The hematopoietic progenitor cell (HPC), Apheresis and HPC, Marrow Donor History Questionnaire (DHQ) materials were developed by the AABB Interorganizational DHQ-HPC Task Force to provide establishments with a standardized tool to screen allogeneic HPC donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), AABB, the Foundation for the Accreditation of Cellular Therapy (FACT), and the National Marrow Donor Program (NMDP).
The FDA does not mandate use of any particular tool to fulfill donor screening requirements for communicable disease risks and has determined that "official" recognition of the HPC, Apheresis and HPC, Marrow DHQ materials in a guidance document is not warranted. The task force believes the DHQ materials, which are harmonized with applicable regulations and guidance documents, will optimize donor comprehension of the questions and provide donor historians with the tools needed to evaluate donor responses. Facilities should read the "User Instructions" carefully before adopting the materials for use.
The task force — which, in addition to AABB, includes an FDA liaison, an ethicist and representatives from the American Society for Blood and Marrow Transplantation, the American Society for Apheresis, FACT, the International Society for Cellular Therapy, and NMDP – will periodically review the documents to ensure continued compliance with regulatory and accrediting agencies. New questions recommended by the task force or the FDA should be added to the section at the end of the questionnaire designated for additional questions until the DHQ materials can be updated to a new version by the task force. International members may find this area of the DHQ a useful place for any additional eligibility questions required by their national competent authority. Institutions will be notified of any changes as well as the timeline for implementation through existing publications and websites maintained by members of the task force. When a new version of the documents is posted, the previous version will be maintained for a period of time to allow facilities to transition to the new version.
When a facility implements a new version of these DHQ materials, they should follow their established change control process for the incorporation of the new DHQ materials. The change control process should address validation of the use of the new version with other existing processes and appropriate staff training. To provide comments, feedback, or questions regarding the use of the HPC, Apheresis and HPC, Marrow DHQ Version 2.0 please send correspondence to regulatory@aabb.org.
The HPC, Apheresis and HPC, Marrow Donor History Questionnaire materials have been updated to version 2.0. The changes update some FDA guidance document names, dates, and/or website links, located within the DHQ, to the current version. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.9.
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