Clinical Laboratory Regulation

Apply for CLIA Certification

• General information about CLIA Program and Medicare Lab Services
  
• Certificate of Compliance or Accreditation
• Certificate of Provider Performed Microscopy Procedures (PPMP)
• Certificate of Waiver

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, phone number or facility name may be reported on the Change Request Form.  Changes in Laboratory Director (for Certificate of PPM, Certificate of Compliance) as well as ownership and change in certificate type 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.

• CLIA Application for Certification - Form CMS-116 (pdf)
  
• Change Request form for Oregon CLIA
  

Laboratories with a CLIA  Certificate of Compliance or Certificate of Accreditation that perform high complexity testing are required to notify us of a change or addition of a Technical Supervisor for high complexity testing within 30 days.  The qualifications of that person will be evaluated.  Please use the form below:

• High Complexity Technical Supervisor Appraisal form (pdf)
  

State of Oregon Licensure Programs

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

Laboratory News

• Post-Public Health Emergency Guidance for CLIA laboratories (QSO-23-15-CLIA)
  
• CLIA announces final rule that affects proficiency testing (QSO-22-21-CLIA)
  
• FDA Authorization for CUE COVID-19 Molecular OTC Test
  
• SD Biosensor recall announcement
  

Oregon's Clinical Laboratories

• Reportable Diseases and Conditions
• Who May Order Laboratory Tests (pdf)
• Laboratory Record Retention Requirements (pdf)

Federal Resources

• CMS CLIA website
  
• Current CLIA Regulations
  
• CDC's Laboratory Outreach Communication System (LOCS)
  
• Verify Complexity of test performed (FDA)
  
• Verify test product is waived (FDA)
  
• Food and Drug Administration's (FDA) Medical Device Recalls
  

Related OHA Programs

• Acute and Communicable Disease Prevention
  
• Oregon Health Plan (OHP)

Federal Websites

Please see Federal Resources heading, below.