Association for the Advancement of Blood & Biotherapies
Standards and accreditation body for blood banks, transfusion services and cellular therapy; its accreditation holds CMS deemed status for the laboratory activities it covers.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
WHAT AABB COVERS
AABB, the Association for the Advancement of Blood & Biotherapies, is an international not-for-profit organisation for transfusion medicine and biotherapies. It was founded in 1947 as the American Association of Blood Banks and took its current name in 2021, keeping the AABB initials. It develops standards, runs an accreditation programme, and provides education. Its standards cover blood banks and transfusion services, cellular therapy services, immunohematology reference laboratories, molecular testing for red cell, platelet and neutrophil antigens, patient blood management, perioperative autologous blood, relationship testing, out-of-hospital transfusion, and cell and gene therapy pharmacy. The flagship Standards for Blood Banks and Transfusion Services is in its 35th edition, effective 1 April 2026.
WHAT AABB PUBLISHES
- 01Standards for Blood Banks and Transfusion Services (35th edition, effective 1 April 2026) and its companion Guidance
- 02Standards for Cellular Therapy Services and the specialty standards for reference, molecular and relationship-testing laboratories
- 03The AABB Technical Manual and Association Bulletins
- 04Variance decisions and standards interpretations, requested through standards@aabb.org
- 05The directory of AABB-accredited facilities
HOW ITS REQUIREMENTS BITE
AABB standards bind through accreditation. An accredited facility must meet every requirement stated with "shall", and a failure is a nonconformance under the AABB Accreditation Program. AABB holds deemed status from the Centers for Medicare & Medicaid Services for its standards on transfusion, donor activities, immunohematology reference, molecular testing and cellular therapy laboratories, so an AABB assessment can also serve as the federal laboratory inspection. California's Department of Public Health also grants deemed status, and several states recognise AABB in law. AABB standards do not preempt federal, state or local law, and FDA regulates licensed and registered blood establishments independently.
What practitioners get wrong
- AABB accreditation sits alongside FDA licensure and does not replace it. Deemed status covers the CMS/CLIA laboratory inspection, not FDA's inspection of a blood establishment under 21 CFR 606, 610, 630 and 640.
- Editions turn over on a two-year cycle with a fixed effective date. Variances are tied to the edition in which they were granted and must be renewed before the next edition takes effect.
- Since the 20th edition in 2000 the standards have been organised on AABB's quality system essentials, last updated in 2023. Assessors read across those essentials, so one weak process can surface in several chapters.
- The pen symbol marks standards that require a record. Retention periods come from the record-retention tables, not from local habit.
WHERE IT SITS INTERNATIONALLY
AABB standards are written to be consistent with US federal requirements, including FDA's blood regulations and CMS's CLIA rules, and can be followed anywhere in the world. AABB states that each edition rests on principles associated with good manufacturing practices and quality assurance. Its cellular therapy standards overlap with FDA's 21 CFR 1271 tissue rules and with the FACT-JACIE standards used by transplant programmes.
AABB STANDARDS SPEQ DECODES · 1
DISCIPLINES IN AABB’S REMIT
AABB: frequently asked questions
Reference answers on Association for the Advancement of Blood & Biotherapies’s mandate, what it publishes, and how its requirements acquire force.
What is the current edition of the AABB Standards for Blood Banks and Transfusion Services?
The 35th edition, released on 2 March 2026 and effective 1 April 2026.
Does AABB accreditation replace an FDA or CMS inspection?
AABB holds deemed status from CMS for its transfusion, donor, immunohematology reference, molecular testing and cellular therapy laboratory standards, so an AABB assessment can serve as the CLIA inspection. It does not replace FDA's regulation and inspection of blood establishments.
What does AABB stand for?
Since 2021 AABB has been the Association for the Advancement of Blood & Biotherapies. It was founded in 1947 as the American Association of Blood Banks.