Quality specifications of routine clinical chemistry methods based on sigma metrics in performance evaluation

Quality specifications of routine clinical chemistry methods based on sigma metrics in... INTRODUCTIONSigma metrics methodology is a process‐based quality management and improvement program developed by Motorola in the early 1980s, which soon became famous and was used by other manufacturers and continues to be used today to drive quality improvements and standards. In the 21st century, sigma metrics were introduced into clinical laboratories by David Nevalainen and Lucia Berta. Quality performance can be assessed by sigma value, where 3 sigma is the minimum performance, and 6 sigma is the world‐class quality, such that 99.99966% of results are error free, corresponding to 3.4 defects per million opportunities.In many Chinese clinical laboratories, the Westgard multiplication rules (13s, 22s, R4s, 41s, 10x) have been widely used in clinical chemistry. In this method, there may be more false rejection, waste of quality control materials and prolonged test awaiting time (TAT), whereas the sigma metrics approach allows a laboratory to take a broader view of the data, joining estimates of bias and imprecision into a practical judgment on the clinical usefulness of the method's quality control criteria. Thus, it is useful and simple to access and choose optimal internal quality control criteria based on sigma metrics.The objective of this study is to evaluate the performances of http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Clinical Laboratory Analysis Wiley

Quality specifications of routine clinical chemistry methods based on sigma metrics in performance evaluation

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Publisher
Wiley Subscription Services, Inc., A Wiley Company
Copyright
Copyright © 2018 Wiley Periodicals, Inc.
ISSN
0887-8013
eISSN
1098-2825
D.O.I.
10.1002/jcla.22284
Publisher site
See Article on Publisher Site

Abstract

INTRODUCTIONSigma metrics methodology is a process‐based quality management and improvement program developed by Motorola in the early 1980s, which soon became famous and was used by other manufacturers and continues to be used today to drive quality improvements and standards. In the 21st century, sigma metrics were introduced into clinical laboratories by David Nevalainen and Lucia Berta. Quality performance can be assessed by sigma value, where 3 sigma is the minimum performance, and 6 sigma is the world‐class quality, such that 99.99966% of results are error free, corresponding to 3.4 defects per million opportunities.In many Chinese clinical laboratories, the Westgard multiplication rules (13s, 22s, R4s, 41s, 10x) have been widely used in clinical chemistry. In this method, there may be more false rejection, waste of quality control materials and prolonged test awaiting time (TAT), whereas the sigma metrics approach allows a laboratory to take a broader view of the data, joining estimates of bias and imprecision into a practical judgment on the clinical usefulness of the method's quality control criteria. Thus, it is useful and simple to access and choose optimal internal quality control criteria based on sigma metrics.The objective of this study is to evaluate the performances of

Journal

Journal of Clinical Laboratory AnalysisWiley

Published: Jan 1, 2018

Keywords: ; ;

References

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