New research, published in Clinical Chemistry, may lead laboratorians to take a close look at their quality control efforts for HbA1c test results. As the study notes, “considerable differences in the probability of reporting unreliable HbA1c results between different NGSP (formerly the National Glycohemoglobin Standardization Program)-certified platforms were observed.” Further, “at a 6% total allowable error, our study indicates all but the Capillarys 2 Flex Piercing requires that the maximum affordable [quality control] QC be run. Risk estimates for individual laboratories’ HbA1c methods can be used to assess QC practices and residual risk of an unreliable HbA1c result.”
The study has practical implications for laboratorians, according to its lead author, Alison Woodworth, PhD, DABCC, FACB. "Our study is significant for several reasons. To our knowledge this is the first example in which risk-based analytical tools were utilized to assess quality control plans,” she says. “It provides some guidance on development of individualized quality control plans, which are now recommended by the Centers for Medicare and Medicaid Services. In addition, this risk-based analysis showed that at the current College of American Pathologists-recommended error goal of 6%, five of six HbA1C assays required that maximum QC—three levels three times a day—be performed to minimize risk of reporting an unreliable patient result. These findings should prompt laboratory directors to examine their QC plans for HbA1c assays." Woodworth is an assistant professor of pathology, microbiology, and immunology at Vanderbilt University Medical Center in Nashville, Tennessee.
The new research serves as an important QC reminder for laboratorians, says an editorial that accompanies the new research. “HbA1c is an important test for the diagnosis and ongoing monitoring of a disease that is increasing in prevalence; laboratories must be vigilant in ongoing quality assurance and monitoring of their HbA1c assays to achieve the levels of performance demanded by the clinical community to ensure optimal patient care,” wrote Randie R. Little, PhD, co-director of the diabetes diagnostic laboratory at the University of Missouri School of Medicine in Columbia.
Read the new research and the accompanying editorial online.