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Virginia 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

What testing sites miss in Virginia

Does Virginia require a state lab license on top of CLIA?

Virginia does not license laboratories or laboratory personnel and has no state regulations for labs; labs follow the federal CLIA rules.

  • Does not reach waived-only labs

Where does a Virginia CMS-116 go?

  • Virginia Department of Health, Office of Licensure and Certification, Division of Acute Care Services
  • Email: CLIAlab@vdh.virginia.gov
  • Phone: (804) 367-2107

Opening a testing site in Virginia?

We prepare the CMS-116 and any Virginia 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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