AABB Accreditation Process Explained

AABB accreditation ensures high-quality standards in cord blood banking and cellular therapies. This voluntary program covers every stage of stem cell preservation, from donor screening to storage, and is recognized in over 50 countries. Accreditation, valid for two years, involves a detailed process including self-assessments, on-site evaluations, and compliance with strict guidelines. Facilities benefit from enhanced credibility with families, insurers, and regulators, while maintaining accreditation requires ongoing adherence to updated standards. For families, choosing an AABB-accredited bank offers confidence in long-term stem cell storage.

AABB Standards Explained

AABB standards combine international quality management principles with detailed technical guidelines for cellular therapies. These standards, built on Quality Systems Essentials (QSEs), cover key areas like organizational structure, resource and equipment management, materials, documentation, and assessment. Lorna Riach, MA, BS, MT(ASCP), from Boston Children's Hospital, highlights their importance:

"AABB quality systems build strong operational processes. By focusing on quality systems as the basis for building operational processes, a facility can execute operations with accuracy and precision while preventing failure."

The language in these standards is precise. When a requirement uses the word "shall", it is mandatory - failure to meet it results in nonconformance during accreditation. In contrast, "may" indicates an advisory guideline. Every standard must be addressed in written policies, processes, and procedures (PPPs), and facilities are required to follow these documents exactly as written. These rules establish a framework for strict compliance in areas like quality systems, donor eligibility, and processing protocols.

Quality Systems and Compliance

Adhering to AABB standards involves meticulous documentation and record-keeping. Facilities must retain records for all specified activities. For cellular therapies, these records must be kept for 10 years from the record's creation or the product's final disposition, whichever is longer.

Before seeking accreditation, facilities must operate in their specific activity - such as cord blood collection - for at least six months. During this preparation phase, staff can use the APEX online portal to conduct a self-assessment against the current standards before undergoing an on-site evaluation. Additionally, all labeling must comply with the ISBT 128 standard, as outlined in AABB’s technical questionnaires for cord blood facilities. Standards are updated every two years, with changes typically taking effect on July 1 of odd-numbered years.

Donor Screening and Eligibility

AABB standards address every step of the process, from donor screening to patient safety. As AABB explains:

"The Standards cover all aspects of operation from donor selection and testing to product processing, storage, clinical administration, and patient outcomes."

Facilities must have written policies, processes, and procedures for donor screening and eligibility. To ensure compliance with safety protocols, the accreditation process includes specific "Infectious Disease Testing Questionnaires." These standards are developed by expert committees using the latest scientific research, best medical practices, and Good Manufacturing Practices (GMP). Meeting these requirements is essential before moving forward in the accreditation process.

Processing, Testing, and Storage

The AABB standards outline detailed requirements for processing and storage. For example, facilities must reduce red cell and plasma components before cryopreservation using approved separation and plasma depletion methods. A cryoprotectant, such as dimethyl sulfoxide (DMSO), must be added, and cells should be frozen at a controlled rate using computerized equipment to preserve their viability.

Storage guidelines require products to be kept in liquid nitrogen at -196°C (-320°F). Facilities must have temperature monitoring and alert systems in place. Studies indicate that umbilical cord blood stem cells cryopreserved for 21 to 23.5 years retain their biological qualities as if freshly frozen. If a facility does not use a controlled-rate freezer, it must validate that its alternative method ensures a viable product after thawing. These technical specifications are key components of a facility's AABB accreditation application.

The AABB Accreditation Process

Achieving AABB accreditation is a thorough, multi-step journey designed to uphold high-quality standards. This process typically spans one to two years and involves careful preparation and execution. As AABB explains:

"Accreditation is an educational, peer reviewed and participatory process, which helps to build a culture of learning and excellence."

Here’s a breakdown of the steps involved:

Step 1: Preparing for Accreditation

Before applying, your facility must have at least six months of operational experience in its specific activity. Start by obtaining the latest edition of the AABB Standards that apply to your services. For example, the 12th edition for cellular therapy services will take effect on July 1, 2025.

Conduct a detailed internal audit to ensure compliance with all required standards. Each standard must be backed by a written policy, process, or procedure (PPP). The AABB Assessment Tool will guide you through this audit, helping you understand which items assessors will review during their visit. Additionally, familiarize your team with the APEX online portal, where you'll complete the required self-assessment. Assign a dedicated team to oversee the accreditation process from start to finish.

Step 2: Submitting the Application

To kick off the application process, submit an Institutional Membership Application along with contact details for your facility's personnel to [email protected]. If you're an existing AABB-accredited facility expanding into new activities, use the New Activity and Facility Personnel Contact Information Form instead.

Your application package must include activity-specific questionnaires. For instance, cord blood banks need to complete the ISBT 128 Labeling Questionnaire, the Infectious Disease Testing Questionnaire, and the Cord Blood Questionnaire. You’ll also need a Locations Table listing the activities performed at each physical site. Importantly, don’t include payment with your application - AABB will send an invoice after processing your submission. Accreditation fees vary based on the type and volume of activities, with specific pricing available for the 2026 cycle.

Step 3: On-Site Assessment

Once your application is approved, the next step is a thorough on-site evaluation. After completing your self-assessment in the APEX portal, AABB will schedule an assessment visit. During this visit, assessors will verify that your facility adheres to its documented PPPs. They’ll review sample items, observe procedures, and identify any areas of noncompliance.

Final accreditation is awarded only after successfully addressing any nonconformances identified during the on-site visit. Until you receive your official accreditation certificate, refrain from advertising any affiliation with AABB. This rigorous process ensures that facilities meet the highest standards in cellular therapy services. Since 1957, AABB has set the benchmark for quality assessment, with accredited facilities now operating in over 50 countries worldwide.

Maintaining AABB Accreditation

After achieving accreditation, the real challenge lies in maintaining it. For cord blood banks, staying compliant with AABB standards is an ongoing process that ensures high-quality operations and adherence to industry best practices.

Biennial Reassessments

AABB accreditation lasts for two years, after which facilities must undergo a thorough reassessment. This process closely resembles the initial accreditation steps. It begins with a self-assessment conducted through the APEX portal, followed by an on-site evaluation. During the on-site visit, assessors confirm that all documented policies, processes, and procedures are being implemented as written. Any nonconformances identified during the evaluation must be addressed and resolved before accreditation can be renewed.

Facilities must also adapt to updates in standards. For example, the 12th edition of the AABB standards, effective July 1, 2025, requires cord blood banks to align their operations with the latest scientific advancements. Special attention should be given to standards containing the word "shall", as these are mandatory. Failure to comply with these requirements is considered a nonconformance. These periodic reviews not only ensure compliance but also help facilities stay at the forefront of operational practices, which is a key factor when you choose the best cord blood bank.

Benefits of Maintaining Accreditation

Maintaining AABB accreditation offers more than just regulatory compliance - it provides several practical benefits. One key advantage is that AABB's deemed status with the Centers for Medicare and Medicaid Services (CMS) allows the biennial assessment to double as a federal or state-mandated inspection for cellular therapy labs. Additionally, the accreditation is recognized by the Health Resources and Services Administration (HRSA) for the Bill Young Transplant Program. Private insurers, such as Aetna, often require AABB accreditation as a condition for coverage and reimbursement of specific cellular therapy services.

As Martin Smithmyer, Founder and CEO of Americord, explains:

"The AABB accreditation reinforces our position as an industry leader and reflects our commitment to the future of regenerative medicine."

Beyond regulatory credibility, maintaining accreditation can lower liability insurance premiums by demonstrating effective risk management. It also provides access to AABB's regulatory experts for guidance on compliance issues and helps distinguish your facility in a competitive market. With AABB-accredited facilities operating in over 50 countries, this credential signifies adherence to internationally recognized standards of excellence.

Conclusion

AABB accreditation stands as the gold standard for cord blood banks and cellular therapy facilities. Since its establishment in 1957, AABB has set the bar for quality assessment, with its standards now recognized across more than 50 countries. While FDA registration is a required step, AABB accreditation is a voluntary measure that highlights a facility's commitment to going beyond basic regulations.

The accreditation process - spanning from initial preparation to biennial reassessments - ensures that every operational detail aligns with strict quality guidelines. This includes critical areas like donor screening, infectious disease testing, processing methods, storage conditions, and clinical applications. By adopting a quality systems approach, facilities can reduce errors and proactively address risks, safeguarding both patients and donors.

For families choosing to bank their hematopoietic and mesenchymal stem cells, AABB accreditation offers peace of mind, emphasizing the scientific integrity of long-term storage. Healthcare providers view this credential as proof of a facility’s operational excellence and dedication to patient safety. On a practical level, many insurance companies require AABB accreditation for coverage, and some states, such as California, legally mandate adherence to AABB standards.

As of March 2026, Americord Registry holds AABB accreditation for its laboratory in Somerset, NJ. This reflects its dedication to providing customers with confidence in the preservation of perinatal stem cells, solidifying its reputation as a trusted name in regenerative medicine.

Whether you're a facility exploring accreditation or a family researching cord blood banking options, understanding the AABB process highlights the value of this globally recognized mark of quality and safety.

FAQs

Is AABB accreditation required or optional?

AABB accreditation is a voluntary process that reflects a commitment to maintaining high standards of quality and safety. Although it’s not a legal requirement, earning this accreditation highlights an organization’s dedication to meeting rigorous compliance and operational benchmarks.

How can a facility avoid nonconformances during the on-site visit?

Facilities can take meaningful steps to prevent nonconformances during an AABB on-site visit. Thorough preparation is essential, starting with internal assessments to identify and resolve any gaps in compliance. Accurate and up-to-date records are another cornerstone of readiness, as they demonstrate adherence to required standards.

Equally important is ensuring that policies and procedures are not only well-documented but also consistently implemented in daily operations. To stay ahead of potential challenges, facilities should encourage staff to participate in AABB educational programs, which can help pinpoint and address issues before they arise.

Finally, regular reviews of AABB standards and ongoing staff training are key to maintaining compliance. Well-prepared and knowledgeable teams are a critical factor in successfully navigating the on-site visit.

How does AABB accreditation affect insurance coverage for cellular therapy services?

AABB accreditation plays a key role in advocating for insurance coverage and reimbursement of cellular therapies. By meeting established quality standards, accredited facilities can strengthen their case with insurers, potentially improving coverage decisions.