(a) The bureau of emergency management (bureau) shall recognize the establishment of a regional emergency medical services (EMS)/trauma system (system) within a trauma service area (TSA) as described in §157.122 of this title (relating to Trauma Service Areas).
(b) Establishment of a regional EMS/trauma system consists of three phases.
  (1) The first phase begins with the establishment of a regional advisory council (RAC) and ends with recognition of the RAC by the bureau.
    (A) All health care entities who care for trauma patients should be offered membership on the RAC. RACs shall:
      (i) be operated in a manner that maximizes inclusion of their constituents and ensures membership approval of "participation requirements";
      (ii) have documented evidence that participation guidelines have been discussed and affirmed by vote of the entire RAC voting membership;
      (iii) have clear definitions of participation guidelines in the organization's by-laws and/or other official RAC files;
      (iv) have documentation that participation guidelines have been communicated to EMS providers and hospitals, regardless of past participation history;
      (v) have documented attendance records;
      (vi) have consistency in the annual participation reporting period;
      (vii) send participation "progress reports" to EMS providers and hospitals at some period during the reporting year;
      (viii) send participation requirements "non-compliancy" letters to appropriate EMS providers and hospitals at end of reporting year;
      (ix) be cognizant of the direct and indirect fiscal roles they play on behalf of their members; and
      (x) be particularly cognizant of the logistical challenges faced by rural and volunteer agencies and open to considering viable alternatives to members' physical presence at all meetings.
    (B) The bureau shall recognize only one official RAC for a TSA.
    (C) At least quarterly, a RAC shall submit evidence of on-going activity, such as meeting notices and minutes, to the bureau.
    (D) Annually, the RAC shall file a report with the bureau which describes progress toward system development, demonstrates on-going activity, and includes evidence that members of the RAC are currently involved in trauma care.
    (E) The RAC functions without the expectation of comprehensive, permanent and/or unrestricted state funding.
    (F) RACs may request technical assistance from the bureau at any time.
  (2) The second phase begins with RAC recognition by the bureau and ends with approval of a complete EMS/trauma system plan (plan) by the bureau.
    (A) The RAC shall develop a system plan based on standard guidelines for comprehensive system development. The system plan is subject to approval by the bureau.
    (B) The bureau shall review the plan to assure that:
      (i) all counties within the TSA have been included unless a specific county, or portion thereof, has been aligned within an adjacent system;
      (ii) all health care entities and interested specialty centers have been given an opportunity to participate in the planning process; and
      (iii) the following components have been addressed:
        (I) injury prevention;
        (II) access to the system;
        (III) communications;
        (IV) medical oversight;
        (V) pre-hospital triage criteria;
        (VI) diversion policies;
        (VII) bypass protocols;
        (VIII) regional medical control;
        (IX) regional trauma treatment guidelines;
          (-a-) Guidelines consistent with current Advanced Trauma Life Support (ATLS), Advanced Pediatric Life Support (APLS), Basic Trauma Life Support (BTLS), Pre-Hospital Trauma Life Support (PHTLS), Trauma Nurse Core Course (TNCC), Emergency Nurse Pediatric Course (ENPC), Pediatric Advanced Life Support (PALS) and Pediatric Education For Pre-Hospital Providers (PEPP) standards shall be developed, implemented, and evaluated.
          (-b-) Individual agencies and medical directors may, and are encouraged, to exceed the minimum standards.
          (-c-) Major/severe trauma patients will be cared for by health professionals with documented education and skill in the assessment and care of injuries throughout their pre-hospital and hospital course.
          (-d-) Major/severe trauma patients will have their medical care, as documented by pre-hospital run forms and hospital charts, reviewed by the individual entity's medical director for appropriateness and quality of care.
          (-e-) Major/severe trauma patients will have deviations from standard of care addressed through a documented trauma performance improvement process.
        (X) facility triage criteria;
        (XI) inter-hospital transfers;
        (XII) planning for the designation of trauma facilities, including the identification of the lead facility(ies); and
        (XIII) regional guidelines for disaster preparedness; and
        (XIV) a performance improvement program that evaluates processes and outcomes from a system perspective.
    (C) Bureau approval of the completed plan may qualify health care entities participating in the system to receive state funding for trauma care if funding is available.
  (3) The third phase begins with approval of a complete plan by the bureau and ends with the regional EMS/trauma system being recognized by the bureau.
    (A) Upon approval, a RAC implements the plan to include:
      (i) education of all entities about the plan components;
      (ii) on-going review of resource, process, and outcome data; and
      (iii) if necessary, revision and re-approval of the plan or plan components by the bureau.
    (B) Following implementation of the plan, the bureau shall recommend to the commissioner of health (commissioner) the designation of a regional EMS/trauma system if the applicant RAC meets or exceeds the current Texas EMS/trauma systems essential criteria; actively participates at the bureau's quarterly RAC Chairs meetings; and submits data as requested.
    (C) The designation process shall consist of three phases:
      (i) The first phase is the application phase which begins with completing and submitting to the bureau a complete application and non-refundable fee for designation as a regional EMS/trauma system and ends when the bureau approves a site survey (survey);
      (ii) The second phase is the review phase which begins with the survey and ends with a bureau recommendation to the commissioner to designate a regional EMS/trauma system; and
      (iii) The third phase is the final phase which begins with the commissioner reviewing the recommendations and ends with his/her final decision. This phase also includes an appeal procedure for the denial of a designation application in accordance with the Administrative Procedure Act, Government Code, Chapter 2001.
    (D) The bureau's analysis of submitted application materials, which may result in recommendations for corrective action when deficiencies are noted, shall include a review of:
      (i) evidence of participation at the bureau's quarterly RAC Chairs meetings;
      (ii) the completeness and appropriateness of the application materials submitted, including the non-refundable application fee.
      (iii) the non-refundable application fee shall be based on the trauma service area's geographic size, population and trauma death rate.
      (iv) a RAC's non-refundable application fee shall be no more than $10,000 and not less than $2500.
    (E) When the application phase results in a bureau approval for survey, the bureau shall notify the regional EMS/trauma system's RAC that will then contract for the survey by a team of approved non-Texas Department of Health (department) surveyors.
      (i) The bureau, at its discretion, may appoint an observer to accompany the survey team. In this event, the cost for the observer(s) shall be borne by the bureau. A RAC shall have the right to refuse to allow non-department observers to participate in a survey.
      (ii) The survey shall be completed within one year of the date of the approval of the application.
      (iii) At any time, a RAC may file a complaint with the bureau regarding the conduct of a surveyor. The bureau will investigate and notify the RAC of the outcome.
    (F) The survey team composition shall consist of at minimum a physician; an EMS provider representative; a trauma nurse from a designated trauma facility; all of which shall have demonstrated knowledge and experience with system development. A fourth surveyor with experience in system management may be requested by the RAC or the bureau.
Cont'd...
(G) Non-department surveyors must meet the following criteria:
      (i) have at least three years experience in the care of trauma patients and active participation in a regional EMS/trauma system;
      (ii) be currently employed in the coordination of care for trauma patients;
      (iii) have direct experience in the preparation for and successful completion of regional EMS/trauma system designation;
      (iv) have successfully completed the department Regional EMS/Trauma System Site Surveyor Course; and
      (v) on-going bureau evaluation of survey reports for compliance with bureau reporting requirements.
    (H) All members of the survey team, except department staff, should come from a non-adjacent public health region and/or trauma service area (TSA). There shall be no business or patient care relationship between the surveyor and/or the surveyor's place of employment and regional EMS/trauma system being surveyed.
    (I) The survey team shall evaluate the regional EMS/trauma system by:
      (i) attendance records, performance improvement committee meeting minutes and other documents specifically relevant to regional EMS/trauma system development;
      (ii) visiting EMS provider stations and hospitals within the TSA; and
      (iii) conducting interviews with RAC members and non-members.
    (J) Findings of the survey team shall be forwarded to the RAC Executive Board within thirty calendar days of the date of the survey. If a RAC wants to continue the designation process, the complete survey report must be submitted to the bureau within three months after receipt of the survey or the application will expire. A request for an extension could be requested for extenuating circumstances.
    (K) The bureau shall review the findings for compliance with the criteria. If a regional EMS/trauma system does not meet the criteria for designation, the bureau shall notify the RAC executive board of the requirements it must meet to achieve designation.
    (L) A recommendation for designation shall be made to the commissioner based on compliance with the criteria.
    (M) In the event there is a problem area in which a regional EMS/trauma system does not comply with the criteria, the bureau shall notify the applicant of deficiencies and recommend corrective action.
    (N) The regional EMS/trauma system shall submit a report to the bureau which outlines the corrective action taken. The bureau may require a second survey to insure compliance with the criteria. If the regional EMS/trauma system and/or bureau report substantiates action that brings the regional EMS/trauma system into compliance with the criteria, the bureau shall recommend designation to the commissioner.
    (O) If a regional EMS/trauma system disagrees with a bureau decision regarding its designation application or status, it may request a secondary review by a designation review committee. Membership on the designation review committee will:
      (i) be voluntary;
      (ii) be appointed by the bureau chief;
      (iii) be representative of trauma care providers within a designated regional EMS/trauma system; and
      (iv) include representation from the department and the Trauma Systems Committee of the Governor's EMS and Trauma Advisory Council (GETAC).
    (P) If the designation review committee disagrees with the bureau recommendation for corrective action, the records shall be referred to the associate commissioner for consumer health protection for recommendation to the commissioner.
    (Q) The bureau shall provide a copy of the survey report, for surveys conducted by or contracted for by the department and results to the applicant regional EMS/trauma system.
    (R) At the end of the secondary review and final phases of the designation process, if a regional EMS/trauma system disagrees with the bureau recommendations, opportunity for an appeal in accordance with the Administrative Procedure Act, Government Code, Chapter 2001 shall be offered.
    (S) The bureau may grant an exception to this section if it finds that compliance with this section would not be in the best interests of the persons served in the affected local system.
    (T) The applicant regional EMS/trauma system shall have the right to withdraw its application at any time prior to the department making a final decision on the application for designation.
    (U) If the commissioner concurs with the recommendation to designate, the RAC shall receive a letter of designation for two years. Site surveys will be required every six years, or more frequently at the bureau's discretion. Additional actions, such as a site review or submission of information, to maintain designation may be required by the department.
    (V) It shall be necessary to repeat the designation process as described in this section prior to expiration of a regional EMS/trauma system designation or the designation will be considered expired:
    (W) A designated regional EMS/trauma system shall:
      (i) notify the bureau within five days if temporarily unable to comply with the essential trauma system criteria;
      (ii) notify the bureau and RAC membership within five days if it is unable to provide the resources as required by its designation.
        (I) If the resources are not critical, the bureau will determine a 30-day to 90-day period from onset date of deficiency for the RAC to achieve compliance.
        (II) If the resources are critical, the bureau will determine a no greater than 30-day period from onset date of the deficiency for the RAC to achieve compliance.
      (iii) notify the bureau if the RAC will no longer provide services commensurate with designation. If the regional EMS/trauma system chooses to permanently relinquish its designation, it shall provide at least 30 days notice to the bureau.
      (iv) comply with the provisions within these sections, all current state and system standards as described in this chapter, and all policies, guidelines, and procedures as set forth in the system plan;
      (v) continue its commitment to provide the resources as required by its designation; and
      (vi) utilize the state trauma registry.
    (X) A regional EMS/trauma system may not use the terms "regional trauma system", "trauma system", or similar terminology in its signs or advertisements or in the printed materials and information it provides to the public unless the regional EMS/trauma system has been designated as a regional EMS/trauma system according to the process described in this section. This subsection also applies to regional EMS/trauma systems whose designation has lapsed.
    (Y) The bureau shall have the right to review, inspect, evaluate, and audit all RAC performance improvement committee minutes and other documents relevant to trauma care in any designated regional EMS/trauma system at any time to verify compliance with the statute and these rules, including the designation criteria. The bureau shall maintain confidentiality of such records to the extent authorized by the Public Information Act, (Government Code, Chapter 552), the Texas Health and Safety Code, Chapter 773 and/or any other relevant confidentiality law or regulation. Such inspections shall be scheduled by the bureau when appropriate.
(c) Regional EMS/trauma system criteria.
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Source Note: The provisions of this §157.123 adopted to be effective June 1, 2004, 29 TexReg 4492