Donor History Questionnaire for Allogeneic HPC, Apheresis and HPC, Marrow (HPC-DHQ)
The HPC-DHQ materials were developed by the AABB Interorganizational Donor History Questionnaire-Cellular Therapies Task Force to provide establishments with a standardized tool 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 and has determined that “official” recognition of the HPC-DHQ materials in a guidance document is not warranted at this time. The task force believes the HPC-DHQ materials which are harmonized with regulations and guidance documents will optimize donor comprehension of the questions and provide donor historians with the tools they need 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 Association of Tissue Banks, American Society for Blood and Marrow Transplantation, American Society for Apheresis, FACT, 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 FDA, for inclusion in the HPC-DHQ, should be added in the section at the end of the questionnaire designated for additional questions until the questionnaire can be updated to a new version 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 Web sites as well. When a new version of the documents is posted on the Web sites, the previous version will be maintained on the Web sites for a period of time, to allow facilities to fastidiously transition to the new version.
When a facility implements a new version of the HPC-DHQ materials, they should follow their change control process for the incorporation of the new HPC-DHQ materials. The change control process should address validation of the new version with your process, acceptance of the new version of materials, training, and implementation.
HPC-DHQ Version 1.1, July 2007
The HPC Donor History Questionnaire (DHQ) materials have been updated to version 1.1 by the AABB Interorganizational Donor History Questionnaire – Cellular Therapies Task Force. This updated version of the HPC-DHQ materials incorporate changes necessitated by the February 2007 release of the FDA guidance document, Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Complete listings of the updates/clarifications incorporated in this new version are in the charts detailing the changes to version 1.0 (see below)
- User Instructions, v1.1 PDF, Word
- Appendix – vCJD countries of risk – United Kingdom PDF, Word
- Appendix – vCJD countries of risk – Europe PDF, Word
- Appendix – HIV Group O countries of risk – Africa PDF, Word
- Charts detailing changes to version 1.0
- Questionnaire PDF
- Flow Charts PDF
- User Instructions PDF
HPC-DHQ Version 1.0, June 2006
This first version, developed June 2006, is compliant with regulations and the draft guidance document on donor eligibility.
- Questionnaire, v1.0 PDF, Word
- Donor Education Materials, v1.0 PDF, Word
- Medication List, v1.0 PDF, Word
- User Instructions, v1.0 PDF, Word
- Flow Charts, v1.0 PDF, Word
- Appendix – vCJD countries of risk – United Kingdom PDF, Word
- Appendix – vCJD countries of risk – Europe PDF, Word
- Appendix – HIV Group O countries of risk – Africa PDF, Word
- Appendix – SARS Questions PDF, Word