应用西格玛进行血清ALT,Cr,Glu检测项目的性能验证

目的 应用西格玛指标评价临床生化检验性能,了解广东省计划生育系统各级计划生育机构临床生化的检验质量现状,以其发现问题,促进质量提高.方法 通过向广东省19家计划生育机构实验室发放相同批号质控品,进行丙氨酸氨基转移酶（ALT）、肌酐（Cr）、血糖（Glu）项目的室内质控室间比对,计算各实验室室内质控结果,剔除离群值后的均值（x）、标准差（s）、室内变异系数（CV）、偏倚（bias）、西格玛（σ）值和质量目标指数（QGI）.结果 ALT,Cr和Glu大于6σ检测性能的实验室分别占16.68％,17.65％和35.29％;3≤σ＜6检测性能的实验室分别占44.44％,29.41％和35.29％.77％以上的实验室在检测ALT,Cr和Glu项目需从精密度和（或）正确度进行改进.结论 广东省计划生育机构实验室临床生化的检验性能有待提高,应用6σ评价室内质控室间比对,能将实验室的检测性能定量化,有助于检验质量的持续改进.

Applying Sigma to Evaluate the Performance of Clinical Biochemistry Test

Objective To evaluate the performance of clinical biochemistry test so that can understand the current status of clinical biochemical testing quality at all levels of family planning system of Guangdong provincial family planning agency,find problems,and promote quality improvement with the index of sigma.Methods The same batch internal quality control （IQC） materials were emailed to 19 family planning agencies laboratories for alanine aminotransferase （ALT）,creatinine （Cr） and blood glucose （Glu） test,and comparison between indoor quality control.Without the outliers,the mean value （x）,standard deviation （s） and the coefficient of variation （CV）,bias,sigma value （σ） and quality target index （QGI） were calculated.Results Sigma value of ALT,Cr and Glu were greater than 6σ detection performance accounted for 16.68％,17.65％ and 35.29％ respectively.The sigma value between 3 and 6 detection performance accounted for 44.44％,29.41％ and 35.29 ％ respectively.More than 77％ laboratories improved the precision and （or） accuracy in the detection of ALT,Cr and Glu.Conclusion Guangdong Provincial Family Planning Agency clinical biochemistry laboratory test performance needs to be improved.Application of 6 σ evaluation of indoor quality control interlaboratory comparison can quantify the detection performance of laboratory,and is helpful to the quality inspection continuous improvement.