Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
Does Indiana require a state lab license on top of CLIA?
The Indiana Department of Health states that it does not license laboratories or laboratory personnel. Labs need only the federal CLIA certificate, plus compliance with Indiana's communicable disease and universal precautions rules.
- Does not reach waived-only labs
What does Indiana charge?
No state laboratory fee; the lab pays only the CMS certificate fee.
Do labs in other states need a Indiana license to test its specimens?
No state laboratory license was found, so a lab in another state needs nothing from this state to test its specimens beyond its own CLIA certificate.
Where does a Indiana CMS-116 go?
- Indiana Department of Health, Division of Acute Care Services
- Email: IndianaCLIA@health.IN.gov
- Phone: (317) 233-7502
Opening a testing site in Indiana?
We prepare the CMS-116 and any Indiana 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.