Section 157.126 - Trauma Facility Designation Requirements Effective on September 1, 2025(a) The department designates hospital applicants as trauma facilities, which are part of the trauma and emergency health care system. Hospitals must meet the designation requirements specific to the level of designation requested by September 1, 2025. Trauma designation surveys conducted on or after September 1, 2025, are evaluated on the requirements in this section.(b) The facility seeking trauma designation submits a completed designation application packet to the department. The department reviews the facility application documents for the appropriate level of designation. The complete designation application packet must include the following: (1) a trauma designation application for the requested level of trauma designation;(2) a completed department designation assessment questionnaire;(3) the documented trauma designation survey summary report that includes findings of requirements met and medical record reviews;(4) evidence of documented data validation and quarterly submission to the State Trauma Registry and National Trauma Data Bank (NTDB) (if applicable) for the past 12 months;(5) evidence of the facility's trauma program and Trauma Medical Director (TMD) or designee participation at Regional Advisory Council (RAC) meetings throughout the designation cycle; and(6) full payment of the non-refundable, non-transferrable designation fee.(c) The department reviews the designation application packet to determine and approve the facility's level of trauma designation. The department defines the final trauma designation level awarded to the facility and this designation may be different than the level requested based on the designation site survey summary. If the department determines the facility meets the requirements for trauma designation the department provides the facility with a designation award letter and a designation certificate. The facility must display its trauma designation certificate in a public area of the licensed premises that is readily visible to patients, employees, and visitors.(d) Eligibility requirements for trauma designation. (1) Health care facilities eligible for trauma designation include: (A) a hospital in Texas, licensed or otherwise, in accordance with Texas Health and Safety Code Chapter 241;(B) a hospital owned and operated by the State of Texas; or(C) a hospital owned and operated by the federal government, in Texas.(2) Each hospital must demonstrate the capability to stabilize and transfer or treat an acute trauma patient, have written trauma management guidelines for the hospital, have a written operational plan, and have a written trauma performance improvement and patient safety (PIPS) plan.(3) Each hospital operating on a single hospital license with multiple locations (multi-location license) may apply for trauma designation separately by physical location for each designation.(A) Hospital departments or services within a hospital must not be designated separately.(B) Hospital departments located in a separate building not contiguous with the designated facility must not be designated separately.(C) Each non-contiguous emergency department of a hospital operating on a single hospital license must have trauma patient care and transfers monitored through the main hospital's trauma program.(e) A facility is defined under subsection (d) of this section as a single location where inpatients receive hospital services and inpatient care. (1) Each facility location must meet the requirements for designation. The department defines the designation level based on the facility's ability to demonstrate designation requirements are met.(2) Each facility must submit a separate trauma designation application based on its resources and the level of designation the facility is seeking.(3) If there are multiple hospitals covered under a single hospital license, each hospital or physical location where inpatients receive hospital services and care may seek designation.(4) Trauma designation is issued for the physical location and to the legal owner of the operations of the designated facility and is non-transferable.(f) Facilities seeking trauma designation must meet department-approved requirements and have them validated by a department-approved survey organization.(g) The four levels of trauma designation are as follows.(1) Comprehensive trauma facility designation (Level I). The facility, including a free-standing children's facility, must:(A) meet the current American College of Surgeons (ACS) trauma verification standards for Level I and receive a letter of verification from the ACS;(B) meet the state trauma designation requirements;(C) meet the participation requirements for the local RAC;(D) have appropriate services for dealing with stressful events available to emergency and trauma care providers; and(E) submit quarterly trauma data to the State Trauma Registry, defined in Chapter 103 (relating to Injury Prevention and Control).(2) Major trauma facility designation (Level II). The facility, including a free-standing children's facility, must: (A) meet the current ACS trauma verification standards for Level II and receive a letter of verification from the ACS;(B) meet the state trauma designation requirements;(C) meet the participation requirements for the local RAC;(D) have appropriate services for dealing with stressful events available to emergency and trauma care providers; and(E) submit quarterly trauma data to the State Trauma Registry, defined in Chapter 103 of this title (relating to Injury Prevention and Control).(3) Advanced trauma facility designation (Level III). The facility, including a free-standing children's facility, must: (A) meet the current ACS trauma verification standards for Level III and receive a letter of verification from the ACS, or complete a designation survey conducted by a department-approved survey organization;(B) meet the state trauma designation requirements;(C) meet the participation requirements for the local RAC;(D) have appropriate services for dealing with stressful events available to emergency and trauma care providers; and(E) submit quarterly trauma data to the State Trauma Registry, defined in Chapter 103 of this title (relating to Injury Prevention and Control).(4) Basic trauma facility designation (Level IV). The facility, including a free-standing children's facility: (A) Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must: (i) meet the current ACS trauma verification standards for Level IV and complete a designation survey conducted by a department-approved survey organization;(ii) meet the state trauma designation requirements;(iii) meet the participation requirements for the local RAC;(iv) have appropriate services for dealing with stressful events available to emergency and trauma care providers; and(v) submit quarterly trauma data to the State Trauma Registry, defined in Chapter 103 of this title (relating to Injury Prevention and Control).(B) Level IV facilities managing 100 or less trauma patients meeting NTDB registry inclusion criteria annually must: (i) meet the defined state trauma designation requirements and complete a designation survey with the department or with a department-approved survey organization;(ii) meet the participation requirements for the local RAC;(iii) have appropriate services for dealing with stressful events available to emergency and trauma care providers; and(iv) submit quarterly trauma data to the State Trauma Registry, defined in Chapter 103 of this title (relating to Injury Prevention and Control).(h) All facilities seeking trauma designation must meet the following requirements.(1) Facilities must have documented evidence of participation in the local RAC.(2) Facilities must have evidence of quarterly trauma data submissions to the State Trauma Registry for patients that meet NTDB registry inclusion criteria, following the National Trauma Data Standards (NTDS) definitions and state definitions.(3) Facilities must have emergency medical services (EMS) communication capabilities.(4) Facilities must have provisions to capture the EMS wristband number or measures for patient tracking in resuscitation documentation.(5) Facilities must have provisions to provide and document EMS hand-off.(6) Facilities must have landing zone capabilities or system processes to establish a landing zone (when rotor-wing capabilities are available) with appropriate staff safety training.(7) Facilities must have a process to provide feedback to EMS providers.(8) All levels of trauma facilities must have written trauma management guidelines specific to the hospital that align with evidence-based practices and current national standards, which must be reviewed a minimum of every three years. These guidelines must be specific to the trauma patient population managed by the facility. Guidelines must be established for the following: (A) trauma activation and response time based on national recommendations;(B) trauma resuscitation and documentation;(C) consultation services requests and response;(D) admission and transfer;(E) screening, management, and appropriate interventions or referral for both suspected and confirmed abuse of all patient populations; and(9) Facilities must have defined documentation of trauma management guidelines pertinent to the care of trauma patients in all nursing units providing care to the trauma patient.(10) The written trauma management guidelines must be monitored though the trauma PIPS process.(11) The trauma program must have provisions for the availability of all necessary equipment and services to administer the appropriate level of care and support for the injured patient meeting the hospital's trauma activation guidelines and meeting NTDB registry inclusion criteria through the continuum of care to discharge or transfer.(12) All levels of adult trauma facilities must meet and maintain the Emergency Medical Services for Children's Pediatric Readiness Criteria, as evidenced by the following: (A) annual completion of the on-line National Pediatric Readiness Project assessment (https://pedsready.org), including a written plan of correction (POC) for identified opportunities for improvement that is monitored through the trauma PIPS plan until resolution;(B) pediatric equipment and resources immediately available at the facility, and staff with defined and documented competency skills and training on the pediatric equipment;(C) education and training requirements for Emergency Nursing Pediatric Course (ENPC) or Pediatric Advanced Life Support (PALS) for the nurses responding to pediatric trauma activations;(D) assessments and documentation include Glasgow Coma Score (GCS); complete vital signs to include temperature, heart rate, respirations, and blood pressure; pain assessment; and weight recorded in kilograms;(E) serial vital signs, GCS, and pain assessments are completed and documented for the highest level of trauma activations or when shock, a traumatic brain injury, or multi-system injuries are identified;(F) pediatric imaging guidelines and processes addressing pediatric age or weight-based appropriate dosing for studies imparting radiation consistent with the ALARA (as low as reasonably achievable) principle; and(G) documented evidence the trauma facility has completed a pediatric trauma resuscitation simulation with medical staff participation every six months, including a completed critique identifying opportunities for improvement integrated into the trauma performance improvement initiatives and tracked until the identified opportunities are corrected. An adult trauma facility managing 200 or more patients less than 15 years of age with an injury severity score (ISS) of 9 or greater is exempt from this requirement of pediatric trauma simulations. If the facility has responded to an actual pediatric trauma resuscitation event during a six-month period, the facility is exempt from this training but must have documented evidence of participation in the after-action-review.(13) Free-standing children's trauma facilities must have resources and equipment immediately available for adult trauma resuscitations, adherence to the nursing requirements for Trauma Nurse Core Course (TNCC) or Advanced Trauma Care for Nurses (ATCN), documented evidence the trauma program has completed an adult trauma resuscitation simulation with medical staff participation every six months, including a completed critique identifying opportunities for improvement integrated into the trauma performance improvement initiatives and tracked until the identified opportunities are corrected. Free-standing children's trauma facilities managing 200 adult patients 15 years or older with an ISS of 9 or greater are exempt from this requirement for adult trauma simulations.(14) Rural Level IV trauma facilities in a county with a population less than 30,000 may utilize telemedicine resources with an Advanced Practice Provider (APP) available to respond to the trauma patient's bedside within 30 minutes of notification, with written resuscitation and trauma management guidelines monitored through the trauma performance improvement and patient safety processes. (A) The APP must be current in Advance Trauma Life Support (ATLS) training, annually maintain an average nine hours of trauma-related continuing medical education, and demonstrate adherence to the trauma patient management guidelines and documentation standards.(B) The facility must have a documented telemedicine physician credentialing process.(C) All assessments, physician orders, and interventions initiated through telemedicine must be documented in the patient's medical record.(15) Telemedicine in trauma facilities in a county with a population of 30,000 or more, if utilized, must have a documented physician credentialing process, written trauma protocols for utilization of telemedicine including physician response times, and measures to ensure the trauma management guidelines and evidence-based practice are monitored through the trauma performance improvement and patient safety processes. (A) Telemedicine cannot replace the requirement for the trauma on-call physician to respond to the trauma activations in-person, to conduct inpatient rounds, or to respond to emergency requests from the inpatient units, when requested.(B) All telemedicine assessments, physician orders, and interventions initiated through telemedicine must be documented in the patient's medical record.(C) Telemedicine services or the telemedicine physician may be requested to assist in trauma performance improvement committee reviews.(16) The trauma medical director (TMD) must define the role and expectations of the hospitalist or intensivist in providing care to the admitted injured patient meeting trauma activation guidelines and meeting NTDB registry inclusion criteria.(17) A trauma program manager (TPM) or designee must be a participating member of the nurse staffing committee.(18) The facility must maintain medical records facilitating the documentation of trauma patient arrival, level of activation, physician response and team response times, EMS hand-off, wristband number or patient tracking identifier, resuscitation, assessments, vital signs, GCS, serial evaluation of needs, interventions, patient response to interventions, reassessments, and re-evaluation through all phases of care to discharge or transfer out of the facility.(19) Level I, II, and III facilities, and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must have an organized, effective trauma service recognized in the medical staff bylaws or rules and regulations and approved by the governing body. Medical staff credentialing must include a process for requesting and granting delineation of privileges for the TMD to oversee the providers participating in trauma call coverage, the trauma panel, and trauma management through all phases of care.(20) Level I, II, and III facilities must have a TMD with requirements aligned with the current ACS standards specific to the level of designation requested and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must have a TMD with a defined job description that is a surgeon, emergency medicine physician, or family practice physician that is board-certified in their specialty, current in ATLS, and meet the other ACS standards specific to the TMD for the level of designation requested. The TMD must complete a trauma performance improvement course approved by the department.(21) Level I, II, and III facilities, and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must have an identified TPM responsible for monitoring trauma patient care throughout the continuum of care, from pre-hospital management to trauma activation, inpatient admission, and transfer or discharge, to include transfer follow-up as appropriate. The TPM must be a registered nurse with clinical background in trauma care and must have completed a trauma performance improvement course approved by the department and the Association for the Advancement of Automotive Medicine (AAAM) Injury Scaling Course, and have current TNCC or ATCN, Emergency Nursing Pediatric Course (ENPC) or Pediatric Advanced Life Support (PALS), and Advanced Cardiac Life Support (ACLS) certifications. It is recommended for the TPM to complete courses specific to the TPM role. The role must be only for that facility and cannot cover multiple facilities. The TPM authority and responsibilities are aligned with the current ACS standards for the specific level of designation.(22) The facility must have an organizational structure that facilitates the TPM's review of trauma care from admission to discharge, allowing for recommendations to improve care through all phases of care, and a reporting structure to an administrator having the authority to recommend and monitor facility system changes and oversee the trauma program.(23) All levels of trauma facilities must maintain a continuous trauma PIPS plan. The plan must be data-driven and must:(A) identify variances in care or system response events for review, including factors that led to the event, delays in care, hospital events such as complications, and all trauma deaths;(B) define the levels of harm;(C) define levels of review;(D) identify factors that led to the event;(E) identify opportunities for improvement;(F) establish action plans to address the opportunities for improvement;(G) monitor the action plan until the desired change is met and sustained;(H) establish a concurrent PIPS process;(I) meet staffing standards that align with the ACS standards for performance improvement personnel; and(J) utilize terminology for classifying morbidity and mortality with the terms:(i) morbidity or mortality without opportunity;(ii) morbidity or mortality with opportunity for improvement; and(iii) morbidity or mortality with regional opportunity for improvement.(24) The trauma PIPS plan must be approved by the TMD, TPM, and the trauma operations committee and be disseminated to all departments providing care to the trauma patient. The departments must ensure staff are knowledgeable of the responsibilities in the trauma PIPS plan and the requested data and information to be presented at the trauma operations committee.(25) The Level I, II, and III facilities, and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must demonstrate that the TMD chairs the secondary level of performance review, chairs the trauma multidisciplinary peer review committee, and co-chairs the trauma operations committee with the TPM.(26) The trauma PIPS plan must outline the roles and responsibilities of the trauma operations committee and its membership.(27) The trauma facility must document and include in its trauma PIPS plan the external review of the trauma verification and designation assessment questionnaire, designation survey documents, the designation survey summary report, including the medical record reviews, and all communication with the department.(28) Trauma facilities must submit required trauma registry data every 90 days or quarterly to the State Trauma Registry and have documented evidence of data validation and correction of identified errors or blank fields. (A) All levels of trauma facilities must demonstrate the current ACS standards for staffing requirements for the trauma registry are met.(B) Trauma facilities utilizing a pool of trauma registrars must have an identified trauma registrar from the pool assigned to the facility to ensure data requests are addressed in a timely manner.(29) All levels of trauma facilities must demonstrate the registered nurses assigned to care for arriving patients meeting trauma activation guidelines have current TNCC or ATCN, ENPC or PALS, and Advanced Cardiac Life Support certifications. Those new to the facility or the facility's trauma resuscitation area must meet these requirements within 18 months.(30) Level I, II, and III facilities, and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must have evidence the trauma program surgeons, trauma liaisons, trauma program personnel, operating suite leaders, and critical care medical director and nursing leaders complete a mass casualty response training on their roles, potential job functions, and job action sheets, to ensure competency regarding actions required for surge capacity, capabilities, and patient flow management from resuscitation to inpatient admission, operative suite, and critical care units or intensive care units during a multiple casualty or mass casualty event. If the facility has responded to an actual mass casualty event during a 12-month period, the facility is exempt from this training but must have documented evidence of participation in the after-action review.(31) Level IV facilities managing 101 or more patients meeting NTDB registry inclusion criteria annually must: (A) meet the current ACS Level IV standards and defined state requirements;(B) have 24-hour on-site coverage by an emergency physician credentialed by the hospital and approved by the TMD to participate in the resuscitation and treatment of trauma patients of all ages and respond to trauma activation patients within 30 minutes of request;(C) have documented guidelines for trauma activations, resuscitation guidelines, documentation standards, and patient transfers, and measures to monitor the guidelines through the trauma performance improvement process. Transfer reviews must include the time of arrival, transfer decision time, transfer acceptance time, transport arrival time, and time transferred;(D) have documented management guidelines specific to the trauma patients admitted at the facility based on trauma registry data;(E) have a written trauma PIPS plan that, at minimum, monitors:(i) trauma team activations;(ii) trauma team member response times;(iii) trauma resuscitation guidelines;(iv) documentation standards;(v) trauma management guidelines;(vi) pediatric trauma resuscitation guidelines;(vii) transfer guidelines; and(viii) all trauma deaths; and(F) have provisions for a multidisciplinary trauma peer review committee and a trauma operations committee.(32) Level IV facilities managing 100 or less trauma patients meeting NTDB registry inclusion criteria annually must: (A) have 24-hour emergency services coverage by a physician credentialed by the hospital and approved by the TMD to participate in the resuscitation and treatment of trauma patients of all ages and respond to trauma activation patients within 30 minutes of request; (B) have a TMD overseeing and monitoring the trauma care provided and who is current in ATLS; (C) have a TPM who is a registered nurse and must: (i) complete a trauma performance improvement course and a trauma program manager course approved by the department; (ii) complete a registry AAAM Injury Scoring Course; (iii) have current TNCC or ATCN, ENPC or PALS, and ACLS certifications; and (iv) oversee and monitor trauma care provided;(D) have documented guidelines for trauma team activation with response times, resuscitation guidelines, and documentation standards for resuscitation through admission, transfer, or discharge;(E) have documented management guidelines specific for the trauma patients admitted to the facility;(F) have documented transfer guidelines that are monitored to identify the arrival time, decision to transfer time, time of transfer acceptance, time of transport arrival, and time of transfer;(G) have a trauma PIPS plan that, at minimum, monitors: (i) trauma team activations;(ii) trauma team member response times;(iii) trauma resuscitation guidelines;(iv) documentation standards;(v) trauma management guidelines;(vi) pediatric trauma resuscitation guidelines;(vii) transfer guidelines; and(viii) all trauma deaths;(H) have provisions for a trauma multidisciplinary peer review process and operational oversight integrated into the hospitals performance review or quality review processes;(I) have provisions for a trauma registry and submit the NTDB data to the State Trauma Registry quarterly to include each patient's ISS;(J) have conventional radiology available 24-hours per day;(K) have laboratory services available 24-hours per day for standard analysis of blood, urine, and other body fluids, including microbiologic sampling when appropriate;(L) have blood bank capabilities including typing and cross-matching and have a minimum of two universal packed red blood cell units available; and(M) participate in the local RAC.(i) A facility seeking trauma designation or renewal of designation must submit the completed designation application packet, have the required documents available at the time of the designation survey, and submit the designation survey summary report and medical record reviews following the completed designation survey. (1) A complete application packet contains the following:(A) a trauma designation application for the requested level of trauma designation;(B) a completed department designation assessment questionnaire;(C) the documented trauma designation survey summary report that includes findings of requirements met and medical record reviews;(D) evidence of documented data validation and quarterly submission to the State Trauma Registry and NTDB (if applicable) for the past 12 months;(E) evidence of the facility's trauma program participation at RAC meetings throughout the designation cycle;(F) full payment of the non-refundable, non-transferrable designation fee and department remit form submitted to the department Cash Branch per the designation application instructions; and(G) the documentation in subparagraphs (A), (B), (D), and (E) of this paragraph must be submitted to the department and department-approved survey organization no less than 45 days before the facility's scheduled designation survey.(2) The facility must have the required documents available and organized for the actual designation survey, including: (A) documentation of a minimum of 12 months of trauma performance improvement and patient safety reviews, including minutes and attendance of the trauma operations meetings and the trauma multidisciplinary peer review committee meetings, all trauma-documented management guidelines or evidence-based practice guidelines, and all trauma-related policies, procedures, and diversion times;(B) evidence of 12 months of trauma registry submissions to the State Trauma Registry;(C) documentation of all injury prevention, outreach education, public education, and research activities (if applicable); and(D) documentation to reflect designation requirements are met.(3) Not later than 90 days after the trauma designation survey, the facility must submit to the department the following documentation:(A) the documented trauma designation survey summary report that includes the requirements met and not met, and the medical record reviews; and(B) a POC, if required by the department, which addresses all designation requirements defined as "not met" in the trauma designation survey summary report, which must include: (i) a statement of the cited designation requirement not met;(ii) a statement describing the corrective actions taken by the facility seeking trauma designation to meet the requirement;(iii) the title of the individuals responsible for ensuring the corrective actions are implemented and monitored;(iv) the date the corrective actions are implemented;(v) a statement on how the corrective actions will be monitored and what data are measured to identify change;(vi) documented evidence the POC is implemented within 60 days of the survey date; and(vii) any subsequent documents requested by the department.(4) The application includes full payment of the appropriate non-refundable, non-transferrable designation fee. (A) For Level I and Level II trauma facility applicants, the fee is no more than $10 per licensed bed with an upper limit of $5,000 and a lower limit of $4,000.(B) For Level III trauma facility applicants, the fee is no more than $10 per licensed bed with an upper limit of $2,500 and a lower limit of $1,500.(C) For Level IV trauma facility applicants, the fee is no more than $10 per licensed bed with an upper limit of $1000 and a lower limit of $500.(5) All application documents except the designation fee are submitted electronically to the department.(j) Facilities seeking initial trauma designation must complete a scheduled conference call with the department and include the facility's chief executive officer (CEO), CNO, chief operating officer (COO), trauma administrator or executive leader, TMD, and TPM before scheduling the designation survey. The following information must be provided to the department before the scheduled conference call with the department: (1) job descriptions for the TMD, TPM, and trauma registrar;(2) trauma operational plan;(4) trauma activation and trauma management guidelines; and(5) trauma registry procedures.(k) Facilities seeking designation renewal must submit the required documents described in subsection (i) of this section to the department no later than 90 days before the facility's current trauma designation expiration date.(l) The application will not be processed if a facility seeking trauma designation fails to submit the required application documents and designation fee.(m) A facility requesting designation at a different level of care or experiencing a change in ownership or a change in physical address must notify the department and submit a complete designation application packet and application fee.(n) Level I, II, and III facilities, and Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must schedule a designation survey with a department-approved survey organization. All aspects of the designation survey process must follow the department designation survey guidelines. All initial designation surveys must be performed in person unless approval for virtual review is given by the department.(1) Facilities requesting Level I and II trauma facility designation must request a verification survey through the ACS trauma verification program. This includes pediatric stand-alone facilities.(2) Level III facilities must request a designation survey through either the ACS trauma verification program or through a department-approved survey organization.(3) Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually must schedule a designation survey with a department-approved survey organization.(4) Level IV facilities managing 100 or less trauma patients meeting the NTDB registry inclusion criteria annually must schedule a designation survey with the department or the facility's executive officers may request a designation survey with a department-approved survey organization.(5) The facility must notify the department of the date of the scheduled designation survey a minimum of 60 days before the survey.(6) The facility is responsible for any expenses associated with the designation survey.(7) The department, at its discretion, may appoint a designation coordinator to participate in the survey process. The designation coordinator's costs are borne by the department.(o) The survey team composition must be as follows: (1) Level I or Level II facilities must be reviewed by a team of surveyors who do not practice in Texas and who currently participate in the management or oversight of trauma patients at a verified or designated Level I or II trauma facility. The survey team must include: (B) an emergency medicine physician; and(C) a registered nurse with trauma expertise.(2) Level III facilities must be reviewed by a team of surveyors currently participating in the management or oversight of trauma patients at a verified or designated Level I, II, or III trauma facility. The survey team must include:(B) a registered nurse with trauma expertise.(3) Level IV facilities must be reviewed by surveyors determined by the facility's number of trauma patients meeting NTDB registry inclusion criteria annually that are managed by the facility.(A) Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually with:(i) evidence of trauma patients having operative interventions, being admitted to the ICU, or having an ISS of 15 or greater must be reviewed by: (II) a registered nurse with trauma expertise;(ii) no evidence of operative interventions, but trauma patients are admitted to the ICU and have an ISS of 15 or greater must be reviewed by: (I) a surgeon, emergency medicine physician, or family practice physician who has the role of TMD or trauma liaison at their facility; and(II) a registered nurse with trauma expertise;(iii) no evidence of operative interventions or ICU admissions must be reviewed by:(I) a surgeon, emergency medicine physician, family practice physician; or(II) a registered nurse with trauma expertise.(B) Level IV facilities managing 100 or less trauma patients meeting NTDB registry inclusion criteria annually have the option of requesting a designation survey by: (ii) a department-approved survey organization. If this option is chosen, the survey team must include: (I) a surgeon, an emergency medicine physician, or family practice physician, currently serving in the role of TMD or trauma liaison; or(II) a registered nurse with trauma expertise.(p) Trauma facilities seeking designation or redesignation and department-approved survey organizations must follow the department survey guidelines and ensure all surveyors follow these guidelines.(1) All members of the survey team for Level III or IV, except department staff, must not be from the same TSA or a contiguous TSA of the facility's location without the written approval from the department. There must be no business or patient care relationship or any known conflict of interest between the surveyor or the surveyor's place of employment and the facility being surveyed.(2) The facility must not accept surveyors with any known conflict of interest. If a conflict of interest is present, the facility seeking trauma designation must decline the assigned surveyor through the survey organization. (A) A conflict of interest exists when the surveyor has a direct or indirect financial, personal, or other interest which would limit or could reasonably be perceived as limiting the surveyor's ability to serve in the best interest of the public.(B) The conflict of interest may include a surveyor who, in the past four years: (i) has trained or supervised key hospital or medical staff in residency or fellowship;(ii) collaborated professionally with key members of the facility's leadership team;(iii) was employed in the same health care system in state or out of state;(iv) participated in a designation consultation with the facility;(v) had a previous working relationship with the facility or facility leader;(vi) conducted a designation survey for the facility; or(vii) is the EMS medical director for an agency that routinely transports trauma patients to the facility.(3) If a designation survey occurs with a surveyor who has a known conflict of interest, the trauma designation survey summary report and medical record review may not be accepted by the department.(4) A survey organization must complete an application requesting to perform designation surveys in Texas and be approved by the department. Each organization must renew its application every four years.(q) Level I and II facilities using the ACS verification program who receive a Type I or three or more Type II standards not met, and Level III facilities surveyed by a department-approved survey organization with four or more requirements not met, must schedule a conference call with the department.(r) If a health care facility seeking re-designation fails to meet the requirements outlined in subsection (j) of this section, the original designation expires on its expiration date. The facility must wait six months and begin the process again to continue as a designated trauma facility.(s) If a facility disagrees with the designation level awarded by the department, the CEO, CNO, or COO may request an appeal, in writing, sent to the EMS/Trauma Systems Section director not later than 30 days after the issuance date of a designation award. (1) All written appeals are reviewed quarterly by the EMS/Trauma Systems Section director in conjunction with the Trauma Designation Review Committee. (A) The Trauma Designation Review Committee consists of the following individuals for trauma designation appeals, exception requests, or contingent designation survey summaries: (i) chair of Governor's EMS and Trauma Advisory Council (GETAC);(ii) chair of the GETAC Trauma System Committee;(iii) current president of the Texas Trauma Coordinators Forum;(iv) two individuals who each have a minimum of 10 years of trauma facility oversight as an administrator, medical director, program manager, or program liaison, all selected by the current chair of GETAC and approved by the EMS/Trauma Systems Section director and Consumer Protection Division (CPD) associate commissioner; and(v) three department representatives from the EMS/Trauma Systems Section.(B) The Trauma Designation Review Committee meetings are closed to maintain confidentiality for all reviews.(C) The GETAC chair and the chair of the Trauma System Committee are required to attend the Trauma Designation Review Committee, in addition to a minimum of three of the other members, to conduct meetings with the purpose of reviewing trauma facility designation appeals, exception requests, and contingent designation survey summaries that identify requirements not met. Agreement from a majority of the members present is required.(2) If the Trauma Designation Review Committee supports the department's designation determination, the EMS/Trauma Systems Section director gives written notice of the review and determination to the facility not later than 30 days after the committee's recommendation.(3) If the Trauma Designation Review Committee recommends a different level of designation, it will provide the recommendation to the department. The department reviews the recommendation and determines the approved level of designation. Additional actions, such as a focused review, re-survey, or submission of information and reports to maintain designation, may be required by the department for identified designation requirements not met or only partially met.(4) If a facility disagrees with the department's awarded level of designation, the facility may request a second appeal review with the department's CPD associate commissioner. The appeal must be submitted to the EMS/Trauma Systems Section no later than 15 days after the issuance date of the department's designation. If the CPD associate commissioner disagrees with the Trauma Designation Review Committee's recommendation, the CPD associate commissioner decides the appropriate level of designation awarded. The department sends a notification letter of the second appeal decision within 30 days of receiving the second appeal request.(5) If the facility continues to disagree with the second level of appeal, the facility may request a hearing, governed by the department's rules for a contested case hearing and by Texas Administrative Procedure Act, Texas Government Code Chapter 2001, and the department's formal hearing procedures in §§ 1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).(t) All designated facilities must follow the exceptions and notifications process outlined in the following paragraphs. (1) A designated trauma facility must provide written or electronic notification of any significant change to the trauma program impacting the capacity or capabilities to manage and care for a trauma patient. The notification must be provided to: (A) all EMS providers that transfer trauma patients to or from the designated trauma facility;(B) the hospitals to which it customarily transfers out or from which it transfers in trauma patients;(2) If the designated trauma facility is unable to meet the requirements to maintain its current designation, it must submit to the department a documented POC and a request for a temporary exception to the designation requirements. Any request for an exception must be submitted in writing from the facility's CEO and define the facility's timeline to meet the designation requirements. The department reviews the request and the POC and either grants the exception with a timeline based on access to care, including geographic location, other levels of trauma facilities available, transport times, impact on trauma outcomes, and the regional trauma system, or denies the exception. If the facility is not granted an exception or it does not meet the designation requirements at the end of the exception period, the department elects one of the following: (A) review the exception request with the Trauma Designation Review Committee with consideration of geographic location, access to trauma care in the local area of the facility, and impact on the regional trauma system;(B) re-designate the facility at the level appropriate to its revised capabilities;(C) outline an agreement with the facility to satisfy all designation requirements for the level of care designation within a time specified under the agreement, which may not exceed the first anniversary of the effective date of the agreement; or(D) accept the facility's relinquishing of its trauma designation certificate.(3) If the facility is relinquishing its trauma designation, the facility must provide 30 day written advance notice of the relinquishment to the department. The facility informs the applicable RACs, EMS providers, and facilities to which it customarily transfers out or from which it transfers in trauma patients. The facility is responsible for continuing to provide trauma care services or ensuring a plan for trauma care continuity for 30 days following the written notice of relinquishment of its trauma designation.(u) A designated trauma facility may choose to apply for a higher level of designation at any time. The facility must follow the initial designation process described in subsection (i) of this section to apply for a higher level of trauma designation. The facility must not claim or advertise the higher level of designation until the facility has received written notification of the award of the higher level of designation.(v) A hospital providing trauma services must not use or authorize the use of any public communication or advertising containing false, misleading, or deceptive claims regarding its trauma designation status. Public communication or advertising is deemed false, misleading, or deceptive if the facility uses these, or similar, terms: (1) trauma facility, trauma hospital, trauma center, functioning as a trauma center, serving as a trauma center, or similar terminology if the facility is not currently designated as a trauma center or designated trauma center at that level; or(2) comprehensive Level I trauma center, major Level II trauma center, advanced Level III trauma center, basic Level IV trauma center, or similar terminology in its signs, website, advertisements, social media, or in the printed materials and information it provides to the public that are different than the current designation level awarded by the department.(w) During a virtual, on-site, or focused designation review conducted by the department or a department-approved survey organization, the department or surveyor has the right to review and evaluate the following documentation to validate designation requirements are met in this section and the Texas Health and Safety Code Chapter 773:(1) trauma patient medical records;(2) trauma PIPS plan and process documents;(3) appropriate committee documentation for attendance, meeting minutes, and documents demonstrating why the case was referred, the date reviewed, pertinent discussion, and any actions taken specific to improving trauma care and outcomes; and(4) documents relevant to trauma care in a designated trauma facility or facility seeking trauma facility designation to validate evidence designation requirements are met.(x) The department and department-approved survey organizations must comply with all relevant laws related to the confidentiality of such records.25 Tex. Admin. Code § 157.126
Adopted by Texas Register, Volume 49, Number 46, November 15, 2024, TexReg 9255, eff. 11/24/2024