肾脏疾病生物样本库的管理及操作规范

发布时间：2018-02-28 03:21

本文关键词： 生物样本库管理操作规范肾脏疾病　出处：《肾脏病与透析肾移植杂志》2017年04期 　论文类型：期刊论文

【摘要】：本标准涵盖了肾脏疾病生物样本库的管理和相关的操作规范。包括:伦理审批、行政许可报批和人员配备、样本采集前准备、样本采集、样本运送与交接、样本处理和分装、样本入库、样本的使用与共享、样本库巡检和应急预案、样本运输、样本销毁、样本库质量控制等。该标准尽可能详尽地描述每一个操作环节的规范,同时将样本库质量管理体系中的管理理念贯穿于技术操作过程中,以期帮助国内肾脏病单位生物样本库人员实现规范化管理和标准化操作。
[Abstract]:This standard covers the management of the biological sample bank for renal diseases and related operational specifications. It includes: ethical examination and approval, administrative license approval and staffing, sample preparation before collection, sample collection, sample transportation and handover, sample handling and distribution, Sample storage, sample usage and sharing, sample base inspection and contingency plans, sample transportation, sample destruction, sample bank quality control, etc. At the same time, the management idea of the quality management system of the sample base is run through the technical operation process, in order to help the staff of the biological sample bank of the domestic kidney disease unit to realize the standardized management and the standardized operation.
【作者单位】：全国生物样本标准化技术委员会肾脏病生物样本标准化工作组;南京总医院国家肾脏疾病临床医学研究中心;
【分类号】：R197.3;R692

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