CLIA waiver state checklist
CLIA Certificate of Waiver requirements in Washington for med spas and clinics.
Washington is CLIA-exempt: use the Medical Test Site Certificate of Waiver pathway instead of filing a separate federal CMS-116.
Last regulatory review 2026-07-24
This page is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device.
State-specific requirements checklist
- Certificate of Waiver Medical Test Site application packet through Washington DOH.
- Applications received July 1, 2026 through June 30, 2027 pay the current prorated fee of $130, half of the $260 biennial fee.
- Washington MTS applicants do not separately apply to CMS or pay a federal CLIA fee; the MTS license includes the CLIA number.
- Specific tests must be listed on the state application.
Fee and timing note
Washington DOH charges $130 for Certificate of Waiver MTS applications received July 1, 2026 through June 30, 2027, the second year of the biennium; the full biennial fee is $260. Because Washington is CLIA-exempt, there is no separate CMS-116, federal e-coupon, Pay.gov fee, or federal e-certificate.
Check my test menuPrep steps
- 1Use the MTS application packet as the front-door process.
- 2List each planned waived test system, not just broad analyte categories.
- 3Submit the signed state application with the $130 fee for applications received July 1, 2026 through June 30, 2027.
- 4Keep manufacturer instructions and quality-control logs ready for site operations.
Frequently asked questions
Does Washington require more than the federal CLIA Certificate of Waiver?
Washington is CLIA-exempt: use the Medical Test Site Certificate of Waiver pathway instead of filing a separate federal CMS-116.
What extra steps does Washington add for waived point-of-care testing?
Certificate of Waiver Medical Test Site application packet through Washington DOH. Applications received July 1, 2026 through June 30, 2027 pay the current prorated fee of $130, half of the $260 biennial fee. Washington MTS applicants do not separately apply to CMS or pay a federal CLIA fee; the MTS license includes the CLIA number. Specific tests must be listed on the state application.
How much does a CLIA waiver cost in Washington and how long does it take?
Washington DOH charges $130 for Certificate of Waiver MTS applications received July 1, 2026 through June 30, 2027, the second year of the biennium; the full biennial fee is $260. Because Washington is CLIA-exempt, there is no separate CMS-116, federal e-coupon, Pay.gov fee, or federal e-certificate.
Does this page confirm CLIA approval or legal compliance in Washington?
No. This is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device. Verify every requirement with CMS, the FDA, and your state agency before testing.