Automated processing of whole blood units: operational value and in vitro quality of final blood components

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1 Automated processing of whole blood units: operational value and in vitro quality of final blood components ORIGINAL ARTICLE Marisa Jurado, Manuel Algora, Félix Garcia-Sanchez, Santiago Vico, Eva Rodriguez, Sonia Perez, Luz Barbolla Community Transfusion Centre, Madrid, Spain Background. The Community Transfusion Centre in Madrid currently processes whole blood using a conventional procedure (Compomat, Fresenius) followed by automated processing of buffy coats with the OrbiSac system (CaridianBCT). The Atreus 3C system (CaridianBCT) automates the production of red blood cells, plasma and an interim platelet unit from a whole blood unit. Interim platelet unit are pooled to produce a transfusable platelet unit. In this study the Atreus 3C system was evaluated and compared to the routine method with regards to product quality and operational value. Materials and methods. Over a 5-week period 810 whole blood units were processed using the Atreus 3C system. The attributes of the automated process were compared to those of the routine method by assessing productivity, space, equipment and staffing requirements. The data obtained were evaluated in order to estimate the impact of implementing the Atreus 3C system in the routine setting of the blood centre. Yield and in vitro quality of the final blood components processed with the two systems were evaluated and compared. Results. The Atreus 3C system enabled higher throughput while requiring less space and employee time by decreasing the amount of equipment and processing time per unit of whole blood processed. Whole blood units processed on the Atreus 3C system gave a higher platelet yield, a similar amount of red blood cells and a smaller volume of plasma. Discussion. These results support the conclusion that the Atreus 3C system produces blood components meeting quality requirements while providing a high operational efficiency. Implementation of the Atreus 3C system could result in a large organisational improvement. Keywords: whole blood processing, automation, Atreus 3C system, blood components, operational value. Introduction The preparation of blood components from whole blood can be a time-consuming procedure involving numerous steps. Currently in our site, in order to obtain transfusable blood components, the unit of whole blood is first processed into a red blood cell (RBC) unit, a plasma unit and a buffy coat. A number of buffy coats are then pooled and processed to produce a platelet concentrate. On a daily basis, the Community Transfusion Centre in Madrid (CTCM) processes approximately 650 whole blood units. In peak operating periods, approximately 1,000 units of whole blood can be processed in 1 day. Until November 2004 the CTCM used a conventional method with semi-automated expressers (Fresenius) and sealers to separate the final blood components. The current procedure implemented at the blood centre is a partially automated process with semi-automated expression of RBC, plasma and buffy coat units. This is followed by an automated process using the OrbiSac system (CaridianBCT) in which a number of buffy coat units are pooled and processed into a leucoreduced unit of platelet concentrate. The impact of automation with OrbiSac has already been demonstrated, with the system providing optimised product standardisation 1 SIMTI Servizi Srl 63

2 Jurado M et al and organisation 2. More recently, systems have been developed to increase automation of the entire process, such as the Atreus Whole Blood processing system (Atreus 3C system, CaridianBCT) 3,4. The Atreus 3C system is a self-contained, automated manufacturing system that processes blood components from whole blood units. The technology integrates or replaces many manual processes including weighing and balancing of units, centrifugation, expression, sealing, volume determination, and data management. The Atreus 3C system simplifies whole blood component preparation by providing a RBC unit, a leucoreduced plasma unit and an interim platelet unit. The interim platelet unit is produced instead of a buffy coat. These interim platelet units need only to be pooled, additive solution added and leucoreduced in order to obtain a transfusable platelet product that requires no secondary centrifugation or separation. Additionally, the RBC unit is leucoreduced using a gravity drain filtration system. The Atreus 3C system also offers a two-component protocol to produce optimal RBC and plasma units when a platelet unit is not required. The aim of this study was to assess the usability of the Atreus 3C system in comparison to the current routine procedure in the component laboratory environment. The study focused on two general areas, the operational value of the system and the yield and in vitro quality of blood components (leucoreduced RBC, plasma and platelet units) produced by the system. Materials and methods Study set-up and design Over a 5-week period two whole blood processing methods, the Atreus 3C system (Test) and the routine (Control) procedure using semi-automated expressers and OrbiSac were compared with regards to in vitro product quality and operational value. Data were collected through observation, interviews, reports and logs. Prior to the trial, representatives from CaridianBCT evaluated and mapped the current Control whole blood collection and processing methods. The same assessment team returned during the study period to evaluate the Atreus 3C process (Test). The blood centre staff was trained by the CaridianBCT Field Implementation Team to process the whole blood units on the Atreus 3C system on their own. The analysis of the process was managed with the support of Caridian BCT. Areas of evaluation included productivity (throughput and staff utilisation), processes (standard operating procedures, tasks, flow, timing, decision points, equipment utilisation and facilities), product quality (yields and conformity), and training (methodology, content and duration). The throughput was determined as follows: the number of whole blood units that could be processed by one employee within a 6-hour shift (n) was calculated by normalizing the time to process a batch of 12 units, as the current Control method uses centrifuges that process 12 units per run. The total time to process a batch of 12 units was then divided into the shift hours to obtain the number of batches of 12 units processed in one shift and multiplied by 12 as follows: n=(shift time/12 units processing time)*12. Blood collection Whole blood 450±45 ml was collected on day 0 from the regular donor population, in agreement with the blood centre's ethical regulations, into either Atreus integrated sets or Top & Bottom bags (Fresenius ). The Atreus integrated set includes a collection bag containing citrate-phosphate-dextrose solution, a conical separation bag and bags for interim platelet units, plasma and RBC. All whole blood units were transported and temporarily stored using temperature control methods (Compocool plates, Fresenius ) after the collection and until processing. The whole blood units were processed between 14 and 24 hours after collection. Whole blood processing: current routine method Over the course of the study, 19,512 units of whole blood were processed with the current routine method (Control). On day 1, the whole blood units are centrifuged for 13 minutes at 3,500 rpm, g, (Heraeus 8500i centrifuge) and RBC, plasma and buffy coat are expressed with Fresenius Compomat G4. After resting for 6-24 hours, four buffy coats are connected with 300 ml of Composol (Fresenius ) and processed on the OrbiSac system. Platelet pools are then stored at 22 C under agitation until release for transfusion. RBC units are leucoreduced by gravity filtration with the filter integrated into the collection set and stored according to the site's standard operating procedure. 64

3 Automation of whole blood processing in Madrid Blood Services Whole blood processing: Atreus 3C method Eight hundred and ten units of whole blood were processed within at least 14 hours after collection (Day 1) on the Atreus 3C system, each producing a RBC unit, a plasma unit and an interim platelet unit. The RBC unit was leucoreduced by gravity filtration through the inline leucoreduction filter into a RBC storage bag containing 100 ml SAGM. The leucoreduced RBC units were sampled and put into the normal inventory according to the site's standard operating procedure. The plasma unit was also prepared according to the site's standard operating procedure with no further need for filtration. After a minimal resting time of 3 hours (1 hour static, 2 hours on a flatbed shaker, Helmer) at standard blood bank conditions of 22±2 C, four interim platelet units were pooled with approximately 200 ml of storage solution (Composol, Fresenius ) and leucoreduced. Platelet units were then stored on shakers (Helmer) at 22±2 C until release for transfusion. Quality control of blood components We currently routinely control 1% of our blood components. For this study we wanted a significant but manageable number of samples and settled for 205 whole blood units, 50 RBC units, 30 plasma units and 30 pools of platelets at Day 1. Units were randomly assigned from each arm for quality control. The randomisation lists for this trial were generated using the Rand function of Excel The volume of blood components was measured by weighing the contents and dividing the weight by the appropriate density as follows: 1.06 g/ml for whole and RBC, 1.03 for plasma and 1.01 for platelets. Some of the leucoreduced RBC, plasma and final platelet units produced were sampled for yield assessment and in vitro quality control. Automated cell counts (Abbott Celldyn 3700) and the platelet unit volumes were used to measure the yield of platelet units on day 3. Haematocrit and haemoglobin (Hb) of RBC or whole blood units were also measured by an automated cell counter. P-selectin expression in platelet units was measured by flow cytometry (Beckman Coulter Cytometics FC 500) on days 2 and 5 with an intermediate measure on day 3 or 4. P-selectin was investigated by measuring the expression of CD62p antigen by flow cytometry. CD62p-fFITC and CD61-PE monoclonal antibodies (Immunotech) were used. Negative controls were prepared by incubating platelet suspension with IgG1-FITC and IgG1-PE isotypes and 15,000 events were acquired for each analysis. Residual white blood cells (WBC) were measured based upon the ability of propidium iodide to bind stoichiometrically to DNA. Flow cytometer (Beckman Coulter Cytometics FC500) measures the fluorescence from each stained cell and provides quantitative data. The concentration of plasma coagulation factors, including fibrinogen (Von Clauss method) was assessed on day 1 with the STA-Compact, DIagnostica Stago Viscosity Based Detection System (Roche Coagulometer), based on mechanical viscosity. The ph of platelet units was not measured in this study. Statistical analysis Descriptive statistics were used to summarize the raw data set (Microsoft Excel 2007). For each parameter a Student's t-test was used to evaluate differences between the two study groups. P-values greater than 0.05 are considered not significant (N.S.). The residual WBC counts were analyzed after log transformation. Results Assessment of the routine process Steps and processes. The current method for the separation of whole blood into RBC, plasma and buffy coat units involves 23 steps (Table I) to carry out activities such as preparation, centrifugation, expression, hanging the RBC unit for filtration and storage. The total time to carry out these steps is 33 minutes for one whole blood unit equivalent. Hands-on tasks involve 21 of the 23 steps and take a total of 2.5 minutes per unit processed. The current process has four inspection points. The preparation of a platelet unit from buffy coats with the OrbiSac system involves 16 steps (Table I) and takes on average 26 minutes per pooled platelet unit. This process involves 14 hands-on tasks, which take an average of 8.5 minutes. The production of platelets from buffy coats has four inspection points. Based on these observations and time studies, it has been calculated that one operator can process 76.1 platelet pools during a 6-hour shift (Table II). Resources (equipment, personnel and space). The site currently processes approximately 185,000 whole blood units annually. Blood is processed 7 days 65

4 Jurado M et al Table I - Steps required for whole blood (WB) processing into plasma, red blood cells (RBC) and buffy coat (BC) or interim platelet units (IPU) with routine or Atreus 3C procedures. WB processing BC/IPU processing Step Control Atreus 3C Control Atreus 3C 1 Remove rubber band from WB unit and prepare for cup Remove rubber band from WB unit Close clamp Close all clamps 2 Pack unit in cup Scan numbers into Atreus Sterile connect PAS to set Sterile connect PAS to set 3 Place cups in cart Load Atreus Sterile connect 4 BCs Sterile connect 4 IPUs 4 Roll cart to centrifuge room Close lids and press start Load BC onto cassete Hang PAS on hook 5 Weigh cups* Atreus Procedure Hang PAS on hook Hang IPUs on other hook 6 Load units into centrifuge Unload Atreus* Load cassette on Orbisac Open blue clamp 7 Close both lids and start Place produ ct in bins Load OrbiSac Equalize solutions with platelets 8 Centrifuge Hang RBC to filter* Open clamps Close blue clamp 9 Remove units and place on cart Roll cart to pre platelet Press start Open white clamp processing room 10 Roll cart to expression area Place IPU on shaker Pooling and rinsing Pool and filter procedure+ 11 Remove unit and place on peg Remove cassette and PAS Seal pool line and disconnect 12 Place plasma on scale Close lid and press start Remove air from platelet unit 13 Place SAGM and crack frangible OrbiSac process+ Roll cart to post platelet processing room 14 Place RBC on scale Unload OrbiSac Place finished platelet on shaker 15 Scan lot numbers Remove air from platelet unit 16 Start expressor 17 Expression 18 Remove plasma* 19 Remove BC* 20 Place product in bins 21 Hang RBC to filter* 22 Roll cart to pre platelet processing room 23 Place Buffy Coat on shaker *Inspection point; Automated step; these steps are unnecessary with the Atreus 3C system due to the prediction of product volumes. Table II- Comparison of throughput, staffing and equipment requirements of the current routine process (Control) and Atreus 3C process (Test) extrapolated to the CTCM setting. Productivity Staffing and Training Equipment and Facilities Processing time per batch of 12 units (minutes) Throughput (Units/Employee/ Shift) employees (per day) Training time (weeks) Pieces of equipment Processing space (m²) Control Atreus 3C */ */29 41*/50 *During normal operating periods, approximately 650 whole blood units are processed each day. Peak operating periods during which up to 1,000 whole blood units are processed per day. 66

5 Automation of whole blood processing in Madrid Blood Services a week, for an average of 650 units per day. The units are processed over two 6-hour shifts (morning and afternoon), during each of which 10 staff members are employed. Seventy percent of the units undergo the first separation during the morning shift (09:00 to 15:00 hours), which requires five operators for whole blood processing. The rest of the staff are involved in other procedures: three employees are required for plasma logistics (packing, pathogen inactivation and data management) and preparation of paediatric units, one for organising the distribution of units to the 25 hospitals served by the CTCM one for quality control. During the second shift (16:00 to 22:00 hours) the remaining 30% of whole blood units are processed by three employees who are responsible for whole blood processing, and six operators who are involved in buffy coat processing. All platelet units are processed during the second shift. One employee is involved with other non-processing procedures such as quality control. Therefore, over the two shifts, a total of 14 employees are involved in processing blood components (Table III). Based on the experience of the blood centre, in order for a new employee to be fully operational on all whole blood processing tasks, they each require a 6-week training period (Table III). The routine CTCM component laboratory equipment for whole blood processing includes one balance, seven centrifuges, 20 Compomat G4s (Fresenius) and one back-up, three sterile connection devices, seven OrbiSac systems, three single-head sealers, one multi-head sealer, one set of scales and four oscillating platelet shakers. The laboratory space required for this process is 105 m² (Table II). Assessment of the Atreus 3C process The separation of whole blood using the Atreus 3C system involves 10 steps (Table I). The processing time to manufacture an interim platelet unit, RBC and plasma units from a unit of whole blood averaged 14 minutes per whole blood unit processed. The process involves nine hands-on tasks, which take an average of 1.5 minutes. The Atreus 3C process has two inspection points. The preparation of a platelet unit from interim platelet units involves 14 steps and takes 26 minutes on average. Twelve of these steps are hands-on tasks, which take an average of 4 minutes per unit. The process has four inspection points. It was calculated that one employee, working a 6-hour shift can process 94.6 units (Table II). For this study, only three Atreus devices were needed. A fourth device was supplied for backup. During the first shift one employee processed the whole blood units using the Atreus 3C system. At times, a "floating" employee would assist with RBC leucoreduction, inspection and storage of processed blood components. In the second shift, a second employee pooled the interim platelet units to produce platelet units. During the assessment period, three Atreus 3C systems, plus one for backup, one sterile connection device, one multi-head sealer and one oscillating platelet shaker were used. Extrapolation of the use of the Atreus 3C system to routine and peak procedures In order to compare the Atreus 3C system to the current procedure, the observations reported above were extrapolated to routine use conditions. For normal operations (650 units/day), ten Atreus 3C systems (2 work cells of 5), two sterile connection devices, two single sealers, one multi-head sealer for segmenting and six platelet shakers would be required, occupying 41 m 2 of space. The process would require three employees to operate the Atreus work cells per shift, and two employees to perform platelet pooling during the second shift. Thus eight employees per day would be involved in processing. It is estimated that new employees would be proficient with the process within 2 weeks (Table II). Although approximately 85% of the time 650 whole blood units are processed per day (normal Table III - Attributes of the Control (current method) and Atreus 3C procedures for the processing of whole blood units. Total number of steps queues hands-on tasks Total handson time (minutes) quality/technical inspections standard operating procedures Unit processing time (minutes) Control Atreus 3C

6 Jurado M et al operations), the throughput at the blood centre is sometimes higher, with approximately 1000 units processed per day. In these peak operation periods in order to be able to keep up with the greater activity, the centre would require a maximum of 15 Atreus 3C systems (split into 3 cells of 5 machines) and eight platelet shakers using 49.5 m 2 of space. The daily staff requirement would be nine operators for the Atreus 3C systems and three operators to take care of platelet pooling (Table II). Product yield and in vitro quality control Quality control and yield data are presented in Table IV. The volume and donor Hb content of the whole blood units used for the two processes were comparable. Leucoreduced RBC units had a significantly larger volume but higher WBC count in the Test arm compared to in the Control arm, with all units in both arms meeting the leucoreduction requirements of <106 WBC/unit. Although the difference was not significant, the Hb content tended to be higher in Test units, with 100% of Test units meeting the minimum Council of Europe requirement of 40 g Hb/unit versus 94% of Control units (n=3/50 <40 g Hb/unit) 5. Test group plasma units were an average of 12 ml smaller and had a lower residual WBC content and a higher fibrinogen content. No significant difference in coagulation factors II and VIII was observed between the two groups. Platelet units from the Test group had a significantly higher yield, with an average of 344x10 9 platelets/unit compared to 311x10 9 platelets/unit in the Control group. Thirteen percent of platelet units from the Test arm and 23% from the Control arm did not meet the local requirement of 270x10 9 platelets per pooled unit. P-selectin expression was slightly lower in the Control group throughout storage, but the difference was only significant on day 1. Table IV- Quality control and yield data of whole blood (WB) units and final blood components processed with two different methods: the routine process utilising manual separation of WB followed by OrbiSac (Contr ol) and the Atreus 3C system. CoE* guidelines Atreus 3C Control P value Mean ±SD n Mean ±SD n Donor Hb (g/dl) > ± ± P=0.44 WB Volume (ml) 450± ± ± P<0.01 RBC Volume (ml) TBD ± ±21 50 P<0.01 Hb (g/unit) > ± ± P=0.06 Haematocrit (%) ± ± ns WBC (10 6 /U) < ± ± P<0.01 Plasma Volume (ml) Na ± ±26 30 P<0.05 Factor VIII (IU/dL) > ± ± ns Factor II (IU/dL) > ± ± ns Fibrinogen (mg/dl) Na ± ± P<0.05 Platelets (x10 9 L) 9.43 ± ± ns RBC (x10 9 /L) 0.00 ± ± ns WBC (10 6 /L) <1 0 ± ± P<0.01 Platelet Volume (ml) >40 per 60x10 9 plt 284 ± ±12 31 P<0.01 Concentration (10 9 /L) <1500 1,214 ± ± P<0.01 Yield (10 9 /Unit) ± ±47 31 P<0.05 CD 62% Day 2 Na 25 ± ± P<0.05 CD 62% Day 3-4 Na 45.3 ± ± ns CD 62% Day 5 Na 49.3 ± ±9 12 ns WBC (10 6 /unit) < ± ± ns *Council of Europe 68

7 Automation of whole blood processing in Madrid Blood Services Discussion In this study the operational value of the Atreus 3C system was assessed and compared to that of the routine semi-automated method for whole blood processing. The study revealed that use of the Atreus 3C system for whole blood processing eliminated several steps and hands-on tasks resulting in a 40% decrease in operational tasks (Table I). This also results in 32% less time required to process one whole blood unit. The actual time an operator spends on the process is reduced by almost half, freeing 5 minutes of operator time per unit. Since many units are processed in parallel by an operator managing a pod of Atreus systems, this 5-minute savings overlaps between processed blood units and is not 5 minutes for every unit processed. Stress and pressure on operators and, therefore, potentially fewer errors and higher job satisfaction, were not assessed during the study but would be an interesting area of investigation in a further evaluation. The training time required for a new employee to become proficient with the Atreus device is three times shorter than that necessary for the semi-automated method for processing whole blood units. The Atreus 3C assessment data were extrapolated to routine practice at the CTCM, revealing that the automated system has a number of advantages. The time saving described above can be extrapolates to the number of operators required to process whole blood units when using the Atreus 3C system. During normal production a 43% reduction in operators would be achieved, while during peak operating periods a 14% reduction in operators could be expected. Therefore, in 1 day during normal operating periods, six employees could be freed for other roles. Even during peak production times, two employees could be freed from whole blood processing, for processes such as pathogen reduction of platelet or plasma units. When looking at the laboratory layout, it became obvious that less equipment would be necessary when the Atreus 3C system is implemented. Equipping the laboratory with the 15 Atreus 3C systems calculated to be necessary to meet the requirements of peak production periods, 55 m² of space would be gained compared to the current layout: this space could be reallocated for other purposes. As part of this study, the blood components produced by the Control and Test systems were compared. The whole blood units used for each process had similar donor Hb content (14.9 g/dl versus 14.8 g/dl, p=0.44) and average volume (451 ml versus 448 ml; this small difference of 0.7% in volume, although mathematically significant, is not significant for the study itself), suggesting that any differences in the final product quality are not due to differences in the initial products. Compared to the current procedure, the Atreus 3C system provided a slightly higher Hb content in the leucoreduced RBC units, and a slightly lower volume of plasma units. These differences were also found in another study comparing the Atreus 3C system to a similar routine process 6. The higher Hb content is expected, as the system does not require a buffy coat for platelet production, and the RBC normally lost as part of the buffy coat process are recovered. The level of WBC contamination in plasma was considerably lower, as a result of the expression of the plasma during centrifugation. Although the platelet yield index (PYI) was not evaluated in this study, the platelet yield in pools produced on the Atreus 3C system was 12% higher than the that of the routine method (Table IV). Previous studies on the implementation of automation with OrbiSac showed that this method provided higher platelet yields when compared to more conventional processes, in some cases resulting in an increase of more than 30% 6,7. The higher yield is important since the proportion of units not meeting local requirements dropped from 23 to 13%. A feature of the Atreus 3C system is the PYI that gives the user an estimation of the platelet yield for each interim platelet unit and allows the blood centre to pool only those interim platelet units that meet desired specifications 8. It is well established that platelet content varies between whole blood units due to donor pre-counts. By using the PYI to produce an interim platelet unit only from selected units, the platelet content of platelet concentrates could be higher and more consistent. Platelet activation was similar between the two methods: although a slightly higher level of P-selectin expression was observed in Atreus 3C products, the difference was not significant throughout the entire storage period (Table IV). The small number of units measured could account for the P values being above 0.05 on days 3 and 5; the differences between the two methods could, therefore, 69

8 Jurado M et al be significant if a larger number of units were to be studied. At least three factors must be considered when attempting an analysis of cost differences between the two processes: the staff needed to perform the work, the equipment and the number of supplies/ disposables for the products. Table V presents the differences and implications of these three elements in both systems. According to our study, implementation of the Atreus 3C system would enable a staff reduction of 42% (6 laboratory technicians could be assigned to other processes or departments of CTCM). There would be a 94% reduction of equipment, mainly due to the amortisation of the seven centrifuges no longer needed for manual fractionation. The investment for disposables is greater with the Atreus 3C system, mainly because of the initial cost of Atreus 3C supplies for RBC units, interim platelet units and fresh-frozen plasma. The cost is doubled. However, the creation of platelet pools costs 2.5 times less when using the Pooling Kits for Atreus 3C instead of Orbisacs disposables. We estimated that the overall costs of disposables in our Centre would be 10% higher with the 3C Atreus system than with our classical production method. With these differences in expenditure, we estimated that the total cost impact of production in the first year would be +0.46% for the Atreus 3C system for the production of 185,000 RBC units, 50,000 platelet units and 185,000 fresh-frozen plasma units. This cost impact also needs to be assessed in the context of the revenue impact of the products. Given that the automatic methodology produces more homogeneous unit and, therefore, presumably lower discard rates (although this point was not specifically investigated in our study) and that labour-saving could offset the increased cost of production, the total net impact (cost of production and revenues of products) can be very balanced. In conclusion, we can say that the different areas evaluated revealed a number of potential advantages of the Atreus 3C system. It is easily adaptable to a blood component laboratory that is already equipped with a partially automated process and was well received by the staff. Automation of whole blood processing met the criteria expected for such a device, providing acceptable product quality and increased operational value. The Atreus 3C system yielded products that meet high standards of quality and despite the fact that automation, in general, can add Table V - Differences of cost in processing 185,000 whole blood units/year. Atreus 3C system Manual + Orbisac Variation (%) A) Employees 8 laboratory technicians 14 laboratory technicians 42% B) Equipment 10 Atreus 3C machines + ASM * 7 whole blood centrifuges 1 balance 20 Compomats* 5 Orbisac machines* 2 sterile connection devices 3 sterile connection devices 94.5% 1 multihead sealer 1 multihead sealer 2 single sealers 1 set of scales 8 oscillating platelet shakers + incubators 4 oscillating platelet shakers + incubators C) Disposables 185,000 Atreus 3C disposables 185,000 quadruple Blood Bags 50,000 Pooling Kits for IPUS 50,000 Orbisac disposables +11.1% 50,000 Additive solutions 50,000 additive solutions Total Cost Impact +0.46% *Material included with disposals. IPUS: interim platelet units 70

9 Automation of whole blood processing in Madrid Blood Services some expenses such as higher costs for disposables, the benefits of automation may offset some of the costs. In this study, we identified several quantifiable benefits. References 1) Janetzko K, Klüter H, van Waeg G, Eichler H. Fully automated processing of buffy-coat derived pooled platelet concentrates. Transfusion 2004; 44: ) Chicchi R, Biguzzi R, Santarelli R. The OrbiSac system: results and organizational impact. Blood Transfus. 2007; 5: ) Larrea L, Ortiz de Salazar M, Guinot M, Roig R. Comparison of an automated whole blood manufacturing system with an established semi-automated system. Transfusion 2009; 49 (Suppl. 3): ) Gulliksson H, Sandgren P, Sjödin A, et al. Platelets prepared from whole blood units within 2-8 hours after blood collection using the Atreus system. Transfusion 2009; 49 (Suppl. 3): ) Guide to the preparation, use and quality assurance of blood components, 2008; 15 th edition. European Directorate for the Quality of Medicines & Healthcare EDQM publishing. 6) Larrea L, Ortiz de Salazar M, Roig R, Soler MA. Fully automated processing of buffy coat- derived pooled concentrates. Transfusion 2005; 45: ) Cid J, Claparols M, Pinacho A, et al. Comparison of blood component preparation methods from whole blood bags based on buffy coat extraction. Transfus Apher Sci 2007; 36: ) Maia S, Duarte S, Pacheco R, et al. Optimization of platelet pool content using the Atreus system and the PYI. Transfusion 2009; 49 (Suppl. 3): 99. Arrived: 24 January Revision accepted: 8 June 2011 Correspondence: Manuel Algora Area de Fraccionameinto Centro de Transfusion de Madrid Avda. de la Democracia s/n Madrid, Spain malgora.trans@salud.madrid.org 71