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• W2113135306 abstract "In this issue of TRANSFUSION, Gomez and colleagues describe the implementation of a novel real-time platelet (PLT) inventory management system utilizing electronic dashboards that display current PLT inventory and patient clinical data. The PLT inventory dashboard includes product ABO/Rh group and unit attributes (irradiation, cytomegalovirus [CMV] seronegativity) and highlights units approaching expiration by changing from green to red when the unit has 1 day or less before expiration. The product demand dashboard includes clinical information pertaining to PLT requests including patient identifiers, location, current PLT count, ABO/Rh group, unit attributes needed (irradiation, CMV seronegativity), and the PLT transfusion threshold. These dashboards were used by a quaternary health care system, composed of multiple hospitals within a 75-km radius of the central transfusion laboratory, transfusing approximately 2500 PLT units annually. Use of this system resulted in a significant decrease in the PLT outdate rate from 24.5% to 15.1% (p < 0.001) over a 48-month study period. The authors also noted a reduction in the PLT age at time of transfusion from 3.60 to 3.46 days (p < 0.001). Novel methods for PLT inventory management are becoming necessary because the utilization of PLTs continues to grow. An overall increase of 7.3% was observed in total number of PLT units transfused in the United States from 2008 to 2011. Hematology-oncology services are the biggest consumers of PLTs (34.4%) followed by surgical services (18%), general medicine (17%), and intensive care (12%). Apheresis PLTs represent the vast majority of PLTs transfused in the United States and comprised 91.1% of total PLTs produced in 2011.1 PLT inventory management is particularly challenging due to unpredictable clinical demand and a limited shelf life. In the United States, the current dating period for PLTs is 5 days. Current requirements for bacterial testing delay the availability of PLTs until up to 48 hours after collection. In an effort to avoid product wastage, the oldest available units are typically selected first. As a result, the mean age of apheresis PLTs at the time of transfusion in the United States is 3.06 days.1 Hospital transfusion services typically strive to maintain sufficient PLT inventory to minimize both inventory shortages and PLT outdate rates (reported as 12.7% for apheresis PLTs and 17.1% for whole blood–derived PLTs in 2011).1 Costs associated with outdated PLTs are high. The mean amount paid per apheresis PLT unit is more than US$500 with smaller volume hospitals paying significantly more than larger volume centers.1 There are also ethical reasons to balance supply with demand given that apheresis PLT production relies on volunteer nonremunerated donors who are willing to spend the 1.5 to 2 hours necessary for donation. Typically, the hospital transfusion service maintains PLT inventory through standing orders and/or an “order-up-to” approach based on historic usage patterns and current clinical demand. Stochastic dynamic programming and computer simulation techniques have been applied to PLT production to reduce outdate rates and improve PLT inventory management.2, 3 Additional considerations for PLT inventory management include provision of ABO plasma compatible transfusions to avoid risk for hemolytic transfusion reactions4 and D-matched PLTs for D– patients of childbearing potential to avoid risk for formation of anti-D.5 However, due to limited hospital inventories, transfusion of ABO- and D-identical PLTs is not always possible.6 Further complicating PLT selection practices are special needs for some patient populations including clinical indications for irradiated, CMV-seronegative, cross-match–compatible, and/or HLA-selected or HLA-identical PLT products. The use of PLT additive solutions and pathogen inactivation methods may address some of these concerns but may also further complicate PLT inventory management. In addition to decreasing the PLT outdate rate, the use of information technology to improve PLT inventory management may also improve patient care. As Gomez and colleagues illustrate, use of the electronic dashboard resulted in a small but significant decrease in the age of PLTs at the time of transfusion. It is unknown whether provision of more recently collected PLTs results in improved clinical efficacy. It is known, however, that the risk of transfusion-associated septic reactions increases over the duration of PLT storage with 85% of septic transfusion reactions occurring after transfusion of Day 4 or Day 5 PLTs.7 PLTs are the blood component with the highest risk for transfusion-related sepsis and bacterial contamination of PLTs poses the leading risk for acquiring an infection from blood transfusion.8 This risk, however, remains extremely low when compared to other nosocomial infections such as Clostridium difficile.9 The most recently released summary of transfusion-related fatalities reported to the Food and Drug Administration (FDA) indicates that between Fiscal Years 2009 to 2013 there were 14 fatalities attributed to microbial contamination of PLT products (four occurring after transfusion of pooled whole blood PLTs and 10 after transfusion of apheresis PLTs).10 Multiple strategies have been implemented by collection centers to reduce the risk of bacterial contamination of PLT products including donor screening, skin disinfection, diversion of the first 15 to 40mL of the collection, and bacterial culture.11, 12 In addition, some transfusion services have implemented rapid bacterial detection testing to further reduce risk.13-15 As a result of these mitigation efforts, fatality reports due to bacterially contaminated PLTs have shown an overall downward trend since 2005 (Fig. 1).10 These data illustrate, however, that there remains a residual risk for bacterial contamination of PLT components.16 Downward trend in fatalities due to bacterial contamination of transfused PLTs reported to the US FDA (Fiscal Years 2005-2013). Given this residual risk, in December 2014 the FDA released a draft guidance for industry addressing the use of bacterial detection to enhance the safety and availability of PLTs.8 This guidance followed two public meetings to discuss this issue held in 2012 by the FDA Blood Products Advisory Committee (BPAC). At that time the BPAC recommended institution of rapid testing on Day 4 and Day 5 of previously culture-negative PLTs.17 The recently released draft guidance offers several options for transfusion services that are designed to improve the safety of PLT transfusions but also have the potential to further complicate PLT inventory management. Considerations proposed for transfusion services include efforts to minimize the proportion of Day 4 and Day 5 PLTs issued and to perform secondary testing (rapid testing or culture based) to enhance safety (Table 1). Since neither option is mandated, another possible approach may be to simply continue with current practices. Additional options to extend the dating of PLTs through Day 6 or Day 7 are provided. Although not currently available, PLTs stored up to 7 days do meet minimum efficacy standards for FDA licensure. Seven-day PLTs were implemented in the United States in September 2005, but approval was withdrawn from the US market in April 2008 after the PASSPORT surveillance study detected two culture-positive units at outdate.18, 19 Under the current draft guidance, extension of the PLT outdate to 7 days would be dependent on the availability of bacterial detection devices cleared by FDA and labeled as a “safety measure” and 7-day PLT storage containers labeled with a requirement to test every product with such devices. There are currently three PLT storage containers that are cleared by the FDA for storage of apheresis PLTs up to 7 days when coupled with universal screening for bacterial contamination.8 Although both options will result in increased cost and workload for the transfusion service, use of a rapid test system for secondary testing would eliminate the need for quarantine of units while awaiting culture results as rapid test results are immediately available. Rapid tests would, however, need to be repeated for all units remaining in inventory on Day 5 and one must also consider the impact of false-positive results, which would most likely result in product discard. Availability of bacterial detection devices cleared by the FDA and labeled as a “safety measure” and 7-day PLT storage containers labeled with a requirement to test every product with such devices would enable extension of the PLT outdate to up to Day 7 with secondary testing. Pursuit of this option would potentially increase PLT availability and may serve to motivate some transfusion services to implement these recommendations. The guidance does not address the potential role of use of the recently approved pathogen inactivation method for apheresis PLTs to further reduce risk or whether use of pathogen inactivation methods would eliminate the need for primary or secondary testing or allow extension of the PLT outdate.20 These are important questions that need clarification for any hospital transfusion service weighing the potential benefits of pathogen-reduced PLTs against the increased cost of this product. It is clear that despite significant efforts to mitigate risk for bacterial contamination of PLTs, residual risk remains. Although the recent FDA draft guidance has proposed methods to further enhance safety, from the hospital transfusion service perspective, they are cumbersome and likely to be costly to implement. These draft recommendations are not yet finalized and public comments may lead the FDA to make significant revisions. Our hospital transfusion service supports a mandated secondary test performed once on Day 4 or thereafter without the need for quarantine of the unit and with extension of the PLT outdate through Day 7 with no further testing.21 Although the optimal approach for enhancing the safety of PLT transfusion is not yet clear, any mandated changes to current PLT bacterial detection testing requirements would require a more robust PLT inventory management system. The use of information technology–based systems, such as the one described by Gomez and colleagues in this edition of TRANSFUSION, may aid hospital transfusion services in this endeavor. The author has disclosed no conflicts of interest. Nancy M. Dunbar e-mail: [email protected] Department of Pathology and Department of Medicine Dartmouth-Hitchcock Medical Center Lebanon, NH" @default.
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• W2113135306 date "2015-09-01" @default.
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• W2113135306 title "Modern solutions and future challenges for platelet inventory management" @default.
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