Section 133.103 - Complaint Investigations(a) A hospital shall provide each patient and applicable legally authorized representative at the time of admission with a written statement identifying the Texas Health and Human Services Commission (HHSC) as the agency responsible for investigating complaints against the hospital.(1) The statement shall inform persons that they may direct a complaint to HHSC Complaint and Incident Intake (CII) and include current CII contact information, as specified by HHSC.(2) The hospital shall prominently and conspicuously post this statement in patient common areas and in visitor's areas and waiting rooms so that it is readily visible to patients, employees, and visitors. The information shall be in English and in a second language appropriate to the demographic makeup of the community served.(b) HHSC evaluates all complaints. A complaint must be submitted using HHSC's current CII contact information for that purpose, as described in subsection (a) of this section.(c) HHSC documents, evaluates, and prioritizes complaints directed to HHSC CII based on the seriousness of the alleged violation and the level of risk to patients, personnel, and the public.(1) Allegations determined to be within HHSC's regulatory jurisdiction relating to a hospital may be investigated under this chapter.(2) HHSC may refer complaints outside HHSC's jurisdiction to an appropriate agency, as applicable.(d) HHSC conducts investigations to evaluate a hospital's compliance following a complaint of abuse, neglect, or exploitation; or a complaint related to the health and safety of patients. Complaint investigations may be coordinated with the federal Centers for Medicare & Medicaid Services and its agents responsible for the inspection of hospitals to determine compliance with the Conditions of Participation under Title XVIII of the Social Security Act, (42 USC, §§ 1395 et seq.), so as to avoid duplicate investigations.(e) HHSC may conduct an unannounced, on-site investigation of a hospital at any reasonable time, including when treatment services are provided, to inspect or investigate:(1) a hospital's compliance with any applicable statute or rule;(2) a hospital's plan of correction;(3) a hospital's compliance with an order of the HHSC executive commissioner or the executive commissioner's designee;(4) a hospital's compliance with a court order granting injunctive relief; or(5) for other purposes relating to regulation of the hospital.(f) An applicant or licensee, by applying for or holding a license, consents to entry and investigation of any of its facilities by HHSC.(g) A hospital shall cooperate with any HHSC investigation and shall permit HHSC to examine the hospital's grounds, buildings, books, records, video surveillance, and other documents and information maintained by, or on behalf of, the hospital, unless prohibited by law.(h) A hospital shall permit HHSC access to interview members of the governing body, personnel, and patients, including the opportunity to request a written statement.(i) A hospital shall permit HHSC to inspect and copy any requested information, unless prohibited by law. If it is necessary for HHSC to remove documents or other records from the hospital, HHSC provides a written description of the information being removed and when it is expected to be returned. HHSC makes a reasonable effort, consistent with the circumstances, to return any records removed in a timely manner.(j) Upon entry, the HHSC representative holds an entrance conference with the hospital's designated representative to explain the nature, scope, and estimated duration of the investigation.(k) The HHSC representative holds an exit conference with the hospital representative to inform the hospital representative of any preliminary findings of the investigation. The hospital may provide any final documentation regarding compliance during the exit conference.(l) Once an investigation is complete, HHSC reviews the evidence from the investigation to evaluate whether there is a preponderance of evidence supporting the allegations contained in the complaint.(m) HHSC shall maintain the confidentiality of hospital records as applicable under state or federal law. Except as provided by subsection (n) of this section, all information and materials in the possession of or obtained or compiled by HHSC in connection with an investigation are confidential and not subject to disclosure under Texas Government Code Chapter 552, and not subject to disclosure, discovery, subpoena, or other means of legal compulsion for their release to anyone other than HHSC or its employees or agents involved in the enforcement action except that this information may be disclosed to:(1) persons involved with HHSC in the enforcement action against the hospital;(2) the hospital that is the subject of the enforcement action, or the hospital's authorized representative;(3) appropriate state or federal agencies that are authorized to inspect, survey, or investigate hospital services;(4) law enforcement agencies as allowed by law; and(5) persons engaged in bona fide research, if all individual-identifying and hospital-identifying information has been deleted.(n) The following information is subject to disclosure in accordance with Texas Government Code Chapter 552, only to the extent that all personally identifiable information of a patient or health care provider is omitted from the information: (1) a notice of the hospital's alleged violation, which must include the provisions of law the hospital is alleged to have violated, and a general statement of the nature of the alleged violation;(2) the number of investigations HHSC conducted of the hospital;(3) the pleadings in any administrative proceeding to impose a penalty against the hospital for the alleged violation;(4) the outcome of each investigation HHSC conducted of the hospital, including: (B) license denial or revocation;(C) corrective action plan adoption; or(D) administrative penalty imposition and the penalty amount;(5) a final decision, investigative report, or order issued by HHSC to address the alleged violation; and(6) any other information required by law to be disclosed under public information laws.(o) Within 90 days after the date HHSC issues a final decision, investigative report, or order to address a hospital's alleged violation, HHSC posts certain information on the HHSC website in accordance with Texas Health and Safety Code Section 241.051 (relating to Inspections).(p) HHSC notifies complainants regarding the investigation's outcome within 10 business days after completing the investigation.25 Tex. Admin. Code § 133.103
Adopted by Texas Register, Volume 49, Number 46, November 15, 2024, TexReg 9233, eff. 11/21/2024