Arguably two of the best things in life are athletic activities and running a clinical lab, so when I saw the title for the Sunday short course “Laboratory Director Boot Camp,” I was immediately sold.
My disappointment that we were not actually going to do push-ups and deadlifts was immediately appeased by the speakers’ practical applications of validating FDA cleared tests in the clinical lab. As laboratory directors, we must maintain a fine balance between meeting regulatory requirements and implementing devices that have been properly characterized by the laboratory. And we must do this while simultaneously not over-compensating or imposing unrealistic validation expectations on our staff.
Speakers Keri Donaldson, MD and Wieslaw Furmaga, MD led the audience through a general overview of the CLIA and CAP regulatory requirements for the implementation of new tests, covering all components of an analytical validation: evaluating precision, defining the analytical measurement range (as appropriate for quantitative assays), establishing reference ranges, and meeting the requirements for ongoing monitoring of test performance (including participation in PT).
They also expanded the discussion outside of chemistry to include examples from the molecular and coagulation sections of the laboratory. The speakers strove to point out the similarities between the laboratory sections, drawing attention to the idea that all sections of the laboratory can validate their assays in a manner similar to chemistry. Similarly, laboratory directors familiar with chemistry should not be intimidated when assisting or managing validation of non-chemistry analytes. “Chemistry is the gold standard for how to validate quantitative tests,” Furmaga said.
Attendees called the course practical and useful. One participant, Dr. Marla Troughton, described it as “a very practical review that met the course objectives by using specific examples across a spectrum of different laboratory assays. They addressed the target audience—laboratory directors.”
A clear highlight of the session was the extensive focus on calibration verification and how the linearity of an assay is the fundamental key to reporting precise results. Furmaga clearly defined the differences between the analytical measuring range (AMR) and the clinical reportable range (CRR). He gave excellent examples of how a director should set and maintain their calibration verifications standards, discussing both the experiments that should be completed and the ideal verification material.
My only recommendation for any future iteration of this course would be to throw in some jumping jacks! No boot camp is complete without a few of those.