Application of Sigma Metrics Analysis for the Assessment and Modification of Quality Control Program in the Clinical Chemistry Laboratory of a Tertiary Care Hospital
Application of Sigma Metrics Analysis for the Assessment and Modification of Quality Control Program in the Clinical Chemistry Laboratory of a Tertiary Care Hospital
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DOI：
10.1007/s12291-016-0565-x
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发表时间：
2017-03-01
影响因子：
2.1
通讯作者：
Mustansar, Tazeen
中科院分区：
文献类型：
--
作者：
Iqbal, Sahar;Mustansar, Tazeen
Sigma是一个度量标准，它将过程的性能量化为每百万次机会的缺陷率。在临床实验室中，西格玛计量分析被用于评估实验室流程系统的性能。西格玛度量也被用作实验室过程的质量管理策略，通过识别错误后的处理来提高质量。本研究的目的是用西格玛度量法评价实验室系统分析相质量控制的误差。为此，利用内部和外部质量控制作为质量指标，对分析物进行了西格玛计量分析。利用西格玛计量分析的结果，找出实验室质量控制程序策略的差距和需要修改的地方。对葡萄糖、氯化物、胆固醇、甘油三酯、高密度脂蛋白、白蛋白、直接胆红素、总胆红素、蛋白质和肌酐等10种临床化学分析物在两个控制水平下的质量控制程序进行Sigma度量计算。分别用内部质量控制数据和外部质量控制数据计算西格玛度量不精度和偏差。最小可接受的性能被认为是3西格玛。采用Westgard sigma规则定制质量控制程序。西格玛水平可接受(
Sigma is a metric that quantifies the performance of a process as a rate of Defects-Per-Million opportunities. In clinical laboratories, sigma metric analysis is used to assess the performance of laboratory process system. Sigma metric is also used as a quality management strategy for a laboratory process to improve the quality by addressing the errors after identification. The aim of this study is to evaluate the errors in quality control of analytical phase of laboratory system by sigma metric. For this purpose sigma metric analysis was done for analytes using the internal and external quality control as quality indicators. Results of sigma metric analysis were used to identify the gaps and need for modification in the strategy of laboratory quality control procedure. Sigma metric was calculated for quality control program of ten clinical chemistry analytes including glucose, chloride, cholesterol, triglyceride, HDL, albumin, direct bilirubin, total bilirubin, protein and creatinine, at two control levels. To calculate the sigma metric imprecision and bias was calculated with internal and external quality control data, respectively. The minimum acceptable performance was considered as 3 sigma. Westgard sigma rules were applied to customize the quality control procedure. Sigma level was found acceptable (