Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Michigan
- A lab with a CLIA certificate from another state may run mobile testing in Michigan only if that certificate carries a multiple site exception.
- Michigan asks for a copy of the director's actual license, not a screenshot of LARA's license lookup page.
Does Michigan require a state lab license on top of CLIA?
LARA's Laboratory Improvement Section runs Michigan's CLIA program for about 10,000 labs under the federal rules in 42 CFR 493. Its pages describe only CLIA certification and say no license or approval is needed for an out-of-state lab to process Michigan specimens.
- Does not reach waived-only labs
What does Michigan charge?
No state laboratory fee; the lab pays only the CMS certificate fee.
Do labs in other states need a Michigan license to test its specimens?
No license or approval is needed to accept, collect or process specimens from Michigan residents in an out-of-state lab; the receiving lab must hold a CLIA certificate.
Does Michigan add a form to the CMS-116?
Michigan publishes its own CLIA Lab Test Menu Form listing every test the lab performs; PPM, Compliance and Accreditation applicants also send a copy of the director's Michigan license.
Where does a Michigan CMS-116 go?
- Michigan Department of Licensing and Regulatory Affairs, Laboratory Improvement Section
- Email: LARA-BSC-CLIA@michigan.gov
- Phone: (517) 241-2648
Opening a testing site in Michigan?
We prepare the CMS-116 and any Michigan 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.