El estado del arte de la trazabilidad metrológica en la Medicina de Laboratorio

Abstract

Equivalence of results issued by clinical laboratories can be achieved by standardization or harmonization. The generation of comparable results allows common reference intervals between laboratories using different measurement procedures and materials for calibration and trueness control. The aim of this article is to describe the state of the art of metrological traceability in laboratory medicine, currently highlighted through the guidelines of ISO 17511, which in its 2020 version, shows six different hierarchical alternatives, ranging from comparability to certified reference materials and reference measurement procedures, to traceability only to the manufacturer. This new version of 17511 adds the possibility to demonstrate traceability to international harmonization protocols. Demonstrating metrological traceability is required to achieve ISO 15189 accreditation for clinical laboratories. To achieve equivalence of measurements in laboratory medicine, it is desirable to bring clinical laboratory professionals closer to the metrological language and the stakeholders involved.