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Establishment of an unrelated umbilical cord blood bank qualification program: ensuring quality while meeting F ood and D rug A dministration vendor qualification requirements
Author(s) -
Rabe Fran,
Kadidlo Diane,
Van Orsow Lisa,
McKenna David
Publication year - 2013
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.12085
Subject(s) - blood bank , umbilical cord , vendor , cord blood , accreditation , medicine , quality (philosophy) , operations management , business , emergency medicine , engineering , medical education , marketing , philosophy , epistemology , anatomy
Background Qualification of a cord blood bank (CBB) is a complex process that includes evaluation of multiple aspects of donor screening and testing, processing, accreditation and approval by professional cell therapy groups, and results of received cord blood units. The U niversity of M innesota M edical C enter C ell T herapy L aboratory has established a CBB vendor qualification process to ensure the CBB meets established regulatory and quality requirements. Study Design and Methods The deployed qualification of CBBs is based on retrospective and prospective review of the CBB . Results Forty‐one CBBs were evaluated retrospectively: seven CBBs were disqualified based on failed quality control ( QC ) results. Eight CBBs did not meet the criteria for retrospective qualification because fewer than 3 cord blood units were received and the CBB was not accredited. As of M arch 2012, three US and one non‐ US CBBs have been qualified prospectively. One CBB withdrew from the qualification process after successful completion of the comprehensive survey and subsequent failure of the provided QC unit to pass the minimum criteria. One CBB failed the prospective qualification process based on processing methods that were revealed during the paper portion of the evaluation. Conclusions A CBB qualification process is necessary for a transplant center to manage the qualification of the large number of CBBs needed to support a umbilical cord blood transplantation program. A transplant center that has utilized cord blood for a number of years before implementation of a qualification process should use a retrospective qualification process along with a prospective process.