Section 135.4 - Ambulatory Surgical Center (ASC) Operation(a) The ASC shall have a governing body that sets policy and assumes full legal responsibility for the total operation of the ASC.(b) The governing body shall be responsible for assuring that medical staff bylaws are current and on file.(c) The governing body shall address and is fully responsible, either directly or by appropriate professional delegation, for the operation and performance of the ASC. Governing body responsibilities include:(1) determining the mission, goals, and objectives of the ASC;(2) assuring that facilities and personnel are adequate and appropriate to carry out the mission;(3) establishing an organizational structure and specifying functional relationships among the various components of the ASC;(4) adopting bylaws or similar rules and regulations for the orderly development and management of the ASC;(5) adopting policies or procedures necessary for the orderly conduct of the ASC;(6) assuring that the quality of care is evaluated and that identified problems are addressed;(7) reviewing all legal and ethical matters concerning the ASC and its staff and, when necessary, responding appropriately;(8) maintaining effective communication throughout the ASC;(9) establishing a system of financial management and accountability that includes an audit appropriate to the ASC;(10) developing, implementing, and enforcing a policy on the rights of patients;(11) approving all major contracts or arrangements affecting the medical care provided under its auspices, including those concerning:(A) the employment of health care practitioners;(B) an effective procedure for the immediate transfer to a hospital of patients requiring emergency care beyond the capabilities of the ASC; (i) the ASC shall have a written transfer agreement with a hospital; or(ii) all physicians performing surgery at the ASC shall have admitting privileges at a local hospital;(C) the use of external laboratories;(D) an effective procedure for obtaining emergency laboratory, radiology, and pharmaceutical services if laboratory, X-ray, and pharmacy services are not provided on site; and(E) the provision of education to students and postgraduate trainees if the ASC participates in such programs;(12) formulating long-range plans in accordance with the mission, goals, and objectives of the ASC;(13) operating the ASC without limitation because of race, creed, sex, or national origin;(14) assuring that all marketing and advertising concerning the ASC does not imply that it provides care or services which it is not capable of providing; and(15) developing a system of risk management appropriate to the ASC including:(A) periodic review of all litigation involving the ASC, its staff, and health care practitioners regarding activities in the ASC;(B) periodic review of all incidents reported by staff and patients;(C) review of all deaths, trauma, or adverse reactions occurring on premises; and(D) evaluation of patient complaints.(d) The governing body shall provide for full disclosure of ownership to the department.(e) The governing body shall meet at least annually and keep such minutes or other records as may be necessary for the orderly conduct of the ASC.(f) If the governing body elects, appoints, or employs officers and administrators to carry out its directives, the authority, responsibility, and functions of all such positions shall be defined.(g) When a majority of its members are physicians, the governing body, either directly or by delegation, shall make (in a manner consistent with state law and based on evidence of the education, training, and current competence of the physician) initial appointments, reappointments, and assignment or curtailment of medical privileges. When a majority of the members of the governing body are not physicians, the ASC's bylaws or similar rules and regulations shall specify a procedure for establishing medical review for the purpose of making (in a manner consistent with state law and based on evidence of the education, training, and current competence of the physician) initial appointments, reappointments, and assignment or curtailment of medical privileges.(h) The governing body shall provide (in a manner consistent with state law and based on evidence of education, training, and current competence) for the initial appointment, reappointment, and assignment or curtailment of privileges and practice for nonphysician health care personnel and practitioners.(i) The governing body shall encourage personnel to participate in continuing education that is relevant to their responsibilities within the ASC.(j) The governing body shall adopt, implement, and enforce written policies to ensure compliance with Texas Health and Safety Code Chapter 324.(k) The governing body shall adopt, implement, and enforce written policies to ensure compliance with applicable state laws.(l) An ASC that performs abortions shall adopt, implement, and enforce a policy to ensure compliance with Texas Health and Safety Code Chapters 245 and 171, Subchapters A and B.(m) An ASC shall comply with the following balance billing requirements.(1) An ASC may not violate a law that prohibits the ASC 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) An ASC 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 ASC.(n) An ASC shall comply with the itemized bill requirements under Texas Health and Safety Code § 185.002.25 Tex. Admin. Code § 135.4
The provisions of this §135.4 adopted to be effective June 18, 2009, 34 TexReg 3948; Amended by Texas Register, Volume 46, Number 15, April 9, 2021, TexReg 2422, eff. 4/15/2021; Amended by Texas Register, Volume 49, Number 33, August 16, 2024, TexReg 6216, eff. 8/18/2024