西格玛质量管理工具在临床生化检验中的应用  

Westgard rules of quality control and standard performance verification figure in the application of the conventional biochemical test

作　　者：曾露云 王瑶 富媛悦 ZENG Luyun;WANG Yao;FU Yuanyue(Department of Clinical Laboratory,Beijing xicheng district maternal and child health hospital,Beijing 100054)

机构地区：[1]北京市西城区妇幼保健院检验科,北京100054

出　　处：《医学检验与临床》2022年第9期30-36,共7页Medical Laboratory Science and Clinics

摘　　要：目的:用西格玛性能验证图评价临床常规生化和脂类检测项目的性能水平,指导设计出适用于自己实验室的合理、有效的质量控制程序。方法:收集2021年1月-12月北京市西城区妇幼保健院检验科23个临床常规生化及脂类检测项目的室内质控数据计算不精密度(CV%),同时根据2021年北京市临床检验中心质量评价计划的室间质评结果计算偏倚(Bias%),分别以卫生行业标准和国家标准中的允许总误差(TEa)计算西格玛水平和质量目标指数(QGI),并绘制标准化的西格玛性能验证图,制订适用于本实验室的质控规则及需要优先改进的方向。结果:2021年北京市西城区妇幼保健院检验科以卫生行业标准的TEa评估实验室各临床常规化学和脂类检测项目后发现,血清葡萄糖(GLU)、血尿素氮(BUN)、总蛋白(TP)、白蛋白(ALB)、乳酸脱氢酶(LDH)、γ-谷氨酰转肽酶(GGT)、总胆固醇(TCHO)、甘油三酯(TG)等检测项目的性能稳定性处于欠佳水平(2≤σ<3);总胆红素(TBIL)、天门冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)等检测项目的性能稳定性处于临界水平(3≤σ<4);血肌酐(CRE)、肌酸激酶(CK)、直接胆红素(DBIL)等检测项目的性能稳定性处于良好水平(4≤σ<5);血尿酸(UA)、丙氨酸氨基转移酶(ALT)、总胆汁酸(TBA)、低密度脂蛋白胆固醇(LDL-C)、载脂蛋白A1(Apo-A1)等检测项目的性能稳定性处于优秀水平(5≤σ<6);血清淀粉酶(AMY)、α羟基丁酸(α-HBDH)、高密度脂蛋白胆固醇(HDL-C)及载脂蛋白B(Apo-B)等检测项目的性能稳定性处于世界一流水平(σ≥6);以国家标准的允许总误差评估实验室各临床化学检测项目的性能水平后,结果显示仅剩TCHO检测项目的性能稳定性处于欠佳水平;BUN的性能稳定性提高到临界水平;TBIL和AST的性能稳定性提高到良好水平;GLU和ALB的性能稳定性提高到优秀水平;DBIL、LDL-C和APOA1的性能稳定性与卫生行业标准下�Objective:Sigma performance verification chart was used to ealuate the clinical routine biochemical and lipid detection performance level of the project,to guide the design suitable for their own laboratory,reasonable and effective quality control procedures.Methods:Collected in January 2021 to December,Beijing xicheng district maternity and child care division 23 clinical routine biochemical and lipid testing indoor quality control data calculation precision(CV%),at the same time according to the 2021 Beijing clinical inspection center room quality evaluation plan of qualitative evaluation of the results between computing Bias(Bias%),respectively by health allows the total error of industry standards and national standards(TEa)computing sigma(sigma)level and the quality goal index(QGI),and map the standardization of sigma performance verification,determine suitable for the laboratory quality control rules and priorities the direction of improvement.Results:In 2021 Beijing xicheng district maternal and child health hospital division to health industry standard TEa evaluation laboratory the clinical findings after conventional chemical and lipid testing project,serum glucose(GLU),blood urea nitrogen(BUN),total protein(TP),albumin(propagated),lactate dehydrogenase(LDH),gamma GGTP(gamma glutamyl transpeptidase)(GGT),total cholesterol(TCHO),triglycerides(TG)and so on in the poor stability of test project performance(2≤σ<3);Total bilirubin(TBIL),aspartate aminotransferase(AST)and alkaline phosphatase(ALP)detection performance stability of the project is in a critical level(3≤σ<4);Serum creatinine(CRE),creatine kinase(CK),direct bilirubin(DBIL),and other project detection performance stability in good level(4≤σ<5);Blood uric acid(UA),alanine aminotransferase(ALT),total bile acid(associates),low density lipoprotein cholesterol(LDL-C),apolipoprotein A1(Apo A1)the performance of the test items such as stability at a good level(5≤σ<6);Serum amylase(AMY),alpha hydroxy butyric acid(alpha HBDH),high-density lipopr

关 键 词：西格玛质控规则 允许总误差 质量目标指数 质量管理 

分 类 号：R446.1[医药卫生—诊断学]