应用6σ质量管理理论评价肿瘤标志物性能及质控方案选择  

Apply 6 sigma quality management theory to evaluate tumor marker′s performance and choose quality control project

作　　者：陈先恋 何月娟[2] 鄢仁晴[1] 韩妮薇 杜文胜[1] 

机构地区：[1]遵义医学院附属医院检验科,贵州遵义563002 [2]遵义医学院附属医院呼吸医学研究室,贵州遵义563002

出　　处：《国际检验医学杂志》2016年第12期1607-1609,共3页International Journal of Laboratory Medicine

基　　金：贵州省卫生计生委科学技术基金项目(gzwjkj2014-2-2174)

摘　　要：目的采用六西格玛（6σ）质量管理理论评价肿瘤标志物性能及选择合适的质控方案。方法收集实验室2015年6~12月血清甲胎蛋白（AFP）、糖类抗原（CA）125、CA199、癌胚抗原（CEA）、铁蛋白（FER）、游离前列腺特异抗原（FPSA）和总前列腺特异抗原（TPSA）的室内质控数据和卫生和计划生育委员会临床检验中心室间质评数据,计算不精密度（CV%）,不准确度（Bias%）和σ值,σ=（TEa%-Bias%）/变异系数（CV）,质量目标为临床化学和分子病理学协会提供的生物学变异确定的＂合适＂和＂理想＂TEa。对于没有达到6σ水平的单个项目计算QGI,查找原因和需改进内容。依据质控软件QCeasy对未达到6σ质量水平项目计算质量水平,可确定选用合适的质控规则及质控品水平的数量。结果依据生物学变异确定的＂合适＂TEa时,CA199、CA125、TPSA、AFP各水平σ值大于4,FPSA在两个水平水平σ值大于4,CEA在两个水平σ值大于3。生物学变异确定的＂理想＂TEa时,CA199、CA125各水平σ值大于4,CEA、AFP在两个水平σ值大于3。QGI质控方案显示大多数项目需优先改进精密度,AFP、CEA还需改进准确度。AFP、CEA、FER、CA199、FPSA质量水平达到2~3σ,如果要求大于4σ,依据QCeasy提供方案可选用13s/22s/R4s/8X/41s等质控规则,AFP、CEA、FER质控品需4个水平,CA199、FPSA质控品需2个水平。结论 6σ质量管理理论及方法可以帮助管理人员了解该实验室检验项目的质量水平,提供改进方案,同时6σ质量目标还可以约束现行的Westgard质控规则,降低假失控概率。Objective Apply 6sigma quality management theory to evaluate tumor marker′s performance and choose quality control project.Methods To collect our laboratory inner quality control data and health department external quality control data of AFP,CA125,CA199,CEA,FER,FPSA and TPSA in second half 2015.To calculate CV%,Bias% andσ,σ=（TEa%-Bias%）/CV.Quality targets were ＂appropriate＂ and ＂ideal＂ TEaproviding by clinical chemistry and molecular pathology.To calculate quality goal index（QGI）of under 6σ,find reasons and need improvement projects.To calculate items quality levels by quality control software QCeasy.It could confirm appropriate quality control rules and amounts.Results Biological variation to determine the ＂appropriate＂ TEa,CA199,CA125,TPSA and AFP all levels of the sigma was greater than 4.FPSA two levels of the sigma was greater than 4.CEA two levels of the sigma is greater than 3.Biological variation to determine the ＂ideal＂ TEa,CA199,CA125 all levels of the sigma is greater than 4.CEA,AFP two levels of the sigma was greater than 3.QGI quality control project show majority items need improve degree of precision,AFP,CEA were needed improve degree of accuracy.AFP,CEA,FER′s quality levels were 2σand3σ.QCeasy provide quality control rules 13s/22s/R4s/8X/41 scould increase 4σ,and quality control need 4levels.CA199,FPSA quality control need 2levels.Conclusion 6σquality management theory and method could help manager know laboratory inspection item′s quality levels and offer improvement projects.While 6σquality objectives could also constrain the current Westgard control rules,reduce the false reject probability.

关 键 词：六西格玛 生物学变异 允许总误差 质控规则 

分 类 号：R730.43[医药卫生—肿瘤]