SECTION 139.60. Other State and Federal Compliance Requirements

(a) A licensed abortion facility shall be in compliance with all state and federal laws pertaining to handling of drugs.

(b) A licensed abortion facility that provides laboratory services shall meet the Clinical Laboratory Improvement Amendments of 1988, 42 United States Code, §263a, Certification of Laboratories (CLIA 1988). CLIA 1988 applies to all facilities with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.

(c) A licensed abortion facility shall ensure that its physicians comply with the Medical Practice Act, Occupations Code, Chapters 151 - 160 and 162 - 165, while functioning in his or her capacity at or for the facility.

(d) A licensed abortion facility utilizing the services of a physician assistant(s) shall ensure that its physician assistants comply with the Physician Assistant Licensing Act, Occupations Code, Chapter 204, while functioning in his or her capacity at or for the facility.

(e) A licensed abortion facility utilizing the services of a registered nurse shall ensure that its registered nurses comply with the Nursing Practice Act, Occupations Code, Chapters 301 and 304, while functioning in his or her capacity at or for the facility.

(f) A licensed abortion facility utilizing the services of a licensed vocational nurse(s) shall ensure that its vocational nurse(s) comply with the Nursing Practice Act, Occupations Code, Chapters 301 and 304, while functioning in his or her capacity at or for the facility.

(g) A licensed abortion facility that provides pharmacy services shall obtain a license as a pharmacy if required by the Texas Pharmacy Act, Occupations Code, Chapters 551 - 569.

(h) A licensed abortion facility shall comply with the following federal Occupational Safety and Health Administration requirements:

(1) 29 Code of Federal Regulations, Subpart E, §1910.38, concerning emergency action plan and §1910.39, concerning fire prevention plans;

(2) 29 Code of Federal Regulations, Subpart I, §1910.132, concerning general requirements for personal protective equipment;

(3) 29 Code of Federal Regulations, Subpart I, §1910.133, concerning eye and face protection;

(4) 29 Code of Federal Regulations, Subpart I, §1910.138, concerning hand protection;

(5) 29 Code of Federal Regulations, Subpart K, §1910.151, concerning medical services and first aid;

(6) 29 Code of Federal Regulations, Subpart L, §1910.157, concerning portable fire extinguishers;

(7) 29 Code of Federal Regulations, Subpart Z, §1910.1030, concerning bloodborne pathogens; and

(8) 29 Code of Federal Regulations, Subpart Z, §1910.1200, Appendices A - E, concerning hazard communication (hazardous use of chemicals).

(i) A licensed abortion facility shall not use adulterated or misbranded drugs or devices in violation of the Health and Safety Code, §431.021. Adulterated drugs and devices are described in Health and Safety Code, §431.111. Misbranded drugs or devices are described in Health and Safety Code, §431.112.

(j) A licensed abortion facility shall not commit a false, misleading, or deceptive act or practice as that term is defined in the Deceptive Trade Practices-Consumer Protection Act, Business and Commerce Code, §17.46.

(k) A licensed abortion facility shall comply with the requirements of the Family Code, §33.002, relating to a Consent Form.

(l) A licensed abortion facility shall comply with the requirements of Health and Safety Code, Chapter 171, the Woman's Right to Know Act.

(m) A licensed abortion facility shall comply with the requirements of Occupations Code, Chapter 102, Solicitation of Patients.

(n) Balance Billing.

(1) A licensed abortion facility may not violate a law that prohibits the licensed abortion facility from billing a patient who is an insured, participant, or enrollee in a managed care plan an amount greater than an applicable copayment, coinsurance, and deductible under the insured's, participant's, or enrollee's managed care plan or that imposes a requirement related to that prohibition.

(2) A licensed abortion facility shall comply with Senate Bill 1264, 86th Legislature, Regular Session, 2019, and with related Texas Department of Insurance rules at 28 TAC Chapter 21, Subchapter OO, §§21.4901 - 21.4904 (relating to Disclosures by Out-of-Network Providers) to the extent this subchapter applies to the licensed abortion facility.

(o) A licensed abortion facility shall comply with human trafficking signage requirements in accordance with Texas Health and Safety Code §245.025 (relating to Human Trafficking Signs Required).

(p) A licensed abortion facility shall not discriminate based on a patient's disability and shall comply with Texas Health and Safety Code Chapter 161, Subchapter S (relating to Allocation of Kidneys and Other Organs Available for Transplant).

Source Note: The provisions of this §139.60 adopted to be effective June 28, 2009, 34 TexReg 4125; amended to be effective April 15, 2021, 46 TexReg 2423; amended to be effective January 6, 2022, 46 Texreg 9306