基于生物学变异的质量规范和六西格玛管理方法在临床生化质量控制中的应用研究

目的探讨基于生物学变异的质量规范和六西格玛(6σ)管理方法在临床生化质量控制中的应用研究。方法根据Westgard生物学变异数据库提供的质量规范,对28个临床生化项目计算西格玛(σ)值;允许不精密度百分变异系数(CV%)表示]的数据是采用本实验室2018年3-9月室内质控数据;百分偏倚(bias%)的数据是采用2018年第二次卫生部临床生化室间质评比对的偏倚数据;根据σ值和功效函数图选择合适的质控规则,以及根据质量目标指数(QGI)查找出不合格项目的主要原因,为实验室全面质量控制管理奠定坚实的基础。结果28个临床生化项目中,有2个、9个和15个项目分别选择了最低、合适和最佳的CV%生物学变异质量规范,Na和Mg未能达到最低目标要求;分别有12个和10个选择了合适和最佳的bias%生物学变异质量规范,Na、Cl、Ca、ALB、TP未能达到最低目标要求;分别有5个、11个和4个选择了最低、合适和最佳的允许总误差(TEa)生物学变异质量规范,GLU、Ca、TP、Na、Cl、Mg、ApoA1、ApoB未能达到6σ目标要求。未能达到6σ目标要求的项目,通过计算QGI值发现需要优先改进精密度的项目占87.5%。结论运用生物学变异不同水平的质量规范和6σ质量管理方法,可以有效地提高临床实验室质量水平,是临床实验室开展质量控制的一项有效的管理工具。

Application of quality specification based on biological variation and six-sigma quality management theory in planning quality control strategy of clinical biochemistry

Objective To discuss the value of biological variation data and six-sigma(6σ)quality management theory for setting quality specifications and assessing laboratory results of clinical biochemistry.Methods According to the quality specification provided by the Westgard biological variation database,σvalues were calculated for 28 clinical biochemical test items based on different biological variation.The data of coefficient of variation(CV%)was based on the laboratory′s indoor quality control data from March to September 2018.The biased data was based on the bias data of the second clinical biochemical inter-laboratory quality comparison in the department of health in 2018.Select the appropriate quality control rules according to theσvalues and power function graph,and find out the main reasons of unqualified projects according to the quality goal index(QGI),so as to provide a solid foundation for the overall quality control management of the laboratory.Results Among the 28 clinical biochemical test items,2,9 and 15 items selected the lowest,appropriate and best CV%as biological variation quality standards respectively,while Na and Mg failed to meet the requirements;12 and 10 items selected the appropriate and optimal bias%as biological variation quality standards respectively,and Na,Cl,Ca and ALB,TP failed to meet the requirements;5,11 and 4 selected the lowest,appropriate and optimalσas biological variation quality standards respectively,and GLU,Ca,TP,Na,Cl,Mg,ApoA1 and ApoB failed to meet the 6σrequirements.There were 87.5%of the items failed to meet the goal of 6σ,which need to improve the precision first.Conclusion The application of biological variation of quality standards and 6σquality management method can effectively improve the quality level of clinical laboratories,and is an effective management tool for quality control in clinical laboratories.