Overview and Background
AABB is an organization formerly known as the “American Association of Blood Banks.”
With the expansion of its scope, it has been renamed the Association for the Advancement of Blood & Biotherapies. It is a nonprofit dedicated to advancing transfusion medicine and biotherapies (including cellular therapies).
Founded in 1957, AABB has driven quality improvement in transfusion medicine in the United States. It develops operational standards for blood banks (blood centers) and transfusion services, and serves as a respected international accreditation body for hospitals and blood centers.
Headquartered in Bethesda, Maryland (USA), AABB accredits hundreds of facilities worldwide.
AABB’s activities respond to societal demands to prevent transfusion-transmitted infections and accidents in transfusion medicine. Ensuring transfusion safety became a major challenge in the latter half of the 20th century, and AABB moved early to establish standardization and audit frameworks.
It launched its accreditation program in the 1970s. As many blood banks obtained AABB accreditation, a nationwide quality assurance network for transfusion services was formed. AABB Standards align closely with U.S. FDA regulations; in practice, FDA blood regulations have been developed in harmony with AABB’s standards.
In the 21st century, AABB extended its scope beyond transfusion to include cellular therapies (e.g., cord blood banking and stem cell transplantation programs), and removed “blood banks” from its name.
Today, AABB is active internationally as a body that develops global standards and accredits not only blood for transfusion but also the quality and safety of cellular and tissue-based products.
Main Requirements and Criteria
To achieve AABB accreditation, an organization must operate in conformance with the AABB Standards. These standards set out detailed requirements for transfusion services and cellular therapy services and are updated periodically by expert committees.
Below is an overview using a cord blood bank (a facility that stores newborn umbilical cord blood) as an example.
Donor Eligibility and Informed Consent
Cord blood banks obtain appropriate informed consent from the mother (donor) and conduct health history screening and infectious disease testing.
AABB Standards describe in detail the donor interview process and required test panels (e.g., HBV, HCV, HIV), thereby helping ensure the safety of stored cord blood.
Collection and Processing Procedures
Procedures from collection through processing and cryopreservation are documented and carried out by trained staff.
Requirements cover aseptic technique, in-process quality testing (e.g., cell counts, cultures), accurate labeling, and other controls to ensure traceability from donor to final use.
Facility and Equipment Requirements
Standards include facility and equipment criteria such as cleanrooms and liquid nitrogen storage. Environmental controls—temperature monitoring, backup power, alarm systems, and related safeguards—are specified to ensure safe storage of cellular material.
Quality Management System
Organizations establish quality management elements in line with AABB Standards: document control, record retention, staff training, internal audits, deviation/nonconformance management, and more.
While similar in concept to ISO-based quality systems, AABB includes domain-specific requirements (e.g., QC for transfusion testing laboratories, transport conditions for cells intended for transplantation).
Transport and Release
Standards also define the process for releasing cord blood units for patient use.
They specify request-to-dispatch workflows, temperature control during transport, receipt verification, and required documentation to ensure safe and reliable delivery to transplant centers.
There are multiple sets of AABB Standards (e.g., for transfusion services, for cellular therapy products), but all share the core purpose of protecting donor and patient safety and ensuring the quality and effectiveness of products (blood and cells).
Each standard is developed by expert committees (physicians, laboratory professionals, ethicists, etc.) and revised regularly to reflect the latest science and practice. Facilities seeking accreditation align their operations to these standards and undergo on-site assessments by AABB assessors.
During assessments, documentation is reviewed, staff are interviewed, and operations are observed to verify conformity. If the facility meets the standards, accreditation is granted.
Accreditation typically renews on a two-year cycle, requiring continuous adherence and ongoing quality improvement.
Significance and Benefits of Accreditation
AABB accreditation enables hospitals and banks to demonstrate that their transfusion and cellular therapy services meet international benchmarks for safety and quality.
This builds confidence among patients and donors and strengthens institutional credibility. For example, when a cord blood bank is AABB-accredited, expectant parents can be reassured that donated units will be managed properly, and transplant physicians can have confidence in unit quality.
In some jurisdictions, cord blood units intended for transplantation are recommended or required to come from AABB-accredited banks. In that sense, AABB accreditation functions as a mark of excellence that helps a facility become a preferred choice for clinicians and users.
Accreditation also drives significant operational improvement.
Aligning workflows and SOPs to the standards, investing in staff training, and upgrading infrastructure collectively raise organizational performance. Ongoing reassessments every two years sustain momentum and incentivize continuous alignment with current standards.
As a result, internal audits and continuing education become routine, deepening staff expertise and morale. The continuous-improvement mindset associated with maintaining AABB accreditation often reduces clinical risk, improves efficiency, and strengthens teamwork across departments. Facilities that hold “dual” accreditations or certifications (e.g., ISO 9001 plus AABB) frequently report synergistic gains—combining general quality system discipline with domain-specific medical standards to deliver even higher service levels.
Overall, AABB accreditation establishes internationally recognized quality assurance, simultaneously enhancing trust among patients and donors and advancing organizational maturity.
Impact on Products, Services, and Consumers
In this context, “consumers” chiefly means patients receiving transfusion or cellular therapy and donors providing blood or cells.
Blood components and cellular therapy products from accredited facilities are managed under rigorous standards, supporting safe and effective treatment. For example, blood components from an AABB-accredited center undergo thorough infectious-disease testing and ABO/Rh verification; storage and transport are controlled, lowering transfusion-transmitted infection risks for recipients.
In cord blood transplantation, units sourced from accredited banks meet defined criteria for cell count and viability, which can improve engraftment outcomes and reduce complications. In short, AABB accreditation benefits patients by providing assurance of high-quality blood and cell-based care.
Donors also benefit.
Blood and cord blood donors want their donations to be properly screened, processed, and used effectively. At AABB-accredited facilities, donor eligibility evaluations and specimen handling are rigorously controlled, providing confidence that donations are managed safely and put to meaningful use.
Standards include ethical requirements such as informed consent procedures and privacy protection, safeguarding donor rights and welfare. This fosters trust and can encourage donor participation.
More broadly, the spread of AABB accreditation has positive societal effects.
Public confidence in transfusion and cellular therapies increases, reducing reluctance to accept necessary care. Robust inter-facility sharing of safe blood and cellular products also strengthens health-system resilience—for example, during disasters or mass-casualty events—helping save more lives. High-quality blood and cell services, underpinned by AABB standards, contribute not only to patients and donors but also to overall improvements in healthcare quality and infrastructure.
Relevant International Bodies and Regulators
Although AABB originated in the United States, its standards and accreditation programs are widely recognized and adopted internationally.
The U.S. Food and Drug Administration (FDA) regulates domestic blood establishments, and AABB Standards complement FDA regulations. AABB accreditation often helps facilities prepare for FDA inspections and maintain compliance. FDA collaborates with AABB—for instance, by participating in AABB annual meetings and engaging AABB experts during guidance development. Many major blood centers are AABB-accredited, making the standards a de facto norm within U.S. healthcare.
Internationally, AABB works with blood services organizations in many regions.
Facilities in Canada, Singapore, and parts of the Middle East, among others, have obtained AABB accreditation.
Other accreditation bodies in related fields include FACT (Foundation for the Accreditation of Cellular Therapy) and JACIE (the European cellular therapy accreditation), whereas AABB is positioned as a comprehensive organization covering transfusion and biotherapies. The WHO also looks to AABB’s work when promoting safe transfusion practices, and programs in some countries incorporate AABB-aligned frameworks.
For example, WHO’s quality systems guidance for safe blood recommends that countries build national quality assurance programs modeled on international standards such as AABB.
In summary, AABB functions as an industry body that also serves as an effective international accreditor, networking with regulators like the FDA, public organizations such as the WHO, and peer accreditation entities. While accreditation is pursued by individual facilities, together they create domestic and international safety nets for blood and biotherapies, complementing and reinforcing public regulation.
AABB is expected to continue evolving its standards with a global perspective, contributing to improved reliability in healthcare.