Form 3204, End Stage Renal Disease Facility License Application

Instructions for Opening a Form

Some forms cannot be viewed in a web browser and must be opened in Adobe Acrobat Reader on your desktop system. Click here for instructions on opening this form.

Documents

Effective Date: 2/2023

Instructions

Updated: 2/2023

Purpose

Form 3204 is used to apply for an initial, relocation or change of ownership license for an end stage renal disease facility. 

Procedure

When to Prepare

An applicant must submit the application form, license fee, other applicable documents, and complete all actions as required by Texas Administrative Code Title 25 (25 TAC) Section 117.12, Application and Issuance of Initial License. Information regarding licensure for end stage renal disease facilities is located on the HHSC End Stage Renal Disease Facilities webpage.

For Health Care Regulation contact information, visit the Health Care Facilities Regulation Contact Us webpage.

Texas Health and Human Services Commission (HHSC) must approve all required application materials received before HHSC will issue a license to the applicant.

Initial Application

An applicant for an initial license must complete the following requirements.

  • Submit the following to HHSC:
    • A completed Form 3204 no earlier than 90 calendar days before the projected opening date of the facility.
    • A license fee ranging from $3,500.00 and $6,700.00, based on the total number of stations. 
      • Make checks payable to the Texas Health and Human Services Commission. 
      • 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 indicating approval by the local fire authority in whose jurisdiction the facility is based that is dated no earlier than one year prior to the opening date. 
    • A complete chemical analysis of the product water and reports to verify that bacteriological and endotoxin levels of product water and dialysate comply with 25 TAC Section 117.32, Water Treatment, Dialysate Concentrates and Reuse.
    • For Medicare certified facilities: A completed Life Safety Code Attestation.
  • Obtain approval for occupancy from the Architectural Review Unit.
  • Attend a pre-licensure conference (previously called pre-survey conference) conducted by the Health Facility Compliance unit. HFC holds pre-licensure conferences once a month and requires the administrator or a licensed professional who is listed on the application to attend. For more information or to schedule the pre-licensure conference, contact the designated Regional Office.

Relocation

A currently licensed facility applying for relocation must complete the following requirements.

  • Submit the following to HHSC:
    • A completed Form 3204 submitted 90 days before relocation of the facility.
    • A license fee ranging from $3,500.00 to $6,700.00, based on the total number of stations. 
      • Make checks payable to the Texas Health and Human Services Commission.
      • 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 indicating approval by the local fire authority in whose jurisdiction the facility is based that is dated no earlier than one year prior to the opening date. 
    • A complete chemical analysis of the product water and reports to verify that bacteriological and endotoxin levels of product water and dialysate comply with 25 TAC Section 117.32 Water Treatment, Dialysate Concentrates and Reuse. 
    • For Medicare certified facilities: A completed Life Safety Code Attestation.
  • Obtain approval for occupancy from the Architectural Review Unit.

Change of Ownership (CHOW) Application

A currently licensed facility applying for a CHOW must complete the following requirements.

  • Submit the following to HHSC:
    • A completed Form 3204 submitted at least 60 calendar days before the date of the change of ownership.
    • A license fee ranging from $3,500.00 to $6,700.00, based on the total number of stations. 
      • Make checks payable to the Texas Health and Human Services Commission. 
      • 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 the following completed Fire Safety Survey Reports indicating approval by the local fire authority in whose jurisdiction the facility is based: 
      • A fire inspection report conducted within the last 12 months and a second report conducted within the year prior.  
    • A complete chemical analysis of the product water and reports to verify that bacteriological and endotoxin levels of product water and dialysate comply with 25 TAC Section 117.32 Water Treatment, Dialysate Concentrates and Reuse. 
    • For Medicare certified facilities: A completed Life Safety Code Attestation or agree to a Life Safety Code survey at a later date.
    • A bill of sale or other legal document that shows both parties’ agreement to the sale.  
  • Attend a pre-licensure conference (previously called pre-survey conference) conducted by the Health Facility Compliance unit. HFC holds pre-licensure conferences once a month and requires the administrator or a licensed professional who is listed on the application to attend. For more information or to schedule the pre-licensure conference, contact the designated Regional Office.
     

Important Items to Note

  • The Doing Business As (DBA) or assumed name of the facility is the name that will appear on the license and should match advertisements and signage of the facility.
  • The legal name and Employer Identification number (EIN) on the application should be an exact match with the IRS letter, Secretary of State documentation and ownership structure.
  • The organizational chart showing ownership structure should reflect all levels of ownership and include EIN numbers. The chart should start with the DBA or assumed name, continue with the legal name and end with any additional ownership levels. Below is an example of ownership structure:
    • Higher Level of Ownership and EIN
    • Legal Name and EIN Number
    • DBA or Assumed Name

Additional Information

Medicare certification information may be obtained from the Health Facility Compliance Regional Office. 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 an HHSC responsibility.

Visit the HHSC Clinical Laboratory Improvement Amendment (CLIA) webpage for information on CLIA.

Mailing Address for Applications with Fees

HHSC AR Mail Code 1470
P.O. Box 149055
Austin, TX 78714-9055

Overnight Address for Applications with Fees

HHSC AR Mail Code 1470
4601 W. Guadalupe Street
Austin, TX 78751