PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 133. HOSPITAL LICENSING

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes 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 Action.

BACKGROUND AND PURPOSE

The proposal 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 proposal 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 proposal revises enforcement procedures to ensure accuracy with current practices and conform to statute. These updates also ensure consistent practices across HHSC Health Care Regulation rulesets, correct outdated language and contact information, and reflect the transition of regulatory authority for hospitals from the Department of State Health Services to HHSC.

A previous version of these repeals, new sections, and amendments was proposed by HHSC in the July 9, 2021, issue of the Texas Register (46 TexReg 4081) and expired without being adopted. This version of the proposal considers comments HHSC received during the previous informal and public comment periods.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §133.47, Abuse and Neglect Issues, updates contact information for submitting a complaint, changes "department" to "the Texas Health and Human Services Commission" or "HHSC" to reflect the change of statutory authority from the Department of State Health Services to HHSC. The proposed amendment updates the title of 25 TAC §1.204 and makes other non-substantive updates to increase clarity and consistency with other Health Care Regulation rulesets.

The proposed repeal of §133.101, Inspection and Investigation Procedures, deletes the rule as it is no longer necessary. The content of the rule has been added to proposed new §§133.102 - 133.104.

Proposed new §133.101, Integrity of Inspections and Investigations, places limits on a facility's authority to record HHSC interviews and internal discussions.

The proposed repeal of §133.102, Complaint Against a Department of State Health Services Surveyor, deletes the rule as it is no longer necessary. The content of the rule has been added to proposed new §133.106.

Proposed new §133.102, Inspections, implements HSC §241.051 and makes necessary updates to hospital and special hospital inspection requirements.

Proposed new §133.103, Complaint Investigations, implements HSC §241.051 and makes necessary updates to hospital and special hospital complaint investigation requirements.

Proposed new §133.104, Notice, informs hospitals of the required timeframes regarding responding to a written Statement of Deficiencies by returning a written Plan of Correction, together with any additional evidence of compliance.

Proposed new §133.105, Professional Conduct, informs providers that HHSC reports to the appropriate licensing authorities any issue or complaint relating to the conduct of a licensed professional, intern, or applicant for professional licensure.

Proposed new §133.106, Complaint Against an HHSC Representative, informs a hospital about registering a complaint against an HHSC inspector or investigator.

The proposed amendment to §133.121, Enforcement Action, updates the rule's title and creates consistency between this ruleset and other HHSC facility types regarding enforcement procedures. The proposed amendment also makes necessary corrections and updates to reflect current practices and conform with statute, including HSC Chapter 327.

FISCAL NOTE

Trey Wood, HHSC Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules does not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

HHSC has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of HHSC employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to HHSC;

(5) the proposed rules will create new regulations;

(6) the proposed rules will expand and repeal existing regulations;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the proposed rules will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Trey Wood has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities because there is no requirement to alter current business practices.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas; do not impose a cost on regulated persons; and are necessary to implement legislation that does not specifically state that §2001.0045 applies to the rules.

PUBLIC BENEFIT AND COSTS

Stephen Pahl, Deputy Executive Commissioner for Regulatory Services, has determined that for each year of the first five years the rules are in effect, the public benefit will be greater clarity, consistency, and accountability in the inspection and investigation of hospitals. The public and the patients in these facilities will benefit from a more robust system for the investigation of complaints, especially those related to patient safety.

Trey Wood has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules because the rules do not impose any additional costs or fees on persons required to comply with the rules.

TAKINGS IMPACT ASSESSMENT

HHSC has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to the Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 701 W. 51st Street, Austin, Texas 78751; or emailed to HCR_PRU@hhs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 22R101" in the subject line.

SUBCHAPTER C. OPERATIONAL REQUIREMENTS

25 TAC §133.47

STATUTORY AUTHORITY

The amendment is authorized by 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 amendment implements Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 241.

§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 [department].

(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 [abuse] or neglect of a child, as defined in §1.204(a) and (b) of this title (relating to [Investigations of] Abuse, Neglect, or Exploitation Defined. [of Children or Elderly or Disabled Persons); and]

(2) Abuse [abuse], neglect, or exploitation of an elderly or disabled person, as defined in §1.204(a) - (c) [§1.204(a) and (b)] 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 [42] United States Code Title 42 (42 USC) Chapter 114 (relating to Protection and Advocacy for Individuals with Mental Illness) [(USC), §10801 et seq.)] 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 [a] individual with mental illness, and includes acts such as:

(I) the rape or sexual assault of an [a] individual with mental illness;

(II) the striking of an [a] individual with mental illness;

(III) the use of excessive force when placing an [a] individual with mental illness in bodily restraints; and [and/or]

(IV) the use of bodily or chemical restraints on an [a] 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 [a] individual with mental illness or which placed an [a] 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 [a] individual with mental illness, the failure to provide adequate nutrition, clothing, or health care to an [a] individual with mental illness, or the failure to provide a safe environment for an [a] 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 [facility ] 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 [of the department's patient information and complaint line at (888) 973-0022].

(3) Reporting responsibility.

(A) Reporting abuse and neglect. A person, including an employee, volunteer, or other person associated with the hospital [facility] 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 [facility] 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, but no later than 24 hours after, report the information supporting the belief to HHSC [the department] 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, [facility] including a health care professional, who reasonably believes or who knows of information that would reasonably cause a person to believe that the hospital [facility] or an employee or health care professional associated with the hospital [facility], 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 [facility] or mental health or chemical dependency services provided in the hospital [facility] shall as soon as possible, but no later than 48 hours after, report the information supporting the belief to HHSC [the department] 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 [abuse] 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 [facility] in identifying patient abuse or neglect and illegal, unprofessional, or unethical conduct by or in the hospital [facility] and establish a means for monitoring compliance with the requirement.

(d) Investigations. A complaint under this subsection will be investigated or referred by HHSC [the department] 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 [§133.101 ] of this chapter [title] (relating to Complaint Investigations [Inspection and Investigation Procedures]). 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 [the department] 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 [the Patient Quality Care Unit, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756-3199, telephone, (888) 973-0022].

(f) Notification.

(1) For complaints under subsection (b) of this section, HHSC [the department] shall provide notification according to the following.

(A) HHSC [The department] shall notify the reporter, if known, in writing of the outcome of the completed [complete] investigation.

(B) HHSC [The department] shall notify the alleged victim, and the alleged victim's [his or her] 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 [the department shall inform], 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 [the department];

(D) whether and to whom the complaint will be referred; and

(E) the findings of the complaint investigation.

(g) HHSC [Department] 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 [the department] may forward a copy of the completed investigative report to the state agency that [which] licenses, certifies, or registers the health care professional. Any information which might reveal the identity of the reporter or any other patients [or clients] of the hospital [facility ] 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 [the department] 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 [The department ] 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 [the department] but shall be referred to law enforcement agencies or other agencies, as appropriate.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 29, 2024.

TRD-202401857

Karen Ray

General Counsel

Department of State Health Services

Earliest possible date of adoption: June 9, 2024

For further information, please call: (512) 834-4591

25 TAC §133.101, §133.102

STATUTORY AUTHORITY

The repeals are authorized by 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 repeals implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 241.

§133.101.Inspection and Investigation Procedures.

§133.102.Complaint Against a Department of State Health Services Surveyor.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 29, 2024.

TRD-202401858

Karen Ray

General Counsel

Department of State Health Services

Earliest possible date of adoption: June 9, 2024

For further information, please call: (512) 834-4591

STATUTORY AUTHORITY

The new sections are authorized by 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 new sections implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 241.

§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; and

(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 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, 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; 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 request 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; 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; and

(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 request 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).

§133.104.Notice.

(a) A hospital is deemed to have received any Texas Health and Human Services Commission (HHSC) correspondence on the date of receipt, or three business days after mailing, whichever is earlier.

(b) When HHSC finds deficiencies:

(1) HHSC provides the hospital with a written Statement of Deficiencies (SOD) within 10 business days after the exit conference via U.S. Postal Service or electronic mail.

(2) Within 10 calendar days after the hospital's receipt of the SOD, the hospital shall return to HHSC a written Plan of Correction (POC) that addresses each cited deficiency, including timeframes for corrections, together with any additional evidence of compliance.

(A) HHSC determines if a POC and proposed timeframes are acceptable, and, if accepted, notifies the hospital in writing.

(B) If HHSC does not accept the POC, HHSC notifies the hospital in writing and requests the hospital submit to HHSC a modified POC and any additional evidence of compliance no later than 10 business days after HHSC notifies the hospital in writing.

(C) The hospital shall correct the identified deficiencies and submit to HHSC evidence verifying implementation of corrective action within the timeframes set forth in the POC, or as otherwise specified by HHSC.

(3) Regardless of a hospital's compliance with this subsection or HHSC's acceptance of a hospital's POC, HHSC may, at any time, propose to take enforcement action as appropriate under this chapter.

§133.105.Professional Conduct.

In addition to any enforcement action under this chapter, the Texas Health and Human Services Commission reports, in writing, to the appropriate licensing board any issue or complaint relating to the conduct of a licensed professional, intern, or applicant for professional licensure.

§133.106.Complaint Against an HHSC Representative.

A hospital may register a complaint against a Texas Health and Human Services Commission (HHSC) representative who conducts an inspection or investigation under this subchapter by following the procedure listed on the HHSC website.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 29, 2024.

TRD-202401859

Karen Ray

General Counsel

Department of State Health Services

Earliest possible date of adoption: June 9, 2024

For further information, please call: (512) 834-4591

25 TAC §133.121

STATUTORY AUTHORITY

The amendment is authorized by 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 amendment implements Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 241.

§133.121.Enforcement [Action].

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 [Enforcement action may be taken for the following reasons].

(1) Denial, suspension or revocation of a license or imposition of an administrative penalty. HHSC [The department] has jurisdiction to enforce violations of the Act or the rules adopted under this chapter. HHSC [The department] may deny, suspend, or revoke a license or impose an administrative penalty for [if the licensee or applicant]:

(A) failure [fails] to comply with any applicable provision of the Texas Health and Safety Code (HSC), including Chapters 241, [or] 311, and 327;

(B) failure [fails] to comply with any provision of this chapter or any other applicable laws [(25 Texas Administrative Code, Chapter 133)];

(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 [fails to comply with a special license condition];

(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) [(D)] failure [fails ] to comply with an order of the HHSC executive commissioner [department] or another enforcement procedure under HSC[,] Chapters 241, [or] 311, or 327;

(H) [(E)] [has] a history of failure to comply with the applicable rules [adopted under this chapter] relating to patient environment, health, safety, and rights that reflect more than nominal noncompliance;

(I) [(F)] the hospital aiding, committing, abetting, or permitting [has aided, abetted or permitted] the commission of an illegal act;

(J) [(G)] the hospital, or any of its employees, committing [has committed] fraud, misrepresentation, or concealment of a material fact on any documents required to be submitted to HHSC [the department ] or required to be maintained by the hospital [facility ] 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) [(H)] failure [fails ] to timely pay an assessed administrative penalty as required by HHSC [penalties in accordance with HSC, Chapter 241];

(M) failure to submit an acceptable plan of correction for cited deficiencies within the timeframe required by HHSC;

(N) [(I)] failure [fails ] to timely implement plans of corrections to deficiencies cited by HHSC within the dates designated in the plan of correction [ the department]; [or]

(O) [(J)] failure [fails ] to comply with applicable requirements within a designated probation period; or [.]

(P) the hospital terminating the hospital's Medicare provider agreement if the hospital is certified under Title XVIII of the Social Security Act, 42 United States Code (USC), §1395 et seq.

(2) Denial of a license. HHSC [The department] has jurisdiction to enforce violations of [the] HSC[,] Chapters 241, [and] 311, and 327 and this chapter. HHSC [The department] may deny a license if the applicant:

(A) fails to provide timely and sufficient information required by HHSC [the department] 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 [state Medicaid or] 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 [the department of state health services (commissioner)] 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 [The department] 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 [the department'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 [the department] may place [schedule] the hospital on [facility for a] probation for a period of not less than 30 days, if HHSC finds that the hospital [facility] is [found] in repeated noncompliance with these rules or HSC[,] Chapter 241, and the hospital's [facility's] noncompliance does not endanger the public's health and safety [of the public].

(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 [The department] has jurisdiction to impose an administrative penalty against a hospital [facility] licensed or regulated under this chapter for violations of [the] HSC[,] Chapters 241, [and] 311, and 327 and this chapter. The imposition of an administrative penalty shall be in accordance with the provisions of [the] HSC[, ] §241.059, [and] §241.060, and §327.008.

(6) Licensure of persons or entities with criminal backgrounds. HHSC [The department] 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 [facility]. HHSC [The department] shall apply the requirements of Texas [the] Occupations Code[,] Chapter 53.

(A) HHSC [The department] is entitled under Texas Government Code Chapter 411 to obtain criminal history information maintained by the Texas Department of Public Safety [(Government Code, §411.122)], the Federal Bureau of Investigation, [(Government Code, §411.087) ] 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 [the department] shall apply the requirements and consider the provisions of Texas Occupations Code[,] Chapter 53 [§53.022 and §53.023].

(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 [inability] or a tendency for the person to be unable to own or operate a hospital [facility]:

(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 [the] 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 [offenses of attempting or conspiring to commit any of the offenses in this clause];

(II) Title 5 [offenses against the person];

(III) Title 7 [offenses against property];

(IV) Title 8 [offenses against public administration];

(V) Title 9 [offenses against public order and decency];

(VI) Title 10 [offenses against public health, safety and morals]; or

(VII) Title 11 [offenses involving organized crime].

(7) [(viii)] Offenses listed in paragraph (6)(C) [subparagraph(C)] of this subsection [paragraph] are not exclusive in that HHSC [the department] may consider similar criminal convictions from other state, federal, foreign, or military jurisdictions that indicate an [demonstrate the] inability or tendency for [of] the person or entity to own or operate a hospital [facility].

(8) [(ix)] HHSC shall revoke a [A] license [shall be revoked] on the licensee's imprisonment following a felony conviction, felony community supervision revocation, revocation of parole, or revocation of mandatory supervision.

(9) [(7)] Notice. If HHSC [the department] proposes to deny, suspend, or revoke a license, or impose an administrative penalty, HHSC [the department] shall send a notice of the proposed action by certified mail, return receipt requested, at the address shown in the current records of HHSC [the department] or HHSC [the department] 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 [imposition of] the action.

(10) [(8)] Acceptance. Within 20 calendar days after receipt of the notice, the applicant or licensee may notify HHSC [the department], in writing, of acceptance of HHSC's [the department's] determination or request a hearing.

(11) [(9)] Hearing request.

(A) A request for a hearing by the applicant or licensee shall be in writing and submitted to HHSC [the department ] 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 [30th] day after the date HHSC mails the notice [is mailed by the department] to the last known address [known] 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)[, Government Code, Chapter 2001].

(12) [(10)] No response to notice. If an [the] applicant or licensee [fails to timely respond to the notice or] does not request a hearing in writing within 20 calendar [30] days after receiving the notice [date] of the proposed action [notice], the case shall be set for a hearing.

(13) [(11)] Notification of HHSC's [department's] final decision. HHSC [The department] shall send the licensee or applicant a copy of HHSC's [the department's] decision for denial, suspension or revocation of a license or imposition of an administrative penalty by certified [registered] mail, which shall include the findings of fact and conclusions of law on which HHSC [the department] 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) [(12)] Decision to suspend or revoke. When HHSC's [the department'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 [is issued by the district court].

(16) [(13)] 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 [the department upon the effective date of the department's determination].

(17) [(14)] Reapplication following denial or revocation.

(A) One year after HHSC's [After the department's] decision to deny or revoke, or the voluntary surrender of a license by a hospital [facility] while enforcement action is pending, a hospital [facility] may petition HHSC [the department], 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 [The department] may allow a reapplication for licensure if there is proof that the reasons for the original action no longer exist.

(C) HHSC [The department] may deny reapplication for licensure if HHSC [the department] 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 [the department] allows a reapplication for licensure, the petitioner shall be required to meet the requirements as described in §133.22 of this chapter [title] (relating to Application and Issuance of Initial License).

(18) [(15)] Expiration of a license during suspension. A hospital [facility] whose license expires during a suspension period may not reapply for license renewal until the end of the suspension period.

(19) [(16)] Surrender of a license. In the event that enforcement, as defined in this subsection, is pending or reasonably imminent, the surrender of a hospital [facility ] license shall not deprive HHSC [the department] of jurisdiction in regard to enforcement against the hospital [facility].

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 29, 2024.

TRD-202401860

Karen Ray

General Counsel

Department of State Health Services

Earliest possible date of adoption: June 9, 2024

For further information, please call: (512) 834-4591

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes 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.

BACKGROUND AND PURPOSE

The purpose of the proposal is 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 proposal revises enforcement procedures to ensure accuracy with current practices and conform to statute. These updates also ensure consistent practices across HHSC Health Care Regulation rulesets, correct outdated language and contact information, and reflect the transition of regulatory authority for ASCs from the Department of State Health Services (DSHS) to HHSC.

A previous version of these repeals, amendment, and new sections was proposed by HHSC in the July 9, 2021, issue of the Texas Register (46 TexReg 4087) and expired without being adopted. This version of the proposal considers comments HHSC received during the previous informal and public comment periods.

SECTION-BY-SECTION SUMMARY

The proposed repeal of §135.21, Inspections, deletes the rule as it is no longer necessary. The content of the rule has been added to proposed new §135.62.

The proposed amendment to §135.22, Renewal of License, makes necessary updates to reflect the transition of regulatory authority from DSHS to HHSC. The proposed amendment also specifies the time frame for an ASC to return the license to HHSC when the ASC cannot provide sufficient evidence that it submitted a renewal application and fee within 30 days prior to the expiration date of the license.

The proposed repeal of §135.24, Enforcement, deletes the rule as it is no longer necessary. The content of the rule has been added to proposed new §135.67.

The proposed repeal of §135.25, Complaints, deletes the rule as it is no longer necessary. The content of the rule has been added to proposed new §135.63.

Proposed new §135.61, Integrity of Inspections and Investigations, places limits on an ASC's authority to record HHSC interviews and internal discussions.

Proposed new §135.62, Inspections, makes necessary updates to ASC inspection requirements.

Proposed new §135.63, Complaint Investigations, makes necessary updates to ASC complaint investigation requirements.

Proposed new §135.64, Notice, informs an ASC of the required timeframes for responding to a written Statement of Deficiencies by returning a written Plan of Correction, together with any additional evidence of compliance.

Proposed new §135.65, Professional Conduct, informs providers that HHSC reports to the appropriate licensing authorities any issue or complaint relating to the conduct of a licensed professional, intern, or applicant for professional licensure.

Proposed new §135.66, Complaint Against an HHSC Representative, informs an ASC about registering a complaint against an HHSC inspector or investigator.

Proposed new §135.67, Enforcement, creates consistency between this ruleset for ASCs and other HHSC facility types regarding enforcement procedures and makes necessary corrections and updates to reflect current practices and conform with statute.

FISCAL NOTE

Trey Wood, HHSC Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules does not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

HHSC has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of HHSC employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to HHSC;

(5) the proposed rules will create a new regulation;

(6) the proposed rules will expand and repeal existing regulations;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the proposed rules will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Trey Wood has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities because there is no requirement to alter current business practices.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas; and do not impose a cost on regulated persons.

PUBLIC BENEFIT AND COSTS

Stephen Pahl, Deputy Executive Commissioner for Regulatory Services, has determined that for each year of the first five years the rules are in effect, the public benefit will be greater clarity, consistency, and accountability in the inspection and investigation of ASCs. The public and the patients in these facilities will benefit from a more robust system for the investigation of complaints, especially those related to patient safety.

Trey Wood has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules because the rules do not impose any additional costs or fees on persons required to comply with the rules.

TAKINGS IMPACT ASSESSMENT

HHSC has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to the Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 701 W. 51st Street, Austin, Texas 78751; or emailed to HCR_PRU@hhs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 22R101" in the subject line.

SUBCHAPTER A. OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS

25 TAC §§135.21, 135.24, 135.25

STATUTORY AUTHORITY

The repeals authorized by 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 repeals implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 243.

§135.21.Inspections.

§135.24.Enforcement.

§135.25.Complaints.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 29, 2024.

TRD-202401861

Karen Ray

General Counsel

Department of State Health Services

Earliest possible date of adoption: June 9, 2024

For further information, please call: (512) 834-4591

STATUTORY AUTHORITY

The amendment is authorized by 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 amendment implements Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 243.

§135.22.Renewal of License.

(a) The Texas Health and Human Services Commission (HHSC) sends [department shall send] written notice of expiration of a license to an ambulatory surgical center (ASC) at least 60 days before the expiration date. If the applicant has not received notice, it is the duty of the ASC to notify HHSC [the department] and request a renewal application.

(b) HHSC [The department] shall issue a renewal license to an ASC that meets the minimum standards for a license set forth in this chapter [these sections].

(1) The ASC shall submit the following to HHSC [the department] no later than 30 days prior to the expiration date of the license:

(A) a completed renewal application form;

(B) a nonrefundable license fee; and

(C) if the ASC is accredited by the Joint Commission, the Accreditation Association for Ambulatory Health Care, or the American Association for Accreditation of Ambulatory Surgery Facilities, documented evidence of current accreditation status.

(2) Renewal licenses shall be valid for two years.

(c) If an [the] applicant fails to timely submit an application and fee in accordance with subsection (b) of this section, HHSC [the department] shall notify the applicant that the ASC shall cease providing ambulatory surgical services. If the ASC can provide HHSC [the department] with sufficient evidence that the submission was completed in a timely manner and all dates were adhered to, HHSC dismisses the cease to perform [shall be dismissed]. If the ASC cannot provide sufficient evidence, the ASC shall [immediately thereafter] return the license to HHSC within 30 days after HHSC's notification by certified mail. If an [the] applicant wishes to provide ambulatory surgical services after the expiration date of the license, the applicant shall reapply for a license under §135.20 of this chapter [title] (relating to Initial Application and Issuance of License).

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 29, 2024.

TRD-202401862

Karen Ray

General Counsel

Department of State Health Services

Earliest possible date of adoption: June 9, 2024

For further information, please call: (512) 834-4591

25 TAC §§135.61 - 135.67

STATUTORY AUTHORITY

The new sections are authorized by 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 new sections implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 243.

§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; and

(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 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, 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, 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.

§135.64.Notice.

(a) An ambulatory surgical center (ASC) is deemed to have received any Texas Health and Human Services Commission (HHSC) correspondence on the date of receipt, or three business days after mailing, whichever is earlier.

(b) When HHSC finds deficiencies:

(1) HHSC provides the ASC with a written Statement of Deficiencies (SOD) within 10 business days after the exit conference via U.S. Postal Service or electronic mail.

(2) Within 10 calendar days after the facility's receipt of the SOD, the ASC shall return to HHSC a written Plan of Correction (POC) that addresses each cited deficiency, including timeframes for corrections, together with any additional evidence of compliance.

(A) HHSC determines if a POC and proposed timeframes are acceptable, and, if accepted, notifies the ASC in writing.

(B) If HHSC does not accept the POC, HHSC notifies the ASC in writing and requests the ASC submit a modified POC and any additional evidence of compliance no later than 10 business days after HHSC notifies the ASC in writing.

(C) The ASC shall correct the identified deficiencies and submit to HHSC evidence verifying implementation of corrective action within the timeframes set forth in the POC, or as otherwise specified by HHSC.

(3) Regardless of an ASC's compliance with this subsection or HHSC's acceptance of an ASC's POC, HHSC may, at any time, propose to take enforcement action as appropriate under this chapter.

§135.65.Professional Conduct.

In addition to any enforcement action under this chapter, the Texas Health and Human Services Commission reports, in writing, to the appropriate licensing board any issue or complaint relating to the conduct of a licensed professional, intern, or applicant for professional licensure.

§135.66.Complaint Against an HHSC Representative.

An ambulatory surgical center may register a complaint against a Texas Health and Human Services Commission (HHSC) representative who conducts an inspection or investigation under this subchapter by following the procedure listed on the HHSC website.

§135.67.Enforcement.

(a) 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.

(b) 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:

(1) failure to comply with any applicable provision of the Texas Health and Safety Code (HSC), including Chapter 243;

(2) failure to comply with any provision of this chapter or any other applicable laws;

(3) the ambulatory surgical center (ASC), or any of its employees, commits an act which causes actual harm or risk of harm to the health or safety of a patient;

(4) the ASC, or any of its employees, materially alters any license issued by HHSC;

(5) failure to comply with minimum standards for licensure;

(6) failure to provide a complete license application;

(7) failure to comply with an order of the HHSC executive commissioner or another enforcement procedure under the Act;

(8) a history of failure to comply with the applicable rules relating to patient environment, health, safety, and rights;

(9) the ASC aiding, committing, abetting, or permitting the commission of an illegal act;

(10) the ASC, 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 ASC pursuant to the Act and the provisions of this chapter;

(11) failure to timely pay an assessed administrative penalty as required by HHSC;

(12) failure to submit an acceptable plan of correction for cited deficiencies within the timeframe required by HHSC;

(13) failure to timely implement plans of correction to deficiencies cited by HHSC within the dates designated in the plan of correction;

(14) failure to comply with applicable requirements within a designated probation period; or

(15) the ASC terminating the ASC's Medicare provider agreement if the ASC is certified under Title XVIII of the Social Security Act, 42 United States Code (USC), §1395 et seq.

(c) HHSC has jurisdiction to enforce violations of the Act and this chapter. HHSC may deny a license if the applicant:

(1) fails to provide timely and sufficient information required by HHSC that is directly related to the license application; or

(2) has had the following actions taken against the applicant within the two-year period preceding the license application:

(A) decertification or cancellation of its contract under the Medicare or Medicaid program in any state;

(B) federal Medicare or state Medicaid sanctions or penalties;

(C) unsatisfied federal or state tax liens;

(D) unsatisfied final judgments;

(E) eviction involving any property or space used as an ASC in any state;

(F) unresolved federal Medicare or state Medicaid audit exceptions;

(G) denial, suspension, or revocation of an ASC license, a hospital license, a private psychiatric hospital license, or a license for any health care facility in any state; or

(H) a court injunction prohibiting ownership or operation of a facility.

(d) 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 an ASC.

(1) In determining whether a criminal conviction directly relates, HHSC shall apply the requirements and consider the provisions of Texas Occupations Code Chapter 53.

(2) The following felonies and misdemeanors directly relate to the duties and responsibilities of the ownership or operation of an ASC because these criminal offenses indicate an ability or a tendency for the person to be unable to own or operate an ASC:

(A) a misdemeanor violation of the Act;

(B) a misdemeanor or felony involving moral turpitude;

(C) a misdemeanor or felony relating to deceptive business practices;

(D) a misdemeanor or felony of practicing any health-related profession without a required license;

(E) a misdemeanor or felony under any federal or state law relating to drugs, dangerous drugs, or controlled substances;

(F) 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;

(G) 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.

(H) Offenses listed in paragraph (2) 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 be unable to own or operate an ASC.

(3) 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.

(e) 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 licensee has an opportunity for a hearing before taking the action.

(f) Within 20 calendar days after receipt of the notice described in subsection (e) of this section, the applicant or licensee shall notify HHSC, in writing, of acceptance of HHSC's determination or request a hearing.

(g) A request for a hearing by the applicant or licensee shall be in writing and submitted to HHSC within 20 calendar days after receipt of the notice described in subsection (e) of this section. 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.

(1) A hearing shall be conducted pursuant to Texas Government Code Chapter 2001 and Texas Administrative Code Title 1 Chapter 357, Subchapter I (relating to Hearings Conducted Under the Administrative Procedure Act).

(2) If an applicant or licensee does not request a hearing in writing within 20 calendar days after receiving the notice of the proposed action described in subsection (e) of this section, the applicant or licensee is deemed to have waived the opportunity for a hearing and HHSC shall take the proposed action.

(h) If HHSC finds that a violation of the standards or licensing requirements prescribed by the Act creates an immediate threat to the health and safety of patients of an ASC, HHSC may petition the district court for a temporary restraining order to restrain continuing violations.

(i) If a person violates the licensing requirements or the standards prescribed by the Act, HHSC may petition the district court for an injunction to prohibit the person from continuing the violation or to restrain or prevent the establishment or operation of an ASC without a license issued under the Act.

(j) HHSC may issue an emergency order to suspend a license issued under this chapter, if HHSC has reasonable cause to believe that the conduct of a licensee creates an immediate danger to public health and safety.

(1) An emergency suspension is effective immediately without a hearing on notice to the licensee.

(2) On written request of the licensee to HHSC for a hearing, HHSC refers the matter to the State Office of Administrative Hearings (SOAH). An administrative law judge of the office conducts a hearing not earlier than the 10th day or later than the 30th day after the date the hearing request is received to determine if the emergency suspension is to be continued, modified, or rescinded. The hearing and any appeal are governed by HHSC's rules for a contested case hearing and Texas Government Code Chapter 2001.

(k) In lieu of denying, suspending or revoking the license, HHSC may place the ASC on probation for a period of not less than 30 days, if HHSC finds the ASC is in repeated non-compliance with this chapter or the Act, and the ASC's noncompliance does not endanger the public's health and safety.

(1) HHSC shall provide notice of the probation to the ASC not later than the 10th day before the date the probation begins. The notice includes the items of noncompliance that resulted in placing the ASC on probation and shall designate the period of the probation.

(2) During the probationary period, the ASC shall correct the items of noncompliance and report the corrections to HHSC for approval.

(3) HHSC may verify the corrective actions through an on-site inspection.

(l) HHSC may impose an administrative penalty on a person licensed under this chapter who violates the Act, this chapter, or an order adopted under this chapter.

(1) A penalty collected under this section shall be deposited in the state treasury in the general revenue fund.

(2) A proceeding to impose an administrative penalty is considered a contested case hearing under Texas Government Code Chapter 2001.

(3) The amount of the penalty may not exceed $1,000 for each violation, and each day a violation continues or occurs is a separate violation for purposes of imposing a penalty. The total amount of the penalty assessed for a violation continuing or occurring on separate days under this paragraph may not exceed $5,000.

(4) In determining the amount of an administrative penalty assessed under this section, HHSC shall consider:

(A) the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation;

(B) the threat to health or safety caused by the violation;

(C) the history of previous violations;

(D) the amount necessary to deter a future violation;

(E) whether the violator demonstrated good faith, including when applicable whether the violator made good faith efforts to correct the violation; and

(F) any other matter that justice may require.

(5) If HHSC initially determines that a violation occurred, HHSC shall give written notice of the report by certified mail to the person alleged to have committed the violation following the exit conference date. The notice includes:

(A) a brief summary of the alleged violation;

(B) a statement of the amount of the recommended administrative penalty; and

(C) a statement of the person's right to a hearing on the occurrence of the violation, the amount of the penalty, or both.

(6) Within 20 calendar days after the date the person receives the notice under paragraph (5) of this subsection, the person in writing may:

(A) accept the determination and recommended administrative penalty of HHSC; or

(B) make a request for a hearing on the occurrence of the violation, the amount of the administrative penalty, or both.

(7) If the person accepts the determination and recommended administrative penalty or if the person fails to respond to the notice, the HHSC executive commissioner or the executive commissioner's designee by order approves the determination and imposes the recommended penalty.

(8) If the person requests a hearing under paragraph (6)(B) of this subsection, the HHSC executive commissioner refers the matter to SOAH. The hearing shall be conducted in accordance with Texas Government Code Chapter 2001, and all applicable SOAH and HHSC rules.

(9) Based on the proposal for the decision made by the administrative law judge under paragraph (8) of this subsection, the HHSC executive commissioner by order may find that a violation occurred or a violation did not occur.

(10) The HHSC executive commissioner or the executive commissioner's designee sends notice of the executive commissioner's order under paragraph (9) of this subsection to the person alleged to have committed the violation in accordance with Texas Government Code Chapter 2001. The notice shall include:

(A) a statement of the right of the person to judicial review of the order;

(B) separate statements of the findings of fact and conclusions of law; and

(C) the amount of any penalty assessed.

(11) Within 30 calendar days after the date an order of the HHSC executive commissioner under paragraph (9) of this subsection that imposes an administrative penalty becomes final, the person shall:

(A) pay the penalty; or

(B) appeal the penalty by filing a petition for judicial review of the executive commissioner's order contesting the occurrence of the violation, the amount of the penalty, or both.

(12) Within the 30-day period prescribed by paragraph (11) of this subsection, a person who files a petition for judicial review may:

(A) stay enforcement of the penalty by:

(i) paying the penalty to the court for placement in an escrow account; or

(ii) giving the court a supersedeas bond that is approved by the court for the amount of the penalty, and that is effective until all judicial review of the HHSC executive commissioner's order is final; or

(B) request the court to stay enforcement of the penalty by:

(i) filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the penalty and is financially unable to give the supersedeas bond; and

(ii) sending a copy of the affidavit to the HHSC executive commissioner by certified mail.

(C) If the HHSC executive commissioner receives a copy of an affidavit under subparagraph (B) of this paragraph, the executive commissioner may file with the court, within five days after the date the copy is received, a contest to the affidavit. In accordance with HSC §243.016(c), the court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the penalty or to give a supersedeas bond.

(13) If the person does not pay the penalty and the enforcement of the penalty is not stayed, HHSC may refer the matter to the attorney general for collection of the penalty. As provided by HSC §243.016(d), the attorney general may sue to collect the penalty.

(14) A decision by the court is governed by HSC §243.016(e) and (f), and provides the following.

(A) If the court sustains the finding that a violation occurred, the court may uphold or reduce the amount of the penalty and order the person to pay the full or reduced amount of the penalty.

(B) If the court does not sustain the finding that a violation occurred, the court shall order that a penalty is not owed.

(15) The remittance of penalty and interest is governed by HSC §243.016(g) and provides the following.

(A) If the person paid the penalty and if the amount of the penalty is reduced or the penalty is not upheld by the court, the court shall order, when the court's judgment becomes final, that the appropriate amount plus accrued interest be remitted to the person within 30 days after the date that the judgment of the court becomes final.

(B) The interest accrues at the rate charged on loans to depository institutions by the New York Federal Reserve Bank.

(C) The interest shall be paid for the period beginning on the date the penalty is paid and ending on the date the penalty is remitted.

(16) The release of supersedeas bond is governed by HSC §243.016(h) and provides the following.

(A) If the person gave a supersedeas bond and the court does not uphold the penalty, the court shall order, when the court's judgment becomes final, the release of the bond.

(B) If the person gave a supersedeas bond and the amount of the penalty is reduced, the court shall order the release of the bond after the person pays the reduced amount.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 29, 2024.

TRD-202401863

Karen Ray

General Counsel

Department of State Health Services

Earliest possible date of adoption: June 9, 2024

For further information, please call: (512) 834-4591