Clinical Laboratory Improvement Amendments (CLIA) Certification
Last updated 03/09/2026
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Fees
| License Fee |
Description |
Exemptions |
| $0.00 |
|
None
|
Description
The Regulatory Section at Oregon State Public Health Laboratory is the CLIA State Agency for Oregon. The Clinical Laboratory Improvement Amendments (CLIA) are federal regulation. All service for CLIA Certification holders in Oregon or those seeking CLIA certification in Oregon should contact the Regulatory Section. Certification is of clinical laboratories testing for biological, microbiological, serological, chemical, immunological, hematological, biophysical, cytological, pathological, or other examinations of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease, or for the assessment of health of human beings. Requires ongoing successful participation in proficiency testing for regulated analytes.
Duration
2 Years
Renewal Information
Renewal every two years. Renewal process depends on type of CLIA certificate held. Certificate of Compliance and Certificate of Accreditation require onsite inspections for renewal every two years. Certificate of Waiver and Certificate of Provider-Performed Microscopy (PPMP) certificates do not require a new application for standard renewal.
Duplicate License Requirements
None
Prerequisites and Requirements
Prerequisites
Qualification based on education and experience exist for defined technical positions, including Laboratory Director, Technical Supervisor, Testing Personnel, etc., in accordance 42 CFR 493, Subpart M.
Required Documentation
Completed and signed CMS-116 application (always), necessary supporting documentation (dependent on certificate type), including Laboratory Director qualification packet.
Examination Information
None
Continuing Education Requirements
None
Bonding Requirements
None
Insurance Requirements
None
Other Information
Laboratories in Oregon are not required to have an Oregon Clinical Laboratory License in addition to a valid CLIA certificate. Send application and supporting documents to the CLIA State Agency. Do not send payment with application. Billing of fees will occur after processing the application.
Statutes, Administrative Rules, Ordinances
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