Texas Register June 14, 2024 Volume: 49 Number: 24

Texas Register Table of Contents

1 Governor
- - 1.0.1 Appointments Re:
2 Texas Health and Human Services Commission
3 Texas Animal Health Commission
- - 3.0.1 Proposed Rules Re:
    - 3.0.1.1 Amending 4 TAC §51.12, to set forth the requirements for sheep entering Texas.
    - 3.0.1.2 Amending 4 TAC §60.1, to eliminate the definition for “Blackfaced Sheep,” reorganize the definition of “Breed Associations and Registries” in alphabetical order, and add a definition for “Breeding Sheep.”
4 Texas Optometry Board
- - 4.0.1 Proposed Rules Re:
  - 4.0.2 Adopted Rule Reviews Re:
    - 4.0.2.1 Adopting Title 22, Part 14, concerning Examinations, Administration, General Rules, and Continuing Education.
5 Texas State Board of Pharmacy
- - 5.0.1 Proposed Rule Re:
    - 5.0.1.1 Amending 22 TAC §281.69, to correct subparagraph lettering and grammatical errors.
6 Department of State Health Services
7 Department of Aging and Disability Services
- - 7.0.1 Transferred Rules Re:
8 Cancer Prevention and Research Institute of Texas
- - 8.0.1 In Addition Re:
    - 8.0.1.1 Notice of Extension of Comment Deadline for Rules Related to the Texas Cancer Plan

Governor

Appointments Re:

Appointed to the Texas Board of Nursing for a term to expire January 31, 2025, Manuel “Manny” Cavazos, IV of Manor, Texas.

Appointed to the Texas Board of Nursing for a term to expire January 31, 2027, Mary Grace Landrum of Houston, Texas.

Appointed to the Texas Board of Nursing for a term to expire January 31, 2029, Nancy A. “Nan” Lewis of Buchanan Dam, Texas.

Texas Health and Human Services Commission

Proposed Rules Re:

Amending 1 TAC §354.1149, to require Medicaid programs to cover vaccines and their administration, provided that the vaccine is approved by the U.S. Food and Drug Administration (FDA) for use by adult populations and is administered in accordance with recommendations of the Advisory Committee on Immunization Practices (ACIP), effective October 1, 2023.

CHAPTER 354. MEDICAID HEALTH SERVICES
SUBCHAPTER A. PURCHASED HEALTH SERVICES
DIVISION 11. GENERAL ADMINISTRATION
1 TAC §354.1149

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §354.1149, concerning Exclusions and Limitations.

BACKGROUND AND PURPOSE

The purpose of the proposal is to align Texas Medicaid coverage of vaccines for adults with federal requirements in section 11405 of the Inflation Reduction Act (IRA) of 2022 (Public Law 117-169). On June 27, 2023, the Centers for Medicare & Medicaid Services issued guidance on its interpretation of the amendments to the Social Security Act made by the IRA to require Medicaid programs to cover vaccines and their administration, provided that the vaccine is approved by the U.S. Food and Drug Administration (FDA) for use by adult populations and is administered in accordance with recommendations of the Advisory Committee on Immunization Practices (ACIP), effective October 1, 2023. States are directed to add coverage for all ACIP-recommended vaccines for adults, including vaccines solely for travel to or from foreign countries. As a result, the Texas Health and Human Services Commission (HHSC) is removing the exclusion of all FDA-approved and ACIP-recommended vaccines used solely for occupation and/or travel as Medicaid benefits for the adult population.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §354.1149 removes the exclusion in subsection (a)(9) of the rule for immunizations specifically for travel to or from foreign countries. This change is consistent with the requirements of the IRA of 2022. The proposed amendment renumbers the remaining paragraphs in subsection (a) and makes minor editing changes.

Amending 1 TAC §371.1721, to summarize OIG’s performance of inspections.

CHAPTER 371. MEDICAID AND OTHER HEALTH AND HUMAN SERVICES FRAUD AND ABUSE PROGRAM INTEGRITY
SUBCHAPTER G. ADMINISTRATIVE ACTIONS AND SANCTIONS
DIVISION 3. ADMINISTRATIVE ACTIONS AND SANCTIONS
1 TAC §371.1721

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Office of Inspector General (OIG), proposes in the Texas Administrative Code (TAC), Title 1, Part 15, Chapter 371, Subchapter G, Division 3, new §371.1721, concerning Recoupment of Overpayments Identified by Inspection.

BACKGROUND AND PURPOSE

The purpose of the proposal is to describe the OIG’s inspection procedures related to records requests, inspection processes, notices, final reports, and due process.

Texas Government Code Section 531.102 authorizes the OIG to conduct inspections related to the provision and delivery of all health and human services in Texas to identify fraud, waste, or abuse.

SECTION-BY-SECTION SUMMARY

The proposed new §371.1721(a) summarizes OIG’s performance of inspections, including the recovery of overpayments when identified during an inspection.

The proposed new §371.1721(b) describes the procedures related to an inspection records request, including the time deadline required to submit records in response to a records request. The proposed new §371.1721(b) also states that failure to timely produce requested records may result in an OIG enforcement action.

The proposed new §371.1721(c) describes the standards OIG inspections follow, the time scope, notice prior to the start of an inspection, and the opportunity to submit documentation to address an inspection finding. A person, as defined in §371.1 of this chapter, is subject to an OIG inspection.

The proposed new §371.1721(d) specifies the notices OIG sends during an inspection, consisting of the draft inspection report and final inspection report.

The proposed new §371.1721(e) outlines the contents of an inspection final report, including a management response, if any, and any recommendations, findings, or overpayment amounts.

The proposed new §371.1721(f) describes the due process provided to a person subject to an OIG inspection, including the requirements for requesting an administrative hearing at the HHSC Appeals Division.

The proposed new §371.1721(g) specifies the timing and circumstances under which results of an OIG inspection become final.

Amending 26 TAC §506.40, to require a facility to complete and submit the Ethics or Medical Committee Reporting Form to HHSC after the facility provides the written notice.

CHAPTER 506. SPECIAL CARE FACILITIES
SUBCHAPTER C. OPERATIONAL REQUIREMENTS
26 TAC §506.40

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes new §506.40, concerning Advance Directives Reporting Requirements.

BACKGROUND AND PURPOSE

The purpose of the proposal is 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.

SECTION-BY-SECTION SUMMARY

Proposed new §506.40(a) ensures consistency with amended HSC §166.054 by requiring a facility to complete and submit the Ethics or Medical Committee Reporting Form to HHSC after the facility provides the written notice required under HSC §166.046(b)(1) and describes the information collected in the form.

New subsection (b) describes the process of publishing the aggregate report.

New subsection (c) provides how the information in the forms may not be used.

Amending 26 TAC §550.1, §550.5, to replace references to DADS, update wording, and delete definitions made obsolete by organizational changes.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER A. PURPOSE, SCOPE, LIMITATIONS, COMPLIANCE, AND DEFINITIONS
26 TAC §550.1, §550.5

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes amendments to §§550.1, 550.5, 550.101 – 550.106, 550.108 – 550.115, 550.118 – 550.123, 550.202, 550.203, 550.205 – 550.207, 550.210, 550.211, 550.301, 550.303 – 550.306, 550.308 – 550.311, 550.402 – 550.406, 550.409 – 550.411, 550.413, 550.415, 550.417, 550.418, 550.504, 550.506 – 550.508, 550.510, 550.511, 550.601 – 550.608, 550.701, 550.703, 550.705, 550.707, 550.802, 550.803, 550.901 – 550.906, 550.1001 – 550.1003, 550.1101, 550.1102, 550.1202 – 550.1204, 550.1206, 550.1207, 550.1211, 550.1215, 550.1217 – 550.1220, 550.1222, 550.1224, 550.1301 – 550.1305, and 550.1401 – 550.1408.

BACKGROUND AND PURPOSE

The purpose of this proposal is to implement provisions of House Bill (H.B.) 1009 and H.B. 3550 from the 88th Legislature, Regular Session, 2023, that apply to Prescribed Pediatric Extended Care Centers (PPECC). H.B. 1009 requires a facility to suspend an employee who has been found by HHSC to have engaged in reportable conduct for purposes of inclusion on the Employee Misconduct Registry during any appeals. H.B. 3550 establishes minimum standards for transportation services whereby a center coordinates the schedule of transportation services with a minor’s parent, guardian, or other legally authorized representative; determines what type of provider needs to be present during transportation; and permits a minor’s parent, guardian, or other legally authorized representative to decline a center’s transportation services entirely or only on a specific date. The proposed rules also set forth that a center may not require a plan of care or physician’s order to document a minor’s need for transportation services to access PPECC services or consider transportation services as nursing services in a minor’s plan of care. In addition, the proposed rules update terminology and references and reflect current processes.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.1, Purpose, replaces references to DADS and updates wording for better understanding.

The proposed amendment to §550.5, Definitions, corrects capitalization errors, deletes definitions made obsolete by organizational changes, corrects numbering changed by the deletion of obsolete definitions, updates the definition for “center,” and adds a definition for “online portal.” It also defines “immediate threat to the health or safety of a minor.”

Amending 26 TAC §§550.101 – 550.106, 550.108 – 550.115, 550.118 – 550.123, to update processes, update outdated references to DADS, and delete obsolete portions.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER B. LICENSING APPLICATION, MAINTENANCE, AND FEES
26 TAC §§550.101 – 550.106, 550.108 – 550.115, 550.118 – 550.123

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.101, Criteria and Eligibility for a License, updates outdated agency references.

The proposed amendment to §550.102, General Application Requirements, updates outdated references to DADS and Texas Administrative Code (TAC), Title 40 §15, and updates processes.

The proposed amendment to §550.103, Building Approval, updates outdated references to DADS and updates processes.

The proposed amendment to §550.104, Applicant Disclosure Requirements, updates outdated references to DADS and updates processes.

The proposed amendment to §550.105, Initial License Application Procedures and Issuance, updates outdated references to 40 TAC §15, updates processes, and deletes obsolete portions of the processes.

The proposed amendment to §550.106, Renewal License Application Procedures and Issuance, updates outdated references to 40 TAC §15, updates processes, and deletes obsolete portions of the processes.

The proposed amendment to §550.108, Change of Ownership License Application Procedures and Issuance and Notice of Changes, adds language to clarify processes.

The proposed amendment to §550.109, Increase in Capacity, updates outdated references to DADS and 40 TAC §15 and updates processes.

The proposed amendment to §550.110, Decrease in Capacity, updates processes.

The proposed amendment to §550.111, Relocation, updates outdated references to DADS and 40 TAC §15, updates processes, and deletes obsolete portions of the processes.

The proposed amendment to §550.112, Licensing Fees, updates outdated references to 40 TAC §15.

The proposed amendment to §550.113, Plan Review Fees, updates outdated references to DADS.

The proposed amendment to §550.114, Time Periods for Processing All Types of License Applications, updates outdated references to DADS and 40 TAC §15, updates processes, and deletes obsolete portions of the processes.

The proposed amendment to §550.115, Criteria for Denial of a License, updates outdated references to DADS and 40 TAC §15, updates processes, and deletes obsolete portions of the processes.

The proposed amendment to §550.118, Reporting Changes in Application Information, updates outdated references to DADS and 40 TAC §15 and updates processes.

The proposed amendment to §550.119, Notification Procedures for a Change in Administration and Management, updates outdated references to DADS and updates processes.

The proposed amendment to §550.120, Notification Procedures for a Change of Contact Information, updates processes.

The proposed amendment to §550.121, Notification Procedures for a Change in Operating Hours, updates outdated references to DADS and updates processes.

The proposed amendment to §550.122, Notification Procedures for a Name Change, updates outdated references to DADS and 40 TAC §15 and updates processes.

The proposed amendment to §550.123, Request and Issuance of Temporary License, updates outdated references to DADS and 40 TAC §15 and updates processes.

Amending 26 TAC §§550.202, 550.203, 550.205 – 550.207, 550.210, 550.211, to update outdated references to DADS and updates processes.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER C. GENERAL PROVISIONS
DIVISION 1. OPERATIONS AND SAFETY PROVISIONS
26 TAC §§550.202, 550.203, 550.205 – 550.207, 550.210, 550.211

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.202, Suspension of Operations, updates outdated references to DADS and 40 TAC §15 and updates processes.

The proposed amendment to §550.203, Financial Solvency and Business Records, updates outdated references to DADS.

The proposed amendment to §550.205, Safety Provisions, makes clarifying edits and updates outdated references to DADS.

The proposed amendment to §550.206, Person-Centered Direction and Guidance, updates an outdated reference to DADS.

The proposed amendment to §550.207, Protective Devices and Restraints, makes clarifying edits and updates outdated references to 40 TAC §15.

The proposed amendment to §550.210, Sanitation, Housekeeping, and Linens, makes clarifying edits.

The proposed amendment to §550.211, Infection Prevention and Control Program and Vaccinations Requirements, clarifies references.

Amending 26 TAC §§550.301, 550.303 – 550.306, 550.308 – 550.311, to update outdated references to DADS and updates processes.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER C. GENERAL PROVISIONS
DIVISION 2. ADMINISTRATION AND MANAGEMENT
26 TAC §§550.301, 550.303 – 550.306, 550.308 – 550.311

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.301, License Holder’s Responsibilities, updates outdated references to DADS and 40 TAC §15 and §99 and clarifies processes.

The proposed amendment to §550.303, Administrator and Alternate Administrator Qualifications and Conditions, updates outdated references to 40 TAC §15 and §99 and clarifies wording.

The proposed amendment to §550.304, Administrator Responsibilities, updates outdated references to 40 TAC §15 and updates processes.

The proposed amendment to §550.305, Initial Training in Administration, updates outdated references to DADS and 40 TAC §15 and makes minor edits to improve readability.

The proposed amendment to §550.306, Continuing Training in Administration, updates outdated references to DADS and 40 TAC §15.

The proposed amendment to §550.308, Medical Director Responsibilities, updates an outdated reference to 40 TAC §15.

The proposed amendment to §550.309, Nursing Director and Alternate Nursing Director Qualifications and Conditions, makes edits for clarity and consistency.

The proposed amendment to §550.310, Nursing Director Responsibilities and Supervision Responsibilities, updates outdated references to 40 TAC §15.

The proposed amendment to §550.311, Prohibition of Solicitation, updates an outdated reference to DADS.

Amending 26 TAC §§550.402 – 550.406, 550.409 – 550.411, 550.413, 550.415, 550.417, 550.418, to correct terms and grammatical errors.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER C. GENERAL PROVISIONS
DIVISION 3. NURSING AND STAFFING REQUIREMENTS
26 TAC §§550.402 – 550.406, 550.409 – 550.411, 550.413, 550.415, 550.417, 550.418

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.402, Registered Nurse Qualifications, corrects a medical term and updates outdated references to 40 TAC §15.

The proposed amendment to §550.403, Registered Nurse Responsibilities, updates wording for active voice and renumbers accordingly.

The proposed amendment to §550.404, Licensed Vocational Nurse Qualifications, updates outdated references to 40 TAC §15 and corrects a spelling mistake.

The proposed amendment to §550.405, Licensed Vocational Nurse Responsibilities, updates wording for active voice and renumbers accordingly.

The proposed amendment to §550.406, Student Nurses, updates outdated references to 40 TAC §15.

The proposed amendment to §550.409, Direct Care Staff Qualifications, updates outdated references to 40 TAC §15 and corrects a medical term.

The proposed amendment to §550.410, Nursing Services Staffing Ratio, updates outdated references to 40 TAC §15, renames the figure, and deletes an inaccurate sentence.

The proposed amendment to §550.411, Rehabilitative and Ancillary Professional Staff and Qualifications, updates wording for active voice.

The proposed amendment to §550.413, Contractors, updates outdated references to 40 TAC §15 and DADS.

The proposed amendment to §550.415, Staffing Policies for Staff Orientation, Development, and Training, updates outdated references to 40 TAC §15 and corrects grammatical errors.

The proposed amendment to §550.417, Personnel Records, updates outdated references to 40 TAC §15.

The proposed amendment to §550.418, Criminal History Checks, Nurse Aide Registry (NAR), and Employee Misconduct Registry (EMR) Requirements, updates the section title and outdated references to DADS, replaces acronyms with proper names, updates a process, and implements H.B. 1009 by requiring a facility to suspend an employee HHSC has found to have engaged in reportable conduct and placed on the EMR and to maintain that suspension during any appeals process.

Amending 26 TAC §§550.504, 550.506 – 550.508, 550.510, 550.511, to update outdated references.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER C. GENERAL PROVISIONS
DIVISION 4. GENERAL SERVICES
26 TAC §§550.504, 550.506 – 550.508, 550.510, 550.511

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.504, Psychosocial Treatment and Services, updates outdated references to 40 TAC §15.

The proposed amendment to §550.506, Rehabilitative Services, updates an outdated reference to 40 TAC §15.

The proposed amendment to §550.507, Functional Developmental Services, corrects a reference.

The proposed amendment to §550.508, Educational Developmental Services, moves an acronym definition and updates an outdated United States Code reference.

The proposed amendment to §550.510, Nutritional Counseling, updates an outdated reference to 40 TAC §15.

The proposed amendment to §550.511, Dietary Services, updates outdated references to 40 TAC §15 and updates the agency name.

Amending 26 TAC §§550.601 – 550.608, to update outdated references, add language for clarity, and correct grammatical errors.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER C. GENERAL PROVISIONS
DIVISION 5. ADMISSION CRITERIA, CONFERENCE, ASSESSMENT, INTERDISCIPLINARY PLAN OF CARE, AND DISCHARGE OR TRANSFER
26 TAC §§550.601 – 550.608

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.601, Admission Criteria, adds detail to who can consent admission to a center and updates an outdated reference to 40 TAC §15.

The proposed amendment to §550.602, Pre-admission Conference, updates an outdated reference to 40 TAC §15 and clarifies wording.

The proposed amendment to §550.603, Agreement and Disclosure, updates outdated references to 40 TAC §15, corrects grammatical errors, updates the agency name, and adds wording for clarity.

The proposed amendment to §550.604, Admission Procedures, updates an outdated reference to 40 TAC §15.

The proposed amendment to §550.605, Initial and Updated Comprehensive Assessment, adds language for clarity and corrects grammatical errors.

The proposed amendment to §550.606, Interdisciplinary Team, updates an outdated reference to 40 TAC §15.

The proposed amendment to §550.607, Initial and Updated Plan of Care, corrects grammatical errors.

The proposed amendment to §550.608, Discharge or Transfer Notification, updates an outdated reference to 40 TAC §15 and replaces a word for clarity.

Amending 26 TAC §§550.701, 550.703, 550.705, 550.707, to correct grammatical errors, update outdated references, and add language for clarity.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER C. GENERAL PROVISIONS
DIVISION 6. PHYSICIAN, PHARMACY, MEDICATION, AND LABORATORY SERVICES
26 TAC §§550.701, 550.703, 550.705, 550.707

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.701, Physician Orders, corrects a grammatical error.

The proposed amendment to §550.703, Pharmacist Services, updates outdated references to 40 TAC §15.

The proposed amendment to §550.705, Administration of Medication, adds a word for clarity.

The proposed amendment to §550.707, Disposal of Special or Medical Waste, updates the agency name and a reference.

Amending 26 TAC §550.802, §550.803, to update wording for active voice and update outdated references to DADS.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER C. GENERAL PROVISIONS
DIVISION 7. CARE POLICIES, COORDINATION OF SERVICES, AND CENSUS
26 TAC §550.802, §550.803

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.802, Coordination of Services, updates wording for active voice.

The proposed amendment to §550.803, Census, updates outdated references to DADS.

Amending 26 TAC §§550.901 – 550.906, to update outdated references, update processes, and correct grammatical mistakes.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER C. GENERAL PROVISIONS
DIVISION 8. RIGHTS AND RESPONSIBILITIES, ADVANCE DIRECTIVES, ABUSE, NEGLECT, AND EXPLOITATION, INVESTIGATIONS, DEATH REPORTING, AND INSPECTION RESULTS
26 TAC §§550.901 – 550.906

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.901, Rights and Responsibilities, updates outdated references to 40 TAC §15 and DADS, updates processes, and corrects a grammatical error.

The proposed amendment to §550.902, Advance Directives, updates an outdated reference to DADS and replaces a word for clarity.

The proposed amendment to §550.903, Abuse, Neglect, or Exploitation Reportable to DADS, updates the section title and outdated references to DADS, corrects a grammatical error, and updates processes.

The proposed amendment to §550.904, Investigations of a Complaint and Grievance, updates an outdated reference to DADS.

The proposed amendment to §550.905, Reporting of a Minor’s Death, updates outdated references to DADS.

The proposed amendment to §550.906, Examination of Inspection Results, updates an outdated reference to DADS.

Amending 26 TAC §§550.1001 – 550.1003, to update outdated references, correct grammatical errors, and reword language for clarity.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER C. GENERAL PROVISIONS
DIVISION 9. MEDICAL RECORDS, QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT, DISSOLUTION AND RETENTION OF RECORDS
26 TAC §§550.1001 – 550.1003

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.1001, Medical Records, updates outdated references to 40 TAC §15, corrects grammatical errors, and rewords language for clarity.

The proposed amendment to §550.1002, Quality Assessment and Performance Improvement, updates an outdated reference to DADS and replaces an acronym with a proper name.

The proposed amendment to §550.1003, Dissolution, updates an outdated reference to 40 TAC §15.

Amending 26 TAC §550.1101, §550.1102, to clarify which staff may accompany minors during transportation and how that is determined.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER D. TRANSPORTATION
26 TAC §550.1101, §550.1102

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.1101, Transportation Services, implements H.B. 3550 by clarifying which staff accompany minors during transportation and how that is determined.

The proposed amendment to §550.1102, Transportation Safety Provisions, implements H.B. 3550 by clarifying which staff accompany minors during transportation and how that is determined and replaces a proper name with an acronym.

Amending 26 TAC §§550.1202 – 550.1204, 550.1206, 550.1207, 550.1211, 550.1215, 550.1217 – 550.1220, 550.1222, 550.1224, to update outdated references to DADS, reword language for clarity, and correct grammatical errors.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER E. BUILDING REQUIREMENTS
26 TAC §§550.1202 – 550.1204, 550.1206, 550.1207, 550.1211, 550.1215, 550.1217 – 550.1220, 550.1222, 550.1224

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.1202, Plan Reviews, updates outdated references to DADS and 40 TAC §15, rewords language for clarity, and corrects a grammatical error.

The proposed amendment to §550.1203, Design Criteria, updates outdated references to DADS.

The proposed amendment to §550.1204, Fire Safety, updates outdated references to DADS and replaces an acronym with a proper name.

The proposed amendment to §550.1206, Exterior Spaces, updates an outdated reference to DADS.

The proposed amendment to §550.1207, Interior Spaces, updates an outdated reference to 40 TAC §15.

The proposed amendment to §550.1211, Linen Storage, updates outdated references to 40 TAC §15.

The proposed amendment to §550.1215, Garbage, updates an outdated reference to 40 TAC §15.

The proposed amendment to §550.1217, Laundry, updates an outdated reference to 40 TAC §15.

The proposed amendment to §550.1218, Housekeeping, updates outdated references to 40 TAC §15 and corrects a typo.

The proposed amendment to §550.1219, Maintenance, updates an outdated reference to 40 TAC §15.

The proposed amendment to §550.1220, Heating, Ventilation, Air Conditioning (HVAC), updates the section title, replaces an acronym with a proper name, and adds a word for clarity.

The proposed amendment to §550.1222, Sewage, updates an outdated reference to 40 TAC §15.

The proposed amendment to §550.1224, Waivers, updates outdated references to DADS.

Amending 26 TAC §§550.1301 – 550.1305, to update outdated references to DADS.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER F. INSPECTIONS AND VISITS
26 TAC §§550.1301 – 550.1305

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.1301, Inspections and Visits, updates outdated references to DADS.

The proposed amendment to §550.1302, Investigation of Complaints and Self-Reported Incidents, updates outdated references to DADS.

The proposed amendment to §550.1303, Cooperation with an Inspection and Visit, updates outdated references to DADS and adds subsections to clarify requirements and limitations for a center recording HHSC staff.

The proposed amendment to §550.1304, Staff Requirements for an Inspection, updates outdated references to DADS and to 40 TAC §15.

The proposed amendment to §550.1305, General Provisions, updates outdated references to DADS, adds an acronym, corrects a grammatical error, and adds wording for clarity.

Amending 26 TAC §§550.1401 – 550.1408, to update outdated references to DADS and correct grammatical errors.

CHAPTER 550. LICENSING STANDARDS FOR PRESCRIBED PEDIATRIC EXTENDED CARE CENTERS
SUBCHAPTER G. ENFORCEMENT
26 TAC §§550.1401 – 550.1408

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §550.1401, Denial of License Application, updates outdated references to DADS and 40 TAC §15.

The proposed amendment to §550.1402, License Suspension, updates outdated references to DADS, 40 TAC §15, and 26 TAC §99.

The proposed amendment to §550.1403, Emergency License Suspension, updates outdated references to DADS and corrects grammatical errors.

The proposed amendment to §550.1404, License Revocation, updates outdated references to DADS, 40 TAC §15, and 26 TAC §99, and replaces a proper name with an acronym.

The proposed amendment to §550.1405, Probation, updates outdated references to DADS.

The proposed amendment to §550.1406, Injunctive Relief or Civil Penalties, updates outdated references to DADS.

The proposed amendment to §550.1407, Opportunity to Show Compliance, updates outdated references to DADS and corrects a grammar error.

The proposed amendment to §550.1408, Administrative Penalties, corrects the figure name to Figure 26 TAC §550.1408(m) to show that it has moved from 40 TAC §15.

Adopted Rules Re:

Adopting 1 TAC §351.825, to update grammar and word choice and add the factors considered when appointing members to the TBIAC.

CHAPTER 351. COORDINATED PLANNING AND DELIVERY OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B. ADVISORY COMMITTEES
DIVISION 1. COMMITTEES
1 TAC §351.825

OVERVIEW

The Texas Health and Human Services Commission (HHSC) adopts an amendment to §351.825, concerning Texas Brain Injury Advisory Council (TBIAC).

The amendment to §351.825 is adopted with changes to the proposed text as published in the January 26, 2024, issue of the Texas Register (49 TexReg 305). This rule will be republished.

BACKGROUND AND JUSTIFICATION

The TBIAC is established under the Texas Government Code Section 531.012 which specifies that Texas Government Code Chapter 2110 applies to this advisory committee. Section 351.825 states that it expires and the TBIAC is abolished on July 1, 2024. The proposed amendment extends the abolishment date by four additional years as permitted by Texas Government Code §2110.008. Additionally, the amendment makes revisions to ensure the rule meets the HHSC standards for its advisory committee rules, corrects formatting, punctuation, and grammar, and updates provisions to adhere to the Open Meetings Act. The amendment also clarifies member terms, outline reimbursement for specific membership categories travel expenses, and completion of required training.

Transferred Rules Re:

Transferring the former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 2, Local Authority Responsibilities, Subchapter C, Charges For Community Services to Texas Administrative Code, Title 26, Part 1, Chapter 301, IDD-BH Contractor Administrative Functions, Subchapter J, Charges For Community Services; and Title 40, Part 1, Chapter 2, Local Authority Responsibilities Subchapter G, Role And Responsibilities Of A Local Authority are being transferred to Title 26, Part 1, Chapter 330, LIDDA Role and Responsibilities.

OVERVIEW:

During the 84th Legislative Session, the Texas Legislature passed Senate Bill 200, addressing the reorganization of health and human services delivery in Texas. As a result, some agencies were abolished and their functions transferred to the Texas Health and Human Services Commission (HHSC). Texas Government Code, §531.0202(b), specified the Department of Aging and Disability Services (DADS) be abolished September 1, 2017, after all its functions were transferred to HHSC in accordance with Texas Government Code, §531.0201 and §531.02011. The former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 2, Local Authority Responsibilities, Subchapter C, Charges For Community Services are being transferred to Texas Administrative Code, Title 26, Part 1, Chapter 301, IDD-BH Contractor Administrative Functions, Subchapter J, Charges For Community Services; and Title 40, Part 1, Chapter 2, Local Authority Responsibilities Subchapter G, Role And Responsibilities Of A Local Authority are being transferred to Title 26, Part 1, Chapter 330, LIDDA Role and Responsibilities.

The rules will be transferred in the Texas Administrative Code effective July 15, 2024.

Transferring the former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 4, Rights and Protection of Individuals Receiving Intellectual Disability Services, Subchapter C, Rights of Individuals with an Intellectual Disability to Texas Administrative Code, Title 26, Part 1, Chapter 334, Rights and Protection of Individuals with an Intellectual Disability.

OVERVIEW:

During the 84th Legislative Session, the Texas Legislature passed Senate Bill 200, addressing the reorganization of health and human services delivery in Texas. As a result, some agencies were abolished and their functions transferred to the Texas Health and Human Services Commission (HHSC). Texas Government Code, §531.0202(b), specified the Department of Aging and Disability Services (DADS) be abolished September 1, 2017, after all its functions were transferred to HHSC in accordance with Texas Government Code, §531.0201 and §531.02011. The former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 4, Rights and Protection of Individuals Receiving Intellectual Disability Services, Subchapter C, Rights of Individuals with an Intellectual Disability are being transferred to Texas Administrative Code, Title 26, Part 1, Chapter 334, Rights and Protection of Individuals with an Intellectual Disability.

The rules will be transferred in the Texas Administrative Code effective July 1, 2024.

Transferring the former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 47, Contracting to Provide Primary Home Care to Texas Administrative Code, Title 26, Part 1, Chapter 277, Contracting to Provide Primary Home Care.

OVERVIEW

During the 84th Legislative Session, the Texas Legislature passed Senate Bill 200, addressing the reorganization of health and human services delivery in Texas. As a result, some agencies were abolished and their functions transferred to the Texas Health and Human Services Commission (HHSC). Texas Government Code, §531.0202(b), specified the Department of Aging and Disability Services (DADS) be abolished September 1, 2017, after all its functions were transferred to HHSC in accordance with Texas Government Code, §531.0201 and §531.02011. The former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 47, Contracting to Provide Primary Home Care are being transferred to Texas Administrative Code, Title 26, Part 1, Chapter 277, Contracting to Provide Primary Home Care.

The rules will be transferred in the Texas Administrative Code effective July 1, 2024.

Proposed Rule Reviews Re:

Reviewing Title 26, Part 1, to consider for readoption, revision, or repeal the chapter concerning State Authority Responsibilities.

The Texas Health and Human Services Commission (HHSC) proposes to review and consider for readoption, revision, or repeal the chapter listed below, in its entirety, contained in Title 26, Part 1, of the Texas Administrative Code:

Chapter 300, State Authority Responsibilities

Texas Animal Health Commission

Proposed Rules Re:

Amending 4 TAC §51.12, to set forth the requirements for sheep entering Texas.

OVERVIEW

CHAPTER 51. ENTRY REQUIREMENTS
4 TAC §51.12

The Texas Animal Health Commission (Commission) proposes amendments to Title 4, Texas Administrative Code, Chapter 51 titled “Entry Requirements.” Specifically, amendments to §51.12, regarding Sheep.

BACKGROUND AND PURPOSE

Scrapie is a fatal, degenerative disease affecting the central nervous systems of sheep and goats. It is classified as a transmissible spongiform encephalopathy (TSE), similar to BSE (bovine spongiform encephalopathy, or “mad cow disease”) in cattle. Scrapie is believed to be caused by a prion, an infectious agent composed of protein, and is known for its long incubation period and eventual severe impact on the brain and spinal cord of affected animals. The disease is of significant concern in the sheep industry due to its impact on animal health and the resulting economic losses.

Research on the susceptibility of various sheep breeds to scrapie has shown that the difference in risk based on breed or type of sheep is too small to measure. However, it has been discovered that certain sheep that have historically had a higher prevalence of scrapie was likely due to management during lambing. The breeds of sheep that tend to lamb in small pens (jugs) lead to more exposure to the scrapie prion, unlike rambouillet sheep, which lamb in large pastures.

Nevertheless, general measures to prevent scrapie, such as selective breeding for resistance and adherence to strict biosecurity protocols, are relevant for all sheep breeds. There have been reports that individuals are seeking to circumvent USDA regulations to bring high-risk sheep into Texas, as well as spreading misinformation concerning the commission rules about scrapie. This proposed amendment is made in conjunction with proposed amendments to Chapter 60 of the Commission rules in an effort to clarify the Commission’s rules and make every effort to reduce the incidence of and control the spread of scrapie in Texas.

SECTION-BY-SECTION DISCUSSION

Section 51.12 sets forth the requirements for sheep entering Texas. The proposed amendments require that all female breeding sheep and crossbred female breeding sheep originate from an Export Certified Flock or have documentation supporting that the animals are of the genotype RR at codon 171 or AA at codon 136 and QR at codon 171.

Amending 4 TAC §60.1, to eliminate the definition for “Blackfaced Sheep,” reorganize the definition of “Breed Associations and Registries” in alphabetical order, and add a definition for “Breeding Sheep.”

CHAPTER 60. SCRAPIE
4 TAC §60.1

OVERVIEW

The Texas Animal Health Commission (Commission) proposes amendments to Title 4, Texas Administrative Code, Chapter 60 titled Scrapie.

BACKGROUND:

Nevertheless, general measures to prevent scrapie, such as selective breeding for resistance and adherence to strict biosecurity protocols, are relevant for all sheep breeds. There have been reports that individuals are seeking to circumvent USDA regulations to bring high-risk sheep into Texas, as well as spreading misinformation concerning the commission rules about scrapie. This proposed amendment is made in conjunction with proposed amendments to Chapter 51 of the Commission rules in an effort to clarify the Commission’s rules and make every effort to reduce the incidence of and control the spread of scrapie in Texas.

SECTION BY SECTION DISCUSSION

The proposed amendments to Section 60.1(8) eliminate the definition for “Blackfaced Sheep” and reorganize the definition of “Breed Associations and Registries” to conform to alphabetical order.

The proposed amendments to Section 60.1(9) adds a definition for “Breeding Sheep.”

Texas Optometry Board

Proposed Rules Re:

Amending 22 TAC §271.1, to repeal the rule in its entirety.

CHAPTER 271. EXAMINATIONS
22 TAC §271.1

OVERVIEW

The Texas Optometry Board proposes the following repeal to 22 TAC Title 14 Chapter 271 Examinations.

Amending 22 TAC §§271.2, 271.6, 271.8 – 271.12, to allow anyone who does not qualify for the Optometric Glaucoma Certification to be licensed as a therapeutic optometrist in Texas.

CHAPTER 271. EXAMINATIONS
22 TAC §§271.2, 271.6, 271.8 – 271.12

OVERVIEW

The Texas Optometry Board proposes amendments and the addition of new sections to 22 TAC Title 14 Chapter 271 Examinations. The Board is amending the following rules: §271.2 and §271.6. The Board is adding the following rules: §§271.8 – 271.12.

BACKGROUND AND JUSTIFICATION

The proposal combines the application of the Therapeutic and Optometric Glaucoma Specialist applications as all graduates after 2008 qualify for the enhanced Optometric Glaucoma Specialist designation. This will clarify the application process for both applicants and staff. Additionally, by moving all new graduates to a single license type, the public is better protected as all licensees will have the enhanced license and be able to treat conditions to the full extent of their optometric education.

The proposal still would allow anyone who does not qualify for the Optometric Glaucoma Certification (i.e. those who graduated from optometry school prior to 2008 and who have not taken the 30-hour glaucoma course) to be licensed as a therapeutic optometrist in Texas. The agency anticipates the number of applicants who fall into this scenario to be less than 10 per year.

The difference in the cost of renewal between a therapeutic license and an optometric glaucoma specialist license is $19.28 which is collected on behalf of the Prescription Monitoring Program.

Amending 22 TAC §§272.1 – 272.9, to update the agency’s rules to better comply with various statutes that require the agency to have administrative rules on these issues.

CHAPTER 272. ADMINISTRATION
22 TAC §§272.1 – 272.9

OVERVIEW

The Texas Optometry Board proposes amendments and new rules to 22 TAC Title 14 Chapter 272 Administration, §§272.1 – 272.9.

BACKGROUND AND JUSTIFICATION

The majority of the changes made to Chapter 272 will update the agency’s rules to better comply with various statutes that require the agency to have administrative rules on these issues. The proposal amends references to other administrative rules that have been updated since the Board last amended the rule. Finally, the amendment would make non-substantive capitalization changes to ensure consistency across the Board’s rules.

The one substantive change is the inclusion of a definition of “synchronous” found in the new §272.5 Definitions which was not part of the original definitions moved from §271.1 – Definitions. The rule defines synchronous as “live, real-time audiovisual interaction between the practitioner and the patient in a separate location.”

Amending 22 TAC §§273.1, 273.4 – 273.10, 273.18, to provide non-substantive capitalization and grammatical changes to ensure consistency across the Board’s rules.

CHAPTER 273. GENERAL RULES
22 TAC §§273.1, 273.4 – 273.10, 273.18

OVERVIEW

The Texas Optometry Board proposes amendments to 22 TAC Title 14 Chapter 273 General Rules, §§273.1, 273.4 – 273.10 and new §273.18.

BACKGROUND AND JUSTIFICATION

The majority of the changes made to Chapter 273 provide non-substantive capitalization and grammatical changes to ensure consistency across the Board’s rules.

Amending 22 TAC §273.11, to repeal the rule in its entirety.

CHAPTER 273. GENERAL RULES
22 TAC §273.11

OVERVIEW

The Texas Optometry Board proposes the following repeal to 22 TAC Title 14 Chapter 273 General Rules, §273.11.

Amending 22 TAC §§280.1, 280.3, 280.8, to repeal the rules related to “Required Education,” “Certified Therapeutic Optometrist Examination,” and “Optometric Glaucoma Specialist: Required Education, Examination and Clinical Skills Evaluation.”

CHAPTER 280. THERAPEUTIC OPTOMETRY
22 TAC §§280.1, 280.3, 280.8

OVERVIEW

The Texas Optometry Board proposes the repeal of 22 TAC Chapter 280 Therapeutic Optometry. The Board is repealing the following rules: §280.1 Required Education; §280.3 Certified Therapeutic Optometrist Examination; and §280.8 Optometric Glaucoma Specialist: Required Education, Examination and Clinical Skills Evaluation.

Amending 22 TAC §§280.1, 280.5, 280.9, to clarify the application process for both applicants and staff.

CHAPTER 280. THERAPEUTIC OPTOMETRY
22 TAC §§280.1, 280.5, 280.9

OVERVIEW

The Texas Optometry Board proposes amendments to 22 TAC Title 14 Chapter 280 Therapeutic Optometry. The Board is amending the following rules: §280.1 Application for Therapeutic Certification; §280.9 Application for Licensure as Optometric Glaucoma Specialist; and §280.5(f) Prescription and Diagnostic Drugs for Therapeutic Optometry.

BACKGROUND AND JUSTIFICATION

Adopted Rule Reviews Re:

Adopting Title 22, Part 14, concerning Examinations, Administration, General Rules, and Continuing Education.

The Texas Health and Human Services Commission (HHSC) adopts the review of the chapter below in Title 22, Part 14, of the Texas Administrative Code (TAC):

Chapter 271 Examinations

Chapter 272, Administration

Chapter 273 General Rules

Chapter 275, Continuing Education

Texas State Board of Pharmacy

Proposed Rule Re:

Amending 22 TAC §281.69, to correct subparagraph lettering and grammatical errors.

CHAPTER 281. ADMINISTRATIVE PRACTICE AND PROCEDURES
SUBCHAPTER C. DISCIPLINARY GUIDELINES
22 TAC §281.69

OVERVIEW

The Texas State Board of Pharmacy proposes amendments to §281.69, concerning Automatic Denial or Revocation. The amendments, if adopted, correct subparagraph lettering and grammatical errors.

Department of State Health Services

Proposed Rules Re:

Amending 25 TAC §133.41, §133.49, to require a health care 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.

CHAPTER 133. HOSPITAL LICENSING
SUBCHAPTER C. OPERATIONAL REQUIREMENTS
25 TAC §133.41, §133.49

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes amendments to §133.41, concerning Hospital Functions and Services, and §133.49, concerning Reporting Requirements.

BACKGROUND AND PURPOSE

HSC §166.046, as amended by H.B. 3162, in part requires a health care 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 a health care facility 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.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §133.41(f)(6)(G) and §133.41(k)(3)(G) updates existing references to HSC Chapter 166 to ensure consistency with amended HSC Chapter 166. The proposed amendment to §133.41 also corrects outdated information, replaces the “Department of State Health Services” or “department” with the “Texas Health and Human Services Commission (HHSC)” or “HHSC” in certain places, and makes minor, non-substantive changes to formatting and grammar for clarity and consistency with HHSC rulemaking guidelines.

The proposed amendment to §133.49 ensures consistency with amended HSC §166.054. New subchapter (d) requires a facility to complete and submit the Ethics or Medical Committee Reporting Form to HHSC after the facility provides the written notice required under HSC §166.046(b)(1) and describes the information collected in the form. New subsection (e) describes the process of publishing the aggregate report. New subsection (f) provides how the information in the forms may not be used. The proposed amendment also corrects outdated information and makes minor, non-substantive changes to formatting and grammar for clarity and consistency with HHSC rulemaking guidelines.

Amending 25 TAC §229.40, §229.41, to replace wording for consistency.

CHAPTER 229. FOOD AND DRUG
SUBCHAPTER D. REGULATION OF COSMETICS
25 TAC §229.40, §229.41

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Texas Department of State Health Services (DSHS), proposes amendments to §§229.40, 229.41, 229.241 – 229.252, and 229.419 – 229.430.

BACKGROUND AND PURPOSE

The purpose of the proposal is to amend Texas Administrative Code, Title 25, Chapter 229, Subchapters D, O, and W. The amendments reflect current federal law, statute, and rule references since the rules were last adopted. The amendments revise and add definitions to clarify intent and improve compliance, update agency addresses and websites, and include clarifying language to ensure consistency in interpretation of the rules.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §229.40 replaces wording for consistency throughout the chapter.

The proposed amendment to §229.41(a) adds a reference for consistency with federal references, adds federal citations, replaces a spelled out reference with the acronym defined in this section, and renumbers the paragraphs. The proposed amendment to §229.41(b) updates DSHS contact information. The proposed amendment to §229.41(c) replaces wording for consistency throughout the chapter.

Amending 25 TAC §§229.241 – 229.252, to replace wording for consistency, update references, and edit language for clarity and consistency.

CHAPTER 229. FOOD AND DRUG
SUBCHAPTER O. LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS–INCLUDING GOOD MANUFACTURING PRACTICES
25 TAC §§229.241 – 229.252

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §229.241 replaces wording for consistency throughout the chapter.

The proposed amendment to §229.242(a) updates certain federal references, updates where copies of the laws and regulations can be found, and updates wording for clarity. The proposed amendment to §229.242(b) updates the DSHS website address. The proposed amendment to §229.242(c) replaces wording for consistency throughout the chapter.

The proposed amendment to §229.243 provides revised and new definitions, adds clarity to the rule language, and ensures consistency in interpretation of the rules.

The proposed amendment to §229.244 replaces wording for consistency throughout the chapter.

The proposed amendment to §229.245 replaces wording for consistency throughout the chapter and simplifies a reference.

The proposed amendment to §229.246 corrects references, edits language for clarity and consistency, and updates DSHS contact information.

The proposed amendment to §229.247 updates DSHS contact information, updates wording for clarity, and revises references.

The proposed amendment to §229.248 adds the time period by which DSHS must be notified of a change in a license application, updates wording for clarity, and updates DSHS contact information.

The proposed amendment to §229.249 replaces “amended” with “issued” throughout the rule for clarification concerning licenses, corrects references, and updates wording for clarity.

The proposed amendment to §229.250 updates wording and punctuation for clarity and grammar, specifies the name of the Department of Public Safety, and corrects references.

The proposed amendment to §229.251 adds new language for nonprescription drugs, updates references, and revises language for consistency and understanding.

The proposed amendment to §229.252 updates language for consistency and revises a reference.

Amending 25 TAC §§229.419 – 229.430, to replace wording for consistency, update references, and edit language for clarity and consistency.

CHAPTER 229. FOOD AND DRUG
SUBCHAPTER W. LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS–INCLUDING GOOD MANUFACTURING PRACTICES
25 TAC §§229.419 – 229.430

OVERVIEW

BACKGROUND AND PURPOSE

SECTION-BY-SECTION SUMMARY

The proposed amendment to §229.419, concerning Purpose, removes a word for clarity.

The proposed amendment to §229.420 updates certain federal references, updates wording for clarity and consistency throughout the chapter, and updates the DSHS website address.

Proposed new amendment §229.421 provides revised and new definitions, adds clarity to the rule language, and ensures consistency in interpretation of the rules.

The proposed amendment to §229.422 replaces the term “giving” with “providing” for consistency in the chapter.

The proposed amendment to §229.423 adds the statement “local intellectual and developmental disability authorities, referred to as,” which describes the facilities a state agency can distribute prescription drugs to, updates references, and revises wording for clarity and consistency.

The proposed amendment to §229.424 updates wording for clarity and consistency throughout the chapter.

The proposed amendment to §229.425 updates wording for clarity and consistency throughout the chapter and updates the DSHS website address.

The proposed amendment to §229.426 updates wording for clarity and consistency throughout this chapter and updates the DSHS mailing address and website address.

The proposed amendment to §229.427 corrects references and updates wording for clarity and consistency.

The proposed amendment to §229.428 updates wording for clarity and consistency throughout the chapter.

The proposed amendment to §229.429 updates wording for clarity and consistency in this chapter, updates certain federal references, and adds new language for prescription drug wholesalers.

The proposed amendment to §229.430 updates wording for clarity and consistency in this chapter and updates certain federal references.

Amending 25 TAC §289.201, §289.202, to establish new definitions; qualify training requirements; and update license application processes, concerning the use of field stations, material storage, and approved methods for waste disposal, and otherwise improve clarity and correct grammatical mistakes.

CHAPTER 289. RADIATION CONTROL
SUBCHAPTER D. GENERAL
25 TAC §289.201, §289.202

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to §289.201, concerning General Provisions for Radioactive Material; §289.202, concerning Standards for Protection Against Radiation from Radioactive Material; §289.253, concerning Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies; §289.255, concerning Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography; §289.256, concerning Medical and Veterinary Use of Radioactive Material; §289.257, concerning Packaging and Transportation of Radioactive Material; and §289.258, concerning the Licensing and Radiation Safety Requirements for Irradiators.

BACKGROUND AND PURPOSE

The proposed amendments are 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 amendments update NRC information and result from the NRC’s adoption of rules related to the use of digital output personnel dosimeters as an acceptable individual monitoring device.

Additional updates to NRC rules involve miscellaneous corrections, including references to the Council on Postdoctoral Training of the American Osteopathic Association and the Accreditation Council for Pharmacy Education, Exempt Material Activity Concentrations, and Exempt Consignment Activity Limits for Radionuclides. Updates also include the requirement to report transactions involving nationally tracked sources, the reference to the list of addresses of the governors’ designees receiving advance notification of transportation of nuclear waste, and references to master material licensees and removal of permits issued under an NRC master material broad scope license.

The proposed amendments establish new definitions; qualify training requirements; and update license application processes, concerning use of field stations, material storage, and approved methods for waste disposal. Amendments update Radiation Safety Committee (RSC) requirements and transportation exemptions for medical and veterinary licensees, identify conditions under which medical licensees may revise their radiation protection programs without the department’s approval, and update contamination control criteria and methods. Amendments clarify record retention requirements related to the receipt, transfer, and disposal of radioactive material and devices and ensure compatibility with NRC requirements not specifically mentioned in the RATS Identification.

The proposed amendments update, correct, improve, and clarify the rule language and incorporate plain language where appropriate.

SECTION-BY-SECTION SUMMARY

Proposed amendment to §289.201(b)(7) deletes the definition of “agency.” Proposed new §289.201(b)(33) adds the definition “department.” Subsequent paragraphs in the definition subsection are renumbered.

Proposed amendments to §289.201(b)(21) and (22) and §289.201(b)(63) update the definitions to specify “permission to engage in regulated activities” as described in the certificate of registration or license.

Proposed amendment to renumbered §289.201(b)(27) updates the definition of “consortium” to meet HHSC plain language guidelines.

Proposed amendment to §289.201(b)(46) updates the definition of “exposure” to remove the obsolete term “negatrons” and conforms with the International Commission on Radiation Units and Measurements definition.

Proposed amendment to §289.201(b)(57) modifies the definition of “individual monitoring device” to ensure compatibility with NRC language and account for the accepted use of digital output personnel dosimeters by the NRC. The references to “pocket dosimeter” and “personal air sampling devices” are removed to mitigate confusion regarding acceptable personnel monitoring devices for well logging and irradiator operations.

Proposed amendment to §289.201(b)(66) deletes the definition of “licensing state,” which is an obsolete term. Subsequent paragraphs in the definition subsection are renumbered.

Proposed amendments to renumbered §289.201(b)(84) and §289.201(b)(143) update the definitions of “physician” and “veterinarian” by specifying the Texas Occupations Code chapters extending the authority to practice medicine and veterinary medicine, respectively.

Proposed new §289.201(b)(85) adds the definition of “pocket dosimeter” based on the proposed update to the definition of “individual monitoring device.” Adding a discrete definition will mitigate confusion regarding acceptable personnel monitoring devices to be used during well logging and irradiator operations.

Proposed amendment to §289.201(b)(114) changes the definition of “sealed source” to maintain compatibility with NRC language.

Proposed new §289.201(b)(129) adds a definition for “temporary job site” as it is also defined in §289.253 and §289.255. Subsequent paragraphs in the definition subsection are renumbered.

Proposed amendment to renumbered §289.201(b)(137), Type A quantity, removes the repeated “A2” value and replaces it with the “A1” value as necessary to maintain NRC compatibility.

Proposed amendment to §289.201(d)(1)(B), Records, clarifies the record retention requirement for the receipt, transfer, and disposal of radioactive material. The update differentiates receipt and transfer from disposal record requirements and maintains compatibility with NRC language.

Proposed amendment to §289.201(d)(5) modifies data retention requirements to account for all media types used to store records.

Proposed amendment to §289.201(g)(1)(A), Tests for leakage or contamination of sealed sources, corrects exception reference from §289.253(i) to §289.253(j) of this chapter.

Proposed amendment to §289.201(m), Open records, removes subsection (m) in its entirety because Texas Government Code and DSHS policy prescribe open records request procedures. Removing subsection (m) also removes Figure: 25 TAC §289.201(m)(2)(A)(ii). Subsequent subsections are renumbered accordingly, Figure: 25 TAC §289.201(n)(1) is renumbered as Figure: 25 TAC §289.201(m)(1), and Figure: 25 TAC §289.201(n)(2) is renumbered as Figure: 25 TAC §289.201(m)(2).

Proposed amendment to §289.202(p)(4) ensures compatibility with NRC language and accounts for the NRC’s accepted use of digital output personnel dosimeters. Individual monitoring devices requiring processing are qualified, and the requirement they be processed and evaluated by an accredited laboratory is retained.

Proposed amendment to §289.202(r)(1)(F) ensures compatibility with NRC language and accounts for the accepted use of digital output personnel dosimeters by the NRC. The change specifies wear periods for individual monitoring devices requiring processing.

Proposed new §289.202(r)(1)(G) accounts for digital output personnel dosimeters not requiring processing and establishes the evaluation periodicity.

Proposed amendment to §289.202(r)(2) adds the term “as applicable” to account for devices not requiring processing.

Proposed new §289.202(ff)(1)(F) accounts for NRC regulation allowing for alternative radioactive material waste disposal procedures when reviewed and approved by DSHS. Subsequent clauses outline documentation and conditions required to be submitted for DSHS’s review.

Proposed amendment to §289.202(fff)(1)(A) and (B) ensures compatibility with NRC language by removing unnecessary references to “iodine-125” and “in vitro clinical or in vitro laboratory testing.”

Proposed amendment to §289.202(ggg)(2)(B)(vi) removes Figure: 25 TAC §289.202(ggg)(2)(B)(vi) and replaces the figure with new rule text describing the use of stochastic and non-stochastic annual limits on intake (ALIs). The subsequent clauses of the subparagraph are renumbered and Figure: 25 TAC §289.202(ggg)(2)(B)(viii) is renumbered as Figure: 25 TAC §289.202(ggg)(2)(B)(vii).

Proposed amendment to §289.202(ggg)(5), in Figure: 25 TAC §289.202(ggg)(5), changes “(ll)(4)” to “(ll)(5)” in the left-hand column of the table and changes “Entries at no > 1 year intervals” to “Entries at not > 1 year intervals” in the right-hand column of the table.

Proposed amendment to §289.202(ggg)(6) adds that the sample area for acceptable surface contamination levels is “(per 100 cm2).” The proposed amendment removes current Figure: 25 TAC §289.202(ggg)(6) and replaces it with a new Figure: 25 TAC §289.202(ggg)(6) that is based on Regulatory Guide 8.23 and is formatted similarly to Table R-3 of Consolidated Guidance About Material Licenses: Program-Specific Guidance About Medical Use Licenses, Final Report (NUREG 1556, Volume 9, Revision 3). Acceptable surface contamination levels are updated to coincide with NRC guidelines.

Proposed amendment deletes §289.202(hhh)(1)(H) and subsequent clauses are removed due to NRC compatibility requirements.

Amending 25 TAC §§289.253, 289.255 – 289.258, to establish new definitions; qualify training requirements; and update license application processes, concerning the use of field stations, material storage, and approved methods for waste disposal, and otherwise improve clarity and correct grammatical mistakes.

CHAPTER 289. RADIATION CONTROL
SUBCHAPTER F. LICENSE REGULATIONS
25 TAC §§289.253, 289.255 – 289.258

OVERVIEW

BACKGROUND AND PURPOSE

The proposed amendments update, correct, improve, and clarify the rule language and incorporate plain language where appropriate.

SECTION-BY-SECTION SUMMARY

Proposed amendment to §289.253(g)(4), Storage precautions, removes language not included in the NRC rule and adds language consistent with NRC guidelines to ensure material may only be stored in locations “specifically authorized by the department.”

Proposed amendment to §289.253(i)(1) and (3) ensure language is consistent with NRC rule by moving the language “capable of detecting beta and gamma radiation” from paragraph (3) and moving it to paragraph (1).

Proposed amendment to §289.253(o)(4) removes the reference to “licensing state,” which is an obsolete term.

Proposed amendments to §289.253(p)(1)(A), Training requirements, and §289.255(e)(1)(A), Requirements for qualifications of radiographic personnel, remove the inference that the department accredits training courses by deleting the language requiring courses to be “accepted by the agency, another agreement state, or the NRC.”

Proposed amendments to §289.253(r)(1) and §289.255(p)(2)(I) ensure compatibility with updated NRC regulations removing the requirement for an accredited laboratory to process individual monitoring devices. Individual monitoring devices are qualified as those “requiring replacement” and those “requiring processing” to account for NRC acceptance of digital output personnel dosimeters not requiring processing. A requirement for all individual monitoring devices to “be evaluated at least quarterly or promptly after replacement, whichever is more frequent,” is retained to account for devices not requiring processing.

Proposed amendment to §289.253(r)(2) changes “exposure to concentrations” to “intake” to clarify the requirement for circumstances requiring internal monitoring or bioassay.

Proposed amendment to §289.253(z)(3), Energy compensation source, replaces erroneous reference to subsection (cc)(4) with (ee)(4)(A), which ensures compatibility with the NRC equivalent requirement for operations not using a surface casing.

Proposed amendment to §289.253(dd)(4)(B), Notification of incidents and lost sources, updates well monitoring requirements to clarify the acceptable methods, and uses a “what/when/why/how” structure. This update meets compatibility requirements with the NRC.

Proposed amendment to Figure: 25 TAC §289.253(ee)(5) distinguishes the receipt and transfer records from the disposal records retention requirements and adds the reference to §289.201(d).

Proposed amendment to §289.255(c)(1) removes the definition of “additional authorized use/storage site” and places the definition of “field station” in §289.255(c)(16). Adopting “field station” directly from NRC rules with an additional reference to “radiation machines” ensures compatibility with NRC rules. Subsequent paragraphs are renumbered.

Proposed amendment to §289.255(c)(17) removes the definition of “fluoroscopic imaging assembly,” as it does not exist in these rules.

Proposed amendment to §289.255(c)(18) removes the definition of “GED” due to proposed deletion of the General Education Development (GED) from the Radiation Safety Office training requirements of §289.255(e)(4)(B). Subsequent paragraphs are renumbered.

Proposed amendment to §289.255(c)(27) removes the definition of “permanent storage site,” as it is no longer used in the rule based on the proposed deletion of the definition of “storage facility” in §289.255(c)(48). Subsequent paragraphs are renumbered.

Proposed amendment to renumbered §289.255(c)(30) updates the compatibility with NRC language by clarifying that an individual “who provides visual surveillance of industrial radiographic operations while in attendance during transport or at the site where the sealed source or sources are being used” is defined as a radiographer.

Proposed amendment to renumbered §289.255(c)(43) for the definition of “storage area” replaces “used for radiographic operations” with “in use” to ensure compatibility with NRC language.

Proposed amendment to §289.255(c)(48) removes the unnecessary definition of “storage facility,” which is not defined in NRC rules. Subsequent paragraphs are renumbered.

Proposed amendment to renumbered §289.255(c)(45) modifies the definition of “temporary job site” to ensure compatibility with the NRC definition.

Proposed amendment to §289.255(d)(4), Exemptions, updates several applicable references. Reference to subsection (k) is added to account for the exemption of radiation machines utilized for industrial radiography at permanent radiographic installations. Inventories of those machines must be conducted under §289.226(m)(9) as now specified in proposed amendment to §289.255(k).

Proposed amendment to §289.255(e)(2)(A)(ii), Requirements for qualifications of radiographic personnel, removes reference to “radiographer trainers authorized on a license or certificate of registration” as trainers are not listed on a license or certificate of registration. A reference to subsection “(e)(3) of this section” is added to clarify training requirements.

Proposed amendment to §289.255(e)(3)(A)(i)(II), Radiographer trainer, clarifies the training requirement by specifying “2000 hours of documented direct experience” instead of “one year” to qualify the necessary training for trainers.

Proposed amendment to §289.255(e)(4)(A) and (B), RSO for industrial radiography, revises training requirements to conform with 10 Code of Federal Regulations (CFR) §34.42 format and language. Changes and additions ensure compatibility with NRC rule. Language describing RSO designation on DSHS-issued licenses and certificates of registration has been moved to paragraph (4) of this subsection.

Proposed amendments to §289.255(i) and §289.255(i)(1), “industrial radiography sealed” and “radiography exposure” have been added to the subsection title and paragraph to clarify the applicability of the rule to industrial sources and devices using depleted uranium (DU) as shielding.

Proposed amendment to §289.255(k), changes the heading to “Inventory” to account for addition of exemption for radiation machines used in industrial radiography. Proposed amendment to §289.255(k)(1) adds language specifying the exemption of machines and prescribes inventory and record retention requirements of §289.226(m)(9).

Proposed amendment to §289.255(o), changes the heading to “Notifications” as the proposed additions of notifications to §289.255(o)(4) and (5) are not limited to incidents.

Proposed new §289.255(o)(4) and (5) adds requirements to notify DSHS when using or storing radioactive material at a location not listed on a license beyond 180 days in a calendar year or when using or storing radiation machines at a location not listed on a certificate of registration beyond 90 days in a calendar year. Proposed amendment to §289.255(t) – (u) deletes the notification language and moves it to subsection (o).

Proposed amendments to §289.255(p)(2)(A)(i) and §289.255(s)(1)(B), regarding the use of individual monitoring devices, updates the incorrect reference to §289.202(p)(3) and (4) and changes it to §289.202(p)(4) and (5).

Proposed amendment to §289.255(p)(2)(E)(i), Individual monitoring, adds “use or” storage “site” and removes the term “location” to clarify and maintain consistency with subsequent rules in the section.

Proposed amendment to §289.255(p)(2)(G), Individual monitoring, adjusts processing and evaluation requirements for an off-scale reading during industrial radiography operations. Devices are distinguished as those requiring processing and those not requiring processing to account for NRC acceptance of digital output personnel dosimeters.

Proposed amendment to §289.255(p)(6)(B), Individual monitoring, removes “received from the device processor” to comply with NRC acceptance of digital output personnel dosimeters.

Proposed amendment to §289.255(t)(1)(B)(iv), Registration requirements for industrial radiographic operations, adds a reference to “all field stations” being listed on the application for a certificate of registration. This precludes the need for the remaining language in clause (iv) and subclauses (I) – (III) of this clause. Language from subclause (IV) is moved to subsection (o).

Proposed amendment to §289.255(u)(1)(B)(iv), Licensing requirements for industrial radiographic operations, adds a reference to “all field stations” being listed on the application for a certificate of registration. This precludes the need for the remaining language in clause (iv) and subclauses (I) – (III) of this clause. Language from subclause (IV) is moved to subsection (o).

Proposed amendments to §289.255(u)(1)(B)(viii)(II) and §289.255(u)(9)(G) replace the terms “storage facilities” and “storage location” with “storage areas” and “storage area,” respectively. The definition of “storage facility” is removed from subsection (c). “Storage area” is defined in the rule.

Proposed amendment to §289.255(u)(4)(B), Permanent storage precautions for the use of sealed sources, removes language not included in the equivalent NRC rule and adds the language “specifically authorized by the department,” consistent with NRC guidelines, to ensure material is only stored at locations specifically authorized by the department.

Proposed amendment to §289.255(u)(5)(D)(iv), Performance requirements for industrial radiography equipment, adds the term “lock box,” included in the equivalent NRC rule. To clarify language found in 10 CFR §34.20, the clause is restructured, and language is added to specify safety plugs or covers “be installed during storage and transportation to” protect the source assembly.

Proposed amendment to §289.255(u)(7)(D), Labeling and storage, adds the term “legible” to describe the required vehicle label used when transporting radioactive material.

Proposed amendments to §289.255(u)(8)(G) and §289.255(u)(8)(J), Operating and internal audit requirements for the use of sealed sources of radiation, updates the subparagraphs to meet compatibility requirements with equivalent NRC rule, specifically 10 CFR §34.41(a) and (b).

Proposed amendments to Figure: 25 TAC §289.255(v)(1), Record/document requirements, adds a separate requirement to retain material and device “disposal” records “until license termination.” This is distinguished from “receipt and transfer” records and is updated for consistency with NRC rules, allowing agreement states to be more restrictive.

Proposed amendments to §289.255(x)(2)(B)(iv) and (v) and §289.255(x)(2)(C)(viii) and (ix), General requirements for inspection of industrial radiographic equipment, remove the requirement to inspect for the “presence of radioactive contamination” as this procedure is not included in the NRC guidelines. Additionally, paragraph (2)(A)(i) already requires licensees to survey the guide tube for radiation levels.

Proposed amendment to §289.256(h)(3)(C), Training for an RSO and ARSO, changes the language, “a NRC master material license” to “an NRC master material licensee,” under NRC compatibility requirements.

Proposed amendment to §289.256(i), Radiation Safety Committee, adds a requirement that licensees authorized for two or more different types of radioactive material use requiring a “written directive” or two or more “therapeutic” units under subsection “(q)” must establish an RSC. This is consistent with the requirement to establish an RSC applicable to other licensees or registrants practicing under provisions of subsections (kk), (rr), and (ddd) of this section. This addition is consistent with agreement state authorization to be more restrictive than the NRC.

Proposed amendment to §289.256(i)(2), Radiation Safety Committee, removes paragraph (2) of this subsection and adjusts paragraph (1) to ensure uniform membership requirements apply to all licensees requiring a radiation safety committee.

Proposed amendment to §289.256(l)(5)(B), Training for experienced RSO, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist, is adjusted to replace “by” with “in accordance with” and reference to “NRC master material license of broad scope” is changed to “NRC master material broad scope license.” This change ensures compatibility with equivalent NRC rule.

Proposed amendment to §289.256(p)(7), replaces “name and/or number” with “designation” to clarify the rule and remove use of “and/or.”

Proposed amendment to §289.256(r)(2)(E), License amendments and notifications, corrects a typographical error by adding a new sentence beginning with “Other.” This ensures compatibility with NRC language and clarifies the rule.

Proposed amendment to §289.256(r)(2)(G), License amendments and notifications, adds conditions under which a medical licensee may revise its radiation protection program without the department’s approval as is consistent with 10 CFR §35.26.

Proposed amendment to §289.256(cc)(1), Release of individuals containing radioactive drugs or implants containing radioactive material, removes the obsolete requirement allowing release of patients treated with temporary eye plaques based on a less than 5 mrem per hour “exposure rate” at a distance of 1 meter from the plaque location.

Proposed amendment to §289.256(ii)(4), Permissible molybdenum-99, strontium-82, and strontium-85 concentrations, replaces reference to subsection “(www)” with “(xxx)” based on comment received from the NRC identifying the error.

Proposed amendment to §289.256(ii)(5), Permissible molybdenum-99, strontium-82, and strontium-85 concentrations, replaces the reference to subsection “(xxx)” with “(www)” based on comment received from the NRC identifying the error.

Proposed amendments to §§289.256(nn)(1)(A), 289.256(zz)(1)(A), 289.256(zz)(2)(B), 289.256(ttt)(1)(A), and 289.256(ttt)(2)(A)(iii) update the accrediting body reference to “the Council on Postdoctoral Training of the American Osteopathic Association” when referring to training requirements for Doctor of Osteopathic Medicine. This update ensures compatibility with the equivalent NRC rules.

Proposed amendment to §289.256(qq)(2)(C)(i) removes the redundant phrase, “and shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or.” This ensures compatibility with the equivalent NRC rule.

Proposed amendment to §289.256(tt)(3)(B), Brachytherapy sealed sources accountability, updates the last sentence to clarify that the date sealed sources “were returned to storage” must be recorded.

Proposed amendments to Figure: 25 TAC §289.256(xxx), Records/documents for department inspection, removes reference to “receipt, transfer, and disposal” of radioactive material and changes to distinguish “Records of receipt and transfer” from “Records of disposal of radioactive material.” Time intervals are updated to “Until disposal of the records is authorized by the department” and “Until termination of the radioactive material license,” respectively. Additionally, cross-references related to RSC meetings, procedures for administrations requiring a written directive, and service provider documentation have been updated or corrected. These changes clarify retention requirements and are compatible with NRC rules.

Proposed amendment to §289.257(g), Exemptions of physicians, adds “and veterinarians” to the title and updates references to “veterinarian” and “veterinary medicine” to include veterinarians to the exemption as they are licensed under the medical rule, §289.256.

Proposed amendment to §289.257(i)(1)(C)(iii), General license, adds “U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001” to the Document Control Desk address to correct omitted information.

Proposed amendment to §289.257(q)(4)(C)(i) removes the clause as required by NRC RATS ID 2020-3. Subsequent clauses to this subparagraph have been renumbered.

Proposed amendment to Figure: 25 TAC §289.257(ee)(6), Appendices for determination of A1 and A2, updates the “Specific activity” of Samarium-147 (Sm-147) in TBq/g (Terabecquerels/gram) from “8.5X10-1” to “8.5X10-10” as required to maintain NRC compatibility.

Proposed amendments to §§289.258(e)(8), 289.258(w)(1), and 289.258(w)(3) remove the reference to “licensing state,” which is an obsolete term.

Proposed amendment to §289.258(u)(1), Personnel monitoring, is required to ensure compatibility with updated NRC regulations removing the requirement for an accredited laboratory to process individual monitoring devices. The previous requirement that the “personnel dosimeter processor must be accredited for” is replaced with “must be capable of detecting” photons in the normal and accident dose ranges. The term “personnel dosimeter” is replaced with “individual monitoring device” to maintain consistency. Individual monitoring devices are qualified as those “requiring replacement” and those “requiring processing” to account for NRC acceptance of digital output personnel dosimeters not requiring processing. A requirement for all individual monitoring devices to “be evaluated at least quarterly or promptly after replacement, whichever is more frequent,” is retained to account for devices not requiring processing.

Proposed amendment to §289.258(u)(2), Personnel monitoring, updates reference to “the paragraph” with “this paragraph.”

Proposed amendment to §289.258(w)(1), Detection of leaking sources, replaces “the commission” with “the NRC” to maintain consistency when referencing the U.S. Nuclear Regulatory Commission (NRC).

Proposed amendment to §289.258(cc)(5), Records/documents, changes reference to “film badge, TLD, or OSL” to “individual monitoring device” so the record retention requirements will apply to digital output personnel dosimeters not requiring processing.

Amending 25 TAC §289.229, to to establish new definitions; qualify training requirements; and update license application processes, concerning the use of field stations, material storage, and approved methods for waste disposal, and otherwise improve clarity and correct grammatical mistakes.

CHAPTER 289. RADIATION CONTROL
SUBCHAPTER E. REGISTRATION REGULATIONS
25 TAC §289.229

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes an amendment to §289.229, concerning Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices.

BACKGROUND AND PURPOSE

The proposal updates regulations concerning accelerator facilities and operations. These changes address concerns that have developed in the field, requiring a comprehensive update to ensure the safety, quality, and effectiveness of accelerator-based facilities.

Language was added to hold an individual using an accelerator to the requirements in §289.229, even if they are not registered. Veterinary requirements have been removed from this rule and incorporated into §289.233, concerning Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine, which is dedicated to veterinary-specific facilities.

Equipment Performance Evaluation (EPE) requirements have been introduced for Computed Tomography (CT) units used in simulation. This addition enhances safety and promotes the principle of ALARA (as low as reasonably achievable). Since most CT units used for simulation also serve diagnostic imaging purposes, the annual EPE requirement is not considered an excessive regulatory burden.

Safety interlock requirements have been included for add-on equipment. This measure ensures the addition of equipment into accelerator systems, after installation, meets specified safety standards protecting both patients and operators.

The rule has been reorganized with Electronic Brachytherapy (EBT) requirements relocated from the end of the rule to the general requirements section. This reorganization makes the rule more accessible and coherent.

SECTION-BY-SECTION SUMMARY

The proposed amendment revises the title of the rule to “Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Radiation Therapy Simulation Systems, and Electronic Brachytherapy Devices.”

Throughout the rule, language has been added to require equipment testing protocols to meet or exceed nationally recognized, published guidelines from a professional body with expertise in the use of therapeutic radiation technologies or manufacturer recommendations.

Edits are made to replace “agency” with “department,” “title” with “chapter,” and “shall” with “must.” Edits are made to improve grammar and clarity, update references, and clarify device names throughout the rule. Formatting edits are made to update numbering.

The proposed amendment to §289.229(a) establishes the purpose for the requirements for the use of accelerators, therapeutic radiation machines, radiation therapy simulation systems, and electronic brachytherapy devices. It includes provisions for registering individuals using radiation machines in healing arts, controls on the receipt and use of radiation machines to ensure radiation dose standards are not exceeded, and specific record keeping obligations.

The proposed amendment to §289.229(b) removes the veterinary accelerator operations from §289.229. New paragraph (4) is added to provide that registrants engaged in veterinary accelerator operations are subject to §289.233, concerning Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine. The requirements were added to §289.233 in April 2021. Edits are also made to improve grammar, update references, clarify device names, and replace “title” with “chapter.” Formatting edits are made to update numbering.

The proposed amendment to §289.229(c)(4) prohibits remote operation of any radiation machine.

The proposed amendment to §289.229(d) removes language exempting veterinary accelerator operations from aural communication requirements. The exemption for a sole physician, sole operator, and the only occupationally exposed person was relocated from current subsection (d)(2) and incorporated into subsection (d).

The proposed amendment to §289.229(e) adds definitions for “accelerator beam quality,” “conventional radiation therapy simulator,” “CT radiation therapy simulator,” “image-guided radiation therapy (IGRT),” “intensity-modulated radiation therapy (IMRT),” “irradiation filter,” “dynamic or virtual wedge,” “multileaf collimator (MLC) wedge filter,” “physical wedge filter,” “stereotactic radiosurgery (SRS) filter,” “quality assurance (QA) check,” “radiation machine,” “radiation treatment head,” “virtual simulation,” and “wedge transmission factor.” The proposal amends the terms “absorbed dose,” “absorbed dose rate,” “air kerma,” “barrier,” “beam-flattening filter,” “beam-limiting device,” “beam quality,” “continuous pressure type switch,” “control panel,” “CT conditions of operation,” “electronic brachytherapy,” “electronic brachytherapy device,” “field size,” “focal spot,” “gantry,” “gray (Gy),” “half-value layer (HVL),” “healing arts,” “image receptor,” “Institutional Review Board (IRB),” “kilovolt (kV) (kiloelectron volt (keV)),” “kilovolt peak (KVp),” “leakage radiation,” “leakage technique factors,” “licensed medical physicist,” “medical event,” “megavolt (MV) (megaelectron volt (MeV)),” “mobile electronic brachytherapy device,” “moving beam radiation therapy,” “nominal treatment distance,” “peak tube potential,” “physician,” “portable shielding,” “prescribed dose,” “primary dose monitoring system,” “protective apron,” “protective barrier,” “protective glove,” “radiation detector,” “radiation field,” “radiation therapy simulation system simulator,” “radiation therapy system,” “scan,” “scan sequence,” “scan time,” “scattered radiation,” “secondary dose monitoring system,” “shutter,” “target,” “termination of irradiation,” “therapeutic radiation machine,” “traceable to a national standard,” “tube housing assembly,” and “useful beam.” The proposal deletes the definitions of “beam quality (accelerator),” “beam scattering foil,” “detector,” “electronic brachytherapy source,” “filter,” “mA,” “primary protective barrier,” “radiation head,” “radiation oncologist,” “secondary protective barrier,” “spot check,” “veterinarian,” and “wedge filter.” The proposal deletes and replaces the definition of “dosimetry system” and “supervision.” Formatting edits are made to update numbering.

Figure 25 TAC §289.229(e)(14) is amended to update the reference.

The proposed amendment to §289.229(f) updates the lead-in phrase to “Accelerators used for research and development or industrial operations.” Paragraph (2)(C)(ii) adds language requiring surveys to be completed upon installation, replacement, or upgrade to a higher energy accelerator. Subsection (f)(3)(A) is amended to add requirements to interlock systems which require inherent, add-on, and aftermarket devices that attach to the accelerator to meet the current interlock requirements for accelerators. Paragraph (3)(B) is amended to add language requiring a registrant to develop, implement, and maintain written operating and safety procedures as specified in subsection (h)(1)(G) of the section. Language regarding operating and safety procedures are removed from paragraph (f)(3)(B) and relocated to subsection (h)(1)(G) to reduce redundancy.

The proposed amendment to §289.229(g) makes edits to improve grammar, updates references, and replaces “chapter” with “title.”

The proposed amendment to §289.229(h) revises the lead-in phrase to “Requirements for therapeutic radiation machines, radiation therapy simulation systems used in the healing arts, and EBT devices.” Subsection (h)(1)(B) clarifies that any individual possessing a radiation therapy simulation system or a therapeutic radiation machine capable of operating below 1 MeV must apply for a certificate of registration within 30 days after energizing the equipment.

The proposed amendment to §289.229(h)(1)(G)(xiv)-(xvi) adds procedures to the written operating and safety requirements. Procedures include methods utilized for testing interlocks, entrance controls, alarm systems, posting notices to workers, notifications and reports to individuals, and record retention requirements.

Figure: 25 TAC §289.229(h)(2)(A)(i) is amended to meet current standards for leakage technique factors measured at 5 centimeters and 1 meter.

The proposed amendment to §289.229(h)(3)(A)(i) is rewritten and separated into subclauses to help with readability. Clause (ii) is rewritten and adds equipment requirements for dynamic or virtual wedge, MLC, SRS, and physical wedge filters.

New subsection (h)(4) relocates EBT requirements from the end of the rule. This change is needed to improve the flow of the rule.

New subsection (h)(5)(B) adds facility design requirements for radiation therapy simulation systems. The addition of viewing system requirements is needed to ensure the patient is always monitored.

New subsection (h)(5)(C) adds equipment requirements for radiation therapy systems utilizing standard CT systems. These requirements are needed to protect the patient and radiation worker from overexposure.

Figure: 25 TAC §289.229(h)(4)(B)(i) is amended to update a reference and “kVp” is added to the “designed operating range” column.

Figure: 25 TAC §289.229(h)(4)(B)(viii) is amended to update the reference and new language is added to improve clarity.

The proposed amendment to §289.229(i) updates the lead-in phrase to “Medical events” and abbreviates “electronic brachytherapy.” The words “shall” and “%” are replaced with “must” and “percent,” respectively and the number 3 is spelled out.

The proposed amendment to §289.229(j) updates the lead-in phrase to “Reports of medical events,” and replaces “agency” with “department” and “shall” with “must.” Other edits are made to improve grammar and correct spelling and punctuation.

Current subsection §289.229(k) is deleted and the contents of the subsection are moved to subsection (h)(4). New subsection (k) is added to describe provisions for emerging and future technologies. These provisions require the registrant to develop, implement, and maintain a dedicated quality management program to control the process of administering therapeutic radiation with newly acquired United States Food and Drug Administration-cleared emerging technologies or previously unused features of a future technology system.

The proposed amendment to §289.229(l) updates the lead-in phrase and replaces “agency” and “shall” with “department” and “must,” respectively.

Figure 25 TAC §289.229(l) is updated to reflect formatting changes and updates from reorganization of the rule.

Proposed Rule Reviews Re:

Reviewing Title 25, Part 1, to consider for readoption, revision, or repeal of the chapter concerning the Distribution of Tobacco Settlement Proceeds to Political Subdivisions.

Chapter 102, Distribution of Tobacco Settlement Proceeds to Political Subdivisions

Adopted Rule Reviews Re:

Adopting the review of Title 25, Part 1, concerning Early and Periodic Screening, Diagnosis, And Treatment, as well as Hospital Licensing.

The Texas Health and Human Services Commission (HHSC) adopts the review of the chapter below in Title 25, Part 1, of the Texas Administrative Code (TAC):

Chapter 33, Early and Periodic Screening, Diagnosis, And Treatment

Chapter 133, Hospital Licensing

In Addition Re:

Licensing Actions for Radioactive Materials

For more information, please visit this week’s edition of the Texas Register at 49 Tex Reg 4479.

Department of Aging and Disability Services

Transferred Rules Re:

Transferring the former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 2, Local Authority Responsibilities, Subchapter C, Charges For Community Services to Texas Administrative Code, Title 26, Part 1, Chapter 301, IDD-BH Contractor Administrative Functions, Subchapter J, Charges For Community Services; and Title 40, Part 1, Chapter 2, Local Authority Responsibilities Subchapter G, Role And Responsibilities Of A Local Authority are being transferred to Title 26, Part 1, Chapter 330, LIDDA Role and Responsibilities.

OVERVIEW

The rules will be transferred in the Texas Administrative Code effective July 15, 2024.

Transferring the former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 4, Rights and Protection of Individuals Receiving Intellectual Disability Services, Subchapter C, Rights of Individuals with an Intellectual Disability to Texas Administrative Code, Title 26, Part 1, Chapter 334, Rights and Protection of Individuals with an Intellectual Disability.

OVERVIEW

During the 84th Legislative Session, the Texas Legislature passed Senate Bill 200, addressing the reorganization of health and human services delivery in Texas. As a result, some agencies were abolished and their functions transferred to the Texas Health and Human Services Commission (HHSC). Texas Government Code, §531.0202(b), specified the Department of Aging and Disability Services (DADS) be abolished September 1, 2017, after all its functions were transferred to HHSC in accordance with Texas Government Code, §531.0201 and §531.02011. The former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 4, Rights and Protection of Individuals Receiving Intellectual Disability Services, Subchapter C, Rights of Individuals with an Intellectual Disability are being transferred to Texas Administrative Code, Title 26, Part 1, Chapter 334, Rights and Protection of Individuals with an Intellectual Disability.

The rules will be transferred in the Texas Administrative Code effective July 1, 2024.

Transferring the former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 47, Contracting to Provide Primary Home Care are being transferred to Texas Administrative Code, Title 26, Part 1, Chapter 277, Contracting to Provide Primary Home Care.

OVERVIEW

During the 84th Legislative Session, the Texas Legislature passed Senate Bill 200, addressing the reorganization of health and human services delivery in Texas. As a result, some agencies were abolished and their functions transferred to the Texas Health and Human Services Commission (HHSC). Texas Government Code, §531.0202(b), specified the Department of Aging and Disability Services (DADS) be abolished September 1, 2017, after all its functions were transferred to HHSC in accordance with Texas Government Code, §531.0201 and §531.02011. The former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 47, Contracting to Provide Primary Home Care are being transferred to Texas Administrative Code, Title 26, Part 1, Chapter 277, Contracting to Provide Primary Home Care.

The rules will be transferred in the Texas Administrative Code effective July 1, 2024.

Cancer Prevention and Research Institute of Texas

In Addition Re:

Notice of Extension of Comment Deadline for Rules Related to the Texas Cancer Plan

Filed with the Office of the Secretary of State on May 20, 2024, the Cancer Prevention and Research Institute of Texas (“CPRIT” or “the Institute”) proposed amending 25 Texas Administrative Code §701.11(5) by removing the hard copy option for the Texas Cancer Plan.