State filing guide
CLIA waiver application and requirements in Washington.
Ask about my application — no payment todayWashington is CLIA-exempt: apply for a state Medical Test Site (MTS) waived license, not a separate federal CMS-116 certificate.
Sources checked 2026-10-31 · next source check due 2026-11-30
State authorization required
These findings describe the linked sources. They do not establish that your facility qualifies for an exemption or that its application is ready. Facility type, ownership, personnel, locations and exact test systems can change the requirements.
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What the official sources say
- CMS expressly says not to submit Form CMS-116 for Washington MTS licensure. The state MTS license includes the CLIA number; there is no separate CMS fee coupon or certificate.
- The current DOH licensing page links the July 2026 combined MTS packet (DOH 505-192/193/194/195). Select New License and Waived and list every test system and manufacturer.
- The packet asks for the UBI, legal owner and FEIN, site, director and contact information, a director professional-license copy if held, and the owner or authorized representative signature. Non-waived director qualifications are a separate section.
- The paper packet directs the application and check or money order to Department of Health, P.O. Box 1099, Olympia, WA 98507-1099. MTS@doh.wa.gov and 360-236-4661 are program contacts; the CMS directory program address is not the initial payment destination.
- DOH now lists Medical Test Sites for HELMS online applications and payments. The older MTS FAQ still says online applications and credit cards are unavailable; confirm the chosen channel before filing.
Fees and timing
The current packet lists $130 for applications submitted July 1, 2026 through June 30, 2027; the full biennial fee is $260 under WAC 246-338-990. Current-cycle licenses expire June 30, 2027. The paper route uses a check or money order payable to Department of Health. Do not add the $248 federal waiver fee or federal Pay.gov workflow. No initial-issuance turnaround was found in the reviewed packet or MTS pages.
Check my test menuWhat still needs confirmation for your facility
- 1Confirm the new-license, one-fixed-site, waived-only category, exact systems and own-patient model. Outside referrals require review of independent-laboratory site designation.
- 2Confirm the director and testing-personnel requirements for the actual practice and retain the professional-license copy requested by the current packet if the director holds one.
- 3Confirm postal versus HELMS handling, current fee period and any accepted fax or email filing option. No Washington program fax or initial-issuance turnaround was published in the reviewed sources.
Frequently asked questions
What filing route does the cited Washington guidance describe?
Washington is CLIA-exempt: apply for a state Medical Test Site (MTS) waived license, not a separate federal CMS-116 certificate.
Which requirements are named in the cited Washington materials?
CMS expressly says not to submit Form CMS-116 for Washington MTS licensure. The state MTS license includes the CLIA number; there is no separate CMS fee coupon or certificate. The current DOH licensing page links the July 2026 combined MTS packet (DOH 505-192/193/194/195). Select New License and Waived and list every test system and manufacturer. The packet asks for the UBI, legal owner and FEIN, site, director and contact information, a director professional-license copy if held, and the owner or authorized representative signature. Non-waived director qualifications are a separate section. The paper packet directs the application and check or money order to Department of Health, P.O. Box 1099, Olympia, WA 98507-1099. MTS@doh.wa.gov and 360-236-4661 are program contacts; the CMS directory program address is not the initial payment destination. DOH now lists Medical Test Sites for HELMS online applications and payments. The older MTS FAQ still says online applications and credit cards are unavailable; confirm the chosen channel before filing.
What do the sources establish about fees and timing in Washington?
The current packet lists $130 for applications submitted July 1, 2026 through June 30, 2027; the full biennial fee is $260 under WAC 246-338-990. Current-cycle licenses expire June 30, 2027. The paper route uses a check or money order payable to Department of Health. Do not add the $248 federal waiver fee or federal Pay.gov workflow. No initial-issuance turnaround was found in the reviewed packet or MTS pages.
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.
Other jurisdictions
Each jurisdiction publishes its own terminology, forms, channel, signatures, and fees.
All 52jurisdictions →Official sources behind this guide
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