Goal 1: Promote Human Health

A risk-based framework for evaluating blood donor selection criteria

Is there a risk-based framework for evaluating the blood donor selection process, to capture relevant risk factors for transfusion-transmitted diseases, while modifying policies that do not contribute to transfusion safety?

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Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

Precautionary measures have been essential to blood safety, but the precautionary principle requires periodic evaluation of donor selection policies as information emerges on their risk, benefit, and cost. For example, the HHS Advisory Committee on Blood and Tissue Safety and Availability recently called for efforts to evaluate the effectiveness of blood donor educational materials and screening questions. Recent research provided a cognitive evaluation of the Donor History questionnaire, assessment of contemporary risk factors for transfusion-transmitted infections, and insight into non-compliance with the current MSM donor deferral policy. Consequently, FDA announced in December 2014 their intent to recommend a change the deferral period for men who have had sex with men (MSM) from an indefinite period to one year. A framework is needed to evaluate other deferral policies to identify relevant risk factors among prospective donors, and modify those questions that do not contribute to blood safety. In addition, the factors that influence blood donors’ compliance and comprehension of the educational material and questions are incompletely characterized but strongly influence the effectiveness of the screening process and validity of the information elicited by the questionnaire. Rational and prudent donor selection, deferral and retrieval policies are crucial to protect transfusion recipients while encouraging repeat blood donation among healthy, motivated individuals.

Feasibility and challenges of addressing this CQ or CC :

Blood centers collect and manage large volumes of information on blood donors, donations, and components after distribution and have successfully collaborated on pilot and exploratory studies to define, collect and analyze specific data to probe specific research questions about donor eligibility criteria. Continued collaboration among blood collection sites should allow for broad representation of blood donors in future research studies which will increase their generalizability.

Name of idea submitter and other team members who worked on this idea : Anne Eder MD PhD and Dana Devine PhD for the 2015 NHLBI Stateof the Science in Transfusion Medicine

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Idea No. 412