临床基因扩增检测的全面质量管理  

Management of quality control for clinical gene amplification test

作　　者：江佳佳[1] 李晓华 Jiang Jiajia;Li Xiaohua(The Affiliated Aoyang Hospital of Jiangsu University, 215600 Zhangjiagang, China;National Center for Gene Testing Technology Application & Demonstration, 230088 Hefei, China;Regional Center for Clinical Genomics, East of China, KingMed Diagnostics Group, 510005 Guangzhou, China)

机构地区：[1]江苏大学附属澳洋医院病理和检验医学中心,215600 [2]国家基因检测技术应用示范中心(安徽),合肥230088 [3]广州金域医学检验集团股份有限公司临床基因组学中心,510005

出　　处：《中华临床实验室管理电子杂志》2017年第4期251-254,共4页Chinese Journal of Clinical Laboratory Management(Electronic Edition）

摘　　要：临床基因扩增检测工作的全面质量管理是在传统检验质量控制体系基础上的延伸。着重整体规划,将实验室建筑流程纳入质量管理范围。从细节着手,把好检测标本质量关。借助信息管理系统,保障分析前阶段的质量管理。加强操作合规性,规范开展性能验证工作,认真评价检测过程有效性,保障实验过程的质量管理。密切联系临床,延伸分析后质量管理内涵。总之,临床基因扩增实验室的质量管理应包括从基因扩增实验室建设和检测标本的前处理,到检测结果获得后与临床的沟通,进行全过程的严格和规范化的管理操作。Overall management of quality control for clinical gene amplification test should be considered as an extension operation of traditional laboratory quality control system.It should initiate from the design of laboratory layout to the process of laboratory construction to emphasize the overall plan.To ensure the quality of pre-analysis management,the quality of specimen should be monitored carefully and all the information and data should be managed by utilizing computerized system.During analytic process,the operational compliance should be strengthened to ensure a correct operation.Then,verification procedure for the result should be standardized,and the effectiveness of the test should be carefully evaluated.In addition,the effective communication between laboratory staff and clinician should be established.In sum,to ensure the clinical significant of results,clinical gene amplification test should be managed carefully from the laboratory design to each step of test practice including the post-analysis and discussion with clinician.

关 键 词：质量管理 基因扩增 实验室 

分 类 号：R440[医药卫生—诊断学]