We instituted procedures to check the identity of cord blood unit provided for transplantation by carrying out ABO and human leukocyte antigen (HLA) typing of the thawed units before transplantation. ABO typing is done using standard techniques. Rapid HLA class I serology is with monoclonal antibody trays (One Lambda Inc) using standard incubations. One mislabeled umbilical cord blood (UCB) unit was detected on the day of intended transplantation by repeat ABO typing of the thawed unit at our transplantation center. Because ABO typing will not detect all labeling errors, the rapid serologic class I HLA typing procedure was done on thawed units just before transplantation for all units without an attached segment. This procedure identified a second mislabeled unit. In a 6-year period, 2 of 871 (0. 2%
IntroductionTransplantation of umbilical cord blood (UCB) stem cells for hematopoietic reconstitution is increasing. [1][2][3][4][5] As a result of the promising results with UCB, the US Congress has appropriated funds to substantially increase the number of UCB units collected and stored. UCB banking has now transitioned from research and development 6-10 to a routine operation. [11][12][13][14][15][16][17][18][19][20] The emphasis is now on increasing collections at the lowest possible cost to develop large numbers of banked units and to increase the ethnic diversity of the banked units to make transplantations available to more patients. The operation of UCB banks is becoming standardized, partly the result of the American Association of Blood Banks (AABB) and the Foundation for Accreditation of Cellular Therapy (FACT-NETCORD) standards for the collection, testing, processing, and banking of UCB for transplantation. 21,22 The AABB and FACT-NETCORD standards are similar to current Good Manufacturing Practices and Good Tissue Practices promulgated by the Food and Drug Administration (FDA). 23,24 The FDA has also considered the establishment of a regulatory framework for UCB publishing a recent guidance on licensure. 25 Despite progress with UCB bank standardization, some shortcomings remain. Some banks are not yet accredited; and standards, although vigorous in many ways, leave considerable room for interpretation and variability. 20 Thus, the overall quality of UCB banks throughout the world is not really known. As the largest UCB transplantation center using UCB from multiple banks, we have observed considerable variability in the quality and consistency of UCB that is provided to us for transplantation. 20 Here we report 2 cases of mislabeled UCB from highly reputable UCB banks (1 in the United States and 1 in Europe) and the effectiveness of ABO and rapid human leukocyte antigen (HLA) typing for verifying unit identity for UCB units without a physically attached segment.
MethodsAt the University of Minnesota, all somatic cell and tissue products for hematopoietic transplantation and immunotherapy are prepared in the University of Minnesota Medical Center Clinical Cell Therapy Laboratory. Cellular products, such ...