Abstract
According to the Standards of the World Marrow Donor Association (WMDA) 2020 [1] unrelated stem cell donor registries are responsible for compliance of their donor centres with these Standards. To ensure high stem cell product quality and high standards for safety and satisfaction of voluntary unrelated stem cell donors, we present here guidelines for audits of donor centres (DC) that can be used by new and established donor registries. They have been developed for registries relying on independent national or international DCs for the recruitment and management of Unrelated Donors (UD) for verification typing (VT)/extended tying (ET), work up processes and Hemopoietic Progenitor Cell (HPC) donation. The main goal of these guidelines is to support registries in verifying and auditing their affiliated DCs to ensure they are compliant with the WMDA Standards, as well as WMDA recommendations. We define the general requirements and recommendations for collaboration with the DC and guidelines to manage the UD, step by step from recruitment to follow-up. We also provide a checklist, intended to serve as a resource for auditors performing an audit at a DC.
Highlights
This document was prepared by the World Marrow Donor Association (WMDA) Quality and Regulatory Working Group (QRWG) and approved by the WMDA board
WMDA ed. 2020 Standard 1.06 states: [https://wmda.info/ professionals/quality-and-accreditation/wmda-standards/] “If a registry relies on an independent donor centre or cord blood bank to recruit and characterise donors/umbilical cord blood units, the registry must ensure that the donor centre/cord blood bank complies with relevant WMDA Standards
The policy process: from maintenance of appropriate policies on suitable should include the importance of donor commitment and the donor counselling, maintaining confidentiality, adherence to the obligation involved when registering as a donor, including the respective health screening and testing requirements, correct time required to complete the donation process and potential sample collection, labelling and shipment procedures, as well as financial impacts if the donor does not receive payment from their timely and accurate processing of requests and transmission of employer for time they are absent from work
Summary
This document was prepared by the World Marrow Donor Association (WMDA) Quality and Regulatory Working Group (QRWG) and approved by the WMDA board. 2020 Standard 1.06 states: [https://wmda.info/ professionals/quality-and-accreditation/wmda-standards/] “If a registry relies on an independent donor centre or cord blood bank to recruit and characterise donors/umbilical cord blood units, the registry must ensure that the donor centre/cord blood bank complies with relevant WMDA Standards The nature of these affiliations and the duties and responsibilities must be documented in an agreement.”. The main goal of these guidelines is to support registries in verifying and auditing their affiliated DCs to ensure they are compliant with the WMDA Standards, based on the 2020 edition This means that the authors interpreted the current standards and deduced specific process steps and requirements for DCs. Registries should be aware that these guidelines may not cover all aspects necessary to comply with local governmental laws and regulations.
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