中国生物样本库质量达标检查结果分析  

Analysis for results of Chinese biobank quality inspection

作　　者：周一峰 闵伟勇 张小燕[2] 郜恒骏[2] 

机构地区：[1]上海济光职业技术学院,上海201901 [2]生物芯片上海国家工程研究中心,上海201203

出　　处：《实用器官移植电子杂志》2017年第6期444-447,共4页Practical Journal of Organ Transplantation(Electronic Version)

基　　金：国家重点研发计划国家质量基础的共性技术研究与应用专项(2016YFF02023);国家人类遗传资源共享服务平台上海创新中心建设项目(2005DKA21300);国家重点研发计划"精准医学研究"重点专项(2017YFC0908300);国家重点研发计划"精准医学研究"重点专项(2017YFC0908403)

摘　　要：对我国生物样本库存在的问题进行总结,为我国生物样本库的建设提供借鉴,也对拟申请质量达标检查的生物样本库提供参考。分析全国各地不同生物样本库建设的现状,分别在组织架构、资源与安全卫生、业务管理、信息化管理、质量等五个方面分析各样本库在质量达标检查过程中出现的各类问题。在我国生物样本库建设的初期阶段,样本和信息的采集内容与方式、样本库的运作与管理等方面异质性非常大。中国医药生物技术协会组织生物样本库分会开展的生物样本库质量达标检查在中国生物样本库的认证认可方面迈出了关键的第一步,通过对我国生物样本库在质量达标检查过程中发现的问题进行总结、讨论,从而促进生物样本库自身能力的提升,进而推动整个行业的标准化建设与管理,保障我国生物样本库在由建设走向统一、由统一形成联合的道路上逐步迈进。To provide references for the construction of biobank in China and for biobank that will apply for quality inspection. Statuses of biobanks in different provinces was studied. Various problems in the inspection of each biobank were analyzed respectively in five aspects, including, framework of organization, resources and safety, business management, information management and quality. The heterogeneities in the collection of bio-material and information, the operation and management of biobank were obvious in the early stages of the biobank construction. The Biobank Quality Inspection of Bioank Branch, China Medicinal Biotech Association had taken a key step in the accreditation of biobank in China. Summarization and discussion of problems found in the process of biobank quality inspection could be helpful for the improvements in capacities of biobanks,construction of standardization and management of the whole biobank industry. We hope that biobank quality Inspection will promote the development of Chinese biobank from building to unity.

关 键 词：生物样本库 质量达标检查 认证 认可 标准化 

分 类 号：R197.2[医药卫生—卫生事业管理]