AABB issued interim standards to the 33rd edition of Standards for Blood Banks and Transfusion Services (BB/TS Standards). The interim standards, outlined in Association Bulletin #22-04, reflect the edits to the weld section of the 33rd edition of BB/TS Standards. These changes were initially proposed for a 30-day public comment period in April of 2022 and, based on feedback received, reissued the interim standards for a second comment period in June.
When the 33rd edition of BB/TS Standards became available in the Standards Portal, AABB’s Standards Department began to receive queries concerning new Standard 5.7.2.1.3. The queries articulated the reality that, due to a lack of expiration times included in some manufacturers’ instructions for certain storage containers (including but not limited to bags and transfer packs), many products would have to be discarded because of the 4-hour expiration requirement.
In creating this new standard, the AABB BB/TS Standards Committee (SC) intended to close a loophole whereby products such as platelets are aliquoted into a container not approved for storage of this component (such as a syringe) before administration to the patient. The BB/TS SC reasoned that, in the absence of labeling indicating the container had been approved for storage of the component and lacking manufacturer’s instructions indicating expiration time for this use (storage), adding a 4-hour expiration time would be appropriate.
The changes to Standard 5.2.7.1.1, creation of new Standard 5.2.7.1.1.1 and the deletion of Standard 5.2.7.1.3 may be implemented immediately. Please note AABB assessors will begin assessing against these standards immediately as well. The changes described in this Association Bulletin are reflected in the 33rd edition of BB/TS Standards and in the Standards Portal.
