Each of these steps should be optimized to ensure the success of the transplant. As part of the accreditation process, cord blood banks and collection sites should be considered an integrated unit. Centers performing transplants should also be accredited to ensure proper unit selection, infusion, follow-up, and outcomes reporting. Ideally, all four components should be accredited by the same organization to ensure consistency.

Cord blood banks are responsible for providing high-quality, HLA-typed units for transplantation to patients in need. The quality of the cells is critical, since the transplant must restore hematopoiesis and immunity in the recipient. Patients have a very low chance of achieving long-term survival if the cells do not engraft.8

Collection Site

The collection process represents the first step in ensuring a high-quality supply of cord blood units. The collection facility should meet minimum standard requirements; that is, it must routinely provide units that are of adequate volume and that test negative for bacterial, viral, or fungal contamination. A designated medical director should be responsible for overseeing the activities of the collection facility.

The collection facility staff should be trained in all aspects of the collection procedure and this training should be documented. The personnel collecting cord blood should be trained in screening and obtaining informed consent from the donors and in the proper methods of effective, sterile collection. Personnel should receive regular evaluation of their performance as well as ongoing training.

A quality management plan that incorporates all aspects of the collection facility’s operations, including personnel training, deviations, adverse event reporting, and internal audits to document compliance with standards, should be in place. The facility should maintain standard operating procedures to ensure an effective sterile collection process, including procedures for the collection, storage, and transportation of units.

Cord Blood Bank

Cord blood units are transferred from the collection site to the cord blood bank where they are processed, tested, and cryopreserved for long-term storage until they are retrieved for transplantation. Each step in this process must be performed properly to ensure a satisfactory outcome for

8  

Though if the patient does manage to survive in the short-term without engraftment, subsequent transplants or autologous recovery may ensure long-term survival.



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