PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 97. COMMUNICABLE DISEASES
SUBCHAPTER A. CONTROL OF COMMUNICABLE DISEASES
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts amendments to §97.3, concerning What Condition to Report and What Isolates to Report or Submit; §97.4, concerning When and How to Report a Condition or Isolate; and §97.6, concerning Reporting and Other Duties of Local Health Authorities and Regional Directors. The amendments to §§97.3, 97.4, and 97.6 are adopted without changes to the proposed text as published in the August 9, 2024, issue of the Texas Register (49 TexReg 5907), and therefore will not be republished.
BACKGROUND AND JUSTIFICATION
The amendments are necessary to comply with Texas Health and Safety Code Chapter 81, amended by Senate Bill 969, 87th Regular Session, 2021, and update the list of notifiable conditions in Texas.
The amendment to §97.3 adds melioidosis and Cronobacter spp. in infants as notifiable conditions in Texas.
The amendments to §97.4 and to §97.6 implement the revisions to Texas Health and Safety Code Chapter 81 by updating the acceptable methods of reporting notifiable conditions to electronic data transmission, telephone, or fax. Notifiable conditions reported by telephone must be followed-up with an electronic data transmission through an approved electronic means within 24 hours of the original notification. The amendments improve the ability of public health entities to plan and implement response and mitigation measures, enhance public surveillance and timely reporting, and increase the availability of public health data in Texas.
COMMENTS
The 31-day comment period ended Monday, September 9, 2024.
During this period, DSHS did not receive any comments regarding the proposed rules.
STATUTORY AUTHORITY
The amendments are adopted under Texas Government Code §531.0055, and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules for the operation and provision of services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001; and Texas Health and Safety Code Chapter 81 (Communicable Disease Prevention and Control Act), which authorizes the Executive Commissioner to identify reportable diseases and prescribe the form and method for reporting.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on October 31, 2024.
TRD-202405214
Cynthia Hernandez
General Counsel
Department of State Health Services
Effective date: January 1, 2025
Proposal publication date: August 9, 2024
For further information, please call: (512) 776-7676
The Texas Health and Human Services Commission (HHSC) adopts the repeal of §133.101, concerning Inspection and Investigation Procedures; and §133.102, concerning Complaint Against Department of State Health Services Surveyor; new §§133.101, concerning Integrity of Inspections and Investigations; 133.102, concerning Inspections; 133.103, concerning Complaint Investigations; 133.104, concerning Notice; 133.105, concerning Professional Conduct; and 133.106, concerning Complaint Against an HHSC Representative; and amendments to §133.47, concerning Abuse and Neglect Issues; and §133.121, concerning Enforcement.
The repeal of §133.101 and §133.102, and new §§133.104, 133.105, and 133.106 are adopted without changes to the proposed text as published in the May 10, 2024, issue of the Texas Register (49 TexReg 3106). These rules will not be republished.
New §§133.101, 133.102, and 133.103 and amended §133.47 and §133.121 are adopted with changes to the proposed text as published in the May 10, 2024, issue of the Texas Register (49 TexReg 3106). These rules will be republished.
BACKGROUND AND JUSTIFICATION
The adoption is necessary to implement House Bill (H.B.) 49, 88th Legislature, Regular Session, 2023. H.B. 49 amended Texas Health and Safety Code (HSC) §241.051 to make certain information related to hospital investigations subject to disclosure and create a requirement for HHSC to post certain information related to hospital investigations on the HHSC website.
The adoption is also necessary to update the inspection, complaint investigation, and enforcement procedures for general and special hospitals. These updates are necessary to hold hospitals accountable during the inspection and investigation processes and ensure hospitals provide necessary documentation in a timely manner to HHSC representatives. The adopted rules revise enforcement procedures to ensure conformity with current practices and statutes. These updates also ensure consistent practices across HHSC Health Care Regulation, correct outdated language and contact information, and reflect the transition of regulatory authority for hospitals from the Department of State Health Services (DSHS) to HHSC.
COMMENTS
The 31-day comment period ended June 10, 2024.
During this period, HHSC received comments regarding the proposed rules from four commenters, including Citizens Commission on Human Rights (CCHR), Disability Rights Texas (DRTx), Texas Hospital Association (THA), and Texas Medical Association (TMA). A summary of comments relating to the rules and HHSC's responses follows.
Comment: THA expressed appreciation for HHSC considering comments from the previous public comment period and incorporating some of the feedback THA and other stakeholders provided.
Response: HHSC acknowledges this comment.
Comment: CCHR recommended including 911 and the contact information for the federally mandated protection and advocacy system to the posting required by §133.47(c)(2) to eliminate the need for multiple postings. DRTx recommended the posting required by §133.47(c)(2) include the contact information for the federally mandated protection and advocacy system.
Response: HHSC declines to revise §133.47(c)(2) because this paragraph is specific to reporting allegations under HSC §161.132. HHSC notes this paragraph does not preclude a hospital from combining the signage with other required postings.
Comment: CCHR, DRTx, TMA commented on the timeframe requirements in §133.47(c)(3)(A) and §133.47(c)(3)(B).
Regarding §133.47(c)(3)(A), CCHR stated abuse and neglect allegations should be reported immediately because these allegations are criminal matters and time is of the essence. They also stated that in a busy hospital, it may be difficult to preserve a crime scene for an extended amount of time and patient safety and evidence collection and preservation should be top priorities.
Regarding §133.47(c)(3)(A), DRTx stated time is of the essence when reporting allegations of abuse or neglect and the ability to gather sufficient evidence is lessened as time passes. DRTx also stated that the report is the trigger to initiate protective actions for the alleged victim and secure the evidence and recommended that the timeframe for reporting be as soon as possible, but no later than one hour.
Regarding §133.47(c)(3)(B), CCHR recommended a 24-hour deadline for reporting illegal, unprofessional, or unethical conduct.
Regarding §133.47(c)(3)(B), DRTx expressed concern with the 48-hour deadline because the sooner a report is made, the sooner actions to protect the alleged victim and evidence collection can occur. DRTx recommended the report be made as soon as possible, but no later than 24 hours.
TMA stated the proposed amendments to §133.47(c)(3)(A) and (B) go beyond the scope of the summary of the proposed amendments HHSC listed for this section in the proposal preamble because they are substantive changes. TMA expressed concern about the time limits for reporting abuse, neglect, and exploitation and illegal, unprofessional, or unethical conduct because these timeframes may not always be possible or practical. TMA further stated these timeframes may discourage physicians and providers from even looking for signs of abuse, neglect, and exploitation and illegal, unprofessional, or unethical conduct because they may fear being held responsible for reporting under these timeframes or encourage overreporting. TMA recommended against HHSC adopting the proposed timeframes or any finite reporting limits and recommended HHSC revert to the "as soon as possible" language stated in HSC §161.132.
Response: HHSC revised §133.47(c)(3)(A) and (B) to remove the 24-hour and 48-hour timeframes. Hospitals must report allegations under these subparagraphs as soon as possible in accordance with HSC §161.132.
Comment: CCHR stated trainings under §133.47(c)(4) should be competency based and a trainee should be able to demonstrate understanding and competence in applying the material.
DRTx recommended trainings under §133.47(c)(4) be competency based. DRTx stated there should be physical evidence at the end of the training that the trainee understood and retained the information provided and the training should have a test to protect the trainer, the facility, and individuals receiving services. Further, DRTx recommended staff being allowed to take a test instead of re-taking the required 8-hour training if there are no recorded concerns about infractions over the past year.
Response: HHSC declines to revise §133.47(c)(4) because HSC §161.133(a) requires the facility to provide a minimum of 8-hours of annual in-service training to staff in identifying patient abuse or neglect and illegal, unprofessional, or unethical conduct by or in the facility.
Comment: CCHR and DRTx recommended that in §133.47(f)(1)(A) and (B), the reporter, alleged victim, and the alleged victim's LAR, if the alleged victim has an LAR, should be informed of any appeal process and the timeframe for submitting an appeal.
Response: HHSC declines to revise §133.47(f)(1)(A) and (B) because investigations under §133.47(b) do not provide an appeal process for a complainant or an alleged violator.
Comment: CCHR stated the complainant should be informed of any appeal timelines and procedures and opportunities to contact an ombudsman under §133.47(f)(2).
DRTx recommended a complainant should receive information about any appeal process and timeframes to submit an appeal request under §133.47(f)(2).
Response: HHSC declines to revise §133.47(f)(2) because investigations under §133.47(c) do not provide an appeal process for a complainant or an alleged violator.
Comment: DRTx recommended HHSC add language to §133.47(g)(4) to require HHSC to inform the complainant, in a timely manner, if HHSC decides not to investigate and of the final disposition of the allegation, including any referrals HHSC made.
Response: HHSC declines to revise §133.47(g)(4) because a complainant notification process is already included under 25 TAC §133.47(f).
Comment: THA stated there was a possible grammatical error or missing words in §133.101(a)(2) and suggested the paragraph instead state, "may not record, listen to, or eavesdrop on any HHSC internal discussions outside the presence of facility staff when HHSC has requested a private room or office or distanced themselves from facility staff unless it first informs HHSC and the facility obtains HHSC's written approval before beginning to record or listen to the discussion."
Response: HHSC revised §133.101(a)(2) by adding "unless the hospital first informs HHSC" to clarify that a hospital must first inform HHSC and then obtain HHSC's written approval before beginning to record or listen to an internal HHSC discussion.
Comment: THA requested HHSC revise §133.101(b) to clarify that a hospital must only inform HHSC of audio-capturing recording devices that are not readily visible. THA stated security cameras are present in many locations in hospitals, particularly hallways and common areas, and that it is possible cameras may be present while HHSC staff are having discussions. THA noted cameras in common areas would be visible to anyone and likely do not capture audio and should not require disclosure by the hospital.
Response: HHSC declines to revise §133.101(b) because HHSC staff need enhanced privacy for internal discussion and this paragraph is necessary to protect HHSC staff from intentional or unintentional eavesdropping.
Comment: THA expressed concern about §133.102(f) and §133.103(h), which require a hospital to permit HHSC access to interview members of a hospital's governing body, personnel, and patients, including the opportunity to request written statements. THA stated members of hospital governing bodies are often community members not involved in the hospital's daily operations and subjecting them to interviews may deter community involvement in hospital boards. THA further stated that requesting written statements from personnel and governing body members could lead to disputes and potential enforcement actions if statements are not provided or deemed unsatisfactory. THA requested HHSC remove the provisions allowing interviews with governing body members and the requirement for written statements to avoid potential adversarial situations if a hospital declines HHSC's request.
Response: HHSC declines to revise §133.102(f) and §133.103(h) because it is important for HHSC staff to have the opportunity to talk to and request statements from relevant individuals, including, at times, members of a hospital's governing body. HHSC notes these subsections do not require a written statement and only allows HHSC the opportunity to request one.
Comment: THA questioned whether HHSC disclosing information to law enforcement agencies as allowed by §133.102(k)(4) and §133.103(m)(4) is appropriate or legally permissible. However, THA noted the statutory language supported this exception. THA stated that the Health Insurance Portability and Accountability Act (HIPAA) provides limited exceptions for disclosures to law enforcement, typically requiring specific legal processes like search warrants or subpoenas. THA further stated that the proposed rule may not comply with HIPAA and HSC §181.004. THA requested HHSC remove §133.102(k)(4) and §133.103(m)(4) because THA does not believe it is appropriate for HHSC to have rules specifically permitting the disclosure of confidential information to a law enforcement agency. Alternatively, THA requested HHSC revise §133.102(k)(4) and §133.103(m)(4) to state "law enforcement agencies as otherwise authorized or required by law."
Response: HHSC revised §133.102(k)(4) and §133.103(m)(4) to add "as allowed by law" to the end of the paragraphs.
Comment: CCHR expressed support for the inclusion of language added by H.B. 49, 88th Regular Session, 2023 at §133.102(l) and §133.103(n). H.B. 49 amended Texas Health and Safety Code (HSC) §241.051 to make certain information related to hospital investigations subject to disclosure and create a requirement for HHSC to post certain information related to hospital investigations on the HHSC website.
Response: HHSC acknowledges this comment.
Comment: TMA stated that §133.102(l) and §133.103(n) tracked the governing statute except for §133.102(l)(6) and §133.103(n)(6). TMA further stated Texas Government Code Chapter 552 generally gives the public the right to access government information on request, so §133.102(l)(6) and §133.103(n)(6) would make all inspection and investigation information, other than certain personally identifying information, subject to public disclosure, which conflicts with HSC §241.051(e). TMA recommended that §133.102(l)(6) and §133.103(n)(6) be removed to properly align with HSC §241.051(e).
Response: HHSC declines to remove §133.102(l)(6) and §133.103(n)(6) as recommended because these paragraphs state that HHSC will follow the requirements of public information laws, which prohibit disclosure of information made confidential by other laws, such as HSC §241.051. These paragraphs do not authorize disclosure of any information contrary to those laws.
Comment: THA expressed concern with the posting requirements at §133.103(a)(2) because the requirements will take time for hospitals to implement and there is a possible conflict with an existing rule at 25 TAC §1.191, which also mandates signage to notify patients where they can file complaints. THA requested HHSC withdraw §133.103(a)(2), review the rule at 25 TAC §1.191 alongside proposed §133.103(a)(2), and propose a unified rule that avoids duplicative or conflicting signage mandates. Alternatively, THA proposed an extended implementation period of at least 12 months for hospitals to comply with the signage requirements and for HHSC to provide guidance on how to reconcile the two rules.
Response: HHSC declines to remove §133.103(a)(2) because HHSC does not enforce 25 TAC §1.191 regarding hospitals. Section 133.103(a)(2) applies to hospitals regulated by HHSC, and 25 TAC §1.191 applies to facilities regulated by DSHS.
Comment: CCHR stated it hoped complaints regarding abuse, neglect, or exploitation, including verbal, physical, and sexual abuse, are given top priority under §133.103(c).
Response: HHSC acknowledges this comment.
Comment: DRTx commented on §133.103(c) and stated the current prioritization system relates to regulatory allegations but should not be used for abuse, neglect, and exploitation allegations. DRTx stated prioritizing one type of allegation over another results in some allegations being routinely delayed, such as verbal abuse or neglect allegations. DRTx recommended prioritizing investigations based on the likelihood of preserving evidence that could be used in making a final determination of the allegation. DRTx proposed that if an allegation is new (as in those reported within 24 hours), the allegation should receive top priority, regardless of the specific type of allegation. DRTx further stated if an allegation was reported several days after the event, the investigation should begin within 48 hours. DRTX stated if an allegation was reported a week or more after the event, delaying the investigation is justified because of the likelihood that the evidence has been contaminated or lost.
Response: HHSC declines to revise §133.103(c) because HHSC complaint prioritization and investigation initiation and completion timeframes are internal HHSC policy. HHSC notes that it investigates allegations of abuse, neglect, or exploitation involving individuals with disabilities, children, or elderly individuals in accordance with the investigation rules at 25 TAC Chapter 1, Subchapter Q and HHSC policies; investigates other abuse, neglect, and exploitation allegations in accordance with 25 TAC §133.47; and reports possible criminal acts to the appropriate law enforcement authorities in accordance with state law and HHSC policies. HHSC notes the HHSC Complaint & Incident Intake webpage contains information about the complaint intake process.
Comment: CCHR stated it assumed that §133.103(d) applies to a concurrent regulatory investigation after an allegation of abuse, neglect, or exploitation. CCHR noted Texas's unique statutory framework and stated that while coordination with the Centers for Medicare & Medicaid Services (CMS) may be desirable in certain cases, HHSC has the duty and funding to uphold laws, regardless of CMS involvement or funding. CCHR cited the HSC regarding electroconvulsive therapy (ECT) as an example and noted that CMS regulations on ECT do not fully align with Texas statutes. CCHR stated that despite state law and CMS regulations not fully aligning, HHSC must investigate violations of Texas law independent of CMS because of the potential for harm.
Response: HHSC declines to revise §133.103(d) because this subsection allows for coordination with CMS in accordance with HSC §222.026(a)(2), but §133.103(d) does not preclude HHSC from conducting investigations independent of CMS or from meeting the agency's responsibilities for conducting investigations as described in Chapter 133 and HHSC internal policies.
Comment: DRTx recommended HHSC revise §133.103(d) by adding language regarding HHSC's duty to complete regulatory investigations regardless of CMS authorization. DRTx stated that HHSC and other state agencies have the authority and receive state funding to complete their responsibilities for facility investigations and regulatory oversight. DRTx further stated it is the responsibility of the state regulatory agency to protect Texas's vulnerable citizens, and HHSC should investigate allegations meeting the definitions of abuse and neglect in Texas law, even if CMS does not authorize an investigation. DRTx expressed concern with HHSC referring investigations of complaints involving psychiatric facilities that HHSC chose not to investigate to the Joint Commission. DRTx stated the Joint Commission is an accrediting body and does not perform investigations of abuse or neglect consistent with Texas regulations. DRTX also stated CMS does not provide any information about any investigation, review, or action on such referrals. DRTx stated such referrals result in the allegations not being addressed by any investigatory entity.
Response: HHSC declines to revise §133.103(d) because this subsection allows for coordination with CMS in accordance with HSC §222.026(a)(2), but §133.103(d) does not preclude HHSC from conducting investigations independent of CMS or from meeting the agency's responsibilities for conducting investigations as described in 25 TAC Chapter 1, Subchapter Q, Chapter 133, and HHSC internal policies.
Comment: THA requested HHSC extend the timeframe for hospitals to submit a plan of correction (POC) under §133.104(b)(2) because THA stated the proposed 10 calendar day timeframe was too compressed to develop an extensive POC and implementation plan. THA suggested language that would lengthen the timeframe to 30 calendar days for deficiencies that did not affect patient health and safety and language to allow flexibility for HHSC to require a shorter timeframe, but no earlier than 10 calendar days, for more urgent issues affecting or potentially affecting patient health and safety.
Response: HHSC declines to revise §133.104(b)(2) because 10 calendar days after receipt of a statement of deficiencies (SOD) is sufficient time to provide HHSC with a POC. HHSC notes a hospital is made aware of the issues HHSC found and the potential citations at the exit conference so the hospital can begin working on correcting any issues even before receipt of the SOD.
Comment: TMA stated §133.105 appears to impose reporting mandates on HHSC. TMA stated not every issue relating to the conduct of a licensed professional, intern, or application for professional licensure will necessarily warrant reporting to the licensing board. TMA recommended replacing "reports" with "may report" in §133.105 to allow HHSC to exercise discretion in its reporting.
Response: HHSC declines to revise §133.105 because the agency prefers to err on the side of caution regarding conduct of licensed professionals. HHSC notes licensing boards have discretion in responding to any complaint.
Comment: THA expressed concern with §133.106 not including the details related to HHSC's internal procedures regarding complaints against an HHSC representative, currently found at §133.102. THA stated it is important for facilities to understand how HHSC handles complaints against surveyors or investigators, including clear expectations for HHSC's response timeframe. THA requested HHSC include procedural details in the final rule to ensure transparency and provide facilities with an opportunity to provide input. Additionally, THA suggested the rule include clear anti-retaliation language to protect hospitals or individuals filing complaints, and proposed language prohibiting retaliation by HHSC or HHSC representatives against hospitals or persons filing a complaint against an HHSC representative.
Response: HHSC declines to revise §133.106 as requested because the agency addresses complaints against HHSC representatives in accordance with its policies, which include requiring staff to perform their duties in a lawful, professional, and ethical manner.
Comment: THA expressed concern with §133.121(1)(P) and stated participation in Medicare is voluntary and should not be a criterion for licensing decisions or penalties. THA requested HHSC remove this paragraph because THA stated a hospital terminating the hospital's Medicare provider agreement should not jeopardize the hospital's licensure status or result in penalties.
Response: HHSC revised §133.121(1)(P) to clarify this subparagraph applies if CMS terminates the hospital's Medicare provider agreement.
Comment: THA expressed concern with §133.121(2)(B)(ii) because THA stated the category is overly broad and that it is not uncommon for providers to make unintentional billing errors that result in Medicare sanctions, and in those cases the provider repays any amounts owed and associated penalties and is free to continue participating in the Medicare program. Further, THA stated other regulatory infractions of Medicare Conditions of Participation may result in citations and sanctions and penalties that are inconsequential and do not justify denying a hospital license.
Response: HHSC declines to revise §133.121(2)(B)(ii) because HHSC has jurisdiction to enforce violations if the facility discloses actions that could result in HHSC denying a license application or suspending or revoking a facility's license.
Comment: THA requested HHSC revise §133.121(2)(B)(iii) to state "federal or state tax liens that are unsatisfied after all avenues of dispute have been exhausted" because THA stated the category is overly broad and stated that the hospital may not have had the opportunity to dispute a lien and HHSC could deny the hospital's license for an unresolved lien for which a dispute is pending.
Response: HHSC declines to revise §133.121(2)(B)(iii) because unsatisfied federal or state tax liens could indicate that an applicant or licensee cannot meet their financial obligations, which may create health and safety concerns.
Comment: THA requested HHSC remove or revise §133.121(2)(B)(iv) because THA stated this clause is overly broad because there is no threshold amount in controversy, it does not account for audit exceptions that are still being disputed, civil judgments may be taken for many reasons that would have no bearing on the fitness to operate a hospital, and final judgments could still be on appeal and therefore be technically unsatisfied. Alternatively, THA requested HHSC revise this clause to specify the specific types of judgments that could result in denial and account for final judgments that may be on appeal and suggested for the rule to state "federal Medicare or state Medicaid audit exceptions that are unresolved after all avenues of dispute are exhausted."
Response: HHSC declines to remove or revise §133.121(2)(B)(iv) because this clause provides HHSC regulatory oversight and could also indicate that an applicant or licensee cannot meet their financial obligations, which may create health and safety concerns.
Comment: THA requested HHSC revise §133.121(2)(B)(vi) to state "federal Medicare or state Medicaid audit exceptions that are unresolved after all avenues of dispute are exhausted." THA stated this clause is overly broad because there is no threshold amount in controversy, and it does not account for audit exceptions that are still being disputed.
Response: HHSC declines to revise §133.121(2)(B)(vi) because HHSC has jurisdiction to enforce violations if the facility discloses actions that could result in HHSC denying a license application or suspending or revoking a facility's license.
Comment: Regarding §133.121(4), CCHR stated a 30-day probation period in lieu of license denial, suspension, or revocation is not a sufficient deterrent to prevent future behavior that may warrant license denial, suspension, or revocation.
Response: HHSC declines to revise §133.121(4) because the language in this paragraph is consistent with HSC §241.053(f). In addition, HSC §241.053(g) provides for HHSC to suspend or revoke the license of a hospital that does not correct items that were in noncompliance or that does not comply with the applicable requirements within the applicable probation period.
HHSC made an editorial change to §133.47(b)(1) to add an end parenthesis after a rule title.
HHSC made an editorial change to §133.47(d) to change the colon to a period to ensure consistency with rule drafting guidelines.
HHSC revised §133.101(a)(1) to connect paragraphs (1) and (2) with "or" instead of "and." HHSC made this change to ensure consistency with the freestanding emergency medical care facility rule at 26 TAC §509.81(a) and the limited services hospital rule at 26 TAC §511.111(a).
HHSC revised §133.102(e) by adding "video surveillance" to the list of items a hospital must permit HHSC to examine during any HHSC inspection. This change is made so that the list in §133.102(e) is consistent with §133.103(g), other HHSC rules in this rule project, and the list in 26 TAC §511.112(e) for a limited services rural hospital.
HHSC revised §133.102(l)(6) and §133.103(n)(6) to remove the word "request" because the laws are about public information laws and not public information request laws.
HHSC revised §133.103 to add new subsection (p), which states HHSC will notify a complainant within 10 business days after completing the investigation of the investigation's outcome.
SUBCHAPTER C. OPERATIONAL REQUIREMENTS
STATUTORY AUTHORITY
The amendment is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and Texas Health and Safety Code §241.026, which requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of licensed hospitals.
§133.47.Abuse and Neglect Issues.
(a) Reporting. Incidents of abuse, neglect, exploitation, or illegal, unethical or unprofessional conduct as those terms are defined in subsections (b) and (c) of this section shall be reported to the Texas Health and Human Services Commission (HHSC) as provided in subsections (b) and (c)(3) of this section.
(b) Abuse or neglect of a child, and abuse, neglect, or exploitation of an elderly or disabled person. The following definitions apply only to this subsection.
(1) Abuse or neglect of a child, as defined in §1.204(a) and (b) of this title (relating to Abuse, Neglect, or Exploitation Defined).
(2) Abuse, neglect, or exploitation of an elderly or disabled person, as defined in §1.204(a) - (c) of this title.
(c) Abuse and neglect of individuals with mental illness, and illegal, unethical, and unprofessional conduct. The requirements of this subsection are in addition to the requirements of subsection (b) of this section.
(1) Definitions. The following definitions are in accordance with Texas Health and Safety Code (HSC) §161.131 and apply only to this subsection.
(A) Abuse--
(i) Abuse (as the term is defined in United States Code Title 42 (42 USC) Chapter 114 (relating to Protection and Advocacy for Individuals with Mental Illness) is any act or failure to act by an employee of a facility rendering care or treatment which was performed, or which was failed to be performed, knowingly, recklessly, or intentionally, and which caused, or may have caused, injury or death to an individual with mental illness, and includes acts such as:
(I) the rape or sexual assault of an individual with mental illness;
(II) the striking of an individual with mental illness;
(III) the use of excessive force when placing an individual with mental illness in bodily restraints; and
(IV) the use of bodily or chemical restraints on an individual with mental illness which is not in compliance with federal and state laws and regulations.
(ii) In accordance with HSC §161.132(j), abuse also includes coercive or restrictive actions that are illegal or not justified by the patient's condition and that are in response to the patient's request for discharge or refusal of medication, therapy or treatment.
(B) Illegal conduct--Illegal conduct (as the term is defined in HSC §161.131(4)) is conduct prohibited by law.
(C) Neglect--Neglect (as the term is defined in 42 USC §10801 et seq.) is a negligent act or omission by any individual responsible for providing services in a facility rendering care or treatment which caused or may have caused injury or death to an individual with mental illness or which placed an individual with mental illness at risk of injury or death, and includes an act or omission such as the failure to establish or carry out an appropriate individual program plan or treatment plan for an individual with mental illness, the failure to provide adequate nutrition, clothing, or health care to an individual with mental illness, or the failure to provide a safe environment for an individual with mental illness, including the failure to maintain adequate numbers of appropriately trained staff.
(D) Unethical conduct--Unethical conduct (as the term is defined in HSC §161.131(11)) is conduct prohibited by the ethical standards adopted by state or national professional organizations for their respective professions or by rules established by the state licensing agency for the respective profession.
(E) Unprofessional conduct--Unprofessional conduct (as the term is defined in HSC §161.131(12)) is conduct prohibited under rules adopted by the state licensing agency for the respective profession.
(2) Posting requirements. A hospital shall prominently and conspicuously post for display in a public area that is readily visible to patients, residents, volunteers, employees, and visitors a statement of the duty to report abuse and neglect, or illegal, unethical, or unprofessional conduct in accordance with HSC §161.132(e). The statement shall be in English and in a second language appropriate to the demographic makeup of the community served and contain the current toll-free telephone number for submitting a complaint to HHSC as specified on the HHSC website.
(3) Reporting responsibility.
(A) Reporting abuse and neglect. A person, including an employee, volunteer, or other person associated with the hospital who reasonably believes or who knows of information that would reasonably cause a person to believe that the physical or mental health or welfare of a patient of the hospital who is receiving mental health or chemical dependency services has been, is, or will be adversely affected by abuse or neglect (as those terms are defined in this subsection) by any person shall as soon as possible report the information supporting the belief to HHSC or to the appropriate state health care regulatory agency in accordance with HSC §161.132(a).
(B) Reporting illegal, unprofessional, or unethical conduct. An employee of or other person associated with a hospital, including a health care professional, who reasonably believes or who knows of information that would reasonably cause a person to believe that the hospital or an employee or health care professional associated with the hospital, has, is, or will be engaged in conduct that is or might be illegal, unprofessional, or unethical and that relates to the operation of the hospital or mental health or chemical dependency services provided in the hospital shall as soon as possible report the information supporting the belief to HHSC or to the appropriate state health care regulatory agency in accordance with HSC §161.132(b).
(4) Training requirements. A hospital that provides comprehensive medical rehabilitation, mental health, or substance use services shall annually provide as a condition of continued licensure a minimum of eight hours of in-service training designed to assist employees and health care professionals associated with the hospital in identifying patient abuse or neglect and illegal, unprofessional, or unethical conduct by or in the hospital and establish a means for monitoring compliance with the requirement.
(d) Investigations. A complaint under this subsection will be investigated or referred by HHSC as follows.
(1) Allegations under subsection (b) of this section will be investigated in accordance with §1.205 of this title (relating to Reports and Investigations) and §1.206 of this title (relating to Completion of Investigation).
(2) Allegations under subsection (c) of this section will be investigated in accordance with §133.103 of this chapter (relating to Complaint Investigations). Allegations concerning a health care professional's failure to report abuse and neglect or illegal, unprofessional, or unethical conduct will not be investigated by HHSC but will be referred to the individual's licensing board for appropriate disciplinary action.
(3) Allegations under both subsections (b) and (c) will be investigated in accordance with §1.205 and §1.206 of this title except as noted in paragraph (2) of this subsection concerning a health care professional's failure to report.
(e) Submission of complaints. A complaint made under this section may be submitted in writing or verbally to HHSC.
(f) Notification.
(1) For complaints under subsection (b) of this section, HHSC shall provide notification according to the following.
(A) HHSC shall notify the reporter, if known, in writing of the outcome of the completed investigation.
(B) HHSC shall notify the alleged victim, and the alleged victim's parent or guardian if a minor, in writing of the outcome of the completed investigation.
(2) For complaints under subsection (c) of this section, HHSC informs, in writing, the complainant who identifies themselves by name and address of the following:
(A) the receipt of the complaint;
(B) if the complainant's allegations are potential violations of this chapter warranting an investigation;
(C) whether the complaint will be investigated by HHSC;
(D) whether and to whom the complaint will be referred; and
(E) the findings of the complaint investigation.
(g) HHSC reporting and referral.
(1) Reporting health care professional to licensing board.
(A) In cases of abuse, neglect, or exploitation, as those terms are defined in subsection (b) of this section, by a licensed, certified, or registered health care professional, HHSC may forward a copy of the completed investigative report to the state agency that licenses, certifies, or registers the health care professional. Any information which might reveal the identity of the reporter or any other patients of the hospital must be blacked out or deidentified.
(B) A health care professional who fails to report abuse and neglect or illegal, unprofessional, or unethical conduct as required by subsection (c)(3) of this section may be referred by HHSC to the individual's licensing board for appropriate disciplinary action.
(2) Sexual exploitation reporting requirements. In addition to the reporting requirements described in subsection (c)(3) of this section, a mental health services provider must report suspected sexual exploitation in accordance with Texas Civil Practice and Remedies Code §81.006.
(3) Referral follow-up. HHSC shall request a report from each referral agency of the action taken by the agency six months after the referral.
(4) Referral of complaints. A complaint containing allegations which are not a violation of HSC Chapter 241 or this chapter will not be investigated by HHSC but shall be referred to law enforcement agencies or other agencies, as appropriate.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 1, 2024.
TRD-202405245
Karen Ray
Chief Counsel
Department of State Health Services
Effective date: November 21, 2024
Proposal publication date: May 10, 2024
For further information, please call: (512) 834-4591
STATUTORY AUTHORITY
The repeals are adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and Texas Health and Safety Code §241.026, which requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of licensed hospitals.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 1, 2024.
TRD-202405246
Karen Ray
Chief Counsel
Department of State Health Services
Effective date: November 21, 2024
Proposal publication date: May 10, 2024
For further information, please call: (512) 834-4591
STATUTORY AUTHORITY
The new sections are adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and Texas Health and Safety Code §241.026, which requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of licensed hospitals.
§133.101.Integrity of Inspections and Investigations.
(a) In order to preserve the integrity of the Texas Health and Human Services Commission's (HHSC's) inspection and investigation process, a hospital:
(1) may not record, listen to, or eavesdrop on any HHSC interview with hospital staff or patients that the hospital staff knows HHSC intends to keep confidential as evidenced by HHSC taking reasonable measures to prevent from being overheard; or
(2) may not record, listen to, or eavesdrop on any HHSC internal discussions outside the presence of hospital staff when HHSC has requested a private room or office or distanced themselves from hospital staff unless the hospital first informs HHSC and the hospital obtains HHSC's written approval before beginning to record or listen to the discussion.
(b) A hospital shall inform HHSC when security cameras or other existing recording devices in the hospital are in operation during any internal discussion by or among HHSC staff.
(c) When HHSC by words or actions permits hospital staff to be present, an interview or conversation for which hospital staff are present does not constitute a violation of this rule.
(d) This section does not prohibit an individual from recording an HHSC interview with the individual.
§133.102.Inspections.
(a) The Texas Health and Human Services Commission (HHSC) may conduct an inspection of each hospital prior to the issuance or renewal of a license.
(1) A hospital is not subject to additional annual licensing inspections subsequent to the issuance of the initial license while the hospital maintains:
(A) certification under Title XVIII of the Social Security Act, 42 United States Code (USC), §§1395 et seq.; or
(B) accreditation from The Joint Commission, the American Osteopathic Association, or other national accreditation organization for the offered services.
(2) HHSC may conduct an inspection of a hospital exempt from an annual licensing inspection under paragraph (1) of this subsection before issuing a renewal license to the hospital if the certification or accreditation body has not conducted an on-site inspection of the hospital in the preceding three years and HHSC determines that an inspection of the hospital by the certification or accreditation body is not scheduled within 60 days of the license expiration date.
(b) HHSC may conduct an unannounced, on-site inspection of a hospital at any reasonable time, including when treatment services are provided, to inspect, investigate, or evaluate compliance with or prevent a violation of:
(1) any applicable statute or rule;
(2) a hospital's plan of correction;
(3) an order or special order of the HHSC executive commissioner or the executive commissioner's designee;
(4) a court order granting injunctive relief; or
(5) for other purposes relating to regulation of the hospital.
(c) An applicant or licensee, by applying for or holding a license, consents to entry and inspection of any of its hospitals by HHSC.
(d) HHSC inspections to evaluate a hospital's compliance may include:
(1) initial, change of ownership, or relocation inspections for the issuance of a new license;
(2) inspections related to changes in status, such as new construction or changes in services, designs, or bed numbers;
(3) routine inspections, which may be conducted without notice and at HHSC's discretion, or prior to renewal;
(4) follow-up on-site inspections, conducted to evaluate implementation of a plan of correction for previously cited deficiencies;
(5) inspections to determine if an unlicensed hospital is offering or providing, or purporting to offer or provide, treatment; and
(6) entry in conjunction with any other federal, state, or local agency's entry.
(e) A hospital shall cooperate with any HHSC inspection and shall permit HHSC to examine the hospital's grounds, buildings, books, records, video surveillance, and other documents and information maintained by or on behalf of the hospital, unless prohibited by law.
(f) A hospital shall permit HHSC access to interview members of the governing body, personnel, and patients, including the opportunity to request a written statement.
(g) A hospital shall permit HHSC to inspect and copy any requested information, unless prohibited by law. If it is necessary for HHSC to remove documents or other records from the hospital, HHSC provides a written description of the information being removed and when it is expected to be returned. HHSC makes a reasonable effort, consistent with the circumstances, to return any records removed in a timely manner.
(h) Upon entry, HHSC holds an entrance conference with the hospital's designated representative to explain the nature, scope, and estimated duration of the inspection.
(i) During the inspection, the HHSC representative gives the hospital representative an opportunity to submit information and evidence relevant to matters of compliance being evaluated.
(j) When an inspection is complete, the HHSC representative holds an exit conference with the hospital representative to inform the hospital representative of any preliminary findings of the inspection, including possible health and safety concerns. The hospital may provide any final documentation regarding compliance during the exit conference.
(k) HHSC shall maintain the confidentiality of hospital records as applicable under state or federal law. Except as provided by subsection (l) of this section, all information and materials in the possession of or obtained or compiled by HHSC in connection with an inspection are confidential and not subject to disclosure under Texas Government Code Chapter 552 (relating to Public Information), and not subject to disclosure, discovery, subpoena, or other means of legal compulsion for their release to anyone other than HHSC or its employees or agents involved in the enforcement action except that this information may be disclosed to:
(1) persons involved with HHSC in the enforcement action against the hospital;
(2) the hospital that is the subject of the enforcement action, or the hospital's authorized representative;
(3) appropriate state or federal agencies that are authorized to inspect, survey, or investigate hospital services;
(4) law enforcement agencies as allowed by law; and
(5) persons engaged in bona fide research, if all individual-identifying and hospital-identifying information has been deleted.
(l) The following information is subject to disclosure in accordance with Texas Government Code Chapter 552, only to the extent that all personally identifiable information of a patient or health care provider is omitted from the information:
(1) a notice of the hospital's alleged violation, which must include the provisions of law the hospital is alleged to have violated, and a general statement of the nature of the alleged violation;
(2) the number of investigations HHSC conducted of the hospital;
(3) the pleadings in any administrative proceeding to impose a penalty against the hospital for the alleged violation;
(4) the outcome of each investigation HHSC conducted of the hospital, including:
(A) reprimand issuance;
(B) license denial or revocation;
(C) corrective action plan adoption; or
(D) administrative penalty imposition and the penalty amount;
(5) a final decision, investigative report, or order issued by HHSC to address the alleged violation; and
(6) any other information required by law to be disclosed under public information laws.
(m) Within 90 days after the date HHSC issues a final decision, investigative report, or order to address a hospital's alleged violation, HHSC posts certain information on the HHSC website in accordance with Texas Health and Safety Code §241.051.
§133.103.Complaint Investigations.
(a) A hospital shall provide each patient and applicable legally authorized representative at the time of admission with a written statement identifying the Texas Health and Human Services Commission (HHSC) as the agency responsible for investigating complaints against the hospital.
(1) The statement shall inform persons that they may direct a complaint to HHSC Complaint and Incident Intake (CII) and include current CII contact information, as specified by HHSC.
(2) The hospital shall prominently and conspicuously post this statement in patient common areas and in visitor's areas and waiting rooms so that it is readily visible to patients, employees, and visitors. The information shall be in English and in a second language appropriate to the demographic makeup of the community served.
(b) HHSC evaluates all complaints. A complaint must be submitted using HHSC's current CII contact information for that purpose, as described in subsection (a) of this section.
(c) HHSC documents, evaluates, and prioritizes complaints directed to HHSC CII based on the seriousness of the alleged violation and the level of risk to patients, personnel, and the public.
(1) Allegations determined to be within HHSC's regulatory jurisdiction relating to a hospital may be investigated under this chapter.
(2) HHSC may refer complaints outside HHSC's jurisdiction to an appropriate agency, as applicable.
(d) HHSC conducts investigations to evaluate a hospital's compliance following a complaint of abuse, neglect, or exploitation; or a complaint related to the health and safety of patients. Complaint investigations may be coordinated with the federal Centers for Medicare & Medicaid Services and its agents responsible for the inspection of hospitals to determine compliance with the Conditions of Participation under Title XVIII of the Social Security Act, (42 USC, §§1395 et seq.), so as to avoid duplicate investigations.
(e) HHSC may conduct an unannounced, on-site investigation of a hospital at any reasonable time, including when treatment services are provided, to inspect or investigate:
(1) a hospital's compliance with any applicable statute or rule;
(2) a hospital's plan of correction;
(3) a hospital's compliance with an order of the HHSC executive commissioner or the executive commissioner's designee;
(4) a hospital's compliance with a court order granting injunctive relief; or
(5) for other purposes relating to regulation of the hospital.
(f) An applicant or licensee, by applying for or holding a license, consents to entry and investigation of any of its facilities by HHSC.
(g) A hospital shall cooperate with any HHSC investigation and shall permit HHSC to examine the hospital's grounds, buildings, books, records, video surveillance, and other documents and information maintained by, or on behalf of, the hospital, unless prohibited by law.
(h) A hospital shall permit HHSC access to interview members of the governing body, personnel, and patients, including the opportunity to request a written statement.
(i) A hospital shall permit HHSC to inspect and copy any requested information, unless prohibited by law. If it is necessary for HHSC to remove documents or other records from the hospital, HHSC provides a written description of the information being removed and when it is expected to be returned. HHSC makes a reasonable effort, consistent with the circumstances, to return any records removed in a timely manner.
(j) Upon entry, the HHSC representative holds an entrance conference with the hospital's designated representative to explain the nature, scope, and estimated duration of the investigation.
(k) The HHSC representative holds an exit conference with the hospital representative to inform the hospital representative of any preliminary findings of the investigation. The hospital may provide any final documentation regarding compliance during the exit conference.
(l) Once an investigation is complete, HHSC reviews the evidence from the investigation to evaluate whether there is a preponderance of evidence supporting the allegations contained in the complaint.
(m) HHSC shall maintain the confidentiality of hospital records as applicable under state or federal law. Except as provided by subsection (n) of this section , all information and materials in the possession of or obtained or compiled by HHSC in connection with an investigation are confidential and not subject to disclosure under Texas Government Code Chapter 552, and not subject to disclosure, discovery, subpoena, or other means of legal compulsion for their release to anyone other than HHSC or its employees or agents involved in the enforcement action except that this information may be disclosed to:
(1) persons involved with HHSC in the enforcement action against the hospital;
(2) the hospital that is the subject of the enforcement action, or the hospital's authorized representative;
(3) appropriate state or federal agencies that are authorized to inspect, survey, or investigate hospital services;
(4) law enforcement agencies as allowed by law; and
(5) persons engaged in bona fide research, if all individual-identifying and hospital-identifying information has been deleted.
(n) The following information is subject to disclosure in accordance with Texas Government Code Chapter 552, only to the extent that all personally identifiable information of a patient or health care provider is omitted from the information:
(1) a notice of the hospital's alleged violation, which must include the provisions of law the hospital is alleged to have violated, and a general statement of the nature of the alleged violation;
(2) the number of investigations HHSC conducted of the hospital;
(3) the pleadings in any administrative proceeding to impose a penalty against the hospital for the alleged violation;
(4) the outcome of each investigation HHSC conducted of the hospital, including:
(A) reprimand issuance;
(B) license denial or revocation;
(C) corrective action plan adoption; or
(D) administrative penalty imposition and the penalty amount;
(5) a final decision, investigative report, or order issued by HHSC to address the alleged violation; and
(6) any other information required by law to be disclosed under public information laws.
(o) Within 90 days after the date HHSC issues a final decision, investigative report, or order to address a hospital's alleged violation, HHSC posts certain information on the HHSC website in accordance with Texas Health and Safety Code Section 241.051 (relating to Inspections).
(p) HHSC notifies complainants regarding the investigation's outcome within 10 business days after completing the investigation.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 1, 2024.
TRD-202405247
Karen Ray
Chief Counsel
Department of State Health Services
Effective date: November 21, 2024
Proposal publication date: May 10, 2024
For further information, please call: (512) 834-4591
STATUTORY AUTHORITY
The amendment is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and Texas Health and Safety Code §241.026, which requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of licensed hospitals.
§133.121.Enforcement.
Enforcement is a process by which a sanction is proposed, and if warranted, imposed on an applicant or licensee regulated by the Texas Health and Human Services Commission (HHSC) for failure to comply with applicable statutes, rules, and orders.
(1) Denial, suspension or revocation of a license or imposition of an administrative penalty. HHSC has jurisdiction to enforce violations of the Act or the rules adopted under this chapter. HHSC may deny, suspend, or revoke a license or impose an administrative penalty for the following:
(A) failure to comply with any applicable provision of the Texas Health and Safety Code (HSC), including Chapters 241, 311, and 327;
(B) failure to comply with any provision of this chapter or any other applicable laws;
(C) the hospital, or any of its employees, committing an act which causes actual harm or risk of harm to the health or safety of a patient;
(D) the hospital, or any of its employees, materially altering any license issued by HHSC;
(E) failure to comply with minimum standards for licensure;
(F) failure to provide a complete license application;
(G) failure to comply with an order of the HHSC executive commissioner or another enforcement procedure under HSC Chapters 241, 311, or 327;
(H) a history of failure to comply with the applicable rules relating to patient environment, health, safety, and rights that reflect more than nominal noncompliance;
(I) the hospital aiding, committing, abetting, or permitting the commission of an illegal act;
(J) the hospital, or any of its employees, committing fraud, misrepresentation, or concealment of a material fact on any documents required to be submitted to HHSC or required to be maintained by the hospital pursuant to HSC Chapter 241 and the provisions of this chapter;
(K) failure to comply with other state and federal laws affecting the health, safety, and rights of hospital patients;
(L) failure to timely pay an assessed administrative penalty as required by HHSC;
(M) failure to submit an acceptable plan of correction for cited deficiencies within the timeframe required by HHSC;
(N) failure to timely implement plans of corrections to deficiencies cited by HHSC within the dates designated in the plan of correction;
(O) failure to comply with applicable requirements within a designated probation period; or
(P) if the hospital is participating under Title XVIII of the Social Security Act, 42 United States Code (USC), §1395 et seq, the Centers for Medicare & Medicaid Services terminating the hospital's Medicare provider agreement.
(2) Denial of a license. HHSC has jurisdiction to enforce violations of HSC Chapters 241, 311, and 327 and this chapter. HHSC may deny a license if the applicant:
(A) fails to provide timely and sufficient information required by HHSC that is directly related to the application; or
(B) has had the following actions taken against the applicant within the two-year period preceding the application:
(i) decertification or cancellation of its contract under the Medicare or Medicaid program in any state;
(ii) federal Medicare or state Medicaid sanctions or penalties;
(iii) unsatisfied federal or state tax liens;
(iv) unsatisfied final judgments;
(v) eviction involving any property or space used as a hospital in any state;
(vi) unresolved federal Medicare or state Medicaid audit exceptions;
(vii) denial, suspension, or revocation of a hospital license, a private psychiatric hospital license, or a license for any health care facility in any state; or
(viii) a court injunction prohibiting ownership or operation of a facility.
(3) Emergency suspension. Following notice and opportunity for hearing, the executive commissioner of HHSC or a person designated by the executive commissioner may issue an emergency order in relation to the operation of a hospital licensed under this chapter if the executive commissioner or the executive commissioner's designee determines that the hospital is violating this chapter, a rule adopted pursuant to this chapter, a special license provision, injunctive relief, an order of the executive commissioner or the executive commissioner's designee, or another enforcement procedure permitted under this chapter and the provision, rule, license provision, injunctive relief, order, or enforcement procedure relates to the health or safety of the hospital's patients.
(A) HHSC shall send written notice of the hearing and shall include within the notice the time and place of the hearing. The hearing must be held within 10 days after the date of the hospital's receipt of the notice.
(B) The hearing shall be held in accordance with HHSC's informal hearing rules.
(C) The order shall be effective on delivery to the hospital or at a later date specified in the order.
(4) Probation. In lieu of denying, suspending, or revoking the license, HHSC may place the hospital on probation for a period of not less than 30 days, if HHSC finds that the hospital is in repeated noncompliance with these rules or HSC Chapter 241, and the hospital's noncompliance does not endanger the public's health and safety.
(A) HHSC shall provide notice to the hospital of the probation and of the items of noncompliance not later than the 10th day before the probation period begins.
(B) During the probation period, the hospital shall correct the items of noncompliance and report the corrections to HHSC for approval.
(5) Administrative penalty. HHSC has jurisdiction to impose an administrative penalty against a hospital licensed or regulated under this chapter for violations of HSC Chapters 241, 311, and 327 and this chapter. The imposition of an administrative penalty shall be in accordance with the provisions of HSC §241.059, §241.060, and §327.008.
(6) Licensure of persons or entities with criminal backgrounds. HHSC may deny a person or entity a license or suspend or revoke an existing license on the grounds that the person or entity has been convicted of a felony or misdemeanor that directly relates to the duties and responsibilities of the ownership or operation of a hospital. HHSC shall apply the requirements of Texas Occupations Code Chapter 53.
(A) HHSC is entitled under Texas Government Code Chapter 411 to obtain criminal history information maintained by the Texas Department of Public Safety, the Federal Bureau of Investigation, or any other law enforcement agency to investigate the eligibility of an applicant for an initial or renewal license and to investigate the continued eligibility of a licensee.
(B) In determining whether a criminal conviction directly relates, HHSC shall apply the requirements and consider the provisions of Texas Occupations Code Chapter 53.
(C) The following felonies and misdemeanors directly relate to the duties and responsibilities of the ownership or operation of a health care facility because these criminal offenses indicate an ability or a tendency for the person to be unable to own or operate a hospital:
(i) a misdemeanor violation of HSC Chapter 241;
(ii) a misdemeanor or felony involving moral turpitude;
(iii) a misdemeanor or felony relating to deceptive business practices;
(iv) a misdemeanor or felony of practicing any health-related profession without a required license;
(v) a misdemeanor or felony under any federal or state law relating to drugs, dangerous drugs, or controlled substances;
(vi) a misdemeanor or felony under Texas Penal Code (TPC), Title 5, involving a patient, resident, or a client of any health care facility, a home and community support services agency or a health care professional; or
(vii) a misdemeanor or felony under the TPC:
(I) Title 4;
(II) Title 5;
(III) Title 7;
(IV) Title 8;
(V) Title 9;
(VI) Title 10; or
(VII) Title 11.
(7) Offenses listed in paragraph (6)(C) of this subsection are not exclusive in that HHSC may consider similar criminal convictions from other state, federal, foreign, or military jurisdictions that indicate an inability or tendency for the person or entity to own or operate a hospital.
(8) HHSC shall revoke a license on the licensee's imprisonment following a felony conviction, felony community supervision revocation, revocation of parole, or revocation of mandatory supervision.
(9) Notice. If HHSC proposes to deny, suspend, or revoke a license, or impose an administrative penalty, HHSC shall send a notice of the proposed action by certified mail, return receipt requested, at the address shown in the current records of HHSC or HHSC may personally deliver the notice. The notice to deny, suspend, or revoke a license, or impose an administrative penalty, shall state the alleged facts or conduct to warrant the proposed action, provide an opportunity to demonstrate or achieve compliance, and shall state that the applicant or license holder has an opportunity for a hearing before taking the action.
(10) Acceptance. Within 20 calendar days after receipt of the notice, the applicant or licensee may notify HHSC, in writing, of acceptance of HHSC's determination or request a hearing.
(11) Hearing request.
(A) A request for a hearing by the applicant or licensee shall be in writing and submitted to HHSC within 20 calendar days of receipt of the notice of the proposed action described in paragraph (9) of this subsection. Receipt of the notice is presumed to occur on the third day after the date HHSC mails the notice to the last known address of the applicant or licensee.
(B) A hearing shall be conducted pursuant to Texas Government Code Chapter 2001, and Title 1, Chapter 357, Subchapter I (relating to Hearings under the Administrative Procedure Act).
(12) No response to notice. If an applicant or licensee does not request a hearing in writing within 20 calendar days after receiving the notice of the proposed action, the case shall be set for a hearing.
(13) Notification of HHSC's final decision. HHSC shall send the licensee or applicant a copy of HHSC's decision for denial, suspension or revocation of a license or imposition of an administrative penalty by certified mail, which shall include the findings of fact and conclusions of law on which HHSC based its decision.
(14) Admission of new patients upon suspension or revocation. Upon HHSC's determination to suspend or revoke a license, the license holder may not admit new patients until HHSC reissues the license.
(15) Decision to suspend or revoke. When HHSC's decision to suspend or revoke a license is final, the licensee must immediately cease operation, unless the district court issues a stay of such action.
(16) Return of original license. Upon suspension, revocation or non-renewal of the license, the original license shall be returned to HHSC within 30 calendar days of HHSC's notification.
(17) Reapplication following denial or revocation.
(A) One year after HHSC's decision to deny or revoke, or the voluntary surrender of a license by a hospital while enforcement action is pending, a hospital may petition HHSC, in writing, for a license. Expiration of a license prior to HHSC's decision becoming final shall not affect the one-year waiting period required before a petition can be submitted.
(B) HHSC may allow a reapplication for licensure if there is proof that the reasons for the original action no longer exist.
(C) HHSC may deny reapplication for licensure if HHSC determines that:
(i) the reasons for the original action continues;
(ii) the petitioner has failed to offer sufficient proof that conditions have changed; or
(iii) the petitioner has demonstrated a repeated history of failure to provide patients a safe environment or has violated patient rights.
(D) If HHSC allows a reapplication for licensure, the petitioner shall be required to meet the requirements as described in §133.22 of this chapter (relating to Application and Issuance of Initial License).
(18) Expiration of a license during suspension. A hospital whose license expires during a suspension period may not reapply for license renewal until the end of the suspension period.
(19) Surrender of a license. In the event that enforcement, as defined in this subsection, is pending or reasonably imminent, the surrender of a hospital license shall not deprive HHSC of jurisdiction in regard to enforcement against the hospital.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 1, 2024.
TRD-202405248
Karen Ray
Chief Counsel
Department of State Health Services
Effective date: November 21, 2024
Proposal publication date: May 10, 2024
For further information, please call: (512) 834-4591
The Texas Health and Human Services Commission (HHSC) adopts the repeal of §135.21, concerning Inspections; §135.24, concerning Enforcement; and §135.25, concerning Complaints; an amendment to §135.22, concerning Renewal of License; and new §135.61, concerning Integrity of Inspections and Investigations; §135.62, concerning Inspections; §135.63, concerning Complaint Investigations; §135.64, concerning Notice; §135.65, concerning Professional Conduct; §135.66, concerning Complaint Against an HHSC Representative; and §135.67, concerning Enforcement.
The repeal of §§135.21, 135.24, and 135.25; new §§135.64, 135.65, 135.66, and 135.67; and amended §135.22 are adopted without changes to the proposed text as published in the May 10, 2024, issue of the Texas Register (49 TexReg 3115). These rules will not be republished.
New §§135.61, 135.62, and 135.63 are adopted with changes to the proposed text as published in the May 10, 2024, issue of the Texas Register (49 TexReg 3115). These rules will be republished.
BACKGROUND AND JUSTIFICATION
The adoption is necessary to update the inspection, complaint investigation, and enforcement procedures for ambulatory surgical centers (ASCs). These updates are necessary to hold ASCs accountable during the inspection and investigation processes and ensure ASCs provide necessary documentation in a timely manner to HHSC representatives. The adopted rules revise enforcement procedures to ensure conformity with current practices and statutes. These updates also ensure consistent practices across HHSC Health Care Regulation, correct outdated language and contact information, and reflect the transition of regulatory authority for ASCs from the Department of State Health Services to HHSC.
COMMENTS
The 31-day comment period ended June 10, 2024.
During this period, HHSC received a comment regarding the proposed rules from one commenter, the Texas Medical Association (TMA).
Comment: TMA stated §135.65 appears to impose reporting mandates on HHSC. TMA stated not every issue relating to the conduct of a licensed professional, intern, or application for professional licensure will necessarily warrant reporting to the licensing board. TMA recommended replacing "reports" with "may report" in §135.65 to allow HHSC to exercise discretion in its reporting.
Response: HHSC declines to revise §135.65 because the agency prefers to err on the side of caution regarding conduct of licensed professionals. HHSC notes licensing boards have discretion in responding to any complaint.
HHSC revised §135.61(a)(1) to connect paragraphs (1) and (2) paragraphs with "or" instead of "and." HHSC made this change to ensure consistency with the freestanding emergency medical care facility rule at 26 TAC §509.81(a) and the limited services rural hospital rule at 26 TAC §511.111(a).
HHSC revised §135.61(a)(2) to add "unless the ASC first informs HHSC." The change is made to clarify a facility must first inform HHSC and then obtain HHSC written approval before beginning to record or listen to an internal HHSC discussion. The change also increases consistency with other HHSC rules in this rule project.
HHSC revised §135.62(d) and §135.63(g) by adding "video surveillance" to the list of items an ASC must permit HHSC to examine during any HHSC inspection. This change is made to increase consistency with other HHSC rules in this rule project and language in 26 TAC §511.112(e) for a limited services rural hospital.
HHSC revised §135.63 to add new subsection (n), which states HHSC will notify a complainant within 10 business days after completing the investigation of the investigation's outcome.
SUBCHAPTER A. OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS
25 TAC §§135.21, 135.24, 135.25
STATUTORY AUTHORITY
The repeals are adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and Texas Health and Safety Code §243.009, which requires HHSC to adopt rules for licensing of ASCs; and §243.010, which requires those rules to include minimum standards applicable to ASCs.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 1, 2024.
TRD-202405238
Karen Ray
Chief Counsel
Department of State Health Services
Effective date: November 21, 2024
Proposal publication date: May 10, 2024
For further information, please call: (512) 834-4591
STATUTORY AUTHORITY
The amendment is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and Texas Health and Safety Code §243.009, which requires HHSC to adopt rules for licensing of ASCs; and §243.010, which requires those rules to include minimum standards applicable to ASCs.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 1, 2024.
TRD-202405240
Karen Ray
Chief Counsel
Department of State Health Services
Effective date: November 21, 2024
Proposal publication date: May 10, 2024
For further information, please call: (512) 834-4591
STATUTORY AUTHORITY
The new rules are adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and Texas Health and Safety Code §243.009, which requires HHSC to adopt rules for licensing of ASCs; and §243.010, which requires those rules to include minimum standards applicable to ASCs.
§135.61.Integrity of Inspections and Investigations.
(a) In order to preserve the integrity of the Texas Health and Human Services Commission's (HHSC's) inspection and investigation process, an ambulatory surgical center's (ASC's) staff:
(1) may not record, listen to, or eavesdrop on any HHSC interview with ASC staff or patients that the ASC staff knows HHSC intends to keep confidential as evidenced by HHSC taking reasonable measures to prevent from being overheard; or
(2) may not record, listen to, or eavesdrop on any HHSC internal discussions outside the presence of ASC staff when HHSC has requested a private room or office or distanced themselves from ASC staff unless the ASC first informs HHSC and the ASC obtains HHSC's written approval before beginning to record or listen to the discussion.
(b) An ASC shall inform HHSC when security cameras or other existing recording devices in the ASC are in operation during any internal discussion by or among HHSC staff.
(c) When HHSC by words or actions permits ASC staff to be present, an interview or conversation for which ASC staff are present does not constitute a violation of this rule.
(d) This section does not prohibit an individual from recording an HHSC interview with the individual.
§135.62.Inspections.
(a) The Texas Health and Human Services Commission (HHSC) may conduct an unannounced, on-site inspection of an ambulatory surgical center (ASC) at any reasonable time, including when treatment services are provided, to inspect, investigate, or evaluate compliance with or prevent a violation of:
(1) any applicable statute or rule;
(2) an ASC's plan of correction;
(3) an order or special order of the HHSC executive commissioner or the executive commissioner's designee;
(4) a court order granting injunctive relief; or
(5) for other purposes relating to regulation of the ASC.
(b) An applicant or licensee, by applying for or holding a license, consents to entry and inspection of any of its ASCs by HHSC.
(c) HHSC inspections to evaluate an ASC's compliance may include:
(1) initial, change of ownership, or relocation inspections for the issuance of a new license;
(2) inspections related to changes in status, such as new construction or changes in services, designs, or bed numbers;
(3) routine inspections, which may be conducted without notice and at HHSC's discretion, or prior to renewal;
(4) follow-up on-site inspections, conducted to evaluate implementation of a plan of correction for previously cited deficiencies;
(5) inspections to determine if an unlicensed ASC is offering or providing, or purporting to offer or provide, treatment; and
(6) entry in conjunction with any other federal, state, or local agency's entry.
(d) An ASC shall cooperate with any HHSC inspection and shall permit HHSC to examine the ASC's grounds, buildings, books, records, video surveillance, and other documents and information maintained by or on behalf of the ASC, unless prohibited by law.
(e) An ASC shall permit HHSC access to interview members of the governing body, personnel, and patients, including the opportunity to request a written statement.
(f) An ASC shall permit HHSC to inspect and copy any requested information, unless prohibited by law. If it is necessary for HHSC to remove documents or other records from the ASC, HHSC provides a written description of the information being removed and when it is expected to be returned. HHSC makes a reasonable effort, consistent with the circumstances, to return any records removed in a timely manner.
(g) HHSC shall maintain the confidentiality of ASC records as applicable under state and federal law.
(h) Upon entry, HHSC holds an entrance conference with the ASC's designated representative to explain the nature, scope, and estimated duration of the inspection.
(i) During the inspection, the HHSC representative gives the ASC representative an opportunity to submit information and evidence relevant to matters of compliance being evaluated.
(j) When an inspection is complete, the HHSC representative holds an exit conference with the ASC representative to inform the facility representative of any preliminary findings of the inspection, including any possible health and safety concerns. The ASC may provide any final documentation regarding compliance during the exit conference.
§135.63.Complaint Investigations.
(a) An ambulatory surgical center (ASC) shall provide each patient and applicable legally authorized representative at the time of admission with a written statement identifying the Texas Health and Human Services Commission (HHSC) as the agency responsible for investigating complaints against the ASC.
(1) The statement shall inform persons that they may direct a complaint to HHSC Complaint and Incident Intake (CII) and include current CII contact information, as specified by HHSC.
(2) The ASC shall prominently and conspicuously post this statement in patient common areas and in visitor's areas and waiting rooms so that it is readily visible to patients, employees, and visitors. The information shall be in English and in a second language appropriate to the demographic makeup of the community served.
(b) HHSC evaluates all complaints. A complaint must be submitted using HHSC's current CII contact information for that purpose, as described in subsection (a) of this section.
(c) HHSC documents, evaluates, and prioritizes complaints directed to HHSC CII based on the seriousness of the alleged violation and the level of risk to patients, personnel, and the public.
(1) Allegations determined to be within HHSC's regulatory jurisdiction relating to health care facilities may be investigated under this chapter.
(2) HHSC may refer complaints outside HHSC's jurisdiction to an appropriate agency, as applicable.
(d) HHSC conducts investigations to evaluate an ASC's compliance following a complaint of abuse, neglect, or exploitation; or a complaint related to the health and safety of patients.
(e) HHSC may conduct an unannounced, on-site investigation of an ASC at any reasonable time, including when treatment services are provided, to inspect or investigate:
(1) an ASC's compliance with any applicable statute or rule;
(2) an ASC's plan of correction;
(3) an ASC's compliance with an order of the HHSC executive commissioner or the executive commissioner's designee;
(4) an ASC's compliance with a court order granting injunctive relief; or
(5) for other purposes relating to regulation of the ASC.
(f) An applicant or licensee, by applying for or holding a license, consents to entry and investigation of any of its ASCs by HHSC.
(g) An ASC shall cooperate with any HHSC investigation and shall permit HHSC to examine the ASC's grounds, buildings, books, records, video surveillance, and other documents and information maintained by, or on behalf of, the ASC, unless prohibited by law.
(h) An ASC shall permit HHSC access to interview members of the governing body, personnel, and patients, including the opportunity to request a written statement.
(i) HHSC shall maintain the confidentiality of ASC records as applicable under state and federal law.
(j) An ASC shall permit HHSC to inspect and copy any requested information, unless prohibited by law. If it is necessary for HHSC to remove documents or other records from the ASC, HHSC provides a written description of the information being removed and when it is expected to be returned. HHSC makes a reasonable effort, consistent with the circumstances, to return any records removed in a timely manner.
(k) Upon entry, the HHSC representative holds an entrance conference with the ASC's designated representative to explain the nature, scope, and estimated duration of the investigation.
(l) The HHSC representative holds an exit conference with the ASC representative to inform the ASC representative of any preliminary findings of the investigation. The ASC may provide any final documentation regarding compliance during the exit conference.
(m) Once an investigation is complete, HHSC reviews the evidence from the investigation to evaluate whether there is a preponderance of evidence supporting the allegations contained in the complaint.
(n) HHSC notifies complainants regarding the investigations outcome within 10 business days after completing the investigation.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 1, 2024.
TRD-202405244
Karen Ray
Chief Counsel
Department of State Health Services
Effective date: November 21, 2024
Proposal publication date: May 10, 2024
For further information, please call: (512) 834-4591
The Texas Health and Human Services Commission (HHSC) adopts the repeal of §140.433, concerning Licensing, Certification, or Registration of Military Service Members, Military Veterans, and Military Spouses, and new §140.433, concerning Licensing, Certification, or Registration of Military Service Members, Military Spouses, and Military Veterans.
Repealed §140.433 and new §140.433 are adopted without changes to the proposed text as published in the July 19, 2024, issue of the Texas Register (49 TexReg 5258). These rules will not be republished.
BACKGROUND AND JUSTIFICATION
The adoption is necessary to implement Senate Bill (S.B.) 422, 88th Legislature, Regular Session, 2023. S.B. 422, in part, amended Texas Occupations Code (TOC) Chapter 55 to update requirements for a state agency's recognition of a military service member's and military spouse's out-of-state professional license, which includes a licensed chemical dependency counselor (LCDC) license.
The adoption increases consistency between the adopted rule, the HHSC rules at 1 Texas Administrative Code (TAC) §351.3 and §351.6, and the statutory requirements regarding the licensing process for military service members, military spouses, and military veterans. The adoption also retains and updates certain language currently found in 25 TAC §140.433.
COMMENTS
The 31-day comment period ended August 19, 2024.
During this period, HHSC received one comment regarding the proposed rules from one individual commenter. A summary of the comment relating to the rules and HHSC's response follows.
Comment: An individual commenter requested HHSC revise new §140.433 to allow LCDCs holding a master's degree in counseling, psychology, or any related field to provide mental health services under their LCDC license. The stakeholder noted that LCDCs are currently allowed to supervise licensed social workers with a bachelor's degree who provide mental health services.
Response: HHSC declines to revise new §140.433 because the decision to authorize LCDCs to provide mental health services is determined by the Legislature, and HHSC does not have authority over this decision.
SUBCHAPTER I. LICENSED CHEMICAL DEPENDENCY COUNSELORS
STATUTORY AUTHORITY
The repeal is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; and Texas Occupation Code Chapter 504, which authorizes the Executive Commissioner to adopt rules governing the performance, conduct, and ethics for persons licensed as LCDCs.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 4, 2024.
TRD-202405304
Karen Ray
Chief Counsel
Department of State Health Services
Effective date: November 29, 2024
Proposal publication date: July 19, 2024
For further information, please call: (512) 834-4591
STATUTORY AUTHORITY
The new section is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; and Texas Occupation Code Chapter 504, which authorizes the Executive Commissioner to adopt rules governing the performance, conduct, and ethics for persons licensed as LCDCs.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 4, 2024.
TRD-202405305
Karen Ray
Chief Counsel
Department of State Health Services
Effective date: November 29, 2024
Proposal publication date: July 19, 2024
For further information, please call: (512) 834-4591
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts amendments to §157.2, concerning Definitions; §157.125, concerning Requirements for Trauma Facility Designation Effective Through August 31, 2025; and §157.128, concerning Denial, Suspension, and Revocation of Trauma Facility Designation; the repeal of §157.123, concerning Regional Emergency Medical Services/Trauma Systems; §157.130, concerning Emergency Medical Services and Trauma Care System Account and Emergency Medical Services, Trauma Facilities, and Trauma Care System Fund; and §157.131, concerning Designated Trauma Facility and Emergency Medical Services Account; and new §157.123, concerning Regional Advisory Councils; §157.126, concerning Trauma Facility Designation Requirements Effective on September 1, 2025; and §157.130, concerning Funds for Emergency Medical Services, Trauma Facilities, and Trauma Care Systems, and the Designated Trauma Facility and Emergency Medical Services Account.
Sections 157.2, 157.123, 157.125, 157.126, and 157.130 are adopted with changes to the proposed text as published in the August 2, 2024, issue of the Texas Register (49 TexReg 5648) and these rules will be republished.
The amendment of §157.128 and the repeals of §§157.123, 157.130 and 157.131 are adopted without changes to the proposed text as published in the August 2, 2024, issue of the Texas Register (49 TexReg 5648) and the rules will not be republished.
BACKGROUND AND JUSTIFICATION
The amendments, repeal, and new sections update the content and processes with the advances, evidence-based practices, and system processes that have developed since these rules were adopted and to align with American College of Surgeons (ACS) standards. The rules also require amendments to implement legislation passed since the rules were last adopted. Senate Bill (S.B.) 330, 79th Legislature, Regular Session, 2005, amends Texas Health and Safety Code §773.203, requiring the development of regional stroke plans. House Bill (H.B.) 15, 83rd Legislature, Regular Session, 2013, and H.B. 3433, 84th Legislature, Regular Session, 2015, amend Texas Health and Safety Code §241.183, requiring the development of perinatal care regions. S.B. 984, 87th Legislature, Regular Session, 2021, amends Texas Health and Safety Code §81.027, directing the Regional Advisory Councils (RACs) to collect specific health care data. S.B. 969, 87th Legislature, Regular Session, 2021, amends Texas Health and Safety Code §81.0445, requiring the RACs to provide public information regarding public health disasters to stakeholders. S.B. 1397, 87th Legislature, Regular Session, 2021, amends Texas Health and Safety Code §773.1141, requiring a RAC with at least one county located on the international border of Texas and at least one county adjacent to the Gulf of Mexico to track all patient transfers and the reasons for the transfers out of its region.
A workgroup was formed to collaborate with DSHS staff to review the public comments received and determine the most appropriate language to ensure the health and safety of trauma patients and prevent any undue burden on the facilities providing trauma care. The workgroup composition included representatives from the Governor’s Emergency Medical Services (EMS) and Trauma Advisory Council (GETAC), GETAC Trauma Systems Committee, Regional Advisory Councils (RACs), Texas Hospital Association (THA), Texas Organization of Rural and Community Hospitals (TORCH), and Texas Medical Association (TMA) with diverse backgrounds and geographic locations.
COMMENTS
The 31-day comment period ended September 3, 2024.
During this period, DSHS received comments regarding the proposed rules from 66 commenters, including Baptist Hospital of Southeast Texas; Border Regional Advisory Council; Capital Area of Texas Regional Advisory Council (CATRAC); Children’s Hospitals Association of Texas (CHAT); Golden Plains Community Hospital; Harris Health; Southeast Texas Regional Advisory Council (SETRAC); Teaching Hospitals of Texas (THOT); Texas College of Emergency Physicians (TCEP); Texas EMS, Trauma and Acute Care Foundation (TETAF); Emergency Medical Services for Children State Partnership, Texas; Texas Health Resources (THR); Texas Hospital Association (THA); Texas Medical Association (TMA); United Regional Health Care (UHRC) System; The University of Texas Medical Branch (UTMB); and 50 individual commenters. A summary of comments relating to Chapter 157 and DSHS’s responses follow.
Comment: One commenter supports not increasing the financial burden for Level IV trauma facilities.
Response: DSHS appreciates the comment. No change is necessary to the rules.
Comment: One commenter recommended revising the definition of "Abandonment" in §157.2(1) because a patient released from a hospital to EMS personnel would be considered an individual of lesser education.
Response: DSHS disagrees and declines to revise the language. EMS personnel work under the direction of a physician EMS Medical Director.
Comment: Several commenters recommended adding "or a department-approved survey organization" to the Level IV hospital with 100 or less trauma patients in §157.2(20) Basic Level IV trauma facility.
Response: DSHS agrees and adds "or a department-approved survey organization."
Comment: Multiple commenters recommended revising the language "evaluate and admit" for the Level IV trauma facility in §157.2(20), §157.126(g)(4)(A) and (B), (h)(8), (h)(19) - (21), (h)(25), (h)(30) - (32), (n), (n)(3) - (4), (o)(3), and (o)(3)(A) - (B).
Response: DSHS agrees and replaces "evaluating and admitting" with "managing" and included changes to §157.125(t) replacing "evaluated" with "managed," (x)(3)(D) replacing "evaluated and admitted" with "managed," and (y)(4)(D) replacing "evaluated and admitted" with "managed by," for consistent language in the rule.
Comment: Two commenters recommended revising the definition of "Bypass" in §157.2(23) by removing the last sentence: "Bypass protocols must have local physician input…be reviewed through the regional performance improvement process."
Response: DSHS acknowledges the comment and revises the definition to "Direction given to prehospital emergency medical services personnel by direct on-line medical control, or off-line medical director protocols to bypass the nearest facility for the most appropriate facility."
Comment: Two commenters recommended replacing "completed within 14 days" with "in process within 14 days" in §157.2(31), Concurrent performance improvement.
Response: DSHS disagrees and declines to revise the language, which would allow unlimited time to complete the review.
Comment: One commenter recommended adding language to clarify the administrator’s duties in §157.2(44), Designated facility administrator.
Response: DSHS disagrees and declines to change the language. The language is sufficient.
Comment: Two commenters recommended listing out all designation programs in §157.2(46), Designation.
Response: DSHS disagrees and declines to add the language. The language is inclusive and applies to all types of designation.
Comment: Two commenters recommended less descriptive language in §157.2(51), Diversion.
Response: DSHS disagrees and declines to modify the language. The language is sufficient.
Comment: One commenter recommended adding "saturation" to §157.2(51), Diversion.
Response: DSHS disagrees and declines to add the language. The term "diversion" is aligned with the American College of Surgeons (ACS) and the Emergency Medical Treatment and Active Labor Act (EMTALA).
Comment: One commenter recommended having emergency medicine physicians added to the definition in §157.2(57), Emergency medical services personnel.
Response: DSHS declines to add the language. Legislation is required to add personnel as this aligns with the statute.
Comment: One commenter recommended replacing the term "person" with "an agency" in §157.2(58), Emergency medical services provider.
Response: DSHS acknowledges the comment and replaces "a person" with "an organization that" and revises 157.2(82) language to be consistent.
Comment: Two commenters recommended replacing "trauma" with "emergency health" care systems in §157.2(68), Extraordinary emergency.
Response: DSHS disagrees and declines to modify the language because it aligns with language in Chapter 773.
Comment: One commenter recommended revising the language to reflect working with multiple EMS providers in §157.2(71), First responder organization (FRO).
Response: DSHS agrees and revises the language to "licensed EMS providers."
Comment: Multiple commenters recommended that §157.2(77), "Injury severity score;" §157.2(84), "Major trauma patient;" and §157.2(122), "Severe trauma patient" align with the Association for the Advancement of Automotive Medicine (AAAM) scoring system.
Response: DSHS acknowledges and removes ISS language and specific scores from the definitions with injury descriptions, including §157.2(41), Critically injured person, because the ACS and AAAM scoring descriptions are different.
Comment: Two commenters requested clarification on why the level of harm is a requirement in §157.2(80), Level of harm and suggest revising to "should."
Response: DSHS disagrees and declines to revise the language. The level of harm assists trauma personnel in defining the urgency of review by the program. It is common terminology used by hospitals and medical providers.
Comment: One commenter recommended revising §157.2(82), Licensee, to be specific for a licensed paramedic.
Response: DSHS disagrees with the recommendation and declines to revise the language.
Comment: Two commenters recommended that the rural county population be changed to 68,570 to align with Medicaid in §157.2(119), Rural county.
Response: DSHS declines to modify the language. The county population for a rural area is specified in Texas Health and Safety Code §773.0045 as 50,000.
Comment: Two commenters recommended revising "housed within the department" to "provided by the department" in §157.2(130), State Trauma Registry.
Response: DSHS acknowledges and revises "housed within the department" to "managed by the department."
Comment: Two commenters recommended changing "transferring, or providing," to "transferring, and providing" in §157.2(133), Stroke facility.
Response: DSHS disagrees and declines to revise the language. The use of "or" in the language allows options for the stroke services provided by a stroke facility based on the available resources.
Comment: One commenter recommended using one term throughout the rule language for §157.2(142), Trauma and emergency health care system plan.
Response: DSHS acknowledges and replaces "EMS/trauma" with "trauma and emergency health care system plan" in §157.2(115), Regional medical control; replaces "RAC system plan development" with "development of the regional trauma and emergency health care system plan" in paragraph (145), Trauma facility; revises "system plan development" to "the development of the regional trauma and emergency health care system plan" in paragraph (146), Trauma medical director (TMD); adds "trauma and emergency health care" in §157.123(c)(1); adds "emergency" in §157.123(e)(2)(C); and adds "trauma and emergency health care" in §157.125(h)(1).
Comment: Several commenters recommended requiring trauma medical director (TMD) participation in the RAC by aligning §157.126(b)(5) language with §157.2(146). The TMD participation in the RAC is essential to providing guidance in patient distribution during surges, emergency preparedness, transfers, and medical care.
Response: DSHS agrees and revises the language to require TMD participation in the RAC. The RACs are required to provide a virtual option for meeting attendance to facilitate TMD participation.
Comment: One commenter recommended to remove TMD participation in the RAC from the definition §157.2(146) Trauma medical director, because it is too burdensome.
Response: DSHS acknowledges and adds "or designee" allowing the TMD to appoint an individual to participate in the RAC when they are unable to attend.
Comment: One commenter supported pediatric readiness in the RAC trauma and emergency health care system plan as required in §157.123(c)(1)(I).
Response: DSHS appreciates the comment and no revisions are made in response to this comment.
Comment: Two commenters recommended the following revisions in §157.123(d): (1) require data collection only during a declared disaster and when funded by the department; (2) remove the reporting requirements; (3) the executive commissioner to identify when and what information will be reported; and (4) for the RAC website to have a DSHS link to the data.
Response: DSHS disagrees and declines to revise the language in §157.123(d) as recommended. However, DSHS revises the language reducing the frequency and volume of data collection and reporting to the department to avoid duplication with new federal reporting requirements.
Comment: Two commenters recommended deleting the requirement or deleting the reference to subsections (a) and (b) in §157.123(f)(1) because it is in RAC contracts.
Response: DSHS disagrees and declines to delete the language. The department is required by Texas Health and Safety Code Chapter 773 to develop performance measures for the RACs.
Comment: Two commenters recommended deleting subsections (a) and (b) in §157.123(f)(3) and deleting the regional trauma and emergency health care system plan in §157.123(f)(3) and §157.130(a)(5)(B)(ii).
Response: DSHS disagrees and declines to delete the language. The department is required by Texas Health and Safety Code Chapter 773 to develop performance measures for the RACs.
Comment: Two commenters recommended revising language in §157.123(i) to replace "must maintain virtual options" with "should maintain virtual options."
Response: DSHS disagrees and declines to revise the language. Participation by all health care personnel in the RAC is essential. The virtual option allows health care personnel to participate when they cannot attend in person.
Comment: Several commenters recommended aligning the neurosurgeon or advanced practice provider (APP) response with the ACS standards in §157.125(x)(17) - (18).
Response: DSHS agrees and modifies the language to "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 lesions; and neurological deficit produced by a potential spinal cord injury. When a neurosurgical 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."
Comment: Two commenters recommended removing advanced trauma life support (ATLS) requirement for APPs or adding a department-approved equivalent for ATLS in §157.125(x)(31)(C)(i).
Response: DSHS acknowledges the comments and revises the language in (x)(31)(C), specifying APPs who participate in trauma patient resuscitations must maintain current ATLS which aligns with the ACS 2022 standards. The department-approved equivalent language is included if a comparable course is proposed to meet the requirement.
Comment: Two commenters recommended adding a 90-day deadline for the department to complete and notify the facility of a designation determination in §157.126(c).
Response: DSHS disagrees and declines to modify the language. The rule language is sufficient.
Comment: Two commenters recommended removing "trauma patient care" in §157.126(d)(3)(C) because it is not defined in §157.2, Definitions, for a non-contiguous emergency department.
Response: DSHS disagrees and declines to revise because the rule language is sufficient.
Comment: One commenter recommended a language revision to include trauma patients managed at a facility’s remote emergency department in the facility’s main campus trauma registry in §157.126(d)(3)(C).
Response: DSHS acknowledges and declines to revise the language. The language is sufficient.
Comment: Two commenters recommended only having one Basic trauma facility designation (Level IV) description in §157.126(g)(4)(A) - (B).
Response: DSHS disagrees and declines to modify the language. The rule language separated by trauma patient volume is necessary to address the considerable variances in the capabilities and resources of the facilities designated at this level. The four levels of trauma designation align with the ACS standards and other designation programs.
Comment: Two commenters recommended replacing National Trauma Data Bank (NTDB) with National Trauma Data Standard (NTDS) in §157.126(g)(4)(B) and (h)(21).
Response: DSHS disagrees and declines to modify the language. The language is sufficient.
Comment: One commenter recommended adding the current year for NTDS definitions in §157.126(h)(2). The commenter is concerned that the State Trauma Registry runs behind the current year of data.
Response: DSHS declines to add the language. This recommendation would need to be addressed in the state trauma registry rules.
Comment: Two commenters recommended removing the EMS wristband number in §157.126(h)(4).
Response: DSHS disagrees and declines to remove the language. The language is sufficient and includes measures for patient tracking.
Comment: Two commenters recommended removing EMS hand-off language in §157.126(h)(5).
Response: DSHS disagrees and declines to remove the language. Effective communication between EMS personnel and the trauma team is essential when transferring patient care.
Comment: Two commenters recommended removing the §157.126(h)(8)(E) management guidelines for trauma due to abuse.
Response: DSHS disagrees and declines to delete the language. Stakeholders requested this language be included while developing the new rule language.
Comment: Multiple commenters support the Pediatric Readiness requirements in §157.126(h)(12) and (h)(12)(A) -(G).
Response: DSHS appreciates the comment. No revisions are made in response to this comment.
Comment: Two commenters recommended revising the language requiring "a written plan of correction addressing identified opportunities in pediatric readiness" in §157.126(h)(12)(A), to "monitoring the results in the Trauma Performance Improvement and Patient Safety (PIPS) plan."
Response: DSHS disagrees and declines to revise the language. The trauma performance improvement (PI) process includes a written plan of correction to address and resolve the identified opportunities.
Comment: One commenter recommended defining "staff" and a threshold for how often the competence should be evaluated in requirement §157.126(h)(12)(B).
Response: DSHS disagrees and declines to modify the language. The language is sufficient and to be defined by the facility.
Comment: One commenter recommended removing §157.126(h)(12)(F) regarding pediatric imaging guidelines addressing pediatric age or weight-based dosing.
Response: DSHS disagrees and declines to remove or revise the language. The language is sufficient and multiple commenters support the new pediatric requirements.
Comment: Two commenters recommended revising the simulation training to "ongoing" from every six months in §157.126(h)(12)(G).
Response: DSHS disagrees and declines to revise the language. The department received multiple comments supporting the pediatric readiness requirements.
Comment: One commenter supports the pediatric readiness language in §157.126(h)(13).
Response: DSHS appreciates the comment No revisions are made in response to this comment.
Comment: Multiple commenters recommended increasing the APP response time from 15 minutes to 30 minutes in §157.126(h)(14).
Response: DSHS agrees and modifies the response time to 30 minutes.
Comment: Multiple commenters recommended revising the TMD defining "the role and expectations of the hospitalist or intensivist" to the TMD "collaborating or overseeing" the physicians in §157.126(h)(16).
Response: DSHS disagrees and declines to revise the language. The TMD has the overall authority for trauma patients and the care provided in the hospital.
Comment: Multiple commenters recommended removing requirement §157.126(h)(17).
Response: DSHS disagrees and declines to revise the language. The Trauma Program Manager (TPM) or designee allows the facility flexibility in meeting the mandatory composition while maintaining trauma program representation on the committee.
Comment: Several commenters recommended revising the language in §157.126(h)(19) and applying the requirement to Medical Staff Services in the hospital.
Response: DSHS acknowledges the comments and declines to revise the language. The requirement aligns with the ACS standards.
Comment: Two commenters recommended removing the TMD requirement to "complete a trauma performance improvement course approved by the department" in §157.126(h)(20).
Response: DSHS disagrees and declines to remove the language. It is essential for the TMD to complete the course to ensure the trauma performance improvement plan and process meets the requirements and improves patient care.
Comment: Multiple commenters recommended adding the same certifications required for nursing staff participating in trauma care to the TPM role in §157.126(h)(21).
Response: DSHS agrees and adds "have current TNCC or ATCN, Emergency Nursing Pediatric Course (ENPC) or Pediatric Advanced Life Support (PALS), Advanced Cardiac Life Support (ACLS) certifications."
Comment: One commenter recommended in §157.126(h)(21) that if the Trauma Registrar has completed the AAAM course it meets the requirement for the TPM.
Response: DSHS disagrees and declines to revise the requirement. Completion of the AAAM course by the TPM provides the knowledge needed to lead the trauma program and oversee the Trauma Registrar and the trauma registry.
Comment: One commenter recommended adding a full-time equivalent (FTE) for the TPM in §157.126(h)(21).
Response: DSHS disagrees and declines to add the language. It is the facility’s responsibility to provide the resources and personnel to meet the requirements for a deficiency-free, successful trauma designation program.
Comment: One commenter recommended revising the language in §157.126(h)(25) to allow the TMD to participate in the trauma multidisciplinary peer review committee or hospital performance improvement (PI)/peer committee, instead of being the chairperson.
Response: DSHS disagrees and declines to revise the language. The requirement applies to Level IV facilities managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually. The TMD is required to have the expertise and oversight of trauma care in the facility, which makes them the most appropriate individual to chair the review committee.
Comment: Two commenters recommended adding an FTE for the Level IV Trauma Registrar in §157.126(h)(28)(A).
Response: DSHS disagrees and declines to revise the language. It is the facility’s responsibility to provide the resources and personnel to meet the requirements for a deficiency-free, successful trauma designation program.
Comment: Multiple commenters recommended revising language to state "clinical leaders or providers" to generalize the required participants and to increase the training and mass casualty event from once every year to once every three years in §157.126(h)(30).
Response: DSHS disagrees and declines to revise the language. Training and practicing for the mass casualty within the hospital ensures better execution when the event occurs.
Comment: Two commenters recommended adding the TNCC or ATCN, ENPC or PALS, and ACLS certifications and a trauma program manager course to the requirement for the Level IV facilities managing 100 or less trauma patients in §157.126(h)(32)(C).
Response: DSHS agrees and adds the trauma program manager course and TNCC or ATCN, ENPC or PALS, and ACLS certifications to the language.
Comment: One commenter recommended clarification on §157.126(h)(32)(C) limiting the Chief Nursing Officer (CNO) to perform the TPM duties if a separate TPM is not identified, as it does not benefit the trauma program when other registered nurses may be available.
Response: DSHS acknowledges the comment and removes the language related to integrating the trauma functions into the CNO functions. The trauma program is required to have a trauma program manager as defined in the language. It is the facility’s decision if the TPM job functions are integrated into the Chief Nursing Officer (CNO) job functions.
Comment: Multiple commenters recommended modifying the language to require only one unit of blood or changing §157.126(h)(32)(L) to a desired requirement.
Response: DSHS disagrees and declines to revise the language because blood availability is important for trauma and other medical and obstetrical patient populations. The department will consider blood center allotments for trauma facilities limited to one unit of packed red blood cells when determining designation deficiencies.
Comment: Two commenters recommended clarifying "participation" in the RAC in §157.126(h)(32)(M).
Response: DSHS disagrees and declines to revise the language. The rule language is sufficient as participation is defined by the RAC and should be voted upon by the general membership.
Comment: Two commenters recommended maintaining the current survey team composition for Level I and II trauma facilities in §157.126(o)(1).
Response: DSHS agrees and revises the language to include two surgeons, an emergency medicine physician, and a registered nurse with trauma expertise.
Comment: Multiple commenters recommended maintaining the registered nurse surveyor for Level I and II trauma facilities in §157.126(o)(1).
Response: DSHS agrees and revises the language to include two surgeons, an emergency medicine physician, and a registered nurse with trauma expertise.
Comment: Multiple commenters support including the registered nurse surveyor or a trauma registered nurse leader in the survey team composition for all trauma facilities in §157.126(o)(2).
Response: DSHS agrees and adds a surgeon and a registered nurse with trauma expertise.
Comment: Multiple commenters support including the registered nurse surveyor or a trauma registered nurse leader in the survey team composition for all trauma facilities in §157.126(o)(3)(A) - (B).
Response: DSHS acknowledges the comments and revises the language.
Comment: Two commenters recommended including the registered nurse surveyor, removing only physician surveyors from the Level IV facilities, and including a surgeon surveyor with the determinations currently utilized by DSHS and TETAF in §157.126(o)(3)(A).
Response: DSHS acknowledges the comments and revises the surveyor requirements for each facility level, as appropriate for the services provided.
Comment: Several commenters recommended revising §157.126(o)(3)(A) to require only one surveyor, a surgeon or registered nurse, for the Level IV facilities managing 101 or more trauma patients annually.
Response: DSHS acknowledges the comments and revises the surveyor requirements for each facility level, as appropriate for the services provided.
Comment: One commenter recommended changing §157.126(o)(3)(A) to maintain the current survey team composition for Level IV facilities.
Response: DSHS acknowledges the comments and revises the surveyor requirements for each facility level, as appropriate for the services provided.
Comment: One commenter supports the inclusion of emergency medicine physicians or family practice physicians in the survey team composition for the Level IV facilities managing 100 or less trauma patients in §157.126(o)(3)(B).
Response: DSHS appreciates the comment. No revisions are made in response to this comment.
Comment: Multiple commenters recommended maintaining the registered nurse surveyor and only a department-approved survey organization for Level IV designation surveys in §157.126(o)(3)(B).
Response: DSHS agrees to maintain a registered nurse surveyor and revises the language including a registered nurse with trauma expertise. DSHS disagrees with only a department-approved survey organization for the Level IV facilities with a low volume of trauma patients meeting NTDB registry inclusion criteria annually. The Level IV facilities may be evaluated for meeting the requirements by a department survey or a department-approved survey organization, at the discretion of the facility.
Comment: One commenter recommended removing a contiguous regional advisory council (RAC) as a conflict of interest for surveyors in §157.126(p)(1).
Response: DSHS disagrees and declines to revise the language. Trauma facilities may transfer patients to facilities in a contiguous RAC. A higher-level facility receiving patients from these facilities is a conflict of interest for conducting surveys.
Comment: One commenter supports the language in requirement §157.126(p)(2)(A) regarding surveyor conflicts when a direct or indirect financial, personal, or other interest would limit or affect their ability to serve.
Response: DSHS appreciates the comment. No revisions are made in response to this comment.
Comment: One commenter recommended removing the language in §157.126(p)(2)(B) regarding a surveyor who has had a prior working relationship in various capacities with a facility or the personnel in the past four years because it is too prescriptive.
Response: DSHS disagrees and declines to remove the language to decrease any surveyor conflicts or perceived conflicts of interest.
Comment: Two commenters recommended changing "protocols" to "guidelines" in §157.130(a)(4)(C)(ii) and deleting "in all TSAs where EMS is provided and verified by each RAC."
Response: DSHS disagrees and declines to modify the language. No revisions are required as "protocols" is not present in the language. All Trauma Services Areas (TSAs) are included in the language for RACs to receive credit and funding for EMS runs occurring in their area.
Comment: Two commenters recommended clarification on the requirement in §157.130(a)(4)(C)(iii) because EMS reporting to the RAC is overly burdensome.
Response: DSHS disagrees and declines to modify the language. The language requires EMS providers eligible for funds in a specific RAC to participate in the RACs where they provide services and may receive funds.
Comment: Two commenters recommended clarification on which requirement the language refers to in §157.130(a)(4)(D).
Response: DSHS agrees and relocates language from (a)(4)(D) to (a)(4)(G) to align with EMS provider county contract requirement.
Comment: Two commenters recommended deleting "and expectations" from §157.130(a)(5)(B)(ii).
Response: DSHS disagrees because the language "and expectations" is not present.
Comment: Two commenters recommended modifying the language in §157.130(a)(6)(C) from a facility "that fails to maintain its designation," to a facility "that is denied designation."
Response: DSHS disagrees and declines to revise the language to "denied." Trauma designated facilities are required to meet trauma designation requirements when submitting an application to receive trauma funding for trauma patient care.
Comment: Two commenters recommended revising the language in §157.130(a)(6)(E) to include "good standing with their RAC" before receiving any future disbursements.
Response: DSHS disagrees and declines to revise the language. The funding is dispersed by the state of Texas. Therefore, state requirements must be met, and any funds owed by the facility to the state would be reconciled.
DSHS revises §157.2(9) to correct a reference that was missing a parenthesis.
DSHS moves "annually" in the Level IV facility descriptions to follow "inclusion criteria" in §157.2(20), §157.126(g)(4)(A) and (B), (h)(19), (21), (25), (30) - (32), (n), (n)(3) - (4), and (o)(3)(A) and (B) to clarify the requirement is not inclusive of all trauma patients annually, but only those "meeting NTDB registry inclusion criteria annually."
DSHS revises §157.2(32) to make allowances for facilities transferring patients out from the emergency department.
DSHS deletes "and system plan" from the §157.2(142) definition because it is redundant.
DSHS replaces "evaluated" with "managed" in §157.125(t) for consistent language with §157.2(20), §157.126(g)(4)(A) and (B), (h)(8), (h)(19) - (21), (h)(25), (h)(30) - (32), (n), (n)(3) - (4), (o)(3), and (o)(3)(A) and (B).
DSHS removes "in order" from §157.125(t) because it is not necessary.
DSHS deletes "surgeon" in §157.125(x)(18) after neurosurgeon because it is a duplication.
DSHS revises §157.125(y)(19) to "in collaboration with the RAC or their health care system" adding another option for facilities providing education to staff physicians, nurses, and allied health personnel, including APPs.
DSHS deletes "evaluating and" from §157.126(h)(12)(G) and (h)(13) to be consistent with revisions made to the rules. DSHS adds "emergency requests from" to §157.126(h)(15)(A) to further define the use of telemedicine for inpatient units.
DSHS adds "wristband number or patient tracking identifier" to §157.126(h)(18) to ensure documentation of §157.126(h)(4) in medical records.
DSHS revises §157.126(h)(20) to clarify the trauma medical director (TMD) requirements for the Level I, II, and III facilities remain aligned with the current ACS standards. Language was added to the Level IV facilities managing 101 or more trauma patients… "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."
DSHS adds "for the TPM" to §157.126(h)(21) to clarify the education is recommended for the TPM position.
DSHS moves "annually" after "inclusion criteria" in §157.126(o)(3) to be consistent with Level IV rule language in §157.2(20), §157.126(g)(4)(A) - (B), (h)(19) - (21), (h)(25), (h)(30-32), (n), (n)(3) - (4), and (o)(3)(A) - (B).
DSHS revises §157.126(o) to clearly separate and list the survey team members for each designation level. Language was revised to ensure appropriate grammar and consistent language in all survey team descriptions.
DSHS adds "organization" to §157.126(o)(3)(B) for consistent language in the requirement and §157.126(o)(3)(A).
DSHS revises the language in §157.126(n)(4) adding "or" for the option of a department-approved survey organization for consistent language with §157.2(20) Basic Level IV trauma facility.
DSHS removes "in writing" from §157.126(n)(4) because it is implied, and the language is sufficient.
DSHS adds "trauma" to the regional system in §157.126(t)(2)(A) for consistent language with §157.126(t)(2).
SUBCHAPTER A. EMERGENCY MEDICAL SERVICES - PART A
STATUTORY AUTHORITY
The amendment is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Health and Safety Code Chapter 773 (Emergency Health Care Act), which authorizes the Executive Commissioner to adopt rules to implement emergency medical services and trauma care systems; Texas Health and Safety Code Chapter 773, Subchapter G, which provides for the authority to adopt rules related to emergency medical services and trauma services; and Texas Health and Safety Code §1001.075, which authorizes the Executive Commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001.
§157.2.Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
(1) Abandonment--Leaving a patient without appropriate medical care once patient contact has been established, unless emergency medical services personnel are following the medical director's protocols, a physician directive, or the patient signs a release; or turning the care of a patient over to an individual of lesser education when advanced treatment modalities have been initiated.
(2) Accreditation--Formal recognition by a national association of a provider's service or an education program based on standards established by that association.
(3) Act--Emergency Health Care Act, Texas Health and Safety Code Chapter 773.
(4) Active pursuit of department designation as a trauma facility--An undesignated facility recognized by the department after applying for designation as a trauma facility and has met the requirement to be eligible for uncompensated trauma care funds.
(5) Acute Stroke-Ready Level IV stroke facility--A hospital reviewed by a department-approved survey organization and meeting the national stroke standards of care for an acute stroke-ready facility as described in §157.133 of this chapter (relating to Requirements for Stroke Facility Designation).
(6) Administrator of record (AOR)--The administrator for an emergency medical services (EMS) provider who meets the requirements of Texas Health and Safety Code §773.05712.
(7) Advanced emergency medical technician (AEMT)--An individual certified by the department and minimally proficient in performing the basic life support skills required to provide emergency prehospital or interfacility care and initiating and maintaining under medical supervision, certain advanced life support procedures, including intravenous therapy and endotracheal or esophageal intubation.
(8) Advanced Level II stroke facility--A hospital that completes a designation survey with a department-approved survey organization, meets the national stroke standards for Non-Comprehensive Thrombectomy Stroke Center, and meets the requirements of an Advanced Level II stroke facility as defined by §157.133 of this chapter.
(9) Advanced Level III trauma facility--A hospital surveyed by a department-approved survey organization that meets the state requirements and American College of Surgeons (ACS) standards for a Level III trauma facility as described in §157.125 of this chapter (relating to Requirements for Trauma Facility Designation Effective Through August 31, 2025) and §157.126 of this chapter (relating to Trauma Facility Designation Requirements Effective on September 1, 2025).
(10) Advanced life support (ALS)--Emergency prehospital or interfacility care that uses invasive medical acts and includes ALS assessment. The provision of advanced life support must be under the medical supervision and control of a licensed physician.
(11) Advanced life support assessment--Assessment performed by an AEMT or paramedic that qualifies as advanced life support based upon initial dispatch information, when it could reasonably be believed the patient was suffering from an acute condition that may require advanced skills.
(12) Advanced life support vehicle--A vehicle designed for transporting the sick and injured and meeting the requirements of §157.11 of this chapter (relating to Requirements for an EMS Provider License) as an ALS vehicle and having sufficient equipment and supplies for providing an advanced level of care based on national standards and the EMS provider's medical director-approved treatment protocols.
(13) Advanced practice provider (APP)--A nurse practitioner or physician assistant reviewed and credentialed by the facility and may have additional credentialing to participate in the designation program.
(14) Air ambulance provider--A person who operates, maintains, or leases a fixed-wing or rotor-wing air ambulance aircraft, equipped and staffed to provide a medical care environment on-board appropriate to the patient's needs. The term air ambulance provider is not synonymous with and does not refer to the Federal Aviation Administration (FAA) air carrier certificate holder unless the air ambulance provider maintains and controls the medical aspects consistent with EMS provider licensure.
(15) Ambulance--A vehicle for transportation of the sick or injured patient to, from, or between places of treatment for an illness or injury and that provides out-of-hospital medical care to the patient.
(16) American College of Surgeons (ACS)--The organization that sets the national standards for trauma centers, trauma verification, the National Trauma Data Standards (NTDS), National Trauma Data Bank (NTDB), Trauma Quality Improvement Program (TQIP), and regional system standards.
(17) Approved survey organization--An organization that has received department authorization to conduct designation surveys, meeting the department's designation survey guidelines and expectations.
(18) Authorized ambulance vehicle--A vehicle authorized to be operated by the licensed provider and meeting all criteria for approval as described in §157.11(e) of this chapter.
(19) Bad debt--The unreimbursed cost for patient care to a hospital providing trauma care.
(20) Basic Level IV trauma facility--A hospital managing 101 or more trauma patients meeting NTDB registry inclusion criteria annually surveyed by a department-approved survey organization and meeting the state requirements and ACS standards, or a hospital managing 100 or less trauma patients meeting NTDB registry inclusion criteria annually surveyed by the department or a department-approved survey organization, and meeting the state designation requirements for a Level IV trauma facility as described in §157.125 and §157.126 of this chapter.
(21) Basic life support (BLS)--Emergency prehospital or interfacility care that uses noninvasive medical acts. The provision of basic life support will have sufficient equipment and supplies for providing basic-level care based on national standards and the EMS provider's medical director-approved treatment protocols.
(22) Basic life support (BLS) vehicle--A vehicle designed for transporting the sick or injured and having sufficient equipment and supplies for providing basic life support based on national standards and the EMS provider's medical director-approved treatment protocols.
(23) Bypass--Direction given to prehospital emergency medical services personnel by direct on-line medical control, or off-line medical director protocols to bypass the nearest facility for the most appropriate facility.
(24) Calculation of the costs of uncompensated trauma care--A calculation of a hospital's total costs of uncompensated trauma care for patients meeting the hospital's trauma activation guidelines and meeting NTDB registry inclusion criteria determined by summing its charges related to uncompensated trauma care as defined in §157.130 of this chapter (relating to Funds for Emergency Medical Services, Trauma Facilities, and Trauma Care Systems, and the Designated Trauma Facility and Emergency Services Account), then applying the cost-to-charge ratio derived in accordance with generally accepted accounting principles.
(25) Candidate--An individual requesting emergency medical services personnel certification, licensure, recertification, or re-licensure from the department.
(26) Certificant--Emergency medical services personnel with current certification from the department.
(27) Charity care--The unreimbursed cost to a hospital providing health care services for an inpatient, emergency department, transferred, or expired person classified by the hospital as "financially indigent."
(28) Commissioner--The commissioner of the Texas Department of State Health Services.
(29) Comprehensive Level I stroke facility--A hospital surveyed by a department-approved survey organization meeting the national standards of care for a Comprehensive Stroke Center, participates in its local Regional Advisory Council (RAC), participates in the regional stroke plan, and submits data to the department, as requested as defined by §157.133 of this chapter.
(30) Comprehensive Level I trauma facility--A hospital surveyed by a department-approved survey organization meeting the state designation requirements and ACS standards for a Level I trauma facility as described in §157.125 and §157.126 of this chapter.
(31) Concurrent performance improvement--Performance improvement reviews occurring from prehospital, trauma activation, or admission through to discharge. The primary level of review must be completed within 14 days of discharge, 80 percent of the time.
(32) Concurrent trauma registry abstraction--Trauma registry data abstraction and registry data entry occurring after the management of the trauma patient and completed within 60 days after the patient's discharge, 80 percent of the time.
(33) Consumer Protection Division (CPD)--A division within the Texas Department of State Health Services responsible for the oversight of EMS provider licensure, certification, education, and complaint investigation. The division is responsible for the hospital designation process for trauma, stroke, maternal, and neonatal facilities; the RAC system development and advances; and funding, grant management, and distribution of funding for the division.
(34) Contingent designation--A designation awarded to a facility with one to three unmet designation requirements. The department develops a corrective action plan (CAP) for the facility and the facility must complete this plan and meet requirements to remain designated. Contingent designations may require a focused survey to validate requirements are met. The facility must demonstrate requirements are met to maintain designation.
(35) Contingent probationary designation--A designation awarded to a facility with four or more unmet designation requirements. The department develops a CAP for the facility and the facility must complete this plan and meet requirements to remain designated. The facility may be required to submit documentation reflecting the CAP to the department at defined intervals. Contingent probationary designation may require a full survey within 12 to 18 months after the original survey date. The facility must demonstrate requirements are met to maintain designation.
(36) Corrective action plan (CAP)--A plan for the facility developed by the department describing the actions the facility is required to correct.
(37) Cost-to-charges ratio--A ratio covering all applicable hospital costs and charges relating to inpatient care determined by the Texas Health and Human Services Commission from the hospital's Medicaid cost report.
(38) County of licensure--The county in which the physical address of a licensed EMS provider is located, as indicated by the provider on the application for licensure that is filed with the department.
(39) Course medical director--A Texas-licensed physician, approved by the department, with experience in and current knowledge of emergency care who must provide direction over all instruction and clinical practice required in EMS training courses.
(40) Credit hour--Continuing education credit unit awarded for successful completion of a unit of learning activity as defined in §157.32 of this chapter (relating to Emergency Medical Services Education Program and Course Approval).
(41) Critically injured person--An individual suffering with multi-system injuries or major single-system injury; the extent of the injury may be difficult to ascertain but has the potential of producing mortality or major disability.
(42) Definitive care--The phase of care in which therapeutic interventions, treatments, or procedures are performed to stop or control an injury, illness, or disease and promote recovery.
(43) Department--The Texas Department of State Health Services.
(44) Designated facility administrator--Administrator responsible for the oversight, funding, contracts, and leadership of designated programs.
(45) Designated infection control officer--A designated officer who serves as a liaison between the employer and the employees who have been or believe to have been exposed to a potentially life-threatening infectious disease through a person who was treated or transported by the EMS provider.
(46) Designation--A formal recognition by the department of a hospital's capabilities, commitment, care practices, and participation in the RAC to serve as a designated facility.
(47) Designation appeal--The process for a hospital that has been downgraded or denied a specific level of designation to appeal the designation decision.
(48) Designation survey--An on-site or virtual review of a facility applicant to determine if it meets the criteria for a particular level of designation.
(49) Dispatch--The sending of individuals and equipment by EMS for assessment, prompt efficient treatment, and transportation, if required, of a sick or injured patient.
(50) Distance learning--A method of learning remotely without being in regular face-to-face contact with an instructor in the classroom.
(51) Diversion--A procedure put into effect by a health care facility notifying EMS when that facility is unable to provide the level of care demanded by a patient's injuries or condition due to lack of capacity or capabilities, or when the facility has temporarily exhausted its resources and requesting patients be transported to another facility.
(52) Emergency call--A call or other similar communication from a member of the public, as part of a 9-1-1 system or other emergency access communication system, made to obtain emergency medical services.
(53) Emergency care attendant (ECA)--An individual who is certified by the department as minimally proficient in performing emergency prehospital care by providing initial aid that promotes comfort and avoids aggravation of an injury or illness.
(54) Emergency medical services (EMS)--Services used to respond to an individual's perceived need for medical care and to prevent death or aggravation of physiological or psychological illness or injury.
(55) EMS medical director--The licensed physician who provides medical supervision to the EMS personnel of a licensed EMS provider or a recognized first responder organization (FRO) under the terms of the Medical Practice Act (Texas Occupations Code Chapters 151 - 165) and rules promulgated by the Texas Medical Board; may also be called "off-line medical control."
(56) Emergency medical services operator--An individual who, as an employee of a public or private agency, receives emergency calls and may provide medical information or medical instructions to the public during those emergency calls.
(57) Emergency medical services personnel--
(A) emergency care attendant (ECA);
(B) emergency medical technician (EMT);
(C) advanced emergency medical technician (AEMT);
(D) emergency medical technician-paramedic (EMT-P); or
(E) licensed paramedic (LP).
(58) Emergency medical services provider--An organization that uses, operates, or maintains EMS vehicles and EMS personnel to provide emergency medical services.
(59) Emergency medical services times--
(A) Time of call--The date and time a phone rings at a public safety answering point (PSAP) or other designated entity, requesting EMS services.
(B) Dispatch time--The date and time a responding EMS provider is notified by dispatch.
(C) En route--The date and time the EMS vehicle starts moving to respond.
(D) On scene--The date and time a responding EMS vehicle stops moving when it arrives at the location of the response.
(E) At patient side--The date and time the EMS personnel of the responding EMS vehicle arrives at the patient's side.
(F) Transport--The date and time the responding EMS vehicle leaves the location of the response and starts moving toward the destination.
(G) Arrival time--The date and time the responding EMS vehicle arrives with the patient at the destination or transfer point.
(H) Transfer of care--The date and time patient care is transferred to the destination health care staff or transfer point of health care.
(I) Back in service--The date and time the EMS vehicle is back in service and available for another response.
(60) Emergency medical services vehicle--
(A) basic life support (BLS) vehicle;
(B) advanced life support (ALS) vehicle;
(C) mobile intensive care unit (MICU) vehicle;
(D) MICU rotor-wing and MICU fixed-wing air medical vehicles; or
(E) specialized emergency medical service vehicle.
(61) Emergency medical services volunteer--EMS personnel who provide emergency prehospital or interfacility care in affiliation with a licensed EMS provider or a registered FRO without remuneration, except for reimbursement for expenses.
(62) Emergency medical services volunteer provider--An EMS provider with at least 75 percent of personnel as volunteers and is a nonprofit organization. See §157.11 of this chapter regarding fee exemption.
(63) Emergency medical technician (EMT)--An individual certified by the department as minimally proficient in performing emergency prehospital care necessary for basic life support and includes the control of hemorrhaging and cardiopulmonary resuscitation.
(64) Emergency medical technician-paramedic (EMT-P)--An individual certified by the department as minimally proficient in performing emergency prehospital or interfacility care in health care facility's emergency or urgent care clinical setting, including a hospital emergency room and a freestanding emergency medical care facility, by providing advanced life support that includes initiation and maintenance under medical supervision of certain procedures, including intravenous therapy, endotracheal or esophageal intubation or both, electrical cardiac defibrillation or cardioversion, and drug therapy.
(65) Emergency prehospital care--Care provided to the sick and injured within a health care facility's emergency or urgent care clinical setting, including a hospital emergency room and freestanding emergency medical care facility, before or during transportation to a medical facility, including any necessary stabilization of the sick or injured in connection with transportation.
(66) Event--A variation from the established care management guidelines or system operations such as delays in response, delays in care, hospital event such as complications, or death. An event or variation in care creates a need for review of the care or system processes to identify opportunities for improvement.
(67) Event resolution--An event, as described in paragraph (66) of this section, that is identified and reviewed to determine the impact to the patient and if opportunities for improvement in care or the system exist, with a specific action plan tracked with data analysis to demonstrate the action plan created the desired change to achieve the desired goal, and improved outcomes are sustained.
(68) Extraordinary emergency--A serious, unexpected event or situation requiring immediate action to reduce or minimize disruption to established health care services within the EMS and trauma care system.
(69) Field triage--The process of determining which facility is most appropriate for patients based on injury severity, time-sensitive disease factors, and facility availability. Refer to paragraph (104) of this section.
(70) Financially indigent--An uninsured or underinsured patient unable to pay for the trauma services rendered based on the hospital's eligibility system.
(71) First responder organization (FRO)--A group or association of certified EMS personnel that work in cooperation with licensed EMS providers.
(72) Fixed location--The address as it appears on the initial or renewal EMS provider license application in which the patient care records and administrative departments are located.
(73) Governmental entity--A county, a city or town, a school district, or a special district or authority created in accordance with the Texas Constitution, including a rural fire prevention district, an emergency services district, a water district, a municipal utility district, and a hospital district.
(74) Governor's EMS and Trauma Advisory Council (GETAC)--An advisory council appointed by the Governor of Texas that provides professional recommendations to the EMS/Trauma System Section regarding EMS and trauma system development and serves as a forum for stakeholder input.
(75) Inactive EMS provider status--The period of time when a licensed EMS provider is not able to respond to an EMS dispatch.
(76) Industrial ambulance--Any vehicle owned and operated by an industrial facility as defined in the Texas Transportation Code §541.201 and used for initial transport or transfer of company employees who become urgently ill or injured on company premises to an appropriate health care facility.
(77) Injury severity score (ISS)--An anatomical scoring system providing an overall score for trauma patients. The ISS standardizes the severity of trauma injuries based on the three worst abbreviated injury scales (AIS) from the body regions. These regions are the head and neck, face, chest, abdomen, extremity, and external as defined by the Association for the Advancement of Automotive Medicine (AAAM). The highest abbreviated injury score in the three most severely injured body regions have the scores squared, then added together to define the patient's ISS.
(78) Interfacility care--Care provided while transporting a patient between health care facilities.
(79) Legal entity name--The name of the lawful or legally standing association, corporation, partnership, proprietorship, trust, or individual. Has legal capacity to:
(A) enter into agreements or contracts;
(B) assume obligations;
(C) incur and pay debts;
(D) sue and be sued in its own right; and
(E) to be accountable for illegal activities.
(80) Level of harm--A classification system defining the impact of an event to the patient and assists in defining the urgency of review. There are five levels of harm used to define the impact to the patient as defined by the American Society for Health Care Risk Management:
(A) No harm--The patient was not symptomatic or no symptoms were detected, and no treatment or intervention was required.
(B) Mild harm--The patient was symptomatic, symptoms were mild, loss of function or harm was either minimal or intermediate but short-term, and no interventions or only minimal interventions were needed.
(C) Moderate harm--The patient was symptomatic, required intervention such as additional operative procedure, therapeutic treatment, or an increased length of stay, required a higher level of care, or may experience long-term loss of function.
(D) Severe harm--The patient was symptomatic, required life-saving or other major medical or surgical intervention, or may experience shortened life expectancy, and may experience major permanent or long-term loss of function.
(E) Death harm--The event was a contributing factor in the patient's death.
(81) Levels of review--Describes the levels of performance improvement review for an event in the designation program's quality improvement or performance improvement patient safety (PIPS) plan. There are four levels of review:
(A) Primary level of review--Initial investigation of identified events by the facility's designation program performance improvement personnel to capture the event details and to validate and document the timeline, contributing factors, and level of harm. The program manager usually addresses system issues with no level of harm, including identifying the opportunities for improvement and action plan appropriate for the event, and keeping the program medical director updated. This must be written in the facility's performance improvement plan.
(B) Secondary level of review--The level of review by the facility's designation program medical director in which the program personnel prepare the documentation and facts for the review. The program medical director reviews the documentation and either agrees or corrects the level of harm, defines the opportunities for improvement with action plans, or refers to the next level of review.
(C) Tertiary level of review--The third level of review by the facility's designation program to evaluate care practices and compliance to defined management guidelines, identify opportunities for improvement, and define a plan of correction (POC). Minutes capturing the event, discussion, and identified opportunities for improvement with action plans must be documented.
(D) Quaternary level of review--The highest level of review, which may be conducted by an entity external to the facility program as an element of the performance improvement plan. The event, review, and discussion of the event, and identified opportunities for improvement with action plans must be documented.
(82) Licensee--A person who holds a current paramedic license from the department, or an organization that uses, maintains, or operates EMS vehicles and provides EMS personnel to provide emergency medical services, and who holds an EMS provider license from the department.
(83) Major Level II trauma facility--A hospital surveyed by a department-approved survey organization meeting the state designation requirements and ACS standards for a Level II trauma facility as described in §157.125 and §157.126 of this chapter.
(84) Major trauma patient--An individual with injuries, or potential injuries, who benefits from treatment at a trauma facility. The patient may or may not present with alterations in vital signs or level of consciousness, or with obvious, significant injuries, but has been involved in an event that produces a high index of suspicion for significant injury and potential disability. Co-morbid factors such as age or the presence of significant preexisting medical conditions are also considered. The patient initiates a system response to include field triage to the most appropriate designated trauma facility.
(85) Medical control--The supervision of prehospital EMS providers and FROs by a licensed physician. This encompasses on-line (direct voice contact) and off-line (written protocol and procedural review).
(86) Medical oversight--The assistance and management given to health care providers and entities involved in regional EMS/trauma systems planning by a physician or group of physicians designated to provide technical assistance to the EMS provider or FRO medical director.
(87) Medical supervision--Direction given to EMS personnel by a licensed physician under the terms of the Medical Practice Act (Texas Occupations Code Chapters 151 - 165) and rules promulgated by the Texas Medical Board.
(88) Mobile intensive care unit--A vehicle designed for transporting the sick or injured, meeting the requirements of the advanced life support vehicle, and having sufficient equipment and supplies to provide cardiac monitoring, defibrillation, cardioversion, drug therapy, and two-way communication with at least one paramedic on the vehicle when providing EMS.
(89) National EMS Compact--The agreement among states to allow the day-to-day movement of EMS personnel across state boundaries.
(90) National EMS Information System (NEMSIS)--A universal standard for how patient care information resulting from an EMS response is collected.
(91) National Trauma Data Bank (NTDB)--The national repository for trauma registry data, defined by the ACS with inclusion criteria and data elements required for submission.
(92) National Trauma Data Standards (NTDS)--The American College of Surgeons' standard data elements with definitions required for submission to the NTDB, as defined in paragraph (91) of this section.
(93) Non-contiguous emergency department--A hospital emergency department located in a separate building, not contiguous with the designated facility. May be referred to as a satellite emergency department.
(94) Off-line medical director--The licensed physician who provides approved protocols and medical supervision to the EMS personnel of a licensed EMS provider under the terms of the Medical Practice Act (Texas Occupations Code Chapters 151 - 165) and rules promulgated by the Texas Medical Board.
(95) On-line course--A directed learning process comprised of educational information (articles, videos, images, web links), communication (messaging, discussion forums) for virtual learning, and measures to evaluate the student's knowledge.
(96) Operational name--Name under which the business or operation is conducted and presented to the world.
(97) Operational policies--Policies and procedures that are the basis for the provision of EMS and that include such areas as vehicle maintenance; proper maintenance and storage of supplies, equipment, medications, and patient care devices; complaint investigations; multi-casualty incidents; and hazardous materials; but do not include personnel or financial policies.
(98) Operations Committee--Committee serving as the facility's trauma program administrative oversight for designation and responsible for the approval of trauma management guidelines, operational plan, and procedures within the program or system having the potential to impact care practices or designation.
(99) Operative or surgical intervention--Any surgical procedure provided to address trauma injuries for patients taken directly from the scene, emergency department, or other hospital location to an operating suite for patients meeting the hospital's trauma activation guidelines and meeting NTDB registry inclusion criteria.
(100) Out of service vehicle--The period of time when a licensed EMS vehicle is unable to respond to an emergency or non-emergency response.
(101) Performance improvement and patient safety (PIPS) plan--The written plan and processes for evaluating patient care, system response, and adherence to established patient management guidelines; defining variations from care or system response; assigning the level of harm and level of review; identifying opportunities for improvement; and developing the CAP. The CAP outlines data analysis and measures to track the action plan to ensure the desired changes are met and maintained to resolve the event. The medical director, program manager, and administrator have the authority and oversight over PIPS.
(102) Plan of correction (POC)--A report submitted to the department by the facility detailing how the facility will correct one or multiple requirements defined as "not met" during a trauma designation survey review that is reported in the survey summary or documented in the self-attestation.
(103) Practical exam--An evaluation that assesses the person's ability to perceive instructions and perform motor responses, also referred to as a psychomotor exam.
(104) Prehospital triage--The process of identifying medical or injury acuity or the potential for severe injury based upon physiological criteria, injury patterns, and high-energy mechanisms and transporting patients to a facility appropriate for the patient's medical or injury needs. Prehospital triage for injured patients or time-sensitive disease events is guided by the approved prehospital triage guidelines adopted by the RAC and approved by the department. May also be referred to as "field triage" or "prehospital field triage."
(105) Primary EMS provider response area--The geographic area in which an EMS agency routinely provides emergency EMS as agreed upon by a local or county governmental entity or by contract.
(106) Primary Level III stroke facility--A hospital designated by the department and meets the department-approved national stroke standards of care for a primary stroke center, participates in its RAC, participates in the regional stroke plan, and submits data as requested by the department.
(107) Protocols--A detailed, written set of instructions by the EMS provider's medical director, which may include delegated standing medical orders, to guide patient care or the performance of medical procedures as approved.
(108) Public safety answering point (PSAP)--The call center responsible for answering calls to an emergency telephone number for ambulance services; sometimes called "public safety access point" or "dispatch center."
(109) Quality management--Quality assessment, quality improvement, and performance improvement activities. See definition of PIPS in paragraph (101) of this section.
(110) Receiving facility--A health care facility to which an EMS vehicle may transport a patient requiring prompt continuous medical care, or a facility receiving a patient being transferred for definitive care.
(111) Recertification--The procedure for renewal of EMS certification.
(112) Reciprocity--The recognition of certification or privileges granted to an individual from another state or recognized EMS system.
(113) Regional Advisory Council (RAC)--A nonprofit organization recognized by the department and responsible for system coordination for the development, implementation, and maintenance of the regional trauma and emergency health care system within its geographic jurisdiction of the Trauma Service Area. A RAC must maintain 501(c)(3) status.
(114) Regional Advisory Council Performance Improvement Plan--A written plan of the RAC's processes to review identified or referred events, identify opportunities for improvement, define action plans and data required to correct the event, and establish measures to evaluate the action plan through to event resolution.
(115) Regional medical control--Physician supervision for prehospital EMS providers in a given trauma service area (TSA) or other geographic area intended to provide standardized oversight, treatment, and transport guidelines, which should, at minimum, follow the RAC's regional trauma and emergency health care system plan components related to these issues and 22 Texas Administrative Code §197.3 (relating to Off-line Medical Director).
(116) Relicensure--The procedure for renewal of a paramedic license as described in §157.40 of this chapter (relating to Paramedic Licensure); the procedure for renewal of an EMS provider license as described in §157.11 of this chapter.
(117) Response pending status--The status of an EMS vehicle that just delivered a patient to a final receiving facility and for which the dispatch center has another EMS response waiting.
(118) Response ready--When an EMS vehicle is equipped and staffed in accordance with §157.11 of this chapter and is immediately available to respond to any emergency call 24-hours per day, seven days per week (24/7).
(119) Rural county--A county with a population of less than 50,000 based on the latest estimated federal census population figures.
(120) Scope of practice--The procedures, actions, and processes EMS personnel are authorized to perform as approved by the EMS provider's medical director.
(121) Scope of services--The types of services and the resources to provide those services that a facility has available.
(122) Severe trauma patient--A person with injuries or potential injuries defined as high-risk for mortality or disability and meeting trauma activation guidelines and meeting NTDB registry inclusion criteria benefitting from definitive treatment at a designated trauma facility. These patients may be identified by an alteration in vital signs or level of consciousness or by the presence of significant injuries and must initiate a level of trauma response defined by the facility, including prehospital triage to a designated trauma facility.
(123) Simulation training--Training, typically scenario-based or skill-based, utilizing simulated patients or system events to improve or assess knowledge, competencies, or skills.
(124) Sole provider--The only licensed EMS provider in a geographically contiguous service area and in which the next closest provider is greater than 20 miles from the limits of the area.
(125) Specialized EMS vehicle--A vehicle designed for responding to and transporting sick or injured persons by any means of transportation other than by standard automotive ground ambulance or rotor or fixed-wing aircraft and that has sufficient staffing, equipment, and supplies to provide for the specialized needs of the patient transported. This category includes watercrafts, off-road vehicles, and specially designed, configured, or equipped vehicles used for transporting special care patients such as critical neonatal or burn patients.
(126) Specialty resource centers--Entities caring for specific types of patients such as pediatric, cardiac, and burn injuries that have received certification, categorization, verification, or other forms of recognition by an appropriate agency regarding the capability to definitively treat these types of patients.
(127) Staffing plan--A document indicating the overall working schedule patterns of EMS or hospital personnel.
(128) Standard of care--Care equivalent to what any reasonable, prudent person of like education or certification level would have given in a similar situation, based on documented, evidence-based practices or adopted standard EMS curricula as adopted by reference in §157.32 of this chapter; also refers to the documented standards of care reflecting evidence-based practice.
(129) State EMS Registry--State repository for the collection of EMS response data as defined in Chapter 103 of this title (relating to Injury Prevention and Control).
(130) State Trauma Registry--Statewide database managed by the department; responsible for the collection, maintenance, and evaluation of medical and system information related to required reportable events as defined in Chapter 103 of this title.
(131) Stroke--A time-sensitive medical condition occurring when the blood supply to the brain is reduced or blocked, caused by a ruptured blood vessel or clot, preventing brain tissue oxygenation.
(132) Stroke activation--The process of mobilizing the stroke care team when a patient screens positive for stroke symptoms; may be referred to as a "stroke alert" or "code stroke."
(133) Stroke facility--A hospital that has successfully completed the designation process and is capable of resuscitating and stabilizing, transferring, or providing definitive treatment to stroke patients and actively participates in its local RAC and system plan.
(134) Stroke medical director (SMD)--A physician meeting the department's requirements for the stroke medical director and having the authority and oversight for the stroke program, including the performance improvement process, data management, and outcome reviews.
(135) Stroke program manager (SPM)--A registered nurse meeting the requirements for the stroke program manager and having the authority and oversight for the stroke program, including the performance improvement process, data management, and outcome reviews.
(136) Substation--An EMS provider station location, not the fixed station, and likely to provide rapid access to a location to which the EMS vehicle may be dispatched.
(137) Telemedicine medical service--A health care service delivered by a physician licensed in this state, or a health professional acting under the delegation and supervision of a physician licensed in this state, and acting within the scope of the physician's or health professional's license to a patient at a different physical location than the physician or health professional using telecommunications or technology as defined in Texas Occupations Code §111.001.
(138) Transport mode--As documented on the patient care record, the usage of emergency warning equipment when responding to an EMS dispatch and when transporting a patient to a receiving facility.
(139) Trauma--An injury or wound to a living body caused by the application of an external force or violence, including burn injuries, and meeting the trauma program's trauma activation guidelines.
(140) Trauma activation guidelines--Established criteria identifying the potential injury risk to the human body and defining the resources and response times required to evaluate, resuscitate, and stabilize the trauma patient. The guidelines must meet the national recommendations, but each trauma program defines the activation guidelines for the facility. The facility may choose to have one activation level, two activation levels, or three activation levels.
(A) The highest level of trauma activation is commonly based on physiological changes in the patient's level of consciousness, airway or potential respiratory compromise, hypotension or signs of shock, significant hemorrhage, or evidence of severe trauma.
(B) The second level of trauma activation is commonly based on the patient's physiological stability with anatomical injuries or mechanisms of injury having the potential for serious injuries.
(C) The third level of trauma activation is designed for low-energy or single-system injuries that may require specialty service evaluation and intervention.
(141) Trauma administrator--Administrator responsible for the facility oversight, funding, contracts, and collaborative leadership of the program, and serves as an interface with the chief executive team as defined by the facility's organizational structure.
(142) Trauma and emergency health care system plan--The inclusive system that refers to the care rendered after a traumatic injury or time-sensitive disease or illness where the optimal outcome is the critical determinant. The system components encompass special populations, epidemiology, risk assessments, surveillance, regional leadership, system integration, business or finance models, prehospital care, definitive care facilities, system coordination for patient flow, prevention and outreach, rehabilitation, emergency preparedness and response, system performance improvement, data management, and research. These components are integrated into the regional self-assessment.
(143) Trauma care--Care provided to an injured patient meeting the hospital's trauma activation guidelines and meeting NTDB registry inclusion criteria and the continuum of care throughout the system, including discharge and follow-up care or transfer.
(144) Trauma Designation Review Committee--Committee responsible for reviewing trauma designation appeals, reviewing requirement exception and waiver requests, and outlining specific requirements not met in order to identify potential opportunities to improve future rule amendments.
(145) Trauma facility--A hospital that has successfully completed the designation process, is capable of resuscitating and stabilizing, transferring, or providing definitive treatment to patients meeting trauma activation criteria, and actively participates in its local RAC and the development of the regional trauma and emergency health care system plan.
(146) Trauma medical director (TMD)--A physician meeting the requirements and demonstrating the competencies and leadership for the oversight and authority of the trauma program as defined by the level of designation and having the authority and oversight for the trauma program, including the performance improvement and patient safety processes, trauma registry, data management, peer review processes, outcome reviews, and participation in the RAC (TMD or designee) and the development of the regional trauma and emergency health care system plan.
(147) Trauma patient--Any injured person who has been evaluated by a physician, a registered nurse, or EMS personnel, and found to require medical care in a trauma facility based on local or national medical standards.
(148) Trauma program manager (TPM)--A registered nurse who in partnership with the TMD and hospital administration is responsible for oversight and authority of the trauma program as defined by the level of designation, including the trauma performance improvement and patient safety processes, trauma registry, data management, injury prevention, outreach education, outcome reviews, and research as appropriate to the level of designation.
(149) Trauma Quality Improvement Program (TQIP)--The ACS risk-adjusted benchmarking program using submitted data to evaluate specific types of injuries and events to compare cohorts' outcomes with other trauma centers; assisting in defining opportunities for improvement in specific patient cohorts.
(150) Trauma registrar--An individual meeting the requirements and whose job responsibilities include trauma patient data abstraction, trauma registry data entry, injury coding, and injury severity scoring, in addition to registry report writing and data management skills specific to the trauma registry and trauma program.
(151) Trauma registry--A trauma facility database capturing required elements of trauma care for each patient.
(152) Trauma service area--Described in §157.122 of this subchapter (relating to Trauma Service Areas).
(153) Uncompensated trauma care--The sum of "charity care" and "bad debt." Contractual adjustments in reimbursement for trauma services based upon an agreement with a payor (including Medicaid, Medicare, Children's Health Insurance Program (CHIP), or other health insurance programs) are not uncompensated trauma care.
(154) Urban county--A county with a population of 50,000 or more based on the latest estimated federal census population figures.
(155) Verification--Process used by the ACS to review a facility seeking trauma verification to validate the defined standards are met with documented compliance for successful trauma center verification. If a Level I or Level II facility is not verified by the ACS, the department cannot designate the facility.
(156) When in service--The period of time when an EMS vehicle is responding to an EMS dispatch, at the scene, or en route to a facility with a patient.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 4, 2024.
TRD-202405306
Cynthia Hernandez
General Counsel
Department of State Health Services
Effective date: November 24, 2024
Proposal publication date: August 2, 2024
For further information, please call: (512) 535-8538
25 TAC §§157.123, 157.130, 157.131
STATUTORY AUTHORITY
The repeals are adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Health and Safety Code Chapter 773 (Emergency Health Care Act), which authorizes the Executive Commissioner to adopt rules to implement emergency medical services and trauma care systems; Texas Health and Safety Code Chapter 773, Subchapter G, which provides for the authority to adopt rules related to emergency medical services and trauma services; and Texas Health and Safety Code §1001.075, which authorizes the Executive Commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 4, 2024.
TRD-202405307
Cynthia Hernandez
General Counsel
Department of State Health Services
Effective date: November 24, 2024
Proposal publication date: August 2, 2024
For further information, please call: (512) 535-8538
STATUTORY AUTHORITY
The amendments and new sections are adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Health and Safety Code Chapter 773 (Emergency Health Care Act), which authorizes the Executive Commissioner to adopt rules to implement emergency medical services and trauma care systems; Texas Health and Safety Code Chapter 773, Subchapter G, which provides for the authority to adopt rules related to emergency medical services and trauma services; and Texas Health and Safety Code §1001.075, which authorizes the Executive Commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001.
§157.123.Regional Advisory Councils.
(a) The department recognizes a Regional Advisory Council (RAC) as the coordinating entity for the development and advancement of the regional trauma and emergency health care system within the defined trauma service area (TSA) as described in §157.122 of this subchapter (relating to Trauma Service Areas).
(1) The department recognizes only one RAC for each TSA.
(2) Trauma, prehospital, perinatal, stroke, cardiac, disaster response, and emergency health care stakeholders in the TSA must be eligible for participation or membership in the RAC.
(b) A RAC must meet the following requirements to be recognized as a RAC:
(1) maintain incorporation as an entity exempt from federal income tax under §501(a) of the United States Internal Revenue Code of 1986, and its subsequent amendments, by being listed as an exempt organization under §501(c)(3) of the code, and to be eligible to receive, distribute, and utilize the emergency medical services (EMS), uncompensated care, and TSA allotments;
(2) submit required documentation to the department that includes, at a minimum, the following:
(A) a summary of regional trauma, prehospital, pediatric, geriatric, perinatal, stroke, cardiac, and emergency health care system activities;
(B) evidence of an annual summary of the EMS, trauma, and emergency health care system performance improvement plan; and
(C) a completed regional self-assessment by the end of each odd state fiscal year, and a current trauma and emergency health care system plan by the end of each even state fiscal year, with documented evidence the performance criteria are met;
(3) maintain external financial audits and financial statements as defined by the department; and
(4) maintain a current website to communicate with regional stakeholders.
(c) Each RAC must develop and maintain a regionally specific comprehensive trauma and emergency health care system plan. The plan must include all counties within the TSA and must be based on current industry standards and guidelines.
(1) The trauma and emergency health care system plan must address the following elements:
(A) epidemiology data resources available;
(B) integration of regional stakeholders, identified coalitions, and community partners pertinent to the priorities and needs identified through the regional self-assessment;
(C) regional guidelines for prehospital field triage and destination, treatment, transport, and transfer of patients with time-sensitive health care injuries or illnesses;
(D) prevention and outreach activities guided by data available;
(E) system coordination and patient flow;
(F) meaningful participation in regional disaster preparedness, planning, response, recovery, after-action review, data tracking needs, and support of the hospital preparedness stakeholders, including the identified health care coalition and the department;
(G) identification of system-wide health care education sponsored or coordinated through the RAC;
(H) execution of a systems performance improvement plan that aligns with the state system performance improvement plan, and includes regional outcome data;
(I) current pediatric readiness capabilities that identifies opportunities to improve pediatric readiness within the region;
(J) integration of public health and business community stakeholders; and
(K) guidelines to support regional research projects.
(2) All health care entities and identified coalition partners should participate in the regional planning process.
(d) A RAC must maintain the ability to collect and report data from each hospital within the TSA to facilitate emergency preparedness and response planning for a public health disaster, public health emergency, or outbreak of communicable disease, in a manner directed by the department and consistent with Texas Health and Safety Code §§81.027, 81.0443, 81.0444, and 81.0445.
(1) Unless otherwise directed by the department, at least once each calendar quarter, a RAC must collect and report to the department the following data from each hospital in their TSA:
(A) general beds available and occupied;
(B) intensive care unit (ICU) beds available and occupied;
(C) emergency department visits;
(D) hospital admissions;
(E) ventilators available and in use; and
(F) hospital deaths.
(2) The department may request more or less frequent collection or reporting or may request different information from individual RACs to adequately prepare for and respond to any public health disaster, public health emergency, outbreak of communicable disease, or federal reporting requirement relating to emergency preparedness and response.
(3) RACs must make the collected data publicly available by posting the data on the RAC's internet website.
(e) A RAC with at least one county within the region located on the international border of Texas and at least one county within the region adjacent to the Gulf of Mexico must provide guidelines and protocols related to trauma patient transfer and related services meeting the following requirements.
(1) The RAC must develop an advisory committee composed of equal representation from designated trauma facilities within the RAC.
(2) The advisory committee must develop regional protocols for managing the dispatch, triage, transport, and transfer of patients.
(A) The advisory committee must periodically review patient transfers ensuring the applicable protocols are met.
(B) Each hospital and EMS provider operating within this TSA must collect and report to the RAC data on patients transferred outside of the TSA following the developed and approved regional protocols.
(C) The advisory committee and activities must be integrated into the regional trauma and emergency health care system plan.
(f) A RAC must meet the defined performance criteria to ensure the mission of the regional system is maintained. A RAC must:
(1) notify the department and RAC membership within five days of the loss of capabilities to maintain the infrastructure to oversee and maintain the regional systems as required by the provisions within subsections (a) and (b) of this section or the department contract;
(2) provide the department with a plan of correction (POC) no more than 90 days from the onset of the deficiency for the RAC; and
(3) comply with the provisions of subsections (a) and (b) of this section, all current state and system standards as described in this chapter, and all guidelines and procedures as set forth in the regional trauma and emergency health care system plan.
(g) If a RAC chooses to relinquish services, it must provide at least a 30-day written advance notice to the department, all RAC membership, RAC coalition partners, and county judges within the impacted TSA.
(1) The RAC must submit a written plan to the department for approval before the 30-day notice to relinquish services.
(2) The RAC funding and assets must be dissolved in accordance with state and federal requirements.
(3) The department must consider options of realigning the TSA with another RAC to continue services.
(h) The department has the authority to schedule conferences, in-person or virtual, with 10-calendar days advanced notice, to review, inspect, evaluate, and audit all RAC documents to validate the department RAC performance criteria are met.
(i) RACs must maintain virtual options for stakeholder participation in committees or other activities.
§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:
(i) be voluntary;
(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;
(F) be full-time; 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) 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;
(iv) suction device;
(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.
(D) Coagulation studies.
(E) Blood gases and pH determinations.
(F) Microbiology.
(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:
(A) physical therapy;
(B) occupational therapy; and
(C) speech therapy.
(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:
(A) staff physicians;
(B) nurses;
(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;
(iv) suction device;
(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.
(E) Coagulation studies.
(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:
(A) staff physicians;
(B) nurses; and
(C) allied health personnel, including APPs.
§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
(F) massive transfusion.
(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;
(3) trauma PIPS 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:
(A) two surgeons;
(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:
(A) a surgeon; and
(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:
(I) a surgeon; and
(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:
(i) the department; or
(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;
(C) applicable RACs; and
(D) the department.
(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.
§157.130.Funds for Emergency Medical Services, Trauma Facilities, and Trauma Care Systems, and the Designated Trauma Facility and Emergency Medical Services Account.
(a) Allocations determination under Texas Health and Safety Code §773.122 and Health and Safety Code Chapter 780.
(1) Department determination. The department determines each year:
(A) eligibility criteria for emergency medical services (EMS), trauma service area (TSA), and hospital allocations; and
(B) the amount of EMS, TSA, and hospital allocations based on language described in Texas Health and Safety Code §773.122 and Chapter 780.
(2) Eligibility requirements. To be eligible for funding from the accounts, all potential recipients must maintain the regional participation requirements.
(3) Extraordinary emergency funding.
(A) To be eligible to receive extraordinary emergency funding, an entity must meet the following requirements:
(i) be a licensed EMS provider, a designated trauma facility, or a recognized first responder organization (FRO);
(ii) submit a completed application and any additional documentation requested by the department; and
(iii) provide documentation of active participation in its local Regional Advisory Council (RAC).
(B) Incomplete applications will not be considered for extraordinary emergency funding.
(4) EMS allocation.
(A) The department contracts with each eligible RAC to distribute the county funds to eligible EMS providers based within counties aligned with the relevant TSA.
(i) The department evaluates submitted support documents per the contract statement of work. Awarded funds must be used in addition to current operational EMS funding of eligible recipients and must not supplant the operational budget.
(ii) Funds are allocated by county to be awarded to eligible providers in each county. Funds are non-transferable to other counties within the RAC if there are no eligible providers in a county.
(B) Eligible EMS providers may contribute funds for a specified purpose within the TSA when:
(i) all EMS providers received communication regarding the intent of the contributed funds;
(ii) the EMS providers voted and approved by majority vote to contribute funds; and
(iii) all EMS providers that did not support contributing funds, receive the eligible funding.
(C) To be eligible for funding from the EMS allocation, providers must:
(i) maintain and comply with all licensure requirements as described in §157.11 of this chapter (relating to Requirements for an EMS Provider License);
(ii) follow RAC regional guidelines regarding patient destination and transport in all TSAs where EMS is provided and verified by each RAC;
(iii) notify the RACs of any potential eligibility to receive funds and meet the RACs' participation requirements, if a provider is contracted to provide EMS within a county of any one TSA and whose county of licensure is another county not in or contiguous with that TSA; and
(iv) provide the department evidence of a contract or letter of agreement with each additional county government or taxing authority in which EMS is provided in any county beyond its county of licensure.
(D) Contracts or letters of agreement must be submitted to the department on or before the stated department contract deadline of the respective year and provide evidence of continued coverage throughout the effective contract dates for which the eligibility of the EMS provider is being considered.
(E) EMS providers with contracts or letters of agreement on file with the department meeting the effective contract dates do not need to resubmit a copy of the contract or letter of agreement unless it has expired or will expire before the effective date of the next contract.
(F) The submitted contracts or letters of agreement must include effective dates to determine continued eligibility.
(G) Inter-facility transfer letters of agreement and contracts or mutual aid letters of agreement and contracts do not meet the requirement of a county contract.
(H) EMS providers are responsible for ensuring all contracts or letters of agreement have been received by the department on or before the listed deadline to be considered for eligibility.
(I) Air ambulance providers must meet the same requirements as ground transport EMS providers to be eligible to receive funds from a specific county other than the county of licensure.
(J) If an EMS provider is licensed in a particular county for a service area considered a geo-political subdivision and whose boundary lines cross multiple county lines, it will be considered eligible for the EMS Allocation for all counties overlapped by that geo-political subdivision's boundary lines. Verification from local jurisdictions will be requested for every county that comprises the geo-political subdivision to determine funding eligibility for each county. The eligibility of EMS providers whose county of licensure is in a geo-political subdivision other than those listed in clauses (i) - (v) of this subparagraph will be evaluated on a case-by-case basis. Geo-political subdivisions include:
(i) municipalities;
(ii) school districts;
(iii) emergency service districts (ESDs);
(iv) utility districts; or
(v) prison districts.
(5) TSA allocation.
(A) The department contracts with eligible RACs to distribute the funds for the operation of the 22 TSAs and for equipment, communications, education, and training for the areas.
(B) To be eligible to distribute funding on behalf of eligible recipients in each county to the TSA, a RAC must be:
(i) officially recognized by the department as described in §157.123 of this subchapter (relating to Regional Advisory Councils);
(ii) in compliance with all RAC performance criteria, have a current RAC self-assessment, and have a current regional trauma and emergency health care system plan; and
(iii) incorporated as an entity exempt from federal income tax under Section 501(a), Internal Revenue Code of 1986, and its subsequent amendments by being listed as an exempt organization under Section 501(c)(3).
(C) The TSA allocation distributed under this paragraph is based on the relative geographic size and population of each TSA and on the relative amount of trauma care provided.
(6) Hospital allocation. The department distributes funds to designated trauma facilities to subsidize a portion of uncompensated trauma care provided or to enhance the facility's delivery of trauma care.
(A) Funds distributed from the hospital allocations are made based on:
(i) the hospital being designated as a trauma facility by the department as defined in Texas Health and Safety Code Chapter 773;
(ii) the percentage of the hospital's uncompensated trauma care cost for patients meeting the National Trauma Data Bank (NTDB) registry inclusion criteria relative to the total uncompensated trauma care cost reported for the identified patient population by qualified facilities that year;
(iii) availability of funds; and
(iv) submission of a complete application to the department within the stated time frame. Incomplete applications will not be considered.
(B) Additional information may be requested by the department to determine eligibility for funding.
(C) A designated trauma facility in receipt of funding from the hospital allocation that fails to maintain its designation as required in §157.125 of this subchapter (relating to Requirements for Trauma Facility Designation Effective Through August 31, 2025) and §157.126 of this subchapter (relating to Trauma Facility Designation Requirements Effective on September 1, 2025), must return to the department all hospital allocation funds received in the prior 12 months within 90 days of failure to maintain trauma designation.
(D) The department may grant an exception to subparagraph (C) of this paragraph if it finds compliance with this section would not be in the best interest of the persons served in the affected local system.
(E) A facility must have no outstanding balance owed to the department or other state agencies before receiving any future disbursements from the hospital allocation.
(7) Department allocations. The department's process for funding allocations defined in this subsection applies to the account defined in Texas Health and Safety Code Chapter 780 and includes designated trauma facilities and those in active pursuit of trauma designation in the funding allocation.
(8) Department unawarded designation. An undesignated facility in active pursuit of designation but that has not been awarded a trauma designation by the department pursuant to Texas Health and Safety Code §780.004 must return to the department all funds received from the hospital allocation, plus a penalty of 10 percent of the awarded amount.
(b) Calculation methods. Calculation of county portions of the EMS allocation, the RAC portions of the TSA allocation, and the hospital allocation are:
(1) EMS allocation.
(A) EMS allocation is derived by adjusting the weight of the statutory criteria to ensure, as closely as possible:
(i) 40 percent of the funds go to urban counties; and
(ii) 60 percent of the funds go to rural counties.
(B) An individual county's portion of the EMS allocation is based on its geographic size, population, and the number of emergency health care runs, multiplied by adjustment factors determined by the department, so the distribution approximates the required percentages for urban and rural counties.
(C) The formula is:
(i) the county's population multiplied by an adjustment factor;
(ii) plus, the county's geographic size multiplied by an adjustment factor;
(iii) plus, the county's total emergency health care runs multiplied by an adjustment factor;
(iv) divided by 3; and
(v) multiplied by the total EMS allocation.
(D) The adjustment factors are manipulated so the distribution approximates the required percentages for urban and rural counties.
(E) Total emergency health care runs are the number of emergency patient care records electronically transmitted to the department in a given calendar year by EMS providers.
(2) TSA allocation.
(A) The TSA allocation is based on its relative geographic size, population, and trauma care provided as compared to all other TSAs.
(B) The formula is:
(i) the TSA's percentage of the state's total population;
(ii) plus, the TSA's percentage of the state's total geographic size;
(iii) plus, the TSA's percentage of the state's total trauma care;
(iv) divided by 3; and
(v) multiplied by the total TSA allocation.
(C) Total trauma care is the number of trauma patient records electronically transmitted to the department in a given calendar year by EMS providers and hospitals.
(3) Hospital allocation.
(A) Distributions, including unexpended portions of the EMS and TSA allocations, are determined by an annual application process.
(B) An annual application must be submitted each state fiscal year. Incomplete applications will not be considered for the hospital allocation calculation.
(C) Based on the information provided in the approved application, each facility will receive allocations as follows.
(i) An equal amount, not to exceed 20 percent of the available hospital allocation, to reimburse designated trauma facilities and those facilities in active pursuit of designation under the program.
(ii) Any funds not allocated in paragraphs (1) and (2) of this subsection are included in the distribution formula in subparagraph (E) of this paragraph.
(D) If the total cost of uncompensated trauma care for patients meeting NTDB registry inclusion criteria exceeds the amount appropriated from the account, minus the amount referred to in subparagraph (C)(i) of this paragraph, the department allocates funds based on a facility's percentage of uncompensated trauma care costs in relation to the total uncompensated trauma care cost reported by qualified hospitals for the funding year.
(E) The hospital allocation formula for trauma designated facilities is:
(i) the facility's reported costs of uncompensated trauma care;
(ii) minus any collections received by the facility for any portion of the facility's uncompensated trauma care previously reported for the purposes of this section;
(iii) divided by the total reported costs of uncompensated trauma care by eligible facilities; and
(iv) multiplied by the total money available after reducing the amount to be distributed in subparagraph (C)(i) of this paragraph.
(F) The reporting period of a facility's uncompensated trauma care must apply to costs incurred during the preceding calendar year.
(c) Loss of funding eligibility. If the department finds an EMS provider, RAC, or hospital has violated Texas Health and Safety Code Chapter 773 or fails to comply with this chapter, the department may withhold account monies for a period of one to three years, depending upon the seriousness of the infraction.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 4, 2024.
TRD-202405308
Cynthia Hernandez
General Counsel
Department of State Health Services
Effective date: November 24, 2024
Proposal publication date: August 2, 2024
For further information, please call: (512) 535-8538