64J-2.007: Trauma Agency Formation Requirements
64J-2.008: Trauma Agency Plan Approval and Denial Process
64J-2.009: Trauma Agency Implementation and Operation Requirements
PURPOSE AND EFFECT: To clarify the trauma agency formation; plan development, submission and approval process; and the implementation and operation requirements of Florida's trauma agencies.
SUMMARY: The proposed revisions:
1. Delineate the initial process of obtaining local authority to operate and form a trauma agency from the renewal process; and the plan development, submission and approval of the initial and five-year plan updates;
2. Clarify content requirements of the initial and the five-year plan updates;
3. Clarify the trauma agency’s role in the review of trauma center applications from any hospital within the defined geographical area of the trauma agency.
4. Clarify and amends the requirements of the annual performance evaluation and the submission of an annual report on the status of the Trauma agency’s trauma system; and
5. Technical amendments for the purpose of consistency and to update the submission process of the trauma agency plan from hard copy to electronic submission.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 395.401, 395.405 FS.
LAW IMPLEMENTED: 395.401, 395.4015, 395.402, 395.4025, 395.404, 395.4045, 395.405 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 2 days before the workshop/meeting by contacting: Janet Collins (850)245-4444, ext. 2775. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Susan McDevitt, Office of Trauma, Department of Health, 4052 Bald Cypress Way, Bin C-18, Tallahassee, Florida 32399-1738, (850)245-4440, ext. 2760; Email: susan_mcdevitt@doh.state.fl.us; Fax: (850)488-2512
THE FULL TEXT OF THE PROPOSED RULE IS:
64J-2.007 Trauma Agency Formation and Plan Requirements.
(1) To form a trauma agency, and for submission of the trauma agency 5 year plan update, a county or counties (if regional), or an entity with which the county or counties contract for the purpose of trauma service administration shall:
(a) Obtain formal authority to create the agency from the county commission of each of the counties in which the agency plans to operate.
(b) Establish interlocal agreements between county governments if the proposed agency shall provide service to more than one county.
(2) For the formation and for continuation of a trauma agency, a county or counties, or an entity with which the county or counties contract for the purpose of trauma agency service administration, shall submit a trauma agency plan initially and an update at five-year intervals thereafter to the department for approval. Prior to the submission of the trauma agency plan or five-year plan update to the department, the county or counties, an entity with which the county or counties contract or the existing trauma agency shall:
(a)(c) Hold a public hearing and give adequate notice of the hearing to the public in the defined geographic area to be served by county or counties in which the proposed trauma agency shall operate. Adequate notice shall consist of publishing the notice, at least 30 days prior to the public hearing, in at least one newspaper of general circulation in each affected county. If a newspaper is not published in a county in which an existing or proposed trauma agency shall operate, adequate notice may be given by publishing the notice in at least one newspaper of general circulation in adjoining affected counties.
(b)(d) Develop and submit an electronic original and four copyies of the trauma agency plan or five-year plan update to the department for review and approval.
(3)(2) The trauma agency initial plan or five-year plan update shall contain the following information in the following order:
(a) Table of Contents;
(b) Population and Geographic Area to be Served.
1. Describe the population and defined geographic area to be served by the trauma agency;
2. Include a map showing the defined geographic area of the proposed trauma agency, each major geographical barrier, all medical facilities, all prehospital ground and air facilities, and all other significant factors that affect the determination of the geographic area boundaries; and
3. Describe the historical patient flow, patient referral, and transfer patterns used to define the geographic areas of the proposed trauma agency.
(c) Organizational Structure:
1. Provide a detailed description of the managerial and administrative structure of the proposed agency;
2. Include a table of organization, the names of the board of directors and each member’s affiliation, and identify the individuals who will administer or operate the trauma agency, if known;
3. Provide the names, job descriptions and responsibilities of officials who shall be directly responsible for trauma agency personnel, and the names, job descriptions and responsibilities of individuals who shall be responsible for managing and operating the trauma agency on a daily basis; and
4. Describe in detail the specific authority that trauma agency personnel shall have in directing the operation of prehospital and hospital entities within the purview of the trauma agency, if approved, be it a single or multi-county trauma agency.
(d) Trauma System Structure:
1. Describe the operational functions of the system; the components of the system; the integration of the components and operational functions; and the coordination and integration of the activities and responsibilities of trauma centers, hospitals, and prehospital EMS providers; and
2. Include a list of all participating and non-participating trauma care resources within the defined geographical area of the proposed trauma agency and documentation showing that these entities have been given the opportunity to participate in the system. Trauma care resources shall include, but are not limited to, hospitals, trauma centers, EMS prehospital providers, training centers, emergency medical dispatch, and planning entities; and
3. Include the proposed trauma agency’s recommendation and justification for the number and location of trauma centers required to serve its defined geographical area.
(e) Objectives, Proposed Actions, and Implementation Schedule. Provide a description of the objectives of the plan, a detailed list of the proposed actions necessary to accomplish each objective, and a timetable for the implementation of the objectives and action. The timetable shall identify the scheduling of the annual audit and evaluation, including the completion date and submission date to the department.
(f) Describe the proposed source of income and anticipated expenses by category for the proposed trauma agency;
(g) Describe the proposed trauma agency’s fiscal impact on the trauma system which includes a description of any increased costs related to providing trauma care.
(h) Transportation System Design:
1. Describe the EMS ground, water, and air transportation system design of the trauma system; and
2. Include trauma patient flow patterns, emergency inter-hospital transfer agreements and procedures, and the number, type, and level of service of the prehospital EMS providers within the trauma system.
(i) TTPs:
1. Provide confirmation that existing department-approved TTPs for each EMS provider, within the defined geographical area of the proposed trauma agency, are accurate and shall be adopted by the proposed trauma agency, pending department approval of the plan;
2. A proposed trauma agency may develop uniform TTPs for department approval that shall be adhered to by all EMS providers that serve the geographical area of the proposed trauma agency. If uniform TTPs are submitted to the department for approval, the TTPs shall include the name of each EMS provider that shall operate according to the uniform TTPs, and proof of consultation with each EMS provider’s medical director. TTPs developed and submitted by a proposed trauma agency shall be processed in accordance with Rule 64J-2.003, F.A.C.; and
3. The proposed trauma agency shall provide a copy of any county ordinance governing the transport of trauma patients within the defined geographic area of the proposed trauma agency.
(j) Medical Control and Accountability. Identify and describe the qualifications, responsibilities and authority of individuals and institutions providing off-line (system) medical direction and on-line (direct) medical control of all hospitals and prehospital EMS providers operating under the purview of the trauma agency.
(k) Emergency Medical Communications:
1. Describe the EMS communication system within the proposed trauma agency’s trauma service area; and
2. Describe the proposed trauma agency’s compliance with the State of Florida Communications Plan, requirements for normal operating conditions, mass casualty and disaster situations in which commercial power, telephone lines or telephone services are not available, including outages of base stations controlled by leased telephone lines. The specific areas to be addressed are:
a. Statewide medical coordination (SMC);
b. Local medical coordination (LMC);
c. Vehicle dispatch and response (VDR);
d. Medical resource coordination;
e. Local scene coordination;
f. Medical alert paging;
g. Communications coverage;
h. LMC and VDR channels;
i. SMC channel;
j. Cellular phone use if applicable; and
k. Locations and types of communications equipment within the proposed trauma agency’s geographical area.
2. Verify that the existing communications within the trauma agency’s trauma service area meet all the requirements for compliance with the State of Florida’s EMS Communication Plan, to include all hospitals with emergency departments.
(l) Data Collection. Describe the trauma data management system developed for the purpose of documenting and evaluating the trauma systems operation.
(m) Trauma System Evaluation. Describe the methodology by which the proposed trauma agency shall evaluate the trauma system.
(n) Mass Casualty and Disaster Plan Coordination. Describe the proposed trauma agency’s role with local and/or regional emergency management entities in the coordination of the prehospital and hospital component’s mass casualty and disaster plan for the defined geographic area it represents.
(o) Public Information and Education. Describe the proposed trauma agency’s programs designed to increase public awareness of the trauma system and public education programs designed to prevent, reduce the incidence of, and care for traumatic injuries within the defined geographic area it represents.
(p) Attachments. Include the following:
1. A sample copy of each type of contract and agreement entered into by the proposed trauma agency, pending department approval of the proposed trauma agency, for the benefit and operation of the trauma system. A description of these agreements may be substituted. and;
2. Documentation showing that the county commission of the county or counties in the geographic area to be served by the trauma agency have endorsed the initial plan or five-year plan update, pending department approval of the same; and
3.2. A copy of the public hearing notice and minutes of the hearing for the initial plan or five-year plan update.
Specific Authority 395.401, 395.405, 401.35 FS. Law Implemented 395.401, 395.4015, 395.402, 395.4025, 395.405, 401.35 FS. History– New 8-3-88, Amended 12-10-92, Formerly 10D-66.104, Amended 11-24-02, 6-9-05, Formerly 64E-2.019, Amended_________.
64J-2.008 Trauma Agency Plan Approval and Denial Process.
(1) The department shall, within 30 days of receipt of the initial formation of a trauma agency plan and the five-year and the trauma agency 5 year plan update, review the proposed trauma agency’s trauma system plan and notify the existing or proposed trauma agency that the plan is complete, or that there are omissions. If there are omissions, the department shall request the required additional information to be submitted by the existing or proposed trauma agency.
(2) The existing or proposed trauma agency shall submit the requested additional information to the department within 30 days of receipt of the notice of omissions.
(3) The department shall deem the plan complete upon receipt of the additional information or the expiration of the 30-day time period, whichever occurs first.
(4) The department shall review the plan to determine compliance with Chapters 395 and 401, F.S., and Chapters 59A-3 and 64J-2, F.A.C., within 60 days of receipt of the additional information or of the plan being deemed complete.
(5) The department shall issue a letter of approval to the existing or proposed trauma agency upon determination that the plan is in compliance with Chapters 395 and 401, F.S., and Chapters 59A-3 and 64J-2, F.A.C.
(6) The department shall issue a letter of denial to the existing or proposed trauma agency upon determination that the plan is not in compliance with Chapters 395 and 401, F.S., and Chapters 59A-3 and 64J-2, F.A.C. The letter shall specify the deficiencies in the plan and include notification of any right to a hearing pursuant to Section 120.57, F.S.
Specific Authority 395.401, 395.405, 401.35 FS. Law Implemented 395.401, 395.4015, 395.402, 395.4025, 395.405, 401.35 FS. History– New 8-3-88, Amended 12-10-92, Formerly 10D-66.106, Amended 11-24-02, Formerly 64E-2.020, Amended_________.
64J-2.009 Trauma Agency Implementation and Operation Requirements.
(1) To implement a trauma system, a department-approved trauma agency shall:
(a) Implement the trauma system in accordance with its department-approved planned timetable for implementation.
(b) Submit proposed changes to the department-approved plan to the department for approval, as provided in Rule 64J-2.008, F.A.C. The trauma agency may, at its own risk, institute proposed changes to the plan and submit a request for department approval within 30 days after a change is instituted if a delay in approval would have an adverse impact on the current level of care. The trauma agency’s request shall explain how the delay in approval would have adversely affected the current level of care. Each request shall document that affected trauma care resources within the defined geographical area of the agency concur with these proposed changes.
(2) Each trauma agency shall operate the trauma system in accordance with the department-approved plan, and shall:
(a) Conduct reviews of trauma center applications from any hospital within the defined geographic area of the trauma agency. Submission of a trauma center’s application to the trauma agency by a hospital seeking approval shall be in accordance with the time frames described in paragraph 64J-2.012(1)(c), F.A.C. The department will coordinate the prospective trauma center’s application development and review process with the relevant trauma agency to facilitate sufficient time to increase familiarity with the application and conduct the final review. Results of the trauma agency’s review shall be submitted to the department no later than April 7 of each year, in order to be considered by the department.
(b) Conduct annual performance evaluations and submit annual reports on the status of the trauma agency’s trauma system to the department to be included in the department’s Florida Trauma System annual reports for approval, as provided in Rule 64J-2.008, F.A.C. The trauma agency annual evaluation report shall be submitted by May 1 March 1 following the end of the previous calendar year. This evaluation shall include at least the following:
1. Description of any funding sources and any other related issues, such as: the fiscal impact on the trauma agency’s system, including increased costs related to providing trauma care, the reduction or increase in budget or human resources, specialty physician coverage, etc. Results of monitoring each EMS provider, trauma center and hospital within the defined geographic area of the trauma agency for compliance with trauma scorecard methodology requirements as provided in Rules 64J-2.004 and 64J-2.005, F.A.C.
2. Results of monitoring each EMS provider, trauma center and hospital within the defined geographic area of the trauma agency for compliance with TTP requirements as provided in Rule 64J-2.002, F.A.C.
3. Collection of data on both prehospital and hospital patient care data, as defined by the trauma agency plan.
4. Documentation of the continuum of care and quality of medical care for all trauma patients from injury through rehabilitation or death.
2.5. Documentation that all trauma centers in the geographic area participate of the trauma agency participate in trauma agency’s quality assurance and improvement processes.
3. Description of public and healthcare education, injury prevention activities, and outreach programs, conducted in the trauma agency’s geographical area, which are designed to prevent, reduce the incidence of and improve the care for traumatic injuries within the defined geographic area.
4. Documentation of data, including the nature of injuries and trends identified in the trauma agency’s defined geographic area.
5. Documentation of monitoring the effectiveness of the adult and pediatric trauma alert criteria with regard to determination of appropriate destinations.
6. Results of monitoring for compliance with trauma registry reporting requirements.
(3) Each trauma agency shall have personnel or arrange for management service personnel with clear authority and responsibility to operate the trauma agency. The administrative function of the trauma agency shall not be carried out or performed under the direct supervision of any individual who administers or operates any health care entity in the trauma system, whether a single or multi-county system.
Specific Authority 395.405, 401.35 FS. Law Implemented 395.401, 395.4015, 395.402, 395.4025, 395.405, 401.35 FS. History–New 12-10-92, Formerly 10D-66.1065, Amended 8-4-98, 11-19-01, 11-24-02, 6-9-05, Formerly 64E-2.0021, Amended_________.