Harmonization: Why You Should Care!

The landmark 1999 report from the Institute of Medicine "To Err Is Human: Building a Safer Health System" emphasized the importance of clinical practice guidelines to standardize decisions and treatments. A 2015 follow up report "Improving Diagnosis in Health Care" again emphasized the importance of guidelines and stressed that cooperation among the health care team including laboratory professionals was essential to reduce diagnostic errors. Neither report recognized that diagnostic errors are made when non-harmonized laboratory test results are interpreted using fixed decision values in clinical practice guidelines. Harmonization of laboratory test results is one of the most pressing issues in laboratory medicine. The laboratory profession has developed an infrastructure for achieving harmonized (or standardized) results; yet several technical challenges have prevented a large fraction of our measurement procedures from achieving harmonized results. Recent initiatives are addressing the challenges to achieve harmonization. It is not widely appreciated that regulations can be an impediment to harmonization. Why do IVD manufacturers need to spend millions of dollars for regulatory approval to conform to international recommendations for harmonization that will improve the quality of patient care? Current activities to address these issues will be presented.

Lecture Presenter
Greg Miller, PhD, DABCC
Greg Miller, PhD, DABCC
Professor of Pathology, Virginia Commonwealth University

Greg Miller is a Professor in the Pathology Department at Virginia Commonwealth University where he serves as Co-Director of Clinical Chemistry and Director of Pathology Information Systems. His professional interests and research has focused on standardization and harmonization of laboratory results, quality control and external quality assessment. He holds leadership positions in several committees and working groups involved with standardization and harmonization activities. He is a past-president of the American Association for Clinical Chemistry and of the Clinical and Laboratory Standards Institute. He received the Outstanding Lifetime Achievement Award in Clinical Chemistry and Laboratory Medicine from the AACC, and the Robert Schaffer Award for Outstanding Achievements in the Development of Standards for Use in Laboratory Medicine from the IFCC.

Objectives

After this presentation, participants will be able to:

Recognize why harmonized laboratory test results are necessary to prevent medical errors.
Understand that harmonized test results require calibration to be traceable to a common reference system.
Appreciate that commutable reference materials are necessary to achieve calibration traceability to a common reference system.
Understand that harmonization of nomenclature, units and reference intervals are important to avoid medical errors.
Recognize that regulatory requirements need to be addressed to enable better implementation of harmonization schemes.