常规干式生化检测项目6σ质量管理法IQC方案的建立

Establishment of routine dry biochemical test IQC rules based on six sigma quality management method

目的采用6西格玛(σ)质量管理方法设计常规干式生化检测项目的室内质量控制(IQC)方案,提高质控效率,改善检测系统性能。方法收集2017年12月2018年5月质控在控的16个干式生化常规检测项目的IQC数据,计算项目的不精密度,利用江苏省室间质量评价结果计算项目偏移,以每个项目的生物学变异系数(CV)为允许总误差(TEa),设计符合实验室的IQC方案,并通过计算目标指数查找需优先改进的项目性能特征。结果丙氨酸氨基转移酶(ALT)、尿素(Urea)、肌酸激酶(CK)IQC方案设计为13s(N=2,R=1),血清总胆红素(TB)质控方案设计为13s/22s/R4s(N=2,R=1),总蛋白(TP)、肌酐(Cr)、尿酸(UA)、葡萄糖(Glu)、钾(K)、氯(Cl)、钙(Ca)IQC方案设计为13s/22s/R4s/41s(N=2,R=2),白蛋白(Alb)、天门冬氨酸氨基转移酶(AST)、乳酸脱氢酶(LDH)、钠(Na)、淀粉酶(AMY)IQC方案设计为13s/22s/R4s/41s/8x(N=2,R=4),均需优先改进精密度。结论不同检测项目性能特征不同,IQC方案应符合实际情况,以满足临床要求。

Objective To apply the six sigma(σ)quality management method designing internal quality control(IQC)rules of routine dry biochemical test.Methods The 16 dry biochemical tests'IQC data under control were collected from December 2017 to May 2018,and the imprecision was calculated.The bias was calculated using the external quality assessment of Jiangsu Province.The coefficient of variation(CV)was used as allowable total error(TEa),and the design of IQC rules conformed to the actual IQC.By the quality control index,the performance characteristics of the tests that needed to be improved were found.Results The alanine aminotransferase(ALT),urea(Urea)and creatine kinase(CK)IQC rules were designed to be 13s(N=2,R=1),and the total bilirubin(TB)IQC rules were designed as 13s/22s/R4s(N=2,R=1).Total protein(TP),creatinine(Cr),uric acid(UA),glucose(Glu),K,Cl and Ca IQC rules were designed as 13s/22s/R4s/41s(N=2,R=2),and albumin(Alb),aspartate aminotransferase(AST),lactate dehydrogenase(LDH),Na and amylase(AMY)IQC rules were designed as 13s/22s/R4s/41s/8x(N=2,R=4).All tests were needed to be optimized the performance characteristics of imprecision.Conclusions The IQC method meeting the actual requirements and the clinical quality requirements has been established.