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
The Issue Whether proposed rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J-2.016 of the Florida Administrative Code (“the Proposed Rules”) are an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes (2016).1/
Findings Of Fact Background on Trauma Centers A “trauma center” is “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or [a] pediatric trauma center ” § 395.4001(14), Fla. Stat. Trauma centers must have a wide array of resources at their disposal at all times. For example, a trauma center must have approximately 30 specialists such as trauma surgeons, neurosurgeons, orthopedic surgeons, and anesthesiologists. A trauma center must also have specially trained nurses, advanced imaging and diagnostic equipment, dedicated operating rooms, a blood bank, specialized nursing units, and a helipad. Many of the personnel working in trauma centers have special training. Trauma surgeons have one or two additional years of critical care training followed by another year of training in emergency surgery or acute care surgery. Trauma center nurses typically have three additional years of training/education. In short, a trauma center is a hospital that has made a substantial investment in order to have the resources and personnel capable of caring for trauma patients. Florida Administrative Code Rule 64J-2.001(15) defines a “trauma patient” as “any person who has incurred a physical injury or wound caused by trauma and who has accessed an emergency medical services system.” Trauma injuries commonly occur as a result of motor vehicle accidents, falls from height, gunshot wounds, and stab wounds. See § 395.4001(18), Fla. Stat. (defining a “trauma victim” as “any person who has incurred a single or multisystem injury due to blunt or penetrating means or burns and who requires immediate medical intervention or treatment.”); Fla. Admin. Code R. 64J-2.001(12) (defining “trauma” as “a blunt, penetrating or burn injury caused by external force or violence.”). Trauma injuries are a leading cause of death for those ranging in age from 1 to 45. Hospitals with emergency departments (i.e., acute care hospitals) are capable of treating patients on an emergency basis. However, they would not necessarily have constant access to all of the resources mentioned above. In addition, acute care hospitals have not gone through the statutory process of being approved by the Department to operate as a trauma center. § 395.4001(14), Fla. Stat. (defining a “trauma center” as “a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or pediatric trauma center, or is designated by the department as a Level II trauma center pursuant to s. 395.4025(14).”). See also § 395.401(1)(k), Fla. Stat. (mandating that “[i]t is unlawful for any hospital or other facility to hold itself out as a trauma center unless it has been so verified or designated pursuant to s. 395.4025(14).”).3/ In general, a patient in danger of imminent death from a trauma injury is likely to have a better chance of survival if he or she is treated in a trauma center as opposed to an acute care hospital. The Parties The Department is the state agency charged with implementing the laws governing the regulation of trauma centers. See § 395.40(3), Fla. Stat. (noting “[i]t is the intent of the Legislature to place primary responsibility for the planning and establishment of a statewide inclusive trauma system with the department. The department shall undertake the implementation of a statewide inclusive trauma system as funding is available.”); § 395.401(2), Fla. Stat. (mandating that “[t]he department shall adopt by rule, standards for verification of trauma centers based on national guidelines . . . .”); § 395.4015(1), Fla. Stat. (mandating that “[t]he department shall establish a state trauma system plan.”); § 395.402(2), Fla. Stat. (mandating that “[t]he department shall review the existing trauma system and determine whether it is effective in providing trauma care uniformly throughout the state.”). Of particular relevance to the instant case is the legislative mandate that the Department shall adopt rules governing the number of trauma centers that can be operated in Florida. See § 395.402(4)(b), Fla. Stat. (mandating that “[t]he department shall allocate, by rule, the number of trauma centers needed for each trauma service area.”). Those rules (see, e.g., rule 64J-2.010) determine how many trauma centers can be in a particular trauma service area (“TSA”). The Legislature has assigned each county in Florida to a TSA, and there are currently 19 TSAs in Florida. See § 395.402(4), Fla. Stat. With regard to Petitioners, Shands Jacksonville operates a Level I trauma center in TSA 5, which consists of Baker, Clay, Duval, Nassau, and St. Johns Counties. Tampa General operates a Level I trauma center in TSA 10, which consists of Hillsborough County. Lee Memorial operates a Level II trauma center in TSA 15, which consists of Charlotte, Glades, Hendry, and Lee Counties. Bayfront Health operates a Level II trauma center in TSA 9, which consists of Pinellas and Pasco Counties. St. Joseph’s Hospital operates a Level II trauma center and a pediatric trauma center in TSA 10, which consists of Hillsborough County. As for the intervenors, JFK Medical Center is a licensed acute care hospital that has submitted a letter of intent to the Department so that it can apply to operate a Level II trauma center in TSA 17, which consists of Palm Beach County. Orange Park operates a provisional Level II trauma center in TSA 5, and Jackson South operates a provisional Level II trauma center in TSA 19, which consists of Miami-Dade and Monroe Counties. The meaning of the term “provisional trauma center” will be explained below. The Statutory Scheme Governing Trauma Centers As noted above, each of Florida’s 67 counties has been assigned to one of 19 TSAs, and the 19 TSAs play an important role in the location of trauma centers throughout the state. See § 395.4025(1), Fla. Stat. (providing that “[f]or purposes of developing a system of trauma centers, the department shall use the 19 trauma service areas established in s. 395.402. Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, and recommendations of the local or regional trauma agency, the department shall establish the approximate number of trauma centers needed to ensure reasonable access to high-quality trauma services.”); § 395.402(4)(b), Fla. Stat. (providing that the Department “shall allocate, by rule, the number of trauma centers needed for each [TSA].”). The Florida Legislature has mandated that every TSA “should have at least one Level I or Level II trauma center.” § 395.402(4)(b), Fla. Stat. However, there is a state-wide, statutory cap of 44 trauma centers. § 395.402(4)(c), Fla. Stat. (mandating that “[t]here shall be no more than a total of 44 trauma centers in the state.”). Hospitals seeking approval to operate trauma centers must complete a rigorous review process, and that process begins with a potential applicant submitting a letter of intent to the Department by October 1 of a particular year. See § 395.4025(2)(a), Fla. Stat. (providing that “[t]he department shall annually notify each acute care general hospital and each local and each regional trauma agency in the state that the department is accepting letters of intent from hospitals that are interested in becoming trauma centers. In order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists. Letters of intent must be postmarked no later than midnight October 1.”). By submitting a letter of intent, a hospital does not become obligated to subsequently file a fully fledged trauma center application. Fla. Admin. Code R. 64J-2.012(1)(a) (providing that “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if an available position, as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.”). “By October 15, the department shall send to all hospitals that submitted a letter of intent an application package that will provide the hospitals with instructions for submitting information to the department for selection as a trauma center.” § 395.4025(2)(c), Fla. Stat. Applications from hospitals seeking to operate trauma centers must be received by the Department by the close of business on April 1 of the following year. Once the Department receives a trauma center application, it conducts “a provisional review of each application for the purpose of determining that the hospital’s application is complete and that the hospital has the critical elements required for a trauma center.” § 395.4025(2)(c), Fla. Stat. The Department’s provisional review includes, but is not limited to, an examination of whether an applicant has: the equipment and facilities necessary to provide trauma services; (b) personnel in sufficient numbers and with proper qualifications to provide trauma services; and (c) an effective quality assurance process. See § 395.4025(2)(c), Fla. Stat. “After April 30, any hospital that submitted an application found acceptable by the department based on provisional review shall be eligible to operate as a provisional trauma center.” § 395.4025(3), Fla. Stat. A hospital that has been approved to operate as a provisional trauma center can immediately begin providing care to trauma victims. From an operational perspective, there is no difference between a provisional trauma center and one that is fully verified. Between May 1 and October 1 of the year following the filing of the letter of intent, the Department conducts an in- depth evaluation of all the applicants that were deemed eligible to operate as provisional trauma centers. § 395.4025(4), Fla. Stat. Then, between October 1 of the year following the filing of the letter of intent and June 1 of the next year, a review team of out-of-state experts assembled by the Department makes “onsite visits to all provisional trauma centers.” The out-of-state experts utilize a survey instrument developed by the Department that includes “objective criteria and guidelines for reviewers based on existing trauma center standards such that all trauma centers are assessed equally.” § 395.4025(5), Fla. Stat. That survey instrument also includes “a uniform rating system that will be used by reviewers to indicate the degree of compliance of each trauma center with specific standards, and to indicate the quality of care provided by each trauma center as determined through an audit of patient charts.” § 395.4025(5), Fla. Stat. Even if a hospital satisfies all of the requirements to operate a trauma center, there must be a need for a trauma center in the relevant TSA. See § 395.4025(5), Fla. Stat. (providing that “hospitals being considered as provisional trauma centers shall meet all the requirements of a trauma center and shall be located in a trauma service area that has a need for such a trauma center.”). (emphasis added). The Department, based on recommendations from the review team, selects trauma centers by July 1 of the second year following the filing of the letter of intent. § 395.4025(6), Fla. Stat. Following this initial approval, “[e]ach trauma center shall be granted a 7-year approval period during which time it must continue to maintain trauma center standards and acceptable patient outcomes as determined by department rule.” Id. An approval, “unless sooner suspended or revoked, automatically expires 7 years after the date of issuance and is renewable upon application for renewal as prescribed by rule of the department.” Id. Also, “[n]otwithstanding any provision of chapter 381, a hospital licensed under ss. 395.001-395.3025 that operates a trauma center may not terminate or substantially reduce the availability of trauma service without providing at least 180 days’ notice [to the Department] of its intent to terminate such services.” § 395.4025(8), Fla. Stat. There are currently 33 approved trauma centers in Florida. Unless the statewide cap of 44 in section 395.402(4)(c) is amended or removed, the Department can only approve 11 more trauma center applicants. Assessment of Need for Trauma Centers under the Current Rules The Department must annually assess Florida’s trauma system, including the number and level of trauma centers needed for each trauma service area. See § 395.402(2)(b), Fla. Stat. (requiring the Department to “[r]eview the number and level of trauma centers needed for each trauma service area to provide a statewide integrated trauma system.”); § 395.402(3), Fla. Stat. (mandating that the Department must consider the following during its annual reviews: recommendations of regional trauma agencies; stakeholder recommendations; the geographic composition of an area; historical patterns of patient referral and transfer in an area; inventories of available trauma care resources; population growth characteristics; transportation capabilities; medically appropriate ground and air travel times; recommendations of the Regional Domestic Security Task Force; the actual number of trauma victims currently being served by each trauma center; and other appropriate criteria). As noted above, the Legislature has empowered the Department to adopt rules governing the procedures and process by which it will determine which applicants will be selected for designation as trauma centers. See § 395.4025(13), Fla. Stat. (providing that “[t]he department may adopt, by rule, the procedures and process by which it will select trauma centers. Such procedures and process must be used in annually selecting trauma centers and must be consistent with subsections (1)-(8) except in those situations in which it is in the best interest of, and mutually agreed to by, all applicants within a service area and the department to reduce the timeframes.”). The rules governing trauma centers are set forth in Florida Administrative Code Chapter 64J-2 (collectively referred to as “the Current Rules”). With regard to the instant case, rule 64J-2.010 is particularly relevant and details how Level I and Level II trauma centers will be allocated among the 19 TSAs. On an annual basis beginning on or before August 30, the Department implements the process set forth in rule 64J- 2.010 by conducting the annual assessment mentioned above and assigning a score to each TSA. The process in rule 64J-2.010 begins by evaluating each TSA pursuant to the following criteria: (a) population; median transport times; (c) community support; (d) severely injured patients discharged from acute care hospitals; (e) Level I trauma centers; and (f) number of severely injured patients. For each of the aforementioned criteria, points are assigned to each TSA based on data from the annual assessment. The point scales associated with each criterion are designed to measure the need in each TSA for trauma center services. For example, a TSA with a population of less than 600,000 would receive 2 points, and a TSA with a population of greater than 2,400,000 would receive 10 points. TSAs with populations between those two extremes would receive 4, 6, or 8 points. See Fla. Admin. Code R. 64J-2.010(1)(a)1. As for median transport time, a TSA with a median transport time of less than 10 minutes would receive 0 points. In contrast, if the median transport time in a TSA was greater than 41 minutes, then that TSA would receive 4 points. TSAs with median transport times between those two extremes would receive 1, 2, or 3 points. See Fla. Admin. Code R. 64J- 2.010(1)(a)2. After a TSA’s total score is determined, the Department compares that score to the scale in rule 64J- 2.010(1)(b) which provides that: The following scoring system shall be used to allocate trauma centers within the TSAs: TSAs with a score of 5 points or less shall be allocated 1 trauma center. TSAs with a score of 6 to 10 points shall be allocated 2 trauma centers. TSAs with a score of 11 to 15 points shall be allocated 3 trauma centers. TSAs with a score of more than 15 points shall be allocated 4 trauma centers. In the Current Rules, rule 64J-2.010(3) contains a table setting forth the results based upon the March 24, 2014, Amended Trauma Service Area Assessment. For example, the table in rule 64J-2.010(3) indicates that TSA 1 consisting of Escambia, Okaloosa, Santa Rosa, and Walton Counties has a need for one trauma center. In contrast, the table indicates that TSA 19 consisting of Dade and Monroe Counties has a need for three trauma centers. The Department Changes Its Interpretation of “Need” In October of 2014, Orange Park filed a letter of intent indicating its desire to operate a trauma center in TSA 5. Because the Current Rules indicated that there was no need for an additional trauma center in TSA 5, the Department rejected Orange Park’s letter of intent. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the maximum number of trauma centers that are needed in a particular TSA. In 2015, Orange Park submitted another letter of intent to operate a trauma center in TSA 5. The Department accepted that letter of intent even though the numeric “need” derived from rule 64J-2.010 for TSA 5 had not changed. That action was consistent with a determination that the numeric “need” derived from rule 64J-2.010 establishes the minimum number of trauma centers that are needed in a particular TSA. After the Department approved Orange Park’s application to operate as a provisional Level II trauma center in TSA 5, Shands Jacksonville challenged that decision, and Administrative Law Judge W. David Watkins issued a Recommended Order on January 27, 2017, concluding that Orange Park’s application must be denied. In the process of doing so, ALJ Watkins also concluded that “[t]he Department’s policy of accepting letters of intent and trauma center applications irrespective of need as established in rule 64J-2.010, constitutes an unadopted rule and is contrary to its validly adopted rules and statute.” Shands Jacksonville Med. Ctr., Inc., d/b/a UF Health Jacksonville v. Dep’t of Health and Orange Park Med. Ctr., Inc., DOAH Case No. 16-3369 (Recommended Order Jan. 27, 2017). Through the Proposed Rules, the Department is seeking to formalize its new interpretation of the term “need” as meaning the minimum number of trauma centers needed in a particular TSA. Assessment of Need under the Proposed Rules During the final hearing in this matter, Department employees described the Department’s impetus for changing its determination of how the term “need” as that term is used in chapter 395, part II, should be interpreted. For instance, the Department’s mission is to promote, protect, and improve the health of those living and visiting Florida. Because approximately 31 percent of severely injured patients were treated at acute care hospitals rather than trauma centers in 2013, the Department believes that there are an insufficient number of trauma centers in Florida. Also, as one or more trauma centers are added to a particular TSA, the Department observed that the number of trauma centers “needed” in that TSA under rule 64J-2.010 would decrease. This decrease would occur because median transport times and the number of severely injured patients discharged from acute care hospitals would decrease with the addition of trauma centers to that TSA. Accordingly, the Department deems the formula in rule 64J-2.010 to be a “diminishing” formula. As explained by Sue Dick, the Department’s Interim Division Director for the Division of Emergency Preparedness and Community Support (and former Chief of the Tallahassee, Florida Fire Department): [W]e saw the numbers required in a certain trauma service area diminishing because care was better. That’s what led us to go, wait a minute, that can’t be a maximum number because we are going to end up at a point where we say a maximum number is zero. So that’s when we started to look at the allocation and say, what we are really determining is how many more should they have to ensure that all patients are reaching median transport time in less than 10 minutes and very few patients are being discharged from acute care hospitals. That’s what led to the logic behind revisiting this rule and this formula. On September 1, 2016, the Department proposed a series of amendments to rules 64J-2.010, 64J-2.012, 64J-2.013, and 64J- 2.016. The Proposed Rules would implement the Department’s new policy of deeming the calculations pursuant to rule 64J- 2.010(1)(b) to represent the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA. For instance, the Proposed Rules’ version of rule 64J- 2.010(1)(b) would amend the current version of rule 64J- 2.010(1)(b) to read as follows: “[t]he following scoring system shall be used to determine the minimum number of allocate trauma centers needed within the TSAs. Also, the Proposed Rules would add a subsection (4) to rule 64J-2.010, which would state that “[t]he allocation of trauma centers, as described in subsections (1) through (3) of this rule, is the minimum allocation needed and shall not affect existing verified trauma centers seeking renewal of their verification status pursuant to subsection 395.4025(6), F.S., . . . .” (emphasis added). The Proposed Rules would amend rule 64J-2.012(1)(a) to read as follows: “[t]he letter of intent is non-binding, but preserves the hospital’s right to complete its application by the required due date if, subject to the trauma center limit in paragraph 395.402(4)(c), F.S., an available position, is open as provided in Rule 64J-2.010, F.A.C., exists in the hospital’s TSA.” As a result, there would no longer be TSA-specific caps in rule 64J-2.010, and the statewide cap of 44 trauma centers in section 395.402(4)(c) would be the only numeric cap on trauma centers. The same result would flow from the Proposed Rules’ amendment to rule 64J-2.013(7): The department shall make a final determination on whether to approve or deny a hospital’s extension request only after the provisional review of all other trauma center applications in the hospital’s TSA are completed, and it has been determined that the number of trauma centers and Provisional Ttrauma Ccenters, in the hospital’s TSA is less than or equal to the allocated number of trauma centers allowed by paragraph 395.402(4)(c), F.S. positions available for that TSA. Finally, subsection (12) of rule 64J-2.013 would become subsection (11) and be amended as follows: A hospital receiving an extension greater than 12 months shall have its extension denied or terminated if the number of trauma centers and or Provisional Ttrauma Ccenters in the hospital’s TSA equals or is greater than the number of trauma centers provided in paragraph 395.402(4)(c), F.S available positions allocated to the TSA, resulting in the denial of its application and the department will inform the applicant of its right to a Section 120.57, F.S., hearing regarding this denial. Because the Proposed Rules would result in the calculations pursuant to rule 64J-2.010(1)(b) representing the minimum number of trauma centers needed in a particular TSA rather than the maximum number of trauma centers allowed in that TSA, the Department could conceivably approve every applicant in that TSA so long as the statutory cap of 44 trauma centers in section 395.402(4)(c) would not be exceeded. The Proposed Rules also establish a tie-breaker system if the sum of provisional trauma centers found eligible for selection by the Department and the number of existing trauma centers would exceed the statutory limit established in section 395.402(4)(c). The tie-breaking criteria would consider the following: (a) whether the TSA in question already has a Level I or Level II trauma center; (b) the level of service that the applicants propose to provide; (c) the number of severely injured patients treated by the applicants; and (d) approval by a Department-approved trauma agency plan. Chief Dick testified that the Department would exercise discretion to ensure that a TSA that already had the minimum number of trauma centers under the Proposed Rules would not receive an additional trauma center if the statutory cap of 44 would be met or exceeded and another TSA lacked the statutory minimum of one: Q: Now, I want to explore a little bit one of the answers that you gave to Mr. Reynolds regarding how the [Proposed Rules] would work in conjunction with the statutory cap of 44 and the requirement for assignment of a trauma center to each TSA. Let me ask you a hypothetical. If there [are] 43, when you get to the point when there [are] 43 trauma centers that are opened around the state but there is still not one in Collier County, how does it work at that point as a potential new applicant comes in? A: If they are not in Collier County, they won’t be verified. We have a statutory obligation to meet the minimum of one per TSA, so – at a statutory cap of 44. So logic would state then as part of that 44, it includes one per TSA. So if there are 43 and there are none in TSA 17, we would have to reserve that spot until such point as there is one at a minimum in TSA 17, which is Collier, I believe. Q: Would that likewise be the approach if you have a TSA where the methodology calculates there is a need for four, but there [are] only three that are opened, how would it work then? A: I think it would be responsible of the Department, as we view the results of this allocation methodology as setting a minimum need to ensure reasonable access to care, that we would withhold spots until such point as that minimum is met per TSA. So if we are at 42 and there is still not one in TSA 17, which we just spoke to, but in addition there is another TSA that has one but through our methodology, we really think they need a minimum of two, I believe it’s within the Department’s authority to withhold that second one as well. However, Chief Dick acknowledged in subsequent testimony that the discretion she relies upon does not originate from a statute or a rule: Q: I think we had put forth that there’s been some testimony concerning the hypothetical, the what if there’s more applications received by the Department in a cycle than there are statewide slots? So in other words, you’ve got enough applications that its’s going to pop you over the [statutory cap of] 44. Do you understand my hypothetical? ALJ: We are still talking about the [Current Rules]? Q: Under [the Proposed Rules]. ALJ: [Proposed Rules]. Okay. Q: Thank you. A: I understand what you are saying. Q: And would you agree that there’s nothing in the [Proposed Rules] that tells you what happens in that circumstance, if the number received in all of the TSAs will put you over the statewide number? A: There’s nothing in the proposed rule that states that if we receive more applications than there are available spots statewide, what we will do. Q: Correct. There’s no criteria or standards? A: No, those procedures are not outlined in the rule, no. Q: Similarly, there’s nothing in [the Proposed Rules] that would preclude that all of the open positions statewide could be in one TSA or two TSAs to the exclusion of others; there’s nothing that prevents that from occurring? A: Well, I think there is something that prevents that from occurring, and the first thing being that – the first thing we would look at is to ensure there is at least one trauma center in each TSA so we would be able to reserve that. And the other thing I think is where it speaks to a trauma service area, trauma service area that has a need, we would interpret that to mean a minimum need as determined by our allocation methodology. So I would say that if there are – if it were an issue of we were going to go over the 44 and there was a TSA that still did not meet their minimum as we’ve outlined in our proposed rule, that it would be within our prerogative of the Department to hold a spot for that TSA to meet that minimum. Q: When you say it would be within your prerogative, there is nothing in the statute that outlines that procedure you just discussed, that you would hold one in your back pocket and say, I need that one for Collier County? A: No. Q: There’s nothing in [the Proposed Rules] that says that? A: No, there’s been a number of hypotheticals presented, and I just don’t think you can craft a rule that would address every hypothetical. So, no, there’s nothing that speaks specifically to that, what our specific process would be under those specific circumstances. * * * Q: I understand. [The Proposed Rules set] a minimum and all – my only question is, there [are] no standards or criteria in [the Proposed Rules] that would identify how many above the minimum should be approved; the Department’s position is it would approve as many as are applied for, if they meet all the standards? A: And have the endorsement of the regional trauma agency, yes. The Potential Utility Associated with Adopting the Proposed Rules All parties have proceeded under the reasonable assumption that adoption of the Proposed Rules would lead to more trauma centers in Florida. The Department and Intervenors’ primary argument in support of the Proposed Rules is that more trauma centers will result in: (a) increased access to the specialized care available at trauma centers; and (b) less time needed to transport trauma patients to trauma centers. Undertriage occurs when a severely injured patient in need of trauma care is treated by an acute care hospital. In that circumstance, the patient does not receive the benefit of being admitted to a facility dedicated to treating severely injured patients. The January 6, 2016, Amended Trauma Service Area Assessment by the Department indicates that approximately 31 percent of severely injured patients in Florida received care in an acute care hospital rather than a trauma center in 2013. Dr. Mark McKenney, an expert in surgical care and trauma care, characterized undertriage as an access to care problem that could threaten one’s life: I don’t think that any of us would feel good to have a third of us, when we have a life- threatening injury, end up in a hospital that doesn’t have a trauma team, doesn’t have trauma nurses, doesn’t have a trauma intensive care unit, doesn’t have an operating room immediately available, doesn’t have a surgeon in the hospital 24/7 who can take care of this, and doesn’t have subspecialists who routinely take care of the traumatically injured patients. A third is just too high a number. With regard to transport times, trauma care professionals refer to a generally accepted clinical principle for rendering treatment known as “the Golden Hour.” Within one hour after a person is injured, all of the following should occur: (a) emergency personnel are notified, arrive at the injury scene, evaluate the patient, and transport the patient to a trauma center; and (b) the trauma center starts resuscitation; conducts another evaluation of the patient; and performs a life-saving procedure. According to the Department and Intervenors, the increased access to trauma centers and the decreased transport times associated with adoption of the Proposed Rules will save lives.4/ Petitioners’ response to that line of reasoning is that an increase in the number of trauma centers will lead to a decrease in the quality of care rendered to trauma patients. A trauma center needs to treat a certain number of severely injured patients in order for its personnel to remain proficient and for the trauma center’s quality of care to remain high. During the final hearing, Petitioners presented persuasive testimony that “practice makes perfect” with regard to the treatment of trauma patients. For instance, Dr. Steven Epstein, an expert in trauma surgery, credibly testified that trauma injuries require a different level of expertise and that experience acquired through treating less severe injuries does not necessarily translate to the treatment of trauma patients: If you have a set number of patients and you put another trauma center geographically close, what happens is that you will cut the number of patients going to each place, each trauma center. And expertise in the general surgery world, as well as the trauma world, is based on volume. Let me start with the general surgery world and then move toward trauma. We know that in general surgery, residencies right now, they are focusing on different areas of surgery: breast surgery, colorectal surgery, laparoscopic surgery, so that people become experts in these areas. The idea of the general surgeon is going away. The same thing occurs with trauma surgery. Only the expertise there is learned during a fellowship and then with practice. If you take, for instance, a gunshot, the anatomy, any general surgeon can take out a gallbladder, but not any general surgeon can handle a gunshot to the abdomen. The anatomy changes. It’s a much different case. So people who have done this on a regular basis have some idea how to do this. The – what I call the voyeur, you bring in a general surgeon to do some trauma because we don’t have enough trauma surgeons, doesn’t have this same expertise. And you wind up as really – it’s a patient problem. We are talking about it as a problem with hospitals, but this is a patient problem. If the doctor doesn’t know how to treat the patient, then the patient suffers. And I think in the end, that’s what happens when you dilute an expertise. And trauma, with the addition of all these hospitals, winds up diluting an expertise. * * * We, meaning the doctors at our hospital and several other hospitals, have always made an assumption we practice, we practice, we practice, and we get better. If you don’t have the patients – because they call it the practice of medicine. If you don’t have the patients to practice with, you are not going to maintain your expertise. And I use the example, for instance, of a gunshot. But we do blunt trauma where people are in auto accidents, they are in shock, how to get them out of shock. There’s this whole sequence of events that takes place. Nursing, how to take care of these patients. It’s quite complex and I firmly believe that dilution of this knowledge is very detrimental in the end to the patient.5/ In addition, an increase in trauma centers would make it more difficult for a trauma center to acquire and retain the trauma center personnel that must be constantly on site. Dr. Epstein testified that trauma surgeons are already a scarce resource, and that scarcity will only be exacerbated with the addition of more trauma centers. Also, Mark Valler, an expert in trauma center and acute care medical staff administration, credibly testified about how the addition of 10 or 11 trauma centers in Florida would impact an existing trauma center’s ability to retain its staff: But I am concerned that 10 or 11 opening statewide, there are going to be advertisements for trauma surgeons, for neurosurgeons, for trauma orthopedic doctors all over the place. People are going to be recruiting like crazy, and they are going to be recruiting in the state of Florida because the physicians already have a Florida state license, so there is going to be a huge, huge recruiting effort if all those centers actually get approved at one time. However, there was no persuasive evidence presented during the final hearing indicating that any recent openings of new trauma centers have resulted in existing trauma centers experiencing declines in patient volume that would negatively impact quality of care. Accordingly, Chief Dick testified that it would be irresponsible for the Department to not facilitate better access to trauma care when the Department has received no evidence that quality of care had suffered. During the final hearing, Petitioners frequently mentioned the theoretical possibility that adoption of the Proposed Rules could lead to an inordinate number of trauma centers opening in a single TSA. Given the substantial amount of resources needed to open and maintain a trauma center, it is unlikely that a rational hospital administrator would seek to open a trauma center in a particular TSA unless the volume of trauma patients would enable it to operate profitably. Nevertheless, the testimony and the evidence leads to an inference that adoption of the Proposed Rules would likely lead to more trauma centers in well-served TSAs and no increase for TSAs in need of more trauma care. The following testimony from Mark Richardson, an expert in healthcare facility and services planning, illustrates this point: Q: There’s been some suggestion, I think you may have heard this during your deposition, that there may be free market forces that would operate to prevent some of these adverse results that you are describing. Do you have an opinion as to whether free market factors would help to prevent the maldistribution or other issues that you described as being bad consequences? A: I do have an opinion. I think if you look in terms of the folks, whoever have applied via a letter of intent for the development of the additional trauma centers, those centers are not located in areas where there currently are longer transport times. Those centers basically are located in basically metropolitan areas where there are already appears to be good reasonable access to care. Basically it’s adding new programs where there’s already a pretty good network of care provided. * * * My point here is that if you look in terms of where these folks are, they are basically in the Jacksonville area; they are basically in the Miami-Dade, south Florida area; they are in the Orlando area; or they are in the Palm Beach and Broward area, where there already are a number of existing transplant programs, where, for example, specific to the median transport time, there’s no problem in those areas. This is not the Panhandle where there is a problem in terms of transport times. This is not north Florida in terms of north Florida area where portions of the area may have some problems. This is basically adding incremental trauma center capacity to locales where there already is adequate care. It is certainly possible that Petitioners’ fears about lower quality of care could be realized if there is nothing other than the statutory cap to prevent hospitals from opening an unlimited number of trauma centers in TSAs encompassing large metropolitan areas. After considering all of the evidence and testimony, the undersigned is of the opinion that it would be impossible to draft a set of rules that would satisfy the concerns/interests of all the relevant stakeholders.6/ The disagreement over the merit of the Proposed Rules boils down to striking a balance between “practice makes perfect” and providing the earliest opportunity for definitive care. In relation to each other, the Current Rules put more emphasis on “practice makes perfect,” and the Proposed Rules emphasize providing more access to care.
The Issue Whether certain forms incorporated by reference into the administrative rules of the Respondent constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Tampa General Hospital ("TGH" or "Petitioner") is a general acute care hospital in Tampa, Florida and is a verified Level I state-approved trauma center. By definition, a Level I trauma center is required to include an adult trauma center and a pediatric trauma referral center. The Department of Health and Rehabilitative Services ("DHRS" or "Respondent") is the state agency with responsibility for certification of trauma centers in Florida. St. Joseph's Hospital ("SJH" or "Intervenor") has filed an application for state approval as a pediatric trauma referral center which is the subject of a separate administrative challenge by TGH. In the instant case, TGH challenges three DHRS forms incorporated by reference into the Florida Administrative Code and which are utilized by applicants seeking certification as state-approved trauma centers. Tampa General has standing to challenge the forms in this proceeding. The three forms challenged by TGH in this case are HRS Form 1840, ("State-Approved Trauma Center Letter of Intent"), HRS Form 1721, ("Application for State-Approved Pediatric Trauma Referral Center"), and the portions of HRSP 150-9, which identify the "critical standards" which must be met by an applicant seeking to obtain approval as a provisional state approved pediatric trauma referral center. The three forms include reference dates of October 1991. The forms were adopted as part of a rule promulgation effort prior to the 1992 Legislative session. Obviously the DHRS did not address the 1992 legislation in the 1991 rules. In relevant part, the 1992 legislation added a requirement that, under conditions set forth in the statute, proposed trauma centers must be certified as consistent with local or regional trauma plans. The forms challenged by TGH fail to reference the requirement. Section 395.4025(2)(a), Florida Statutes, requires submissions of letters of intent from hospitals seeking to become certified as state-approved trauma centers. Section 395.4025(2)(a), Florida Statutes, further requires that "[i]n order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a state-approved trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists." The statute states that the requirement is not applicable to hospitals which were provisional or verified trauma centers on January 1, 1992. There are five local or regional trauma agencies in Florida which have been approved by the DHRS. Hillsborough County, where both the Petitioner and the Intervenor operate hospitals, has one of the five local trauma agencies. Rule 10D-66.109(a), Florida Administrative Code provides that the department "shall accept a letter of intent, HRS Form 1840, October 91, State- Approved Trauma Care Center Letter of Intent, which is incorporated by reference and available from the department. " The form letter of intent provided to applicants by the DHRS fails to reference the local plan consistency requirement or the conditions under which the requirement is applicable. Section 395.4025(2)(a), Florida Statutes, relates only to letters of intent. It clearly indicates that the certification of local plan consistency is an issue to be addressed as part of the letter of intent filed by a provider. The form letter of intent does not provide notice to the applicant that such certification may be required, either as part of the completed letter of intent or otherwise. The omission of the certification requirement from the letter of intent form is misleading. It fails to indicate that a hospital should address the issue in its letter of intent. The form contravenes the statute. TGH also challenges HRS Form 1721, October 91, ("Application for State-Approved Pediatric Trauma Referral Center",) and the portions of HRSP 150- 9, October 91, which identify the "critical standards" which must be met by an applicant. Section 395.4025(2)(c), Florida Statutes, (1994 Supplement) provides as follows: In order to be considered by the department, applications from those hospitals seeking selection as state-approved trauma centers, including those current verified trauma centers which seek to be state-approved trauma centers, must be received by the department no later than the close of business on April 1. The department shall conduct a provisional review of each application for the purpose of deter- mining that the hospital's application is complete and that the hospital has the critical elements required for a state approved trauma center. This critical review will be based on trauma center verification standards and shall include, but not be limited to, a review of whether the hospital has: Equipment and physical facilities necessary to provide trauma services. Personnel in sufficient numbers and with proper qualifications to provide trauma services. An effective quality assurance program. Submitted written confirmation by the local or regional trauma agency that the verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists. This sub- paragraph applies to any hospital that is not a provisional or verified trauma center on January 1, 1992. Rule 10D-66.109(c), Florida Administrative Code, requires that an applicant for licensure as a provisional state-approved pediatric trauma referral center must submit an application on HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center. The form is incorporated by reference in the rule. HRS Form 1721, October 91, Application for State-Approved Pediatric Trauma Referral Center, fails to reference the local plan consistency issue or the conditions under which the requirement is applicable. However, the instructions to the form provide as follows: INSTRUCTIONS: To be eligible for approval as a SAPTRC, a hospital must complete this application and submit all requested information to the HRS, Office of EMS, for review. The following must be used to complete this application: HRS Pamphlet (HRSP) 150-9 entitled "State Approved Trauma Centers and State-Approved Pediatric Trauma Referral Center Approval Standards", Oct 91 (standards document), and the application requirements of Chapter 395, Florida Statutes (F.S.), and Chapter 10D-66, Florida Administrative Code (F.A.C.). Following discussion of a three phase review process, the HRS Form 1721 instructions again state that "HRS Pamphlet (HRSP) 150-9, Oct 91, the application requirements of Chapter 395, F.S., and Chapter 10D-66, F.A.C., will be used as criteria for application review." By reference to the statute and rules, the instructions to the application notify an applicant as to the requirements for certification. The failure of the actual application to specifically restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement. As to the standards document in which the critical standards for provisional approval are set forth, rule 10D-66.109(d)2, Florida Administrative Code, provides as follows: The minimum standards for review for Provisional SAPTRCs are the following portions of HRSP 150-9, October 91; STANDARD Type of Hospital Surgery Department; Division; Services; Sections: A Surgical Specialties Availabilities: A 1, 2, 3 & 4 Non-Surgical Specialties Availabilities: 1, 8 & 13 Emergency Department (ED): A, B, D & H Operating Suite Special Requirements: A IX. Pediatric Intensive Care (P-ICU): A, C, 1 XVI. Quality Management: A, B, C, D, & E It is unnecessary to address each critical standard in this order. Essentially, they relate to the first three "critical elements" set forth as Section 395.4025(2)(c)1-3, Florida Statutes. However, review of the cited portions indicates that there is no reference within the cited sections of HRSP 150-9, October 91, which addresses the possible requirement of local trauma plan consistency certification. The application processing framework set forth by the administrative rules indicates that local plan consistency is to be considered prior to the DHRS's commencement of provisional review. Rule 10D-66.109(d), Florida Administrative Code, provides that "[a]fter considering the results of the local or regional trauma agency's recommendations, the department shall, by April 15, conduct a provisional review to determine completeness of the application and the hospital's compliance with the critical standards for provisional standards." If, as the rule suggests, certification of local plan consistency is considered prior to commencement of provisional review, it would be duplicative to include the requirement in the technical critical standards set forth in the standards document. The failure of the standards document to restate the potential requirement of certification of local trauma plan consistency does not contravene or modify the requirement.
The Issue The issue for determination is whether Petitioner is in substantial compliance with the requirements in section 395.4025, Florida Statutes, and, therefore, has the critical elements required for a trauma center, so that Respondent must find Petitioner's Level II Trauma Center Application acceptable for approval, which would make Petitioner eligible to operate as a provisional trauma center.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order (i) deeming JSCH's Application acceptable, verifying that the hospital is in substantial compliance with the requirements in section 395.4025, and (iii) approving JSCH to operate as a provisional Level II trauma center until the 2014-16 application cycle is concluded with finality vis-à- vis TSA 19. DONE AND ENTERED this 29th day of February, 2016, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of February, 2016.
Conclusions THE PARTIES resolved all disputed issues and executed a Settlement Agreement. The parties are directed to comply with the terms of the attached settlement agreement. Based on the foregoing, this file is CLOSED. DONE and ORDERED on this the ----3_ day of J--+Ni 1_c..y....,....,_-..._.{_· , 2014, m Tallahassee, Florida. /\ /' f ' .' C \ ).;'-(/ '((l /r- ELIZABETH DUDEK, SECRETARY (Agency for Health Care Admforstration A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO A JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. (OPPOSING COUNSEL) Peter A Lewis, Esquire 302 North Shannon Lakes Drive Suitel0l Tallahassee, Florida 32309 (Via U.S. Mail) Bureau of Health Quality Assurance 2727 Mahan Drive, Mail Station 9 Tallahassee, Florida 32308 (Interoffice Mail) Stuart Williams, General Counsel Agency for Health Care Administration 2727 Mahan Drive Building 3, Mail Station 3 Tallahassee, Florida 32308 (Interoffice Mail) Shena Grantham, Chief Medicaid FFS Counsel Agency for Health Care Administration 2727 Mahan Drive Building 3, Mail Station 3 Tallahassee, Florida 32308 (Interoffice Mail) Karen Chang, Bureau Chief Medicaid Program Analysis 2727 Mahan Drive Building 2, Mail Station 21 Tallahassee, Florida 32308 (Interoffice Mail) Agency for Health Care Administration Bureau of Finance and Accounting 2727 Mahan Drive Building 2, Mail Station 14 Tallahassee, Florida 32308 (Interoffice Mail) Zainab Day, Medicaid Audit Services Agency for Health Care Administration 2727 Mahan Drive, Mail Station 21 Tallahassee, Florida 32308 (Interoffice Mail) Kristin M. Bigham Office of the Attorney General The Capitol PL - 01 Tallahassee, FL 32399-1050 (Via US Mail) State of Florida, Division of Administrative Hearings The Desoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (Via U.S. Mail) CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished to the above named addressees by U.S. Mail on this the of -;,;;-D, 2014. Richard Shoop, Esquire Agency Clerk State of Florida Agency for Health Care Administration 2727 Mahan Drive, Building #3 Tallahassee, Florida 32308-5403
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.
