Blood Donor History Questionnaires

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 Related 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 the DHQ v2.1 Implementation Toolkit.
  • 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)

On 05/05/2020, the FDA formally recognized the v2.1 DHQ and Related Materials as acceptable for use.
Blood collection establishments are responsible for:

  • Reviewing the guidance to ensure compliance with FDA’s recommendations, and reporting and implementation requirements.
  • Reviewing the DHQ User Brochure for detailed instructions 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 and related documents as a minor change in the Annual Report [§601.12(d)] to FDA when implemented as accepted by FDA and without modifications of the version v2.1 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 v2.1 DHQ materials, such as submission of a PAS [§601.12(b)] for FDA approval prior to implementation of major changes.

Please don’t hesitate to send your questions regarding the v2.1 documents to Regulatory Affairs at regulatory@aabb.org.

Important Links

Full-Length Blood Donor History Questionnaire (DHQ), Version 2.1 April 2020

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 Full-Length DHQ v2.1 System for blood donor screening:

  1. Full-Length DHQ User Brochure v2.1 – designed to guide blood centers collecting blood and blood components in the use of the Full-Length DHQ and all related materials. Review of the User Brochure is encouraged for detailed instructions on change control and limitations to documents recognized by the FDA (adding questions, reformatting materials).

  2. Full-Length DHQ v2.1 – 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.

  3. Full-Length DHQ Flowcharts v2.1 – 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.

  4. Blood Donor Educational Material v2.1 - 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.

  5. Medication Deferral List v2.1 – 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.

  6. References v2.1 - a list of relevant documents used in the development of the DHQ and related materials.

Abbreviated Blood Donor History Questionnaire (aDHQ), Version 2.1 April 2020

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 User Brochure v2.1 for criteria for use of the aDHQ and related materials.

The following six elements make up the aDHQ v2.1 System for blood donor screening:

  1. aDHQ User Brochure v2.1 – designed to guide blood centers collecting blood and blood components in the use of the aDHQ and all accompanying materials. Review of the User Brochure is encouraged for detailed instructions on change control and limitations to documents recognized by the FDA (adding questions, reformatting materials).

  2. aDHQ v2.1 – 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.

  3. aDHQ Flowcharts v2.1 – 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.

  4. Blood Donor Educational Material v2.1 - 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.

  5. Medication Deferral List v2.1 – 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.

  6. References v2.1 - a list of relevant documents used in the development of the aDHQ and related materials.