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W Greg Miller, Harmonization: Its Time Has Come, Clinical Chemistry, Volume 63, Issue 7, 1 July 2017, Pages 1184–1186, https://doi.org/10.1373/clinchem.2017.274860
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The importance of standardization of laboratory test results has a long history traceable to the first proficiency testing results in 1947 that demonstrated large discrepancies among results from 59 hospital laboratories (1). The AACC published a series of monographs in 1953–1972 titled Standard Methods of Clinical Chemistry that promoted a single measurement procedure (MP)2 for a measurand. This effort ultimately failed because technology and commercial interests produced different MPs for the same measurand. A conference organized in 1977 by the Centers for Disease Control [now the Centers for Disease Control and Prevention (CDC)], the Food and Drug Administration (FDA), and the National Bureau of Standards (now NIST) spawned the National Reference System for the Clinical Laboratory that established the hierarchy of Certified Reference Materials (CRMs) and reference measurement procedures (RMPs) that are now accepted as higher-order references for standardization of measurand results (2). The IFCC and professional organizations in various countries began to publish RMPs for different measurands in the mid-1970s. About this time, professional organizations and metrology institutes introduced matrix-based CRMs as the basis for calibration traceability of medical laboratory MPs for measurands for which there were no RMPs.
