PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 133. HOSPITAL LICENSING
SUBCHAPTER C. OPERATIONAL REQUIREMENTS
The Texas Health and Human Services Commission (HHSC) adopts amendments to §133.41, concerning Hospital Functions and Services, and §133.49, concerning Reporting Requirements.
Amended §133.41 is adopted without changes to the proposed text as published in the June 14, 2024, issue of the Texas Register (49 TexReg 4148). This rule will not be republished.
Amended §133.49 is adopted with changes to the proposed text as published in the June 14, 2024, issue of the Texas Register (49 TexReg 4148). This rule will be republished.
BACKGROUND AND JUSTIFICATION
The adoption is necessary to implement House Bill (H.B.) 3162, 88th Legislature, Regular Session, 2023. H.B. 3162 amended Texas Health and Safety Code (HSC) Chapter 166, Subchapters B and E, and HSC Chapter 313.
HSC §166.046, as amended by H.B. 3162, in part, requires a facility's ethics or medical committee to review a physician's refusal to honor an advance directive or health care or treatment decision made by or on behalf of a patient determined to be incompetent or otherwise mentally or physically incapable of communication. Amended HSC §166.046 also requires the facility to provide a written notice to the person responsible for the patient's health care decisions that the facility's ethics or medical committee will meet at least seven days later to review the physician's refusal to honor the patient's advanced directive or health care treatment decision.
HSC §166.054, as added by H.B. 3162, requires health care facilities to report certain information to HHSC within 180 days after the health care facility provides the written notice required under HSC §166.046. New HSC §166.054 also requires HHSC to adopt rules for reporting, protecting, and aggregating this information.
COMMENTS
The 31-day comment period ended July 15, 2024.
During this period, HHSC received comments regarding the proposed rules from five commenters, including Not Dead Yet, the Texas Hospital Association (THA), the Texas Medical Association (TMA), and two individuals. THA and TMA commented jointly. A summary of comments relating to the rules and HHSC's responses follows.
Comment: An individual commenter stated they are in support of the rules and the opportunity to aggregate information surrounding refused advanced directives.
Response: HHSC acknowledges this comment.
Comment: An individual commenter requested HHSC amend HSC §166.046 to require facilities to include the reason why a physician refused to honor a patient's advance directive in addition to the notice required by HSC §166.046(b)(3)(D)(i). The commenter also noted the word "notice" is vague.
Response: HHSC does not have the authority to revise HSC §166.046. No revisions are made to §133.41 or §133.49 because the language is consistent with HSC §166.046.
Comment: Not Dead Yet requested HHSC clarify in §133.41 and §133.49 that an ethics or medical committee must not consider a patient's pre-existing disability or any disability that may arise from the patient's injury or disease.
Response: HHSC declines to revise §133.41 and §133.49 because such revisions are beyond the scope of the amendments in §133.41 and new reporting requirements in §133.49. Additionally, HHSC notes §133.45(c) already prohibits a hospital from discriminating based on a patient's disability.
Comment: THA and TMA requested HHSC amend §133.49(d) to closely mirror HSC §166.054. THA and TMA stated §133.49(d) as proposed may be interpreted to mean a facility must deliver the written notice about the meeting to review a physician's refusal to honor an advance directive regardless of whether the physician refused to honor an advance directive.
Response: HHSC revises §133.49(d) by replacing the words "delivers the" with "provides" and deleting the word "required" to further align §133.49(d) with HSC §166.054.
Comment: THA and TMA suggested HHSC revise §133.49(d)(5) by splitting the paragraph into two paragraphs and adding language to clarify "if life-sustaining treatment was withheld or withdrawn from the patient at the hospital after expiration of the time period described by HSC §166.046(e), the disposition of the patient after the withholding or withdrawal of life-sustaining treatment at the hospital, as selected from the following categories."
THA and TMA also requested HHSC amend §133.49(e) to clarify "HHSC publishes on its website by April 1st of each year an aggregate report as described by HSC §166.054(c)-(d) that does not include any information included in previous aggregate reports. THA and TMA stated §133.49(e) as proposed does not account for instances in which the annual report may contain information aggregated from multiple prior years.
Response: HHSC declines to revise §133.49(d)(5) and §133.49(e) because the language as proposed is in accordance with HSC §166.054(c)-(e). HHSC notes that HHSC is required to comply with statute and has internal policies in place to ensure such compliance.
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; HSC §241.026, which requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of licensed hospitals; and HSC §166.054, which requires HHSC to adopt rules to establish a standard form for the requirements for reporting meetings of an ethics or medical committee meeting to review a physician's refusal to honor an advance directive of or health care or treatment decision made by or on behalf of a patient who is determined to be incompetent or is otherwise mentally or physically incapable of communication and to protect and aggregate any information HHSC receives under this section.
§133.49.Reporting Requirements.
(a) A hospital shall submit reports to the Texas Department of State Health Services (DSHS) in accordance with the reporting requirements in Texas Health and Safety Code (HSC) §98.103 and §98.1045.
(b) A hospital that donates human fetal tissue under HSC Chapter 173 shall submit an annual report to the Texas Health and Human Services Commission (HHSC) that includes for each donation the specific type of fetal tissue donated and the accredited public or private institution of higher learning that received the donation. The hospital shall submit the annual report no later than January 31st of the subsequent year.
(c) A hospital that diagnoses or treats an abortion complication, as defined in §139.2 of this title (relating to Definitions), shall comply with §139.5 of this title (relating to Additional Reporting Requirements).
(d) Pursuant to HSC §166.054, a hospital shall complete and submit to HHSC the Ethics or Medical Committee Reporting Form, which is located on the HHSC website, no later than the 180th day after the hospital provides written notice under HSC §166.046(b)(1). The Ethics or Medical Committee Reporting Form collects the following information:
(1) the number of days that elapsed from the patient's admission to the hospital to the date notice was provided under HSC §166.046(b)(1);
(2) whether the ethics or medical committee met to review the case under HSC §166.046 and, if the committee did meet, the number of days that elapsed from the date notice was provided under HSC §166.046(b)(1) to the date the meeting was held;
(3) whether the patient was:
(A) transferred to a physician within the same hospital who was willing to comply with the patient's advance directive or a health care or treatment decision made by or on behalf of the patient;
(B) transferred to a different health care facility; or
(C) discharged from the hospital to a private residence or other setting that is not a health care facility;
(4) whether the patient died while receiving life-sustaining treatment at the hospital;
(5) whether life-sustaining treatment was withheld or withdrawn from the patient at the hospital after expiration of the time period described by HSC §166.046(e) and, if so, the disposition of the patient after the withholding or withdrawal of life-sustaining treatment at the hospital, as selected from the following categories:
(A) the patient died at the hospital;
(B) the patient is currently a patient at the hospital;
(C) the patient was transferred to a different health care facility; or
(D) the patient was discharged from the facility to a private residence or other setting that is not a health care facility;
(6) the age group of the patient selected from the following categories:
(A) 17 years of age or younger;
(B) 18 years of age or older and younger than 66 years of age; or
(C) 66 years of age or older;
(7) the health insurance coverage status of the patient selected from the following categories:
(A) private health insurance coverage;
(B) public health plan coverage; or
(C) uninsured;
(8) the patient's sex;
(9) the patient's race;
(10) whether the hospital was notified of and able to reasonably verify any public disclosure of the contact information for the hospital's personnel, physicians or health care professionals who provide care at the hospital, or members of the ethics or medical committee in connection with the patient's stay at the hospital; and
(11) whether the hospital was notified of and able to reasonably verify any public disclosure by hospital personnel of the contact information for the patient's immediate family members or the person responsible for the patient's health care decisions in connection with the patient's stay at the hospital.
(e) In accordance with HSC §166.054(c)-(e), HHSC publishes on its website an aggregate report of information submitted under subsection (d) of this section in the preceding year by April 1st of each year.
(f) Pursuant to HSC §166.054(g), information collected or submitted under subsection (d) of this section:
(1) is not admissible in a civil or criminal proceeding in which a physician, health care professional acting under the direction of a physician, or health care facility is a defendant;
(2) may not be used in relation to any disciplinary action by a licensing or regulatory agency with oversight over a physician, health care professional acting under the direction of a physician, or health care facility; and
(3) is not public information or subject to disclosure under Texas Government Code Chapter 552, except as permitted by Texas Government Code §552.008.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on October 9, 2024.
TRD-202404806
Karen Ray
Chief Counsel
Department of State Health Services
Effective date: November 1, 2024
Proposal publication date: June 14, 2024
For further information, please call: (512) 834-4591
SUBCHAPTER B. VITAL RECORDS
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts an amendment to §181.22, concerning Fees Charged for Vital Records Services; and the repeal of §181.35, concerning Parental Consent of Underage Applicants to Marriage.
The amendment to §181.22 and repeal of §181.35 are adopted without changes to the proposed text as published in the August 2, 2024, issue of the Texas Register (49 TexReg 5683). These rules will not be republished.
BACKGROUND AND JUSTIFICATION
The amendment is necessary to clarify and enhance the transparency of Vital Statistics fees in rule and the repeal is necessary to remove outdated rules identified during the rule review process.
The amendment to §181.22 consolidates fees charged for vital records services to clearly state each fee amount. There is no fee increase with this consolidation.
The expedited service fee, which shortens processing time, is available if the applicant chooses to pay the extra sum. The expedited service fee increased from $5 to $25 per application. This expedited service fee has not increased in 33 years and does not cover the costs for the service. The public does not need to pay this fee to obtain a vital record.
The amendment includes longstanding services being provided but not listed in rule.
Section 181.35 is repealed to comply with Senate Bill 1705, 85th Legislature, Regular Session, 2017, that repealed the statutory authority in Texas Family Code §2.102.
COMMENTS
The 31-day comment period ended September 3, 2024.
During this period, DSHS did not receive any comments regarding the proposed rules.
STATUTORY AUTHORITY
The amendment is adopted under Texas Government Code §531.0055 and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001; and Texas Health and Safety Code §191.0045, which authorizes rules necessary to prescribe fees for vital statistics services.
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 October 9, 2024.
TRD-202404790
Cynthia Hernandez
General Counsel
Department of State Health Services
Effective date: November 20, 2024
Proposal publication date: August 2, 2024
For further information, please call: (512) 776-7646
STATUTORY AUTHORITY
The repeal is adopted under Texas Government Code §531.0055 and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001; and Texas Health and Safety Code §191.0045, which authorizes rules necessary to prescribe fees for vital statistics services.
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 October 9, 2024.
TRD-202404793
Cynthia Hernandez
General Counsel
Department of State Health Services
Effective date: November 20, 2024
Proposal publication date: August 2, 2024
For further information, please call: (512) 776-7646
SUBCHAPTER F. LICENSE REGULATIONS
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts an amendment to §289.252, concerning Licensing of Radioactive Material. The amendment to §289.252 is adopted without changes to the proposed text as published in the July 19, 2024, issue of the Texas Register (49 TexReg 5261), and therefore will not be republished.
BACKGROUND AND JUSTIFICATION
The amendment is necessary for Texas (an Agreement State) to comply with United States Nuclear Regulatory Commission (NRC) requirements, as identified in the Review Summary Sheets for Regulation Amendments (RATS Identification). The amendment updates NRC information, including the sum of ratios equation, used for determining whether aggregate quantities of radionuclides exceed the category 1 or category 2 radioactive material thresholds. An additional RATS Identification prescribes an update to the 21 Code of Federal Regulations (CFR) reference used when evaluating applications for specific licenses to manufacture, prepare, or transfer for commercial distribution, radioactive drugs containing radioactive material.
The amendment clarifies Radiation Safety Officer training requirements; updates licensee responsibility for providing documentation to support nuclear pharmacist designation; specifies cut-off dates for nuclear pharmacy practice experience as they relate to authority to designate nuclear pharmacists; corrects the reference for reporting and notifying DSHS when radiopharmaceutical generator eluates exceed permissible concentrations; and simplifies the "Form of records" requirements for category 1 and category 2 protection standards by removing references to obsolete storage media. The amendment ensures compatibility with NRC requirements not specifically mentioned in the RATS Identification.
The amendment updates, corrects, improves, and clarifies the rule language and incorporates plain language where appropriate.
COMMENTS
The 31-day comment period ended August 19, 2024.
During this period, DSHS received no public comments regarding the proposed rule.
STATUTORY AUTHORITY
The amendment is authorized by Texas Health and Safety Code Chapter 401 (the Texas Radiation Control Act), which provides for DSHS radiation control rules and regulatory program to be compatible with federal standards and regulation; §401.051, which provides the required authority to adopt rules and guidelines relating to the control of sources of radiation; §401.052, which provides authority for rules providing for transportation and routing of radioactive material and waste in Texas; §401.103, which provides authority for licensing and registration for transportation of sources of radiation; §401.104 which provides for rulemaking authority for general or specific licensing of radioactive material and devices or equipment using radioactive material; §401.224, which provides rulemaking authority relating to the packaging of radioactive waste; Chapter 401, Subchapter J, which authorizes enforcement of the Act; Texas Government Code §531.0055; and Texas Health and Safety Code §1001.075, which authorizes the Executive Commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on October 9, 2024.
TRD-202404785
Cynthia Hernandez
General Counsel
Department of State Health Services
Effective date: October 29, 2024
Proposal publication date: July 19, 2024
For further information, please call: (512) 834-6655