Pregledni rad

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

Sažetak

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.

Ključne riječi

biological variation; Six Sigma; Sigma metrics; total error; number of distinct categories

Hrčak ID:

201526

URI

https://hrcak.srce.hr/201526

Datum izdavanja:

15.6.2018.

Posjeta: 1.190 *