§ 395.4025 — Trauma centers; selection; quality assurance; records

Florida § 395.4025

• Jurisdiction: Florida
• Title: XXIX
• Ch. 395: HOSPITAL LICENSING AND REGULATION

Text

(1) For purposes of developing a system of trauma centers, the department shall use the 18 trauma service areas established in s. 395.402. The department shall designate those hospitals that are to be recognized as trauma centers.

(2)(a) The department shall prepare an analysis of the Florida trauma system by August 31, 2020, and every 3 years thereafter, using the hospital discharge database described in s. 408.061 for the most current year and the most recent 5 years of population data for the state available from the American Community Survey 5-Year Estimates by the United States Census Bureau. The department’s report must, at a minimum, include all of the following: 1. The population growth for each trauma service area and for the state. 2. The number of high-risk patients treated at each trauma center within each trauma service area, including pediatric trauma centers. 3. The total number of high-risk patients treated at all acute care hospitals, including nontrauma centers, in each trauma service area. 4. The percentage of each trauma center’s sufficient volume of trauma patients, as described in subparagraph (3)(d)2., in accordance with the International Classification Injury Severity Score for the trauma center’s designation, inclusive of the additional caseload volume required for those trauma centers with graduate medical education programs. (b) The department shall make available all data, formulas, methodologies, calculations, and risk adjustment tools used in preparing the report.

(3)(a) The department shall notify each acute care general hospital and each local and each regional trauma agency in a trauma service area with an identified need for an additional trauma center that the department is accepting letters of intent from hospitals that are interested in becoming trauma centers. The department may accept a letter of intent only if there is statutory capacity for an additional trauma center in accordance with subsection (2), paragraph (d), and s. 395.402. Letters of intent must be postmarked no later than midnight October 1 of the year in which the department notifies hospitals that it plans to accept letters of intent. (b) By October 15, the department shall send to all hospitals that submitted a letter of intent an application package that will provide the hospitals with instructions for submitting information to the department for selection as a trauma center. The standards for trauma centers provided for in s. 395.401(2), as adopted by rule of the department, shall serve as the basis for these instructions. (c) In order to be considered by the department, applications from those hospitals seeking selection as trauma centers, including those current verified trauma centers that seek a change or redesignation in approval status as a trauma center, must be received by the department no later than the close of business on April 1 of the year following submission of the letter of intent. The department shall conduct an initial review of each application for the purpose of determining whether the hospital’s application is complete and the hospital is capable of constructing and operating a trauma center that includes the critical elements required for a trauma center. This critical review must be based on trauma center standards and must include, but need not be limited to, a review as to whether the hospital is prepared to attain and operate with all of the following components before April 30 of the following year: 1. Equipment and physical facilities necessary to provide trauma services. 2. Personnel in sufficient numbers and with proper qualifications to provide trauma services. 3. An effective quality assurance process. (d) Except as otherwise provided in this part, the department may not approve an application for a Level I trauma center, Level II trauma center, Level II trauma center with a pediatric trauma center, jointly certified pediatric trauma center, or stand-alone pediatric trauma center if approval of the application would exceed the limits on the numbers of Level I trauma centers, Level II trauma centers, Level II trauma centers with a pediatric trauma center, jointly certified pediatric trauma centers, or stand-alone pediatric trauma centers set forth in s. 395.402(1). However, the department shall review and may approve an application for a trauma center when approval of the application would result in a total number of trauma centers which exceeds the limit on the number of trauma centers in a trauma service area as set forth in s. 395.402(1), if the applicant demonstrates and the department determines that: 1. The existing trauma center’s actual caseload volume of high-risk patients exceeds the minimum caseload volume capabilities, including the additional caseload volume for graduate medical education critical care and trauma surgical subspecialty residents or fellows, by more than two times the statutory minimums listed in sub-subparagraphs 2.a.-d. or three times the statutory minimum listed in sub-subparagraph 2.e., and the population growth for the trauma service area exceeds the statewide population growth by more than 15 percent based on the American Community Survey 5-Year Estimates by the United States Census Bureau for the 5-year period before the date the applicant files its letter of intent; and 2. A sufficient caseload volume of potential trauma patients exists within the trauma service area to ensure that existing trauma centers caseload volumes are at the following levels: a. For Level I trauma centers in trauma service areas with a population of greater than 1.5 million, a minimum caseload volume of the greater of 1,200 high-risk patients admitted per year or, for a trauma center with a trauma or critical care residency or fellowship program, 1,200 high-risk patients admitted plus 40 cases per year for each accredited critical care and trauma surgical subspecialty medical resident or fellow. b. For Level I trauma centers in trauma service areas with a population of less than 1.5 million, a minimum caseload volume of the greater of 1,000 high-risk patients admitted per year or, for a trauma center with a critical care or trauma residency or fellowship program, 1,000 high-risk patients admitted plus 40 cases per year for each accredited critical care and trauma surgical subspecialty medical resident or fellow. c. For Level II trauma centers and Level II trauma centers with a pediatric trauma center in trauma service areas with a population of greater than 1.25 million, a minimum caseload volume of the greater of 1,000 high-risk patients admitted or, for a trauma center with a critical care or trauma residency or fellowship program, 1,000 high-risk patients admitted plus 40 cases per year for each accredited critical care and trauma surgical subspecialty medical resident or fellow. d. For Level II trauma centers and Level II trauma centers with a pediatric trauma center in trauma service areas with a population of less than 1.25 million, a minimum caseload volume of the greater of 500 high-risk patients admitted per year or, for a trauma center with a critical care or trauma residency or fellowship program, 500 high-risk patients admitted plus 40 cases per year for each accredited critical care and trauma surgical subspecialty medical resident or fellow. e. For pediatric trauma centers, a minimum caseload volume of the greater of 500 high-risk patients admitted per year or, for a trauma center with a critical care or trauma residency or fellowship program, 500 high-risk patients admitted per year plus 40 cases per year for each accredited critical care and trauma surgical subspecialty medical resident or fellow. The International Classification Injury Severity Score calculations and caseload volume must be calculated using the most recent available hospital discharge data collected by the agency from all acute care hospitals pursuant to s. 408.061. The agency, in consultation with the department, shall adopt rules, for trauma centers and acute care hospitals for the submission of data required for the department to perform its duties under this chapter. (e) If the department determines that the hospital is capable of attaining and operating with the components required in paragraph (c), the applicant must be ready to operate in compliance with state trauma center standards no later than April 30 of the year following the department’s initial review and approval of the hospital’s application to proceed with preparation to operate as a trauma center. A hospital that fails to comply with this subsection may not be designated as a trauma center.

(4) By May 1, the department shall select one or more hospitals that submitted an application found acceptable by the department based on initial review for approval to prepare to operate with the components required in paragraph (3)(c). If the department receives more applications than may be approved, the department must select the best applicant or applicants from the available pool based on the department’s determination of the capability of an applicant to provide the highest quality patient care using the most recent technological, medical, and staffing resources available and which is located the farthest away from an existing trauma center in the applicant’s trauma service area to maximize access. The number of applicants selected is limited to available statutory need in the specified trauma service area as designated in paragraph (3)(d) or s. 395.402(1).

(5) Following its initial review, the department shall conduct an in-depth evaluation of all applications found acceptable in the initial review. The applications shall be evaluated against criteria enumerated in the application packages as provided to the hospitals by the department. An applicant may not operate as a provisional trauma center until the department completes the initial and in-depth reviews and approves the application through those review stages.

(6) Within 1 year after the hospital begins operating as a provisional trauma center, a review team of out-of-state experts assembled by the department shall make onsite visits to all provisional trauma centers. The department shall develop a survey instrument to be used by the expert team of reviewers. The instrument must include objective criteria and guidelines for reviewers based on existing trauma center standards such that all trauma centers are assessed equally. The survey instrument must also include a uniform rating system that reviewers must use to indicate the degree of compliance of each trauma center with specific standards, and to indicate the quality of care provided by each trauma center as determined through an audit of patient charts. In addition, hospitals being considered as provisional trauma centers must meet all the requirements of a trauma center and must be located in a trauma service area that has a need for such a trauma center.

(7) Based on recommendations from the review team, the department shall approve for designation a trauma center that is in compliance with trauma center standards, as established by department rule, and with this section. Each trauma center shall be granted a 7-year approval period during which time it must continue to maintain trauma center standards and acceptable patient outcomes as determined by department rule. An approval, unless sooner suspended or revoked, automatically expires 7 years after the date of issuance and is renewable upon application for renewal as prescribed by rule of the department.

(8) Only an applicant or hospital with an existing trauma center in the same trauma service area or in a trauma service area contiguous to the trauma service area where the applicant has applied to operate a trauma center may protest a decision made by the department with regard to whether the application should be approved, or whether a need has been established pursuant to the criteria in paragraph (3)(d). Hearings held under this subsection shall be conducted in the same manner as provided in ss. 120.569 and 120.57. Cases filed under chapter 120 may combine all disputes between parties.

(9) Notwithstanding any provision of chapter 381, a hospital licensed under ss. 395.001-395.3025 that operates a trauma center may not terminate or substantially reduce the availability of trauma service without providing at least 180 days’ notice of its intent to terminate such service. Such notice shall be given to the department, to all affected local or regional trauma agencies, and to all trauma centers, hospitals, and emergency medical service providers in the trauma service area. The department shall adopt by rule the procedures and process for notification, duration, and explanation of the termination of trauma services.

(10) Except as otherwise provided in this subsection, the department or its agent may collect trauma care and registry data, as prescribed by rule of the department, from trauma centers, hospitals, emergency medical service providers, local or regional trauma agencies, or medical examiners for the purposes of evaluating trauma system effectiveness, ensuring compliance with the standards, and monitoring patient outcomes. A trauma center, hospital, emergency medical service provider, medical examiner, or local trauma agency or regional trauma agency, or a panel or committee assembled by such an agency under s. 395.50(1) may, but is not required to, disclose to the department patient care quality assurance proceedings, records, or reports. However, the department may require a local trauma agency or a regional trauma agency, or a panel or committee assembled by such an agency to disclose to the department patient care quality assurance proceedings, records, or reports that the department needs solely to conduct quality assurance activities under s. 395.4015, or to ensure compliance with the quality assurance component of the trauma agency’s plan approved under s. 395.401. The patient care quality assurance proceedings, records, or reports that the department may require for these purposes include, but are not limited to, the structure, processes, and procedures of the agency’s quality assurance activities, and any recommendation for improving or modifying the overall trauma system, if the identity of a trauma center, hospital, emergency medical service provider, medical examiner, or an individual who provides trauma services is not disclosed.

(11) Out-of-state experts assembled by the department to conduct onsite visits are agents of the department for the purposes of s. 395.3025. An out-of-state expert who acts as an agent of the department under this subsection is not liable for any civil damages as a result of actions taken by him or her, unless he or she is found to be operating outside the scope of the authority and responsibility assigned by the department.

(12) Onsite visits by the department or its agent may be conducted at any reasonable time and may include but not be limited to a review of records in the possession of trauma centers, hospitals, emergency medical service providers, local or regional trauma agencies, or medical examiners regarding the care, transport, treatment, or examination of trauma patients.

(13) Patient care, transport, or treatment records or reports, or patient care quality assurance proceedings, records, or reports obtained or made pursuant to this section, s. 395.3025(4)(f), s. 395.401, s. 395.4015, s. 395.402, s. 395.403, s. 395.404, s. 395.4045, s. 395.405, s. 395.50, or s. 395.51 must be held confidential by the department or its agent and are exempt from the provisions of s. 119.07(1). Patient care quality assurance proceedings, records, or reports obtained or made pursuant to these sections are not subject to discovery or introduction into evidence in any civil or administrative action.

(14) The department may adopt, by rule, the procedures and process by which it will select trauma centers. Such procedures and process must be used in selecting trauma centers and must be consistent with subsections (1)-(9) except in those situations in which it is in the best interest of, and mutually agreed to by, all applicants within a service area and the department to reduce the timeframes.

(15) Notwithstanding the procedures established pursuant to subsections (1)-(14), hospitals located in areas with limited access to trauma center services shall be designated by the department as Level II trauma centers based on documentation of a valid certificate of trauma center verification from the American College of Surgeons. Areas with limited access to trauma center services are defined by the following criteria: (a) The hospital is located in a trauma service area with a population greater than 600,000 persons but a population density of less than 225 persons per square mile; (b) The hospital is located in a county with no verified trauma center; and (c) The hospital is located at least 15 miles or 20 minutes travel time by ground transport from the nearest verified trauma center.

(16)(a) Notwithstanding the statutory capacity limits established in s. 395.402(1), the provisions of subsection (8), or any other provision of this part, an adult Level I trauma center, an adult Level II trauma center, a Level II trauma center with a pediatric trauma center, a jointly certified pediatric trauma center, or a stand-alone pediatric trauma center that was verified by the department before December 15, 2017, is deemed to have met the trauma center application and operational requirements of this section and must be verified and designated as a trauma center. (b) Notwithstanding the statutory capacity limits established in s. 395.402(1), the provisions of subsection (8), or any other provision of this part, a trauma center that was not verified by the department before December 15, 2017, but that was provisionally approved by the department to be in substantial compliance with Level II trauma standards before January 1, 2017, and is operating as a Level II trauma center, is deemed to have met the application and operational requirements of this section for a trauma center and must be verified and designated as a Level II trauma center. (c) Notwithstanding the statutory capacity limits established in s. 395.402(1), the provisions of subsection (8), or any other provision of this part, a trauma center that was not verified by the department before December 15, 2017, as a Level I trauma center but that was provisionally approved by the department to be in substantial compliance with Level I trauma standards before January 1, 2017, and is operating as a Level I trauma center is deemed to have met the application and operational requirements of this section for a trauma center and must be verified and designated as a Level I trauma center. (d) Notwithstanding the statutory capacity limits established in s. 395.402(1), the provisions of subsection (8), or any other provision of this part, a trauma center that was not verified by the department before December 15, 2017, as a pediatric trauma center but was provisionally approved by the department to be in substantial compliance with the pediatric trauma standards established by rule before January 1, 2018, and is operating as a pediatric trauma center is deemed to have met the application and operational requirements of this section for a pediatric trauma center and, upon successful completion of the in-depth and site review process, shall be verified and designated as a pediatric trauma center. Notwithstanding subsection (8), no existing trauma center in the same trauma service area or in a trauma service area contiguous to the trauma service area where the applicant is located may protest the in-depth review, site survey, or verification decision of the department regarding an applicant that meets the requirements of this paragraph. (e) Notwithstanding the statutory capacity limits established in s. 395.402(1) or any other provision of this part, a hospital operating as a Level II trauma center after January 1, 2017, must be designated and verified by the department as a Level II trauma center if all of the following apply: 1. The hospital was provisionally approved after January 1, 2017, to operate as a Level II trauma center, and was in operation on or before June 1, 2017; 2. The department’s decision to approve the hospital to operate a provisional Level II trauma center was in litigation on or before January 1, 2018; 3. The hospital receives a recommended order from the Division of Administrative Hearings, a final order from the department, or an order from a court of competent jurisdiction that it was entitled to be designated and verified as a Level II trauma center; and 4. The department determines that the hospital is in substantial compliance with the Level II trauma center standards, including the in-depth and site reviews. Any provisional trauma center operating under this paragraph may not be required to cease trauma operations unless a court of competent jurisdiction or the department determines that it has failed to meet the trauma center standards, as established by department rule. (f) Notwithstanding the statutory capacity limits established in s. 395.402(1), or any other provision of this act, a joint pediatric trauma center involving a Level II trauma center and a specialty licensed children’s hospital which was verified by the department before December 15, 2017, is deemed to have met the application and operational requirements of this section for a pediatric trauma center and shall be verified and designated as a pediatric trauma center even if the joint program is dissolved upon the expiration of the existing certificate and the pediatric trauma center continues operations independently through the specialty licensed children’s hospital, provided that the pediatric trauma center meets all requirements for verification by the department. (g) Nothing in this subsection shall limit the department’s authority to review and approve trauma center applications.

Legislative History

ss. 6, 15, ch. 90-284; s. 78, ch. 91-282; ss. 38, 98, ch. 92-289; s. 1, ch. 94-129; s. 3, ch. 94-260; s. 1052, ch. 95-148; s. 27, ch. 95-398; s. 218, ch. 96-406; s. 125, ch. 96-410; s. 106, ch. 99-8; s. 4, ch. 2000-189; s. 7, ch. 2004-259; s. 3, ch. 2013-153; s. 6, ch. 2018-66; s. 61, ch. 2019-3.