ArticlePractical laboratory medicine2021
Analysis of performance of clinical biochemistry laboratory using Sigma metrics and Quality Goal Index.
Article in Practical laboratory medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed, 19 citations in OpenAlex.
- Risk-based redesign of internal quality control procedures for emergency immunoassays in clinical laboratories: a multicenter study from China.Frontiers in medicine · 2026Article
- Article
- An assessment of analytical performance using the six sigma scale in second-trimester maternal prenatal screening practices in China.Practical laboratory medicine · 2024Article
- Quality analysis of the clinical laboratory literature and its effectiveness on clinical quality improvement: a systematic review.Journal of clinical biochemistry and nutrition · 2023Article
- Analysis of biochemical analytes using six sigma metrics with two analyzers at an Indian lab setting.Bioinformation · 2023Article
- Application of a six sigma model to evaluate the analytical performance of urinary biochemical analytes and design a risk-based statistical quality control strategy for these assays: A multicenter study.Journal of clinical laboratory analysis · 2021Article
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUnreliable and ingenuine results issued by clinical laboratories have serious consequences for the patients. Sigma metrics is a standardized tool for Quality assessment for test performance in a laboratory.
objectiveTo evaluate the performance of routine biochemistry laboratory at MMIMSR, Mullana in terms of Sigma metrics and Quality Goal Index. MATERIAL AND
methodsThis cross sectional study evaluated performance of 14 routine chemistry parameters using retrospective Internal Quality Control data of two levels on Siemens Dimension Rxl from Feb to Jul 2019 for CV% and EQAS reports from CMC, Vellore for Bias%. Sigma metrics was calculated using total allowable error targets as per CLIA and Biological Variability database guidelines.
resultsFor level-2 IQC; TG, Chol, ALP showed excellent performance with σ > 6 while σ < 3 was observed for AST, Total Protein, Glucose, BUN and ALT using CLIA guidelines while in IQC Level-3 poor performers were only BUN and ALT with Ca, TG and Chol showing σ > 6. Further by using Biological Variability data guidelines; 10 parameters of IQC Level-2 and 5 of IQC level-3 were poor performers with σ < 3.
conclusionSigma metrics is an excellent tool for performance analysis of tests performed in a clinical laboratory. Lack of precision in terms of CV% was seen for majority of the poor performers. Total allowable error targets using Biological Variability data revealed σ < 3 for 10 parameters while using CLIA guidelines σ < 3 was seen for only 5 parameters of IQC level-2.
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