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The Secure Transfusion Services, Inc (STS) mission is to improve patient outcomes by improving the availability of platelets by augmenting the supply chain to hospitals.  We provide safe components that comply with FDA guidance on bacterial contamination mitigation strategies by employing the responsible use of a compensated donor strategy. Blood products are essential for the treatment of a wide range of medical conditions.  This post will describe how platelet procurement functions in the United States, particularly from the hospital perspective.

The blood supply system in the US is complicated. Platelets are predominantly sourced from volunteer donors today.  Once collected, platelets are processed and tested, utilizing disposables and equipment purchased from commercial organizations. Non-profit blood collection centers then sell platelet units to hospitals. The hospitals, not the blood centers, receive payment by Medicare or other health care payers.

The market for transfusable blood products is competitive, and these non-profit blood centers enter into supply agreements with hospitals competing for market share.  Factors influencing pricing include regional operating costs, the presence of local blood collection center competitors, and the overall demand for blood products.  In addition to the competition, new blood business models, hospital consolidation, and an increasing focus on cost control have contributed to lower prices generally for blood components, while collection, processing, and testing costs have increased over time. This cost increase has caused considerable financial stress on blood collection centers in recent years.

In contrast to other transfusable blood components, apheresis platelets are a high-value component with favorable supply/demand dynamics for the collection centers.  Due to the short shelf life (5-7 days from collection) of platelets and given the new FDA guidance on bacterial contamination, which will require higher safety standards starting in March 2021, hospitals need to consider how they will satisfy the guidance while maintaining an adequate inventory for patient needs. Further, the industry now recognizes the need to address emerging pathogens such as COVID-19, which continue to add to the cost. These factors, coupled with the aging volunteer blood donor population and the steadily increasing demand for platelets, lead to increased fragility of the US blood system. 

As a result, there is a need for a more sustainable system. An ideal system would strive to improve the overall safety of blood products, provide an adequate supply of products at a competitive cost to cover the full spectrum of clinical indications for transfusion, and offer the ability to deliver these products in a timely fashion such that patient care is not compromised.

STS has addressed this challenge by providing an innovative model for apheresis platelet collection. By following the best practices of the proven incentive-based donor source plasma model, STS can systematically collect and process pathogen reduced (PR) platelets, which not only satisfies FDA’s Bacterial Risk Control Strategies guidance but raises the bar on blood product safety around other pathogens, both known and unknown. Today, most non-profit blood centers cannot efficiently convert their current platelet collections to 100% PR, as only 70-80% of platelets collected will meet processing criteria.  Only 16% of US platelet inventories are pathogen reduced as of February 2020. 

The STS collection processes address many of the limitations of the current blood collection system. First, a compensated donation model improves donor recruitment, frequency, and retention. This model also allows for identifying and retaining donors who enable higher split rates, enabling improved efficiencies across the collection and manufacturing process. To further optimize the platelet collection process, STS emphasizes a single collection technology, thereby reducing product variability and optimizing both final volume and quantity of platelets available for pathogen reduction. Finally, as a for-profit, commercial entity, STS has the flexibility to hire, incentivize, and retain high performing collection center staff, providing them with a standardized playbook formulated to reduce failure rates and waste.    

References

Mulcahy AW, Kapinos KA, Briscombe B, et al. Blood supply in the United States: an analysis of the current system and alternatives for the future. RAND Corporation 2016; ISBN: 978-0-8330-9679-1.
Cerus Q4 earnings call February 2020