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 

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..)
• CDC booklet 'Ready? Set? TEST!' describes recommended practices for laboratories performing waived tests

• Personnel 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
• Foreign academic credential evaluation may be performed by any nationally recognized organization (493.2(d). Such organizations may include:
• National Association Credential Evaluation Service, Inc.
• Association of International Credential Evaluators
  

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