Westgard西格玛规则在临床血液学检验项目室内质量控制规则选择中的应用

摘要

目的：利用Westgard西格玛规则帮助某实验室选择适当的临床血液学检验项目室内质量控制（简称室内质控）规则。方法选择1家参加2013年卫生部临床检验中心血细胞计数室间质量评价（简称室间质评）和室内质控计划的实验室，用实验室室内质控累积变异系数（CV）作为测量不精密度的估计值，将该实验室在室间质评计划中的百分差值作为该实验室的偏移估计值，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Westgard西格玛规则为实验室血液学检验各项目选择适当的质量控制规则。结果采用生物学变异导出要求的TEa，全血细胞计数各项目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，血红蛋白和血小板的σ值分别为5.20和5.13，应使用13s/22s/R4s规则；采用我国卫生行业标准，血红蛋白和血细胞比容的σ值分别为4.35和4.62，应使用13s/22s/R4s/41s规则。结论 Westgard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和质量控制测定值个数。%Objective To use Westgard sigma rules in selecting suitable internal quality control rules for clinical hematology tests. Methods A laboratory which participated complete blood count external quality assessment and internal quality control of the National Center for Clinical Laboratories in 2013 was enrolled. 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.σvalue was calculated, and suitable internal quality control rules were selected by Westgard sigma rules. Results When using TEa based on biological variation,13s/22s/R4s/41s/8x multi-rules were selected for all complete blood counts whoseσvalues were< 4. If TEa in CLIA'88 was employed,13s/22s/R4s multi-rules were selected for hemoglobin and platelet whose σvalues were 5.20 and 5.13. When TEa in national health industry standard was used,13s/22s/R4s/41s multi-rules were suitable for hemoglobin and hematocrit whoseσvalues were 4.35 and 4.62. Conclusions Westgard sigma rules are convenient and feasible,and laboratories can use them for selecting internal quality control rules correctly.