Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation

The terms calibration, calibration verification and method validation are sometimes used interchangeably. The reality is that all of these are distinctly different processes and are all required by CLIA as related to medical laboratories. This presentation will explore the definitions, distinctions and rules of all three. The Clinical Laboratory Improvement Amendments presentation will outline the CLIA standards for frequency, methodology and give examples of practical application. These rules have been in place since 2003 and compliance will be judged on inspections by CLIA, JCAHO, COLA, CAP and AAB. This presentation will give outlines for compliance and address basic formulas used to calculate precision, accuracy etc.

Areas Covered in the seminar:

• What do calibration, calibration verification and method validation mean?
• When each of these processes should take place.
• What systems are required to use these processes and which ones are not.
• Requirements for validation of new test systems.
• Remedial action if these processes are unsuccessful or have unexpected results.
• Reasoning behind each process and why they are necessary.

Who will benefit:

This webinar will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests. All automated non-waived systems fall under these regulations. Employees who would benefit include:

• Chemistry and special chemistry supervisors and techs
• Hematology and coagulation supervisors and techs.
• Blood bank supervisors and techs.
• Validation specialists
• Microbiology (automated) supervisors and techs

Instructor Profile:
Barry Craig, is the founder and CEO of Laboratory Consulting, LLC, a consulting firm dedicated to the clinical laboratory. The company works with medical laboratories, research facilities, and physician office laboratories. They currently manage over 35 POLs.