Certificate of Compliance and Certificate of Accreditation

The Certificate of Compliance and Certificate of Accreditation authorizes a high complexity laboratory to perform all levels of testing. A moderate complexity lab may perform all levels of testing up to and including moderate level tests. In addition, the Certificate of Compliance or Certificate of Accreditation authorizes a laboratory to perform only specific specialties and subspecialties for which the laboratory has been certified to perform. Complexity levels may be obtained from the manufacturer of laboratory reagents/kits or equipment.

To apply for a Certificate of Compliance or Certificate of Accreditation 

• Labs NOT located in Oregon: Link here to find your State Agency address
• CLIA Fees
  • Information regarding fees and submission of application
  • Table of CLIA Certificate fees Accredited and Non-Accredited CLIA Laboratory fees
• Applying for CLIA certification
  • CLIA application form (HCFA-116) (includes instructions and how to count test volume)
• Personnel 
  • Director Qualification Appraisal form (To qualify Director - submit completed form with application) 
  • Personnel requirements
• Proficiency Testing (PT) information
  • Proficiency Testing requirements
• Oregon Laboratory Reporting Requirements
  • Poster of Reportable Conditions
  • Reporting Log, County Phone & Fax information for reporting, more..
• CLIA Surveys
  • Preparing for Initial Laboratory Survey
  • How to Write a Procedure
  • How to Write a Plan of Correction (POC) 
• List of Accrediting Agency contacts
  • Accrediting Agencies

Rules and regulations

• Oregon Administrative Rule (OAR) for Oregon clinical laboratories
• Oregon Revised Statute (ORS) for Oregon clinical laboratories
• Synopsis of the OAR for clinical laboratories
• OAR for Accredited Laboratories 
• 42 CFR Part 493 - Federal CLIA regulations
• Oregon laboratory - requirements (Includes Who may Order Tests, Record Retention requirements, more..)

• Personnel requirements (pdf)
• All director requirements (pdf)
• Delegation of director responsibilities (pdf)
• Director Qualification Appraisal form 
• High Complexity Testing: Laboratory Director Qualifications 
• CME Courses for Laboratory Directors of Moderate Complexity Laboratories
  • University of Iowa
  • University of Wisconsin and COLA - Lab University
    

Free software to view, navigate and print Portable Document files (PDFs) can be downloaded from Adobe (go get Acrobat Reader)