Quality Control (QC) only provides value to clinical laboratories if QC failures are meaningfully managed. Too often, however, the questions asked about QC relate to the number, type, and frequency of QC required, which all are irrelevant if the lab does not deal with QC failures thoughtfully and substantively. Yet in many clinical laboratories, QC is reduced to an almost robotic process of checking off boxes to meet the specified number and frequency. Presented here are three suggestions for how laboratories can turn QC failures into more meaningful insights.
Make review of QC proactive. Taking a proactive role in QC involves routinely assessing QC before a major event brings QC failures to the leadership’s attention. When lab leaders manage QC proactively, two major changes follow. The first is cultural: When leaders make QC a priority, the rest of the laboratory begins to prioritize it as well. Part of making QC a priority includes giving technologists protected time to manage QC.
The second change is the potential to provide positive encouragement to personnel for their handling of QC events. Enlightened lab leaders do not want to be in the position of only providing negative feedback when poorly handled events come to light. Instead, they strive to make positive encouragement for well-handled QC events part of the cultural norm. The ultimate goal of proactive QC evaluation is to instill a culture which values QC and recognizes proper handling of QC events.
Deal with alert fatigue. An optimized false rejection rate balances the potential for alert fatigue against the possibility of accepting results that really should be rejected. It is almost unavoidable that laboratories have a false rejection rate, but when the rate is too high, technologists tire of responding to QC events in the same way that clinicians develop alert fatigue. By the same token, a false rejection rate that is too low means the lab risks accepting results that should be rejected. Today’s instruments enable laboratories to re-evaluate the frequency of control (within regulatory requirements) and the limits they define as acceptable. Lab leaders should keep these considerations in mind when implementing individualized QC programs. The more that technologists find QC events actually signal problems, the more likely they will be to pay attention to these events.
Analyze QC trends. Laboratorians should view QC failures not as isolated events, but as part of a global picture of what is occurring in the laboratory. QC events too commonly are viewed in isolation and neither investigated nor corrected so that other issues are addressed. Any College of American Pathologists-accredited laboratory is required to investigate proficiency testing (PT) failures thoroughly. Rarely, however, are such investigations undertaken for QC failures, even though unaddressed QC failures precede many PT failures. Unacknowledged 10X rule violations eventually lead to unacceptable bias and a PT failure. In order to address QC failures before they become PT failures, it is useful to evaluate QC trends rather than just individual QC failures. A reoccurring QC failure should prompt the laboratory to examine the underlying cause closely. Does the instrument in question need to be calibrated more frequently? Does the maintenance schedule need to be adjusted? Is the lab experiencing more failures at certain times of the year or day? Common QC failures should be studied with a root cause analysis. Taking the time to evaluate global trends in QC enables laboratories to focus on the underlying issues causing these failures, leading them to a more meaningful QC process.
Employing these three strategies should make your lab’s management of QC events a meaningful part of its culture—one that helps ensure that QC events do not go unreported or ignored. A number of technological solutions are available in the event these cultural changes prove difficult. For instance, most major vendors now offer functionalities that force technologists to address QC events through middleware applications. Still, even these technological advances are no substitute for setting a culture in your laboratory that values meaningful QC management over an attitude of merely checking off QC number, type, and frequency.
Joshua Hayden, PhD, DABCC, is assistant professor of pathology and laboratory medicine at Weill Cornell Medical College, and director of toxicology and therapeutic drug monitoring and assistant director of the central laboratory at New York Presbyterian Hospital-Cornell Campus in New York City. +EMAIL: [email protected]