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Routine use of Day 6 and Day 7 platelets with rapid testing: two hospitals assess impact 1 year after implementation
Sarah K Harm1, Zbigniew M Szczepiorkowski2,3, Nancy M Dunbar2
1Department of Pathology and Laboratory Medicine, University of Vermont Medical Center, Burlington, Vermont.
Insights
Rapid testing for platelet (PLT) outdate extension significantly reduced wastage and increased bacterial screening. This enhances transfusion safety and conserves a vital blood product.
Area of Science:
- Transfusion Medicine
- Blood Banking
- Medical Device Technology
Background:
- US FDA guidance in March 2016 aimed to improve platelet (PLT) transfusion safety.
- Hospital transfusion services explored rapid testing to extend apheresis PLT shelf-life to 7 days.
- This study evaluated the impact of routine Day 6 and Day 7 PLT use post-implementation of rapid testing.
Purpose of the Study:
- To assess the effect of rapid testing for extending apheresis platelet outdates on wastage rates.
- To determine the impact on secondary bacterial contamination screening.
- To evaluate the overall enhancement of PLT transfusion safety and resource conservation.
Main Methods:
- Retrospective analysis of PLT transfusion and inventory data from two hospital transfusion services.
- Data collected for 12 months pre- and 12 months post-implementation of rapid testing for outdate extension.
- Comparison of outdate rates and secondary screening proportions before and after the intervention.
Main Results:
- Outdate rates decreased significantly: from 5% to 2% (Hospital 1) and 28% to 14% (Hospital 2).
- Proportion of apheresis PLTs undergoing secondary bacterial screening increased: from 33% to 54% (Hospital 1) and 0% to 31% (Hospital 2).
Conclusions:
- Routine use of Day 6 and Day 7 PLTs, enabled by rapid testing, significantly reduces platelet wastage.
- Extended dating increases the proportion of PLTs screened for bacterial contamination, enhancing transfusion safety.
- Rapid testing for apheresis PLT outdate extension up to 7 days improves safety and reduces waste 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In March 2016 the US Food and Drug Administration published a draft guidance to enhance the safety of platelets (PLTs) for transfusion.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.
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