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

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

Instructor Profile:

Shahrzad V. Radahd, CLS, MSc, PhD, has more than 30 years’ experience in the clinical laboratory field. She retired from the California Department of Public Health in 2009, after spending 15 years as a federal (CLIA) and California state clinical laboratory inspector and manger of the CLS Continuing Education and Medical Laboratory Technician programs. She has traveled world-wide as a clinical laboratory consultant and speaker, and spent a year as lab specialist consultant for Doctors Without Borders, setting up an HIV testing laboratory for the Nigerian Ministry of Health’s Comprehensive HIV Program in Lagos. While she was the manager of the quality improvement and quality control programs at Berkeley HeartLab, Inc., a subsidiary of Celera Genomics/Quest Diagnostics, she led CAP inspection teams in performing laboratory inspections under the CAP Laboratory Evaluation Program.

Topic Background:

All clinical laboratory testing in the U.S. is regulated by the federal CLIA regulations. Clinical laboratory testing is a multi-billion dollar industry in the United States, and advances in science and technology are presenting new opportunities for the diagnosis and monitoring of disease through clinical laboratory testing. Often, new tests are developed in research and biotechnology laboratories that are not regulated under the complex regulations that comprise CLIA, and when a laboratory has developed a test that they wish to offer to the public, they find that they must then become CLIA certified, a complex process. The CLIA regulations require laboratories to obtain federal certification, establish a quality assurance program, enroll in proficiency testing, and employ qualified personnel before starting testing on human specimen.

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