Outdate Reduction and Cost Savings with Rapid Testing for Seven-Day Platelet Storage

Abstract

Platelets for transfusion in the US are stored at room temperature which is associated with a risk of bacterial transmission and subsequent sepsis. A recent FDA Final Guidance has been issued with options to mitigate this risk while maintaining or enhancing platelet availability.Storage had been limited to five days for many years due to the risk of bacterial growth. The short shelf-life has resulted in a national outdate rate of approximately 16%. FDA has recently cleared two devices as "safety measures" the use of which now allows seven-day platelet storage in bags cleared for this option. The Platelet PGD Test (Verax Biomedical, Marlborough, MA) is one such device and the other is the bioMérieux BacT/Alert Microbial Detection System (Durham, NC). These "safety measure" options are included in the Final Guidance.In 2018 and 2019, we conducted a survey of 16 blood collection centers and 66 hospitals that use the PGD Test to extend platelet dating to seven days to ascertain how this has resulted in reduced outdating and thereby saved costs. The surveyed institutions were collectively responsible for 21-22% of the annual volume of platelet transfusions in the US.The blood collection centers reported that extension of platelet storage to seven days resulted in a mean outdate reduction of 69% (median 67%, range 23%-92%) and mean cost savings of $415,000 (median $300,000, range $150,000-$900,000). The hospitals reported that extension of platelet storage to seven days resulted in a mean outdate reduction of 74% (median 80%, range 17%-100%) and mean cost savings of $176,803 (median $150,000, range $30,000-$1,200,000). Hospitals saved 24,080 platelet doses annually and blood centers saved 18,700 doses annually. From these institutions alone, this represents a savings of more than 2% of platelet transfusions in the US.Extending platelet shelf-life to seven days with the PGD Test significantly reduced outdating of this valuable resource, increased product availability in accord with FDA Final Guidance recommendations, and saved more money than bacterial testing costs in the surveyed institutions.Results have been presented in part at the Association of Clinical Scientists Annual Meeting, Hershey, PA May 2019.