The Issue The issue in this case is whether an application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital (“Wolfson”), to operate a pediatric trauma center should be approved.
Findings Of Fact The following findings of fact are derived from the stipulation of the parties, the admitted exhibits, and the testimony at final hearing. DOH is the state agency responsible for, inter alia, the review and approval (or denial) of applications to operate trauma centers, including pediatric trauma centers. DOH denied the trauma center application filed by Wolfson, not due to an absence of need in the area, but due to Wolfson’s failure to comply with some requirements set forth in the application. Wolfson is a 216-bed not-for-profit children’s hospital located in Jacksonville, Duval County, Florida. It is part of the Baptist Health organization and is one of three hospitals operated under that entity’s license. Wolfson is located on the same campus as Baptist Medical Center – Jacksonville. The two hospitals share a pharmacy which is located in the children’s hospital and a laboratory located in the adult hospital, but no other services or staff. Interestingly, Wolfson was developed by the sons of Morris Wolfson, a Jewish immigrant to the United States. One of Mr. Wolfson’s children had died at an early age due to lack of access to health care services. Later in his life, after acquiring a small fortune from his business, Mr. Wolfson asked his five remaining sons to develop a children’s hospital accessible to every child, regardless of race, creed, or religious affiliation. By 1951 the sons had raised over half a million dollars and were prepared to construct a hospital. They approached the Baptists, who agreed to build the children’s hospital as part of their development of Baptist Hospital. In 1955, Mr. Wolfson’s dream became a reality. Wolfson provides a wide range of services to children, including but not limited to: two neonatal intensive care units; cardiac catheterization; open heart surgery; bone marrow transplants; and extracorporeal membrane oxygenation, a less complex bypass procedure. There is an emergency department at Wolfson. It receives approximately 60,000 patients per year. Wolfson also operates three satellite emergency departments and has three mobile ICUs (known as “Kids Kare” mobile units). Wolfson’s service area is quite large, comprised of a triangle identified by the vertices of Savannah, Georgia – Dothan, Alabama – and Daytona Beach, Florida. About ninety percent of Wolfson’s patients come from within that area. There is not currently a pediatric trauma center in Jacksonville, which is located in Trauma Service Area (“TSA”) 5. There are five counties in TSA 5: Duval, Baker, Clay, Nassau, and St. Johns. The closest pediatric trauma center to Jacksonville is located in Gainesville, Alachua County, Florida, some 60 miles away. There is a Level II trauma center located at UF Health Jacksonville, but it is not specifically for pediatrics. There are differences in the provision of care to pediatric patients versus adult trauma patients, including specialized equipment, age-appropriate drugs, and modified procedures. Pediatric trauma patients from TSA 5 must be transported to UF Health Jacksonville or Shands in Gainesville. Some of those patients are designated as “trauma alert patients.” Those are individuals identified by emergency medical services as requiring immediate, high-level treatment by skilled professionals. Not all trauma patients are trauma alert patients. Once a pediatric trauma patient has been stabilized at UF Health Jacksonville or Shands, the patient can be transferred to Wolfson for further treatment. Wolfson then undertakes the care needed by the patient. UF Health Jacksonville transfers about 20 to 30 pediatric trauma patients per month to Wolfson. Not all of those patients have previously been deemed trauma alert patients, but Wolfson has extensive experience treating patients with significant needs. It is Wolfson’s desire to operate its own pediatric trauma center, thereby obviating the need for a trauma patient to first go to UF Health Jacksonville or Shands before being transferred. There are times when a delay in transfer can have negative consequences for the patient. The number of such occurrences was not quantified by Wolfson, but Wolfson considers it a significant problem. There is, by rule, a very precise process for a hospital to obtain verification as a trauma center. There are three stages to the process: provisional review, in-depth review, and site visit. Hospitals are given only one opportunity each year to apply for verification. In order to apply, a hospital must file a letter of intent (“LOI”) between September 1 and October 1. On or before October 15, the Department sends an application package to each hospital which had timely submitted an LOI. After receiving the application package, a hospital has until April 1 of the following year to complete and submit the application. DOH must complete its provisional review of the application and notify the applicant, by April 15, of any deficiencies which should be addressed. The hospital then has five business days to submit clarifying or corrective information. In accordance with this process, Wolfson timely filed its application to operate a pediatric trauma center. By rule, the application must contain responses and support relating to nineteen “critical elements” related to trauma care. The Department then reviews the application to make sure that all minimum standards for approval have been met. An applicant is not required to necessarily satisfy each element or subpart of a standard in order for it to be approved by the Department. However, failure to comply with a critical element overall can result in denial of the application. The initial review of an application by the Department is extremely important because, if provisionally approved, the applicant can immediately commence operating as a trauma center. In the present case, Wolfson’s application was reviewed by two persons under contract with the Department: Dr. Robert Reed and Susan Cox, RN. The Department deems each of those persons to be an expert in the field of trauma care based on their background and training. The provisional review by the reviewers was for the purpose of determining whether the application was complete and whether the hospital satisfied the critical elements required for a trauma center. After completion of their initial review, the reviewers sent a letter to Wolfson identifying certain deficiencies they had found in the application. There were a number of deficiencies identified by Dr. Reed and Nurse Cox in Wolfson’s application. However, the most important of those (and the ones at issue in this proceeding) were as follows: Standard II.B.1.b relates to trauma-related continuing medical education (“CME”) requirements for emergency physicians; Standard XVII relates to required multidisciplinary conferences which must be held throughout the year; and Standard XVIII addresses Quality Management a/k/a Quality Improvement (“QI”), also referred to as Performance Improvement. Wolfson was given an opportunity to address each of the stated deficiencies and did, in fact, submit some additional information. Despite the additional information, Wolfson’s application was still deemed insufficient and was denied. The Department now concedes that the CME standard was satisfied in Wolfson’s application. The same is true for the standard relating to multidisciplinary conferences. The QI standard (Standard XVIII), however, remains in dispute. DOH contends that the information submitted by Wolfson in its initial application and deficiency response falls short of proving compliance with this critical element. The QI standard requires a system of procedures and protocols that will promote performance improvement while maintaining patient safety. The goal is to establish processes to ensure a hospital is continually improving the quality of care provided. The subparts of the QI standard require detailed demonstrations of various processes, including: A.2 – A clearly defined performance improvement program for the trauma population; – Review of all trauma patient records from five specified categories; – Monitoring of six indicators relevant to the respective facility (which are in addition to four state-mandated indicators); – Review of cases relevant to the six indicators by the trauma medical director (“TMD”) and trauma program director (“TPD”), to decide whether the cases should be referred to the quality management committee (“QMC”). B.5 – Evaluation by QMC of the effectiveness of action taken to ensure problem resolution; – Preparation and submittal of a quarterly report showing which cases have been selected for corrective action; and – Maintenance of an in-hospital trauma registry with information on patients being treated. The gist of Wolfson’s QI program is set forth on a flow chart contained in the application. That chart is entitled, “Trauma PI Process: Levels of Review.” Though not explained at final hearing, the “PI” in the chart is presumably “Performance Improvement.” The flow chart indicates there to be a primary (daily) review, a secondary (weekly) review, and a tertiary (monthly) review involving certain designated persons. In each of the “boxes” for the respective reviews, there is a stated purpose for the review. For the primary review, the purpose is stated as: Identification of opportunities for Improvement/Validation. The secondary review’s purpose is: Adverse Event/Audit Filter Review. And the purpose of the tertiary review is: Peer Review/Accountability Determination, Loop Closure Plan, Trended Data Review. Phases of care identified in the flow chart are: Pre- hospital, Resuscitation, Inpatient Care Review, and Readmission Review. There is a list of “actions” in the flow chart: Education; Counseling; Trend Report; Guidance/Policy/Protocol Development; and Hospital PI Project. From that list, there is an arrow pointing back toward the primary review box. There is no narrative in the flow chart to explain how the various boxes interconnect or how the information therein ties to the requirements as outlined in the application form. Wolfson asserts that all relevant information is contained in the flow chart, whether in narrative form or not. There is also additional information in the application, attached as a “Scope of Services” addendum, which further elucidates what is found in the flow chart. The Department deems the flow chart and scope of services information insufficient for determining whether the proposal satisfies the critical elements. Wolfson says the flow chart is a “clearly defined performance improvement program.” It is, in fact, only an outline of a clearly defined program. The testimony provided at final hearing by Wolfson’s TPM explained how that outline would work to improve performance. With that explanation, the flow chart/scope of service information minimally satisfies this critical element of the application. Wolfson maintains that the information provided supports the requirement for review of all records from five specified categories, i.e., all trauma alert cases, critical or ICU admissions, operating room admissions for traumatic injury, critical trauma transfers, and in-hospital deaths. Upon review of the flow chart there is insufficient evidence concerning those five areas. However, the scope of information addendum at least minimally refers to those areas as part of the review process. The flow chart/scope of service information addresses the four state-required indicators. The other six indicators required in the application are listed as “to be determined by the [Quality Management] committee.” Wolfson points out that in the minutes from a QMC meeting in February (which was included in the application), nine additional indicators are listed. So, although not easily found, the application does provide sufficient response to the required element. The application is also supposed to identify cases relevant to the six selected indicators in order to determine whether any of those cases should be referred to the QMC. The determination to refer cases is followed up by an evaluation of the effectiveness of actions taken by the committee. The flow chart can be interpreted to address this requirement, but it is fairly nebulous. The scope of services information provides some additional support, but only in general terms. The required quarterly reports are supposed to show which cases have been selected for corrective action by the committee. Wolfson asserts that it cannot submit any such reports until it is operating as a pediatric trauma center, i.e., until it actually has patient cases to report. That position is plausible. The Department did not provide any evidence as to how other applicants satisfied this requirement, so Wolfson’s position cannot be measured against other providers.1/ The same is true as to the requirement for an in- hospital registry of information concerning patients who are being treated. Wolfson has purchased the software needed to commence its registry once patients are being admitted, but it cannot do so at this time, again because it has no such patients. All things considered, Wolfson’s application was not a superlative response to the question of its abilities, but it at least minimally met the requirements for approval of a provisional license. Considering, de novo, all of the evidence concerning Wolfson’s proposed trauma center operations, the application is complete. Wolfson provided extensive testimony and evidence as to the need for a pediatric trauma center in the service area and its willingness and ability to meet that need. There is no doubt that, if approved, the pediatric trauma center would be beneficial to the area. However, need was not an issue in the proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent, Department of Health, enter a Final Order approving the pediatric trauma center application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital. DONE AND ENTERED this 14th day of November, 2017, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN 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 14th day of November, 2017.
The Issue DOAH Case No. 01-3148: Whether the Respondent's licensure status should be reduced from standard to conditional. DOAH Case No. 01-4649: Whether the Respondent committed the violations alleged in the Administrative Complaint dated October 15, 2001, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: AHCA is the state agency responsible for licensing and regulating the operation of nursing home facilities, including ensuring that nursing homes are in compliance with criteria established by Florida statute. Chapter 400, Part II, Florida Statutes (2001). AHCA is authorized in Section 400.23(8), Florida Statutes, to impose administrative fines on nursing home facilities that fail to meet the applicable criteria. Florence Treakle conducted surveys of Life Care on May 9, 2001, and June 12, 2001, as a result of complaints received by AHCA. Because the surveys were conducted as a result of complaints received by AHCA, Ms. Treakle was the only AHCA surveyor conducting the surveys. The results of the surveys were reported on a form identified as "HCFA-2567," which is generated by the federal Department of Health and Human Services, Health Care Financing Administration, and is commonly referred to as a "Form 2567." Several deficiencies were identified in the Form 2567s completed for the May 9, 2001, and June 12, 2001, surveys, which were each cited to a federal "tag number" designated as "F" tags,1 to the applicable provision of the Code of Federal Regulations, and to the applicable Florida administrative rule. Each deficiency was also classified under Florida law as either a Class II or a Class III deficiency, and a factual narrative was included to support each deficiency cited. May 9, 2001, survey.2 The Form 2567 for the May 9, 2001, survey included a citation for a Class III deficiency under F-279, "Resident Assessment," and Section 483.13(c), Code of Federal Regulations. This citation involved the care provided to residents L.D. and A.M. and was supported by the assertion that, "[b]ased on observation and record review[,] . . . the facility did not have comprehensive care plans in place for healing of the residents [sic] pressure sores." A care plan is a tool used by the nursing staff to ensure that the resident is getting consistent care and is compiled from data included in a resident's Comprehensive Assessment. An entry in a care plan includes the identification of a problem, a goal for resolving or improving the problem, and the approaches, or means, to be used to reach the goal. Resident L.D. L.D. came into Life Care with pressure ulcers, including a Stage IV pressure ulcer3 on his coccyx, which is located at the bottom of the backbone. L.D. was receiving wound care both at Life Care and at a wound care center pursuant to a physician's order dated April 4, 2001, which contained the following requirement: "[O]ffload[] all boni [sic] prominences as much as possible." In accordance with this order, L.D. was turned and repositioned in bed every two hours, and he was provided with a special, pressure-relieving mattress. L.D. was a very quiet person, but he had no cognitive impairment and was able to communicate his needs to staff. L.D.'s wife visited him every day; she usually arrived in mid-morning and left in mid-afternoon, and she returned for a few hours in the evening. Both L.D. and his wife made it clear to the Life Care staff that L.D. wanted to sit in a wheelchair as much as possible so that he could move around the facility, take walks outdoors with his wife, and have his meals sitting up. L.D. used a special, high-backed wheelchair that he provided for his use while he was a resident of Life Care. The chair reclined so that pressure on his coccyx could be relieved somewhat, and Life Care furnished him a gel cushion for his wheelchair, also to help relieve pressure on his coccyx. On May 9, 2001, Ms. Treakle observed L.D. sitting in his wheelchair for over two hours, from 10:20 a.m. until 1:00 p.m. She found nothing in L.D.'s Care Plan regarding the amount of time L.D. would be permitted to sit in a wheelchair. Resident A.M. A.M. entered Life Care with a Stage III pressure ulcer on his left buttock. A.M. was receiving wound care at Life Care in accordance with the approaches included in his Care Plan. A.M. was not cognitively impaired, and he could communicate his needs to staff. His granddaughter and one year-old great-grandson visited him every day, and he enjoyed sitting outside in a wheelchair with his great-grandson on his lap. A.M. also liked to spend most of his time outside his room, moving himself around the facility in a wheelchair. Life Care provided a gel cushion for his wheelchair to help relieve pressure on A.M.'s buttock. On May 9, 2001, Ms. Treakle observed A.M. sitting in a wheelchair from 2:00 p.m. until 3:30 p.m. A.M.'s Care Plan did not contain an entry establishing the amount of time A.M. would be permitted to sit in a wheelchair. Summary. AHCA has failed to establish by even the greater weight of the evidence that the Care Plans developed for L.D. and A.M. were deficient. AHCA failed to present credible evidence of the contents of L.D.'s Care Plan,4 but the evidence is uncontroverted that L.D.'s wound care orders contained approaches for healing his pressure sores. A.M.'s Care Plan included several approaches for healing his pressure sores, and AHCA has not alleged that the required wound care was not provided to either L.D. or A.M. Rather, AHCA's specific complaint regarding the Care Plans of L.D. and A.M. is that there was no approach specifying the amount of time L.D. and A.M. would be permitted to sit in their wheelchairs. This complaint is based exclusively on the expectations of Ms. Treakle. Ms. Treakle expected to find this approach in the Care Plans because, in her opinion, pressure on the coccyx and buttocks can never be completely relieved when a resident is sitting,5 and any pressure on a pressure ulcer impedes healing because it decreases blood flow to an area. Accordingly, Ms. Treakle "would expect good practice would [sic] be for the Care Plan to indicate how long the resident was going to sit on this pressure sore."6 AHCA did not, however, submit any evidence of a standard of care requiring that the duration of time a resident can sit in a wheelchair be included as an approach in the care plan of a resident with a pressure ulcer, especially when the resident is alert, mobile, and able to communicate with staff. June 12, 2001, survey. The Form 2567 for the June 12, 2001, survey cited Life Care for three deficiencies: A Class II deficiency was cited under F-224, "Staff Treatment of Residents," and Section 483.13(c)(1)(i), Code of Federal Regulations, involving the care provided to residents E.G. and N.D. and supported by the assertion that "[b]ased on observation, record review and interview[,] the facility did not monitor and supervise the delivery of care and services." A Class III deficiency was cited under F-279, "Resident Assessment," and Section 483.20(k), Code of Federal Regulations, supported by the assertion that, "[b]ased on review of the care plan for resident #1 [N.D.], . . . the facility did not complete a comprehensive care plan that was revised to reflect all fall risks." A Class II deficiency was cited under F-281, "Resident Assessment," and Section 483.20(k)(3)(i), Code of Federal Regulations, supported by the assertion that, "[b]ased on citations at F 224[,] F 279 and F 324[,] the facility nursing staff did not provide care that met professional standards for residents #1 [N.D.] and #2 [E.G.]." Resident E.G. Diabetes management. Pertinent to these proceedings, E.G. was diagnosed with insulin-dependent diabetes; his blood sugar generally ranged from 150 to 270, which is in the mid-range, although it once reached 348. E.G. was alert, oriented, self-ambulatory, and somewhat grouchy. E.G.'s brother visited him about three times each week, and E.G. often left the facility with his brother for a meal. He did not adhere strictly to his diet, but often ate fried foods when he went out with his brother, and he kept a supply of orange juice in the small refrigerator in his room. Both fried foods and orange juice are contraindicated for diabetics. Pursuant to physician's orders, E.G.'s blood sugar was to be monitored four times a day, before each meal and at bedtime,7 and insulin was to be administered on a sliding scale, in an amount to be determined based on his blood sugar level. This order was transcribed on E.G.'s Medication Record, which, for each day of the month, included spaces for the time, the blood sugar level, the insulin coverage (the dosage expressed in number of units administered), and the site of injection, together with the initials of the staff member providing the care. Life Care staff also maintained glucose monitoring sheets, which included spaces for the date, the time, the blood sugar level, the dosage of insulin administered, and the initials of the staff member providing the care. There is no documentation in E.G.'s Medication Records, his glucose monitoring sheets, or the Nurses Notes that his blood sugar was checked at 11:30 a.m. on June 7, 2001. When his blood sugar was checked at 4:30 p.m. on June 7, it was 317, which is substantially higher than usual. For the 6:30 a.m. checks on June 2, 3, and 8, 2001, E.G.'s blood sugar level was documented and there are notations that insulin was given, but the dosages and sites of injection were not noted; E.G.'s blood sugar at the 11:30 a.m. checks on these days was either virtually the same as, or less than, the levels noted at the 6:30 a.m. checks. For the 6:30 a.m. check on June 4, 2001, E.G.'s blood sugar level was documented, but there is no notation that insulin was given; E.G.'s blood sugar at the 11:30 a.m. check on June 4 was less than the level noted at the 6:30 a.m. check. Wound Care. On June 5, 2001, a dermatologist removed a lesion from the top of E.G.'s left hand. The dermatologist prescribed Bactroban ointment, which was to be applied to the wound twice a day. Wound care instructions were included with the prescription, which provided as follows: Leave bandage on for 24 hours only without getting wet. Remove bandage after 24 hours and then do not apply another bandage. Leave the area open and clean the wound twice daily with warm water. Pat the wound dry and then apply Bactroban Ointment. Bactroban Ointment is a topical antibiotic that can be purchased without a prescription. Continue to do this until the wound has healed. Normal bathing can be resumed after the bandage is removed. Some redness and swelling are normal in the immediate area of the wound. If the wound develops significant redness, tenderness or a yellow drainage, please contact this office immediately . . . . A physician's order dated June 5, 2001, was written for E.G. for "Bactroban oint to wound on L hand, 45gm." The order did not state how often the ointment was to be applied or include the other instructions accompanying the prescription. The order was transcribed on E.G.'s Treatment Record on June 5, 2001, but the entry provided only that Bactroban ointment was to be applied to the wound once a day. There is nothing in E.G.'s Care Plan, Treatment Record, or Medication Record to document that his wound was treated between June 5 and June 12, 2001, nor was there any indication in E.G.'s chart that anyone signed for the Bactroban ointment. Marion Neuhaus, the Director of Nursing at Life Care at the times pertinent to these proceedings, observed E.G.'s wound every day because E.G. came to her office to show her the wound and other bumps and scrapes he accumulated as he walked around the facility. Ms. Neuhaus noted that the wound was scabbed, that there was a pink area around the wound, and that there was no swelling or drainage. Treatment was begun on the wound on June 12, 2001, and it healed without any complications. Summary. AHCA has established clearly and convincingly that Life Care did not provide E.G. with the wound care that was ordered by his physician. AHCA has, however, failed to establish by even the greater weight of the evidence that the healing process of E.G.'s wound was compromised by this lack of treatment. Ms. Treakle observed E.G.'s wound on June 12, 2001, and noted that it was scabbed and red around the edges. Ms. Treakle concluded that this redness alone indicated that the wound was infected. This conclusion is undermined by the notation in the wound care instructions included with E.G.'s prescription from the Dermatology Center that "[s]ome redness and swelling are normal in the immediate area of the wound." Furthermore, Ms. Treakle did not follow E.G.'s wound after June 12, 2001, and the evidence presented by Life Care that E.G.'s wound healed in a timely manner is uncontroverted. AHCA has established clearly and convincingly that there are several omissions in the documentation of Life Care's monitoring of E.G.'s blood, but these omissions do not reasonably support the inference that Life Care failed to monitor E.G.'s blood sugar and administer insulin on these dates as required by the physician's orders; rather, Life Care's failure on these occasions was inadequate documentation, not inadequate care. AHCA has, however, established clearly and convincingly that Life Care did not monitor E.G.'s blood sugar as required by his physician's order at 11:30 a.m. on June 7, 2001; this inference may reasonably be drawn based on the lack of documentation and E.G.'s elevated blood sugar at the next check at 4:30 p.m. Ms. Treakle assumed that E.G. suffered actual harm as a result of this omission because, in her view, hyperglycemia, or elevated blood sugar, always causes damage to the body; Ms. Treakle could not, however, identify any specific harm to E.G. caused by this one omission. AHCA has failed to establish by even the greater weight of the evidence that E.G.'s physical well-being was compromised by Life Care's failure to monitor his blood sugar on this one occasion. Resident N.D. Fall from Shower Chair.8 At the times pertinent to these proceedings, N.D. was a 79 year-old woman who had been a resident of Life Care since October 26, 1999. According to the assessment of N.D. included in the Minimum Data Set completed on May 3, 2001, N.D. suffered from Alzheimer's disease, had long- and short-term memory problems, and was severely impaired and unable to make decisions; as of June 12, 2001, N.D. was almost entirely dependent on staff for all of the activities of daily living. N.D.'s Care Plan for November 6, 2000, which was updated with handwritten notes, reflects that she had poor safety awareness. The Interdisciplinary Notes maintained by Life Care reflect that, on June 5, 2001, a nurse observed N.D. leaning forward in her wheelchair at breakfast; this was the first mention of this behavior in N.D.'s chart. Dr. Gil, N.D.'s physician, included a notation in the Physician's Progress Notes for June 8, 2001, that he observed N.D. leaning forward but was unable to assess her abdomen because of her anxiety. The Interdisciplinary Notes reflect that Dr. Gil visited N.D. on Saturday, June 9, 2001, and that she was again leaning forward in her wheelchair, "almost falling out of [her] chair." Dr. Gil ordered an ultra-sound of N.D.'s abdomen and a "lap buddy while in w/c [wheelchair] to prevent falls." Dr. Gil's order was noted in the Interdisciplinary Notes for June 9, 2001, as well as on a physician's order form signed by Dr. Gil on June 10, 2001. According to Life Care's written policy, physician orders are to be transcribed into a patient's care plan, treatment plan, or medication administration record, depending on the nature of the order. Dr. Gil's order for a lap buddy had not been transcribed into N.D.'s November 6, 2000, Care Plan at the time Ms. Treakle conducted her survey on June 12, 2001.9 A lap buddy was used on N.D.'s wheelchair beginning on the morning of June 11, 2001. On the evening of June 11, 2001, CNA Nova Coleman was caring for N.D. Ms. Coleman had been working for Life Care for only a short time, and N.D. was one of the first patients Ms. Coleman cared for after finishing her initial training. Ms. Coleman was, however, not an inexperienced CNA, having previously worked at another nursing home. At approximately 8:30 p.m., Ms. Coleman and another CNA had just finished showering N.D., and N.D. was sitting in a shower chair; her hair had been toweled dry, and she was dressed in her night clothes. The second CNA left the room, and Ms. Coleman, who had been standing in front of N.D., moved to the back of the shower chair so she could push N.D. out of the shower area. As she moved around the chair, N.D. pitched forward and fell face-first onto the floor. Ms. Coleman tried to grab N.D. to stop her from falling, but N.D. toppled over so quickly that Ms. Coleman could not reach her. N.D. suffered severe bruises to her face and a laceration on her lip as a result of the fall, but she did not break any bones. Ms. Coleman had not been advised prior to the fall of N.D.'s tendency to lean forward in her chair. N.D.'s tendency to lean forward in her wheelchair should have been entered in her Care Plan, together with the requirement that a lap buddy was to be used whenever she was in a wheelchair. In addition, Ms. Coleman should have been briefed on N.D.'s condition, including her tendency to lean forward, before Ms. Coleman was allowed to care for N.D. Although a lap buddy was not ordered for the shower chair and, in fact, could not appropriately have been used on a shower chair, the former Nursing Director of Life Care conceded that there were other means by which N.D.'s fall could have been prevented.10 The former Nursing Director also conceded that the failure to brief Ms. Coleman on N.D.'s condition probably contributed to the fall from the shower chair. Summary. AHCA has established clearly and convincingly that Life Care failed to provide N.D. with the services necessary to prevent her from falling from the shower chair and injuring herself, that Life Care failed to provide services that met professional standards, and that Life Care failed to revise N.D.'s Care Plan to include the risk of her falling forward while seated and the approaches Life Care would take to prevent her from injuring herself. Life Care conceded that the Care Plan should have included N.D.'s tendency to lean forward while seated and Dr. Gil's order of June 9, 2001, that N.D. be provided with a lap buddy when she was in the wheelchair. Life Care also conceded that the CNA should have been briefed on N.D.'s condition before she was assigned to care for N.D. Life Care further conceded that, even though Dr. Gil did not specifically prescribe a restraint to be used in the shower chair, measures could have been taken to ensure that N.D. did not fall out of the shower chair. AHCA has also established clearly and convincingly that Life Care's failure to provide proper care to N.D. resulted in her suffering significant injuries to her face. Although the injuries were to soft tissue and ultimately healed, N.D.'s physical well-being was adversely affected. In addition, AHCA has established clearly and convincingly that, even had N.D. not fallen and suffered injuries, the failure to include in N.D.'s Care Plan her tendency to lean forward and its failure to transcribe the physician's orders regarding the lap buddy into the Care Plan could have caused a lapse in the care provided to N.D. that could have possibly resulted in injury.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order Sustaining the reduction in the licensure status of Life Care Center of Port Saint Lucie to conditional for the period extending from June 12, 2001, to August 17, 2001; and Imposing an administrative fine in the amount of $5,000.00. DONE AND ENTERED this 15th day of May, 2002, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of May, 2002.
The Issue The issue in this case is whether the application filed with the Department of Health (“Department”) on March 31, 2017, by Galencare Inc., d/b/a Northside Hospital (“Northside”), to operate as a provisional Level II trauma center met the applicable criteria and standards under Part II, Chapter 395, Florida Statutes (2017),1/ and Florida Administrative Code Chapter 64J-2.
Findings Of Fact Parties The Department is an agency of the State of Florida created pursuant to section 20.43, Florida Statutes. The Department’s mandate is to “promote, protect and improve the health of all people in the state,” and it has a primary responsibility for evaluating provisional trauma center applications submitted by acute care hospitals. §§ 381.001 and 395.40(3), Fla. Stat. Northside is a 288-bed acute-care hospital located in TSA 9, Pinellas County, Florida. Northside provides a wide range of services, including inpatient cardiovascular and neuroscience services. Northside has developed a trauma program and submitted an application to operate as a provisional Level II trauma center in March 2017. The Department’s preliminary determination to deny Northside’s application on May 1, 2017, is the subject of this proceeding. Bayfront is an acute-care hospital located in TSA 9, Pinellas County, Florida. Bayfront has been designated by the Department as a Level II trauma center. Northside’s Trauma Center Application Northside Submitted a Timely Letter of Intent In the summer of 2016, Northside received a letter from the Department notifying Northside of the opportunity to submit a letter of intent to become a trauma center. Northside timely submitted a letter of intent with the Department in September 2016. This letter indicated that Northside would seek approval from the Department to operate as a Level II trauma center. Northside was well-situated for a trauma center because of the resources and services already in place at the hospital. Moreover, Northside was prepared to open a trauma program because it already had extensive experience treating critically ill patients. After Northside submitted its letter of intent, the Department responded by sending Northside a notice accepting its letter of intent and providing information on the application process. The notice directed Northside to the Department’s trauma center application and contained instructions for the completion and submission of the application. Northside Established a Full Trauma Program after the Department Accepted its Letter of Intent Once Northside received the Department’s notice confirming acceptance of its letter of intent, it began making significant investments of resources and capital to develop its trauma program. It did so to ensure that its forthcoming application was compliant with the requirements set forth in DOH Pamphlet (DHP) 150-9 (the “Trauma Standards” or “DHP”), which is incorporated by reference in rule 64J-2.011. As part of the development of its trauma program, Northside hired Doreen Gilligan in October 2016 to serve as director of Trauma Services. The hospital also worked with Angie Chisolm to draw on resources from other approved trauma centers, such as trauma-related policies and procedures and best practices for trauma center operations. Northside’s expertise in advanced, life-saving care, including cardiovascular and neuroscience programs and its intensive care unit (“ICU”), made it a well-qualified candidate to open a new trauma center. Between October 1, 2016, and April 1, 2017, Northside invested over $4 million to develop its trauma program. Northside invested $2.5 million in physical plant improvements and equipment. These improvements included: A helipad, which is properly licensed by the Department of Transportation and FAA. The helipad is operational and Northside is already receiving patients from helicopters on a daily basis in its capacity as an acute- care hospital. Two state-of-the-art trauma resuscitation bays in the emergency department (“ED”) that are in immediate proximity to the helipad. These new trauma bays can accommodate up to four trauma patients at the same time. The expansion of the ICU to include 12 beds that are specifically designated for trauma patients. The expansion of one of the operating rooms because trauma patients often require care from multiple doctors simultaneously. The purchase of new equipment, including new ICU monitors, operating room equipment, and equipment to support physician subspecialists. The purchase of a blood track machine for the emergency department. This machine dramatically reduces the amount of time it takes for patients to receive blood transfusions. The purchase of a platelet function testing machine and a thromboelastography machine. These machines help identify where a trauma patient is bleeding. These machines also play a critical role in quickly stopping bleeding – one of the key functions that every trauma center must perform. The purchase of a second computed tomography (“CT”) machine dedicated solely to the provision of radiology services needed by trauma patients. Northside invested approximately $1.7 million in physician and staff employment and recruitment. This investment has enabled Northside to do the following: Provide continuous, around-the-clock trauma surgeon coverage, 7 days a week (beginning February 16, 2017). Provide continuous, around-the-clock anesthesiology coverage. Provide hospital coverage for the required 19 physician sub-specialty groups. These physicians are able to arrive at the hospital within 30 minutes or less. Hire more than 30 additional full-time nurses to meet the staffing requirements in the Trauma Standards. These hires have allowed Northside to provide a continuous, in-house presence of operating room nurses and technicians. Hire specialized administrative staff for the trauma program, including Doreen Gilligan (Director of Trauma Services), a trauma registrar, and a performance improvement coordinator dedicated solely to ensuring Northside’s trauma patients receive high quality care. Once Northside’s trauma program becomes operational, Northside plans to hire a second trauma performance improvement coordinator. Between January and March 2017, Northside provided over 5,000 hours of trauma training to its staff, including the CEO and CFO of the hospital. The major focus of this training was the Trauma Nursing Core Course (“TNCC”) for nursing staff, which is the foundation of emergency nursing education and ensures that the nursing staff can provide high-quality care for the most severely injured patients. The hospital implemented nursing education requirements which exceeded the Trauma Standards. Some of this training included actual operational practice using simulations and mock trauma drills. Northside implemented over 200 new facility policies related to trauma during this period. Northside subsequently trained its staff on these new programs. Northside made all of these investments prior to March 31, 2017, the date on which Northside submitted its application to the Department. Northside Timely Assembled and Submitted Its Trauma Center Application and Deficiency Response to the Department Northside’s application was prepared by a core team whose mission was to ensure that the application fully complied with the Trauma Standards. The key members of that team were Peter Kennedy, chief operating officer; Doreen Gilligan, director of Trauma Services; Dr. Erik Barquist, interim trauma medical director; and Angie Chisolm, assistant vice president of Trauma Services for HCA East and West Florida Divisions. The final application submitted to the Department encompassed over 10,000 pages of information. Because the application was too voluminous for any one person to prepare alone, each of the team members played an important role in ensuring the application addressed each Trauma Standard. Preparation of the application involved thousands of staff hours and required close cooperation with the physicians, staff, and community members. Northside timely submitted its trauma center application (“Northside Application”) to the Department on March 31, 2017. After receiving the Northside Application, the Department arranged for it to be reviewed by two outside experts, Dr. Lawrence Reed and Nurse Susan Cox. Both Dr. Reed and Nurse Cox have reviewed trauma applications on behalf of the Department in the past. On April 14, 2017, the Department sent Northside a letter notifying it of the deficiencies that Dr. Reed and Nurse Cox had identified (the “Deficiency Notice”). The Department provided a checklist (Department of Health Initial Provisional Review Checklist for Northside, April 5, 2017, hereafter referred to as the “Initial Checklist”) based on the Trauma Standards with boxes marked “Yes” or “No” to indicate whether the reviewers found evidence to demonstrate that each particular Trauma Standard and subpart was met. The checklist also contained written comments from the reviewers for subparts which were checked “No.” Of the more than 350 subparts that make up the Trauma Standards, the reviewers only identified 35 about which they had concerns or additional questions. Most of the comments from the reviewers consisted of simple requests for clarification. In some cases, the reviewers asked for information that Northside had already submitted with the initial application on March 31, 2017. Northside timely responded to each deficiency identified by the Department on April 21, 2017 (the “Deficiency Response”), five business days after receipt of the Deficiency Notice. The Deficiency Response was prepared by the same team that prepared the initial application. Much like the initial application, the team’s role was to ensure that each concern was addressed and that the application demonstrated that the hospital met the Trauma Standards. The Deficiency Response included 78 supporting exhibits consisting of hundreds of pages. The Deficiency Response was divided in two sections: (1) a narrative table; and (2) supporting exhibits to the narrative table. In the narrative table, Northside addressed each Trauma Standard subpart identified in the Initial Checklist as an area not met or an area of concern. The table was organized into three columns: the first reciting the subpart language; the second copying the reviewer concern from the Initial Checklist; and the third detailing Northside’s narrative response or explanation to each comment. The Deficiency Response was also reviewed by Dr. Reed and Nurse Cox. These reviewers determined that Northside addressed and corrected the vast majority of deficiencies identified in the initial review. Only three Trauma Standard subparts were identified as remaining areas of concern: Standard V(B)(3)(a)(1), Standard V(B)(3)(d), and Standard XVIII(G). Each of these issues was identified by Dr. Reed. Neither Dr. Reed nor Nurse Cox recommended to the Department that Northside’s application be denied. On May 1, 2017, the Department informed Northside that its application was not in compliance with the applicable Trauma Standards and would be denied (“Denial Letter”). The Denial Letter did not identify which (if any) of the Standards that the Department believed that Northside had not met. Instead, the Denial Letter attached a checklist indicating concerns with only three subparts. The Department now takes the position that Northside’s application is deficient because it did not satisfy Standard V(B)(3)(a)(1), Standard V(B)(3)(d), and Standard XVIII(G), although the Department has not stated whether each one of these Standards, standing alone, would have (in its view) warranted denial of the application. The Denial Letter did not afford Northside any opportunity to address the potential issues identified with respect to the three Standards. Instead, it informed Northside that its only options were to seek an administrative hearing challenging the Department’s denial or to submit a trauma center application the following year. Northside therefore did not submit any additional documentation to the Department. Northside’s Evidence Establishes That It Satisfied Each of the Three Standards the Department Claimed Were Deficient Standard V(B)(3)(a)(1) Standard V addresses the facility requirements relating to the emergency department. It includes requirements for a trauma resuscitation area, helipad, emergency physicians, support staff, and trauma flow sheet, among other criteria. This Standard also details the required qualifications for emergency room physicians who may provide care to trauma patients. Emergency room physicians must be board certified in emergency medicine or meet stringent alternate criteria demonstrating their qualifications. There are two ways to meet the alternate criteria. The first includes attestation from the trauma medical director that there is a critical need for the physician, completion of an accredited residency training program, documentation that the physician participated in the Advanced Trauma Life Support (“ATLS”) program, 48 hours of trauma-related continuing medical education in the past three years, evidence that the physician attends at least 50 percent of the trauma performance improvement meetings, evidence of membership or attendance at regional or national trauma meetings during the past three years, and attestation by the trauma medical director and emergency department director that the physician compares favorably with other physicians on the trauma call schedule. The second way for a physician to meet the alternate criteria is by providing evidence of board certification in a primary care specialty and attestation by the emergency department director that the physician has worked as a full-time emergency physician for three of the last five years. As part of its initial application, Northside provided the Department with staffing schedules for March, April, and May 2017, which documented the physicians on staff in the emergency room during those months and the shift times they would cover. Northside also submitted substantial evidence regarding the qualifications of each of these emergency room physicians. One of these emergency room physicians was Dr. Abraham Wilks. At the time it submitted its initial application, Northside believed Dr. Wilks met both paths of the alternate criteria. In preparation for the initial application, Dr. Wilks, working with Northside, went to extraordinary lengths to secure the seven required components under the first alternate criteria path. Northside also provided evidence that Dr. Wilks qualified under the second alternate criteria path since he was board eligible for family medicine and had been working as an emergency physician for the past five years. The staffing schedules submitted with Northside’s application on March 31, 2017, showed that Dr. Wilks was scheduled to be the sole physician provider for short periods of time on a limited number of days. During his review of the initial application, Dr. Reed concluded that Dr. Wilks did not meet either of the alternative criteria because he did not complete an emergency medicine residency and was no longer board-certified in family medicine. Because Dr. Wilks did not meet these qualification requirements in Standard V(B)(3) as an emergency department physician, he could not be the sole physician provider in the emergency department. After receiving the Deficiency Notice and Initial Checklist, Northside immediately took steps to address Dr. Reed’s comments. Northside’s leadership worked with the director of the emergency department to ensure that Dr. Wilks would not be the sole physician provider in the emergency room. After April 18, 2017, Dr. Wilks never served as the sole physician provider in the emergency room. The emergency department physician staffing schedule for April and May 2017, was updated to reflect these changes (“Updated Staffing Schedule”). The other physicians listed on the staffing schedule were appropriately qualified, and the staffing schedule provided for appropriate physician coverage. In its Deficiency Response, Northside noted these operational changes regarding Dr. Wilks and specifically addressed Dr. Reed’s concerns. Northside informed the Department that “Dr. Wilks has been removed from the ED Trauma assignment and will never be the single provider in the ED, effective immediately.” Dr. Reed agreed at his deposition that if Dr. Wilks were removed from the staffing schedule, Northside would be in compliance with Standard V(B)(3)(a)(1). The Deficiency Response also referenced a related exhibit, which Northside intended to be the amended staffing schedule. However, due to a clerical error, Northside’s Deficiency Response included the old staffing schedule from the initial application, which incorrectly showed Dr. Wilks as the sole provider for limited periods. The old staffing schedule contradicted the narrative explanation of Northside’s operational changes included in the Deficiency Response and was clearly submitted in error. Dr. Reed himself noted this contradiction: The response document also states that “Dr. Wilks has been removed from the ED Trauma assignment and will never be the single provider in the ED, effective immediately. However, it appears that Dr. Wilks is the only ED physician on site from 6a-8a on May 4, May 7, May 20, and May 21. Please clarify this contradiction.” The Department did not follow Dr. Reed’s recommendation. It never contacted Northside to ask why the staffing schedule listed Dr. Wilks as the sole provider for limited periods of time when Northside’s submission expressly stated that Dr. Wilks would no longer be the sole provider. Had the Department contacted Northside, it would have learned that the “old” staffing schedule had been submitted rather than the current and correct staffing schedule, i.e., the one that did not include Dr. Wilks as the sole provider. Thus, there can be no dispute that, as of April 18, 2017, (1) Northside’s operative emergency department staffing schedule was updated to reflect that Dr. Wilks would never be the sole provider; and (2) at all times, Northside’s emergency department was fully staffed by properly qualified emergency department physicians. Under these circumstances, the Department erred in taking the position that Northside did not satisfy Standard V(B)(3)(a)(1) simply because it mistakenly submitted an outdated staffing schedule to the Department in conjunction with its clear narrative explanation. Standard V(B)(3)(d) The physician qualifications included in Standard V also require that each physician maintain a current ATLS provider certification. The ATLS certification is required only of emergency department physicians and trauma surgeons because these are the physicians who treat trauma patients when they first arrive at the trauma center. One of the emergency department physicians included in Northside’s application is Dr. Joseph Nelson. Dr. Nelson also serves as the emergency department’s pre-hospital trauma care expert for the Committee of Emergency Preparedness and Readiness, meaning that he is the state’s expert on issues relating to the emergency care provided on-site before patients are brought to the hospital. Northside’s application included an extensive set of documents that established Dr. Nelson’s credentials, including the following: a compilation of Dr. Nelson’s certifications, proof of his osteopathic board certification, his Florida Department of Health medical license, his physician profile with the American Medical Association, proof of his continuing medical education hours, his letter of privileges at Northside, and his most recent ATLS certificate. Dr. Nelson’s ATLS certificate included a letter from ATLS that recognized Dr. Nelson for high scores on his written and practical tests and recommended that he apply to be an ATLS course instructor, an honor that is accorded only to doctors who attain the best performances at the training course. At the time Northside submitted its initial application, Dr. Nelson’s ATLS certification had recently expired and he was planning to take a course to renew his certification. Dr. Nelson was aware of the expiration before the submission and made a concerted effort to complete the course in advance by registering for a course in February 2017. However, the course Dr. Nelson was originally scheduled to take in February 2017 was cancelled due to a snowstorm. Because ATLS courses are in high demand and often full, Dr. Nelson was not able to immediately reschedule for a course in his region. After working with Northside and Angie Chisolm, he registered for another course to be held in Tallahassee on April 23, 2017. Northside included proof of his course registration with its initial application. In the Deficiency Notice and Initial Checklist provided by the Department, Dr. Reed noted that Dr. Nelson’s ATLS certificate had expired and acknowledged that he was scheduled to take his ATLS course on April 23, 2017. Dr. Reed asked the hospital to “provide evidence of successful completion of the ATLS course he is scheduled to take on 4/23/2017.” Dr. Reed did not ask the hospital to submit any further documentation before the certificate arrived. On multiple occasions, Northside sought clarification from the Department regarding how it should establish that Dr. Nelson was in compliance with Standard V(B)(3)(d). Before Northside submitted its initial application to the Department, it informed the Department that Dr. Nelson was registered for and planned to take the ATLS course on April 23, 2017, and asked for guidance regarding how it should establish that Dr. Nelson was in compliance with Standard V(B)(3)(d). The Department advised Northside to provide proof of registration with its initial application, and Northside did just that. Northside returned to the Department for guidance after receiving the Deficiency Notice and reminded the Department that Dr. Nelson planned to complete the ATLS course on April 23, 2017. Once again, the Department directed Northside to submit documentation of course registration and to later submit Dr. Nelson’s updated ATLS certificate when available. In its Deficiency Response, Northside reiterated that Dr. Nelson was registered for and scheduled to complete the ATLS certification course on April 23, 2017, just two days later. Based on the Department’s guidance, Northside also included Dr. Nelson’s ATLS course registration, which demonstrated that he was scheduled to take the course in Tallahassee on April 23, 2017, as well as email communication from the course host confirming that Dr. Nelson paid for and secured a seat at that course. Northside further indicated that it would provide evidence to the Department of Dr. Nelson’s ATLS recertification following successful completion of the course. Northside also informed the Department that if Dr. Nelson did not attend and pass the course on April 23, 2017, he would be removed from the call schedule effective May 1, 2017. Dr. Nelson successfully completed the course on April 23, 2017, and thus satisfied his ATLS requirement that day. Northside immediately confirmed with the ATLS coordinator that Dr. Nelson had passed the course and concluded that he was in compliance with Standard V(B)(3)(d). Dr. Reed’s review of Northside’s Deficiency Response stated: “Upon receipt of a copy of Dr. Nelson’s updated ATLS certification, compliance with this standard will have been met.” Northside subsequently received Dr. Nelson’s updated ATLS certification. It did not arrive at Northside until after May 1, 2017, due to normal delays in processing by the American College of Surgeons. At hearing, Northside presented Dr. Nelson’s updated ATLS certification reflecting his successful completion on April 23, 2017. In sum, Dr. Nelson was ATLS-certified as of April 23, 2017, which is before the Department’s May 1, 2017, deadline. Northside also provided a litany of information to the Department with its initial application and Deficiency Response detailing Dr. Nelson’s efforts to secure his ATLS certification. Northside therefore satisfied Standard V(B)(3)(d). Standard XVIII(G) Standard XVIII addresses quality management, which is one of the core requirements of a trauma program. Since the time that Northside began building its trauma program, it has prioritized quality management. Northside began developing its trauma quality management program in early December 2016. As part of this effort, Northside developed a trauma quality management plan, which is essential for any quality management program. Following the beginning of limited trauma-related operations on February 16, 2017, Northside held its first peer review meeting on February 22, 2017, to discuss patient treatment issues. Dr. Barquist attended these meetings and minutes were kept. Northside also began to hold nursing and ancillary staff meetings, known as trauma quality management (“TQM”) meetings, during this time. The directors of each department at the hospital attended these meetings, as well as the chief operating officer and chief financial officer. The objective of these meetings was to operationalize the more than 200 trauma-specific policies and procedures put in place during the trauma program development. Any issues identified in these meetings were addressed immediately with the whole trauma staff to ensure program-wide compliance. To demonstrate compliance with this Standard, Northside submitted nearly 400 pages of documents with its initial application. These included Northside’s Trauma Performance Improvement and Patient Safety Plan, policies and procedures, and peer review minutes. As part of its application, Northside submitted the minutes of its peer review meetings at which quality management issues were discussed. Even though Northside was not receiving trauma alert patients from local emergency medical services (something it could not do prior to becoming a provisionally approved trauma center), it routinely conducted quality management activities with regard to patients in the hospital with trauma injuries. With this patient population, Northside employed its trauma improvement processes to identify areas in which there was room for improvement in care, and to determine how education, training, and equipment could be enhanced to improve care for similar patients in the future. In his review of Standard XVIII(F), Dr. Reed affirmed that Northside held quality management meetings at which the following issues were discussed: The subject matter discussed, including an analysis of all issues related to each case referred by the trauma service medical director to the trauma program manager, cases involving morbidity or mortality determining whether they were disease related or provider related and the preventability, and cases with other quality of care concerns. A summary of cases with variations not referred to the committee. A description of committee discussion of cases not requiring action, with an explanation or each decision. Any action taken to resolve problems or improve patient care and outcomes. Evidence that the committee evaluated the effectiveness of any action taken to resolve programs or improve patient care and outcomes. Northside also submitted documents addressing Standard XVIII(G). This subpart addresses a quarterly report prepared by the trauma quality management committee which must be submitted to the Department by approved trauma centers 15 days after the end of each quarter. If approved as a provisional trauma center, Northside would have submitted its first quality report to the Department on August 15, 2017. The report, which is only submitted by provisionally approved and verified trauma centers, must include information related to patient case reviews, select clinical indicators, and patient complications. The report is only made available by the Department to approved trauma centers; it is not provided to applicants. The report form is not referenced in any Department rule, the Trauma Standards, or the Department’s website. However, to establish that Northside was prepared to provide the required report once it received provisional approval, Northside obtained a copy of the template from an affiliated operating trauma center and included that template in its application. Because it was not an approved trauma center, Northside ultimately submitted a detailed template of the quality report to be submitted following approval as required. The detailed template included blank fields with the quality indicators selected by the Department and the hospital, benchmarking data points, patient complications, and case review information. The fields in the report regarding patient complications and case review information can be taken directly from the peer review minutes, which Northside submitted with its initial application and were located directly in front of its detailed template. In his review of Northside’s initial application, Dr. Reed concluded that Northside provided much of the required evidence, demonstrating “an active and effective trauma quality improvement program” and met the vast majority of subparts in this Standard. However, regarding Standard XVIII(G), Dr. Reed identified deficiencies on the basis that “[a] template of a report was submitted, but there were no cases recorded.” Dr. Reed confirmed that he reviewed the peer review minutes Northside submitted with its application. In response to Dr. Reed’s comment, Northside submitted updated templates with additional information. The quality indicator and benchmarking templates were populated with data from its trauma registry regarding the patients with traumatic injuries that the hospital had treated since February 16, 2017. In addition to these documents, which specifically addressed Standard XVIII(G), Northside also submitted more peer review minutes from subsequent meetings since the initial application, which were included directly in front of Exhibit 75. Dr. Reed ultimately concluded that Northside had not demonstrated compliance with Standard XVIII(G)(1)-(3). That conclusion, however, is unsupportable by the evidence at hearing. Dr. Reed acknowledged that Northside’s Deficiency Response provided the “quarterly data regarding the state required indicators and the additional institution-specific indicators.” The only reason he believed that Northside’s application remained deficient was that it did not “address the individual case quality review issues required in Standard XVIII.G.1-3.” This conclusion is undermined by Dr. Reed’s recognition-–as reflected in his review of Standard XVIII(F)-–that Northside was conducting case quality reviews. In his deposition, Dr. Reed agreed that Northside’s Deficiency Response “did include information regarding the number of cases and indicators and that sort of thing.” Indeed, Dr. Reed’s true concern appears to have been that Northside’s “numbers,” i.e., the number of patient cases reviewed by Northside, were “still kind of thin.” But Dr. Reed himself recognized that prior to the time that a trauma center application is provisionally approved and the trauma program begins treating trauma alert patients, a trauma program is unlikely to have a large number of patient cases to review. The Department’s view that Northside did not satisfy Standard XVIII(G) is not supported by the evidence. The section of the quality report addressing individual case reviews is simply a summary of the information contained in the hospital’s peer review minutes-–and Northside conducted the required peer review meetings. Northside demonstrated at hearing that it was capable of preparing a table summarizing its peer review cases and the corrective action taken for each case. All the information contained in the completed table was taken verbatim from the peer review minutes that Northside submitted with its initial application and Deficiency Response. If approved, Northside was prepared to submit the quarterly report as required on August 15, 2017. Thus, at worst, Northside did not copy and paste information from one place to another. To the extent possible, Northside complied with this Standard. The Department’s review of an earlier trauma center application confirms that the Department should not have determined that Northside did not satisfy Standard XVIII(G). In April 2016, the Department approved an application to operate as a provisional Level II trauma center submitted by Jackson South Community Hospital. As part of its approval, the Department-- based on a review by Dr. Reed--determined that Jackson South met each of the requirements in Standard XVIII(G). However, Jackson South only submitted hospital policies, promising to prepare and submit the required quality report if approved. Jackson South did not submit any quality report or even a template of such a report. Despite submitting far less evidence demonstrating compliance, Dr. Reed did not note any deficiencies for this Standard with regard to Jackson South’s application. The Department ultimately approved the application. Dr. Reed confirmed that Northside’s quality management program was significantly more developed than the one for Jackson South Community Hospital that Dr. Reed himself had recommended be approved only two years earlier. At hearing, Chief Dick could not explain the inconsistency. In sum, the Department erred in concluding that Northside had not satisfied Standard XVIII(G) because Northside had an active and effective quality management program that involved thorough case reviews and Northside demonstrated that it was capable of submitting the required forms once its program was approved and its fully operational. Contemporaneous Emails Demonstrate That the Department Denied Northside’s Application for Reasons Having Nothing to Do with the Merits of Northside’s Program The Department’s decision to deny Northside’s application was not made in a vacuum. On April 28, 2017-–only two days before the Department sent Northside the Denial Letter-– a circuit judge in Leon County entered an order (“Injunction Order”) temporarily enjoining Northside from operating as a trauma center and enjoining the Department from permitting Northside to operate as a provisional trauma center. This injunction was based exclusively on issues of administrative law and did not in any manner address the merits of Northside’s application. In fact, the Department strongly opposed the injunction. The injunction did not prevent the Department from approving Northside’s application. The Department’s internal correspondence demonstrates that the injunction led the Department to deny Northside’s application, presumably because it was concerned about the ramifications of provisionally approving Northside’s application while the injunction was pending and Northside could not begin trauma center operations. On April 28, 2017, just hours before the Injunction Order was issued, Kate Kocevar, head of the Department’s Trauma Section, emailed Dr. Reed’s final conclusions to Chief Dick and informed her that in her opinion “Northside Hospital appears to have passed the reviewers [sic] survey and will be granted Provisional status.” Chief Dick confirmed at hearing that her initial impression based on Ms. Kocevar’s email was that Northside passed the survey. Later that day, Chief Dick received the injunction order and immediately emailed other Department personnel, “[l]ooks like the letter to Northside will not be going out on Monday as originally written.” Three days later, on May 1, 2017, the Department sent Northside the Denial Letter, notifying the hospital that its application had not met the Trauma Standards and would be denied. Given the looming injunction order, the Department’s internal correspondence, and the fact that the three alleged deficiencies are minor, at the very most, the Department’s decision to deny the application was apparently motivated by an administrative decision that it should not approve an application while the injunction was in place-–not by any genuine concerns regarding the merits of Northside’s program. Northside Has Expended, and Continues to Expend, Millions of Dollars to Maintain an Operational Trauma Program Northside has continued to maintain its trauma service capability, including retaining physicians and staff, while proceeding with its challenge of the Department’s preliminary denial. As part of its readiness efforts, Northside’s quality management program remains in place, meaning that Northside is still holding peer review and quality improvement meetings. Maintaining a continued state of readiness to initiate operations as a provisional Level II trauma center will cost Northside approximately $13 million this year.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department enter a final order finding that Northside met its burden of establishing that its trauma center application met the applicable standards, and awarding provisional Level II status to the applicant. DONE AND ENTERED this 20th day of December, 2017, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN 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 20th day of December, 2017.
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed to practice in the State of Florida, having been issued license number ME 0025685. For 18 years prior to the event complained of herein, Respondent worked at Indian River Memorial Hospital, where he practiced as an anaesthesiologist. Also prior to the event complained of herein, Respondent was a tri- athlete, training in swimming, biking, and running. During the summer of 1992 he competed in five or six tri-athalons and did quite well in his age class. Respondent was also a snow skier. In accordance with his physical fitness values, Respondent does not drink alcoholic beverages or smoke cigarettes. He is also a vegetarian. Peter G. Wernicke is an orthopedic surgeon in the Vero Beach area. After arriving there, he and Respondent became social friends and went on ski trips together. He also became Respondent's treating physician, caring for Respondent when Respondent suffered broken bones, strains, and sprains as a result of his sporting activities. In early winter of 1992 Respondent seriously injured his knee while snow skiing. Respondent discussed his need for surgery with Wernicke after Respondent returned to the Vero Beach area. Wernicke was insistent that he perform Respondent's knee surgery, but Respondent wanted to have the surgery performed by Dr. Richard Steadman in Vail, Colorado, since he believed that Dr. Steadman was probably the best in the world at taking care of that particular kind of knee injury. Wernicke then insisted that Respondent allow Wernicke to perform the knee surgery with Respondent awake, and once the knee was opened up, Wernicke and Respondent would look at it and decide whether it was something Wernicke was able to take care of or if the knee should be closed and Respondent would then go to whomever he wanted to have the surgery performed. Respondent would not agree to that approach since he well understood that opening the knee twice would double Respondent's risk of infection in that injured knee. Up to the time that Respondent left to travel to Vail for his knee surgery, Wernicke maintained that he was not giving Respondent his blessing for having the surgery performed by someone else. Respondent went to Vail and had Dr. Steadman perform the surgery in early December of 1992. Respondent remained in Vail post-operatively undergoing physical therapy which commenced within hours of surgery being completed to increase his chances of obtaining full range of motion with that knee by keeping it moving and preventing scarring. Respondent returned to Vero Beach on December 13 and returned to work the next morning, working a full shift that day. After his shift was over, he drove himself to Orlando for a meeting. While in Orlando, Respondent began to have very severe pain and swelling in his knee. He drove back to Vero Beach, arriving at his home at approximately 9:30 p.m. Upon his arrival, he telephoned Wernicke, told Wernicke he was in a great deal of pain, and begged Wernicke to help him by meeting him at the hospital and looking at Respondent's knee. Wernicke told Respondent that he would not go to the hospital to meet Respondent, that Respondent should elevate his knee and apply ice, and then see Wernicke in the morning. Respondent elevated his leg and applied ice for the next few hours. By approximately midnight the pain had become "absolutely excruciating," unlike any Respondent had experienced with all of his broken bones and other sports injuries. Although Respondent's tolerance for pain was high enough that he had gone through the surgery performed by Dr. Steadman without pain pills and had tolerated getting on an exercise bike 12 hours after that surgery, Respondent knew that he could no longer endure the pain, that he had a serious problem with his post-operative knee, and that he needed to get help immediately. Respondent got himself up with crutches and got in the car to drive himself to the emergency room. While driving, he telephoned the emergency room at Indian River Memorial Hospital and told the staff he was on his way there and asked the name of the orthopedist who was on call. He was advised that Dr. Wernicke was not only on call, but was present in the emergency room at that moment. Respondent told the emergency room staff to tell Wernicke to wait for him. Respondent then called the operating room at Indian River Memorial Hospital and asked if an anaesthesiologist were there so he could get something to relieve his pain. He was told that Dr. Brennan had just finished with surgery and had taken the patient to the intensive care unit. Respondent then asked for two things: (1) to have Dr. Brennan go to the emergency room to take care of Respondent and (2) to bring Respondent's anaesthesia cart to the emergency room. The operating room staff agreed. Respondent's requests resulted from his experience with that hospital's emergency room staff and procedures. He knew he needed medication for his knee and for his pain. He knew that Dr. Brennan was not employed by the hospital and did not have his own anaesthesia cart there. He knew that the emergency room staff were notoriously slow in responding to patient needs or doctor requests. Therefore, over the years, Respondent had learned that whenever he was called to the emergency room, the patient was better served if Respondent took his own anaesthesia cart and supplies with him. As a result of his telephoning ahead, Respondent's arrival was expected. Dr. Wernicke waited for him. Someone took Respondent's anaesthesia cart to the emergency room and placed it next to a stretcher. Dr. Brennan was paged and told that Respondent needed him in the emergency room, and Dr. Brennan went to the emergency room to assist his colleague. When Brennan got there, Respondent had not yet arrived, but Wernicke was present. Brennan told Wernicke he was there to help with Respondent. For whatever reason, Wernicke told Brennan that Brennan was not needed and told him to leave. Before leaving the emergency room, Brennan told Wernicke that if he were needed he would be nearby in the intensive care unit and to please summon him. Respondent arrived at the hospital emergency room on crutches. The emergency room was currently under construction and had no dividing walls or partitions so that it was simply one room in which everyone could see everything occurring. There were no patients in the emergency room when Respondent arrived, but there were three or four nurses and the emergency room doctor at the nurses' station. Respondent went to the nurses' station to be admitted. He was told that he should wait in the lobby and he would be called when they were ready to begin the admission process. Respondent refused to do that, told them he was in excruciating pain, and insisted that he be given the emergency room release form and financial responsibility form to sign and be taken to one of the emergency room stretchers. He was given the forms to sign, which he did, and he was then escorted to the stretcher next to his anaesthesia cart. For the remainder of his time in the emergency room, Respondent remained on that stretcher which was no more than 30 feet from the nurses' station. No chart for his emergency room visit was prepared by the hospital personnel. Further, no one took his vital signs; no one took his blood pressure; no one asked what his problem or complaints were which caused his visit; and no one asked whether Respondent had any allergies or had recently eaten. Respondent lay on the stretcher waiting for Wernicke to return to the emergency room for approximately five minutes. When Wernicke came in, he was wearing a big smile. He remarked to Respondent that Wernicke could see that Respondent had a problem with his knee. Wernicke then gave one swipe across Respondent's knee with an alcohol swab and prepared to jab an 18 gauge needle into the knee to aspirate it, i.e., to drain the fluid. Respondent became terrified and told Wernicke to stop. Respondent's terror was caused by two fears. First, it was apparent that his knee was full of blood. He knew that blood outside of its normal confines is an irritant which causes inflammation and he knew that it was also the perfect medium in which bacteria could grow. He also knew that the risk of infection in his knee was substantial because it was a post-operative knee. Infection in such a knee presents a best-case scenario of a damaged knee and a worst-case scenario of rendering him a cripple, requiring a total knee replacement. Yet, Respondent saw that Wernicke intended to stick the needle into Respondent's dirty knee without even using a Betadine preparation to remove bacteria from the skin. Second, Respondent was in "unbelievable" pain from the significant swelling in his knee. The surgical incisions above and below his knee had ruptured from the pressure caused by the swelling. In order for Wernicke to aspirate Respondent's knee, it would be necessary for him to poke his fingers into the swollen knee area in order to locate the right place to stick the needle, and it was impossible for Respondent to hold his leg still for Dr. Wernicke to palpate, let alone insert the needle in the correct location. Respondent told Wernicke that he needed an I.V. started; that he needed Kefzol, an I.V. antibiotic, to prevent infection; that he needed Toradol intravenously for its anti-inflammatory effect; and that he was in very, very severe pain and needed pain medication so he could hold his leg still for Wernicke to aspirate. Although Wernicke recognized that Respondent was in significant, severe pain, he told Respondent he would agree to the antibiotic and he would agree to the anti-inflammatory, but that he didn't think Respondent needed anything for pain. Respondent's anaesthesia cart was not equipped with I.V. fluids. Someone brought an I.V. bag and set-up. Respondent does not know who brought the I.V. and whether it was on Dr. Wernicke's order or ordered by the emergency room doctor, but Respondent did not order the I.V. brought. No one offered to start Respondent's I.V. for him, and Wernicke did not tell Respondent that Dr. Brennan had come to the emergency room, had been sent away by Wernicke but was nearby, and had told Wernicke to summon him if he were needed. Wernicke kept telling Respondent to hurry up because it was late and he wanted to go home. He told Respondent that they needed to get finished because Wernicke was doing Respondent a favor just by being there. Respondent, while still lying on his stretcher, started his own I.V. Wernicke assisted Respondent by handing him tape for the I.V. since Respondent was performing the task with one hand. Respondent then removed his medication box from the bottom of his anaesthesia cart. He took out an ampule of Kefzol, a dry powder. He took a syringe and drew fluid from the I.V. that was running into him and mixed up that dry powder antibiotic by flushing it back and forth. He then gave the antibiotic to himself. He attempted to delay Wernicke from inserting the needle into his knee until after the antibiotic could circulate through his system and get to his knee before any bacteria was introduced, a process which would take approximately six minutes to complete enough circulations. Respondent next prepped his own knee with Betadine solution while Dr. Wernicke continued to stand there by his side, watching him. Respondent then took an ampule of Toradol, a new anti-inflammatory medication, and gave himself 60 milligrams intravenously, while Wernicke stood and watched. Although that anti-inflammatory medication would also serve to reduce Respondent's pain, Toradol is a slow-acting medication in that regard, having a slow onset but thereafter lasting for a number of hours. Respondent then removed from his medication box a 5 cc ampule of Alfenta. That ampule is a 2 1/2 inch object made of glass with its name in blue lettering on the outside, large enough to read. Alfenta is a Schedule II controlled substance and is a narcotic. Alfenta has a fast onset and a fast offset; it works in 30 to 60 seconds, and its effect lasts for approximately 10 minutes. While Dr. Wernicke watched, Respondent filled a needle and gave himself 1 cc of Alfenta which is a very conservative test dose for a man weighing 190 pounds who is in good condition. Respondent then waited a minute or a minute and a half to see what effect it had on his pain level and trembling leg. It had very little effect. Therefore, Respondent injected an additional 1/2 cc and waited. That additional amount was sufficient. Wernicke watched as Respondent gave himself the Alfenta, standing, as he had been, within inches of Respondent. As he injected the medications, Respondent filled out the chart on his anaesthesia cart, noting the medication, the dosage, and that he was the patient. Respondent then laid back on the stretcher, closed his eyes, and then told Wernicke he was ready. Wernicke then palpated Respondent's knee and inserted the needle to aspirate Respondent's knee. The pressure in his knee was so high that it blew the syringe back. Wernicke commented that he had never before seen that happen and had never seen pressure like that. Wernicke withdrew approximately 100 ccs of fluid from Respondent's knee, commenting that he did not think he'd seen one with more volume. Although initially Wernicke had said that he did not agree that Respondent needed any pain medication, Wernicke totally acquiesced in everything Respondent did to assist Wernicke in treating Respondent. Wernicke accepted Respondent's judgment and watched Respondent execute step by step the course of treatment Respondent said was needed to render proper medical treatment. Wernicke totally agreed and acquiesced with the use of Alfenta as much as he did the antibiotic and the anti-inflammatory as evidenced by Wernicke's own conduct. Wernicke never told Respondent to stop doing Wernicke's work for him. Wernicke never told him not to administer the medications. Wernicke never suggested that he or someone else perform the administration. Wernicke could have easily stopped Respondent who was laying on a stretcher but did not. Wernicke knew that Alfenta was a pain killer and a narcotic. He did nothing to stop or prevent Respondent from injecting a medication Respondent needed. Further, Wernicke continued to treat Respondent after the administration of Alfenta by thereafter performing the aspiration. After he completed the aspiration, Wernicke left. Respondent lay on the stretcher for a little while. The nurses and the emergency room doctor remained at the nurses' station, and there were still no other patients in the emergency room. Respondent asked if someone would bring him a wheelchair so he could leave, and he was told that they were too busy. Respondent took his crutches and hobbled out of the emergency room. The next morning Respondent reported to work for his regular shift which began at 7:00 a.m. After Respondent completed the first case on his shift that day, at approximately 10:30 to 11:30 a.m. he called Haynes McDaniel, the hospital's pharmacist, and told him what had happened the night before, what medications Respondent had used, and that he had used the medications on himself. Respondent said he needed to do whatever paperwork the pharmacist wanted and specifically asked the pharmacist to bill him for the medications he had used. McDaniel told Respondent that there was no problem regarding the Kefzol and the Toradol and that he would simply send Respondent a bill for those medications; however, as to the Alfenta, the pharmacist needed a prescription for his records. McDaniel asked Respondent who the attending physician had been, and Respondent told him that Peter Wernicke was the attending doctor. McDaniel told Respondent to get a prescription from Wernicke for the Alfenta so that the hospital record keeping would be proper. Respondent went to Wernicke and asked him for a prescription for the Alfenta that had been used, and Wernicke refused. Respondent then personally went to McDaniel and told him that Wernicke would not write the prescription and told McDaniel why, i.e., that Wernicke was still mad that Respondent had not considered him good enough to do Respondent's surgery. McDaniel asked Respondent who could write the prescription because Respondent needed a prescription from somebody and Respondent could not write the prescription for himself. Respondent told McDaniel that he had asked Dr. Brennan to be there to give him the pain medication, that Dr. Brennan had never showed up, but that Brennan was in the hospital at the time the medication was administered. McDaniel suggested that Respondent see if Brennan would sign a prescription. Respondent went to Brennan's office and told Brennan exactly what had happened. He told Brennan he had given himself 1 1/2 ccs of Alfenta and that Wernicke was the attending physician. He told Brennan that Respondent had self- administered and why, that Wernicke had refused to write the prescription and why, and that Haynes McDaniel had suggested that Brennan could sign the prescription for the hospital's records. Dr. Brennan became upset that he had not been there to help when his colleague needed him, agreed to sign the prescription, and offered Respondent pain pills or anything else Respondent needed for what remained a painful knee and leg. Respondent declined the offer of any additional medication. In good faith and in the course of his professional practice, Dr. Brennan signed a prescription for 1 1/2 ccs of Alfenta for Respondent. Respondent then hand- delivered that prescription to the pharmacist. After receiving the prescription from Respondent, the pharmacist wrote an Unusual Occurrence Report dated December 16, 1992. In January of 1993 the hospital summarily suspended Respondent's privileges, and he has been unable to practice medicine since that time. Respondent's emergency room visit happened on a Monday evening. On the following Thursday, Respondent and Wernicke's partner Dr. Jim Cain were in the doctor's lounge together. Respondent told Cain that his leg really hurt him and was swollen, and Cain offered to look at it. Respondent pulled up his scrub suit and showed Cain his calf which was twice its normal size and "hot". Cain suggested that Respondent get an ultrasound and get some blood thinner since it looked as though Respondent had developed phlebitis, a dangerous condition. Respondent immediately went to the x-ray department and had an ultrasound performed. The ultrasound revealed that Respondent had compartment syndrome in his calf, four days after the aspiration was performed. Dr. Wernicke's office notes regarding Respondent's emergency room visit, supposedly dictated that same evening or the following day, discussed the ultrasound that Respondent had. Accordingly, Dr. Wernicke did not dictate his notes regarding his treatment of Respondent on Monday evening or on Tuesday. Those notes, however, do bear Tuesday's date and are included in the hospital's medical record for Respondent's emergency room visit. The medical chart created by the hospital was likely created on December 21, 1992, the date stated on the Unusual Occurrence Report as the date the chart was initiated. The chart which thereafter purports to be Respondent's emergency room record is actually a composite of different patients' charts. To the extent it purports to be Respondent's chart, the entries contained therein are false. The Alfenta used by Respondent was an appropriate drug for the purpose for which it was used. It is a rapid but short-acting narcotic analgesic when given in the amount in which it was given. Further, the amount of Alfenta administered was an appropriate dose. Respondent used the Alfenta because it was an appropriate drug for immediate relief so he could endure the palpation and aspiration of his knee and so he could stop his leg from trembling allowing Wernicke to aspirate it. He knew the Alfenta would be worn off even before the analgesic effect of the anti- inflammatory medication was felt. It is noteworthy that all physicians who testified in this proceeding rated the pain Respondent was in as between eight and ten on a pain scale where ten is the worst. Respondent did not use Alfenta as a result of any addiction, and his use of the drug under the circumstances in this case was not related to any abuse of narcotics. Respondent has not exhibited any of the behavior of a drug user. Respondent did not engage in any attempt to "cover up" his administration of Alfenta to himself. He called the hospital and requested his anaesthesia cart be brought and that an anaesthesiologist come to the emergency room to administer the medication. The administration occurred with the implicit consent of Wernicke and it took place in front of Wernicke, in front of three or four emergency room nurses, and in front of the emergency room doctor. At the time, he filled out the narcotics record on his anaesthesia cart and telephoned the hospital's pharmacist the following day to tell him what had occurred and request that he be billed for the medication he used. His giving the hospital a prescription from Dr. Brennan was caused by Wernicke's refusal to document the treatment he rendered to Respondent, by Respondent's inability to write his own prescription, and was in response to the hospital's specific request that a prescription be written for the purpose of the hospital's record keeping. Further, Dr. Wernicke knew what had happened, as did the other emergency room personnel present that evening, and Respondent fully disclosed the events that had occurred to both Dr. Brennan and to the hospital pharmacist. Respondent's use of Alfenta on December 14, 1992, was not in any way related to patient care and had no impact on any patient care rendered by Respondent.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty and dismissing the Administrative Complaint filed against him in this cause. DONE and ENTERED this 28th day of March, 1995, at Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of March, 1995. APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact numbered 2-6 and 9-12 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed finding of fact numbered 1 has been rejected as not constituting a finding of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. Petitioner's proposed findings of fact numbered 7, 8, 13, 14, and 16 have been rejected as not being supported by the weight of the competent evidence in this cause. Petitioner's proposed finding of fact numbered 15 has been rejected as being subordinate to the issues herein. Respondent's proposed findings of fact numbered 1, 3-19, 21-31, 33-35, 38-40, 42, 43, and 45 have been adopted either verbatim or in substance in this Recommended Order. Respondent's proposed findings of fact numbered 2, 20, 32, 36, 37, and 44 have been rejected as not constituting findings of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. Respondent's proposed finding of fact numbered 41 has been rejected as being subordinate to the issues herein. COPIES FURNISHED: Arthur B. Skafidas, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Joseph L. Mannikko, Esquire 215 South Federal Highway, Suite 100 Stuart, Florida 34994 Dr. Marm Harris, Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792 Tom Wallace, Assistant Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether a letter of the Department of Health dated January 15, 2002, violates Section 120.54(1)(a), Florida Statutes?
Findings Of Fact Westside (Petitioner) is an acute care general hospital licensed by the State of Florida, Agency for Health Care Administration, pursuant to Part I of Chapter 395, Florida Statutes. Westside is located at 8201 West Broward Boulevard, Plantation, Florida. Westside's location is in Trauma Service Area ("TSA") 18 comprised exclusively of Broward County as established by Section 395.402(3)(a)18., Florida Statutes. The Department, created pursuant to Section 20.43, Florida Statutes, is the state agency charged with primary responsibility for the planning and establishment of a statewide inclusive trauma system. See Section 395.40(3), Florida Statutes (2001). See also Rule 64E-2.021, Florida Administrative Code. "'Trauma agency' means a department-approved agency established and operated by one or more counties . . . for the purpose of administering an inclusive regional trauma system." Section 395.4001(10), Florida Statutes. The Broward County Trauma Agency ("BCTA") is the local trauma agency established by processes and procedures established, in turn, by rule of the Department. Section 395.401, Florida Statutes. It is the Department-approved trauma agency in TSA 18. Each local trauma agency, such as the BCTA, is directed by Section 395.401(1)(b), Florida Statutes, to "develop and submit to the department plans for local and regional trauma service systems." The plans must include certain components outlined in the statute. Among them are "the number and location of needed state approved trauma centers based on local needs, population, and location and distribution of resources." Section 395.401(1)(b)4., Florida Statutes. The statute also calls for periodic updates of the plans: After the submission of the initial trauma system plan, each trauma agency shall, every 5th year, submit to the department for approval an updated plan that identifies the changes, if any, to be made in the regional trauma system. Section 395.401(1)(n), Florida Statutes. The Broward County Trauma Agency Plan that had been in effect "a little bit longer" than since 1995 or 1996, was updated and submitted for approval to the state in 2001. (Deposition of Danz, p. 6.) Although it may have been somewhat delayed (the record is not clear about the precise amount of time between the approval of the plan in effect prior to the update and the update's approval), the timing of the submission was intended to accord with the statutory requirement that updates be reviewed by the BCTA and submitted for approval "every five years." (Id.) The plan in effect at the time of an update approval process that took place largely in the year 2001 stated: State trauma center planning has resulted in an estimated need for four (4) trauma centers in Broward County. For the purposes of network development this plan envisions the initial establishment of three (3) Level II facilities with additional facilities being placed on line as need and funding requires. Each center will act as the primary receiving facility for a designated geographical catchment area (see maps d1 and d2). (Exhibit 20, Part D, p. 4.) The updated plan, denominated Broward County Trauma Plan 2001 (also referred to as the "2001 Plan" or the "Plan"), made a change to the above language. The 2001 Plan states: The establishment of three (3) facilities (two Level I Adult and Pediatric Centers and one Level II Adult Center) each as the primary receiving facility for a designated geographical catchment area, has been determined to be the correct compliment for the County's current need. (Exhibit 6, p. 50.) George Danz is the chief of operations for the Broward County Medical Examiner's Office. He is also the Director of the BCTA. Director Danz outlined "[i]n a nutshell" (Deposition of Danz, p. 7), the process for approval of the updated trauma plan for TSA 18, Broward County Trauma Plan 2001, as follows: (Id.) The process is fairly lengthy. First of all, the [BCTA] goes through the plan and looks at what areas we need to make revisions and changes to and so forth. We make those changes. We then have a Trauma Advisory Committee. We take those changes to the Trauma Advisory Committee for their recommendations and approval. We then are required by state law to notify all of the hospitals and EMS providers in Broward County that revisions are being drafted. We have to provide public notice, advertise that the changes are being made. We have to have a formal public hearing before the Broward County Commissioners. We have that hearing, and if it's approved by the Board of County Commissioners, we then submit the plan to the State of Florida. The State reviews the plan. If they have any changes that they want us to make to the plan, they let us know. They make the change that the state requires and then the state finally provides us with an approval or denial of the plan. In keeping with the process outlined by him, Director Danz sent a memorandum to "Broward County Hospital Administrators" and "Trauma Care Providers" on January 26, 2001. (Exhibit 1.) The memorandum informed the administrators and providers of trauma care that the BCTA with the aid of the Trauma Advisory Committee and the Regional Health Planning Council, Inc., had updated the Broward County Trauma Plan in accordance with law. The memorandum further advised that the Broward County Commission had directed that notice be given that the updates to the plan would be considered at a public hearing to be held on February 27, 2001. In the meantime, the Broward County Trauma Advisory Committee on February 14, 2001, approved an updated trauma plan for TSA 18. Less than two weeks later, as announced in Director Danz's earlier memorandum to hospital administrators and trauma providers, the 2001 Plan was presented to the Broward County Commission at a public hearing. The Commission voted unanimously at the hearing held as scheduled February 27, 2001, to approve the 2001 Plan. On April 30, 2001, Director Danz submitted the 2001 Plan to the Department. In response, the Department, on May 24, 2001, wrote to Director Danz announcing the conclusion of its "review for completeness of the Broward County Trauma Agency Plan Update that was received May 2, 2001." (Exhibit 3.) Although the Department found the 2001 Plan to include a majority of required elements, it found six "to be missing or incomplete." (Id.) These six elements were listed in the May 24, 2001, letter from the Department to the BCTA Director. On June 26, 2001, Director Danz sent a letter to Program Administrator Frederick A. Williams at the Department's Bureau of Emergency Medical Services. The letter outlined how each of the six deficient elements had been addressed by BCTA. The letter was received June 29, 2001, by the Department. Twelve days later, on July 11, 2001, Bureau of Emergency Medical Services Chief Charles Bement wrote Director Danz: We have completed the review of the Broward County Trauma Agency Plan Update submitted to this office on May 2, 2001, with the changes and additions we had requested in our letter to you May 24, 2001. We are pleased to inform you that your plan update is approved effective as of the date of this letter. (Exhibit 5.) Although the 2001 Plan provided for only three trauma centers in Broward County, and there were already three existing centers, with the plan having been approved for more than two months, on September 26, 2001, Michael Joseph, the Chief Executive Officer of Westside executed a "STATE-APPROVED TRAUMA CENTER LETTER OF INTENT." (Exhibit 17). The letter expressed Westside's "interest in becoming a State-Approved Trauma Center (SATC) or State-Approved Pediatric Trauma Referral Center (SAPTRC), or in upgrading the trauma care services already being provided." (Id.) CEO Joseph's letter was not out of step with the latest thinking of the Department. It crossed in the mail with a letter from the Department dated September 28, 2001. This letter, under signature of Bureau Chief Bement to Director Danz and the BCTA reflected the Department's conclusion that the Broward County Trauma Plan 2001 (although previously approved by the Department) conflicted with a rule of the Department of Health. Accordingly, the letter announced Department action: amendment of the 2001 Plan to bring it into compliance with the rule. The letter stated: It has recently come to my attention that the trauma services system plan approved by the Bureau for the Broward County Trauma Agency conflicts with the provisions of Fla. Admin. Code R. 64E-2.022(3). The plan recommends three state approved trauma centers or pediatric trauma referral centers for trauma service area 18 while the Administrative Code provides for four. The Legislature has assigned responsibility for determining the number of trauma centers allocated to each trauma service area to the Department of Health. See [s.] 395.402(3)(b), Fla. Stat. The Department has allocated, by rule, four centers for your area (sic) therefore, the trauma services systems plan for Broward County Trauma Agency is amended in accordance with the law to provide for four centers. (Exhibit 7, emphasis supplied.) On the same day of the Department's letter announcing the amendment of the 2001 Plan, a memorandum was issued by M. Susan McDivitt, R.N., the Department's Executive Community Health Nursing Director. Bearing a subject line of "Letter of Intent for State Approved Trauma Centers," and dated September 28, 2001, the memorandum informed specific parties of the notice of amendment to the Broward County Trauma Plan. Ms. McDivitt's memo refers to the amendment as one that "provides for four state approved trauma centers or state approved pediatric trauma referral centers for Broward County, as outlined in the [rule]." Exhibit 16. The memorandum goes on, As you may know, [s.] 395.4025(2), Florida Statutes, provides that in order to be considered for approval as a trauma center an applicant must certify that its operation would be consistent with the trauma agency plan. Prior to this amendment, no acute care general hospital in Broward County could make that certification as the trauma agency plan only provided for three centers and Broward County has three centers. The above- referenced notification [by amending the 2001 Plan to provide for four trauma centers] has addressed that situation. (Id.) The following Monday, the Bureau of Emergency Medical Services stamped as received on October 1, 2001, Westside's letter of intent. Two weeks later, on October 15, 2001, the Office of the County Attorney for Broward County responded to the September 28, 2001, letter in writing. This written communication requested reconsideration of the action reflected in the Department's September 28 letter, that is, the amendment of the 2001 Plan to provide for four state-approved trauma centers rather than three. As part of the basis for reconsideration, the County Attorney's office wrote: [s.] 395.401(1)(c), Florida Statutes, provides that the Department must approve or disapprove a trauma plan within one hundred twenty (120) days of submission. Here, the Department approved the plan (which was submitted May 2, 2001) on July 11, 2001. There does not appear to be any statutory authority for the Department of Health to unilaterally "amend" a trauma plan once approved. Moreover, the Department's action here was taken after the 120 day window of consideration had closed, and more importantly, after the Department had already determined that the plan was consistent with Rule 64E-2.-22(3). (Exhibit 8.) On October 23, 2001, Bureau Chief Bement issued a memorandum to Nursing Director McDivitt. It details reasons "[t]here should be three trauma centers in Broward County. " (Exhibit 9.) By letter dated November 5, 2001, Art Clawson, Director of the Division of Emergency Medical Services and Community Health Resources in the Department, notified the Broward County Attorney's Office that Bureau Chief Bement's letter of September 28 amending the 2001 Plan constituted agency action that provided a point of entry into administrative proceedings. The letter further advised that formal administrative proceedings could be initiated within 21 days of receipt of the November 5 letter. On November 29, 2001, NBHD filed a petition for formal administrative hearing pursuant to Sections 120.569 and 120.57(1), Florida Statutes. The case was assigned DOH Case No. 02-0131-FOI-HSEM. In the case, NBHD challenged the authority of the State of Florida to amend the Broward County Trauma Plan 2001 as done in the Department's September 28 letter. Westside moved to intervene in the proceeding. While NBHD's case pended at the Department, Division Director Clawson wrote the letter which contains the statements that Westside seeks to have determined in this proceeding to violate Section 120.54(1)(a), Florida Statutes. The letter, written January 15, 2002, states, in pertinent part, Be advised that this correspondence is the official withdrawal by the Department of Health of its amendment of the Broward County Trauma Agency (BCTA) plan. More specifically, the Department withdraws its letter of September 28th 2001 to the BCTA. Likewise, the Department withdraws its Notice of final agency action of November 5th, 2001. It has been determined that the Department lacked the authority to unilaterally amend the BCTA plan after it had been approved by the Department on July 11th, 2001. (Exhibit 11.) No part of this letter has been promulgated as a rule through the procedures in Section 120.54, Florida Statutes. The effect of the January 15, 2002, letter is to render Westside's letter of intent submitted for a new state-approved trauma center in Broward County inconsistent with the requirement of Section 395.4025(2) that "[i]n order to be considered by the department, a hospital [that submits a letter of intent] . . . must certify that its intent . . . is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, " On January 24, 2002, the Department issued a final order in DOH Case No. 02-01310FOI-HSEM denying the petition of NBHD challenging the Department's September 28 action of amending the Plan. The basis of the denial is that the relief requested by NBHD had been obtained as the result of the January 15, 2002, letter. Westside now seeks a determination that the January 15, 2002, letter is an agency statement in violation of Section 120.54(1)(a), Florida Statutes, that is, an unpromulgated rule. Such a determination will reinstate the Department's letter of September 28 and its amendment to the 2001 Plan to provide for four (4) trauma centers in TSA 18. The restoration of the amendment, in turn, will open the door to the potential of Department approval of the fourth trauma center in Broward County that Westside hopes to operate as expressed in its letter of intent. North Broward Hospital District, the operator of two trauma centers in Broward County, opposes such a determination because it could lead to approval of a fourth trauma center in Broward County. Approval of a fourth trauma center would have an impact on the currently approved trauma centers, including those of NBHD because the number of patients seen by the existing trauma centers would be reduced. As Dr. Lottenberg testified in his deposition, "[I]n order to effectively have a proficient trauma center, you need to have about 1,000 severely injured patient per trauma center per year. Currently[,] all three trauma centers [in Broward County] are operating somewhat under that number." (Lottenberg, pgs. 26- 27.) Approval of a fourth trauma center would reduce the existing provider's number of severely injured patients when, in Dr. Lottenberg's opinion, the trauma center's in Broward County need more patients to ensure proficiency rather than less.
The Issue The issue in these consolidated cases is whether proposed amendments to Rule 10-5.011(1)(o), and (p) F.A.C. relating to certificates of need for hospital inpatient general psychiatric services, are invalid exercises of delegated legislative authority, as defined in Section 120.52(8), F.S.
Findings Of Fact Metamorphosis of the Rules Prior to 1983, hospitals were not separately licensed, and certificates of need (CON) were not required for the designation of beds for psychiatric and substance abuse services. In 1983, statutory amendments to Chapter 381, F.S. addressed psychiatric beds as reviewable projects in the CON program. In 1983, HRS adopted rules establishing four new categories of beds, now found in Rules 10-5.011(1)(o), (p), and (q), F.A.C.: Short-term psychiatric, long-term psychiatric, and short and long-term substance abuse. At the time that the categories were created, HRS conducted an inventory of the hospitals, asking how many beds were designated in each category. Based on the responses, published in the Florida Administrative Weekly, future projections of need were made and applications were considered for CONs. Another category of psychiatric beds was not included in the 1983 rules. Intensive residential treatment programs for children and adolescents were created by statute in 1982, and are defined in Section 395.002(8), F.S. as: a specialty hospital accredited by the Joint Commission on Accreditation of Hospitals which provides 24-hour care and which has the primary functions of diagnosis and treatment of patients under the age of IS having psychiatric disorders in order to restore such patients to an optimal level of functioning. These facilities, called IRTFs, may become licensed as hospitals pursuant to Section 395.003(2)(f), F.S., but as hospitals they must obtain CON approval pursuant to Sections 381.702(7) and (12), F.S. and Section 381.706(1) (b), F.S. IRTFs have no statutory or regulatory restrictions on length of stay and were approved by HRS at one time under an unwritten policy that there be one such facility available in each HRS planning district, without regard to the availability of other long or short term psychiatric programs. In 1985, HRS proposed a rule amendment which would have eliminated the short and long term distinction, as well as the distinction between psychiatric services and substance abuse services. Six months later, the proposed rule amendment was withdrawn. It was highly controversial; several challenges were filed; objections were made by various local health councils; and a new administrator took over. The agency decided to rework its proposed change~;. The agency next began the process of revision in 1987, and in 1988 convened a workshop group to review an issue paper prepared by agency staff. Another work group met in 1989 to consider the consolidation of psychiatric and substance abuse rules. HRS staff reviewed literature on the subjects of substance abuse and psychiatric services, including literature relating to access by indigent patients and the provision of services to children and adolescents. Staff prepared rule drafts which were circulated in- house, including the alcohol, drug abuse and mental health program office; and to such outside groups as the Association of Voluntary Hospitals of Florida, the Florida Hospital Association and the League of Hospitals. The proposed rule amendments which are the subject of this proceeding were filed on January 19, 1990 (substance abuse), and on January 26, 1990 (inpatient psychiatric services) in the Florida Administrative Weekly. The Parties HRS administers the CON program pursuant to Section 381.701, et seq., F.S. (1989). The CON program regulates entry into the Florida health care market by providers through review and approval of certain capital expenditures, services and beds. The petitioner, Florida League of Hospitals, Inc. is a nonprofit corporation which is organized and maintained for the benefit of investor-owned hospitals which comprise its membership. The remaining petitioners and intervenors are current providers of hospital inpatient psychiatric services, long and short term, and of inpatient substance abuse services, long and short term. The petitioners and intervenors are all substantially affected by the proposed rules and have stipulated to the standing of all parties in this proceeding. Abolishing Distinctions Between Long-Term & Short-Term Psychiatric Beds "Short term hospital inpatient psychiatric services" is defined in existing rule 10-5.011(1)(o)1, FAC, as follows: Short term hospital inpatient psychiatric services means a category of services which provides a 24-hour a day therapeutic milieu for persons suffering from mental health problems which are so severe and acute that they need intensive, full-time care. Acute psychiatric inpatient care is defined as a service not exceeding three months and averaging length of stay of 30 days or less for adults and a stay of 60 days or less for children and adolescents under 18 years. "Long term psychiatric services" is defined in existing rule 10- 5.011(1)(p)1., FAC as a category of services which provides hospital based inpatient services averaging a length of stay of 90 days. Neither rule addresses services to adults with an average length of stay (ALOS) of 30-90 days, or services to children and adolescents with a 60-90 day ALOS. Because of this, and the "averaging" process, long term hospitals legitimately serve "short term" patients and short term hospitals may serve "long term" patients. One party has calculated than a long term facility could legally provide short term services for 80% of its patients, and long term services for only 20% of its patients and still have an ALOS of 90 days. Under the existing rules a facility must file a CON application to convert from long term to short term beds, or vice versa, and is subject to sanctions for failure to comply with the designation on its CON. The proposed changes would repeal rule 10-5.011(1) (p), FAC regarding long term services, and would amend rule 10- 5.011(1) (o), FAC to delete the definition of short term services, thereby permitting facilities to serve patients without regard to length of stay. The proposed changes are supported by several factors upon which a reasonable person could rely. Substantial changes have occurred in the last decade in clinical practices and in third party reimbursement to reduce the ALOS for hospital inpatient psychiatric care. Prior to the 1960s, there was no distinction between long and short term care, as all hospital based care was long term with an emphasis on psychoanalytic therapy. Beginning in the 1960s, the concept of community mental health programs evolved with an emphasis on deinstitutionalization of patients in large public "asylums" and with a goal of treatment in the least restrictive environment. In more recent years the trend has spread to the private sector. Improvements in the availability and use of psychiatric drugs, the use of outpatient care or partial hospitalization, and improved follow up care have led to a dramatic decrease in ALOS. Long term care is costly, and whether third party payors have been a driving force, or are merely responding to the trends described above, long term inpatient reimbursement is virtually nonexistent. During the 19805, most insurance companies imposed a 30-day limit on psychiatric inpatient care or imposed monetary limits which would have effectively paid for less than a 90-day term. CHAMPUS, the program providing insurance to military dependents, was providing long term coverage in 1982, but by 1986 its coverage was rarely available for more than 30-60 days, and today, under CHAMPUS' case management system, 30 days is a "luxurious amount". Other large third-party payors such as Blue Cross/Blue Shield have similar limits or aggressively use case management (the close scrutiny of need on a case by case basis) to limit reimbursement for inpatient care. Of the two or three long term facilities in existence at the time that HRS' rules were originally adopted, only one, Anclote Manor still reported an ALOS of over 90 days by 1989, dropping from an ALOS of 477.9 days in 1986 to 145.4 days in 1989. At the same time its occupancy rate dropped below 50%. There is an interesting dialogue among experts as to whether there still exists a clinical distinction between long term and short term inpatient psychiatric care. Studies at the Florida Mental Health Institute found no difference in rate of rehospitalization over a 12 month period between patients who were in a nine week program and patients from Florida State Hospital with a 500 day length of stay. Some mental health practitioners are looking now at treating the chronic psychiatric patient with repeated short term hospital stays and less intensive care between episodes, rather than a single long term inpatient stay. Other practitioners maintain that a long term psychiatric problem is behavioral in nature and requires a total life readjustment and longer length of stay. Whichever practice may be preferable, the facts remain that fewer and fewer mental patients are being treated with long term hospitalization. The proposed rules would not foreclose any facility from providing long term care, if it finds the need. To the extent that a clinical distinction exists between short and long term care, the existing rules do not address that distinction, except from a wholly arbitrary length of stay perspective. The existing rules no longer serve valid health care objectives. Existing providers with short term CONs are concerned that the allowing long term facilities to convert will further glut an underutilized market and will result in an increase in vacant beds and a rise in the cost of health services, contrary to the intent of the CON program. Intensive residential treatment facilities (IRTFs), which will be folded into the need methodology for children and adolescent beds, have no current restrictions on length of stay and may already compete with impunity with the short term providers. Moreover, long term facilities are also providing substantial short term care as a result of the trends discussed above. HRS has not consistently enforced the length of stay restrictions of long term providers' CONs. Whether those CONs were improvidently granted is beside the point. The capital costs have already been incurred; the beds are available; and the beds are being used, in part, for short term services. Abolishing the distinction is a rational approach to current conditions. And in determining that all existing providers would be placed in the same position regarding length of stay, HRS avoids the regulatory nightmare of trying to enforce limitations on existing providers and approving new beds without limitations. Creating a Distinction Between Adult and Children/Adolescent Beds Rule 10-5.011(1)(o)3.c. creates a CON distinction between general psychiatric services for adults, and those services for children and adolescents. Rule 10-5.011(1)(o)4., as proposed, would create separate need criteria for hospital inpatient general psychiatric services for adults and for children/adolescents. Adolescents are defined in Rule 10- 5.011(1)(o)2.a., as persons age 14 through 17 years. Persons over 17 years are adults, and under 14 years are children. There are valid clinical reasons to distinguish between programs fob the separate age groups. Although there is some overlap, differing therapies are appropriate with different ages. The types of services offered to adults are not the same as those which are offered to children. Children, for example, often receive academic educational services while being hospitalized. Adults receive career or vocational counseling and marriage counseling. The required separation by age categories would remove some flexibility from providers. However, this is offset by the Department's valid need to track for planning purposes inpatient services to children and adolescents separately from those provided to adults. Based on anecdotal evidence, HRS' Office of Alcohol, Drug Abuse and Mental Health Program Office is concerned about the possible overutilization of hospital inpatient services for children and adolescents and the potential that when insurance reimbursement expires they are discharged without clinical bases. Taking Inventory Under the proposed rule, in order to separately regulate adult and children/adolescent beds, HRS will fix an inventory of uses as of the time that the rule takes effect. For facilities with CONs which already allocate beds between the two groups, the proposed rule will have no effect. For facilities without a designation, as long as adults and children/adolescents are kept in separate programs, the allocation can now be mixed and changed at will. The rule amendment will freeze that use in place. HRS has conducted a preliminary survey to determine the existing uses of psychiatric, substance abuse and residential treatment program beds. The survey of approximately 120 facilities is complete, but is not intended to limit those facilities unless their CON already provides a limit. A final inventory will be taken after the proposed rules become effective. The inventory will be published, and providers will be given an opportunity to contest its findings. The ultimate outcome will be amended CONs and licenses which reflect each facility's mix of adult and children/adolescent beds. The process is a fair and reasonable means of commencing separate regulation of services to these age groups. The Definitions Proposed rules 10-5.011(1)(o)2.1., 2.p., and 2.t.) define "hospital inpatient general psychiatric services", "psychiatric disorder" and "substance abuse", respectively. Each of these provisions defines the terms by reference to classifications contained in the Diagnostic and Statistical Manual of Mental Diseases (DSM-III-R Manual) and equivalent classifications contained- in the International Classification of Diseases (ICD-9 Codes). The rule as originally proposed included the phrase "or its subsequent revisions", after incorporating the manuals by reference. In testimony, and in the parties second agreement (Hearing Office exhibit 3) the phrase is deleted. However, it still appears in proposed rule 10-5.011(1) (o)2.1., perhaps inadvertently. The DSM-III-R is a generally recognized manual for the classification of mental disorders and is widely used by clinicians and medical records professionals to categorize the conditions of patients. The ICD-9 codes are broader than just mental disorders, but they have a section on mental disorders with numbers that are identical to those in the DSM-III-R. Although the manuals are complex and subject to interpretation, clinicians are accustomed to their use and they provide a reasonable guide as to the services which may be provided in an inpatient substance abuse program, as distinguished from an inpatient psychiatric program. Advertising Limited Proposed rule 10-5.011(1)(o)3.d. (as amended in the parties second agreement, Hearing Officer exhibit #3), provides: D. Advertising of services. The number of beds for adult or for children and adolescent hospital inpatient general psychiatric services shall be indicated on the face of the hospital's license. Beds in intensive residential treatment programs for children and adolescents which are licensed as specialty hospital beds will be indicated as intensive residential treatment program beds on the face of the hospital's license. Only hospitals with separately-licensed hospital inpatient general psychiatric services, including facilities with intensive residential treatment programs for children and adolescents which are licensed as specialty hospitals, can advertise to the public the availability of hospital inpatient general psychiatric services. A hospital with separately licensed hospital inpatient general psychiatric services that does not have a certificate of need for hospital inpatient substance abuse services may advertise that they [sic] provide services for patients with a principal psychiatric diagnosis excluding substance abuse and a secondary substance abuse disorder. The Department does not currently have CON, licensure, or other rules which limit the ability of a health care provider to advertise its services, and has never used advertising as a factor in conducting CON review for any proposed services. HRS included provisions regarding advertising in its proposed rules because it had evidence that existing facilities have used misleading advertisements. The evidence came from other providers, rather than consumers. However, it is the consumer whom the agency feels may be confused by advertising which implies that services are available when such services cannot be legally provided under the facility's license. The advertising provision is prospective in nature, seeking to prevent licensed providers from advertising services for which they are not licensed. The provisions do not relate to CON review, and the staff is unclear as to how the rule would be implemented. Licensing and CON review are two separate functions within the agency. Although the term is not defined in the proposed rule, advertising broadly includes word of mouth referrals and public presentations by professionals in the community, as well as traditional media and written advertisements. Properly utilized, advertising helps consumers exercise choice and gain access to needed services. Improper advertising is subject to the regulation of federal and state agencies other than the department. New Need Methodology, with Preferences Proposed Rule 10-5.011(1)(o)4., deletes the existing population ratio methodology and creates a need formula based upon use rate, for adult and children/adolescent inpatient psychiatric services. Certain preferences are also described. 34. Rule 10-5.011(1) (o)4.e.(III) provides: In order to insure access to hospital inpatient general psychiatric services for Medicaid-eligible and charity care adults, forty percent of the gross bed need allocated to each district for hospital inpatient general psychiatric services for adults should be allocated to general hospitals. The same provision for children and adolescent services is found in rule 10-5.011(1)(o)4.h.(III). Medicaid reimbursement is not available for inpatient services in a specialty hospital. 35. Rule 10-5.011(1)(o)4.i. provides: Preferences Among Competing Applicants for Hospital Inpatient General Psychiatric Services. In weighing and balancing statutory and rule review criteria, preference will be given to applicants who: Provide Medicaid and charity care days as a percentage of its total patient days equal to or greater than the average percentage of Medicaid and charity care patient days of total patient days provided by other hospitals in the district, as determined for the most recent calendar year prior to the year of the application for which data are available from the Health Care Cost Containment Board. Propose to serve the most seriously mentally ill patients (e.g. suicidal patients; patients with acute schizophrenia; patients with severe depression) to the extent that these patients can benefit from a hospital-based organized inpatient treatment program. Propose to service Medicaid-eligible persons. Propose to service individuals without regard to their ability to pay. Provide a continuum of psychiatric services for children and adolescents, including services following discharge. The preferences are similar to those in CON rules relating to other types of health services and are intended to implement, in part, the legislative mandate that the agency consider an applicant's ". . . past and proposed provision of health care services to medicaid patients and the medically indigent." Section 381.705(1) (n), F.S. Under Medicaid reimbursement general hospitals are paid a set per diem based on a variety of services provided to all Medicaid patients, regardless of actual cost of the individual service. As psychiatric services are generally less costly than other services on a per diem basis, hospitals may recoup a greater percentage of their costs in serving Medicaid psychiatric patients. This and the fact that public hospitals receive some governmental subsidies do not obviate the need for incentives in the CON program. Not all of the charity care provided by these hospitals is funded and a large amount is written off. Although Petitioners argue that the preferences are not needed, or are too generous, none provide competent evidence that the facilities who do not enjoy the preferences are unduly prejudiced. The 40% allocation of bed need to general hospitals is a guideline, not a maximum, as applied by the agency, and presumes that there are general hospitals competing in any batch in question. It is not intended to frustrate a separate section of the rule which allows a hospital with at least an 85% occupancy rate to expand regardless of need shown in the formula and the occupancy rate district-wide. See 10- 5.011(1) (o)4.d. and g. "Evaluation of Treatment Outcomes" The proposed rules contain three provisions relating to a hospital's evaluation of its patients' treatment outcomes. Rule 10-5.011(1) (o)3.i, includes among "required services", ". . . an overall program evaluation of the treatment outcomes for discharged patients to determine program effectiveness." Rule 10-5.011(1)(o)8.j., requires in the application, A description of the methods to be used to evaluate the outcome of the treatments provided and to determine the effectiveness of the program, including any summary evaluation outcome results for hospital inpatient psychiatric services provided at other facilities owned or operated by the applicant in Florida and other states. The data shall exclude patient specific information. Rule 10-5.011(1)(o)9.e., imposes a similar additional requirement in applications from providers seeking more beds: A summary description of any treatment outcome evaluation of the hospital inpatient general psychiatric services provided at the facility for which additional beds are requested, for children, adolescents or adults as applicable to the facility for the 12-month period ending six months prior to the beginning date of the quarter of the publication of the fixed bed need pool. The purpose of these requirements, according to HRS, is to insure that hospitals will know whether its patients are better off when they leave than when they were admitted to the program. Most hospitals have such knowledge. The terms, "outcome determination", "summary evaluation outcome results", "summary description of treatment outcome evaluation" and "overall program evaluation of treatment outcomes", are nowhere defined in the proposed rules, and the department intends to leave to each applicant or provider the methodology for determining whether its patients are "better off" for having been in its program. Hospitals do not routinely evaluate their patients after discharge and such follow up would be difficult and costly. Most hospitals do, however, establish a treatment plan upon admission, continue to review and revise that plan as needed throughout treatment, and determine the patients' readiness for discharge based on the goals successfully attained. This is the process described by Florida Hospital's Center of Psychiatry Administrative Director. The rules require no more than a description similar to that provided by Florida Hospital. The rules set no standards and do not dictate that follow- up of discharged patients be accomplished, even though post discharge evaluation may be of value and is generally accepted as the best tool for measuring treatment effectiveness. The measurement of treatment outcome is an inexact process and relies on a series of subjective standards which need to be described. HRS does not intend to set those standards and, other than have its applicants demonstrate that a process is in place, the agency has no idea how the required information will impact its CON review. Without definitions and standards, the agency will have no way of comparing one applicant's information with another's. Without specificity and more guidance the rules fail to apprise the applicant of what is required and will provide no meaningful information to the agency in its CON review function. Miscellaneous Provisions The Non-Physician Director. The proposed definition of "Hospital Inpatient General Psychiatric Services" in Rule 10-5.011(1) (o)2.1. includes services provided under the direction of a psychiatrist or clinical psychologist In drafting this definition, agency staff relied on advice from experts at their workshops and on advice from the agency's own Alcohol, Drug Abuse and Mental Health Program Office, to the effect that professionals, other than physicians, are qualified to direct the units. Interpretation and Application. It is not the intention of HRS that its rules be interpreted to override good medical practice or the sound judgement of treating physicians. Thus, the rules would not prohibit stabilization of a patient who is presented to the emergency room of a hospital without a CON for substance abuse or psychiatric services. Stabilized Alzheimers patients may be housed in nursing homes. Nor do the rules prohibit or subject to sanctions the occasional admission of a psychiatric or substance abuse patient to a non-substance abuse or psychiatric bed so long as this occurs infrequently in a hospital without psychiatric or substance abuse programs. "Scatter" beds are not eliminated. Those beds would continue to be licensed as acute-care beds, as they would not be considered part of an organized program, with staff and protocols, to provide psychiatric or substance abuse services. Proposed rule 10-5.011(1)(o)4.h.(v) provides that applicants for IRTPs for children and adolescents seeking licensing as a specialty hospital must provide documentation that the district's licensed non-hospital IRTPs do not meet the need for the proposed service. The department is not seeking specific utilization data in this regard, as such is not available. General information on the availability of alternatives to inpatient hospital services is obtainable from local health councils and mental health professionals in the community. Quarterly Reports. Proposed rule 10-5.011(1)(o)10. requires: Facilities providing licensed hospital inpatient general psychiatric services shall report to the department or its designee, within 45 days after the end of each calendar quarter, the number of hospital inpatient general psychiatric services admissions and patient days by age and primary diagnosis ICD-9 code. The Health Care Cost Containment Board (HCCCB) is already collecting similar quarterly data from providers. The reporting system is being updated and improved but in the meantime HRS is experiencing problems with the type and accuracy of the data it receives from HCCCB. One problem is that HCCCB collects its data with regard to all discharges in a psychiatric or substance abuse diagnostic category, whereas HRS is interested only in data from a psychiatric or substance abuse program. Until the system improves, HRS needs the information it seeks from the providers in order to plan and apply the need methodology. The agency intends to designate local health councils to collect the data and has already worked with them to set up a system. If reports provided to the HCCCB comply with the proposed requirement, HRS has no problem in receiving a duplicate of those reports. The Economic Impact Statement Pursuant to Section 120.54(2), F.S., HRS prepared an economic impact statement for the proposed rule. It was authored by Elfie Stamm, a Health Services and Facilities Consultant Supervisor with HRS. Ms. Stamm has a Masters degree in psychology and has completed course work for a Ph.D. in psychology. She has been employed by HRS for 13 years, including the last ten years in the Office of Comprehensive Health Planning. She is responsible for developing CON rules, portions of the state health plan, and special health care studies. It was impossible for Ms. Stamm to determine how the rule could impact the public at large. The economic impact statement addresses generally the effect of abolishing the distinction between long and short term services and acknowledges that the rule will increase competition among short term service providers. The impact statement also addresses a positive impact on current long term providers.
The Issue Whether Florida Administrative Code Rule 64J-2.010 enlarges, modifies or contravenes the specific provisions of law implemented, or is arbitrary or capricious, and thus constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Parties Bayfront is a 480-bed tertiary hospital located in St. Petersburg, Pinellas County, Florida. In addition to serving as a teaching hospital, Bayfront is designated as a Level II trauma center pursuant to chapter 395, Part II, Florida Statutes. Bayfront had a $3.6 million operating deficit in 2009 and a positive operating margin below one percent ($1.969 million) in 2010. Due to its financial strife in recent years, Bayfront has been forced to defer needed capital projects due to a poor liquidity position, inadequate borrowing capacity and insufficient cash flow. Tampa General is a major tertiary hospital that is designated by the state as a Level I trauma center. TGH also serves as a teaching hospital for the University of South Florida, College of Medicine ("USF"). TGH is located in Tampa, Hillsborough County, Florida. Like Bayfront, TGH has also experienced significant financial challenges in recent years. For fiscal year 2011, TGH's budget reflected only a $7 million (one percent) operating margin. However, due to subsequent events, including Medicaid cuts and flat utilization year-to-date, TGH now expects to do no better than break-even, and may even incur a $4 million operating loss in FY 2011. This is significant because TGH has reached its borrowing capacity and must rely on its operating margin to build cash that will be used to fund needed capital projects and expenditures. Maintaining a positive and substantial operating margin is therefore critical to TGH's ability to replace equipment and infrastructure. St. Joseph's Hospital has served the Tampa area for 75 years and has approximately 800 licensed acute care beds. SJH offers a broad array of acute care services, including tertiary health care, serves as a comprehensive regional stroke center, and has been repeatedly recognized as a Consumers Choice hospital. SJH operates a Level II trauma center, and in 2010, treated approximately 2,700 trauma patients. SJH also has one of the busiest emergency departments in the state, with approximately 145,000 patient visits in 2010. Shands Jacksonville is an existing Level I trauma center. It is one of only seven such Level I providers in the state of Florida. Located in Jacksonville (Duval County), Shands treats approximately 4,000 trauma victims every year. Respondent Department of Health is the state agency authorized to verify and regulate trauma centers in the state of Florida pursuant to chapter 395, Part II, Florida Statutes and Florida Administrative Code Rule 64J-2.001 et seq. The Division of Emergency Medical Operations, Office of Trauma, oversees the Department's responsibilities with respect to the statewide trauma system. Intervenor Bayonet Point is a general acute-care hospital located in Pasco County, Florida. Bayonet Point is currently seeking to obtain designation as a trauma center. As of the date of the hearing in this matter, Bayonet Point's application for designation as a trauma center was not complete and Bayonet Point was in the process of developing the facilities and retaining the medical staff necessary to meet the standards and criteria required for its application to be deemed complete. Intervenor Blake Medical Center is a general acute care hospital located in Manatee County, Florida. Blake is currently seeking to obtain designation as a trauma center. As of the date of the hearing in this matter, Blake's application for designation as a trauma center was not complete and Blake was in the process of developing the facilities and retaining the medical staff necessary to meet the standards and criteria required for its application to be deemed complete. Although not a party to this case, HCA/Orange Park Medical Center ("Orange Park") is also currently in the process of applying for trauma center designation. Orange Park is located in Clay County, immediately to the south of Duval County. The Florida Trauma System For purposes of organizing a statewide network of trauma services, the Florida Legislature directed the Department to "undertake the implementation of a statewide inclusive trauma system as funding is available." § 395.40(3), Fla. Stat. The statewide trauma network includes not just verified trauma centers, but all other acute care hospitals in the State, as well as ground and air emergency medical services providers, and "every health care provider or facility with resources to care for the injured trauma victim." § 395.40(2), Fla. Stat. The network is premised on the basic principle that a trauma victim who is timely transported and triaged to receive specialized trauma care will have a better clinical outcome. § 395.40(2), Fla. Stat. A trauma victim's injuries are evaluated and assigned an Injury Severity Score ("ISS"). § 395.4001(5), Fla. Stat. Patients with ISS scores of 9 or greater are considered trauma patients. § 395.402(1), Fla. Stat. Trauma experts speak in terms of "a Golden Hour," a clinical rule of thumb that postulates no more than 60 minutes should elapse from the occurrence of an injury to the beginning of definitive treatment. There is, however, no current consensus on what constitutes the "Golden Hour" for transport times. A 1990 Department study recommended travel time of 25-35 minutes as the outside range for optimal outcomes. A 1999 Department study favored a goal of 30 minutes transport time by ground, and a 50-mile radius by helicopter. By contrast, a 2005 study conducted for the Department used 85 minutes "total evacuation time" as "acceptable." Because of the necessity for rapid transport, key components of the trauma network are ground and air EMS transportation. It is important to get the trauma victim to the nearest trauma center as rapidly as possible, because "you can't do surgery in the back of an ambulance." Each EMS provider operates pursuant to Uniform Trauma Transport Protocols and inter-facility guidelines which give guidance for how, where and when trauma patients should be transported. Trauma centers are required to have numerous different kinds of physician specialists at the ready at all times. For instance, with respect to surgical services, a Level I trauma center must have "a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary (in-hospital) and backup trauma coverage 24 hours a day at the trauma center when summoned." Further, in addition to having at least one "neurosurgeon to provide in-hospital trauma coverage 24 hours a day at the trauma center," a Level I provider must also have surgeons "available to arrive promptly at the trauma center" in 11 other specialties, including (but not limited to) hand surgery, oral/maxillofacial surgery, cardiac surgery, orthopedic surgery, otorhinolaryngologic surgery and plastic surgery. Level II trauma centers must comply with similar physician specialist standards. Not surprisingly, it is a constant struggle for existing trauma centers to ensure the availability of qualified clinical staff, technicians, specialty physicians and other personnel and resources necessary to continually meet the rigorous programmatic requirements of a trauma center. In general, trauma centers are not profitable due to the intensity of resources necessary to achieve an appropriately functioning trauma program, and the scarcity of such resources. The Challenged Rule In 1992, the Department of Health and Rehabilitative Services ("HRS") adopted Florida Administrative Code Rule 64J- 2.010, (the "Rule"). Respondent Department of Health assumed administration of the Rule in 1996, when the Legislature split HRS into two new agencies, the Department of Health and the Department of Children and Families. The Rule is a statement of need, sometimes referred to as "open slots" for a specific number of trauma centers allocated among 19 geographic service areas ("trauma service areas" or "TSAs") in the state. The current version1/ of rule 64J-2.010, the subject of this rule challenge, reads in its entirety as follows: 64J-2.010 Apportionment of Trauma Centers within a Trauma Service Area (TSA). The number and composition of TSAs shall be in accordance with section 395.402, F.S. The number of trauma centers in each TSA shall be in accordance with the maximum number set forth in the table below. Each trauma service area shall have at least one Level I or Level II trauma center position. The number of trauma center positions for each TSA is as follows: TSA Counties Trauma Centers 1 Escambia; Okaloosa; Santa 2 Rosa; Walton 2 Bay; Gulf; Holmes; Washington 1 3 Calhoun; Franklin; Gadsden; 1 Jackson; Jefferson; Leon; Liberty; Madison; Taylor; Wakulla 4 Alachua; Bradford; Columbia; 2 Dixie; Gilchrist; Hamilton; Lafayette; Levy; Putnam; Suwannee; Union 5 Baker; Clay; Duval; Nassau; St. 2 Johns 6 Citrus; Hernando; Marion 1 7 Flagler; Volusia 2 8 Lake; Orange; Osceola; 3 Seminole; Sumter 9 Pasco; Pinellas 3 10 Hillsborough 2 11 Hardee; Highlands; Polk 3 12 Brevard; Indian River 2 13 DeSoto; Manatee; Sarasota 3 14 Martin; Okeechobee; St. Lucie 1 15 Charlotte; Glades; Hendry; Lee 2 16 Palm Beach 2 17 Collier 1 18 Broward 3 19 Dade; Monroe 6 TOTAL 42 The trauma center will be assigned by the department according to section 395.402(4), F.S. Specific Authority 395.405 FS. Law Implemented 395.401, 395.4015, 395.402, 395.405 FS. History–New 12-10-92, Formerly 10D-66.1075, Amended 6-9-05, 12-18-06, Formerly 64E-2.022. A hospital seeking to establish a new trauma center must file an application with the Department. If a TSA has fewer trauma centers than the number allocated to the TSA in the Rule, the Department deems need to exist without reference to any additional analysis or data. Accordingly, if a hospital's application to establish a new trauma center complies with trauma center programmatic requirements, the Department will approve the application. As will be discussed in greater detail infra, the Department believes it is bound by the determination of need set forth in the Rule and that it does not have authority to deny an application that meets programmatic requirements so long as there is an "open slot" for a new trauma center within a particular TSA. Indeed, the Department has never denied an application that met the programmatic requirements when need existed under the Rule. History of the Rule In 1989, the Legislature directed HRS (DOH's predecessor) to submit a report by February 1, 1990, (the "1990 Report"). The 1990 Report was to include a proposal for funding trauma centers that "will result in funding of the number of strategically placed trauma centers necessary to ensure adequate trauma care throughout the state." Ch. 89-275, § 6, Laws of Fla. The 1990 Report was to include "an estimation of . . . the approximate number and generalized location of state-sponsored trauma centers needed to ensure adequate trauma care throughout the state . . . ." Id. The 1990 Report was prepared by the Committee on State-Sponsored Trauma Centers (the "1990 Committee"). Although HRS timely submitted the Committee's report to the Legislature on February 1, 1990, HRS indicated that it did not "fully support all of the conclusions and recommendations contained in the task force report." In its report, the 1990 Committee recommended the creation of 19 trauma service areas. The boundary of each TSA was drawn to include a "nucleus county" along with its sending (later referred to as "feeder") counties. A nucleus county was one that retained at least 90 percent of its resident trauma alert patients, but also included any county that had a retention rate greater than 75 percent (but less than 90 percent) if no contiguous county had the requisite 90 percent retention rate. Any county that retained less than 75 percent of its trauma alert patients was designated a feeder county. This feeder county was then grouped with the nucleus county that received a majority of the feeder county's outbound patients. After reviewing 1988 patient flow data and applying the above rules, the 1990 Committee created and assigned counties to 19 trauma service areas. Under the 1990 Committee's methodology, a nucleus county was a candidate for a trauma center, but a feeder county was not. Table 3.3 of the 1990 Report set forth the Committee's recommendation as to the number of trauma centers to be allocated to each of the 19 TSAs: Table 3.3 Recommended Trauma Service Areas and Number of Trauma Centers 1988 Number Treated 1988 Number Residing Recommended No. Trauma Centers Service Area ISS Level 9+ ISS Level 16+ ISS Level 9+ ISS Level 16+ Min Max 1 1332 275 | 1166 223 2 3 2 489 117 | 452 105 1 1 3 815 185 | 701 152 1 2 4 1183 269 | 1011 226 2 3 5 2268 662 | 2566 546 2 3 6 869 138 | 877 143 1 2 7 1376 225 | 1286 190 2 3 8 3756 698 | 3329 592 3 4 9 3978 626 | 3709 552 3 4 10 2458 604 | 2222 507 2 3 11 1834 302 | 1665 290 3 4 12 1487 220 | 1433 218 2 3 13 1900 264 | 1810 247 3 4 14 687 105 | 698 102 1 2 15 1455 243 | 1386 236 2 4 16 2310 365 | 2233 371 2 3 17 476 73 | 436 75 1 1 18 4238 670 | 4204 652 4 5 19 7346 1370 | 6633 1176 6 7 Total 40857 7411 | 37817 6603 44 60 Table 3.3 indicates a total trauma center need ranging from 432/ to 60 trauma centers, although only 12 trauma centers were in existence at the time of the report. As the table reflects, the need estimate was apparently based on only one factor: the number of trauma patients residing and treated within each TSA in 1988. However, the 1990 Report indicates that members of the "number and location subcommittee" may have considered other factors in arriving at their recommendation: The study design formulated by the CHSPA called for identification and analysis of trauma patient incidence and patient flow for a one-year period based on the HCCB detailed case mix data. This data analysis effort alone, however, would not specifically identify the number of trauma centers needed in the state, nor their generalized location. The patient incidence and flow information needs to be considered in relation to the following factors in order to reach sound recommendations: . . . The injury severity level for which trauma center care is required; the minimum number of cases which should be treated at a trauma center in order to maintain skill proficiencies consistent with high quality outcomes; appropriate travel times from accident location to a trauma center; and, the existing level of facility resources available in an area upon which one or more trauma centers could be built. While information on certain of these points was available through trauma care literature and previous research, its applicability to Florida’s circumstances was not clear in all instances. Therefore, the Department sought recommendations on these issues from the committee and, especially, from the number and location subcommittee. The subcommittee’s recommendations, as ratified by the full committee, were integral to the development to the approximate number and generalized locations of state-sponsored trauma care throughout the state. However, no methodology was provided within the Report to show how the number of trauma centers was allocated among the TSAs based upon the data considered by the committee. The committee also cautioned that their estimate did not take into account other relevant factors or local conditions within each TSA that should be assessed before deciding how many trauma centers were in fact needed, including resource availability. As stated in the 1990 Report: It was the full committee's feeling that the number of hospitals able to apply to be state-sponsored trauma centers would be limited by the lack of resources in the service area. For instance, the standards require that trauma centers have certain physician specialists committed to the facility for availability 24 hours a day, seven days a week. There are not enough specialists available in any area of the state to staff more than a few trauma centers. The reality of the situation lead the full committee to believe that there cannot be a proliferation of trauma centers. Dialogue between the state and local/regional agency would be essential to making the decision on the number of trauma centers needed. The 1990 Report did not include data or analysis relating to factors such as the availability of physician specialists within geographic areas, existing trauma center patient volumes, patient outcomes, or the capacity and adequacy of existing trauma centers. Following receipt of the 1990 Report, the Legislature amended the trauma statute by adopting the 19 trauma service areas proposed in the 1990 Report. Chapter 90-284, § 5, at 2188-89, Laws of Fla. However, the Legislature did not consider the trauma service area boundaries to be permanent or static. Instead, the Legislature provided that: [t]hese areas are subject to periodic revision by the Legislature based on recommendations made as part of local or regional trauma plans approved by the department . . . These areas shall, at a minimum, be reviewed by the Legislature prior to the next 7-year verification cycle of state sponsored trauma centers. As part of the 1990 trauma statute amendment, the Legislature provided that, in addition to complying with the trauma center standards, a trauma center applicant must "be located in a trauma service area which has a need for such a center." Ch. 90-284, § 6, at 2191, Laws of Fla. In this regard, the Legislature directed HRS to "establish [within each service area] the approximate number of state-sponsored trauma centers needed to ensure reasonable access to high quality trauma services." Id. (emphasis added). This need determination, which must be promulgated via rule, was to be "based on the state trauma system plan and the [1990 Report]." Id.; § 395.402(3)(b) ("[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area"). However, the Legislature rejected the 1990 Report's recommended minimum of 43 and maximum of 60 trauma centers. Instead, the Legislature stipulated that there should be a minimum of 19 trauma centers (i.e., one trauma center in each service area) and "no more than" 44 trauma centers. Ch. 90-284, § 5, at 2189-90, Laws of Fla. In 1992, HRS promulgated rule 64J-2.010. The Rule adopted the column in Table 3.3 of the 1990 Report reflecting the "minimum" recommended number of trauma centers, and stated that "[t]he number of trauma centers in each TSA shall be in accordance with the minimum number set forth in the table.3/” The trauma center need allocated by rule 64J-2.010, which merely replicates Table 3.3, has remained unchanged since 1992 with the exception of TSA 18. Subsequent Developments In 1998, the Legislature directed DOH via a committee (the "1999 Committee") to prepare a report by February 1, 1999, (the "1999 Report") "on how best to ensure that patients requiring trauma care have timely access to a trauma center." In furtherance of this objective, the 1999 Committee was required to "study . . . the strategic geographical location of trauma centers . . . ." Id. In its report, the 1999 Committee recommended that "[t]he goal for timely access to trauma centers should be to assure that every trauma victim can be delivered to a trauma center, either by emergency medical ground or air transport, within 30 minutes of beginning transport." As stated in the 1999 Report: There must be an adequate number of trauma centers distributed statewide in order to ensure timely access. . . [T]he ideal trauma system would assure that every trauma victim can be delivered to a trauma center within 30-minute air or ground transport. The geographical locations of the 19 trauma centers either verified or provisional as of July 1998 are shown on Map 1 in Appendix F. The circles around each trauma center location illustrate a fifty-mile flight radius, which translates into an average 30- minutes transport time by helicopter for a trauma victim. Helicopter transport time is used for this illustration because air medical transport allows trauma victims to be transported further distances within the 30-minute timeframe. The 1999 Committee found that some areas in Florida were not within a fifty-mile flight radius of one of the 19 existing trauma centers, which meant residents in these areas could not access a trauma center within 30 minutes. In fact, at that time, only 80 to 85 percent of Florida residents were within 30 minutes of a trauma center.4/ The committee therefore concluded "Florida does not have an adequate number of trauma centers distributed statewide to ensure timely access to appropriate trauma care." As a result of its findings, the 1999 Committee "developed two additional criteria for use by the department: 1) the overall goal of 30-minute transport time to trauma centers, and; 2) its equivalent, 50 miles, for helicopter flight times." The committee stated that these access criteria "should be considered by [DOH] in developing administrative rules for the planning and development of additional trauma centers . . ." The 1999 Committee made no attempt to quantify the number of additional trauma centers that were needed statewide, or within each TSA, to achieve the 30-minute goal.5/ Nor did the committee seek to update the Rule (i.e., Table 3.3) using the 1990 Report's methodology. However, the committee cautioned that: [r]etaining the limit on the number of trauma centers was . . . essential in order to maintain a reasonable volume of patients who are trauma victims as well as to avoid conflicts between competing trauma centers for recruitment of key professional staff. The 1999 Committee recommended giving DOH the "statutory authority to assign counties to trauma service areas" and that DOH "conduct a review of the regional structure of the 19 trauma service areas and the assignment of the counties between these areas and make changes, if found to be appropriate." The 1999 Report offered the following explanation for this recommendation: The committee did recommend that authority to assign counties to trauma service areas should be given to the department. Current authority resides with the Legislature. Shifting this authority to the department will allow flexibility in the system to more quickly respond to changing needs at the local level. Consistent with the 1999 Committee's recommendation, the Legislature repealed the statutory provision that made the trauma service areas subject to periodic review and "revision by the Legislature." Ch. 99-397, § 195, at 164, Laws of Fla. This repealed provision was replaced with an amendment to section 395.402(3) that delegated to DOH the statutory duty to review and revise the TSA boundaries, which stated as follows: Trauma service areas are to be used. The department shall periodically review the assignment of the 67 counties to trauma service areas. These assignments are made for the purpose of developing a system of trauma centers. Revisions made by the department should take into consideration the recommendations made as part of the regional trauma system plans approved by the department, as well as the recommendations made as part of the state trauma system plan. These areas must, at a minimum, be reviewed in the year 2000 and every 5 years thereafter. Until the department completes its initial review, the assignment of counties shall remain as established pursuant to chapter 90-284, Laws of Florida. Ch. 99-397, § 195, at 163-64, Laws of Fla. (Emphasis added). In response to the Legislature's directive, DOH initiated a review of the service areas and prepared a draft report entitled “Trauma Service Area Study-Year 2000” (the "2000 Draft Study"). However, for reasons unknown in this record, DOH apparently never finalized that study, and it was received in evidence in draft form only. In the 2000 Draft Study, DOH noted that the "primary purpose" of the TSA review mandated by section 395.402(3) "is to determine if the 19 trauma service areas . . . continue to be rational service areas." Based on the 1990 Report's methodology, the draft study's tentative recommendation was not to change the trauma service areas, although DOH "should continue to study and review the trauma service areas . . . to determine if different county configurations might lead to more timely access . . . ." At the same time, after analyzing more recent data, the draft study recommended the allocation of a different number of trauma centers to TSAs 9, 10, 11, and 12 as compared to the Rule.6/ Additionally, the 2000 Draft Study made the following finding: Because of the substantial financial commitment made by a hospital to be a trauma center, patient volume becomes an important factor for a hospital in terms of being financially viable and having enough work for trauma surgeons to maintain their skills. The old adage of practice makes perfect is particularly applicable to those treating the seriously injured trauma patient. . . To meet [the American College of Surgeons] caseload recommendations, locating trauma centers in areas where skill levels can be maintained by trauma surgeons is an important factor. Furthermore, to recruit and retain well-qualified surgeons to work in a trauma center, it is important to have a sufficient number of patients to treat, especially to the surgeon. Thus, the 2000 Study emphasized that trauma centers must see enough patients to be financially viable and for trauma surgeons to maintain their skills, and referenced the American College of Surgeons recommendation that Level I trauma centers treat 600 to 1000 patients annually and Level II trauma centers treat 350 to 600 patients annually. The 2000 Study concluded: -No change in trauma service areas should be made at this time. This study found that minimal change occurred in those counties identified as nucleus counties. Furthermore, the relationship between nucleus counties and those identified as sending or "feeder" counties remains intact. -The 19 trauma service areas should continue to serve as the geographical basis for the allocation of the 44 authorized trauma center slots. -The 44 authorized trauma center slots in chapter 395.401 Florida Statutes [now section 395.402(4)(c) should remain as the maximum number required to meet trauma patient care demands. 2004 Amendments to the Trauma Statutes and the 2005 Assessment In 2004, the Legislature made substantial revisions to the trauma statute. Chapter 2004-259, Section 6, Laws of Florida amended section 395.402 to direct the Department to complete a statewide assessment of the trauma system by February 1, 2005 ("the 2005 Assessment"). § 395.402(2), Fla. Stat. The scope of this assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. An appropriation of $300,000 was authorized for the Department to contract with a state university to perform the actions required under the amended statute. Ch. 2004-259, § 10, Laws of Florida. One objective of the 2005 Assessment was to "[c]onsider aligning trauma service areas within [sic] the trauma region boundaries as established in" section 395.4015(1). §395.402(2)(a), Fla. Stat. In a related 2004 amendment, the Legislature added a sunset provision that, upon completion of the 2005 Assessment, ended the statutory mandate to use the service areas created in 1990. See § 395.402(2) ("[t]rauma service areas as defined in this section are to be utilized until [DOH] completes" the 2005 Assessment) (emphasis added); § 395.402(4) ("[u]ntil the department completes the February 2005 Assessment, the assignment of counties shall remain as established in this section.") The obvious intent of the above statutory change was for the section 395.402(4) service areas to be replaced by the service areas DOH established or adopted once it had the results of the 2005 Assessment. "Annually thereafter" (as opposed to every five years per the 1999 version of the statute) DOH was required to "review the assignment of the 67 counties to trauma service areas . . . ." Ch. 2004-259, § 6, at 13, Laws of Florida (amending § 395.402(3)). Another objective of the 2005 Assessment was to "establish criteria for determining the number and level of trauma centers needed to serve the population in a defined trauma service area or region." § 395.402(2)(c), Fla. Stat. Based on these criteria, DOH was then to "[r]eview the number and level of trauma centers needed for each trauma service area to provide a statewide integrated trauma system." § 395.402(2)(b), Fla. Stat. As part of this need assessment, DOH was required to consider the "[i]nventories of available trauma care resources, including professional medical staff," as well as the "[r]ecommendations of the Regional Domestic Security Task Force" and "the actual number of trauma victims currently being served by each trauma center." § 395.402(3), Fla. Stat. However, unlike the situation with the 1990 Report, the Legislature did not intend for DOH to rely on the 2005 Assessment indefinitely. To avoid this, the Legislature therefore required DOH to update the 2005 Assessment by annually reviewing "the requirements of paragraphs (2)(b )-(g) and subsection (3)" of section 395.402. This meant that each annual review, like the initial 2005 Assessment, had to "[r]eview the number and level of trauma centers needed for each trauma service area or region" by, among other things, considering "[i]nventories of available trauma care resources, including professional medical staff." §§ 395.402(2)(b) and (3)(e). The need determinations resulting from these annual reviews would then have to be codified in a rule per section 395.402(4)(b) ("[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area"). The 2004 Legislature clearly intended for DOH to rely on the updated need assessments required by section 395.402(4), rather than the need allocation in the 1990 Report (which was incorporated into the Rule). This is evident from the fact that the 2004 Legislature repealed the provision that previously required DOH to establish need based on the 1990 Report. See chapter 2004-259, § 7, at page 14, Laws of Florida (amending section 395.4026(1)), which states in relevant part: Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, and recommendations of the local or regional trauma agency, and the 1990 Report and Proposal for Funding State Sponsored Trauma Centers, the department shall establish the approximate number of state approved trauma centers needed to ensure reasonable access to high-quality trauma services. The Using the guidelines and procedures outlined in the 1990 report, except when in conflict with those prescribed in this section, the department shall select those hospitals that are to be recognized as state approved trauma centers . . . [emphasis added] By repealing the statutory reference to the 1990 Report, the Legislature expressly required the Department to discontinue any reliance on the 1990 Report as a basis for allocating trauma center need. In addition, the 2004 Legislature imposed a moratorium on the submission of applications for new trauma centers in any TSA that already had one trauma center until the 2005 Assessment was complete, regardless of whether the Rule indicated a need for an additional trauma center within the TSA. § 395.4025(14), Fla. Stat. It is reasonable to infer that the imposition of a moratorium notwithstanding unmet need in several of the TSA's under the Rule indicates that the Legislature considered the Rule to be outdated and no longer valid. The moratorium therefore had the effect of maintaining the status quo until the Rule could be updated with a new assessment. The Department timely submitted its 2005 Assessment to the Legislature on February 1, 2005. The assessment itself was conducted by a group of investigators from the University of South Florida and the University of Florida. This group was assisted by a National Steering Committee "composed of recognized experts in the fields of trauma care and trauma system analysis " In its transmittal letter to the Legislature, DOH specifically noted that the assessment included a recommendation regarding “the number and level of trauma centers needed to provide a statewide integrated trauma system. . . .” In contrast with HRS' contemporaneous objections to the 1990 Report, the DOH transmittal letter identified no areas of disagreement with the 2005 Assessment. The 2005 Assessment included 5 "Recommendations", including: 3. Designation of additional trauma centers should be based on the need as determined by trauma region.7/ Deployment of additional trauma centers should take place based not only on the number of patients served per trauma center, but according to a concept of “trauma center capacity,” which would be determined by the staffing levels of medical specialists and other healthcare professionals. An annual regional assessment is also recommended to analyze pre-hospital resources, ICU beds, capacity, trauma center performance including trauma registry data, and other medical resources based on per population estimates to plan for response and improvements. (Emphasis added) Thus, unlike the 1990 Report (and the Rule), the authors of the 2005 Assessment recommended that the availability of existing resources should be taken into account in determining the need for new trauma centers. In evaluating need based on DSTF region, the 2005 Assessment identified an unmet need for only four more trauma centers in the state,8/ which "would provide access to a trauma center for 99 percent of the people in Florida." Given the 20 trauma centers in existence at the time, this meant that the total trauma center need was 24, which is substantially below the need established by the Rule of 42 trauma centers. This lower need determination was due in part to the fact that the 2005 Assessment took "trauma center capacity," and not just the number of patients served per trauma center, into account. According to the 2005 Assessment, the recommended four new trauma centers were needed in DSTF Regions 1, 2, 3 and 5. However, the assessment concluded there was no need for another trauma center in DSTF Region 4 (Tampa Bay), which was found to have "adequate trauma center access at this time." This contrasts with the Rule, which purports to authorize five more trauma centers in the counties assigned to Region 4. In particular, under the Rule, there is a net need for two new trauma centers in Pasco County (TSA 9), two new trauma centers in Manatee County (TSA 13) and one new trauma center in either Citrus or Hernando County (TSA 6). The only legislative response to the 2005 Assessment was an increase in funding to trauma centers. Likewise, the Department has not amended the Rule to implement the recommendations contained in the Assessment. In 2008, the Department held rule development workshops in order for trauma system constituents to indicate whether trauma center allocations contained in the Rule should be changed. Pursuant to stakeholder requests arising out of the workshops, the Department began consideration of an increase in the maximum number of trauma center positions allocated to TSA 1 (Escambia, Santa Rosa, Fort Walton and Okaloosa Counties). Following numerous public workshops and hearings, the Department filed notice of its intent to amend the Rule to increase the allocation of trauma centers in TSA 1 from 2 to 3. However, the amendment did not become final due to matters unrelated to the determination itself and was withdrawn by the Department.9/ The January, 2011 TSA Report In 2011, a study was completed for DOH entitled "Florida Trauma Service Area Analysis" (the "2011 TSA Report") that relied on the 1990 Report's patient flow methodology for assigning counties to trauma service areas. However, this study did not take into account all of the section 395.402(3) criteria. The 2011 TSA Report disclosed this deficiency, stating: This study provides an analysis of TSAs and counties to assess retention of trauma alert patients within the county. Rules for designating counties as nucleus counties for trauma centers and counties for consideration for trauma centers were defined in analyses of TSAs conducted for the office of Trauma in 1990 and 2000. * * * This report analyzes hospital discharges by TSA from 2000 to 2009. Hospital discharge data from [AHCA] is used to analyze the county of residence and treating facility for all trauma patients with an Injury Severity Score (ISS) of 9 or greater, as deemed by statute . . . . Other considerations required, by statute, in the assignment of counties to TSAs include recommendations of regional trauma system plans, stakeholder recommendations, geographical composition to assure rapid access to trauma care, inventories of available trauma care resources, transportation capabilities, medically appropriate travel times, recommendations by the Regional Domestic Security Task Force, and any appropriate criteria. These considerations are not integrated into this analysis of TSAs. (Emphasis added). Although the 2011 TSA Study used the same methodology as the 1990 Report, the 2011 TSA Study supports a different TSA configuration than the one established in the 1990 Report because patient flow patterns have changed since 1990. For example, in the 1990 analysis, the primary treatment county for Manatee County was Sarasota County. Because Manatee served as a feeder county for Sarasota (a nucleus county), it was grouped in the 1990 Report with Sarasota County in TSA 13. However, the updated information in the 2011 TSA study shows that the primary treatment county for Manatee County residents is now Pinellas (TSA 9's nucleus county), which requires that Manatee County be reassigned to TSA 9 per the 1990 Report's methodology. A similar shift in patient flow also dictates the reassignment of Hernando County from TSA 6 to TSA 10 (Hillsborough County). Indeed, it appears that all of the counties in TSA 6 would have to be merged with other trauma service areas since Marion County, which was designated as TSA 6's nucleus county in the 1990 Report, no longer qualifies as a nucleus county. The Department maintains that its employees are continuously reviewing trauma volume, injury severity scores, population and other data and that this activity qualifies as the annual need and trauma service area reviews required by section 395.402(4). However, DOH has not established a need methodology by rule, policy or otherwise that it could apply to this data to quantify the number of trauma centers needed in each TSA. In the absence of an articulable need methodology, it is not possible to verify or replicate any assessment DOH may have done based on the data it claims to have reviewed. More significantly, the Department has itself acknowledged the problem of not having a methodology or process in place for conducting regular assessments. In its "2011-2015 Florida Trauma System Strategic Plan" (the "2011 State Plan"), DOH identified as a "threat" to the achievement of Goal 8 (Regional Trauma System Evaluation) the "[l]ack of effective evaluation criteria, tools and a systematic and periodic process to evaluate trauma service areas and apportionment of trauma centers." In furtherance of Goal 8, DOH also recognized the need to "[c]onduct a statewide comprehensive assessment of the Florida Trauma System access to care based on s. 395.402, F.S., the Western-Bazzoli criteria and other criteria to evaluate access to care and the effectiveness of the trauma service areas/regions." The specified timeline for this future assessment was "December 2011, with annual reviews thereafter as funding is available." On May 19, 2011, the Department's State Surgeon General signed an "Issue Paper" approving a "Florida Trauma System Special Study." This study is intended to "assist the department in developing a process and evidence-based guidelines to be utilized by [DOH] in determining the need for trauma center locations throughout the state." According to the Department's witness, Susan McDevitt (former Director of the Office of Trauma), DOH intends to use this study to develop a formula or methodology for determining the need for new trauma centers in the state. DOH determined this study was needed because the "trauma network has matured and changed" since 2005 when the "last comprehensive assessment of the Florida trauma system" was done. However, December 2011 is the earliest anticipated date for completion of this study, and DOH has no timeline for when this study may result in any rule amendment. As noted, the 1990 Report forms the basis for the configuration of the existing 19 TSA's as well as the need allocated to each of the TSA's within the Rule (with the exception of the reduction in Broward County). However, Dr. Lewis Flint, an expert in trauma surgery and trauma system assessment, credibly explained how Florida's trauma system has "matured and changed" since the 1990 Study was completed: Q. Now, Doctor, can you describe what changes there have been in the trauma system since the 1990 study was completed? A. Well, in 1990, there were fewer trauma centers than there currently are. I believe there were only about 12 designated centers in 1990. There are 22 now. The availability and the efficiency and quality of pre-hospital care has changed in a major way since 1990. We have far more advanced life support staff on ambulances than we had in 1990. We have far more plentiful air evacuation capability than we had in 1990, and the quality and efficiency of the existing trauma centers has changed in a major way as the centers have matured. So that the combination of greatly improved pre-hospital care and significant improvements in efficiency and in-patient outcomes in the existing trauma centers has meant that this system has matured into a very effective trauma system. It is not free of shortcomings, it is not an entire system yet. It has some holes in it, but the system as such has changed in a major way since 1990, such that it was our view at the close of the 2005 comprehensive assessment, that a decision about deployment of trauma centers that was based solely on distance and geography was not going to be an optimum method of determining how the system should be deployed. Whether or not the 1990 Report was valid when issued, its recommended service area configurations and need allocations have been rendered obsolete by the passage of time, changes in patient flow patterns, and significant advances in the trauma care delivery system since the Rule was adopted. Reasonable health planning requires the use of the most recent data available and systematic evaluation of the multiplicity of factors that determine the appropriate number and location of trauma centers in the state. No doubt that is why the Legislature directed DOH to conduct assessments annually. § 395.402(4). Here, the 1990 Report's recommendations were predicated on 1988 information that is now more than two decades old.10/ It is inappropriate to rely on 1988 data to justify the service area configuration or need allocation in 2011, particularly given the major changes and maturation of the trauma system since 1988. The 1990 Report (and rule) also fails to take into account criteria that must now be considered pursuant to the 2004 amendment to section 395.402. In particular, section 395.402(3) as amended, requires the DOH annual need and service area reviews to take into account Regional Domestic Security Task Force recommendations, transportation capabilities (including air transport), and inventories of available trauma care resources (including professional medical staff). The 1990 Report took none of these factors into account in making the need recommendations that were eventually incorporated into the Rule. Notably, had the availability of professional medical staff been factored into the analysis, need would likely have been reduced, as the 1990 Report itself observed, stating: It was the full committee's feeling that the number of hospitals able to apply to be state-sponsored trauma centers would be limited by the lack of resources in the service area. For instance, the standards require that trauma centers have certain physician specialists committed to the facility for availability 24 hours a day, seven days a week. There are not enough specialists available in any area of the state to staff more than a few trauma centers. The reality of the situation lead the full committee to believe that there cannot be a proliferation of trauma centers. (Emphasis added). Standing Petitioners TGH and SJH are located in TSA 10 (Hillsborough County). Petitioner Bayfront is located in Pinellas County in TSA 9 (Pinellas and Pasco Counties). Intervenor Bayonet Point is also located in TSA 9, but in Pasco County. Intervenor Blake is located in Manatee County, in TSA 13 (Manatee, Sarasota, and DeSoto Counties), adjacent to TSA 9. Petitioner Shands is located in TSA 5 (Baker, Clay, Duval, Nassau, and St. Johns Counties). Trauma center applicant Orange Park (a non-party) is located in TSA 5 but in a different county (Clay) from Petitioner Shands (Duval). As noted earlier, because of the intensity of resources that must be devoted to a trauma center, hospitals generally lose money in their operation. Specifically, in FY 2010 Tampa General's Level I trauma center had a $15.7 million net loss, while Bayfront's Level II trauma center had a $3 million net loss. Similarly, Shands lost approximately $2.7 million and SJH lost $8.3 million from the operation of their trauma centers in FY 2010. Of the 42 trauma center positions available statewide, the Rule allocates three to TSA 9 and three to TSA 13. Because TSA 9 currently has one designated trauma center (Bayfront) while TSA 13 has none, the Rule establishes a net need for two more trauma centers in TSA 9 and three more trauma centers in TSA 13. The Intervenors' pending trauma center applications propose to establish Level II trauma centers at Regional Medical Center Bayonet Point in Pasco County, (TSA 9), and at Blake Medical Center in Manatee County (TSA 13). The filing of the Intervenors' applications triggered the application review process set forth in section 395.4025(2). Pursuant to this statute, the deadline for submitting a trauma application is April 1 of each year. § 395.4025(2)(c). The filing of an application triggers a 30-day provisional review period (which in this case is delayed until October 1, 2011, due to an 18-month extension request made by Intervenors). The limited purpose of this provisional review is to determine if the hospital's application is complete "and that the hospital has the critical elements required for a trauma center." Id. The "critical element" portion of the review is based on the trauma center standards and includes a review of whether the hospital meets the equipment, facility, personnel and quality assurance standards. Id. Any hospital that (i) submitted an application found acceptable in the provisional review (i.e., meets the trauma center standards) and (ii) is located in a TSA that has a need for a trauma center may operate as a provisional trauma center after the 30-day provisional review period has concluded. §§ 395.4025(2)(d) and (5). Based upon the facts of record, there is a reasonable probability that the Intervenor hospitals will achieve provisional trauma center status by October 30, 2011, (the end of the 30-day provisional review period that will start October 1, 2011). First, Intervenors' witness James Hurst, M.D. (who is assisting Intervenors and Orange Park in recruiting trauma surgeons and in the application process) testified without contradiction that the HCA applications would be complete and in compliance with the applicable trauma center standards by the extended October 1st application submission deadline. Second, both Intervenor hospitals are located in trauma service areas with a need as established by the Rule. As confirmed by Ms. McDevitt, if the applications meet the programmatic requirements as determined by the provisional review, and there is a need indicated by the Rule, DOH will approve the applications and award the Intervenor hospitals in TSA 9 and 13 provisional trauma center status. Likewise, it is reasonable to expect that the Orange Park application will be approved if it meets the programmatic requirements, given the available slot in TSA 5. Upon receiving the provisional trauma center designation, the EMS providers will be required to treat Bayonet Point, Blake, and Orange Park as trauma centers. This means that the EMS providers will have to revise their protocols to redirect the transport of trauma alert patients from other existing trauma centers to the new centers. See, Fla. Admin. Code R. 64J-2.002(3)(g). A "trauma alert" patient is defined as a "person whose primary physical injury is a blunt, penetrating or burn injury, and who meets one or more of the adult trauma scorecard criteria . . . ." Fla. Admin. Code R. 64J-2.001(14). Pursuant to the DOH Trauma Transport Protocols Manual (which all EMS providers must follow), EMS providers must transport all trauma alert patients to the closest trauma center that is "within 30 minutes by ground or air transport or within 50 miles by air transport." As a result, any trauma alert patient who is closest to Bayonet Point, Blake, or Orange Park will have to be transported to one of those hospitals once they are designated as provisional trauma centers. A provisional trauma center at Bayonet Point would become the closest trauma center for Pasco, Hernando, and Citrus residents (the "northern Tampa Bay region"). Trauma alert patients from these counties would therefore have to be transported to Bayonet Point instead of to the existing trauma centers in Hillsborough (SJH and Tampa General) or Pinellas (Bayfront). Likewise, a provisional trauma center at Blake would become the closest trauma center to Manatee and Sarasota (the "southern Tampa Bay region") requiring transport of their trauma alert patients to Blake rather than to the Hillsborough or Pinellas trauma centers. In 2010, 669 trauma alert patients (16 and over) were transported to Bayfront from the counties in the northern and southern regions of Tampa Bay. This represents 42 percent of all the trauma alert patients (16 and over) transported to Bayfront. From the same area and during the same time period, 120 trauma alert patients (16 and over) were transported to Tampa General. All of these trauma alert patients would be redirected away from Bayfront and Tampa General and transported to the closer Intervenor trauma centers per the EMS transport protocols. The redirection of these trauma alert patients to Bayonet Point and Blake would substantially and adversely affect both Bayfront and Tampa General. In Bayfront’s case, the lost contribution margin caused by the annual diversion of even 400 trauma patients would reduce Bayfront's total margin by at least $2.3 million each year. Likewise, the yearly diversion of 120 trauma patients from Tampa General would result in an annual lost contribution margin and reduction in total margin in excess of $1 million. Notably, for both hospitals this represents the minimum potential loss of trauma patients and revenue as a result of the approval of the Intervenors' trauma centers. Annual losses in excess of a million dollars would be material to both Bayfront and Tampa General given the financial challenges both hospitals are already facing. Although physically located in TSA 10 (Hillsborough County) SJH now receives trauma patients from Hillsborough, Pasco, Citrus, Hernando, and Sumter counties. If approved, the trauma center at Bayonet Point would become the closest trauma center for Pasco, Hernando, and Citrus residents and would likely result in the immediate loss of between 149 and 307 from SJH's trauma program. If the Orange Park trauma center is approved, it is reasonable to expect that all of Shands trauma patients originating from Clay County would instead be redirected to Orange Park. This would represent a loss of approximately 1,000 patients annually, or 25 percent of Shands current trauma volume. With fewer cases to absorb the high fixed costs of trauma preparedness, Shands expects that it would lose $3,400 per case, on a fully allocated basis, rather than the $665/case it now loses. Thus, whereas Shands' trauma center currently loses $2.7 million annually, that loss would increase to approximately $10 million per year. And on a contribution margin basis (where fixed costs are excluded) Shands will experience a decline in contribution margin of $6-7 million annually once the Orange Park trauma center becomes operational. In addition to the direct loss of trauma patients and corresponding revenue, it is reasonable to anticipate that the approval of new trauma centers in relatively close proximity to existing centers will result in increased competition for scarce surgical subspecialists currently associated with the existing trauma programs. Specifically, the opening of new trauma centers in TSA's 5, 9, and 13 are likely to increase the difficulty and escalate the cost of ensuring adequate on-call specialty physician coverage for the Petitioner's hospitals and to adversely affect their ability to retain highly skilled nurses, technicians, and other trauma program staff.
The Issue At issue is whether obstetrical services were delivered by a participating physician in the course of labor, delivery, or resuscitation in the hospital.
Findings Of Fact Fundamental findings Jackson Joseph Fischler (Jackson) is the legally adopted son of Kenneth J. and Laura P. Fischler. He was born a live infant on June 1, 1992, at Memorial Hospital West, a hospital located in Pembroke Pines, Florida, and his birth weight was in excess of 2,500 grams. During the course of labor, delivery or resuscitation in the immediate post-delivery period in the hospital, Jackson sustained an injury to the brain or spinal cord caused by oxygen deprivation and/or mechanical injury which rendered him permanently and substantially mentally and physically impaired. As a consequence of the foregoing, the sole issue to be resolved in deciding whether this claim should be accepted for compensation is whether obstetrical services were delivered by a participating physician in the course of labor, delivery, or resuscitation in the immediate post-delivery period in the hospital, as required by Subsections 766.309(1)(b) and 766.31(1), Florida Statutes. The birth of Jackson Joseph Fischler At or about 7:09 p.m., June 1, 1992, the Pembroke Pines Fire Department, Emergency Medical Services (EMS), arrived at the residence of Shirley George, Jackson's birth mother, in response to a 911 call. At the time, Ms. George reported that she was at term, with a caesarean section scheduled 5 days hence for a breach presentation and that her "water may have broken." Subsequent medical records reflect a spontaneous rupture of the membrane at 7:00 p.m. When examined by EMS, Ms. George was experiencing contractions approximately 2 minutes apart, lasting 30-40 seconds. EMS transported Ms. George to Memorial Hospital West, where she was admitted through the emergency room at approximately 7:15 p.m., in labor. Ms. George was then taken to an examination room, and the labor and delivery unit was requested to provide a nurse to examine her. At or about 7:17 p.m., a labor and delivery nurse performed a pelvic examination of Ms. George and immediately diagnosed a prolapse of the umbilical cord, and a fetal heart rate of approximately 60 beats per minute. A prolapsed umbilical cord is a obstetrical emergency, which in the instant case required prompt surgical intervention to address fetal distress. Consequently, Ms. George was immediately rushed to the operating room for an emergency caesarean section. At the time, the on-call obstetrician, Robert Klein, M.D., was at Hollywood Memorial East, where he had been called for surgery. Therefore, shortly after 7:17 p.m., Dr. Klein was advised by telephone of the emergency involving Ms. George, and was requested to come to Memorial Hospital to attend to the situtation. Consequently, according to Dr. Klein, he "unscrubbed the patient of mine at Hollywood Memorial East . . . and in my greens I drove to Memorial Hospital West." Following notice to Dr. Klein and prior to his arrival at Memorial Hospital West, an overhead page was made for any obstetrician or surgeon in house to call the operating room, and 2-3 minutes later a blue alert to the operating room was called. The emergency room physician responded to the blue alert. Upon arrival in the operating room, he was apparently advised that the fetal heart rate was in the 40 beat per minute range and was asked if he could perform a caesarean section. The emergency room physician, not being qualified to perform the operation, declined, and Rudy Zepeda, M.D., the house physician, who was also present, agreed to perform the caesarean section "to save the baby's life." At this point in the factual narrative it is worth observing, considering the central issue in this case, that Dr. Zepeda, an unlicensed house physician, was not, at anytime material to this case, a "participating physician" in the Florida Birth-Related Neurological Injury Compensation Plan (the Plan), as defined by Section 766.302(7), Florida Statutes. Conversely, Dr. Klein, the on-call obstetrician, albeit not in attendance at the time, was a "participating physician" in the Plan. In the operating room, Ms. George was on the table at 7:23 p.m., anesthesia was started at 7:25 p.m., and Dr. Zepeda commenced the operation at 7:38 p.m. Jackson was delivered at 7:48 p.m., and the placenta at 7:49 p.m. Upon delivery, Dr. Zepeda handed Jackson to Dr. McIntyre, the on-call neonatologist, and he was immediately intubated and bagged with 100 percent oxygen, with good response in heart rate and color only, and first gasp was noted at 7 minutes. Apgar scores were 2 at one minute, 3 at 5 minutes, and 4 at 10 minutes, and at or about 8:00 p.m. Jackson was transferred to the neonatal intensive care unit (ICU) with positive ventilator support. Following Dr. Zepeda's delivery of Jackson and the placenta, but before Jackson's transfer to the neonatal ICU, Dr. Klein entered the operating room. Observing the situation, Dr. Klein reportedly asked Dr. Zepeda to finish the case on his own, but Dr. Zepeda "told him to scrub in." Dr. Klein was noted to have entered the operative field at 7:55 p.m., at which time he observed "the uterus was closed in the first layer," which would be the first step in the procedure after delivery of the placenta, and he proceeded to complete the operation. According to his operative report, Dr. Klein provided, inter alia, the following services incident to the caesarean section: . . . UPON ENTERING THE OPERATIVE FIELD THE UTERUS WAS [observed to have been] CLOSED IN THE FIRST LAYER AND I USED NUMBER 0 CHROMIC TO CLOSE THE SECOND LAYER. IT WAS VERY DIFFICULT TO FIND THE BLADDER FLAP WHICH WAS NOT CREATED UPON ENTRY TO THE UTERUS. TWO VIALS OF METHYLENE BLUE WERE INJECTED INTRAVENOUS BY THE ANESTHESIOLOGIST. APPROXIMATELY TEN MINUTES LATER METHYLENE BLUE DYE WAS NOTED IN THE FOLEY BAG. UPON CLOSURE OF THE UTERUS THE OVARIES AND TUBES WERE FOUND TO BE WITHIN NORMAL LIMITS. THE PERITONEUM WAS NOT CLOSED BUT APPROXIMATED. THE MUSCLE WAS CLOSED IN THREE SEGMENTS CREATING NORMAL LOOKING MUSCLE, APPROXIMATING LONGITUDINAL AND VERTICAL INCISION OF THE MUSCLE WHICH WAS DONE UNDER EMERGENCY CONDITIONS BY THE SURGICAL RESIDENT. THERE WAS MODERATE AMOUNT OF BLEEDING, HOWEVER, THIS WAS CONTROLLED WITH THE BOVIE AND THREE PIECES OF SURGICEL WERE PLACED OVER THE MUSCLE ABOVE THE FASCIA. THE FASCIA THEN WAS CLOSED WITH NUMBER 0 VICRYL IN A CONTINUOUS INTERLOCKING FASHION IN TWO SEGMENTS. SUBCUTANEOUS TISSUE WAS IRRIGATED. HEMODYNAMICALLY THE PATIENT WAS UNDER GOOD CONTROL AND THERE WAS NO EVIDENCE OF LOW PRESSURE DURING THE SURGERY. SHE WAS GIVEN FLUIDS AND PITOCIN 20 UNITS AND FULL LITER OF HALF NORMAL SALINE. SHE WAS ALSO GIVEN TWO GRAMS OF MEFOXIN BY THE ANESTHESIOLOGIST THE SKIN WAS APPROXIMATED AND CLOSED WITH STAPLES. COVERED WITH TELFA, 4X4, STERILE TAPE. THE URINE OUTPUT WAS ADEQUATE MIXED WITH METHYLENE BLUE. ROUTINE POSTOP ORDERS WERE WRITTEN IN THE CHART. The services Dr. Klein provided Ms. George, albeit post-delivery, were an integral part of the caesarean section delivery procedure, and were unquestionably obstetrical services. 1/ Moreover, such services were provided, at least in part, while Jackson was being resuscitated in the immediate post- delivery period. 2/ 16 As heretofore noted, Jackson was transferred to the neonatal ICU, with positive ventilator support, at or about 8:00 p.m. Upon arrival in the ICU, Jackson was placed on a respirator ("Baby Bird" mechanical ventilator support), with initial settings being an IMV of 50, pressure of 22/4 and 100 percent oxygen. Jackson's first movement, which consisted of some flexion of the extremities, was noted at or about 30 minutes of life, and there was some associated twitching of the lower jaw, which was thought to represent seizure activity. At or about 10:30 p.m., June 1, 1992, Jackson was discharged from Memorial Hospital West and transported to the neonatal ICU at Hollywood Memorial East. At the time he was on stable ventilator settings, and his seizures were under control with phenobarbital. Diagnosis on discharge was perinatal asphyxia secondary to prolapsed cord, and seizure disorder. Jackson remained at Memorial Hospital until discharged on June 23, 1992. At the time, examination revealed "slight increased tone, intermittent arching of back and retracting of head, cortical thumbs bilaterally with excessive fisting, brisk DTR's bilaterally, moro present, . . . and oral thrush." An MRI of June 6, 1992, "showed abnormal brain signal in each parietal lobe and decreased white matter signal in the basal gaglion, brain stem, mid brain and cerebellar hemispheres, possible watershed ischemia." Following maturation, neurologic examination revealed evidence of four limb spasticity with double hemiparesis, marked expressive language and motor delay. Severe swallowing and sucking difficulties necessitated gastrostomy placement.
The Issue Whether St. Joseph's Hospital, Inc.'s application for certification as a State Approved Pediatric Trauma Referral Center should be approved.
Findings Of Fact The Hillsborough County Hospital Authority d/b/a Tampa General Hospital ("TGH" or "Petitioner") is a licensed general acute care hospital in Tampa, Florida and is a verified level I trauma center. By definition, a level I trauma center is required to include an adult trauma center and a state-approved pediatric trauma referral center ("SAPTRC"). The Department of Health and Rehabilitative Services ("DHRS" or "Respondent") is the state agency with statutory responsibility for certification and regulation of trauma centers in Florida. St. Joseph's Hospital ("SJH" or "Intervenor") is a licensed general acute care hospital in Tampa, Florida and is a verified level II trauma center. SJH was provisionally approved as a level II trauma center on May 1, 1991 and was verified on July 1, 1992. A level II trauma center is not required to operate a SAPTRC. By letter of August 17, 1993, the DHRS notified the chief executive officers for all Florida hospitals of next trauma center application review cycle. Pursuant to statute, letters of intent were due by October 1, 1993 for the referenced review cycle. A letter of intent to apply for certification as a trauma center is an nonbinding expression of intent. Frequently a hospital files a letter of intent to become a trauma center but and then fails to file the application. A hospital seeking trauma unit certification must submit a letter of intent by the October 1 preceding the April 1 application deadline. A letter of intent is only valid for the application review cycle for which it is submitted. A hospital which submits a letter of intent but does not file the subsequent application must submit another letter of intent in order to file an application in a later review cycle. Pursuant to Section 395.4025(2)(a), Florida Statutes, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a state-approved trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists. The cited statute specifically provides that this requirement does not apply to any hospital that is certified as a provisional or verified trauma center on January 1, 1992. A trauma agency ("agency") is a planning unit of one or more county governments which plans for the development of the trauma system in that county or multi-county region. The DHRS is charged with review and approval of all local trauma agencies, the trauma systems plans adopted by such agencies and annual updates and amendments to local trauma plans. The Hillsborough County Trauma Agency ("HCTA"), is the DHRS-approved local trauma agency for Hillsborough County, Florida and is responsible for trauma service area #10. The Petitioner asserts that the SJH application will increase the number of service area #10 trauma centers beyond the limit of two imposed by statute and rule. There are currently two trauma centers in Hillsborough County (service area #10) including the Petitioner and the Intervenor. The expansion of services proposed by SJH will not increase the number of trauma centers in service area #10. If SJH is awarded the certification, there will still be two trauma centers. The trauma services plan submitted by the HCTA and approved by the DHRS does not expressly address whether or not any need exists for a second SAPTRC in service area #10. The 1990 amendment to the local plan references SJH's interest in operating a SAPTRC, but does not state whether need exists for a second SAPTRC. By letter of intent dated September 23, 1993 and received by the DHRS on September 30, 1993, SJH filed notice of intent to apply for certification as a state approved pediatric trauma referral center. By letter of October 14, 1993, the DHRS acknowledged receipt of SJH's letter of intent. The SJH letter of intent does not certify that the SJH's planned pediatric trauma referral center was consistent with the local trauma agency's plan. The failure of SJH to certify that the proposed SAPTRC is consistent with the local trauma agency plan is of no consequence. Section 395.4025(2)(a), Florida Statutes, specifically exempts any hospital that is certified as a provisional or verified trauma center on January 1, 1992. SJH was provisionally approved as a level II trauma center on May 1, 1991. Consideration of whether the local plan indicates need for an additional SAPTRC or whether the SJH proposal is consistent with the local trauma plan is not required. Until immediately prior to this case being heard, and despite the aforementioned exemption for some facilities, the DHRS required all hospitals located in areas where local or regional trauma agencies exist to submit some type of certification that the proposed trauma unit was consistent with the local plan. Since adoption of the 1992 statutory amendments, the DHRS has failed to appropriately apply the referenced exemption. Immediately preceding commencement of the hearing in this matter, the DHRS position was revised to reflect the exemption. The SJH application for certification as a SAPTRC was filed with the DHRS on or before April 1, 1993. On May 13, 1993, the DHRS notified SJH of certain omissions and requested additional information. On May 19, 1993, SJH filed its response to the request for information. Thereafter, the DHRS performed a preliminary review of the application to determine whether SJH met the requirements for approval as a "provisional" SAPTRC. Included in the information considered by the DHRS in evaluating the SJH application were documents submitted by representatives of the HCTA related to whether the SJH application was supported by the local agency and was consistent with the local trauma plan. The HCTA documents submitted are immaterial because, as previously addressed, SJH is exempted from the requirement related to local trauma plan consistency. The DHRS determined that the SJH application met the required critical standards for provisional approval. The DHRS notified SJH of the provisional approval on May 31, 1994. TGH challenged the DHRS determination that the SJH application met the critical standards. A hospital which meets the "critical elements" set forth in statute may receive provisional approval as a SAPTRC. Section 395.4025(2)(c), Florida Statutes, provides as follows: ....The department shall conduct a provisional review of each application for the purpose of determining that the hospital's application is complete and that the hospital has the critical elements required for a state approved trauma center. This critical review will be based on trauma center verification standards and shall include, but not be limited to, a review of whether the hospital has: Equipment and physical facilities necessary to provide trauma services. Personnel in sufficient numbers and with proper qualifications to provide trauma services. An effective quality assurance program. Submitted written confirmation by the local or regional trauma agency that the verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists. This subparagraph applies to any hospital that is not a provisional or verified trauma center on January 1, 1992. As previously stated, because SJH was a provisionally approved trauma center on January 1, 1992, it is not required to submit written confirmation by the local or regional trauma agency that verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency. The parties stipulated that the SJH application meets the standards regarding staffing, facilities, equipment, and quality assurance required for provisional approval, except as to the following: Whether St. Joseph's will have adequate surgeon coverage and support to meet the require- ments to be a provisional SAPTRC. Whether St. Joseph's will have adequate physician coverage in its pediatric ICU to meet the requirements to be a provisional SAPTRC. Whether St. Joseph's meets the statute and rule requirements for provisional review as they relate to quality of care to pediatric trauma alert patients. There was attention directed at the hearing to the fact that the DHRS application form fails to accurately track the applicable rules setting forth the requirements for certification as a SAPTRC. Notwithstanding the agency's failure to create an accurate application form, the minimum standards for review for Provisional SAPTRCs as identified in Rule 10D-66.109(d)2, Florida Administrative Code, are the following portions of HRSP 150-9, October 91: STANDARD Type of Hospital Surgery Department; Division; Services; Sections: A Surgical Specialties Availabilities: A 1, 2, 3 & 4 Non-Surgical Specialties Availabilities: 1, 8 & 13 Emergency Department (ED): A, B, D & H Operating Suite Special Requirements: A IX. Pediatric Intensive Care (P-ICU): A, C, 1 XVI. Quality Management: A, B, C, D, & E The booklet identified as "State-Approved Trauma Center and State- Approved Pediatric Trauma Referral Center Approval Standards, HRSP 150-9, October 91" provides specific information related to each standard. The following constitutes review of the minimum standards for Provisional SAPTRCs as related to the application submitted by SJH. Standard I. Type of Hospital SJH is a level II trauma facility and is a general acute care hospital with independent pediatric trauma patient care services within the facility, from emergency department admission through rehabilitation, separate and distinct from adult patient care services. SJH meets the Standard I requirement. Standard II. Surgery Department; Division; Services; Sections: A SJH offers the required types of surgery, including general surgery, orthopedic surgery and neurosurgery. Orthopedic surgery and neurosurgery are divisions within the Department of Surgery. SJH meets the Standard II A requirement. Standard III. Surgical Specialties Availabilities: A 1, 2, 3 & 4 SJH meets the Standard III A requirement. SJH offers general surgery, neurosurgery, orthopedic surgery and otorhinolaryngologic surgery on call and promptly available 24 hours a day. Standard V. Non-Surgical Specialties Availabilities: 1, 8 & 13 SJH meets the specified Standard V requirement. SJH offers the required types of non-surgical specialties, including anesthesia, pediatric intensive and critical care medicine, and radiology including diagnostic x-ray and computerized tomography. The specialists in each area have special competence in the care of the pediatric trauma patient in their specialties. Standard VI. Emergency Department (ED): A, B, D & H SJH meets the specified Standard VI A requirement. SJH has an identifiable intake and resuscitation area specifically equipped for pediatric trauma patients . The SJH pediatric trauma area is located in the Emergency Department and is easily accessible to land and air transportation. SJH meets the specified Standard VI B requirement. SJH's Emergency Department has a designated medical director/physician for pediatrics, a trauma/general surgeon, emergency department physicians, a nursing staff and respiratory therapy staff. The personnel have special competence in the care of the pediatric trauma patients. SJH Emergency Department staff are available as follows: At least one E.D. physician is present in the E.D. 24 hours a day; Nursing staff is present in the E.D. 24 hours a day; and Respiratory therapy staff are on call and immediately available in-hospital 24 hours a day. SJH meets the specified Standard VI D requirement. SJH has a radio communication system that conforms to the State EMS Communications Plan and telephone and paging equipment to contact trauma team members. The equipment is functional and is located in the trauma center intake area. SJH meets the specified Standard VI H requirement. SJH has written protocols for the immediate response to the emergency department from the blood bank, laboratory, respiratory therapy and operating room. Standard VII. Operating Suite Special Requirements: A SJH meets the specified Standard VII A requirement. SJH has a fully staffed and equipped operating room, available 24 hours a day for immediate use. Written operating procedures for 24 hour a day operating room availability for pediatric trauma patients and staffing are available for review by the DHRS. Standard IX. Pediatric Intensive Care (P-ICU): A, C, 1 SJH fails to comply with Standard IX as set forth in Rule 10D- 66.109(d)2, Florida Administrative Code, referencing "State-Approved Trauma Center and State-Approved Pediatric Trauma Referral Center Approval Standards, HRSP 150-9, October 91." Standard A, C, 1 specifically requires that the P-ICU medical director or a physician designated by the P-ICU medical director must be available in the unit 24 hours a day. SJH does not propose to place the P-ICU medical director or a physician designated by the P-ICU medical director in the unit 24 hours a day. SJH proposes to make the P-ICU medical director or a physician designated by the P-ICU medical director available to the unit 24 hours a day. "Available to" the unit does not require that the identified employee be present in the hospital. As much as 30 minutes could pass before the P-ICU medical director or his designee arrives at the P-ICU. Although the evidence establishes that the DHRS has accepted such arrangements in previous applications, the rule specifically requires that the referenced personnel be located in the P-ICU. There is no legal authority for the DHRS to disregard the requirement set forth in its own rules. Standard XVI. Quality Management: A, B, C, D, & E SJH meets the specified Standard XVI A requirement in that it has a comprehensive quality management plan in operation. SJH meets the specified Standard XVI B requirement. SJH's quality management plan include protocols for 1) pediatric trauma patient triage and the issuance of an in-hospital trauma alert; 2) response of trauma team and documentation of response time in each patient record for members of the trauma team, neurosurgical, laboratory, x-ray, social work, pastoral, consultants and elapsed time for laboratory results. Protocols are also included related to trauma, medical and nursing staff patient care responsibilities, trauma operating room team response, assuring operating room and operating room staff availability to the pediatric trauma patient, pediatric trauma patient care in ICU, post-anesthetic recovery room and wards, transport of the pediatric trauma patient to the operating room, x-ray suites, CT scanner, ICU, and other hospital areas and hospital transfers. SJH meets the specified Standard XVI C requirement. SJH plan includes, and SJH will implement and perform monthly trauma quality management, consisting of a trauma quality management committee that will meet at least monthly to review pediatric trauma cases, including cases involving morbidity and mortality. The pediatric trauma service medical director or trauma nurse coordinator will review specified cases including all pediatric trauma alert cases, all critical admissions for traumatic injuries, all pediatric trauma Operating Room admissions from the emergency department and/or state-approved trauma center, any critical pediatric trauma transfers into or out of the emergency department and/or trauma center, and all traumatic deaths. Review of such cases will include application of "audit filters" as identified in the rule. Appropriate records will be maintained in-hospital, of all cases to which audit filters were applied. Pediatric trauma cases will be evaluated by the medical director of the trauma service and/or trauma nurse coordinator. The trauma nurse coordinator and the medical director will present a summary of the reviewed cases not referred to the committee, along with cases requiring further evaluation where there is no clear and appropriate reason for a situation to have occurred. Cases referred to the trauma quality management committee for which the committee can find no clear and appropriate reason for the situation to have occurred will be sent to appropriate persons or committees responsible for corrective action. The medical director of the trauma service will report back to the trauma quality assessment committee the resolution of each case. The SJH trauma quality management committee is composed of the trauma nurse coordinator, a trauma surgeon (other than the pediatric trauma service medical director), an emergency physician, a surgical specialist (other than trauma surgeon), a representative from SJH administration, the operating room nursing director, the Emergency Department nursing director and the intensive care unit nursing director. At least 75 percent attendance of the committee members is required at the monthly trauma quality management committee meetings. SJH will maintain minutes of all trauma quality management committee meetings for at least three years and are readily available for review by the DHRS. The minutes shall include at a minimum, the names of the attendees and the subject matter discussed, and actions toward resolution(s) of identified problems. The trauma quality management committee will prepare and submit a quarterly report to the DHRS at the end of each calendar year quarter by the 15th of the month following the end of the previous quarter. The report will list every case selected for corrective action by the trauma quality management committee and will provide identify the hospital case number, the trauma registry number (from HRS Form 1728, "Trauma/Head Injury/Spinal Cord Injury Registry"), a description of questionable care, and the corrective action taken. If corrective action is not necessary, an explanation is required. The medical director/chair of the trauma management committee will compile monthly statistics on each trauma surgeon on the trauma call roster. The statistics will be available for the DHRS review or will be submitted upon request. The statistics for each surgeon shall reflect the total number of cases per calendar month for which each trauma surgeon was notified to respond to a pediatric trauma alert and the total number of cases for which the trauma surgeon did not meet the pediatric trauma alert patient at the time of the trauma alert patient's arrival at the SAPTRC. SJH will conduct a monthly multi-disciplinary trauma conference for case management and education. When appropriate, the conference will include review of the local/regional emergency medical service system, individual case management, the SAPTRC, solution of specific problems including organ procurement and donations, and trauma care education. The attendees will include representatives from trauma services, the emergency department, neurosurgery, orthopedics, nursing, social work, rehabilitation medicine, laboratory, x-ray, prehospital providers and hospital administration. At least 50 percent attendance will be required at the monthly multi-disciplinary trauma conference. Minutes from these conferences, including the names of the attendees and subject matter discussed, will be maintained at the SAPTRC for a minimum of three years and will be readily available for review by the DHRS upon request. SJH meets the specified Standard XVI D requirement relating to file maintenance. The trauma unit will have on file credentials of all surgeons in the trauma service as well as consultants, morbidity and mortality figures for the pediatric trauma service, CME data on all physicians participating in the pediatric trauma service, research and CME activities on all surgeons participating in the trauma services, nursing credentials, nursing CEU, any nursing research, a written plan of how the trauma nurse coordinator and the trauma service medical director's duties and responsibilities are integrated, a written disaster plan, the county or regional disaster plan and evidence of disaster drill activities. SJH meets the specified Standard XVI E requirement relating to file maintenance. The SAPTRC will fully participate in the trauma registry
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is hereby RECOMMENDED that the Department of Health and Rehabilitative Services enter a Final Order denying the application of St. Joseph's Hospital for certification as a State-Approved Pediatric Trauma Referral Unit. DONE and RECOMMENDED this 3rd day of March, 1995, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of March, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3669 The following constitute rulings on proposed findings of facts submitted by the parties. Petitioner Tampa General Hospital The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 1-14. Rejected, irrelevant. 15-20. Rejected, unnecessary. It is not unreasonable to address free standing units or new trauma centers differently that service expansions to existing facilities. 21-22. Rejected, irrelevant. 24-79. Rejected, irrelevant. 81. Rejected, unnecessary. 83-120. Rejected, irrelevant. 121. Rejected, unnecessary. 123-128. Rejected, irrelevant. 130-134. Rejected, irrelevant. Rejected, irrelevant. The rules which set forth the specific requirements for certification supersede application form. Rejected, irrelevant. Respondent Department of Health and Rehabilitative Services The Respondent's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 11-13. Rejected, unnecessary. Rejected, subordinate. Rejected, unnecessary. 17. Rejected, unnecessary. 19. Rejected, unnecessary. 21-23. Rejected, subordinate. 24. Rejected, irrelevant. 25-27. Rejected, subordinate. 28-29. Rejected, unnecessary. 30. Rejected, not supported by credible evidence. 32. Rejected, unnecessary. 34. Rejected, irrelevant. 36. Rejected, irrelevant. 38-40. Rejected, irrelevant. 41. Rejected, unnecessary. 42-58. Rejected, irrelevant. 59. Rejected, unnecessary. 60-81. Rejected, irrelevant. 82. Rejected, not supported by the greater weight of the evidence. 83-86. Rejected, unnecessary. Rejected, not supported by the greater weight of the evidence. Rejected, irrelevant. 89-91. Rejected, unnecessary. 92. Rejected, contrary to law. The rules set forth the specific requirements which must be met for certification as a provisional SAPTRC. The rule unambiguously requires that the Pediatric Intensive Care Unit medical director or a physician designated by the P-ICU medical director must be available in the unit 24 hours a day. There is no legal authority for the DHRS to disregard the requirement, notwithstanding the agency's apparent failure to enforce the rule in previous instances. Intervenor St. Joseph's Hospital The Intervenor's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 7-9. Rejected, unnecessary. 13-14. Rejected, unnecessary. 16-17. Rejected, unnecessary. 19-31. Rejected, unnecessary. 64-65. Rejected, not supported by the greater weight of the evidence. Despite the DHRS practice, the rule specifically requires that the referenced personnel be located in the P-ICU. The rule is not satisfied by the SJH proposal. 82. Rejected, not supported by the greater weight of the evidence. COPIES FURNISHED: Robert L. Powell, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Kim Tucker, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Elizabeth McArthur, Esquire Radey Hinkle Thomas & McArthur 101 N. Monroe Street, Suite 1000 Post Office Drawer 11307 Tallahassee, Florida 32302 Robert P. Daniti, Esquire Senior Attorney Emergency Medical Services Department of Health and Rehabilitative Services 1317 Winewood Blvd. Tallahassee, Florida 32399-0700 Bruce D. Lamb, Esquire Christopher J. Schulte, Esquire 201 East Kennedy Blvd., Suite 1000 Tampa, Florida 33602
Findings Of Fact Background On September 28, 1988, First Hospital Corporation of Florida d/b/a First Hospital of Palm Beach County (First Hospital) filed a timely application for the July 1993 planning horizon with the Department of Health and Rehabilitative Services (Department) for a certificate of need (CON) to construct a 48- bed short-term psychiatric specialty hospital, dedicated to the care of children and adolescents, in District IX. 1/ District IX is comprised of Palm Beach, Martin, St. Lucie, Indian River, and Okeechobee Counties. On February 3, 1989, the Department published notice in the Florida Administrative Weekly of its intent to grant First Hospital's application. Petitioners, Lake Hospital & Clinic, Inc. d/b/a Lake Hospital of the Palm Beaches (Lake Hospital), and Community Hospital of the Palm Beaches, Inc. d/b/a Humana Hospital Palm Beaches (Humana), existing providers of psychiatric services to adolescents in Palm Beach County, filed timely petitions for a formal administrative hearing to oppose the grant of the subject application. The matter was referred to the Division of Administrative Hearings for the assignment of a hearing officer to conduct a formal hearing pursuant to section 120.57(1), Florida Statutes, and Savannas Hospital Limited Partnership (Savannas), an existing provider of psychiatric services to adolescents in St. Lucie County, was granted leave to intervene. 2/ The proposed facility At issue in this proceeding is the application of First Hospital for a CON to construct a 48-bed short-term psychiatric specialty hospital dedicated to the care of children and adolescents. This project is, however, only a portion of an 80-bed facility that First Hospital proposes to construct on a 30-acre parcel of land adjacent to Wellington Regional Memorial Hospital in western Palm Beach County. As sited, the proposed facility would be located west of the Florida Turnpike; on the west side of State Road 7 and approximately .2 miles north of Forest Hills Boulevard. The 80-bed facility that First Hospital proposes to construct would consist of a central core area and three attached wings or units. Two of the wings, each containing 24 beds, will be dedicated as short-term psychiatric beds, with one wing for young adolescents (10-14 years of age) and one wing for older adolescents (14-18 years of age). The third wing, consisting of 32 beds, will be dedicated as a residential treatment center (RTC) for adolescents. The central core area would include administrative, therapy, kitchen and dining, gymnasium classroom areas and other support functions, and is essential to the operation of the psychiatric units, but will be shared with the residential treatment unit. A therapeutic preschool program, for children 3-5 years of age, as well as a partial hospitalization program for adolescents, are also proposed to be offered, and will be located in the central core area. 3/ The psychiatric program proposed by First Hospital for its 48-bed short-term psychiatric facility will address emotional and behavioral disorders that may affect adolescents, and which require admission to a short-term acute care facility for treatment. In its application, First Hospital estimates an average length of stay of 45 to 60 days. The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization and adequacy of like and existing health card services in the service district As a touchstone for assessing need within a service district, the Department has established a short-term psychiatric bed need methodology that must normally be satisfied before a favorable need determination will be found. That methodology, codified in Rule 10-5.011(1)(0)(4), Florida Administrative Code, contains two identifiable parts. The first part deals with the mathematical derivation of a net bed need for the planning horizon by assuming a gross bed need ratio of .35 beds per 1,000 population, and reducing that figure by the number of existing and approved beds. Based on the population projections of the Executive Office of the Governor, July 1988 release, application of this methodology derives a net need for 48 short-term psychiatric beds for the July 1993 planning horizon (gross bed need of 480- existing and approved beds of 432 = 48 net bed need. 4/ The second part of the Department's need methodology addresses occupancy standards for existing facilities that must be satisfied before a favorable need determination will normally be found. For short-term child and adolescent beds, the rule mandates an average annual occupancy rate of not less than 70 percent for all such existing facilities for the preceding 12- month period. Here, the proof demonstrates an average annual occupancy rate in excess of 70 percent for the 12-month period preceding the Department's need calculation, and satisfaction of the second part of the Department's need methodology. On August 12, 1988, the Department, pursuant to Rule 10-5.008(2)(a), Florida Administrative Code, published notice of the hospital fixed need pool for the July 1993 planning horizon in the Florida Administrative Weekly. Pertinent to this case, such notice erroneously established a net need for 33 short-term psychiatric beds in District IX. Following publication of the fixed need pool, the Department received information that its calculation of the net need for short-term psychiatric beds in District IX was erroneous. Upon review, the Department established that its initial calculation was in error, and on August 26, 1988, the Department published a notice of correction in the Florida Administrative Weekly, which correctly established a net need for 48 short-term psychiatric beds in District IX for the July 1993 planning horizon. This adjustment to the fixed need pool did not result from any intervening changes in population estimates, bed inventories, or other factors which would lead to different projections of need, but from an error in the Department's mathematical calculation. Under the circumstances, the Department's correction of the fixed need pool was appropriate and timely, and a need for 48 short-term child and adolescent psychiatric beds for the July 1993 planning horizon has been demonstrated. Of the 432 short-term psychiatric beds approved and existing within the district on August 17, 1988, 119 beds were reported to the local health council as dedicated to short-term child and adolescent psychiatric services, and the balance of 313 beds as dedicated to adult psychiatric services. Allocation of the 119 short-term child and adolescent beds was reported as follows: Lake Hospital 26 beds, Fair Oaks 27 beds, Humana 27 beds, Savannas 15 beds, and Lawnwood (Harbour Shores) 24 beds. Lake Hospital is a 98-bed freestanding psychiatric specialty hospital located in Lake Worth, Palm Beach County, Florida, that treats adolescents and adults for psychiatric disorders and substance abuse. As of August 17, 1988, Lake Hospital was licensed to operate 56 short-term psychiatric beds, 26 long- term psychiatric beds, and 16 short-term substance abuse beds. Of the 56 short- term psychiatric beds, 26 beds were approved for adolescent care and 30 beds were approved for adult care. During calendar year 1987, Lake Hospital enjoyed an occupancy rate of 91.8 percent for its 26 short-term psychiatric beds, which were dedicated to the care of adolescents, ages 12- 17. In January 1988, Lake Hospital opened a replacement facility on its campus consisting of a two-story structure with four 18- bed units, and reported to the local health council that two of those units (36 beds) were dedicated to short-term adolescent care in January and February 1988, and that thereafter only 18 beds were dedicated to short-term adolescent care. Based on such utilization, Lake Hospital enjoyed an occupancy rate of 95 percent for the first four months of 1988 and a 93.9 percent occupancy rate for calendar year 1988 for its adolescent beds. 5/ Fair Oaks is a 102-bed free standing psychiatric specialty hospital located in Delray Beach, Palm Beach County, Florida, that treats children, adolescents, and adults for psychiatric disorders and substance abuse. As of August 17, 1988, Fair Oaks was licensed to operate 70 short-term psychiatric beds, 15 long-term psychiatric beds, and 17 short-term substance abuse beds. Of the 70 short-term psychiatric beds, 27 beds were approved for child and adolescent care and 43 beds for adult care. During the calendar year 1987, Fair Oaks' second year of operation, it achieved an occupancy rate of 73.1 percent for its 27 short-term child and adolescent psychiatric beds. For the first four months of calendar year 1988, Fair Oaks enjoyed an occupancy rate of 99.7 percent, and for all of calendar year 1988 an occupancy rate of 91 percent. 6/ Humana is a 250-bed general hospital located in West Palm Beach, Florida. Of its existing beds, 162 are dedicated as medical/surgical beds, and 88 as short-term psychiatric beds. For calendar year 1987, Humana reported to the local health council that 27 of its 88-bed complement of psychiatric beds were dedicated to short- term adolescent services, but declined or neglected to report its utilization so that an average length of stay could be calculated. In fact, Humana did not operate a short-term adolescent program for 1987, but operated a long-term program without Department approval. Pertinent to this conclusion, the proof demonstrated that Humana applied for the development of an 88-bed psychiatric pavilion in 1983. Certificate of Need No. 2647 was issued to Humana on November 17, 1983, for 80 short-term psychiatric beds consisting of 48 adult psychiatric beds, 24 geriatric beds, and 8 adult special beds; and, on January 8, 1985, Humana received CON No. 3237 for the additional 8 short-term adult psychiatric beds. Humana opened its psychiatric pavilion in November 1986, and by January 1987 was serving adolescents, ages 13 through 18, in a 27-bed unit notwithstanding the absence of Department approval. As to the services provided in that unit, the proof is compelling that it was dedicated to long-term adolescent psychiatric services with an average length of stay of approximately 280 days. At some point thereafter, but not earlier than July 1989, Humana also began providing short-term adolescent psychiatric services at its facility. 7/ Following the Department's investigation into Humana's operation of a long-term adolescent psychiatric program, Humana applied for a modification of its CON Nos. 2647 and 3237 to allow it to operate a district adolescent unit. On July 14, 1989, Humana received Department approval, and such CON's were modified to allow 15 short-term adolescent psychiatric beds. This modification is, however, currently the subject of an appeal to the District Court. In the interim, on December 14, 1988, Humana received CON No. 5294 for the addition of 15 short-term beds for adolescents and adults, and on February 25, 1989, Humana received CON No. 5722 for the redesignation of 15 short-term psychiatric beds to 15 long-term beds. Currently, Humana has available 30 short-term psychiatric beds for adolescent use, and 15 long-term beds, but its short-term program is in a start-up mode. Savannas is a 70-bed freestanding psychiatric hospital located in Port St. Lucie, St. Lucie County, Florida, approximately 40 miles north of Palm Beach County, that treats adolescents and adults for psychiatric disorders and substance abuse. As of August 17, 1988, Savannas was licensed to operate 50 short-term psychiatric beds and 20 short-term substance abuse beds. Of the 50 short-term psychiatric beds, 15 beds were approved for adolescent care and dedicated to patients ages 14- 17, and 35 beds were approved for adult care. Savannas opened its facility in October 1987, and for that calendar year reported 1,215 patient days for its short- term adolescent unit, For calendar year 1988, its first full year of operation, Savanna's adolescent unit achieved 3,589 patient days, or an occupancy rate of 65.5 percent. Lawnwood (Harbour Shores) is a general hospital located in Fort Pierce, St. Lucie County, Florida, that, as of August 17, 1988, was licensed to operate 60 short-term psychiatric beds. Of the 60 short-term psychiatric beds, 24 beds were approved for child and adolescent care, and 36 for adult care. The date Lawnwood commenced operations does not appear of record; however, during calendar year 1987, it achieved a 62 percent occupancy rate for its 24-bed adolescent unit. For calendar year 1988, Lawnwood maintained a similar occupancy rate even though Savannas was drawing patients from the same service area to its new facility. Considering the availability, accessibility, extent of utilization and adequacy of short-term child and adolescent beds in the service district at all times pertinent to this case, there exists a need for the 48 beds requested by First Hospital, and such beds should be located in Palm Beach County consistent with the local health plan, discussed infra. The need for the proposed facility in relation to the district plan and state health plan Applicable to this case is the 1985-87 state health plan, which contains the following goals and objectives pertinent to short-term inpatient psychiatric beds: GOAL 1: ENSURE THE AVAILABILITY OF MENTAL HEALTH AND SUBSTANCE ABUSE SERVICES TO ALL FLORIDA RESIDENTS IN A LEAST RESTRICTIVE SETTING. OBJECTIVE 1.1: The ratio of short term inpatient hospital psychiatric beds to Florida's population should not exceed .35 beds per 1000 population thru 1987. RECOMMENDED ACTIONS: a: Restrain increases in the supply of short term inpatient hospital psychiatric beds to no more than .35 beds per 1000 population. OBJECTIVE 1.2: Through 1987, additional short term inpatient hospital psychiatric beds should not normally be approved unless the average annual occupancy rate for all existing and approved adult short term inpatient psychiatric beds in the service district is at least 75% and average annual occupancy for existing and approved adolescent and children beds is at least 70%. RECOMMENDED ACTIONS: a. Restrict approval of additional short term inpatient psychiatric beds to these service districts which have an average annual occupancy of 75% for existing and approved adult beds and 70% for existing and approved adolescent and children beds. GOAL 2.: PROMOTE THE DEVELOPMENT OF A CONTINUUM OF HIGH QUALITY, COST EFFECTIVE PRIVATE SECTOR MENTAL HEALTH AND SUBSTANCE ABUSE TREATMENT AND PREVENTIVE SERVICES. OBJECTIVE 2.1: Define, develop and implement policy regarding the appropriate treatment settings and the role of each setting in the delivery of mental health and substance abuse services by 1987. GOAL 3: DEVELOP A COMPLETE RANGE OF ESSENTIAL PUBLIC MENTAL HEALTH SERVICES IN EACH HRS DISTRICT. First Hospital's application is consistent with the goals and objectives of the state health plan. Here, First Hospital proposes to provide a 24-hour-a-day therapeutic milieu, with an average length of stay of 60 days or less, for children and adolescents suffering from mental health problems which are so severe and acute that they need intensive, full-time care. As such, First Hospital will offer care for those individuals for whom short-term inpatient psychiatric care is the least restrictive setting appropriate, and which care, consistent with the Department's need methodologies, will complement the range of mental health services needed in the district. Also applicable to this case, is the 1988 District IX local health plan. Pertinent to this case, the local health plan divides District IX into two subdistricts when planning for short-term psychiatric beds. Subdistrict one consists of Indian River, Martin, St. Lucie and Okeechobee Counties, and subdistrict two consists of Palm Beach County. In allocating short-term psychiatric beds between subdistricts, the local plan provides: When bed need is shown in District IX for either short-term psychiatric services or substance abuse services in accordance with Chapter 10-5.11 of the Florida Administrative Code, the method for allocating beds among subdistricts shall be based upon projected subdistrict occupancy figures as determined by use-rates during the most recent calendar year in combination with projected subdistrict population figures. New beds shall be allocated to the subdistrict showing the highest projected percent occupancy, to the extent that the projected percent occupancy equal that of the other subdistrict. When projected occupancy figures show parity, any remaining beds shall be allocated based upon each subdistrict's percentage of projected patient days for District IX. All projections shall be five years into the future to correspond with the planning horizon governing the addition of psychiatric and substance abuse beds as set forth in state rule. Applying the local plan's methodology to the facts of this case demonstrates that the beds identified by the Department's need methodology should be allocated to subdistrict two, Palm Beach County, which is the county within which First Hospital proposes to locate. The local plan also requires an examination of an applicant's commitment or record of service to medicaid/indigent and underserved population groups. The First Hospital facility will be a specialty hospital and therefore not eligible to provide medicaid services; however, First Hospital has committed to dedicate 8 percent of its patient days to indigent care. Under such circumstances, First Hospital's application is, on balance, consistent with the local plan. The ability of the applicant to provide quality of care and the applicant's record of providing quality of care First Hospital is a wholly owned subsidiary of First Hospital Corporation, an established provider of psychiatric services to children and adolescents since 1983. As of this date, First Hospital Corporation owns and operates 15 hospitals nationally, and has demonstrated the commitment and ability to provide quality care to its patients. Here, First Hospital's staffing is reasonable, and while the program proposed by First Hospital is generic in nature, and similar to that offered by other short-term providers of such services, it will assure, in light of demonstrated need, that patients needing acute short-term psychiatric services in the district will continue to receive quality care. To the extent that the needs of the district may subsequently evidence the need for more specialized programs, First Hospital has demonstrated its ability to address such needs, and to provide quality programs and services. The availability and adequacy of other health care facilities and services in the service area which may serve as alternatives for the health care facilities and services proposed by the applicant The Department's short-term psychiatric bed rule addresses the need for psychiatric facilities that will treat emotional and behavioral disorders which require admission to a short-term acute care facility for treatment. Where such short- term psychiatric care is indicated, any other type of placement would not be appropriate under existing rules (not long-term, residential treatment, group home, or out-patient care), and there are no alternatives for the services proposed by First Hospital. The availability of resources, including health manpower, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation First Hospital has demonstrated that it either has or can obtain all resources, including health manpower, management personnel, and funds for capital and operating expenditures, for project accomplishment and operation. As heretofore noted, First Hospital Corporation, the parent of the applicant, has provided psychiatric services to children and adolescents since 1983, and currently owns and operates 15 hospitals nationally. It has never experienced any serious difficulty in financing its operations, either start-up or operational, and has in place an existing program for the recruitment and training of medical, administrative, clerical and other personnel that might be needed for the proposed facility. First Hospital Corporation has no other new projects pending at this time, and has committed itself to the project proposed by its subsidiary. Additionally, Dr. Ronald Dozoretz, who is president, chairman of the board, and the principal stockholder of First Hospital Corporation, has the available resources to finance the subject project, and has also committed to do so if necessary. 8/ The extent to which the proposed services will be accessible to all residents of the service district, and the applicant's past and proposed provision of health care services to Medicaid patients and the medically indigent As a freestanding psychiatric facility, First Hospital is not eligible to receive Medicaid funds for the treatment of psychiatric disorders; however, it has committed to provide 8 percent of its patient days to the care of patients who qualify as indigent, and has agreed that its CON be so conditioned. In view of this commitment, as well as the demonstrated need within the district for the proposed services, approval of First Hospital's application will increase accessibility to all residents of the district. The probable impact of the proposed project on the costs of providing health services proposed by the applicant. The proof demonstrates that existent facilities in Palm Beach County are operating near capacity, and that to meet expected demand at the planning horizon an additional 48 short- term psychiatric beds are needed. Under such circumstances, approval of First Hospital's application will stimulate competition and promote quality assurance and cost-effectiveness. While the proof establishes the need for 48 additional beds at the horizon year, the protestants to First Hospital's application contend that, due to the finite number of qualified professionals within the area to staff the facility and the finite number of patients requiring such care, they will be adversely impacted if the application is approved. Succinctly, they contend that they may lose staff or be compelled to pay higher salaries, and that they may lose patients and therefore revenue, if the facility is approved. The protestants' proof regarding potential impact to their existing staff or competition for staff was unpersuasive. In light of the number of existing facilities that already offer mental health type services within the district, and therefore currently compete for the same professionals, First Hospital's entry into the market should not significantly impact existing competition. As importantly, the protestants failed to quantify any such impact or otherwise persuasively demonstrate that, assuming they were compelled to pay more to retain or attract competent staff, such increased expense would adversely affect their operation. With regard to the protestants' concerns regarding lost patient days and revenue, the demonstrated need for the additional 48 beds at the horizon year mitigates the potential for any adverse impact to existent providers in the long term. However, this does suggest that First Hospital's application, as proposed, does not demonstrate a potential to significantly adversely affect existent providers in the short term. To the contrary, should First Hospital achieve the level of utilization it projects in its application, its facility would have a significant adverse impact on existing programs. In this regard, First Hospital's application projects that it will achieve 8,956 patient days in 1991, its first year of operation, and 13,193 patient days in 1992, its second year of operation. Through 1991, there will only be a growth of approximately 3,498 patient days over those that were served by existing facilities in 1988, and through 1992, there will only be a growth of approximately 4,664 patient days over those that were served by existing facilities in 1988. Therefore, to achieve it's projected occupancy levels, First Hospital would have to capture 5,458 patient days in 1991 and 8,529 patient days in 1992 from the patient base that had previously been served at existing facilities. Such impact to those facilities, should First Hospital be able to achieve its projected levels of occupancy, would be significant and adverse. 9/ The costs and methods of the proposed construction As heretofore discussed, First Hospital proposes to construct an 80- bed facility on approximately 30 acres of land in Palm Beach County, Florida, which will include the 48 short-term psychiatric beds which are the subject of this proceeding, as well as the 32 residential treatment beds which the Department concluded were not subject to CON review. The 80-bed facility proposed, at 49,142 gross square feet, will consist of a central core area of approximately 25,000 square feet, which includes three wings; an education and activity wing, a food service wing, and an administrative wing. These wings will house the therapy, kitchen and dining, gymnasium, classrooms, administrative offices, and other services necessary to support the psychiatric facility. Attached to the core area, are two psychiatric wings, at 7,592 square feet each, which will each contain 24 beds dedicated to short-term psychiatric care, and one wing, at 8,944 square feet, which will contain 32 beds dedicated as residential treatment beds. On the adjacent grounds, First Hospital also proposed a swimming pool, tennis courts, baseball field, and sports filed. In its application, First Hospital estimated its total project cost for the proposed psychiatric facility at $4,213,522. This project cost was composed of development cost of $61,500, financing/refinancing costs of $259,800, professional services of $162,000, construction costs of $2,503,162, equipment costs of $480,000, and other related costs of $150,000. But for the construction cost category ($2,503,162), First Hospital derived its estimate of total project costs by allocating 60 percent of the cost of each component of the total cost to the psychiatric facility and 40 percent to the residential treatment facility (the 60/40 methodology). In the case of construction costs, First Hospital based its estimate on the square footage of the psychiatric wings and 60 percent of the core area, which derived a gross square footage for this cost item based on 30,184 square feet, to which it added 60 percent of its estimated costs for site preparation and contingency of construction. Based on this premise, First Hospital's proposal is driven by a $76.33 per square foot cost of construction. 10/ Assuming the propriety of First Hospital's 60/40 allocation of costs, its estimate of project costs is still significantly understated. Here, the proof demonstrates that, as opposed to the $76.33 per square foot cost for construction and site preparation costs estimated by First Hospital, the cost for such work will be $105 per square foot, inclusive of construction and site preparation costs. Based on the 30,184 square feet First Hospital allocated to the project, such cost will amount to $3,169,320, which, when added to the 5 percent contingency factor, the $96,000 allocated for the proposed pool, and the addition of 460 square feet to patient rooms needed to meet Department standards, derives a construction cost figure of $3,472,086, as opposed to the $2,503,162 estimated by First Hospital. In addition to straight construction costs, First Hospital also underestimated its equipment costs. In this regard, First Hospital's equipment list omits many necessary items, including: nurse call equipment, a security system, an emergency generator, therapy and recreational equipment, gym equipment, ice machines, defibrillators, crashcarts, educational materials, media equipment, graphic artwork, interior design items, shelving/lockers for staff and patients, housekeeping items, medication carts, and other necessary equipment. Had First Hospital properly calculated its equipment costs, it would have derived a cost of at least $1 million for movable equipment and at least $150,000 for fixed equipment for the 80--bed facility as opposed to the $700,000 for movable equipment and $100,00 for fixed equipment it estimated. Under such circumstances, applying First Hospital's 60/40 methodology would establish an equipment cost for the subject project at $690,000, as opposed to the $480,000 estimated by First Hospital. 11/ Since financing costs and professional services fees would also require an upward adjustment because of the increase in construction and equipment costs, the total cost for the subject project, utilizing First Hospital's 60/40 methodology, would reach at least $5,488,843, as opposed to the $4,213,522 estimated by First Hospital. 12/ The foregoing analysis of construction costs assumed the reasonableness of First Hospital's 60/40) allocation methodology. For reasons discussed infra, First Hospital's allocation methodology is not reasonable, and its construction costs are therefore dramatically understated. In this regard, the proof demonstrated that the core area, consisting of 25,000 square feet, would be necessary to support the 48-bed psychiatric units whether the 32-bed residential treatment unit were built or not, and that it would be more appropriate to combine the core area and the psychiatric area to assess the subject application. When this is done, the construction cost alone for the project calculates to $4,638,501. 13/ In addition to straight construction costs, all of the other estimated project costs appearing on Table 25 of First Hospital's exhibit 1 are also suspect because of its 60/40 methodology; however, for purposes of this analysis item a, project development costs, and item f, other related costs are assumed accurate, as are construction supervision costs and loan fees. Notably, capitalized interest would increase to at least $355,621, architectural/engineering fees would increase to approximately $242,969, and equipment costs would increase to approximately $726,000. With these adjustments alone, the cost of the 48-bed psychiatric project, which includes the core area, comes to approximately $6,821,000, or over $2,607,000 more than First Hospital estimated. 14/ The unreasonableness of First Hospital's 60/40 methodology To assess the financial feasibility of the proposed project, First Hospital's pro formas address only the expected financial performance of the 48 psychiatric beds and ignore the financial feasibility of the 32-bed residential treatment unit, even through First Hospital postulates that such unit will support 40 percent of the cost of the hospital's core area. At hearing, the explanation offered by First Hospital and the Department for not addressing the financial feasibility of the residential treatment unit, as well as the out-patient services, was their contention that such services are not CON reviewable because First Hospital, as regards the residential treatment unit, is not yet a "health care facility" and, as regards the outpatient services, that such services are exempt from review. In this regard, they point to the provisions of Section 381.706(1), Florida Statutes, which provides; . . . all health-care-related projects, as described in paragraphs (a)-(n), shall be subject to review and shall file an application for a certificate of need with the department . . . (c) A capital expenditure of $1 million or more by or on behalf of a health care facility . . . for a purpose directly related to the furnishing of health services at such facility; provided that a Certificate of Need shall not be required for an expenditure to provide an outpatient health service . . . (Emphasis added) They also point to the provision of Section 381.702, Florida Statutes, which contains the following definitions: (7) "Health care facility" means a hospital. . . . (12) "Hospital" means a health care facility licensed under chapter 395. Based on these statutory provisions, First Hospital and the Department conclude that the residential treatment unit and the outpatient services are not CON reviewable because First Hospital is not yet licensed or the outpatient services are exempt. While the logic of First Hospital's and the Department's conclusion seems questionable where, as here, the projects are proposed to be integrated and constructed simultaneously, the Department's reading of the statute comports with its literal reading and is accepted. However, although the residential treatment unit and outpatient services may not be subject to CON review does not suggest that their financial feasibility is not relevant to this proceeding. To the contrary, their financial feasibility is critical if First Hospital's 60/40 methodology is to be considered rational. Here, the 48-bed psychiatric facility proposed by First Hospital is comprised of two 24-bed units and a core unit that provides all necessary support functions, including administrative, therapy, kitchen and dining, gymnasium and classroom areas, for those units. That core area, of 25,000 square feet, is an essential part of the proposed psychiatric hospital; without it there would be no psychiatric hospital, and at a lesser square footage the project would be lacking sufficient space to provide necessary services. When licensed by the Department, the two 24-bed units and the core area will be licensed as a psychiatric hospital. Notwithstanding, the fact that the 25,000 square foot support area is an integral and essential part of the proposed hospital, the Department chose to ignore 40 percent of its costs and expenses in assessing the financial feasibility of the project. The basis for the Department's action was its conclusion that the non-CON reviewable residential treatment unit comprised 40 percent of the overall population of the entire facility (80-beds overall), and that since it would share the core area, 40 percent of the costs of constructing that area, as well as subsequent operating expenses, were not pertinent to an evaluation of the proposed hospital. Here, the Department's reasoning and its conclusion, be they incipient policy, do not have evidentiary support. The psychiatric hospital proposed by First Hospital is, as heretofore noted, the two 24-bed units and the core area. This is the only portion of the project over which the Department has control, and necessarily the only portion that it can assure will be built as proposed; it has no control over whether the residential treatment unit will ever be built or be built as proposed. Therefore, since the core unit is an essential part of the psychiatric hospital, and the residential treatment unit is exempt from CON review, an assessment of the subject application must consider the cost of the entire core area as part of the project under review. While economies of scale permit utilization of the core unit by the residential treatment unit without additional space, this does not detract from the conclusion that the cost of the core is a cost of the hospital. Rather, such excess capacity is fortuitous for First Hospital, and may permit it to spread the expenses of its operation over a larger population base if the residential treatment unit is built. However, to reasonably assess whether those expenses of operation can be spread to or supported by the residential treatment unit to any extent, much less 40 percent, requires an analysis of the financial feasibility of those services. Here, First Hospital offered no proof of the financial feasibility of the residential treatment unit, and there is no rational basis on which any allocation of operating expenses for the core area can be demonstrated to be supportable by it. Accordingly, to assess the financial feasibility of the proposed psychiatric hospital it is necessary to attribute the cost of the core area to the proposed project, as well as the costs of carrying and operating that part of the proposed hospital. 15/ The immediate and long-term financial feasibility of the proposal To assess the financial feasibility of the proposed project, First Hospital's pro forma assumes that it will achieve 8,956 patient days in its first year of operation and 13,193 patient days in its second year of operation, with a per diem patient charge of $500 in year one and $525 in year two, and that it will thereby achieve a gross revenue of $4,478,000 in its first year of operation and a gross revenue of $6,926,325 in its second year of operation. While the proposed patient charges are reasonable, First Hospital's occupancy projections are not supported by persuasive proof and, therefore, it has failed to demonstrate what revenues it could reasonably expect to generate. A facility's projected patient days are typically a product of an informed analysis of projected admissions and projected average length of stay. Here, First Hospital undertook no such analysis, but simply assumed a number of patient days, without any rational predicate in an effort to demonstrate financial feasibility. Notably, there is a clear trend toward shorter lengths of stay in psychiatric hospitals, which was even recognized by First Hospital's Dr. Dozoretz who reasonably expected an average length of stay at the proposed facility of 30 to 40 days. However, First Hospital assumed in its pro forma an average length of stay ranging from 45 to 60 days. Such assumption could not have been the basis for any considered analysis of utilization since it is excessive, as well as too imprecise. Moreover, in testing the reasonableness of a utilization projection, it is also important to consider physician support, the extent of waiting lists, community support, the extent of competition, and the depth of local needs assessment. Here, there is no persuasive proof that First Hospital enjoys any support from local physicians, that there are any waiting lists, that the market is not competitive, that there is any community support for the project, or that it undertook any reasonable assessment of local need. In addition to its failure to demonstrate what utilization level it could reasonably achieve in its first two years of operation, and therefore establish a reasonable estimate of its gross revenue, First Hospital's pro forma also, significantly underestimated building depreciation, equipment depreciation, and interest expense because of its failure to adequately address construction and equipment costs, discussed supra. Had First Hospital properly assessed such costs, by subsuming the psychiatric hospital to include 100 percent of the psychiatric wings and core area, it would have calculated building depreciation at $176,230 per annum, equipment depreciation at $72,600 per annum, and interest at $750,360 per annum. At these rates, assuming the validity of First Hospital's projection of gross revenue, the facility's projected loss in year one would increase from $115,629 to $529,848, and its projected profit in year two of $442,184 would be reduced to $27,965. 16/ As well as underestimating the foregoing expenses, First Hospital's pro forma also significantly underestimates a number of other expenses, including deductions from gross revenue, supplies and other expenses, and the indigent care tax assessment. In this regard, the proof demonstrates that First Hospital underestimated its deductions from revenue by $367,000 in year one and $214,000 in year two; underestimated its supplies and other expenses in year one by at least $645,000, and in year two by at least $561,000; and omitted the indigent care tax assessment of $56,000 in year one and $75,000 in year two. Considering these additional adjustments, First Hospital's project, even assuming its gross revenue projections are reasonable, is not financially feasible in either the short-term or long-term. 17/ The criteria on balance In evaluating the application at issue in this proceeding, none of the criteria established by Section 381.705, Florida Statutes, or Rule 10- 5.011(1)(o), Florida Administrative Code, has been overlooked. First Hospital's failure to demonstrate the financial feasibility of its proposal is, however, dispositive of its application, and such failure is not outweighed by any other, or combination of any other, criteria.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that: As to Case NO. 89-1415, that a final order be entered denying First Hospital's application for Certificate of Need. As to Case NO. 89-1438, that a final order be entered dismissing Humana's petition for formal hearing. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 23rd day of May 1990. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of May 1990.
