1. (a) An applicant shall comply with this subsection before receiving an initial license.

   1. (1) The applicant shall submit an accurate and complete application form to the Texas Health and Human Services Commission (HHSC) in accordance with HHSC instructions, including evidence that:

      1. (A) the facility has at least one qualified physician on staff; and
      2. (B) each dialysis technician on staff completed the training program requirements as required by §507.72 of this chapter (relating to Training Curricula and Instructors).
   2. (2) The applicant shall submit the appropriate license fee, as required in §507.20 of this subchapter (relating to Fees).
   3. (3) The applicant for a new or existing facility that is increasing the number of in-center dialysis treatment stations shall have an isolation room, as specified in the current CMS Conditions for Coverage or shall provide a CMS waiver.
   4. (4) The applicant shall attend a prelicensure conference conducted by HHSC to review facility staff qualifications and licensure rules, and to receive consultation before the on-site licensure inspection. HHSC may waive the prelicensure conference requirement at its discretion.

   5. (5) The applicant shall submit a copy of a fire safety inspection that:

      1. (A) indicates approval by an individual certified by the Texas Commission on Fire Protection; and
      2. (B) is dated no earlier than 12 months before the facility licensure date.
   6. (6) The facility physical plant shall meet the requirements set forth in Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements) before HHSC issues an end stage renal disease (ESRD) facility license for a newly constructed ESRD facility or an ESRD facility converted from a non-ESRD facility building.
   7. (7) The applicant shall submit to HHSC, in accordance with HHSC instructions, a complete chemical analysis of the product water and reports to verify that bacteriological and endotoxin levels of product water and dialysate are compliant with §507.33 of this chapter (relating to Water Treatment) and §507.34 of this chapter (relating to Dialysate). The facility shall keep the reports on file at the facility and make the reports available to HHSC staff during an on-site inspection or when requested by HHSC.

2. (b) When HHSC determines the applicant has complied with subsection (a) of this section, HHSC issues the license to the applicant.

   1. (1) The license is effective on the issue date.
   2. (2) The license expires on the last day of the month two years after the issue date.
3. (c) HHSC will not process an application until HHSC receives the fee required in subsection (a)(2) of this section.
4. (d) An applicant may withdraw their application by notifying HHSC in accordance with HHSC instructions.
5. (e) If the applicant does not complete all requirements of subsection (a) of this section within six months after the date HHSC receives the license application and appropriate fee, HHSC will consider the application withdrawn. The applicant must reapply for an initial license in accordance with this section.
6. (f) Any fee paid for a withdrawn application is nonrefundable, as indicated by §507.20(a) of this subchapter.
7. (g) Denial of a license is governed by §507.90 of this chapter (relating to Enforcement).

8. (h) Within the first two years of licensure, HHSC inspects the facility to determine the facility's compliance with the provisions of Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities) and this chapter.

   1. (1) HHSC may conduct this inspection at the same time as the inspection to determine compliance with Code of Federal Regulations Title 42, Part 494 (relating to Conditions for Coverage for End-Stage Renal Disease Facilities).
   2. (2) After the facility admits and provides services to at least one patient, the facility shall request an on-site inspection in accordance with HHSC instructions. An HHSC representative will conduct the inspection while patients are in the facility being dialyzed.
   3. (3) At the time of inspection, the facility shall provide services to at least one patient in each modality the facility requested in their application. An HHSC representative may interview patients at the time of the inspection, either in the patient's home or at the facility. An HHSC representative may interview peritoneal and home hemodialysis patients trained or retrained at the facility as part of the inspection.

Source Note:The provisions of this §507.12 adopted to be effective December 23, 2025, 50 TexReg 8289.