FACT-accredited Cellular Therapy Programs have demonstrated
compliance with the current FACT Cellular Therapy Standards. The accreditation
process involves the submission of documentation to demonstrate compliance with
the standards and a subsequent on-site inspection conducted by inspectors
qualified by training and experience in cellular therapy. Accredited programs
have met rigorous standards, as defined by the leading experts in the field and
based on the latest knowledge of the field of cellular therapy product
transplantation. Programs are accredited for the types of transplants they
perform or the services they provide.
ACCREDITED SERVICES
Transplantation: Clinical program that is responsible for
all aspects of patient care and treatment, including the administration of
cells with the intent of providing transient or permanent engraftment in
support of therapy of disease.
- Adult - An adult patient as defined by the program.
- Pediatric - A pediatric patient as defined by
the program.
- Auto - Autologous transplant: Cells are taken
from one individual and transplanted back into the same individual.
- Allo - Allogeneic transplant: Cells are taken
from one individual and transplanted into another genetically distinct individual.
Collection: Facility where cellular therapy products are
collected from a donor.
- Marrow - Marrow collection: the collection of
material that contains immature and mature blood cells, including white blood
cells, red blood cells, and platelets from the interior of a large bone of a
donor.
- Peripheral blood by Apheresis - Peripheral blood collected
by apheresis as a source of hematopoietic progenitor cells and/or other mononucleated
cells.
Processing: A
facility where cellular therapy product processing activities are performed.
- Processing – All aspects of manipulation,
cryopreservation, packaging, and labeling of cellular therapy products
regardless of source. This accreditation was divided into two accreditation
goals (minimal and/or more than minimal manipulation) in 2012.
- Minimal – Minimal Manipulation: Processing that
does not alter the relevant biological characteristics of cells.
- More than Minimal – More than Minimal Manipulation: Processing
that does alter the relevant biological characteristics of cells.