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The Florida Statutes

The 2017 Florida Statutes

Title XXIX
PUBLIC HEALTH
Chapter 395
HOSPITAL LICENSING AND REGULATION
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F.S. 395.4025
395.4025 Trauma centers; selection; quality assurance; records.
(1) For purposes of developing a system of trauma centers, the department shall use the 19 trauma service areas established in s. 395.402. Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, and recommendations of the local or regional trauma agency, the department shall establish the approximate number of trauma centers needed to ensure reasonable access to high-quality trauma services. The department shall select those hospitals that are to be recognized as trauma centers.
(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 trauma centers. In order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists. Letters of intent must be postmarked no later than midnight October 1.
(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. 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 trauma center. This critical review will be based on trauma center 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 hospital applying to become a trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists.
(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 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 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 trauma center.
(3) After April 30, any hospital that submitted an application found acceptable by the department based on provisional review shall be eligible to operate as a provisional trauma center.
(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 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 standards such that all trauma 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 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 shall meet all the requirements of a trauma center and shall be located in a trauma service area that has a need for such a trauma center.
(6) Based on recommendations from the review team, the department shall select trauma centers by July 1. An applicant for designation as a trauma 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 trauma 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 trauma 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 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.
(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 ss. 120.569 and 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 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.
(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, 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.
(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, 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.
(13) 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 annually selecting trauma centers and must be consistent with subsections (1)-(8) except in those situations in which it is in the best interest of, and mutually agreed to by, all applicants within a service area and the department to reduce the timeframes.
(14) Notwithstanding the procedures established pursuant to subsections (1) through (13), 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.
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.
Note.Former s. 395.0335.