TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 133. HOSPITAL LICENSING

SUBCHAPTER C. OPERATIONAL REQUIREMENTS

25 TAC §133.48

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes the repeal of §133.48, concerning Patient Safety Program.

BACKGROUND AND PURPOSE

The purpose of the proposal is to remove outdated references to the Patient Safety Program. House Bill (H.B.) 1614, 78th Legislature, Regular Session, 2003, amended Texas Health and Safety Code, Chapter 241, by adding Subchapter H, Patient Safety Program, requiring hospitals to report certain medical errors to HHSC. This subchapter expired under its own terms on September 1, 2007; therefore, the reporting requirements associated with H.B. 1614 are defunct. The proposed repeal is necessary to remain consistent with Texas Health and Safety Code, Chapter 241.

SECTION-BY-SECTION SUMMARY

The proposed repeal of §133.48 deletes an unnecessary rule resulting from the expiration of the Patient Safety Program and medical error reporting requirements.

FISCAL NOTE

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

GOVERNMENT GROWTH IMPACT STATEMENT

HHSC determined during the first five years the repeal will be in effect:

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

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

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

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

(5) the proposed repeal will not create a new rule;

(6) the proposed repeal will limit existing rules;

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

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

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

Trey Wood has also determined there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rules repeal does not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

LOCAL EMPLOYMENT IMPACT

The proposed repeal will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to this rule because the rule is necessary to protect the health, safety, and welfare of the residents of Texas; does not impose a cost on regulated persons; and is repealed to reduce the burden or responsibilities imposed on regulated persons by the rules.

PUBLIC BENEFIT AND COSTS

David Kostroun, Deputy Executive Commissioner of Regulatory Services, has determined that for each year of the first five years the rule repeal is in effect, the public will benefit from greater clarity of reporting requirements for hospitals and conformity with existing statutes.

Trey Wood has also determined that for each year of the first five years the repeal is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed repeal, because the repeal of outdated rules ensures HHSC rules are consistent with current existing statutes and removes references to outdated reporting requirements.

TAKINGS IMPACT ASSESSMENT

HHSC has determined 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 Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 4900 North Lamar Boulevard, Austin, Texas 78751; or by email to HCQ_PRT@hhsc.state.tx.us.

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 20R010" in the subject line.

STATUTORY AUTHORITY

The proposed repeal 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 the 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 repeal implements Texas Government Code §531.0055 and Texas Health and Safety Code, §241.026.

§133.48.Patient Safety Program.

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 November 6, 2020.

TRD-202004717

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: December 20, 2020

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


CHAPTER 135. AMBULATORY SURGICAL CENTERS

SUBCHAPTER A. OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes amendments to §135.26, concerning Reporting Requirements, and the repeal of §135.27, concerning Patient Safety Program.

BACKGROUND AND PURPOSE

The purpose of the proposal is to remove outdated references to the Patient Safety Program and update reporting requirements for Ambulatory Surgical Centers (ASCs). House Bill (H.B.) 1614, 78th Legislature, Regular Session, 2003, amended Texas Health and Safety Code, Chapter 243, by adding Subchapter B, Patient Safety Program requiring ASCs to report certain medical errors to HHSC. This subchapter expired under its own terms on September 1, 2007; therefore, the reporting requirements associated with H.B. 1614 are no longer current. The proposed amendment and repeal is necessary to remain consistent with Texas Health and Safety Code, Chapter 243.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §135.26 removes outdated references to the Department of State Health Services and add HHSC Complaint and Incident Intake as the appropriate place to send incident reports.

The proposed repeal of §135.27 deletes an unnecessary rule, resulting from the expiration of the Patient Safety Program and related medical error reporting requirements.

FISCAL NOTE

Trey Wood, Chief Financial Officer, has determined for each year of the first five years the repeal 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 determined during the first five years the repeal 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 not create a new rule;

(6) the proposed rules will limit existing rules;

(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 there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. These Rules do not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

LOCAL EMPLOYMENT IMPACT

The proposed repeal 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 repealed or amended to reduce the burden or responsibilities imposed on regulated persons by the rules.

PUBLIC BENEFIT AND COSTS

David Kostroun, Deputy Executive Commissioner of Regulatory Services, determined that for each year of the first five years the rules are in effect, the public will benefit from greater clarity regarding reporting requirements for ASCs and conformity with existing statutes.

Trey Wood has also determined that for each year of 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 these amendments ensure that HHSC rules are consistent with current existing statutes and remove references to outdated reporting requirements.

TAKINGS IMPACT ASSESSMENT

HHSC has determined 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 Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 4900 North Lamar Boulevard, Austin, Texas 78751; or by email to HCQ_PRT@hhsc.state.tx.us.

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 20R010" in the subject line.

25 TAC §135.26

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 the Texas Health and Safety Code, §243.010, which requires HHSC to adopt rules for the minimum standards applicable to an ASC.

The amendment implements Texas Government Code §531.0055 and Texas Health and Human Safety Code, §243.010.

§135.26.Reporting Requirements.

(a) The ambulatory surgical center (ASC) shall make a report of the following incidents to the Texas Health and Human Services Commission (HHSC) [department]. An incident report form shall be submitted to HHSC Complaint and Incident Intake [A written letter of explanation with supporting documents shall be mailed to the department] within 10 business days of the incident. [The mailing address is Department of State Health Services, Facility Licensing Group, Post Office Box 149347, Austin, Texas 78714-9347.]

(1) The death of a patient while under the care of the ASC;

(2) The transfer of a patient to a hospital;

(3) Patient development of complications within 24 hours of discharge from the ASC resulting in admission to a hospital; and

(4) A patient stay exceeding 23 hours.

(b) On an annual basis, the ASC shall report the types and numbers of procedures performed and the average length of stay during the previous 12-month period. The report shall be made using a form to be prescribed by the department.

(c) Any theft of drugs and/or diversion of controlled drugs shall be reported to the local police agency, the Texas State Board of Pharmacy, the Texas Department of Public Safety, and/or the Drug Enforcement Administration, and HHSC [the Department of State Health Services].

(d) An ASC that performs abortions shall comply with the reporting requirements specified in the Texas Health and Safety Code, Chapters 171 and 245, and Chapter 139 of this title.

(e) The ASC shall submit reports to the Department of State Health Services [department] in accordance with the reporting requirements in Texas Health and Safety Code, §98.103 and §98.1045 (relating to Reportable Infections and Reporting of Preventable Adverse Events), and associated rules.

(f) Occurrences of fire in the ASC shall be reported as specified under §135.41(a)(2) of this title (relating to Fire Prevention and Protection) and §135.43(b)(6) of this title (relating to Handling and Storage of Gases, Anesthetics, and Flammable Liquids).

(g) An ASC that donates human fetal tissue under Texas Health and Safety Code, Chapter 173, shall submit an annual report to the Health and Human Services Commission 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 ASC shall submit the annual report no later than January 31st of the subsequent year.

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 November 6, 2020.

TRD-202004718

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: December 20, 2020

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


25 TAC §135.27

STATUTORY AUTHORITY

The repeal 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 the Texas Health and Safety Code, §243.010, which requires HHSC to adopt rules for the minimum standards applicable to an ASC.

The repeal implements Texas Government Code §531.0055 and Texas Health and Human Safety Code, §243.010.

§135.27.Patient Safety Program.

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 November 6, 2020.

TRD-202004719

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: December 20, 2020

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