Washington's Medical Test Site License

Washington is one of the two states CMS treats as exempt from federal CLIA. That does not mean Washington sites are unregulated. It means the state's own program does the job. Under RCW 70.42.020, "no person may advertise, operate, manage, own, conduct, open, or maintain a test site without first obtaining a license for the tests to be performed." The license is a Medical Test Site (MTS) license from the Washington State Department of Health, and it replaces the federal certificate for sites in Washington.

CMS's own State Agency list (updated May 2026) says it in one line under Washington: "Please do not submit a Form CMS-116 for WA MTS Licensure." The application goes to the Department of Health's Medical Test Site Program at MTS@doh.wa.gov, (360) 236-4661.

Which sites need a Medical Test Site license?

A "test site" under RCW 70.42.010 is "any facility or site, public or private, which analyzes materials derived from the human body for the purposes of health care, treatment, or screening." That reaches physician offices, urgent care centers, pharmacies, schools, employer clinics and home health agencies alike.

The statute carves out one case that matters for telehealth and home testing: a test site "does not mean a facility or site, including a residence, where a test approved for home use by the federal food and drug administration is used by an individual to test himself or herself without direct supervision or guidance by another and where this test is not part of a commercial transaction." A patient running their own home-use test is outside the law. A clinic running the same test on a patient is not. See home tests, self-testing and CLIA.

What are the license types?

WAC 246-338-020 sets three types, and they mirror the federal certificates closely:

• Certificate of Waiver. "Applicable if the medical test site performs only the tests classified as waived." Washington's statute calls this a waiver from licensure (RCW 70.42.030), granted "for two years" to sites performing only tests with "insignificant risk of an erroneous result."
• PPMP. For sites that limit testing to the listed provider-performed microscopy procedures, done by the licensed professionals the rule names, "in conjunction with a patient's visit," plus waived tests.
• Moderate/high complexity. Low volume or Categories A through J by annual test count, or the accredited version of each for sites inspected by an accreditation organization the department approves.

For a Certificate of Waiver site, the rule's requirements table is short: restrict testing to waived tests, meet the licensing, renewal and notification rules, and "Follow manufacturers' instructions for performing the test." Inspections happen on complaint, "When indicated."

How much does it cost?

WAC 246-338-990, effective April 1, 2023, sets biennial fees. As of October 2026:

• Certificate of Waiver: $260 every two years
• PPMP: $300 every two years
• Low volume (1 to 2,000 tests a year): $620
• Categories A through J: from $1,900 up to $17,260 for more than 1,000,000 tests a year

Accredited sites pay a lower schedule starting at $230. The department charges "prorated fees for the remainder of the two-year cycle" when a site is first licensed partway through a biennium, so a new site's first bill is usually less than the full amount. These are state fees, paid by the site to the Department of Health.

When do Washington licenses renew?

All at once. WAC 246-338-024: "A license is issued for a period of two years. License expiration dates are based on a two-year cycle, expiring on June 30th of odd-numbered years." The owner submits a renewal application and fee "At least thirty days prior to the expiration date." The next statewide expiration is June 30, 2027.

That shared date is different from federal CLIA, where each certificate runs two years from its own effective date. A national group with sites in Washington and other states ends up with two kinds of calendars: rolling CMS coupons for most sites and one June deadline for every Washington site. Our renewal guide covers the federal side.

What changes need notice?

• Adding tests. A waiver site "shall report to the department any changes in the type of tests it intends to perform thirty days in advance of the changes," and "In no case shall a test site with a waiver perform tests which require a license under this chapter" (RCW 70.42.030(4)).
• Changing license type. If a change means the site now needs a different type of license, "the owner must submit a reapplication form, within thirty days of the change, and pay applicable fees" (WAC 246-338-024(7)).
• Selling the site. A license "shall not be transferred or assigned without thirty days' prior notice to the department and the department's timely approval" (RCW 70.42.110). Build that into a purchase timeline.

Washington also has a site supervisor rule in statute: a test site "shall have a designated test site supervisor who shall meet the qualifications determined by the department in rule" (RCW 70.42.080). Check the current rule for the license type you hold before naming that person.

Does a Washington license work in other states?

No. It is a state license for a Washington site. A group opening sites in Oregon or Idaho applies for federal CLIA certificates there, through each state's CLIA State Agency. And a lab outside Washington testing specimens from Washington residents should check Washington's rules and its own state's, since out-of-state requirements vary; see testing specimens from other states.

Where does our service fit?

We prepare the MTS application for a waiver or PPMP site, build the test list from each kit's instructions, and track the June 30 cycle and the 30-day notices. The owner signs and submits; the state fee is paid by the site to the Department of Health. Our State Lab Registration service is $299 per state, and Additional Site Tracking is $99 per site per year for groups. The Washington requirements page has the program contacts.