6σ管理方法在临床实验室分析前质量控制中的应用研究

Application of 6σ management method in preanalytical quality control of clinical laboratory

目的应用6σ方法寻找临床实验室分析前质量缺陷的原因,提出改进方法,建立分析前质量控制综合管理体系,降低分析前缺陷数(率)。方法建立分析前面质量缺陷登记数据库系统,采用用于6σ管理的Minitab○RRelease 14和SPC XL2000○R软件对样本的检验分析前质量缺陷类型、影响因素进行测量、分析和评价,并对过程改进前后的资料进行对比分析。结果临床实验室分析前影响质量的因素共有11类。在过程改进以后,影响质量的因素控制水平由81.82%(9/11)提高到100.00%(11/11),样本送检缺陷数(率)由44 996件(4.50%)降低到2 075件(0.21%),样本送检合格率由95.50%提高到99.79%,分析前质量总体水平由3.20σ提高到4.37σ。结论6σ管理是一项有效的临床实验室分析前质量控制的管理工具,有助于发现影响分析前质量的潜在因素,全面提高临床实验室分析前质量水平,降低分析前缺陷数(率)。

Objective To investigate the causes of the defects on the preanalytical quality in clinical laboratories by applying 6σ management method, for improving preanalytical quality level. Methods We established the preanalytical defects recording database system for clinical laboratory, and using Minitab Release 14 and SPC XL 2000 software for 6σ management, we measured, analyzed and appraised the catogories of influence factors of the preanalytical quality defects of the samples in the preanalytical quality control processes, and carried on the parallel hypothesis tests for the the data before and after the process improvements. Results There are 11 categories of the influent factors of the preanalytical quality. The control level of the influence factors has increased from 81.82% （9/11 ） to 100% （11/11 ） of all the categories, the quality defects quantities （rates） have decreased from 44996 （4.50 % ） to 2075 （0.21% ）, but the qualified percentage of the samples has increased from 95.50% to 99.79% , the total preanalytical quality level has been promoted from 3.2σ to 4.37σ respectively, before and after the process improvements. Conclusions 6σ management is an effective tool for preanalytical quality control, it is helpful for finding out the latent influence factors to the preananlytical quality, promoting the preanalytical quality level and decreasing the preanalytical defects quatities （rates） in the clinical laboratories.