AABB Issues Emergent Standards to 34th Edition of BBTS Standards and 11th Edition of CT Standards

AABB issued emergent standards to the 34th edition of Standards for Blood Banks and Transfusion Services (BB/TS Standards) and 11th edition of Standards for Cellular Therapy Services (CT Standards). The emergent standards are highlighted in Association Bulletins (AB) #24-03 and #24-04. 

The updates to each set of standards in the cited association bulletins are based on recent decisions by the Food and Drug Administration.

 

In the case of AB #24-03, AABB added a new deferral period for individuals who have received Ixchiq (Valneva Austria GmbH) to Reference Standard 5.4.1A, “Allogeneic Donor Qualification,” in the 34th edition of BB/TS Standards. The vaccine in question protects against the disease caused by chikungunya virus (CHIKV) for individuals 18 years or older who are at increased risk of exposure to CHIKV. Because of the complexity of adding a deferral period, members will have until February 2025 to implement this update.

In the case of AB #24-04, AABB removed the requirement to screen donors for Zika virus from Reference Standards 5.12B, “Clinical Evaluation and Laboratory Testing of Living Allogeneic Donors;” 512D, “Clinical Evaluation and Laboratory Testing of Mothers of Cord Blood or Gestational Material Donors;” and 5.12E, “Clinical Evaluation and Laboratory Testing of Cadaveric Donors,” in the 11th edition of CT Standards. The decision to remove the screening requirement is based on FDA’s decision that this is no longer needed for donors of cellular therapy products. As this is a removal of a requirement, members can implement this change immediately or can continue to screen donors if they wish. AB #24-04 links to AABB’s tool to assist users in the removal of this requirement.

The changes to the Standards for Blood Banks and Transfusion Services and Standards for Cellular Therapy Services may be implemented immediately. 

The changes described in these bulletins are reflected in the 34th edition of BB/TS Standards and 11th edition of CT Standards in the Standards Portal. Users with questions may contact AABB’s Standards Department at standards@aabb.org.