1. (a) The Bureau of Emergency Management (bureau) shall recommend to the commissioner of health (commissioner) the designation of trauma facilities by levels of care capability as defined by the publications titled "Texas Trauma Facility Criteria" (criteria), "Qualifications of Texas Trauma Care Personnel," and/or "Pediatric Trauma Care" which the Texas Department of Health (department) adopts by reference in §157.121 of this title (relating to Purpose). The levels are as follows:

   1. (1) Level I--comprehensive trauma facility;
   2. (2) Level II--major trauma facility;
   3. (3) Level III--general trauma facility; and
   4. (4) Level IV--basic trauma facility.

2. (b) The designation process shall consist of three phases.

   1. (1) The first phase is the application phase which begins with completing and submitting to the bureau an application and nonrefundable fee as described in §157.126 of this title (relating to Fees) for designation as a trauma facility and ends when the bureau recommends a site survey (survey).
   2. (2) The second phase is the review phase which begins with the survey and ends with a bureau recommendation to the commissioner to designate the hospital.
   3. (3) The third phase is the final phase which begins with the commissioner reviewing the recommendation and ends with his or her final decision. This phase also includes an appeal procedure for the denial of a designation application in accordance with the department formal hearing procedures as described in Chapter 1 of this title (relating to Texas Board of Health).
3. (c) A secondary review shall be utilized in the event the bureau recommendation (of whether or not) to designate differs from the findings of the survey team. A secondary review shall also be used when a hospital does not agree with a bureau request for specific corrective action prior to recommending designation.
4. (d) The bureau may provide technical assistance to all hospitals throughout the three phases of the designation process for the purpose of answering questions and clarifying the process.

5. (e) 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:

   1. (1) the evidence of participation in system planning;
   2. (2) the completeness of the application materials submitted; and
   3. (3) the hospital's self-study for comparison with the criteria.

6. (f) When the application phase results in a bureau recommendation for a survey, the bureau shall notify the hospital to contract for the survey, as follows.

   1. (1) A hospital may choose to request a survey by an American College of Surgeons survey team, may request the bureau to approve an alternate survey team assembled by a bureau-approved organization, or may request the bureau to select individual survey team members.
   2. (2) The hospital shall notify the bureau of the date of the planned survey and the composition of the survey team.
   3. (3) The hospital shall be responsible for any costs associated with the survey.
   4. (4) The bureau may appoint an observer to accompany the survey team. In this event, the cost for the observer shall be borne by the bureau.

7. (g) The survey team composition shall be as follows.

   1. (1) A survey team for a comprehensive, major, or lead general trauma facility applicant shall be multidisciplinary and include at a minimum: a general surgeon, an emergency physician, and a trauma nurse all active in the management of trauma patients. The inclusion of a neurosurgeon on the survey team for a potential comprehensive or major trauma facility is recommended.
   2. (2) Other general trauma facility applicants shall be surveyed by a survey team consisting of a nurse and a surgeon both active in the management of trauma patients and a bureau representative.

   3. (3) Basic trauma facility applicants shall be surveyed by a department representative, registered nurse or licensed physician. A second surveyor may be requested by the hospital or the department. Non-department surveyors must meet the following criteria:

      1. (A) have at least three years experience in the care of trauma patients;
      2. (B) be currently employed in the coordination of care for trauma patients;
      3. (C) have direct experience in the preparation for and successful completion of trauma facility verification/designation;
      4. (D) have successfully completed the department Trauma Facility Site Surveyor Course;

      5. (E) have current credentials as follows:

         1. (i) Trauma Nurse Core Curriculum for nurses; or
         2. (ii) Advanced Trauma Life Support for physicians; and
         3. (iii) Advanced Cardiac Life Support; and
         4. (iv) a pediatric advanced life support course; and
      6. (F) have successfully completed a site survey internship with department staff.
   4. (4) It is recommended that a pediatric trauma surgeon and/or pediatric trauma nurse be a member of the survey team for review of a pediatric trauma facility applicant.
   5. (5) Any member of the survey team, except department staff, should come from a public health region outside the hospital's location and at least 100 miles from the applicant hospital.
8. (h) When an applicant hospital is notified of the survey team composition, it has 15 postmark days to alert the bureau of potential conflict of interest concerns.
9. (i) From the date the survey team is selected and prior to the survey, the applicant's administration, faculty, medical staff, employees, and representatives are prohibited from having any discussions regarding the upcoming survey with any survey team member except as directed by the bureau. A violation of this provision may be grounds for delaying the survey and reorganizing the composition of the survey team.

10. (j) The survey team shall evaluate the quality of each hospital's compliance with the requirements set forth in the criteria, by:

    1. (1) reviewing medical records, staff rosters and schedules, quality management committee meeting minutes, and other documents relevant to trauma care;
    2. (2) reviewing equipment and the physical plant; and
    3. (3) conducting interviews with hospital personnel.

11. (k) Findings of the survey team shall be forwarded to the bureau within 90 days.

    1. (1) The bureau shall review the findings for compliance with the criteria. If a hospital does not meet the criteria for the level of designation for which it applied, the bureau may discuss designation at a lower level with the hospital.
    2. (2) A recommendation for designation shall be made to the commissioner based on compliance with the criteria.

    3. (3) In the event there is a problem area in which a hospital does not comply with the criteria, the bureau shall notify the hospital of deficiencies and recommend corrective action.

       1. (A) The hospital 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 hospital and/or bureau report substantiates action that brings the hospital into compliance with the criteria, the bureau shall recommend designation to the commissioner.
       2. (B) If the hospital disagrees that there is need for corrective action, the bureau shall refer the complete file to the trauma technical advisory committee (TTAC) for review.
       3. (C) If TTAC disagrees with the bureau recommendation for corrective action, the records shall be referred to the deputy commissioner of health for review.
12. (l) The bureau shall provide a copy of the survey report, for surveys conducted by department staff, and results to the applicant hospital.
13. (m) At the end of the secondary review and final phases of the designation process, if a hospital disagrees with the bureau recommendations, opportunity for an appeal in accordance with the department formal hearing procedures as described in Chapter 1 of this title (relating to Texas Board of Health) shall be offered.
14. (n) 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.
15. (o) The applicant hospital shall have the right to withdraw its application at any time prior to being awarded trauma facility designation by the bureau.
16. (p) If the commissioner concurs with the bureau recommendation, a letter of notification shall be forwarded to the hospital. If the decision is to designate, the hospital shall receive a certificate of designation for three years.
17. (q) When a facility has been designated for a period of three years, it shall be necessary to repeat the designation process as described in this section.

18. (r) A designated trauma facility shall:

    1. (1) notify the bureau and the regional advisory council (RAC) within five days if temporarily unable to comply with designation standards;

    2. (2) notify the bureau and the RAC if it chooses to no longer provide trauma services commensurate with its designation level, as follows:

       1. (A) if the trauma facility chooses to apply for a lower level of designation, it may do so at any time; however, it shall be necessary to repeat the designation process as described in subsections (b)-(e) of this section. There shall be a paper review by the bureau to determine if a full survey shall be required;
       2. (B) if the trauma facility chooses to permanently relinquish its designation, it shall provide at least 30 days notice to the RAC and the bureau;
    3. (3) comply with the provisions within these sections, all current state and system standards as described in this chapter, and all policies, protocols, and procedures as set forth in the system plan;
    4. (4) continue its commitment to provide the resources, personnel, equipment, and response as required by its designation level; and
    5. (5) participate in the state trauma registry as described in §157.129 of this title (relating to State Trauma Registry).
19. (s) After September 1, 1993, a hospital may not use the terms "trauma facility," "trauma hospital," "trauma center," or similar terminology in its signs or advertisements or in the printed materials and information it provides to the public unless the hospital has been designated as a trauma facility according to the process described in this section. This subsection also applies to hospitals whose designation has lapsed.
20. (t) A trauma facility shall not advertise or publicly assert in any manner that its trauma facility designation affects its care capabilities for non-trauma patients or that its trauma facility designation should influence the referral of non-trauma patients.
21. (u) The bureau shall have the right to review, inspect, evaluate, and audit all trauma patient records, trauma quality management committee minutes, and other documents relevant to trauma care in any designated trauma facility at any time to verify compliance with criteria. The bureau shall maintain confidentiality of such records to the extent authorized by the Open Records Act, Texas Civil Statutes, Article 6252-17a. Such inspections shall be scheduled by the bureau when appropriate.

Source Note:The provisions of this §157.125 adopted to be effective February 17, 1992, 17 TexReg 943; amended to be effective November 29, 1994, 19 TexReg 8981.