CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Dr. Kahn
Commotion and concern has surrounded application of the guidance where meters were being used for critically ill patients, Dr. Kahn agrees. “The draft guidance that came out in early 2014 from the FDA was really directed to the manufacturers, and the requirements were even more stringent than the CLSI guidelines in terms of expected accuracy and precision. Then CMS came out later that year and sort of underscored the need for strict requirements, but a few months later, CMS backed off a little and said further study was called for.”
The CLSI guideline (POCT12-A3) is more stringent than the accuracy and precision requirements that have been followed for several years, he notes. But the CAP—and, Dr. Kahn believes, all the major laboratory organizations—considers POCT12-A3 a reasonable approach.
“The Chemistry Resource Committee is consistently thorough, deliberate, and thoughtful whenever it considers a decision about any aspect of PT whether it’s for a new Survey, new analyte, or new material,” he maintains. “I have not seen anything but a thoughtful, serious consideration of the issues from this committee, and always with an effort to balance what we do with quality in PT testing while also considering practical, real-world issues from the manufacturer’s perspective as well as from the customer perspective and that of participating labs.”
“I was surprised at the strong pushback we heard about and that despite the official response from CAP a few months ago, Nova decided to send that letter out to their customers,” Dr. Kahn says. “The Chemistry Resource Committee strives to use commutable materials whenever it is feasible. There are certain Surveys like WB glucose where we have yet to identify commutable materials although grading is still by peer group.” He is not aware of any reason why Nova performance should be affected in a different way than other manufacturers’ performance.
It’s possible to have an approach to proficiency testing that passes virtually everybody, Dr. Kahn points out. “But that’s never the purpose of PT. Unless a small percentage, or a very small percentage at least, doesn’t pass each and every time, then what good are the PT criteria? You’re doing nothing to focus on comparably poor performing methods. Plus you’re doing nothing to focus on potential labs or institution sites where there might be some type of quality problem, whether it’s analytical performance or operator based, or whatever the case may be.”
Dr. Kahn thought the CAP PT program to be strong and robust long before he joined the Chemistry Resource Committee, and his experience on the committee has only reinforced his impression of how meticulous the CAP’s approach to offering proficiency testing is. Regarding Nova’s information bulletin about the PT criteria, Dr. Kahn says, “Should we [Loyola] use Nova in the future, we will continue to look very closely at our PT performance. But we have been participating in the CAP Whole Blood Glucose Survey for several years and we intend to continue for the foreseeable future. We don’t see any reason to change.”
As the CAP Survey goes forward, he believes, it will continue to keep its standards relevant and useful in maintaining the high quality of the meters’ performance. “The most important consideration, first and foremost, is to try to do whatever you can to optimize patient safety and try to minimize the likelihood of medical error, particularly with such a commonly performed test as glucose meter testing.”
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Anne Paxton is a writer and attorney in Seattle.