facility assessments are based on AABB standards which are designed with both quality management system and technical requirements. Each assessment is customized to fit the activities of the facility. Reassessment documents are required for a “desk assessment” before the assessors visit. Areas of concern are identified in advance so that the assessors can carry on a dialogue with a facility to allow it to make necessary changes or additions. An AABB lead assessor and a cell therapy subject matter expert assessor perform the assessments. Any questions concerning the assessment are referred to the AABB Standards Committee before accreditation is given. Otherwise, accreditation is awarded without further board review. At present, AABB has approximately 60 trained assessors with expertise in HPCs and cord blood. AABB assessments are intended to ensure compliance with AABB requirements, provide education, improve the efficiency of operations and ensure consistency in the provision of safe and efficacious products.
FACT is a nonprofit organization founded in 1996 by the International Society for Cellular Therapy (ISCT) and the American Society of Blood and Marrow Transplantation (ASBMT). ISCT is a professional society established in 1992 to represent scientists and physicians working in the area of hematopoietic stem cell graft manipulation. ASBMT was formed in 1993 as a professional organization to represent physicians and investigators involved in the clinical aspect of HPC transplantation. The two societies established FACT to develop standards and a voluntary inspection and accreditation program.
The primary purpose of FACT is to develop standards for hematopoietic stem cell collection, processing and transplantation. FACT’s major objective is to promote high-quality patient care and high-quality laboratory performance in the belief that accreditation must assess the clinical aspects of transplantation as well as collection and laboratory practices. FACT standards are comprehensive and include quality management; facility design and operations; policies and procedures; donor evaluation, selection, and management; record keeping; labeling; processing; storage; transportation; the issue and release of HPCs; adverse event reporting; auditing; and outcomes analysis for the purposes of voluntary inspection and accreditation in the field of HPC therapy.
FACT has developed a voluntary inspection program that, if it is successfully completed, leads to a 3-year accreditation in the field of HPC therapy. FACT inspection teams always include a team leader, a physician trained in stem cell transplantation, and professional experts in the areas of stem cell collection and laboratory practices. The inspection team assesses the compliance of a facility with the standards and reports back to an