1. (a) The Texas Health and Human Services Commission (HHSC) may conduct an inspection of each end stage renal disease (ESRD) facility prior to the issuance or renewal of a license.

   1. (1) A facility is not subject to additional annual licensing inspections subsequent to the issuance of the initial license while the facility maintains:

      1. (A) certification under Title XVIII of the Social Security Act, 42 United States Code §§1395 et seq.; or
      2. (B) accreditation from a national accreditation organization for the offered services.
   2. (2) HHSC may conduct an inspection of a facility exempt from an annual licensing inspection under paragraph (1) of this subsection before issuing a renewal license to the facility if the certification or accreditation organization has not conducted an on-site inspection of the facility in the preceding three years and HHSC determines that an inspection of the facility by the certification or accreditation body is not scheduled within 60 days of the license expiration date.

2. (b) HHSC may conduct an unannounced, on-site inspection of a facility at any reasonable time, including when treatment services are provided, to inspect, investigate, or evaluate compliance with or prevent a violation of:

   1. (1) any applicable statute or rule;
   2. (2) a facility's plan of correction;
   3. (3) an order or special order of the HHSC executive commissioner or the executive commissioner's designee;
   4. (4) a court order granting injunctive relief; or
   5. (5) for other purposes relating to regulation of the facility.
3. (c) An applicant or licensee, by applying for or holding a license, consents to entry and inspection of any of its facilities by HHSC.

4. (d) HHSC inspections to evaluate a facility's compliance may include:

   1. (1) initial, change of ownership, or relocation inspections for the issuance of a new license;
   2. (2) inspections related to changes in status, such as new construction or changes in services, designs, or licensed station numbers;
   3. (3) routine inspections, which may be conducted without notice and at HHSC discretion, or prior to renewal;
   4. (4) follow-up on-site inspections, conducted to evaluate implementation of a plan of correction for previously cited deficiencies;
   5. (5) inspections to determine if an unlicensed facility is offering or providing, or purporting to offer or provide, treatment; and
   6. (6) entry in conjunction with any other federal, state, or local agency's entry.
5. (e) A facility shall cooperate with any HHSC inspection and shall permit HHSC to examine the facility's grounds, buildings, books, records, video surveillance, and other documents and information maintained by or on behalf of the facility, unless prohibited by law.
6. (f) A facility shall permit HHSC access to interview members of the governing body, personnel, and patients, including the opportunity to request a written statement.
7. (g) A facility 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 facility, 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.
8. (h) Upon entry, HHSC holds an entrance conference with the facility's designated representative to explain the nature, scope, and estimated duration of the inspection.
9. (i) During the inspection, the HHSC representative gives the facility representative an opportunity to submit information and evidence relevant to matters of compliance being evaluated.
10. (j) When an inspection is complete, the HHSC representative holds an exit conference with the facility representative to inform the facility representative of any preliminary findings of the inspection, including possible health and safety concerns. The facility may provide any final documentation regarding compliance during the exit conference.
11. (k) HHSC maintains the confidentiality of facility records as applicable under state or federal law.

Source Note:The provisions of this §507.82 adopted to be effective December 23, 2025, 50 TexReg 8289.