ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceability chain, it recognizes that for many measurands there is no reference above the manufacturer's selected measurement procedure and the manufacturer's working calibrator. Some immunoassays, although they intend to measure the same quantity and may even refer to the same reference material, unfortunately produce different results because of differences in analytical selectivity as manufacturers select different epitopes and antibodies for the same analyte. In other cases, the cause is the use of reference materials, which are not commutable. The uncertainty associated with the result is another important aspect in metrological traceability implementation. As the measurement uncertainty on the clinical samples is influenced by the uncertainty of all steps higher in the traceability chain, laboratories should be provided with adequate and appropriate information on the uncertainty of the value assignment to the commercial calibrators that they use. Although the between-lot variation in value assignment will manifest itself as part of the long-term imprecision as estimated by the end-user, information on worst-case to be expected lot-lot variation has to be communicated to the end-user by the IVD provider. When laboratories use ancillary equipment that potentially could have a critical contribution to the reported results, such equipment needs verification of its proper calibration and criticality to the result uncertainty could be assessed by an approach based on risk analysis, which is a key element of ISO15189:2012 anyway. This paper discusses how the requirement for metrological traceability as stated in ISO15189 should be met by the medical laboratory and how this should be assessed by accreditation bodies.

Center of Medical Biochemistry Clinical Center of Serbia Center of Medical Biochemistry Clinical Center of Serbia Belgrade Serbia

Central Laboratory Oncology Education and Research Hospital Ankara Turkey

CHU Montpellier University Montpellier Department of Genetics Rare Diseases and Personalized Medicine Montpellier France

Clinical Chemistry Laboratory Spedali Civili Brescia Italy

Clinical Laboratory Hospital Kladno Kladno Czech Republic

Consultant Clinical Biochemist Limerick Ireland

Consultant European Specialist in Clinical Chemistry and Laboratory Medicine The Hague The Netherlands

Department of Biomedical and Clinical Sciences Luigi Sacco University of Milano Medical School Research Centre for Metrological Traceability in Laboratory Medicine Milan Italy

Department of Clinical Biochemistry Attikon University General Hospital Medical School National and Kapodistrian University of Athens Haidari Greece

Faculty of Medicine Helsinki University Helsinki Finland

Fédération Hospitalière de France Paris France

Hôpital Saint Antoine AH HP Département de Biochimie Paris France

Laboratoriemedicin NU Sjukvården Trollhättan Sweden

Laboratory for Clinical Chemistry and Haematology Amphia PO Box 90158 4800 RK Breda The Netherlands

Laboratory Medicine Department of Public Health Biomedical Sciences Group University Hospital Leuven Leuven Belgium

Servicio de Análisis Clinicos H U Puerta de Hierro Majadahonda Majadahonda Madrid Spain

Sestre Milosrdnice University Hospital Center Department of Clinical Chemistry Zagreb Croatia

SKML Radboud University Nijmegen The Netherlands

University Clinic for Respiratory and Allergic Diseases Golnik Slovenia

Citace poskytuje Crossref.org