应用质量目标指数和西格玛多规则提升临床实验室干化学检测质量  

Using Quality Objective Index and Sigma Rules to Improve Laboratory Qualityof Dry Type Biochemical Analytes

作　　者：张云丽 王鑫[1] 曲波[1] 邵玲 赵鸿梅[1] ZHANG Yunli;WANG Xin;QU Bo;SHAO Ling;ZHAO Hongmei(Department of Clinical Laboratory,the People’s Hospital of China Medical University,Liaoning Provincial People’s Hospital,Shenyang 110000,China)

机构地区：[1]辽宁省人民医院暨中国医科大学人民医院检验医学科,辽宁沈阳110016

出　　处：《标记免疫分析与临床》2021年第11期1974-1979,共6页Labeled Immunoassays and Clinical Medicine

摘　　要：目的用西格玛度量值评价实验室干化学项目检测结果,通过质量目标指数(QGI)查找原因改进精密度和准确度,进行干化学项目的个性化室内质量控制,提升临床实验室干化学项目检测质量。方法收集辽宁省人民医院检验科2019年干化学18个检验项目的月不精密度数据及2019年全国室间质量评价回报结果数据,计算2019年3月份的干化学项目σ度量值绘制西格玛性能验证图,评价检验项目的分析性能。对于σ度量值<6的项目计算质量目标指数,改进不精密度和/或准确度后监测实验室σ度量值,评估改进效果。结果各项目医学决定水平σ提升情况为:TG和CRE项目σ提升8个单位;Na项目σ提升4个单位;TBIL、BUN和P 3个项目σ提升3个单位;GLU、Cl及ALB 3个项目σ提升2个单位;CK,TC,MG及TP 4个项目σ提升1个单位。2019年9月份18个干化学项目中AST、ALT、γ-GT、CRE及TG 5个项目σ≥6;P、CK、TC、GLU、TBIL、BUN及Na 7个项目5≤σ<6;Ca,Mg和Cl 3个项目4≤σ<5;K,TP和ALB 3个项目3≤σ<4。结论应用质量目标指数和西格玛多规则可以有针对性地查找质量问题及有效提升实验室干化学项目检测质量。Objective Sigma was used to evaluate the performance of laboratory dry type biochemical analytes,to identify causes and improve precision and accuracy by quality objective index(QGI),and to conduct personalized indoor quality control of dry type biochemical analytes,and further to improve the quality of dry type biochemical analytes.Methods Monthly non-precision data of 18 dry type biochemical analytes in the Laboratory Department of Liaoning Provincial People’s Hospital in 2019 and the return result data of National Laboratory Quality Evaluation in 2019 were collected to calculate the measurement value of dry type biochemical analytes in March,2019 and draw a sigma performance verification chart to evaluate the analytical performance of the inspection items.We calculated the quality objective index for items withσ<6,so as to monitor the laboratory measureσafter improving its precision and/or accuracy,and to evaluate the improvement.Results Theσof TG and CRE improved by 8 units,Na improved by 4 units,TBIL,BUN and P improved by 3 units,GLU,Cl and ALB improved by 2 units,and CK,TC,Mg and TP improved by 1 unit.In September,2019,among the 18 dry type biochemical analytes,5 projects of AST,ALT,γ-GT,CRE and TGσ≥6,7 projects of P,CK,TC,GLU,TBIL,BUN and Na 5≤σ<6,3 projects of Ca,Mg and Cl 4≤σ<5,and 3 projects of K,TP and ALB 3≤σ<4.Conclusion The application of quality objective index and sigma rules can be used to identify the quality problems and effectively improve the test quality of laboratory dry type biochemical analytes.

关 键 词：六西格玛 西格玛规则 质量控制 干化学 

分 类 号：R-331[医药卫生]