临床环境中分析生物化学过程中基于运行大小的 Westgard Sigma 规则的实际应用。
Practical application of Westgard Sigma rules with run size in analytical biochemistry processes in clinical settings.
机构信息
Department of Clinical Laboratory, Shengzhou People's Hospital, Shengzhou Branch of the First Affiliated Hospital of Zhejiang University, Shengzhou, China.
Key laboratory of digestive system diseases of Shengzhou, Shengzhou People's Hospital, Shengzhou, China.
出版信息
J Clin Lab Anal. 2021 Mar;35(3):e23665. doi: 10.1002/jcla.23665. Epub 2020 Dec 3.
BACKGROUND
The performance of 18 routine chemical detection methods was evaluated by the sigma (σ) metric, and Westgard Sigma rules with run size were used to establish internal quality control (IQC) standards to reduce patient risks.
MATERIALS AND METHODS
External quality assessment (EQA) and internal quality control data from 18 assays in a biochemical laboratory were collected from January to June 2020. The sigma values of each assay were calculated, based on the bias, total error allowable, and coefficient of variation, appropriate quality control rules were selected. According to the quality goal index, the main causes of poor performance were determined to guide quality improvement.
RESULTS
At IQC material level 1, seven of the 18 assays achieved five sigma (excellent), and five assays (UA, Crea, AMY, TC and Na) showed world-class performance. At IQC material level 2, 14 of the 18 assays achieved 5 sigma (excellent), and thirteen assays (UA, ALT, CK, Crea, AMY, K, AST, ALP, Na, LDH, Mg, TC and GGT) showed world-class performance. The quality goal index (QGI) was calculated for items with analysis performance <5 sigma, and the main causes of poor performance were determined to guide quality improvement.
CONCLUSIONS
Westgard sigma rules with run size are an effective tool for evaluating the performance of biochemical assays. These rules can be used to more simply and intuitively select the quality control strategy of related items and reduce the risk to patients.
背景
采用西格玛（σ）度量法评估了 18 项常规化学检测方法的性能，并采用带有运行规模的 Westgard Sigma 规则来制定内部质量控制（IQC）标准，以降低患者风险。
材料和方法
从 2020 年 1 月至 6 月，收集了生化实验室的 18 项检测的外部质量评估（EQA）和内部质量控制数据。根据偏倚、总允许误差和变异系数计算每个检测的σ值，选择适当的质量控制规则。根据质量目标指标，确定性能不佳的主要原因，以指导质量改进。
结果
在 IQC 材料水平 1 时，18 项检测中有 7 项达到 5σ（优秀），5 项检测（UA、Crea、AMY、TC 和 Na）显示出世界级的性能。在 IQC 材料水平 2 时，18 项检测中有 14 项达到 5σ（优秀），13 项检测（UA、ALT、CK、Crea、AMY、K、AST、ALP、Na、LDH、Mg、TC 和 GGT）显示出世界级的性能。对于分析性能<5σ的项目计算质量目标指数（QGI），确定性能不佳的主要原因，以指导质量改进。
结论
带有运行规模的 Westgard Sigma 规则是评估生化检测性能的有效工具。这些规则可用于更简单、直观地选择相关项目的质量控制策略，降低患者风险。
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