AABB accreditation (sometimes searched as “AABB certification”) is the voluntary credential AABB — the Association for the Advancement of Blood & Biotherapies, formerly the American Association of Blood Banks — awards to blood banks, transfusion services, cellular therapy facilities, and related organizations that meet its published Standards following an on-site assessment. It is distinct from AABB membership, from FDA registration/licensure, and from CLIA certification, though the four often apply to the same facility at the same time.
This guide covers what AABB accreditation actually verifies, who needs it, how the assessment process works, how it relates to AABB membership and to CLIA, and where to find the current edition of AABB Standards.
What Is AABB and What Does Its Accreditation Cover?
AABB is an international, not-for-profit standards-development and accreditation organization focused on transfusion medicine and cellular therapies. It publishes a family of standards documents — not one single standard — each covering a different type of facility or activity, including:
- Standards for Blood Banks and Transfusion Services
- Standards for Cellular Therapy Services
- Standards for a Patient Blood Management Program
- Standards for Immunohematology Reference Laboratories
- Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens
- Standards for Perioperative Autologous Blood Collection and Administration
- Standards for Emergency Prehospital and Scheduled Out-of-Hospital Transfusions
- Standards for Relationship Testing Laboratories
- Cell and Gene Therapy Standards for Pharmacy
- Fundamental Standards for Blood Collection and Transfusion
Accreditation is issued against whichever of these standards applies to the specific activity a facility performs — a hospital transfusion service, a community blood center, and a cellular-therapy processing lab are each assessed against a different document, and a single institution running more than one of these functions may hold accreditation to more than one AABB standard at once.
The oldest and most frequently updated of these — Standards for Blood Banks and Transfusion Services — is periodically revised; the “35th edition” some readers search for by name refers to the current numbered revision of that specific document. Because AABB revises its standards on a recurring cycle, always confirm the current edition number and effective date directly from AABB’s Standards catalog rather than relying on a cached figure, including the one in this paragraph.
AABB Accreditation vs. AABB Membership
These are two separate relationships with AABB, and it’s a common point of confusion:
| AABB Membership | AABB Accreditation | |
|---|---|---|
| What it is | An institutional or individual relationship with the association — access to AABB’s education, publications, meetings, and professional community | A credential awarded after an on-site assessment against a specific AABB Standards document |
| Does one require the other? | A facility can be an AABB member without ever pursuing accreditation | A facility does not have to be an AABB member to apply for or hold accreditation, though members typically pay reduced program fees |
| What it signals to a regulator or auditor | Nothing on its own — membership is not a quality credential | Documented conformance to a named, externally assessed standard |
| Renewal | Annual dues | Ongoing assessment cycle to maintain accredited status |
If a search for “AABB membership” was what brought you here looking for accreditation requirements: membership and accreditation are administered through the same organization but are not the same product, and neither substitutes for the other on an inspection report.
Who Needs AABB Accreditation
AABB accreditation is voluntary, not a legal mandate on its own, but it is the de facto quality benchmark across most of transfusion medicine and cellular therapy in the US and internationally. Organizations that typically pursue it include:
- Hospital transfusion services — the unit that stores, crossmatches, and issues blood components for patient transfusion.
- Community and independent blood centers that collect, process, and distribute blood and blood components.
- Cellular therapy facilities collecting or processing hematopoietic progenitor cells and related cellular therapy products.
- Patient blood management programs operating within a hospital or health system.
- Immunohematology reference laboratories performing complex antibody identification and compatibility testing.
- Relationship (parentage/kinship) testing laboratories and molecular red cell/platelet/neutrophil antigen testing labs.
Many of these facilities are also separately subject to CLIA certification (because they perform laboratory testing on human specimens) and to FDA registration and licensure (because collecting, processing, or distributing blood and blood components is regulated as a biologic under 21 CFR Parts 600–680). AABB accreditation, CLIA certification, and FDA registration are three distinct regulatory/quality relationships that commonly apply to the same blood bank or transfusion service simultaneously — holding one does not substitute for the others, though AABB’s Standards are written to align closely with FDA’s blood-establishment regulations, which is one reason many facilities pursue AABB accreditation as their primary quality framework.
The AABB Accreditation Process
While specific steps and timelines vary by program and facility type (and should always be confirmed against AABB’s current published process for the standard in question), AABB accreditation generally follows this sequence:
- Application. The facility applies to AABB’s accreditation program for the specific standard(s) that apply to its scope of activity (e.g., blood bank/transfusion service, cellular therapy).
- Self-assessment. The facility completes a self-assessment against the relevant AABB Standards, identifying gaps before an assessor ever visits.
- On-site assessment. A trained AABB assessor (often a peer volunteer from another AABB-accredited facility, a model similar to peer-assessment systems used by other laboratory accreditors) conducts an on-site evaluation of the facility’s processes, records, personnel qualifications, and quality system against the applicable Standards.
- Deficiency response / corrective action. Where the assessment identifies nonconformances, the facility submits a corrective action plan addressing root cause, remediation, and prevention of recurrence.
- Accreditation decision. Once outstanding deficiencies are resolved to AABB’s satisfaction, accreditation is awarded (or renewed).
- Ongoing maintenance. Accredited status is not permanent or one-time — facilities remain subject to a recurring reassessment cycle, self-assessment updates, and reporting of significant changes (new testing methods, new locations, adverse events) between formal assessments.
Because the exact cycle length, fee structure, and documentation requirements are updated periodically and differ by standard, treat any specific timeline you find (including elsewhere on this page) as a starting point for planning, not a substitute for the current process documentation on AABB’s own accreditation program pages.
AABB Accreditation vs. CLIA Certification vs. ISO 15189/17025
These credentials are frequently confused because a single laboratory can hold several of them at once, each answering a different question:
| Credential | What it verifies | Who administers it | Mandatory? |
|---|---|---|---|
| AABB Accreditation | Conformance to AABB’s transfusion-medicine/cellular-therapy Standards | AABB (a voluntary, private accrediting body) | Voluntary, but the de facto quality benchmark in the field |
| CLIA Certification | Legal authority to perform laboratory testing on human specimens, categorized by test complexity | CMS, under 42 CFR Part 493 | Legally required for any lab performing testing in CLIA’s scope |
| ISO/IEC 17025 | Technical competence of a testing/calibration laboratory generally (not specific to transfusion medicine) | National accreditation bodies against the international ISO standard | Voluntary; more common outside clinical/human-testing labs |
A CMS-approved laboratory accreditation organization can be granted “deeming authority,” under which its accreditation is accepted by CMS as evidence that a facility meets CLIA requirements, avoiding a separate CLIA-specific survey. Facilities should confirm current deemed-status arrangements directly with AABB and CMS, since these designations are reviewed and can change.
Frequently Asked Questions
What does AABB stand for?
AABB originally stood for the American Association of Blood Banks. The organization now uses “AABB” as its formal name, unpacked as the Association for the Advancement of Blood & Biotherapies, reflecting its expanded scope beyond blood banking into cellular therapies and biotherapies.
What is AABB accreditation?
AABB accreditation is a voluntary credential awarded to blood banks, transfusion services, cellular therapy facilities, and related organizations after an on-site assessment confirms their processes meet the relevant AABB Standards document for their type of activity.
What’s the difference between AABB accreditation and AABB membership?
Membership is an institutional or individual relationship giving access to AABB’s education, publications, and professional community. Accreditation is a separate, assessed quality credential. A facility can hold either without the other, though AABB members typically receive reduced accreditation program fees.
What is “AABB Standards 35th edition”?
This refers to a specific numbered revision of AABB’s Standards for Blood Banks and Transfusion Services — the oldest and most frequently updated title in AABB’s Standards family. Because AABB revises its standards periodically, confirm the current edition number and effective date directly on AABB’s Standards catalog before citing it in a policy or procedure.
Is AABB accreditation legally required?
Not on its own — it is a voluntary, private credential. Separately, CLIA certification (for laboratory testing) and FDA registration/licensure (for blood collection, processing, and distribution) are legally required where their scopes apply. Many facilities pursue AABB accreditation as their primary quality framework because its Standards align closely with FDA’s blood-establishment regulations, and because AABB can hold CMS-recognized deeming authority for CLIA purposes.
How is AABB accreditation different from CLIA certification?
CLIA certification is a legal requirement administered by CMS for any laboratory performing testing on human specimens, categorized by test complexity. AABB accreditation is a voluntary, standards-based credential specific to transfusion medicine and cellular therapy. A transfusion service commonly holds both.
Related reading: CLIA Certification, ISO/IEC 17025, Proficiency Testing & External Quality Assessment (EQA), Laboratory Compliance & Quality.
