AABB's Standards Program has evolved over time in response to changes in the field. To learn more about AABB's Standards Program, please visit our FAQs About AABB Standards page. To request more information about a particular Standard, individuals may request a Standards Clarification.
Each edition of AABB's Standards are developed by a team of experts who volunteer their time as a member of a Standards Committee. Each edition of AABB's Standards are based on best 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 from that of the United States.
Much of the ongoing work of AABB's Standards Committees is geared toward helping those in the field understand the process by which standards are set and to understand how to effectively implement the requirements. In an effort to assist users, AABB maintains a Standards Library, which includes Standards-related documents currently available for public review.
Any individual AABB individual member can apply to serve on a Standards Committee. 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 Committee and the AABB Board of Directors.
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.