Blood Donor History Questionnaire 

The Food and Drug Administration (FDA) maintains all versions of the Donor History Questionnaire (DHQ) that they have officially recognized, with the latest version at the top of the page on their Web site. To view the documents visit www.fda.gov/cber/dhq/dhq.htm.

There may be times when the latest FDA officially recognized DHQ version is not the same as the one posted on the AABB Web site.  This would occur when AABB determines that the actions FDA has proposed in draft guidance are clear enough to update the version of the DHQ prior to FDA finalizing the guidance recognizing the new version.  When this scenario occurs, the Donor History Task Force (DHTF) will notify the membership through relevant AABB publications prior to posting the new version on the AABB Web site.  It is important to note that should this happen, the latest version of the DHQ on the FDA Web site and the AABB Web site will be different.  Another scenario in which the versions may be different on the FDA and AABB Web sites is when a change is made to the DHQ and/or materials related to donor eligibility issues for which FDA makes no requirement nor recommendation (i.e. history of cancer; previous organ, tissue, or bone marrow transplant; bone or skin graft; and pregnancy).  

Any licensed blood establishment planning to implement a new version of the DHQ materials, which have not been officially recognized by the FDA, must submit a formal request to the FDA for approval.  They should call their Consumer Safety Officer for the proper reporting category.

Once a new version of the DHQ materials is officially recognized by the FDA, prior approval will most likely not be required to implement if the officially recognized DHQ materials are implemented without modifications.  Consult the FDA guidance document, Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components, dated October 2006, or a new guidance document recognizing the new version of the DHQ materials for the appropriate reporting category (see below).  Also consult these guidance documents if you want to implement officially recognized DHQ materials with modifications, including major or minor modifications.

When a facility implements a new version of the DHQ materials, they should follow their change control process for the incorporation of the new DHQ materials. For example – if a facility has a stock of pre-printed DHQ version X.X forms and wishes to incorporate an AABB recommended question or modification of an existing question; they can choose to add the question in the section at the end of the DHQ version X.X, per the User Brochure.



Blood Donor History Questionnaire Version 1.2 February 2007
(This version has not been officially recognized by the FDA)

The Donor History Questionnaire (DHQ) materials have been updated to version 1.2 by the AABB Donor History Task Force.  One of the significant updates was incorporating criteria from the draft FDA vCJD guidance, Aug 2006, regarding screening donors for a history of receiving a transfusion in France since 1980.  All indications point to the acceptance of this screening criterion and the recognition of this version of the DHQ materials (v1.2) by the FDA in the vCJD guidance once it is finalized.  To view a complete list of the updates/clarifications incorporated in the new version, refer to the charts below.

• Full-Length Donor History Questionnaire, v1.2  PDF, Word
• Donor Educational Material, v1.2  PDF, Word
• Medication Deferral List, v1.2  PDF, Word
• User Brochure, v1.2  PDF, Word
• User Brochure Flowcharts, v1.2  PDF, Word
   
• Chart detailing changes to version 1.1
  • Questionnaire PDF
  • Flowcharts PDF
  • User Brochure PDF

• Full-Length Donor History Questionnaire, v1.1  PDF, Word
• Donor Educational Material, v1.1  PDF, Word
• Medication Deferral List, v1.1  PDF, Word
• User Brochure, v1.1  PDF, Word
• User Brochure Flowcharts, v1.1  PDF, Word
   
• Chart detailing changes to version 1.0
  • Questionnaire and Medication List PDF
  • Flowcharts PDF
  • User Brochure PDF

• Response to comments to draft guidance PDF