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Standard Setting Activities

Since 1957, the AABB has been a leader in the development of standards for voluntary compliance in blood bank blood component collection, processing and transfusion. In the years since, AABB standards-setting programs have expanded to encompass several new disciplines. In addition to the Standards for Blood Banks and Transfusion Services, AABB now publishes Standards for Cellular Therapy Product Services (including hematopoeitic progenitor cells, somatic cells and cord blood), Standards for Immunohematology Reference Laboratories, Standards for Relationship Testing Laboratories (formerly Standards for Parentage Testing Laboratories), Standards for Perioperative Autologous Blood Collection and Administration, and Standards for Molecular Testing for Red Cell, Platelet, Neutrophil Antigens and Standards for a Patient Blood Management Program.

Each set of Standards is developed by a volunteer committee of experts. The requirements contained in Standards are based on good medical practice, scientific data, principles associated with good manufacturing practices and quality assurance, applicable regulations, and the requirements of other standards-setting and accrediting bodies. These standards, along with the requirements detailed in the Accreditation Information Manual have provided the basis for the AABB Accreditation Program.

AABB Standards are a matrix that combines internationally accepted quality management system requirements with technical requirements appropriate for each given discipline. As such, the Standards can serve as the basis for accreditation anywhere in the world. Due to the fact that some requirements are based on the United States of America’s Food and Drug Administration, a committee of volunteers with international expertise can review requests for variance that involve a departure from U.S. public health priorities.

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

AABB’s Standards and Accreditation Programs are separate departments of AABB and operate independently of AABB’s Consulting Services.