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

CMS 116 Instructions for Completion (pdf)

See our Guidelines for Emergency Testing Authorization (pdf)

Oregon CLIA Certified Labs Testing COVID-19 (pdf)

CMS CLIA Guidance for SARS-CoV-2 Lab Testing (pdf)

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

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

CDC Guidance

CDC: Guidance for SARS-CoV-2 Point-of-Care Testing

Apply for CLIA Certification

Update Laboratory Information

Laboratories issued any type of CLIA certificate in Oregon must notify Laboratory Compliance within 30 days of any change in ownership, name, location or Laboratory Director. Notifications should always be made in writing, on the appropriate form. Changes such as address and phone number may be reported on the Change Request Form. Changes in certificate type and Laboratory Director must be reported on the CMS-116 form. For further information on how to report laboratory changes please contact us at LC.info@odhsoha.oregon.gov or call 503-693-4125. Please have your CLIA ID Number available.