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

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.

Impact of implementing pathogen reduction technologies for platelets on reducing outdates.

BACKGROUND AND OBJECTIVES: Applying pathogen reduction technologies (PRT) to platelets can extend their shelf life from 5 to 7 days, but there have been few systematic studies of the repercussions of such technologies on outdate rates. MATERIAL AND METHODS: The benefits in terms of outdate rates of applying PRT to platelets are studied via a mathematical simulation. Specifically, statistical methods are used to determine the daily production rate needed to meet demand while not exceeding a maximum amount set as a result of limitations on donations and while assuring a minimum daily stock. RESULTS: The results show that a 2-day extension in the shelf life of platelet concentrates (PC) results in reductions in outdates ranging from 88·4% to 100% at the production centres analysed. It may be the case for budgetary reasons that only part of the PCs produced can be treated. This being so, we show that if the proportion treated per annum exceeds 25% the best option is to treat part of the output every day, otherwise, it is preferable to concentrate treatment on the last two production days of the week. CONCLUSIONS: Extending the shelf life of PC from five to seven days and setting up suitable production logistics can drastically reduce outdates at production centres. If only a part of all PCs is treated, the best choices are to distribute PRT overall production days or, if the percentage of PCs treated is very low, to apply PRT on the days preceding the weekend break.

Designing the blood supply chain: how much, how and where?

BACKGROUND: The topology of the blood supply chain network can take different forms in different settings, depending on geography, politics, costs, etc. Many developed countries are moving towards centralized networks. The goal for all blood distribution networks, regardless of topology, remains the same: to satisfy demand at minimal cost and minimal wastage. STUDY DESIGN AND METHODS: Mathematically, the blood supply system design can be viewed as a location-allocation problem, where the aim is to find the optimal location of collection and production facilities and to assign hospitals to them to minimize total system cost. However, most location-allocation models in the blood supply chain literature omit several important aspects of the problem, such as selecting amongst differing methods of collection and production. In this paper, we present a location-allocation model that takes these factors into account to support strategic decision-making at different levels of centralization. RESULTS: Our approach is illustrated by a case study (Colombia) to redesign the national blood supply chain under a range of realistic travel time limitations. For each scenario, an optimal supply chain configuration is obtained, together with optimal collection and production strategies. We show that the total costs for the most centralized scenario are around 40% of the costs for the least centralized scenario. CONCLUSION: Centralized systems are more efficient than decentralized systems. However, the latter may be preferred for political or geographical reasons. Our model allows decision-makers to redesign the supply network per local circumstances and determine optimal collection and production strategies that minimize total costs.

A cost analysis of public cord blood banks belonging to the Italian Cord Blood Network.

BACKGROUND: Public cord blood banking is currently managed in Italy by a network of 19 regional cord blood banks coordinated by the National Blood Centre and the National Transplant Centre. A cost analysis was carried out within the Italian network to determine the relationship between cost of cord blood collection and banking and size of the bank inventory, which ranged from 106 to 9,341 units on December 31st, 2012. MATERIALS AND METHODS: The 19 banks were invited to report costs incurred in 2012 related to cord blood unit collection, transportation, biological validation, characterisation, manipulation, cryopreservation, storage, data management, and general costs. Missing information on selected items was replaced with standardised costs represented by average data obtained from the reporting banks. Eight banks (52%) participated in the study. Average costs were determined in the three banks with inventories of >3,000 units vs the three banks with inventories of <1,000 units. RESULTS: Both cord blood collection and cord blood banking costs per unit were lower in the larger banks than in the smaller banks (average collection costs: € 119.25 and € 151.31, respectively; average banking costs: € 3,614.15 and € 8,158.37, respectively). DISCUSSION: The study outlined an inverse relationship between the costs of cord blood collection and banking and the size of the bank inventory, suggesting that scale economies could be obtained through centralisation of banking activities.

A novel approach to improving efficiency and cost saving in preoperative blood preparation.

BACKGROUND: Preoperative ordering of blood products has been an area of optimization due to considerable variability among physicians; overpreparation can lead to extra costs and underpreparation of blood can potentially compromise patient safety. STUDY DESIGN AND METHODS: We examined the potential cost savings of extending the storage interval of a presurgical type-and-screen sample from 7 to 14 days, thereby reducing the need for a new specimen on the day of surgery. RESULTS: Sensitivity analysis showed annual cost savings for our institution to be an estimated $38,770 ($22,420-$73,120). CONCLUSION: These results are even more robust when incorporating the additional potential savings from improved operating room efficiency.

Addressing the risk of bacterial contamination in platelets: a hospital economic perspective.

BACKGROUND: Bacterially contaminated platelets (PLTs) remain a serious risk. The Food and Drug Administration has issued draft guidance recommending hospitals implement secondary testing or transfuse PLTs that have been treated with pathogen reduction technology (PRT). The cost implications of these approaches are not well understood. STUDY DESIGN AND METHODS: We modeled incurred costs when hospitals acquire, process, and transfuse PLTs that are PRT treated with INTERCEPT (Cerus Corp.) or secondary tested with the PLT PGD Test (Verax Biomedical). RESULTS: Hospitals will spend $221.27 (30.0%) more per PRT-treated apheresis PLT unit administered compared to a Zika-tested apheresis PLT unit that is irradiated and PGD tested in hospital. This difference is reflected in PRT PLT units having: 1) a higher hospital purchase price ($100.00 additional charge compared to an untreated PLT); 2) lower therapeutic effectiveness than untreated PLTs among hematologic-oncologic patients, which contributes to additional transfusions ($96.05); or 3) fewer PLT storage days, which contributes to higher outdating cost from expired PLTs ($67.87). Only a small portion of the incremental costs for PRT-treated PLTs are offset by costs that may be avoided, including primary bacterial culture, secondary bacterial testing ($26.65), hospital irradiation ($8.50), Zika testing ($4.47), and other costs ($3.03). CONCLUSION: The significantly higher cost of PRT-treated PLTs over PGD-tested PLTs should interest stakeholders. For hospitals that outdate PLTs, savings associated with expiration extension to 7 days by adding PGD testing will likely be substantially greater than the cost of implementing PGD-testing. Our findings might usefully inform a hospital's decision to select a particular blood safety approach.

A haemovigilance team provides both significant financial and quality benefits in a University Hospital.

BACKGROUND: Haemovigilance is the process of surveillance of blood transfusion procedures including unexpected hazards and reactions during the transfusion pathway in both donors and recipients. The haemovigilance team aims to increase blood transfusion safety and to decrease both morbidity and mortality in donors and recipients. The team collects data about transfusion reactions and incidents, instructs the involved health workers and assures the tracing of blood components. The haemovigilance team at the University Hospitals Leuven has played a pioneering role in the development of haemovigilance in Belgium Although the literature about safety and quality improvements by haemovigilance systems is abundant, there are no published data available measuring their financial impact in a hospital. Therefore, we studied the costs and returns of the haemovigilance team at the University Hospitals Leuven. MATERIAL AND METHODS: This study has a descriptive explorative design. Research of the current costs and returns of the haemovigilance team were based upon data from the Medical Administration of the hospital. Data were analyzed descriptively. RESULTS: The haemovigilance team of the University Hospitals Leuven is financially viable: the direct costs are covered by the annual financial support of the National Public Health Service. The indirect returns come from two important tasks of the haemovigilance team itself: correction of the electronic registration of administered blood component and improvement of the return of conform preserved blood components to the blood bank. DISCUSSION: Besides safety and quality improvement, which are obviously their main goals, the haemovigilance team also implies a financial benefit for the hospital.

[Transfusion supply optimization in multiple-discipline surgical hospital].

AIM: To define optimal variant of transfusion supply of hospital by blood components and to decrease donor blood expense via application of blood preserving technologies. MATERIAL AND METHODS: Donor blood components expense, volume of hemotransfusions and their proportion for the period 2012-2014 were analyzed. RESULTS: Number of recipients of packed red cells, fresh-frozen plasma and packed platelets reduced 18.5%, 25% and 80% respectively. Need for donor plasma decreased 35%. Expense of autologous plasma in cardiac surgery was 76% of overall volume. Preoperative plasma sampling is introduced in patients with aortic aneurysm. Number of cardiac interventions performed without donor blood is increased 7-31% depending on its complexity.

Strategies to reduce wastage of red blood cell units.

BACKGROUND AND OBJECTIVES: Wastage of red blood cell units (RBCs) due to their inappropriate storage at the clinical ward has become both a financial and ethical challenge in the daily hospital practice. This study was aimed at identifying the extent of RBC wastage and evaluating the effects of various interventions in reducing this wastage. MATERIALS AND METHODS: From January 2011 to March 2011, baseline wastage level was evaluated using temperature-sensitive labels. Following this initial analysis, various interventions were implemented, including modifying the transfusion practice, intensifying training of and communication with the medical staff and improving the transport conditions. The impact of these interventions on wastage was measured during two periods, and results were compared with baseline wastage level. RESULTS: Based on the extent of label colouring, 7·5% of the units dispensed by the transfusion laboratory were determined as non-reusable at baseline. After implementation of the various interventions, wastage decreased to 1% of the units dispensed, potentially leading to an annual saving for our hospital of approximately €208·000/$230·600 on the total number of RBCs dispensed. CONCLUSION: Relative straightforward interventions, such as raising awareness among medical staff and particularly improving transport conditions, had a clear impact on the level of RBC wastage, accommodating the financial issue not to waste public money as well as the ethical issue that RBC wastage should be as low as possible.

EFS Centre-Atlantique donor's biobank: Ten years of samples usage.

INTRODUCTION: The French Establishment of Blood Centre Atlantique (EFSCA) is one of the French regional blood transfusion centers. Donor's biobank is a mandatory activity leading to the storage of biological samples taken from the blood donor. Samples of each blood donation are preserved for a 5-year period at Châteauroux in the form of two straws of 500microliters stored in liquid nitrogen. The aim of this study was to analyze the samples usage by studying quantitative, qualitative and economic criteria. MATERIAL AND METHOD: We analyzed all the requests of stored blood samples from 2005 to 2014. They were coming either from the blood donor qualification laboratory (BDQL), in order to perform complementary tests, or from hemovigilance inquiry. RESULTS: Among the blood donation samples, 2,144,636 (whole blood, plasma or platelets apheresis) were preserved during these ten years. During this period, 548 (0.025%) requests for samples were received; 78% were in relation with a request of the BDQL and 22% in relation with a request of hemovigilance. For the straws, the mean exit delay with regard to the blood donation date was 11.5 months (2-55). The cost of samples exit includes only working hours of a laboratory technician. On average, the annual working time dedicated to this activity was 23h. Also, the average price for one-year issuing activity was 620.31 euros. CONCLUSION: In our study, the donor's biobank was little used. The part of hemovigilance was weak but essential for the blood safety.

Cost implications of implementation of pathogen-inactivated platelets.

BACKGROUND: Pathogen inactivation (PI) is a new approach to blood safety that may introduce additional costs. This study identifies costs that could be eliminated, thereby mitigating the financial impact. STUDY DESIGN AND METHODS: Cost information was obtained from five institutions on tests and procedures (e.g., irradiation) currently performed, that could be eliminated. The impact of increased platelet (PLT) availability due to fewer testing losses, earlier entry into inventory, and fewer outdates with a 7-day shelf life were also estimated. Additional estimates include costs associated with managing (1) special requests and (2) test results, (3) quality control and proficiency testing, (4) equipment acquisition and maintenance, (5) replacement of units lost to positive tests, (6) seasonal or geographic testing, and (7) health department interactions. RESULTS: All costs are mean values per apheresis PLT unit in USD ($/unit). The estimated test costs that could be eliminated are $71.76/unit and a decrease in transfusion reactions corresponds to $2.70/unit. Avoiding new tests (e.g., Babesia and dengue) amounts to $41.80/unit. Elimination of irradiation saves $8.50/unit, while decreased outdating with 7-day storage can be amortized to $16.89/unit. Total potential costs saved with PI is $141.65/unit. Costs are influenced by a variety of factors specific to institutions such as testing practices and the location in which such costs are incurred and careful analysis should be performed. Additional benefits, not quantified, include retention of some currently deferred donors and scheduling flexibility due to 7-day storage. CONCLUSIONS: While PI implementation will result in additional costs, there are also potential offsetting cost reductions, especially after 7-day storage licensing.

Evaluation of a low-cost procedure for sampling, long-term storage, and extraction of RNA from blood for qPCR analyses.

BACKGROUND: In large clinical trials, where RNA cannot be extracted immediately after sampling, preserving RNA in whole blood is a crucial initial step in obtaining robust qPCR data. The current golden standard for RNA preservation is costly and designed for time-consuming column-based RNA-extraction. We investigated the use of lysis buffer for long-term storage of blood samples for qPCR analysis. METHODS: Blood was collected from 13 healthy adults and diluted in MagMAX lysis/binding solution or PAXgene Blood RNA tubes and stored at -20 °C for 0, 1, or 4 months before RNA extraction by the matching method. RNA integrity, yield and purity were evaluated and the methods were compared by subsequent analyses of the gene expression levels of 18S, ACTB, IL1B, IL1RN, IL1R2, and PGK1 using qPCR. RESULTS: The MagMAX system extracted 2.3-2.8 times more RNA per mL blood, with better performance in terms of purity, and with comparable levels of integrity relative to the PAXgene system. Gene expression analysis using qPCR of 18S, ACTB, IL1B, IL1RN, IL1R2, and the promising blood-specific reference gene, PGK1, revealed negligible differences (<1-fold) between the samples stored in MagMAX lysis/binding solution over time and between samples stored and extracted by the two systems. CONCLUSIONS: The MagMAX system can be used for storage of human blood for up to 4 months and is equivalent to the PAXgene system for RNA extraction. It furthermore, provides a means for significant cost reduction in large clinical trials.

The protection and stabilization of whole blood at room temperature.

Preservation of biospecimens for biobanking applications traditionally involves freezing while maintaining the integrity of the product throughout multiple freeze-thaw cycles. The protection and stabilization of DNA at room temperature (RT) may eliminate the costs associated with freezer storage and reduce the maintenance costs for biobanks. However, there is a paucity of information describing the yield, purity, and integrity of DNA extracted from biospecimens stored at RT. To evaluate the yield, purity, and integrity of DNA extracted from whole blood samples stored at RT (18°C), low (-20°C), and ultra-low (-80°C) temperatures, whole blood samples from sheep and human subjects were collected, and aliquots were stored at RT (18°C), -20°C, and -80°C. Blood samples at RT were stored utilizing biostabilization technology designed to protect genomic DNA in whole blood. The quantification of the extracted DNA was determined by spectrophotometry, and the integrity was assessed following gel electrophoresis. Storage temperature did not influence the DNA yield (p=0.52); DNA yield averaged 13.6 ± 1.2 ng/µL across all storage temperatures. However, DNA yield was influenced (p=0.04) by species. The DNA yield was not influenced by a species × storage temperature interaction (p=0.84). Among the samples stored at RT, the species, type of technology utilized, and the interaction did not influence (p>0.13) DNA yield for both DNAgard and DNAstable. The 260/280 ratio was influenced by a species × storage temperature interaction (p=0.01). Generally, the 260/280 ratios were higher (p<0.05) for human samples stored at low and ultra-low temperatures compared to sheep samples stored at similar temperatures. Ambient temperature-based technologies offer an alternative to low temperature biospecimen preservation for blood that can be utilized by biobanks to reduce freezer storage costs while maintaining the quality of the biospecimen.

The ONTraC Ontario program in blood conservation.

Blood conservation, or Patient Blood Management (PBM), is a paradigm shift in transfusion practice. Recognizing the potential adverse effects associated with blood transfusion, PBM emphasises the use of alternatives to transfusion in order to minimize unnecessary or inappropriate blood transfusion. The ONTraC program is a network of transfusion coordinators in 25 Ontario hospitals with the focus of implementing PBM. The program has been highly successful in reducing transfusion rates and improving clinical outcomes, and has proven very cost-effective. This paper summarizes results of the program from its inception in 2002-2011.

Family-directed umbilical cord blood banking.

Umbilical cord blood transplantation from HLA-identical siblings provides good results in children. These results support targeted efforts to bank family cord blood units that can be used for a sibling diagnosed with a disease which can be cured by allogeneic hematopoietic stem cell transplantation or for research that investigates the use of allogeneic or autologous cord blood cells. Over 500 patients transplanted with related cord blood units have been reported to the Eurocord registry with a 4-year overall survival of 91% for patients with non-malignant diseases and 56% for patients with malignant diseases. Main hematologic indications in children are leukemia, hemoglobinopathies or inherited hematologic, immunological or metabolic disorders. However, family-directed cord blood banking is not widely promoted; many cord blood units used in sibling transplantation have been obtained from private banks that do not meet the necessary criteria required to store these units. Marketing by private banks who predominantly store autologous cord blood units has created public confusion. There are very few current validated indications for autologous storage but some new indications might appear in the future. Little effort is devoted to provide unbiased information and to educate the public as to the distinction between the different types of banking, economic models and standards involved in such programs. In order to provide a better service for families in need, directed-family cord blood banking activities should be encouraged and closely monitored with common standards, and better information on current and future indications should be made available.

[The quality of platelet concentrates in dependence on storage time before pathogen inactivation]. / Jakosc koncentratów plytek krwi w zaleznosci od czasu ich przechowywania przed wykonaniem procedury inaktywacji patogenów.

UNLABELLED: Pathogen inactivation procedure performed just before distribution of platelet concentrates (PCs) may decrease costs caused by loss of these components due to relatively short expiry date. THE AIM OF STUDY: To evaluate the quality of PCs pathogen inactivated on the first or the fifth day of storage. MATERIAL AND METHODS: PCs preparated from buffy-coats were suspended in platelet additive solution (Intersol, Baxter Healthcare Corporation, Belgium). The photochemical pathogen inactivation was performed on the 1st or the 5th day of storage using amotosalen and UVA (Cerus, Europe BV). PCs were stored for 7 days. RESULTS: There were observed increased expression of CD62 and CD63, elevated activity of LDH and lower concentration of glucose in PCs pathogen inactivated on day 1 compare to the control group. PCs pathogen inactivated on day 5 showed decreased expression of CD62 and CD63 compare to the control group. There were no significant differences in platelet number, pH, lactate concentration, hypotonic shock response and release of platelet derived microparticles in both groups of pathogen inactivated PCs. CONCLUSIONS: Time of storage of PCs before pathogen inactivation has no significant impact on PCs quality. Pathogen inactivation procedure performed just after having received request for PCs is more cost effective than the routine pathogen inactivation in all PCs before storage.