AM25-MN-11-L - From Blueprint to Benchmark: A Journey Through AABB Standards Development and Accreditation

Monday, October 27, 2025

2:30 PM - 3:30 PM PT

Location: 20A

Program Chair(s)

Katherine S. Brown, PhD (she/they)

Director, Life Sciences R&D
CooperSurgical, Inc
San Francisco, California

Disclosure(s): No relevant disclosure to display

Speaker(s)

Randall Schaefer, DNP, RN, ACNS-BC, CEN

CEO
Schaefer Consulting, LLC
New Braunfels, Texas

Disclosure(s): No financial relationships to disclose
J. Wade W. Atkins, MS MLS SBB CQA,CABP(H)

Supervisor, QA and RA
NIH Clinical Center
Frederick, Maryland

Disclosure(s): No financial relationships to disclose

Proposed Session Description: Join us for an insightful session where we delve into why, when, and how new standards for AABB accreditation are developed as a response to continued evolution within the Blood and Biotherapies industry, drawing upon the 1st Edition Cell and Gene Therapy Standards for Pharmacy and 1st Edition Scheduled Out of Hospital and Emergency Prehospital Transfusion as case studies. We will also hear about lessons learned and considerations from an institution undergoing the process of seeking accreditation under the 1st edition Standards for Scheduled Out of Hospital and Emergency Prehospital Transfusion. Finally, the session will explore how standards are refined and modified in subsequent editions to ensure they remain relevant and effective. This session will build upon what was previously presented as part of the pre-Meeting Assessor Day, and we are excited to bring this to AABB’s general membership.

Learning Objectives:

Recognize how activities within the Blood and Biotherapies space amenable to AABB accreditation are identified and the process by which Standards are developed.
Explore how an institution prepares for accreditation of an activity covered under a newly established standard.
Review how standards are modified and updated in subsequent editions.