the transplant recipient. The standards should be flexible and allow the incorporation of new advances in the field; however, cord blood banks must always be able to provide units that meet established minimum standards. Like the collection sites, banks should have a designated director and a medical director who are suitably qualified to supervise all operations and oversee a quality management program that includes scientifically validated methods for processing, storage, thawing, and transportation of the cord blood units. The thawing method should be provided to the transplant facility before or at the time that the unit is shipped. The cord blood bank personnel should be trained in unit receipt, processing, storage, and shipment; and competency assessments should be conducted on an ongoing basis. To ensure adherence to standards, internal audits should be performed at regular intervals. Deviations and adverse events should be monitored and reported appropriately to regulatory and oversight boards. In order to provide another layer of safety and supervision, all banks providing units for allogeneic transplant should have an IND on file with FDA. The IND annual report should be shared with the accrediting agency and oversight board.
Transplant centers that receive cord blood units from the proposed national program should be accredited and should adhere to standards. They should demonstrate competency in the selection, handling, thawing, and transplantation of cord blood units. Facilities should have appropriately trained physicians, nurses, and staff, as well as a qualified, appropriately trained medical director. The transplant center should have a demonstrated quality management program for ongoing monitoring of the facility itself, the clinical unit, the experience and training of transplant center personnel, policies and procedures, patient evaluation and selection, administration, data management, and record keeping. Facilities should have a proven record of successful cord blood transplantation or, at a minimum, demonstrated competence with marrow and peripheral blood and a willingness to participate in a mentoring process in order to gain familiarity with cord blood. The time to engraftment after cord blood transplantation should be monitored, and engraftment failures and infections should be reported to the appropriate regulatory agencies. Transplant facilities should report patient outcomes to the accrediting agency, and patient outcomes should also be shared with the cord blood bank and the collection facilities that provided the unit.