National Cord Blood Inventory

In Process

The 13 banks with NCBI contracts reported various practices that could increase the number of cord blood units banked at existing and new collection sites, as well as increasing the diversity of the units collected. However, challenges to increasing collection for these banks include resource limitations, as well as competition from other cord blood banks, which collect units for use only by family members of the donor, and slowing growth in demand for U.S. cord blood units. Cord blood banks reported that increasing staff at collection sites, providing feedback to those who collect cord blood, and lowering the age for those donating could increase the number of units collected for the NCBI at existing sites. Expanding the number of collection sites could also increase the number and diversity of NCBI units. However, the banks in our review reported financial challenges related to increasing the number of units collected at existing or new collection sites, such as a limited ability to address the costs associated with hiring additional staff to cover more hours of collection or to support bank and hospital staff salaries at new sites. These banks identified additional practices for increasing the diversity of the units collected for the NCBI, but also reported that the units collected from some racial groups have lower volumes or cell counts compared to other groups, making such units less likely to meet standards for inclusion in the NCBI. Further, growth in sales of U.S. cord blood units, banks' primary source of funding, has slowed and could challenge banks' efforts. Demand for cord blood could increase or decrease depending on a number of variables, such as whether new research identifies ways to increase the benefits of cord blood or conversely, the development of alternative treatments to cord blood transplantation. Most of the 13 banks with NCBI contracts reported adopting practices to reduce costs and improve the efficiency of cord blood banking, but also reported some uncertainty about the effect on costs and revenues of complying with FDA licensure regulations that now apply to cord blood. These banks reported practices such as using an early screening process to identify units that do not meet NCBI or the bank's own requirements prior to incurring the costs of processing these units. Further, banks with NCBI contracts reported that efforts to comply with applicable FDA regulations could increase the costs of banking cord blood. For example, some banks reported hiring external consultants or additional staff, reorganizing staff duties, beginning building renovations, or purchasing new processing equipment in attempts to comply with FDA regulations regarding cord blood manufacture and licensing. Some banks also said they were uncertain whether these efforts would comply with FDA requirements or if their collection sites would have to register with the FDA as an establishment that manufactures cord blood. However, FDA officials told GAO that neither individuals nor collection sites that have agreements with banks to collect units will be required to register, though banks must ensure the collection sites comply with FDA regulations. Further, some banks also reported that they were uncertain whether potential increased revenue from licensed units will offset their costs of cord blood banking. HHS provided additional information regarding our findings, which was incorporated as appropriate.