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 The issue in this case is whether the Certificate of Need (CON) application No. 9757 filed by Select Specialty Hospital - Marion, Inc. (Select) for the establishment of a 44-bed free standing Long-Term Care Hospital (LTCH) in Agency for Health Care Administration (Agency or AHCA) Service District 6, in Polk County, should be approved.
Findings Of Fact The Parties AHCA. The Agency for Health Care Administration is the state agency authorized to evaluate and render final determinations on CON applications pursuant to Section 408.034(1), Florida Statutes.2 Select. Select Specialty Hospital-Marion, Inc. is the applicant in this proceeding. Select is a wholly-owned subsidiary of Select Medical Corporation, which operates approximately 99 LTCHs in 27 states. LTCH Services Generally. An LTCH is defined by statute and Agency rule as "a hospital licensed under chapter 395 which meets the requirements of 42 C.F.R. s. 412.23(e) and seeks exclusion from the Medicare prospective payment system for inpatient hospital services." LTHCs are licensed as acute care hospitals, but are clearly different. In Florida, existing LTCHs can add beds without undergoing CON review. Approximately 93 to 96 percent of LTCH patients are admitted from short-term acute care hospitals. LTCHs are a part of the continuum of care that runs from hospitals to post-acute care facilities such as nursing homes, skilled nursing facilities (SNFs), hospital-based skilled nursing units (SNUs), and comprehensive medical rehabilitation (CMR) facilities. LTCHs are designed to serve patients that would otherwise have to be maintained in a traditional acute care hospital (often in the ICU), or be moved to a traditional post- acute care facility where the patient may not receive the level of care needed. Patients with co-morbidities, complex medical conditions, severe injuries due to trauma, or frailties due to age are typically appropriate LTCH patients, particularly if the patient would otherwise remain in the ICU of a traditional acute care hospital. For such patients, an LTCH is likely the most appropriate setting from both a financial and patient-care standpoint. There is a distinct population of patients who, because of the complexity or severity of their medical condition, are best served in an LTCH. However, there is an overlap between the population of patients that can be served in an LTCH and the population of patients that could also be well-served in the ICU of an acute care hospital or a traditional post acute care setting with ventilator capability. SNFs, SNUs, CMR facilities, and home health care are not appropriate for the typical LTCH patient because the patient's acuity level and medical/therapeutic needs are higher than those generally treated in those settings. Unlike traditional post- acute care settings, which typically do not admit patients who still require acute care, the core patient-group served by LTCHs are patients who require considerable acute care through daily physician visits and intensive nursing care in excess of seven hours of direct nursing care per patient day and remain at an LTCH for an average length of stay (ALOS) of 25 days or greater. (Depending on the Diagnostic Related Group (DRG) category for a particular diagnosis, generally, the ALOS for a short-term acute care hospital patient is between three and five days.) It is important for an LTCH patient that the family be involved in the treatment and the continued care of the patient after the patient has been discharged to home or to another level of care on the continuum, such as an SNF/SNU or CMR. Select offers four basic care programs: pulmonary, wound care, neurotrauma, and medically complex. At Select facilities, patients are screened prior to admission to an LTCH to determine whether they are appropriate for admission. InterQual is a set of proprietary criteria used by Select to determine whether patients are suitable candidates for admission to an LTCH or another form of care. CON Application and Preliminary Agency Action Select applied for a CON to establish a 44-bed free- standing LTCH in Polk County, one county located in District 6. The facility will consist of 48,598 GSF of new construction. The total project cost is estimated at $14,373,624. The application was complete, and according to prehearing stipulations, the only reason that the application was denied and the issue in the case at hand is need. Select has the burden of proving that there is a need for the LTCH in District 6. Select agreed, as a condition for approval of its application, to provide 2.8 percent of patient days for Medicaid and charity care. The Agency's review of CON application No. 9757 complied with statutory and regulatory requirements. The Agency's review of CON application No. 9757 resulted in the issuance of a State Agency Action Report (SAAR) on June 10, 2004, which recommended the denial of CON application No. 9757 based on Select's failure to demonstrate a need for the proposed facility. District 6 and Polk County Demographics The population of District 6 as of July 2005 was 2,084,339 and is projected to increase nine percent to 2,272,017 by July 2010. This population is dispersed throughout five counties comprising District 6: Polk, Hillsborough, Hardee, Manatee, and Highlands. This includes a population of 354,327 in the age cohort 65+ (the age group eligible for Medicare) and is projected to increase by 15.94 percent by July 2010. This age group contains the patients that are mainly served by LTCHs, as more than 75 percent of admissions to an LTCH are elderly (65+). The population of Polk County in July 2005 was 532,100, projected to increase by eight percent by July 2010 and 103,257 for the 65+ age cohort, projected to increase by 15.13 percent by July 2010. There are two LTCHs that currently serve District 6. Both are operated by Kindred and have a combined 175 LTCH beds.3 According to AHCA data, Polk County residents were discharged from an LTCH in Florida 505 times in the years 2000 to 2005 (first three quarters). Of those 505 LTCH discharges, a total of 452, or 89.5 percent, were from a Kindred facility4 in Hillsborough County. AHCA 3.5 However, this data does not indicate which hospital or other facility the patient may have been referred from, which may be significant. For example, the patients could have been discharged from hospitals or other facilities other than a Polk County hospital/facility. Notwithstanding, this data shows that from year 2002 to 2005, Polk County residents have accessed the LTCHs in Hillsborough County. Also, aside from an upward, unexplained spike in 2002, the utilization numbers are relatively flat. Kindred Hospital - Bay Area - Tampa (Kindred Bay Area) operates 73 licensed LTCH beds and is located one county west of Polk County, in Hillsborough County. It is located approximately one (1) hour away from Winter Haven, which is Select's proposed site in the central area of Polk County. From July 2004 through June 2005, the total occupancy of Kindred Bay Area was at 62.20 percent. From July 2002 to June 2003, the total occupancy for this facility was 67.15 percent. Kindred Hospital - Central Tampa (Kindred Central Tampa) is also located in Hillsborough County, approximately one (1) hour away from Winter Haven.6 From July 2004 through June 2005, the total occupancy of Kindred Central Tampa was 67.37 percent. From July 2002 thru June 2003, the total occupancy for this facility was 77.03 percent. Select's sister facility, Select-Orlando, approved for 40 LTCH beds, is located in AHCA Service District 7 in Orange County, which is northeast of Polk County. (Select Specialty Hospital - Orlando is also located in District 7, operating 35 licensed LTCH beds with occupancy for the year ending June 2005 of 75.83 percent.) In the years 2003-2005 (2003 was the first year the facility was operational), Polk County residents were discharged from the Select-Orlando facility 38 times. This is approximately 7.5 percent of the total Polk County patients discharged. In 2005, only one Polk County resident was discharged from a facility other than the two Kindred facilities or the Select Orlando facility. For July 2004 to June 2005, the occupancy for all LTCHs in the State of Florida was 66.91 percent and 65.21 percent for District 6. From July 2002 to June 2003, the occupancy for all LTCHs in the State of Florida was 73.23 percent and 72.91 percent for District 6. There has been a decline in utilization of LTCHs on a statewide and district-wide (District 6) basis. Select presented letters of support for the LTCH facility in Polk County, including letters from local hospital administration and physicians. See, e.g., S 2, Volume I, Tab 2 at 38-43 and Tab 4; S 2, Volume II, Tabs 7 and 8. Select's Analysis of Need The Agency has not adopted a need methodology for LTCH services. There is no published fixed need pool for LTCHs. Select examined population estimates for Polk County and surrounding areas; the number of acute care hospital beds in the area; the number of LTCH beds in the area; discharge data from area acute care hospitals; the types of patients treated at acute care hospitals; the lengths of stays of the patients treated at those hospitals; and input from local hospital personnel and physicians. Select started its analysis of need on a district-wide basis, but ultimately defined its primary service area as Polk County. T 131-134, 156-157. (Select defined its primary service areas as an area within a 20 mile radius.) Select used four methods to establish the need for the LTCH in Polk County: Extended length of stay analysis GMLOS (Geometric Mean Length of Stay) + 15 days analysis Long-stay short-term acute care versus LTCH penetration analysis UB-92 patient discharge analysis (Polk County) An extended length of stay analysis involves analyzing discharges by DRG from Polk County hospitals to arrive at the top DRGs experienced by these hospitals. This analysis will exclude lengths of stays under 25 days, patients under the age of 14, substance abuse diagnosis, obstetric diagnosis, newborn diagnosis, psychiatric diagnosis, and rehabilitation diagnosis. The total amount of discharges is multiplied by the anticipated length of stay for an LTCH patient (the analysis can be done statewide or using a national average) and then divided by 365 to arrive at an average daily census of patients. Select analyzed Polk County discharges that matched the criteria above and came up with 644 patients, which was multiplied by 40.6 (Florida average LTCH stay at time of application) in one calculation and 33 (national average LTCH stay at time of application) in a second calculation, before dividing by 365 in both to arrive at an average daily census (ADC). Using 40.6 as the average length of stay (ALOS), there is an ADC of 72. With an average occupancy of 72 percent, there is a need for 96 beds in Polk County. Using 33 as the ALOS, there is an ADC of 58 and a need for 77 beds in Polk County at 75 percent occupancy. Select LTCHs have a 28-day ALOS, which yields an average daily census of 49.4 with a bed need for 66 beds in Polk County at 75 percent occupancy. The GMLOS + 15 analysis involves looking at geometric mean lengths of stays for individual DRGs that begin at eight (8) days, excluding obstetrics, psychological, substance abuse, and rehab patients, and then calculating how many of these patients stayed 15 days past their GMLOS for the particular DRG. The number of patients is then multiplied by the ALOS for Florida and the nation and a bed need is determined.7 Using this analysis and data for the 12 months ending September, 2003, Select contends that there were 823 patients who would have exceeded their GMLOS by 15 days. Using 40.6 as the Florida average LTCH stay, results in an ADC of 92. Operating at 75 percent occupancy yields a need for 122 beds. Using 33 days as the national average LTCH stay, results in an ADC of 74. Operating at 75 percent occupancy, yields a net need for 99 beds in Polk County. (Using calendar year 2004 data and the same ALOS of 33 days and occupancy of 75 percent, yields a net need in Polk County for 130 beds. Select's GMLOS + 15 analysis also yields a positive net bed need for Polk County exceeding the 44-beds requested, using an ALOS of 30 and 28 and either 2003 or 2004 data.) S 6 at pages 8-10; T 149-151. Select also used the GMLOS + 15 methodology to predict need for additional LTCH beds on a county-wide basis (for the five counties within District 6) and a district-wide basis. Using 2003 data and 33 days as the average LTCH stay, there is a projected net need for 305 beds district-wide operating at 75 percent occupancy. (A net need for additional LTCH beds is also shown when either 2003 or 2004 data is used with ALOSs of 30 and 28.) S 6 at 8-10. When applied to Hillsborough County, using different patient days and GMLOS + 15 case numbers, but the same occupancy percentages, the GMLOS + 15 methodology reflects a net LTCH bed need for Hillsborough County. For example, using 2003 and 2004 data, a 28 ALOS, and a 75 percent occupancy level, the methodology yields a net bed need of 99 beds in Hillsborough County. Id. A net bed need also is calculated for Hillsborough County when an adjustment is made to the data for severity. S 6 at 11-13. (Select's "most conservative position", using a "capture rate analysis of severity adjusted matters," yields a negative bed need for Hillsborough County and a much lower district-wide net bed need than the other GMLOS + 15 analyses described herein. Select suggests that this analysis understates need. S 6 at 14.) Notwithstanding the overall favorable bed need analysis discussed above, as noted herein, the occupancy levels at the Kindred facilities in Hillsborough County have been declining in recent years and are below the 75 percent occupancy level. Absent persuasive evidence that residents of Hillsborough County are being deprived of access to LTCH services, it appears that Select's net bed need projections for Hillsborough County and District 6 are overstated. Select did not prove (by use of its GMLOS + 15 analysis or otherwise) that there is a need for additional LTCH beds in District 6. GMLOS + 7 was also discussed by Select, but is too aggressive for purposes of LTCH planning. The third method of comparing patients in Polk County who had a long stay (24+ days) in a Short Term Acute Care (STAC) facility versus those who went to an LTCH does not produce an actual bed need number, but instead provides evidence of a need for an LTCH in a particular area. Select contends that the application of this method shows that there is a lack of access to the other facilities in District 6 and there is a need for an LTCH facility in Polk County. An analysis of UB-92 patient discharge data involves pulling the uniform billing records for each patient and looking at the severity adjustment of the long stay patients. The information is available on the AHCA database. (According to Mr. Gregg, UB-92 data "would be one of the best sources that one could use to define severity and eliminate some patients from this length of stay group." T 382.) The DRG alone will not take into account co-morbidities, but the UB-92 will. The analysis of UB-92 data does not compute a specific bed need, but may show that the existence of need. Both parties contend that using the GMLOS + 15 method is the most accurate. Using the GMLOS + 15 method quoted above, Select determined that there was a need for a 44-bed LTCH facility in Polk County and District 6. Issues Regarding Need Analysis There are some problems with the GMLOS + 15 method for determining need. One problem is the inflated length of stay of 40.6 days used in the application. Other problems include the assumption of 100 percent capture of eligible patients and the assumption that any patient who stays 15 days over their GMLOS would be eligible for LTCH services, which is not necessarily true. There have been numerous recent approvals for LTCHs in the State of Florida, and some of these new facilities will impact the capacity numbers of the already existing facilities.8 Proper patient identification is a concern of the Agency with regard to overlap with other suitable services. The Agency contends that using the UB-92 forms is a more accurate way of determining which patients are most suitable for LTCH services. LTCH patients cost Medicare more than patients in other settings. The Medicare Payment Advisory Commission (MedPAC) was established to advise Congress on issues that affect the Medicare program. The Agency introduced into evidence Chapter 5 of the June 2004 MedPAC report into evidence, which concentrated on "Defining long-term care hospitals". AHCA 5; see also AHCA 6 and 7. The Agency has been concerned with the identification of patients who are in need of LTCH services as compared with patients who would be better suited in a post-acute care setting, such as a SNU/SNF or CMR facility. The June 2004 MedPAC report stated in part that LTCH services are for a small number of medically complex patients and that acute hospitals and SNFs are the principal alternatives to an LTCH. The report also contends that LTCH supply is a strong predictor of their use. In other words, according to Mr. Gregg, LTCHs "are a supplier-induced demand." T 317. Travel Patterns and Family/Physician Involvement Patient, family, and physician preferences have always been a part of health care planning. They affect both availability and accessibility. Families and other care givers play a critical role regarding the delivery of care to LTCH patients. The elderly are a special population with special needs. They commonly have to manage multiple problems, including financial difficulties, drug management, transportation logistics, and sometimes fragile mental and physical conditions. Older patients, as care givers, also have a more difficult time driving, especially over longer distances. Medical experts have opined that having an LTCH over one hour away from the patient population in Polk County (the Winter Haven area) is not geographically accessible for the elderly needing LTCH services in Polk County. Further, while primary care physicians may choose to travel to an LTCH to continue to serve their patients, in reality, this does not generally occur when the LTCH is a fair distance from their usual practice area. Select believes the travel patterns from Polk County to Hillsborough County, where the two LTCHs in District 6 are located, show that there is a need for one in the Winter Haven area of Polk County. Although the travel patterns and the travel time to the current facilities may make it inconvenient for the patient or the families, the benefits of LTCH care greatly outweigh this inconvenience. Need on a Subdistrict vs. District Level The Agency reviews the need for additional LTCHs on a district-wide basis. S 12 at 52-54. The fact that there are existing facilities already in District 6 that are being underutilized is a counterargument for "need" in District 6. Select conducted the majority of its needs analysis on a subdistrict level. If a CON application for an LTCH could be reviewed and approved on a subdistrict level, here using Polk County alone, Select would be able to satisfy the need requirement, based, in part, on the number of acute care beds in Polk County, the lack of any LTCH beds in Polk County, travel and accessibility-related issues, population trends, and the county-wide health care provider support for the facility.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency issue a final order denying Select Specialty Hospital - Marion, Inc.'s CON application No. 9757. DONE AND ENTERED this 11th day of July, 2006, in Tallahassee, Leon County, Florida. S CHARLES A. STAMPELOS 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 11th day of July, 2006.
Findings Of Fact At all times relevant hereto Respondent was licensed as a physician in the State of Florida having been issued license number ME0040318. Respondent completed a residency in internal medicine and later was a nephrology fellow at Mayo Clinic. He was recruited to Florida in 1952 by Humana. In 1984 he became associated with a Health Maintenance Organization (HMO) in an administrative position but took over treating patients when the owner became ill. This HMO was affiliated with IMC who assimilated it when the HMO had financial difficulties. At all times relevant hereto Respondent was a salaried employee of IMC and served as Assistant Medical DIRECTOR in charge of the South Pasadena Clinic. On October 17, 1985, Alexander Stroganow, an 84 year old Russian immigrant and former cossack, who spoke and understood only what English he wanted to, suffered a fall and was taken to the emergency Room at a nearby hospital. He was examined and released without being admitted for inpatient treatment. Later that evening his landlady thought Stroganow needed medical attention and again called the Emergency Medical Service. When the ambulance with EMS personnel arrived they examined Stroganow, and concluded Stroganow was no worse than earlier when he was transported to the emergency Room, and refused to again take Stroganow to the emergency Room. The landlady then called the HRS hotline to report abuse of the elderly. The following morning, October 18, 1985, an HRS case worker was dispatched to check on Stroganow. Upon arrival, she was admitted by the landlady and found an 84 year old man who was incontinent, incoherent, and apparently paralyzed from the waist down, with whom she could not engage in conversation to determine his condition. She called for a Cares Unit team to come and evaluate Stroganow. An HRS Cares Unit is a two person team consisting of a social worker and nurse whose primary function is to screen clients for admission to nursing homes and adult congregate living facilities (ACLF). The nurse on the team carries no medical equipment such as stethoscope, blood pressure cuff, or thermometer, but makes her evaluation on visual examination. Upon arrival of the Cares Unit, and, after examining Stroganow, both members of the team agreed he needed to be placed where he could be attended. A review of his personal effects produced by his landlady revealed his income to be above that for which he could qualify for medicaid placement in a nursing home; that he was a member of IMC's Gold-Plus HMO; his social security card; and several medications, some of which had been prescribed by Dr. Dayton, Respondent, a physician employed by IMC at the South Pasadena Clinic. The Cares team ruled out ACLF placement because Stroganow was not ambulatory, but felt he needed to be placed in a hospital or nursing home and not left alone with the weekend approaching. To accomplish this, they proceeded to the South Pasadena HMO clinic of IMC to lay the problem on Dr. Dayton, who was in charge of the South Pasadena Clinic, and, they thought, was Stroganow's doctor. Stroganow had been a client of the South Pasadena HMO for some time and was well known at the clinic as well as by EMS personnel. There were always two, and occasionally three, doctors on duty at South Pasadena Clinic between 8:00 and 5:00 daily and, unless the patient requested a specific doctor he was treated by the first available doctor. Stroganow had not specifically requested to be treated by Respondent. When the Cares unit met with Respondent they advised him that Stroganow had been taken to Metropolitan General Hospital Emergency Room the previous evening but did not advise Respondent that the EMS squad had refused to return Stroganow to the emergency Room when they were recalled for Stroganow the same evening. Respondent telephoned the Metropolitan General Emergency Room and had the emergency Room medical report on Stroganow read to him. With the information provided by the Cares unit and the hospital report, Respondent concluded that Stroganow needed emergency medical treatment and the quickest way to obtain such treatment would be to call the EMS and have Stroganow taken to an emergency Room for evaluation. When the Cares unit arrived, Respondent was treating patients at the clinic. A clinic, or doctors office, is not a desirable or practical place to have an incontinent, incoherent, and non-ambulatory patient brought to wait with other patients until a doctor is free to see him. Nor is the clinic equipped to perform certain procedures that may be required for emergency evaluation of an ill patient. At a hospital emergency Room such equipment is available. EMS squads usually arrive within minutes of a call being placed to 911 for emergency medical treatment and it was necessary that someone be with Stroganow when the EMS squad arrived. Accordingly, Respondent suggested that the Cares team return to Stroganow and call 911 to transport Stroganow to an emergency Room for an evaluation. Upon leaving the South Pasadena clinic the Cares team returned to Stroganow. Enroute they stopped to call a supervisor at HRS to report that the HMO had not solved their problem with Stroganow. The supervisor then called the Administrator at IMC Tampa Office to tell them that one of their Gold-Plus HMO patients had an emergency situation which was not being property handled. Respondent left the South Pasadena Clinic around noon and went to IMC's Tampa Office where he was available for the balance of the afternoon. There he spoke with Dr. Sanchez, the INC Regional Medical Director, but Stroganow was not deemed to be a continuing problem. By 2:00 p.m. when no ambulance had arrived the Cares Unit called 911 for EMS to take Stroganow to an emergency Room. Upon arrival shortly thereafter the EMS squad again refused to transport Stroganow. The Cares team communicated this to their supervisor who contacted IMC Regional Office to so advise. At this time Dr. Sanchez authorized the transportation of Stroganow to Lake Seminole Hospital for admission. Although neither Respondent nor Sanchez had privileges at Lake Seminole Hospital, IMC had contracted with Lake Seminole Hospital to have IMC patients admitted by a staff doctor at Lake Seminole Hospital. Subsequent to his meeting with the Cares team Respondent received no further information regarding Stroganow until well after Stroganow was admitted to Lake Seminole Hospital. No entry was made on Stroganow's medical record at IMC of the meeting between Respondent and the Cares Unit. Respondent was a salaried employee whose compensation was not affected by whether or not he admitted an IMC Gold-Plus patient to a hospital.
Findings Of Fact The Petitioner herein petitioned the Division of Administrative Hearings seeking a determination of the validity of proposed Rule 100-86.008, Florida Administrative Code, in accordance with Section 120.54(4), Florida Statutes. Petitioner has demonstrated its standing to participate in the formal hearing to consider the validity of Rule 100- 86.008, Florida Administrative Code. The parties stipulated that to determine standing, no proof of the facts with regard to standing as alleged within the original Petition would be required and that these might be taken as admitted. Petitioner is a non-profit corporation organized and maintained for the benefit of the 220 governmental- investor-owned- and nonprofit hospitals which comprise its membership and all of Petitioner's 220 members are hospitals subject to the verification requirements of Section 395.031, Florida Statutes and the Proposed Rule. Respondent Department of Health and Rehabilitative Services' (DHRS') contention that Petitioner cannot show injury in fact since only 31 hospitals are currently verified and only 30 more are expected to seek verification within the next biennium is without merit. In the first placed that latter 30 applicants figure is determined to be arbitrary and capricious elsewhere within this order. DHRS also suggests that even if all of the 31 already verified trauma centers were members of Petitioners which they are not, this figure cannot constitute a "substantial number" as discussed in Florida Home Builders Association v. Department of Labor and Employment Security, 412 So.2d 351 (Fla. 1982) of a membership as high as 220. This suggestion begs the question. DHRS thereby illogically assumes that in every case, the more members a Petitioner represents, the less standing to represent them Petitioner has. DHRS' last contention that Petitioner cannot show standing in fact because the trauma center verification program is voluntary in nature is also without merit. To accept DHRS' position that there is no standing since the program is voluntary in nature and no hospital is forced or required to apply for verification would, carried to its reasonable end, mean that no hospital would ever have standing to challenge the Proposed Rule even though the Proposed Rule clearly affects those hospital members of Petitioner who will soon face biennial recertification or reclassification plus other members who may hereafter desire initial certification. Petitioner has standing to bring this challenge. The Economic Impact Statement supports this finding as does the prior participation of Petitioner in the rule-making process. The challenge to the subject rule as offered by Petitioner was timely made. The parties by stipulation have waived the time limitations set forth in Section 120.54(4), Florida Statutes. The thrust of Petitioner's allegations are that Proposed Rule 100- 86.008 is arbitrary, capricious, without rational basis in fact and constitutes an invalid exercise of delegated legislative authority by imposing higher verification fees upon hospitals which desire verification of their emergency rooms as trauma centers than are reasonably needed or authorized under Chapter 395, Florida Statutes. Furthers Petitioner claims that the Economic Impact Statement for this proposed rule is inadequate and unfair and has "impaired the correctness of the rule adoption proceedings," primarily upon the allegation that there is no relationship of fee by proposed rule to the statutory authorization and purpose. Petitioner challenges an amendment to Rule 10D-86.008 which seeks to increase the cost of the verification fee which must be paid by each hospital emergency room applicant for every initial verification, for any reclassification and for continued verification every two years as a "trauma center. Using strike-throughs for the deletions and underlining for the additions, the proposed rule seeks to amend current Rule 10D-86.08 as follows: 10D-86.008 Fees. The Department shall charge fees to each applicant hospital. The fee shall be submitted with each application. All such fees will be used solely to defray the cost of the verification program. The following fee schedule shall apply to initials reclassification and continued verification applications: (a) Level I ... 3,000.00 $11,000.00 (b) Level II ... 2,000.00 $11,000.00 (c) Level III ... 1,500.00 $11,000.00 Statutory authorization for the existing and for the proposed rule is found in Section 395.031, Florida Statutes, which provides in pertinent part, as follows: * * * (3) Any hospital licensed in the state that desires to be verified as a trauma center shall submit to the department a request for verification as a trauma center. * * * (5) Biennially thereafter- the department shall review the trauma center to verify its compliance with the standards set forth by subsection (6). The department shall notify the hospital of such verification. If the department finds that the trauma center does not comply with those standards the department shall within 30 days, notify the hospital of its findings. Within 30 days after receiving such findings the hospital may request a hearing in which to contest the findings of the department. The hearing shall be held in accordance with chapter 120. If a hospital does not desire to contest the findings of the department but desires to continue its verification as a trauma center, the hospital shall be given 90 days in which to comply with the standards set forth in subsection (6). After verification of compliance with those standards- the department shall continue the verification of the hospital as a trauma center or verify a reclassification of the trauma center pursuant to the standards set forth in subsection (6). * * * (7) The cost of verification shall be borne by the applicant, based on a fee schedule set by the department not to exceed the cost of verification. (Emphasis supplied.) The trauma center verification program (see Chapter 100- 86, Florida Administrative Code) establishes procedures and fees to verify that facilities and services-of licensed hospitals that apply for trauma center verification meet current standards of the American College of Surgeons. DHRS is the only state agency with any responsibility for verification of trauma centers. A hospital may offer the same services as are offered by a bona fide trauma center without being verified but it may not hold itself out as a trauma center without being verified by DHRS. Upon this limited basis, the program is voluntary as to the hospitals applying and is administered by DHRS' Emergency Medical Services Section. The Emergency Medical Services Section (EMS) is divided into two subsections. One is "Regulatory Services" in which all licensing functions other than trauma center verification are placed and includes such diverse matters as licensing of ambulance services, non-emergency transportation services, emergency medical technicians and paramedics. The licensing of trauma centers is logistically placed within "Program Development," which subsection administers certain grants and which has as its principal function general planning activities pursuant to EMS' statutory responsibility to produce a state plan for emergency medical services. DHRS characterizes the categories of trauma center as follows: a Level I Trauma Center" is the top level and requires a surgeon in the emergency room 24 hours per day as well as a demonstrated commitment to research and training in the area. A "Level II Trauma Center" is quite similar to the Level I center except that it does not have the mandatory commitment to trauma research and training. A "Level III Trauma Center" is largely found in rural areas where the population base is insufficient to support a Level I or Level II trauma center, but represents a maximum commitment to trauma center service based on available resources. Although only a single application form is utilized, it may be logically inferred that the category or level" of verification sought by the applicant to be verified will affect the size, scope, detail, and supporting documentation of its initial application and likewise will affect the scope of the agency procedure leading either to verification or denial of the initial application of each applicants and to any reclassification or continued verification of a previously verified trauma center. This inference was apparently codified in the existing rules by charging application fees graduated by level of verification requested. It is recognized by DHRS that the three respective levels have different configurations of services, equipment, and general effort towards the treatment of trauma and that a Level I application is "significant" in comparison to the other levels. Nonetheless, the proposed rule amendment seeks to establish only the same fee amount or "cost of verifying" the application for all applicants regardless of level of verification requested. When the original trauma center verification program fees were promulgated (Rule 100-86.08), on-site visits (live inspections by an accreditation or verification team) to applicants' trauma centers and program overhead were not calculated into the fees as established because on-site visits were not originally contemplated by the verification program as a whole. When the original trauma center verification program fees were promulgated, it was anticipated that 65 or 70 trauma centers would apply for verification over the first biennium. This estimate was based on a survey of all licensed hospitals. However, in the first year, only 15 trauma centers applied for verification. However, the trauma center verification process, as planned into the next biennium, (1985-1987) now contemplates application and document reviews plus on-site visits as direct costs and overall program overhead as indirect costs. The new proposed fee schedule within Proposed Rule 10D- 86.008 was derived by using anticipated expenses for the 1935- 1987 biennium as a base. DHRS anticipated the total amount needed for the trauma center verification program and program compliance as $329,904. This figure lumps together salaries, expenses and travel for employees of DHRS' Emergency Medical Services Section within the trauma center verification program, physician review of applications, trauma center on-site visits, legal expenses for denial hearings pursuant to Section 120.57(1) and (2), Florida statutes, and expenses of contracting with a medical records consultant and medical director. DHRS candidly admits that these expenses have been calculated into the new proposed fee schedule and maintains that these expenses should be calculated into any fee schedule established. Petitioner's view is that it is only the costs attributable to the actual processing of individual applications which may properly be included as a "cost of verification ... borne by the applicant" pursuant to Section 395.031(7), Florida statutes, and asserts that inclusion of any other costs is arbitrary, capricious, excessive, and not statutorily justified. By its proposed findings of fact as well as by the direct evidence of all of its witnesses, DHRS acknowledges that it has considered the cost of compliance 1/ in devising the non-graduated fee schedule within the Proposed Rule. In calculating the proposed fee schedule, DHRS divided the total amount needed for program operation and compliance (the $329,904 previously referenced) by the estimated number of trauma centers (the 15 per year based on the first year's experience multiplied by 2 for the two-year biennium horizon) to yield a verification fee per trauma center of $10,996.80. The agency then rounded this amount to $11,000 per anticipated applicant for the 1985-1987 biennium, and thus the non-graduated fee in the Proposed Rule was devised. This method does not bear any logical or rational relationship to the size, scope, detail and supporting documentation of the applications as they vary among Levels I, II, and III. Nor can it be said that this method takes into consideration any of the logical or rational differences inherent in the paperwork processing and physician review as it differs by level applied for, or in the type of projected on-site compliance review of the physical plants of applicants for the differing levels. Moreover, although it may be appropriate to begin with the assumption that 15 is a representative idea of the number of initial applications that may require processing in each year, there is simply no documentation or rationale provided by the agency to determine whether the number of initial applications will diminish or increase as the finite number of potentially verifiable hospitals is approached. Therefore, this divisor figure of 15 x 2 borders on mere estimation or speculation and is not statutorily justified. It is not saved by an intention without guarantee of a biennial review of the rule. Unless it somehow embraces a rational projected calculation of reclassifications from one level to another and biennial reviews for compliance with the verification standards, the 15 x 2 figure is further skewed. Since there is testimony that EMS can only hope to do 6 annual on-site reviews at random (presumably encompassing all three categories) , the (15 x 2 30) divisor remains askew, arbitrary, capricious and unjustified. It is interesting that DHRS acknowledges, to a point at least that the 11,0O0 fee schedule figure is inaccurate. Specifically, despite DHRS' rounding up to the nearest thousand dollar amount so as to reach $11,000, it is DHRS' position that its procedure for establishing the non-graduated fee schedule actually underestimates or understates the amount required to fund the verification program. Neither rounding "up" versus rounding "down" nor rounding to the nearest even $1,000 as opposed to the nearest dollar amount was specifically raised as an issue by the parties. However, since it is partly through DHRS' contention that it has actually understated the amount required to fund the verification program that DHRS attempts to parry Petitioner's assertion that DHRS is seeking to cause trauma center verification applicants to bear the cost of the entire trauma center program instead of merely requiring applicants to bear the cost of the single application verification function of that program, some assessment of this "rounding" methodology is in order. DHRS has not demonstrated any specific reason to "round" in this manner, nor how "rounding" relates, if at ally to understatement of fees needed or how it relates, if at ally to precise calculation of the funding amounts actually required. It is easy to appreciate that $11,000 looks better in a printed, codified rule and is easier to administer than an odd number but even those shallow rationales have not been advanced by those rule drafters who testified. Even if one could accept the reasoning that because of the high amounts of fixed costs for the improved verification program DHRS is somehow justified in spreading the cost of the entire verification program equally among all applicants instead of graduating the fees by level, there remains the unrefuted testimony of Mr. Lawn an accepted expert in the area of accounting matters in state government, that the Statement of Justification does not identify which costs are fixed and which costs are variable and does not determine the relevant range of activity which affects allocation of fees to the number of applicants. Thus, the conclusion must still be reached that the $11,000 fee is unreasonable, without rational basis in fact, and without statutory justification. As calculated by Larry Jordan, EMS Administrator, and as reflected in the Statement of Justification prepared by Terry Davis, Program Analyst within the EMS Section, Programs Subsection, and supervisor of the trauma center verification Program, part of the $329,904 figure reflects salaries, expenses, and travel. That portion for salaries is represented as $187,995. Supposedly, the relevant portion of six individual employees' actual salaries was a component. On the other hand, full time equivalents (FTEs) were devised according to the percentage of time Larry Jordan would or could permit these EMS Section employees to devote to the trauma center verification program. FTEs derived in the context of rational experience or mathematical certainty may constitute a portion of a valid formula for fixing a fee schedule but that cannot be said to have occurred with regard to this Proposed Rule. The methodology employed for calculating these particular FTEs lumps a lot of "guesstimating" and conjecture with very little viable quantification of time allotments. Jordan determined, on the basis of what he described as "an educated guess" after review of a staff roster with Terry Davis that although 7.8 FTEs were required for program compliance only 2.5 FTEs could be allotted to the trauma center verification program. It is largely upon the basis of all of DHRS' witnesses' evidence in connection with this FTE computation that the determination must be reached that when agency personnel refer to the calculation of "costs of compliance" they do not mean merely biennial review pursuant to Section 395.031(5) to ensure that subsection (6) statutory standards continue to be met by a hospital once it has been verified as a trauma center. Inclusion of those types of compliance cost figures in the verification program is clearly authorized by the statute. No, rather, the DHRS drafters use the word "compliance" with the implied meaning of encompassing all of the operations of the EMS Section relative in any respect to trauma center matters. In line with its position that the proposed fee schedule is understated, DHRS suggested at hearing that contrary to the Statement of Justification, actual experience has shown that a slightly higher amount of employee time is devoted to the trauma center verification program than is reflected by the 2.5 FTE figure: 2.5 FTEs (allowed) as opposed to 2.73 FTEs (actual) which Mr. Caldwell calculated at hearing would result in a $12,556.79 fee per application for the 1986-1988 biennium. This is not the biennium originally calculated for the rule or projected in its published Statement of Justification. As serious as this is; confession of an originally inaccurate FTE computation figure and inaccurate Statement of Justification is problematic in light of the total lack of logic and rationality with regard to the method of arriving at either the original 2.5 or the recalculated 2.73 FTE figure. The time sampling study does not render 2.73 FTEs rational. 2/ Mr. Jordan, who could not even describe the process of application approval or rejection is credited in the original FTE calculation for the Statement of Justification with 20 percent of his time and salary component devoted to the verification program. Jaime Caldwell Program Development Supervisor, also could not describe the process of application approval or rejection and his testimony reflects that rather than the 40 percent credited in the original FTE calculation for his time and salary component for direct supervisory responsibility over trauma center verification matters, he, Caldwell was equally at ease assessing his own time and salary component as either 35 percent or between 3 and 5 percent. The change and range assigned by Mr. Caldwell is as unsupported as the initial 40 percent assessment made by Jordan and Davis together in April 1985. (Davis actually denied having significant input to the initial assessment). This discrepancy and range are not explainable reconcilable, or justified on the basis of Mr. Caldwell's vague testimony concerning a recent time sampling based on the overall trauma center program which embraces far more than just the trauma center verification process and procedures. 3/ Of those who testified, only Terry Davis had a working knowledge of the existing process by which a trauma center verification application is initially approved or denied. He personally handles all applications from the time one is received until it is approved or denied. Using the maximum amount of time estimated by Mr. Davis, it has taken roughly 12 hours of his time spread over the 60 days provided by statute to process each of the applications received. Davis also denied that Jordan's estimate of his (Davis') time at 100 percent for the verification program was accurate. Davis confirms that the involvement of both Jordan and Caldwell has been infrequent. No witness could delineate with any certainty what, if any, involvement a secretary, a word processor, and Mr. Jordan's personal secretary did in relation to actually processing trauma center verification applications. Although Mr. Davis volunteered someone must do his typing during the application process, this record exhibits no justification for assigning percentages of 60 percent, 20 percent, and 10 percent respectively of each of these clerical employees' time to the verification program for purposes of arriving at an FTE component. These figures appear to have sprung directly from "up front" line item budgeting based on position assignments which by actual testimony are directly contrary to experience that these positions do not participate directly or to any meaningful degree in the verification process. Based on this evidence, and also upon the tacit admission of both Caldwell and Davis that the FTEs reflect EMS employees' percentage of time in the trauma center program as a whole, the methodology employed to obtain the FTE figures must be deemed to be arbitrary and capricious. As calculated by Larry Jordan and as reflected in the Statement of Justification prepared by Terry Davis, expenses and travel were also calculated using FTEs and the percentage of trauma center verification program time for each employee was multiplied by the relevant object category in the Legislative Budget Request: Standards for New Positions 1985-1987. This figure is skewed by the 2.5 FTE figure for all of the reasons already discussed and is likewise arbitrary and capricious. It is also arguable, but not conclusively demonstrated, that this figure is skewed arbitrary, and capricious in anticipated travel and expenses by duplication of some costs and expenses as regards the physician and medical records consultant to be assigned to on-site reviews. See infra. In the Statement of Justification, with respect to "Physician Review of Applications," a figure of eight applications per year was selected based on anticipation that since there are 8 trauma centers in Jacksonville, Florida and the present trauma center verification program's Medical Director, Dr. Raymond Alexander resides in Jacksonville and is employed at a Level I trauma center there potential conflicts of interest exist if any of these entities become applicants for any of the three levels of verification and that if any did, the agency would have to contract with a different physician for review of these eight applications at $200 per application reviewed. It was also anticipated that due to fluctuations in workload and the desire of Dr. Alexander that some Level I applications elsewhere in the state receive a backup application review by another physician, these situations might also require contracting with physicians other than Dr. Alexander. Although DHRS' motives are commendable at first glance it strains credibility that out of 15 per year (total 30) eight (total 16) will come from the finite "Jacksonville 8" number or arrive at a peak workload period. There is no evidence of record what criteria besides Dr. Alexander's request will be used to decide which Level I applicants will get dual reviews and there is a suggestion that there is going to be duplication of effort on these applications for the purpose of avoiding even the appearance of conflict. There is no evidence of record to show how reclassification or continued verification reviews or on-site reviews, if any, work into this figure either. Nonetheless, the parties appear to accept this figure of 16 spread over the biennium. If the figure of 16 is accepted, a remainder of 14 applications (based on DHRS' questionably anticipated 30 applications for the biennium horizon) remain for Dr. Alexander's review. DHRS assigned a 50 percent time allotment (based on Dr. Alexander's annual $42,600 contract) to its Statement of Justification. Incongruously, Dr. Alexander's contract itemizes 15 percent of his time for the combined duties of listing other physicians willing to review applications and his own time reviewing these applications. Petitioner desires the inference to be drawn that either Dr. Alexander is being paid slightly more than $3,000 per application review ($42,600 divided by 14) as compared to $200 per review by other physicians or that the 15 percent figure should be used instead of the 50 percent time/salary component. Neither inference is fully supported by the record as a whole nor by mathematics. However, even assigning the deference due to the discretion afforded an agency in the exercise of its rulemaking authority, that quality of deference will not withstand Larry Jordan's characterization of this 50 percent figure as coming from the attachment at the "front end" of an arbitrary percentage. Although submission of subsequent reports by Dr. Alexander supposedly justify that 50 percent figure as being paid from the trauma center verification activities budget, these reports are not before the undersigned, and Mr. Jordan admits that no analysis was done to establish this 50 percent figure in relation to time/salary solely related to verification. Therefore, the use of this figure of 50 percent is at least arbitrary and capricious in that there is nothing to substantiate what it means with regard to actual medical director duties concerning verification. In the Statement of Justification, with respect to "Trauma Center Site Visits", Larry Jordan determined that an on- site visit for each application is necessary in order to comply with the statutory mandate of Section 395.031(5) that DHRS ensure that the statutory standards set forth in Section 395.031(6) are maintained by trauma centers subsequent to their initial verification. This is permissible discretion within the agency administering the statute. Upgrading its methods of meeting its statutory mandate is a laudable goal of the executive branch and ought not to be violated except where it can be clearly shown that the method exceeds the statutory mandate. That has not been shown here with regard to establishing on-site reviews for the future. Jordan decided to phase in on-site visits commencing with 6 per year. Nothing in this decision to start with 6 a year first has been demonstrated to be arbitrary, capricious, or outside the statutory mandate. However, the dollar amount is another matter. The dollar amount for this upgraded procedure was taken from information from the Joint Committee on Accreditation of Hospitals who conduct similar hospital site visits for accreditation purposes of entire hospitals. Relative to the on- site inspection fee cost calculation contained in the Statement of Justification which is set forth as $54,736 (including a medical records consultant figure discussed infra.) there is no clear indication of whether this figure is based on a prognosis of entire hospital review as with the model accreditation team or upon review of just the emergency room. Trauma is a life-threatening injury a/k/a surgical disease. Since availability of surgeons, surgery rooms, and anesthesiologists as opposed to emergency room physicians is crucial to trauma center qualification it is conveivable that more than just emergency rooms will be inspected but there is insufficient indication even by job description of exactly who will be assigned to the team, what the on-site reviews will cover, what the team duties will entail or how the balance of the $54,736 figure relates to these items. Past agency experience with a single on-site review using existing agency personnel resulted in total expenses of $400.00. The agency also regularly meets the Section 395.006(3)(a) directive to inspect whole hospitals at a cost of not more than $12.00 per bed. By contrast with this information- EMS' component of cost for on-site review of trauma centers is arbitrary, capricious, excessive, and not statutorily justified. In the Statement of Justifications with respect to "Legal Expenses for Denial Hearings," Larry Jordan estimated that $6,000 was a minimal amount that would-be needed for denial hearings. Although testimony is clear that there had never been a denial hearing or even a denial of a trauma center application, provision for such hearings is clearly set out in Section 395.031(4) and (5), and it is naive in the extreme to assume that in meeting its statutory mandate, the agency will never deny any initial applications reclassification- or continued verification application or that of those denied none will ever seek a hearing in accord with Chapter 120, Florida Statutes. There is, however, no rationale within the record for why the figure of $6,000 was arbitrarily selected. In the Statement of Justification, with respect to "Medical Records Consultant Contract," it was determined that such a position is necessary to the trauma center verification program and would be paid approximately $16,000 per year. The asserted justification for a medical records consultant is to support the proposed six on-site visits per year. This purpose is plausible and reasonable within the discretion normally afforded agencies and supportable by the laudable goal to upgrade the method of meeting this agency's statutory mandate already discussed, but DHRS has neither legislative nor budgetary authorization for the medical records consultant position and this renders speculative its inclusion at this time in the calculations for the fee schedule rule. Even recognizing that sometimes an indication that the position can be supported by outside fees is a necessary prerequisite to getting an agency position authorized, inclusion of this speculative cost in this fee schedule is not justified by the statute which requires that the verification program fees to applicants not exceed its cost. Petitioner has adequately demonstrated that an undesignated amount of time of various employees utilized in calculating the FTE function was devoted to legislation, rules drafting, grant disbursal, and meetings of the EMS Advisory Council not directly related to the trauma center verification program and that these elements included within the FTE calculation have skewed the fee need calculations and rendered the fee excessive and not statutorily justified. The record does not support DHRS' contention that the fee increase is necessary to cover its operation deficit or that the cash deficit discussed in the Statement of Justification applies to the verification program alone. It is Petitioner's view that DHRS, in fact performing two distinct functions concerning trauma centers, one of which may be designated "the trauma center program" encompassing every activity of DHRS' Emergency Medical Services Section relative to trauma center matters (including preparation of a statewide medical services program, drafting, analysis, and lobbying of legislation, public education, service in connection with the mandate of the EMS Advisory Council, preparation, negotiation, and litigation concerning promulgation of this and other rules, and non-specific administrative time) and the other function being the "trauma center verification program" pursuant to which applications filed with the EMS Section are received and approved or denied. Petitioner further contends that it is only costs attributable to the latter function, the cost of processing individual applications of hospitals for trauma center verification which may properly be included as a "cost of verification borne by the applicant" pursuant to Section 395.031(7), Florida Statutes. Petitioner seems to suggest that only the 12 hours of Mr. Davis' time multiplied by the number of projected applications should be calculated into the proposed fee. Petitioner's view is too narrow in regard to the full mandate of the statute. The trauma center verification program cannot operate in a vacuum and except as set out in previous findings of fact Petitioner has failed to demonstrate that any elements used in the agency's calculations are not integral parts of the verification program. However, for all the reasons set forth in the preceding findings of fact it is clear that an excessive, arbitrary and capricous calculation of components have rendered the rule itself arbitrary and capricious and its fee schedule excessive to the point of being confiscatory. As such, the fee schedule embodied in the Proposed Rule exceeds the statutory mandate of Sub-Section (7). The foregoing findings are not altered by Respondent's negotiating during the rule making process a $9,000 reduction from an originally anticipated $20,0OO ungraduated fee by the deletion of two additional plans to upgrade the trauma center verification program.
The Issue 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.
Conclusions Competent substantial evidence supports the conclusion that Adrian Fuentes disabilities are the result of the failure to deliver him before his mother loss amniotic fluid, or up to an estimated 12 hours earlier. An earlier delivery was the standard of care expected in a case of IUGR. His permanent and severe disabilities were directly and proximately caused by the failure of SBHD employees to handle an ultrasound report expeditiously as directed and as their policy provided. ATTORNEYS’ FEES AND LOBBYISTS’ FEES: In compliance with s. 768.28(8), F.S., but not with Section 3 of this claim bill, Claimant's attorneys' fees are set at 25 percent. There is no lobbyist for the bill at this time. As of October 9, 2007, the attorneys reported having incurred costs of $115,246.02 for representing the Claimant. The Claimants entered into an agreement to pay attorneys’ fees and costs. RECOMMENDATIONS: For the reasons set forth in this report, I recommend that Senate Bill 60 (2008) be reported FAVORABLY. Respectfully submitted, Eleanor M. Hunter Senate Special Master cc: Senator Jeremy Ring Representative Evan Jenne Faye Blanton, Secretary of the Senate House Committee on Constitution and Civil Law Tom Thomas, House Special Master Counsel of Record
The Issue The issues are whether Respondent withdrew controlled substances from the narcotics dispensing system and failed to document the administration or wastage of those substances; if yes, whether this conduct fails to conform to minimum acceptable standards of prevailing nursing practice; and, if yes, what penalty should be imposed on Respondent's license as a registered nurse.
Findings Of Fact The Department is the state agency charged with regulating the practice of nursing in the State of Florida. Respondent Marla Gunderson ("Respondent") is, and has been at all times material hereto, a licensed registered nurse in the State of Florida, having been issued license number 2832622 by the Florida Board of Nursing in 1994. Respondent was employed by Lee Memorial Health Care System Rehabilitation Hospital ("Lee Memorial") as a registered nurse from about January 29, 2001, until about March 22, 2001. During the first three or four weeks of Respondent's employment, she participated in a full-time training program through Lee Memorial's education department. A part of this training included training in the administration of medications to patients. After completing the three or four-week training program, Respondent began working directly with patients. From about mid-February 2001 through early-March 2001, Respondent had no problems with documenting the administration of medications to patients. Some time in or near the middle of March 2001, Melanie Simmons, R.N. ("Simmons"), Lee Memorial's Nursing Supervisor, received a complaint from the night nurse following Respondent's shift. The complaint alleged that a patient's wife reported that the pain medication her husband was given by Respondent was not the Codeine that had been ordered by the physician. Pursuant to Lee Memorial's policies and procedures, Simmons conducted an investigation into the allegations of the above-referenced complaint regarding the Respondent. Lee Memorial's policies and procedures set out a specific method for conducting investigations regarding the administration of medications to patients. First, the physician's orders are checked to see what medications have been ordered for the patient. Next, the Pyxis records are pulled to determine if and when medications were withdrawn for administration to patients. The Pyxis system is a computerized medication delivery system. Each nurse has an assigned user code and a password, which must be entered before medication can be withdrawn from the Pyxis system. Then, medication administration records (MARs), the documents used by nurses to record the administration of medications to patients, are checked to verify whether the nurse documented the administration of the medications to the patients for whom they were withdrawn. Finally, the Patient Focus Notes, the forms used by nurses to document non-routinely administered medications, are also checked to determine if, when, and why a medication was given to a patient. If after comparing the physician's orders, Pyxis records, MARs, and Patient Focus Notes, it is determined that medications were not properly administered or documented, the nurse making the errors is advised of the discrepancy and given an opportunity to review the documentation and explain any inconsistencies. Simmons' investigation, which included comparing the physician's orders, Pyxis records, MARs and Patient Focus Notes, revealed discrepancies in medications withdrawn by Respondent and the MARs of the three patients under her care. The time period covered by the investigation was March 12 through March 17, 2001. Of the six days included in the investigation period, Simmons determined that all the discrepancies had occurred on one day, March 13, 2001. Nurses are required to record the kind and amount of medication that they administer to patients. This information should be recorded at or near the time the medication is administered. It is the policy of Lee Memorial that should a nurse not administer the medication or the entire amount of the medication dispensed under his or her password, that nurse should have another nurse witness the disposal of the medication. The nurse who serves as a witness to the disposal of medication would then enter his or her identification number in the Pyxis. As a result of that entry, the nurse who observed the disposal of the medication would be listed on the Pyxis report as a witness to the disposal of the medication not administered to patients. Such excess medication is termed waste or wastage. The physician's order for Patient F.R. indicated that the patient could have 1 to 2 Percocet tablets, to be administered by mouth, as needed every 3 to 4 hours. On March 13, 2001, at 14:06 Respondent withdrew 2 Percocet tablets for Patient F.R. However, there was no documentation in the patient's MAR, focus notes, and other records which indicated that Respondent administered the Percocet tablets to Patient F.R. The physician's order for Patient G.D. indicated that 1 to 2 Percocet tablets could be administered to the patient by mouth as needed every 4 to 6 hours. On March 13, 2001, at 11:18 Respondent withdrew 2 Percocet tablets and on that same day at 17:16, Respondent withdrew another 2 Percocet tablets for Patient G.D. However, there was no documentation in the patient's MAR, focus notes, or any other records which indicated that Respondent administered the Percocet tablets to Patient G.D. The physician's order for Patient T.G. indicated that 1 to 1.5 Lortab/Vicodin tablets could be administered to the patient by mouth as needed every 4 to 6 hours. On March 13, 2001, Respondent withdrew 2 Lortab/Vicodin tablets for Patient T.G. However, Respondent failed to document on the patient's MAR, focus notes, or other records that the medication had been administered to Patient T.G. With regard to the above-referenced medications withdrawn by Respondent on March 13, 2001, there is no documentation that any of the medications were wasted. All the medications listed in paragraphs 13, 14, and 15 are narcotics or controlled substances. Because Respondent did not document the patients' MARs or focus notes after she withdrew the medications, there was no way to determine whether the medications were actually administered to the patients. Proper documentation is very important because the notations made on patient records inform nurses on subsequent shifts if and when medications have been administered to the patients as well as the kind and amount of medications that have been administered. Without such documentation, the nurses taking over the subsequent shifts have no way of knowing whether medication has been administered, making it possible for affected patients to be overmedicated. Respondent has been a registered nurse since 1994 and knows or should have known the importance of documenting the administration of medications to patients. Respondent does not dispute that she did not document the administration and/or wastage of the narcotics or controlled substance she withdrew from the Pyxis system on March 13, 2001, for the patients identified in paragraphs 13, 14, and 15. Moreover, Respondent provided no definitive explanation as to why she did not properly document the records. According to Respondent, she "could have been busy, called away, [or] got distracted." Following Simmons' investigation of Respondent relating to the withdrawal and/or administration of medications, Respondent agreed to submit to a drug test. The results of the drug test were negative. Prior to being employed by Lee Memorial, all of Respondent's previous experience as an R.N. had been in long- term care. Except for the complaint which is the subject of this proceeding, there have been no complaints against Respondent's registered nurse's license.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a Final Order (1) imposing an administrative fine of $250; (2) requiring Respondent to remit the Agency's costs in prosecuting this case; (3) requiring Respondent to complete a continuing education course, approved by the Board of Nursing, in the area administration and documentation of medications; and (4) suspending Respondent's nursing license for two years. DONE AND ENTERED this 1st day of April, 2002, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD 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 1st day of April, 2002. COPIES FURNISHED: Reginald D. Dixon, Esquire Agency for Health Care Administration General Counsel's Office-Practitioner Regulation Post Office Box 14229 2727 Mahan Drive Tallahassee, Florida 32317-4229 Marla Gunderson 1807 Northeast 26 Terrace Cape Coral, Florida 33909 Ruth R. Stiehl, Ph.D., R.N. Executive Director Board of Nursing Department of Health 4080 Woodcock Drive, Suite 202 Jacksonville, Florida 32207-2714 Mr. R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether proposed rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J-2.016 of the Florida Administrative Code (“the Proposed Rules”) are an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes (2016).1/
Findings Of Fact Background on Trauma Centers A “trauma center” is “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or [a] pediatric trauma center ” § 395.4001(14), Fla. Stat. Trauma centers must have a wide array of resources at their disposal at all times. For example, a trauma center must have approximately 30 specialists such as trauma surgeons, neurosurgeons, orthopedic surgeons, and anesthesiologists. A trauma center must also have specially trained nurses, advanced imaging and diagnostic equipment, dedicated operating rooms, a blood bank, specialized nursing units, and a helipad. Many of the personnel working in trauma centers have special training. Trauma surgeons have one or two additional years of critical care training followed by another year of training in emergency surgery or acute care surgery. Trauma center nurses typically have three additional years of training/education. In short, a trauma center is a hospital that has made a substantial investment in order to have the resources and personnel capable of caring for trauma patients. Florida Administrative Code Rule 64J-2.001(15) defines a “trauma patient” as “any person who has incurred a physical injury or wound caused by trauma and who has accessed an emergency medical services system.” Trauma injuries commonly occur as a result of motor vehicle accidents, falls from height, gunshot wounds, and stab wounds. See § 395.4001(18), Fla. Stat. (defining a “trauma victim” as “any person who has incurred a single or multisystem injury due to blunt or penetrating means or burns and who requires immediate medical intervention or treatment.”); Fla. Admin. Code R. 64J-2.001(12) (defining “trauma” as “a blunt, penetrating or burn injury caused by external force or violence.”). Trauma injuries are a leading cause of death for those ranging in age from 1 to 45. Hospitals with emergency departments (i.e., acute care hospitals) are capable of treating patients on an emergency basis. However, they would not necessarily have constant access to all of the resources mentioned above. In addition, acute care hospitals have not gone through the statutory process of being approved by the Department to operate as a trauma center. § 395.4001(14), Fla. Stat. (defining a “trauma center” as “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or pediatric trauma center, or is designated by the department as a Level II trauma center pursuant to s. 395.4025(14).”). See also § 395.401(1)(k), Fla. Stat. (mandating that “[i]t is unlawful for any hospital or other facility to hold itself out as a trauma center unless it has been so verified or designated pursuant to s. 395.4025(14).”).3/ In general, a patient in danger of imminent death from a trauma injury is likely to have a better chance of survival if he or she is treated in a trauma center as opposed to an acute care hospital. The Parties The Department is the state agency charged with implementing the laws governing the regulation of trauma centers. See § 395.40(3), Fla. Stat. (noting “[i]t is the intent of the Legislature to place primary responsibility for the planning and establishment of a statewide inclusive trauma system with the department. The department shall undertake the implementation of a statewide inclusive trauma system as funding is available.”); § 395.401(2), Fla. Stat. (mandating that “[t]he department shall adopt by rule, standards for verification of trauma centers based on national guidelines . . . .”); § 395.4015(1), Fla. Stat. (mandating that “[t]he department shall establish a state trauma system plan.”); § 395.402(2), Fla. Stat. (mandating that “[t]he department shall review the existing trauma system and determine whether it is effective in providing trauma care uniformly throughout the state.”). Of particular relevance to the instant case is the legislative mandate that the Department shall adopt rules governing the number of trauma centers that can be operated in Florida. See § 395.402(4)(b), Fla. Stat. (mandating that “[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area.”). Those rules (see, e.g., rule 64J-2.010) determine how many trauma centers can be in a particular trauma service area (“TSA”). The Legislature has assigned each county in Florida to a TSA, and there are currently 19 TSAs in Florida. See § 395.402(4), Fla. Stat. With regard to Petitioners, Shands Jacksonville operates a Level I trauma center in TSA 5, which consists of Baker, Clay, Duval, Nassau, and St. Johns Counties. Tampa General operates a Level I trauma center in TSA 10, which consists of Hillsborough County. Lee Memorial operates a Level II trauma center in TSA 15, which consists of Charlotte, Glades, Hendry, and Lee Counties. Bayfront Health operates a Level II trauma center in TSA 9, which consists of Pinellas and Pasco Counties. St. Joseph’s Hospital operates a Level II trauma center and a pediatric trauma center in TSA 10, which consists of Hillsborough County. As for the intervenors, JFK Medical Center is a licensed acute care hospital that has submitted a letter of intent to the Department so that it can apply to operate a Level II trauma center in TSA 17, which consists of Palm Beach County. Orange Park operates a provisional Level II trauma center in TSA 5, and Jackson South operates a provisional Level II trauma center in TSA 19, which consists of Miami-Dade and Monroe Counties. The meaning of the term “provisional trauma center” will be explained below. The Statutory Scheme Governing Trauma Centers As noted above, each of Florida’s 67 counties has been assigned to one of 19 TSAs, and the 19 TSAs play an important role in the location of trauma centers throughout the state. See § 395.4025(1), Fla. Stat. (providing that “[f]or purposes of developing a system of trauma centers, the department shall use the 19 trauma service areas established in s. 395.402. Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, and recommendations of the local or regional trauma agency, the department shall establish the approximate number of trauma centers needed to ensure reasonable access to high-quality trauma services.”); § 395.402(4)(b), Fla. Stat. (providing that the Department “shall allocate, by rule, the number of trauma centers needed for each [TSA].”). The Florida Legislature has mandated that every TSA “should have at least one Level I or Level II trauma center.” § 395.402(4)(b), Fla. Stat. However, there is a state-wide, statutory cap of 44 trauma centers. § 395.402(4)(c), Fla. Stat. (mandating that “[t]here shall be no more than a total of 44 trauma centers in the state.”). Hospitals seeking approval to operate trauma centers must complete a rigorous review process, and that process begins with a potential applicant submitting a letter of intent to the Department by October 1 of a particular year. See § 395.4025(2)(a), Fla. Stat. (providing that “[t]he department shall annually notify each acute care general hospital and each local and each regional trauma agency in the state that the department is accepting letters of intent from hospitals that are interested in becoming trauma centers. In order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists. Letters of intent must be postmarked no later than midnight October 1.”). By submitting a letter of intent, a hospital does not become obligated to subsequently file a fully fledged trauma center application. Fla. Admin. Code R. 64J-2.012(1)(a) (providing that “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if an available position, as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.”). “By October 15, the department shall send to all hospitals that submitted a letter of intent an application package that will provide the hospitals with instructions for submitting information to the department for selection as a trauma center.” § 395.4025(2)(c), Fla. Stat. Applications from hospitals seeking to operate trauma centers must be received by the Department by the close of business on April 1 of the following year. Once the Department receives a trauma center application, it conducts “a provisional review of each application for the purpose of determining that the hospital’s application is complete and that the hospital has the critical elements required for a trauma center.” § 395.4025(2)(c), Fla. Stat. The Department’s provisional review includes, but is not limited to, an examination of whether an applicant has: the equipment and facilities necessary to provide trauma services; (b) personnel in sufficient numbers and with proper qualifications to provide trauma services; and (c) an effective quality assurance process. See § 395.4025(2)(c), Fla. Stat. “After April 30, any hospital that submitted an application found acceptable by the department based on provisional review shall be eligible to operate as a provisional trauma center.” § 395.4025(3), Fla. Stat. A hospital that has been approved to operate as a provisional trauma center can immediately begin providing care to trauma victims. From an operational perspective, there is no difference between a provisional trauma center and one that is fully verified. Between May 1 and October 1 of the year following the filing of the letter of intent, the Department conducts an in- depth evaluation of all the applicants that were deemed eligible to operate as provisional trauma centers. § 395.4025(4), Fla. Stat. Then, between October 1 of the year following the filing of the letter of intent and June 1 of the next year, a review team of out-of-state experts assembled by the Department makes “onsite visits to all provisional trauma centers.” The out-of-state experts utilize a survey instrument developed by the Department that includes “objective criteria and guidelines for reviewers based on existing trauma center standards such that all trauma centers are assessed equally.” § 395.4025(5), Fla. Stat. That survey instrument also includes “a uniform rating system that will be used by reviewers to indicate the degree of compliance of each trauma center with specific standards, and to indicate the quality of care provided by each trauma center as determined through an audit of patient charts.” § 395.4025(5), Fla. Stat. Even if a hospital satisfies all of the requirements to operate a trauma center, there must be a need for a trauma center in the relevant TSA. See § 395.4025(5), Fla. Stat. (providing that “hospitals being considered as provisional trauma centers shall meet all the requirements of a trauma center and shall be located in a trauma service area that has a need for such a trauma center.”). (emphasis added). The Department, based on recommendations from the review team, selects trauma centers by July 1 of the second year following the filing of the letter of intent. § 395.4025(6), Fla. Stat. Following this initial approval, “[e]ach trauma center shall be granted a 7-year approval period during which time it must continue to maintain trauma center standards and acceptable patient outcomes as determined by department rule.” Id. An approval, “unless sooner suspended or revoked, automatically expires 7 years after the date of issuance and is renewable upon application for renewal as prescribed by rule of the department.” Id. Also, “[n]otwithstanding any provision of chapter 381, a hospital licensed under ss. 395.001-395.3025 that operates a trauma center may not terminate or substantially reduce the availability of trauma service without providing at least 180 days’ notice [to the Department] of its intent to terminate such services.” § 395.4025(8), Fla. Stat. There are currently 33 approved trauma centers in Florida. Unless the statewide cap of 44 in section 395.402(4)(c) is amended or removed, the Department can only approve 11 more trauma center applicants. Assessment of Need for Trauma Centers under the Current Rules The Department must annually assess Florida’s trauma system, including the number and level of trauma centers needed for each trauma service area. See § 395.402(2)(b), Fla. Stat. (requiring the Department to “[r]eview the number and level of trauma centers needed for each trauma service area to provide a statewide integrated trauma system.”); § 395.402(3), Fla. Stat. (mandating that the Department must consider the following during its annual reviews: recommendations of regional trauma agencies; stakeholder recommendations; the geographic composition of an area; historical patterns of patient referral and transfer in an area; inventories of available trauma care resources; population growth characteristics; transportation capabilities; medically appropriate ground and air travel times; recommendations of the Regional Domestic Security Task Force; the actual number of trauma victims currently being served by each trauma center; and other appropriate criteria). As noted above, the Legislature has empowered the Department to adopt rules governing the procedures and process by which it will determine which applicants will be selected for designation as trauma centers. See § 395.4025(13), Fla. Stat. (providing that “[t]he department may adopt, by rule, the procedures and process by which it will select trauma centers. Such procedures and process must be used in annually selecting trauma centers and must be consistent with subsections (1)-(8) except in those situations in which it is in the best interest of, and mutually agreed to by, all applicants within a service area and the department to reduce the timeframes.”). The rules governing trauma centers are set forth in Florida Administrative Code Chapter 64J-2 (collectively referred to as “the Current Rules”). With regard to the instant case, rule 64J-2.010 is particularly relevant and details how Level I and Level II trauma centers will be allocated among the 19 TSAs. On an annual basis beginning on or before August 30, the Department implements the process set forth in rule 64J- 2.010 by conducting the annual assessment mentioned above and assigning a score to each TSA. The process in rule 64J-2.010 begins by evaluating each TSA pursuant to the following criteria: (a) population; median transport times; (c) community support; (d) severely injured patients discharged from acute care hospitals; (e) Level I trauma centers; and (f) number of severely injured patients. For each of the aforementioned criteria, points are assigned to each TSA based on data from the annual assessment. The point scales associated with each criterion are designed to measure the need in each TSA for trauma center services. For example, a TSA with a population of less than 600,000 would receive 2 points, and a TSA with a population of greater than 2,400,000 would receive 10 points. TSAs with populations between those two extremes would receive 4, 6, or 8 points. See Fla. Admin. Code R. 64J-2.010(1)(a)1. As for median transport time, a TSA with a median transport time of less than 10 minutes would receive 0 points. In contrast, if the median transport time in a TSA was greater than 41 minutes, then that TSA would receive 4 points. TSAs with median transport times between those two extremes would receive 1, 2, or 3 points. See Fla. Admin. Code R. 64J- 2.010(1)(a)2. After a TSA’s total score is determined, the Department compares that score to the scale in rule 64J- 2.010(1)(b) which provides that: The following scoring system shall be used to allocate trauma centers within the TSAs: TSAs with a score of 5 points or less shall be allocated 1 trauma center. TSAs with a score of 6 to 10 points shall be allocated 2 trauma centers. TSAs with a score of 11 to 15 points shall be allocated 3 trauma centers. TSAs with a score of more than 15 points shall be allocated 4 trauma centers. In the Current Rules, rule 64J-2.010(3) contains a table setting forth the results based upon the March 24, 2014, Amended Trauma Service Area Assessment. For example, the table in rule 64J-2.010(3) indicates that TSA 1 consisting of Escambia, Okaloosa, Santa Rosa, and Walton Counties has a need for one trauma center. In contrast, the table indicates that TSA 19 consisting of Dade and Monroe Counties has a need for three trauma centers. The Department Changes Its Interpretation of “Need” In October of 2014, Orange Park filed a letter of intent indicating its desire to operate a trauma center in TSA 5. Because the Current Rules indicated that there was no need for an additional trauma center in TSA 5, the Department rejected Orange Park’s letter of intent. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the maximum number of trauma centers that are needed in a particular TSA. In 2015, Orange Park submitted another letter of intent to operate a trauma center in TSA 5. The Department accepted that letter of intent even though the numeric “need” derived from rule 64J-2.010 for TSA 5 had not changed. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the minimum number of trauma centers that are needed in a particular TSA. After the Department approved Orange Park’s application to operate as a provisional Level II trauma center in TSA 5, Shands Jacksonville challenged that decision, and Administrative Law Judge W. David Watkins issued a Recommended Order on January 27, 2017, concluding that Orange Park’s application must be denied. In the process of doing so, ALJ Watkins also concluded that “[t]he Department’s policy of accepting letters of intent and trauma center applications irrespective of need as established in rule 64J-2.010, constitutes an unadopted rule and is contrary to its validly adopted rules and statute.” Shands Jacksonville Med. Ctr., Inc., d/b/a UF Health Jacksonville v. Dep’t of Health and Orange Park Med. Ctr., Inc., DOAH Case No. 16-3369 (Recommended Order Jan. 27, 2017). Through the Proposed Rules, the Department is seeking to formalize its new interpretation of the term “need” as meaning the minimum number of trauma centers needed in a particular TSA. Assessment of Need under the Proposed Rules During the final hearing in this matter, Department employees described the Department’s impetus for changing its determination of how the term “need” as that term is used in chapter 395, part II, should be interpreted. For instance, the Department’s mission is to promote, protect, and improve the health of those living and visiting Florida. Because approximately 31 percent of severely injured patients were treated at acute care hospitals rather than trauma centers in 2013, the Department believes that there are an insufficient number of trauma centers in Florida. Also, as one or more trauma centers are added to a particular TSA, the Department observed that the number of trauma centers “needed” in that TSA under rule 64J-2.010 would decrease. This decrease would occur because median transport times and the number of severely injured patients discharged from acute care hospitals would decrease with the addition of trauma centers to that TSA. Accordingly, the Department deems the formula in rule 64J-2.010 to be a “diminishing” formula. As explained by Sue Dick, the Department’s Interim Division Director for the Division of Emergency Preparedness and Community Support (and former Chief of the Tallahassee, Florida Fire Department): [W]e saw the numbers required in a certain trauma service area diminishing because care was better. That’s what led us to go, wait a minute, that can’t be a maximum number because we are going to end up at a point where we say a maximum number is zero. So that’s when we started to look at the allocation and say, what we are really determining is how many more should they have to ensure that all patients are reaching median transport time in less than 10 minutes and very few patients are being discharged from acute care hospitals. That’s what led to the logic behind revisiting this rule and this formula. On September 1, 2016, the Department proposed a series of amendments to rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J- 2.016. The Proposed Rules would implement the Department’s new policy of deeming the calculations pursuant to rule 64J- 2.010(1)(b) to represent the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA. For instance, the Proposed Rules’ version of rule 64J- 2.010(1)(b) would amend the current version of rule 64J- 2.010(1)(b) to read as follows: “[t]he following scoring system shall be used to determine the minimum number of allocate trauma centers needed within the TSAs. Also, the Proposed Rules would add a subsection (4) to rule 64J-2.010, which would state that “[t]he allocation of trauma centers, as described in subsections (1) through (3) of this rule, is the minimum allocation needed and shall not affect existing verified trauma centers seeking renewal of their verification status pursuant to subsection 395.4025(6), F.S., . . . .” (emphasis added). The Proposed Rules would amend rule 64J-2.012(1)(a) to read as follows: “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if, subject to the trauma center limit in paragraph 395.402(4)(c), F.S., an available position, is open as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.” As a result, there would no longer be TSA-specific caps in rule 64J-2.010, and the statewide cap of 44 trauma centers in section 395.402(4)(c) would be the only numeric cap on trauma centers. The same result would flow from the Proposed Rules’ amendment to rule 64J-2.013(7): The department shall make a final determination on whether to approve or deny a hospital’s extension request only after the provisional review of all other trauma center applications in the hospital’s TSA are completed, and it has been determined that the number of trauma centers and Provisional Ttrauma Ccenters, in the hospital’s TSA is less than or equal to the allocated number of trauma centers allowed by paragraph 395.402(4)(c), F.S. positions available for that TSA. Finally, subsection (12) of rule 64J-2.013 would become subsection (11) and be amended as follows: A hospital receiving an extension greater than 12 months shall have its extension denied or terminated if the number of trauma centers and or Provisional Ttrauma Ccenters in the hospital’s TSA equals or is greater than the number of trauma centers provided in paragraph 395.402(4)(c), F.S available positions allocated to the TSA, resulting in the denial of its application and the department will inform the applicant of its right to a Section 120.57, F.S., hearing regarding this denial. Because the Proposed Rules would result in the calculations pursuant to rule 64J-2.010(1)(b) representing the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA, the Department could conceivably approve every applicant in that TSA so long as the statutory cap of 44 trauma centers in section 395.402(4)(c) would not be exceeded. The Proposed Rules also establish a tie-breaker system if the sum of provisional trauma centers found eligible for selection by the Department and the number of existing trauma centers would exceed the statutory limit established in section 395.402(4)(c). The tie-breaking criteria would consider the following: (a) whether the TSA in question already has a Level I or Level II trauma center; (b) the level of service that the applicants propose to provide; (c) the number of severely injured patients treated by the applicants; and (d) approval by a Department-approved trauma agency plan. Chief Dick testified that the Department would exercise discretion to ensure that a TSA that already had the minimum number of trauma centers under the Proposed Rules would not receive an additional trauma center if the statutory cap of 44 would be met or exceeded and another TSA lacked the statutory minimum of one: Q: Now, I want to explore a little bit one of the answers that you gave to Mr. Reynolds regarding how the [Proposed Rules] would work in conjunction with the statutory cap of 44 and the requirement for assignment of a trauma center to each TSA. Let me ask you a hypothetical. If there [are] 43, when you get to the point when there [are] 43 trauma centers that are opened around the state but there is still not one in Collier County, how does it work at that point as a potential new applicant comes in? A: If they are not in Collier County, they won’t be verified. We have a statutory obligation to meet the minimum of one per TSA, so – at a statutory cap of 44. So logic would state then as part of that 44, it includes one per TSA. So if there are 43 and there are none in TSA 17, we would have to reserve that spot until such point as there is one at a minimum in TSA 17, which is Collier, I believe. Q: Would that likewise be the approach if you have a TSA where the methodology calculates there is a need for four, but there [are] only three that are opened, how would it work then? A: I think it would be responsible of the Department, as we view the results of this allocation methodology as setting a minimum need to ensure reasonable access to care, that we would withhold spots until such point as that minimum is met per TSA. So if we are at 42 and there is still not one in TSA 17, which we just spoke to, but in addition there is another TSA that has one but through our methodology, we really think they need a minimum of two, I believe it’s within the Department’s authority to withhold that second one as well. However, Chief Dick acknowledged in subsequent testimony that the discretion she relies upon does not originate from a statute or a rule: Q: I think we had put forth that there’s been some testimony concerning the hypothetical, the what if there’s more applications received by the Department in a cycle than there are statewide slots? So in other words, you’ve got enough applications that its’s going to pop you over the [statutory cap of] 44. Do you understand my hypothetical? ALJ: We are still talking about the [Current Rules]? Q: Under [the Proposed Rules]. ALJ: [Proposed Rules]. Okay. Q: Thank you. A: I understand what you are saying. Q: And would you agree that there’s nothing in the [Proposed Rules] that tells you what happens in that circumstance, if the number received in all of the TSAs will put you over the statewide number? A: There’s nothing in the proposed rule that states that if we receive more applications than there are available spots statewide, what we will do. Q: Correct. There’s no criteria or standards? A: No, those procedures are not outlined in the rule, no. Q: Similarly, there’s nothing in [the Proposed Rules] that would preclude that all of the open positions statewide could be in one TSA or two TSAs to the exclusion of others; there’s nothing that prevents that from occurring? A: Well, I think there is something that prevents that from occurring, and the first thing being that – the first thing we would look at is to ensure there is at least one trauma center in each TSA so we would be able to reserve that. And the other thing I think is where it speaks to a trauma service area, trauma service area that has a need, we would interpret that to mean a minimum need as determined by our allocation methodology. So I would say that if there are – if it were an issue of we were going to go over the 44 and there was a TSA that still did not meet their minimum as we’ve outlined in our proposed rule, that it would be within our prerogative of the Department to hold a spot for that TSA to meet that minimum. Q: When you say it would be within your prerogative, there is nothing in the statute that outlines that procedure you just discussed, that you would hold one in your back pocket and say, I need that one for Collier County? A: No. Q: There’s nothing in [the Proposed Rules] that says that? A: No, there’s been a number of hypotheticals presented, and I just don’t think you can craft a rule that would address every hypothetical. So, no, there’s nothing that speaks specifically to that, what our specific process would be under those specific circumstances. * * * Q: I understand. [The Proposed Rules set] a minimum and all – my only question is, there [are] no standards or criteria in [the Proposed Rules] that would identify how many above the minimum should be approved; the Department’s position is it would approve as many as are applied for, if they meet all the standards? A: And have the endorsement of the regional trauma agency, yes. The Potential Utility Associated with Adopting the Proposed Rules All parties have proceeded under the reasonable assumption that adoption of the Proposed Rules would lead to more trauma centers in Florida. The Department and Intervenors’ primary argument in support of the Proposed Rules is that more trauma centers will result in: (a) increased access to the specialized care available at trauma centers; and (b) less time needed to transport trauma patients to trauma centers. Undertriage occurs when a severely injured patient in need of trauma care is treated by an acute care hospital. In that circumstance, the patient does not receive the benefit of being admitted to a facility dedicated to treating severely injured patients. The January 6, 2016, Amended Trauma Service Area Assessment by the Department indicates that approximately 31 percent of severely injured patients in Florida received care in an acute care hospital rather than a trauma center in 2013. Dr. Mark McKenney, an expert in surgical care and trauma care, characterized undertriage as an access to care problem that could threaten one’s life: I don’t think that any of us would feel good to have a third of us, when we have a life- threatening injury, end up in a hospital that doesn’t have a trauma team, doesn’t have trauma nurses, doesn’t have a trauma intensive care unit, doesn’t have an operating room immediately available, doesn’t have a surgeon in the hospital 24/7 who can take care of this, and doesn’t have subspecialists who routinely take care of the traumatically injured patients. A third is just too high a number. With regard to transport times, trauma care professionals refer to a generally accepted clinical principle for rendering treatment known as “the Golden Hour.” Within one hour after a person is injured, all of the following should occur: (a) emergency personnel are notified, arrive at the injury scene, evaluate the patient, and transport the patient to a trauma center; and (b) the trauma center starts resuscitation; conducts another evaluation of the patient; and performs a life-saving procedure. According to the Department and Intervenors, the increased access to trauma centers and the decreased transport times associated with adoption of the Proposed Rules will save lives.4/ Petitioners’ response to that line of reasoning is that an increase in the number of trauma centers will lead to a decrease in the quality of care rendered to trauma patients. A trauma center needs to treat a certain number of severely injured patients in order for its personnel to remain proficient and for the trauma center’s quality of care to remain high. During the final hearing, Petitioners presented persuasive testimony that “practice makes perfect” with regard to the treatment of trauma patients. For instance, Dr. Steven Epstein, an expert in trauma surgery, credibly testified that trauma injuries require a different level of expertise and that experience acquired through treating less severe injuries does not necessarily translate to the treatment of trauma patients: If you have a set number of patients and you put another trauma center geographically close, what happens is that you will cut the number of patients going to each place, each trauma center. And expertise in the general surgery world, as well as the trauma world, is based on volume. Let me start with the general surgery world and then move toward trauma. We know that in general surgery, residencies right now, they are focusing on different areas of surgery: breast surgery, colorectal surgery, laparoscopic surgery, so that people become experts in these areas. The idea of the general surgeon is going away. The same thing occurs with trauma surgery. Only the expertise there is learned during a fellowship and then with practice. If you take, for instance, a gunshot, the anatomy, any general surgeon can take out a gallbladder, but not any general surgeon can handle a gunshot to the abdomen. The anatomy changes. It’s a much different case. So people who have done this on a regular basis have some idea how to do this. The – what I call the voyeur, you bring in a general surgeon to do some trauma because we don’t have enough trauma surgeons, doesn’t have this same expertise. And you wind up as really – it’s a patient problem. We are talking about it as a problem with hospitals, but this is a patient problem. If the doctor doesn’t know how to treat the patient, then the patient suffers. And I think in the end, that’s what happens when you dilute an expertise. And trauma, with the addition of all these hospitals, winds up diluting an expertise. * * * We, meaning the doctors at our hospital and several other hospitals, have always made an assumption we practice, we practice, we practice, and we get better. If you don’t have the patients – because they call it the practice of medicine. If you don’t have the patients to practice with, you are not going to maintain your expertise. And I use the example, for instance, of a gunshot. But we do blunt trauma where people are in auto accidents, they are in shock, how to get them out of shock. There’s this whole sequence of events that takes place. Nursing, how to take care of these patients. It’s quite complex and I firmly believe that dilution of this knowledge is very detrimental in the end to the patient.5/ In addition, an increase in trauma centers would make it more difficult for a trauma center to acquire and retain the trauma center personnel that must be constantly on site. Dr. Epstein testified that trauma surgeons are already a scarce resource, and that scarcity will only be exacerbated with the addition of more trauma centers. Also, Mark Valler, an expert in trauma center and acute care medical staff administration, credibly testified about how the addition of 10 or 11 trauma centers in Florida would impact an existing trauma center’s ability to retain its staff: But I am concerned that 10 or 11 opening statewide, there are going to be advertisements for trauma surgeons, for neurosurgeons, for trauma orthopedic doctors all over the place. People are going to be recruiting like crazy, and they are going to be recruiting in the state of Florida because the physicians already have a Florida state license, so there is going to be a huge, huge recruiting effort if all those centers actually get approved at one time. However, there was no persuasive evidence presented during the final hearing indicating that any recent openings of new trauma centers have resulted in existing trauma centers experiencing declines in patient volume that would negatively impact quality of care. Accordingly, Chief Dick testified that it would be irresponsible for the Department to not facilitate better access to trauma care when the Department has received no evidence that quality of care had suffered. During the final hearing, Petitioners frequently mentioned the theoretical possibility that adoption of the Proposed Rules could lead to an inordinate number of trauma centers opening in a single TSA. Given the substantial amount of resources needed to open and maintain a trauma center, it is unlikely that a rational hospital administrator would seek to open a trauma center in a particular TSA unless the volume of trauma patients would enable it to operate profitably. Nevertheless, the testimony and the evidence leads to an inference that adoption of the Proposed Rules would likely lead to more trauma centers in well-served TSAs and no increase for TSAs in need of more trauma care. The following testimony from Mark Richardson, an expert in healthcare facility and services planning, illustrates this point: Q: There’s been some suggestion, I think you may have heard this during your deposition, that there may be free market forces that would operate to prevent some of these adverse results that you are describing. Do you have an opinion as to whether free market factors would help to prevent the maldistribution or other issues that you described as being bad consequences? A: I do have an opinion. I think if you look in terms of the folks, whoever have applied via a letter of intent for the development of the additional trauma centers, those centers are not located in areas where there currently are longer transport times. Those centers basically are located in basically metropolitan areas where there are already appears to be good reasonable access to care. Basically it’s adding new programs where there’s already a pretty good network of care provided. * * * My point here is that if you look in terms of where these folks are, they are basically in the Jacksonville area; they are basically in the Miami-Dade, south Florida area; they are in the Orlando area; or they are in the Palm Beach and Broward area, where there already are a number of existing transplant programs, where, for example, specific to the median transport time, there’s no problem in those areas. This is not the Panhandle where there is a problem in terms of transport times. This is not north Florida in terms of north Florida area where portions of the area may have some problems. This is basically adding incremental trauma center capacity to locales where there already is adequate care. It is certainly possible that Petitioners’ fears about lower quality of care could be realized if there is nothing other than the statutory cap to prevent hospitals from opening an unlimited number of trauma centers in TSAs encompassing large metropolitan areas. After considering all of the evidence and testimony, the undersigned is of the opinion that it would be impossible to draft a set of rules that would satisfy the concerns/interests of all the relevant stakeholders.6/ The disagreement over the merit of the Proposed Rules boils down to striking a balance between “practice makes perfect” and providing the earliest opportunity for definitive care. In relation to each other, the Current Rules put more emphasis on “practice makes perfect,” and the Proposed Rules emphasize providing more access to care.
Findings Of Fact THE PARTIES Health Management Associates, Inc. (HMA), is a publicly owned hospital corporation with corporate offices located in Naples, Florida. It owns and/or operates 17 hospitals in the United States, including 2 owned facilities in the State of Florida, and one which it operates for the State under contract. Psychiatric service is limited in scope. Charter Medical Corporation, operating 66 hospitals, owns and operates Charter Glade Hospital, a 104-bed specialty psychiatric hospital located in Ft. Myers, Lee County, Florida. The facility is located approximately 2 miles west of I-75 and approximately 22 miles north of the site identified by HMA for its facility. As an existing facility in the service area, it has intervened herein to protest any award of a Certificate of Need to a competing facility, here, HMA proposed hospital. THE FACILITIES Of Charter Glades' 104 beds, 80 are licensed as short-term psychiatric beds, of which 56 are utilized for adults and 24 for adolescents. The remaining 24 beds are licensed as short-term substance abuse beds. It draws approximately 91 percent of its patients from Lee County, where it is located, and the remaining 9 percent from Collier County, contiguous to the south. It also operates an outpatient program in Naples, Florida, further south in Collier County, and utilizes substantial marketing and advertising programs within Collier County to inform and attract patients from that area. HMA proposes to establish a 50-bed, freestanding, psychiatric hospital in Collier County, 30 beds of which will be on a unit dedicated to adult patients and 20 beds dedicated to adolescents. The facility is designed to be built on an 8 to 10 acre tract of land and due to efforts by HMA's vice president for psychiatric operations, Mr. Beatty, who has personally surveyed the northern Collier County area, at least one adequate tract of property, already appropriately zoned, with access to adequate roads and utilities, has been identified. The project was designed by Architect Bruce Hartwigson, a professional with over 20 years experience in the design of health care facilities. Construction is projected to take approximately 8 months from the beginning of construction, with the facility being ready for operations within one month after completion of construction. As designed, the facility will provide a state of the art atmosphere for the psychiatric patients. Design provides for a residential appearance with allowance for quiet space, counseling offices, and recreational and therapeutic areas in addition to patient rooms. The adult and adolescent units will be physically separated and those areas scheduled for use by both categories of patient, such as dining and recreation areas, will not be utilized by both at the same time. The building, consisting of approximately 47,670 square feet, will also include, in addition to those facilities described above, necessary support facilities including doctors' and nurses' offices, administrative and business offices, storage, educational and physical activities areas, a swimming pool, and various therapy and treatment/examination rooms, as well as a chapel, beauty and barber shops, and support activities. The design proposed provides good visibility from the nurses' station to the entire unit served by that facility. All outside doors and those between units will be secured. Outdoor courtyards will be enclosed by fences or walls, and security/seclusion rooms have been designed to promote patient safety. The design proposed by HMA, complies with all codes and regulations of state and local agencies, and the size and layout proposed is reasonable. NEED HRS District 8 includes Charlotte, Collier, DeSoto, Glades, Hendry, Lee and Sarasota counties. HMA's proposed facility will serve, primarily, Collier county. Collier county is located, along with Lee county, in the southernmost of two separate marketing regions within District 8. Currently, almost all psychiatric inpatient services provided in both Lee and Collier counties are provided by Charter Glade Hospital in Lee county, and in the limited psychiatric service at Naples Community Hospital in Collier county. These two facilities are the only facilities licensed to provide hospital inpatient psychiatric services in their respective counties and the services are substantially different. Whereas Charter Glade Hospital is a freestanding psychiatric facility, Naples Community Hospital is a general, acute care hospital with a hospital-based psychiatric unit. In the Naples Community Hospital psychiatric facility, the average length of stay is 7.8 days. Naples Community Hospital is currently licensed to operate a 32-bed short-term psychiatric unit, and an 11-bed substance abuse unit. Consistent with the terms of a Certificate of Need issued to Naples Community Hospital for the establishment of a satellite facility, the hospital has agreed to de-license 9 of the 32 short-term psychiatric beds and the 11 short-term substance abuse beds. At the time of the hearing, the psychiatric unit at Naples Community Hospital had 20 beds staffed. The unit is used by area psychiatrists primarily for providing crisis intervention and the treating of immediate symptoms. Crisis stabilization/intervention is a psychiatric service which in normal circumstances results in an average length of stay of between 10 and 12 days. It differs substantially from longer term care, available in a psychiatric hospital. Under the shorter term programs, the disturbed and disoriented patient does not have sufficient opportunity to benefit from the programs available in a more comprehensive long term program. In short, Naples Community Hospital's program is oriented primarily to short term treatment, and this would not be contradicted or duplicated by the proposed service to be offered by HMA in its facility. Additional psychiatric care is provided by the David Lawrence Center located in Naples, which is Collier county's comprehensive community mental health center. At this facility, psychiatric care ranges from outpatient care through group and family therapy, to inpatient crisis stabilization and residential treatment programs for substance abuse or mental health problems. As a part of its inpatient program, David Lawrence operates a 12-bed crisis stabilization unit and a 12-bed short-term residential treatment program, with the former operating at an average occupancy of 66 percent and the latter at an average occupancy of 70 percent. The average length of stay at David Lawrence Center is generally between 5 and 7 days, at which time the patient is generally released and medicated for outpatient care with the opportunity then existing to obtain appropriate therapeutic care from other sources. As a publicly funded facility, David Lawrence refers most paying patients to either Naples Community Hospital or Charter Glade. Little difficulty has been experienced in placing inpatient referrals with the exception of younger children. There is also a community health center operating 30 crisis stabilization and short-term residential treatment service beds located in Lee County. Since this facility's mandate includes providing provision of services for all of the southwest portion of District 8, some patients come from Collier county as well as Lee county. This facility also operates an adult residential treatment service, which has been funded to add an additional 80 to 100 beds in the foreseeable future. Other relevant resources, either actual or potential, include an adult residential treatment service funded to begin operation in Charlotte county, which will give access to geriatric psychiatric patients residing in Collier county, and the Naples Research and Counseling Center (The Willows), located in Collier county, whose program is primarily oriented to the treatment of bulimia and other food disorders. This facility, under the terms of its license, is primarily oriented to serving patients outside District 8, but may devote up to 3 percent of its total patient days to District 8 patients. Though it does serve as a resource, its impact on the need for psychiatric services in the southernmost portion of District 8 is minimal. Other outpatient psychiatric services available to Collier county residents include the activities of the six practicing psychiatrists located within the county, who provide outpatient services in conjunction with non- medical professionals. There is also psychologists and psychiatric social workers practicing within the county. In February, 1987, DHRS published projections for the January, 1992 Planning Horizon which revealed the net need for 61 short-term psychiatric beds in District 8. It was noted at the time that the short-term psychiatric bed need projection had not yet been adjusted for occupancy rates according to the terms of Rule 10-5.011(1)(o), Florida Administrative Code. The Agency thereafter promulgated Rule 10-5.008(2), which established the "fixed pool" concept for Certificate of Need Review. HMA submitted its application based on the 61-bed projection. Upon review of the applications, during which time the Agency calculated a net need numerically for 55 additional short-term psychiatric beds, DHRS denied HMA's application on September 9, 1987, even though a 55-bed need was established. Under the provisions of Rule 10-5.011(o)(4)(e), Florida Administrative Code, the Department determined the numeric need to be inapplicable, because the average annual occupancy rates for all existing adult short-term inpatient psychiatric beds in District 8 did not exceed 75 percent for the preceding 12 month period. By the same token, the same rate for adolescents and children did not exceed 70 percent for the same time period. DHRS's observation regarding occupancy rate thresholds was accepted by HMA's health planner. The difference between the 61-bed need published by DHRS initially and the 55-bed projection is an award of 6 short-term psychiatric beds to Venice Hospital. During the course of the hearing, and after HMA had presented its case in chief, the Department revised its numeric need calculation to reflect a 44- bed net need for January, 1992. This change was attributed to the mistaken assumption that 20 beds at Naples Community Hospital would be de-licensed. In reality, only 9 beds will actually be de-licensed. Under the terms of the Rule, gross need is calculated upon a standard of 35 beds per 1,000 population, and this figure must be reduced by the number of licensed and approved beds within the District. The proper count, therefore, should be a total of 295 beds including 23 at Naples Community Hospital instead of 12. HMA objected to the introduction of evidence relating to the change in numeric bed need on the basis that it had already presented its case in chief, and had not been advised of the change in advance. The basis for the original denial of HMA's application by the Department included as a important part thereof the fact that the occupancy standards outlined in the Department's Rules had not been met regardless of the bed need established by use of the methodology. This is as much a factor with a numeric need of 44, as it was with a numeric need of 55. The evidence did not establish that the occupancy rates had increased so as to meet the Department's standards. It is nonetheless appropriate for the Department to correct, at the hearing, an obvious miscalculation which goes to the very heart of the numeric need methodology. If accurate information is not included in the calculations under the methodology, then the methodology result is totally unreliable. Consequently, it is found that the appropriate bed need for the January, 1992 Planning Horizon is 44 beds. Turning to the question of occupancy levels, statistics compiled for District 8 for the years 1984 through 1987, reflect that district wide, the average occupancy for 1984 was 54.7 percent; for 1985, 69.22 percent; for 1986, 59.29 percent; and for 1987 through October, 59.12 percent. Though the health plan does not call for sub-district districting, if one looks at the two major facilities located in the Lee and Collier counties, that is Naples Community Hospital and Charter Glade Hospital, the average for those two is 51.35 percent, with Charter Glade at 33.2 percent. For 1985, the two had an average occupancy of 55.75 percent; for 1986, an average of 49.92 percent, and for 1987, an average of 50.81 percent. Therefore, no matter how it is looked at, either on a district wide basis or considering only the two counties, the average occupancy is well below the 75 percent standard for adults or 70 percent for adolescents. Under the provisions of the DHRS Rule, when numeric need has not been established, no new beds will "normally be approved." It has long been settled that this means that if other circumstances exist which indicate the need, outside of the numeric calculation, for additional beds, DHRS may consider and award them. The occupancy rates catalogued above would be one possible example of abnormal circumstances, if they had exceeded the Rule standards. Another is the access standard, contained in Rule 10-5.011(o)4g, which provides that short- term, inpatient hospital psychiatric services should be available within a maximum travel time of 45 minutes, under average travel conditions, for at least 90 percent of the service area population. As was stated above, service area means the entire District 8. It was clearly established at final hearing that more than 90 percent of the District 8 population is within a 45 minute travel time of short-term, inpatient hospital psychiatric services with only 6.3 percent falling outside that parameter. In fact, the local health plan indicates that 90 percent of the district population falls within 30 minutes travel time. Other real factors which may be considered are the shortage of psychiatrists in the area, in both counties, and a definite shortage of psychiatrically trained nurses in both counties. It has been shown, however, that physicians, like nature, abhor a vacuum. If facilities are available, medically trained personnel will generally gravitate to the area of availability, and it is consequently found that these two factors are not controlling. OTHER FACTORS The issue of the financial feasibility of the project is always pertinent. HMA proposes to develop this project, utilizing 20 percent equity contribution, and 80 percent debt financing. HMA has access to a $75,000,000.00 line of credit and financing drawn on that line would be at prime rate. It is estimated that costs and fees associated with financing will total approximately $57,000.00. The method of funding and the proposed interest expense and fees are considered reasonable. The applicant proposes to charge an all-inclusive rate of $398.00 per patient day in the first year and $415.00 per patient day in the second year. These are not contested and are considered reasonable. During the first year, total deductions of $508,000.00 include contractual allowances of $400,000.00, plus a bad debt allowance of approximately $100,000.00. Intervenor contends that HMA's bad debt factor of 4 percent is unrealistic, and Charter Glade's experience of 5 percent would be more reasonable. An adjustment of that nature would total $41,600.00, which is not particularly significant when compared against the overall project estimated yearly income. The second year's proposed revenue deductions of $716,500.00 are also contested by the Intervenor on the basis of what it considers unrealistic projections, but again, there is insufficient evidence to indicate HMA's projections are unreasonable. Intervenor has contested many of the line items on HMA's pro forma statement. Whereas HMA projects a 4 to 5 percent per year inflation rate for salaries and benefits, Intervenor suggests that an inflation rate of 6 percent would be more appropriate. Supplies and expenses figures should be increased according to Intervenor, who also contends that HMA's projected depreciation and other expense is understated, as were the projected pre- opening expenses. If all adjustments suggested by the Intervenor were to be made, HMA's facility would lose $588,000.00 in its second year of operation, in the event HMA's projected second year occupancy of 55 percent were to be realized. Intervenor contests this, contending that because of lack of bed need and lack of demand, it is doubtful HMA will achieve the projected occupancy and its position is well taken. The growth rate in the two county area is projected to be a sum equivalent to 19.6 percent of the 1980 population. Applying this same figure to the average daily census for the two existing facilities reveals an additional 12.4 patients per day available to HMA, if one assumes Naples Community Hospital and Charter Glade would continue to serve the existing population base. The 12.4 patient census would constitute a 25 percent occupancy rate, as opposed to 55 percent. In light of the currently existing occupancy rates, it is found that HMA's projected 55 percent occupancy rate at year two is overly generous and would likely not be achieved in light of the various factors discussed previously. While the criticisms and suggested adjustments by the Intervenor as to expense and salary items are considered unconvincing, there is some question, in light of proposed occupancy rates, whether Petitioner can operate the facility feasibly within two years. There is, however, little doubt that HMA would construct a quality facility and operate it in such a manner as to meet, if not exceed, all state standards. Its prior record would tend to establish that. Proposed staffing ratios are reasonable and consistent with industry standards, and the programs incorporated within the proposal are appropriate and reasonable. HMA has access to adequate capital resources to fund the construction and operate it for the first several years. There is some question, however, as to whether adequate, qualified staff can be recruited in sufficient numbers. HMA proposes to serve indigent patients in numbers sufficiently high to meet its proportionate share of indigent mental health problems within the service area. There was some evidence, through the deposition of Dr. Mack, which tends to indicate that from time to time, psychiatrists practicing in Collier county have difficulty from a logistical standpoints securing inpatient placement for their psychiatric patients at Charter Glade, and there can be little doubt that the distribution of psychiatric beds in District 8 is unbalanced, with far more beds in the northern portion of the district than in the south. Whether this justifies construction of a new psychiatric hospital in Collier county, however, is another matter. The evidence clearly indicates that the short- term beds at Naples Community Hospital are not fully utilized and the occupancy rates would tend to indicate that the demand within the two counties, as it currently exists and is proposed to exist within the framework of the Planning Horizon, is currently being met. Another legitimate factor to be considered is the adverse impact construction of a new facility, such as proposed by HMA, would have on the existing Charter Glade facility which, more than any other existing facility, provides the same service. Evidence of record indicates that Charter Glade gets 85 percent of its patients from Lee county, in which it is located, and 17 percent of that number comes from that area of Lee county, south of the Charter Glade facility. In addition, 9.3 percent of Charter Glade's patients come from Collier county. Adding the south Lee county patients to the north Collier county patients, accounts for approximately 23.75 percent of Charter Glade's total patients. (.17 X .85 .1445 + .093 .2375) If HMA's new facility were to draw 50 percent of that figure, approximately 12 percent of Charter Glade's total patient days would be lost. (.2375 X .50 .11875) In 1987, Charter Glade's charge per day was slightly in excess of $431.00, which resulted in a net profit of slightly over $105,000.00. Were Charter Glade to lose approximately 12 percent of its patient days, the net adverse effect to its revenue picture would be substantial.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is therefore: RECOMMENDED that Petitioner, Health Management Associates, Inc.'s application for Certificate of Need Number 5170 to establish a 50-bed, freestanding, short-term psychiatric hospital in Collier county be denied. Recommended in Tallahassee this 30th day of June, 1988. ARNOLD H. POLLOCK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of June, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-4741 The following constitutes my ruling on Proposed Findings of Fact submitted by the parties hereto, consistent with Section 120.59(2), Florida Statutes. For HMA: 1 - 2. Accepted and incorporated herein. 3. Irrelevant. 4 - 5. Accepted and incorporated herein. 6 - 14. Accepted and incorporated herein. 15 - 16. Accepted and incorporated herein. 17. First and third sentences accepted and incorporated herein. Second sentence is irrelevant. 18. First and second sentences accepted and incorporated herein. Third sentence is irrelevant. 19 - 22. Accepted and incorporated herein. Accepted and incorporated herein. Cumulative. 25 - 26. Accepted and incorporated herein. Not a finding but a restatement of evidence. Accepted. First sentence accepted and incorporated herein. Second sentence rejected as a restatement of evidence. 30 - 37. Accepted and incorporated herein. Rejected as a restatement of evidence. Accepted. Accepted. Accepted and incorporated herein. 42 - 43. Accepted. 44 - 46. Accepted and incorporated herein. 47 - 48. Accepted. 49. Rejected as contra to the weight of the evidence. 50. Irrelevant. 51 - 53. Accepted and incorporated herein. 54 - 58. Accepted and incorporated herein. 59 - 61. Accepted and incorporated herein. 62. Accepted and incorporated herein. 63 - 69. Accepted and incorporated herein. 70. Rejected as contra to the weight of the evidence. 71 - 81. Accepted and incorporated herein. 82. Rejected. 83. Irrelevant. 84. Accepted. 85 - 87. Rejected as an overstatement of the situation as it exists. By DHRS: 1 - 2. Accepted and incorporated herein. 3 - 6. Accepted and incorporated herein. 7 - 8. Accepted and incorporated herein. 9 - 10. Accepted. 11. Accepted and incorporated herein. 12 - 14. Accepted and incorporated herein. By Charter Glade Hospital: 1 - 4. Not Findings of Fact but Introduction. 5 - 8. Accepted and incorporated herein. 9. Accepted. 10 - 12. Accepted and incorporated herein. 13 - 15. Accepted and incorporated herein. 16 - 17. Accepted and incorporated herein. 18 - 20. Accepted and incorporated herein. 21 - 22. Accepted. Not a Finding of Fact but a comment on the evidence. Accepted. Not a Finding of Fact but a comment on the evidence. 26 - 27. Accepted. 28. Accepted and incorporated herein. 29 - 34. Accepted and incorporated herein. 35 - 36. Accepted and incorporated herein. Accepted and incorporated herein. Accepted. 39 - 40. Accepted and incorporated herein. First sentence accepted and incorporated herein. Remainder is irrelevant. Accepted. 43. Accepted and incorporated herein. 44 - 46. Accepted and incorporated herein. 47. Irrelevant. 48 - 51. Accepted and incorporated herein. 52. Accepted and incorporated herein. 53 - 55. Accepted and incorporated herein. 56 - 59. Accepted and incorporated herein. 60 - 65. Accepted and incorporated herein. Not a Finding of Fact. Accepted. 68 - 70. Not a Finding of Fact but a comment on the evidence. 71 - 72. Accepted and incorporated herein. Accepted. Not a Finding of Fact but a comment on the evidence. 75. Accepted. Accepted. Accepted. Accepted and incorporated herein. Not a Finding of Fact but a recitation of and comment on the evidence. Not a Finding of Fact but a restatement of and comment on the evidence. 81-83(o). Accepted in part by HMA and commented on in Recommended Order. 84 - 86. Not a Finding of Fact but a speculative projection. 87 - 89. Accepted and incorporated herein. 90. First sentence accepted - Second sentence rejected as a restatement of evidence designed to bolster first sentence. 91 - 94. Accepted and incorporated herein. COPIES FURNISHED: John F. Gilroy, III, Esquire Robert S. Cohen, Esquire Haben and Culpepper Post Office Box 10095 Tallahassee, Florida 32302 John Rodriguez, Esquire Assistant General Counsel Department of Health and Rehabilitative Services 2727 Mahan Drive Tallahassee, Florida 32308 Michael Cherniga, Esquire Roberts, Baggett, Laface & Richards 101 East College Avenue Tallahassee, Florida 32301 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 R. S. Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
