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Licensing Requirements - End-Stage Renal Disease Facilities

License Application

The following documents, fees, and actions shall be completed and approved before a license will be issued:


Initial Application

  • A license application form (PDF, 188KB) submitted no earlier than 90 calendar days prior to the projected opening date of the facility. A license fee ranging from $3,500.00 – $6,700.00 based on total number of stations shall be submitted. Please refer to the license application to determine required fee. License fees are not refundable.
  • A written plan for the orderly transfer of care of patients and clinical records in the event the facility is unable to maintain services under the license.
  • A completed Fire Safety Survey Report form shall be submitted. Annual fire safety inspections are required for continued licensure status. Please include a copy of a fire inspection report conducted within the last 12 months indicating approval by the local fire authority.
  • Approval for occupancy shall be obtained from the Department of State Health Services, Architectural Review Group.
  • The applicant or the applicant’s representative shall attend a pre-survey conference at the zone office designated by the department. Please contact the designated zone office to schedule the pre-survey conference.
  • 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 (relating to water treatment, dialysate concentrates, and reuse). Reports shall be submitted to the designated zone office for approval. Please contact the designated zone office with any questions.
  • Facilities shall complete the Life Safety Code Attestation (PDF, 20KB).

Relocation Application

  • A license application form (PDF, 188KB) submitted no earlier than 90 calendar days prior to the projected opening date of the facility.
  • A license fee ranging from $3,500.00 – $6,700.00 based on total number of stations shall be submitted. Please refer to the license application to determine required fee. License fees are not refundable.
  • A written plan for the orderly transfer of care of patients and clinical records in the event the facility is unable to maintain services under the license.
  • A completed Fire Safety Survey Report form shall be submitted. Annual fire safety inspections are required for continued licensure status. Please include a copy of a fire inspection report conducted within the last 12 months indicating approval by the local fire authority.
  • Approval for occupancy shall be obtained from the Department of State Health Services, Architectural Review Group.
  • 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 (relating to water treatment, dialysate concentrates, and reuse). Reports shall be submitted to the designated zone office for approval. Please contact the designated zone office with any questions.
  • Facilities shall complete the Life Safety Code Attestation (PDF, 20KB).

Change of Ownership (CHOW) Application

  • A license application form (PDF, 188KB) to be submitted at least 60 calendar days before the date of the change of ownership.
  • A license fee ranging from $3,500.00 – $6,700.00 based on total number of stations shall be submitted. Please refer to the license application to determine required fee. License fees are not refundable.
  • A written plan for the orderly transfer of care of patients and clinical records in the event the facility is unable to maintain services under the license.
  • A copy of two completed Fire Safety Survey Report forms shall be submitted. Annual fire safety inspections are required for continued licensure status. Please include a copy of a fire inspection report conducted within the last 12 months and a second report conducted within the last 13 to 24 months indicating approval by the local fire authority.
  • The applicant or the applicant’s representative shall attend a pre-survey conference at the zone office designated by the department. The designated zone office may waive the pre-survey conference requirement for a Change of Ownership. Please contact the designated zone office to schedule the pre-survey conference or to request a wavier.
  • Medicare certified facilities shall complete the Life Safety Code Attestation (PDF, 20KB) or agree to have a Life Safety Code survey at a later date.
  • The applicant shall include evidence (bill of sale, lease agreement, or legal court document) of the change of ownership. This document can be submitted separately from the license application.

Provider Certification

Medicare certification information may be obtained from the zone office for your location. The Social Security Act directs the Secretary of the Department of Health and Human Services to use the help of State health agencies or other appropriate agencies to determine if health care entities meet Federal standards. This task is one of the Department of State Health Services’ responsibilities. For information on gaining provider certification, please contact zone office staff.


CLIA Information

CLIA information is located on the department’s website. For more information, please contact the zone office for your location.


Survey Components

During the initial licensing period, department zone office staff will conduct an on-site survey to ascertain compliance with the provisions of the Health and Safety Code and associated rules. An entrance conference will be held with key facility personnel. Zone office staff will explain the survey process and answer questions. During the survey, zone office staff will:

  • Review clinical records
  • Review facility policies and procedure
  • Review quality assurance activities
  • Review personnel records
  • Interview staff
  • Conduct an exit conference with key facility personnel
  • Discuss survey findings

Contact Information

The Facility Licensing Group is dedicated to assist you through this process and is available to answer your questions. If you have any questions, please contact the Facility Licensing Group: phone (512) 834-6646, fax (512) 834-4514.

Mailing Address For Applications With Fees:
Department Of State Health Services
Regulatory Licensing Unit - Facility Licensing Group,
Mail Code 2003
P.O. Box 149347
Austin, TX 78714-9347

Overnight Mailing Address For Applications With Fees:
Department Of State Health Services
Facility Licensing Group
Mail Code 2003
1100 West 49th Street
Austin, TX 78756

Last updated April 26, 2017