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.
 

Apply for CLIA Certification

• Certificate of Compliance or Accreditation
• Certificate of Provider Performed Microscopy Procedures (PPMP)
• Certificate of Waiver  

Update Laboratory Information

• Laboratory Change Request Form for CLIA Laboratories (pdf)

State of Oregon Licensure Programs

• SOA Registration - Non-medical Testing for Substances of Abuse
• Health Screen Testing Permit - Health Fair Testing

Laboratory News

• Cadmium in urine is now reportable. The Oregon Health Authority, Public Health Division is temporarily amending OAR 333-018-0015 pertaining to disease reporting. See the Memo sent to Oregon laboratories. The amendment adds to the list of reportable diseases "cadmium demonstrated by laboratory testing of urine." The rulemaking is effective February 18, 2016 - August 16, 2016. Learn more..
• Individual Quality Control Plan (IQCP) Read about IQCP
• You can now pay your CLIA Fees online using your credit card
  
• CMS Booklet: Provider-Performed Microscopy Procedures A Focus on Quality Practices
• CMS Brochure: "What Do I Need to Do to Assess Personnel Competency?" (pdf)

Oregon's Clinical Laboratories

• Reportable Diseases and Conditions
• Who May Order Laboratory Tests (pdf)
• Laboratory Record Retention Requirements (pdf) 
• Oregon Health Plan (OHP) link

Federal websites

• CMS CLIA Website
• Verify complexity of test performed/FDA
• Verify test product is Waived/FDA
• Current CLIA Regulations

In the News

• CMS Letter: 'Multiple Site' clarification
• News items