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Editorial
. 2019 Sep 25;57(10):1488-1493.
doi: 10.1515/cclm-2019-0197.

Extra-analytical sources of uncertainty: which ones really matter?

Andrea Padoan  1   2 , Laura Sciacovelli  1 , Rui Zhou  3   4 , Mario Plebani  1   5
Affiliations
Editorial

Extra-analytical sources of uncertainty: which ones really matter?

Andrea Padoan et al. Clin Chem Lab Med. .

Abstract

Since the endorsement by ISO15189:2012 of measurement uncertainty (MU) for the estimation of error in measurement procedures, the debate has been ongoing with questions concerning which method should be used for estimating MU and the benefits of using MU over other error methods. However, only limited attention has been given to extra-analytical sources of uncertainty and, currently, a clear standpoint is still missing. This opinion paper aims to evaluate whether extra-analytical variables could be included in MU. Considering coagulation tests as an example, the possible sources of preanalytical variations are evaluated by using a fishbone diagram. After excluding preanalytical errors, additional sources of uncertainty are divided into amenable to standardization/harmonization and/or possible random sources, which are not standardizable nor harmonizable. Finally, sources of uncertainty are evaluated for a possible inclusion into MU. In addition, postanalytical uncertainty is discussed, particularly considering the laboratory results calculated through a mathematical equation, derived from one or more quantities affected by their specific uncertainty.

Keywords: extra-analytical; harmonization; measurement uncertainty; postanalytical; preanalytical; standardization.

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References

    1. ISO. ISO 15189: Medical laboratories – requirements for quality and competence. Geneva: International Organization for Standardization (ISO), 2012.
    1. Westgard JO. Error methods are more practical, but uncertainty methods may still be preferred. Clin Chem 2018;64:636–8.
    1. Farrance I, Badrick T, Frenkel R. Uncertainty in measurement and total error: different roads to the same quality goal? Clin Chem Lab Med 2018;56:2010–4.
    1. Farrance I, Badrick T, Sikaris KA. Uncertainty in measurement and total error – are they so incompatible? Clin Chem Lab Med 2016;54:1309–11.
    1. Padoan A, Sciacovelli L, Aita A, Antonelli G, Plebani M. Measurement uncertainty in laboratory reports: a tool for improving the interpretation of test results. Clin Biochem 2018;57:41–7.

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