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.

Agence de la Biomedecine RFGM Saint Denis France

Cellex Medical Services GmbH Köln Germany

Czech National Marrow Donors Registry Pilsen Czech Republic

DKMS Tübingen Germany

Ezer Mizion Bone Marrow Donor Registry Petah Tikva Israel

Fundacja DKMS Warsaw Poland

National Marrow Donor Program Minneapolis USA

South African Bone Marrow Registry Cape Town South Africa

Zentrales Knochenmarkspender Register Deutschland Ulm Germany

References provided by Crossref.org