分析批长度Westgard西格玛规则在酶学室内质量控制中的应用

Application of analytical batch length Westgard sigma rule in enzymological laboratory internal quality control

目的运用分析批长度Westgard西格玛(σ)规则为酶学室内质量控制设置合理的质控策略。方法收集盘锦辽油宝石花医院2020年参加国家临检中心室间质量评价数据及本实验室室内质量控制数据作为偏倚及变异系数。采用国家卫健委颁布的《临床生物化学检验常规项目分析质量指标》(卫生行业标准WS/T403-2012)提供的允许总误差作为规范,计算σ度量,根据分析批长度Westgardσ规则选择质控策略,计算质量目标指数,评价酶学的分析性能。结果酶学各项目中,2个项目的σ≥6,选择1_(3s)规则,分析批长度为1000;2个项目的σ水平为6>σ≥5,质控规则为1_(3s)/2_(2s)/R_(4s),每450个测试做一次质控;2个项目的σ水平为5>σ≥4,质控规则为1_(3s)/2_(2s)/R_(4s)/4_(1s),每200个测试做一次质控;1个项目的σ水平为4>σ≥3,质控规则为1_(3s)/2_(2s)/R_(4s)/4_(1s)/6_(x),每45个测试做一次质控。结论分析批长度Westguardσ规则是一种基于患者风险的质控策略,能够优化质控策略,改进质量方案,提高实验室的检测能力。

Objective Using the Westgard sigma(σ)rule of analytical batch length to set up a reasonable quality control strategy for the indoor quality control of enzymology.Methods Data of Panjin Liaoyou Baoshihua Hospital participating in the national laboratory quality evaluation center in 2020 and data of laboratory indoor quality control were collected as bias and coefficient of variation.The allowed total error provided by the Quality Index of Routine Item Analysis of Clinical Biochemical Tests issued by the National Health Commission(health industry standard WS/T403-2012)was used as the criterion to calculate theσmeasure,select the quality control strategy according to the Westgardσrule of analytical batch length,calculate the quality objective index,and evaluate the analytical performance of enzymology.Results Among all enzymology items,2 items had aσ≥6;the 1_(3s)rule was selected,and the analytical batch length was 1000.Theσlevels of 2 items were 6>σ≥5;the quality control rule was 1_(3s)/2_(2s)/R_(4s),and the quality control was conducted every 450 tests.Theσlevels of 2 items were 5>σ≥4;the quality control rule was 1_(3s)/2_(2s)/R_(4s)/4_(1s),and the quality control was conducted every 200 tests.Theσlevel of 1 item was 4>σ≥3;the quality control rule was 1_(3s)/2_(2s)/R_(4s)/4_(1s)/6_(x),and the quality control was conducted every 45 tests.Conclusion The analytical batch length Westgardσrule is a patient-risk-based quality control strategy that optimizes quality control strategies,improves quality programs,and improves laboratory testing capabilities.