Sigma metrics in laboratory medicine revisited: We are on the right road with the wrong map

Biochemia Medica
Wytze P Oosterhuis, Abdurrahman Coskun

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.

References

Jun 22, 2011·Clinical Chemistry·Wytze P Oosterhuis
Mar 13, 2014·Clinical Chemistry and Laboratory Medicine : CCLM·Koen HensSten Westgard
May 14, 2016·Clinical Chemistry and Laboratory Medicine : CCLM·Anna CarobeneUNKNOWN Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine
Apr 22, 2017·Clinical Chemistry·Anna CarobeneUNKNOWN European Biological Variation Study of the EFLM Working Group on Biological Variation
Jul 20, 2017·Clinical Chemistry·Anna CarobeneUNKNOWN European Biological Variation Study of the EFLM Working Group on Biological Variation
Aug 11, 2017·Clinical Chemistry and Laboratory Medicine : CCLM·Wytze P OosterhuisElvar Theodorsson

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Citations

Mar 1, 2019·Clinical Chemistry and Laboratory Medicine : CCLM·Abdurrahman CoskunIbrahim Ünsal
Jul 20, 2018·Biochemia Medica·Sten WestgardJames O Westgard
Dec 29, 2018·Biochemia Medica·Abdurrahman CoskunIbrahim Ünsal
Dec 29, 2018·Biochemia Medica·Sten WestgardJames O Westgard
Feb 18, 2020·Biochemia Medica·Abdurrahman Coskun, Wytze P Oosterhuis
Jan 26, 2021·Practical Laboratory Medicine·Tony Badrick
May 10, 2021·Clinical Biochemistry·Tony Badrick
Jun 2, 2021·The Journal of Applied Laboratory Medicine·Matthew FeldhammerJames H Nichols

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Software Mentioned

Six
DPMO

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