| (a) A change of ownership occurs when there is a change in the person legally responsible for the operation of the facility, whether by lease or by ownership. If a corporate licensee amends its articles of incorporation to revise its name, this subsection does not apply, except that the corporation shall notify the department not later than the 10th calendar day after the effective date of the name change. The sale of stock of a corporate licensee does not cause this subsection to apply. (1) The new owner shall submit an application for an initial license to the department at least 60 days before the date of the change of ownership. The application shall be in accordance with subsections (a) and (b) of this section. The applicant shall include the effective date of the change of ownership. The new owner shall be responsible for previous regulatory violations, and shall ensure compliance with all rules and regulations. (2) The inspection required by subsection (h) of this section may be waived by the department. (3) When the new owner has complied with the provisions of subsections (a) and (b) of this section, the department shall issue a license which shall be effective the date of the change of ownership. (4) The expiration date of the license shall be in accordance with subsection (e)(2) of this section. (5) The previous owner's license shall be void on the effective date of the new owner's license. (b) A facility planning to relocate shall notify the department at least 90 days before the planned relocation. Relocations shall be within the same geographical area, and services shall continue to be provided to the facility's existing patient population. (1) The facility shall submit an application for an initial license to the department prior to the date of the relocation. The application shall be in accordance with subsections (a) - (d) of this section. (2) The inspection required by subsection (h) of this section may be waived by the department. (3) The license shall be effective on the date the facility is determined to be in compliance with subsections (a) - (d) of this section. (4) The expiration date of the license shall be in accordance with subsection (e)(2) of this section. (5) The previous facility license shall be void on the effective date of the relocation. (c) Changes which affect the license. (1) A facility shall notify the department in writing at least 30 days before the occurrence of any of the following: (A) any remodeling, renovations, additions and alterations, shall comply with the provisions of §117.101(b) of this title (relating to Construction Requirements for an Existing End Stage Renal Disease Facility); (B) change in facility name, mailing address, telephone number, or fax number; (C) planned change of administrator, or within five working days of an unplanned change of administrator; or (D) cessation of operation of the facility. (2) A facility shall obtain written approval from the department prior to the utilization of added services or an increased number of stations. The written request shall be submitted 30 days prior to the planned change. (A) For an additional service or increase in stations, the department may request that the facility provide evidence of appropriate staffing and policies and procedures which demonstrate the intent to comply with the applicable requirements, and any other documentation it determines is necessary to evaluate the request. (B) For an increase in stations, the facility shall also be required to submit written evidence that the water treatment system is of sufficient size to accommodate the increase and maintain a safe water supply. (C) The department may conduct an on-site inspection prior to taking action on the requested change. (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 next on-site inspection. (E) The department shall send the facility written notice of the approval or disapproval of the requested change. (F) As of February 9, 2009, all existing facilities increasing the number of in-center dialysis treatment stations shall have an isolation room or be granted 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. A written request for waiver shall be made 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. (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. 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, 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. |
