临床生物样本库血液样本的可控性采集和质量管理

目的建立医疗过程中血液样本可控性采集模式，保证样本的采集、处理过程可回溯，为肿瘤、自身免疫性疾病、心脑血管疾病及代谢性疾病的研究提供高质量的血液样本。方法通过建立网络化样本采集管理流程，将样本采集电子申请、项目管理以及样本处理中涉及血液样本的各项前处理因素整合到电子工作程序中，保证标准流程的执行情况处于可控状态，形成规范化的血液采集、前处理、保存和管理办法。结果仁济医院血液样本库有临床疾病20余种，含有完整的临床及随访资料。血液样本与相应的组织样本、临床信息相匹配；系统记录每份样本采集时间、到库时间、入库时间等；可通过组合查询筛选相应质量要求的样本。共采集血液样本40 000余份，抽样检查90%的样本分子生物学指标稳定。结论仁济医院可控性血液采集、处理模式和管理模式为综合性医院血液生物样本库建设提供管理经验，为血液样本的规范化、高质量采集、前处理、保存提供详细操作经验参考，为肿瘤、自身免疫性疾病、心脑血管疾病及代谢性疾病的研究提供高质量的血液样本及信息资源。

The controllability collection and quality management of clinical biobank for blood biospecimen

ObjectiveThe aim of the Renji hospital biobank blood sample controllability collection and quality management is to establish a blood sample controllable acquisition mode for medical procedure, ensure that the sample collection, the process can be traced back and provide high quality blood samples for cancer, autoimmune diseases, cardiovascular diseases and metabolic diseases research. MethodsIntegrated the sample collection electronic filing, project management as well as the various preanalytical variables of blood sample to electronic work program through the establishment of the network management process to ensure the implementation of standard processes under control, formed a standardized blood collection, pre processing, conservation and management approach. ResultsRenji Hospital biobank has collected more than 20 kinds of clinical disease blood samples, and all samples contained the complete clinical follow up data. Blood samples were correspond with tissue samples and matched with clinical information; information management system recorded each sample collection time, time to biobank and the storage time. Samples can be screened for the corresponding requirements through the information management system. Till now, Renji hospital has collected more than 40 000 blood samples, 90% of them have stable molecular markers. ConclusionThe controllable blood collection, processing and management model of Renji Hospital provide management experience for comprehensive hospital in construction of blood biobank, provide detailed experience reference for standard, high quality, pre process, storage, etc of blood specimen, and provide high quality boold specimen and information for cancer, autoimmune diseases, cardiovascular diseases and metabolic diseases research.