Abstract
According to the Standards of the World Marrow Donor Association (WMDA), unrelated stem cell donor registries and donor centers are responsible for compliance of their collection and apheresis centers with these Standards. To ensure high stem cell product quality and high standards for safety and satisfaction of voluntary unrelated stem cell donors, we here present guidelines for audits of collection and apheresis centers that can be used by new and established donor registries, as well as by collection centers in preparation of audits. We define the general requirements and recommendations for collaboration with the collection and apheresis centers and define critical procedures for the collection of the stem cell product, such as information session, medical assessment, product collection, quality controls, product handover for transportation, and donor follow-up. The specific guidelines are accompanied by detailed checklists and forms that can be found in Supplementary Information and may be used during an initial or follow-up on-site or paper-based audit.
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Acknowledgements
We thank Sabine Grünig previously at DKMS and Katrin Gnant from DKMS for their support for the Working Group in editing the document. We further thank all members of the WGQR, especially the current chair Salmah Ahmed from the Anthony Nolan (UK) and the members of the WMDA Accreditation Committee and the WMDA Board in 2016/2017 for their critical review of this document.
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Lara-Weisshaupt, E., Tistl, I., Hale, K. et al. Audits of collection and apheresis centers: guidelines by the World Marrow Donor Association Working Group Quality and Regulation. Bone Marrow Transplant 54, 244–257 (2019). https://doi.org/10.1038/s41409-018-0252-z
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DOI: https://doi.org/10.1038/s41409-018-0252-z
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