摘要
目的采用六西格玛(6σ)理论分析临床生化检验项目质量控制数据,提供合理、有效的实验室检测质控管理方案。方法收集2018年2月1日至6月30日湖南省人民医院检验科生化室Beckman AU5800全自动生化分析仪10项检验项目的室内质控及室间质量评估数据,以美国1992年实施的临床实验室改进法案修正案(CLIA′88)规定的允许总误差(TEa%)、偏倚(Bias%)和变异系数(CV%)计算各项目σ水平和质量目标指数(QGI),并辅以标准化σ性能评价图来评估项目的检测性能,设计合适质控管理规则,分析部分项目性能不佳的原因并指导其质量改进。结果10个检测项目中,肌酸激酶(CK)、三酰甘油(TG)、尿酸(UA)、碱性磷酸酶(ALP)σ值>6,天门冬氨酸氨基转移酶(AST)σ值处于5~6,总蛋白(TP)、总胆固醇(TC)σ值处于4~5,丙氨酸氨基转移酶(ALT)、葡萄糖(GLU)σ值处于3~4,钙(Ca)σ值处于2~3。ALT、AST、TC、TP、Ca的QGI<0.8,GLU的QGI处于0.8~1.2。结论6σ质量管理方案能有效地评价临床生化检验项目的性能指标,有助于实验室及时发现问题并采取合理措施控制项目检测质量。
Objective To analyze the quality control data of clinical biochemical test items by using of Six Sigma(6σ)theory,and to provide a reasonable and effective quality control management plan for the laboratory tests.Methods The indoor quality control and inter-room quality assessment data of 10 test items of the Beckman AU5800 automatic biochemical analyzer in the laboratory of the Hunan Provincial People′s Hospital from February 1 to June 30,2018 were collected.Theσvalue and quality objective index(QGI)for each items were calculated according to the allowable total error(TEa%),Bias%and coefficient of variation(CV%)stipulated in CLIA′88,a Clinical Laboratory Improvement and Modification Act of 1992.The standardizedσperformance evaluation chart was used to evaluate the test performance of the items,design appropriate quality control management rules,analyze the reasons for poor performance of some items,and guide the quality improvement.Results Among the 10 test items,theσvalue of creatine kinase(CK),triacylglycerol(TG),uric acid(UA),alkaline phosphatase(ALP)were over 6,aspartate aminotransferase(AST)was 5-6,total protein(TP)and total cholesterol(TC)were 4-5,alanine aminotransferase(ALT)and glucose(GLU)were 3-4,and calcium(Ca)were 2-3.The QGI of ALT,AST,TC,TP and Ca was below 0.8,and the QGI of GLU was 0.8-1.2.Conclusion The 6σquality management program could effectively evaluate the performance indicators of clinical biochemical testing projects,which could help the laboratory to find problems in a timely manner and take reasonable measures to control the testing quality of the items.
作者
范笑笑
曾璇
扶春艳
田佳慧
周兵飞
何翰林
吴意
FAN Xiaoxiao;ZENG Xuan;FU Chunyan;TIAN Jiahui;ZHOU Bingfei;HE Hanlin;WU Yi(Department of Clinical Laboratory,Hunan Provincial People′s Hospital/the First Affiliated Hospital of Hunan Normal University,Changsha,Hunan 410002,China;Immunodiagnostic Reagents Engineering Research Center of Hunan Province,Changsha,Hunan 410002,China;Department of Laboratory Medicine,Hunan Normal University,Changsha,Hunan 410002,China)
出处
《国际检验医学杂志》
CAS
2020年第19期2402-2405,2432,共5页
International Journal of Laboratory Medicine
基金
湖南省自然科学基金面上项目(2018JJ2226)
仁术科研发展基金二类项目(RS201608)。
关键词
六西格玛
质量管理
允许总误差
质量目标指数
质量控制
Six Sigma
quality management
allowable total error
quality goal index
quality control
