End Stage Renal Disease Facilities

As defined by Texas Health and Safety Code Section 251.001 and Texas Administrative Code Part 1, Chapter 117, Section 117.2, an end stage renal disease facility is a facility that provides dialysis treatment or dialysis training and support to individuals with end stage renal disease.

Texas Health and Safety Code Chapter 251 establishes the state licensing requirements for ESRD facilities. Under state law, HHSC is responsible for the licensing and regulation of ESRD facilities in Texas, and the Regulatory Services Division within HHSC carries out these duties.

HHSC adopts rules for ESRD facilities including establishing standards for:

• Licensing procedures and fees
• License denial, probation, suspension, and revocation
• Qualifications and supervision of a facility's professional staff and other facility personnel
• Facility equipment, sanitary and hygienic conditions, and clinical records
• Quality assurance for patient care
• Facility treatment and service provision and coordination
• Indicators of the quality of care provided by a facility
• Water treatment and reuse by the facility
• Facility design and space requirements for safe access by patients and facility personnel and for ensuring patient privacy

Laws and Rules

Texas Laws

• Texas Health and Safety Code Chapter 251

Rules and Regulations

• Texas Administrative Code Title 25, Part 1, Chapter 117, End Stage Renal Disease Facilities
• ESRD Additional Staffing Guidelines Chart (PDF)

Federal Regulations

• Code of Federal Regulations Title 42 Chapter IV, Subchapter B, Part 405, Subpart U, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services
• Centers for Medicare and Medicaid’s Guidance to Federal Laws and Regulations

Find or Verify a License

• Verify a facility license by searching  the Online Licensing System
• View the accessible version of the Directory of End Stage Renal Disease Facilities (Excel)

Licensing

An applicant seeking an ESRD facility license must submit a completed application, license fee, and other applicable documents to HHSC. The Health Facility Licensing Unit will not process an application until after HHSC Accounts Receivable receives and posts the license fee.

Refer to the application or instructions linked in this section for specific requirements.

HHSC must review and approve all required application materials received before issuing a license to an applicant.

Initial Licensure Application

• Form 3204, End Stage Renal Disease Facility License Application

Change of Ownership Application

• Change of Ownership Instructions (PDF)
• Form 3204, End Stage Renal Disease Facility License Application

Relocation Application

• Form 3204, End Stage Renal Disease Facility License Application

Renewal Licensure Application

• Form 3205, End Stage Renal Disease Facility License Renewal Addendum

Supporting Forms and Documents

• CMS - ESRD Application and Survey and Certification Report (PDF)
• ESRD Emergency Rule Exception Request Form (PDF)

Architectural Review Information and Forms

• Life Safety Code Attestation Form (PDF)

Refer to the Architectural Information page for more information.

Complaint and Incident Submission Information

• Incidents Submission Portal for Health Care Regulation Providers
• File a Complaint for a Health Facility

Inspection Components

HHSC conducts health compliance on-site inspections to determine compliance with the provisions of the Health and Safety Code and associated rules listed in the Laws and Rules section of this page. During the inspection, HHSC staff generally perform the following activities:

• Conduct an entrance and an exit conference with applicable facility personnel
• Explain the inspection process and answer questions
• Review clinical records
• Review facility and personnel records
• Review facility policies and procedures
• Review quality assurance activities
• Interview staff
• Assess the facility’s compliance with applicable statutes and rules
• Discuss final inspection findings with applicable facility personnel

Enforcement Actions

• End Stage Renal Disease Facilities Enforcement Actions (PDF)

Human Trafficking Resources

• HHSC Texas Human Trafficking Resource Center

Provider Certification

The Secretary of the United States Department of Health and Human Services directs state health agencies or other appropriate agencies to determine whether health care entities meet federal standards. This helping function is termed "provider certification." Health Care Regulation staff are responsible for providing certification oversight on behalf of CMS for ESRD facilities.

For more information on the certification process, refer to our Centers for Medicare & Medicaid Services Information page, or contact your regional office (PDF).

Clinical Laboratory Improvement Amendments Information

Refer to our CLIA information page. For more information on CLIA, contact your regional office (PDF).

Contact Information

Health Care Regulation

For Health Care Regulation contact information, visit our Contact Us page.

Health Care Facility Enforcement

Phone: 512-438-5439
Fax: 512-438-3697
Email:Health.Facilities.Enforcement@hhsc.state.tx.us
Mailing Address:
Texas Health and Human Services Commission
Regulatory Services Division
Health Care Facility Enforcement, MC 1866
P.O. Box 149347
Austin, TX 78714-9347

Open Records Requests

Texas Health and Human Services is committed to providing full access to public information. For information on how to submit an open records request, visit the Open Records Policy and Procedures webpage.