Financial analysis of large-volume delayed sampling to reduce bacterial contamination of platelets.

BACKGROUND: Effective and financially viable mitigation approaches are needed to reduce bacterial contamination of platelets in the US. Expected costs of large-volume delayed sampling (LVDS), which would be performed by a blood center prior to shipment to a hospital, were compared to those of pathogen reduction (PR), point-of-release testing (PORt), and secondary bacterial culture (SBC). METHODS: Using a Markov-based decision-tree model, the financial and clinical impact of implementing all variants of LVDS, PR, PORt, and SBC described in FDA guidance were evaluated from a hospital perspective. Hospitals were assumed to acquire leukoreduced apheresis platelets, with LVDS adding $30 per unit. Monte Carlo simulations were run to estimate the direct medical costs for platelet acquisition, testing, transfusion, and possible complications associated with each approach. Input parameters, including test sensitivity and specificity, were drawn from existing literature and costs (2018US$) were based on a hospital perspective. A one-way sensitivity analysis varied the assumed additional cost of LVDS. RESULTS: Under an approach of LVDS (7-day), the total cost per transfused unit is $735.78, which falls between estimates for SBC (7-day) and PORt. Assuming 20,000 transfusions each year, LVDS would cost $14.72 million annually. Per-unit LVDS costs would need to be less than $22.32 to be cheaper per transfusion than all other strategies, less than $32.02 to be cheaper than SBC (7-day), and less than $196.19 to be cheaper than PR (5-day). CONCLUSIONS: LVDS is an effective and cost-competitive approach, assuming additional costs to blood centers and associated charges to hospitals are modest.

Optimal collecting policy for apheresis platelets in a regional blood center.

BACKGROUND AND OBJECTIVES: Planning platelet collection and inventory must rely not only on adequate forecasts of transfusion demand but also sophisticated mathematical modeling techniques. This research aims to develop a better demand forecasting model of apheresis platelets and a mathematical programming model to determine the best target amounts of apheresis platelet collection. MATERIALS AND METHODS: Time series data of apheresis platelets collected from donors and platelets supplied to hospitals daily in Taipei Blood Center from January 2014 to December 2015 was used to fit a forecasting model which combines a regression-type model for formulating the deterministic trends and seasonal variation and an autoregressive moving average model (ARMA) for explaining remaining serial correlations. A seasonal autoregressive integrated moving average (SARIMA) model was also used for benchmarking the prediction performance. A linear programming model was then formulated to solve for the optimal daily target collection volumes that maximize the total social benefits. RESULTS: The time series model achieved good predictive power with a mean absolute percentage error less than 10%. The appropriateness of the proposed target collection volumes was also verified by using a simulation model, and the proportion of the total platelets requested by hospitals that can be filled by collected apheresis platelets can increase significantly by using the new policy. CONCLUSION: The methods proposed in this study can be easily implemented to enhance the management efficiency of blood collecting and supplying of a blood center, and to decrease the costs of the blood outdates and shortages.

The effects of apheresis, storage time, and leukofiltration on microparticle formation in apheresis platelet products.

BACKGROUND: Although platelet microparticles (PMPs) were the most abundant micoparticles (MPs) in platelet (PLT) products, other MPs and their parental cells can also be brought into the plasma during PLT apheresis. However, the effects of PLT apheresis, storage time, and leukofiltration on these MPs remain largely unclear. STUDY DESIGN AND METHODS: Apheresis PLTs with or without leukofiltration were stored in 22 ± 2 °C for 5 days. PLT-poor plasma (PPP) was generated by centrifugation of donor blood or PLT products at 2500 × g for 15 minutes on the point day. PPP was labeled with CD41a (PLT-derived MP, PMP), CD235 (red blood cell-derived MP, RMP), CD45 (leukocyte-derived MP, LMP), CD14 (monocyte-derived MP, MMP), and CD144 (endothelial cell-derived MP, EMP), and then measured by flow cytometry. RESULTS: Higher-level TMPs (total microparticles) and PMPs, but lower-level RMPs, LMPs, and MMPs were detected in fresh PLTs on the day of collection compared with those before collection. During storage, TMP, PMP, and RMP counts were significantly higher on Day 3 and Day 5, but MMP and LMP counts were only marginally higher on Day 3 in PLT supernatants. There were no significant differences in MP levels in PLTs with or without leukofiltration. CONCLUSION: MP formation was affected by the apheresis procedure. RMPs, LMPs and MMPs were lower after PLT apheresis. During storage, TMPs, PMPs, RMPs, LMPs, and MMPs were found to be higher in PLT supernatants. Leukofiltration exerted no significant effect on all MPs in PLT products.

Quality of irradiated and non-irradiated plateletpheresis concentrates stored in platelet additive solution.

INTRODUCTION: Platelet additive solutions (PAS) allow to maintain platelet storage properties in platelet concentrates (PCs). The aim of the present study was to evaluate the in-vitro quality of irradiated and non-irradiated PCs, suspended in PAS, over a storage period of 6 days. METHODS: Plateletpheresis donors fulfilling current eligibility criteria underwent plateletpheresis with the MCS+ blood cell separator. The PAS SSP+ was used to store platelets (PLT) for up to 6 days. Aliquots were drawn from the PCs after collection, at day 4, 5 and 6 of storage. A battery of tests was performed to analyse the quality of the PCs: PLT count, mean PLT volume (MPV), PLT activation marker CD 62, swirl, RBC and WBC contamination, pH, citrate, glucose, lactate and lactate dehydrogenase. RESULTS: An average of 2.53 ±â€¯0.21 × 1011 PLT were collected in a product volume of 231 ±â€¯5 mL in irradiated and 233 ±â€¯6 mL in non-irradiated PCs, respectively. RBC- and WBC-contamination were within the allowed ranges. Δ CD62 steadily decreased in irradiated and non-irradiated PCs while the pH was well maintained over storage time. Glucose and lactate levels of irradiated and non-irradiated PCs showed characteristic pattern of PC storage within acceptable ranges. CONCLUSION: Our data demonstrate that parameters of PC quality were well maintained over a storage period of 6 days using PAS. Irradiation had no impact on the quality of PCs. The product quality of irradiated and non-irradiated PCs met national and European guidelines.

Apheresis technology correlates with bacterial contamination of platelets and reported septic transfusion reactions.

BACKGROUND: Apheresis technology to collect platelet (PLT) components differs among devices. We evaluated the relationship of the plateletpheresis device with bacterial contamination and reported septic transfusion reactions. STUDY DESIGN AND METHODS: Plateletpheresis was performed using Amicus (Fenwal, a Fresenius Kabi Company) or Trima (Trima Accel, TerumoBCT) from 2010 to 2014. All donations used inlet-line sample diversion and were tested by quality control (QC; Day 1) aerobic culture. Rates of bacterial contamination and septic reactions to PLTs were calculated for both devices. RESULTS: During the 5-year study period, plateletpheresis collections using Amicus and Trima devices totaled 1,486,888 and 671,955 donations, respectively. The rate of confirmed-positive bacterial cultures of apheresis PLT donations was significantly higher with Amicus than with Trima (252 vs. 112 per 106 donations [odds ratio {OR}, 2.3; 95% confidence interval {CI}, 1.8-2.9]). Septic transfusion reactions were caused by 30 apheresis PLT units from 25 contaminated Amicus procedures and three apheresis PLT units from three contaminated Trima procedures. The overall rate of septic reactions was significantly higher with apheresis PLT components collected with Amicus than with Trima (16.8 vs. 4.5 per 106 donations [OR, 3.8; 95% CI, 1.1-12.5]). All apheresis PLT components implicated in septic transfusion reactions had negative QC culture results incubated through Day 5 (i.e., false negatives). CONCLUSION: Apheresis technology affects bacterial contamination of plateletpheresis collections. The device-specific, higher rate of confirmed-positive bacterial culture results also correlated with a significantly higher rate of reported septic transfusion reactions to apheresis PLTs.

Bacterial screening of platelet components by National Health Service Blood and Transplant, an effective risk reduction measure.

BACKGROUND: Bacterial contamination of blood components remains a major cause of sepsis in transfusion medicine. Between 2006 and 2010 in the 5 years before the introduction of bacterial screening of platelet (PLT) components by National Health Service Blood and Transplant (NHSBT), seven cases of PLT component-associated transmission of bacterial infection were recorded for 10 patients, three of which were fatal. STUDY DESIGN AND METHODS: Sampling of individual PLT components was undertaken at 36 to 48 hours after donation and tested in the BacT/ALERT system with 8 mL inoculated into each of aerobic and anaerobic culture bottles. Bottles were incubated until the end of the 7-day shelf life and initial reactive bottles were examined for contamination. Bacterial screened time-expired PLTs were tested as in the screen method. RESULTS: From February 2011 to September 2015, a total of 1,239,029 PLT components were screened. Initial-reactive, confirmed-positive, and false-positive rates were 0.37, 0.03, and 0.19%, respectively. False-negative cultures, all with Staphylococcus aureus, occurred on four occasions; three were visually detected before transfusion and one confirmed transmission resulted in patient morbidity. The NHSBT screening protocol effectively reduced the number of clinically adverse transfusion transmissions by 90% in this reporting period, compared to a similar time period before implementation. Delayed testing of 4515 time-expired PLT units after screening revealed no positives. CONCLUSION: The implementation of bacterial screening of PLT components with the NHSBT BacT/ALERT protocol was an effective risk reduction measure and increased the safety of the blood supply.

Quality control of apheresis platelets: a multicentre study to evaluate factors that can influence pH measurement.

BACKGROUND AND OBJECTIVES: Blood operators routinely monitor the pH of apheresis platelets as a marker of the so-called storage lesion, which can result from manufacturing problems. It is also suspected that some donor characteristics can increase the risk of poor platelet storage. To explore this hypothesis, we analysed a large, multinational data set of quality control (QC) pH test results on apheresis platelets. MATERIALS AND METHODS: For the period between September 2011 and August 2014, seven blood operators in Canada, the USA, the Netherlands, the United Kingdom, France and Australia provided pH QC test results and donor characteristics on a total of 21,671 apheresis platelets. RESULTS: Some variations in pH distribution between blood operators were in part explained by differences in collection, processing and testing methods. Younger age and female gender were significantly associated with a pH value below the 10th percentile. Among donors who had two or more pH measurements (n = 3672), there was a strong correlation between pH results (r = 0·726; P < 0·0001). CONCLUSION: The strong intradonor correlation of pH measurements and the association between donor characteristics and pH results suggest that donor factors play a role in the quality of platelets.

Platelet corrected count increments by apheresis platform.

BACKGROUND: Automated blood collection platforms use different technological systems to isolate and collect individual blood components. These unique systems could potentially result in differences in platelet in vivo viability, as measured by the corrected count increment (CCI). STUDY DESIGN AND METHODS: This retrospective study evaluated CCI data of platelet transfusions among oncology patients who received multiple unmanipulated apheresis platelets between January 1, 2006 and December 31, 2009. Apheresis platelets were collected from our community blood center by standard procedures using two different collection systems and were transfused to patients in a blinded manner. RESULTS: The CCI of the platelet recipient was significantly higher at 0-2 hours post-transfusion among the individuals who received platelets collected on Trima Accel (Terumo BCT) (mean = 6281, standard deviation = 3650) compared to the platelets collected by the Amicus system (Fresenius Kabi) (mean = 5251, standard deviation = 3311, p = 0.004). CONCLUSIONS: These hypothesis-generating data suggesting improved recovery and survival of Trima Accel platelets demonstrate the need for the investigation and implementation of the best collection methods to provide better platelet transfusion support.

Washing of platelets can be fully automated using a closed-system cell processor and BRS-A platelet additive solution.

This study evaluated the in vitro properties of platelets (PLTs) washed with BRS-A additive solution in the Haemonetics ACP215 automated processing system. Two washing modes, 'manually/automatically adding ACD-A to BRS before/during the washing process', represented the control and test groups, respectively. Outcomes were compared over 7 days of storage (n = 7, for both). PLT recovery following washing processing (26-27 min) was 86·2 ± 1·7% and 86·0 ± 2·2% and plasma protein removal was 98·8 ± 0·3% and 99·0 ± 0·2% in the control and test groups, respectively (not significant). Both groups exhibited comparable in vitro properties.

Predicted effect of selectively testing female donors for HLA antibodies to mitigate transfusion-related acute lung injury risk from apheresis platelets.

BACKGROUND: The use of male-donor-predominant plasma has reduced the risk of transfusion-related acute lung injury (TRALI), but the possible benefit of different mitigation strategies for other components is unknown. We evaluated the risk of TRALI from apheresis platelets (PLTs) to predict the effect of selectively testing female plateletpheresis donors who have been pregnant for HLA antibodies. STUDY DESIGN AND METHODS: The American Red Cross hemovigilance program classified TRALI cases from apheresis PLTs or red blood cells (RBCs) in 2006 to 2013 or from predominantly male-donor (>95%) plasma in 2008 to 2013 and compared the component-specific TRALI rates. RESULTS: The overall rate of TRALI was significantly higher for apheresis PLTs (6.2 cases per 10(6) units; OR [95% CI], 3.3 [2.3-4.8]) or plasma (3.8 cases per 10(6) units; OR [95% CI], 2.0 [1.4-2.9]) compared to RBCs (1.9 per 10(6) units). Twenty-nine of the 41 apheresis PLT cases involved female donors; 28 had been pregnant, and one had not been pregnant and was not tested. Twenty-five (61%) of the apheresis PLT TRALI cases had female donors with HLA Class I or Class II antibodies. In five of six cases that implicated specific HNA antibodies, the female parous donors also had multiple HLA antibodies. CONCLUSIONS: TRALI was more likely after transfusion of apheresis PLTs than male-donor-predominant plasma or RBCs. A selective strategy to test all female plateletpheresis donors who have been pregnant for HLA antibodies might reduce the risk of TRALI by approximately 60% and prevent some cases from coexisting HNA antibodies.

Quality assessment of platelets stored in a modified platelet additive solution with trehalose at low temperature (10 °C) and in vivo effects on rabbit model of thrombocytopenia.

Trehalose is widely used as a cryoprotective reagent to preserve various cells. Platelet additive solution-III (PAS) has been used to maintain platelet function, benefit the virus inactivation, and extend the storage period. PAS with trehalose (PAS-III M + T) may effectively protect platelets (PLTs) at a relatively low temperature (10 °C). The apheresis PLTs from six donors were divided into two groups. Group A was stored in PAS-III M + T at 10 °C as experimental group and group B in plasma at 22 °C as control group. The samples were collected on different storage dates, and multiple parameters were determined or investigated for in vitro studies. The in vivo recovery and survival of rabbit PLTs stored in the same conditions, and then labeled with (51)Cr were measured and evaluated using a rabbit model of thrombocytopenia. Over 9 days, P-selectin expression increased significantly in a time-dependent manner in both groups (n = 6). The levels of the hypotonic shock reaction and PLT aggregation rate decreased in both groups and were significantly higher in group A than B after 1 day of storage. The lactate dehydrogenase (LDH) release and glucose (GLU) consumption increased similarly, but the levels were significantly lower in group A than B. The pH decreased significantly after 5 days of storage in group B but did not change in group A. After 5 days, the morphology of the PLTs in group B maintained a more normal shape than that of group A. The recovery and survival of PLTs stored in both groups were not significantly different (p > 0.05). The bacteria growth was not examined out in both groups for up to 5 (group A) and 9 (group B) days. Storage of PLTs in the modified PAS at low temperature was more effective in protecting PLT functions than that of standard storage method and may have the potential to decrease the risk of PLT activation and bacterial contamination.

Reducing the financial impact of pathogen inactivation technology for platelet components: our experience.

BACKGROUND: Pathogen inactivation (PI) technology for blood components enhances blood safety by inactivating viruses, bacteria, parasites, and white blood cells. Additionally, PI for platelet (PLT) components has the potential to extend PLT storage time from 5 to 7 days. STUDY DESIGN AND METHODS: A retrospective analysis was conducted into the percentage of outdated PLT components during the 3 years before and after the adoption of PLT PI technology in our institution. The PLT transfusion dose for both pre-PI and post-PI periods was similar. A retrospective analysis to study clinical safety and component utilization was also performed in the Balearic Islands University Hospital. RESULTS: As a result of PI implementation in our institution, the PLT production cost increased by 85.5%. However, due to the extension of PLT storage time, the percentage of outdated PLT units substantially decreased (-83.9%) and, consequently, the cost associated with outdated units (-69.8%). This decrease represented a 13.7% reduction of the initial cost increase which, together with the saving in blood transportation (0.1%), led to a saving of 13.8% over the initial cost. Therefore, the initial 85.5% increase in the cost of PLT production was markedly reduced to 71.7%. The mean number of PLT concentrates per patient was similar during both periods. CONCLUSIONS: The extension of PLT storage time can substantially contribute to reducing the financial impact of PI by decreasing the percentage of outdated PLTs while improving blood safety. Since the adoption of PI, there have been no documented cases of PLT transfusion-related sepsis in our region.

Feasibility of applying the 2day deferral for repeat plateletpheresis: Indian perspective.

As the use of single donor apheresis platelets and plateletpheresis procedures done steadily increases in India, the plateletpheresis donors are at an increased risk of postpheresis anemia and thrombocytopenia. This study was planned in order to evaluate the effect of plateletpheresis on the hematological parameters in the local donor population and to evaluate the possibility of following the 2day deferral for repeat plateletpheresis. A total of 60 plateletpheresis procedures performed over a period of 1year with CS 3000 Plus Baxter Fenwal were evaluated. All the post-donation hematological parameters showed a significant decrease from the pre-donation values (p<0.001). Post-donation hemoglobin <12g, which is defined by WHO as anemia irrespective of the gender occurred in 25% (n=15) of the donors. The post-donation platelet count was less than 100×10(9)/L in 16.6% (n=10) of the procedure. The ability of these donors to serve as repeat plateletpheresis donor after 2days as recommended by AABB needs to be evaluated by further studies done post donation. Keeping in view the hematological profile of our donor population we recommend that donors who already have a low or borderline pre-donation platelet count and hemoglobin should be assessed and monitored post-donation for decrements in these parameters. While serving as repeat donors, their pre donation hemoglobin and platelet counts should be tested again.

Concentrados de plaquetas obtenidos a partir de sangre entera vs por aféresis / Platelet concentrates: random vs apheresis

En la actualidad disponemos de tres tipos de concentrados de plaquetas (CP): CP procesados por el método de plasma rico en plaquetas (CP-PRP) o por el método de capa leucocitaria "buffycoat" (CP-BC) a partir de unidades de sangre entera donadas al azar (CPR) y CP obtenido por aféresis (CP-aféresis). La calidad y caracerísticas de las plaquetas durante el almacenamiento se afectan por una serie de factores, tales como el anticoagulante, la centrifugación y procesamiento después de la colecta, y el agrupamiento antes o después del almacenamiento. Por último, el uso de cada uno de estos componentes ya sean originales, o leucorreducidos, o suspendidos en solución de almacenamiento, o procesados con una técnica de inactivacion de patógenos agrega nuevos factores de complejidad para compararlos. Aunque está claro que el CP-BC retiene mucho más funciones in vitro que el CP-PRP, lo que indica que no se debería utilizar más este último, es mucho más difícil encontrar diferencias con los CP-aféresis. Otro factor que puede afectar la decisión política es la aparición de reacciones adversas en los receptores. Si se consideran solamente los datos comparables, por ejemplo CPR leucorreducida en comparación con CP-aféresis leucorreducida, hay pruebas de que este último está más asociado con reacciones adversas en los receptores. Muy pocos estudios se han publicado comparando la eficacia clínica de los CPR frente a CP-aféresis, considerando como resultado final principalmente el incremento del recuento corregido de plaquetas (IRC). De manera similar a los estudios in vitro, aunque el CP-PRP muestra IRC más bajos, no existe una diferencia clara entre CP-BC y CP-aféresis. Otros aspectos que pueden afectar la decisión es el hecho de que el uso de CP-aféresis en lugar de CPR reduce la exposición total de los pacientes a los donantes, lo cual se considera crítico en algunos países para reducir el riesgo de transmisión de infecciones transmisibles por la sangre...

Concentrados de plaquetas obtenidos a partir de sangre entera vs por aféresis / Platelet concentrates: random vs apheresis

En la actualidad disponemos de tres tipos de concentrados de plaquetas (CP): CP procesados por el método de plasma rico en plaquetas (CP-PRP) o por el método de capa leucocitaria "buffycoat" (CP-BC) a partir de unidades de sangre entera donadas al azar (CPR) y CP obtenido por aféresis (CP-aféresis). La calidad y caracerísticas de las plaquetas durante el almacenamiento se afectan por una serie de factores, tales como el anticoagulante, la centrifugación y procesamiento después de la colecta, y el agrupamiento antes o después del almacenamiento. Por último, el uso de cada uno de estos componentes ya sean originales, o leucorreducidos, o suspendidos en solución de almacenamiento, o procesados con una técnica de inactivacion de patógenos agrega nuevos factores de complejidad para compararlos. Aunque está claro que el CP-BC retiene mucho más funciones in vitro que el CP-PRP, lo que indica que no se debería utilizar más este último, es mucho más difícil encontrar diferencias con los CP-aféresis. Otro factor que puede afectar la decisión política es la aparición de reacciones adversas en los receptores. Si se consideran solamente los datos comparables, por ejemplo CPR leucorreducida en comparación con CP-aféresis leucorreducida, hay pruebas de que este último está más asociado con reacciones adversas en los receptores. Muy pocos estudios se han publicado comparando la eficacia clínica de los CPR frente a CP-aféresis, considerando como resultado final principalmente el incremento del recuento corregido de plaquetas (IRC). De manera similar a los estudios in vitro, aunque el CP-PRP muestra IRC más bajos, no existe una diferencia clara entre CP-BC y CP-aféresis. Otros aspectos que pueden afectar la decisión es el hecho de que el uso de CP-aféresis en lugar de CPR reduce la exposición total de los pacientes a los donantes, lo cual se considera crítico en algunos países para reducir el riesgo de transmisión de infecciones transmisibles por la sangre...(AU)

Events at blood collection area due to nonconforming blood bags and plateletpheresis kits: need for timely corrective and preventive actions.

BACKGROUND: Good blood banking practice requires that every effort should be made to detect any deviation or defect in blood bank products and to identify any potential risk to blood donor or recipient(s). We report the findings of an exercise that provide an insight into why feedback from the user side is crucial. STUDY DESIGN AND METHODS: Various events involving blood bags and plateletpheresis kits and the corresponding appropriate actions instituted for remedial measures were recorded. These scattered events were recorded for 6 months following the use of a new batch of improved blood bags with add-on features. Several events related to plateletpheresis kits from three different manufacturers were also recorded for 1 year. RESULTS: The affected blood bags were utilized with no untoward incident. The complaint was closed following satisfactory response from the blood bag manufacturing company that acted in a timely manner in addressing the root causes of the problems. However, corrective and preventive actions (CAPA) could not be implemented for plateletpheresis kits. The rate of undesirable events was higher with plateletpheresis kits as compared with whole blood bags (1.75% vs. 0.06%). CONCLUSION: As defects or deviations that trigger the need for CAPA can stem from numerous sources, it is important to clearly identify and document the problems and level of risk so that appropriate investigations can be instituted and remedial actions can be taken in a timely manner. This study demonstrates the usefulness of a quality initiative to collate and analyze blood product faults in conjunction with blood product manufacturers.