目的：评估国内行业标准（WS／T 403-2012，临床生物化学检验常规项目分析质量指标）和国家标准（GB／T 20470-2006，临床实验室室间质量评价要求）提供的允许总误差在σ度量评估临床生化检测项目分析质量应用中的差异，用操作过程规范图（OPSpecs 图）来选择适当的质控程序。方法从卫生部临床检验中心2014年2月常规化学室内质控数据及2014年第一次常规化学室间质评中获得某一家实验室21个检测项目的变异系数（CV％）及百分差值（用其估计偏倚大小），利用国内行业标准（WS／T 403-2012）和国家标准（GB／T 20470-2006）提供的允许总误差计算两个批次质控品的σ值。使用临床检验定量测定室内质量控制设计软件（QCCS）绘制21个项目的操作过程规范图（OPSpecs 图），根据该图选择质控程序。结果使用国内行业标准（WS／T 403-2012）得到的σ值在0～7之间。而使用国家标准（GB／T 20470-2006）计算的σ值大多在3～15之间。在标准化方法决定图上，使用国家标准（GB／T 20470-2006）提供的允许总误差评估的试验分析性能普遍比使用国内行业标准（WS／T 403-2012）得到的高至少一个层级。使用国内行业标准（WS／T 403-2012）制定的质控程序明显比在国家标准（GB／T 20470-2006）下制定的质控程序严格。使用国内行业标准制定的质控程序中，多规则检测四次的有：ALB，ALP，Ca，Cl，TC，Crea，Glu，LDH，K，Na，TP，TG 和 Urea；13 s 检测四次的有：Mg；12.5 s 检测两次的有：CK，AMY 和 Fe；13 s 检测两次的有：TBIL；13.5 s 检测两次的有：ALT，AST 和 UA。结论国内行业标准（WS／T 403-2012）提供的允许总误差较国内行业标准（WS／T 403-2012，临床生物化学检验常规项目分析质量指标）严格，临床实验室还需要不断提高其检测质量水平。%Objective To evaluate the difference of two sources of allowable total errors provided by National Health Industry Standard (WS/T 403-2012,analytical quality specification for routine analytes in clinical biochemistry)and National Stand-ard (GB/T 20470-2006,requirements of external quality assessment for clinical laboratories)in assessing the analytical qual-ity byσmetrics,and selecting quality control procedures using operational process specifications graphs.Methods Selected one of the laboratories participating in the internal quality control activity of routine chemistry of February,2014 and the first time external quality assessment activity of routine chemistry in 2014 organized by National Center for Clinical Labora-tories for its coefficient of variation and the bias of nineteen clinical chemistry tests.With the CV% and Bia%,σmetrics of controls at two analyte concentrations were calculated using two different allowable total errors targets (National Health In-dustry Standard (WS/T 403-2012)and National Standard (GB/T 20470-2006).Could obtain a operational process specifica-tions graph by which Could select quality control procedures using the Quality control computer simulat software developed by National Center for Clinical Laboratories and the company zhongchuangyida.Results The σ metrics under National Health Industry Standard (WS/T 403-2012)were from 0 to 7.Most of the values (86% and 76.2%)under National Stand-ard (GB/T 20470-2006)were from 3 to 15.On the normalized method decision chart,the assay quality using the allowable total errors targets of National Standard (GB/T 20470-2006)was at least one hierarchy more than one using National Health Industry Standard (WS/T 403-2012).The quality control rules under National Health Industry Standard (WS/T 403-2012)were obviously more strict than that under National Standard (GB/T 20470-2006).Among the control procedures using National Health Industry Standard (WS/T 403-2012),multirule (n=4):ALB,ALP,Ca,Cl,TC,Crea,Glu,LDH,K, Na,TP,TG and Urea;13s (n=4):Mg;12.5s (n=2):CK,AMY ang Fe;13s (n=2):TBIL;13.5s (n=2):ALT,AST and UA.Conclusion The allowable total errors provided by National Health Industry Standard (WS/T 403-2012)are more stringent than that from National Standard (GB/T 20470-2006).So Laboratories need to improve the analytical quality of their tests furthermore.
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