State filing guide
CLIA waiver application and requirements in Arizona.
Ask about my application — no payment todayArizona keeps the initial CMS-116 route through ADHS OLLC; official FAQ accepts email or fax.
Sources checked 2026-10-31 · next source check due 2026-11-30
Federal application procedure
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.
Get the Arizona CLIA waiver checklist by email
The federal CMS-116 steps, what Arizona'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
- The ADHS notification matrix still requires CMS-116 for an initial application; CMS and the ADHS mirror both serve revision 04/2026; CMS source rechecked 2026-11-09 (OMB expiration April 30, 2029).
- ADHS accepts initial applications at cliaaz@azdhs.gov or fax 602-364-0759. The September 2026 CMS directory lists 250 N. 17th Avenue, Phoenix, AZ 85007 and phone 602-364-0720; the ADHS contact tab leaves its phone field empty.
- ADHS FAQ states Arizona has no state laboratory licensure and clinical laboratories require CLIA certification. No separate routine state surcharge was published in the consulted program/forms/FAQ; do not infer all other facility/professional obligations are absent.
- The forms page/FAQ describe the ownership disclosure and Facility Status Changes for existing-certificate changes. The ownership PDF says all CLIA laboratories must complete Parts I-VII(b), but also says upon request/return original: initial applicability requires Eric review.
- ADHS publishes a minimum of four weeks to process an application, not a guaranteed certificate date. Its legacy mailed-certificate and linked check/COVID quick-start text conflicts with current federal instructions.
- CMS requires Pay.gov, electronic coupons/certificates from March 1, 2026 and receipt of the certificate before testing. Keep one monitored business email and no payment with CMS-116.
Fees and timing
Federal Certificate of Waiver: $248 per two-year certificate (effective January 27, 2024), paid through Pay.gov after the emailed CMS invoice; no payment with CMS-116 and no paper checks. ADHS states no state laboratory licensure; no separate routine state surcharge was identified, which is not a $0 fee determination. Published Arizona processing minimum: four weeks, not a promised certificate date. Government fees remain separate from preparation-service fees.
Check my test menuWhat still needs confirmation for your facility
- 1Confirm one fixed own-patient site and exact waived systems; route outside referrals, existing-certificate changes and mobile/multisite exceptions separately.
- 2CHANGE — needs Eric: does ADHS require Form -1513 with this initial physician-office waiver, despite the forms/FAQ describing ownership changes? If requested, is an original required or is a signed email/fax copy sufficient?
- 3Confirm the accepted electronic-signature/attachment format for the client-signed initial CMS-116 and any additional case-specific state surcharge; do not replace the confirmed human route.
- 4Does the published minimum four-week processing estimate still describe current intake? Resolve legacy mailed-certificate/check/COVID text using current CMS instructions; promise no approval deadline.
Frequently asked questions
What filing route does the cited Arizona guidance describe?
Arizona keeps the initial CMS-116 route through ADHS OLLC; official FAQ accepts email or fax.
Which requirements are named in the cited Arizona materials?
The ADHS notification matrix still requires CMS-116 for an initial application; CMS and the ADHS mirror both serve revision 04/2026; CMS source rechecked 2026-11-09 (OMB expiration April 30, 2029). ADHS accepts initial applications at cliaaz@azdhs.gov or fax 602-364-0759. The September 2026 CMS directory lists 250 N. 17th Avenue, Phoenix, AZ 85007 and phone 602-364-0720; the ADHS contact tab leaves its phone field empty. ADHS FAQ states Arizona has no state laboratory licensure and clinical laboratories require CLIA certification. No separate routine state surcharge was published in the consulted program/forms/FAQ; do not infer all other facility/professional obligations are absent. The forms page/FAQ describe the ownership disclosure and Facility Status Changes for existing-certificate changes. The ownership PDF says all CLIA laboratories must complete Parts I-VII(b), but also says upon request/return original: initial applicability requires Eric review. ADHS publishes a minimum of four weeks to process an application, not a guaranteed certificate date. Its legacy mailed-certificate and linked check/COVID quick-start text conflicts with current federal instructions. CMS requires Pay.gov, electronic coupons/certificates from March 1, 2026 and receipt of the certificate before testing. Keep one monitored business email and no payment with CMS-116.
What do the sources establish about fees and timing in Arizona?
Federal Certificate of Waiver: $248 per two-year certificate (effective January 27, 2024), paid through Pay.gov after the emailed CMS invoice; no payment with CMS-116 and no paper checks. ADHS states no state laboratory licensure; no separate routine state surcharge was identified, which is not a $0 fee determination. Published Arizona processing minimum: four weeks, not a promised certificate date. Government fees remain separate from preparation-service fees.
Does this page confirm CLIA approval or legal compliance in Arizona?
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
Need help with your Arizona CLIA route?
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From test research to your Arizona application
An analyte label does not confirm a device. The exact test system and the clinic’s state route need separate review before a filing scope or price can be confirmed.