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Standards Setting

About AABB’s Standards Programs

Since 1957, AABB has been a leader in the development of voluntary standards in blood bank blood component collection, processing, and transfusion. These standards, along with the requirements detailed in the Accreditation Portal (APEX), provide the basis for the AABB Accreditation Program. Over the years, AABB’s standards-setting program has moved beyond the blood bank to encompass new disciplines and activities.

Learn more about our Standards Programs and the current versions of Standards that AABB publishes.

How Standards are Created

A volunteer committee of experts, known as a Standards Committee (SC), develops each set of Standards. Each SC is composed of AABB members who serve as technical experts, liaisons from other AABB committees, and representatives from other organizations.

The Standards requirements are based on good medical practice, scientific data, principles associated with good manufacturing practices and quality assurance, and applicable regulations. When possible, the standards are written to be consistent with the requirements of other standards setting and accrediting bodies and to recognize regulatory environments different form that of the United States.

How to Join a Standards Committee

Any individual AABB individual member can apply to serve on an SC at any point during the year. Terms of service last for a minimum of one edition of Standards and a maximum of two editions. Committee membership is determined once every two years for each edition of Standards and approved by the current or incoming chair of the SC and the AABB Board of Directors.

Setting Standards Around the World

AABB Standards combine internationally accepted quality management system requirements with relevant technical requirements for each discipline. As such, the Standards can serve as the basis for accreditation anywhere in the world. While some requirements are based on the U.S. FDA’s regulations, a committee with international expertise can review requests for variance that involve a departure from U.S. public health priorities. Learn more about Requesting a Variance.

AABB has also helped international public health systems by using Standards templates to assist the Latin American, Caribbean, and African regions in developing region-specific standards. AABB hopes that these Standards templates, which incorporate blood banking terminology and are compatible with the universally accepted ISO (International Organization for Standardization) 9000 standards, can be used as the foundation for standards-setting and accreditation programs in any region of the world.