Teaching and Assessing New Method Verification Skills Using Interactive Simulations

Extract

Since the introduction of the Clinical Laboratory Improvement Act of 1988 every laboratory has faced new regulatory compliance challenges including Clinical Laboratory Improvement Amendments/Centers for Medicare and Medicaid Services (CLIA/CMS) pre-use verifications of the manufacturer's performance claims of each new instrument and method used in the laboratory. Skills in planning and conducting such verification studies are among those which should be taught to students preparing for careers as clinical laboratory scientists.

I present a method to teach and assess student skills in planning and conducting a new method verification that is being successfully utilized in my CLS-3314 Advanced Clinical Chemistry course of Weber State University's (WSU) CLS program, both on-campus and online. The method, which does not impact actual patient care or the laboratory work-flow or significantly affect program budget, uses an interactive simulation approach in which each and every student has the opportunity to design and direct a customized verification study. In a prerequisite course, the students first define the components of method verification prescribed by the current CLIA/CMS regulations.² They learn the requirements for verifying accuracy, precision, analytical measurement range, sensitivity, and that the reference range used is appropriate for the patient population being served. Next, in the Advanced Clinical Chemistry course these verification skills are assessed and enhanced. The course requires that student assume the role of a technical consultant to a laboratory, plan and design each verification experiment, and create explicit written instructions on how each experiment should be conducted.

This simulation follows this concept: “If…

ABBREVIATIONS: CLIA = Clinical Laboratory Improvement Amendments; CLS = clinical laboratory science; CMS = Centers for Medicare and Medicaid Services; WSU = Weber State University.