Leemhuis T, Padley D, Keever-Taylor C, Niederwieser D, Teshima T, Lanza F, Chabannon C, Szabolcs P, Bazarbachi A, Koh M B C
Hoxworth Blood Center, University of Cincinnati Academic Health Center, Cincinnati, OH, USA.
Human Cellular Therapy Laboratory Mayo Clinic, Rochester, MN, USA.
Bone Marrow Transplant. 2014 Aug;49(8):1098-105. doi: 10.1038/bmt.2014.104. Epub 2014 Jun 16.
The Graft Processing subcommittee of the Worldwide Network for Blood and Marrow Transplantation wrote this guideline to assist physicians and laboratory technologists with the setting up of a cell processing laboratory (CPL) to support a hematopoietic stem cell transplant program, thereby facilitating the start-up of a transplant program in a new location and improving patient access to transplantation worldwide. This guideline describes the minimal essential features of designing such a laboratory and provides a list of equipment and supply needs and staffing recommendations. It describes the typical scope of services that a CPL is expected to perform, including product testing services, and discusses the basic principles behind the most frequent procedures. Quality management (QM) principles specific to a CPL are also discussed. References to additional guidance documents that are available worldwide to assist with QM and regulatory compliance are also provided.
全球血液和骨髓移植网络的移植物处理小组委员会编写本指南，以协助医生和实验室技术人员建立细胞处理实验室（CPL），以支持造血干细胞移植项目，从而促进在新地点启动移植项目，并改善全球患者获得移植的机会。本指南描述了设计此类实验室的最低基本特征，并提供了设备和用品需求清单以及人员配备建议。它描述了CPL预期执行的典型服务范围，包括产品检测服务，并讨论了最常见程序背后的基本原则。还讨论了CPL特有的质量管理（QM）原则。此外，还提供了全球范围内可用于协助质量管理和法规遵从性的其他指导文件的参考文献。
