Update on current concepts and meanings in laboratory medicine --Standardization, traceability and harmonization

Abstract

An increasingly important quality objective in laboratory medicine is ensuring the equivalence of test results among different measurement procedures, different laboratories and health care systems, over time. In recent years, interest in sharing a single patient's clinical laboratory data, regardless of where the measurements are performed, has moved out of the domain of the scientific community and spilled over into the domain of regulators, lawmakers and the general population in many parts of the world. For all parties involved in the dialog, establishing and maintaining a clear understanding of the essential concepts that are vital to achieving global equivalence among clinical laboratory measurements have therefore become a priority. Concepts that are critical to this discussion include standardization, traceability and harmonization. This report provides an updated discussion and practical definitions for these terms and others that are linked to metrological principles.

Keywords: Calibration; Harmonization; Metrology; SI; Standardization; Traceability.