摘要
目的利用西格玛规则帮助本实验室选择适当的临床干化学检验项目室内质量控制(简称室内质控)规则。方法收集本实验室2017年全国室间质量评价干化学的3次回报结果以及全年室内质量控制数据和2018年上半年全国室间质量评价干化学的2次回报结果以及半年室内质量控制数据,计算室内质控累积变异系数(CV)并且作为测量不精密度的估计值,将室间质评计划中的百分差值作为偏移估计值,采用生物学变异导出要求、美国临床实验室改进修正法案(CLIA′88)能力验证评价限和我国卫生行业标准WS/T406-2012的允许总误差(TEa)作为质量规范,计算各项目的σ值,根据σ值利用西格玛规则为本实验室干化学检验各项目选择适当的质量控制规则,并结合质量要求,计算QGI值,查找导致性能不佳的主要原因并改进。结果采用生物学变异导出要求的TEa,除UREA、TBIL、ALT、GGT外各项目σ值均<4,应使用13s/22s/R4s/41s/8x规则;采用美国CLIA′88能力验证评价限,K、NA、CL、UREA、TP、ALB、ALT的σ值均<4,应使用13s/22s/R4s/41s/8x规则;采用我国卫生行业标准,UA、GGT的σ值均>4,应使用13s/22s/R4s/41s规则。采用生物学变异导出要求的TEa,UREA、TBIL、GGT的σ值均>6,采用美国CLIA′88能力验证评价限,CA、ALP的σ值均>6,按QGI要求可以不进行性能改进。采用3种TEa,2018年相比2017年干化学各项目的σ值由2.97,4.24,2.72分别提高到3.05,5.01,3.02。结论西格玛规则是一种方便、实用的质量控制规则选择工具,实验室可利用它得到正确的质量控制规则,可为质量改进提供明确方向。
Objective To use sigma rules in selecting suitable internal quality control rules for clinical dry chemistry tests.Methods The data from internal quality control and external quality assessment in clinical laboratory were collected for the clinical dry chemistry tests in 2017 and 2018.Accumulated coefficient of variation( CV ) in internal quality control was regarded as the estimation value of imprecision,and the percentage difference in external quality assessment was chosen to be the estimation value of bias.The allowable total errors(TEa) based on biological variation, the Clinical Laboratory Improvement Amendments of 1988(CLIA′88)and national health industry standard WS/T406-2012 were adopted as quality specification.σ value was calculated,and suitable internal quality control rules were selected by sigma rules.Results When using TEa based on biological variation,13s/22s/R4s/41s/8x multi-rules were selected for the tests whose σ values were< 4.If TEa in CLIA′88 was employed,13s/22s/R4s/41s/8x multi-rules were selected for K、NA、CL、UREA、TP、ALB、ALT whose σ values were < 4.When TEa in national health industry standard was used,13s/22s/R4s/41s multi-rules were suitable for UA、GGT whose σ values was > 4.According to quality goal index (QGI) requirements,quality improvement need not to be performed when σ values was > 6.The sigma average quality level increased from 2.97,4.24,2.72 (2017) to 3.05,5.01,3.02 (2018).Conclusion Sigma rules are convenient and feasible,and laboratories can use them for selecting internal quality control rules correctly.They can provide clear direction for quality improvement.
作者
郭金虎
方欢英
吴文娟
马俊
GUO Jinhu;FANG Huanying;WU Wenjuan;MA Jun(Department of Laboratory Medicine,Shanghai East Hospital,Tongji University School of Medicine,Shanghai 200120,China)
出处
《国际检验医学杂志》
CAS
2019年第A01期4-7,共4页
International Journal of Laboratory Medicine
基金
上海市浦东新区卫生系统重点学科建设资助,(PWZxk2017-09)
上海市市级医疗卫生优秀学科带头人培养计划资助(2017BR032)。
关键词
干化学
室内质量控制
西格玛规则
internal quality control
quality management
westgard sigma rules
