摘要
目的 利用韦斯特加氏六西格玛(Westgard 6σ)规则建立生化实验室检测项目的个性化质控方案.方法 将实验室2017年参加原卫生部临检中心(NCCL)室间质评的28个项目回报数据进行汇总,通过线性回归计算偏倚(Bias);通过加权法获得2017年全年实验室内28个项目的变异系数(CV);根据公式σ=[允许总误差(%)-|Bias(%)|]/[CV(%)],计算出各个检测项目中、高值浓度的σ值,利用Westgard 6σ规则来确定28个项目及中、高值质控品的质控规则.结果 28个检验项目中、高值浓度控制处的σ值参差不齐.高值≥6σ的项目15个(53.57%),5σ~<6σ的项目4个(14.29%),4σ~<5σ的项目2个(7.14%),3σ~<4σ的项目6个(21.43%),<3σ的项目1个(3.57%);中值≥6σ的项目11个(39.29%),5σ~<6σ的项目7个(21.00%),4σ~<5σ的项目1个(3.57%),3σ~<4σ的项目5个(32.14%),<3σ的项目4个(14.29%).结论 不同检测项目、同一项目不同浓度控制处应根据其σ值采取相对应的质控方案;<3σ的项目必须查找和分析原因并采取纠正措施,确保满足性能要求;Westgard 6σ规则是实验室制订个性化的质控方案的便捷途径.
Objective To establish a personalized quality control scheme for biochemical laboratory testing projects by using Westgard Six Sigma (6σ) management method. Methods The return data of28 laboratory projects participating in the External Quality Assessment (EIA) of the Ministry of Health′s Provisional Inspection Center (NCCL) in2017 were collected,and the Bias was calculated by linear regression,and2017 was obtained by weighting method.Coefficient of variation ( CV ) of 28 items in the laboratory throughout the year was calculated according to the formula σ=[TEa(%)-|Bias(%)|]/[ CV (%)].The σ values of medium and high concentration ranges of each item were calculated,and the Westgard 6σ tool was used to determine 28 items and medium and high value quality control. Results The sigma values of the 28 test items and the high value concentration control departments were uneven.Totally 53.57% of the items were higher than 6σ,14.29 % of the items were between 5σ and 6σ,7.14% of the items were between 4σ to 5σ,24.43% of the items were between3σ to 4σ,3.57% of the of the items was lower than1σ.The median value of items which were higher than 6σ were11 (39.29%),which were between 5σ to 6σ,4σ to 5σ,3σ to 4σ and lower than3σ were 7 (21.00%),1 (3.57%),5 (32.14%) and 4 (14.29%). Conclusion The quality control scheme should be adopted according to the σ value of different test items and different concentration control points of the same project.And lower than3σ items must find and analyze the reasons and take corrective measures to ensure the performance requirements.Westgard 6σ rule is a convenient way for the laboratory to develop personalized quality control scheme.
作者
陈荣贵
张勇刚
黄荣萍
CHEN Ronggui;ZHANG Yonggang;HUANG Rongping(Department of Clinical Laboratory,Shenzhen Longhua District Central Hospital,Shenzhen,Guangdong 518110,China)
出处
《检验医学与临床》
CAS
2019年第18期2630-2633,共4页
Laboratory Medicine and Clinic
关键词
六西格玛
总误差
偏倚
变异系数
质控规则
线性回归
Six Sigma
total error
bias
coefficient of variation
quality control rules
linear regression
