Balance of the unsuccessful systematization of measurement uncertainty in medical laboratories

Abstract

Since the publication of the Guide to the Expression of Uncertainty in Measurement (GUM) [ [1] Joint Committee for Guides in Metrology Evaluation of measurement data – Guide to the expression of uncertainty in measurement. JCGM 100: 2008, GUM 1995 with minor corrections. JCGM, 2008 Google Scholar ], several opinions have been expressed; some defending the “Uncertainty Approach” and measurement uncertainty [ 2 Dybkaer R. From total allowable error via metrological traceability to uncertainty of measurement of the unbiased result. Accredit Qual Assur. 1999; 4: 401-405 Crossref Scopus (18) Google Scholar , 3 Kallner A. The uncertainty concept and its implications for laboratory medicine. Bioquimia. 2007; 32: 25-29 Google Scholar , 4 Kallner A. Theodorsson. Uncertainty of measurement in laboratory medicine. Stockholm, 2005 Google Scholar ], and others defending the “Error Approach” and total analytical error (TAE) [ 5 Petersen P.H. Jørgensen L.G.M. Jensen E. Kynde K. Brandslund I. Sandberg S. et al. Er GUM skadelig? – eller blot overflødig (Is GUM harmful? – or simply unnecessary). Klinisk Biokemi i Norden. 2003; 15: 27-31 Google Scholar , 6 Westgard J. Managing quality vs. measuring uncertainty in the medical laboratory. Clin Chem Lab Med. 2010; 48: 31-40 Crossref PubMed Scopus (40) Google Scholar , 7 Farrance I. Badrick T. Sikaris K.A. Uncertainty in measurement and total error – are they so incompatible?. Clin Chem Lab Med. 2016; 54: 1309-1311 Crossref PubMed Scopus (26) Google Scholar ]. The 2016 conference “Quality in the Spotlight” in Antwerp had a vigorous open discussion by recognized researchers related to the use of measurement uncertainty vs. TAE. Weaponry sounds were even heard! Our long experience in the medical laboratory let us assume that this “battle” remains out of most labs and that the implementation of measurement uncertainty in medical laboratories could be classified as unsuccessful – close to 23 years since the GUM publication. The Westgard QC 2015 survey [ [8] Westgard Q.C. MU Survey 2015: the global results. 2015 Google Scholar ] “speaks” to the labs’ technicians: It shows that the determination of measurement uncertainty in medical laboratories uniquely occurs when it is mandatory to ISO.