基于生物学变异的质量规范在临床生化室内质量控制管理中的应用  

The application of quality specifications based on biological variation in clinical chemica internal quality control management

作　　者：栗秀芳[1] 张鸿伟[1] 黎海生[1] 

机构地区：[1]昆明市第一人民医院检验科,云南昆明650011

出　　处：《医学检验与临床》2016年第1期7-10,共4页Medical Laboratory Science and Clinics

摘　　要：目的：探讨基于生物学变异的允许不精密度（CVA）和允许总误差（TEa）质量规范在临床常规化学质量控制管理中的应用。方法：在评估本实验室现有检测系统性能特征（实际不精密度CV及偏倚Bias）的基础上，把基于生物学变异不同水平的质量规范（CV、Bias、TEa）应用于常规化学分析室内质量控制中，通过对应用后的2013至2014年常规化学TC等23项项目室内质量控制在控数据及同年参加室间质评活动的结果进行统计分析，综合评价检测系统分析性是否满足质量规范，根据统计结果比较进一步选择适合本实验室的质量规范。结果：两年来，常规化学23个项目已达最佳期望和最低水平的生物学变异质量规范的情况：CVA均为22项占95．7％、TEa均为21项占91．3％．Ca、Na项目的TEa和Na项目CVA均不达质量目标要求，这两个项目由于个体间生物学变异较小，和我室选用了Ralibak的质量目标要求是一致的。结论：基于生物学变异的质量规范对于当前的技术和方法容易满足，对分析质量的提高是有效的，可以根据检测系统的性能特征来确定选用不同水平的生物学变异质量规范。Objective ： To investigate the application of allowed imprecision（CVA）and allowed total error（TEa） quality specifications based on biological variation in clinical routine chemical quality control management. Methods ： On the basis of evaluating the performance characteristics of the existing detection system （CV, Bias） in the laboratory, the quality standards （CV, TEa, Bias） based on different levels of biological variation are applied to the conventional chemical analysis of indoor quality control. Through statistical analysis of the conventional chemical TC, other 23 projects indoor quality control data and quality assessment of different laboratory during 2013 and 2014, comprehensive evaluation was performed to judge whether the analyticity of detection system meets the quality standards. According to the statistical results, the quality standard which is suit for our laboratory was selected.Results ： 23 conventional chemical projects have reached the best during recent two years, quality standards for biological variation in expected and lowest levels ： CVA was 22, accounted for 91.3%; TEa was 21, accounted for 95.7%. Both TEa of Ca, Na detection and CVA of Ca detection are not upto the requirements of quality objectives. Due to the smaller biological variation among individual, these two projects are consistent with the quality of the R.alibak in our lab. Conclusions ： Because quality specification based on biological variation is easy to meet according to the current technology and methods, improving the quality of the analysis is effective. It＇ s better to select different levels of quality specifications of biological variation according to the performance characteristics of the detection system.

关 键 词：生物学变异 允许不精密度 允许总误差 质量规范 质量控制 

分 类 号：R197.3[医药卫生—卫生事业管理]