State filing guide
CLIA waiver application and requirements in Texas.
Ask about my application — no payment todayTexas retains CMS-116 plus Texas HHS Form 3225 through the county-specific HHSC CLIA regional office; no separate state laboratory license.
Sources checked 2026-10-31 · next source check due 2026-11-30
Additional application documents
These findings describe the linked sources. They do not establish that your facility qualifies for an exemption or that its application is ready. Facility type, ownership, personnel, locations and exact test systems can change the requirements.
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The federal CMS-116 steps, what Texas's official sources say, what to confirm for your facility, and the official links, in one email you can keep. Free.
What the official sources say
- HHSC and the current Form 3225 instructions require CMS-116 plus Form 3225 (April 2021-E ownership/control supplement) for an initial Certificate of Waiver. Laboratories are not separately state licensed; no separate laboratory-license fee is identified for this route.
- HHSC CLIA contact: MSC 1979 – CLIA, Health Facility Compliance – CLIA, P.O. Box 149030, Austin TX 78714-9030; CLIA@hhs.texas.gov; phone 512-438-5952; fax 512-438-5973 (Attn: CLIA). The correct regional office processes the initial packet; confirm county, channel, destination and signature format before sending.
- Regional emails are CLIA.Austin@hhs.texas.gov (1/7/9/10), CLIA.Arlington@hhs.texas.gov (2/3), CLIA.Tyler@hhs.texas.gov (4/5), CLIA.Houston@hhs.texas.gov (6), CLIA.SanAntonio@hhs.texas.gov (8/11). HHSC gives San Antonio phone 210-415-7652; CMS September 2026 gives 210-531-7397. The July HHSC general contact sheet lists a different Austin P.O. Box 149347; resolve before dispatch.
- Texas links the currently downloaded CMS-116 (03/24). A separate CMS guide labeled November 2026 illustrates 04/2026; Eric must confirm the accepted edition before signing. Form 3225 is dynamic XFA and needs a compatible viewer. No additional waived-route state form or director-qualification attachment was identified in the reviewed instructions. Rechecked 2026-11-09: the direct CMS download now serves Form CMS-116 (04/2026), OMB 0938-0581, expiration 04/30/2029, matching the November 2026 guide; the edition discrepancy observed on October 31 is resolved.
- CMS requires electronic coupons/certificates and Pay.gov from March 1, 2026. HHSC still contains conflicting mailed-check instructions; those are not the current federal payment route.
Fees and timing
Federal Certificate of Waiver: $248 for two years, paid by the client through Pay.gov after CMS emails the fee notification and CLIA ID; no payment with the application and no paper check. Texas states that laboratories are not state licensed; no separate Texas laboratory-license fee is identified for this route. Government fees are separate from preparation-service fees. No fixed initial HHSC/CMS processing or approval interval was published in the reviewed sources.
Check my test menuWhat still needs confirmation for your facility
- 1Confirm the county-specific CLIA office and accepted initial-packet channel/signature format; reconcile San Antonio telephone and Austin postal-address conflicts before dispatch.
- 2Confirm the accepted CMS-116 edition given the 03/24 download versus 04/2026 guide illustration, and verify complete Form 3225 rendering/signatures in an XFA-capable viewer. Rechecked 2026-11-09: the direct CMS download now serves Form CMS-116 (04/2026), OMB 0938-0581, expiration 04/30/2029, matching the November 2026 guide; the edition discrepancy observed on October 31 is resolved.
Frequently asked questions
What filing route does the cited Texas guidance describe?
Texas retains CMS-116 plus Texas HHS Form 3225 through the county-specific HHSC CLIA regional office; no separate state laboratory license.
Which requirements are named in the cited Texas materials?
HHSC and the current Form 3225 instructions require CMS-116 plus Form 3225 (April 2021-E ownership/control supplement) for an initial Certificate of Waiver. Laboratories are not separately state licensed; no separate laboratory-license fee is identified for this route. HHSC CLIA contact: MSC 1979 – CLIA, Health Facility Compliance – CLIA, P.O. Box 149030, Austin TX 78714-9030; CLIA@hhs.texas.gov; phone 512-438-5952; fax 512-438-5973 (Attn: CLIA). The correct regional office processes the initial packet; confirm county, channel, destination and signature format before sending. Regional emails are CLIA.Austin@hhs.texas.gov (1/7/9/10), CLIA.Arlington@hhs.texas.gov (2/3), CLIA.Tyler@hhs.texas.gov (4/5), CLIA.Houston@hhs.texas.gov (6), CLIA.SanAntonio@hhs.texas.gov (8/11). HHSC gives San Antonio phone 210-415-7652; CMS September 2026 gives 210-531-7397. The July HHSC general contact sheet lists a different Austin P.O. Box 149347; resolve before dispatch. Texas links the currently downloaded CMS-116 (03/24). A separate CMS guide labeled November 2026 illustrates 04/2026; Eric must confirm the accepted edition before signing. Form 3225 is dynamic XFA and needs a compatible viewer. No additional waived-route state form or director-qualification attachment was identified in the reviewed instructions. Rechecked 2026-11-09: the direct CMS download now serves Form CMS-116 (04/2026), OMB 0938-0581, expiration 04/30/2029, matching the November 2026 guide; the edition discrepancy observed on October 31 is resolved. CMS requires electronic coupons/certificates and Pay.gov from March 1, 2026. HHSC still contains conflicting mailed-check instructions; those are not the current federal payment route.
What do the sources establish about fees and timing in Texas?
Federal Certificate of Waiver: $248 for two years, paid by the client through Pay.gov after CMS emails the fee notification and CLIA ID; no payment with the application and no paper check. Texas states that laboratories are not state licensed; no separate Texas laboratory-license fee is identified for this route. Government fees are separate from preparation-service fees. No fixed initial HHSC/CMS processing or approval interval was published in the reviewed sources.
Does this page confirm CLIA approval or legal compliance in Texas?
No. This is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device. Verify every requirement with CMS, the FDA, and your state agency before testing.
Other jurisdictions
Each jurisdiction publishes its own terminology, forms, channel, signatures, and fees.
All 52jurisdictions →Official sources behind this guide
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