Cornish J M
Department of Paediatric Bone Haematology/Oncology/Bone Marrow Transplantation, Paediatric Stem Cell Transplantation, Women and Children's Services, Bristol Royal Hospital for Children, Bristol, UK.
Bone Marrow Transplant. 2008 Oct;42 Suppl 2:S82-6. doi: 10.1038/bmt.2008.290.
The Joint Accreditation Committee of the International Society for Cellular Therapy (ISCT) and European Group for Blood and Marrow Transplantation (EBMT), known as JACIE, is a nonprofit body established for the purposes of assessment and accreditation in the field of haemopoietic SCT (HSCT). The committee was established in 1999 with the aim of creating a standardized system of accreditation officially recognized across Europe and based on the accreditation standards established by the US-based Foundation for the Accreditation of Cellular Therapy (FACT). The major objectives of JACIE are to improve the quality of HSCT in Europe by providing a means whereby transplant centres, cell collection facilities and processing facilities can demonstrate high-quality practice. JACIE launched its official inspection programme in January 2004, and since then more than 35 centres in Europe have been inspected. The history of paediatric-specific accreditation guidelines has lagged behind the overall development but is now incorporated within the standards. There is now acknowledgement that a paediatric transplant team will be headed by a paediatric programme director, that an independent paediatric unit will perform no less than 10 allogeneic transplants in children under the age of 18 per year, be looked after by nurses and junior doctors specifically trained in paediatric practice and have access to paediatric subspecialties with an intensive care unit on site. Paediatric units will be examined by a paediatric-trained inspector. Remaining issues of difference with the guidelines relate to the numbers required for accreditation in combined units. Overall, the paediatric community in Europe has embraced the JACIE guidelines. JACIE is working more closely with other international organizations in cellular therapy to develop international standards for all aspects of SCT. The recent implementation of Directive 2004/23/EC has provided an impetus for the implementation of JACIE in European Union (EU) member states, and in particular the requirements for safety of imported tissues and cells have emphasized the need for global harmonization.
国际细胞治疗协会（ISCT）和欧洲血液与骨髓移植组（EBMT）的联合认证委员会，即JACIE，是一个为造血干细胞移植（HSCT）领域的评估和认证而设立的非营利性机构。该委员会成立于1999年，旨在创建一个基于美国细胞治疗认证基金会（FACT）制定的认证标准、在欧洲得到官方认可的标准化认证体系。JACIE的主要目标是通过提供一种方式，使移植中心、细胞采集设施和处理设施能够展示高质量的实践，从而提高欧洲HSCT的质量。JACIE于2004年1月启动了其官方检查计划，自那时起，欧洲已有35多个中心接受了检查。儿科专用认证指南的历史发展滞后于整体发展，但现在已纳入标准之中。目前人们认识到，儿科移植团队将由一名儿科项目主任领导，一个独立的儿科单位每年将为18岁以下儿童进行不少于10例的同种异体移植，由专门接受过儿科实践培训的护士和初级医生护理，并可使用现场设有重症监护病房的儿科亚专业服务。儿科单位将由一名经过儿科培训的检查员进行检查。与指南仍存在差异的问题涉及联合单位认证所需的数量。总体而言，欧洲的儿科界已经接受了JACIE指南。JACIE正在与细胞治疗领域的其他国际组织更紧密地合作，以制定SCT各方面的国际标准。2004/23/EC号指令的近期实施为JACIE在欧盟成员国的实施提供了动力，特别是对进口组织和细胞安全的要求强调了全球协调的必要性。
