CLIA Certificate of Compliance or Accreditation

Application Information and Resources: CLIA

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.

Please don’t send hard copy following a fax or email of a lab form! Double forms can cause duplication and extra work. You can verify receipt of your forms by calling 503-693-4125 or by e-mailing LC.info@odhsoha.oregon.gov.

To Apply for a Certificate of Compliance or Certificate of Accreditation

• Labs NOT located in Oregon: Find your state agency and mail forms to them (pdf)

CLIA Fees and Application

• CLIA CMS-116 application form (pdf)
  
• Information regarding submission of application (pdf)
• Table of CLIA Certificate fees (pdf) - Accredited and non-accredited CLIA laboratory fees
• Pay your CLIA Fees online
• Pay CLIA Fees by mail (pdf)

Personnel

• Director Qualification Appraisal form (pdf) - To qualify Director, submit completed form with application
• Personnel Qualification Requirements (pdf)
• CMS Brochure: "What Do I Need to Do to Assess Personnel Competency?" (pdf)
• Personnel Competency Review form (pdf)
• Personnel Qualification Requirements - from another view (pdf)
• Certification Boards for Laboratory Directors of High Complexity Testing
• Delegation of director responsibilities (pdf)
  
• High Complexity Testing: Laboratory Director Qualifications (pdf)
  
• High Complexity Technical Supervisor Appraisal form (pdf)
  

CMS and Implementation of IQCP

• IQCP - Individual Quality Control Plan

CME Courses for Laboratory Directors of Moderate Complexity Laboratories

• University of Iowa
• 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

Proficiency Testing (PT) information

• Proficiency Testing requirements

Oregon Laboratory Reporting Requirements

• Communicable Disease Resources: For Providers and Laboratories

CLIA Surveys

• Preparing for Initial Laboratory Survey (pdf)
• How to Write a Procedure (pdf)
• Evidence of Correction (pdf)
• CLIA Form 209 - Laboratory Personnel Report (pdf) 

Rules and Regulations

• Oregon Administrative Rule (OAR) for Oregon clinical laboratories (Chapter 333-024)
• Oregon Revised Statute (ORS) for Oregon clinical laboratories
• Synopsis of the OAR for clinical laboratories (pdf)
• 42 CFR Part 493 - Federal CLIA regulations
• Oregon Laboratory Requirements - Includes who may order tests, record retention requirements, and more
• CDC booklet "Ready? Set? TEST!" - Describes recommended practices for laboratories performing waived tests
• Safety in the Laboratory

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