Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Arizona
- Health screening laboratory services in Arizona may be performed only by a CLIA-certified lab.
- Arizona rules require a clinical lab to test only on a licensed practitioner's order, and the practitioner list includes naturopathic and homeopathic physicians.
Does Arizona require a state lab license on top of CLIA?
Arizona's statute still says no one may run a clinical laboratory without a state license, but the licensing rules have expired and ADHS describes clinical labs as needing CLIA certification, which it administers. Whether ADHS issues any state license today was not confirmed.
- Issued by Arizona Department of Health Services
Citation: A.R.S. 36-461, 36-462, 36-463; A.A.C. R9-14-701
Who is exempt in Arizona?
The statute exempts federal labs and lets the ADHS director exempt classes of labs and tests by rule; the rules that once did so have expired. Home-use tests run by a patient, family member or paid caregiver fall outside the health screening rule.
Citation: A.R.S. 36-461; A.A.C. R9-14-701(C)
Where does a Arizona CMS-116 go?
- Arizona Department of Health Services, Office of Laboratory Licensing and Certification
- Email: CLIAAZ@AZDHS.GOV
- Phone: (602) 364-0720
Opening a testing site in Arizona?
We prepare the CMS-116 and any Arizona 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 State Agency list, updated May 2026)
- exemptions (A.R.S. 36-461)
- stateLicense.summary (license requirement in statute)
- stateLicense.citation (license terms in statute)
- stateLicense.summary (licensing articles expired), exemptions, notes (A.A.C. Title 9, Ch. 14)
- stateLicense.summary (labs must be CLIA certified)