International Journal of Clinical Biochemistry and Research

Print ISSN: 2394-6369

Online ISSN: 2394-6377

CODEN : IJCBK6

International Journal of Clinical Biochemistry and Research (IJCBR) open access, peer-reviewed quarterly journal publishing since 2014 and is published under auspices of the Innovative Education and Scientific Research Foundation (IESRF), aim to uplift researchers, scholars, academicians, and professionals in all academic and scientific disciplines. IESRF is dedicated to the transfer of technology and research by publishing scientific journals, research content, providing professional’s more...


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Original Article


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253-259


Authors Details

Juby Sara Koshy*, Afsheen Raza


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Sigma metrics in quality control- An innovative tool


Original Article

Author Details : Juby Sara Koshy*, Afsheen Raza

Volume : 8, Issue : 4, Year : 2021

Article Page : 253-259

https://doi.org/10.18231/j.ijcbr.2021.055



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Abstract

Background: The clinical laboratory in today’s world is a rapidly evolving field which faces a constant pressure to produce quick and reliable results. Sigma metric is a new tool which helps to reduce process variability, quantitate the approximate number of analytical errors, and evaluate and guide for better quality control (QC) practices.
Objectives: To analyze sigma metrics of 16 biochemistry analytes using ERBA XL 200 Biochemistry analyzer, interpret parameter performance, compare analyzer performance with other Middle East studies and modify existing QC practices.
Materials and Methods: This study was undertaken at a clinical laboratory for a period of 12 months from January to December 2020 for the following analytes: albumin (ALB), alanine amino transferase (SGPT), aspartate amino transferase (SGOT), alkaline phosphatase (ALKP), bilirubin total (BIL T), bilirubin direct (BIL D), calcium (CAL), cholesterol (CHOL), creatinine (CREAT), gamma glutamyl transferase (GGT), glucose (GLUC), high density lipoprotein (HDL), triglyceride (TG), total protein (PROT), uric acid (UA) and urea. The Coefficient of variance (CV%) and Bias % were calculated from internal quality control (IQC) and external quality assurance scheme (EQAS) records respectively. Total allowable error (TEa) was obtained using guidelines Clinical Laboratories Improvement Act guidelines (CLIA). Sigma metrics was calculated using CV%, Bias% and TEa for the above parameters.
Results: It was found that 5 analytes in level 1 and 8 analytes in level 2 had greater than 6 sigma performance indicating world class quality. Cholesterol, glucose (level 1 and 2) and creatinine level 1 showed >4 sigma performance i.e acceptable performance. Urea (both levels) and GGT (level 1) showed <3> Conclusion: Sigma metrics helps to assess analytic methodologies and can serve as an important self assessment tool for quality assurance in the clinical laboratory. Sigma metric evaluation in this study helped to evaluate the quality of several analytes and also categorize them from high performing to problematic analytes, indicating the utility of this tool. In conclusion, parameters showing lesser than 3 sigma need strict monitoring and modification of quality control procedure with change in method if necessary.


Keywords: Six sigma, Westgard rule, Bias, Total allowable error, Laboratory quality control.


How to cite : Koshy J S, Raza A, Sigma metrics in quality control- An innovative tool. Int J Clin Biochem Res 2021;8(4):253-259

Copyright © 2021 by author(s) and Int J Clin Biochem Res. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License (creativecommons.org)







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