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Blood Donor History Questionnaires

The blood donor history questionnaires are designed to aid blood establishments in evaluating a prospective donor’s history relative to current known blood safety risks, FDA regulations and recommendations, and AABB Standards. The Full-Length Donor History Questionnaire (DHQ) is designed to evaluate any donor, while the Abbreviated Donor History Questionnaire (aDHQ) can be used with qualified frequent blood donors.

There are five documents in each set, whether the Full-Length (DHQ) or Abbreviated (aDHQ) version:

  • Questionnaire – a list of broad capture questions to be answered by the donor
  • Educational Materials – information required by FDA or AABB to be provided to the donor prior to answering the Questionnaire
  • Medication Deferral List – a list of medications required by FDA or AABB to be used in the donor’s evaluation prior to or while answering the Questionnaire
  • User Brochure (UB) – instructions for blood establishment staff on how to use all the materials in evaluating a donor’s eligibility to donate blood, as well as maintenance of and revisions to the materials.
  • vCJD Countries of Risk – a list of countries used by the donor while answering questions on the DHQs and by the donor historian to identify risk of vCJD transmission according to current recommendations in FDA guidance
  • Flowcharts – optional resource to aid blood establishment staff in completing the interview process
  • References – a list of relevant documents used in the development of the DHQs and accompanying materials

The version 2.0 Blood Donor History Questionnaires and Accompanying Materials were officially recognized by the FDA in Guidance, May 27, 2016. FDA and AABB consider v2.0 to be the current version of the AABB DHQ/aDHQ materials that replaced v1.3 DHQ and materials.

As stated in the May 27, 2016 Weekly Report announcing FDA acceptance of the DHQs, the change tables, found under the “Supporting Documents” tab, are intended to help blood centers identify significant revisions made during the review process. Blood centers are responsible for preparing accurate DHQs and accompanying materials, prior to implementation, that are consistent with FDA-recognized version 2.0 documents.

Those with questions regarding the version 2.0 documents may contact AABB at regulatory@aabb.org.

 DHQ v2.0

Full-Length Blood Donor History Questionnaire, Version 2 May 2016

(Officially Recognized by the FDA in Guidance)

  • Full-Length Donor History Questionnaire (DHQ), v2.0 PDF, Word
  • Blood Donor Educational Material, v2.0 PDF, Word
  • Medication Deferral List, v2.0 PDF, Word
  • DHQ User Brochure, v2.0 PDF, Word
  • DHQ Flowcharts, v2.0 PDF, Word
  • vCJD Countries of Risk, v2.0 PDF, Word
  • References, v2.0 PDF, Word

 aDHQ v2.0

Abbreviated Blood Donor History Questionnaire, Version 2 May 2016

(Officially Recognized by the FDA in Guidance)

  • Abbreviated Donor History Questionnaire (aDHQ), v2.0 PDF, Word
  • Blood Donor Educational Material, v2.0 PDF, Word
  • Medication Deferral List, v2.0 PDF, Word
  • aDHQ User Brochure, v2.0 PDF, Word
  • aDHQ Flowcharts, v2.0 PDF, Word
  • vCJD Countries of Risk, v2.0 PDF, Word
  • References, v2.0 PDF, Word
 

The FDA posted information regarding the officially recognized DHQ versions on the FDA Webpage. Those documents may differ from the ones posted here if:

  • AABB determines that the actions FDA has proposed in draft guidance are clear and important enough to warrant updating the DHQ before FDA issues the final guidance document recognizing the new DHQ version.
  • A change is made to the DHQ and/or materials related to donor eligibility issues for which FDA makes no requirement nor recommendation (e.g., history of cancer; previous organ, tissue, or bone marrow transplant and bone or skin graft).
  • The Medication Deferral List has been updated.

When a change is made, the DHTF will notify membership through relevant AABB publications prior to posting the new version on the AABB website. The DHTF evaluates drugs for risks relevant to blood donation and will determine if a drug will be added to the Medication Deferral List (MDL). The updated MDL will differ from that officially recognized by the FDA and posted on the FDA webpage.

Licensed blood establishments planning to implement a new version of the DHQ materials that has not been officially recognized by the FDA must submit a formal request to the FDA for approval. The facility should call its Consumer Safety Officer for the proper reporting category.