Pamphilon Derwood, Apperley Jane F, Samson Diana, Slaper-Cortenbach Ineke, McGrath Eoin
JACIE Accreditation Office, EBMT Secretariat, Barcelona, Spain.
Hematol Oncol Stem Cell Ther. 2009;2(2):311-9. doi: 10.1016/s1658-3876(09)50019-2.
JACIE was initiated as a small pilot project in Spain in 2000 and launched as a formal Europe-wide inspection program in January 2004. Since 2000, over 150 applications for accreditation have been received by the JACIE Office and more than 130 inspections have been completed in European centers and facilities. Almost all of these were found to be functioning at a high level of excellence, with the majority having only minor deficiencies in compliance with the standards. In one-third of centers there were more significant deficiencies. The most common deficiencies were in quality management. Following correction of deficiencies 86 centers have to date achieved full accreditation and many more are nearing the completion of the process. Implementation of JACIE involves a significant investment of time and resources by applicant centers. The majority require at least 18 months to prepare for accreditation and 85% have needed to employ a quality manager and/or data manager on an ongoing basis. However, all centers felt their program had benefited from the implementation of JACIE. JACIE is also working closely with other international organisations related to cellular therapy as part of the Alliance for the Harmonisation of Cell Therapy Accreditation (AHCTA), which is examining the differences in existing standards and aiming to develop international standards for all aspects of stem cell transplantation. In particular the requirements for safety of imported tissues and cells has emphasised the need for global harmonisation. The recent implementation of Directive 2004/23/EC and the associated Commission Directives 2006/17/EC and 2006/86/EC has provided an impetus for the implementation of JACIE in European Union (EU) member states. It will be important in the future to examine how JACIE can co-operate with the EU Competent Authorities (CA) to ease the burden of the inspection process for haemopoietic stem cell (HSC) transplant programs.
JACIE于2000年在西班牙作为一个小型试点项目启动，并于2004年1月作为一项正式的全欧洲检查计划推出。自2000年以来，JACIE办公室已收到150多份认证申请，并且在欧洲的中心和机构完成了130多次检查。几乎所有这些都被发现运作卓越，大多数仅在符合标准方面存在一些小缺陷。三分之一的中心存在更严重的缺陷。最常见的缺陷在于质量管理。在缺陷得到纠正后，迄今为止已有86个中心获得了全面认证，还有更多中心即将完成认证过程。JACIE的实施需要申请中心投入大量的时间和资源。大多数中心至少需要18个月来准备认证，85%的中心需要长期聘请质量经理和/或数据经理。然而，所有中心都认为其项目因JACIE的实施而受益。JACIE还作为细胞治疗认证协调联盟（AHCTA）的一部分，与其他与细胞治疗相关的国际组织密切合作，该联盟正在研究现有标准的差异，并旨在为干细胞移植的各个方面制定国际标准。特别是对进口组织和细胞安全性的要求强调了全球协调的必要性。2004/23/EC指令以及相关的委员会指令2006/17/EC和2006/86/EC的近期实施为JACIE在欧盟成员国的实施提供了动力。未来研究JACIE如何与欧盟主管当局（CA）合作以减轻造血干细胞（HSC）移植项目检查过程的负担将很重要。
