Warkentin P I
Department of Pathology, University of Nebraska Medical Center, Omaba, NE 68198-2168, USA.
Cytotherapy. 2003;5(4):299-305. doi: 10.1080/14653240310002298.
Voluntary accreditation of cells, tissues, and cellular and tissue-based products intended for human transplantation is an important mechanism for improving quality in cellular therapy. The Foundation for the Accreditation of Cellular Therapy (FACT) has developed and implemented programs of voluntary inspection and accreditation for hematopoietic cellular therapy, and for cord blood banking. These programs are based on the standards of the clinical and laboratory professionals of the American Society of Blood and Marrow Transplantation (ASBMT), the International Society for Cellular Therapy (ISCT), and NETCORD. FACT has collaborated with European colleagues in the development of the Joint Accreditation Committee in Europe (jACIE). FACT has published standards documents, a guidance manual, accreditation checklists, and inspection documents; and has trained as inspectors over 300 professionals active in the field. All inspectors have a minimum of 5 years' experience in the area they inspect. Since the incorporation of FACT in 1996, 215 hematopoietic progenitor cell facilities have applied for FACT accreditation. Of these facilities, 113 are fully accredited; the others are in the process of document submission or inspection. Significant opportunities and challenges exist for FACT in the future, including keeping standards and guidance materials current and relevant, recruiting and retaining expert inspectors, and establishing collaborations to develop standards and accreditation systems for new cellular products. The continuing dialogue with the Food and Drug Administration (FDA) is also important to ensure that they are aware of the accomplishments of voluntary accreditation, and keep FACT membership alerted to FDA intentions for the future. Other potential avenues of communication and cooperation with FDA and other regulatory agencies are being investigated and evaluated.
对用于人类移植的细胞、组织以及基于细胞和组织的产品进行自愿认证，是提高细胞治疗质量的一项重要机制。细胞治疗认证基金会（FACT）已制定并实施了针对造血细胞治疗和脐带血库的自愿检查与认证计划。这些计划基于美国血液和骨髓移植学会（ASBMT）、国际细胞治疗学会（ISCT）以及NETCORD的临床和实验室专业人员标准。FACT与欧洲同行合作，共同制定了欧洲联合认证委员会（jACIE）。FACT已发布标准文件、指南手册、认证清单和检查文件；并培训了300多名活跃在该领域的专业人员作为检查员。所有检查员在其检查领域至少有5年经验。自1996年FACT成立以来，已有215家造血祖细胞设施申请FACT认证。其中，113家已获得完全认证；其他设施正在提交文件或接受检查。FACT未来面临重大机遇和挑战，包括使标准和指导材料与时俱进、招募和留住专家检查员，以及建立合作关系以制定新细胞产品的标准和认证系统。与美国食品药品监督管理局（FDA）持续对话也很重要，以确保他们了解自愿认证的成果，并让FACT成员随时了解FDA未来的意图。正在研究和评估与FDA及其他监管机构沟通与合作的其他潜在途径。
