AABB26: Ask the Standards

Attendees at this year's “Ask the Standards” session, held on Saturday, got an early look at the proposed changes to two sets of AABB Standards: the 13th edition of Standards for Biotherapy Services (formerly Standards for Cellular Therapy Services), and the 2nd edition of Standards for Emergency Prehospital and Scheduled Out-of-Hospital Transfusion Services. Presenters Audra L. Taylor, MS, SBB(ASCP) and Yvette Tanhehco, PhD, MD, MS, CABP stressed that the proposed changes have not been approved as final.

Prehospital Standards

Many of the proposed changes to the Standards for Emergency Prehospital and Scheduled Out-of-Hospital Transfusion Services match practices already expected of hospital transfusion services and blood centers. The committee also proposed closing gaps between the prehospital and out-of-hospital sections: product or component type is now verified before transfusion, records must include the volume transfused and records of final disposition must be kept for all blood and blood components.

Some notable changes include:

• Validate equipment where it will be used. Coolers and other equipment must be validated in the field environment, not on a lab bench.
• New QC for temperature recorders, alarms and warning systems. Facilities will start with the manufacturer’s instructions and test at least annually. A representative of the first program accredited under these Standards noted during the session’s Q&A portion that many device makers offer no QC guidance; her program asked and got it added.
• Dried plasma is added to the storage and transport table following its recent FDA approval, deferring to the manufacturer's instructions. It is currently available mainly to the Department of Defense.
• Utilization and wastage must now be reviewed and acted on. EMS agencies were encouraged to join partner hospitals’ existing utilization committees.

AI Joins the Standards

Both editions add new requirements on artificial intelligence, and these same standards will appear in every set of AABB Standards going forward. They cover four areas:

• Oversight: A framework for responsible use wherever AI influences policy, critical decisions or donor/patient/staff safety.
• Risk management: Defined roles, a stated intended use and a risk assessment before the AI is put in place.
• Verification: Confirming the output is fit for its intended use.
• Monitoring: Checking AI performance on a set schedule for unintended outcomes.

  AI is part of a broader effort to make requirements consistent across all of AABB’s Standards.

  A New Name

  The most visible change discussed during this session: the title of what was previously named Standards for Cellular Therapy Services will now be “Standards for Biotherapy Services.” Tanhehco explained that “cellular therapy” accurately described the field when the Standards were first written. Scientific and technological advances have since widened the field to include more complex cell- and tissue-derived products. “Biotherapy” is a broader term that covers cellular therapies and other cell- and tissue-derived products, and the new wording appears throughout the edition.

  The committee was clear that the new title does not mean a bigger scope. It keeps the existing requirements for traditional cellular therapies and gives the Standards a framework that can grow as the science, the regulatory environment, and professional practice mature.

  Other Notable Biotherapy Updates

• Director requirements are moving into two reference tables, 1.1A (qualifications) and 1.1B (responsibilities).
• Fixed rules are being replaced with requirements that each facility defines and justifies.
• New safety requirements: genetically modified products and materials must be handled and discarded in a way that limits human exposure, and facilities must define how often they clean and disinfect.
• Updated terminology includes “donor and recipient” for “patient,” “indeterminate or reactive” for “abnormal” and “gestational parent” and “genetic parent” for “birth mother” and “biologic mother.”