Current through Reg. 49, No. 49; December 6, 2024
Section 157.125 - Requirements for Trauma Facility Designation Effective Through August 31, 2025(a) The Emergency Medical Services (EMS)/Trauma Systems Section recommends to the Commissioner of the Department of State Health Services (commissioner) the designation of an applicant facility (facility) as a trauma facility at the level for each location of a facility the department deems appropriate. Trauma designation surveys conducted on or before August 31, 2025, are evaluated on the requirements of this section. For surveys conducted on or after September 1, 2025, see §157.126 of this subchapter (relating to Trauma Facility Designation Requirements Effective on September 1, 2025) for the requirements. (1) Comprehensive (Level I) trauma facility designation--The facility, including a free-standing children's facility, meets the current American College of Surgeons (ACS) essential criteria for a verified Level I trauma center; meets the "Advanced Trauma Facility Criteria" in subsection (x) of this section; actively participates on the appropriate Regional Advisory Council (RAC); has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the State Trauma Registry.(2) Major (Level II) trauma facility designation--The facility, including a free-standing children's facility, meets the current ACS essential criteria for a verified Level II trauma center; meets the "Advanced Trauma Facility Criteria" in subsection (x) of this section; actively participates on the appropriate RAC; has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the State Trauma Registry.(3) Advanced (Level III) trauma facility designation--The facility meets the "Advanced Trauma Facility Criteria" in subsection (x) of this section; actively participates on the appropriate RAC; has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the State Trauma Registry. A free-standing children's facility, in addition to meeting the requirements listed in this section, must meet the current ACS essential criteria for a verified Level III trauma center.(4) Basic (Level IV) trauma facility designation--The facility meets the "Basic Trauma Facility Criteria" in subsection (y) of this section; actively participates on the appropriate RAC; has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the State Trauma Registry.(b) A health care facility is defined in this subchapter as a single location where inpatients receive hospital services or each location if there are multiple buildings where inpatients receive hospital services and are covered under a single hospital license. Each location is considered separately for designation and the department will determine the designation level for that location, based on, but not limited to, the location's own resources and levels of care capabilities; Trauma Service Area (TSA) capabilities; and the essential criteria and requirements outlined in subsection (a)(1) - (4) of this section. The final determination of the level of designation may not be the level requested by the facility.(c) The designation process consists of three phases. (1) First phase--The application phase begins with submitting to the department a timely and sufficient application for designation as a trauma facility and ends when the survey report is received by the department.(2) Second phase--The review phase begins with the department's review of the survey report and ends with its recommendation to the commissioner whether to designate the facility and at what level. This phase also includes an appeal procedure 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).(3) Third phase--The final phase begins with the commissioner reviewing the recommendation and ends with the commissioner's final decision.(d) For a facility seeking initial designation, a timely and sufficient application must include: (1) the department's current "Complete Application" form for the appropriate level, with all fields correctly and legibly filled-in and all requested documents attached, hand-delivered, or sent by postal services to the department;(2) full payment of the designation fee enclosed with the submitted "Complete Application" form;(3) any subsequent documents submitted by the date requested by the department;(4) a trauma designation survey completed within one year of the date of the receipt of the application by the department; and(5) a complete survey report, including patient care reviews, that is within 90 days of the date of the survey and is submitted to the department.(e) If a hospital seeking initial designation fails to meet the requirements in subsection (d)(1) - (5) of this section, the application is denied.(f) For a facility seeking re-designation, a timely and sufficient application must include:(1) the department's current "Complete Application" form for the appropriate level, with all fields correctly and legibly filled-in and all requested documents attached, submitted to the department one year before the expiration of the current designation;(2) full payment of the designation fee enclosed with the submitted "Complete Application" form;(3) any subsequent documents submitted by the date requested by the department; and(4) a complete survey report, including patient care reviews, that is within 90 days of the date of the survey and is submitted to the department and at least 60 days before the expiration of the current designation.(g) If a health care facility seeking re-designation fails to meet the requirements outlined in subsection (f)(1) - (4) of this section, the original designation will expire on its expiration date.(h) The department's analysis of the submitted "Complete Application" form may result in recommendations for corrective action when deficiencies are noted and must include a review of: (1) the evidence of current participation in RAC and regional trauma and emergency health care system planning; and(2) the completeness and appropriateness of the application materials submitted, including the submission of a non-refundable application fee as follows: (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; and(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.(i) When a "Complete Application" form for initial designation or re-designation from a facility is received, the department will determine the level it deems appropriate for pursuit of designation or re-designation for each facility location based on: the facility's resources and levels of care capabilities, TSA resources, and the essential criteria for Levels I, II, III, and IV trauma facilities. In general, physician services capabilities described in the application must be in place 24-hours a day/7 days a week. In determining whether a physician services capability is present, the department may use the concept of substantial compliance that is defined as having said physician services capability at least 90% of the time. (1) If a facility disagrees with the level determined by the department to be appropriate for pursuit of designation or re-designation, it may make an appeal in writing within 60 days to the EMS/Trauma Systems Section director. The written appeal must include a signed letter from the facility's governing board with an explanation as to why designation at the level determined by the department would not be in the best interest of the citizens of the affected TSA or the citizens of the State of Texas.(2) If the department upholds its original determination, the EMS/Trauma Systems Section director will give written notice of such to the facility within 30 days of its receipt of the applicant's complete written appeal.(3) The facility may, within 30 days of the department sending written notification of its denial, submit a written request for further review. Such written appeal is submitted to the associate commissioner, Consumer Protection Division.(j) When the analysis of the "Complete Application" form results in acknowledgement by the department that the facility is seeking an appropriate level of designation or re-designation, the facility may then contract for the survey, as follows. (1) Level I and II facilities and all free-standing children's facilities must request a survey through the ACS trauma verification program.(2) Level III facilities must request a survey through the ACS trauma verification program or through a department-approved survey organization.(3) Level IV facilities must request a survey through a department-approved survey organization, or by a department-credentialed surveyor.(4) The facility must notify the department of the date of the planned survey and the composition of the survey team.(5) The facility is responsible for any expenses associated with the survey.(6) The department, at its discretion, may appoint a designation coordinator to accompany the survey team. In this event, the cost for the designation coordinator is borne by the department.(k) The survey team composition must be as follows. (1) Level I or Level II facilities must be surveyed by a team that is multidisciplinary and includes at a minimum: two general surgeons, an emergency physician, and a trauma nurse all active in the management of trauma patients.(2) Free-standing children's facilities of all levels must be surveyed by a team consistent with current ACS policy and includes at a minimum: a pediatric surgeon, a general surgeon, a pediatric emergency physician, and a pediatric trauma nurse coordinator or a trauma nurse coordinator with pediatric experience.(3) Level III facilities must be surveyed by a team that is multidisciplinary and includes at a minimum: a trauma surgeon and a trauma nurse (ACS or department-credentialed), both active in the management of trauma patients.(4) Level IV facilities must be surveyed by a department-credentialed representative, registered nurse, or licensed physician. A second surveyor may be requested by the facility or by the department.(5) Department-credentialed surveyors must meet the following criteria: (A) have at least three years' experience in the care of trauma patients;(B) be currently employed in the coordination of care for trauma patients;(C) have direct experience in the preparation for and successful completion of trauma facility verification or designation;(D) have successfully completed a department-approved trauma facility site surveyor course and be successfully re-credentialed every four years; and(E) have current credentials as follows: (i) for nurses: Trauma Nurses Core Course (TNCC) or Advanced Trauma Course for Nurses (ATCN); and Pediatric Advanced Life Support (PALS) or Emergency Nurses Pediatric Course (ENPC);(ii) for physicians: Advanced Trauma Life Support (ATLS); and(iii) have successfully completed a site survey internship.(6) All members of the survey team, except department staff, must come from a TSA outside the facility's location and at least 100 miles from the facility. There must be no business or patient care relationship or any potential conflict of interest between the surveyor or the surveyor's place of employment and the facility being surveyed.(l) The survey team evaluates the facility's compliance with the designation criteria, by: (1) reviewing medical records; staff rosters and schedules; process improvement committee meeting minutes; and other documents relevant to trauma care;(2) reviewing equipment and the physical plant;(3) conducting interviews with facility personnel;(4) evaluating compliance with participation in the State Trauma Registry; and(5) evaluating appropriate use of telemedicine capabilities where applicable.(m) The site survey report in its entirety must be part of a facility's performance improvement program and subject to confidentiality as articulated in the Texas Health and Safety Code § 773.095.(n) The surveyor must provide the facility with a written, signed survey report regarding the evaluation of the facility's compliance with trauma facility criteria. This survey report must be forwarded to the facility within 30 calendar days of the completion date of the survey. The facility is responsible for forwarding a copy of this report to the department if it intends to continue the designation process.(o) The department must review the findings of the survey report for compliance with trauma facility criteria. (1) A recommendation for designation must be made to the commissioner based on meeting the designation requirements.(2) If a facility does not meet the criteria for the level of designation deemed appropriate by the department, the department must notify the facility of the requirements it must meet to achieve the appropriate level of designation.(3) If a facility does not meet the requirements, the department must notify the facility of deficiencies and recommend corrective action.(A) The facility must submit to the department a report that outlines the corrective action taken. The department may require a second survey to ensure compliance with the criteria. If the department substantiates action that brings the facility into compliance with the criteria, the department recommends designation to the commissioner.(B) If a facility disagrees with the department's decision regarding its designation application or status, it may request a secondary review by a designation review committee. Membership on a designation review committee will: (ii) be appointed by the EMS/Trauma Systems Section director;(iii) be representative of trauma care providers and appropriate levels of designated trauma facilities; and(iv) include representation from the department and the Trauma Systems Committee of the Governor's EMS and Trauma Advisory Council (GETAC).(C) If a designation review committee disagrees with the department's recommendation for corrective action, the records must be referred to the associate commissioner for recommendation to the commissioner.(D) If a facility disagrees with the department's recommendation at the end of the secondary review, the facility has a right to 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).(p) The facility has the right to withdraw its application at any time before being recommended for trauma facility designation by the department.(q) If the associate commissioner concurs with the recommendation to designate, the facility receives a letter and a certificate of designation valid for three years. Additional actions, such as a site review or submission of information/reports to maintain designation, may be required by the department.(r) It is necessary to repeat the designation process as described in this section prior to expiration of a facility's designation or the designation expires.(s) A designated trauma facility must comply with the provisions of this chapter; all current state and system standards as described in this chapter; all policies, protocols, and procedures as set forth in the system plan; and meet the following requirements. (1) Continue its commitment to provide the resources, personnel, equipment, and response as required by its designation level.(2) Participate in the State Trauma Registry. Data submission requirements for designation purposes are as follows.(A) Initial designation--Six months of data prior to the initial designation survey must be uploaded. Subsequent to initial designation, data should be uploaded to the State Trauma Registry on at least a quarterly basis (with monthly submissions recommended) as indicated in Chapter 103 of this title (relating to Injury Prevention and Control).(B) Re-designation--The facility's trauma registry should be current with at least quarterly uploads of data to the State Trauma Registry (monthly submissions recommended) as indicated in Chapter 103 of this title.(3) Notify the department, its RAC, and other affected RACs of all changes that affect air medical access to designated landing sites.(A) Non-emergent changes must be implemented no earlier than 120 days after a written notification process.(B) Emergency changes related to safety may be implemented immediately along with immediate notification to department, the RAC, and appropriate air medical providers.(C) Conflicts relating to helipad air medical access changes must be negotiated between the facility and the EMS provider.(D) Any unresolved issues must be managed utilizing the nonbinding alternative dispute resolution (ADR) process of the RAC in which the helipad is located.(4) Within five days, notify the department; its RAC and other affected RACs; and the health care facilities to which it customarily transfers-out trauma patients or from which it customarily receives trauma transfers-in if temporarily unable to comply with a designation. If the health care facility intends to meet the requirements and maintain current designation status, it must also submit to the department a plan for corrective action and a request for a temporary exception to requirements within five days.(A) If the requested essential requirements exception is not critical to the operations of the health care facility's trauma program and the department determines the facility has intent to meet the requirements, a 30-day to 90-day exception period from the onset date of the deficiency may be granted for the facility to meet requirements.(B) If the requested essential requirements exception is critical to the operations of the health care facility's trauma program and the department determines the facility has intent to meet requirements, no greater than a 30-day exception period from the onset date of the deficiency may be granted for the facility to meet requirements. Essential requirements that are critical include: (i) neurological surgery capabilities (Level I, II);(ii) orthopedic surgery capabilities (Level I, II, III);(iii) general/trauma surgery capabilities (Level I, II, III);(iv) anesthesiology (Levels I, II, III);(v) emergency physicians (all levels);(vi) trauma medical director (all levels);(vii) trauma program manager (all levels); and(viii) trauma registry (all levels).(C) If the health care facility has not met the requirements at the end of the exception period, the department may at its discretion elect one of the following. (i) Allow the facility to request designation at the level appropriate to its revised capabilities.(ii) Propose to re-designate the facility at the level appropriate to its revised capabilities.(iii) Propose to suspend the facility's designation status. If the facility is amenable to this action, the department will develop a corrective action plan for the facility and a specific timeline for the facility to meet the requirements.(iv) Propose to extend the facility's temporary exception to criteria for an additional period not to exceed 90 days. The department will develop a corrective action plan for the facility and a specific timeline for the facility to meet the requirements. (I) Suspensions of a facility's designation status and exceptions to criteria for facilities are documented on the EMS Trauma Systems Section website.(II) If the facility disagrees with a proposal by the department or is unable or unwilling to meet the department-imposed timelines for completion of specific actions plans, it may request a secondary review by a designation review committee as defined in subsection (o)(3)(B) of this section.(III) The department may at its discretion choose to activate a designation review committee at any time to solicit technical advice regarding criteria deficiencies.(IV) If the designation review committee disagrees with the department's recommendation for corrective actions, the case is referred to the associate commissioner for recommendation to the commissioner.(V) If a facility disagrees with the department's recommendation at the end of the secondary review process, the facility has a right to 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).(VI) Designated trauma facilities seeking exceptions to essential criteria have the right to withdraw the request at any time prior to resolution of the final appeal process.(5) Notify the department; its RAC and other affected RACs; and the health care facilities to which it customarily transfers-out trauma patients or from which it customarily receives trauma transfers-in if it no longer provides trauma services commensurate with its designation level.(A) If the facility chooses to apply for a lower level of trauma designation, it may do so at any time; however, it is necessary to repeat the designation process. There must be a review by the department to determine if a full survey is required.(B) If the facility chooses to relinquish its trauma designation, it must provide at least 30 days' notice to the RAC and the department.(6) Within 30 days, notify the department; its RAC and other affected RACs; and the health care facilities to which it customarily transfers-out trauma patients or from which it customarily receives trauma transfers-in, of the change if it adds capabilities beyond those that define its existing trauma designation level. (A) It is necessary to repeat the trauma designation process.(B) There must be a review by the department to determine if a full survey is required.(t) Any facility seeking trauma designation must have measures in place that define the trauma patient population managed at the facility or at each of its locations, and the ability to track trauma patients throughout the course of care within the facility or at each of its locations to maximize funding opportunities for uncompensated care.(u) 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 is currently designated as a trauma facility according to the process described in this section.(v) The department has 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 or applicant facility at any time to verify meeting requirements in the statute and this section, including the designation requirements. The department maintains confidentiality of such records to the extent authorized by the Texas Public Information Act, Texas Government Code Chapter 552, and consistent with current laws and regulations related to the Health Insurance Portability and Accountability Act of 1996. Such inspections must be scheduled by the department when deemed appropriate. The department provides a copy of the survey report, for surveys conducted by or contracted for the department, and the results to the health care facility.(w) The department may grant an exception to this section if it finds meeting requirements in this section would not be in the best interests of the persons served in the affected local system.(x) Advanced (Level III) Trauma Facility Requirements. An advanced trauma facility (Level III) provides resuscitation, stabilization, and assessment of injured patients and either provides treatment or arranges for appropriate transfer to a higher level designated trauma facility.(1) The facility must identify a trauma medical director (TMD) responsible for the provision of trauma care and must have a defined job description and organizational chart delineating the TMD's role and responsibilities. The TMD must be a physician who meets the following:(A) is a general surgeon;(B) is currently credentialed in ATLS or an equivalent department-approved course;(C) is charged with overall management of trauma services provided by the facility;(D) must have the authority and responsibility for the clinical oversight of the trauma program, including: (i) credentialing of medical staff who provide trauma care;(ii) recommending trauma team privileges;(iii) providing trauma care;(iv) developing trauma management guidelines;(v) collaborating with nursing to address educational needs; and(vi) developing, implementing, and maintaining the trauma performance improvement and patient safety (PIPS) plan with the trauma program manager (TPM);(E) must be credentialed by the facility to participate in the resuscitation and treatment of trauma patients and must: (i) have current board-certification or board-eligibility;(ii) complete nine hours of trauma-related continuing medical education per year;(iii) comply with trauma management guidelines; and(iv) participate in the trauma PIPS program;(F) must participate in a leadership role in the facility, community, and emergency management (disaster) response committee; and(G) should participate in the development of the regional trauma system plan.(2) An identified TPM is a registered nurse and must: (A) successfully complete and remain current in the TNCC or ATCN or an equivalent department-approved course;(B) successfully complete and remain current in a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC);(C) have the authority and responsibility to monitor trauma patient care from emergency department (ED) admission through operative intervention, intensive care unit (ICU) care, stabilization, rehabilitation care, and discharge, including the trauma PIPS program;(D) have a defined job description and organizational chart delineating the TPM's role and responsibilities;(E) participate in a leadership role in the facility, community, and regional emergency management (disaster) response committee;(G) complete a course designed for their role that provides essential information on the structure, process, organization, and administrative responsibilities of a PIPS program to include a department-approved trauma outcomes and performance improvement course.(3) The trauma program must have written trauma management guidelines, developed with approval by the trauma multidisciplinary committee and facility's medical staff with evidence of implementation, for:(A) trauma team activation;(B) trauma resuscitation guidelines for the roles and responsibilities of team members during a resuscitation;(C) triage, admission, and transfer of trauma patients; and(D) trauma management guidelines specific to the trauma population managed by the facility as defined by the State Trauma Registry.(4) All major, severe, and critical trauma patients must be admitted to an appropriate surgeon and all multi-system trauma patients must be admitted to a general surgeon.(5) A general surgeon participating in trauma-call coverage must: (A) be credentialed in ATLS or an equivalent department-approved course at least one time if board-certification maintained; and(B) be credentialed by the TMD to participate in the resuscitation and treatment of trauma patients and must maintain:(i) current board-certification or board-eligibility, or must maintain current ATLS or an equivalent department-approved course;(ii) nine hours of trauma-related continuing medical education per year;(iii) compliance with trauma management guidelines;(iv) participation in the trauma PIPS program; and(v) attendance at 50 percent or more of multidisciplinary and peer review trauma committee meetings.(6) A non-board-certified general surgeon desiring inclusion in a facility's trauma program must meet the ACS guidelines as specified in its most current version of the "Resources for Optimal Care of the Injured Patient," Alternate Criteria section.(7) The general surgeon must be present in the ED at the time of arrival of the highest level of trauma activation or within 30 minutes of notification of the trauma activation. This must be continuously monitored by the trauma PIPS program.(8) In facilities with surgical residency programs, evaluation and treatment may be started by a team of surgeons that must include a post-graduate year four (PGY4) or more senior surgical resident who is a member of that facility's residency program. The attending surgeon must participate in major therapeutic decisions, be present in the emergency department for major resuscitations, be present in the emergency department for the highest and secondary trauma activations, and be present at operative procedures. These must be continuously monitored by the trauma PIPS program.(9) When the attending surgeon is not activated initially and an urgent surgical consult is necessary, the maximum response time of the attending surgeon is 60 minutes from notification to physical presence at the patient's bedside. This must be continuously monitored by the trauma PIPS program.(10) There must be a published on-call schedule for obtaining general surgery care. There must be a documented system for obtaining general surgical care for situations when the attending general surgeon on-call is not available. This must be continuously monitored by the trauma PIPS program.(11) An orthopedic surgeon participating in trauma-call coverage must be credentialed by the TMD to participate in the resuscitation and treatment of trauma patients and must maintain:(A) current board-certification, board-eligibility, or meet ACS standards as specified in its current addition of "Resources for Optimal Care of the Injured Patient," Alternate Criteria section;(B) compliance with trauma management guidelines; and(C) participation in the trauma PIPS program.(12) An orthopedic surgeon providing trauma coverage must be promptly available (physically present) at the major, severe, or critical trauma patient's bedside within 30 minutes of request by the attending trauma surgeon or emergency physician, from inside or outside the facility. This must be continuously monitored by the trauma PIPS program.(13) When the orthopedic surgeon is not activated initially and an urgent surgical consult is necessary, the maximum response time of the orthopedic surgeon is 60 minutes from notification to physical presence at the patient's bedside. This must be continuously monitored by the trauma PIPS program.(14) There must be a published on-call schedule for obtaining orthopedic surgery care. There must be a documented system for obtaining orthopedic surgery care for situations when the attending orthopedic surgeon on-call is not available. This must be continuously monitored by the trauma PIPS program.(15) The orthopedic surgeon representative to the multidisciplinary trauma committee maintains nine hours of trauma-related continuing medical education per year and attends 50 percent or more of multidisciplinary and peer review trauma committee meetings.(16) When a Level III facility has either full-time, routine, or limited neurosurgical coverage, a neurosurgeon participating in trauma-call coverage must be credentialed by the TMD to participate in the resuscitation and treatment of trauma patients and must maintain:(A) current board-certification, board-eligibility, or meet ACS standards as specified in its current addition of "Resources for Optimal Care of the Injured Patient," Alternate Criteria section;(B) compliance with trauma management guidelines; and(C) participation in the trauma PIPS program.(17) A neurosurgeon providing trauma coverage must be promptly available (physically present) at the major, severe, or critical trauma patient's bedside and neurosurgical evaluation must occur within 30 minutes for the following criteria: severe traumatic brain injury (TBI) with a Glasgow coma scale (GCS) less than 9 and computed tomography (CT) evidence of TBI; moderate TBI with GCS of 9-12 and CT evidence of potential intracranial lesion; and neurological deficit produced by a potential spinal cord injury. When a neurosurgical advanced practice provider (APP) or neurosurgical resident is utilized, there must be documented evidence of consultation with the neurosurgical attending on-call prior to implementation of the plan of care. This must be continuously monitored by the trauma PIPS program, including the consult times and response times.(18) When the neurosurgeon is not notified of the initial activation or was not consulted by the evaluating team and it has been determined by the emergency physician or trauma surgeon that an urgent neurosurgical consult is necessary, the maximum response time of the neurosurgeon is 60 minutes from notification to physical presence at the patient's bedside. This must be continuously monitored by the trauma PIPS program.(19) There must be a published on-call schedule for obtaining neurosurgical care.(20) There must be a documented system for obtaining neurosurgical care for situations when the neurosurgeon on-call is not available. This must be continuously monitored by the trauma PIPS program.(21) The neurosurgeon representative to the multidisciplinary trauma committee must have nine hours of trauma-related continuing medical education per year and attend 50 percent or more of multidisciplinary and peer review trauma committee meetings.(22) An emergency physician must be available in the emergency department 24-hours a day and physicians providing trauma coverage must meet the following: (A) be credentialed by the facility to provide emergency medical services; and(B) be credentialed by the TMD to participate in the resuscitation and treatment of trauma patients of all ages and must maintain: (i) current board-certification, board-eligibility, or maintain current ATLS or an equivalent department-approved course;(ii) compliance with trauma management guidelines; and(iii) participation in the trauma PIPS program.(23) A board-certified emergency medicine physician providing trauma coverage must have successfully completed an ATLS Student Course or an equivalent department-approved ATLS course at least once.(24) Current ATLS verification is required for all physicians who work in the emergency department and are not board-certified in Emergency Medicine.(25) The emergency physician representative to the multidisciplinary trauma committee must have nine hours of trauma-related continuing medical education per year and attend 50 percent or more of multidisciplinary and peer review trauma committee meetings.(26) The radiology physician on-call must respond within 30 minutes of request, from inside or outside the facility. This system must be continuously monitored by the trauma PIPS program.(27) The anesthesiology physician on-call must respond within 30 minutes of request, from inside or outside the facility. This system must be continuously monitored by the trauma PIPS program. (A) Requirements may be fulfilled by a member of the anesthesia care team credentialed by the TMD to participate in the resuscitation and treatment of trauma patients that may include: (i) current board certification or board eligibility;(ii) trauma continuing education;(iii) compliance with trauma management guidelines; and(iv) participation in the trauma PIPS program.(B) The anesthesiology physician representative to the multidisciplinary trauma committee that provides trauma coverage to the facility must attend 50 percent or more of multidisciplinary and peer review trauma committee meetings.(28) All nurses caring for trauma patients throughout the continuum of care have ongoing documented knowledge and skill in trauma nursing for patients of all ages to include trauma specific orientation, annual clinical competencies, and continuing education.(29) Written guidelines for nursing care of trauma patients for all units (e.g., ED, ICU, Operating Room (OR), Post Anesthesia Care Unit (PACU), Medical/Surgical Units) in the facility must be implemented.(30) The facility must have a written plan, developed by the facility, for acquisition of additional staff on a 24-hour basis to support units with increased patient acuity, and multiple emergency procedures and admissions (i.e., a written disaster plan.)(31) The facility must have emergency services available 24-hours a day.(A) The ED must have a designated physician director.(B) The ED must have physicians with special competence in the care of critically injured patients, designated as members of the trauma team, and physically present in the ED 24-hours per day. Neither a facility's telemedical capabilities nor the physical presence of advanced practice providers (APPs) satisfies this requirement.(C) APPs who participate in trauma patient resuscitations and telemedicine-support physicians who participate in the care of major, severe, or critical trauma patients must be credentialed by the facility to participate in the resuscitation and treatment of trauma patients and must maintain:(i) board-certification or board-eligibility in specialty, or current ATLS or an equivalent department-approved ATLS course;(ii) nine hours of trauma-related continuing medical education per year;(iii) compliance with trauma management guidelines; and(iv) participation in the trauma PIPS program.(D) The ED physician must be activated on EMS communication with the ED or after a primary assessment of patients who arrive to the ED by private vehicle for the highest level of trauma activation and must respond within 30 minutes from notification of the trauma activation. This must be monitored in the trauma PIPS program.(E) A minimum of two registered nurses who have trauma nursing training must participate in the highest level trauma activations.(F) All registered nursing staff responding to the highest levels of trauma activations must have successfully completed and hold current credentials in an advanced cardiac life support course (e.g., Advanced Cardiac Life Support (ACLS) or an equivalent department-approved course), a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC), and TNCC or ATCN or an equivalent department-approved course. A free-standing children's facility is exempt from the ACLS requirement.(G) Nursing documentation for trauma activation patients must be systematic and meet the trauma primary and secondary assessment guidelines.(H) 100 percent of nursing staff must have successfully completed and hold current credentials in an advanced cardiac life support course (e.g., ACLS or an equivalent department-approved course), a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC), and TNCC or ATCN or an equivalent department-approved course, within 18 months of date of employment in the ED.(I) 100 percent of a free-standing children's facility nursing staff who care for trauma patients must have successfully completed and hold current credentials in a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC) and TNCC or ATCN or an equivalent department-approved course, within 18 months of date of employment in the ED.(J) Two-way communication with all pre-hospital emergency medical services vehicles must be available.(K) Equipment and services for the evaluation and resuscitation of, and to provide life support for, critically or seriously injured patients of all ages must include: (i) airway control and ventilation equipment including laryngoscope and endotracheal tubes of all sizes, bag-valve-mask devices (BVMs), pocket masks, advanced airway management devices, and oxygen;(ii) mechanical ventilator;(iii) pulse oximetry and capnography;(v) electrocardiograph, oscilloscope, and defibrillator;(vi) internal age-specific paddles;(vii) all standard intravenous fluids and administration devices, including large-bore intravenous catheters and a rapid infuser system;(viii) sterile surgical sets for procedures standard for the emergency department such as thoracostomy, venous cutdown, central line insertion, thoracotomy, diagnostic peritoneal lavage (if performed at facility), airway control/cricothyrotomy, etc.;(ix) drugs and supplies necessary for emergency care;(x) cervical spine stabilization device;(xi) length-based body weight and tracheal tube size evaluation system (e.g., a current Broselow tape) and resuscitation medications and equipment that are dose-appropriate for all ages;(xii) long bone stabilization device;(xiii) pelvic stabilization device;(xiv) thermal control equipment for patients and a rapid warming device for blood and fluids; and(xv) non-invasive continuous blood pressure monitoring devices.(32) Imaging capability must be available, with an in-house technician 24-hours a day or on-call and responding within 30 minutes of request. This must be continuously monitored by the trauma PIPS program.(33) Psychosocial support services must be available for staff, patients, and their families.(34) Operating room services must be available 24-hours a day.(A) With advanced notice, the operating room must be opened and ready to accept a patient within 30 minutes. This must be continuously monitored by the trauma PIPS program.(B) Equipment for all trauma patient populations and anticipated special requirements must include: (i) thermal control equipment for patient and for blood and fluids;(ii) imaging capability including c-arm image intensifier with technologist available 24-hours a day;(iii) endoscopes, all varieties, and bronchoscope;(iv) equipment for long bone and pelvic fixation;(v) rapid infuser system;(vi) appropriate monitoring and resuscitation equipment;(vii) capability to measure pulmonary capillary wedge pressure; and(viii) capability to measure invasive systemic arterial pressure.(35) A PACU or surgical ICU must be available for trauma patients following operative interventions and include the following. (A) Registered nurses and other essential personnel 24-hours a day.(B) Appropriate monitoring and resuscitation equipment.(C) Pulse oximetry and capnography.(D) Thermal control equipment for patients and a rapid warming device for blood and fluids.(36) An ICU must be available for trauma patients 24-hours a day and include the following. (A) Designated surgical director or surgical co-director responsible for setting policies and administration related to trauma ICU patients. A physician providing this coverage must be a surgeon credentialed by the TMD to participate in the resuscitation and treatment of trauma patients and must maintain: (i) board-certification, board-eligibility, or current in ATLS or an equivalent department-approved course;(ii) trauma continuing medical education;(iii) compliance with trauma management guidelines; and(iv) participation in the trauma PIPS program.(B) Physician, credentialed in critical care by the TMD, on duty in ICU 24-hours a day or immediately available from in-facility. Arrangements for 24-hour surgical coverage of all trauma patients must be provided for emergencies and routine care. This must be continuously monitored by the trauma PIPS program.(C) Registered nurse-patient minimum ratio of 1:2 on each shift for patients identified as critical acuity.(D) Appropriate monitoring and resuscitation equipment.(E) Pulse oximetry and capnography.(F) Thermal control equipment for patients and a rapid warming device for blood and fluids.(G) Capability to measure pulmonary capillary wedge pressure.(H) Capability to measure invasive systemic arterial pressure.(37) Respiratory services in-house and must be available 24-hours per day.(38) Clinical laboratory services must be available 24-hours per day and provide the following. (A) Standard analyses of blood, urine, and other body fluids, including microsampling.(B) Blood typing and cross-matching, to include massive transfusion guidelines and emergency release of blood guidelines.(C) Comprehensive blood bank or access to a community central blood bank and adequate facility storage.(E) Blood gases and pH determinations.(G) Drug and alcohol screening.(H) Infectious disease standard operating procedures.(I) Serum and urine osmolality.(39) Special imaging capabilities must be available. (A) Sonography is available 24-hours per day or on-call and if notified, responds within 30 minutes of notification.(B) Computerized tomography (CT) is available on-call 24-hours per day and if notified, responds within 30 minutes. This must be continuously monitored by the trauma PIPS program.(C) Angiography of all types is available 24-hours per day and if on-call, responds within 30 minutes.(D) Nuclear scanning is available and responds as defined in the trauma management guidelines.(40) Acute hemodialysis capability is available or transfer agreements are documented if not available.(41) Established criteria for care of burn patients with a process to expedite the transfer of burn patients to a burn center or higher level of care.(42) In circumstances where a designated spinal cord injury rehabilitation center exists in the region, early transfer should be considered and transfer agreements in effect.(43) In circumstances where a moderate to severe head injury center exists in the region, transfer should be considered in selected patients and transfer agreements in effect.(44) Physician-directed rehabilitation service, staffed by personnel trained in rehabilitation care and properly equipped for care of the injured patient, or transfer guidelines to a rehabilitation facility for patients needing a higher level of care or specialty services, including:(B) occupational therapy; and(45) Social services must be available to assist with management of trauma patients.(46) The facility must have a defined trauma PIPS plan approved by the TMD, TPM, and the multidisciplinary committee.(A) On initial designation, a facility must have completed at least six months of reviews on all qualifying trauma records with evidence of "loop closure" on identified variances. Compliance with internal trauma management guidelines must be evident.(B) On re-designation, a facility must show continuous PIPS activities throughout its designation and a rolling current three-year period must be available for review at all times.(C) Minimum PIPS inclusion criteria must include: all trauma team activations (including those discharged from the ED); all trauma deaths; all identified facility events; transfers-in and transfers-out; and readmissions within 48 hours after discharge.(D) The trauma PIPS program must be organized and include a pediatric-specific component with trauma audit filters. (i) Review of trauma medical records for appropriateness and quality of care.(ii) Documented evidence of identification of all variances from trauma management guidelines and system response guidelines, with in-depth critical review.(iii) Documented evidence of corrective actions implemented to address all identified variances with tracking of data analysis.(iv) Documented evidence of secondary level of review and participation by the TMD.(v) Morbidity and mortality review including decisions by the TMD as to whether the trauma management guidelines were followed.(vi) Documented resolutions "loop closure" of all identified variance to prevent future recurrences.(vii) Specific reviews of all trauma deaths and other specified cases, including complications, utilizing age-specific criteria.(viii) Multidisciplinary hospital trauma PIPS committee structure in place.(E) Multidisciplinary trauma committee meetings for PIPS activities must include department communication, data review, and measures for problem solving.(F) Multidisciplinary trauma conferences must include all disciplines caring for trauma patients. This conference must be for the purpose of addressing PIPS activities and continuing education.(G) Feedback regarding trauma patient transfers-in must be provided to all transferring facilities.(H) Feedback regarding trauma patient transfers-out must be obtained from receiving facilities.(I) The trauma program must maintain a trauma registry or utilize the State Trauma Registry for data entry of NTDB registry inclusion criteria patients. Trauma registry data must be submitted to the State Trauma Registry on at least a quarterly basis.(J) The trauma program must participate in the RAC's performance improvement (PI) program, including adherence to regional guidelines, submitting data preapproved by the RAC membership such as summaries of transfer delays and transfers to facilities outside of the RAC.(K) The trauma program must track the times and reasons for diversion must be documented and reviewed by the trauma PIPS program and multidisciplinary committee.(L) The trauma program must maintain published on-call schedules must be maintained for general surgeons, orthopedic surgeons, neurosurgeons, anesthesia, radiology, and other major specialists, if available.(M) The trauma program must have performance improvement personnel dedicated to and specific for the trauma program.(47) The trauma program must participate in the regional trauma system per RAC requirements.(48) The trauma program must have a process to expedite the transfer of major, severe, or critical trauma patients to include written management guidelines, written transfer agreements, and participation in a regional trauma system transfer plan for patients needing higher level of care or specialty services.(49) The facility must have a system for establishing an appropriate landing zone near the facility (if rotor-wing services are available).(50) The trauma program must provide education and consultations to physicians of the community and outlying areas.(51) The trauma program must have an identified individual to coordinate the facility's community outreach programs for the public and professionals.(52) The trauma program must have a public education program to address specific injuries identified by the facility's trauma registry. Documented participation in a RAC injury prevention program is acceptable.(53) The trauma program must have formal programs in trauma continuing education provided by facility for staff or in collaboration with the RAC, based on needs identified from the trauma PIPS program for:(C) allied health personnel, including advanced practice providers;(D) community physicians; and(E) pre-hospital personnel.(54) The facility may participate in trauma-related research.(y) Basic (Level IV) Trauma Facility Requirements. A Basic Trauma Facility (Level IV) provides resuscitation, stabilization, and arranges for appropriate transfer of trauma patients requiring a higher level of definitive care. (1) The facility must identify a TMD responsible for the provision of trauma care and must have a defined job description and organizational chart delineating the TMD's role and responsibilities. The TMD must be a physician who meets the following: (A) is currently credentialed in ATLS or an equivalent department-approved course;(B) is charged with overall management of trauma services provided by the facility;(C) must have the authority and responsibility for the clinical oversight of the trauma program, including: (i) credentialing of medical staff who provide trauma care;(ii) providing trauma care;(iii) developing trauma management guidelines;(iv) collaborating with nursing to address educational needs; and(v) developing and implementing the trauma PIPS plan with the TPM;(D) must be credentialed by the facility to participate in the resuscitation and treatment of trauma patients and must: (i) have current board-certification or board-eligibility in surgery, emergency medicine or family medicine, or must maintain current ATLS or an equivalent department-approved course;(ii) complete nine hours of trauma-related continuing medical education per year;(iii) comply with trauma management guidelines; and(iv) participate in the trauma PIPS program;(E) must participate in a leadership role in the facility, community, and emergency management (disaster) response committee; and(F) should participate in the development of the regional trauma system plan.(2) An identified TPM is a registered nurse and must:(A) successfully complete and remain current in the TNCC or ATCN or an equivalent department-approved course;(B) successfully complete and remain current in a nationally recognized pediatric advanced life support course (e.g., PALS or the ENPC);(C) have the authority and responsibility to monitor trauma patient care from ED admission through operative intervention, ICU care, stabilization, rehabilitation care, and discharge, including the trauma PIPS program;(D) have a defined job description and organizational chart delineating the TPM's role and responsibilities;(E) participate in a leadership role in the facility, community, and regional emergency management (disaster) response committee;(F) ensure the TPM hours dedicated to the trauma program maintains a concurrent PIPS process and trauma registry; and(G) complete a course designed for their role that provides essential information on the structure, process, organization, and administrative responsibilities of a PIPS program to include a department-approved trauma outcomes and performance improvement course.(3) An identified Trauma Registrar or TPM must have appropriate training (e.g., the Association for the Advancement of Automotive Medicine (AAAM) course) in injury severity scaling. Typically, one full-time equivalent (FTE) employee dedicated to the registry is required to process approximately 500 patients annually.(4) Written trauma management guidelines must be developed with approval by the TMD, TPM, and the facility's medical staff with evidence of implementation, for: (A) trauma team activation, including defined response times;(B) trauma resuscitation, defining the roles and responsibilities of team members during a resuscitation;(C) triage, admission, and transfer of trauma patients; and(D) trauma management specific to the trauma population managed by the facility as defined by the trauma registry.(5) The emergency department must have physician coverage 24-hours per day. The physician providing coverage in the ED must be credentialed by the facility to provide emergency medical services. (A) A physician providing trauma coverage must be credentialed by the TMD to participate in the resuscitation and treatment of trauma patients of all ages and must maintain: (i) current board-certification or board-eligibility in emergency medicine or family medicine, or current ATLS or an equivalent department-approved course;(ii) nine hours of trauma-related continuing medical education per year;(iii) compliance with trauma management guidelines; and(iv) participation in the trauma PIPS program.(B) A board-certified emergency medicine physician providing trauma coverage must have successfully completed an ATLS Student Course or an equivalent department-approved ATLS course, at least once.(C) Current ATLS verification is required for all physicians who work in the ED and are not board-certified in emergency medicine.(D) The emergency physician representative to the multidisciplinary committee that provides trauma coverage to the facility must attend 50 percent or more of multidisciplinary and peer review trauma committee meetings.(6) Radiology physician services must be available.(7) Anesthesiology may be fulfilled by a member of the anesthesia care team credentialed in assessing emergent situations in trauma patients and providing any indicated treatment if operative services are provided.(8) All nurses caring for trauma patients throughout the continuum of care must have ongoing documented knowledge and skill in trauma nursing for patients of all ages to include trauma specific orientation, annual clinical competencies, and continuing education.(9) Written guidelines for nursing care of trauma patients for all units (i.e., ED, ICU, OR, PACU, medical/surgical units) in the facility must be implemented.(10) The facility must have a written plan, developed by the facility, for acquisition of additional staff on a 24-hour basis to support units with increased patient acuity, multiple emergency procedures, and admissions (i.e., written disaster plan.)(11) The facility must have emergency services available 24-hours a day.(A) Physician on-call schedule must be published.(B) Physicians with special competence in the care of critically injured patients, designated as members of the trauma team and on-call (if not in-house 24/7) must be promptly available within 30 minutes of request from inside or outside the facility. Neither a facility's telemedicine medical service capabilities nor the physical presence of APPs satisfy this requirement with the exception of the following: (i) A health care facility located in a county with a population of less than 30,000 may satisfy a Level IV trauma facility designation requirement relating to physicians through the use of telemedicine medical service in which an on-call physician who has special competence in the care of critically injured patients provides patient assessment, diagnosis, consultation, or treatment, or transfers medical data to a physician, advanced practice registered nurse, or physician assistants located at the facility; and(ii) APPs and telemedicine-support physicians who participate in the care of major, severe, or critical trauma patients must be credentialed by the facility to participate in the resuscitation and treatment of trauma patients, to include requirements such as current board-certification or board-eligibility in surgery or emergency medicine, nine hours of trauma-related continuing medical education per year, compliance with trauma management guidelines, and participation in the trauma PIPS program.(C) The ED physician must be activated on EMS communication with the ED or after a primary assessment of patients who arrive to the ED by private vehicle for the highest level of trauma activation and must respond within 30 minutes from notification. This must be continuously monitored in the trauma PIPS program.(D) A minimum of one and preferably two registered nurses who have trauma nursing training must participate in initial resuscitation of the highest level of trauma activations.(E) All registered nursing staff responding to the highest levels of trauma activations must have successfully completed and hold current credentials in an advanced cardiac life support course (e.g., ACLS or an equivalent department-approved course ), a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC), and TNCC or ATCN or an equivalent department-approved course.(F) 100 percent of nursing staff must have successfully completed and hold current credentials in an advanced cardiac life support course (e.g., ACLS or an equivalent department-approved course ), a nationally recognized pediatric advanced life support course (e.g., PALS or ENPC), and TNCC or ATCN or an equivalent department-approved course, within 18 months of date of employment in the ED.(G) Nursing documentation for trauma activation patients must be systematic and meet the trauma primary and secondary assessment guidelines.(H) Two-way communication with all pre-hospital emergency medical services vehicles must be available.(I) Equipment and services for the evaluation and resuscitation of, and to provide life support for, critically or seriously injured patients of all ages must include:(i) airway control and ventilation equipment including laryngoscope and endotracheal tubes of all sizes, BVMs, pocket masks, advanced airway management devices, and oxygen;(ii) mechanical ventilator;(iii) pulse oximetry and capnography;(v) electrocardiograph, oscilloscope, and defibrillator;(vi) all standard intravenous fluids and administration devices, including large-bore intravenous catheters and a rapid infuser system;(vii) sterile surgical sets for procedures standard for the ED such as thoracostomy, central line insertion, thoracotomy if surgeons participate in trauma care, airway control/cricothyrotomy, etc.;(viii) drugs and supplies necessary for emergency care;(ix) cervical spine stabilization device;(x) length-based body weight & tracheal tube size evaluation system (e.g., a current Broselow tape) and resuscitation medications and equipment that are dose-appropriate for all ages;(xi) long bone stabilization device;(xii) pelvic stabilization device;(xiii) thermal control equipment for patients and a rapid warming device for blood and fluids; and(xiv) non-invasive continuous blood pressure monitoring devices.(12) Clinical laboratory services must be available 24-hours per day and provide the following. (A) Call-back process for trauma activations available within 30 minutes. This must be continuously monitored in the trauma PIPS program.(B) Standard analyses of blood, urine, and other body fluids, including microsampling.(C) Blood-typing and cross-matching with a minimum of two units of universal packed red blood cells (PRBCs) immediately available.(D) Capability for immediate release of blood for a transfusion and measures to obtain additional blood supply.(F) Blood gases and pH determinations.(G) Drug and alcohol screening.(13) Imaging capabilities must be available 24-hours per day. Call-back process for trauma activations must be available within 30 minutes. This must be continuously monitored in the trauma PIPS program.(14) The trauma program must have a defined trauma PIPS plan approved by the TMD, TPM, and the trauma multidisciplinary committee. (A) On initial designation, a facility must have completed at least six months of reviews on all qualifying trauma records with evidence of "loop closure" on identified variances. Compliance with internal trauma management guidelines must be evident.(B) On re-designation, a facility must show continuous PIPS activities throughout its designation and a rolling current three-year period must be available for review at all times.(C) Minimum PIPS inclusion criteria includes: all trauma team activations (including those discharged from the ED); all trauma deaths; all identified facility events; transfers-in and transfers-out; and readmissions within 48-hours after discharge.(D) The trauma PIPS program must be organized and include a pediatric-specific component with trauma audit filters. (i) Review of trauma medical records for appropriateness and quality of care.(ii) Documented evidence of identification of all variances from trauma management guidelines and system response guidelines, with in-depth critical review.(iii) Documentation of corrective actions implemented to address all identified variances with tracking of data analysis.(iv) Documented evidence of secondary level of review and participation by the TMD.(v) Morbidity and mortality review including decisions by the TMD as to whether the trauma management guidelines were followed.(vi) Documented resolutions "loop closure" of all identified issues to prevent future recurrences.(vii) Specific reviews of all trauma deaths and other specified cases, including complications, utilizing age-specific criteria.(viii) Multidisciplinary facility trauma PIPS committee structure must be in place and include department communication, data review, and measures for problem solving.(E) Feedback regarding trauma patient transfers-out must be obtained from receiving facilities.(F) Facility must maintain a trauma registry or utilize the State Trauma Registry for data entry of patients meeting NTDB registry inclusion criteria. Trauma registry data must be submitted to the State Trauma Registry on at least a quarterly basis.(G) Participation with the RAC's PI program, including adherence to regional guidelines, submitting data preapproved by the membership to the RAC such as summaries of transfer delays and transfers to facilities outside of the RAC.(H) Times and reasons for diversion must be documented and reviewed by the trauma PIPS program and multidisciplinary committee.(15) The trauma program must participate in the regional trauma system per RAC requirements.(16) The trauma program must have processes in place to expedite the transfer of major, severe, or critical trauma patients to include written management guidelines, written transfer agreements, and participation in a regional trauma system transfer plan for patients needing higher level of care or specialty services.(17) The facility must have a system in place for establishing an appropriate landing zone in close proximity to the facility (if rotor-wing services are available).(18) Facility may participate in a RAC injury prevention program.(19) Formal programs in trauma continuing education must be provided by the facility or in collaboration with the RAC or their health care system based on needs identified from the trauma PIPS program for: (C) allied health personnel, including APPs.25 Tex. Admin. Code § 157.125
The provisions of this §157.125 adopted to be effective December 26, 2006, 31 TexReg 10300; Amended by Texas Register, Volume 44, Number 48, November 29, 2019, TexReg 7397, eff. 12/5/2019; Amended by Texas Register, Volume 49, Number 46, November 15, 2024, TexReg 9255, eff. 11/24/2024