Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in North Dakota
- North Dakota labs may refer specimens only to CLIA-certified labs.
Does North Dakota require a state lab license on top of CLIA?
North Dakota does not license laboratories or laboratory directors and follows the federal CLIA rules. It does license clinical laboratory personnel through the State Board of Clinical Laboratory Practice.
- Does not reach waived-only labs
Do labs in other states need a North Dakota license to test its specimens?
An out-of-state reference lab needs only the appropriate CLIA certificate to test North Dakota specimens. Sites that only collect specimens need no North Dakota license or certification.
Where does a North Dakota CMS-116 go?
- North Dakota Department of Health and Human Services, Health Facilities Unit
- Email: CLIAlab@nd.gov
- Phone: (701) 328-2352
Opening a testing site in North Dakota?
We prepare the CMS-116 and any North Dakota 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.