TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 405. PATIENT CARE--MENTAL HEALTH SERVICES

The Texas Health and Human Services Commission (HHSC) adopts an amendment to the title of Subchapter K in Texas Administrative Code (TAC) Title 25, Chapter 405, relating to Deaths of Persons Served by TXMHMR Facilities or Community Mental Health and Mental Retardation Centers; amendments to §405.261, concerning Purpose, §405.262, concerning Application, §405.263, concerning Definitions, §405.266, concerning Community Centers: Actions Taken upon the Death of Persons Served, §405.268, concerning Facility Community-Based Services and Community Centers: General Guidelines upon Death of a Person Served, §405.269, concerning Facility Campus-Based Programs, Facility Community-Based Services and Community Centers: Administrative Death Review Determination, §405.272, concerning Facility Community-Based Services and Community Centers: Clinical Death Review Determination, §405.274, concerning Community Centers: Clinical Death Review, §405.275, concerning Facility Campus-Based Programs, Facility Community-Based Services, and Community Centers: Administrative Death Review, §405.276, concerning Reporting of Systemic Issues Emerging from Death Reviews; and the repeal of §405.264, concerning Facility Campus-Based Programs: Actions Taken upon the Death of Person Served; §405.265, concerning Facility Community-Based Services: Actions Taken upon the Death of Person Served; §405.267, concerning Facility Campus-Based Programs: Statutory Requirements; §405.270, concerning Facility Campus-Based Programs and Facility Community-Based Services: Clinical Death Review Committee; §405.271, concerning Facility Campus-Based Programs: Clinical Death Review Determination; §405.273, concerning Facility Campus-Based Programs and Facility Community-Based Services: Clinical Death Review, §405.277, concerning Distribution, and §405.279, concerning References.

The subchapter title and §§405.261 - 405.263, 405.266, 405.268, 405.269, 405.274, and 405.275 are adopted with changes to the proposed text as published in the February 25, 2022, issue of the Texas Register (47 TexReg 878). These rules will be republished.

Sections 405.272 and 405.276, and the repeal of §§405.264, 405.265, 405.267, 405.270, 405.271, 405.273, 405.277, and 405.279 are adopted without changes to the proposed text as published in the February 25, 2022, issue of the Texas Register (47 TexReg 878). These rules and repeals will not be republished.

BACKGROUND AND JUSTIFICATION

The current TAC provisions reflect internal agency practices that are being updated at the discretion of the State Hospital System Administration. Pursuant to Government Code Section 531.008(c)(5) the HHSC facilities division was created "for the purpose of administering state facilities, including state hospitals and state supported living centers." In furtherance of this purpose, the State Hospital System is voluntarily participating in a Patient Safety Evaluation System. The updated agency practices are intended to implement the Patient Safety Quality Improvement Act (42 U.S.C. §299, et seq.) and related agency regulations by the United States Department of Health and Human Services (42 C.F.R. Part 3). The amendments and repeals to this subchapter are related to the facility references (which included state hospitals, state schools, and state centers per rule definitions) and modify or repeal language or requirements regarding community center death reviews.

The amendments and repeals remove sections, references, and language related to the internal process by which reviews of deaths in state hospitals occur. The process of reviewing deaths occurs through a federally chartered Patient Safety Organization operated by the Texas A&M University Rural and Community Health Institute. Accordingly, the state hospital system has implemented through its Governing Body an operating procedure that outlines the updated process and procedure for the review process.

COMMENTS

The 31-day comment period ended on March 28, 2022.

During this period, HHSC received comments regarding the proposed rules from one organization, Disability Rights Texas. A summary of comments relating to the rules and HHSC responses follows.

Comment: A commenter recommends the rules include the process state hospitals use to report deaths of individuals served to an external entity and to the state office for two reviews to occur and the requirement that the state hospitals will implement any recommendations made by both reviews.

Response: HHSC disagrees because this is included in current internal operating procedures. Pursuant to Government Code §2001.003(6) "a statement regarding only the internal management or organization of a state agency and not affecting private rights or procedures" is not included in the definition of a "rule".

Comment: A commenter recommended §§405.264(a) and 405.264(b) outline what staff should do when a deceased individual is found at a state hospital.

Response: HHSC disagrees as this is addressed within internal operating procedures. Specifically, the internal operating procedures require compliance with existing state laws regarding how to address such situations, and HHSC procedures do not create additional requirements or obligations that affect private rights. Pursuant to Government Code §2001.003(6) "a statement regarding only the internal management or organization of a state agency and not affecting private rights or procedures" is not included in the definition of a "rule".

Comment: A commenter recommended retaining in rule §405.265 and §405.267, to include how state hospital staff should notify the individual's family or legally authorized representative of the death and how to access information relating to the individual's death.

Response: HHSC disagrees as this is addressed within internal operating procedures. Specifically, the internal operating procedures require compliance with existing state laws regarding how to address such situations, and HHSC procedures do not create additional requirements or obligations that affect private rights. Pursuant to Government Code §2001.003(6) "a statement regarding only the internal management or organization of a state agency and not affecting private rights or procedures" is not included in the definition of a "rule".

HHSC revises §405.269(a)(3) to replace the language "commits suicide" with "died by suicide."

HHSC also replaces "persons" with "individuals" in the title of Subchapter K and §405.261, §405.263, in the title of §405.266, in the title of §405.268, §405.269, §405.274, and §405.275.

SUBCHAPTER K. DEATHS OF INDIVIDUALS SERVED BY COMMUNITY MENTAL HEALTH CENTERS

25 TAC §§405.261 - 405.263, 405.266, 405.268, 405.269, 405.272, 405.274 - 405.276

STATUTORY AUTHORITY

The amendments are adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and Health and Safety Code §552.001, which authorizes HHSC to operate the State Hospital System.

The amendments affect Texas Government Code §531.0055 and Health and Safety Code §552.001. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

§405.261.Purpose.

The purpose of this subchapter is to provide clinical peer review procedures and, separately, administrative review procedures to be followed upon the death of an individual receiving services directly operated or contracted for by a community mental health center, and their respective contract providers, in order to improve the quality of care.

§405.262.Application.

The provisions of this subchapter apply to community mental health centers and to their respective contract providers.

§405.263.Definitions.

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Administrative death review--An administrative/quality assurance review activity to identify non-clinically related problems requiring correction and opportunities to improve the quality of care.

(2) Attending physician--A physician licensed to practice medicine in the State of Texas who is responsible for the general medical care and/or psychiatric care of the individual served.

(3) Chief executive officer or CEO--The executive director of a community center.

(4) Clinical death review--A clinical quality assurance/peer review activity conducted to identify clinically related problems requiring correction and opportunities to improve the quality of care pursuant to the statutes that authorize peer review activities in the State of Texas.

(5) Community center--A community mental health center organized pursuant to the Texas Health and Safety Code, Title 7, Chapter 534, §534.053 (formerly the Texas Mental Health and Mental Retardation Act, §3, as amended, Texas Civil Statutes, Article 5547-201 et seq.).

(6) Contract provider--An entity which, through written agreement or contract, is providing services to an individual served by a community center, including entities regulated by other governmental agencies.

(7) Deceased--An individual who, at death, is receiving services directly operated or contracted for by a community center.

(8) HHSC--The Texas Health and Human Services Commission.

(9) Investigating officer--A physician or registered nurse who is neither the attending physician nor anyone significantly involved as the primary provider of treatment to the deceased immediately preceding the death.

(10) Registered nurse--A nurse licensed by the Texas Board of Nurse Examiners to practice professional nursing in the State of Texas.

(11) Unusual circumstances--A death which occurs under circumstances including, but not limited to, the following: unnatural death; death by unlawful means or suspicion of death by unlawful means; absence of witnesses; suicide or suspicion of suicide; or death within 24 hours of admission to the community center.

§405.266.Community Centers: Actions Taken upon the Death of an Individual Served.

(a) Each community center shall develop separate clinical peer review and administrative review procedures consistent with this subchapter to be implemented at the time that a determination has been made to conduct a death review.

(b) When appropriate, the community center CEO or designee shall notify the deceased's personal representative (primary or emergency correspondent(s)) of the death; provide an explanation of the relevant facts related to the death; and inform them of their right to examine the deceased's medical information relevant to the death, death certificate, and autopsy findings, if any. A physician shall request consent to conduct an autopsy when appropriate.

(c) Immediately after determination of the need to conduct an administrative death review, the community center CEO shall be responsible for ensuring that the completed HHSC reporting form is submitted to HHSC.

§405.268.Community Centers: General Guidelines upon Death of an Individual Served.

(a) When a death has been determined to require an administrative death review, a copy of the certificate of death shall be made a part of the deceased's record, when possible.

(b) When appropriate, the property of the deceased will be disposed of under the provisions of the Texas Probate Code.

§405.269.Community Centers: Administrative Death Review Determination.

(a) Within one working day of the knowledge of death of an individual receiving services in an HHSC-funded or HHSC-contracted program, the community center CEO is responsible for conducting a preliminary review to determine whether:

(1) the death occurred on the premises of an HHSC-funded or HHSC-contracted program (e.g., the individual dies in his/her sleep at an MHA/MRA funded group home);

(2) the death occurred while the individual was participating in HHSC-funded or HHSC-contracted program activities (e.g., the individual dies in a community hospital after being transferred from the community center; the individual drowns while on a psychosocial program outing);

(3) other conditions indicate that the death may reasonably have been related to the individual's care or activities as part of the community center program (e.g., the individual overdoses on a psychoactive drug; the individual dies by suicide); or

(4) other conditions indicate that although the death is not reasonably related to the individual's care or activities as part of the community center program, an evaluation of policy is warranted (e.g., the individual dies of a chronic illness in a community hospital).

(b) If none of the conditions described in subsection (a) of this section is met, then the community center CEO may elect not to conduct an administrative death review. Documentation that this preliminary review was conducted must be included in the deceased's record.

(c) If any of the conditions described in subsection (a) of this section are met, an administrative death review must be conducted in compliance with this section. In addition, the need for a clinical death review must be determined as described in §405.272 of this subchapter (relating to Community Centers: Clinical Death Review Determination).

§405.274.Community Centers: Clinical Death Review.

(a) Each community center shall develop and implement procedures consistent with this subchapter for the timely reporting and review of deaths.

(b) Deaths subject to a clinical death review will be reviewed by a medical review committee pursuant to the statutes that authorize peer review activities in the State of Texas, consisting of the previously appointed investigating officer and at least two other medical/nursing professionals (M.D., D.O., or R.N.), one of which should be a medical professional whom is neither an employee of the community center nor was the deceased's attending physician (if such medical professional is not available, then the effort to obtain external membership must be documented in the information sent to the administrative death review committee). Of these three committee members, all must be either medical doctors or registered nurses. The community center CEO shall appoint one of the three medical/nursing professionals as chair of the clinical death review committee. For the purposes of this subchapter the term employee does not refer to consultants or contractors. Additionally, the membership of the clinical death review committee may include the community center CEO and/or the director of clinical quality assurance, designee, or the person who is responsible for clinical quality assurance functions.

(1) Upon determination of the need for a clinical death review, the investigating officer shall provide to the clinical death review committee:

(A) the individual's medical record;

(B) a copy of the death certificate, bearing a valid diagnosis, if available;

(C) a copy of the preliminary or full autopsy report, if available;

(D) the probable final diagnosis, including contributory causes, and reasons for variance from the death certificate, if any; and

(E) a briefing of possible issues involving clinically related community center operational policies and procedures and quality of medical care.

(2) Within 14 calendar days (or 45 days in which an autopsy is performed, or for deaths occurring at medical facilities to which the individual was transferred before death) of the determination of the need for a clinical death review, the clinical death review committee shall meet to review the information the investigating officer has provided as described in subsection (b)(1) of this subsection. On the basis of the review, the committee shall evaluate the quality of medical and nursing care given before death and shall formulate written recommendations, if appropriate, for changes in policy and procedures, professional education, operations, or patient care. Suspected abuse or neglect must be reported in accordance with the rules of the Texas Department of Family and Protective Services.

(c) Within 21 calendar days of the determination of the need for a clinical death review (or 52 days in cases in which an autopsy is performed, or for deaths occurring at medical facilities to which the individual was transferred before death), the clinical death review committee shall submit to the administrative death review committee the following:

(1) the clinical death review committee's recommendations;

(2) a copy of the death/discharge summary, if available;

(3) a copy of the death certificate, bearing a valid diagnosis, if available;

(4) the probable final diagnosis, including contributory causes, and reasons for variance from the death certificate, if any; and

(5) documentation of the effort to obtain an external medical professional, if no such person was available.

(d) To maintain the effectiveness of the death review process, HHSC may conduct reviews of the community center's clinical death review process.

(e) The community center CEO is authorized to grant variances from the timelines by this section on a case-by-case basis. Reasons for timeline variances must be justified and documented.

§405.275.Community Centers: Administrative Death Review.

(a) The community center CEO shall convene an administrative death review committee:

(1) immediately after the determination of the need for an administrative death review, if a clinical death review was not conducted;

(2) when a preliminary administrative death review is to take place as determined in §405.272(b) of this subchapter (relating to Community Centers: Clinical Death Review Determinations); or

(3) immediately after the receipt of the information from the clinical death review committee as described in §405.274(c) of this subchapter (relating to Community Centers: Clinical Death Review).

(b) The membership of the administrative death review committee shall consist of:

(1) three senior administrative and medical personnel (e.g., CEO, medical director, director of nursing, director of quality assurance, etc.) one of whom shall be designated as the chair by the CEO;

(2) a representative of the public, external to HHSC and not related to or associated with the deceased (e.g., a member of the public responsibility committee, a member of the community hospital's ethics committee, a family member, an advocate, a consumer, etc.). If such representative of the public is not available, then the effort to obtain external membership must be documented in the information sent to HHSC; and

(3) other individuals appropriate to the death being reviewed (e.g., the investigating officer).

(c) The purpose of the administrative death review committee is to:

(1) review the information and recommendations provided by the clinical death review committee and/or from the preliminary investigation;

(2) review operational policies and procedures and continuity of care issues which may have affected the care of the individual and formulate written recommendations for changes in policies and procedures, if appropriate; and

(3) act upon the recommendations described in paragraphs (1) and (2) of this subsection.

(d) If information presented during the administrative review indicates the need for a clinical death review or a re-review, then the administrative death review committee has the authority to request such review.

(e) Suspected abuse or neglect must be reported in accordance with the rules of the Texas Department of Family and Protective Services.

(f) Within 14 calendar days of the determination of the need for an administrative death review (or 45 days in cases in which an autopsy is performed, or for deaths occurring at medical facilities to which the individual was transferred before death) or within 14 calendar days after the receipt of the information from the clinical death review committee, the administrative death review committee shall submit the following elements to HHSC:

(1) a copy of the death/discharge summary, if available;

(2) a copy of the death certificate, bearing a valid diagnosis, if available;

(3) a copy of the preliminary or full autopsy report, if available;

(4) the probable final diagnosis, including contributory causes, and reasons for variance from the death certificate, if any;

(5) a copy of the clinical death review committee's recommendations, if such review was conducted;

(6) a copy of the administrative death review committee's recommendations; and

(7) if applicable, documentation of the effort to obtain external membership for the clinical death review committee and/or the administrative death review committee, if no such medical professional and/or representative of the public was available.

(g) A summary of the resulting actions taken in response to the recommendations of the administrative and clinical death review committees shall be forwarded by the CEO or designee to HHSC within 28 calendar days following the submission of the elements contained in subsection (f)(1) - (7) of this section.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 6, 2022.

TRD-202201788

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: May 26, 2022

Proposal publication date: February 25, 2022

For further information, please call: (512) 438-3049


25 TAC §§405.264, 405.265, 405.267, 405.270, 405.271, 405.273, 405.277, 405.279

STATUTORY AUTHORITY

The repeals are adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and Health and Safety Code §552.001, which authorizes HHSC to operate the State Hospital System.

The repeals affect Texas Government Code §531.0055 and Health and Safety Code §552.001. This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 6, 2022.

TRD-202201789

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: May 26, 2022

Proposal publication date: February 25, 2022

For further information, please call: (512) 438-3049