American Association of Blood Banks

The AABB Accreditation program promotes the highest standards of care for both patients and donors in all aspects of blood banking, transfusion medicine, relationship testing, hematopoietic, cord blood and other cellular therapies. In June 1995 and again in May of 2008, AABB was granted “deemed status” as an accrediting organization under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Most recently, the accreditation program was accredited by the International Society for Quality in Healthcare (ISQua).

Good manufacturing practice (cGMP) regulations, good tissue practice (cGTP) regulations, CLIA ’88 requirements, increased regulations from the FDA for unlicensed blood establishments and transfusion services, the introduction of Quality Management systems, competition within the blood banking profession, advances in the cellular therapy arena, and increased pressure to improve safety with limited resources have changed the way the blood banking and cellular therapy communities conduct business. Conducting business in a quality framework is no longer an option, but a must. Ensuring that all systems are working efficiently and in compliance with AABB Standards and federal regulations is the foundation of any successful operation.

The goal of accreditation is to verify compliance with applicable AABB Standards and federal regulatory requirements and to assist in improving the quality of services provided. Verification of compliance is accomplished by peer review assessments performed in a competent and reliable manner.

Compliance and Education

The assessment provides a review of a facility’s compliance with AABB Standards. This includes an audit of the quality and operational systems. The experience and expertise of the AABB assessors also makes the assessment process an educational experience.

Foundation for the Accreditation of Cellular Therapy

FACT accredits facilities under the two sets of international standards developed in cooperation with JACIE and NetCord:

FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration. These Standards apply to hematopoietic progenitor cells isolated from bone marrow or peripheral blood and to all phases of collection, processing, and administration of these cells.

NetCord-FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release. These Standards apply to facilities and individuals performing cord blood collection, processing, testing, banking, selection and release of cord blood units.

These standards were developed by international teams of experts in the field of cellular therapy and cord blood banking. The standards contain the minimum guidelines for facilities and individuals performing cellular therapy product transplantation, cord blood banking, or providing support services for such activities.

Accreditation is awarded after successful documentation of compliance with the current standards. Compliance is determined by evaluation of written documents provided by the facility and by on-site inspection. On-site inspections are carried out by a team of inspectors who are qualified by training and experience, have attended inspector training and who have a working knowledge of FACT-JACIE Cellular Therapy Product Standards or NetCord-FACT Cord Blood Banking Standards, as appropriate, and of their application to various aspects of the facilities being inspected. The inspection process is quality-oriented and follows the FDA’s rules for current Good Tissue Practice (cGTP).