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

The CMS-116 application must be used for initial applications, certificate type changes, reinstatement of a CLIA certificate, when adding a new multiple site exception as well as Laboratory Director change on a Certificate of Provider Performed Microscopy or Certificate of Compliance.  Changes such as address, phone number or facility name may be reported on the Change Request Form.  Please note that the Change Request for Oregon CLIA form, linked below, has been updated as of 04/03/2025 to include detailed instructions.  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
  

A laboratory with a CLIA Certificate of Compliance that performs 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

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.