The Issue Whether certain forms incorporated by reference into the administrative rules of the Respondent constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Tampa General Hospital ("TGH" or "Petitioner") is a general acute care hospital in Tampa, Florida and is a verified Level I state-approved trauma center. By definition, a Level I trauma center is required to include an adult trauma center and a pediatric trauma referral center. The Department of Health and Rehabilitative Services ("DHRS" or "Respondent") is the state agency with responsibility for certification of trauma centers in Florida. St. Joseph's Hospital ("SJH" or "Intervenor") has filed an application for state approval as a pediatric trauma referral center which is the subject of a separate administrative challenge by TGH. In the instant case, TGH challenges three DHRS forms incorporated by reference into the Florida Administrative Code and which are utilized by applicants seeking certification as state-approved trauma centers. Tampa General has standing to challenge the forms in this proceeding. The three forms challenged by TGH in this case are HRS Form 1840, ("State-Approved Trauma Center Letter of Intent"), HRS Form 1721, ("Application for State-Approved Pediatric Trauma Referral Center"), and the portions of HRSP 150-9, which identify the "critical standards" which must be met by an applicant seeking to obtain approval as a provisional state approved pediatric trauma referral center. The three forms include reference dates of October 1991. The forms were adopted as part of a rule promulgation effort prior to the 1992 Legislative session. Obviously the DHRS did not address the 1992 legislation in the 1991 rules. In relevant part, the 1992 legislation added a requirement that, under conditions set forth in the statute, proposed trauma centers must be certified as consistent with local or regional trauma plans. The forms challenged by TGH fail to reference the requirement. Section 395.4025(2)(a), Florida Statutes, requires submissions of letters of intent from hospitals seeking to become certified as state-approved trauma centers. Section 395.4025(2)(a), Florida Statutes, further requires that "[i]n 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 state-approved 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." The statute states that the requirement is not applicable to hospitals which were provisional or verified trauma centers on January 1, 1992. There are five local or regional trauma agencies in Florida which have been approved by the DHRS. Hillsborough County, where both the Petitioner and the Intervenor operate hospitals, has one of the five local trauma agencies. Rule 10D-66.109(a), Florida Administrative Code provides that the department "shall accept a letter of intent, HRS Form 1840, October 91, State- Approved Trauma Care Center Letter of Intent, which is incorporated by reference and available from the department. " The form letter of intent provided to applicants by the DHRS fails to reference the local plan consistency requirement or the conditions under which the requirement is applicable. Section 395.4025(2)(a), Florida Statutes, relates only to letters of intent. It clearly indicates that the certification of local plan consistency is an issue to be addressed as part of the letter of intent filed by a provider. The form letter of intent does not provide notice to the applicant that such certification may be required, either as part of the completed letter of intent or otherwise. The omission of the certification requirement from the letter of intent form is misleading. It fails to indicate that a hospital should address the issue in its letter of intent. The form contravenes the statute. TGH also challenges HRS Form 1721, October 91, ("Application for State-Approved Pediatric Trauma Referral Center",) and the portions of HRSP 150- 9, October 91, which identify the "critical standards" which must be met by an applicant. Section 395.4025(2)(c), Florida Statutes, (1994 Supplement) provides as follows: In order to be considered by the department, applications from those hospitals seeking selection as state-approved trauma centers, including those current verified trauma centers which seek to be state-approved trauma centers, must be received by the department no later than the close of business on April 1. The department shall conduct a provisional review of each application for the purpose of deter- mining that the hospital's application is complete and that the hospital has the critical elements required for a state approved trauma center. This critical review will be based on trauma center verification standards and shall include, but not be limited to, a review of whether the hospital has: Equipment and physical facilities necessary to provide trauma services. Personnel in sufficient numbers and with proper qualifications to provide trauma services. An effective quality assurance program. Submitted written confirmation by the local or regional trauma agency that the verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists. This sub- paragraph applies to any hospital that is not a provisional or verified trauma center on January 1, 1992. Rule 10D-66.109(c), Florida Administrative Code, requires that an applicant for licensure as a provisional state-approved pediatric trauma referral center must submit an application on HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center. The form is incorporated by reference in the rule. HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center, fails to reference the local plan consistency issue or the conditions under which the requirement is applicable. However, the instructions to the form provide as follows: INSTRUCTIONS: To be eligible for approval as a SAPTRC, a hospital must complete this application and submit all requested information to the HRS, Office of EMS, for review. The following must be used to complete this application: HRS Pamphlet (HRSP) 150-9 entitled "State Approved Trauma Centers and State-Approved Pediatric Trauma Referral Center Approval Standards", Oct 91 (standards document), and the application requirements of Chapter 395, Florida Statutes (F.S.), and Chapter 10D-66, Florida Administrative Code (F.A.C.). Following discussion of a three phase review process, the HRS Form 1721 instructions again state that "HRS Pamphlet (HRSP) 150-9, Oct 91, the application requirements of Chapter 395, F.S., and Chapter 10D-66, F.A.C., will be used as criteria for application review." By reference to the statute and rules, the instructions to the application notify an applicant as to the requirements for certification. The failure of the actual application to specifically restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement. As to the standards document in which the critical standards for provisional approval are set forth, rule 10D-66.109(d)2, Florida Administrative Code, provides as follows: The minimum standards for review for Provisional SAPTRCs are the following portions of HRSP 150-9, October 91; STANDARD Type of Hospital Surgery Department; Division; Services; Sections: A Surgical Specialties Availabilities: A 1, 2, 3 & 4 Non-Surgical Specialties Availabilities: 1, 8 & 13 Emergency Department (ED): A, B, D & H Operating Suite Special Requirements: A IX. Pediatric Intensive Care (P-ICU): A, C, 1 XVI. Quality Management: A, B, C, D, & E It is unnecessary to address each critical standard in this order. Essentially, they relate to the first three "critical elements" set forth as Section 395.4025(2)(c)1-3, Florida Statutes. However, review of the cited portions indicates that there is no reference within the cited sections of HRSP 150-9, October 91, which addresses the possible requirement of local trauma plan consistency certification. The application processing framework set forth by the administrative rules indicates that local plan consistency is to be considered prior to the DHRS's commencement of provisional review. Rule 10D-66.109(d), Florida Administrative Code, provides that "[a]fter considering the results of the local or regional trauma agency's recommendations, the department shall, by April 15, conduct a provisional review to determine completeness of the application and the hospital's compliance with the critical standards for provisional standards." If, as the rule suggests, certification of local plan consistency is considered prior to commencement of provisional review, it would be duplicative to include the requirement in the technical critical standards set forth in the standards document. The failure of the standards document to restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement.
The Issue Whether the Proposed 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 Shands operates an 852-bed hospital and Level I trauma center in Gainesville, Alachua County, Florida. Its business address is 1600 Southwest Archer Road, Gainesville, Florida. Shands treats about 2,500 trauma patients each year. Shands is located within trauma service area (TSA) 4, which is comprised of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, and Union counties. St. Joseph’s is a regional tertiary hospital and has served the Tampa area for 75 years and has approximately 800 licensed acute care beds. St. Joseph 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. St. Joseph operates a Level II trauma center and a Level I pediatric trauma center. St. Joseph is located in TSA 10, consisting of a single county, Hillsborough. Tampa General is a major tertiary hospital that is designated by the state as a Level I trauma center. Tampa General also serves as a teaching hospital for the University of South Florida, College of Medicine ("USF"). Tampa General is located in Tampa, Hillsborough County, Florida, TSA 10. Bayfront is a 480-bed tertiary hospital located in 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. It is located in TSA 9, composed of Pinellas and Pasco counties. The Public Health Trust of Miami-Dade County, is an entity which governs and operates the Jackson Health System, including the Ryder Trauma Center at Jackson Memorial Hospital. It is in TSA 19, consisting of Dade and Monroe counties. The Florida 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. Osceola is a licensed acute care general hospital, located at 700 West Oak Street, Kissimmee, Florida. Osceola provides a wide array of high quality health services to the residents and visitors within its service area. It is located in TSA 8, consisting of Lake, Orange, Osceola, Seminole, and Sumter counties. 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 need for a trauma system 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 nine 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." A trauma center is a hospital that has a collection of resources and personnel who are charged with taking care of trauma patients. They are recognized by the community as a resource for care of severely injured patients. The International Classification Injury Severity Score (“ICISS”) methodology, considered with discharged patient data from the Agency for Health Care Administration database, was used by DOH to determine severely injured patients. An ICISS score is the product of the survival risk ratios (i.e., the probabilities of survival) calculated for each traumatic injury a single patient suffers. Level I trauma centers are generally larger and busier and treat more patients than Level II centers. Level I trauma centers are required to engage in education and research. Trauma centers are required to have several types 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. Little if any credible evidence was presented in the present case to suggest that the ability to hire qualified clinical staff, technicians, specialty physicians and other personnel would be severely impacted if the Proposed Rule is implemented. Rather, the existing trauma centers lamented the possibility of reduced case loads which could make it more difficult to retain proficiency. Invalidation of Former Rule 64J-2.010 In 1992, the Department of Health and Rehabilitative Services (HRS), the Department of Health's predecessor, promulgated Florida Administrative Code Rule 64J-2.010, titled "Apportionment of Trauma Centers within a Trauma Service Area," (hereinafter referred to as the “Former Rule”). The Department of Health assumed administration of the Former Rule in 1996, when the Legislature split HRS into two new agencies, the Department of Health and the Department of Children and Families. The Former Rule regulated the number of trauma centers that could be established in Florida. The Former Rule divided the state into TSAs as set forth in section 395.402(4), and for each TSA, announced the number of trauma center "positions" available. In 2004, the Florida Legislature amended section 395.402 to require the Department to complete an assessment of Florida's trauma system, and to provide a report to the Governor and Legislature no later than February 1, 2005 (the 2005 Assessment). The scope of the assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. One objective of the assessment was to consider aligning trauma service areas within the trauma region boundaries as established in section 395.4015(1). It required the Department to establish trauma regions that cover all geographic areas of the state and have boundaries that are coterminous with the boundaries of the Regional Domestic Security Task Forces (“RDSTF”) established under section 943.0312. In a related 2004 amendment, the Legislature added a provision that gave the Department the option to use something other than the trauma service areas codified in section 395.402(4) upon completion of the 2005 Assessment. See § 395.402(2), Fla. Stat. ("Trauma service areas as defined in this section are to be utilized until the Department of Health completes" the 2005 Assessment.) § 395.402(4), Fla. Stat. ("Until the department completes the February 2005 assessment, the assignment of counties shall remain as established in this section."). As part of the 2004 amendments to the trauma statute, the Legislature also required the Department to conduct "subsequent annual reviews" of Florida's trauma system. In conducting such annual assessments, the Legislature required the Department to consider a non-exhaustive list of criteria set forth in section 395.402(3)(a)-(k). Further, the Legislature required the Department to annually thereafter review the assignment of Florida’s 67 counties to trauma service areas. The Department timely submitted its 2005 Assessment to the Legislature on February 1, 2005. With respect to its review of the trauma service areas, the 2005 Assessment recommended against the continued use of the 19 trauma service areas. The 2005 Assessment instead suggested that it may be feasible for the existing trauma service areas to be modified to fit the seven RDSTF regions to facilitate regional planning. Following receipt of the 2005 Assessment, the Department took no action to amend the Former Rule and adopt the recommendations of the 2005 Assessment. As a result, in June 2011, several existing trauma centers challenged the validity of the Former Rule pursuant to sections 120.56(1) and (3). See Bayfront Med. Ctr., Inc. et al. v. Dep't of Health, DOAH Case Nos. 11-2602RX, 11-2603RX, 11-2746RX, 11-2796RX (Fla. Div. Admin. Hear., Sept. 23, 2011). On September 23, 2011, an administrative law judge of the Division of Administrative Hearings entered a final order holding that the Former Rule was an invalid exercise of delegated legislative authority. The administrative law judge concluded that the Former Rule was invalid because it contravened the laws it purportedly implemented, including section 395.402. The judge found: The authority granted by section 395.402 for the use of the [nineteen] identified TSAs existed only until February 2005. After that time, the Department was required to consider the findings of the 2005 Assessment, as well as the recommendations made as part of the regional trauma system plan. Thus, section 395.402 can no longer service as a valid basis for the Rule. However, as set forth below, the authority to utilize the 19 TSAs was not rescinded; rather, the mandated requirement to use only the TSAs was rescinded. The Department was required to review the assignment of Florida’s 67 counties to trauma service areas, taking into consideration the factors set forth in paragraphs (2)(b)-(g) and subsection (3) of section 395.402. Having done so, it was incumbent on the Department to amend its [Former] Rule to allocate the number of trauma centers determined to be needed within each designated area through systematic evaluation and application of statutory criteria. On November 30, 2012, the First District Court of Appeal affirmed the administrative law judge's determination that the Former Rule was an invalid exercise of delegated legislative authority. See Dep't of Health v. Bayfront Med. Ctr., Inc., 134 So. 3d 1017 (Fla. 1st DCA 2012). After noting that the Former Rule claimed to implement sections 395.401, 395.4015, and 395.402, the appellate court held that the Former Rule was invalid because it failed to reflect the substantial amendments to those laws that were enacted in 2004. The appellate court held: Both the pre-and post-2004 versions of the statute require the Department to establish trauma regions that "cover all geographic areas of the state." However, the 2004 amendment requires that the trauma regions both "cover all geographical areas of the state and have boundaries that are coterminous with the boundaries of the regional domestic security task forces established under s. 943.0312." § 395.4015(1), Fla. Stat. (2004). Similarly, the rule fails to implement the 2004 amendments to section 395.402. The version of the statute in effect at the time the rule was promulgated set forth the nineteen trauma service areas reflected in the rule. [T]he 2004 version of the statute required the Department to complete an assessment of Florida's trauma system no later than February 1, 2005. It further provides that the original nineteen trauma service areas shall remain in effect until the completion of the 2005 Assessment. Bayfront, 134 So. 3d at 1019-20 (Emphasis added). It should be noted that the 2004 version of the statute does not specify at what point in time the 19 TSAs could no longer be utilized, only that they would have to be used at least until completion of the 2005 Assessment. Rule Development The Department thereafter initiated rule development workshops to commence construction of a new rule. The first workshop concerning this rule was in Tallahassee, Florida, on December 21, 2012. In January and February 2013, workshops were then held in Pensacola, Tampa, Ocala, Jacksonville, and Miami, as DOH continued working on a new rule. Each of the sessions involved input from interested persons both live and by telephone. Written comments and oral presentations by these persons were considered by the Department. After these first six workshops, held in various regions of the State to make them more accessible to more citizens, DOH then scheduled three more workshops in March 2013, to be held in areas where there were no existing trauma centers, specifically Ft. Walton Beach, Naples, and Sebring. DOH also considered the recommendations of a report issued by the American College of Surgeons (“ACS”), the lead professional group for trauma systems and trauma care in the United States. The ACS sent a consultation team to Tallahassee, Florida, to conduct a three-day site visit and hold public workshops in February 2013. The ACS ultimately issued a report entitled “Trauma System Consultation Report: State of Florida,” in May 2013. The report included as one of its recommendations the use of RDSTF regions as the TSA areas to be used in determining need for additional trauma centers. In November 2013, DOH released a draft proposed rule and a draft of its first TSA Assessment (the January TSA Assessment). The Department then conducted three additional workshops in Pensacola, Orlando, and Miami. Again, DOH solicited comments from interested persons and entered into a dialogue as to what the proposed rule should look like upon publication. On January 23, 2014, DOH conducted a Negotiated Rulemaking Committee meeting at the Department’s headquarters in Tallahassee, Florida. The committee consisted of seven persons: Karen Putnal, Esquire and Dr. Fred Moore--representing existing trauma centers; Steve Ecenia, Esquire and Dr. Darwin Ang-- representing new trauma centers currently under challenge; Dr. Patricia Byers--representative of the EMS Advisory Council; Jennifer Tschetter, Esquire and Dr. Ernest Block--representing DOH. The public was invited to attend the session but was not afforded an opportunity to speak. The Department considered all the input from each of the workshops, the ACS Report, and the negotiated session, as well as all the applicable items enumerated in section 395.402(3)(a)-(k). The Proposed Rule On February 3, 2014, the Department published Notice of Development of Proposed Rule 64J-2.010 (the "Proposed Rule") in Florida Administrative Register, Volume 40, Number 22. The Department's Notice cited section 395.405, as rulemaking authority for the Proposed Rule. The Notice also cited sections 395.401, 395.4015, 395.402, and 395.405 as the laws intended to be implemented by the Proposed Rule. The following day, February 4, 2014, the Department published a Notice of Correction in Florida Administrative Register, Volume 40, No. 23, to correct the history notes of the Proposed Rule. In the corrected Notice, the Department cited section 395.402 as its rulemaking authority in addition to section 395.405. The correction also removed reference to sections 395.401, 395.4015, and 395.405, as laws implemented by the Proposed Rule. Following the Department's correction, the Proposed Rule was intended only to implement section 395.402. The Proposed Rule established 19 TSAs and determined the number of trauma centers to be allocated within each TSA, based upon a scoring system established in the Proposed Rule. Under the scoring system, TSAs were awarded positive or negative points based on data in an annual Trauma Service Area Assessment relating to the following six criteria: (1) population; (2) median transport times; (3) community support; (4) severely injured patients not treated in trauma centers; (5) Level 1 trauma centers; and (6) number of severely injured patients (in each TSA). Ms. Tschetter added the last two criteria (Level I Trauma Centers and Number of Severely Injured Patients) in response to comments received at the negotiated rulemaking session. Subsequent to a final public hearing held on February 25, 2014, DOH revised its January TSA Assessment and the earlier version of the Proposed Rule. The revised TSA assessment (the “March TSA Assessment”) reflected more conservative calculations (as gleaned from input and discussions with stakeholders) and documents the statutory patient volumes for the existing Level I and Level II trauma centers in each TSA. The March TSA Assessment further recalculated the Median Transport times, including all transports from 0-10 minutes (as opposed to only those transports greater than 10 minutes) and only transports to trauma centers (as opposed to transports to all hospitals). On March 25, 2014, a Notice of Change was published in the Florida Administrative Register. The Proposed Rule, as published on that date, is as follows: Notice of Change/Withdrawal DEPARTMENT OF HEALTH Division of Emergency Medical Operations RULE NO.: RULE TITLE: 64J-2.010 Apportionment of Trauma Centers within a Trauma Service Area (TSA) NOTICE OF CHANGE Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 40, No. 22, February 3, 2014 issue of the Florida Administrative Register. 64J-2.010 Allocation of Trauma Centers Aamong the Trauma Service Areas (TSAs). Level I and Level II trauma centers shall be allocated among the trauma service areas (TSAs) based upon the following: The following criteria shall be used to determine a total score for each TSA. Points shall be determined based upon data in the Trauma Service Area Assessment. Population A total population of less than 0 to 600,000 receives 2 points. A total population of 600,001 to 1,200,000 receives 4 points. A total population of 1,200,001 to 1,800,000 1,700,000 receives 6 points. d. A total population of 1,800,000 1,700,001 to 2,400,000 2,300,000 receives 8 points. e. A total population greater than 2,400,000 2,300,000 receives 10 points. Median Transport Times Median transport time of less than 0 to 10 minutes receives 0 points. Median transport time of 101 to 20 minutes receives 1 point. Median transport time of 21 to 30 minutes receives 2 points. Median transport time of 31 to 40 minutes receives 3 points. Median transport time of greater than 41 minutes receives 4 points. Community Support Letters of support for an additional trauma center from 250 to 50 percent of the city and county commissions located within the TSA receive 1 point. Letters of support must be received by the Department on or before April 1 annually. Letters of support for an additional trauma center from more than 50 percent of the city or county commissions located within the TSA receive 2 points. Letters of support must be received by the Department on or before April 1 annually. Severely Iinjured Patients Discharged from Acute Care Hospitals Not Treated In Trauma Centers Discharge of 0 to 200 patients with an International Classification Injury Severity Score (“ICISS”) score of less than 0.85 (“severely injured patients”) from hospitals other than trauma centers receives 0 points. Discharge of 201 to 400 severely injured patients from hospitals other than trauma centers receives 1 point. Discharge of 401 to 600 severely injured patients from hospitals other than trauma centers receives 2 points. Discharge of 601 to 800 severely injured patients from hospitals other than trauma centers receives 3 points. Discharge of more than 800 severely injured patients from hospitals other than trauma centers receives 4 points. Level I Trauma Centers The existence of a verified Level I trauma center receives one negative point. The existence of two verified Level I trauma centers receives two negative points. The existence of three verified Level I trauma centers receives three negative points. Number of Severely Injured Patients If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives 2 points. If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives 1 point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives one negative point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives two negative points. 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. An assessment and scoring shall be conducted by the Department annually on or before August 30th, beginning August 30, 2015. The number of trauma centers allocated for each TSA based upon the Amended Trauma Service Area Assessment, dated March 24, 2014 January 31, 2014, which can be found at www.FLHealth.gov/licensing- and-regulation/trauma-system/_documents/trauma-area-service- assessment.pdf, is as follows: TSA Counties Trauma Centers 1 Escambia, Okaloosa, Santa Rosa, Walton 1 2 Bay, Gulf, Holmes, Washington 1 3 Calhoun, Franklin, Gadsden, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, Wakulla 1 4 Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, Union 1 5 Baker, Clay, Duval, Nassau, St. Johns 12 6 Citrus, Hernando, Marion 2 7 Flagler, Volusia 1 8 Lake, Orange, Osceola, Seminole, Sumter 3 9 Pasco, Pinellas 23 10 Hillsborough 1 11 Hardee, Highlands, Polk 1 12 Brevard, Indian River 1 13 DeSoto, Manatee, Sarasota 2 14 Martin, Okeechobee, St. Lucie 1 15 Charlotte, Glades, Hendry, Lee 12 16 Palm Beach 1 17 Collier 1 18 Broward 2 19 Dade, Monroe 3 Rulemaking Authority 395.402, 395.405 FS. Law Implemented 395.402 FS. History–New 12-10-92, Formerly 10D-66.1075, Amended 6-9-05, 12-18- 06,Formerly 64E-2.022, Amended . DOH did not incorporate the March TSA Assessment by reference in the rule. After exchanges of communications with the Joint Administrative Procedures Committee (“JAPC”), wherein DOH sought guidance concerning this matter, there was no directive by JAPC that such adoption by reference would be required. DOH revised the population criterion in the Proposed Rule to have even breaks in intervals of 600,000 people. The February proposed rule awarded 6 points in TSAs with a population of 1,200,001 to 1,700,000 people (i.e., a 500,000 person interval), where all other measures were based upon a 600,000 person interval. This discrepancy is corrected in the newly Proposed Rule. DOH revised the community support criterion in the Proposed Rule to no longer award a point to TSAs where 0-50% of the city and county commissions send letters of support, because this could have reflected the need for a trauma center (by awarding points to the TSA) when no letters of support were received. The Proposed Rule now awards a point to TSAs where 25-50% of the county commissions send letters of support. DOH chose twenty-five percent as the minimum necessary community support because the smallest number of city and county commissions in all of the TSAs is four, which ensures everyone has a voice. DOH revised the title of the fourth criterion from “severely injured patients not treated in trauma centers” to “severely injured patients discharged from acute care hospitals,” which more accurately depicts the function of the criterion. DOH revised the sixth criterion to include citations to the statutory minimum volumes for Level I and Level II trauma centers in response to a request by the staff attorney for the Joint Administrative Procedures Committee. DOH also revised the rule to reference the March TSA Assessment in place of the January TSA Assessment. Finally, DOH revised the Proposed Rule’s allocation table based on the revisions to the rule and assessment. The Proposed Rule as amended allocates a total of 27 trauma centers throughout Florida’s 19 TSAs. Each TSA is still allocated at least one trauma center. The Proposed Rule allocates only Level I and Level II trauma centers, not pediatric trauma centers. The rulemaking directive in section 395.402(4) is interpreted by DOH to be limited to the allocation of Level I and Level II trauma centers. In addition, the allocation of stand-alone pediatric centers would not be feasible because pediatric trauma patients make up such a small percentage of the population and all of the Level I and II trauma centers have the ability to become pediatric trauma centers. Currently, all of the existing Level I trauma centers provide pediatric care and there are only two stand-alone pediatric centers in Florida. The Proposed Rule’s allocation of 27 trauma centers is conservative. There are currently 27 verified trauma centers in the state, including two verified trauma centers under administrative challenge. There are several elements of the Proposed Rule which Petitioners have raised as evidence of the Department’s failure to comply with its rulemaking authority. Petitioners maintain that DOH failed to consider all of the items enumerated in section 395.402(3)(a)-(k). Each of those criteria is addressed below. (a) The recommendations made as part of the regional trauma system plans submitted by regional trauma agencies-- There is only one regional trauma agency in Florida. DOH reviewed the regional agency’s plan, but it was devoid of any recommendations related to trauma center allocation within the TSAs. The regional agency did not amend its plan or submit any separate recommendations throughout the year-long, public rulemaking process. (b) Stakeholder recommendations--Petitioners complain that DOH did not do enough to solicit input from everyone who would be affected by the Proposed Rule. The Department, however, obtained stakeholder testimony from 171 individuals and written comments from 166 stakeholders through the course of the 12 rule development workshops conducted around the state. The workshops were held in several cities to allow for geographic access by more residents. Over 400 people attended the workshops. The January TSA Assessment was also modified prior to its publication as a result of the stakeholder discussions at the workshops and the negotiated rulemaking session. The March TSA Assessment was further amended after its publication as a result of testimony at the public hearing for the Proposed Rule. (c) The geographical composition of an area to ensure rapid access to trauma care by patients--While Florida contains no mountains, its geography is unique to other states in that it contains several inlets, bays, jetties, and swamplands. As such, the DOH data unit examined the coastal areas versus non- coastal areas. The unit also analyzed urban versus rural areas. The unit also looked at the communities surrounding Lake Okeechobee. Ultimately, the analysis was not meaningful because the effect geography has on access to trauma centers is captured by Florida’s transport time records for emergency vehicles and helicopters. Thus, by reviewing the Emergency Medical Services Tracking and Reporting System (“EMSTARS”) database, DOH could know the actual effects of Florida’s geography on access to trauma centers. (d) Historical patterns of patient referral and transfer--This item was considered, but the January TSA Assessment does not address it because it was neither measurable nor meaningful. The data was not measurable because of limitations of data quality in the Trauma Registry. Even if the data were measureable it would not have been meaningful because it would have only illustrated the catchment areas--i.e., the geographic distribution of patients served by existing trauma centers. As recommended by the ACS, DOH’s primary focus is on the trauma system as a whole, not individual trauma centers. Moreover, transfer and referral history is not meaningful to an assessment designed to inform an allocation rule because, again, DOH does not have the authority to define where new trauma centers are developed within a TSA. See § 402.395(4)(b), Fla. Stat. (charging DOH with allocating by rule the number of trauma centers in each TSA, not trauma center location within a trauma service area). (e) Inventories of available trauma care resources, including professional medical staff--Petitioners suggest that DOH should have made a determination of existing professional medical staff, but suggest no viable means of doing so. The January TSA Assessment catalogues several trauma care resources within TSAs, including financing, trauma centers, acute care hospitals, and EMS response capabilities. The January TSA Assessment does not catalogue available professional medical staff. DOH is unaware of any database that compiles this information. DOH sent a survey to the existing trauma centers requesting information as to their resources and professional staff, however it was not useful due to the limited responses and potential for bias. The data unit also reviewed the DOH Division of Medical Quality Assurance health professional licensure database (COMPASS), however, it was not helpful because physician specialty reporting is voluntary. Similarly, the data unit reviewed AHCA’s inventory of licensed acute care hospitals and the DOH annual physician workforce survey results, but neither data source provided trauma-specific information. As such, the information was not complete and so was not included in the January TSA Assessment. (f) Population growth characteristics--In response to this criterion, the DOH data unit analyzed the potential for growth in all of the TSAs, but the January TSA Assessment did not include this analysis because it was not meaningful given DOH’s requirement to conduct the assessment annually. The January TSA Assessment does however document the population in each TSA. DOH decided that in light of the continuing change of population in Florida, the best it could do would be to make a finding as to the population in each TSA and use it--year by year--to look at the potential need for additional (or presumably fewer) trauma centers in an area. Obviously the population of an area is not directly commensurate with the number of severely injured patients that might be found. Not all areas have equal percentages of severely injured patients; urban areas would have higher percentages than rural areas, in general. Areas through which a major interstate highway runs would expect a higher percentage. There are a number of factors that could potentially affect an area’s expectation of trauma services. Inasmuch as they could not all possibly be included in an analysis, DOH defaulted to a more general view, i.e., the total population. The total population figure became the first measurement in the Proposed Rule. (g) Transportation capabilities; and (h) Medically appropriate ground and air travel times--DOH considered these two factors together and determined to cover them by way of a determination of median transport time, which was to become the second measurement in the Proposed Rule. The data unit gathered transport capability data by reviewing the COMPASS licensure database and archived paper applications to discern the number of licensed emergency medical stations, helicopters, and vehicles in each TSA. The data unit further calculated the number of ground vehicles per the population in each TSA and every 100 square miles. The January TSA Assessment included this information because it was meaningful and gathered from a reliable database. DOH considered the testimony from a number of trauma surgeons during the 12 workshops regarding transport times and learned that the medically appropriate transport time depends on the nature of injuries and individual patients, which are not always discernable at the scene of an accident. Because of this, the sooner a patient can be transported to a trauma center, the better it is for patient outcomes. In light of the patient-specific realities of establishing a medically appropriate transport time, the data team used EMSTARS to calculate the median emergency transport times in each TSA for the assessment. Granted the EMSTARS is a fairly new system under development, and it reports all 911 calls voluntarily reported (not just trauma patients), so it is not a completely accurate measure. But it is a reasonable approach based upon what is available. Also, the transport times do not reflect whether pre-hospital resources are sufficient for the patient or how far away the closest trauma center may be. It is not an absolutely perfect measurement, but it is reasonable and based on logic. (i) Recommendations of the Regional Domestic Security Task Force--Like Florida’s lone regional trauma agency, the RDSTF did not offer any input throughout the year-long, public rulemaking process. However, DOH considered the testimony of numerous emergency management and law enforcement officials during the rule development process. For example, Chief Loren Mock, the Clay County fire chief and also a member of the Domestic Security Oversight Council, testified at the Jacksonville workshop. There is no evidence DOH directly contacted a RDSTF representative to solicit input. (j) The actual number of trauma victims currently being served by each trauma center--The March TSA Assessment included the annual trauma patient volume reported to the Trauma Registry by the existing trauma centers. When comparing the average patient volume reported to trauma registry from 2010- 2012 to the data unit’s calculation of the average number of severely injured patients treated in trauma centers during this same time span, the volumes reported by the trauma centers were approximately 333% greater. This large disparity prompted DOH to follow the example of many other states and use population as a proxy for the number of potential trauma patients in each TSA in its Proposed Rule. DOH found that: greater population means a greater need for health care; population is a good indicator of need for medical services; population is a reasonable proxy for patient volume; and, more people in a given area results in more trauma cases in a given area. (k) Other appropriate criteria: It was well documented in literature presented to DOH during the rulemaking process that there were a large percentage of severely injured patients in Florida not being seen by trauma centers. The data unit confirmed this by evaluating the AHCA administrative database, which identifies the injuries suffered by patients as well as the type of hospitals discharging those patients, i.e., comparing the total number of severely injured patients with the number of severely injured patients discharged from acute care hospitals in each TSA. This disparity was worrisome to DOH and therefore included in the March TSA Assessment. As pointed out by Petitioners, the Department’s figures include patients who may have received treatment outside the TSA in which the injury occurred. The figures may not have contained patients who needed trauma care but could not access it for other reasons. The Proposed Rule, however, makes as complete an evaluation of the potential patient base for trauma centers as is possible. Notwithstanding complaints about how the Department addressed some of the criteria set forth in the statute, it is clear that all criteria were considered and implemented into the Proposed Rule to the extent feasible and possible. The most credible testimony at final hearing supports the Department’s process. Criticisms of the various elements within the Proposed Rule expressed by Petitioners at final hearing seemed to be based on the concept that the Proposed Rule may allow competition to existing trauma centers rather than real complaints about the elements themselves. All agree, for example, that population, transportation times, number of patients, and the existence of nearby trauma centers are important factors that should be considered. Petitioners just seemed to want those factors expressed in different (though unspecified) terms. Petitioners did enunciate certain shortcomings they felt made the Proposed Rule less than complete. St. Joseph lamented the absence of all the Department’s analysis and background for each of the proposed measurements contained in the Proposed Rule. Jackson Memorial pointed out that pediatric trauma centers were not specifically included in the Proposed Rule. Shands showed that odd or unusual results could arise from implementation of the Proposed Rule. For example, the March TSA Assessment showed a total of 216 severely injured patients in TSA 6, comprised of Marion, Citrus, and Hernando counties. The Proposed Rule called for two trauma centers in that TSA. Although the number of patients necessary to maintain a trauma center’s proficiency was disputed by various experts in the field, it is clear that 108 patients per center would be extremely low. However, the figure appearing in the March Assessment is not absolute or necessarily completely definitive of need. There are other factors concerning population and patients that may affect that figure. The Six Measurement Criteria in the Proposed Rule Petitioners also took exception to the measurement criteria in the Proposed Rule. Each of those six criterion is discussed below. Population The Proposed Rule awards from two to ten points to a TSA, depending on the TSA total population. Two points are awarded for a population of less than 600,000 and ten points are awarded for a popu1ation greater than 2.4 million. The Department used total population as a "proxy" for the actual number of trauma patients in the state rather than using the actual number of trauma victims in the state. The Proposed Rule does not define “population” or “Total Population,” nor are those terms defined in the trauma statute, but those words are subject to their normal definition. The Proposed Rule does not re-state the source of the summary Total Population data; it is already contained in the TSA Assessment. Neither the Proposed Rule nor the March TSA Assessment contains any data or analysis reflecting population by age cohort, population density, or incidence of trauma injury in relation to these factors, and the Department did not specifically conduct any analysis of the significance of any aspect of population data as it relates to the need for new trauma centers, other than determining the total population growth rate in the TSAs. Rather, DOH decided upon total population as the most reliable measure available. Traumatic injury rates and the severity of traumatic injury vary widely based on a number of factors, including whether the area is urban or rural, the population age cohort, and the infrastructure and physical characteristics or features of the geographic area. Thus, the most reasonable way to measure possible need was to look at the total population of an area and extrapolate from that basis. The Department presented no specific data or analysis to support the incremental cutoff points for the Total Population scale contained in the Proposed Rule. Rather, the Department took population as a whole because it was the most readily available, annually updateable, and understandable factor it could access. The use of population as a proxy is not without problems, however. In TSA 19, for instance, the population has increased by about thirty-eight percent in recent decades, but the number of trauma victims has declined by approximately twelve percent. As stated, the Proposed Rule as written is not inerrant. Median Transport Times The Proposed Rule awards from zero to four points to a TSA, depending on the Median Transport Time within a TSA. “Median Transport Time” is not defined in the Proposed Rule, nor is the methodology for determining the summary “Median Transport Time” statistics set forth in the TSA Assessment and relied on in the Proposed Rule. Information concerning transport times is, however, contained within the TSA Assessment. The Median Transport Time used in the Proposed Rule represents the average transport time for all 911 transports voluntarily reported to the state EMSTARS database. EMSTARS is a database that is under development and that collects information voluntarily provided by emergency medical transport providers throughout the state. Although not all EMS providers currently report to EMSTARS (most notably, Miami-Dade County EMS does not participate), the database is useful for research and quality improvement initiatives. The Median Transport Time set forth in the March TSA Assessment and used in the Proposed Rule includes transport time for all patients, regardless of the nature of the emergency, whether the call involved trauma, other types of injury, or illness, and regardless of whether the transport was conducted with the regular flow of traffic or required “lights and siren.” The Median Transport Time used in the Proposed Rule includes all EMS transports of up to two hours in duration. The Median Transport Time excludes transports of patients to trauma centers operating pursuant to the initial stage of trauma center licensure known as “provisional approval.” The Department addressed “medically appropriate air or ground transport times,” as required by section 395.402(3)(h), by its generally accepted conclusion that "faster is better." Not all injured patients, however, benefit from receiving care at a trauma center. Thus, while an existing trauma center is an appropriate destination for all patients with any level of injury who live in the area of a trauma center, the trauma center’s value beyond its immediate area is as a resource for the most severely injured patients whose problems exceed the capabilities of their nearest hospital. The Department did not undertake any analysis to balance its "faster is better" approach to trauma planning against the reality that the resources necessary to provide high quality trauma care are limited, as is the number of severely injured patients. There is a general (but not universal) consensus among trauma experts that access to a trauma center within 30-50 minutes is an appropriate benchmark for access to trauma care. Other than "faster is better," the Department did not determine a medically appropriate travel time for any type of trauma or any geographic area, but recognizes the general consensus as appropriate. The Proposed Rule awards from one to four points that weigh in favor of approval of a new trauma center within a TSA if the Median Transport Time of patients transported in response to any 911 call is between 10 and 42 minutes, i.e., within but faster than the generally accepted consensus. Community Support The Proposed Rule awards from one to two points to each TSA depending on the number of letters of support written by elected city or county commissioners. The Proposed Rule allows for consideration of stakeholder recommendations by way of allowing letters of support from local governments. “Stakeholders” in the state trauma system include existing trauma centers, as well as all acute care hospitals, and pre- and post-hospital care providers, including emergency transport services, air ambulances, and emergency management planning agencies. The Department could find no better way to acknowledge support from those stakeholders, and citizens in general, than to have their elected representatives listen to their constituents and then reflect those people’s desires and comments. Severely Injured Patients Discharged from Acute Care Hospitals The Proposed Rule awards from zero to four points to a TSA, depending on the number of severely injured patients discharged from acute care hospitals (non-trauma centers). The Proposed Rule addresses the number of severely injured patients, i.e., those with an ICISS score of < 0.85, discharged from hospitals other than trauma centers. The Proposed Rule does not specifically define “severely injured patient,” but it is obvious from the context in which that term is used. The summary data in the TSA Assessment labeled "number of severely injured patients” within each TSA is intended to reflect the number of severely injured patients who “didn’t get to trauma care.” The Department's numbers may include patients who received treatment at a trauma center outside of the TSA in which the injury occurred. The Department did not conduct any analysis of the "number of severely injured patients not treated at a trauma center" to determine whether the patients not treated at a trauma center received timely and appropriate care at a non-trauma center hospital with the capability to treat the patient's injuries. The number of “severely injured patients who did not get to trauma care” as reported by the Department is unlikely to reflect the actual number of patients who required care at a trauma center but did not have access, and suggests that this number is far higher than it actually is. The Department, for example (and in response to discussion with stakeholders), excluded from its analysis all patients with isolated hip fractures as well as all patients who were released from the hospital within 24 hours, which resulted in fewer severely injured patients. Neither the Proposed Rule nor the TSA Assessment considers demographics or outcomes for "severely injured patients" treated at general acute care hospitals or outcome data for these patients. The Proposed Rule does not include any method for projecting the actual demand for trauma services in the future; it is used to determine need at a single point in time (and will be done so annually). The Proposed Rule does not include any criteria or method for evaluating whether there are any capacity problems at existing trauma centers, or other barriers that impede access to trauma care. The Department intended this criterion to show a highly conservative estimate of patients who definitely need trauma care. Level I Trauma Centers With respect to “Level I Trauma Centers,” the Proposed Rule awards from negative one to negative three points to a TSA, depending on whether the TSA already has one, two, or three verified Level I trauma center(s), respectively. The Proposed Rule creates the opportunity for establishment of both additional Level I and also additional Level II trauma centers, pursuant to the allocation of need, but the Proposed Rule does not assign or subtract points for the existence of Level II trauma centers. This criterion reflects the recommendations of stakeholders at the rule workshops. It was the consensus of many stakeholders that Level I trauma centers should be protected in order to safeguard the research and teaching missions of those centers. The earlier proposal of a “halo” around existing centers, i.e., not approving a new trauma center within a certain radius of existing centers, was not incorporated into the Proposed Rule. This criterion, however, offers some protection for existing centers. Number of Severely Injured Patients The Proposed Rule awards negative two to two points based on the "number of severely injured patients" in a TSA. The criterion awards points based on the number of Severely Injured Patients which exceed the target trauma center patient volumes as provided in section 395.402(1). If the annual number of Severely Injured Patients exceeds the statutory volumes by more than 500 patients, the TSA will receive two points; if it exceeds it by less than 500 the TSA receives one point; if the number of Severely Injured Patients is less than the statutory volumes by zero to 500 patients, the TSA receives one negative point; if it is less than the volumes by more than 500 patients, the TSA receives two negative points. The Proposed Rule does not include any criterion addressing the actual number of trauma victims currently being served by each trauma center. Instead, Section 6 of the Proposed Rule substitutes the "minimum statutory capacity" of existing trauma centers for the actual capacity of existing trauma centers. The Department could not find “a meaningful” way to measure actual capacity of existing trauma centers. The most accurate way to measure capacity was a contentious topic at rule workshops, and the Department spent a good deal of time working with stakeholders on how to measure capacity in such a way that it could be included as a factor in the Proposed Rule. One suggestion as to how to measure trauma center capacity is by how often existing trauma centers actually divert trauma patients to other facilities. However, trauma centers rarely admit that they are not able to take any more patients, and this is not a realistic method to evaluate capacity. The capacity of an existing trauma center may be measured by various means, including the number of beds at the trauma center, the number of ICU beds, the number of trauma bays, number of operating rooms, as well as the frequency of and reasons for diversion. The trauma center’s clinical staff, including medical and surgical specialists, and supporting clinical personnel, are also indicators of capacity. The Department already routinely collects data reflecting trauma center capacity as part of the quarterly and annual reports that all existing trauma centers are required to submit, and by way of on-site licensure surveys. None of those means, however, provided DOH with sufficiently reliable information and data. The Proposed Rule comports with the DOH Mission to protect, promote, and improve the health of all Floridians through integrated state, county, and community efforts. While by no means perfect, the Proposed Rule is based upon logic and reason derived from an extensive analysis of all relevant factors. History of the Rule The rationale for DOH’s inclusion of those particular six criteria in the Proposed Rule can be better understood by considering some more history of the trauma rule. As stated earlier herein, in 2004 the Legislature made substantial revisions to the trauma statute and ordered the Department to complete an assessment of Florida’s trauma system. 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 proposal 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 ended the statutory mandate to use the service areas created in 1990. The obvious conclusion from the above statutory change is that the section 395.402(4) service areas could be replaced by the service areas DOH established or adopted once it had the results of the 2005 Assessment. Unlike the prior statute, there is no mandate for specific new service areas, only the option not to use the prior service areas. The 2005 Assessment included five "Recommendations": Trauma centers should be placed in Tallahassee and in Bay County, which do not currently have a trauma center . . . . It is reasonable to set, as a system goal, that 65 percent of trauma center patients will be treated at a trauma center. . . . Designation of additional trauma centers should be based on the need as determined by trauma region. Deployment of additional trauma centers should take place based, not only on the number of patients served per trauma center, but according to the concept of “trauma center capacity” which should be determined by the staffing levels of medical specialists and other healthcare professionals. . . . The data support the feasibility of transforming the Florida Trauma Services Areas so that these would coincide with the Domestic Security Task Force Regions. . . . It is reasonable to fund trauma centers with public funds, based on the unrecoverable financial burden incurred by trauma centers. The only legislative response to the 2005 Assessment was an increase in funding to trauma centers. The Legislature did not repeal the statute establishing the current 19 TSAs. Likewise, the Department has not amended the Rule to implement the recommendations contained in the 2005 Assessment until the present Proposed Rule. The Department, instead, reviewed existing statutes, interpreted section 395.4015 to mandate the establishment of a trauma system plan (which plan would include trauma regions that have boundaries coterminous with those of the regional domestic security task force boundaries). The development of the trauma system plan is distinct from the determination of need for new trauma systems addressed by the Proposed Rule.
The Issue The issue for determination in this proceeding is whether Respondent is entitled to a refund of $285,648.26 paid for Medicaid services that Petitioner provided during the respective hospitalizations of four psychiatric patients.
Findings Of Fact Petitioner operates two hospitals in the name of Florida Hospital. Each hospital is separately located. Both hospitals participate in the Florida Medicaid program in accordance with Chapter 409, Florida Statutes, 1/ and Florida Administrative Code Rule 59G. 2/ Respondent is the state agency responsible for administering the Florida Medicaid program. In order for the state to receive federal funds, federal statutes and regulations mandate that Respondent control the utilization of services subject to Medicaid payments. 3/ Respondent contracts with a professional review organization to control the utilization of psychiatric services subject to Medicaid payments. 4/ Keystone Peer Review Organization ("KEPRO") retrospectively reviews admissions and lengths of stay for psychiatric patients to determine whether alternative sources of payment exist and whether Medicaid services are medically necessary. Respondent claims that alternative sources of payment existed for two of the four Medicaid recipients at issue in this proceeding. Respondent also claims that the inpatient services Petitioner provided to all four recipients were medically unnecessary. 5/ Alternative Sources Of Payment 5. Medicaid is the payor of last resort. 6/ Irrespective of whether the services provided by Petitioner were medically necessary, Respondent is entitled to a refund if other sources of payment existed for those services. Alternative sources of payment are primary and prior to Medicaid payments ("alternative source(s) of payment"). Medically Necessary Respondent claims that the inpatient services Petitioner provided to all four recipients were medically unnecessary. The terms "medically necessary" or "medical necessity" are not defined by applicable state and federal law. 7/ Medical necessity is determined by applying a two-prong test to the facts and circumstances surrounding each case. 8/ The first prong requires inpatient services during admission and treatment of Medicaid recipients to be consistent with appropriate medical care. 9/ The second prong of the test requires alternative placements to be considered in prescribing inpatient services. 10/ First Prong: Appropriate Medical Care Services that alleviate a harmful medical condition are consistent with appropriate medical care. Services alleviate a harmful medical condition if they are reasonably calculated to prevent, diagnose, correct, cure, alleviate, or prevent the worsening of conditions in the recipient that endanger life, cause suffering or pain, result in illness or infirmity, threaten to cause or aggravate a handicap, or cause physical deformity or malfunction. 11/ Services are consistent with appropriate medical care if they are provided to protect the patient's life, prevent significant illness or disability, or to alleviate severe pain. Services must be consistent with individualized treatment. They must be specific and consistent with symptoms or a confirmed diagnosis of the illness or injury under treatment. 12/ Services are consistent with appropriate medical care if they do not exceed the patient's individual needs. Services may not be primarily intended for the convenience of the recipient or the provider. 13/ KEPRO considers the intensity of service, the severity of illness, and discharge screens in determining medical necessity ("ISD criteria"). 14/ ISD criteria are subdivided into approximately 14 subgroups. ISD criteria represent a list of signs and symptoms and diagnostic and therapeutic services. They are general guidelines for determining the medical necessity of inpatient services. ISD criteria are not dispositive of medical necessity. ISD criteria are not binding on the treating physician. 15/ The treating physician can override ISD criteria based on his or her clinical judgment concerning a particular Medicaid recipient. 16/ The clinical judgment to override ISD criteria must be consistent with appropriate medical care. 17/ The four Medicaid recipients did not improve significantly within the time prescribed by ISD criteria. A patient that fails to make significant improvement in a timely manner does not satisfy ISD criteria for continued inpatient services. 2.1(a) Matters Not At Issue Respondent does not challenge the admission of the four Medicaid recipients. 18/ Their admission to Florida Hospital satisfied applicable ISD criteria and was consistent with appropriate medical care. Respondent does not claim that inpatient services provided before the date each Medicaid recipient failed to satisfy ISD criteria for continued inpatient services were medically unnecessary ("initial treatment"). Initial treatment satisfied applicable ISD criteria and was consistent with appropriate medical care. 2.1(b) Matters At Issue Respondent acknowledges that inpatient services provided after initial treatment of the four Medicaid recipients were consistent with appropriate medical care. 19/ When asked if Respondent challenged the level of services, the quality of care, or the appropriateness of care, Respondent stated: Oh, absolutely [not]. We're not saying that the care was either substandard or . . . rank overutilization . . . . We're not saying there was substandard care or [that] they . . . [tried] . . . to . . . game the system. We certainly don't believe that. Transcript at 172-173. 20/ Respondent claims that inpatient services were medically unnecessary after initial treatment because the recipients no longer satisfied ISD criteria for continued inpatient services. Second Prong: Alternative Placement The second prong of the medical necessity test provides that inpatient services are medically unnecessary if, consistent with appropriate medical care, they could have been effectively furnished more economically either on an outpatient basis or in an inpatient facility of a different type. 21/ Thus, discharge to outpatient care or to an inpatient facility of a different type ("alternative") must be made in a manner that is consistent with appropriate medical care. 22/ In addition, an alternative must be available and suitable for the needs of the individual patient. 23/ An alternative placement exists if several conjunctive requirements are satisfied. An alternative placement exists if inpatient services could have been: effectively furnished; more economically; in an available and suitable alternative; in a manner that is suitable for the needs of the individual patient and consistent with appropriate medical care ("alternative placement"). 24/ The parties agree on two requirements of the alternative placement test. Inpatient services provided by Petitioner could have been provided more economically in an alternative setting. The parties also agree that relevant alternatives were facilities of a different type than Florida Hospital. The parties contest the remaining requirements of the alternative placement test. The contested issues are whether, prior to the respective dates of discharge, the inpatient services provided by Petitioner could have been: effectively furnished; in an available and suitable alternative; in a manner that was suitable for the needs of the individual patient; and in a manner consistent with appropriate medical care. 2.2(a) Matters Not At Issue An alternative placement did not exist when Petitioner admitted the four Medicaid recipients to Florida Hospital. Respondent does not challenge Petitioner's admission of the four recipients. Petitioner used appropriate procedures and due diligence to determine if an alternative placement existed for each of the four Medicaid recipients. 25/ Respondent does not challenge the procedures and diligence used to determine whether an alternative placement existed. 26/ An alternative placement did not exist for the four Medicaid recipients during their initial treatment. Respondent does not challenge the inpatient services provided by Petitioner while the recipients satisfied ISD criteria. 27/ 2.2(b) Matters At Issue As a threshold matter, Respondent asserts that it is not required to consider an alternative placement in determining medical necessity. Respondent argues that it can determine medical necessity solely by applying ISD criteria. Even if Respondent is required to consider an alternative placement, Respondent claims that it is not required to consider the availability or suitability of an alternative. If Respondent is required to consider availability and suitability, Respondent claims that a suitable alternative was available for all four Medicaid recipients on the respective dates that the recipients no longer satisfied ISD criteria. 28/ 2.2(c) A Difficult And Litigious Task The medical determination of the existence of an alternative placement is a difficult task and a risky one for physicians and hospitals in today's litigious society. 29/ It may be suitable for the patient's needs and consistent with appropriate medical care to discharge the patient to an alternative facility. However, an alternative may be unavailable when a patient no longer satisfies ISD criteria. Unavailability of suitable alternatives may be caused by a variety of factors. There may be a shortage of existing facilities. Existing facilities with available space may lack funding to accept new residents. Existing facilities may have the necessary funding but lack available space. Outpatient case loads may be so great that the delay between discharge and the delivery of outpatient services may effectively deny any timely and meaningful availability of outpatient care. In such cases, it may not be suitable for the patient's needs or consistent with appropriate medical care to discharge the patient without an available alternative. When a patient no longer satisfies ISD criteria, alternatives may be available, but available alternatives may not be suitable for the patient's individual needs. The services furnished by an available alternative may not be suitable for the needs of the patient. Conversely, an available alternative may offer suitable services but may not be capable of furnishing those services effectively. It may not be consistent with appropriate medical care to discharge the patient to an available alternative that is either unsuitable or ineffective; or to discharge the patient without an alternative. Even if an alternative is available, suitable, and effective, the condition of the patient may need to improve or stabilize before discharge to an alternative is suitable for the individual needs of the patient and consistent with appropriate medical care. Earlier discharge of such a patient may be inconsistent with appropriate medical care. A provider must determine whether to continue to furnish services during the interim required until the patient can be discharged to an alternative placement or can be discharged with no alternative placement ("interim services"). Interim services are medically necessary if prior discharge of a patient would either violate ISD criteria or be inconsistent with appropriate medical care. 30/ The Four Medicaid Recipients The identity of the patients for which Respondent seeks a refund, the dates of their hospitalization, the contested dates, and the amount of contested payments are set forth in the following table. Patient Dates Of Hosp. Contested Dates Contested Amount J.H. 08/24/92-10/29/92 09/25/92-10/29/92 $ 24,953.96 N.S. 10/18/89-06/14/91 11/18/89-06/14/91 $232,831.16 A.B. 10/04/91-11/04/91 10/12/91-11/04/91 $ 15,808.36 B.W. 05/10/91-06/10/91 05/23/91-06/10/91 $ 12,054.78 TOTAL $285,648.26 Respondent claims that it is entitled to a refund of $257,785.12 because alternative sources of payment existed for the inpatient services provided to J.H. and N.S. after their initial treatment. Respondent does not allege that alternative sources of payment existed for J.H. and N.S. upon admission or during their initial treatment. Respondent does not claim that alternative sources of treatment existed for A.B. and B.W. at any time during their hospitalization. Respondent claims that it is entitled to a refund of $285,648.26 because the inpatient services Petitioner provided to all four recipients was medically unnecessary after their initial treatment. After their initial treatment, none of the four recipients satisfied ISD criteria for continued inpatient services. If Respondent is required to consider alternative placements in determining medical necessity, Respondent alleges that inpatient services Petitioner provided to J.H. and N.S. after their initial treatment could have been furnished more economically in an inpatient facility of a different type. Respondent asserts that inpatient services Petitioner provided to A.B. and B.W. after their initial treatment could have been furnished more economically on an outpatient basis. J.H. J.H. was admitted to Florida Hospital's acute care unit on August 24, 1992. On October 29, 1992, Petitioner transferred J.H. to Daniel Memorial Residential Treatment Center in Jacksonville, Florida. Respondent does not seek a refund of Medicaid payments from August 24, 1992, through September 24, 1992. Respondent seeks a refund of payments made from September 25 through October 29, 1992. Alternative Source Of Payment No alternative source of payment existed for the inpatient services Petitioner provided to J.H. J.H. was involuntarily committed to the hospital on August 31, 1992, pursuant to the Baker Act. 31/ Respondent does not allege that the Baker act provided an alternative source of payment prior to September 25, 1992. 32/ Respondent failed to show why the Baker Act did not provide an alternative source of payment prior to September 25, 1992, but did provide an alternative source of payment on September 25, 1992, and thereafter. 33/ Medical Necessity Once J.H. was admitted to Florida Hospital on August 24, 1992, he did not make significant improvement after 30 days. He did not meet ISD criteria for continued inpatient services. 4.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician for J.H. Inpatient services Petitioner provided to J.H. after his initial treatment were consistent with appropriate medical care. Although J.H. did not make significant improvement within the time prescribed by ISD criteria, he did make significant improvement during his stay at Florida Hospital. He was successfully treated and timely discharged in a manner that was suitable for his individual needs and consistent with appropriate medical care. 4.2(a)(1) Mental Impairment J.H. was 15 years old when he was admitted to Florida Hospital on August 24, 1992. He had chronic schizophrenia, with borderline intellectual capabilities ("mental retardation"), and a well-documented explosive disorder. 4.2(a)(2) Emotional Impairment J.H. had attention deficit disorder ("ADD"). He could not process information. He had difficulty sitting still and focusing. J.H. had previously been treated in a residential placement setting. He set fires and abused animals. J.H. attempted to choke a dog and had to be restrained. He broke windows and committed acts of mischief. J.H. picked up other children by their neck and ears. He jumped up and down on their toes and punched them in the face. He struck staff and used razor blades to attack authority figures. 4.2(a)(3) Medication The combination of ADD, mental retardation, and schizophrenia made appropriate medical care for J.H. difficult and slow. Medicines used to control the ADD often make schizophrenia more fluid. J.H. had been treated successfully with medications in the past. However, J.H. was noncompliant with medication. More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for J.H. in this instance. When the right combination was determined, additional time was needed to stabilize the multiple medications. 4.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for J.H. after his initial treatment. Petitioner identified an available alternative for J.H. on August 28, 1992. However, no alternative placement existed for J.H. prior to the date he was stabilized and discharged by Petitioner. Discharge before J.H. was stabilized would have been neither suitable for the needs of the individual patient nor consistent with appropriate medical care. Before J.H. was stabilized, he was a danger to himself and others. J.H. was a danger to himself and others when he resided in an alternative facility prior to his admission to Florida Hospital. The services that were medically necessary to stabilize J.H. could only be provided in an acute care facility like Florida Hospital. They could not have been furnished effectively in an alternative facility. Florida Hospital provided J.H. with 24 hour supervision, nursing staff, physicians, and support personnel trained in psychology and psychiatry. N.S. N.S. was admitted through Florida Hospital's emergency room on October 18, 1989, when she was 14 years old. She was discharged on June 14, 1991, to a long term residential treatment facility. Respondent does not seek a refund of Medicaid payments from October 18, 1989, through November 17, 1989. Respondent seeks a refund of payments made from November 18, 1989, through June 14, 1991. Alternative Source Of Payment Respondent alleges that an alternative source of payment existed in a settlement agreement to which neither Petitioner nor Respondent were parties. The settlement agreement resolved a federal law suit filed by the mother of N.S. against the Department of Health and Rehabilitative Services ("HRS") and the Orange County School Board (the "school board"), Case No. 90- 134-CIV-ORL-18. The settlement agreement was executed on November 30, 1990, between the mother of N.S., HRS, the school board, and BRV, Inc., ("BRV"). BRV is a Florida non-profit corporation named after its three directors: Usher L. Brown, Esquire, counsel for N.S.; Wynelle Roberson; and Gregory Valcante. BRV was formed to create an alternative placement that is suitable for N.S.'s individual needs. BRV operates a long term residential facility that effectively furnishes services to N.S. in a manner that is suitable for her needs and consistent with appropriate medical care. The BRV program is designed and supervised by Dr. Ralph Maurer, an expert in the disorders suffered by N.S. Dr. Maurer designs and supervises the protocols, strategies, and approaches utilized in the BRV program. The BRV program provides N.S. with residential and educational components. The program also provides N.S. with components in behavior management and medical care and treatment. HRS paid $60,000 for the residential component and support staff required in the BRV program. The school board paid $100,000 to BRV for the education component. None of the settlement proceeds are allocated to the type of services provided by Petitioner during N.S.'s hospitalization, including behavior management and medical care and treatment. Petitioner did not receive any funds from the settlement agreement. Petitioner is not a party to the settlement agreement. The settlement agreement does not address payment of the Medicaid services provided by Petitioner. The settlement agreement is not an alternative source of payment for the Medicaid services provided by Petitioner. If Respondent is entitled to a refund as a result of the settlement agreement, Respondent must seek its refund from the settlement proceeds. 34/ Applicable law mandates that Respondent, "shall seek recovery of reimbursement from third-party benefits." 335/ Even if Respondent were entitled to a refund from Petitioner as a result of the settlement agreement, the amount of refund would be limited to the portion of the settlement proceeds actually received by Petitioner. 36/ The maximum amount of refund to which Respondent would be entitled is $160,000; not the $232,831.16 sought by Respondent. Medical Necessity Once N.S. was admitted to Florida Hospital on October 18, 1989, she did not make significant improvement after 30 days. She did not meet ISD criteria for continued inpatient services. 5.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician for N.S. Inpatient services Petitioner provided to N.S. after her initial treatment were consistent with appropriate medical care. Although N.S. did not make significant improvement within the time prescribed by ISD criteria, she did make significant improvement during her stay at Florida Hospital. She was successfully treated and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 5.2(a)(1) Mental Impairment N.S. is mentally retarded. She was born missing the right and left temporal lobes of her brain. As a result of her brain damage, N.S. suffers rapid mood changes and can not process certain higher orders of function. 5.2(a)(2) Emotional Impairment N.S. also suffers from agenesis. Agenesis is a brain development problem in which N.S. can not control emotional circuits in her brain. N.S. suffers from animalistic and aggressive patterns of behavior. Her symptoms include stalking, leaping, biting, screaming, spitting, and smashing. 5.2(a)(3) Learning Impairment N.S. has significantly impaired memory. Her memory consists of short term memory from day to day. N.S. has difficulty learning. She can not process certain higher orders of functions. It is difficult for her to pay attention. She has a significant language disorder. The memory disorder dates from birth. N.S. has no period of normal learning to use as a point of reference. N.S. learns differently from others. She does not respond to praise or punishment and does not understand discipline. N.S. does not learn from consequences. She can not store the information necessary to learn from consequences. N.S. reacts to undesired behavior with aggression. As a simplistic example, if one gives N.S. candy, the donor is a nice person. If one withholds candy, that person is not nice. Adverse treatment from others will lead to aggression from N.S. The learning strategies used to teach N.S. are similar to those used to tame a frightened animal. They are comparable to those used to train dolphins at Seaworld. Prior to her admission to Florida Hospital, N.S. was treated at the Children's Mental Health Unit, Shands Teaching Hospital, University of Florida ("Shands"). She was treated by Dr. Maurer, who later set up the program at BRV. 5.2(a)(4) Post Traumatic Stress Disorder N.S. was admitted to Florida Hospital as a result of an incident at the school where HRS placed N.S. at the time. N.S. had been aggressive toward her teacher. Two large males held N.S.'s head between her legs for 45 minutes to teach her not to be aggressive. The inappropriate attempt to discipline N.S. caused post traumatic stress disorder. The disorder required over a year and a half to control. In this type of post traumatic stress disorder, normal antipredator behavior is intensified in a manner similar to that an animal might experience in the presence of predators. Because N.S. is a frail individual, this one incident was sufficient to require hospitalization in the acute care unit at Florida Hospital. N.S. went berserk. At the time of admission, N.S. was grossly psychotic. Her paranoia was global. She was totally out of control with aggressive and violent behavior. She bit a security guard, and had to be restrained. N.S. grunted and did not speak. She neither fed nor dressed herself. She leaped off of chairs, bit others and herself, and did not socialize. She had no sustained attention. Doctors at Shands correctly determined that N.S. needed an acute care facility because N.S. was acutely psychotic and uncontrollable. The objective was to control her, settle her down, and transition her out to a long term residential program. N.S. was treatable. She was appropriately not "warehoused" in an alternative facility that was not suitable for her needs. 5.2(a)(5) Significant Improvement At the time of her discharge on June 14, 1991, N.S. showed dramatic improvement for the severity of impairment that she suffered. She was alert and cooperative. She had learned some language and communication skills. N.S. dressed herself and ate appropriately. Her affect and mood were stable. She did not attack others and was able to socialize. N.S.'s global paranoia was reduced. She was able to go out from seclusion with one-to-one adult supervision. However, the potential to hurt herself and others persists. She requires close adult supervision. 5.2(a)(6) Medication N.S. was a very complex and difficult patient to treat. Her developmental disabilities and severe psychiatric disorders were difficult by themselves. The incident at school superimposed a post traumatic disorder over her existing disabilities and disorders. More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for N.S. When the right combination was determined, additional time was needed to stabilize the multiple medications. There is no specific medication for the treatment of post traumatic stress disorder. Medicines used for all disorders may be tried on an empirical basis and juggled until the right medication, or combination of medications, is found. N.S. is very fragile. The margin of error for her medication is very small. N.S. was treated with a variety of medications. She had reactions to some medications, and they had to be changed. She did not respond well to others, and they had to be changed. The treating physician conducted an elaborate search for an effective combination of medications. The medications were titrated slowly. A total of nine combinations were tried. Unlike antibiotics that work in 24 to 36 hours, medications for psychiatric disorders and major depression may require two to six weeks before their effectiveness can be determined. During the time that her treating physician was attempting to stabilize N.S.'s medications, N.S. needed the medical care provided by doctors and nurses in a hospital setting. N.S. could not have been discharged to a less restrictive setting due to her level of acuity. Medications for N.S. were not stabilized until April 16, 1991. It was consistent with appropriate medical care to keep N.S. in Florida Hospital until June 14, 1991; approximately two months after her medications were stabilized. 5.2(a)(7) Violence And Seclusion Violent behavior was another reason why it took so much time to stabilize N.S. N.S. was violent throughout much of her treatment. N.S. had to be repeatedly secluded. The seclusion was medically necessary. However, the intervals of seclusion slowed her improvement. 5.2(a)(8) Behavior Modification And Learning Disabilities Even without intervals of seclusion, behavior modification would have been slow because N.S. suffered from memory disorder. She could not store the information necessary to make ordinary means of discipline and learning effective. 5.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for N.S. after her initial treatment. No alternative placement existed for N.S. prior to June 14, 1991. The acute care admission and treatment of N.S. at Florida Hospital for approximately 605 days was suitable for the needs of N.S. and consistent with appropriate medical care. Earlier discharge would have been neither suitable for the needs of the individual patient nor consistent with appropriate medical care. Before N.S. was stabilized, she was a danger to herself and others. It would have been unsuitable for the individual needs of N.S. and inconsistent with appropriate medical care to discharge N.S. while she was a danger to herself and others. N.S. was a danger to herself and others when HRS placed her in an alternative facility prior to her admission to Florida Hospital. 5.2(b)(1) Suitable Services Effectively Furnished The services that were medically necessary to stabilize N.S. could only be provided in an acute care facility like Florida Hospital. Florida Hospital provided N.S. with 24 hour supervision, nursing staff, physicians, and support personnel trained in psychology and psychiatry. The inpatient services Petitioner provided could not have been furnished effectively in an alternative facility prior to June 14, 1991. Multiple medications could only be administered in an acute care facility. Nursing staff monitored N.S. for side effects at 15 minute intervals, 24 hours a day. They monitored the effectiveness of multiple medications and the toxicity of those medications. Psychiatric acute care nurses are best equipped to work with patients who are very sick. The doctors and nurses at Florida Hospital know how to handle disturbed, depressive, and psychotic people. N.S. was one of those people for most of her inpatient treatment. N.S. was isolated and safe in Florida Hospital. She became familiar with staff and settled down. Florida Hospital was close enough that N.S.'s mother could visit her regularly. Visitation from her mother was an integral part of the medical treatment and behavior modification that was suitable for N.S. Petitioner effectively treated N.S.'s disorders. Doctors and nurses at the hospital changed N.S.'s behavioral pattern, stabilized her behavior, and taught N.S. the social skills needed for her to function in a residential treatment facility like BRV. 5.2(b)(2) Available And Suitable Alternatives An alternative facility, if it had been available, was not suitable for the needs of N.S. prior to her discharge. Until N.S. was stabilized, she was the type of patient who could not function in a residential setting. N.S. could not use even a word or two. She could not communicate in any intelligible manner. She could not dress or feed herself. Petitioner considered every reasonable alternative in prescribing treatment for N.S. Petitioner reviewed every reasonable alternative in the state and elsewhere, including Texas. One factor that complicated an alternative placement was the need for staff at an alternative facility to be able to consult with doctors at Florida Hospital. As the distance between the two increased, the ability to consult decreased. It was medically necessary for N.S.'s mother to provide support. The ability to provide such support decreased as distance increased. Residential treatment facilities and group homes would not accept N.S. due to her degree of disorganization. Those types of facilities were unable to guarantee N.S.'s safety. Many facilities used treatment plans that were unsuitable for N.S.'s condition. The Montanari and Au Clair Palms programs, for example, were punitive and relied on consequences. Punishment and consequences are ineffective and unsuitable for N.S. Petitioner attempted to place N.S. in the Brown School in Texas. However, that facility refused to accept N.S. N.S. could not be placed in a residential program until her medication was stabilized. None of the residential programs had an acute care psychiatric unit where multiple medications could be administered and monitored until N.S. was stabilized. Petitioner could not return N.S. to Shands. The patients there are younger and severely handicapped. Shands does not have an adolescent unit. Petitioner could not place N.S. in Northeast Florida Mental Health Hospital ("Northeast"). It would not have been consistent with appropriate medical care for Petitioner to make such a placement. Northeast did not have long term acute care for chronically ill children. N.S. did not meet Northeast's criteria. Northeast refused to accept N.S. Petitioner attempted to involuntarily admit N.S. at Medico pursuant to the Baker Act. However, Medico refused to accept N.S. Treating physicians created a facility and program that was suitable for N.S.'s needs and consistent with appropriate medical care. BRV effectively furnishes services in a program that includes a high level of supervision, structure, and behavioral management. N.S. has done well since being placed in BRV. She is functioning well in school. A.B. A.B. was admitted to Florida Hospital on October 4, 1991, and discharged on November 4, 1991. Respondent claims a refund of Medicaid payments for A.B.'s hospitalization from October 12, through November 4, 1991. Alternative Sources Of Payment No alternative sources of payment existed for the inpatient services Petitioner provided to A.B. after her initial treatment. Respondent does not claim that any alternative sources of payment existed for A.B. Medical Necessity After A.B. was admitted to Florida Hospital on October 4, 1991, she did not make significant improvement after eight days. She did not meet ISD criteria for continued inpatient services. 6.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician for A.B. Inpatient services Petitioner provided to A.B. after her initial treatment were consistent with appropriate medical care. Although A.B. did not make significant improvement within the time prescribed by ISD criteria, she did make significant improvement during her stay at Florida Hospital. She was successfully treated and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 6.2(a)(1) Mental Impairment A.B. suffered from multiple medical problems. She had cerebral palsy and was wheel chair bound. She had arthritis. A.B. had a brain injury and suffered seizure disorders. Her arms, hands, and legs were drawn into distorted positions. She was unable to take care of herself. A.B. had a progressive depressive disorder. At the time of admission, A.B. suffered from major depression. She had a history of attempted suicides. 6.2(a)(2) Substance Abuse And Suicide A.B. had a long history of alcohol and drug abuse, including cocaine and crack cocaine. A.B. abused alcohol while on Antabuse. Antabuse is a medicine that makes the patient sick if the patient ingests alcohol. If a patient ingests alcohol in sizeable quantities, Antabuse may cause a severe reaction that can be fatal. A.B. consumed excessive amounts of alcohol while on Antabuse in the hope that she would kill herself. 6.2(a)(3) Medication More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for A.B. When the right combination was determined, additional time was needed to stabilize the multiple medications. It took approximately 30 days for A.B.'s treating physician to stabilize her with medications. Four to six weeks are usually required before the effectiveness of psychiatric medications can be determined. The patient requires time to adjust to the level of dosage needed to treat the particular impairment. After the appropriate dosage of medication is administered, additional time is needed to determine whether the drug is effective. Eight to ten days are needed for the medication to reach a steady blood level in the patient. Until that time, the medication is not at a therapeutic level. Once the medication has reached a therapeutic level, it takes another 8 to 10 days to determine if the patient is at an appropriate dosage and is responding. Psychiatric medications require longer to work when the level of impairment is high. The level of impairment in A.B. was high because she had to be detoxified. The time needed for the medications to work was greater because they created side affects for A.B.'s brain and other conditions. For example, antidepressant medication increases the risk of seizure. This is particularly true when a patient suffers from cerebral palsy and substance abuse. Side affects had to be monitored to make sure that the medication was not at a toxic level. 6.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for A.B. after her initial treatment. No alternative placement existed for A.B. until she was stabilized. Prior to that time, A.B. was a danger to herself. It would have been inconsistent with appropriate medical care for Petitioner to discharge A.B. when she was a danger to herself. 6.2(b)(1) Effective And Appropriate Medical Care Earlier outpatient services would not have been suitable for the needs of A.B. An outpatient clinic could not effectively furnish the services A.B. needed prior to the date of her discharge. A.B. could not be discharged before she was ambulatory and functional. The treating physician prescribed physical therapy. At the time of discharge, A.B. was ambulatory and able to take care of her essential needs. She was timely discharged for outpatient care at the mental health clinic. 6.2(b)(2) No Available And Suitable Alternative It takes approximately six to eight weeks to obtain an appointment as an outpatient at the local mental health clinic. A.B. has no social support network. The risk of suicide is high if patients such as A.B, who have little or no support network, are discharged as soon as they say they are no longer suicidal. A.B. needed to be kept in the hospital until she was in remission from her depression and until she developed some insight into self-medication. B.W. B.W. was admitted to Florida Hospital on May 10, 1991. She was discharged on June 10, 1991. Respondent claims a refund of Medicaid payments for B.W.'s hospitalization from May 23, through June 10, 1991. Alternative Source Of Payment No alternative source of payment existed to pay the medical services Petitioner provided to B.W. Respondent does not assert that any alternative sources of payment were available. Medical Necessity After B.W. was admitted to Florida Hospital on May 10, 1991, she did not make significant improvement after 13 days. She did not meet ISD criteria for continued inpatient services. 7.2(a) Appropriate Medical Care ISD criteria were correctly overridden by the treating physician. Inpatient services Petitioner provided to B.W. after her initial treatment were consistent with appropriate medical care. Although B.W. did not make significant improvement within the time prescribed by ISD criteria, she did make significant improvement during her stay at Florida Hospital. She was successfully treated and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 7.2(a)(1) Mental Impairment At the time of admission, B.W. had organic affective disorder with severe depression. She was psychotic and was hallucinating. She heard voices and talked to herself. She was acutely suicidal. B.W. had a history of prolonged depression, multiple hospitalizations, and failed courses of outpatient treatment. This was B.W.'s fifth psychiatric admission. B.W. was last admitted on March 3, 1991, for an overdose of medication. She was hospitalized for four days and discharged. B.W. was obsessed with suicide and how she was going to carry out her suicide. She had a specific plan to kill herself. 7.2(a)(2) Emotional Impairment B.W. was unwashed, unkept, disheveled, and depressed. Her speech was blurred. She suffered from sleep disorder and loss of appetite. B.W. suffered from multiple substance abuse problems and impaired judgment. B.W.'s substance abuse was an attempt to self medicate for anxiety. The anxiety was caused by conditions in her home environment. B.W. was responsible for the care of minor children. She was separated from her husband and living with an elderly mother who could not take care of B.W. Her mother was significantly depressed and was, herself, at risk of suicide. 7.2(a)(3) Medication More time than that prescribed by ISD criteria was medically necessary to discover the combination of medicines that would be effective for B.W. When the right combination was determined, additional time was needed to stabilize the medications. B.W. was on antipsychotic drugs because she was hallucinating and hearing voices. She was also on antidepressants. It takes time for psychiatric drugs to take effect. The treating physician had to gradually increase the dosage administered to B.W. until the medication reached a therapeutic level. B.W. made steady improvement during her hospitalization. As late as June 4, 1991, however, B.W. was nauseated, vomiting, and had headaches. B.W. was treated effectively and timely discharged in a manner that was suitable for her individual needs and consistent with appropriate medical care. 7.2(b) Alternative Placement Petitioner correctly considered alternative placements in prescribing inpatient services for B.W. after her initial treatment. No alternative placement existed for B.W. before she was stabilized and discharged. It was consistent with appropriate medical care for Petitioner to keep B.W. in the hospital until her treating physician stabilized her. It required approximately 30 days for B.W.'s treating physician to stabilize her. Outpatient care would not have been effective before B.W. was stabilized. At the time that Respondent claims B.W. should have been discharged, B.W. was depressed and was hallucinating. She was still in withdrawal from her substance abuse. Earlier outpatient care would have been neither effective nor suitable for the needs of B.W. It would not have been consistent with appropriate medical care to discharge B.W. to her home. B.W. is responsible for the care of two minor children. She has an unstable home environment. It would not have been consistent with appropriate medical care to discharge B.W. to such an environment before she was stabilized.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a Final Order denying its claim for refund of the Medicaid payments at issue in this proceeding. RECOMMENDED this 20th day of December, 1995, in Tallahassee, Florida. DANIEL S. MANRY, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 1995.
The Issue Whether St. Joseph's Hospital, Inc.'s application for certification as a State Approved Pediatric Trauma Referral Center should be approved.
Findings Of Fact The Hillsborough County Hospital Authority d/b/a Tampa General Hospital ("TGH" or "Petitioner") is a licensed general acute care hospital in Tampa, Florida and is a verified level I trauma center. By definition, a level I trauma center is required to include an adult trauma center and a state-approved pediatric trauma referral center ("SAPTRC"). The Department of Health and Rehabilitative Services ("DHRS" or "Respondent") is the state agency with statutory responsibility for certification and regulation of trauma centers in Florida. St. Joseph's Hospital ("SJH" or "Intervenor") is a licensed general acute care hospital in Tampa, Florida and is a verified level II trauma center. SJH was provisionally approved as a level II trauma center on May 1, 1991 and was verified on July 1, 1992. A level II trauma center is not required to operate a SAPTRC. By letter of August 17, 1993, the DHRS notified the chief executive officers for all Florida hospitals of next trauma center application review cycle. Pursuant to statute, letters of intent were due by October 1, 1993 for the referenced review cycle. A letter of intent to apply for certification as a trauma center is an nonbinding expression of intent. Frequently a hospital files a letter of intent to become a trauma center but and then fails to file the application. A hospital seeking trauma unit certification must submit a letter of intent by the October 1 preceding the April 1 application deadline. A letter of intent is only valid for the application review cycle for which it is submitted. A hospital which submits a letter of intent but does not file the subsequent application must submit another letter of intent in order to file an application in a later review cycle. Pursuant to Section 395.4025(2)(a), Florida Statutes, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a state-approved 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. The cited statute specifically provides that this requirement does not apply to any hospital that is certified as a provisional or verified trauma center on January 1, 1992. A trauma agency ("agency") is a planning unit of one or more county governments which plans for the development of the trauma system in that county or multi-county region. The DHRS is charged with review and approval of all local trauma agencies, the trauma systems plans adopted by such agencies and annual updates and amendments to local trauma plans. The Hillsborough County Trauma Agency ("HCTA"), is the DHRS-approved local trauma agency for Hillsborough County, Florida and is responsible for trauma service area #10. The Petitioner asserts that the SJH application will increase the number of service area #10 trauma centers beyond the limit of two imposed by statute and rule. There are currently two trauma centers in Hillsborough County (service area #10) including the Petitioner and the Intervenor. The expansion of services proposed by SJH will not increase the number of trauma centers in service area #10. If SJH is awarded the certification, there will still be two trauma centers. The trauma services plan submitted by the HCTA and approved by the DHRS does not expressly address whether or not any need exists for a second SAPTRC in service area #10. The 1990 amendment to the local plan references SJH's interest in operating a SAPTRC, but does not state whether need exists for a second SAPTRC. By letter of intent dated September 23, 1993 and received by the DHRS on September 30, 1993, SJH filed notice of intent to apply for certification as a state approved pediatric trauma referral center. By letter of October 14, 1993, the DHRS acknowledged receipt of SJH's letter of intent. The SJH letter of intent does not certify that the SJH's planned pediatric trauma referral center was consistent with the local trauma agency's plan. The failure of SJH to certify that the proposed SAPTRC is consistent with the local trauma agency plan is of no consequence. Section 395.4025(2)(a), Florida Statutes, specifically exempts any hospital that is certified as a provisional or verified trauma center on January 1, 1992. SJH was provisionally approved as a level II trauma center on May 1, 1991. Consideration of whether the local plan indicates need for an additional SAPTRC or whether the SJH proposal is consistent with the local trauma plan is not required. Until immediately prior to this case being heard, and despite the aforementioned exemption for some facilities, the DHRS required all hospitals located in areas where local or regional trauma agencies exist to submit some type of certification that the proposed trauma unit was consistent with the local plan. Since adoption of the 1992 statutory amendments, the DHRS has failed to appropriately apply the referenced exemption. Immediately preceding commencement of the hearing in this matter, the DHRS position was revised to reflect the exemption. The SJH application for certification as a SAPTRC was filed with the DHRS on or before April 1, 1993. On May 13, 1993, the DHRS notified SJH of certain omissions and requested additional information. On May 19, 1993, SJH filed its response to the request for information. Thereafter, the DHRS performed a preliminary review of the application to determine whether SJH met the requirements for approval as a "provisional" SAPTRC. Included in the information considered by the DHRS in evaluating the SJH application were documents submitted by representatives of the HCTA related to whether the SJH application was supported by the local agency and was consistent with the local trauma plan. The HCTA documents submitted are immaterial because, as previously addressed, SJH is exempted from the requirement related to local trauma plan consistency. The DHRS determined that the SJH application met the required critical standards for provisional approval. The DHRS notified SJH of the provisional approval on May 31, 1994. TGH challenged the DHRS determination that the SJH application met the critical standards. A hospital which meets the "critical elements" set forth in statute may receive provisional approval as a SAPTRC. Section 395.4025(2)(c), Florida Statutes, provides as follows: ....The department shall conduct 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 state approved trauma center. This critical review will be based on trauma center verification standards and shall include, but not be limited to, a review of whether the hospital has: Equipment and physical facilities necessary to provide trauma services. Personnel in sufficient numbers and with proper qualifications to provide trauma services. An effective quality assurance program. Submitted written confirmation by the local or regional trauma agency that the verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists. This subparagraph applies to any hospital that is not a provisional or verified trauma center on January 1, 1992. As previously stated, because SJH was a provisionally approved trauma center on January 1, 1992, it is not required to submit written confirmation by the local or regional trauma agency that verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency. The parties stipulated that the SJH application meets the standards regarding staffing, facilities, equipment, and quality assurance required for provisional approval, except as to the following: Whether St. Joseph's will have adequate surgeon coverage and support to meet the require- ments to be a provisional SAPTRC. Whether St. Joseph's will have adequate physician coverage in its pediatric ICU to meet the requirements to be a provisional SAPTRC. Whether St. Joseph's meets the statute and rule requirements for provisional review as they relate to quality of care to pediatric trauma alert patients. There was attention directed at the hearing to the fact that the DHRS application form fails to accurately track the applicable rules setting forth the requirements for certification as a SAPTRC. Notwithstanding the agency's failure to create an accurate application form, the minimum standards for review for Provisional SAPTRCs as identified in Rule 10D-66.109(d)2, Florida Administrative Code, are the following portions of HRSP 150-9, October 91: STANDARD Type of Hospital Surgery Department; Division; Services; Sections: A Surgical Specialties Availabilities: A 1, 2, 3 & 4 Non-Surgical Specialties Availabilities: 1, 8 & 13 Emergency Department (ED): A, B, D & H Operating Suite Special Requirements: A IX. Pediatric Intensive Care (P-ICU): A, C, 1 XVI. Quality Management: A, B, C, D, & E The booklet identified as "State-Approved Trauma Center and State- Approved Pediatric Trauma Referral Center Approval Standards, HRSP 150-9, October 91" provides specific information related to each standard. The following constitutes review of the minimum standards for Provisional SAPTRCs as related to the application submitted by SJH. Standard I. Type of Hospital SJH is a level II trauma facility and is a general acute care hospital with independent pediatric trauma patient care services within the facility, from emergency department admission through rehabilitation, separate and distinct from adult patient care services. SJH meets the Standard I requirement. Standard II. Surgery Department; Division; Services; Sections: A SJH offers the required types of surgery, including general surgery, orthopedic surgery and neurosurgery. Orthopedic surgery and neurosurgery are divisions within the Department of Surgery. SJH meets the Standard II A requirement. Standard III. Surgical Specialties Availabilities: A 1, 2, 3 & 4 SJH meets the Standard III A requirement. SJH offers general surgery, neurosurgery, orthopedic surgery and otorhinolaryngologic surgery on call and promptly available 24 hours a day. Standard V. Non-Surgical Specialties Availabilities: 1, 8 & 13 SJH meets the specified Standard V requirement. SJH offers the required types of non-surgical specialties, including anesthesia, pediatric intensive and critical care medicine, and radiology including diagnostic x-ray and computerized tomography. The specialists in each area have special competence in the care of the pediatric trauma patient in their specialties. Standard VI. Emergency Department (ED): A, B, D & H SJH meets the specified Standard VI A requirement. SJH has an identifiable intake and resuscitation area specifically equipped for pediatric trauma patients . The SJH pediatric trauma area is located in the Emergency Department and is easily accessible to land and air transportation. SJH meets the specified Standard VI B requirement. SJH's Emergency Department has a designated medical director/physician for pediatrics, a trauma/general surgeon, emergency department physicians, a nursing staff and respiratory therapy staff. The personnel have special competence in the care of the pediatric trauma patients. SJH Emergency Department staff are available as follows: At least one E.D. physician is present in the E.D. 24 hours a day; Nursing staff is present in the E.D. 24 hours a day; and Respiratory therapy staff are on call and immediately available in-hospital 24 hours a day. SJH meets the specified Standard VI D requirement. SJH has a radio communication system that conforms to the State EMS Communications Plan and telephone and paging equipment to contact trauma team members. The equipment is functional and is located in the trauma center intake area. SJH meets the specified Standard VI H requirement. SJH has written protocols for the immediate response to the emergency department from the blood bank, laboratory, respiratory therapy and operating room. Standard VII. Operating Suite Special Requirements: A SJH meets the specified Standard VII A requirement. SJH has a fully staffed and equipped operating room, available 24 hours a day for immediate use. Written operating procedures for 24 hour a day operating room availability for pediatric trauma patients and staffing are available for review by the DHRS. Standard IX. Pediatric Intensive Care (P-ICU): A, C, 1 SJH fails to comply with Standard IX as set forth in Rule 10D- 66.109(d)2, Florida Administrative Code, referencing "State-Approved Trauma Center and State-Approved Pediatric Trauma Referral Center Approval Standards, HRSP 150-9, October 91." Standard A, C, 1 specifically requires that the P-ICU medical director or a physician designated by the P-ICU medical director must be available in the unit 24 hours a day. SJH does not propose to place the P-ICU medical director or a physician designated by the P-ICU medical director in the unit 24 hours a day. SJH proposes to make the P-ICU medical director or a physician designated by the P-ICU medical director available to the unit 24 hours a day. "Available to" the unit does not require that the identified employee be present in the hospital. As much as 30 minutes could pass before the P-ICU medical director or his designee arrives at the P-ICU. Although the evidence establishes that the DHRS has accepted such arrangements in previous applications, the rule specifically requires that the referenced personnel be located in the P-ICU. There is no legal authority for the DHRS to disregard the requirement set forth in its own rules. Standard XVI. Quality Management: A, B, C, D, & E SJH meets the specified Standard XVI A requirement in that it has a comprehensive quality management plan in operation. SJH meets the specified Standard XVI B requirement. SJH's quality management plan include protocols for 1) pediatric trauma patient triage and the issuance of an in-hospital trauma alert; 2) response of trauma team and documentation of response time in each patient record for members of the trauma team, neurosurgical, laboratory, x-ray, social work, pastoral, consultants and elapsed time for laboratory results. Protocols are also included related to trauma, medical and nursing staff patient care responsibilities, trauma operating room team response, assuring operating room and operating room staff availability to the pediatric trauma patient, pediatric trauma patient care in ICU, post-anesthetic recovery room and wards, transport of the pediatric trauma patient to the operating room, x-ray suites, CT scanner, ICU, and other hospital areas and hospital transfers. SJH meets the specified Standard XVI C requirement. SJH plan includes, and SJH will implement and perform monthly trauma quality management, consisting of a trauma quality management committee that will meet at least monthly to review pediatric trauma cases, including cases involving morbidity and mortality. The pediatric trauma service medical director or trauma nurse coordinator will review specified cases including all pediatric trauma alert cases, all critical admissions for traumatic injuries, all pediatric trauma Operating Room admissions from the emergency department and/or state-approved trauma center, any critical pediatric trauma transfers into or out of the emergency department and/or trauma center, and all traumatic deaths. Review of such cases will include application of "audit filters" as identified in the rule. Appropriate records will be maintained in-hospital, of all cases to which audit filters were applied. Pediatric trauma cases will be evaluated by the medical director of the trauma service and/or trauma nurse coordinator. The trauma nurse coordinator and the medical director will present a summary of the reviewed cases not referred to the committee, along with cases requiring further evaluation where there is no clear and appropriate reason for a situation to have occurred. Cases referred to the trauma quality management committee for which the committee can find no clear and appropriate reason for the situation to have occurred will be sent to appropriate persons or committees responsible for corrective action. The medical director of the trauma service will report back to the trauma quality assessment committee the resolution of each case. The SJH trauma quality management committee is composed of the trauma nurse coordinator, a trauma surgeon (other than the pediatric trauma service medical director), an emergency physician, a surgical specialist (other than trauma surgeon), a representative from SJH administration, the operating room nursing director, the Emergency Department nursing director and the intensive care unit nursing director. At least 75 percent attendance of the committee members is required at the monthly trauma quality management committee meetings. SJH will maintain minutes of all trauma quality management committee meetings for at least three years and are readily available for review by the DHRS. The minutes shall include at a minimum, the names of the attendees and the subject matter discussed, and actions toward resolution(s) of identified problems. The trauma quality management committee will prepare and submit a quarterly report to the DHRS at the end of each calendar year quarter by the 15th of the month following the end of the previous quarter. The report will list every case selected for corrective action by the trauma quality management committee and will provide identify the hospital case number, the trauma registry number (from HRS Form 1728, "Trauma/Head Injury/Spinal Cord Injury Registry"), a description of questionable care, and the corrective action taken. If corrective action is not necessary, an explanation is required. The medical director/chair of the trauma management committee will compile monthly statistics on each trauma surgeon on the trauma call roster. The statistics will be available for the DHRS review or will be submitted upon request. The statistics for each surgeon shall reflect the total number of cases per calendar month for which each trauma surgeon was notified to respond to a pediatric trauma alert and the total number of cases for which the trauma surgeon did not meet the pediatric trauma alert patient at the time of the trauma alert patient's arrival at the SAPTRC. SJH will conduct a monthly multi-disciplinary trauma conference for case management and education. When appropriate, the conference will include review of the local/regional emergency medical service system, individual case management, the SAPTRC, solution of specific problems including organ procurement and donations, and trauma care education. The attendees will include representatives from trauma services, the emergency department, neurosurgery, orthopedics, nursing, social work, rehabilitation medicine, laboratory, x-ray, prehospital providers and hospital administration. At least 50 percent attendance will be required at the monthly multi-disciplinary trauma conference. Minutes from these conferences, including the names of the attendees and subject matter discussed, will be maintained at the SAPTRC for a minimum of three years and will be readily available for review by the DHRS upon request. SJH meets the specified Standard XVI D requirement relating to file maintenance. The trauma unit will have on file credentials of all surgeons in the trauma service as well as consultants, morbidity and mortality figures for the pediatric trauma service, CME data on all physicians participating in the pediatric trauma service, research and CME activities on all surgeons participating in the trauma services, nursing credentials, nursing CEU, any nursing research, a written plan of how the trauma nurse coordinator and the trauma service medical director's duties and responsibilities are integrated, a written disaster plan, the county or regional disaster plan and evidence of disaster drill activities. SJH meets the specified Standard XVI E requirement relating to file maintenance. The SAPTRC will fully participate in the trauma registry
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is hereby RECOMMENDED that the Department of Health and Rehabilitative Services enter a Final Order denying the application of St. Joseph's Hospital for certification as a State-Approved Pediatric Trauma Referral Unit. DONE and RECOMMENDED this 3rd day of March, 1995, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of March, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3669 The following constitute rulings on proposed findings of facts submitted by the parties. Petitioner Tampa General Hospital The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 1-14. Rejected, irrelevant. 15-20. Rejected, unnecessary. It is not unreasonable to address free standing units or new trauma centers differently that service expansions to existing facilities. 21-22. Rejected, irrelevant. 24-79. Rejected, irrelevant. 81. Rejected, unnecessary. 83-120. Rejected, irrelevant. 121. Rejected, unnecessary. 123-128. Rejected, irrelevant. 130-134. Rejected, irrelevant. Rejected, irrelevant. The rules which set forth the specific requirements for certification supersede application form. Rejected, irrelevant. Respondent Department of Health and Rehabilitative Services The Respondent's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 11-13. Rejected, unnecessary. Rejected, subordinate. Rejected, unnecessary. 17. Rejected, unnecessary. 19. Rejected, unnecessary. 21-23. Rejected, subordinate. 24. Rejected, irrelevant. 25-27. Rejected, subordinate. 28-29. Rejected, unnecessary. 30. Rejected, not supported by credible evidence. 32. Rejected, unnecessary. 34. Rejected, irrelevant. 36. Rejected, irrelevant. 38-40. Rejected, irrelevant. 41. Rejected, unnecessary. 42-58. Rejected, irrelevant. 59. Rejected, unnecessary. 60-81. Rejected, irrelevant. 82. Rejected, not supported by the greater weight of the evidence. 83-86. Rejected, unnecessary. Rejected, not supported by the greater weight of the evidence. Rejected, irrelevant. 89-91. Rejected, unnecessary. 92. Rejected, contrary to law. The rules set forth the specific requirements which must be met for certification as a provisional SAPTRC. The rule unambiguously requires that the Pediatric Intensive Care Unit medical director or a physician designated by the P-ICU medical director must be available in the unit 24 hours a day. There is no legal authority for the DHRS to disregard the requirement, notwithstanding the agency's apparent failure to enforce the rule in previous instances. Intervenor St. Joseph's Hospital The Intervenor's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 7-9. Rejected, unnecessary. 13-14. Rejected, unnecessary. 16-17. Rejected, unnecessary. 19-31. Rejected, unnecessary. 64-65. Rejected, not supported by the greater weight of the evidence. Despite the DHRS practice, the rule specifically requires that the referenced personnel be located in the P-ICU. The rule is not satisfied by the SJH proposal. 82. Rejected, not supported by the greater weight of the evidence. COPIES FURNISHED: Robert L. Powell, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Kim Tucker, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Elizabeth McArthur, Esquire Radey Hinkle Thomas & McArthur 101 N. Monroe Street, Suite 1000 Post Office Drawer 11307 Tallahassee, Florida 32302 Robert P. Daniti, Esquire Senior Attorney Emergency Medical Services Department of Health and Rehabilitative Services 1317 Winewood Blvd. Tallahassee, Florida 32399-0700 Bruce D. Lamb, Esquire Christopher J. Schulte, Esquire 201 East Kennedy Blvd., Suite 1000 Tampa, Florida 33602
Findings Of Fact Background On September 28, 1988, First Hospital Corporation of Florida d/b/a First Hospital of Palm Beach County (First Hospital) filed a timely application for the July 1993 planning horizon with the Department of Health and Rehabilitative Services (Department) for a certificate of need (CON) to construct a 48- bed short-term psychiatric specialty hospital, dedicated to the care of children and adolescents, in District IX. 1/ District IX is comprised of Palm Beach, Martin, St. Lucie, Indian River, and Okeechobee Counties. On February 3, 1989, the Department published notice in the Florida Administrative Weekly of its intent to grant First Hospital's application. Petitioners, Lake Hospital & Clinic, Inc. d/b/a Lake Hospital of the Palm Beaches (Lake Hospital), and Community Hospital of the Palm Beaches, Inc. d/b/a Humana Hospital Palm Beaches (Humana), existing providers of psychiatric services to adolescents in Palm Beach County, filed timely petitions for a formal administrative hearing to oppose the grant of the subject application. The matter was referred to the Division of Administrative Hearings for the assignment of a hearing officer to conduct a formal hearing pursuant to section 120.57(1), Florida Statutes, and Savannas Hospital Limited Partnership (Savannas), an existing provider of psychiatric services to adolescents in St. Lucie County, was granted leave to intervene. 2/ The proposed facility At issue in this proceeding is the application of First Hospital for a CON to construct a 48-bed short-term psychiatric specialty hospital dedicated to the care of children and adolescents. This project is, however, only a portion of an 80-bed facility that First Hospital proposes to construct on a 30-acre parcel of land adjacent to Wellington Regional Memorial Hospital in western Palm Beach County. As sited, the proposed facility would be located west of the Florida Turnpike; on the west side of State Road 7 and approximately .2 miles north of Forest Hills Boulevard. The 80-bed facility that First Hospital proposes to construct would consist of a central core area and three attached wings or units. Two of the wings, each containing 24 beds, will be dedicated as short-term psychiatric beds, with one wing for young adolescents (10-14 years of age) and one wing for older adolescents (14-18 years of age). The third wing, consisting of 32 beds, will be dedicated as a residential treatment center (RTC) for adolescents. The central core area would include administrative, therapy, kitchen and dining, gymnasium classroom areas and other support functions, and is essential to the operation of the psychiatric units, but will be shared with the residential treatment unit. A therapeutic preschool program, for children 3-5 years of age, as well as a partial hospitalization program for adolescents, are also proposed to be offered, and will be located in the central core area. 3/ The psychiatric program proposed by First Hospital for its 48-bed short-term psychiatric facility will address emotional and behavioral disorders that may affect adolescents, and which require admission to a short-term acute care facility for treatment. In its application, First Hospital estimates an average length of stay of 45 to 60 days. The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization and adequacy of like and existing health card services in the service district As a touchstone for assessing need within a service district, the Department has established a short-term psychiatric bed need methodology that must normally be satisfied before a favorable need determination will be found. That methodology, codified in Rule 10-5.011(1)(0)(4), Florida Administrative Code, contains two identifiable parts. The first part deals with the mathematical derivation of a net bed need for the planning horizon by assuming a gross bed need ratio of .35 beds per 1,000 population, and reducing that figure by the number of existing and approved beds. Based on the population projections of the Executive Office of the Governor, July 1988 release, application of this methodology derives a net need for 48 short-term psychiatric beds for the July 1993 planning horizon (gross bed need of 480- existing and approved beds of 432 = 48 net bed need. 4/ The second part of the Department's need methodology addresses occupancy standards for existing facilities that must be satisfied before a favorable need determination will normally be found. For short-term child and adolescent beds, the rule mandates an average annual occupancy rate of not less than 70 percent for all such existing facilities for the preceding 12- month period. Here, the proof demonstrates an average annual occupancy rate in excess of 70 percent for the 12-month period preceding the Department's need calculation, and satisfaction of the second part of the Department's need methodology. On August 12, 1988, the Department, pursuant to Rule 10-5.008(2)(a), Florida Administrative Code, published notice of the hospital fixed need pool for the July 1993 planning horizon in the Florida Administrative Weekly. Pertinent to this case, such notice erroneously established a net need for 33 short-term psychiatric beds in District IX. Following publication of the fixed need pool, the Department received information that its calculation of the net need for short-term psychiatric beds in District IX was erroneous. Upon review, the Department established that its initial calculation was in error, and on August 26, 1988, the Department published a notice of correction in the Florida Administrative Weekly, which correctly established a net need for 48 short-term psychiatric beds in District IX for the July 1993 planning horizon. This adjustment to the fixed need pool did not result from any intervening changes in population estimates, bed inventories, or other factors which would lead to different projections of need, but from an error in the Department's mathematical calculation. Under the circumstances, the Department's correction of the fixed need pool was appropriate and timely, and a need for 48 short-term child and adolescent psychiatric beds for the July 1993 planning horizon has been demonstrated. Of the 432 short-term psychiatric beds approved and existing within the district on August 17, 1988, 119 beds were reported to the local health council as dedicated to short-term child and adolescent psychiatric services, and the balance of 313 beds as dedicated to adult psychiatric services. Allocation of the 119 short-term child and adolescent beds was reported as follows: Lake Hospital 26 beds, Fair Oaks 27 beds, Humana 27 beds, Savannas 15 beds, and Lawnwood (Harbour Shores) 24 beds. Lake Hospital is a 98-bed freestanding psychiatric specialty hospital located in Lake Worth, Palm Beach County, Florida, that treats adolescents and adults for psychiatric disorders and substance abuse. As of August 17, 1988, Lake Hospital was licensed to operate 56 short-term psychiatric beds, 26 long- term psychiatric beds, and 16 short-term substance abuse beds. Of the 56 short- term psychiatric beds, 26 beds were approved for adolescent care and 30 beds were approved for adult care. During calendar year 1987, Lake Hospital enjoyed an occupancy rate of 91.8 percent for its 26 short-term psychiatric beds, which were dedicated to the care of adolescents, ages 12- 17. In January 1988, Lake Hospital opened a replacement facility on its campus consisting of a two-story structure with four 18- bed units, and reported to the local health council that two of those units (36 beds) were dedicated to short-term adolescent care in January and February 1988, and that thereafter only 18 beds were dedicated to short-term adolescent care. Based on such utilization, Lake Hospital enjoyed an occupancy rate of 95 percent for the first four months of 1988 and a 93.9 percent occupancy rate for calendar year 1988 for its adolescent beds. 5/ Fair Oaks is a 102-bed free standing psychiatric specialty hospital located in Delray Beach, Palm Beach County, Florida, that treats children, adolescents, and adults for psychiatric disorders and substance abuse. As of August 17, 1988, Fair Oaks was licensed to operate 70 short-term psychiatric beds, 15 long-term psychiatric beds, and 17 short-term substance abuse beds. Of the 70 short-term psychiatric beds, 27 beds were approved for child and adolescent care and 43 beds for adult care. During the calendar year 1987, Fair Oaks' second year of operation, it achieved an occupancy rate of 73.1 percent for its 27 short-term child and adolescent psychiatric beds. For the first four months of calendar year 1988, Fair Oaks enjoyed an occupancy rate of 99.7 percent, and for all of calendar year 1988 an occupancy rate of 91 percent. 6/ Humana is a 250-bed general hospital located in West Palm Beach, Florida. Of its existing beds, 162 are dedicated as medical/surgical beds, and 88 as short-term psychiatric beds. For calendar year 1987, Humana reported to the local health council that 27 of its 88-bed complement of psychiatric beds were dedicated to short- term adolescent services, but declined or neglected to report its utilization so that an average length of stay could be calculated. In fact, Humana did not operate a short-term adolescent program for 1987, but operated a long-term program without Department approval. Pertinent to this conclusion, the proof demonstrated that Humana applied for the development of an 88-bed psychiatric pavilion in 1983. Certificate of Need No. 2647 was issued to Humana on November 17, 1983, for 80 short-term psychiatric beds consisting of 48 adult psychiatric beds, 24 geriatric beds, and 8 adult special beds; and, on January 8, 1985, Humana received CON No. 3237 for the additional 8 short-term adult psychiatric beds. Humana opened its psychiatric pavilion in November 1986, and by January 1987 was serving adolescents, ages 13 through 18, in a 27-bed unit notwithstanding the absence of Department approval. As to the services provided in that unit, the proof is compelling that it was dedicated to long-term adolescent psychiatric services with an average length of stay of approximately 280 days. At some point thereafter, but not earlier than July 1989, Humana also began providing short-term adolescent psychiatric services at its facility. 7/ Following the Department's investigation into Humana's operation of a long-term adolescent psychiatric program, Humana applied for a modification of its CON Nos. 2647 and 3237 to allow it to operate a district adolescent unit. On July 14, 1989, Humana received Department approval, and such CON's were modified to allow 15 short-term adolescent psychiatric beds. This modification is, however, currently the subject of an appeal to the District Court. In the interim, on December 14, 1988, Humana received CON No. 5294 for the addition of 15 short-term beds for adolescents and adults, and on February 25, 1989, Humana received CON No. 5722 for the redesignation of 15 short-term psychiatric beds to 15 long-term beds. Currently, Humana has available 30 short-term psychiatric beds for adolescent use, and 15 long-term beds, but its short-term program is in a start-up mode. Savannas is a 70-bed freestanding psychiatric hospital located in Port St. Lucie, St. Lucie County, Florida, approximately 40 miles north of Palm Beach County, that treats adolescents and adults for psychiatric disorders and substance abuse. As of August 17, 1988, Savannas was licensed to operate 50 short-term psychiatric beds and 20 short-term substance abuse beds. Of the 50 short-term psychiatric beds, 15 beds were approved for adolescent care and dedicated to patients ages 14- 17, and 35 beds were approved for adult care. Savannas opened its facility in October 1987, and for that calendar year reported 1,215 patient days for its short- term adolescent unit, For calendar year 1988, its first full year of operation, Savanna's adolescent unit achieved 3,589 patient days, or an occupancy rate of 65.5 percent. Lawnwood (Harbour Shores) is a general hospital located in Fort Pierce, St. Lucie County, Florida, that, as of August 17, 1988, was licensed to operate 60 short-term psychiatric beds. Of the 60 short-term psychiatric beds, 24 beds were approved for child and adolescent care, and 36 for adult care. The date Lawnwood commenced operations does not appear of record; however, during calendar year 1987, it achieved a 62 percent occupancy rate for its 24-bed adolescent unit. For calendar year 1988, Lawnwood maintained a similar occupancy rate even though Savannas was drawing patients from the same service area to its new facility. Considering the availability, accessibility, extent of utilization and adequacy of short-term child and adolescent beds in the service district at all times pertinent to this case, there exists a need for the 48 beds requested by First Hospital, and such beds should be located in Palm Beach County consistent with the local health plan, discussed infra. The need for the proposed facility in relation to the district plan and state health plan Applicable to this case is the 1985-87 state health plan, which contains the following goals and objectives pertinent to short-term inpatient psychiatric beds: GOAL 1: ENSURE THE AVAILABILITY OF MENTAL HEALTH AND SUBSTANCE ABUSE SERVICES TO ALL FLORIDA RESIDENTS IN A LEAST RESTRICTIVE SETTING. OBJECTIVE 1.1: The ratio of short term inpatient hospital psychiatric beds to Florida's population should not exceed .35 beds per 1000 population thru 1987. RECOMMENDED ACTIONS: a: Restrain increases in the supply of short term inpatient hospital psychiatric beds to no more than .35 beds per 1000 population. OBJECTIVE 1.2: Through 1987, additional short term inpatient hospital psychiatric beds should not normally be approved unless the average annual occupancy rate for all existing and approved adult short term inpatient psychiatric beds in the service district is at least 75% and average annual occupancy for existing and approved adolescent and children beds is at least 70%. RECOMMENDED ACTIONS: a. Restrict approval of additional short term inpatient psychiatric beds to these service districts which have an average annual occupancy of 75% for existing and approved adult beds and 70% for existing and approved adolescent and children beds. GOAL 2.: PROMOTE THE DEVELOPMENT OF A CONTINUUM OF HIGH QUALITY, COST EFFECTIVE PRIVATE SECTOR MENTAL HEALTH AND SUBSTANCE ABUSE TREATMENT AND PREVENTIVE SERVICES. OBJECTIVE 2.1: Define, develop and implement policy regarding the appropriate treatment settings and the role of each setting in the delivery of mental health and substance abuse services by 1987. GOAL 3: DEVELOP A COMPLETE RANGE OF ESSENTIAL PUBLIC MENTAL HEALTH SERVICES IN EACH HRS DISTRICT. First Hospital's application is consistent with the goals and objectives of the state health plan. Here, First Hospital proposes to provide a 24-hour-a-day therapeutic milieu, with an average length of stay of 60 days or less, for children and adolescents suffering from mental health problems which are so severe and acute that they need intensive, full-time care. As such, First Hospital will offer care for those individuals for whom short-term inpatient psychiatric care is the least restrictive setting appropriate, and which care, consistent with the Department's need methodologies, will complement the range of mental health services needed in the district. Also applicable to this case, is the 1988 District IX local health plan. Pertinent to this case, the local health plan divides District IX into two subdistricts when planning for short-term psychiatric beds. Subdistrict one consists of Indian River, Martin, St. Lucie and Okeechobee Counties, and subdistrict two consists of Palm Beach County. In allocating short-term psychiatric beds between subdistricts, the local plan provides: When bed need is shown in District IX for either short-term psychiatric services or substance abuse services in accordance with Chapter 10-5.11 of the Florida Administrative Code, the method for allocating beds among subdistricts shall be based upon projected subdistrict occupancy figures as determined by use-rates during the most recent calendar year in combination with projected subdistrict population figures. New beds shall be allocated to the subdistrict showing the highest projected percent occupancy, to the extent that the projected percent occupancy equal that of the other subdistrict. When projected occupancy figures show parity, any remaining beds shall be allocated based upon each subdistrict's percentage of projected patient days for District IX. All projections shall be five years into the future to correspond with the planning horizon governing the addition of psychiatric and substance abuse beds as set forth in state rule. Applying the local plan's methodology to the facts of this case demonstrates that the beds identified by the Department's need methodology should be allocated to subdistrict two, Palm Beach County, which is the county within which First Hospital proposes to locate. The local plan also requires an examination of an applicant's commitment or record of service to medicaid/indigent and underserved population groups. The First Hospital facility will be a specialty hospital and therefore not eligible to provide medicaid services; however, First Hospital has committed to dedicate 8 percent of its patient days to indigent care. Under such circumstances, First Hospital's application is, on balance, consistent with the local plan. The ability of the applicant to provide quality of care and the applicant's record of providing quality of care First Hospital is a wholly owned subsidiary of First Hospital Corporation, an established provider of psychiatric services to children and adolescents since 1983. As of this date, First Hospital Corporation owns and operates 15 hospitals nationally, and has demonstrated the commitment and ability to provide quality care to its patients. Here, First Hospital's staffing is reasonable, and while the program proposed by First Hospital is generic in nature, and similar to that offered by other short-term providers of such services, it will assure, in light of demonstrated need, that patients needing acute short-term psychiatric services in the district will continue to receive quality care. To the extent that the needs of the district may subsequently evidence the need for more specialized programs, First Hospital has demonstrated its ability to address such needs, and to provide quality programs and services. The availability and adequacy of other health care facilities and services in the service area which may serve as alternatives for the health care facilities and services proposed by the applicant The Department's short-term psychiatric bed rule addresses the need for psychiatric facilities that will treat emotional and behavioral disorders which require admission to a short-term acute care facility for treatment. Where such short- term psychiatric care is indicated, any other type of placement would not be appropriate under existing rules (not long-term, residential treatment, group home, or out-patient care), and there are no alternatives for the services proposed by First Hospital. The availability of resources, including health manpower, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation First Hospital has demonstrated that it either has or can obtain all resources, including health manpower, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation. As heretofore noted, First Hospital Corporation, the parent of the applicant, has provided psychiatric services to children and adolescents since 1983, and currently owns and operates 15 hospitals nationally. It has never experienced any serious difficulty in financing its operations, either start-up or operational, and has in place an existing program for the recruitment and training of medical, administrative, clerical and other personnel that might be needed for the proposed facility. First Hospital Corporation has no other new projects pending at this time, and has committed itself to the project proposed by its subsidiary. Additionally, Dr. Ronald Dozoretz, who is president, chairman of the board, and the principal stockholder of First Hospital Corporation, has the available resources to finance the subject project, and has also committed to do so if necessary. 8/ The extent to which the proposed services will be accessible to all residents of the service district, and the applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent As a freestanding psychiatric facility, First Hospital is not eligible to receive Medicaid funds for the treatment of psychiatric disorders; however, it has committed to provide 8 percent of its patient days to the care of patients who qualify as indigent, and has agreed that its CON be so conditioned. In view of this commitment, as well as the demonstrated need within the district for the proposed services, approval of First Hospital's application will increase accessibility to all residents of the district. The probable impact of the proposed project on the costs of providing health services proposed by the applicant. The proof demonstrates that existent facilities in Palm Beach County are operating near capacity, and that to meet expected demand at the planning horizon an additional 48 short- term psychiatric beds are needed. Under such circumstances, approval of First Hospital's application will stimulate competition and promote quality assurance and cost-effectiveness. While the proof establishes the need for 48 additional beds at the horizon year, the protestants to First Hospital's application contend that, due to the finite number of qualified professionals within the area to staff the facility and the finite number of patients requiring such care, they will be adversely impacted if the application is approved. Succinctly, they contend that they may lose staff or be compelled to pay higher salaries, and that they may lose patients and therefore revenue, if the facility is approved. The protestants' proof regarding potential impact to their existing staff or competition for staff was unpersuasive. In light of the number of existing facilities that already offer mental health type services within the district, and therefore currently compete for the same professionals, First Hospital's entry into the market should not significantly impact existing competition. As importantly, the protestants failed to quantify any such impact or otherwise persuasively demonstrate that, assuming they were compelled to pay more to retain or attract competent staff, such increased expense would adversely affect their operation. With regard to the protestants' concerns regarding lost patient days and revenue, the demonstrated need for the additional 48 beds at the horizon year mitigates the potential for any adverse impact to existent providers in the long term. However, this does suggest that First Hospital's application, as proposed, does not demonstrate a potential to significantly adversely affect existent providers in the short term. To the contrary, should First Hospital achieve the level of utilization it projects in its application, its facility would have a significant adverse impact on existing programs. In this regard, First Hospital's application projects that it will achieve 8,956 patient days in 1991, its first year of operation, and 13,193 patient days in 1992, its second year of operation. Through 1991, there will only be a growth of approximately 3,498 patient days over those that were served by existing facilities in 1988, and through 1992, there will only be a growth of approximately 4,664 patient days over those that were served by existing facilities in 1988. Therefore, to achieve it's projected occupancy levels, First Hospital would have to capture 5,458 patient days in 1991 and 8,529 patient days in 1992 from the patient base that had previously been served at existing facilities. Such impact to those facilities, should First Hospital be able to achieve its projected levels of occupancy, would be significant and adverse. 9/ The costs and methods of the proposed construction As heretofore discussed, First Hospital proposes to construct an 80- bed facility on approximately 30 acres of land in Palm Beach County, Florida, which will include the 48 short-term psychiatric beds which are the subject of this proceeding, as well as the 32 residential treatment beds which the Department concluded were not subject to CON review. The 80-bed facility proposed, at 49,142 gross square feet, will consist of a central core area of approximately 25,000 square feet, which includes three wings; an education and activity wing, a food service wing, and an administrative wing. These wings will house the therapy, kitchen and dining, gymnasium, classrooms, administrative offices, and other services necessary to support the psychiatric facility. Attached to the core area, are two psychiatric wings, at 7,592 square feet each, which will each contain 24 beds dedicated to short-term psychiatric care, and one wing, at 8,944 square feet, which will contain 32 beds dedicated as residential treatment beds. On the adjacent grounds, First Hospital also proposed a swimming pool, tennis courts, baseball field, and sports filed. In its application, First Hospital estimated its total project cost for the proposed psychiatric facility at $4,213,522. This project cost was composed of development cost of $61,500, financing/refinancing costs of $259,800, professional services of $162,000, construction costs of $2,503,162, equipment costs of $480,000, and other related costs of $150,000. But for the construction cost category ($2,503,162), First Hospital derived its estimate of total project costs by allocating 60 percent of the cost of each component of the total cost to the psychiatric facility and 40 percent to the residential treatment facility (the 60/40 methodology). In the case of construction costs, First Hospital based its estimate on the square footage of the psychiatric wings and 60 percent of the core area, which derived a gross square footage for this cost item based on 30,184 square feet, to which it added 60 percent of its estimated costs for site preparation and contingency of construction. Based on this premise, First Hospital's proposal is driven by a $76.33 per square foot cost of construction. 10/ Assuming the propriety of First Hospital's 60/40 allocation of costs, its estimate of project costs is still significantly understated. Here, the proof demonstrates that, as opposed to the $76.33 per square foot cost for construction and site preparation costs estimated by First Hospital, the cost for such work will be $105 per square foot, inclusive of construction and site preparation costs. Based on the 30,184 square feet First Hospital allocated to the project, such cost will amount to $3,169,320, which, when added to the 5 percent contingency factor, the $96,000 allocated for the proposed pool, and the addition of 460 square feet to patient rooms needed to meet Department standards, derives a construction cost figure of $3,472,086, as opposed to the $2,503,162 estimated by First Hospital. In addition to straight construction costs, First Hospital also underestimated its equipment costs. In this regard, First Hospital's equipment list omits many necessary items, including: nurse call equipment, a security system, an emergency generator, therapy and recreational equipment, gym equipment, ice machines, defibrillators, crashcarts, educational materials, media equipment, graphic artwork, interior design items, shelving/lockers for staff and patients, housekeeping items, medication carts, and other necessary equipment. Had First Hospital properly calculated its equipment costs, it would have derived a cost of at least $1 million for movable equipment and at least $150,000 for fixed equipment for the 80--bed facility as opposed to the $700,000 for movable equipment and $100,00 for fixed equipment it estimated. Under such circumstances, applying First Hospital's 60/40 methodology would establish an equipment cost for the subject project at $690,000, as opposed to the $480,000 estimated by First Hospital. 11/ Since financing costs and professional services fees would also require an upward adjustment because of the increase in construction and equipment costs, the total cost for the subject project, utilizing First Hospital's 60/40 methodology, would reach at least $5,488,843, as opposed to the $4,213,522 estimated by First Hospital. 12/ The foregoing analysis of construction costs assumed the reasonableness of First Hospital's 60/40) allocation methodology. For reasons discussed infra, First Hospital's allocation methodology is not reasonable, and its construction costs are therefore dramatically understated. In this regard, the proof demonstrated that the core area, consisting of 25,000 square feet, would be necessary to support the 48-bed psychiatric units whether the 32-bed residential treatment unit were built or not, and that it would be more appropriate to combine the core area and the psychiatric area to assess the subject application. When this is done, the construction cost alone for the project calculates to $4,638,501. 13/ In addition to straight construction costs, all of the other estimated project costs appearing on Table 25 of First Hospital's exhibit 1 are also suspect because of its 60/40 methodology; however, for purposes of this analysis item a, project development costs, and item f, other related costs are assumed accurate, as are construction supervision costs and loan fees. Notably, capitalized interest would increase to at least $355,621, architectural/engineering fees would increase to approximately $242,969, and equipment costs would increase to approximately $726,000. With these adjustments alone, the cost of the 48-bed psychiatric project, which includes the core area, comes to approximately $6,821,000, or over $2,607,000 more than First Hospital estimated. 14/ The unreasonableness of First Hospital's 60/40 methodology To assess the financial feasibility of the proposed project, First Hospital's pro formas address only the expected financial performance of the 48 psychiatric beds and ignore the financial feasibility of the 32-bed residential treatment unit, even through First Hospital postulates that such unit will support 40 percent of the cost of the hospital's core area. At hearing, the explanation offered by First Hospital and the Department for not addressing the financial feasibility of the residential treatment unit, as well as the out-patient services, was their contention that such services are not CON reviewable because First Hospital, as regards the residential treatment unit, is not yet a "health care facility" and, as regards the outpatient services, that such services are exempt from review. In this regard, they point to the provisions of Section 381.706(1), Florida Statutes, which provides; . . . all health-care-related projects, as described in paragraphs (a)-(n), shall be subject to review and shall file an application for a certificate of need with the department . . . (c) A capital expenditure of $1 million or more by or on behalf of a health care facility . . . for a purpose directly related to the furnishing of health services at such facility; provided that a Certificate of Need shall not be required for an expenditure to provide an outpatient health service . . . (Emphasis added) They also point to the provision of Section 381.702, Florida Statutes, which contains the following definitions: (7) "Health care facility" means a hospital. . . . (12) "Hospital" means a health care facility licensed under chapter 395. Based on these statutory provisions, First Hospital and the Department conclude that the residential treatment unit and the outpatient services are not CON reviewable because First Hospital is not yet licensed or the outpatient services are exempt. While the logic of First Hospital's and the Department's conclusion seems questionable where, as here, the projects are proposed to be integrated and constructed simultaneously, the Department's reading of the statute comports with its literal reading and is accepted. However, although the residential treatment unit and outpatient services may not be subject to CON review does not suggest that their financial feasibility is not relevant to this proceeding. To the contrary, their financial feasibility is critical if First Hospital's 60/40 methodology is to be considered rational. Here, the 48-bed psychiatric facility proposed by First Hospital is comprised of two 24-bed units and a core unit that provides all necessary support functions, including administrative, therapy, kitchen and dining, gymnasium and classroom areas, for those units. That core area, of 25,000 square feet, is an essential part of the proposed psychiatric hospital; without it there would be no psychiatric hospital, and at a lesser square footage the project would be lacking sufficient space to provide necessary services. When licensed by the Department, the two 24-bed units and the core area will be licensed as a psychiatric hospital. Notwithstanding, the fact that the 25,000 square foot support area is an integral and essential part of the proposed hospital, the Department chose to ignore 40 percent of its costs and expenses in assessing the financial feasibility of the project. The basis for the Department's action was its conclusion that the non-CON reviewable residential treatment unit comprised 40 percent of the overall population of the entire facility (80-beds overall), and that since it would share the core area, 40 percent of the costs of constructing that area, as well as subsequent operating expenses, were not pertinent to an evaluation of the proposed hospital. Here, the Department's reasoning and its conclusion, be they incipient policy, do not have evidentiary support. The psychiatric hospital proposed by First Hospital is, as heretofore noted, the two 24-bed units and the core area. This is the only portion of the project over which the Department has control, and necessarily the only portion that it can assure will be built as proposed; it has no control over whether the residential treatment unit will ever be built or be built as proposed. Therefore, since the core unit is an essential part of the psychiatric hospital, and the residential treatment unit is exempt from CON review, an assessment of the subject application must consider the cost of the entire core area as part of the project under review. While economies of scale permit utilization of the core unit by the residential treatment unit without additional space, this does not detract from the conclusion that the cost of the core is a cost of the hospital. Rather, such excess capacity is fortuitous for First Hospital, and may permit it to spread the expenses of its operation over a larger population base if the residential treatment unit is built. However, to reasonably assess whether those expenses of operation can be spread to or supported by the residential treatment unit to any extent, much less 40 percent, requires an analysis of the financial feasibility of those services. Here, First Hospital offered no proof of the financial feasibility of the residential treatment unit, and there is no rational basis on which any allocation of operating expenses for the core area can be demonstrated to be supportable by it. Accordingly, to assess the financial feasibility of the proposed psychiatric hospital it is necessary to attribute the cost of the core area to the proposed project, as well as the costs of carrying and operating that part of the proposed hospital. 15/ The immediate and long-term financial feasibility of the proposal To assess the financial feasibility of the proposed project, First Hospital's pro forma assumes that it will achieve 8,956 patient days in its first year of operation and 13,193 patient days in its second year of operation, with a per diem patient charge of $500 in year one and $525 in year two, and that it will thereby achieve a gross revenue of $4,478,000 in its first year of operation and a gross revenue of $6,926,325 in its second year of operation. While the proposed patient charges are reasonable, First Hospital's occupancy projections are not supported by persuasive proof and, therefore, it has failed to demonstrate what revenues it could reasonably expect to generate. A facility's projected patient days are typically a product of an informed analysis of projected admissions and projected average length of stay. Here, First Hospital undertook no such analysis, but simply assumed a number of patient days, without any rational predicate in an effort to demonstrate financial feasibility. Notably, there is a clear trend toward shorter lengths of stay in psychiatric hospitals, which was even recognized by First Hospital's Dr. Dozoretz who reasonably expected an average length of stay at the proposed facility of 30 to 40 days. However, First Hospital assumed in its pro forma an average length of stay ranging from 45 to 60 days. Such assumption could not have been the basis for any considered analysis of utilization since it is excessive, as well as too imprecise. Moreover, in testing the reasonableness of a utilization projection, it is also important to consider physician support, the extent of waiting lists, community support, the extent of competition, and the depth of local needs assessment. Here, there is no persuasive proof that First Hospital enjoys any support from local physicians, that there are any waiting lists, that the market is not competitive, that there is any community support for the project, or that it undertook any reasonable assessment of local need. In addition to its failure to demonstrate what utilization level it could reasonably achieve in its first two years of operation, and therefore establish a reasonable estimate of its gross revenue, First Hospital's pro forma also, significantly underestimated building depreciation, equipment depreciation, and interest expense because of its failure to adequately address construction and equipment costs, discussed supra. Had First Hospital properly assessed such costs, by subsuming the psychiatric hospital to include 100 percent of the psychiatric wings and core area, it would have calculated building depreciation at $176,230 per annum, equipment depreciation at $72,600 per annum, and interest at $750,360 per annum. At these rates, assuming the validity of First Hospital's projection of gross revenue, the facility's projected loss in year one would increase from $115,629 to $529,848, and its projected profit in year two of $442,184 would be reduced to $27,965. 16/ As well as underestimating the foregoing expenses, First Hospital's pro forma also significantly underestimates a number of other expenses, including deductions from gross revenue, supplies and other expenses, and the indigent care tax assessment. In this regard, the proof demonstrates that First Hospital underestimated its deductions from revenue by $367,000 in year one and $214,000 in year two; underestimated its supplies and other expenses in year one by at least $645,000, and in year two by at least $561,000; and omitted the indigent care tax assessment of $56,000 in year one and $75,000 in year two. Considering these additional adjustments, First Hospital's project, even assuming its gross revenue projections are reasonable, is not financially feasible in either the short-term or long-term. 17/ The criteria on balance In evaluating the application at issue in this proceeding, none of the criteria established by Section 381.705, Florida Statutes, or Rule 10- 5.011(1)(o), Florida Administrative Code, has been overlooked. First Hospital's failure to demonstrate the financial feasibility of its proposal is, however, dispositive of its application, and such failure is not outweighed by any other, or combination of any other, criteria.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that: As to Case NO. 89-1415, that a final order be entered denying First Hospital's application for Certificate of Need. As to Case NO. 89-1438, that a final order be entered dismissing Humana's petition for formal hearing. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 23rd day of May 1990. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of May 1990.
The Issue The issue for determination is whether Petitioner is in substantial compliance with the requirements in section 395.4025, Florida Statutes, and, therefore, has the critical elements required for a trauma center, so that Respondent must find Petitioner's Level II Trauma Center Application acceptable for approval, which would make Petitioner eligible to operate as a provisional trauma center.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order (i) deeming JSCH's Application acceptable, verifying that the hospital is in substantial compliance with the requirements in section 395.4025, and (iii) approving JSCH to operate as a provisional Level II trauma center until the 2014-16 application cycle is concluded with finality vis-à- vis TSA 19. DONE AND ENTERED this 29th day of February, 2016, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of February, 2016.
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 DOAH Case No. 01-3148: Whether the Respondent's licensure status should be reduced from standard to conditional. DOAH Case No. 01-4649: Whether the Respondent committed the violations alleged in the Administrative Complaint dated October 15, 2001, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: AHCA is the state agency responsible for licensing and regulating the operation of nursing home facilities, including ensuring that nursing homes are in compliance with criteria established by Florida statute. Chapter 400, Part II, Florida Statutes (2001). AHCA is authorized in Section 400.23(8), Florida Statutes, to impose administrative fines on nursing home facilities that fail to meet the applicable criteria. Florence Treakle conducted surveys of Life Care on May 9, 2001, and June 12, 2001, as a result of complaints received by AHCA. Because the surveys were conducted as a result of complaints received by AHCA, Ms. Treakle was the only AHCA surveyor conducting the surveys. The results of the surveys were reported on a form identified as "HCFA-2567," which is generated by the federal Department of Health and Human Services, Health Care Financing Administration, and is commonly referred to as a "Form 2567." Several deficiencies were identified in the Form 2567s completed for the May 9, 2001, and June 12, 2001, surveys, which were each cited to a federal "tag number" designated as "F" tags,1 to the applicable provision of the Code of Federal Regulations, and to the applicable Florida administrative rule. Each deficiency was also classified under Florida law as either a Class II or a Class III deficiency, and a factual narrative was included to support each deficiency cited. May 9, 2001, survey.2 The Form 2567 for the May 9, 2001, survey included a citation for a Class III deficiency under F-279, "Resident Assessment," and Section 483.13(c), Code of Federal Regulations. This citation involved the care provided to residents L.D. and A.M. and was supported by the assertion that, "[b]ased on observation and record review[,] . . . the facility did not have comprehensive care plans in place for healing of the residents [sic] pressure sores." A care plan is a tool used by the nursing staff to ensure that the resident is getting consistent care and is compiled from data included in a resident's Comprehensive Assessment. An entry in a care plan includes the identification of a problem, a goal for resolving or improving the problem, and the approaches, or means, to be used to reach the goal. Resident L.D. L.D. came into Life Care with pressure ulcers, including a Stage IV pressure ulcer3 on his coccyx, which is located at the bottom of the backbone. L.D. was receiving wound care both at Life Care and at a wound care center pursuant to a physician's order dated April 4, 2001, which contained the following requirement: "[O]ffload[] all boni [sic] prominences as much as possible." In accordance with this order, L.D. was turned and repositioned in bed every two hours, and he was provided with a special, pressure-relieving mattress. L.D. was a very quiet person, but he had no cognitive impairment and was able to communicate his needs to staff. L.D.'s wife visited him every day; she usually arrived in mid-morning and left in mid-afternoon, and she returned for a few hours in the evening. Both L.D. and his wife made it clear to the Life Care staff that L.D. wanted to sit in a wheelchair as much as possible so that he could move around the facility, take walks outdoors with his wife, and have his meals sitting up. L.D. used a special, high-backed wheelchair that he provided for his use while he was a resident of Life Care. The chair reclined so that pressure on his coccyx could be relieved somewhat, and Life Care furnished him a gel cushion for his wheelchair, also to help relieve pressure on his coccyx. On May 9, 2001, Ms. Treakle observed L.D. sitting in his wheelchair for over two hours, from 10:20 a.m. until 1:00 p.m. She found nothing in L.D.'s Care Plan regarding the amount of time L.D. would be permitted to sit in a wheelchair. Resident A.M. A.M. entered Life Care with a Stage III pressure ulcer on his left buttock. A.M. was receiving wound care at Life Care in accordance with the approaches included in his Care Plan. A.M. was not cognitively impaired, and he could communicate his needs to staff. His granddaughter and one year-old great-grandson visited him every day, and he enjoyed sitting outside in a wheelchair with his great-grandson on his lap. A.M. also liked to spend most of his time outside his room, moving himself around the facility in a wheelchair. Life Care provided a gel cushion for his wheelchair to help relieve pressure on A.M.'s buttock. On May 9, 2001, Ms. Treakle observed A.M. sitting in a wheelchair from 2:00 p.m. until 3:30 p.m. A.M.'s Care Plan did not contain an entry establishing the amount of time A.M. would be permitted to sit in a wheelchair. Summary. AHCA has failed to establish by even the greater weight of the evidence that the Care Plans developed for L.D. and A.M. were deficient. AHCA failed to present credible evidence of the contents of L.D.'s Care Plan,4 but the evidence is uncontroverted that L.D.'s wound care orders contained approaches for healing his pressure sores. A.M.'s Care Plan included several approaches for healing his pressure sores, and AHCA has not alleged that the required wound care was not provided to either L.D. or A.M. Rather, AHCA's specific complaint regarding the Care Plans of L.D. and A.M. is that there was no approach specifying the amount of time L.D. and A.M. would be permitted to sit in their wheelchairs. This complaint is based exclusively on the expectations of Ms. Treakle. Ms. Treakle expected to find this approach in the Care Plans because, in her opinion, pressure on the coccyx and buttocks can never be completely relieved when a resident is sitting,5 and any pressure on a pressure ulcer impedes healing because it decreases blood flow to an area. Accordingly, Ms. Treakle "would expect good practice would [sic] be for the Care Plan to indicate how long the resident was going to sit on this pressure sore."6 AHCA did not, however, submit any evidence of a standard of care requiring that the duration of time a resident can sit in a wheelchair be included as an approach in the care plan of a resident with a pressure ulcer, especially when the resident is alert, mobile, and able to communicate with staff. June 12, 2001, survey. The Form 2567 for the June 12, 2001, survey cited Life Care for three deficiencies: A Class II deficiency was cited under F-224, "Staff Treatment of Residents," and Section 483.13(c)(1)(i), Code of Federal Regulations, involving the care provided to residents E.G. and N.D. and supported by the assertion that "[b]ased on observation, record review and interview[,] the facility did not monitor and supervise the delivery of care and services." A Class III deficiency was cited under F-279, "Resident Assessment," and Section 483.20(k), Code of Federal Regulations, supported by the assertion that, "[b]ased on review of the care plan for resident #1 [N.D.], . . . the facility did not complete a comprehensive care plan that was revised to reflect all fall risks." A Class II deficiency was cited under F-281, "Resident Assessment," and Section 483.20(k)(3)(i), Code of Federal Regulations, supported by the assertion that, "[b]ased on citations at F 224[,] F 279 and F 324[,] the facility nursing staff did not provide care that met professional standards for residents #1 [N.D.] and #2 [E.G.]." Resident E.G. Diabetes management. Pertinent to these proceedings, E.G. was diagnosed with insulin-dependent diabetes; his blood sugar generally ranged from 150 to 270, which is in the mid-range, although it once reached 348. E.G. was alert, oriented, self-ambulatory, and somewhat grouchy. E.G.'s brother visited him about three times each week, and E.G. often left the facility with his brother for a meal. He did not adhere strictly to his diet, but often ate fried foods when he went out with his brother, and he kept a supply of orange juice in the small refrigerator in his room. Both fried foods and orange juice are contraindicated for diabetics. Pursuant to physician's orders, E.G.'s blood sugar was to be monitored four times a day, before each meal and at bedtime,7 and insulin was to be administered on a sliding scale, in an amount to be determined based on his blood sugar level. This order was transcribed on E.G.'s Medication Record, which, for each day of the month, included spaces for the time, the blood sugar level, the insulin coverage (the dosage expressed in number of units administered), and the site of injection, together with the initials of the staff member providing the care. Life Care staff also maintained glucose monitoring sheets, which included spaces for the date, the time, the blood sugar level, the dosage of insulin administered, and the initials of the staff member providing the care. There is no documentation in E.G.'s Medication Records, his glucose monitoring sheets, or the Nurses Notes that his blood sugar was checked at 11:30 a.m. on June 7, 2001. When his blood sugar was checked at 4:30 p.m. on June 7, it was 317, which is substantially higher than usual. For the 6:30 a.m. checks on June 2, 3, and 8, 2001, E.G.'s blood sugar level was documented and there are notations that insulin was given, but the dosages and sites of injection were not noted; E.G.'s blood sugar at the 11:30 a.m. checks on these days was either virtually the same as, or less than, the levels noted at the 6:30 a.m. checks. For the 6:30 a.m. check on June 4, 2001, E.G.'s blood sugar level was documented, but there is no notation that insulin was given; E.G.'s blood sugar at the 11:30 a.m. check on June 4 was less than the level noted at the 6:30 a.m. check. Wound Care. On June 5, 2001, a dermatologist removed a lesion from the top of E.G.'s left hand. The dermatologist prescribed Bactroban ointment, which was to be applied to the wound twice a day. Wound care instructions were included with the prescription, which provided as follows: Leave bandage on for 24 hours only without getting wet. Remove bandage after 24 hours and then do not apply another bandage. Leave the area open and clean the wound twice daily with warm water. Pat the wound dry and then apply Bactroban Ointment. Bactroban Ointment is a topical antibiotic that can be purchased without a prescription. Continue to do this until the wound has healed. Normal bathing can be resumed after the bandage is removed. Some redness and swelling are normal in the immediate area of the wound. If the wound develops significant redness, tenderness or a yellow drainage, please contact this office immediately . . . . A physician's order dated June 5, 2001, was written for E.G. for "Bactroban oint to wound on L hand, 45gm." The order did not state how often the ointment was to be applied or include the other instructions accompanying the prescription. The order was transcribed on E.G.'s Treatment Record on June 5, 2001, but the entry provided only that Bactroban ointment was to be applied to the wound once a day. There is nothing in E.G.'s Care Plan, Treatment Record, or Medication Record to document that his wound was treated between June 5 and June 12, 2001, nor was there any indication in E.G.'s chart that anyone signed for the Bactroban ointment. Marion Neuhaus, the Director of Nursing at Life Care at the times pertinent to these proceedings, observed E.G.'s wound every day because E.G. came to her office to show her the wound and other bumps and scrapes he accumulated as he walked around the facility. Ms. Neuhaus noted that the wound was scabbed, that there was a pink area around the wound, and that there was no swelling or drainage. Treatment was begun on the wound on June 12, 2001, and it healed without any complications. Summary. AHCA has established clearly and convincingly that Life Care did not provide E.G. with the wound care that was ordered by his physician. AHCA has, however, failed to establish by even the greater weight of the evidence that the healing process of E.G.'s wound was compromised by this lack of treatment. Ms. Treakle observed E.G.'s wound on June 12, 2001, and noted that it was scabbed and red around the edges. Ms. Treakle concluded that this redness alone indicated that the wound was infected. This conclusion is undermined by the notation in the wound care instructions included with E.G.'s prescription from the Dermatology Center that "[s]ome redness and swelling are normal in the immediate area of the wound." Furthermore, Ms. Treakle did not follow E.G.'s wound after June 12, 2001, and the evidence presented by Life Care that E.G.'s wound healed in a timely manner is uncontroverted. AHCA has established clearly and convincingly that there are several omissions in the documentation of Life Care's monitoring of E.G.'s blood, but these omissions do not reasonably support the inference that Life Care failed to monitor E.G.'s blood sugar and administer insulin on these dates as required by the physician's orders; rather, Life Care's failure on these occasions was inadequate documentation, not inadequate care. AHCA has, however, established clearly and convincingly that Life Care did not monitor E.G.'s blood sugar as required by his physician's order at 11:30 a.m. on June 7, 2001; this inference may reasonably be drawn based on the lack of documentation and E.G.'s elevated blood sugar at the next check at 4:30 p.m. Ms. Treakle assumed that E.G. suffered actual harm as a result of this omission because, in her view, hyperglycemia, or elevated blood sugar, always causes damage to the body; Ms. Treakle could not, however, identify any specific harm to E.G. caused by this one omission. AHCA has failed to establish by even the greater weight of the evidence that E.G.'s physical well-being was compromised by Life Care's failure to monitor his blood sugar on this one occasion. Resident N.D. Fall from Shower Chair.8 At the times pertinent to these proceedings, N.D. was a 79 year-old woman who had been a resident of Life Care since October 26, 1999. According to the assessment of N.D. included in the Minimum Data Set completed on May 3, 2001, N.D. suffered from Alzheimer's disease, had long- and short-term memory problems, and was severely impaired and unable to make decisions; as of June 12, 2001, N.D. was almost entirely dependent on staff for all of the activities of daily living. N.D.'s Care Plan for November 6, 2000, which was updated with handwritten notes, reflects that she had poor safety awareness. The Interdisciplinary Notes maintained by Life Care reflect that, on June 5, 2001, a nurse observed N.D. leaning forward in her wheelchair at breakfast; this was the first mention of this behavior in N.D.'s chart. Dr. Gil, N.D.'s physician, included a notation in the Physician's Progress Notes for June 8, 2001, that he observed N.D. leaning forward but was unable to assess her abdomen because of her anxiety. The Interdisciplinary Notes reflect that Dr. Gil visited N.D. on Saturday, June 9, 2001, and that she was again leaning forward in her wheelchair, "almost falling out of [her] chair." Dr. Gil ordered an ultra-sound of N.D.'s abdomen and a "lap buddy while in w/c [wheelchair] to prevent falls." Dr. Gil's order was noted in the Interdisciplinary Notes for June 9, 2001, as well as on a physician's order form signed by Dr. Gil on June 10, 2001. According to Life Care's written policy, physician orders are to be transcribed into a patient's care plan, treatment plan, or medication administration record, depending on the nature of the order. Dr. Gil's order for a lap buddy had not been transcribed into N.D.'s November 6, 2000, Care Plan at the time Ms. Treakle conducted her survey on June 12, 2001.9 A lap buddy was used on N.D.'s wheelchair beginning on the morning of June 11, 2001. On the evening of June 11, 2001, CNA Nova Coleman was caring for N.D. Ms. Coleman had been working for Life Care for only a short time, and N.D. was one of the first patients Ms. Coleman cared for after finishing her initial training. Ms. Coleman was, however, not an inexperienced CNA, having previously worked at another nursing home. At approximately 8:30 p.m., Ms. Coleman and another CNA had just finished showering N.D., and N.D. was sitting in a shower chair; her hair had been toweled dry, and she was dressed in her night clothes. The second CNA left the room, and Ms. Coleman, who had been standing in front of N.D., moved to the back of the shower chair so she could push N.D. out of the shower area. As she moved around the chair, N.D. pitched forward and fell face-first onto the floor. Ms. Coleman tried to grab N.D. to stop her from falling, but N.D. toppled over so quickly that Ms. Coleman could not reach her. N.D. suffered severe bruises to her face and a laceration on her lip as a result of the fall, but she did not break any bones. Ms. Coleman had not been advised prior to the fall of N.D.'s tendency to lean forward in her chair. N.D.'s tendency to lean forward in her wheelchair should have been entered in her Care Plan, together with the requirement that a lap buddy was to be used whenever she was in a wheelchair. In addition, Ms. Coleman should have been briefed on N.D.'s condition, including her tendency to lean forward, before Ms. Coleman was allowed to care for N.D. Although a lap buddy was not ordered for the shower chair and, in fact, could not appropriately have been used on a shower chair, the former Nursing Director of Life Care conceded that there were other means by which N.D.'s fall could have been prevented.10 The former Nursing Director also conceded that the failure to brief Ms. Coleman on N.D.'s condition probably contributed to the fall from the shower chair. Summary. AHCA has established clearly and convincingly that Life Care failed to provide N.D. with the services necessary to prevent her from falling from the shower chair and injuring herself, that Life Care failed to provide services that met professional standards, and that Life Care failed to revise N.D.'s Care Plan to include the risk of her falling forward while seated and the approaches Life Care would take to prevent her from injuring herself. Life Care conceded that the Care Plan should have included N.D.'s tendency to lean forward while seated and Dr. Gil's order of June 9, 2001, that N.D. be provided with a lap buddy when she was in the wheelchair. Life Care also conceded that the CNA should have been briefed on N.D.'s condition before she was assigned to care for N.D. Life Care further conceded that, even though Dr. Gil did not specifically prescribe a restraint to be used in the shower chair, measures could have been taken to ensure that N.D. did not fall out of the shower chair. AHCA has also established clearly and convincingly that Life Care's failure to provide proper care to N.D. resulted in her suffering significant injuries to her face. Although the injuries were to soft tissue and ultimately healed, N.D.'s physical well-being was adversely affected. In addition, AHCA has established clearly and convincingly that, even had N.D. not fallen and suffered injuries, the failure to include in N.D.'s Care Plan her tendency to lean forward and its failure to transcribe the physician's orders regarding the lap buddy into the Care Plan could have caused a lapse in the care provided to N.D. that could have possibly resulted in injury.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order Sustaining the reduction in the licensure status of Life Care Center of Port Saint Lucie to conditional for the period extending from June 12, 2001, to August 17, 2001; and Imposing an administrative fine in the amount of $5,000.00. DONE AND ENTERED this 15th day of May, 2002, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of May, 2002.
