From POCT to PT to MS to verification protocols, a generous serving of sessions at the 69th AACC Annual Scientific Meeting & Clinical Lab Expo addresses an issue of great importance to laboratorians: quality.
When faced with verification tasks, laboratory staff often feel anxious and confused. An AACC University course, Trust, But Verify: Getting the Most Out of Verification Protocols For FDA Approved Methods (191002), offers practice advice for successfully performing this task, drawing from Clinical and Laboratory Standards Institute (CLSI) guidelines as well as Sigma-metrics assessment tools.
Trust But Verify, offered this year on July 30 at 10:30 a.m., is the longest-running workshop the AACC Annual Scientific Meeting offers and is a perennial favorite in laboratory medicine, Sten Westgard, the session’s moderator and director of client services and technology at Westgard QC in Madison, Wisconsin, told CLN Stat. “My father, James O. Westgard, started it with his colleagues back in the 1970s, and he passed the torch on to them. Several of them taught this course for 10, 20, 30 years! Only for the last five years have I been involved,” Westgard noted.
The verification workshop fills an important education gap that schools aren’t providing. It’s rare that lab staff get training in statistics, method verification, or even the core quality control statistics, he said. “They are worried about what to do, and it’s a struggle to find out how to do it correctly,” Westgard said.Even when lab staff perform a verification study, they don’t always know how to properly handle the resulting statistics, Westgard cautioned. “If you misinterpret the results, if you don’t comprehend the proper utility of a statistic, you may reach the opposite conclusion and accept a method into routine practice when you should be rejecting it,” he said.
Westgard’s presentation will advise laboratorians on setting objective goals for analytical performance and selecting methods to meet those goals. David Koch, PhD, associate professor of pathology at Emory University School of Medicine and director of clinical chemistry, special chemistry, toxicology and point-of-care testing at Grady Memorial Hospital in Atlanta, will join Westgard on the dais to discuss Clinical and Laboratory Standards Institute (CLSI) guidelines for method verification. “Dave Koch has the longest serving tenure of this workshop of any of us, and it would have been longer, but he had to take a few years off serve in leadership roles at AACC,” Westgard said.
Clinical laboratory professionals will learn about the experiments they need to run and the key statistics they need to generate in order to interpret things correctly. “A lot of what this workshop does is dispel the myths of statistics. For instance, the idea that a high correlation coefficient means you have a good method—every year we show the danger of relying on that assumption,” Westgard said.
Another AACC University course at 10:30 a.m. on July 30, New External Programs for Laboratory Quality Assurance (191003), delves into the College of American Pathologists’ (CAP) accuracy-based proficiency testing (PT) materials and reporting procedures as well as PT quality requirements issued by the Centers for Medicare and Medicaid Services (CMS).
Accuracy-based PT surveys have their advantages and disadvantages, according to session moderator Keri Donaldson, MD, CEO and medical director of Prescient Medicine in Hummelstown, Pennsylvania. “They are more than just fulfilling the regulatory requirements of PT and getting a passing score. Knowing that a result is not just in agreement with the peer group but is also accurate, is important,” Donaldson told CLN Stat.
Routine PT identifies differences between analytical peer groups. Yet, the presence of matrix effects in PT materials “often makes it difficult to determine whether these differences, or what proportion of these differences, are due to assay variations that could affect patient samples,” Donaldson observed.
The range (result values) of material available at high volumes and the increased cost of sourcing these materials, pose other challenges. “In accuracy-based PT, analytes are targeted at only a few at a time, maybe one, or four or five, whereas the chemistry survey for conventional proficiency testing, for example, has 70-plus analytes in the same bottle, for the same price,” he explained.
CMS in 2014 issued a prohibition against testing and reporting PT samples from multiple instruments unless it’s part of a lab’s standard operating procedure (SOP) for testing patient specimens. Additionally, a lab’s written SOP must reflect that process. CMS recently told approved PT providers that this directive applies to all analytes. This includes those not listed in Subpart I of the Clinical Laboratory Improvement Amendments regulations and analytes/methods categorized as waived tests (such as whole blood glucose meters). To maintain compliance, Donaldson and his colleagues developed the CAP Quality Cross Check Program, which will be the focus of his discussion.
“CAP Quality Cross Check is a convenient solution for monitoring all the instruments in a laboratory on a routine basis while augmenting your instrument comparability efforts,” he explained. The programs are designed to complement existing proficiency testing and enhance quality assurance efforts. They allow for multiple instrument comparison—numerically and graphically—and rapid trend and cluster analysis.
Donaldson has seen CAP’s PT programs steadily improve agreement and precision among different methods.
“The analytes that have been chosen are those that have clinical practice guidelines associated with them, so there’s a strong motivation from a patient management point of view to ensure uniformity and standardization of results,” he said. Collective performance of methods measuring creatinine and HbA1c, have seen major improvements in particular. Manufacturers observe and react to these results, Donaldson added, “because they want their method to be chosen when people go out shopping for methods.”
Charles Eby, MD, BS, professor in the departments of medicine and pathology and immunology at Washington University School of Medicine in St. Louis, and Anthony Killeen, MD, PhD, director of clinical laboratories at the University of Minnesota Medical Center in Minneapolis will join Donaldson on the panel to discuss PT surveys for coagulation assays, and accuracy-based PT surveys, respectively.
The 69th AACC Annual Scientific Meeting & Clinical Lab Expo takes place July 30–Aug. 3 in San Diego. Register today to participate in the conference’s many sessions and discussions about quality.