Donor History Questionnaire for Allogeneic HPC, Apheresis and HPC, Marrow (HPC-DHQ)
HPC-DHQ Version 1.2, July 2009
The HPC Donor History Questionnaire materials have been updated to version 1.2 to incorporate recommendations published by the FDA in Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products, March 2009. The AABB Interorganizational DHQ Cellular Therapies Task Force decided to update the DHQ in advance of final recommendations being issued by FDA as the additional screening offers an increase in patient safety. The HPC-DHQ, version 1.2, and accompanying materials also have been revised to provide updated references in several places. A complete listing of the updates/clarifications incorporated in this new version is in the chart detailing the changes to version 1.1.
October 2009 Revisions for HIV Group O
Guidance for Industry: Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection, issued August 2009, includes five additional countries in Africa where HIV group O is endemic. Three documents within version 1.2 (July 2009) of the HPC-DHQ have been modified to incorporate this information. The documents retain version 1.2 and July 2009 as the master reference number and October 2009 has been added as an additional reference number.
The HPC-DHQ materials were developed by the 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 to support eligibility determination of 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. 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 may 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 transition to the new version.
When a facility implements a new version of the HPC-DHQ materials, they should follow their established change control process for the incorporation of the new HPC-DHQ materials. The change control process should address validation of the use of the new version with other existing processes and appropriate staff training.
- Questionnaire, v1.2 PDF, Word
- Donor Education Materials, v1.2 PDF, Word
- Medication List, v1.2 PDF, Word
- User Instructions, v1.2 PDF, Word
- Appendicies
- References PDF, Word (Revised October 2009)
- Flow Charts PDF , Word
- vCJD countries of risk – United Kingdom PDF, Word
- vCJD countries of risk – Europe PDF, Word
- HIV Group O countries of risk – Africa PDF, Word (Revised October 2009)
- Chart detailing changes to version 1.1 PDF (Revised October 2009)
HPC-DHQ Version 1.1, July 2007
Version 1.1 is current with the publication of 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).
- 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