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Clinical Laboratory Regulation

The Oregon Laboratory Compliance Section contracts with the Centers for Medicare and Medicaid Services to carry out the Clinical Laboratory Improvement Amendments (CLIA) in Oregon. Clinical laboratory regulations ensure laboratories follow state and federal regulations for clinical laboratory testing performed on human specimens, as well as non-medical (employment) substance of abuse testing, and health screening or health fair testing.

Questions about out-of-state testing on Oregon specimens?

See our FAQ page

COVID-19 Updates

COVID-19 Testing for Oregon CLIA

See our Guidelines for Emergency Testing Authorization - April 9, 2020 (pdf)

Oregon CLIA Certified Labs Testing COVID-19 - July 1, 2020 (pdf)

CMS CLIA Guidance for SARS-CoV-2 Lab Testing - April 30, 2020 (pdf)

FDA Fact Sheet: Antibody Test Oversight & Use for COVID-19 - May 3, 2020 (pdf)

Provisional Guidance for Point-of-Care Antigen Testing in Long-term Care Facilities - September 21, 2020 (pdf)

Emergency Rulemaking Notice - Effective April 23, 2020

A temporary rule has been adopted to permit waived laboratories and pharmacies or pharmacy sponsored facilities that have a certificate of waiver to perform certain COVID-19 testing. In addition, it permits a pharmacist that is employed by or contracts with a pharmacy or a pharmacy sponsored facility with a waived laboratory license to perform COVID-19 tests as identified in the rule to screen patients for COVID-19 tests, order and administer COVID-19 tests for patients and report the results of COVID-19 tests. These temporary rules are effective April 23, 2020 through October 19, 2020 or until terminated when no longer needed due to current state of emergency.

Please see the Notice of Temporary Rule Filing for complete information.

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