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

Amita R; Arya AB PGDBBT; Sathyabhama  S; Debasish  Gupta

doi:10.18502/ijml.v9i1.9086

Amita R Department of Transfusion Medicine, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India
Arya AB PGDBBT Department of Transfusion Medicine, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India
Sathyabhama S Department of Transfusion Medicine, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India
Debasish Gupta Department of Transfusion Medicine, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India

DOI: https://doi.org/10.18502/ijml.v9i1.9086

Keywords: Haemolysis Leucofiltration Packed red cells Root cause analysis Storage Temperature

Abstract

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.