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.