ASCP applauds the recently released
FDA final guidance which implements a shift toward Individual Donor Assessment (IDA) to determine blood donor eligibility criteria, which will remove biases in former policy. ASCP strongly supports the shift as it expands access to blood donation formerly unavailable to some members of the LGBTQ+ community -- representing a step toward greater equity in the healthcare system. IDAs also help standardize the screening process, while maintaining the highest safety standards. ASCP has long supported policy change that creates more equity and inclusivity. For example, we signed on to a
letter commending the FDA for their evidence-based recommendations that no longer unnecessarily exclude potential donors.
With the final guidance recommendations come policy changes that our partner organizations, the Association for the Advancement of Blood & Biotherapies (AABB) and America’s Blood Centers (ABC), are prepared to assist the blood banking community with. For example, AABB is offering a variety of tools and educational resources to aid in implementing the new protocols and communicating with LGBQT+ community members:
•
FDA-recognized AABB Donor History Questionnaire
•
Individual Donor Assessment (IDA) Resource Library
• Series of
complimentary educational courses designed to help blood center staff members address potential challenges associated with the new IDA protocols
• A
“Train the Trainer” program for blood collectors seeking more in-depth education and tools to lead sex-positive awareness and donor conversation training with their staff
ABC continues to provide support to their community-based, independent blood center members and work that has already begun across the blood community to welcome newly eligible donors. It is important to note that although the FDA has accepted updates to the donor history questionnaire, the Agency has yet to validate the computer systems regulated by the FDA that are necessary for implementation. Each blood center will need time to evaluate and respond to these policy changes. ASCP will be working with our association partners to support FDA’s new policy. As part of this effort, ASCP will be working closely with our members to ensure that FDA is aware of their views regarding the policy’s adoption and implementation.
We again applaud the FDA for making policy changes that create a uniform screening process for blood donation, remove stigmas and biases, and create room for greater equity in the healthcare system overall.
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