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 the Proposed Rule 64J-2.010 enlarges, modifies or contravenes the specific provisions of law implemented, or is arbitrary or capricious, and thus constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Parties Shands operates an 852-bed hospital and Level I trauma center in Gainesville, Alachua County, Florida. Its business address is 1600 Southwest Archer Road, Gainesville, Florida. Shands treats about 2,500 trauma patients each year. Shands is located within trauma service area (TSA) 4, which is comprised of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, and Union counties. St. Joseph’s is a regional tertiary hospital and has served the Tampa area for 75 years and has approximately 800 licensed acute care beds. St. Joseph offers a broad array of acute care services including tertiary health care, serves as a comprehensive regional stroke center, and has been repeatedly recognized as a Consumers Choice hospital. St. Joseph operates a Level II trauma center and a Level I pediatric trauma center. St. Joseph is located in TSA 10, consisting of a single county, Hillsborough. Tampa General is a major tertiary hospital that is designated by the state as a Level I trauma center. Tampa General also serves as a teaching hospital for the University of South Florida, College of Medicine ("USF"). Tampa General is located in Tampa, Hillsborough County, Florida, TSA 10. Bayfront is a 480-bed tertiary hospital located in Pinellas County, Florida. In addition to serving as a teaching hospital, Bayfront is designated as a Level II trauma center pursuant to chapter 395, Part II, Florida Statutes. It is located in TSA 9, composed of Pinellas and Pasco counties. The Public Health Trust of Miami-Dade County, is an entity which governs and operates the Jackson Health System, including the Ryder Trauma Center at Jackson Memorial Hospital. It is in TSA 19, consisting of Dade and Monroe counties. The Florida Department of Health is the state agency authorized to verify and regulate trauma centers in the state of Florida pursuant to chapter 395, Part II, Florida Statutes, and Florida Administrative Code Rule 64J-2.001 et seq. The Division of Emergency Medical Operations, Office of Trauma, oversees the Department's responsibilities with respect to the statewide trauma system. Osceola is a licensed acute care general hospital, located at 700 West Oak Street, Kissimmee, Florida. Osceola provides a wide array of high quality health services to the residents and visitors within its service area. It is located in TSA 8, consisting of Lake, Orange, Osceola, Seminole, and Sumter counties. The Florida Trauma System For purposes of organizing a statewide network of trauma services, the Florida Legislature directed the Department to undertake the implementation of a statewide inclusive trauma system as funding is available. § 395.40(3), Fla. Stat. The need for a trauma system is premised on the basic principle that a trauma victim who is timely transported and triaged to receive specialized trauma care will have a better clinical outcome. § 395.40(2), Fla. Stat. A trauma victim's injuries are evaluated and assigned an Injury Severity Score ("ISS"). § 395.4001(5), Fla. Stat. Patients with ISS scores of nine or greater are considered trauma patients. § 395.402(1), Fla. Stat. Trauma experts speak in terms of "a Golden Hour," a clinical rule of thumb that postulates no more than 60 minutes should elapse from the occurrence of an injury to the beginning of definitive treatment. There is, however, no current consensus on what constitutes the "Golden Hour" for transport times. A 1990 Department study recommended travel time of 25-35 minutes as the outside range for optimal outcomes. A 1999 Department study favored a goal of 30 minutes transport time by ground, and a 50-mile radius by helicopter. By contrast, a 2005 study conducted for the Department used 85 minutes "total evacuation time" as "acceptable." A trauma center is a hospital that has a collection of resources and personnel who are charged with taking care of trauma patients. They are recognized by the community as a resource for care of severely injured patients. The International Classification Injury Severity Score (“ICISS”) methodology, considered with discharged patient data from the Agency for Health Care Administration database, was used by DOH to determine severely injured patients. An ICISS score is the product of the survival risk ratios (i.e., the probabilities of survival) calculated for each traumatic injury a single patient suffers. Level I trauma centers are generally larger and busier and treat more patients than Level II centers. Level I trauma centers are required to engage in education and research. Trauma centers are required to have several types of physician specialists at the ready at all times. For instance, with respect to surgical services, a Level I trauma center must have a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary (in-hospital) and backup trauma coverage 24 hours a day at the trauma center when summoned. Further, in addition to having at least one neurosurgeon to provide in-hospital trauma coverage 24 hours a day at the trauma center, a Level I provider must also have surgeons available to arrive promptly at the trauma center in 11 other specialties, including (but not limited to) hand surgery, oral/maxillofacial surgery, cardiac surgery, orthopedic surgery, otorhinolaryngologic surgery and plastic surgery. Level II trauma centers must comply with similar physician specialist standards. Little if any credible evidence was presented in the present case to suggest that the ability to hire qualified clinical staff, technicians, specialty physicians and other personnel would be severely impacted if the Proposed Rule is implemented. Rather, the existing trauma centers lamented the possibility of reduced case loads which could make it more difficult to retain proficiency. Invalidation of Former Rule 64J-2.010 In 1992, the Department of Health and Rehabilitative Services (HRS), the Department of Health's predecessor, promulgated Florida Administrative Code Rule 64J-2.010, titled "Apportionment of Trauma Centers within a Trauma Service Area," (hereinafter referred to as the “Former Rule”). The Department of Health assumed administration of the Former Rule in 1996, when the Legislature split HRS into two new agencies, the Department of Health and the Department of Children and Families. The Former Rule regulated the number of trauma centers that could be established in Florida. The Former Rule divided the state into TSAs as set forth in section 395.402(4), and for each TSA, announced the number of trauma center "positions" available. In 2004, the Florida Legislature amended section 395.402 to require the Department to complete an assessment of Florida's trauma system, and to provide a report to the Governor and Legislature no later than February 1, 2005 (the 2005 Assessment). The scope of the assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. One objective of the assessment was to consider aligning trauma service areas within the trauma region boundaries as established in section 395.4015(1). It required the Department to establish trauma regions that cover all geographic areas of the state and have boundaries that are coterminous with the boundaries of the Regional Domestic Security Task Forces (“RDSTF”) established under section 943.0312. In a related 2004 amendment, the Legislature added a provision that gave the Department the option to use something other than the trauma service areas codified in section 395.402(4) upon completion of the 2005 Assessment. See § 395.402(2), Fla. Stat. ("Trauma service areas as defined in this section are to be utilized until the Department of Health completes" the 2005 Assessment.) § 395.402(4), Fla. Stat. ("Until the department completes the February 2005 assessment, the assignment of counties shall remain as established in this section."). As part of the 2004 amendments to the trauma statute, the Legislature also required the Department to conduct "subsequent annual reviews" of Florida's trauma system. In conducting such annual assessments, the Legislature required the Department to consider a non-exhaustive list of criteria set forth in section 395.402(3)(a)-(k). Further, the Legislature required the Department to annually thereafter review the assignment of Florida’s 67 counties to trauma service areas. The Department timely submitted its 2005 Assessment to the Legislature on February 1, 2005. With respect to its review of the trauma service areas, the 2005 Assessment recommended against the continued use of the 19 trauma service areas. The 2005 Assessment instead suggested that it may be feasible for the existing trauma service areas to be modified to fit the seven RDSTF regions to facilitate regional planning. Following receipt of the 2005 Assessment, the Department took no action to amend the Former Rule and adopt the recommendations of the 2005 Assessment. As a result, in June 2011, several existing trauma centers challenged the validity of the Former Rule pursuant to sections 120.56(1) and (3). See Bayfront Med. Ctr., Inc. et al. v. Dep't of Health, DOAH Case Nos. 11-2602RX, 11-2603RX, 11-2746RX, 11-2796RX (Fla. Div. Admin. Hear., Sept. 23, 2011). On September 23, 2011, an administrative law judge of the Division of Administrative Hearings entered a final order holding that the Former Rule was an invalid exercise of delegated legislative authority. The administrative law judge concluded that the Former Rule was invalid because it contravened the laws it purportedly implemented, including section 395.402. The judge found: The authority granted by section 395.402 for the use of the [nineteen] identified TSAs existed only until February 2005. After that time, the Department was required to consider the findings of the 2005 Assessment, as well as the recommendations made as part of the regional trauma system plan. Thus, section 395.402 can no longer service as a valid basis for the Rule. However, as set forth below, the authority to utilize the 19 TSAs was not rescinded; rather, the mandated requirement to use only the TSAs was rescinded. The Department was required to review the assignment of Florida’s 67 counties to trauma service areas, taking into consideration the factors set forth in paragraphs (2)(b)-(g) and subsection (3) of section 395.402. Having done so, it was incumbent on the Department to amend its [Former] Rule to allocate the number of trauma centers determined to be needed within each designated area through systematic evaluation and application of statutory criteria. On November 30, 2012, the First District Court of Appeal affirmed the administrative law judge's determination that the Former Rule was an invalid exercise of delegated legislative authority. See Dep't of Health v. Bayfront Med. Ctr., Inc., 134 So. 3d 1017 (Fla. 1st DCA 2012). After noting that the Former Rule claimed to implement sections 395.401, 395.4015, and 395.402, the appellate court held that the Former Rule was invalid because it failed to reflect the substantial amendments to those laws that were enacted in 2004. The appellate court held: Both the pre-and post-2004 versions of the statute require the Department to establish trauma regions that "cover all geographic areas of the state." However, the 2004 amendment requires that the trauma regions both "cover all geographical areas of the state and have boundaries that are coterminous with the boundaries of the regional domestic security task forces established under s. 943.0312." § 395.4015(1), Fla. Stat. (2004). Similarly, the rule fails to implement the 2004 amendments to section 395.402. The version of the statute in effect at the time the rule was promulgated set forth the nineteen trauma service areas reflected in the rule. [T]he 2004 version of the statute required the Department to complete an assessment of Florida's trauma system no later than February 1, 2005. It further provides that the original nineteen trauma service areas shall remain in effect until the completion of the 2005 Assessment. Bayfront, 134 So. 3d at 1019-20 (Emphasis added). It should be noted that the 2004 version of the statute does not specify at what point in time the 19 TSAs could no longer be utilized, only that they would have to be used at least until completion of the 2005 Assessment. Rule Development The Department thereafter initiated rule development workshops to commence construction of a new rule. The first workshop concerning this rule was in Tallahassee, Florida, on December 21, 2012. In January and February 2013, workshops were then held in Pensacola, Tampa, Ocala, Jacksonville, and Miami, as DOH continued working on a new rule. Each of the sessions involved input from interested persons both live and by telephone. Written comments and oral presentations by these persons were considered by the Department. After these first six workshops, held in various regions of the State to make them more accessible to more citizens, DOH then scheduled three more workshops in March 2013, to be held in areas where there were no existing trauma centers, specifically Ft. Walton Beach, Naples, and Sebring. DOH also considered the recommendations of a report issued by the American College of Surgeons (“ACS”), the lead professional group for trauma systems and trauma care in the United States. The ACS sent a consultation team to Tallahassee, Florida, to conduct a three-day site visit and hold public workshops in February 2013. The ACS ultimately issued a report entitled “Trauma System Consultation Report: State of Florida,” in May 2013. The report included as one of its recommendations the use of RDSTF regions as the TSA areas to be used in determining need for additional trauma centers. In November 2013, DOH released a draft proposed rule and a draft of its first TSA Assessment (the January TSA Assessment). The Department then conducted three additional workshops in Pensacola, Orlando, and Miami. Again, DOH solicited comments from interested persons and entered into a dialogue as to what the proposed rule should look like upon publication. On January 23, 2014, DOH conducted a Negotiated Rulemaking Committee meeting at the Department’s headquarters in Tallahassee, Florida. The committee consisted of seven persons: Karen Putnal, Esquire and Dr. Fred Moore--representing existing trauma centers; Steve Ecenia, Esquire and Dr. Darwin Ang-- representing new trauma centers currently under challenge; Dr. Patricia Byers--representative of the EMS Advisory Council; Jennifer Tschetter, Esquire and Dr. Ernest Block--representing DOH. The public was invited to attend the session but was not afforded an opportunity to speak. The Department considered all the input from each of the workshops, the ACS Report, and the negotiated session, as well as all the applicable items enumerated in section 395.402(3)(a)-(k). The Proposed Rule On February 3, 2014, the Department published Notice of Development of Proposed Rule 64J-2.010 (the "Proposed Rule") in Florida Administrative Register, Volume 40, Number 22. The Department's Notice cited section 395.405, as rulemaking authority for the Proposed Rule. The Notice also cited sections 395.401, 395.4015, 395.402, and 395.405 as the laws intended to be implemented by the Proposed Rule. The following day, February 4, 2014, the Department published a Notice of Correction in Florida Administrative Register, Volume 40, No. 23, to correct the history notes of the Proposed Rule. In the corrected Notice, the Department cited section 395.402 as its rulemaking authority in addition to section 395.405. The correction also removed reference to sections 395.401, 395.4015, and 395.405, as laws implemented by the Proposed Rule. Following the Department's correction, the Proposed Rule was intended only to implement section 395.402. The Proposed Rule established 19 TSAs and determined the number of trauma centers to be allocated within each TSA, based upon a scoring system established in the Proposed Rule. Under the scoring system, TSAs were awarded positive or negative points based on data in an annual Trauma Service Area Assessment relating to the following six criteria: (1) population; (2) median transport times; (3) community support; (4) severely injured patients not treated in trauma centers; (5) Level 1 trauma centers; and (6) number of severely injured patients (in each TSA). Ms. Tschetter added the last two criteria (Level I Trauma Centers and Number of Severely Injured Patients) in response to comments received at the negotiated rulemaking session. Subsequent to a final public hearing held on February 25, 2014, DOH revised its January TSA Assessment and the earlier version of the Proposed Rule. The revised TSA assessment (the “March TSA Assessment”) reflected more conservative calculations (as gleaned from input and discussions with stakeholders) and documents the statutory patient volumes for the existing Level I and Level II trauma centers in each TSA. The March TSA Assessment further recalculated the Median Transport times, including all transports from 0-10 minutes (as opposed to only those transports greater than 10 minutes) and only transports to trauma centers (as opposed to transports to all hospitals). On March 25, 2014, a Notice of Change was published in the Florida Administrative Register. The Proposed Rule, as published on that date, is as follows: Notice of Change/Withdrawal DEPARTMENT OF HEALTH Division of Emergency Medical Operations RULE NO.: RULE TITLE: 64J-2.010 Apportionment of Trauma Centers within a Trauma Service Area (TSA) NOTICE OF CHANGE Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 40, No. 22, February 3, 2014 issue of the Florida Administrative Register. 64J-2.010 Allocation of Trauma Centers Aamong the Trauma Service Areas (TSAs). Level I and Level II trauma centers shall be allocated among the trauma service areas (TSAs) based upon the following: The following criteria shall be used to determine a total score for each TSA. Points shall be determined based upon data in the Trauma Service Area Assessment. Population A total population of less than 0 to 600,000 receives 2 points. A total population of 600,001 to 1,200,000 receives 4 points. A total population of 1,200,001 to 1,800,000 1,700,000 receives 6 points. d. A total population of 1,800,000 1,700,001 to 2,400,000 2,300,000 receives 8 points. e. A total population greater than 2,400,000 2,300,000 receives 10 points. Median Transport Times Median transport time of less than 0 to 10 minutes receives 0 points. Median transport time of 101 to 20 minutes receives 1 point. Median transport time of 21 to 30 minutes receives 2 points. Median transport time of 31 to 40 minutes receives 3 points. Median transport time of greater than 41 minutes receives 4 points. Community Support Letters of support for an additional trauma center from 250 to 50 percent of the city and county commissions located within the TSA receive 1 point. Letters of support must be received by the Department on or before April 1 annually. Letters of support for an additional trauma center from more than 50 percent of the city or county commissions located within the TSA receive 2 points. Letters of support must be received by the Department on or before April 1 annually. Severely Iinjured Patients Discharged from Acute Care Hospitals Not Treated In Trauma Centers Discharge of 0 to 200 patients with an International Classification Injury Severity Score (“ICISS”) score of less than 0.85 (“severely injured patients”) from hospitals other than trauma centers receives 0 points. Discharge of 201 to 400 severely injured patients from hospitals other than trauma centers receives 1 point. Discharge of 401 to 600 severely injured patients from hospitals other than trauma centers receives 2 points. Discharge of 601 to 800 severely injured patients from hospitals other than trauma centers receives 3 points. Discharge of more than 800 severely injured patients from hospitals other than trauma centers receives 4 points. Level I Trauma Centers The existence of a verified Level I trauma center receives one negative point. The existence of two verified Level I trauma centers receives two negative points. The existence of three verified Level I trauma centers receives three negative points. Number of Severely Injured Patients If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives 2 points. If the annual number of severely injured patients exceeds the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives 1 point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by 0 to 500 patients, the TSA receives one negative point. If the annual number of severely injured patients is less than the statutory trauma center patient volumes identified in Section 395.402(1), F.S., by more than 500 patients, the TSA receives two negative points. The following scoring system shall be used to allocate trauma centers within the TSAs: TSAs with a score of 5 points or less shall be allocated 1 trauma center. TSAs with a score of 6 to 10 points shall be allocated 2 trauma centers. TSAs with a score of 11 to 15 points shall be allocated 3 trauma centers. TSAs with a score of more than 15 points shall be allocated 4 trauma centers. An assessment and scoring shall be conducted by the Department annually on or before August 30th, beginning August 30, 2015. The number of trauma centers allocated for each TSA based upon the Amended Trauma Service Area Assessment, dated March 24, 2014 January 31, 2014, which can be found at www.FLHealth.gov/licensing- and-regulation/trauma-system/_documents/trauma-area-service- assessment.pdf, is as follows: TSA Counties Trauma Centers 1 Escambia, Okaloosa, Santa Rosa, Walton 1 2 Bay, Gulf, Holmes, Washington 1 3 Calhoun, Franklin, Gadsden, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, Wakulla 1 4 Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, Union 1 5 Baker, Clay, Duval, Nassau, St. Johns 12 6 Citrus, Hernando, Marion 2 7 Flagler, Volusia 1 8 Lake, Orange, Osceola, Seminole, Sumter 3 9 Pasco, Pinellas 23 10 Hillsborough 1 11 Hardee, Highlands, Polk 1 12 Brevard, Indian River 1 13 DeSoto, Manatee, Sarasota 2 14 Martin, Okeechobee, St. Lucie 1 15 Charlotte, Glades, Hendry, Lee 12 16 Palm Beach 1 17 Collier 1 18 Broward 2 19 Dade, Monroe 3 Rulemaking Authority 395.402, 395.405 FS. Law Implemented 395.402 FS. History–New 12-10-92, Formerly 10D-66.1075, Amended 6-9-05, 12-18- 06,Formerly 64E-2.022, Amended . DOH did not incorporate the March TSA Assessment by reference in the rule. After exchanges of communications with the Joint Administrative Procedures Committee (“JAPC”), wherein DOH sought guidance concerning this matter, there was no directive by JAPC that such adoption by reference would be required. DOH revised the population criterion in the Proposed Rule to have even breaks in intervals of 600,000 people. The February proposed rule awarded 6 points in TSAs with a population of 1,200,001 to 1,700,000 people (i.e., a 500,000 person interval), where all other measures were based upon a 600,000 person interval. This discrepancy is corrected in the newly Proposed Rule. DOH revised the community support criterion in the Proposed Rule to no longer award a point to TSAs where 0-50% of the city and county commissions send letters of support, because this could have reflected the need for a trauma center (by awarding points to the TSA) when no letters of support were received. The Proposed Rule now awards a point to TSAs where 25-50% of the county commissions send letters of support. DOH chose twenty-five percent as the minimum necessary community support because the smallest number of city and county commissions in all of the TSAs is four, which ensures everyone has a voice. DOH revised the title of the fourth criterion from “severely injured patients not treated in trauma centers” to “severely injured patients discharged from acute care hospitals,” which more accurately depicts the function of the criterion. DOH revised the sixth criterion to include citations to the statutory minimum volumes for Level I and Level II trauma centers in response to a request by the staff attorney for the Joint Administrative Procedures Committee. DOH also revised the rule to reference the March TSA Assessment in place of the January TSA Assessment. Finally, DOH revised the Proposed Rule’s allocation table based on the revisions to the rule and assessment. The Proposed Rule as amended allocates a total of 27 trauma centers throughout Florida’s 19 TSAs. Each TSA is still allocated at least one trauma center. The Proposed Rule allocates only Level I and Level II trauma centers, not pediatric trauma centers. The rulemaking directive in section 395.402(4) is interpreted by DOH to be limited to the allocation of Level I and Level II trauma centers. In addition, the allocation of stand-alone pediatric centers would not be feasible because pediatric trauma patients make up such a small percentage of the population and all of the Level I and II trauma centers have the ability to become pediatric trauma centers. Currently, all of the existing Level I trauma centers provide pediatric care and there are only two stand-alone pediatric centers in Florida. The Proposed Rule’s allocation of 27 trauma centers is conservative. There are currently 27 verified trauma centers in the state, including two verified trauma centers under administrative challenge. There are several elements of the Proposed Rule which Petitioners have raised as evidence of the Department’s failure to comply with its rulemaking authority. Petitioners maintain that DOH failed to consider all of the items enumerated in section 395.402(3)(a)-(k). Each of those criteria is addressed below. (a) The recommendations made as part of the regional trauma system plans submitted by regional trauma agencies-- There is only one regional trauma agency in Florida. DOH reviewed the regional agency’s plan, but it was devoid of any recommendations related to trauma center allocation within the TSAs. The regional agency did not amend its plan or submit any separate recommendations throughout the year-long, public rulemaking process. (b) Stakeholder recommendations--Petitioners complain that DOH did not do enough to solicit input from everyone who would be affected by the Proposed Rule. The Department, however, obtained stakeholder testimony from 171 individuals and written comments from 166 stakeholders through the course of the 12 rule development workshops conducted around the state. The workshops were held in several cities to allow for geographic access by more residents. Over 400 people attended the workshops. The January TSA Assessment was also modified prior to its publication as a result of the stakeholder discussions at the workshops and the negotiated rulemaking session. The March TSA Assessment was further amended after its publication as a result of testimony at the public hearing for the Proposed Rule. (c) The geographical composition of an area to ensure rapid access to trauma care by patients--While Florida contains no mountains, its geography is unique to other states in that it contains several inlets, bays, jetties, and swamplands. As such, the DOH data unit examined the coastal areas versus non- coastal areas. The unit also analyzed urban versus rural areas. The unit also looked at the communities surrounding Lake Okeechobee. Ultimately, the analysis was not meaningful because the effect geography has on access to trauma centers is captured by Florida’s transport time records for emergency vehicles and helicopters. Thus, by reviewing the Emergency Medical Services Tracking and Reporting System (“EMSTARS”) database, DOH could know the actual effects of Florida’s geography on access to trauma centers. (d) Historical patterns of patient referral and transfer--This item was considered, but the January TSA Assessment does not address it because it was neither measurable nor meaningful. The data was not measurable because of limitations of data quality in the Trauma Registry. Even if the data were measureable it would not have been meaningful because it would have only illustrated the catchment areas--i.e., the geographic distribution of patients served by existing trauma centers. As recommended by the ACS, DOH’s primary focus is on the trauma system as a whole, not individual trauma centers. Moreover, transfer and referral history is not meaningful to an assessment designed to inform an allocation rule because, again, DOH does not have the authority to define where new trauma centers are developed within a TSA. See § 402.395(4)(b), Fla. Stat. (charging DOH with allocating by rule the number of trauma centers in each TSA, not trauma center location within a trauma service area). (e) Inventories of available trauma care resources, including professional medical staff--Petitioners suggest that DOH should have made a determination of existing professional medical staff, but suggest no viable means of doing so. The January TSA Assessment catalogues several trauma care resources within TSAs, including financing, trauma centers, acute care hospitals, and EMS response capabilities. The January TSA Assessment does not catalogue available professional medical staff. DOH is unaware of any database that compiles this information. DOH sent a survey to the existing trauma centers requesting information as to their resources and professional staff, however it was not useful due to the limited responses and potential for bias. The data unit also reviewed the DOH Division of Medical Quality Assurance health professional licensure database (COMPASS), however, it was not helpful because physician specialty reporting is voluntary. Similarly, the data unit reviewed AHCA’s inventory of licensed acute care hospitals and the DOH annual physician workforce survey results, but neither data source provided trauma-specific information. As such, the information was not complete and so was not included in the January TSA Assessment. (f) Population growth characteristics--In response to this criterion, the DOH data unit analyzed the potential for growth in all of the TSAs, but the January TSA Assessment did not include this analysis because it was not meaningful given DOH’s requirement to conduct the assessment annually. The January TSA Assessment does however document the population in each TSA. DOH decided that in light of the continuing change of population in Florida, the best it could do would be to make a finding as to the population in each TSA and use it--year by year--to look at the potential need for additional (or presumably fewer) trauma centers in an area. Obviously the population of an area is not directly commensurate with the number of severely injured patients that might be found. Not all areas have equal percentages of severely injured patients; urban areas would have higher percentages than rural areas, in general. Areas through which a major interstate highway runs would expect a higher percentage. There are a number of factors that could potentially affect an area’s expectation of trauma services. Inasmuch as they could not all possibly be included in an analysis, DOH defaulted to a more general view, i.e., the total population. The total population figure became the first measurement in the Proposed Rule. (g) Transportation capabilities; and (h) Medically appropriate ground and air travel times--DOH considered these two factors together and determined to cover them by way of a determination of median transport time, which was to become the second measurement in the Proposed Rule. The data unit gathered transport capability data by reviewing the COMPASS licensure database and archived paper applications to discern the number of licensed emergency medical stations, helicopters, and vehicles in each TSA. The data unit further calculated the number of ground vehicles per the population in each TSA and every 100 square miles. The January TSA Assessment included this information because it was meaningful and gathered from a reliable database. DOH considered the testimony from a number of trauma surgeons during the 12 workshops regarding transport times and learned that the medically appropriate transport time depends on the nature of injuries and individual patients, which are not always discernable at the scene of an accident. Because of this, the sooner a patient can be transported to a trauma center, the better it is for patient outcomes. In light of the patient-specific realities of establishing a medically appropriate transport time, the data team used EMSTARS to calculate the median emergency transport times in each TSA for the assessment. Granted the EMSTARS is a fairly new system under development, and it reports all 911 calls voluntarily reported (not just trauma patients), so it is not a completely accurate measure. But it is a reasonable approach based upon what is available. Also, the transport times do not reflect whether pre-hospital resources are sufficient for the patient or how far away the closest trauma center may be. It is not an absolutely perfect measurement, but it is reasonable and based on logic. (i) Recommendations of the Regional Domestic Security Task Force--Like Florida’s lone regional trauma agency, the RDSTF did not offer any input throughout the year-long, public rulemaking process. However, DOH considered the testimony of numerous emergency management and law enforcement officials during the rule development process. For example, Chief Loren Mock, the Clay County fire chief and also a member of the Domestic Security Oversight Council, testified at the Jacksonville workshop. There is no evidence DOH directly contacted a RDSTF representative to solicit input. (j) The actual number of trauma victims currently being served by each trauma center--The March TSA Assessment included the annual trauma patient volume reported to the Trauma Registry by the existing trauma centers. When comparing the average patient volume reported to trauma registry from 2010- 2012 to the data unit’s calculation of the average number of severely injured patients treated in trauma centers during this same time span, the volumes reported by the trauma centers were approximately 333% greater. This large disparity prompted DOH to follow the example of many other states and use population as a proxy for the number of potential trauma patients in each TSA in its Proposed Rule. DOH found that: greater population means a greater need for health care; population is a good indicator of need for medical services; population is a reasonable proxy for patient volume; and, more people in a given area results in more trauma cases in a given area. (k) Other appropriate criteria: It was well documented in literature presented to DOH during the rulemaking process that there were a large percentage of severely injured patients in Florida not being seen by trauma centers. The data unit confirmed this by evaluating the AHCA administrative database, which identifies the injuries suffered by patients as well as the type of hospitals discharging those patients, i.e., comparing the total number of severely injured patients with the number of severely injured patients discharged from acute care hospitals in each TSA. This disparity was worrisome to DOH and therefore included in the March TSA Assessment. As pointed out by Petitioners, the Department’s figures include patients who may have received treatment outside the TSA in which the injury occurred. The figures may not have contained patients who needed trauma care but could not access it for other reasons. The Proposed Rule, however, makes as complete an evaluation of the potential patient base for trauma centers as is possible. Notwithstanding complaints about how the Department addressed some of the criteria set forth in the statute, it is clear that all criteria were considered and implemented into the Proposed Rule to the extent feasible and possible. The most credible testimony at final hearing supports the Department’s process. Criticisms of the various elements within the Proposed Rule expressed by Petitioners at final hearing seemed to be based on the concept that the Proposed Rule may allow competition to existing trauma centers rather than real complaints about the elements themselves. All agree, for example, that population, transportation times, number of patients, and the existence of nearby trauma centers are important factors that should be considered. Petitioners just seemed to want those factors expressed in different (though unspecified) terms. Petitioners did enunciate certain shortcomings they felt made the Proposed Rule less than complete. St. Joseph lamented the absence of all the Department’s analysis and background for each of the proposed measurements contained in the Proposed Rule. Jackson Memorial pointed out that pediatric trauma centers were not specifically included in the Proposed Rule. Shands showed that odd or unusual results could arise from implementation of the Proposed Rule. For example, the March TSA Assessment showed a total of 216 severely injured patients in TSA 6, comprised of Marion, Citrus, and Hernando counties. The Proposed Rule called for two trauma centers in that TSA. Although the number of patients necessary to maintain a trauma center’s proficiency was disputed by various experts in the field, it is clear that 108 patients per center would be extremely low. However, the figure appearing in the March Assessment is not absolute or necessarily completely definitive of need. There are other factors concerning population and patients that may affect that figure. The Six Measurement Criteria in the Proposed Rule Petitioners also took exception to the measurement criteria in the Proposed Rule. Each of those six criterion is discussed below. Population The Proposed Rule awards from two to ten points to a TSA, depending on the TSA total population. Two points are awarded for a population of less than 600,000 and ten points are awarded for a popu1ation greater than 2.4 million. The Department used total population as a "proxy" for the actual number of trauma patients in the state rather than using the actual number of trauma victims in the state. The Proposed Rule does not define “population” or “Total Population,” nor are those terms defined in the trauma statute, but those words are subject to their normal definition. The Proposed Rule does not re-state the source of the summary Total Population data; it is already contained in the TSA Assessment. Neither the Proposed Rule nor the March TSA Assessment contains any data or analysis reflecting population by age cohort, population density, or incidence of trauma injury in relation to these factors, and the Department did not specifically conduct any analysis of the significance of any aspect of population data as it relates to the need for new trauma centers, other than determining the total population growth rate in the TSAs. Rather, DOH decided upon total population as the most reliable measure available. Traumatic injury rates and the severity of traumatic injury vary widely based on a number of factors, including whether the area is urban or rural, the population age cohort, and the infrastructure and physical characteristics or features of the geographic area. Thus, the most reasonable way to measure possible need was to look at the total population of an area and extrapolate from that basis. The Department presented no specific data or analysis to support the incremental cutoff points for the Total Population scale contained in the Proposed Rule. Rather, the Department took population as a whole because it was the most readily available, annually updateable, and understandable factor it could access. The use of population as a proxy is not without problems, however. In TSA 19, for instance, the population has increased by about thirty-eight percent in recent decades, but the number of trauma victims has declined by approximately twelve percent. As stated, the Proposed Rule as written is not inerrant. Median Transport Times The Proposed Rule awards from zero to four points to a TSA, depending on the Median Transport Time within a TSA. “Median Transport Time” is not defined in the Proposed Rule, nor is the methodology for determining the summary “Median Transport Time” statistics set forth in the TSA Assessment and relied on in the Proposed Rule. Information concerning transport times is, however, contained within the TSA Assessment. The Median Transport Time used in the Proposed Rule represents the average transport time for all 911 transports voluntarily reported to the state EMSTARS database. EMSTARS is a database that is under development and that collects information voluntarily provided by emergency medical transport providers throughout the state. Although not all EMS providers currently report to EMSTARS (most notably, Miami-Dade County EMS does not participate), the database is useful for research and quality improvement initiatives. The Median Transport Time set forth in the March TSA Assessment and used in the Proposed Rule includes transport time for all patients, regardless of the nature of the emergency, whether the call involved trauma, other types of injury, or illness, and regardless of whether the transport was conducted with the regular flow of traffic or required “lights and siren.” The Median Transport Time used in the Proposed Rule includes all EMS transports of up to two hours in duration. The Median Transport Time excludes transports of patients to trauma centers operating pursuant to the initial stage of trauma center licensure known as “provisional approval.” The Department addressed “medically appropriate air or ground transport times,” as required by section 395.402(3)(h), by its generally accepted conclusion that "faster is better." Not all injured patients, however, benefit from receiving care at a trauma center. Thus, while an existing trauma center is an appropriate destination for all patients with any level of injury who live in the area of a trauma center, the trauma center’s value beyond its immediate area is as a resource for the most severely injured patients whose problems exceed the capabilities of their nearest hospital. The Department did not undertake any analysis to balance its "faster is better" approach to trauma planning against the reality that the resources necessary to provide high quality trauma care are limited, as is the number of severely injured patients. There is a general (but not universal) consensus among trauma experts that access to a trauma center within 30-50 minutes is an appropriate benchmark for access to trauma care. Other than "faster is better," the Department did not determine a medically appropriate travel time for any type of trauma or any geographic area, but recognizes the general consensus as appropriate. The Proposed Rule awards from one to four points that weigh in favor of approval of a new trauma center within a TSA if the Median Transport Time of patients transported in response to any 911 call is between 10 and 42 minutes, i.e., within but faster than the generally accepted consensus. Community Support The Proposed Rule awards from one to two points to each TSA depending on the number of letters of support written by elected city or county commissioners. The Proposed Rule allows for consideration of stakeholder recommendations by way of allowing letters of support from local governments. “Stakeholders” in the state trauma system include existing trauma centers, as well as all acute care hospitals, and pre- and post-hospital care providers, including emergency transport services, air ambulances, and emergency management planning agencies. The Department could find no better way to acknowledge support from those stakeholders, and citizens in general, than to have their elected representatives listen to their constituents and then reflect those people’s desires and comments. Severely Injured Patients Discharged from Acute Care Hospitals The Proposed Rule awards from zero to four points to a TSA, depending on the number of severely injured patients discharged from acute care hospitals (non-trauma centers). The Proposed Rule addresses the number of severely injured patients, i.e., those with an ICISS score of < 0.85, discharged from hospitals other than trauma centers. The Proposed Rule does not specifically define “severely injured patient,” but it is obvious from the context in which that term is used. The summary data in the TSA Assessment labeled "number of severely injured patients” within each TSA is intended to reflect the number of severely injured patients who “didn’t get to trauma care.” The Department's numbers may include patients who received treatment at a trauma center outside of the TSA in which the injury occurred. The Department did not conduct any analysis of the "number of severely injured patients not treated at a trauma center" to determine whether the patients not treated at a trauma center received timely and appropriate care at a non-trauma center hospital with the capability to treat the patient's injuries. The number of “severely injured patients who did not get to trauma care” as reported by the Department is unlikely to reflect the actual number of patients who required care at a trauma center but did not have access, and suggests that this number is far higher than it actually is. The Department, for example (and in response to discussion with stakeholders), excluded from its analysis all patients with isolated hip fractures as well as all patients who were released from the hospital within 24 hours, which resulted in fewer severely injured patients. Neither the Proposed Rule nor the TSA Assessment considers demographics or outcomes for "severely injured patients" treated at general acute care hospitals or outcome data for these patients. The Proposed Rule does not include any method for projecting the actual demand for trauma services in the future; it is used to determine need at a single point in time (and will be done so annually). The Proposed Rule does not include any criteria or method for evaluating whether there are any capacity problems at existing trauma centers, or other barriers that impede access to trauma care. The Department intended this criterion to show a highly conservative estimate of patients who definitely need trauma care. Level I Trauma Centers With respect to “Level I Trauma Centers,” the Proposed Rule awards from negative one to negative three points to a TSA, depending on whether the TSA already has one, two, or three verified Level I trauma center(s), respectively. The Proposed Rule creates the opportunity for establishment of both additional Level I and also additional Level II trauma centers, pursuant to the allocation of need, but the Proposed Rule does not assign or subtract points for the existence of Level II trauma centers. This criterion reflects the recommendations of stakeholders at the rule workshops. It was the consensus of many stakeholders that Level I trauma centers should be protected in order to safeguard the research and teaching missions of those centers. The earlier proposal of a “halo” around existing centers, i.e., not approving a new trauma center within a certain radius of existing centers, was not incorporated into the Proposed Rule. This criterion, however, offers some protection for existing centers. Number of Severely Injured Patients The Proposed Rule awards negative two to two points based on the "number of severely injured patients" in a TSA. The criterion awards points based on the number of Severely Injured Patients which exceed the target trauma center patient volumes as provided in section 395.402(1). If the annual number of Severely Injured Patients exceeds the statutory volumes by more than 500 patients, the TSA will receive two points; if it exceeds it by less than 500 the TSA receives one point; if the number of Severely Injured Patients is less than the statutory volumes by zero to 500 patients, the TSA receives one negative point; if it is less than the volumes by more than 500 patients, the TSA receives two negative points. The Proposed Rule does not include any criterion addressing the actual number of trauma victims currently being served by each trauma center. Instead, Section 6 of the Proposed Rule substitutes the "minimum statutory capacity" of existing trauma centers for the actual capacity of existing trauma centers. The Department could not find “a meaningful” way to measure actual capacity of existing trauma centers. The most accurate way to measure capacity was a contentious topic at rule workshops, and the Department spent a good deal of time working with stakeholders on how to measure capacity in such a way that it could be included as a factor in the Proposed Rule. One suggestion as to how to measure trauma center capacity is by how often existing trauma centers actually divert trauma patients to other facilities. However, trauma centers rarely admit that they are not able to take any more patients, and this is not a realistic method to evaluate capacity. The capacity of an existing trauma center may be measured by various means, including the number of beds at the trauma center, the number of ICU beds, the number of trauma bays, number of operating rooms, as well as the frequency of and reasons for diversion. The trauma center’s clinical staff, including medical and surgical specialists, and supporting clinical personnel, are also indicators of capacity. The Department already routinely collects data reflecting trauma center capacity as part of the quarterly and annual reports that all existing trauma centers are required to submit, and by way of on-site licensure surveys. None of those means, however, provided DOH with sufficiently reliable information and data. The Proposed Rule comports with the DOH Mission to protect, promote, and improve the health of all Floridians through integrated state, county, and community efforts. While by no means perfect, the Proposed Rule is based upon logic and reason derived from an extensive analysis of all relevant factors. History of the Rule The rationale for DOH’s inclusion of those particular six criteria in the Proposed Rule can be better understood by considering some more history of the trauma rule. As stated earlier herein, in 2004 the Legislature made substantial revisions to the trauma statute and ordered the Department to complete an assessment of Florida’s trauma system. The scope of this assessment was defined in paragraphs (2)(a) through (g) and subsection (3) of section 395.402. An appropriation of $300,000 was authorized for the Department to contract with a state university to perform the actions required under the amended statute. Ch. 2004-259, § 10, Laws of Florida. One proposal of the 2005 Assessment was to "[c]onsider aligning trauma service areas within [sic] the trauma region boundaries as established in" section 395.4015(1). § 395.402(2)(a), Fla. Stat. In a related 2004 amendment, the Legislature ended the statutory mandate to use the service areas created in 1990. The obvious conclusion from the above statutory change is that the section 395.402(4) service areas could be replaced by the service areas DOH established or adopted once it had the results of the 2005 Assessment. Unlike the prior statute, there is no mandate for specific new service areas, only the option not to use the prior service areas. The 2005 Assessment included five "Recommendations": Trauma centers should be placed in Tallahassee and in Bay County, which do not currently have a trauma center . . . . It is reasonable to set, as a system goal, that 65 percent of trauma center patients will be treated at a trauma center. . . . Designation of additional trauma centers should be based on the need as determined by trauma region. Deployment of additional trauma centers should take place based, not only on the number of patients served per trauma center, but according to the concept of “trauma center capacity” which should be determined by the staffing levels of medical specialists and other healthcare professionals. . . . The data support the feasibility of transforming the Florida Trauma Services Areas so that these would coincide with the Domestic Security Task Force Regions. . . . It is reasonable to fund trauma centers with public funds, based on the unrecoverable financial burden incurred by trauma centers. The only legislative response to the 2005 Assessment was an increase in funding to trauma centers. The Legislature did not repeal the statute establishing the current 19 TSAs. Likewise, the Department has not amended the Rule to implement the recommendations contained in the 2005 Assessment until the present Proposed Rule. The Department, instead, reviewed existing statutes, interpreted section 395.4015 to mandate the establishment of a trauma system plan (which plan would include trauma regions that have boundaries coterminous with those of the regional domestic security task force boundaries). The development of the trauma system plan is distinct from the determination of need for new trauma systems addressed by the Proposed Rule.
The Issue The issue in this case is whether an application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital (“Wolfson”), to operate a pediatric trauma center should be approved.
Findings Of Fact The following findings of fact are derived from the stipulation of the parties, the admitted exhibits, and the testimony at final hearing. DOH is the state agency responsible for, inter alia, the review and approval (or denial) of applications to operate trauma centers, including pediatric trauma centers. DOH denied the trauma center application filed by Wolfson, not due to an absence of need in the area, but due to Wolfson’s failure to comply with some requirements set forth in the application. Wolfson is a 216-bed not-for-profit children’s hospital located in Jacksonville, Duval County, Florida. It is part of the Baptist Health organization and is one of three hospitals operated under that entity’s license. Wolfson is located on the same campus as Baptist Medical Center – Jacksonville. The two hospitals share a pharmacy which is located in the children’s hospital and a laboratory located in the adult hospital, but no other services or staff. Interestingly, Wolfson was developed by the sons of Morris Wolfson, a Jewish immigrant to the United States. One of Mr. Wolfson’s children had died at an early age due to lack of access to health care services. Later in his life, after acquiring a small fortune from his business, Mr. Wolfson asked his five remaining sons to develop a children’s hospital accessible to every child, regardless of race, creed, or religious affiliation. By 1951 the sons had raised over half a million dollars and were prepared to construct a hospital. They approached the Baptists, who agreed to build the children’s hospital as part of their development of Baptist Hospital. In 1955, Mr. Wolfson’s dream became a reality. Wolfson provides a wide range of services to children, including but not limited to: two neonatal intensive care units; cardiac catheterization; open heart surgery; bone marrow transplants; and extracorporeal membrane oxygenation, a less complex bypass procedure. There is an emergency department at Wolfson. It receives approximately 60,000 patients per year. Wolfson also operates three satellite emergency departments and has three mobile ICUs (known as “Kids Kare” mobile units). Wolfson’s service area is quite large, comprised of a triangle identified by the vertices of Savannah, Georgia – Dothan, Alabama – and Daytona Beach, Florida. About ninety percent of Wolfson’s patients come from within that area. There is not currently a pediatric trauma center in Jacksonville, which is located in Trauma Service Area (“TSA”) 5. There are five counties in TSA 5: Duval, Baker, Clay, Nassau, and St. Johns. The closest pediatric trauma center to Jacksonville is located in Gainesville, Alachua County, Florida, some 60 miles away. There is a Level II trauma center located at UF Health Jacksonville, but it is not specifically for pediatrics. There are differences in the provision of care to pediatric patients versus adult trauma patients, including specialized equipment, age-appropriate drugs, and modified procedures. Pediatric trauma patients from TSA 5 must be transported to UF Health Jacksonville or Shands in Gainesville. Some of those patients are designated as “trauma alert patients.” Those are individuals identified by emergency medical services as requiring immediate, high-level treatment by skilled professionals. Not all trauma patients are trauma alert patients. Once a pediatric trauma patient has been stabilized at UF Health Jacksonville or Shands, the patient can be transferred to Wolfson for further treatment. Wolfson then undertakes the care needed by the patient. UF Health Jacksonville transfers about 20 to 30 pediatric trauma patients per month to Wolfson. Not all of those patients have previously been deemed trauma alert patients, but Wolfson has extensive experience treating patients with significant needs. It is Wolfson’s desire to operate its own pediatric trauma center, thereby obviating the need for a trauma patient to first go to UF Health Jacksonville or Shands before being transferred. There are times when a delay in transfer can have negative consequences for the patient. The number of such occurrences was not quantified by Wolfson, but Wolfson considers it a significant problem. There is, by rule, a very precise process for a hospital to obtain verification as a trauma center. There are three stages to the process: provisional review, in-depth review, and site visit. Hospitals are given only one opportunity each year to apply for verification. In order to apply, a hospital must file a letter of intent (“LOI”) between September 1 and October 1. On or before October 15, the Department sends an application package to each hospital which had timely submitted an LOI. After receiving the application package, a hospital has until April 1 of the following year to complete and submit the application. DOH must complete its provisional review of the application and notify the applicant, by April 15, of any deficiencies which should be addressed. The hospital then has five business days to submit clarifying or corrective information. In accordance with this process, Wolfson timely filed its application to operate a pediatric trauma center. By rule, the application must contain responses and support relating to nineteen “critical elements” related to trauma care. The Department then reviews the application to make sure that all minimum standards for approval have been met. An applicant is not required to necessarily satisfy each element or subpart of a standard in order for it to be approved by the Department. However, failure to comply with a critical element overall can result in denial of the application. The initial review of an application by the Department is extremely important because, if provisionally approved, the applicant can immediately commence operating as a trauma center. In the present case, Wolfson’s application was reviewed by two persons under contract with the Department: Dr. Robert Reed and Susan Cox, RN. The Department deems each of those persons to be an expert in the field of trauma care based on their background and training. The provisional review by the reviewers was for the purpose of determining whether the application was complete and whether the hospital satisfied the critical elements required for a trauma center. After completion of their initial review, the reviewers sent a letter to Wolfson identifying certain deficiencies they had found in the application. There were a number of deficiencies identified by Dr. Reed and Nurse Cox in Wolfson’s application. However, the most important of those (and the ones at issue in this proceeding) were as follows: Standard II.B.1.b relates to trauma-related continuing medical education (“CME”) requirements for emergency physicians; Standard XVII relates to required multidisciplinary conferences which must be held throughout the year; and Standard XVIII addresses Quality Management a/k/a Quality Improvement (“QI”), also referred to as Performance Improvement. Wolfson was given an opportunity to address each of the stated deficiencies and did, in fact, submit some additional information. Despite the additional information, Wolfson’s application was still deemed insufficient and was denied. The Department now concedes that the CME standard was satisfied in Wolfson’s application. The same is true for the standard relating to multidisciplinary conferences. The QI standard (Standard XVIII), however, remains in dispute. DOH contends that the information submitted by Wolfson in its initial application and deficiency response falls short of proving compliance with this critical element. The QI standard requires a system of procedures and protocols that will promote performance improvement while maintaining patient safety. The goal is to establish processes to ensure a hospital is continually improving the quality of care provided. The subparts of the QI standard require detailed demonstrations of various processes, including: A.2 – A clearly defined performance improvement program for the trauma population; – Review of all trauma patient records from five specified categories; – Monitoring of six indicators relevant to the respective facility (which are in addition to four state-mandated indicators); – Review of cases relevant to the six indicators by the trauma medical director (“TMD”) and trauma program director (“TPD”), to decide whether the cases should be referred to the quality management committee (“QMC”). B.5 – Evaluation by QMC of the effectiveness of action taken to ensure problem resolution; – Preparation and submittal of a quarterly report showing which cases have been selected for corrective action; and – Maintenance of an in-hospital trauma registry with information on patients being treated. The gist of Wolfson’s QI program is set forth on a flow chart contained in the application. That chart is entitled, “Trauma PI Process: Levels of Review.” Though not explained at final hearing, the “PI” in the chart is presumably “Performance Improvement.” The flow chart indicates there to be a primary (daily) review, a secondary (weekly) review, and a tertiary (monthly) review involving certain designated persons. In each of the “boxes” for the respective reviews, there is a stated purpose for the review. For the primary review, the purpose is stated as: Identification of opportunities for Improvement/Validation. The secondary review’s purpose is: Adverse Event/Audit Filter Review. And the purpose of the tertiary review is: Peer Review/Accountability Determination, Loop Closure Plan, Trended Data Review. Phases of care identified in the flow chart are: Pre- hospital, Resuscitation, Inpatient Care Review, and Readmission Review. There is a list of “actions” in the flow chart: Education; Counseling; Trend Report; Guidance/Policy/Protocol Development; and Hospital PI Project. From that list, there is an arrow pointing back toward the primary review box. There is no narrative in the flow chart to explain how the various boxes interconnect or how the information therein ties to the requirements as outlined in the application form. Wolfson asserts that all relevant information is contained in the flow chart, whether in narrative form or not. There is also additional information in the application, attached as a “Scope of Services” addendum, which further elucidates what is found in the flow chart. The Department deems the flow chart and scope of services information insufficient for determining whether the proposal satisfies the critical elements. Wolfson says the flow chart is a “clearly defined performance improvement program.” It is, in fact, only an outline of a clearly defined program. The testimony provided at final hearing by Wolfson’s TPM explained how that outline would work to improve performance. With that explanation, the flow chart/scope of service information minimally satisfies this critical element of the application. Wolfson maintains that the information provided supports the requirement for review of all records from five specified categories, i.e., all trauma alert cases, critical or ICU admissions, operating room admissions for traumatic injury, critical trauma transfers, and in-hospital deaths. Upon review of the flow chart there is insufficient evidence concerning those five areas. However, the scope of information addendum at least minimally refers to those areas as part of the review process. The flow chart/scope of service information addresses the four state-required indicators. The other six indicators required in the application are listed as “to be determined by the [Quality Management] committee.” Wolfson points out that in the minutes from a QMC meeting in February (which was included in the application), nine additional indicators are listed. So, although not easily found, the application does provide sufficient response to the required element. The application is also supposed to identify cases relevant to the six selected indicators in order to determine whether any of those cases should be referred to the QMC. The determination to refer cases is followed up by an evaluation of the effectiveness of actions taken by the committee. The flow chart can be interpreted to address this requirement, but it is fairly nebulous. The scope of services information provides some additional support, but only in general terms. The required quarterly reports are supposed to show which cases have been selected for corrective action by the committee. Wolfson asserts that it cannot submit any such reports until it is operating as a pediatric trauma center, i.e., until it actually has patient cases to report. That position is plausible. The Department did not provide any evidence as to how other applicants satisfied this requirement, so Wolfson’s position cannot be measured against other providers.1/ The same is true as to the requirement for an in- hospital registry of information concerning patients who are being treated. Wolfson has purchased the software needed to commence its registry once patients are being admitted, but it cannot do so at this time, again because it has no such patients. All things considered, Wolfson’s application was not a superlative response to the question of its abilities, but it at least minimally met the requirements for approval of a provisional license. Considering, de novo, all of the evidence concerning Wolfson’s proposed trauma center operations, the application is complete. Wolfson provided extensive testimony and evidence as to the need for a pediatric trauma center in the service area and its willingness and ability to meet that need. There is no doubt that, if approved, the pediatric trauma center would be beneficial to the area. However, need was not an issue in the proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent, Department of Health, enter a Final Order approving the pediatric trauma center application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital. DONE AND ENTERED this 14th day of November, 2017, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of November, 2017.
The Issue Whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact The Department is the State agency charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to this proceeding, Dr. Mationg was a licensed physician in the State of Florida. His license, numbered ME 0028183, was issued on April 13, 1976. Dr. Mationg is the primary care physician of A.A. Dr. Mationg referred A.A. to Dr. Steven Schafer, an orthopedic surgeon, for pain in the right shoulder, which was found to require arthroscopic surgery and repair of a rotator cuff. On January 10, 2000, A.A. was admitted to Regional Medical Center Bayonet Point (Bayonet Point) for surgery. At the time of his admission to the hospital, A.A. was 65 years old and suffered from numerous medical problems. He had cardiomyopathy, meaning his heart was enlarged and not functioning properly. A.A. had high blood pressure and a history of heavy smoking. He had generalized arteriosclerosis and peripheral artery disease. A.A. had previously had surgeries involving the placement of a stint and angioplasty. Based on his medical history, A.A. was subject to a stroke and a heart attack. Prior to his admission to the hospital, A.A. had been taking aspirin daily. Approximately three days prior to surgery, A.A. was directed by Dr. Schafer to discontinue taking aspirin. The aspirin was discontinued to reduce the risk of A.A.'s blood not being able to clot sufficiently. The hospital records of A.A. contain a request for consultation with Dr. Mationg for medical management dated January 10, 2000. The discharge summary shows that the medical evaluation was obtained so that A.A. could be followed by his primary care physician for his hypertension and other medical history. Dr. Schafer performed the surgical procedure on A.A. on January 10, 2000. A.A. had some respiratory problems, and Dr. Mationg ordered a pulmonary consultation with Dr. Patel the afternoon of January 10, 2000. Because of the respiratory problems, A.A. was placed on a ventilator and transferred to the intensive care unit. On January 11, 2000, Dr. Patel extubated A.A., which means that A.A. was taken off the ventilator. On January 11, 2000, Dr. Mationg saw A.A. at 9:00 a.m. and wrote and signed an order for lasix and lanoxin for A.A. Around 3:15 a.m. on January 12, 2000, A.A. was awakened for respiratory therapy and experienced numbness in his left arm and slurring of speech. When A.A. smiled, the left side of his mouth remained flat while the right side turned up. The nurse on duty was called, and he observed A.A.'s symptoms. A.A.'s symptoms indicated that he was having a stroke. Nurse Culligan notified Drs. Schafer and Mationg. Dr. Mationg did not come to the hospital to evaluate A.A. The standard of care would have required him to come to the hospital to evaluate A.A. because A.A. was exhibiting the symptoms of a stroke. Instead of coming to the hospital to do an evaluation, Dr. Mationg gave the following orders telephonically to Nurse Culligan at 4 a.m., on January 12, 2000: T.O. Dr. Mationg/M. Culligan do CT head [without] contrast today a.m. do carotid doppler study today a.m. consult Dr. S. Shah for neuro eval. get speech therapy eval. and video swallow today. Nurse Culligan wrote the orders on A.A.'s chart; Dr. Mationg later countersigned the orders. The term "stat" in medical parlance means immediately or as soon as possible. An order is not presumed to be stat if the order does not specify that it is stat. The tests and consultation which Dr. Mationg ordered at 4 a.m., on January 12, 2000, were not ordered to be implemented stat. The standard of care for treating A.A. required that Dr. Mationg order a stat neurological consultation and a stat head CT scan. Bayonet Point has established policies for its imaging services department, including CT services. The normal hours for CT services are 7 a.m. to 11 p.m., Monday through Sunday. After normal hours, the services are provided on-call. Bayonet Point's call-back procedures include the following: When an emergent radiologic procedure is ordered after hours, the Radiology personnel will contact the appropriate on call technologist via the hospital operator. Once the procedure is complete, the Technologist will call the Radiologist on call and then transmit those images via Teleradiography. Definition of an emergent procedure: In- house STAT, Emergency Department physician requesting radiologist interpretation, any outpatient whose physician requests immediate radiologist interpretation or "wet reading." Prior to A.A.'s experiencing the symptoms of a stroke at 3:15 a.m., no orders had been given for A.A. to resume taking aspirin. At 10 p.m. on January 10, 2000, Dr. Schafer ordered that "till further notified" all medications taken by mouth which could be taken intravenously were to be administered via an IV. Aspirin could not be administered intravenously. Because Dr. Schafer had ordered that aspirin therapy be stopped prior to surgery, it would be the responsibility of Dr. Schafer to order the aspirin to be restarted. Dr. Schafer was at A.A.'s bedside at 8:30 a.m., on January 12, 2000. Dr. Schafer noted that a head CT scan was ordered for that morning and that the patient was on his way down for the test. Dr. Schafer also noted that a neurological evaluation had been ordered for A.A. for that morning. The hospital records show that at 8:50 a.m., on January 12, 2000, a call was made to Dr. Shah's answering service, requesting a neurological consultation. The request for consultation form, which was filled out after Dr. Schafer's visit at 8:30 a.m., indicated that the request was an emergency request. The request for consultation form was filled out by someone other than the nurse who charted Dr. Mationg's verbal order for a neurological consultation. Based on the evidence presented, the request for a neurological consultation was not treated as an emergency request until after Dr. Schafer saw A.A. at 8:30 a.m. Tissue Plaminogen Activators (TPA) are used to dissolve clots which may be causing a stroke. The use of TPA is limited to a three-hour window following the onset of stroke symptoms. Dr. Mationg did consider the use of TPA, but felt that it was contraindicated based on the recent surgery. This opinion was confirmed at final hearing by a neurologist.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Dr. Mationg violated Subsection 458.331(1)(t), Florida Statutes; finding that Dr. Mationg did not violate Subsection 458.331(1)(m), Florida Statutes; placing Dr. Mationg on two years probation; imposing an administrative fine of $5,000; and requiring that Dr. Mationg attend ten hours of continuing medical education courses in the diagnosis and treatment of strokes and four hours of continuing medical education courses in risk management. DONE AND ENTERED this 3rd day of July, 2003, in Tallahassee, Leon County, Florida. S ___________________________________ SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of July, 2003. COPIES FURNISHED: James W. Earl, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 A. S. Weekley, Jr., Esquire Holland & Knight, LLP 400 North Ashley Drive, Suite 2300 Tampa, Florida 33602 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
The Issue Whether the application filed on April 1, 2016, by Orange Park Medical Center, Inc., d/b/a Orange Park Medical Center (Orange Park), to operate as a Level II trauma center met the applicable statutory and rule criteria to receive provisional approval? Whether the Department of Health’s (Department) approval of the application was based upon an unadopted rule?
Findings Of Fact The Parties The Department is an agency of the State of Florida created pursuant to section 20.43, Florida Statutes (2016). The Department’s mandate is to “promote, protect and improve the health of all people in the state,” and it has primary responsibility for evaluating provisional trauma center applications submitted by acute care hospitals. §§ 381.001, 395.40(3), and 395.401(c), Fla. Stat. A "trauma center" is a "hospital that has been verified by the Department to be in substantial compliance with the requirements in section 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." § 395.4001(14), Fla. Stat. Petitioner, UF Health Jacksonville, operates a licensed 695-bed hospital and a Level I trauma center in Jacksonville, Duval County, Florida. UF Health Jacksonville's Level I trauma center is in TSA 5. The number of trauma patients treated by UF Health Jacksonville has declined sharply since the Department authorized Orange Park to operate as a trauma center. UF Health Jacksonville projects an annual loss of 320 to 540 trauma cases as a result of Orange Park's operation of a trauma center. Orange Park is a 317-bed acute-care hospital located in TSA 5, Clay County, Florida. Orange Park provides a wide range of services, including inpatient pediatric care, open-heart surgery, and a comprehensive stroke program. Orange Park is also a teaching hospital with residency programs in internal medicine and family practice. It provides behavioral health services and is the only Baker Act receiving facility in Clay County. Orange Park applied for provisional approval to operate a Level II trauma center in TSA 5. Pursuant to the application decision that is the subject of this litigation, Orange Park has operated as a provisional Level II trauma center since May 2016. Subsequent to the initiation of this proceeding, Orange Park worked with the Department to purportedly complete the in-depth review of its application and has scheduled a final verification survey. The Trauma Center Application and Review Process Chapter 395, Part II, Florida Statutes, codifies the process and substantive standards for licensing trauma centers in Florida. As noted, the Department has primary responsibility for administering the trauma center statute, including licensing trauma centers pursuant to chapter 395, Part II, and Florida Administrative Code Chapter 64J-2. The Legislature has capped at 44 the total number of trauma centers that may operate in Florida at a given time. Pursuant to section 395.402(4)(b), the Department has adopted rule 64J-2.010(3), which currently allocates one trauma center to TSA 5, which consists of Baker, Clay, Duval, Nassau, and St. Johns counties. Section 395.4025(2) establishes a 21-month process a hospital must follow to obtain verification--i.e., final approval--as a trauma center, and the Department has, by rule, established additional procedures governing the selection of trauma centers. During this multi-stage process, there are discrete decision points at which the Department must take action on a hospital's application to become licensed as a trauma center. The first stage of the trauma center review and approval process--which is the stage at issue in this proceeding--is the provisional review stage. This stage commences when the Department receives a hospital's application to be licensed as a trauma center. § 395.4025(2)(c), Fla. Stat. At the provisional review stage, the Department determines whether the hospital has the critical elements required for the level of trauma center for which the hospital has applied. Id. The provisional review stage culminates with the Department announcing its decision that the application is acceptable, or denying the application. If the proposed decision is to deny the application, the applicant is entitled to challenge that decision; if the proposed decision is to find the application acceptable, other hospitals must be given an opportunity to "protest," or challenge, that decision. Section 395.4025(7) requires challenges to the Department's trauma center licensure decisions to be conducted pursuant to sections 120.569 and 120.57. Procedural History and the Processing of Orange Park's Application On or before October 1, 2015, Orange Park filed a letter of intent to establish a new Level II trauma center in TSA 5. Thereafter, on or before April 1, 2016, Orange Park filed an application with the Department to become a Level II trauma center. Consistent with statute, the Department sent the application for review by out-of-state reviewers. On or about April 14, 2016, the Department set forth a list of omitted items that prevented Orange Park's application from being deemed complete. Critical elements missing from Orange Park's application included proof of adequate and up-to- date training of several trauma surgeons and emergency room physicians. In particular, reviewers selected by the Department noted that Orange Park failed to meet the following requirements: at least one qualified trauma surgeon to be on backup trauma call at all times to provide trauma service care; documentation that the medical director shall approve all trauma-related patient care protocols before implementation; a minimum of five qualified trauma surgeons, assigned to the trauma service, with at least two trauma surgeons available to provide primary and backup trauma coverage 24 hours a day at the trauma center when summoned; evidence that an orthopedic surgeon is available to arrive promptly at the trauma center when summoned; all specialists are board-certified or actively participating in the certification process and granted medical staff privileges by the hospital to care for adult and pediatric patients; at least one scrub nurse technician and one circulating registered nurse in the operating room and post- anesthesia recovery; at least eight hours of continuing education every two years for the rehabilitation unit; a radiologist, board-certified or actively participating in the certification process and granted privileges by the hospital to provide radiological services for adult and pediatric patients, on trauma call and can arrive promptly at the trauma center when summoned; adequate quarterly reporting to the Department of Health; and adequate in-hospital trauma registry minimum data set. The Department made Orange Park's lengthy trauma application available to UF Health Jacksonville through a public records request. Cynthia Gerdik, who holds a Ph.D. in nursing, spent over 40 hours reviewing Orange Park's application on behalf of UF Health Jacksonville. Like the outside reviewers used by the Department, Dr. Gerdik found several discrepancies related to qualifications and training of trauma surgeons and personnel proposed to serve Orange Park's trauma center. Specifically, Dr. Gerdik's review found that one trauma surgeon's advanced trauma life support (ATLS) certification had expired on June 27, 2016, and that an emergency department physician's ATLS certification had expired on June 29, 2016. Orange Park’s witness, Keri Deaton, testified that Orange Park retained documentation that the certifications were renewed but never provided the documentation to the Department. At hearing, it was revealed that one of the physicians, who had ostensibly missing education requirements, had been married and was the same person identified by a different last name in the application. After April 14, 2016, Orange Park supplemented its application, and the Department deemed the application complete. Section 395.4001(10) defines “provisional trauma center” as follows: “Provisional trauma center” means 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 provisional Level I trauma center, Level II trauma center, or pediatric trauma center. (emphasis added). Notwithstanding her criticisms of the Orange Park application, Dr. Gerdik conceded that Orange Park’s application met the required trauma program standards. At hearing, Ms. Gerdik testified: Q. Did you form an opinion that the Orange Park application met the minimum criteria for critical elements? A. Yes, sir. I did testify to that. Q. Did you also conclude that they were in substantial compliance with all critical elements set forth in 150-9? A. Correct. (Tr. 492-93). With the exception of need, as evidenced by an available allocation slot determined pursuant to rule 64J- 2.010(3) as discussed below, the Orange Park application is in substantial compliance with the statutory and rule requirements for provisional approval. On April 28, 2016, the Department sent a letter to Orange Park indicating that the Department intended to approve Orange Park's application. The same letter informed Orange Park that it may open its trauma center immediately and "begin to operate as a Provisional Level II trauma center beginning May 1, 2016." The Department informed emergency responders to alter their trauma transport protocols, effective that same date, so that trauma patients that would have otherwise been seen at UF Health Jacksonville or another trauma provider could instead be sent to Orange Park for trauma services. Beginning on May 1, 2016, and throughout the course of this administrative proceeding, Orange Park has operated a provisional Level II trauma center. UF Health Jacksonville timely filed a petition challenging the provisional approval of Orange Park's application. The Department referred UF Health Jacksonville’s petition to DOAH so that a fact-finding hearing could be conducted to resolve the question of whether Orange Park's application should be provisionally approved to operate a trauma center. After UF Health Jacksonville's petition was transferred to DOAH and the instant proceeding begun, the Department continued to process Orange Park's application through the in-depth review phase. During the in-depth review stage, the Department informed Orange Park of five additional deficiencies that needed to be corrected in order to be approved. Orange Park participated in the Department's in-depth review of its application by submitting responses to the Department's listed deficiencies. On or before September 30, 2016, Orange Park received a letter from the Department indicating that the in-depth review stage was complete, and the verification site survey had been scheduled. The Department never published its decision that the in-depth review was complete and, until this activity was revealed at the final hearing, never notified UF Health Jacksonville of its action. The Department and Orange Park also worked to arrange the verification site survey, now scheduled for some time in February 2017. The Department's Consideration of Need When Reviewing Orange Park's Application The Department's existing rule 64J-2.010 is titled "Allocation of Trauma Centers Among Trauma Service Areas." The rule allocates the maximum number of trauma centers needed in each of 19 trauma service areas. See Id. Rule 64J-2.010(3) allocates a need for only one trauma center in TSA 5. Rule 64J-2.010 references an Amended Trauma Service Area Assessment, dated March 14, 2014. See Fla. Admin. Code R. 64J-2.010(3). That assessment contains most of the data relevant to assess "points," the sum of which determines the number of trauma programs needed in a trauma service area. When data relevant to population, transport times, the number of severely injured patients, where they are served, and the presence of UF Health Jacksonville's existing Level I trauma center were scored and tallied, a total of five points was found for TSA 5. See Fla. Admin. Code R. 64J-2.010(1)(b)1. This number of points led to the allocation of just one program needed for TSA 5. The 2014 Assessment incorporated into rule 64J-2.010 makes no reference to community support for an additional trauma center in TSA 5, or anywhere else in the state. The 2014 Assessment does not contain any information that could result in the award of an additional point for TSA 5 due to community support. Thus, at all times relevant to the consideration of Orange Park's application, rule 64J-2.010 allocated a need for just one trauma center in TSA 5, and UF Health Jacksonville's long-standing Level I trauma center fills that need. No party disputed the allocation for just one trauma center in TSA 5 under the current version of rule 64J-2.010. Pursuant to the Department's existing trauma application processing rule, the lack of an available slot for an additional trauma program in TSA 5 should have caused the rejection of Orange Park's letter of intent and application. The Department's existing rule 64J-2.012(1)(a) provides as follows: The department shall accept a letter of intent, DH Form 1840, January 2010, “Trauma Center Letter of Intent”, which is incorporated by reference and available from the department, as defined by subsection 64J-2.001(4), F.A.C., postmarked no earlier than September 1 and no later than midnight, October 1, from any acute care general or pediatric hospital. The 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. If the hospital does not submit a completed application or does not request an extension to complete its application by April 1 of the following year, in accordance with Rule 64J-2.013, F.A.C., the hospital’s letter of intent is void; Fla. Admin. Code R. 64J-2.012(1)(a)1/(emphasis added). Though the Department made proposals to amend rule 64J-2.010 on several occasions, no amendments have been made to rule 64J-2.010 since July 29, 2014. At all times relevant to this proceeding, rule 64J- 2.010 allocated a need for only one trauma center in TSA 5, and rule 64J-2.012(1)(a) only permitted the filing of a provisional trauma center application "if an available position, as provided in rule 64J-2.010, F.A.C., exists in the hospital’s TSA." Prior to 2015, the Department's practice was to reject a letter of intent when there was no allocated need available for an additional trauma center in the relevant TSA under rule 64J-2.010. This practice was consistent with the requirements of rule 64J-2.012(1)(a). In October of 2014, pursuant to its prior practice, the Department rejected Orange Park's letter of intent because there was no need for an additional program allocated in TSA 5. However, the Department changed its practice beginning in 2015, at which time it began accepting letters of intent and applications regardless of whether any need for an additional trauma center was allocated to the TSA under rule 64J-2.010. In October 2015, the Department accepted Orange Park's letter of intent pursuant to its new practice, despite the lack of any allocated need for an additional trauma center in TSA 5. As noted above, Orange Park was approved to operate a provisional trauma center beginning May 1, 2016. On September 1, 2016, many months after the Department's preliminary decision to approve Orange Park's provisional application, and many months after this proceeding was initiated, the Department proposed amendments to rules 64J-2.010 and 64J-2.012. See Fla. Admin. Reg., Sept. 1, 2016, Vol. 42, No. 171. The Department offered no testimony or evidence to demonstrate why it was not feasible or practicable to adopt the Department's new policies into rules before applying them. If adopted, those new amendments would alter the Department's consideration of the number of trauma centers allocated in rule 64J-2.010. However, those proposals have been challenged and are the subject of separate administrative proceedings. See Shands Jacksonville Med. Ctr., Inc., d/b/a UF Health Jacksonville v. Dep’t of Health, DOAH Case Nos. 16- 5837RP, 16-5838RP, 16-5839RP, 16-5840RP, and 16-5841RP. The Department's recently proposed changes to its trauma allocation and trauma application processing rules have not been adopted and are not presumed to be valid or invalid. See § 120.56(2)(c), Fla. Stat. The Department's newly proposed amendments to its trauma rules reveal the unadopted rule that the Department began to implement in 2015, when it accepted Orange Park's letter of intent, despite the lack of an available slot allocated for an additional trauma center. Pursuant to rule amendments that the Department now proposes to codify, but which presently constitute unadopted rules, the Department will now accept and process applications to operate as provisional trauma centers, regardless of any allocated need set forth in rule 64J-2.010. UF Health Jacksonville has alleged that the Department's approval of Orange Park cannot be sustained because the approval violates the Department's own rules and governing statutes, but also because the approval is based upon an unadopted rule–-a new policy that would allow the approval of provisional trauma centers regardless of any need allocated in rule 64J-2.010. Ms. Colston acknowledged that no statute changed in 2014 or 2015 to inspire the Department to change its practice. However, she indicated that the Department's position was evolving due to consideration of a recent Recommended Order stemming from litigation over a trauma center application. That Order, The Public Health Trust of Miami-Dade County Florida, d/b/a Jackson South Community Hospital v. Department of Health, Case. No. 15-3171 (Fla. DOAH Feb. 29, 2016), was rejected as moot in a Final Order issued by the Department on July 7, 2016. Nevertheless, Ms. Colston cited the rejected Order as the basis for the Department's new interpretation of rule 64J-2.012 and processing of provisional trauma applications in the absence of an allocated need: Q: I did read the language correctly? Is that what the existing rule required when Orange Park was approved? A: I would start with our full reading of the rule, which says that we shall accept the letter of intent. We, again, looked at these rules and we looked at the statute, and we have some "shall" language in both the statute and the rule that tells us what we shall do that's interpreted by the Department in general and by me as something that we shall do. So we shall accept the provisional application, we shall receive the letter of intent. And then the other part that would have inspired us to act the way we did was a ruling that said that we are required to accept these--that we shall accept and shall act and shall do these things at the risk of being sued. So that was a consideration that the Department was also taking into-– under consideration when we did these actions. Furthermore, I mean, there's been some discussion about need. But what we've seen and what was upheld especially in the latest lawsuit was that need is not determined on the front end during the provisional review and during the letter of intent process. So all of these things contributed to the Department's decision. Q: I may have mislead [sic] you with the timing of my question. I thought I understood you to say the policy processes that are announced in the September changes did not come into fruition in the Department's mind, become a firm way of doing things until they were proposed in September, is that true? A: No. (Tr. 420-421). Ms. Colston had difficulty explaining the Department's position regarding its interpretation and compliance with existing versions of rule 64J-2.010 and rule 64J-2.012. Ms. Colston offered conflicting testimony regarding whether the Department was operating under the process set forth in the Department's newly proposed rule: Q: Okay. Did that process described in the newly proposed rule, was that in place as a process that the Department would use when Orange Park was approved in late April 2016? A: We can't function under an unadopted rule. So we would have been functioning under the current rule. (Tr. 418). At hearing, Ms. Colston confirmed that the Department considers "preliminary" and "provisional" reviews required by Florida law to be synonymous. She further testified that the Department makes three separate decision points during its review of trauma center applications: provisional status; in- depth review; and then final verification. Ms. Colston then testified that the availability of allocated need (pursuant to rule 64J-2.010) is now only dispositive at the final stage of review-–the verification stage which follows site reviews and inspections. According to Ms. Colston, the Department now takes the position (and took the position during its review of Orange Park's application) that the availability of an allocated TSA slot is only applicable at the final verification stage. Ms. Colston acknowledged that the establishment of a provisional trauma center involves millions of dollars of investment in equipment, staff, and expertise. When asked if it was reasonable to interpret Department rules in a way that would allow the operation of provisional trauma centers only to be told, at the final stage of review, that the lack of an available allocation “slot” prevents the trauma program's final verification, Ms. Colston admitted that the interpretation was not reasonable. By approving Orange Park's provisional application in the absence of an available slot allocated by rule 64J-2.010, the Department failed to follow its own rules and precedent. Its new interpretation constitutes a generally applicable, unadopted rule that the Department is only now attempting to codify. The Department's new "interpretation" of its existing rule is unsupported by the facts adduced at hearing and is, as admitted by the Department's representative, not reasonable. But for the Department's reliance on an unadopted rule, the Department would have never processed Orange Park's application, nor permitted Orange Park to operate as a provisional trauma center. Impact of Orange Park's Trauma Center on UF Health Jacksonville High volumes of patients with high injury severity are necessary for trauma centers to improve and maintain quality through educational opportunities to their trauma staff. Trauma nurses require a year and a half to two years of experience with severely injured patients to enable them to be a primary nurse in a trauma critical care unit. Reduced volumes of trauma cases cause a trauma center to have fewer educational opportunities to enable trauma nurses to gain experience. UF Health Jacksonville is a teaching hospital that trains nurses and trauma surgeons. The decline in trauma volumes caused by Orange Park's operation as a trauma center has reduced training opportunities at UF Health Jacksonville. The opening of Orange Park's trauma center has caused the average injury severity score (ISS) for trauma patients to decrease at UF Health Jacksonville, thereby reducing the educational opportunities for UF Health Jacksonville's trauma nurses to treat the most severely injured patients. During the first three months after Orange Park opened its trauma center in 2016, UF Health Jacksonville's volume of its most severely injured patients decreased by 17 percent. Overall, UF Health Jacksonville projects an annual loss of 320 to 540 trauma cases caused by Orange Park's operation of a trauma center. UF Health Jacksonville projects that a contribution margin loss of approximately $3.5 million to $5.9 million annually will be caused by Orange Park's operation of a trauma center.
Recommendation Based on the forgoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order denying Orange Park's Application to operate a provisional trauma center in TSA 5. DONE AND ENTERED this 27th day of January, 2017, in Tallahassee, Leon County, Florida. S W. DAVID WATKINS 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 27th day of January, 2017.
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.
Findings Of Fact Based upon the Stipulation and Joint Petition, the undersigned makes the following Findings of Fact: Petitioners are the natural parents of Onazjah Cutley (“Onazjah”) and are the “claimants,” as defined in section 766.302(3), Florida Statutes. 1 All references to the Florida Statutes are to the 2019 versions, none of which have materially changed since 2019. Onazjah suffered a “birth-related neurological injury” (“Injury”), as defined in section 766.302(2), on or about December 2, 2019. The Injury solely and proximately caused Onazjah’s medical condition, which resulted in her death on December 14, 2019. At birth, Onazjah weighed 3,165 grams. Stephen W. Tobia, M.D., rendered obstetrical services in the delivery of Onazjah and, at all material times, was a “participating physician,” as defined in section 766.302(7). Health First’s Holmes Regional Medical Center, in Melbourne, Florida, is the “hospital,” as defined in section 766.302(6), where Onazjah was born. On September 22, 2020, Petitioners filed a Petition seeking compensation from NICA, pursuant to section 766.305, Florida Statutes. The Petition is incorporated herein by reference in its entirety, including all attachments. Any reference to NICA made within that document encompasses, where appropriate, the Florida Birth-Related Neurological Injury Compensation Plan (“Plan”).
