The Issue Whether certain forms incorporated by reference into the administrative rules of the Respondent constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Tampa General Hospital ("TGH" or "Petitioner") is a general acute care hospital in Tampa, Florida and is a verified Level I state-approved trauma center. By definition, a Level I trauma center is required to include an adult trauma center and a pediatric trauma referral center. The Department of Health and Rehabilitative Services ("DHRS" or "Respondent") is the state agency with responsibility for certification of trauma centers in Florida. St. Joseph's Hospital ("SJH" or "Intervenor") has filed an application for state approval as a pediatric trauma referral center which is the subject of a separate administrative challenge by TGH. In the instant case, TGH challenges three DHRS forms incorporated by reference into the Florida Administrative Code and which are utilized by applicants seeking certification as state-approved trauma centers. Tampa General has standing to challenge the forms in this proceeding. The three forms challenged by TGH in this case are HRS Form 1840, ("State-Approved Trauma Center Letter of Intent"), HRS Form 1721, ("Application for State-Approved Pediatric Trauma Referral Center"), and the portions of HRSP 150-9, which identify the "critical standards" which must be met by an applicant seeking to obtain approval as a provisional state approved pediatric trauma referral center. The three forms include reference dates of October 1991. The forms were adopted as part of a rule promulgation effort prior to the 1992 Legislative session. Obviously the DHRS did not address the 1992 legislation in the 1991 rules. In relevant part, the 1992 legislation added a requirement that, under conditions set forth in the statute, proposed trauma centers must be certified as consistent with local or regional trauma plans. The forms challenged by TGH fail to reference the requirement. Section 395.4025(2)(a), Florida Statutes, requires submissions of letters of intent from hospitals seeking to become certified as state-approved trauma centers. Section 395.4025(2)(a), Florida Statutes, further requires that "[i]n order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a state-approved trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists." The statute states that the requirement is not applicable to hospitals which were provisional or verified trauma centers on January 1, 1992. There are five local or regional trauma agencies in Florida which have been approved by the DHRS. Hillsborough County, where both the Petitioner and the Intervenor operate hospitals, has one of the five local trauma agencies. Rule 10D-66.109(a), Florida Administrative Code provides that the department "shall accept a letter of intent, HRS Form 1840, October 91, State- Approved Trauma Care Center Letter of Intent, which is incorporated by reference and available from the department. " The form letter of intent provided to applicants by the DHRS fails to reference the local plan consistency requirement or the conditions under which the requirement is applicable. Section 395.4025(2)(a), Florida Statutes, relates only to letters of intent. It clearly indicates that the certification of local plan consistency is an issue to be addressed as part of the letter of intent filed by a provider. The form letter of intent does not provide notice to the applicant that such certification may be required, either as part of the completed letter of intent or otherwise. The omission of the certification requirement from the letter of intent form is misleading. It fails to indicate that a hospital should address the issue in its letter of intent. The form contravenes the statute. TGH also challenges HRS Form 1721, October 91, ("Application for State-Approved Pediatric Trauma Referral Center",) and the portions of HRSP 150- 9, October 91, which identify the "critical standards" which must be met by an applicant. Section 395.4025(2)(c), Florida Statutes, (1994 Supplement) provides as follows: In order to be considered by the department, applications from those hospitals seeking selection as state-approved trauma centers, including those current verified trauma centers which seek to be state-approved trauma centers, must be received by the department no later than the close of business on April 1. The department shall conduct a provisional review of each application for the purpose of deter- mining that the hospital's application is complete and that the hospital has the critical elements required for a state approved trauma center. This critical review will be based on trauma center verification standards and shall include, but not be limited to, a review of whether the hospital has: Equipment and physical facilities necessary to provide trauma services. Personnel in sufficient numbers and with proper qualifications to provide trauma services. An effective quality assurance program. Submitted written confirmation by the local or regional trauma agency that the verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists. This sub- paragraph applies to any hospital that is not a provisional or verified trauma center on January 1, 1992. Rule 10D-66.109(c), Florida Administrative Code, requires that an applicant for licensure as a provisional state-approved pediatric trauma referral center must submit an application on HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center. The form is incorporated by reference in the rule. HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center, fails to reference the local plan consistency issue or the conditions under which the requirement is applicable. However, the instructions to the form provide as follows: INSTRUCTIONS: To be eligible for approval as a SAPTRC, a hospital must complete this application and submit all requested information to the HRS, Office of EMS, for review. The following must be used to complete this application: HRS Pamphlet (HRSP) 150-9 entitled "State Approved Trauma Centers and State-Approved Pediatric Trauma Referral Center Approval Standards", Oct 91 (standards document), and the application requirements of Chapter 395, Florida Statutes (F.S.), and Chapter 10D-66, Florida Administrative Code (F.A.C.). Following discussion of a three phase review process, the HRS Form 1721 instructions again state that "HRS Pamphlet (HRSP) 150-9, Oct 91, the application requirements of Chapter 395, F.S., and Chapter 10D-66, F.A.C., will be used as criteria for application review." By reference to the statute and rules, the instructions to the application notify an applicant as to the requirements for certification. The failure of the actual application to specifically restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement. As to the standards document in which the critical standards for provisional approval are set forth, rule 10D-66.109(d)2, Florida Administrative Code, provides as follows: The minimum standards for review for Provisional SAPTRCs are the following portions of HRSP 150-9, October 91; STANDARD Type of Hospital Surgery Department; Division; Services; Sections: A Surgical Specialties Availabilities: A 1, 2, 3 & 4 Non-Surgical Specialties Availabilities: 1, 8 & 13 Emergency Department (ED): A, B, D & H Operating Suite Special Requirements: A IX. Pediatric Intensive Care (P-ICU): A, C, 1 XVI. Quality Management: A, B, C, D, & E It is unnecessary to address each critical standard in this order. Essentially, they relate to the first three "critical elements" set forth as Section 395.4025(2)(c)1-3, Florida Statutes. However, review of the cited portions indicates that there is no reference within the cited sections of HRSP 150-9, October 91, which addresses the possible requirement of local trauma plan consistency certification. The application processing framework set forth by the administrative rules indicates that local plan consistency is to be considered prior to the DHRS's commencement of provisional review. Rule 10D-66.109(d), Florida Administrative Code, provides that "[a]fter considering the results of the local or regional trauma agency's recommendations, the department shall, by April 15, conduct a provisional review to determine completeness of the application and the hospital's compliance with the critical standards for provisional standards." If, as the rule suggests, certification of local plan consistency is considered prior to commencement of provisional review, it would be duplicative to include the requirement in the technical critical standards set forth in the standards document. The failure of the standards document to restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement.
Conclusions Competent substantial evidence supports the conclusion that Adrian Fuentes disabilities are the result of the failure to deliver him before his mother loss amniotic fluid, or up to an estimated 12 hours earlier. An earlier delivery was the standard of care expected in a case of IUGR. His permanent and severe disabilities were directly and proximately caused by the failure of SBHD employees to handle an ultrasound report expeditiously as directed and as their policy provided. ATTORNEYS’ FEES AND LOBBYISTS’ FEES: In compliance with s. 768.28(8), F.S., but not with Section 3 of this claim bill, Claimant's attorneys' fees are set at 25 percent. There is no lobbyist for the bill at this time. As of October 9, 2007, the attorneys reported having incurred costs of $115,246.02 for representing the Claimant. The Claimants entered into an agreement to pay attorneys’ fees and costs. RECOMMENDATIONS: For the reasons set forth in this report, I recommend that Senate Bill 60 (2008) be reported FAVORABLY. Respectfully submitted, Eleanor M. Hunter Senate Special Master cc: Senator Jeremy Ring Representative Evan Jenne Faye Blanton, Secretary of the Senate House Committee on Constitution and Civil Law Tom Thomas, House Special Master Counsel of Record
The Issue The issue in this case is whether Respondent should be sanctioned for an alleged violation of Chapters 395 and 401, Florida Statutes (1989).
Findings Of Fact Based upon the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made. HCA Raulerson is the only hospital in Okeechobee County, Florida. As such, it serves all of Okeechobee County and parts of the surrounding counties. It is a small community hospital that is best characterized as a primary care receiving facility as opposed to a secondary hospital or a tertiary care or trauma center hospital. The Hospital does not provide heart-bypass surgery, cardiac catherization, neuro-surgery services or even obstetrical services (other than the emergency delivery of babies.) The Hospital provided approximately three million dollars in uncompensated care to indigent residents of Okeechobee County in the year preceding the incident involved in this case. Under existing Florida law, a hospital is not required to provide either orthopedic surgery services or peripheral vascular services and there is no requirement for a hospital to have on its medical staff any orthopedic surgeons or peripheral vascular surgeons. The Hospital does not have the angiography equipment necessary for peripheral vascular surgery. As a result, the Hospital does not provide peripheral vascular surgery and there are no vascular surgeons on staff. Such services were not offered at the Hospital for at least several months prior to the incident in question. The Hospital has a single orthopedic surgeon on staff, Dr. Zafar Kureshi. Dr. Kureshi is board certified in orthopedic surgery. He has been engaged in the private practice of medicine in Okeechobee, Florida since October of 1986. While many of Dr. Kureshi's patients are treated at the Hospital, Dr. Kureshi is not employed by or under contract with the Hospital. This arrangement is not unusual since surgeons, including orthopedic and vascular surgeons, do not typically become employees of hospitals or enter into contracts with hospitals. The Hospital has tried to recruit additional orthopedic surgeons and other specialists for its medical staff, but has been unsuccessful. There is a shortage of orthopedic surgeons in Florida, especially in rural areas, and recruiting orthopedic surgeons to such areas is extremely difficult. It is unrealistic to expect that the Hospital would be able to recruit or retain any orthopedic surgeons if it required them to be "on call" at all times. For a short time after he first obtained staff privileges, Dr. Kureshi provided "on call" services for the Hospital's emergency room several nights per month. On those occasions, he treated patients irrespective of their financial status. At the time of the incident in question, however, Dr. Kureshi had ceased providing "on call" services. His decision was consistent with the Hospital medical staff by-laws. The by-laws of the Hospital medical staff state that, if there is only one physician on staff in a specialty, then that specialty does not have to make emergency department call rosters available to the emergency room. Since he was the only specialist on staff in his area of practice, Dr. Kureshi was not required to provide "on call" coverage. Subsequent to the incident involved in this case, Dr. Kureshi, at the request of the Hospital, has voluntarily agreed to be "on-call" several nights per month. Even when Dr. Kureshi is not formally "on call," the emergency room staff often contacts him when a patient presents at the emergency room in need of orthopedic care. On some such occasions, Dr. Kureshi will treat the patient if he was capable of doing so. When an orthopedic patient or a peripheral vascular patient presents at the Hospital and Dr. Kureshi can not or will not treat the patient, the Hospital (1) provides such care as can be rendered by the emergency room physician or others on HCA Raulerson's medical staff, (2) stabilizes the patient for transfer, (3) calls hospitals and their on-call physicians to arrange transfer, and (4) arranges suitable transportation and transfers the patient. In the months preceding the incident in question, the Hospital arranged the transfer to other hospitals of approximately eleven patients who presented at the Hospital's emergency room in need of orthopedic care. Four of those patients were "paying" patients covered by third party insurers, four were covered by Medicare or Medicaid and the remaining three were self-pay patients. There is no indication that financial status and/or the ability to pay in any way influenced the Hospital's actions with respect to these patients. HRS contends that Sections 395.0142, 395.0143 and 401.45, Florida Statutes, require a hospital that provides any given specialty service (e.g., orthopedic surgery services) to arrange 24-hour a day, seven day a week coverage for that service, either by providing coverage through physicians on staff or entering into advance transfer agreements with other hospitals to cover any such patients who may present in need of such services. The Hospital has attempted, but has been unsuccessful in its attempts, to obtain advance transfer agreements from other hospitals regarding the transfer of patients presenting themselves at the Hospital's emergency room in need of orthopedic surgery services or in need of peripheral vascular surgery services. The Hospital has limited bargaining power in attempting to induce other hospitals to enter into an advance transfer agreement. Because the Hospital is a small rural hospital, virtually all the services it offers are already available at the neighboring hospitals which are potential transfer partners. The only advance transfer agreements that the Hospital has been offered would require the Hospital to assume full responsibility for payment for services rendered to transferred patients by the transferee hospital. Those proposals have been rejected because the financial burden of such an arrangement would probably cause the Hospital to close. As of August 24, 1989, the date of the incident which is the subject of the Administrative Complaint in this case, HRS had not notified the Hospital of any rule or policy interpreting Sections 395.0142, 395.0143, and 401.45, Florida Statutes. As of August 24, 1989, HRS had not adopted any rule which stated a specific requirement that hospitals which provide orthopedic surgery must staff or provide on-call orthopedic surgery services on a continuous basis, i.e. twenty-four (24) hours per day, 365 days per year or have in place an agreement with another hospital(s) to provide such coverage. HRS contends that this requirement is imposed by the clear language of the statutes. On the evening of August 24, 1989 at approximately 7:45 p.m., K.H., a 28 year old male, presented himself at the Hospital's emergency room for treatment of a shotgun wound to his lower left leg. Dr. Charles Vasser, the emergency room physician on duty when K.H. arrived, stabilized the Patient and provided all the treatment that could be provided by an emergency room physician not trained in orthopedic surgery or vascular surgery. The radiology report prepared at the Hospital diagnosed the Patient's condition as follows: "focal soft tissue injury, with multiple metallic fragments of variable size, super imposed over soft tissues of distal right leg are noted. Comminuted compound fracture of distal tibial shaft, as well as linear fracture through distal fibula at same site, are observed. Findings are due to gun shot injury with residual bullet fragments within soft tissues. Correlation with patient's clinical findings is recommended." Because of the nature of the injury and the extent of the damage to the soft tissue of the Patient's lower leg, Dr. Vasser and the attending staff were concerned about the possibility of vascular damage. They frequently checked and charted the Patient's distal pulses. While the distal pulses appeared normal, the presence of distal pulses does not rule out vascular injury. A vascular injury is possible with a comminuted fracture even when the distal pedal pulses appear normal. A vascular problem is especially likely when the wound was inflicted by a shotgun blast and numerous metallic fragments are involved. After providing initial emergency room services to the Patient, Dr. Vasser felt that the assistance of appropriate specialists, i.e., an orthopedic surgeon and at least a consult with a vascular surgeon, would be required for further treatment. Dr. Vasser called the only orthopedic surgeon on the Hospital's medical staff, Dr. Zafar Kureshi, at 8:50 p.m. Dr. Kureshi was not on call that evening. Based on Dr. Vasser's description of K.H.'s condition, Dr. Kureshi stated that he was not capable of treating K.H. without the backup availability of a vascular surgeon and advised that K.H. should be transferred. This recommendation was made not only because Dr. Kureshi was not on call, but also because Dr. Kureshi was not capable of treating the Patient at an acceptable level of medical care without the availability of a vascular surgeon. As indicated in Findings of Fact 3 above, there are no vascular surgeons on staff at the Hospital and the Hospital does not offer vascular surgery services. In determining whether a patient needs the services of a physician in a particular specialty, the Hospital relies upon the medical judgment of the attending physician and any consulting physician. The Hospital did not and should not have ignored the medical determination made by the emergency room physician, in consultation with Dr. Kureshi, that the Patient, K.H., needed vascular backup in order to be properly treated. With the assistance of emergency technician Wendy Johns, Dr. Vasser began placing calls to other hospitals and their on-call physicians at 9:15 p.m. in an effort to arrange a transfer of the Patient. The first physician contacted through another hospital, Dr. Floyd, indicated that he would be unable to treat the Patient because of the extent of the soft-tissue injuries and the corresponding likelihood of vascular involvement. A number of additional hospitals and physicians were contacted and they also refused to accept the transfer of the Patient. All told, nineteen different physicians and/or hospitals were contacted between 9:00 p.m. and 12:00 a.m. A variety of reasons were cited by those who refused to accept the transfer. Many of the reasons given for refusing the transfer were arguably a pretext and/or contravened the language and intent of Sections 395.0142, 395.0143 and 395.0144, Florida Statutes. Several of the doctors who were contacted confirmed that the treatment of the Patient would require the availability of a vascular surgeon as well as an orthopedist. After numerous unsuccessful attempts to transfer the Patient, Dr. Vasser contacted a general surgeon on the Hospital's medical staff, Dr. Husain, at approximately 12:10 a.m. Dr. Vasser and Dr. Husain again contacted Dr. Kureshi. The three physicians concurred that they were unable to treat the Patient because of the need for a vascular backup and the Hospital's inability to provide the necessary vascular backup. After he talked to Dr. Kureshi the second time, Dr. Vasser resumed calling other hospitals and their on-call physicians. The next call was to a vascular surgeon, Dr. Viamentes. Dr. Viamentes was reached through his beeper, but was unable to accept the transfer because he was out of town. At approximately 12:30 a.m., a social worker for the Hospital, Terry Cooper, contacted St. Mary's Hospital in West Palm Beach. After some discussion and deliberation, St. Mary's agreed to accept the transfer of K.H. The Patient was transferred in stable condition via ambulance to St. Mary's Hospital where he arrived at approximately 3:00 a.m. Surgery was initiated at approximately 4:30 a.m. After the Patient was admitted to St. Mary's Hospital, the administration of that hospital filed a complaint with HRS pursuant to Section 395.0142, Florida Statutes. That complaint recites the facts surrounding the transfer of the Patient and the refusal of several other hospitals to accept the transfer. It is not clear whether St. Mary's was questioning the medical necessity of the transfer or simply the refusal of the other hospitals to accept the transfer. HRS initiated an investigation of the transfer of the Patient and submitted the Patient's medical records from both HCA Raulerson and St. Mary's to its expert, Dr. Slevenski, for review. Dr. Slevenski is an emergency room physician who has no specialized training in orthopedic surgery or vascular surgery. Dr. Slevenski testified that he saw no evidence in the Hospital's medical records that a vascular evaluation or consultation was necessary to treat this Patient and that the Hospital inappropriately transferred the Patient to another hospital. Dr. Slevenski's opinions are rejected. Dr. Slevenski erroneously assumed that the Hospital had not attempted to contact an orthopedic surgeon regarding the Patient. In fact, the Hospital contacted Dr. Kureshi, the only orthopedic surgeon on its staff, who indicated he was not qualified to treat the Patient's injury. The evidence established that both the emergency room physician and the orthopedic surgeon who was contacted at home felt that a vascular consult was necessary. These opinions were reasonable under the circumstances. The testimony of Dr. Henderson, the Respondent's expert, is accepted and confirms that the opinions of the emergency room physician and the orthopedic surgeon were reasonable under the circumstances and given the nature of the Patient's injury. There is no evidence that the Patient's care was deficient in any respect at either St. Mary's or the Hospital. The Patient progressed normally and a good result was achieved. In sum, the evidence established that the Hospital secured appropriate treatment for K.H. by providing an on-site emergency room physician and supporting staff who (1) provided immediate emergency care and stabilized the patient for transfer, (2) confirmed with the orthopedic surgeon on the Hospital's medical staff that a transfer was medically necessary, (3) called hospitals and their on-call physicians to arrange the transfer, and (4) arranged suitable transportation and transfer of the patient. The Hospital provided all the care that it could within its service capability. In view of his injury, the Patient's best interests were served by transferring him rather than treating him at the Hospital. The evidence did not establish whether K.H. was a paying or nonpaying patient. The evidence did establish that the decision to transfer K.H. was not based on his financial status.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered which dismisses the Administrative Complaint filed against HCA Raulerson Hospital. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 17th day of January, 1991. J. STEPHEN MENTON 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 17th day of January, 1991.
Findings Of Fact Maliyah Jones was born on May 28, 2013, at North Florida Regional Medical Center located in Gainesville, Florida. Maliyah weighed 3,870 grams at birth. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Maliyah. In a medical report dated September 15, 2015, Dr. Willis opined as follows: In summary, delivery was complicated by a shoulder dystocia, which resulted in an Erb’s palsy. Although depressed at birth, the baby had a good response to resuscitation (bag and mask ventilation) with an Apgar score of 9 at five minutes. The baby’s condition was stated to be stable on admission to the NICU. The newborn hospital course was complicated only by the Erb’s palsy. Discharge was on DOL 2. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery or the immediate post delivery period. NICA retained Laufey Y. Sigurdardottir, M.D. (Dr. Sigurdardottir), a pediatric neurologist, to examine Maliyah and to review her medical records. Dr. Sigurdardottir examined Maliyah on October 28, 2015. In a medical report regarding her independent medical examination of Maliyah, Dr. Sigurdardottir opined as follows: Summary: Maliyah is a 2-1/2 year-old born at term after an uncomplicated pregnancy with shoulder dystocia resulting in a near complete Erb’s palsy. She has required 2 surgical procedures and does have significant disability as per the Mallet scale and is likely to need more surgical procedures to enhance her functional abilities in her right upper extremity. She is, however, functioning well from a cognitive level and her gross motor skills are otherwise intact. In review of the medical records available, it seems clear that her right brachial plexopathy did occur at birth due to mechanical injury. In light of her favorable cognitive and language development our findings are the following: Result as to question 1: The patient is found to have a permanent physical impairment, but to have none or mild delays in language development. She is therefore not found to have a substantial mental and physical impairment at this time. * * * In light of the above-mentioned details, Maliyah’s restricted motor disability and near normal cognitive development, I do not recommend Maliyah to be included into the Neurologic Injury Compensation Association Program and would be happy to answer additional questions or review further medical records. In light of her favorable mental and developmental state it is doubtful that additional records would alter the outcome of our review. She is not felt to have a substantial mental impairment at this time. A review of the file in this case reveals that there have been no expert opinions filed that are contrary to the opinion of Dr. Willis that there was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby's brain or spinal cord during labor, delivery or the immediate post-delivery period. Dr. Willis’ opinion is credited. There are no contrary expert opinions filed that are contrary to Dr. Sigurdardottir’s opinion that Maliyah is not found to have a substantial mental impairment at this time. Dr. Sigurdardottir’s opinion is credited.
The Issue Whether the Proposed Rule 64J-2.010 enlarges, modifies or contravenes the specific provisions of law implemented, or is arbitrary or capricious, and thus constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Parties Shands operates an 852-bed hospital and Level I trauma center in Gainesville, Alachua County, Florida. Its business address is 1600 Southwest Archer Road, Gainesville, Florida. Shands treats about 2,500 trauma patients each year. Shands is located within trauma service area (TSA) 4, which is comprised of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, and Union counties. St. Joseph’s is a regional tertiary hospital and has served the Tampa area for 75 years and has approximately 800 licensed acute care beds. St. Joseph offers a broad array of acute care services including tertiary health care, serves as a comprehensive regional stroke center, and has been repeatedly recognized as a Consumers Choice hospital. St. Joseph operates a Level II trauma center and a Level I pediatric trauma center. St. Joseph is located in TSA 10, consisting of a single county, Hillsborough. Tampa General is a major tertiary hospital that is designated by the state as a Level I trauma center. Tampa General also serves as a teaching hospital for the University of South Florida, College of Medicine ("USF"). Tampa General is located in Tampa, Hillsborough County, Florida, TSA 10. Bayfront is a 480-bed tertiary hospital located in Pinellas County, Florida. In addition to serving as a teaching hospital, Bayfront is designated as a Level II trauma center pursuant to chapter 395, Part II, Florida Statutes. It is located in TSA 9, composed of Pinellas and Pasco counties. The Public Health Trust of Miami-Dade County, is an entity which governs and operates the Jackson Health System, including the Ryder Trauma Center at Jackson Memorial Hospital. It is in TSA 19, consisting of Dade and Monroe counties. The Florida Department of Health is the state agency authorized to verify and regulate trauma centers in the state of Florida pursuant to chapter 395, Part II, Florida Statutes, and Florida Administrative Code Rule 64J-2.001 et seq. The Division of Emergency Medical Operations, Office of Trauma, oversees the Department's responsibilities with respect to the statewide trauma system. Osceola is a licensed acute care general hospital, located at 700 West Oak Street, Kissimmee, Florida. Osceola provides a wide array of high quality health services to the residents and visitors within its service area. It is located in TSA 8, consisting of Lake, Orange, Osceola, Seminole, and Sumter counties. The Florida Trauma System For purposes of organizing a statewide network of trauma services, the Florida Legislature directed the Department to undertake the implementation of a statewide inclusive trauma system as funding is available. § 395.40(3), Fla. Stat. The need for a trauma system is premised on the basic principle that a trauma victim who is timely transported and triaged to receive specialized trauma care will have a better clinical outcome. § 395.40(2), Fla. Stat. A trauma victim's injuries are evaluated and assigned an Injury Severity Score ("ISS"). § 395.4001(5), Fla. Stat. Patients with ISS scores of nine or greater are considered trauma patients. § 395.402(1), Fla. Stat. Trauma experts speak in terms of "a Golden Hour," a clinical rule of thumb that postulates no more than 60 minutes should elapse from the occurrence of an injury to the beginning of definitive treatment. There is, however, no current consensus on what constitutes the "Golden Hour" for transport times. A 1990 Department study recommended travel time of 25-35 minutes as the outside range for optimal outcomes. A 1999 Department study favored a goal of 30 minutes transport time by ground, and a 50-mile radius by helicopter. By contrast, a 2005 study conducted for the Department used 85 minutes "total evacuation time" as "acceptable." A trauma center is a hospital that has a collection of resources and personnel who are charged with taking care of trauma patients. They are recognized by the community as a resource for care of severely injured patients. The International Classification Injury Severity Score (“ICISS”) methodology, considered with discharged patient data from the Agency for Health Care Administration database, was used by DOH to determine severely injured patients. An ICISS score is the product of the survival risk ratios (i.e., the probabilities of survival) calculated for each traumatic injury a single patient suffers. Level I trauma centers are generally larger and busier and treat more patients than Level II centers. Level I trauma centers are required to engage in education and research. Trauma centers are required to have several types of physician specialists at the ready at all times. For instance, with respect to surgical services, a Level I trauma center must have a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary (in-hospital) and backup trauma coverage 24 hours a day at the trauma center when summoned. Further, in addition to having at least one neurosurgeon to provide in-hospital trauma coverage 24 hours a day at the trauma center, a Level I provider must also have surgeons available to arrive promptly at the trauma center in 11 other specialties, including (but not limited to) hand surgery, oral/maxillofacial surgery, cardiac surgery, orthopedic surgery, otorhinolaryngologic surgery and plastic surgery. Level II trauma centers must comply with similar physician specialist standards. Little if any credible evidence was presented in the present case to suggest that the ability to hire qualified clinical staff, technicians, specialty physicians and other personnel would be severely impacted if the Proposed Rule is implemented. Rather, the existing trauma centers lamented the possibility of reduced case loads which could make it more difficult to retain proficiency. Invalidation of Former Rule 64J-2.010 In 1992, the Department of Health and Rehabilitative Services (HRS), the Department of Health's predecessor, promulgated Florida Administrative Code Rule 64J-2.010, titled "Apportionment of Trauma Centers within a Trauma Service Area," (hereinafter referred to as the “Former Rule”). The Department of Health assumed administration of the Former Rule in 1996, when the Legislature split HRS into two new agencies, the Department of Health and the Department of Children and Families. The Former Rule regulated the number of trauma centers that could be established in Florida. The Former Rule divided the state into TSAs as set forth in section 395.402(4), and for each TSA, announced the number of trauma center "positions" available. In 2004, the Florida Legislature amended section 395.402 to require the Department to complete an assessment of Florida's trauma system, and to provide a report to the Governor and Legislature no later than February 1, 2005 (the 2005 Assessment). The scope of the assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. One objective of the assessment was to consider aligning trauma service areas within the trauma region boundaries as established in section 395.4015(1). It required the Department to establish trauma regions that cover all geographic areas of the state and have boundaries that are coterminous with the boundaries of the Regional Domestic Security Task Forces (“RDSTF”) established under section 943.0312. In a related 2004 amendment, the Legislature added a provision that gave the Department the option to use something other than the trauma service areas codified in section 395.402(4) upon completion of the 2005 Assessment. See § 395.402(2), Fla. Stat. ("Trauma service areas as defined in this section are to be utilized until the Department of Health completes" the 2005 Assessment.) § 395.402(4), Fla. Stat. ("Until the department completes the February 2005 assessment, the assignment of counties shall remain as established in this section."). As part of the 2004 amendments to the trauma statute, the Legislature also required the Department to conduct "subsequent annual reviews" of Florida's trauma system. In conducting such annual assessments, the Legislature required the Department to consider a non-exhaustive list of criteria set forth in section 395.402(3)(a)-(k). Further, the Legislature required the Department to annually thereafter review the assignment of Florida’s 67 counties to trauma service areas. The Department timely submitted its 2005 Assessment to the Legislature on February 1, 2005. With respect to its review of the trauma service areas, the 2005 Assessment recommended against the continued use of the 19 trauma service areas. The 2005 Assessment instead suggested that it may be feasible for the existing trauma service areas to be modified to fit the seven RDSTF regions to facilitate regional planning. Following receipt of the 2005 Assessment, the Department took no action to amend the Former Rule and adopt the recommendations of the 2005 Assessment. As a result, in June 2011, several existing trauma centers challenged the validity of the Former Rule pursuant to sections 120.56(1) and (3). See Bayfront Med. Ctr., Inc. et al. v. Dep't of Health, DOAH Case Nos. 11-2602RX, 11-2603RX, 11-2746RX, 11-2796RX (Fla. Div. Admin. Hear., Sept. 23, 2011). On September 23, 2011, an administrative law judge of the Division of Administrative Hearings entered a final order holding that the Former Rule was an invalid exercise of delegated legislative authority. The administrative law judge concluded that the Former Rule was invalid because it contravened the laws it purportedly implemented, including section 395.402. The judge found: The authority granted by section 395.402 for the use of the [nineteen] identified TSAs existed only until February 2005. After that time, the Department was required to consider the findings of the 2005 Assessment, as well as the recommendations made as part of the regional trauma system plan. Thus, section 395.402 can no longer service as a valid basis for the Rule. However, as set forth below, the authority to utilize the 19 TSAs was not rescinded; rather, the mandated requirement to use only the TSAs was rescinded. The Department was required to review the assignment of Florida’s 67 counties to trauma service areas, taking into consideration the factors set forth in paragraphs (2)(b)-(g) and subsection (3) of section 395.402. Having done so, it was incumbent on the Department to amend its [Former] Rule to allocate the number of trauma centers determined to be needed within each designated area through systematic evaluation and application of statutory criteria. On November 30, 2012, the First District Court of Appeal affirmed the administrative law judge's determination that the Former Rule was an invalid exercise of delegated legislative authority. See Dep't of Health v. Bayfront Med. Ctr., Inc., 134 So. 3d 1017 (Fla. 1st DCA 2012). After noting that the Former Rule claimed to implement sections 395.401, 395.4015, and 395.402, the appellate court held that the Former Rule was invalid because it failed to reflect the substantial amendments to those laws that were enacted in 2004. The appellate court held: Both the pre-and post-2004 versions of the statute require the Department to establish trauma regions that "cover all geographic areas of the state." However, the 2004 amendment requires that the trauma regions both "cover all geographical areas of the state and have boundaries that are coterminous with the boundaries of the regional domestic security task forces established under s. 943.0312." § 395.4015(1), Fla. Stat. (2004). Similarly, the rule fails to implement the 2004 amendments to section 395.402. The version of the statute in effect at the time the rule was promulgated set forth the nineteen trauma service areas reflected in the rule. [T]he 2004 version of the statute required the Department to complete an assessment of Florida's trauma system no later than February 1, 2005. It further provides that the original nineteen trauma service areas shall remain in effect until the completion of the 2005 Assessment. Bayfront, 134 So. 3d at 1019-20 (Emphasis added). It should be noted that the 2004 version of the statute does not specify at what point in time the 19 TSAs could no longer be utilized, only that they would have to be used at least until completion of the 2005 Assessment. Rule Development The Department thereafter initiated rule development workshops to commence construction of a new rule. The first workshop concerning this rule was in Tallahassee, Florida, on December 21, 2012. In January and February 2013, workshops were then held in Pensacola, Tampa, Ocala, Jacksonville, and Miami, as DOH continued working on a new rule. Each of the sessions involved input from interested persons both live and by telephone. Written comments and oral presentations by these persons were considered by the Department. After these first six workshops, held in various regions of the State to make them more accessible to more citizens, DOH then scheduled three more workshops in March 2013, to be held in areas where there were no existing trauma centers, specifically Ft. Walton Beach, Naples, and Sebring. DOH also considered the recommendations of a report issued by the American College of Surgeons (“ACS”), the lead professional group for trauma systems and trauma care in the United States. The ACS sent a consultation team to Tallahassee, Florida, to conduct a three-day site visit and hold public workshops in February 2013. The ACS ultimately issued a report entitled “Trauma System Consultation Report: State of Florida,” in May 2013. The report included as one of its recommendations the use of RDSTF regions as the TSA areas to be used in determining need for additional trauma centers. In November 2013, DOH released a draft proposed rule and a draft of its first TSA Assessment (the January TSA Assessment). The Department then conducted three additional workshops in Pensacola, Orlando, and Miami. Again, DOH solicited comments from interested persons and entered into a dialogue as to what the proposed rule should look like upon publication. On January 23, 2014, DOH conducted a Negotiated Rulemaking Committee meeting at the Department’s headquarters in Tallahassee, Florida. The committee consisted of seven persons: Karen Putnal, Esquire and Dr. Fred Moore--representing existing trauma centers; Steve Ecenia, Esquire and Dr. Darwin Ang-- representing new trauma centers currently under challenge; Dr. Patricia Byers--representative of the EMS Advisory Council; Jennifer Tschetter, Esquire and Dr. Ernest Block--representing DOH. The public was invited to attend the session but was not afforded an opportunity to speak. The Department considered all the input from each of the workshops, the ACS Report, and the negotiated session, as well as all the applicable items enumerated in section 395.402(3)(a)-(k). The Proposed Rule On February 3, 2014, the Department published Notice of Development of Proposed Rule 64J-2.010 (the "Proposed Rule") in Florida Administrative Register, Volume 40, Number 22. The Department's Notice cited section 395.405, as rulemaking authority for the Proposed Rule. The Notice also cited sections 395.401, 395.4015, 395.402, and 395.405 as the laws intended to be implemented by the Proposed Rule. The following day, February 4, 2014, the Department published a Notice of Correction in Florida Administrative Register, Volume 40, No. 23, to correct the history notes of the Proposed Rule. In the corrected Notice, the Department cited section 395.402 as its rulemaking authority in addition to section 395.405. The correction also removed reference to sections 395.401, 395.4015, and 395.405, as laws implemented by the Proposed Rule. Following the Department's correction, the Proposed Rule was intended only to implement section 395.402. The Proposed Rule established 19 TSAs and determined the number of trauma centers to be allocated within each TSA, based upon a scoring system established in the Proposed Rule. Under the scoring system, TSAs were awarded positive or negative points based on data in an annual Trauma Service Area Assessment relating to the following six criteria: (1) population; (2) median transport times; (3) community support; (4) severely injured patients not treated in trauma centers; (5) Level 1 trauma centers; and (6) number of severely injured patients (in each TSA). Ms. Tschetter added the last two criteria (Level I Trauma Centers and Number of Severely Injured Patients) in response to comments received at the negotiated rulemaking session. Subsequent to a final public hearing held on February 25, 2014, DOH revised its January TSA Assessment and the earlier version of the Proposed Rule. The revised TSA assessment (the “March TSA Assessment”) reflected more conservative calculations (as gleaned from input and discussions with stakeholders) and documents the statutory patient volumes for the existing Level I and Level II trauma centers in each TSA. The March TSA Assessment further recalculated the Median Transport times, including all transports from 0-10 minutes (as opposed to only those transports greater than 10 minutes) and only transports to trauma centers (as opposed to transports to all hospitals). On March 25, 2014, a Notice of Change was published in the Florida Administrative Register. The Proposed Rule, as published on that date, is as follows: Notice of Change/Withdrawal DEPARTMENT OF HEALTH Division of Emergency Medical Operations RULE NO.: RULE TITLE: 64J-2.010 Apportionment of Trauma Centers within a Trauma Service Area (TSA) NOTICE OF CHANGE Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 40, No. 22, February 3, 2014 issue of the Florida Administrative Register. 64J-2.010 Allocation of Trauma Centers Aamong the Trauma Service Areas (TSAs). Level I and Level II trauma centers shall be allocated among the trauma service areas (TSAs) based upon the following: The following criteria shall be used to determine a total score for each TSA. Points shall be determined based upon data in the Trauma Service Area Assessment. Population A total population of less than 0 to 600,000 receives 2 points. A total population of 600,001 to 1,200,000 receives 4 points. A total population of 1,200,001 to 1,800,000 1,700,000 receives 6 points. d. A total population of 1,800,000 1,700,001 to 2,400,000 2,300,000 receives 8 points. e. A total population greater than 2,400,000 2,300,000 receives 10 points. Median Transport Times Median transport time of less than 0 to 10 minutes receives 0 points. Median transport time of 101 to 20 minutes receives 1 point. Median transport time of 21 to 30 minutes receives 2 points. Median transport time of 31 to 40 minutes receives 3 points. Median transport time of greater than 41 minutes receives 4 points. Community Support Letters of support for an additional trauma center from 250 to 50 percent of the city and county commissions located within the TSA receive 1 point. Letters of support must be received by the Department on or before April 1 annually. Letters of support for an additional trauma center from more than 50 percent of the city or county commissions located within the TSA receive 2 points. Letters of support must be received by the Department on or before April 1 annually. Severely Iinjured Patients Discharged from Acute Care Hospitals Not Treated In Trauma Centers Discharge of 0 to 200 patients with an International Classification Injury Severity Score (“ICISS”) score of less than 0.85 (“severely injured patients”) from hospitals other than trauma centers receives 0 points. Discharge of 201 to 400 severely injured patients from hospitals other than trauma centers receives 1 point. Discharge of 401 to 600 severely injured patients from hospitals other than trauma centers receives 2 points. Discharge of 601 to 800 severely injured patients from hospitals other than trauma centers receives 3 points. Discharge of more than 800 severely injured patients from hospitals other than trauma centers receives 4 points. Level I Trauma Centers The existence of a verified Level I trauma center receives one negative point. The existence of two verified Level I trauma centers receives two negative points. The existence of three verified Level I trauma centers receives three negative points. Number of Severely Injured Patients If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives 2 points. If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives 1 point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives one negative point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives two negative points. The following scoring system shall be used to allocate trauma centers within the TSAs: TSAs with a score of 5 points or less shall be allocated 1 trauma center. TSAs with a score of 6 to 10 points shall be allocated 2 trauma centers. TSAs with a score of 11 to 15 points shall be allocated 3 trauma centers. TSAs with a score of more than 15 points shall be allocated 4 trauma centers. An assessment and scoring shall be conducted by the Department annually on or before August 30th, beginning August 30, 2015. The number of trauma centers allocated for each TSA based upon the Amended Trauma Service Area Assessment, dated March 24, 2014 January 31, 2014, which can be found at www.FLHealth.gov/licensing- and-regulation/trauma-system/_documents/trauma-area-service- assessment.pdf, is as follows: TSA Counties Trauma Centers 1 Escambia, Okaloosa, Santa Rosa, Walton 1 2 Bay, Gulf, Holmes, Washington 1 3 Calhoun, Franklin, Gadsden, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, Wakulla 1 4 Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, Union 1 5 Baker, Clay, Duval, Nassau, St. Johns 12 6 Citrus, Hernando, Marion 2 7 Flagler, Volusia 1 8 Lake, Orange, Osceola, Seminole, Sumter 3 9 Pasco, Pinellas 23 10 Hillsborough 1 11 Hardee, Highlands, Polk 1 12 Brevard, Indian River 1 13 DeSoto, Manatee, Sarasota 2 14 Martin, Okeechobee, St. Lucie 1 15 Charlotte, Glades, Hendry, Lee 12 16 Palm Beach 1 17 Collier 1 18 Broward 2 19 Dade, Monroe 3 Rulemaking Authority 395.402, 395.405 FS. Law Implemented 395.402 FS. History–New 12-10-92, Formerly 10D-66.1075, Amended 6-9-05, 12-18- 06,Formerly 64E-2.022, Amended . DOH did not incorporate the March TSA Assessment by reference in the rule. After exchanges of communications with the Joint Administrative Procedures Committee (“JAPC”), wherein DOH sought guidance concerning this matter, there was no directive by JAPC that such adoption by reference would be required. DOH revised the population criterion in the Proposed Rule to have even breaks in intervals of 600,000 people. The February proposed rule awarded 6 points in TSAs with a population of 1,200,001 to 1,700,000 people (i.e., a 500,000 person interval), where all other measures were based upon a 600,000 person interval. This discrepancy is corrected in the newly Proposed Rule. DOH revised the community support criterion in the Proposed Rule to no longer award a point to TSAs where 0-50% of the city and county commissions send letters of support, because this could have reflected the need for a trauma center (by awarding points to the TSA) when no letters of support were received. The Proposed Rule now awards a point to TSAs where 25-50% of the county commissions send letters of support. DOH chose twenty-five percent as the minimum necessary community support because the smallest number of city and county commissions in all of the TSAs is four, which ensures everyone has a voice. DOH revised the title of the fourth criterion from “severely injured patients not treated in trauma centers” to “severely injured patients discharged from acute care hospitals,” which more accurately depicts the function of the criterion. DOH revised the sixth criterion to include citations to the statutory minimum volumes for Level I and Level II trauma centers in response to a request by the staff attorney for the Joint Administrative Procedures Committee. DOH also revised the rule to reference the March TSA Assessment in place of the January TSA Assessment. Finally, DOH revised the Proposed Rule’s allocation table based on the revisions to the rule and assessment. The Proposed Rule as amended allocates a total of 27 trauma centers throughout Florida’s 19 TSAs. Each TSA is still allocated at least one trauma center. The Proposed Rule allocates only Level I and Level II trauma centers, not pediatric trauma centers. The rulemaking directive in section 395.402(4) is interpreted by DOH to be limited to the allocation of Level I and Level II trauma centers. In addition, the allocation of stand-alone pediatric centers would not be feasible because pediatric trauma patients make up such a small percentage of the population and all of the Level I and II trauma centers have the ability to become pediatric trauma centers. Currently, all of the existing Level I trauma centers provide pediatric care and there are only two stand-alone pediatric centers in Florida. The Proposed Rule’s allocation of 27 trauma centers is conservative. There are currently 27 verified trauma centers in the state, including two verified trauma centers under administrative challenge. There are several elements of the Proposed Rule which Petitioners have raised as evidence of the Department’s failure to comply with its rulemaking authority. Petitioners maintain that DOH failed to consider all of the items enumerated in section 395.402(3)(a)-(k). Each of those criteria is addressed below. (a) The recommendations made as part of the regional trauma system plans submitted by regional trauma agencies-- There is only one regional trauma agency in Florida. DOH reviewed the regional agency’s plan, but it was devoid of any recommendations related to trauma center allocation within the TSAs. The regional agency did not amend its plan or submit any separate recommendations throughout the year-long, public rulemaking process. (b) Stakeholder recommendations--Petitioners complain that DOH did not do enough to solicit input from everyone who would be affected by the Proposed Rule. The Department, however, obtained stakeholder testimony from 171 individuals and written comments from 166 stakeholders through the course of the 12 rule development workshops conducted around the state. The workshops were held in several cities to allow for geographic access by more residents. Over 400 people attended the workshops. The January TSA Assessment was also modified prior to its publication as a result of the stakeholder discussions at the workshops and the negotiated rulemaking session. The March TSA Assessment was further amended after its publication as a result of testimony at the public hearing for the Proposed Rule. (c) The geographical composition of an area to ensure rapid access to trauma care by patients--While Florida contains no mountains, its geography is unique to other states in that it contains several inlets, bays, jetties, and swamplands. As such, the DOH data unit examined the coastal areas versus non- coastal areas. The unit also analyzed urban versus rural areas. The unit also looked at the communities surrounding Lake Okeechobee. Ultimately, the analysis was not meaningful because the effect geography has on access to trauma centers is captured by Florida’s transport time records for emergency vehicles and helicopters. Thus, by reviewing the Emergency Medical Services Tracking and Reporting System (“EMSTARS”) database, DOH could know the actual effects of Florida’s geography on access to trauma centers. (d) Historical patterns of patient referral and transfer--This item was considered, but the January TSA Assessment does not address it because it was neither measurable nor meaningful. The data was not measurable because of limitations of data quality in the Trauma Registry. Even if the data were measureable it would not have been meaningful because it would have only illustrated the catchment areas--i.e., the geographic distribution of patients served by existing trauma centers. As recommended by the ACS, DOH’s primary focus is on the trauma system as a whole, not individual trauma centers. Moreover, transfer and referral history is not meaningful to an assessment designed to inform an allocation rule because, again, DOH does not have the authority to define where new trauma centers are developed within a TSA. See § 402.395(4)(b), Fla. Stat. (charging DOH with allocating by rule the number of trauma centers in each TSA, not trauma center location within a trauma service area). (e) Inventories of available trauma care resources, including professional medical staff--Petitioners suggest that DOH should have made a determination of existing professional medical staff, but suggest no viable means of doing so. The January TSA Assessment catalogues several trauma care resources within TSAs, including financing, trauma centers, acute care hospitals, and EMS response capabilities. The January TSA Assessment does not catalogue available professional medical staff. DOH is unaware of any database that compiles this information. DOH sent a survey to the existing trauma centers requesting information as to their resources and professional staff, however it was not useful due to the limited responses and potential for bias. The data unit also reviewed the DOH Division of Medical Quality Assurance health professional licensure database (COMPASS), however, it was not helpful because physician specialty reporting is voluntary. Similarly, the data unit reviewed AHCA’s inventory of licensed acute care hospitals and the DOH annual physician workforce survey results, but neither data source provided trauma-specific information. As such, the information was not complete and so was not included in the January TSA Assessment. (f) Population growth characteristics--In response to this criterion, the DOH data unit analyzed the potential for growth in all of the TSAs, but the January TSA Assessment did not include this analysis because it was not meaningful given DOH’s requirement to conduct the assessment annually. The January TSA Assessment does however document the population in each TSA. DOH decided that in light of the continuing change of population in Florida, the best it could do would be to make a finding as to the population in each TSA and use it--year by year--to look at the potential need for additional (or presumably fewer) trauma centers in an area. Obviously the population of an area is not directly commensurate with the number of severely injured patients that might be found. Not all areas have equal percentages of severely injured patients; urban areas would have higher percentages than rural areas, in general. Areas through which a major interstate highway runs would expect a higher percentage. There are a number of factors that could potentially affect an area’s expectation of trauma services. Inasmuch as they could not all possibly be included in an analysis, DOH defaulted to a more general view, i.e., the total population. The total population figure became the first measurement in the Proposed Rule. (g) Transportation capabilities; and (h) Medically appropriate ground and air travel times--DOH considered these two factors together and determined to cover them by way of a determination of median transport time, which was to become the second measurement in the Proposed Rule. The data unit gathered transport capability data by reviewing the COMPASS licensure database and archived paper applications to discern the number of licensed emergency medical stations, helicopters, and vehicles in each TSA. The data unit further calculated the number of ground vehicles per the population in each TSA and every 100 square miles. The January TSA Assessment included this information because it was meaningful and gathered from a reliable database. DOH considered the testimony from a number of trauma surgeons during the 12 workshops regarding transport times and learned that the medically appropriate transport time depends on the nature of injuries and individual patients, which are not always discernable at the scene of an accident. Because of this, the sooner a patient can be transported to a trauma center, the better it is for patient outcomes. In light of the patient-specific realities of establishing a medically appropriate transport time, the data team used EMSTARS to calculate the median emergency transport times in each TSA for the assessment. Granted the EMSTARS is a fairly new system under development, and it reports all 911 calls voluntarily reported (not just trauma patients), so it is not a completely accurate measure. But it is a reasonable approach based upon what is available. Also, the transport times do not reflect whether pre-hospital resources are sufficient for the patient or how far away the closest trauma center may be. It is not an absolutely perfect measurement, but it is reasonable and based on logic. (i) Recommendations of the Regional Domestic Security Task Force--Like Florida’s lone regional trauma agency, the RDSTF did not offer any input throughout the year-long, public rulemaking process. However, DOH considered the testimony of numerous emergency management and law enforcement officials during the rule development process. For example, Chief Loren Mock, the Clay County fire chief and also a member of the Domestic Security Oversight Council, testified at the Jacksonville workshop. There is no evidence DOH directly contacted a RDSTF representative to solicit input. (j) The actual number of trauma victims currently being served by each trauma center--The March TSA Assessment included the annual trauma patient volume reported to the Trauma Registry by the existing trauma centers. When comparing the average patient volume reported to trauma registry from 2010- 2012 to the data unit’s calculation of the average number of severely injured patients treated in trauma centers during this same time span, the volumes reported by the trauma centers were approximately 333% greater. This large disparity prompted DOH to follow the example of many other states and use population as a proxy for the number of potential trauma patients in each TSA in its Proposed Rule. DOH found that: greater population means a greater need for health care; population is a good indicator of need for medical services; population is a reasonable proxy for patient volume; and, more people in a given area results in more trauma cases in a given area. (k) Other appropriate criteria: It was well documented in literature presented to DOH during the rulemaking process that there were a large percentage of severely injured patients in Florida not being seen by trauma centers. The data unit confirmed this by evaluating the AHCA administrative database, which identifies the injuries suffered by patients as well as the type of hospitals discharging those patients, i.e., comparing the total number of severely injured patients with the number of severely injured patients discharged from acute care hospitals in each TSA. This disparity was worrisome to DOH and therefore included in the March TSA Assessment. As pointed out by Petitioners, the Department’s figures include patients who may have received treatment outside the TSA in which the injury occurred. The figures may not have contained patients who needed trauma care but could not access it for other reasons. The Proposed Rule, however, makes as complete an evaluation of the potential patient base for trauma centers as is possible. Notwithstanding complaints about how the Department addressed some of the criteria set forth in the statute, it is clear that all criteria were considered and implemented into the Proposed Rule to the extent feasible and possible. The most credible testimony at final hearing supports the Department’s process. Criticisms of the various elements within the Proposed Rule expressed by Petitioners at final hearing seemed to be based on the concept that the Proposed Rule may allow competition to existing trauma centers rather than real complaints about the elements themselves. All agree, for example, that population, transportation times, number of patients, and the existence of nearby trauma centers are important factors that should be considered. Petitioners just seemed to want those factors expressed in different (though unspecified) terms. Petitioners did enunciate certain shortcomings they felt made the Proposed Rule less than complete. St. Joseph lamented the absence of all the Department’s analysis and background for each of the proposed measurements contained in the Proposed Rule. Jackson Memorial pointed out that pediatric trauma centers were not specifically included in the Proposed Rule. Shands showed that odd or unusual results could arise from implementation of the Proposed Rule. For example, the March TSA Assessment showed a total of 216 severely injured patients in TSA 6, comprised of Marion, Citrus, and Hernando counties. The Proposed Rule called for two trauma centers in that TSA. Although the number of patients necessary to maintain a trauma center’s proficiency was disputed by various experts in the field, it is clear that 108 patients per center would be extremely low. However, the figure appearing in the March Assessment is not absolute or necessarily completely definitive of need. There are other factors concerning population and patients that may affect that figure. The Six Measurement Criteria in the Proposed Rule Petitioners also took exception to the measurement criteria in the Proposed Rule. Each of those six criterion is discussed below. Population The Proposed Rule awards from two to ten points to a TSA, depending on the TSA total population. Two points are awarded for a population of less than 600,000 and ten points are awarded for a popu1ation greater than 2.4 million. The Department used total population as a "proxy" for the actual number of trauma patients in the state rather than using the actual number of trauma victims in the state. The Proposed Rule does not define “population” or “Total Population,” nor are those terms defined in the trauma statute, but those words are subject to their normal definition. The Proposed Rule does not re-state the source of the summary Total Population data; it is already contained in the TSA Assessment. Neither the Proposed Rule nor the March TSA Assessment contains any data or analysis reflecting population by age cohort, population density, or incidence of trauma injury in relation to these factors, and the Department did not specifically conduct any analysis of the significance of any aspect of population data as it relates to the need for new trauma centers, other than determining the total population growth rate in the TSAs. Rather, DOH decided upon total population as the most reliable measure available. Traumatic injury rates and the severity of traumatic injury vary widely based on a number of factors, including whether the area is urban or rural, the population age cohort, and the infrastructure and physical characteristics or features of the geographic area. Thus, the most reasonable way to measure possible need was to look at the total population of an area and extrapolate from that basis. The Department presented no specific data or analysis to support the incremental cutoff points for the Total Population scale contained in the Proposed Rule. Rather, the Department took population as a whole because it was the most readily available, annually updateable, and understandable factor it could access. The use of population as a proxy is not without problems, however. In TSA 19, for instance, the population has increased by about thirty-eight percent in recent decades, but the number of trauma victims has declined by approximately twelve percent. As stated, the Proposed Rule as written is not inerrant. Median Transport Times The Proposed Rule awards from zero to four points to a TSA, depending on the Median Transport Time within a TSA. “Median Transport Time” is not defined in the Proposed Rule, nor is the methodology for determining the summary “Median Transport Time” statistics set forth in the TSA Assessment and relied on in the Proposed Rule. Information concerning transport times is, however, contained within the TSA Assessment. The Median Transport Time used in the Proposed Rule represents the average transport time for all 911 transports voluntarily reported to the state EMSTARS database. EMSTARS is a database that is under development and that collects information voluntarily provided by emergency medical transport providers throughout the state. Although not all EMS providers currently report to EMSTARS (most notably, Miami-Dade County EMS does not participate), the database is useful for research and quality improvement initiatives. The Median Transport Time set forth in the March TSA Assessment and used in the Proposed Rule includes transport time for all patients, regardless of the nature of the emergency, whether the call involved trauma, other types of injury, or illness, and regardless of whether the transport was conducted with the regular flow of traffic or required “lights and siren.” The Median Transport Time used in the Proposed Rule includes all EMS transports of up to two hours in duration. The Median Transport Time excludes transports of patients to trauma centers operating pursuant to the initial stage of trauma center licensure known as “provisional approval.” The Department addressed “medically appropriate air or ground transport times,” as required by section 395.402(3)(h), by its generally accepted conclusion that "faster is better." Not all injured patients, however, benefit from receiving care at a trauma center. Thus, while an existing trauma center is an appropriate destination for all patients with any level of injury who live in the area of a trauma center, the trauma center’s value beyond its immediate area is as a resource for the most severely injured patients whose problems exceed the capabilities of their nearest hospital. The Department did not undertake any analysis to balance its "faster is better" approach to trauma planning against the reality that the resources necessary to provide high quality trauma care are limited, as is the number of severely injured patients. There is a general (but not universal) consensus among trauma experts that access to a trauma center within 30-50 minutes is an appropriate benchmark for access to trauma care. Other than "faster is better," the Department did not determine a medically appropriate travel time for any type of trauma or any geographic area, but recognizes the general consensus as appropriate. The Proposed Rule awards from one to four points that weigh in favor of approval of a new trauma center within a TSA if the Median Transport Time of patients transported in response to any 911 call is between 10 and 42 minutes, i.e., within but faster than the generally accepted consensus. Community Support The Proposed Rule awards from one to two points to each TSA depending on the number of letters of support written by elected city or county commissioners. The Proposed Rule allows for consideration of stakeholder recommendations by way of allowing letters of support from local governments. “Stakeholders” in the state trauma system include existing trauma centers, as well as all acute care hospitals, and pre- and post-hospital care providers, including emergency transport services, air ambulances, and emergency management planning agencies. The Department could find no better way to acknowledge support from those stakeholders, and citizens in general, than to have their elected representatives listen to their constituents and then reflect those people’s desires and comments. Severely Injured Patients Discharged from Acute Care Hospitals The Proposed Rule awards from zero to four points to a TSA, depending on the number of severely injured patients discharged from acute care hospitals (non-trauma centers). The Proposed Rule addresses the number of severely injured patients, i.e., those with an ICISS score of < 0.85, discharged from hospitals other than trauma centers. The Proposed Rule does not specifically define “severely injured patient,” but it is obvious from the context in which that term is used. The summary data in the TSA Assessment labeled "number of severely injured patients” within each TSA is intended to reflect the number of severely injured patients who “didn’t get to trauma care.” The Department's numbers may include patients who received treatment at a trauma center outside of the TSA in which the injury occurred. The Department did not conduct any analysis of the "number of severely injured patients not treated at a trauma center" to determine whether the patients not treated at a trauma center received timely and appropriate care at a non-trauma center hospital with the capability to treat the patient's injuries. The number of “severely injured patients who did not get to trauma care” as reported by the Department is unlikely to reflect the actual number of patients who required care at a trauma center but did not have access, and suggests that this number is far higher than it actually is. The Department, for example (and in response to discussion with stakeholders), excluded from its analysis all patients with isolated hip fractures as well as all patients who were released from the hospital within 24 hours, which resulted in fewer severely injured patients. Neither the Proposed Rule nor the TSA Assessment considers demographics or outcomes for "severely injured patients" treated at general acute care hospitals or outcome data for these patients. The Proposed Rule does not include any method for projecting the actual demand for trauma services in the future; it is used to determine need at a single point in time (and will be done so annually). The Proposed Rule does not include any criteria or method for evaluating whether there are any capacity problems at existing trauma centers, or other barriers that impede access to trauma care. The Department intended this criterion to show a highly conservative estimate of patients who definitely need trauma care. Level I Trauma Centers With respect to “Level I Trauma Centers,” the Proposed Rule awards from negative one to negative three points to a TSA, depending on whether the TSA already has one, two, or three verified Level I trauma center(s), respectively. The Proposed Rule creates the opportunity for establishment of both additional Level I and also additional Level II trauma centers, pursuant to the allocation of need, but the Proposed Rule does not assign or subtract points for the existence of Level II trauma centers. This criterion reflects the recommendations of stakeholders at the rule workshops. It was the consensus of many stakeholders that Level I trauma centers should be protected in order to safeguard the research and teaching missions of those centers. The earlier proposal of a “halo” around existing centers, i.e., not approving a new trauma center within a certain radius of existing centers, was not incorporated into the Proposed Rule. This criterion, however, offers some protection for existing centers. Number of Severely Injured Patients The Proposed Rule awards negative two to two points based on the "number of severely injured patients" in a TSA. The criterion awards points based on the number of Severely Injured Patients which exceed the target trauma center patient volumes as provided in section 395.402(1). If the annual number of Severely Injured Patients exceeds the statutory volumes by more than 500 patients, the TSA will receive two points; if it exceeds it by less than 500 the TSA receives one point; if the number of Severely Injured Patients is less than the statutory volumes by zero to 500 patients, the TSA receives one negative point; if it is less than the volumes by more than 500 patients, the TSA receives two negative points. The Proposed Rule does not include any criterion addressing the actual number of trauma victims currently being served by each trauma center. Instead, Section 6 of the Proposed Rule substitutes the "minimum statutory capacity" of existing trauma centers for the actual capacity of existing trauma centers. The Department could not find “a meaningful” way to measure actual capacity of existing trauma centers. The most accurate way to measure capacity was a contentious topic at rule workshops, and the Department spent a good deal of time working with stakeholders on how to measure capacity in such a way that it could be included as a factor in the Proposed Rule. One suggestion as to how to measure trauma center capacity is by how often existing trauma centers actually divert trauma patients to other facilities. However, trauma centers rarely admit that they are not able to take any more patients, and this is not a realistic method to evaluate capacity. The capacity of an existing trauma center may be measured by various means, including the number of beds at the trauma center, the number of ICU beds, the number of trauma bays, number of operating rooms, as well as the frequency of and reasons for diversion. The trauma center’s clinical staff, including medical and surgical specialists, and supporting clinical personnel, are also indicators of capacity. The Department already routinely collects data reflecting trauma center capacity as part of the quarterly and annual reports that all existing trauma centers are required to submit, and by way of on-site licensure surveys. None of those means, however, provided DOH with sufficiently reliable information and data. The Proposed Rule comports with the DOH Mission to protect, promote, and improve the health of all Floridians through integrated state, county, and community efforts. While by no means perfect, the Proposed Rule is based upon logic and reason derived from an extensive analysis of all relevant factors. History of the Rule The rationale for DOH’s inclusion of those particular six criteria in the Proposed Rule can be better understood by considering some more history of the trauma rule. As stated earlier herein, in 2004 the Legislature made substantial revisions to the trauma statute and ordered the Department to complete an assessment of Florida’s trauma system. The scope of this assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. An appropriation of $300,000 was authorized for the Department to contract with a state university to perform the actions required under the amended statute. Ch. 2004-259, § 10, Laws of Florida. One proposal of the 2005 Assessment was to "[c]onsider aligning trauma service areas within [sic] the trauma region boundaries as established in" section 395.4015(1). § 395.402(2)(a), Fla. Stat. In a related 2004 amendment, the Legislature ended the statutory mandate to use the service areas created in 1990. The obvious conclusion from the above statutory change is that the section 395.402(4) service areas could be replaced by the service areas DOH established or adopted once it had the results of the 2005 Assessment. Unlike the prior statute, there is no mandate for specific new service areas, only the option not to use the prior service areas. The 2005 Assessment included five "Recommendations": Trauma centers should be placed in Tallahassee and in Bay County, which do not currently have a trauma center . . . . It is reasonable to set, as a system goal, that 65 percent of trauma center patients will be treated at a trauma center. . . . Designation of additional trauma centers should be based on the need as determined by trauma region. Deployment of additional trauma centers should take place based, not only on the number of patients served per trauma center, but according to the concept of “trauma center capacity” which should be determined by the staffing levels of medical specialists and other healthcare professionals. . . . The data support the feasibility of transforming the Florida Trauma Services Areas so that these would coincide with the Domestic Security Task Force Regions. . . . It is reasonable to fund trauma centers with public funds, based on the unrecoverable financial burden incurred by trauma centers. The only legislative response to the 2005 Assessment was an increase in funding to trauma centers. The Legislature did not repeal the statute establishing the current 19 TSAs. Likewise, the Department has not amended the Rule to implement the recommendations contained in the 2005 Assessment until the present Proposed Rule. The Department, instead, reviewed existing statutes, interpreted section 395.4015 to mandate the establishment of a trauma system plan (which plan would include trauma regions that have boundaries coterminous with those of the regional domestic security task force boundaries). The development of the trauma system plan is distinct from the determination of need for new trauma systems addressed by the Proposed Rule.
