The AABB is a United States-based professional body and standards organization that was founded in 1947 as the American Association of Blood Banks. The organization is now international with members in 80 countries and has taken on a broader scope to include all of transfusion medicine as well as cellular therapies specifically ones based on hematopoietic stem cells. In 2005, the organization changed its name to AABB to reflect the changes in scope and operations.
The AABB works closely with the US Food and Drug Administration and provides technical input into the development of blood regulations for the US. While membership is not a regulatory requirement, virtually all major blood banks in the United States are accredited by the AABB. More than 80 percent of hospital transfusion services and similar facilities in the US are members. Accreditation by AABB meets the requirements of the Clinical Laboratory Improvement Amendments (CLIA) for blood bank, transfusion service, and immunohematology reference laboratory operations.
The organization publishes a newsletter as well as a research journal named Transfusion, which is published through Blackwell Publishing. Every three years the AABB publishes a Technical Manual; as of 2011, it is in its seventeenth edition. The organization also publishes a variety of other blood banking related materials, including the standards that it uses to accredit members.
Since 1953, the organization has operated a National Blood Exchange to facilitate transfers of blood between blood banks during shortage or in requirement of rare blood types.
The organization also accredits laboratories that perform parentage testing. These tests are primarily performed through DNA testing, but historically involved blood types. The AABB is the accrediting body for these DNA testing laboratories in the United States.
The Accreditation Program promotes the highest standard of care for patients, donors and products in all aspects of transfusion medicine, cellular therapies, transplantation, and relationship testing. The AABB supports high standards for medical, technical and administrative performance, scientific investigation, clinical application and education. The resulting Accreditation Program specifically assesses quality systems and operational areas for compliance with Standards. The basis for assessment includes compliance with Standards, United States Code of Federal Regulations and federal guidance documents. This independent assessment of operations assists in preparation for other inspections, and serves as a valuable tool to improve both compliance and operations. The program offers both educational and peer review opportunities. It is the intent of the program that accreditation be recognized at both a national and international level.
Accreditation is granted for collection/procurement, processing, testing, storage, distribution, and administration for transfusion medicine activities (donor center, transfusion, perioperative, immunohematology reference laboratories and molecular testing laboratories); cellular therapy activities (clinical, HPC, cord blood, and somatic cell); relationship testing activities; and SBB schools.
AABB and ABHH (Associacao Brasileira de Hematologia, Hemoterapia e Terapia Celular) in Brazil, provide a joint accreditation for facilities located in Brazil using ABHH Standards (AABB Standards translated into Portuguese and customized to reflect local Brazilian requirements).
Our Consultancy Scope of Services:
- GAP Assessment as per the standard requirement
- Assisting in Preparation AABB Quality and Answer manual as per AABB checklist
- Interpretation of AABB checklist requirement
- Designing and Development of Quality Management system requirement as per AABB checklist
- Preparation of AABB self Assessment documentation
- AABB Application filing
- Answering all AABB challenges/Non conformance and compliance query raised by CAP assessment team
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