a template for the other organizations involved in this field. Thus, there should be no conflict between the FACT Standards and those of other standard-setting organizations that had joined the NATF. The first edition of the FACT Standards was published in September 1996. The first inspections began in September of 1997.
In July 2004, NMDP published a revised edition of its standards, intended to outline the most basic guidelines for facilities involved in the transplantation of HPCs (NMDP, 2004). These guidelines were not intended to be a comprehensive list encompassing all requirements; rather, they were intended to serve as a standard of care for patients in such facilities. They apply to all activities related to donor screening, collection, processing, release, and transplantation of bone marrow, peripheral blood, and cord blood progenitor cells facilitated through the NMDP network of banks and transplant centers.
In contrast to adult marrow and peripheral blood donors, who can be examined immediately prior to harvest, the umbilical cord blood donor is not available for additional testing. For this reason, it is critical that the transplant physicians be assured that a thorough screen for genetic and infectious diseases has been performed and be aware of any risk factors prior to final selection and shipment.
Because cord blood transplantation is a dynamic area of clinical research, standards should be stringent yet flexible enough to allow for the incorporation of new advances in the field. Many issues in the methodology of cord blood banking and transplantation are not fully resolved and require ongoing investigation, including procedures for processing, storage, and thawing. Numerous steps in the transplantation process ought to be considered, including:
donor selection and consent;
collection of units;
processing, testing, and storage of units;
selection of units for transplantation;
release and shipment of units to transplant centers;
thawing and infusion;
outcomes monitoring by the transplant site.