The Donor History Questionnaire materials are prepared by the AABB Donor History Task Force (DHTF). Representatives on the task force include those from AABB, the American Red Cross, America’s Blood Centers, the Armed Services Blood Program, Canadian Blood Services, the Centers for Disease Control and Prevention, the Plasma Protein Therapeutics Association and liaisons from FDA as well as a public ethicist. The Food and Drug Administration (FDA) maintains all versions of the Donor History Questionnaire (DHQ) that they have officially recognized through issuance of a guidance document, with the latest version at the top of the page on their Web site. To view the documents visit www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/ucm164185.htm.
It is possible that the latest FDA officially recognized DHQ version may not always be harmonized with what is posted on the AABB Web site. This would occur when AABB determines that the actions FDA has proposed in draft guidance are clear and important enough to warrant updating the DHQ before FDA issues the final guidance document recognizing the new DHQ version. When this scenario occurs, the DHTF will notify membership through relevant AABB publications prior to posting the new version on the AABB Web site. 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 (e.g., 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, 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.
After 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for Use in Screening Donors of Blood and Blood Components, dated October 2006, or a new guidance document recognizing a newer version of the DHQ materials for the appropriate reporting category (see below). These guidance documents should also be consulted 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, it should follow its change control process for incorporating 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 a modified existing question the facility can choose to add the question at the end of the DHQ version X.X, per the User Brochure.
Blood DHQ Materials Updated to Include Dutasteride-Containing Drug Jalyn
The Donor History Questionnaire Medication Deferral List, version 1.3, and flow chart corresponding to question 4 — "Are you now or have you ever taken any medications on the Medication Deferral List?" — have been updated to include Jalyn as a second dutasteride-containing medication. The AABB Donor History Task Force discussed the modifications with its Food and Drug Administration liaisons, including the mechanism for reporting implementation to FDA. Version control of the materials has been maintained by expanding footer information on specific pages of the updated documents. Blood establishments may add the information about Jalyn by modifying the materials they currently use or by replacing them with those updated by AABB. Licensed blood establishments may report this change (along with the date of implementation) in their next annual report under 21 CFR 601.12(d), and include a brief description of the change or submit a copy of the new medication list and flow chart with the report (AABB Weekly Report, Oct. 1, 2010).
Blood Donor History Questionnaire Version 1.3 May 2008
(This version has been officially recognized by the FDA)
The FDA has issued "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products’’ dated May 2010, recognizing the Donor History Questionnaire version 1.3 (DHQ v1.3) dated May 2008, prepared by the AABB Donor History Task Force, as acceptable DHQ documents. FDA acknowledges the AABB DHQ documents as an effective donor screening tool which provides licensed and unlicensed facilities one way to meet FDA requirements (21 CFR 640.3 and 640.63). The guidance document contains instructions for implementation of version 1.3 and reporting the changes to FDA.
- Full-Length Donor History Questionnaire, v1.3 PDF, Word
- Donor Educational Material, v1.3 PDF, Word
- Medication Deferral List, v1.3 PDF, Word (Revised Sept 2010 – See Jalyn)
- User Brochure, v1.3 PDF, Word
- User Brochure Flowcharts, v1.3 PDF, Word (Q#4 Revised Sept 2010 – See Jalyn)
- Chart detailing revisions that created version 1.3
- Educational Material PDF
- Medication List PDF
- Flowcharts PDF
- User Brochure PDF
UDHQ Task Force Responds to Concerns About “Attention” Questions