分析批长度Westgard西格玛规则图在甲状腺功能检查项目质控中的应用
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摘要
目的运用分析批长度Westgard西格玛规则图选择甲状腺功能项目的质控策略,降低患者的风险。方法采用实验室室内在控的累积不精密度(CV)和2018年参加第二次临床检验中心的室间质评的结果与靶值之间的偏倚(Bias),并采用2017年卫生部临床检验中心内分泌室间质评性能规范中的总允许误差(Tea),计算各项目的西格玛(σ)值,再根据分析批长度Westgard西格玛规则流程图选择相应的质控数目、质控次数、质控规则及分析批长度。结果甲状腺功能项目的σ值分别为TSH:5.71,FT4:8.48,T4:3.54,T3:5.04和FT3:3.84。根据流程图FT4采用1_(3s),N=2,R=1,分析批长度为1 000;TSH和T3采用多规则1_(3s)/2_(2s)/R_(4s),N=2,R=1,分析批长度为450;FT3和T4采用多规则1_(3s)/2_(2s)/R_(4s)/4_(1s)/6x,N=6,R=1,分析批长度为45。结论分析批长度Westgard西格玛规则流程图是一种新的基于风险的统计质量控制(SQC)工具,运用它更能简单直观选择相关项目的质控策略,减少患者风险。
引文
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[2] 费阳,王薇,王治国.临床检验室内质量控制规则设计新工具-Westward西格玛规则[J].现代检验医学杂志,2015,30(1):149-152.FEI Yang,WANG Wei,WANG Zhiguo.A new internal quality control rules design tool in clinical laboratory-Westgard sigma rules[J].Journal of Modern Laboratory Medicine,2015,30(1):149-152.
[3] 中华人民共和国家卫生健康委员会.WS/T641-2018临床检验定量测定室内质量控制[S].北京:中国标准出版社,2018.National Health Commission of People’s Republic of China.WS/T641-2018 Guideline for internal quality control for quantitative measurements in clinical laboratory[S].Beijing:China Standard Press,2018.
[4] Clinical and Laboratory Standards Institute.Statistical quality control for quantitative measurement procedures:principles and definitions[S].Wayne,PA:Clinical and Laboratory Standards Institute C24A3Ed4,2016.
[5] WESTGARD J O.Basic quality control practices[M].4th Ed.Madison (WI):Westgard QC,2016:148-151.