Talking about CLIA and Risk in Clin Lab News

by Sten Westgard, MS
Updated 11/7/08

One of the most outspoken critics of the EQC guidelines has been James Westgard, PhD, FACB, emeritus professor in the department of pathology and laboratory medicine at the University of Wisconsin Medical School and president of Westgard QC, Inc. “So what are equivalent QC procedures? Equivalent in performance? Equivalent in detecting medically important errors? Equivalent in assuring the necessary desired quality is achieved?” asked Westgard at a September 4 AACC audioconference called “New Directions in Laboratory QC: EQC, Alternate QC and Risk Assessment.” “No, it’s none of the above. It’s just a name. It has nothing to do with any practical meaning in terms of what we think of equivalents. It’s just a name,” he said.

Back a few years ago, there were more critics of Equivocal QC, for example CAP, but then their deeming status came up for review. Now all the deemed providers have implemented equivalent QC options. CMS flexed its muscle, and now there are fewer people to be outspoken.

Steven Gutman, MD, director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety indicates that FDA will not directly review a manufacturer’s risk assessment material. “Because they’re providing straight-forward information on risks and risk management, we would view that as an acceptable practice, and there might be various formats for them to do that,” Gutman explained. “It might be technical bulletins, it might be on their websites, but it wouldn’t be a part of FDA-sanctioned labeling unless they violate FDA regulations, in which case our compliance program would become concerned.” Gutman said the FDA would look to see if companies were going overboard with explicit or implicit claims about their products, reviewing the information only if the agency thought there was a problem.