With the federal government’s phaseout of equivalent quality control (EQC) and subsequent introduction of Individualized Quality Control Plans (IQCP), labs have had to adjust, learn, and adapt, Julie Kirkwood writes in April’s Clinical Laboratory News.
“Under the new rules, which took effect in January 2016 after a 2-year educational period, labs needed to write an IQCP for every test that had been operating with EQC or perform default QC,” Kirkwood summarizes. Lab managers, particularly those in point-of-care testing (POCT), initially felt overwhelmed by the prospect of conducting risk assessments and writing IQCPs for possibly hundreds of tests.
“Now that we’re doing it and now that we’ve got it in place, it’s like, ‘Yeah, this works. Yeah, we can do this,’” Deborah A. Perry, MD, medical director at Methodist Hospital in Omaha, Nebraska, and chair of the College of American Pathologists’ (CAP) Point-of-Care Testing Committee, tells CLN.
Kirkwood’s article describes the journey of several labs that have adopted IQCP strategies. This approach enabled TriCore Reference Laboratories in Albuquerque, New Mexico, to broaden its focus from the analytical phase and systematically detect risks in the preanalytical and postanalytical testing phases. Meanwhile, IQCPs didn’t reveal any new risks in the analytical phase of testing at Temple University and Episcopal Hospitals in Philadelphia, according to Adil I. Khan, MSc, PhD, director of the institutions’ point-of-care testing and clinical chemistry. However, IQCP has fostered a more scientific approach to QC, he adds. “It put a rationale behind the quality assurance and the QC procedures that we do for these moderately complex tests,” Khan says.
Labs once faced a big learning curve with IQCPs, but quite a few resources are available today to help them write new IQCPs, such as templates from vendors and accrediting organizations. Labs can also use existing IQCPs as a starting point, Perry says. “You don’t have to reinvent the wheel every time. You can modify the wheel that’s already in place,” she says.
So far, IQCPs have been adopted mainly by microbiology and POCT departments, but experts predict that they will catch on in other laboratory divisions. “I think there is going to be a change in the way laboratories approach quality control, and it’s going to be within the patient risk paradigm,” Curtis Parvin, PhD, retired manager of advanced statistical research in the Quality Systems Division of Bio-Rad, tells CLN.
Pick up the April CLN, and learn more about the future of quality and adoption of IQCP strategies in clinical labs.