December 13, 2019
AABB finalized the addition of interim standards to the 31st edition of Standards for Blood Banks and Transfusion Services to address transfusion-transmitted babesiosis. The finalized interim standards, available in Association Bulletin (AB) #19-03, recommend actions to comply with the May 2019 Food and Drug Administration guidance, “Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis,” and incorporate feedback received during AABB's 30-day public comment period.
AB #19-03 describes additional testing requirements for blood collections in states specified in the FDA guidance (Standards 5.8.5 and 5.8.6) and recommendations for quarantine and disposition of collections when a repeat donor has a reactive screening test for Babesia (Standard 5.8.7). The interim standards also update Reference Standards 5.1.6A (Requirements for Labeling Blood and Blood Components) and 5.4.1A (Donor Qualification). In addition, four new standards (22.214.171.124, 126.96.36.199, 188.8.131.52 and 184.108.40.206) address the requirements’ effective date and the use of FDA-approved pathogen reduction technology.
The interim standards can be implemented immediately; all accredited facilities should implement the regional strategy for donor testing, pathogen reduction or donor screening for Babesia, as recommended by FDA, by May 10. The 32nd edition of Standards for Blood Banks and Transfusion Services takes effect April 1, except for the standards cited in AB #19-03, which take effect May 10.