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AABB > Resource Center > Blood Donation Information > Donor History Questionnaires > Hematopoietic Progenitor Cell, Apheresis and Marrow Donor History Questionnaire

Hematopoietic Progenitor Cell, Apheresis and Marrow Donor History Questionnaire 

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 Association of Tissue Banks, 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, for inclusion in the DHQ, 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. Updated documents may be made available on those websites as well. When a new version of the documents is posted on the websites, the previous version will be maintained on the websites 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.

HPC, Apheresis and HPC, Marrow DHQ Version 1.3, December 2012

The HPC, Apheresis and HPC, Marrow DHQ materials have been updated to version 1.3 to capture some of the clinical evidence recommendations found in section IV.F of FDA's Guidance for Industry document titled "Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products," August 2007, namely those regarding a history of positive test results. The title of the questionnaire also was updated to better represent the applicability to HPC, Apheresis and HPC, Marrow and to differentiate it from the HPC, Cord Blood DHQ materials which were created in April 2012. Additional revisions were made to harmonize the DHQ materials with the NMDP questionnaire, and minor updates were implemented to provide additional clarity, specificity and consistency. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.2.

  • Questionnaire, v1.3 PDF, Word
  • Donor Education Materials, v1.3 PDF, Word
  • Medication List, v1.3 PDF, Word
  • User Instructions, v1.3 PDF, Word
    • Appendices
      • References PDF, Word
      • 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
  • Chart detailing changes from version 1.2 PDF

HPC, Apheresis and HPC, Marrow DHQ Version 1.2, July 2009

(Version 1.2 materials will be available until July 2013)

The HPC, Apheresis and HPC, Marrow DHQ materials were 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 task force decided to update the DHQ in advance of final recommendations being issued by the 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.

  • Questionnaire, v1.2 PDF, Word
  • Donor Education Materials, v1.2 PDF, Word
  • Medication List, v1.2 PDF, Word
  • User Instructions, v1.2 PDF, Word
    • Appendices
      • 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)

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