How to Transition a Research Laboratory to a CLIA Certified Clinical Laboratory

This training program will explain to participants the processes and requirements to become CLIA certified. All U.S. laboratories performing testing of human specimens for the diagnosis, treatment or mitigation of human disease are required by law to be certified under CLIA. Becoming CLIA certified is a complex process, and this webinar will provide a roadmap to obtaining certification, saving time, frustration, and resources.

Why Should You Attend:

Bringing a medical research testing laboratory into compliance as a clinical (medical) diagnostic testing laboratory is a complicated and often confusing process. Clinical laboratories are regulated under federal law by the “Clinical Laboratory Improvement Amendments of 1988”. Many medical research and biotechnology laboratories are developing tests that they hope to one day offer as clinical laboratory tests, and these laboratories will have to come into compliance with CLIA.

This webinar will explain the process and requirements of taking a laboratory from research to a CLIA regulated and certified clinical laboratory. There are four major requirements to be met in obtaining CLIA certification:

• The lab must have laboratory personnel at all phases of testing that meet the CLIA requirements.
• There must be a system in place to perform on-going assessments of all lab operations to ensure quality of the lab’s testing.
• The lab must enroll and successfully participate in proficiency testing.
• There must be written policies and procedures in place that meet all requirements specified in the CLIA regulations.
• The course will also discuss compliance with all the above stated mandates.

Areas Covered in the Webinar:

What is the difference between a CLIA certified laboratory and a clinical research laboratory?

• Overview of the CLIA regulations, with emphasis on the basic requirements to become CLIA certified
• Clinical laboratory tests: FDA approved tests and Laboratory Developed Tests (LDTs)
• CLIA mandated personnel and their functions
• On-going quality assessment policies and procedures for all phases of testing
• Successful proficiency testing
• State and federal oversight of clinical laboratories
• Accreditation by non-profit organizations
• Inspections: federal, state, accreditation, validations, and complaints

Who Will Benefit:

• Medical research professionals
• Academic authorities
• Biotechnology laboratory directors
• Compliance officers
• Managers
• Researchers who are developing and utilizing tests on human specimens that may one day be offered as clinical diagnostics