Association Bulletin #21-03 Updates BB/TS Standards Related to ZIKV Testing

AABB released Association Bulletin (AB) #21-03 today, which contains updates to several standards within the 32nd edition of Standards for Blood Banks and Transfusion Services (BB/TS Standards) related to infectious disease testing and Zika virus (ZIKV). The revisions follow the Food and Drug Administration’s withdrawal of the July 2018 ZIKV testing guidance last month, in which the agency’s stated that ZIKV is no longer a relevant transfusion-transmitted infection under FDA’s regulations because the virus no longer has sufficient incidence and/or prevalence to affect the potential donor population. 

As a result of FDA’s withdrawal, AABB has revised the BB/TS Standards to remove the requirement to perform ZIKV testing for future donations effective today. However, the discontinuation of testing requires a transition period during which most blood collectors will modify numerous highly regulated processes and procedures, including an extensive re-validation of the changes to their blood establishment computer system, an FDA regulated medical device that serves as the last step in a system of safety measures to help prevent distribution of unsafe blood products. 

Hospitals should be aware that they may continue to receive ZIKV-tested units from their blood supplier during this time, and associated costs may remain in place under the terms of existing contracts. Accordingly, blood collectors may distribute ZIKV-tested inventory for the next several months until staff training is completed and new, validated processes are fully implemented. Facilities planning to discontinue ZIKV testing should ensure that they follow the requirements articulated in Standard 5.1.1.