1. (a) The Bureau of Emergency Management (bureau) shall recommend to the commissioner of health (commissioner) the designation of trauma facilities as follows:

   1. (1) Comprehensive (Level I) trauma facility designation, if the applicant hospital meets or exceeds the current American College of Surgeons (ACS) essential criteria for a verified Level I trauma center, actively participates on the appropriate regional advisory council (RAC), and submits data to the state trauma registry;
   2. (2) Major (Level II) trauma facility designation, if the applicant hospital meets or exceeds the current ACS essential criteria for a verified Level II trauma center, actively participates on the appropriate RAC, and submits data to the state trauma registry;
   3. (3) General (Level III) trauma facility designation, if the hospital meets or exceeds the Texas General Trauma Facility Criteria; and
   4. (4) Basic (Level IV) trauma facility designation, if the hospital meets or exceeds the Texas Basic Trauma Facility Criteria.

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 for designation as a trauma facility and ends when the bureau approves 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/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.

3. (c) 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 and appropriateness of the application materials submitted, including the non-refundable application fee as follows:

      1. (A) for comprehensive and major trauma facility applicants, the fee will be no more than $3.00 per licensed bed with an upper limit of $3000 and a lower limit of $100;
      2. (B) for general trauma facility applicants, the fee will be no more than $2.00 per licensed bed with an upper limit of $2000 and a lower limit of $100; and
      3. (C) for basic trauma facility applicants, the fee will be no more than $1.00 per licensed bed with an upper limit of $1000 and a lower limit of $100.

4. (d) When the application phase results in a bureau approval for a survey, the bureau shall notify the hospital to contract for the survey, as follows.

   1. (1) Level I and II applicants shall request a survey through the ACS verification program.
   2. (2) Level III and IV applicants may request a survey through the ACS verification program or by a team of approved non- Texas Department of Health (department) surveyors.
   3. (3) The applicant shall notify the bureau of the date of the planned survey and the composition of the survey team.
   4. (4) The applicant shall be responsible for any expenses associated with the survey.
   5. (5) The bureau at its discretion may appoint an observer to accompany the survey team. In this event, the cost for the observer shall be borne by the bureau. A hospital shall have the right to refuse to allow non-department observers to participate in a survey.
   6. (6) The survey shall be completed within one year of the date of the approval of the application.
   7. (7) At any time a hospital may file a complaint with the bureau regarding the conduct of a surveyor. The bureau will investigate the complaint and notify the hospital of the outcome.

5. (e) The survey team composition shall be as follows.

   1. (1) A survey team for a Level I, Level II, or lead Level III trauma facility applicant, shall be multi-disciplinary and include at a minimum: two general surgeons, an emergency physician, and a trauma nurse all active in the management of trauma patients.
   2. (2) Other Level III trauma facility applicants shall be surveyed by a survey team consisting of a trauma nurse and surgeon active in the management of trauma patients.
   3. (3) Level IV 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.

   4. (4) 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
      6. (F) have successfully completed a site survey internship.
   5. (5) All members of the survey team, except department staff, should come from a public health region and/or RAC outside the hospital's location and at least 100 miles from the applicant hospital. There shall be no business or patient care relationship between the surveyor and/or the surveyor's place of employment and the hospital being surveyed.
6. (f) When an applicant hospital is notified of the survey team composition, it has 30 days from the date of the letter to alert the bureau of potential conflict of interest concerns.

7. (g) The survey team shall evaluate the hospital's compliance with the designation criteria, by:

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

8. (h) Findings of the survey team shall be forwarded to the hospital within 30 calendar days of the date of the survey. If a hospital wants to continue the designation process, the complete survey report, including patient care reviews, must be submitted to the bureau within six months of the date of the survey or the application will expire.

   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 shall notify the hospital of the requirements it must meet to achieve designation at the appropriate level.
   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 a hospital disagrees with a bureau decision regarding its designation application or status, it may request a secondary review by the designation review committee. Membership on the designation review committee will:

         1. (i) be voluntary;
         2. (ii) be appointed by the bureau chief;
         3. (iii) be representative of trauma care providers and all levels of designated trauma facilities; and
         4. (iv) include representation from the department and the Trauma Subcommittee of the statewide emergency systems advisory committee.
      3. (C) If the designation review committee disagrees with the bureau recommendation for corrective action, the records shall be referred to the associate commissioner for health care quality and standards for recommendation to the commissioner.
9. (i) 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 hospital.
10. (j) 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 Administrative Procedure Act, Government Code, Chapter 2001 shall be offered.
11. (k) 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.
12. (l) The applicant hospital shall have the right to withdraw its application at any time prior to being awarded trauma facility designation by the bureau.
13. (m) If the commissioner concurs with the recommendation to designate, the hospital shall receive a letter of designation for three years. Additional actions, such as a site review or submission of information, to maintain designation may be required by the department.
14. (n) It shall be necessary to repeat the designation process as described in this section prior to expiration of a facility's designation or the designation will be considered expired.

15. (o) A designated trauma facility shall:

    1. (1) notify the bureau and RAC the 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) - (c) 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.
16. (p) A health care facility 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 health care facility 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.
17. (q) 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.
18. (r) The bureau shall have the right to review, inspect, evaluate, and audit all trauma patient records, trauma performance improvement committee minutes, and other documents relevant to trauma care in any designated trauma facility 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 Government Code, Chapter 552, Public Information. Such inspections shall be scheduled by the bureau when appropriate.
19. (s) General (Level III) trauma facility criteria.
    Attached Graphic
    
20. (t) Basic (Level IV) trauma facility criteria.
    Attached Graphic
    

Source Note:The provisions of this §157.125 adopted to be effective September 1, 2000, 25 TexReg 3749.