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Blood Donor History Questionnaires 

The full-length and abbreviated Donor History Questionnaire (DHQ) 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 the Food and Drug Administration (FDA) as well as a public ethicist.

The FDA maintains all versions of the DHQ that have been officially recognized through issuance of a guidance document. To view the DHQ documents and associated guidance visit www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/ucm164185.htm. 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.

It is possible that the latest FDA officially recognized DHQ versions may not always be harmonized with what is posted on the AABB website. This would occur when AABB determines that the actions FDA has proposed in draft guidance are clear and important enough to warrant updating the DHQ before FDA issues the final guidance document recognizing the new DHQ version.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 website. Other scenarios in which the versions may be different on the FDA and AABB websites 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) or when the Medication Deferral List has been updated.

The Medication Deferral List Has Been Updated And Is Not Consistent With AABB Documents Posted On The FDA Website

The AABB DHTF discussed the modifications with its FDA 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 the drug updates 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.

Full-length DHQ Medication Deferral List, v1.3, May 2008 has been updated to include Jalyn as a second dutasteride-containing medication and Absorica, Myorisan, and Zenatane as additional isotretinoin-containing medications.  In addition Amnesteem, Claravis, and Sotret -  three of the isotretinoin-containing medications already contained in the listing on the top portion of the Medication Deferral List - are now listed in the additional reading section on the lower portion. They have also been added to the appropriate one-month diamond on the flowchart for Question 4. Revised materials include the DHQ Medication Deferral List, version 1.3, and flowchart corresponding to question 4 — "Are you now or have you ever taken any medications on the Medication Deferral List?"

aDHQ Medication Deferral List, v1.3, Dec 2012 was approved by FDA with the Jalyn update included. The aDHQ Medication Deferral List v1.3 and the flowchart corresponding to Question 11 — "Since your last donation have you taken any of the medications on the Medication Deferral List?" — have been updated to include Absorica, Myorisan, and Zenatane as additional isotretinoin-containing medications. In addition, Amnesteem, Claravis, and Sotret - three of the isotretinoin-containing medications already contained in the listing on the top portion of the Medication Deferral List - are now listed in the additional reading section on the lower portion. They have also been added to the appropriate one-month diamond on the flowchart for Question 11.

v1.3 Malaria Flowcharts Will be Revised to be Compliant with New FDA Recommendations on Malaria

The DHTF is working with its FDA liaisons to update the flowcharts corresponding to Question 28 on the full-length DHQ and Question 12 on the aDHQ. According to implementation instructions in the August guidance document when the AABB revised materials are found acceptable by FDA, implementation of the questionnaire and accompanying materials can be reported as minor changes in an establishment’s annual report under 21 CFR 601.12(d), noting the date the process was implemented. AABB and the DHTF will alert members when this process is complete and the new flowcharts are available.

Assistance is available by contacting regulatory@aabb.org.

Full-Length 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, 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 (DHQ), v1.3 PDF, Word
  • Donor Educational Material, v1.3 PDF, Word
  • Medication Deferral List, v1.3 PDF, Word (Rev. Sept 2010 – See Jalyn; Rev. May 2013-See Absorica; Rev. August 2013 – See Myorisan, Zenatane)
  • User Brochure, v1.3 PDF, Word
  • User Brochure Flowcharts, v1.3 PDF, Word (Q#4 Rev. Sept 2010 – See Jalyn; Rev. May 2013-See Absorica; Rev. August 2013 – See Myorisan, Zenatane)

Abbreviated Blood Donor History Questionnaire, Version 1.3 December 2012

(This version has been officially recognized by the FDA)

The FDA has issued "Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components" dated May 2013, recognizing the AABB aDHQ version 1.3 (December 2012) as an acceptable mechanism for collecting blood donor history information from frequent donors. The guidance document reinforces the aDHQ User Brochure requirement that establishments implementing the AABB aDHQ documents also should administer the AABB full-length DHQ.

aDHQ Postimplementation Study

The AABB DHTF has committed to studying the postimplementation use of the aDHQ. Summary results of the study will be provided to the FDA. Participation in the study is not required, however all establishments that implement the aDHQ will be invited to participate. Information about – and instructions for participating in – the study are posted. All questions should be directed to aDHQ@aabb.org

  • Abbreviated Donor History Questionnaire (aDHQ), v1.3 PDF, Word
  • Donor Educational Material, v1.3 PDF, Word
  • Medication Deferral List, v1.3 PDF, Word (Rev. May 2013-See Absorica; Rev. August 2013 – See Myorisan, Zenatane)
  • aDHQ User Brochure, v1.3 PDF, Word
  • aDHQ User Brochure Flowcharts, v1.3 PDF, Word (Q#11 Rev. May 2013-See Absorica; Rev. August 2013 – See Myorisan, Zenatane)

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