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Blood Donor History Questionnaires

In a May 11, 2023 Guidance, FDA formally recognized the DHQ Version 4.0 (DHQ v4.0) and Accompanying Materials as acceptable for use.

Blood collection establishments are responsible for:

  • Reviewing the guidance to ensure compliance with FDA’s recommendations, reporting, and implementation requirements.
  • Reviewing the DHQ v4.0 User Brochure for detailed information on the limitations and appropriate use of AABB’s FDA-recognized DHQ(s) (for example, adding questions, reformatting materials).
  • Reporting the implementation of AABB’s DHQ v4.0 and Accompanying Materials as a minor change in the Annual Report [§601.12(d)] to FDA when implemented as accepted by FDA and without modifications of the DHQ v4.0 documents posted by AABB.
  • Compliance with additional FDA requirements under §601.12, as noted in the guidance, for licensed blood establishments implementing a modified version of the FDA-accepted DHQ v4.0 and Accompanying Materials, such as submission of a PAS [§601.12(b)] for FDA approval prior to implementation of major changes.

Full-Length Blood Donor History Questionnaire Version 4.0 (DHQ v4.0), May 2023

Officially Recognized by the FDA in Guidance as an acceptable mechanism for collecting blood donor history information to establish donor eligibility that is consistent with FDA requirements and recommendations.

The following six elements make up the DHQ v4.0 and Accompanying Materials for blood donor screening:

  1. DHQ v4.0 User Brochure – designed to guide blood centers collecting blood and blood components in the appropriate use of the DHQ and Accompanying Materials. Review of the User Brochure is encouraged for detailed information on change control and limitations to documents recognized by the FDA (adding questions, reformatting materials). PDF

  2. DHQ v4.0 – made up of capture questions, grouped into common timeframes and based on principles of cognitive psychology, to facilitate donor understanding and accurate recall of relevant risk activities. PDF, Word

  3. DHQ v4.0 Flowcharts – an optional resource to guide the donor historian through the screening process. Use of the flowcharts is NOT REQUIRED if the blood center has an equivalent method for evaluating responses to the DHQ. PDF, Word

  4. Blood Donor Educational Material v4.0 - provided to the donor for review on the day of, and prior to donation which includes information required by FDA or AABB concerning relevant transfusion-transmitted infections and additional information about the donation process. PDF, Word

  5. Medication Deferral List v4.0 – a list of relevant medications and timeframes required by FDA or AABB to be used in the donor’s evaluation prior to or while answering questions on the DHQ/aDHQ. PDF, Word

  6. References v4.0 - a list of relevant documents used in the development of the DHQ System of Documents. PDF

Abbreviated Blood Donor History Questionnaire Version 4.0 (aDHQ v4.0), May 2023

Officially Recognized by the FDA in Guidance use of the aDHQ is limited to qualified frequent donors with no changes to their eligibility. Refer to the aDHQ v4.0 User Brochure for criteria for use of the aDHQ and Accompanying Materials.

The following six elements make up the aDHQ v4.0 and Accompanying Materials for blood donor screening:

  1. aDHQ v4.0 User Brochure – designed to guide blood centers collecting blood and blood components in the appropriate use of the aDHQ and Accompanying Materials. Review of the User Brochure is encouraged for detailed information on change control and limitations to documents recognized by the FDA (adding questions, reformatting materials). PDF

  2. aDHQ v4.0 – made up of capture questions, grouped into common timeframes and based on principles of cognitive psychology, to facilitate donor understanding and accurate recall of relevant risk activities. PDF, Word

  3. aDHQ v4.0 Flowcharts – an optional resource to guide the donor historian through the screening process. Use of the flowcharts is NOT REQUIRED if the blood center has an equivalent method for evaluating responses to the aDHQ. PDF, Word

  4. Blood Donor Educational Material v4.0 - provided to the donor for review on the day of, and prior to donation which includes information required by FDA or AABB concerning relevant transfusion-transmitted infections and additional information about the donation process. PDF, Word

  5. Medication Deferral List v4.0 – a list of relevant medications and timeframes required by FDA or AABB to be used in the donor’s evaluation prior to or while answering questions on the DHQ/aDHQ. PDF, Word

  6. References v4.0 - a list of relevant documents used in the development of the aDHQ System of Documents. PDF

Important Links

The volunteer member experts of the Donor History Task Force, in collaboration with AABB’s Regulatory Affairs staff, have developed the current Blood Donor History Questionnaire(s) (DHQs) and Accompanying Materials to provide a system:

  • That is submitted by AABB Regulatory Affairs for FDA review as an acceptable mechanism for collecting blood donor history information from donors of blood and blood components that is consistent with the FDA requirements and recommendations. [21 CFR 630.10] and AABB Standards.
  • That is posted on the AABB website and where it remains publicly available along with a DHQ v4.0 Toolkit for Implementation
  • That may be reported by licensed manufacturers as a minor change in a facility’s annual report to FDA under §601.12(d) if implemented as accepted by FDA (refer to the Implementation section of the guidance)

Please don’t hesitate to send your questions regarding the DHQ v4.0 System of Documents to Regulatory Affairs at regulatory@aabb.org.

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