Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Washington
- A waiver site must report changes in the tests it plans to perform 30 days in advance and may never run tests that need a full license.
- A license cannot be transferred or assigned without 30 days' prior notice to the Department and its approval.
Does Washington require a state lab license on top of CLIA?
Washington licenses medical test sites under its own law in place of federal CLIA certificates. Anyone operating a site that analyzes human specimens for health care, treatment or screening must hold a Medical Test Site license; a waived-only site gets the Certificate of Waiver license type.
- Washington runs its own program in place of CLIA
- Medical Test Site license (Certificate of Waiver, PPMP, or moderate/high complexity)
- Issued by Washington State Department of Health, Medical Test Site Program
- Reaches labs doing only waived tests
Citation: RCW 70.42; WAC 246-338-020
Who is exempt in Washington?
Not a medical test site: a person using an FDA home-use test on themselves without supervision and outside a commercial transaction, or a site testing only for forensic purposes.
Citation: WAC 246-338-010(25)
What does Washington charge?
Moderate and high complexity: $620 low volume up to $17,260 (Category J) per 2 years; accredited labs pay less. Initial licenses issued mid-cycle are prorated (as of October 2026).
- Waived: $260 per 2 years for a Certificate of Waiver license (as of October 2026)
- PPM: $300 per 2 years for a PPMP license (as of October 2026)
Citation: WAC 246-338-990
How often does a Washington lab registration renew?
- Renews every two years
- Due All licenses expire June 30 of odd-numbered years; submit the renewal application and fee at least 30 days before expiration.
Does Washington add a form to the CMS-116?
CMS asks Washington sites not to submit a CMS-116; the license comes from the Department of Health's Medical Test Site program.
Where does a Washington CMS-116 go?
- Washington State Department of Health, Medical Test Site Program
- Email: MTS@doh.wa.gov
- Phone: (360) 236-4661
Opening a testing site in Washington?
Washington runs its own program in place of CLIA for most labs, so its own registration or license comes first. We prepare the CMS-116 and any Washington 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.