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RULE §117.12Application and Issuance of Initial License

(a) The applicant shall comply with the following before the projected opening date of the facility:

  (1) the applicant shall submit an accurate and complete application form;

  (2) the applicant shall submit the appropriate license fee as required in §117.16 of this title (relating to Fees); and

  (3) as of February 9, 2009, the applicant for a new facility or for an existing facility that is increasing the number of in-center dialysis treatment stations in existing facilities shall have an isolation room or shall provide a waiver by the Centers for Medicare and Medicaid Services. The waiver shall demonstrate that there is sufficient capacity in the geographic area for isolation rooms for hepatitis B positive patients. An applicant may submit a written request for waiver through the Texas Department of State Health Services, Health Facility Compliance Group, Mail Code 1979, P.O. Box 149347, Austin, Texas, 78714-9347 for transmission to CMS.

(b) The applicant or the applicant's representative shall attend a presurvey conference at the office designated by the department. The purpose of the presurvey conference, which is conducted by department staff, is to review facility staff qualifications, survey documents and licensure rules, and to provide consultation prior to the on-site licensure survey. The department staff conducting the presurvey conference is responsible for making a recommendation regarding the issuance of the initial license. The department may waive the presurvey conference requirement.

(c) In addition to the document submittal requirements in subsection (a) of this section, the following shall be completed prior to the issuance of an ESRD facility license to newly constructed ESRD facility or ESRD facility from conversion of non-ESRD building.

  (1) Final construction documents shall be reviewed and approved by the department in accordance with §117.104 of this title (relating to Preparation, Submittal, Review and Approval of Plans and Retention of Records).

  (2) For new construction, necessary intermediate inspections and final construction inspections shall be conducted by the department in accordance with §117.105(b) of this title (relating to Construction, Inspections, and Approval of Project) to determine that the ESRD facility was constructed in compliance with this chapter.

  (3) When an applicant intends to reopen and relicense a building formerly licensed as a ESRD facility, an on-site inspection shall be conducted by the department in accordance with §117.105 of this title to determine compliance with applicable construction and fire safety requirements.

  (4) A certificate of occupancy for the project issued by the local building authority, if applicable and a written approval of the project by the fire authority.

  (5) A complete and accurate Final Construction Approval form shall be submitted to the department.

(d) The facility shall submit a complete chemical analysis of the product water, and reports to verify that bacteriological and endotoxin levels of product water and dialysate are in compliance with §117.32 of this title (relating to Water Treatment, Dialysate Concentrates, and Reuse). The reports shall be kept on file at the facility and made available to department staff during the on-site inspection.

(e) When it is determined that the facility has complied with subsections (a) - (d) of this section, the department shall issue the license to the applicant.

  (1) The license shall be effective on the date the facility is determined to be in compliance with subsections (a) - (d) of this section.

  (2) Expiration date.

    (A) If the effective date of the license is the first day of a month, the license expires on the last day of the 23rd month after issuance.

    (B) If the effective date of the license is the second or any subsequent day of a month, the license expires on the last day of the 24th month after issuance.

(f) If an applicant decides not to continue the application process for a license or renewal of a license, the application may be withdrawn.

(g) Denial of a license shall be governed by §117.84 of this title (relating to Disciplinary Action).

(h) During the initial licensing period, the department shall conduct an inspection of the facility to ascertain compliance with the provisions of the Health and Safety Code, Chapter 251, and this chapter.

  (1) A facility shall request an on-site inspection to be conducted after at least one patient has been admitted and provided services.

  (2) A facility shall be providing services to at least one patient at the time of the inspection. The department may interview patients at the time of the inspection in the patient's home or at the facility.

Source Note: The provisions of this §117.12 adopted to be effective July 6, 2010, 35 TexReg 5835

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