AABB Outlines Notable Changes to Upcoming BB/TS Standards, IRL Standards

AABB encourages members of the blood and biotherapies community to review the notable changes to the 35th edition of the Standards for Blood Banks and Transfusion Services (BB/TS Standards) and 14th edition of Standards for Immunhematology Reference Laboratories (IRL Standards). Both editions will take effect April 1 and will soon be available for purchase in the AABB Store.

BB/TS Standards

The 35th edition clarifies requirements for notifying AABB of accreditation-relevant changes, refines expectations for equipment investigations following nonconformances, establishes monitoring requirements for critical technology infrastructure, and adds a new standard requiring preparation of pathogen-reduced cryoprecipitated fibrinogen complex in accordance with manufacturer instructions.

AABB encourages members with questions about the 35th edition to join AABB’s upcoming eCast, in which members of the BB/TS Standards Committee will discuss significant changes and the rationale behind them. The program will take place 2-3 p.m. ET on Wednesday, Feb. 25.

Additional information about the BB/TS Standards is available on the AABB website.

IRL Standards

The 14th edition of IRL Standards includes new requirements for laboratories to notify AABB when changes may affect accreditation status or when the laboratory is subject to a regulatory enforcement action by a relevant competent authority.

Additional standards require laboratories to actively monitor their technology infrastructure through risk-based monitoring and testing at defined intervals, and to establish a defined process to detect titration testing errors by performing appropriate controls each day that titration testing is conducted.

Additional information about the IRL Standards is available online.