移植用同种异体组织库流程及质量管理

背景：随着组织移植学和保存技术的发展，移植用组织库更广泛的发展，技术水平不断提高。同时，组织库标准和指导原则协同化日益突出，质量管理问题越来越受到重视。目的：结合20多年同种异体组织库的科研、医学临床和管理实践，对组织库的建立及应用进行阐述。方法：由第二、三作者检索美国医学索引Medline 1966/2010、荷兰生物医学文摘1974/2010,中国科技文献数据库1999/1999和中国生物医学文献数据库1978/2009等移植用组织库建立与管理、质量标准与控制等方面文献。结果与结论：移植用同种异体组织库在临床治疗中的发挥重要作用，为临床医生提供了一种有效、方便的治疗选择。组织库的建立与应用管理是一个综合性的，并且具有一定特殊性的医学领域，具有它自己独特的管理模式和质量控制体系。一个完整的组织库应具备的流程管理主要包括设置及管理模式、技术操作流程、质量控制体系等。应对组织库的所有操作环节进行规范，并把其纳入到医疗机构科学化管理范畴中来，使同种异体组织库更好地服务于中国医学事业。

The process and quality management of allograft tissue bank

BACKGROUND: With the development of tissue transplantation and preservation technology, allograft tissue bank has been widely developed and its technical level has improved constantly. Meanwhile, the synergism of involved standards and governing principles are becoming increasingly prominent, and the quality control attracts more and more attention.OBJECTIVE: To explore the establishment and application of tissue bank based on the experiences of scientific research, clinical medicine, and management about allograft tissue bank over the past 25 years.METHODS: The literature related to establishment and management, quality standard and control of allograft tissue bank from Medline database (1966/2010), Excerpta Medica database (1974/2010), Chinese Scientific and Technical Literature database 1999/1999), and Chinese Biomedical Literature database (1978/2009) was retrieved by the second and the third author.RESULTS AND CONCLUSION: Allograft tissue bank plays an important role in clinical treatment and provides an effective and convenient approach for doctors. The establishment and application of allograft tissue bank constitute a comprehensive and particular medical field, which possesses its own management mode and quality control system. A complete process management involved in a tissue bank should includes the setting and management mode, operational process of technology, and quality control system. Tissue bank should regulate operation, and included into areas of scientific management of medical institution, in order to make allograft tissue bank assist Chinese medical course more efficiently.