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AABB Accreditation: What It Is & How to Get Accredited

What is AABB Accreditation?

“A connected community dedicated to advancing transfusion medicine and biotherapies. From donor to patient. From lab to bedside.” This is a tagline adopted by the American Association of Blood Banks (AABB).

The AABB is an international, non-profit association that comprises and represents those involved in the fields of cellular therapies and transfusion medicine

The AABB accreditation program promotes the highest standard for donors and patient safety in all aspects of blood banking, transfusions, biotherapies, relationship testing, and other related cellular therapies. 

Its comprehensive quality management system (QMS) guides organizations towards continuous improvement and providing the highest quality services. It ensures the organization’s commitment to optimizing its standards of care by managing risks and focusing on blood donors, patients, employees, and regulators quality of care.

The AABB collaborates and works with the U.S. Food and Drug Administration (FDA); together, they provide valuable input into the developmental regulations and policies involving blood and blood components. When an organization is AABB accredited, it becomes an AABB institutional member, which confers valuable benefits, including: 

  • Continuing education
  • Regulatory updates
  • Technical specialists available to answer questions
  • Access to AABB’s highly regarded and reputable experts

All these benefits help facilities and leadership committees maintain optimal performance in their respective organizations.

Types of AABB accreditation 

An AABB accreditation affirms an organization’s commitment to improving the quality and safety of collecting, processing, storing, and distributing cellular and blood products. The accreditation is available for different types of blood-related activities. These are mentioned below:

  • Transfusion Services: Provides services for compatibility testing, storage, selection, and issuing of blood, blood components, tissues, and derivatives intended for recipients in need of transfusion.
  • Blood Bank: Performs the collection, processing, compatibility testing, storage, selection, and issuing of blood, components, tissues, and derivatives intended for transfusion and transplantation.
  • Cellular Therapy Clinical Activities: Includes the patient care teams responsible for the administration of the blood product and related patient care.
  • Donor Center: A facility that performs or is responsible for the collection, processing, testing, or distribution.
  • Donor Testing: A laboratory or facility that tests and studies samples collected from blood donors.
  • HPC Service: A facility involved in one or more activities such as qualifying/assessing donor candidates, collection, processing, distributing, or administration of these products.
  • Cord Blood Service: Like an HPC facility, this is a facility involved in qualifying donors, collecting, processing, and storing cord blood products.
  • Somatic Cell: Centers involved in any of the following procedures: qualifying donors, collection, processing, storage, and distribution of these products.
  • Relationship Testing Facility: A facility responsible for customer service, sample collection, testing, or result reporting of relationship testing.
  • Immunohematology Reference Laboratories: Performs advanced investigational procedures that relate to immunohematology studies.
  • Perioperative Service: Involves an operational area within a facility whose staff or personnel perform activities like intraoperative and postoperative autologous blood recovery, product collection, storage, administration, and more.
  • Molecular Testing: A laboratory or facility that uses molecular testing methods to identify platelets, red blood cells, or neutrophil antigens.
  • Out of Hospital Transfusion Administrative Services: Performs transfusion activities in settings other than a typical hospital, such as hospice and home care settings. 

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Benefits of the AABB Certification

AABB standards comply with the U.S. Code of Federal Regulations and other federal guidance documents. The AABB itself is accredited by ISQua, the International Society for Quality in Health Care. 

Some other key advantages include: 

  • Continuous education: AABB has education programs and publications designed for various careers and expertise levels. The programs are developed, led, and written by renowned experts in respective fields, helping individuals advance their practice and further professional development.
  • Third-party endorsement and distinction: With AABB accreditations, blood testing laboratories and other related facilities are able to attract new patients and referrals better, demonstrate a culture of excellence, and mitigate costly outcomes. This support helps AABB-accredited organizations to differentiate their facility and services from competitors.
  • Show your facility’s commitment to quality and safety: AABB accreditation is designed to improve the quality and safety of different blood-related services, highlighting a facility’s dedication to patient safety and process quality.
  • Receive regulatory updates: AABB members get access to all regulatory updates, including changing regulations and how your facility can maintain compliance. Further, AABB-accredited facilities also obtain regular updates on CLIA regulations and their potential risks and challenges.
  • Support from technical specialists and access to AABB’s experts: AABB-accredited facilities gain direct access to experts who advise on different issues related to accreditation, national blood exchange, and general membership inquiries.
  • Minimize risk at your facility: AABB assessors are trained to identify any potential risks or violations that could result in health risks for patients or donors.

Steps to Becoming AABB Accredited

There are 2 phases to achieving AABB accreditation: self-assessment and an on-site assessment. These phases involve several steps that are as follows.

  1. Determine what type of accreditation you desire. Decide for which activity you need the accreditation, which can include transfusion activity, cord blood activity, hematopoietic progenitor cell activity, relationship testing activity, and many more. 

  2. Review pricing information for accreditation. AABB institutional membership pricing for accreditation includes basic membership, volume fees, and an accreditation activity fee based upon your primary business focus.

  3. Determine who will be involved in the process. The individuals involved in the accreditation process will need to submit an application form with the required details. 

  4. Fill in the details on the following required docs depending on the chosen activity:

    • Locations Table: List what types of activities you perform at which locations. 

    • ISBT 128 Labeling Questionnaire: Meant for those who are involved in the activities at blood banks, blood donor centers, transfusion facilities, and cell therapy facilities.

    • Infectious Disease Testing Questionnaire: Provide additional details on activities like blood banks, blood donor centers, transfusion facilities, and cell therapy facilities. 

    • Cord Blood Questionnaire: Here, you need to fill in the information related to cord blood banks.

    • Relationship Testing Questionnaire: Provide additional details on relationship facilities.

  5. Email your information. Send applications containing all the required information filled in steps #3-4 to [email protected]

  6. Pay dues on the invoice. After sending the details, you will receive an invoice for the mentioned activities. This invoice will be sent to you via email.

  7. Perform a self-assessment. Conduct self-assessment in APEX, an online accreditation portal.

  8. On-site assessment takes place. AABB reviews the self-assessment. Upon approval, the next step is an on-site assessment.

  9. Achieve accreditation. Upon completing the on-site assessment and resolving any nonconformances, the facility achieves AABB accreditation.

Once accredited, a lab will go through the process (on-site assessment) every two years to ensure the consistent maintenance of standard and patient safety.

How Excedr Can Help Your Lab Meet Today’s Accreditation Standards

The AABB accreditation program is focused on assisting biotherapy and blood-related facilities—including blood banking, transfusion, biotherapies, and relationship testing facilities—to achieve the highest standard in quality and care. It helps facilities maintain their optimal performance with high-quality patient safety support and quality management systems.

After obtaining certification for AABB standards of practice, a facility gains several benefits that range from minimizing risk to demonstrating the quality and safety of its services on a global scale.

Equipment used during the collection, testing, and processing of samples plays a significant role in determining the quality and accuracy of obtained results.

Excedr can help labs meet accreditation standards through our flexible and custom lease program. We can help your lab avoid huge upfront costs that come as standard with purchasing lab equipment. With our lease program, your lab can procure the high-quality equipment needed to achieve different accreditations and R&D goals.

Don’t have the budget to purchase lab equipment outright? Consider leasing through Excedr to save your lab time and money. Browse your leasing options today!

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