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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
Cord blood collection facilities, banks, and transplant centers should be accredited by a central accrediting organization to participate in the proposed National Cord Blood Program. The central accrediting agency should adopt or develop consensus standards and establish a program of inspection and accreditation. This agency should monitor ongoing compliance with standards and the outcomes of transplants. The accrediting agency should report to the policy board of the proposed National Cord Blood Stem Cell Bank Program. Collection centers, banks, and transplant centers should maintain their accreditation and should report the required data to continue to participate in the National Cord Blood Stem Cell Bank Program. The accrediting agency should have a policy in place to detect facilities that become noncompliant in the interim between inspections. The accrediting agency should have a mechanism to withdraw the accreditation for any facility that is found to be noncompliant.
FDA recently issued standards for current good tissue practice which address general issues related to cellular therapies but which are not specific to cord blood banking or transplantation. At present, FDA does not license cord blood.
As mentioned above, two existing organizations, AABB and FACT/NetCord, have developed standards and are accrediting cord blood banks in the United States. In addition, NMDP, while not an accrediting organization, has developed a process to define the minimum acceptable criteria for units to be stored by member banks and listed in their search databases. These criteria do not address all of the quality management issues described above.
The Health Resources and Services Administration should issue a request for proposals to select or create the proposed accrediting body. The organization should meet the standards for the functions for ensuring quality in cord blood collection centers, banks, and transplant centers described above. The organization should demonstrate that it has a comprehensive process, documented by standard operating procedures for standards development and implementation, thorough on-site evaluation of facilities, consistent and comprehensive review of inspection reports, board or oversight committee approval for accreditation, and follow-up procedures throughout the accreditation period. The organization should demonstrate the expertise of the inspectorate, the mechanism for training and competency of the inspectors, ongoing quality control of inspectors, a mechanism for investigating problems uncovered during an inspection, and criteria for retaining or dismissing inspectors. The accrediting organization should define a mechanism for assessing foreign cord blood banks that is comparable to the mechanism for assessing U.S. facilities to guarantee quality and allow those inventories to be available to U.S. recipients.