West Virginia CLIA and State Lab Requirements

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

What testing sites miss in West Virginia

West Virginia HIV-certified sites, waived ones included, must run proficiency testing twice a year (waived sites may use blind samples), two levels of quality control each testing day or an IQCP, and keep a written post-exposure plan.
West Virginia licenses lab personnel, but anyone performing only CLIA-waived tests is exempt; from July 1, 2026, licensed pharmacists running waived COVID-19, flu and RSV tests are also exempt.

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

West Virginia law lets the health department license clinical labs, but the Office of Laboratory Services lists no general lab license among its programs: only CLIA, personnel licensure, HIV/AIDS-related testing certification and prenatal syphilis testing certification. A site running rapid HIV tests, even waived ones, needs the HIV certification.

Does not reach waived-only labs

Citation: W. Va. Code 16-5J-4 (licensure authority)

What does West Virginia charge?

HIV/AIDS-related testing certification: $30 a year for in-state labs, $40 for out-of-state labs, valid January 1 to December 31 (as of October 2026).

Do labs in other states need a West Virginia license to test its specimens?

Out-of-state labs performing HIV or AIDS-related tests on West Virginia residents need the state HIV/AIDS-related testing certification too. No general out-of-state lab license was found.

Where does a West Virginia CMS-116 go?

West Virginia Department of Health, Bureau for Public Health, Office of Laboratory Services
Email: DHOLSCLIA@wv.gov
Phone: (304) 205-8913

Opening a testing site in West Virginia?

We prepare the CMS-116 and any West 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.