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• W2885284219 abstract "At the dawn of the 21st century, a call was made for the blood collection community to immediately initiate a program for detecting the presence of bacteria in units of platelets (PLTs). At that time, bacterial contamination of PLTs represented the largest transfusion-transmitted disease risk, bacterial detection technology was available, screening via bacterial culture had been shown to be practical and effective, and no pathogen reduction technologies for PLT concentrates were available.1 AABB Standard 5.1.5.1, requiring methods to limit and detect bacterial contamination in all PLT components, was published in 2003 and became effective on March 1, 2004. Along with other complementary mitigation measures (namely, enhanced arm disinfection and the use of a diversion pouch), blood collection organizations implemented primary testing of PLTs by culture, initially with a 4- to 6-mL sample volume, rapidly moving to 8- to 10-mL sample volume, inoculating an aerobic culture bottle at least 24 hours after collection. This remains the prevailing practice at most blood collection organizations in the United States today.2 These measures were effective in interdicting contaminated units.3-5 However, false-negative culture results were observed in bacteriologic surveillance studies, and septic transfusion reactions, some fatal, after the transfusion of culture-negative PLTs demonstrated that current screening protocols have appreciable failure rates.6, 7 Calls for more robust strategies to control bacterial risk and enhance PLT transfusion safety have been renewed.1, 8 Failure of primary cultures to detect all bacterial contamination near the time of collection is mainly due to 1) the uneven distribution of bacteria at low concentrations in PLT units and 2) the contaminating slow-growing (generally Gram-positive) organisms failing to reach detection level by the time of sampling. Rarely, an anaerobic organism that does not grow in aerobic culture medium is at fault. Hence, enhancing PLT safety could be achieved through: 1) pathogen reduction technology; 2) increasing the sensitivity of primary culture through a) increasing sample volume, b) delaying sampling time to at least 36 hours after collection, and/or c) incorporating an anaerobic culture bottle; or 3) performing secondary bacterial testing of previously cultured PLTs closer to the time of transfusion.9 For logistic reasons, secondary testing, for example, using a rapid point-of-release test, is likely to be performed by the transfusion service rather than the collection facility. In this issue of TRANSFUSION, Bloch and colleagues10 demonstrate the feasibility and utility of implementing a secondary 5-mL aerobic bacterial culture of apheresis PLTs on Day 3 after collection as an alternative to point-of-release testing. Cultures were performed by hospital blood bank staff using a sterile connection device and a sampling kit, and PLTs were stored for a maximum of 5 days. Bloch and colleagues reasoned that on Day 3, PLT units remained within the period of “bacteriologic safety” provided by primary culture, so units were put into inventory immediately after inoculation. During the 13-month study period, eight positive cultures (one in 2881 PLT products) were obtained; five were confirmed positive on reculture, while in three cases, the units had been transfused without adverse events before positive culture results were obtained. As expected, the bacteria were slow-growers such as coagulase-negative Staphylococcus spp. There were no septic transfusion reactions during the study period, compared to three definite reactions, including one fatality, in the 13 months before the study period. The authors concluded that their protocol was logistically simple and cost-effective and decreased septic transfusion reactions. Bloch and colleagues are to be commended on their approach, which contributed to the safety of PLT transfusions in their hospital. Of note, the investigators opted not to pursue shelf life extension to 7 days. Several blood collection organizations and transfusion facilities that took the initiative to implement additional bacterial mitigation strategies have shared their experiences (Table 1). Many such organizations have focused recently on improving the sensitivity of primary bacterial culture. This strategy should interdict a larger proportion of contaminated units, leading to a lower yield of any secondary test performed by the transfusion facility. Other advantages to enhanced primary cultures performed by blood centers include efficiencies of scale, good manufacturing practice, and computer control over key critical process points. The volume of culture can be adjusted for the volume of product collected, and all hospitals supplied benefit from a safer transfusion product for the duration of PLT storage. For some blood suppliers, including those that supply an entire jurisdiction or country, the denominator of products distributed is very large, allowing for data analysis of rare outcomes such as severe or fatal septic transfusion reactions and quality assurance testing of outdated components. Among blood collectors who implemented a variation on the delayed, large-volume primary bacterial culture theme, the NHS Blood and Transplant (NHSBT) screening protocol in the United Kingdom effectively reduced the number of septic transfusion reactions by 90% in the reporting period, compared to a similar time period before implementation of any bacterial detection protocol.12 In the United States, at Blood Systems, Inc., minimal proportional sample volume improved the sensitivity of primary testing and identified contaminated collections that could have escaped detection had a single bottle with 8 to 10 mL volume been used.13 At Héma-Québec, 7-day PLTs are now processed by inoculating a 20-mL sample divided into aerobic and anaerobic culture bottles at 48 hours after collection. Early reporting indicates an increase in the rate of positive culture and decrease in the PLT outdate rate.14 Australian Red Cross’ 5-day PLTs are screened with 15 to 20 mL from the mother bag at 24 hours or more after collection inoculated into aerobic and anaerobic culture bottles.15 Canadian Blood Services (CBS) adopted a delayed, large-volume primary bacterial culture protocol, similar to the one in use in the United Kingdom, in late 2017, with promising initial results. When four bottles are to be inoculated for a double collection, CBS inoculates only one anaerobic bottle to minimize false-positive results. It is difficult to compare residual risk with each strategy, for a variety of reasons. Most published reports, such as the study by Bloch and colleagues, compare results before and after implementation of a given approach (before and after study design), and to our knowledge there are no randomized studies comparing different strategies. Bacterial contamination and growth in a PLT component may be influenced by a variety of factors, including adequacy of donor skin disinfection, type of PLT component produced (apheresis or buffy coat–pooled whole blood–derived PLTs, use of PLT additive solution), and equipment used for apheresis collection.16, 17 Bacterial detection rates will be influenced by methods used (cultures compared to rapid test methods) and the time interval between collection and testing. For culture methods, volume of sampling compared to volume of the product and use of an anaerobic bottle in addition to an aerobic bottle will affect detection rates; the variability in many of these variables in primary culture protocols is reflected in Table 1. The yield of secondary detection methods will depend on initial contamination rates, and the efficacy of the primary culture strategy in use. Although the most important outcome measure is reduction in clinically significant septic transfusion reactions, the rarity of these reactions and variability in detection and reporting makes rates difficult to assess and compare. The rate of bacterial detection is therefore often used as a surrogate marker of the efficacy of a given strategy; however, bacteria vary greatly in their pathogenicity, and increased detection of organisms such as Propionibacterium acnes likely does not contribute to recipient safety. Different strategies may also have variable effects on product availability, due to false-positive results and time PLTs are available in inventory for transfusion. Finally, some strategies may result in a shift in the mean age of PLTs being transfused, which may have an impact on PLT function. In the study by Bloch and colleagues, out of approximately 23,000 PLT units transfused, no septic transfusion reactions were reported at Johns Hopkins Hospital in the 13 months after implementation of secondary bacterial culture. A longer observation period would assist in comparisons with other detection strategies, such as one septic transfusion reaction in approximately 1 million PLT transfusions reported in the UK Serious Hazards of Transfusion (SHOT) Hemovigilance system, using the enhanced primary culture protocol described by McDonald and coworkers.12 The current Food and Drug Administration draft guidance recommends either pathogen reduction in lieu of culture or secondary testing on Days 4 and 5 to ensure the safety of 5-day PLTs.18 Further, extension to a 7-day shelf life is allowed for suitably stored PLTs that are secondarily tested with either a rapid or culture-based bacterial detection device labeled as a “safety measure.” In November 2017, the Blood Products Advisory Committee (BPAC) voted in favor of strategies that allow the storage of apheresis PLTs without secondary testing for 5 days if PLTs are cultured no sooner than 24 hours after collection with a sample volume of at least 3.8% of the collection and for 7 days if PLTs are cultured no sooner than 36 hours after collection using a sample volume of at least 16 mL from each component. The committee noted that primary testing of PLTs with large volumes should include the use of both anaerobic and aerobic culture bottles. Further, the committee voted in favor of a strategy allowing 7-day storage with negative repeat culture on Day 4 with a volume of 16 mL per component divided into both aerobic and anaerobic culture bottles.19 Some recent publications describe real-world experience with extending PLT storage. The Irish Blood Transfusion Service performed culture on PLTs still in stock on Day 4 of storage, returning these PLTs to inventory with 2 extra days of shelf life.20 Dartmouth-Hitchcock Medical Center performed a rapid test on Day 5, with routine outdate extension to 7 days by performing a second rapid test on Day 6 and a third on Day 7.21 Current and proposed enhancements are based on data presented in peer-reviewed publications. Should modifications to published strategies be considered? For example, as stated, Bloch and colleagues decided not to pursue shelf life extension to 7 days with their method. Could increasing the sample volume reported in the article by Bloch and colleagues from 5 to 10 mL in an aerobic bottle (or divided equally into aerobic and anaerobic bottles) on Day 3 or Day 4 provide safe PLTs for 7 days? Could the 3.8% minimal sample volume provide 7-day safe PLTs if an anaerobic bottle is added and inoculation delayed to 36 or 48 hours after collection? To minimize the false-positive results observed with anaerobic bottles, is a minimum of one anaerobic bottle, in lieu of a 50% inoculum sufficient when more than one bottle is to be inoculated, as implemented by CBS? Enhanced PLT safety was demonstrated with every strategy described when compared to existing practice. Each has a different economic profile, and each may represent a different set of operational challenges. However, each was feasible and was successfully implemented by different blood collection organizations and by transfusion facilities. Having more than one strategy is advantageous as one strategy may not meet the needs of diverse blood collection organizations and transfusion services. The two enhanced primary test protocols allowing 5- and 7-day storage without secondary testing (as voted on by BPAC) may be beneficial to some blood collection organizations to better manage their apheresis collections and PLT inventory, especially as some practicing clinicians remain in favor of “fresher” PLTs. The bacterial risk control strategies discussed should enhance the safety and availability of PLTs for transfusion. However, there should be no illusion that septic transfusion reactions will cease to occur, albeit at a reduced rate. Pathogen reduction should remain an option for transfusion facilities provided it meets the facility's risk-based decision-making variables. From an economic perspective, despite its demonstrated effectiveness,22 it may be difficult to justify universal implementation of pathogen reduction of PLTs for the sole purpose of resolution of bacterial contamination. At a calculated cost per quality-adjusted life-year saved of more than £1 million for three pathogen inactivation systems, the UK Advisory Committee on the Safety of Blood, Tissue and Organs did not recommend the implementation of pathogen inactivation of PLTs for the UK Blood Services (NHSBT).23 Enhancements in the logistics of application of pathogen reduction, and further developments of an inactivation system for whole blood, may dramatically change the operational and economic feasibility of universal implementation. The authors have disclosed no conflicts of interest. Hany Kamel, MD1 e-mail: hkamel@bloodsystems.org Mindy Goldman, MD2 1Department of Medical Affairs Blood Systems Scottsdale, AZ 2Medical, Scientific and Research Affairs Canadian Blood Services Ottawa, Ontario, Canada" @default.
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• W2885284219 title "More than one way to enhance bacterial detection in platelet components" @default.
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