California Umbilical Cord Blood Collection Program: Addressing The Diversity Of The National Registry Through Creative Partnerships With Cord Blood Banks and Provision Of High-Quality Cord Blood Units For Research

Abstract

California's Umbilical Cord Blood Collection Program (UCBCP) is a unique, state-funded system designed to capture the diverse HLA profiles of its residents' umbilical cord blood units (CBUs) for public banking and use in unrelated transplants, while providing a source of high quality cord blood units for qualified researchers. The legislation's unifying directive to create a sustainable program to collect diverse California CBUs for banking and research guided the development of tools useful for the assessment of potential cord blood collection sites and partner cord blood banks. Here, we present the methodology utilized to develop the UCBCP network of collection sites and partner cord blood banks, and describe mechanisms for sustainability. The process of contract negotiations between the UCBCP, host hospital and partner cord blood bank (CBB) is preceded by identification and analysis of each party, with an emphasis on parameters that are directly related to the intent of the legislation. The Collection Site Assessment Tool evaluates hospitals based on, but not limited to the following criteria; birth rate, ethnic/racial diversity of patient population, proximity to partner cord blood bank, shipping logistics, shipping costs, preferred collection model, and space availability. Data are collected from the CA Dept. of Public Health and hospital staff. Our CBB Assessment Tool was developed as a scoring mechanism to evaluate proposals from cord blood banks wishing to be qualified to receive California's CBUs. Parameters considered include CBB licensure by the FDA, collection model, capacity, experience and CBB financials.By tailoring negotiations and contracts based on results from the assessment tools, each partnership between collection site and cord blood bank is uniquely suited to the needs of each party and promotes the UCBCP mission, which ultimately serves the patients who receive the transplants. This approach requires effort, creativity and transparency up front as term lists are created and negotiated, and success is dependent on reaching a consensus between hospital administrators, Labor and Delivery staff, CBB officials and the UCBCP, prior to contract signing. The number of contracts uniting hospital, CBB and the UCBCP range from 1-3, depending on the requirements of each party. UCBCP sustainability issues are covered under contracts between the CBB and the UCBCP, such as disbursement of CBUs that do not meet public banking criteria to researchers or fees paid to the UCBCP upon retrieval of a UCBCP-funded CBU for transplant. Distribution of high-quality CBUs for research is an important aspect of the legislation that also supports the UCBCP sustainability funding plan and is non-negotiable, although the UCBCP does provide funding and support for these activities. Our research-grade CBUs are provided fresh and are not manipulated, with an average volume of 94 mL and an average total nucleated cell count of 8.7 x 108. Our standards for research-grade CBUs are high to encourage the use of cord blood stem and progenitor cells in basic and pre-clinical studies, which also ultimately serves the transplant patient community. The flexible model the UCBCP has developed to increase cord blood collections in California can serve as a template for other states and collection programs. Disclosures:No relevant conflicts of interest to declare.