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Harmonization of clinical laboratory measurement procedures

Professor Greg Miller from Virginia Commonwealth University gives an opening lecture: The Harmonization Journey: Where Are We Going on Thursday 6th of February at the International Congress on Quality in Laboratory Medicine 2020. Professor Miller points out that harmonized results are required for medical diagnosis, treatment and monitoring based on decision values for laboratory test results. In his presentation, Professor Miller also discusses the milestones in understanding and applying processes for standardization and harmonization of laboratory test results.

About the Speaker: Ph.D.Greg Miller

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 activities and research have focused on standardization and harmonization of laboratory results, quality control and external quality assessment/proficiency testing. 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 American Association for Clinical Chemistry, the Robert Schaffer Award for Outstanding Achievements in the Development of Standards for Use in Laboratory Medicine from the International Federation of Clinical Chemistry and Laboratory Medicine, and the Russell J. Eilers Memorial Award from the Clinical and Laboratory Standards Institute.

Abstract: The harmonization journey: where are we going

Clinical decisions require equivalent results from clinical laboratory measurement procedures.  Harmonization and standardization processes are capable of achieving equivalent results but need to be more universally applied.  External quality assessment (EQA) identified that results were not equivalent in different laboratories beginning in 1947.  Approaches to use the same methods were promoted in the 1950s and 1960s. A need for standardized reference systems for calibration was recognized as in-vitro diagnostics manufacturers introduced a variety of technologies to meet the demand for clinical laboratory testing services.  Hierarchies of national and international reference systems were developed in the 1970-1990 period that were hampered by inadequate understanding of the importance of commutable reference materials. Standards for metro-logical traceability were developed by the International Organization for Standardization in the 2000s that provided a global approach for establishing robust standardization that has been used for approximately 100 measurands. The limitations of non-commutable reference materials became widely appreciated in the 2000s.  In 2010 and going forward, laboratory medicine recognized the need for harmonization approaches for the large number of measurands for which higher order certified reference materials and reference measurement procedures are not available.  Metrological traceability to an international harmonization protocol provides an alternative when no other approach is realistically feasible.  The toolbox to achieve equivalent results among different medical laboratory measurement procedures has grown and been refined to better support medical decisions based on decision values included in clinical practice guidelines.

Labquality Days – International Congress on Quality in Laboratory Medicine

Welcome to the International Congress on Quality in Laboratory Medicine on 6-7 February 2020. The scientific program of the next International Congress on Quality in Laboratory Medicine will be built around the theme of optimizing quality. The program covers the topics on harmonization of medical practices, how to communicate the results to clinicians and patients and the quality assurance of new measurement technologies. Welcome to Helsinki!

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