摘要
目的探讨核酸实验室的管理方法,为提高血液核酸检测结果的可靠性和可信性,保障血液核酸集中化检测的程序化和规范化。方法分析核酸实验室应用ISO15189标准的必要性和可行性,建立核酸实验室质量认可管理体系,进行核酸检测前、中、后全过程质量管理。结果通过ISO15189标准的应用,建立了核酸实验室质量安全管理体系,有效保障了实验室人员、检测结果、工作环境的安全性和可靠性。结论 ISO15189标准为血液核酸检测实验室管理提供了科学的标准和思路;在血液集中化检测中有效利用社会公共资源、减少重复性实验室建设和仪器设备采购,最大限度为实验室服务对象和社会节约成本,保障我国血液核酸检测的有序健康开展。
OBJECTIVE To discuss the management of nucleic acid laboratory so as to improve the reliability and credibility of blood nucleic acid testing and to ensure that blood nucleic acid test can be made procedurally with standards .METHODS Analysis of the necessity and feasibility of using ISO15189 from Dec .2006 to Aug .2008 in nucleic acid laboratory was conducted .And the management system of quality approval of the nucleic acid labora‐tory was established to monitor the process before , during and after the testing . RESULTS Application of ISO15189 standard can help to establish laboratory quality and safety management system and effectively protect the safety and reliability of laboratory personnel ,test results and working environment .CONCLUSION ISO15189 provides a scientific standard and thoughts for the management of blood nucleic acid testing laboratory ,hence is conducive to effective use of public resources .It also help to reduce repetitive lab construction and equipment pro‐curement ,maximally save costs for lab service objects and social in blood centralized testing ,therefore is helpful for guaranting orderly development of our countrys blood nucleic acid testing .
出处
《中华医院感染学杂志》
CAS
CSCD
北大核心
2015年第16期3827-3829,共3页
Chinese Journal of Nosocomiology
基金
北京市科技工作基础专项基金资助项目(201303004)
