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Wisconsin CLIA and State Lab Requirements

The state lab license or registration, exemptions, fees and where the CMS-116 goes, with citations.

Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states

Where does a Wisconsin CMS-116 go?

  • Wisconsin Department of Health Services, Division of Quality Assurance, Clinical Laboratory Section
  • Email: DHSDQACLIA@dhs.wisconsin.gov
  • Phone: (608) 261-0654

Opening a testing site in Wisconsin?

We prepare the CMS-116 and any Wisconsin 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

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