Application of Sigma Metrics for Evaluating Analytical Performance of HbA1C Testing on D10- HbA1C Analyzer

B. P. Magar, Amit Thapa, Shreeman Acharya, Narayan Ghimire, Sanjiv Kumar Pandey, R. Rokaya, Suman Lamichhane
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Abstract

In this study, analyzed HbA1C over a period of 6 months. Six Sigma improves the quality of process outputs by analyzing and eliminating the source of defects and reducing variability in manufacturing and business practices. In terms of clinical laboratory, the identification of test with low Sigma values (< 3σ) indicate that actions should be taken to improve analytic quality or the laboratory should use alternate methods and reagents. Our study showed methodologies for HbA1C is of world class performance achieving Sigma value ˃6, to maintain and improve this frequency of QC should be run as rule as per the westguard QC rule. Sigma metrics helps to assess analytical methodologies and augment laboratory performance. It acts as a guide for planning quality control strategy. It can be a self -assessment tool regarding the functioning of clinical laboratory. Using Six Sigma techniques, able to identify problem areas as well as recurring issues that affect the overall quality expectation of laboratory result. Keywords: HbA1C, Six Sigma, Six Sigma values
应用西格玛指标评估 D10- HbA1C 分析仪的 HbA1C 测试分析性能
在这项研究中,对 6 个月内的 HbA1C 进行了分析。六西格玛通过分析和消除缺陷源,减少生产和业务实践中的变异性,从而提高流程产出的质量。就临床实验室而言,如果发现西格玛值较低(< 3σ)的检验项目,则表明实验室应采取措施提高分析质量,或使用替代方法和试剂。我们的研究表明,HbA1C 的检测方法具有世界一流的性能,西格玛值达到了 ˃6,为了保持和提高质量控制的频率,应按照 westguard 质量控制规则的规定进行。西格玛指标有助于评估分析方法和提高实验室绩效。它是规划质量控制策略的指南。它可以作为临床实验室运作的自我评估工具。利用六西格玛技术,能够识别问题领域以及影响实验室结果整体质量预期的反复出现的问题。关键词HbA1C 六西格玛 六西格玛值
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