ǂa ǂconsensus statement about the practice of the implementation and auditing of this norm element
Marc H. M. Thelen (Author), Florent Vanstapel (Author), Pika Meško-Brguljan (Author), Bernard Gouget (Author), Guilaine Boursier (Author), Edward Barrett (Author), Christos Kroupis (Author), Maria Lohmander (Author), Luděk Šprongl (Author), Tatjana Vodnik (Author)

Abstract

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.

Keywords

metrological traceability;

Data

Language: English
Year of publishing:
Typology: 1.01 - Original Scientific Article
Publisher: Walter de Gruyter
UDC: 542
COBISS: 2048429937 Link will open in a new window
ISSN: 1437-4331
Views: 738
Downloads: 128
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Other data

Secondary keywords: metrološka sledljivost;Laboratories;Medical laboratory science;Risk management;Quality control;Quality improvement;Quality assurance, health care;Laboratoriji;Laboratorijska medicina;Obvladovanje tveganja;Nadzorovanje kakovosti;Izboljšanje kakovosti;Zagotavljanje kakovosti zdravstvene oskrbe;
Source comment: Soavtorji: Florent Vanstapel, Pika Meško Brguljan, Bernard Gouget, Guilaine Boursier, Edward Barrett, Christos Kroupis, Maria Lohmander, Luděk Šprongl, Tatjana Vodnik, Francisco Bernabeu-Andreu, Ines Vukasović, Çiğdem Sönmez, Solveig Linko, Duilio Brugnoni, Michel Vaubourdolle, Willem Huisman, Mauro Panteghini and on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO); Nasl. z nasl. zaslona; Opis vira z dne 18. 4. 2019;
Pages: str. 459-464
Volume: ǂVol. ǂ57
Issue: ǂiss. ǂ4
Chronology: Mar. 2019
DOI: 10.1515/cclm-2018-1212
ID: 12094443
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