REGULATORY UPDATE: AABB Releases Toolkit With Example Whole Blood Donor Risk Educational Material and Acknowledgement Models

AABB is pleased to introduce a new toolkit, Informing Blood Donors of Whole Blood Donation Risks, Use of Donor Information and Blood Samples, and Acknowledgement to Donate Whole Blood – Example Models.

Developed by a subgroup of the AABB Donor Health and Safety Committee, this toolkit provides example models for blood centers to consider when creating their own predonation reading materials (PRMs). These models can be used alongside AABB’s Blood Donor Educational Material v4.0, which includes the FDA-required minimum information on the blood donation process, HIV risk, definitions of sexual contact and travel history considerations.

Locally developed PRMs that explain donation risk and provide an overview of the donation process have historically lacked standardization, with significant variability in length and complexity across different blood collection establishments. When applicable, a donor acknowledgement should also include the possibility that a blood sample may be used in research and explain the donor’s right to opt out.

The example model documents were developed to be readable, concise and instructive. The toolkit includes a section titled “Risks of Whole Blood Donation, Use of Donor Information and Blood Samples,” which lists serious and/or frequent adverse events associated with donation, describes the implications of test results for the donor, and informs the donor of the possible use of their blood sample in research. Another section of the toolkit, titled “Acknowledgement to Donate Whole Blood,” provides information regarding noting donors’ acknowledgement of the information provided to them and agreement to donate.

Members with questions may contact regulatory@aabb.org.