6σ质量管理体系在临床化学分析中的应用研究

Research of Application of 6σ Quality Management System During Clinical Chemistry Analysis

目的以Beckman LX20全自动生化分析系统为平台,进行6σ质量管理体系在临床化学分析中的应用研究,证明6σ质量标准能指导临床化学检验更系统、深入地进行全面质量管理,更好地为临床诊疗服务。方法1用Beckman公司提供的Beckman LX20全自动生化分析仪及配套试剂构建LX20分析系统;以Beckman公司提供的校准液及低、中、高定值质控物对该分析系统进行溯源、校准、系统证实。2确定该系统检测有可溯源性,校准通过,系统证实可靠。3低、中、高定值质控物连续测定30d,计算各检测项目的-x,s以及与各项目定值的偏差bias(bias=-x-T);根据CLIA’88查找各参数的最大允许误差(TEa)。4根据公式σ=(TEa-bias)/s计算其各参数的σ值。结果低值各项目σ值在4.2～7.3之间,中值各项目σ值在4.4～7.6之间,高值各项目σ值在4.1～9.3之间。结论6σ质量标准能指导实验室人员在临床化学检验方面更系统、深入地进行全面质量管理。

Objective To study 6σ quality management system during clinical chemistry analysis by using Beckman LX20 automatic biochemistry analysis system and identify that 6σ can direct us to serve the clinic better. Methods （1）LX20 analysis system was established by reagents offered by Beckman company;According to the titer and the criterion liquid of low ,middle and high what offered by Beckman company,could put up the trace of the origin ,the calibration and the confirmation of this system. （2）Could make certain that test of the system showed its trace,standardization and reliability. （3）Evaluate quality control agents of low,middle and high were detected 30 days continuously. x,s in every detection item and deviation bias （bias =x-T） were calculated. Maximum errors excepted of parameter was found according CLIA＇ 88. （4）The value of every parameter was calculated according to the formula σ= （TEa-bias）/s. Results The value of a in low was between 4.2 and 7.3,that in middle was between 4.4 and 7.6,that in high was between 4.1 and 9.3. Conclusion 6σ quality standard can direct lab personnel to carry out quality management systematically.