Harmonization and Standardization: Where Are We Now?

Abstract

The purpose of a medical laboratory test is to provide information on the pathophysiologic condition of an individual patient as an aid in diagnosis, therapy, or assessment of risk for a disease. For optimal laboratory service, results from different measurement procedures (MPs) for the same measurand should be equivalent (harmonized) within stated specifications, enabling the results to be used reliably for medical decisions. The term "harmonization" refers to any process that enables establishing equivalence of reported values among different end-user MPs. The term "standardization" refers to achieving harmonization by metrological traceability of patients' results to higher order reference materials and/or reference measurement procedures. New procedures for harmonization and standardization were published in 2020 by the International Organization for Standardization (ISO) and by the IFCC. ISO 17511:2020 provides revised requirements for establishing metrologically traceable calibration hierarchies for end-user MPs used in clinical laboratories. ISO 21151:2020 provides new requirements to implement a harmonization protocol to address the situation when there are no fit-for-purpose certified reference materials or reference MPs available for a measurand. The IFCC Working Group on Commutability published recommendations for applying a correction for noncommutability of a certified reference material to enable using that material in a metrologically traceable calibration hierarchy for an end-user MP. We review metrological traceability and how these new approaches will improve the capability to achieve harmonized results for clinical samples.