Attorney's Office that Bureau Chief Bement's letter of September 28 amending the 2001 Plan constituted agency action that provided a point of entry into administrative proceedings. The letter further advised that formal administrative proceedings could be initiated within 21 days of receipt of the November 5 letter. On November 29, 2001, NBHD filed a petition for formal administrative hearing pursuant to Sections 120.569 and 120.57(1), Florida Statutes. The case was assigned DOH Case No. 02-0131-FOI-HSEM. In the case, NBHD challenged the authority of the State of Florida to amend the Broward County Trauma Plan 2001 as done in the Department's September 28 letter. Westside moved to intervene in the proceeding. While NBHD's case pended at the Department, Division Director Clawson wrote the letter which contains the statements that Westside seeks to have determined in this proceeding to violate Section 120.54(1)(a), Florida Statutes. The letter, written January 15, 2002, states, in pertinent part, Be advised that this correspondence is the official withdrawal by the Department of Health of its amendment of the Broward County Trauma Agency (BCTA) plan. More specifically, the Department withdraws its letter of September 28th 2001 to the BCTA. Likewise, the Department withdraws its Notice of final agency action of November 5th, 2001. It has been determined that the Department lacked the authority to unilaterally amend the BCTA plan after it had been approved by the Department on July 11th, 2001. (Exhibit 11.) No part of this letter has been promulgated as a rule through the procedures in Section 120.54, Florida Statutes. The effect of the January 15, 2002, letter is to render Westside's letter of intent submitted for a new state-approved trauma center in Broward County inconsistent with the requirement of Section 395.4025(2) that "[i]n order to be considered by the department, a hospital [that submits a letter of intent] . . . must certify that its intent . . . is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, " On January 24, 2002, the Department issued a final order in DOH Case No. 02-01310FOI-HSEM denying the petition of NBHD challenging the Department's September 28 action of amending the Plan. The basis of the denial is that the relief requested by NBHD had been obtained as the result of the January 15, 2002, letter. Westside now seeks a determination that the January 15, 2002, letter is an agency statement in violation of Section 120.54(1)(a), Florida Statutes, that is, an unpromulgated rule. Such a determination will reinstate the Department's letter of September 28 and its amendment to the 2001 Plan to provide for four (4) trauma centers in TSA 18. The restoration of the amendment, in turn, will open the door to the potential of Department approval of the fourth trauma center in Broward County that Westside hopes to operate as expressed in its letter of intent. North Broward Hospital District, the operator of two trauma centers in Broward County, opposes such a determination because it could lead to approval of a fourth trauma center in Broward County. Approval of a fourth trauma center would have an impact on the currently approved trauma centers, including those of NBHD because the number of patients seen by the existing trauma centers would be reduced. As Dr. Lottenberg testified in his deposition, "[I]n order to effectively have a proficient trauma center, you need to have about 1,000 severely injured patient per trauma center per year. Currently[,] all three trauma centers [in Broward County] are operating somewhat under that number." (Lottenberg, pgs. 26- 27.) Approval of a fourth trauma center would reduce the existing provider's number of severely injured patients when, in Dr. Lottenberg's opinion, the trauma center's in Broward County need more patients to ensure proficiency rather than less.
Findings Of Fact The Petitioner herein petitioned the Division of Administrative Hearings seeking a determination of the validity of proposed Rule 100-86.008, Florida Administrative Code, in accordance with Section 120.54(4), Florida Statutes. Petitioner has demonstrated its standing to participate in the formal hearing to consider the validity of Rule 100- 86.008, Florida Administrative Code. The parties stipulated that to determine standing, no proof of the facts with regard to standing as alleged within the original Petition would be required and that these might be taken as admitted. Petitioner is a non-profit corporation organized and maintained for the benefit of the 220 governmental- investor-owned- and nonprofit hospitals which comprise its membership and all of Petitioner's 220 members are hospitals subject to the verification requirements of Section 395.031, Florida Statutes and the Proposed Rule. Respondent Department of Health and Rehabilitative Services' (DHRS') contention that Petitioner cannot show injury in fact since only 31 hospitals are currently verified and only 30 more are expected to seek verification within the next biennium is without merit. In the first placed that latter 30 applicants figure is determined to be arbitrary and capricious elsewhere within this order. DHRS also suggests that even if all of the 31 already verified trauma centers were members of Petitioners which they are not, this figure cannot constitute a "substantial number" as discussed in Florida Home Builders Association v. Department of Labor and Employment Security, 412 So.2d 351 (Fla. 1982) of a membership as high as 220. This suggestion begs the question. DHRS thereby illogically assumes that in every case, the more members a Petitioner represents, the less standing to represent them Petitioner has. DHRS' last contention that Petitioner cannot show standing in fact because the trauma center verification program is voluntary in nature is also without merit. To accept DHRS' position that there is no standing since the program is voluntary in nature and no hospital is forced or required to apply for verification would, carried to its reasonable end, mean that no hospital would ever have standing to challenge the Proposed Rule even though the Proposed Rule clearly affects those hospital members of Petitioner who will soon face biennial recertification or reclassification plus other members who may hereafter desire initial certification. Petitioner has standing to bring this challenge. The Economic Impact Statement supports this finding as does the prior participation of Petitioner in the rule-making process. The challenge to the subject rule as offered by Petitioner was timely made. The parties by stipulation have waived the time limitations set forth in Section 120.54(4), Florida Statutes. The thrust of Petitioner's allegations are that Proposed Rule 100- 86.008 is arbitrary, capricious, without rational basis in fact and constitutes an invalid exercise of delegated legislative authority by imposing higher verification fees upon hospitals which desire verification of their emergency rooms as trauma centers than are reasonably needed or authorized under Chapter 395, Florida Statutes. Furthers Petitioner claims that the Economic Impact Statement for this proposed rule is inadequate and unfair and has "impaired the correctness of the rule adoption proceedings," primarily upon the allegation that there is no relationship of fee by proposed rule to the statutory authorization and purpose. Petitioner challenges an amendment to Rule 10D-86.008 which seeks to increase the cost of the verification fee which must be paid by each hospital emergency room applicant for every initial verification, for any reclassification and for continued verification every two years as a "trauma center. Using strike-throughs for the deletions and underlining for the additions, the proposed rule seeks to amend current Rule 10D-86.08 as follows: 10D-86.008 Fees. The Department shall charge fees to each applicant hospital. The fee shall be submitted with each application. All such fees will be used solely to defray the cost of the verification program. The following fee schedule shall apply to initials reclassification and continued verification applications: (a) Level I ... 3,000.00 $11,000.00 (b) Level II ... 2,000.00 $11,000.00 (c) Level III ... 1,500.00 $11,000.00 Statutory authorization for the existing and for the proposed rule is found in Section 395.031, Florida Statutes, which provides in pertinent part, as follows: * * * (3) Any hospital licensed in the state that desires to be verified as a trauma center shall submit to the department a request for verification as a trauma center. * * * (5) Biennially thereafter- the department shall review the trauma center to verify its compliance with the standards set forth by subsection (6). The department shall notify the hospital of such verification. If the department finds that the trauma center does not comply with those standards the department shall within 30 days, notify the hospital of its findings. Within 30 days after receiving such findings the hospital may request a hearing in which to contest the findings of the department. The hearing shall be held in accordance with chapter 120. If a hospital does not desire to contest the findings of the department but desires to continue its verification as a trauma center, the hospital shall be given 90 days in which to comply with the standards set forth in subsection (6). After verification of compliance with those standards- the department shall continue the verification of the hospital as a trauma center or verify a reclassification of the trauma center pursuant to the standards set forth in subsection (6). * * * (7) The cost of verification shall be borne by the applicant, based on a fee schedule set by the department not to exceed the cost of verification. (Emphasis supplied.) The trauma center verification program (see Chapter 100- 86, Florida Administrative Code) establishes procedures and fees to verify that facilities and services-of licensed hospitals that apply for trauma center verification meet current standards of the American College of Surgeons. DHRS is the only state agency with any responsibility for verification of trauma centers. A hospital may offer the same services as are offered by a bona fide trauma center without being verified but it may not hold itself out as a trauma center without being verified by DHRS. Upon this limited basis, the program is voluntary as to the hospitals applying and is administered by DHRS' Emergency Medical Services Section. The Emergency Medical Services Section (EMS) is divided into two subsections. One is "Regulatory Services" in which all licensing functions other than trauma center verification are placed and includes such diverse matters as licensing of ambulance services, non-emergency transportation services, emergency medical technicians and paramedics. The licensing of trauma centers is logistically placed within "Program Development," which subsection administers certain grants and which has as its principal function general planning activities pursuant to EMS' statutory responsibility to produce a state plan for emergency medical services. DHRS characterizes the categories of trauma center as follows: a Level I Trauma Center" is the top level and requires a surgeon in the emergency room 24 hours per day as well as a demonstrated commitment to research and training in the area. A "Level II Trauma Center" is quite similar to the Level I center except that it does not have the mandatory commitment to trauma research and training. A "Level III Trauma Center" is largely found in rural areas where the population base is insufficient to support a Level I or Level II trauma center, but represents a maximum commitment to trauma center service based on available resources. Although only a single application form is utilized, it may be logically inferred that the category or level" of verification sought by the applicant to be verified will affect the size, scope, detail, and supporting documentation of its initial application and likewise will affect the scope of the agency procedure leading either to verification or denial of the initial application of each applicants and to any reclassification or continued verification of a previously verified trauma center. This inference was apparently codified in the existing rules by charging application fees graduated by level of verification requested. It is recognized by DHRS that the three respective levels have different configurations of services, equipment, and general effort towards the treatment of trauma and that a Level I application is "significant" in comparison to the other levels. Nonetheless, the proposed rule amendment seeks to establish only the same fee amount or "cost of verifying" the application for all applicants regardless of level of verification requested. When the original trauma center verification program fees were promulgated (Rule 100-86.08), on-site visits (live inspections by an accreditation or verification team) to applicants' trauma centers and program overhead were not calculated into the fees as established because on-site visits were not originally contemplated by the verification program as a whole. When the original trauma center verification program fees were promulgated, it was anticipated that 65 or 70 trauma centers would apply for verification over the first biennium. This estimate was based on a survey of all licensed hospitals. However, in the first year, only 15 trauma centers applied for verification. However, the trauma center verification process, as planned into the next biennium, (1985-1987) now contemplates application and document reviews plus on-site visits as direct costs and overall program overhead as indirect costs. The new proposed fee schedule within Proposed Rule 10D- 86.008 was derived by using anticipated expenses for the 1935- 1987 biennium as a base. DHRS anticipated the total amount needed for the trauma center verification program and program compliance as $329,904. This figure lumps together salaries, expenses and travel for employees of DHRS' Emergency Medical Services Section within the trauma center verification program, physician review of applications, trauma center on-site visits, legal expenses for denial hearings pursuant to Section 120.57(1) and (2), Florida statutes, and expenses of contracting with a medical records consultant and medical director. DHRS candidly admits that these expenses have been calculated into the new proposed fee schedule and maintains that these expenses should be calculated into any fee schedule established. Petitioner's view is that it is only the costs attributable to the actual processing of individual applications which may properly be included as a "cost of verification ... borne by the applicant" pursuant to Section 395.031(7), Florida statutes, and asserts that inclusion of any other costs is arbitrary, capricious, excessive, and not statutorily justified. By its proposed findings of fact as well as by the direct evidence of all of its witnesses, DHRS acknowledges that it has considered the cost of compliance 1/ in devising the non-graduated fee schedule within the Proposed Rule. In calculating the proposed fee schedule, DHRS divided the total amount needed for program operation and compliance (the $329,904 previously referenced) by the estimated number of trauma centers (the 15 per year based on the first year's experience multiplied by 2 for the two-year biennium horizon) to yield a verification fee per trauma center of $10,996.80. The agency then rounded this amount to $11,000 per anticipated applicant for the 1985-1987 biennium, and thus the non-graduated fee in the Proposed Rule was devised. This method does not bear any logical or rational relationship to the size, scope, detail and supporting documentation of the applications as they vary among Levels I, II, and III. Nor can it be said that this method takes into consideration any of the logical or rational differences inherent in the paperwork processing and physician review as it differs by level applied for, or in the type of projected on-site compliance review of the physical plants of applicants for the differing levels. Moreover, although it may be appropriate to begin with the assumption that 15 is a representative idea of the number of initial applications that may require processing in each year, there is simply no documentation or rationale provided by the agency to determine whether the number of initial applications will diminish or increase as the finite number of potentially verifiable hospitals is approached. Therefore, this divisor figure of 15 x 2 borders on mere estimation or speculation and is not statutorily justified. It is not saved by an intention without guarantee of a biennial review of the rule. Unless it somehow embraces a rational projected calculation of reclassifications from one level to another and biennial reviews for compliance with the verification standards, the 15 x 2 figure is further skewed. Since there is testimony that EMS can only hope to do 6 annual on-site reviews at random (presumably encompassing all three categories) , the (15 x 2 30) divisor remains askew, arbitrary, capricious and unjustified. It is interesting that DHRS acknowledges, to a point at least that the 11,0O0 fee schedule figure is inaccurate. Specifically, despite DHRS' rounding up to the nearest thousand dollar amount so as to reach $11,000, it is DHRS' position that its procedure for establishing the non-graduated fee schedule actually underestimates or understates the amount required to fund the verification program. Neither rounding "up" versus rounding "down" nor rounding to the nearest even $1,000 as opposed to the nearest dollar amount was specifically raised as an issue by the parties. However, since it is partly through DHRS' contention that it has actually understated the amount required to fund the verification program that DHRS attempts to parry Petitioner's assertion that DHRS is seeking to cause trauma center verification applicants to bear the cost of the entire trauma center program instead of merely requiring applicants to bear the cost of the single application verification function of that program, some assessment of this "rounding" methodology is in order. DHRS has not demonstrated any specific reason to "round" in this manner, nor how "rounding" relates, if at ally to understatement of fees needed or how it relates, if at ally to precise calculation of the funding amounts actually required. It is easy to appreciate that $11,000 looks better in a printed, codified rule and is easier to administer than an odd number but even those shallow rationales have not been advanced by those rule drafters who testified. Even if one could accept the reasoning that because of the high amounts of fixed costs for the improved verification program DHRS is somehow justified in spreading the cost of the entire verification program equally among all applicants instead of graduating the fees by level, there remains the unrefuted testimony of Mr. Lawn an accepted expert in the area of accounting matters in state government, that the Statement of Justification does not identify which costs are fixed and which costs are variable and does not determine the relevant range of activity which affects allocation of fees to the number of applicants. Thus, the conclusion must still be reached that the $11,000 fee is unreasonable, without rational basis in fact, and without statutory justification. As calculated by Larry Jordan, EMS Administrator, and as reflected in the Statement of Justification prepared by Terry Davis, Program Analyst within the EMS Section, Programs Subsection, and supervisor of the trauma center verification Program, part of the $329,904 figure reflects salaries, expenses, and travel. That portion for salaries is represented as $187,995. Supposedly, the relevant portion of six individual employees' actual salaries was a component. On the other hand, full time equivalents (FTEs) were devised according to the percentage of time Larry Jordan would or could permit these EMS Section employees to devote to the trauma center verification program. FTEs derived in the context of rational experience or mathematical certainty may constitute a portion of a valid formula for fixing a fee schedule but that cannot be said to have occurred with regard to this Proposed Rule. The methodology employed for calculating these particular FTEs lumps a lot of "guesstimating" and conjecture with very little viable quantification of time allotments. Jordan determined, on the basis of what he described as "an educated guess" after review of a staff roster with Terry Davis that although 7.8 FTEs were required for program compliance only 2.5 FTEs could be allotted to the trauma center verification program. It is largely upon the basis of all of DHRS' witnesses' evidence in connection with this FTE computation that the determination must be reached that when agency personnel refer to the calculation of "costs of compliance" they do not mean merely biennial review pursuant to Section 395.031(5) to ensure that subsection (6) statutory standards continue to be met by a hospital once it has been verified as a trauma center. Inclusion of those types of compliance cost figures in the verification program is clearly authorized by the statute. No, rather, the DHRS drafters use the word "compliance" with the implied meaning of encompassing all of the operations of the EMS Section relative in any respect to trauma center matters. In line with its position that the proposed fee schedule is understated, DHRS suggested at hearing that contrary to the Statement of Justification, actual experience has shown that a slightly higher amount of employee time is devoted to the trauma center verification program than is reflected by the 2.5 FTE figure: 2.5 FTEs (allowed) as opposed to 2.73 FTEs (actual) which Mr. Caldwell calculated at hearing would result in a $12,556.79 fee per application for the 1986-1988 biennium. This is not the biennium originally calculated for the rule or projected in its published Statement of Justification. As serious as this is; confession of an originally inaccurate FTE computation figure and inaccurate Statement of Justification is problematic in light of the total lack of logic and rationality with regard to the method of arriving at either the original 2.5 or the recalculated 2.73 FTE figure. The time sampling study does not render 2.73 FTEs rational. 2/ Mr. Jordan, who could not even describe the process of application approval or rejection is credited in the original FTE calculation for the Statement of Justification with 20 percent of his time and salary component devoted to the verification program. Jaime Caldwell Program Development Supervisor, also could not describe the process of application approval or rejection and his testimony reflects that rather than the 40 percent credited in the original FTE calculation for his time and salary component for direct supervisory responsibility over trauma center verification matters, he, Caldwell was equally at ease assessing his own time and salary component as either 35 percent or between 3 and 5 percent. The change and range assigned by Mr. Caldwell is as unsupported as the initial 40 percent assessment made by Jordan and Davis together in April 1985. (Davis actually denied having significant input to the initial assessment). This discrepancy and range are not explainable reconcilable, or justified on the basis of Mr. Caldwell's vague testimony concerning a recent time sampling based on the overall trauma center program which embraces far more than just the trauma center verification process and procedures. 3/ Of those who testified, only Terry Davis had a working knowledge of the existing process by which a trauma center verification application is initially approved or denied. He personally handles all applications from the time one is received until it is approved or denied. Using the maximum amount of time estimated by Mr. Davis, it has taken roughly 12 hours of his time spread over the 60 days provided by statute to process each of the applications received. Davis also denied that Jordan's estimate of his (Davis') time at 100 percent for the verification program was accurate. Davis confirms that the involvement of both Jordan and Caldwell has been infrequent. No witness could delineate with any certainty what, if any, involvement a secretary, a word processor, and Mr. Jordan's personal secretary did in relation to actually processing trauma center verification applications. Although Mr. Davis volunteered someone must do his typing during the application process, this record exhibits no justification for assigning percentages of 60 percent, 20 percent, and 10 percent respectively of each of these clerical employees' time to the verification program for purposes of arriving at an FTE component. These figures appear to have sprung directly from "up front" line item budgeting based on position assignments which by actual testimony are directly contrary to experience that these positions do not participate directly or to any meaningful degree in the verification process. Based on this evidence, and also upon the tacit admission of both Caldwell and Davis that the FTEs reflect EMS employees' percentage of time in the trauma center program as a whole, the methodology employed to obtain the FTE figures must be deemed to be arbitrary and capricious. As calculated by Larry Jordan and as reflected in the Statement of Justification prepared by Terry Davis, expenses and travel were also calculated using FTEs and the percentage of trauma center verification program time for each employee was multiplied by the relevant object category in the Legislative Budget Request: Standards for New Positions 1985-1987. This figure is skewed by the 2.5 FTE figure for all of the reasons already discussed and is likewise arbitrary and capricious. It is also arguable, but not conclusively demonstrated, that this figure is skewed arbitrary, and capricious in anticipated travel and expenses by duplication of some costs and expenses as regards the physician and medical records consultant to be assigned to on-site reviews. See infra. In the Statement of Justification, with respect to "Physician Review of Applications," a figure of eight applications per year was selected based on anticipation that since there are 8 trauma centers in Jacksonville, Florida and the present trauma center verification program's Medical Director, Dr. Raymond Alexander resides in Jacksonville and is employed at a Level I trauma center there potential conflicts of interest exist if any of these entities become applicants for any of the three levels of verification and that if any did, the agency would have to contract with a different physician for review of these eight applications at $200 per application reviewed. It was also anticipated that due to fluctuations in workload and the desire of Dr. Alexander that some Level I applications elsewhere in the state receive a backup application review by another physician, these situations might also require contracting with physicians other than Dr. Alexander. Although DHRS' motives are commendable at first glance it strains credibility that out of 15 per year (total 30) eight (total 16) will come from the finite "Jacksonville 8" number or arrive at a peak workload period. There is no evidence of record what criteria besides Dr. Alexander's request will be used to decide which Level I applicants will get dual reviews and there is a suggestion that there is going to be duplication of effort on these applications for the purpose of avoiding even the appearance of conflict. There is no evidence of record to show how reclassification or continued verification reviews or on-site reviews, if any, work into this figure either. Nonetheless, the parties appear to accept this figure of 16 spread over the biennium. If the figure of 16 is accepted, a remainder of 14 applications (based on DHRS' questionably anticipated 30 applications for the biennium horizon) remain for Dr. Alexander's review. DHRS assigned a 50 percent time allotment (based on Dr. Alexander's annual $42,600 contract) to its Statement of Justification. Incongruously, Dr. Alexander's contract itemizes 15 percent of his time for the combined duties of listing other physicians willing to review applications and his own time reviewing these applications. Petitioner desires the inference to be drawn that either Dr. Alexander is being paid slightly more than $3,000 per application review ($42,600 divided by 14) as compared to $200 per review by other physicians or that the 15 percent figure should be used instead of the 50 percent time/salary component. Neither inference is fully supported by the record as a whole nor by mathematics. However, even assigning the deference due to the discretion afforded an agency in the exercise of its rulemaking authority, that quality of deference will not withstand Larry Jordan's characterization of this 50 percent figure as coming from the attachment at the "front end" of an arbitrary percentage. Although submission of subsequent reports by Dr. Alexander supposedly justify that 50 percent figure as being paid from the trauma center verification activities budget, these reports are not before the undersigned, and Mr. Jordan admits that no analysis was done to establish this 50 percent figure in relation to time/salary solely related to verification. Therefore, the use of this figure of 50 percent is at least arbitrary and capricious in that there is nothing to substantiate what it means with regard to actual medical director duties concerning verification. In the Statement of Justification, with respect to "Trauma Center Site Visits", Larry Jordan determined that an on- site visit for each application is necessary in order to comply with the statutory mandate of Section 395.031(5) that DHRS ensure that the statutory standards set forth in Section 395.031(6) are maintained by trauma centers subsequent to their initial verification. This is permissible discretion within the agency administering the statute. Upgrading its methods of meeting its statutory mandate is a laudable goal of the executive branch and ought not to be violated except where it can be clearly shown that the method exceeds the statutory mandate. That has not been shown here with regard to establishing on-site reviews for the future. Jordan decided to phase in on-site visits commencing with 6 per year. Nothing in this decision to start with 6 a year first has been demonstrated to be arbitrary, capricious, or outside the statutory mandate. However, the dollar amount is another matter. The dollar amount for this upgraded procedure was taken from information from the Joint Committee on Accreditation of Hospitals who conduct similar hospital site visits for accreditation purposes of entire hospitals. Relative to the on- site inspection fee cost calculation contained in the Statement of Justification which is set forth as $54,736 (including a medical records consultant figure discussed infra.) there is no clear indication of whether this figure is based on a prognosis of entire hospital review as with the model accreditation team or upon review of just the emergency room. Trauma is a life-threatening injury a/k/a surgical disease. Since availability of surgeons, surgery rooms, and anesthesiologists as opposed to emergency room physicians is crucial to trauma center qualification it is conveivable that more than just emergency rooms will be inspected but there is insufficient indication even by job description of exactly who will be assigned to the team, what the on-site reviews will cover, what the team duties will entail or how the balance of the $54,736 figure relates to these items. Past agency experience with a single on-site review using existing agency personnel resulted in total expenses of $400.00. The agency also regularly meets the Section 395.006(3)(a) directive to inspect whole hospitals at a cost of not more than $12.00 per bed. By contrast with this information- EMS' component of cost for on-site review of trauma centers is arbitrary, capricious, excessive, and not statutorily justified. In the Statement of Justifications with respect to "Legal Expenses for Denial Hearings," Larry Jordan estimated that $6,000 was a minimal amount that would-be needed for denial hearings. Although testimony is clear that there had never been a denial hearing or even a denial of a trauma center application, provision for such hearings is clearly set out in Section 395.031(4) and (5), and it is naive in the extreme to assume that in meeting its statutory mandate, the agency will never deny any initial applications reclassification- or continued verification application or that of those denied none will ever seek a hearing in accord with Chapter 120, Florida Statutes. There is, however, no rationale within the record for why the figure of $6,000 was arbitrarily selected. In the Statement of Justification, with respect to "Medical Records Consultant Contract," it was determined that such a position is necessary to the trauma center verification program and would be paid approximately $16,000 per year. The asserted justification for a medical records consultant is to support the proposed six on-site visits per year. This purpose is plausible and reasonable within the discretion normally afforded agencies and supportable by the laudable goal to upgrade the method of meeting this agency's statutory mandate already discussed, but DHRS has neither legislative nor budgetary authorization for the medical records consultant position and this renders speculative its inclusion at this time in the calculations for the fee schedule rule. Even recognizing that sometimes an indication that the position can be supported by outside fees is a necessary prerequisite to getting an agency position authorized, inclusion of this speculative cost in this fee schedule is not justified by the statute which requires that the verification program fees to applicants not exceed its cost. Petitioner has adequately demonstrated that an undesignated amount of time of various employees utilized in calculating the FTE function was devoted to legislation, rules drafting, grant disbursal, and meetings of the EMS Advisory Council not directly related to the trauma center verification program and that these elements included within the FTE calculation have skewed the fee need calculations and rendered the fee excessive and not statutorily justified. The record does not support DHRS' contention that the fee increase is necessary to cover its operation deficit or that the cash deficit discussed in the Statement of Justification applies to the verification program alone. It is Petitioner's view that DHRS, in fact performing two distinct functions concerning trauma centers, one of which may be designated "the trauma center program" encompassing every activity of DHRS' Emergency Medical Services Section relative to trauma center matters (including preparation of a statewide medical services program, drafting, analysis, and lobbying of legislation, public education, service in connection with the mandate of the EMS Advisory Council, preparation, negotiation, and litigation concerning promulgation of this and other rules, and non-specific administrative time) and the other function being the "trauma center verification program" pursuant to which applications filed with the EMS Section are received and approved or denied. Petitioner further contends that it is only costs attributable to the latter function, the cost of processing individual applications of hospitals for trauma center verification which may properly be included as a "cost of verification borne by the applicant" pursuant to Section 395.031(7), Florida Statutes. Petitioner seems to suggest that only the 12 hours of Mr. Davis' time multiplied by the number of projected applications should be calculated into the proposed fee. Petitioner's view is too narrow in regard to the full mandate of the statute. The trauma center verification program cannot operate in a vacuum and except as set out in previous findings of fact Petitioner has failed to demonstrate that any elements used in the agency's calculations are not integral parts of the verification program. However, for all the reasons set forth in the preceding findings of fact it is clear that an excessive, arbitrary and capricous calculation of components have rendered the rule itself arbitrary and capricious and its fee schedule excessive to the point of being confiscatory. As such, the fee schedule embodied in the Proposed Rule exceeds the statutory mandate of Sub-Section (7). The foregoing findings are not altered by Respondent's negotiating during the rule making process a $9,000 reduction from an originally anticipated $20,0OO ungraduated fee by the deletion of two additional plans to upgrade the trauma center verification program.
The Issue This hearing dealt with the consideration of the adequacy of the proposals by the Petitioner and Intervenor which were offered in response to the Respondent agency's RFP inquiry about a contract for the delivery of health services. Consideration of the dispute was as envisioned by Section 120.53(5), Florida Statutes. Respondent had determined that the Petitioner's proposal was unresponsive, and the proposal of the Intervenor was found to be acceptable. Petitioner challenged this opinion, leading to an assessment through the hearing process of the responsiveness of the proposals submitted by the Petitioner and Intervenor.
Findings Of Fact On September 12, 1985, the State of Florida, Department of Corrections, the Respondent in this action, issued request for proposals number 85-CO-2336-R. (A request for proposals is commonly referred to as an "RFP.") The purpose of this RFP was to obtain the assistance of a vendor or contractor in the provision and management of medical services at a newly constructed reception/medical facility located in southern Florida. Following the review of four responses to the RFP a decision was made on October 15, 1985, to award the project to Emergency Medical Services Associates, Inc., the Intervenor. In the face of this intended agency action, the Petitioner, Correctional Medical Systems, Inc., filed a Notice of Intent to Protest on October 18, 1985. This was followed by a Formal Written Protest dated October 23, 1985, which was amended on November 7, 1985. These pleadings raise the issues which are described in this Recommended Order. In particular Respondent, through the RFP, sought the ideas of the contractors necessary for the provision of comprehensive health care services in the new facility which is known as the South Florida Reception Center. Among the specific requirements of the RFP were the supply of medical and psychological personnel physical and psychological examinations, x-ray and laboratory facilities, the provision of an infirmary and an intensive care mental health unit. The RFP called for the provision of the services for three years with an option to renew for a second three-year term upon agreement of the provider and Respondent. In addition to the Petitioner and Intervenor, two other firms submitted responses to the RFP. Those companies were Correctional Health Services, Ltd., and Prison Health Services, Inc. The price quotations given by the four responding vendors were as follows: Correctional Medical Systems, Inc. $11,084,805.00 Correctional Health Services, Ltd. 11,560,000.00 Emergency Medical Services Associates Inc. 13,687,419.00 Prison Health Services, Inc. 15,720,387.00 In issuing the RFP the Respondent had as its goal the ability to select from competitive proposals that proposal which best met the needs of the agency. This method of selection was utilized, notwithstanding the fact that health services are not required to undergo the rigors associated with the bid laws of Florida. The RFP, in its terms, had allowed the unsuccessful bidders to protest the Respondent's decision of the matter of a contract award based upon authority set forth in Section 120.53(5), Florida Statutes. Three of the four proposals submitted by the four companies were rejected by the Respondent as being nonresponsive or irregular. Petitioner's proposal was rejected in view of the Respondent's belief that the proposal failed to contain a firm fixed price. Prison Health Services' bid was depicted as being inadequate, in that it failed to offer a fixed price and to include a legally binding proposal. Correctional Health Services' proposal was deemed nonresponsive for the failure to include resumes of key personnel within that organization. These determinations of irregularity or of lack of responsiveness were based upon a facial review of the submissions by the contractors and no further steps were taken by the Respondent to make an in- depth analysis of those proposals or to compare them to other proposals prior to deciding the ultimate question of which contractor it preferred to engage in this undertaking. The proposals from the four contractors were received and opened on October 7, 1985. William Stancill, the General Services Administrator to the Respondent had reviewed the submissions by the four vendors with an eye for any failings in those documents pertaining to what he perceived to be mandatory requirements of the PEP. This assessment lead Stancill to recommend the rejection of the three vendors for lack of compliance with mandatory requirements. Having reached this conclusion, the vendors other than the Intervenor were told that their proposals were unacceptable. Again, upon the facial examination of the proposals, only that proposal of Emergency Medical Services Associates was found to be responsive. 1/ Before the proposals were received from the various contractors, Respondent held what is known as a responders' conference to discuss the terms of the RFP. In the course of this conference, an indication was given to the potential responding parties on the topic of the Respondent's desires as to a price quotation. In the RFP, paragraph 5.2 [page 28] indicates "The cost proposal will be stated in terms of a fixed price for each year of the contract and option " In the course of the proposal submitted by the Petitioner, it offered the following comments about its price: CMS' price for each year of the contract is shown based on a 5 percent yearly increase. If the Medical Care Component of the Consumer Price Index deviates more than 2 percent from the projected 5 percent increase in a given year, CMS reserves the right to renegotiate its price with the Florida Department of Corrections for that year. This price is not fixed as contemplated by the terms of PEP, and this submission by the Petitioner fails to comply with the PEP on this subject. This failing is not cured by the testimony of Richard Turpenoff, Vice President of Financial Services for the Petitioner, when he describes personal involvement with the submission of seventy-five to a hundred health care proposals for correctional facilities and the fact that this language set forth in the present response to PEP had been used on those occasions. Nor is it beneficial to the Petitioner when it indicates that this type of language set forth in the response to the price demands of the PEP is that which has been used by health care providers throughout the industry. Petitioner's idea of reserving to itself the ability to discuss with the Respondent an equitable adjustment in the price of its services, in what the Petitioner foresees as an unlikely event that the Medical Care Component of the Consumer Price Index were to rise drastically over the period of the contract, is in itself a departure from the terms of the PEP. The PEP does not allow for this interference with the orderly process of the contract terms through any suggested negotiations, and it does not suffice to say that those negotiations are not unilateral in nature. Further, it is insufficient rehabilitation of the response to the PEP to indicate that the Petitioner has not abandoned any of its contracts before the expiration of the terms of those agreements. In this connection, the testimony of Joseph Rowan, Executive Director of Juvenile and Criminal Justice International, an expert in health care, states that he has reviewed a large number of proposals and has seen numerous proposals with provisions similar to that set forth in the Respondent's statement on price and concludes that the provision in the proposal is a firm fixed price. That statement is rejected. It is rejected because the interpretation given to this provision on the part of the Respondent in the person of Mr. Stancill is more compelling. Stancill believes that the Petitioner's quotation is not binding and is therefore not a fixed price, and that understanding is accepted. The Petitioner's deviation from the requirement for fixed price is one which may not be considered a minor irregularity, in that it is not an item which does not have an adverse effect on the cost or performance as described in paragraph 4.7 [page 25] of the PEP. The terms of the PEP as paragraph 4.7 and Rule 13A-1.02, Florida Administrative Code, contemplate the waiver of minor irregularities in the proposals submitted by the contractors. By not submitting a fixed price, Petitioner has failed to comply with a mandatory requirement of the PEP, and its offer is unresponsive. Finally, in the last four years, the Medical Care Component of the Consumer Price Index has exceeded 5% in each of those years and has reached as high as 8.7% in one of those years. As with the Petitioner's submittal, in examining the propriety of the submission by the Intervenor, it is the question of mandatory compliance with the RFP that is critical to the qualification of the latter proposal. To this end, the Petitioner has attempted to identify in the course of the final hearing those items within the proposal by the Intervenor which Petitioner argues constitute noncompliance in categories in which compliance is mandated. The first area of concern by the Petitioner pertains to subparagraph 5.1.2 of the RFP [page 27]. This provision relates to job descriptions and resumes of employees included within the FTE count. It says: A job description for all employees to be employed by the Contractor in the institu- tion, must be included. (Format samples are attached.) Resumes of any designated senior administrative/management or professional personnel should be included. As a minimum, the positions equivalent to senior adminis- trator, the chief health officer, and the nursing Director must be designated and a resume provided. Having considered the language of this provision, and the explanation concerning the provision as provided by Stancill, this provision is found to require the submission of job descriptions for all employees that the contractor intends to utilize in the institution. Further, it is necessary that the contractor designate by name and provide resumes for those persons holding the positions within the organization which are equivalent to the senior administrator, chief health officer and nursing director. This provision cannot be construed, as urged by the Respondent and Intervenor, to countenance the idea that only the job descriptions pertaining to positions equivalent to senior administrator, chief health officer and nursing director must be provided. In its submission, the Intervenor failed to submit job descriptions for employees in the classifications clerical assistant, medical records librarian, rehabilitative therapist ward clerk, clerk typist, pharmacy assistant and, arguably, clinical psychologist. Those job descriptions identified were provided at a later date. An additional conference was held between the Respondent and Intervenor following the Respondent's stated intention to select the Intervenor as the contractor, and in the course of this meeting, the Respondent established what it would accept in the way of the provision of services under the term medical assistant. That indication was to the effect that this job title must pertain to licensed nurses and medical technicians. In Florida, there is a specific category of licensed professional referred to as "medical assistant," found at Section 458.34, Florida Statutes, (Ch. 84-543, Laws of Florida) as it deals with assistants to physicians. The job description related to medical assistants as provided by the Intervenor more closely corresponds to the duties of licensed nurses or persons who assist those nurse practitioners, not persons who work under the direct supervision of a physician as described in Chapter 458, Florida Statutes. This job description also refers to the possibility of filling positions with persons who have worked as emergency medical technicians, EMTs. While the Intervenor failed to submit the job descriptions which have been identified in the previous paragraph, and as such violated subparagraph 5.1.2 of the RFP, this noncompliance is not a failure to comport with mandatory terms of the RFP. The mandatory terms as generally described in paragraph 3.1, and as defined by the following paragraphs and subparagraphs, do not point to the idea that the failure to provide the job descriptions is mandatory and a fatal defect in the proposal. While paragraph 3.1 and its ensuing provisions do regard the provision of resumes and background information related to key personnel as being mandatory the provision of job descriptions for the personnel at issue is not a mandatory item. Finally, the omission of those job descriptions in this instance has not been found to have a bearing on cost or performance. In a related vein, the inability, in theory, to compare the job descriptions of one contractor with those of another would impair the purchaser's efforts at selecting between the proposals. However, this comparison is not needed if the other contractors have been excluded based upon noncompliance with mandatory requirements of the RFP. Indeed, the other three proposals were properly discarded for noncompliance, and no comparison has been made. In the absence of the necessity of comparing job descriptions, it was not inappropriate for the Respondent to allow for the provision of the missing job descriptions subsequent to the submission of the basic proposal or to engage in discussion about the needs under the category medical assistant following the submission of the proposal. The Petitioner next challenges the accuracy of the claims which have been made by the Intervenor reference James A. Brigham, a key person in the plans of the Intervenor in its attempts at honoring the terms of a contract with the Respondent. Brigham is the Intervenor's Director of Marketing. On page 3 of the proposal of the Intervenor, in the introductory remarks, it is stated: Mr. Brigham was formerly an executive with and helped to found and manage Correctional Medical Systems, Inc. He has worked directly with the Department of Corrections in the states of Illinois, Alabama, Georgia and Missouri. In fact, Brigham neither founded nor managed Correctional Medical Systems, Inc. Although he has offered advice in the formative years of that corporation through his affiliation with another corporate entity which was associated with Correctional Medical Systems, Inc., that experience cannot be elevated, even under the most liberal construction, to a level of founding and managing. Brigham has never been employed by Correctional Medical Systems per se and has not served in any executive capacity with that organization. The resume of Brigham, which is a part of the proposal by the Intervenor, also sets forth that Brigham served as the Executive Vice President of Spectrum Emergency Care, Inc., in the years 1977-1983. (Spectrum is the other corporation previously mentioned which Brigham was associated with when advising Correctional Medical Systems.) His service as Executive Vice President lasted from 1977 through October 1, 1982. He did serve as an employee of Spectrum Emergency Care between the years 1977 and 1983. In the course of that employment, he prepared proposals and consulted with various states in the area of provision of medical care within correctional facilities. In that regard he had some contact with the states of Illinois, Georgia, Missouri, Arkansas and Alabama. Correctional Medical Systems was organized in 1979 to promote comprehensive medical services within correctional facilities throughout the United States. The focus of Spectrum in this regard had been primarily the provision of physician staffing in correctional facilities. It is not evident from what has been presented in the course of this hearing why these inaccurate statements were set forth in the RFP in describing Brigham's association with Correctional Medical Systems and Spectrum. On balance, having considered those statements and having reviewed the deposition of the witness Brigham on the subject of his experience, these inaccuracies within the RFP response are not found to be sufficient to recommend the rejection of this proposal. Paragraph 2.7 [page 1O] of the RFP states: The proposal shall indicate the contractor's plans to secure and maintain standards of the Commission on Corrections accreditation of the health services program, regardless of whether the entire institution may be accredited. This refers to standards established by the American Correctional Association. Petitioner claims that the Intervenor did not describe in its proposal how it intends to provide access information to the incoming prisoners pertaining to health care. As argued by the Petitioner, this is a requirement by the American Correctional Association in its standards dealing with the provision of medical care access information to prisoners. However, the RFP cannot be construed as requiring a contractor to identify how it would comply with that provision as a feature of its response to the RFP. The RFP is read to stand for the proposition that the contractor, in cooperation with the Respondent, shall make efforts to gain accreditation by the American Correctional Association and does not extend to the idea of a separate statement in its proposal of how it will provide access information to incoming prisoners. Moreover, it was established in the course of the hearing that at the point of intake of inmates into the Florida system of corrections, those inmates are routinely made aware of their right to receive medical services. At paragraph 2.1, lettered section C, [page 7] of the RFP, there is a discussion of the length of stay contemplated in the mental health unit of the facility. In particular it states: The patients in this mental health unit are expected to be successfully treated or stabi- lized within 30 to 60 days so as to permit assignment to another institution. This obligates the contractor to the establishment of a program varying in length from thirty to sixty days which will meet those requirements of successful treatment or stabilization. In preparing a budget to address this requirement, it leaves to the contractor the decision on whether the program needs to be thirty or more days. The latitude is afforded to use as few as thirty days in preparing the budget, which the intervenor did. By its terms, the RFP calls for the processing of eighty adult offenders and twenty youthful offenders per week for a total of a hundred inmates a week to be seen at reception for routine physical exams. This requirement of the RFP has been addressed in the budget statement of the Intervenor in Attachment D [page 2], described as a hundred physicals times 52 weeks or fifty-two hundred examinations. This item is separate from another item set forth on that page dealing with physical examinations which are on an annualized basis with a calculation being made that approximately five persons will be examined per day in the category of annual examinations. It has not been shown that the Intervenor budgeted for five examinations a day related to the intake function of receiving and processing inmates, when twenty per day was called for by the RFP. None of the other claims of the Petitioner set forth in the formal protest and its amendments on the subject of alleged infirmities within the Intervenor's response to proposal have been proven. The Emergency Medical Services Associates proposal had been reviewed by the evaluation committee of the Respondent which had the responsibility to make decisions on the sufficiency of such proposals and was found to be satisfactory. This determination has not been shown to be in error through proof in this hearing.
