(1) For purposes of developing a system of state-approved trauma centers, the department shall use the 19 trauma service areas established in s. 395.402. Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, recommendations of the local or regional trauma agency, and the 1990 Report and Proposal for Funding State-Sponsored Trauma Centers, the department shall establish the approximate number of state-approved trauma centers needed to ensure reasonable access to high-quality trauma services. Using the guidelines and procedures outlined in the 1990 report, except when in conflict with those prescribed in this section, the department shall select those hospitals that are to be recognized as state-approved trauma centers and shall include all trauma centers verified as of October 1, 1990, and subsequently, subject to specific programmatic and quality of care standards.

(2)

(a) The department shall annually notify each acute care general hospital and each local and each regional trauma agency in the state that the department is accepting letters of intent from hospitals that are interested in becoming state-approved trauma centers. In order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a 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. Letters of intent must be postmarked no later than midnight October 1. This paragraph does not apply to any hospital that is a provisional or verified trauma center on January 1, 1992.

(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 state-approved trauma center. The standards for verification of trauma centers and pediatric trauma referral centers provided for in s. 395.401(3), 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 state-approved trauma centers, including those current verified trauma centers that seek to be state-approved trauma centers, must be received by the department no later than the close of business on April 1. The department shall conduct a provisional review of each application for the purpose of 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: 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. 4. 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.

(d) 1. Notwithstanding other provisions in this section, the department may grant up to an additional 18 months to a hospital applicant that is unable to meet all requirements as provided in paragraph (c) at the time of application if the number of applicants in the service area in which the applicant is located is equal to or less than the service area allocation, as provided by rule of the department. An applicant that is granted additional time pursuant to this paragraph shall submit a plan for departmental approval which includes timelines and activities that the applicant proposes to complete in order to meet application requirements. Any applicant that demonstrates an ongoing effort to complete the activities within the timelines outlined in the plan shall be included in the number of state-approved trauma centers at such time that the department has conducted a provisional review of the application and has determined that the application is complete and that the hospital has the critical elements required for a state-approved trauma center. 2. Timeframes provided in subsections (1)-(8) shall be stayed until the department determines that the application is complete and that the hospital has the critical elements required for a state-approved trauma center.

(3) After April 30, any hospital that submitted an application found acceptable by the department based on provisional review, including all trauma centers verified as of December 1, 1989, shall be eligible to operate as a provisional state-approved trauma center.

(4) Between May 1 and October 1 of each year, the department shall conduct an in-depth evaluation of all applications found acceptable in the provisional review. The applications shall be evaluated against criteria enumerated in the application packages as provided to the hospitals by the department.

(5) Beginning October 1 of each year and ending no later than June 1 of the following year, a review team of out-of-state experts assembled by the department shall make onsite visits to all provisional state-approved trauma centers. The department shall develop a survey instrument to be used by the expert team of reviewers. The instrument shall include objective criteria and guidelines for reviewers based on existing trauma center and pediatric trauma referral center verification standards such that all trauma centers and pediatric trauma referral centers are assessed equally. The survey instrument shall also include a uniform rating system that will be used by reviewers to indicate the degree of compliance of each center with specific standards, and to indicate the quality of care provided by each center as determined through an audit of patient charts. In addition, hospitals being considered as provisional state-approved trauma centers shall meet all the requirements of a verified trauma center or pediatric trauma referral center, and shall be located in a trauma service area that has a need for such a center.

(6) Based on recommendations from the review team, the department shall select state-approved trauma centers by July 1. An applicant for designation as a state-approved trauma center or a state-approved pediatric trauma referral center may request an extension of its provisional status if it submits a corrective action plan to the department. The corrective action plan must demonstrate the ability of the applicant to correct deficiencies noted during the applicant's onsite review conducted by the department between the previous October 1 and June 1. The department may extend the provisional status of an applicant for designation as a state-approved trauma center or a state-approved pediatric trauma referral center through December 31 if the applicant provides a corrective action plan acceptable to the department. The department or a team of out-of-state experts assembled by the department shall conduct an onsite visit on or before November 1 to confirm that the deficiencies have been corrected. The provisional state-approved trauma center or the provisional state-approved pediatric trauma referral center is responsible for all costs associated with the onsite visit in a manner prescribed by rule of the department. By January 1, the department must approve or deny the application of any provisional applicant granted an extension. Each state-approved trauma center shall be granted a 7-year verification period during which time it must continue to maintain trauma center verification standards and acceptable patient outcomes as determined by department rule. A verification, 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. After July 1, 1992, only those hospitals selected as state-approved trauma centers may operate as trauma centers.

(7) Any hospital that wishes to protest a decision made by the department based on the department's preliminary or in-depth review of applications or on the recommendations of the site visit review team pursuant to this section shall proceed as provided in chapter 120. Hearings held under this subsection shall be conducted in the same manner as provided in s. 120.57. Cases filed under chapter 120 may combine all disputes between parties.

(8) Notwithstanding any provision of chapter 381, a hospital licensed under ss. 395.001-395.3025 that operates a state-approved trauma center may not terminate or substantially reduce the availability of trauma service without providing at least 6 months' notice of its intent to terminate such service. Such notice shall be given to the Department of Health and Rehabilitative Services, to all affected local or regional trauma agencies, and to all state-approved trauma centers, hospitals, and emergency medical service providers in the trauma service area.

(9) 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, pediatric trauma referral 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 of verification, and monitoring patient outcomes. A trauma center, pediatric trauma referral 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, pediatric trauma referral center, hospital, emergency medical service provider, medical examiner, or an individual who provides trauma services is not disclosed.

(10) 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.

(11) 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, pediatric trauma referral centers, hospitals, emergency medical service providers, local or regional trauma agencies, or medical examiners regarding the care, transport, treatment, or examination of trauma patients.

(12) 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. The exemption from s. 119.07(1) provided by this subsection is subject to the Open Government Sunset Review Act in accordance with [Footnote 1] s. 119.14.

(13) The department may adopt, by rule, the procedures and process by which it will select state-approved trauma centers. Such procedures and process must be used in annually selecting state-approved trauma centers and must be consistent with subsections (1)-(8) except in those situations in which it is in the best interest of, and mutually agreed to by, all applicants within a service area and the department to reduce the timeframes. 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. [Footnote 1] Note. A. Repealed by s. 1, ch. 95-217. B. Section 4, ch. 95-217, provides that "notwithstanding any provision of law to the contrary, exemptions from chapter 119, Florida Statutes, or chapter 286, Florida Statutes, which are prescribed by law and are specifically made subject to the Open Government Sunset Review Act in accordance with section 119.14, Florida Statutes, are not subject to review under that act, and are not abrogated by the operation of that act, after October 1, 1995." Note. Former s. 395.0335.