Abstract 9 Identification of Effective Changes to Workflow Triaging Criteria and Production Planning

Abstract

Abstract Introduction The Cleveland Cord Blood Center (CCBC) analyzes fresh incoming cord blood units for the total nucleated cell (TNC) count. Units that meet the TNC criteria are processed for clinical banking and units not meeting the defined criteria are made available for research collaborations. CCBC sought to understand if adding additional pre-screening criteria would reduce post-manufacturing deferral rates and increase production of licensed units. Objectives To identify the main failure modes resulting in cord blood unit deferral for clinical banking post-manufacturing. To identify key factors resulting in unlicensed status of processed cord blood units. To implement changes to pre-screening strategies to reduce deferral rates and increase production of licensed units. Methods CCBC created four cross-departmental teams to evaluate the main reasons for deferrals post-manufacturing and to evaluate travel-risk history. Each committee had representation from collections, quality, and laboratory staff. Data was evaluated that was collected between January and June 2022. Results The committees identified that 19% of all deferrals post-manufacturing were related to low CD34 count and/or viability and that 17% of all processed units were unlicensed due to travel to Zika related areas. In March 2023, pre-screening criteria was updated to include a pre-processed CD34 count and viability and a pre-screening of the donating mother for travel history after consenting and prior to manufacturing. Units that fulfilled both the TNC and CD34 cut offs and did not have a high-risk travel history were processed for clinical banking. Data evaluated from March and April 2023 indicated that the deferral rates for low viable CD34 counts post-manufacturing went from 19% down to 0% and the percentage of high-risk travel units manufactured was reduced from 17% to 7%. Discussion Review of failure modes identified two main factors to guide improved triage efficiency. By implementing a pre-processing CD34 count, the larger TNC and CD34 cord blood units were identified for banking for clinical use. By using a pre-screening process at collection sites, high-risk travel donations were identified prior to processing. In the two-month timeframe evaluated, the overall deferral rates were reduced by roughly 7% and post-manufacturing licensure status increased from 83% to 93%.