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- Closing the Gap: How the CAP Is Advancing Accuracy in Lab Testing Through Harmonization and Standardization
Many diseases are diagnosed and managed based solely on laboratory results. Of course, imaging and physical exams are also important, but diagnostic medicine relies on measurements performed on blood, urine, and cerebrospinal or other body fluids. Indeed, providers spend more than 60% of their time interacting with electronic medical records to view laboratory results.
Identifying variables that affect the accuracy of test results is a priority for all health care providers. Often, these variables are related to errors within the laboratory (like human error) or analytical errors (for example, when an instrument is out of calibration). There can also be bias specific to instrument platforms or methods that can affect the accuracy of patient test results.
Pursing Harmonization, Standardization
The College of American Pathologists (CAP) has spent decades ensuring that laboratories can address variables that influence the accuracy of test results. The process of getting laboratory test results to be the same from laboratory to laboratory and manufacturer to manufacturer is called harmonization. When a reference method is available and all test results agree with the accurate results from that reference method, the effect is called standardization.
As the largest provider of proficiency testing (PT) materials, which help laboratories ensure they are performing their testing properly, the CAP has generated data facilitating harmonization and standardization. This allows testing platform manufacturers to compare labs to other labs, and instrument manufacturers to other manufacturers. The CAP’s conventional PT materials allow laboratories to evaluate their own performance (their fundamental purpose), but also allow labs and manufacturers to compare their test results with those from other instruments.
The source of this data lies within the CAP’s comprehensive portfolio of PT programs: the Accuracy-Based Programs. These programs do what proficiency tests can’t: they verify the accuracy of test results against a gold standard, which is the reference measurement procedure. While PT provides a check on procedural methodology and results reliability as compared with peer laboratories, sometimes an entire peer group could be getting inaccurate results.
Improving Accuracy
These accuracy-based programs use challenge specimens that are matrix-related, bias free, and have target values traceable to certified reference materials. Using this approach, the CAP has helped improve the accuracy of testing for creatinine, which is used to diagnose kidney disease; hemoglobin A1c, which is used to diagnose and monitor therapy in diabetes; and cholesterol, which is used to identify patients at increased risk for heart disease.
Accurate lab results are the foundation of effective diagnosis and treatment. Through its pioneering work in harmonization and standardization, the CAP is helping ensure that patients receive consistent, reliable care—no matter where their tests are performed.
To explore how the CAP’s Accuracy-Based Programs are transforming laboratory medicine, explore our ongoing efforts to be part of the movement toward better, more accurate laboratory testing:
Andy Hoofnagle, MD, PhD, FCAP, is the Chair of the CAP’s Accuracy-Based Programs Committee under the Council on Scientific Affairs. He is a board-certified pathologist for Laboratory Medicine at UW Medical Center, head of Clinical Chemistry and a UW professor of Laboratory Medicine.