A Root Cause Analysis of Haemolysis Encountered in Leuco-filtration of Stored Packed Red Cells Units

Background and Aims: Leukoreduction of blood components has reduced the incidence of transfusion-associated adverse events. Leucofiltration is the most effective method of leukoreduction. We encountered haemolysis in a series of leucofiltered units. This stressed our precious inventory, added to financial loss, increased our turn around time to issue leucofiltered blood units, and placed doubts on the safety of our leucofiltered products. A systematic root cause analysis was done to identify the reason for haemolysis. Materials and Methods: A total of 69 units were leucofiltered during the study period, of which 13 units showed lysis following filtration. Results: This study warranted a review of our existing leucofiltration standard operating procedures to keep strict adherence to manufacturer instructions to ensure quality in the end product. Conclusions: Among the leucofiltered units showing hemolysis, 62% were due to higher temperature, 23% due to increased time for filtration, and 15% due to increased holding time of red cell units.