临床生化项目应用不同允许总误差评价及西格玛规则进行质量管理探讨

目的 利用生化质控新批次数据累积,运用生物学变异和卫生部行业标准的不同允许总误差,用以验证何种质量标准适合该室当前质量,建立相应的质控规则进行质量管理。方法 收集四个月室内质控数据,结合生物学变异计算相对应档次的变异系数(CV)及允许总误差(TEa),以及中华人民共和国卫生行业标准WS/T403-2012《临床生物化学检验常规项目分析质量目标》的允许总误差,计算各项目的西格玛值并利用第三代Westgard Sigma规则确定控制规则、控制检测数(N)以及指定可以检测病人样品运行量大小的SQC事件频率; 同时利用质量目标指数(QGI),对实验室未达到质量检测能力的项目提供优先改进方案。结果 利用生物学变异计算出相应项目的σ值,σ<2:TP,CHE,LDH; 2≤σ<3:ALT,CREA,ALB; 3≤σ<4:AST,UREA; 4≤σ<5:ALP,GGT; 5≤σ<6:Tbil,UA; σ≥6:无。利用中华人民共和国卫生行业标准计算出的相应项目σ值,2≤σ<3:UREA,CREA; 3≤σ<4:ALT,TP; 4≤σ<5:AST,ALB; 5≤σ<6:Tbil,GGT; σ≥6:ALP,CHE,UA。结论 当前实验室生化项目适合利用卫生部行业标准进行质量控制,使用适合的质量目标等级建立质控规则,利用质量目标指数分析进行优先改进; 但部分项目并不能达到QC方法与每批可以检测样品数的完美结合,只能以此作为参考; 另以生物学变异的最佳水平作为长远目标,不断改进。

Discussion on Quality Management of Clinical Biochemical Projects Using Different Permitted Total Errors Evaluation and Sigma Rules

Objective To establish the corresponding quality control rules for quality management using the data accumulation of the new batches of biochemical quality control and apply the biological variation and the different allow total error of the standard of the ministry of health to verify which quality standard is suitable for the current quality of the laboratory.Methods Collected the data of the indoor quality controlling for four months, combined with the coefficient variation(CV)and the allow total error(TEa)for the corresponding grades calculated by biological variation,and the total allow error of Peopel's Republic of China health industry standard WS/T403-2012 Clinical Biochemical Inspection Conventional Project Analysis Quality Objective, calculated the sigma value of each item and used the third-generation westgard Sigma rule to determine the control rules and control the number of detections(N)and specified the frequency of SQC events that can detect the amount of patient sample run,at the same time, the Quality Objective Index(QGI)was used to provide priority improvement programs for projects that did not meet the quality testing capabilities of the laboratory. Results The corresponding sigma value was calculated by using biological variation: σ <2, TP, CHE, LDH. 2≤σ<3, ALT, CREA, ALB. 3≤σ < 4, AST,UREA. 4≤σ< 5, ALP, GGT. 5≤σ<6, Tbil,GGT. σ≥6, no. Made use of our national health industry standards to calculate the σ value for related projects: 2≤σ <3,UREA,CREA. 3≤σ < 4,ALT,TP. 4≤σ< 5,AST,ALB. 5≤ σ <6,Tbil,GGT. σ≥6,ALP,CHE,UA. Conclusion The current laboratory biochemical project is suitable for quality control using the health industry standards, using quality target grades to establish quality control rules, and using quality target index analysis to prioritize improvements, however, some projects cannot achieve QC methods and the number of samples that can be tested per batch. The perfect combination can only be used as a reference. The best level of biological variation is the long-term goal and continuous improvement.