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Donor History Questionnaire for Allogeneic HPC, Apheresis and HPC, Marrow Version 1.0, June 2006 (HPC-DHQ)
HPC-DHQ materials were developed by an interorganizational Donor History Questionnaire-Cellular Therapies Task Force to screen allogeneic hematopoietic progenitor cell (HPC) donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), National Marrow Donor Program (NMDP), AABB and Foundation for the Accreditation of Cellular Therapy (FACT). The materials are not designed for use with cord blood donors.
FDA does not mandate the use of any particular screening tool to fulfill the requirements for screening donors for communicable disease risks. However, the task force believes the HPC-DHQ will optimize donor comprehension of the questions they are asked and will provide donor historians with the tools they need to evaluate donor responses, so it is encouraging facilities to begin using the questionnaire and accompanying materials. Facilities should read the “User Instructions” carefully before adopting the materials for use.
This material was submitted to FDA June 12, 2006, for review. FDA was asked to endorse the materials as an acceptable tool to screen donors for communicable disease risk factors.
The task force — which in addition to AABB includes an FDA liaison, an ethicist, and representatives from the American Association of Tissue Banks, American Society for Blood and Marrow Transplantation, American Society for Apheresis, FACT, International Society for Cellular Therapy and the NMDP, periodically will review the documents to ensure continued compliance with regulatory and accrediting agencies. New questions recommended by the task force or FDA for inclusion in the HPC-DHQ should be placed on the questionnaire in the area designated for additional questions until it is updated to a new version date by the task force. Institutions will be notified of any changes as well as the timeline for implementation through existing publications and Web sites maintained by members of the task force. Updated documents will be made available on those sites as well.
To view a copy of the HPC-DHQ or any of the accompanying materials, click on a link below:
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