Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Texas
- Texas sends the CMS-116 to one of five regional CLIA offices; the Austin region also covers West Texas.
- Do not send CLIA fees to Texas Health and Human Services; pay CMS from the emailed fee coupon.
Does Texas require a state lab license on top of CLIA?
Texas labs are not state licensed. Texas Health and Human Services certifies labs for CMS under CLIA and processes applications using its own supplement to the CMS-116.
- Does not reach waived-only labs
Does Texas add a form to the CMS-116?
Form 3225, Application for Certification: Supplement to CMS 116, a disclosure of ownership sent with the CMS-116 to the right regional CLIA office. Texas will not process the application until the regional office has the completed form.
Where does a Texas CMS-116 go?
- Texas Health and Human Services, Health Facility Compliance, CLIA (five regional offices: Arlington, San Antonio, Houston, Tyler, Austin)
- Email: CLIA.Austin@hhs.texas.gov
- Phone: (512) 438-5952
Opening a testing site in Texas?
We prepare the CMS-116 and any Texas filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.
Sources
- stateAgency (CMS list updated May 2026)
- stateLicense ("Laboratories are not state licensed"), supplement (Form 3225), notes (regional offices process initial applications)
- notes (do not send CLIA fees to HHSC; Wayback copy of February 2023)
- supplement (Form 3225 purpose, disclosure of ownership, processing rule; form updated 4/2021)