395.401 Trauma services system plans; approval of trauma centers and pediatric trauma centers; procedures; renewal.—
(1)(a) The local and regional trauma agencies shall plan, implement, and evaluate trauma services systems, in accordance with this section and ss. 395.4015, 395.404, and 395.4045, which consist of organized patterns of readiness and response services based on public and private agreements and operational procedures. The department shall establish, by rule, processes and procedures for establishing a trauma agency and obtaining its approval from the department.
(b) The local and regional trauma agencies shall develop and submit to the department plans for local and regional trauma services systems. The plans must include, at a minimum, the following components:
1. The organizational structure of the trauma system.
2. Prehospital care management guidelines for triage and transportation of trauma cases.
3. Flow patterns of trauma cases and transportation system design and resources, including air transportation services, provision for interfacility trauma transfer, and the prehospital transportation of trauma victims. The trauma agency shall plan for the development of a system of transportation of trauma alert victims to trauma centers where the distance or time to a trauma center or transportation resources diminish access by trauma alert victims.
4. The number and location of needed trauma centers based on local needs, population, and location and distribution of resources.
5. Data collection regarding system operation and patient outcome.
6. Periodic performance evaluation of the trauma system and its components.
7. The use of air transport services within the jurisdiction of the local trauma agency.
8. Public information and education about the trauma system.
9. Emergency medical services communication system usage and dispatching.
10. The coordination and integration between the trauma center and other acute care hospitals.
11. Medical control and accountability.
12. Quality control and system evaluation.
(c) The department shall receive plans for the implementation of inclusive trauma systems from trauma agencies. The department may approve or not approve trauma agency plans based on the conformance of the plan with this section and ss. 395.4015, 395.404, and 395.4045 and the rules and definitions adopted by the department pursuant to those sections. The department shall approve or disapprove the plans within 120 days after the date the plans are submitted to the department. The department shall, by rule, provide an application process for establishing a trauma agency. The application must, at a minimum, provide requirements for the trauma agency plan submitted for review, a process for reviewing the application for a trauma agency, a process for reviewing the trauma transport protocols for the trauma agency, and a process for reviewing the staffing requirements for the agency. The department shall, by rule, establish minimum requirements for a trauma agency to conduct an annual performance evaluation and submit the results to the department.
(d) A trauma agency shall not operate unless the department has approved the local or regional trauma services system plan of the agency.
(e) The department may grant an exception to a portion of the rules adopted pursuant to this section or s. 395.4015 if the local or regional trauma agency proves that, as defined in the rules, compliance with that requirement would not be in the best interest of the persons served within the affected local or regional trauma area.
(f) A local or regional trauma agency may implement a trauma care system only if the system meets the minimum standards set forth in the rules for implementation established by the department and if the plan has been submitted to, and approved by, the department. At least 60 days before the local or regional trauma agency submits the plan for the trauma care system to the department, the local or regional trauma agency shall hold a public hearing and give adequate notice of the public hearing to all hospitals and other interested parties in the area to be included in the proposed system.
(g) Local or regional trauma agencies may enter into contracts for the purpose of implementing the local or regional plan. If local or regional agencies contract with hospitals for trauma services, such agencies must contract only with hospitals which are verified trauma centers.
(h) Local or regional trauma agencies providing service for more than one county shall, as part of their formation, establish interlocal agreements between or among the several counties in the regional system.
(i) This section does not restrict the authority of a health care facility to provide service for which it has received a license pursuant to this chapter.
(j) Any hospital which is verified as a trauma center shall accept all trauma victims that are appropriate for the facility regardless of race, sex, creed, or ability to pay.
(k) It is unlawful for any hospital or other facility to hold itself out as a trauma center unless it has been so verified.
(l) A county, upon the recommendations of the local or regional trauma agency, may adopt ordinances governing the transport of a patient who is receiving care in the field from prehospital emergency medical personnel when the patient meets specific criteria for trauma, burn, or pediatric centers adopted by the local or regional trauma agency. These ordinances must be consistent with s. 395.4045, ordinances adopted under s. 401.25(6), and the local or regional trauma system plan and, to the furthest possible extent, must ensure that individual patients receive appropriate medical care while protecting the interests of the community at large by making maximum use of available emergency medical care resources.
(m) The local or regional trauma agency shall, consistent with the regional trauma system plan, coordinate and otherwise facilitate arrangements necessary to develop a trauma services system.
(n) After the submission of the initial trauma system plan, each trauma agency shall, every 5th year, submit to the department for approval an updated plan that identifies the changes, if any, to be made in the regional trauma system.
(o) This section does not preclude a local or regional trauma agency from adopting trauma care system standards.
(2) The department shall adopt, by rule, standards for verification of trauma centers based on national guidelines, including those established by the American College of Surgeons entitled “Hospital and Prehospital Resources for Optimal Care of the Injured Patient” and published appendices thereto. Standards specific to pediatric trauma referral centers shall be developed in conjunction with Children’s Medical Services and adopted by rule of the department.
(3) The department may withdraw local or regional agency authority, prescribe corrective actions, or use the administrative remedies as provided in s. 395.1065 for the violation of any provision of this section and ss. 395.4015, 395.402, 395.4025, 395.403, 395.404, and 395.4045 or rules adopted thereunder. All amounts collected pursuant to this subsection shall be deposited into the Emergency Medical Services Trust Fund provided in s. 401.34.
History.—s. 1, ch. 82-60; s. 1, ch. 84-317; s. 1, ch. 85-65; s. 4, ch. 87-399; s. 1, ch. 88-186; s. 4, ch. 89-275; s. 5, ch. 89-283; s. 4, ch. 90-284; s. 36, ch. 92-78; ss. 35, 98, ch. 92-289; s. 730, ch. 95-148; s. 38, ch. 97-237; s. 8, ch. 98-89; s. 194, ch. 99-397; s. 2, ch. 2000-189; s. 25, ch. 2000-242; s. 4, ch. 2004-259.