Abstract 11 Monitoring Cord Blood Inventory Reliability by Key Quality Indicators At and After Release

Abstract

Abstract Introduction As per FACT standards, Cord Blood Banks (CBB) have to verify that they provide a safe and effective product for transplant. Validated processing methods and storage conditions are the first steps towards this goal, but what are the final steps to monitor the quality of the cord blood units (CBU) released for transplant? Objectives We present here a retrospective analysis of our Program’s final verification process to meet this FACT requirement. Methods CBU shipped between January 2018 and December 2022 were reviewed for out of specification events. The following Quality Control (QC) parameters were measured on attached segments before shipment: total nucleated cells (TNC), viable CD34 cells (vCD34), and colony forming units (CFU). Confirmed date of infusion and engraftment data were obtained from CIBMTR. Results A total of 619 CBU were shipped during the study period. 550 had a segment analyzed at the time of shipment. Average post-thaw CD34 viability on the segments was 93.5% (Table 1). Average recoveries for TNC, viable CD34 and CFU were 83.3%, 64.90% and 60.86%, respectively (Table 1). 6 (1%) CBUs were found to have CD34 viability lower than FACT requirement (≥70%) (Table 1). Investigations were performed for each CBU, concluding that these were technical issues with no repercussion on the final product. No segments demonstrated absence of CFU growth. 544 CBUs had an infusion date recorded by CIBMTR (Table 1). 250 of the CBU infused had engraftment data, and 242 engrafted. 8 (3%) CBU transplants resulted in non-engraftment. All had QC results within expected range (Table 1). Discussion Our QC results confirm the continued stability of the CBU until shipment. The small subset of CBU with out of specification results were linked to technical issues and did not affect the outcome of transplant. Outcome data is another way of assessing the quality of the CBUs, even though it may be influenced by many factors out of the CBB’s responsibility (such as diagnosis, conditioning, multiple transplants, etc…). The combined analysis of the two datasets is a good way for a CBB to ensure processes are performing as expected over time and monitor the quality of the final product.