New official guidelines for donor center audits

According to the World Marrow Donor Association (WMDA) 2020 standards, unrelated hematopoietic stem cell donor registries are responsible for their donor centers' compliance with WMDA standards. Therefore, also the DKMS Registry conducts regular audits of DKMS donor centers.

These audits are now officially supported by fixed guidelines and checklists on the part of the WMDA. The guidelines have been drafted over the past years by the “WMDA’s Quality and Regulatory Working Group”. Ten members from six countries have defined the general requirements and recommendations for the cooperation between registries and donor centers – covering all steps: from the recruitment of potential hematopoietic stem cell donors to post-donation follow-up. Also included is a checklist to directly assist auditors performing the donor center audits. The guidelines as well as all checklists have already been released by the WMDA last year. Last month, they have also been published in the scientific journal “Bone Marrow Transplantation”.

The WMDA standards include information relevant to registries, donor centers, and collection centers. Thus, by interpreting the currently defined standards, the authors assist not only registries in auditing, but also donor centers in assuring compliance. However, additional applicable local laws and regulations are not covered, so the checklists may need to be adapted. Overall, it is an important step in ensuring donor center quality as well as donor safety and stem cell product quality as the overarching goals.

As DKMS, we are particularly pleased that two colleagues were substantially involved in the process and the corresponding publication. “The members of the working group brought in a great expertise. This has led to some discussions and an interesting exchange for everyone involved. In the end, we can be sure that the results are well usable and will ease the verification of compliance with the standards”, says Maren Weber, Team Lead of Process and Quality Management at DKMS and member of WMDA’s Quality and Regulatory Working Group. Lydia Foeken, Executive Director of WMDA, is also pleased with this new guidance: „Congratulations on this achievement! I would like to thank you for the hard work done and for making this milestone happen.”

For the guideline and checklists, please refer to the publication “Audit of donor centre: guidelines by the World Marrow Donor Association Quality and Regulation Working Group"