摘要
丰富的生物样本资源对探索疾病机制、发现治疗靶点、支持临床试验及推动医学创新具有重要价值。伴随着医疗机构科研战略的推进及医学“卡脖子”技术攻关需求,生物样本库规模发展迅速,然而,受单个院区空间限制,一库多区布局已成为研究型医院的普遍模式。尽管这一模式在功能拓展方面具有一定优势,但也带来了人员与设备投入重复、质量管控风险增加及管理监督难度加大等挑战。本文探讨了一库多区模式下的一体化管理实践,通过构建一体化组织架构,在多库区同质化推行ISO 20387质量管理体系,将全流程质量控制贯穿多库区管理,库区间数据转移确保样本信息互联互通,保障了多库区业务衔接流畅与功能协同;创新构建的“准入—培训—监督”体系,有力支撑医院临床科研融合创新研究。本文还探索了生物样本资源共享机制,并引入成本管理体系,旨在提升样本利用率,为生物样本库可持续发展提供了参考方案。
Abundant biological sample resources have significant value in disease mechanism research,therapeutic targets identification,clinical trials and medical innovation.Driven by the advancement of research strategies and the need to address critical“bottleneck”technologies of medical institutions,the scale of biobank has expanded rapidly.However,constrained by spatial limitations in single-campus settings,the multi-site layout has become a common choice for research-oriented hospital biobanks.Although this model has certain advantages in functional expansion,it also brings challenges including redundant staff and equipment investments,increased quality control risks,and greater management difficulty.This paper discusses integrated management practices under the multi-site model.By establishing a unified organizational structure,implementing the ISO 20387 quality management system across all sites,integrating full-process quality control throughout multi-site operations,facilitating data transfer among multi-site enables sample information interoperability,guarantees seamless operational continuity and functional synergy among multiple biobanking sites;the innovatively developed“access-training-supervision”mechanism robustly supports integrated clinical and translational research.Furthermore,this paper investigates sample resource-sharing mechanism and introduces a cost management framework,aiming to enhance sample utilization rates and provide a reference solutions for the sustainable development of biobanks.
作者
张姝
樊萍
席佳蕾
谭维维
黄伟
ZHANG Shu;FAN Ping;XI Jialei;TAN Weiwei;HUANG Wei(West China Biobank,West China Hospital,Sichuan University,Sichuan Province,Chengdu610041,China)
出处
《中国医药导报》
2025年第23期148-153,共6页
China Medical Herald
基金
地球深部探测与矿产资源勘查国家科技重大专项(2024ZD1000600、2024ZD1000602)。
关键词
生物样本库
一库多区
多维度服务
一体化管理
样本利用
Biobank
Multi-site
Multidimensional services
Integrated management
Sample utilization
