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Washington Licensing Requirements

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State-Specific CLIA Applications

Chapter 70.42 RCW. Washington State Department of Health Division. Clinical Laboratories.

Each page includes everything you need, from links to state agencies and compliance sections to step-by-step instructions for accessing CLIA certificates. Whether you’re setting up a new lab, ensuring continued compliance, or simply staying informed, these resources are designed to simplify the process and save you time.

Our goal is to support you in running a successful lab, and this resource is a significant step forward in supporting your success.

a. RCW 70.42.050 Permission to perform tests not covered by license—License amendment.

A licensee that desires to perform tests for which it is not currently licensed shall notify the department. To the extent allowed by federal law and regulations, upon notification and pending the department’s determination, the department shall grant the licensee temporary permission to perform the additional tests. The department shall amend the license if it determines that the licensee meets all applicable requirements.

b. RCW 70.42.020 License required.

After July 1, 1990, 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, except as provided in RCW 70.42.030.

c. WA Laboratory “Rules” section of the code WA Laboratory “Rules”

Washington

Washington has a CMS-approved laboratory program and operates its own regulatory program. The state’s inspection process covers all CLIA conditions, and the state’s licensure requirements meet or exceed CLIA requirements.

Online Access to CLIA Certificates

CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool. All certificates generated after September 27, 2023 should be available for download. Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top). When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.