AABB Issues Emergent Standards to 33rd Edition of BB/TS Standards

AABB issued emergent standards to the 33rd edition of Standards for Blood Banks and Transfusion Services (BB/TS Standards) to reflect a shortened deferral period from 12 months to 3 months for donors who have lived with or had sexual contact with an individual with acute or chronic hepatitis B or symptomatic hepatitis C. The emergent standards, outlined in Association Bulletin #23-04, update donor eligibility criteria requirements in Reference Standard 5.4.1A, Donor Qualification, based on the FDA’s May 2023 Level 2 guidance that recognized the Donor History Questionnaire, version 4.0 (DHQ v4.0).

AABB notes that this change in deferral period is possible because all regulatory references to a 12-month deferral for hepatitis risk were removed in 2015. FDA removed the regulations in 21 CFR 640.3 in the May 2015 final rule. Since the final rule took effect in May 2016, FDA has not issued recommendations specifying the deferral period for hepatitis risk. Regulations in 21 CFR 630.10(e)(1)(v) require donor assessment for intimate contact with risk for relevant transfusion-transmitted infections but do not establish specific deferral timeframes.

The changes to Reference Standards 5.4.1A may be implemented immediately; however, facilities that wish to retain a longer deferral period for these donors can do so. The changes described in this Association Bulletin are reflected in the 33rd edition of BB/TS Standards and in the Standards Portal.

 

Those with questions may contact the AABB Standards Department at standards@aabb.org.