Biochemia Medica, Vol. 28 No. 2, 2018.
Review article
https://doi.org/10.11613/BM.2018.020503
Sigma metrics in laboratory medicine revisited: We are on the right road with the wrong map
Wytze P. Oosterhuis
; Department of Clinical Chemistry and Hematology, Zuyderland Medical Center, Heerlen, The Netherlands
Abdurrahman Coskun
; Department of Medical Biochemistry, Acibadem University School of Medicine, Istanbul, Turkey
Abstract
Reliable procedures are needed to quantify the performance of instruments and methods in order to increase the quality in clinical laboratories. The
Sigma metrics serves that purpose, and in the present study, the current methods for the calculation of the Sigma metrics are critically evaluated.
Although the conventional model based on permissible (or allowable) total error is widely used, it has been shown to be flawed. An alternative
method is proposed based on the within-subject biological variation. This model is conceptually similar to the model used in industry to quantify
measurement performance, based on the concept of the number of distinct categories and consistent with the Six Sigma methodology. The quality
of data produced in clinical laboratories is expected, however, to be higher than the quality of industrial products.
It is concluded that this model is consistent with Six Sigma theory, original Sigma metrics equation and with the nature of patients’ samples. Therefore,
it can be used easily to calculate the performance of measurement methods and instruments used in clinical laboratories.
Keywords
biological variation; Six Sigma; Sigma metrics; total error; number of distinct categories
Hrčak ID:
201526
URI
Publication date:
15.6.2018.
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