Sarah K Harm1, Zbigniew M Szczepiorkowski2,3, Nancy M Dunbar2. 1. Department of Pathology and Laboratory Medicine, University of Vermont Medical Center, Burlington, Vermont. 2. Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire. 3. Institute of Hematology and Transfusion Medicine, Warsaw, Poland.
Abstract
BACKGROUND: In March 2016 the US Food and Drug Administration published a draft guidance to enhance the safety of platelets (PLTs) for transfusion. Options for hospital transfusion services include the use of rapid testing to extend apheresis PLT dating for up to 7 days. This report describes the impact of routine use of Day 6 and Day 7 PLTs at two hospital transfusion services 1 year after implementation of rapid testing for outdate extension. STUDY DESIGN AND METHODS: PLT transfusion and inventory data were obtained from two hospital-based transfusion services for 12 months before and 12 months after implementation of rapid testing to extend the outdate of apheresis PLTs to 7 days. RESULTS: The outdate rate decreased from 5% to 2% (p < 0.0001) at Hospital 1 and 28% to 14% (p < 0.001) at Hospital 2 after implementation of routine use of Day 6 and Day 7 PLTs. The proportion of apheresis PLT units that underwent secondary screening for bacterial contamination before transfusion in the postimplementation period increased from 33% to 54% at Hospital 1 and from 0% to 31% at Hospital 2. CONCLUSION: A significant decrease in outdate rate was observed after routine use of Day 6 and Day 7 PLTs. Use of rapid testing to extend PLT outdate also resulted in a larger proportion of PLTs that underwent secondary testing for bacterial contamination before transfusion. These observations demonstrate that use of rapid testing to extend apheresis PLT dating up to 7 days enhances the safety of PLTs for transfusion and decreases wastage of a limited resource.
BACKGROUND: In March 2016 the US Food and Drug Administration published a draft guidance to enhance the safety of platelets (PLTs) for transfusion. Options for hospital transfusion services include the use of rapid testing to extend apheresis PLT dating for up to 7 days. This report describes the impact of routine use of Day 6 and Day 7 PLTs at two hospital transfusion services 1 year after implementation of rapid testing for outdate extension. STUDY DESIGN AND METHODS: PLT transfusion and inventory data were obtained from two hospital-based transfusion services for 12 months before and 12 months after implementation of rapid testing to extend the outdate of apheresis PLTs to 7 days. RESULTS: The outdate rate decreased from 5% to 2% (p < 0.0001) at Hospital 1 and 28% to 14% (p < 0.001) at Hospital 2 after implementation of routine use of Day 6 and Day 7 PLTs. The proportion of apheresis PLT units that underwent secondary screening for bacterial contamination before transfusion in the postimplementation period increased from 33% to 54% at Hospital 1 and from 0% to 31% at Hospital 2. CONCLUSION: A significant decrease in outdate rate was observed after routine use of Day 6 and Day 7 PLTs. Use of rapid testing to extend PLT outdate also resulted in a larger proportion of PLTs that underwent secondary testing for bacterial contamination before transfusion. These observations demonstrate that use of rapid testing to extend apheresis PLT dating up to 7 days enhances the safety of PLTs for transfusion and decreases wastage of a limited resource.