Teaching and Assessing New Method Verification Skills Using Interactive Simulations

ABBREVIATIONS: CLIA = Clinical Laboratory Improvement Amendments; CL = clinical laboratory science; CM = Center for Medicare and Medicaid Services; WSU = Weber State University.

INDEX TERMS: education; laboratory simulations, fresh method verifications.

Clin Lab Sci 2006;19(3):188

Since the introduction of the Clinical Laboratory Improvement Act of 1988 each 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 of recent origin instrument and method used in the laboratory. Skills in planning and conducting of that kind verification studies are among those which should be taught to pupils preparing for careers as clinical laboratory scientists.

I not away a method to teach and assess learner skills in planning and conducting a fresh method verification that is being fortunately utilized in my CLS-3314 Advanced Clinical Chemistry course of Weber State University's (WSU) CL program, the couple on-campus and online. The [i]modus operandi[/i] which does not impact actual patient care or the laboratory workflow or significantly affect program bag uses an interactive simulation approach in which each and each student has the opportunity to design and direct a customized verification inquiry In a prerequisite course, the learners first define the components of means verification prescribed by the popular CLIA/CMS regulations.2 They learn the requirements for verifying accuracy, precision, analytical measurement range, sensitivity, and that the concern range used is appropriate for the patient population being serv nearest in the Advanced Clinical Chemistry course these verification skills are assessed and enhanced. The course requires that pupil assume the role of a technical consultant to a laboratory, plan and design each verification experiment, and create explicit written instructions upon how each experiment should be directioned

This simulation tread in the steps ofs this concept: "If one can teach someone other to do something, then the teacher has mastered the task" (source unknown). As a former technical consultant to a large concern laboratory who has directed and designed numerous instrument and [i]modus operandi[/i] verifications, I rarely performed the actual testing. Rather, I disentangleed very detailed experimental designs and assay instructions that allowed others to perform it. After the actual testing had been performed, I evaluated the flows of each experiment using appropriate statistical analyses, and then made the appropriate decisions or recommendations regarding die use of the manner for patient care. I believe that the greatest in quantity critical method verification skills involve:

* knowing exactly what experimental studies must be done.

* carefully designing each verification experiment.

* developing explicit written instructions for others to come [i]or[/i] go after [i]or[/i] behind

* evaluating the ordeal data and performing appropriate statistical analyses upon that data.

* drawing the appropriate conclusions about each verification experiment.

* documenting the verification proces and conclusion as a formal report.

Actually performing the analytical testing is the least significant of all the [i]modus operandi[/i] verification skills. During this simulation the pupils follow the critical steps outline above. The scholars are assigned to serve as a "technical consultant" to a certain number of hypothetical laboratory in this simulation exercise. They exhibit very detailed experimental design instructions that are submitted to a fictitious bench technologist who supposedly actually performs the testing according to those experimental designs. The proof results are then returned to the learner who must evaluate the issues of each experiment using appropriate statistical courses and then make appropriate decisions or recommendations regarding the adoption of the means for patient care.

VERIFICATION TOOLS

During the simulation, the couple the students and the teacher use Microsoft Excel(TM) and Microsoft Word(TM) for the simulation.3 cast in the shade is used for the statistical analysis using the Analysis ToolPak library, and Word is used to generate the experimental designs and assay instructions, process performance summary, and the final validation report. Alternate spreadsheet and word-processing software can be used, as well as specialized tools of that kind as EP Evaluator(TM) if desired.4 For simplicity the simulation involves verifying an alternate commercial reagent to be used upon a specific analyzer platform for a specific analyte, similar as magnesium. In our simulations we use the Roche Gobas Mira S(TM) platform since these instruments are used in our scholar laboratories.5

PERFORMING THE SIMULATION

In the simulation, a of recent origin hypothetical reagent ("NuLab" magnesium reagent, as an example) is being considered for use upon the analyzer, and the learners are told that it has already been meat and Drug Administration/CMS-approved for use upon that analyzer. The students are given the pertinent manufacturers performance claims for this reagent, and the verification involves documenting that the fresh reagent meets or exceeds the bread and Drug Administration-approved minimum performance criteria as specified in the manufacturer's package insert. If for a like reason the use of the of recent origin reagent can be implemented. If not, adoption of the reagent must be cast offed