摘要
目的应用标准化6σ质量管理方法,评价高压液相色谱(HPLC)全自动糖化血红蛋白分析仪使用国产与进口不同过滤器检测方法性能。方法糖化血红蛋白(HbA1c)分析仪中使用的过滤器耗材,2023年上半年用国产替代,下半年改用进口原装。基于上海市临床检验中心(SCCL)对HbA1c允许总误差(TEa)标准,以2023年SCCL室间质评回报结果和室内质控(IQC)为依据,计算σ度量。使用Excel软件制作标准化6σ方法性能决定图,评价HbA1c的方法性能,计算质量目标指数(QGI),实现质量持续改进。结果HbA1c在2023年上半年和下半年偏倚(Bias)分别为2.15和0.94,室内质控低、高值的变异系数(CV)分别为1.38、1.23和1.46、0.85,TEa为6,计算σ度量分别为2.79和4.71,QGI分别为1.04和0.54。结论应用6σ质量管理方法对检测项目性能进行整体评价,有助于质量持续改进;若需要更改分析仪器中使用的耗材品牌,必须进行性能验证,通过后方可使用。
Objective To apply standardized 6σquality management methods and evaluate the performance of high-pressure liquid chromatography(HPLC)fully automatic glycated hemoglobin analyzer using different domestic and imported filter detection methods.Methods The filter consumables used in the hemoglobin A1c(HbA1c)analyzer were replaced by domestic products in the first half of 2023 and imported original products in the second half.Based on the allowable total error(TEa)standard for HbA1c set by the Shanghai Clinical Laboratory Center(SCCL),and the 2023 SCCL inter laboratory quality assessment report and indoor quality control(IQC)were used as the basis,and the sigma metric was calculated.Excel software was used to create a standardized 6σmethod performance determination chart,the method performance of HbA1c was evaluated,the Quality Objective Index(QGI)was calculated,so as to achieve continuous quality improvement.Results The bias of HbA1c in the first and second half of 2023 was 2.15 and 0.94,respectively.The coefficient of variation(CV)for low and high values in indoor quality control was 1.38,1.23,and 1.46,0.85,respectively.The TEa was 6,and the calculated sigma measures were 2.79 and 4.71,respectively.The QGI was 1.04 and 0.54,respectively.Conclusion Applying the 6σquality management method to evaluate the overall performance of testing projects is helpful for continuous quality improvement.If it is necessary to change the brand of consumables used in the analytical instrument,performance verification must be conducted and approved before use.
作者
胡海强
胡嘉琪
赵宗惠
林晓菲
周翎
HU Haiqiang;HU Jiaqi;ZHAO Zonghui;LIN Xiaofei;ZHOU Ling(Department of Clinical Laboratory,Shanghai Putuo People's Hospital,Tongji University,Shanghai 200060,China)
出处
《国际检验医学杂志》
CAS
2024年第S02期92-95,共4页
International Journal of Laboratory Medicine
