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      CAPA analysis of clotted red cell unit detected during leukodepletion process: Importance of quality check on blood collection monitors


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          Sir, To ensure thorough anticoagulation of blood, its proper mixing with blood is essential during the whole blood (WB) collection process. Proper ratio of blood to anticoagulant and mixing are essential to prevent the start of blood coagulation process and to achieve standardized WB and its components, subsequently. This process can have critical consequences not only for the immediate quality of the resulting components but also for their long-term quality during storage. Blood collection monitors/mixers (BCM) are available and widely used to optimize WB collection process having set up alerts and intuitive instructions to guide the user throughout the draw process, with the view panel for easy viewing during donation. Regular quality check of equipment is must to prevent adverse event during any process. At our center, an average of 90 blood units (WB) are collected every day in the 450 ml citrate-phosphate-dextrose with saline-adenine-glucose-mannitol triple blood bag system (Compoflex; Fresenius Kabi, Germany) using BCM having auto mixing and auto clamping facility (Hemolight plus, Fresenius Kabi, Germany). We practice universal leukodepletion within 72 h of WB collection using separate laboratory leukodepletion filters (BioR 01 max BBS, Fresenius Kabi, Germany) for red cells and platelets using sterile connecting device (Compo Dock, Fresenius Kabi, Germany). We came across a red cell unit with a huge clot in the bag measuring 8 cm × 7 cm during the leukodepletion process on day 2 of blood collection [Figure 1]. The clot was surprisingly missed during the collection and separation process. Bag was segregated, and other products of the same unit were identified and quarantined. Blood culture of red cell unit and its components was done. BCM are checked weekly for volume limitation and agitations per minute using standard calibrated weights and stopwatch respectively. On corrective and preventive action analysis, it was found that red cell unit was prepared from a WB donation from a 29-year-old first time male donor with the weight 83 kg, who completed the donation process (donor-in to donor-out) within 20 min. All the five BCMs installed in the blood donor collection room were checked for movements and volume limitation and found that one of them was defective in agitation process with 15 agitation/min while the normal range of agitation was 28-32/min; which led to incomplete mixing of anticoagulant to WB while there was no problem in auto clamping [Figure 2]. This particular collection was collected on the malfunctioning BCM. This problem was encountered for the first time; defective BCM was replaced by the alternate one till the problem was rectified by the company engineer. Culture of red cell unit and its components was sterile. Figure 1 Extraordinary large clot detected during the leukodepletion process Figure 2 Blood collection mixer Clots and fibrin strands in the blood units result from the activation of the clotting processes and can be a mixture of clotting proteins (including fibrin) and platelets. However, clots in the unit may also indicate bacterial contamination. In our case, clot formed was most likely due to the activation of clotting process as culture of red cell unit and its components was sterile. The necessary citrate concentration for prevention of activation process is much lower, but because of the risk of inadequate mixing and the biological variation of coagulation capacity among donors, a much higher concentration (1:14) is used.[1 2 3] If the citrate is not completely mixed with the blood immediately, during the blood collection process there will be inadequate anticoagulation and clump(s) formation which lead to loss of labile coagulation factors, loss of quality of platelets or even complete coagulation of the unit (clotted unit). Mixing devices are widely used to facilitate proper mixing of collected blood and anticoagulant to a similar level as that obtained by manual mixing. Regular quality control check of each BCM is must to ensure proper mixing of anticoagulant and blood to yield good quality products. De Korte et al. also suggest that most blood-mixing devices fail to mix efficiently at normal and low bleeding rates.[3] Quality control of BCM must include agitation counts for proper mixing using stopwatch and weighing the known standard weights for ensuring the volume limitations. Normal limits for the agitation should be 28-32/min while ±2% variation in weight is allowed.[4]

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          Half-Strength Citrate CPD Combined with a New Additive Solution for Improved Storage of Red Blood Cells Suitable for Clinical Use

          Currently used systems for red blood cell (RBC) collection and storage for transfusion have the disadvantage that the RBC 2,3-bisphosphoglycerate (BPG) concentration is depleted within two weeks of storage, resulting in a left-shift of the oxygen dissociation curve and a temporarily impaired capacity to deliver oxygen. We have studied the effects on red cell metabolism, morphology and in vivo recovery of 49-day storage of RBC, with collection in half-strength citrate CPD (0.5CPD) and storage in an additive solution containing citrate, adenine, mannitol, phosphate and glucose (RAS2). Traditional CPD-SAGM was used for comparison. Component preparation was performed after an initial holding period of the whole blood at ambient temperature for 8 h. The BPG concentration in 0.5CPD-RAS2 RBC was 0.633 +/- 0.120 mol (mol Hb)-1 as compared to 0.454 +/- 0.138 mol (mol Hb)-1 in CPD-SAGM RBC which implied a decrease to 67 and 48% of normal concentration, respectively. The mean RBC BPG concentration was maintained at the initial level for 28 days in the new system but decreased to very low levels within 14 days in the controls. The total adenine nucleotides were well maintained in both systems, adenosine triphosphate slightly better in the new system. Hemolysis after 49 days was 0.35 +/- 0.21% in the new system and 0.72 +/- 0.25% in the controls (p < 0.001). The morphology was better maintained in the new system (p < 0.001). The 24-hour posttransfusion survival of 49-day stored RBC was 78.9 +/- 7.1%. The membrane leakage of sodium and potassium was not significantly different in the two systems.(ABSTRACT TRUNCATED AT 250 WORDS)
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            Automated blood-mixing devices still fail to mix at low bleeding rates.

            The study evaluated mixing performance for various commercial blood-mixing devices at different flow rates.
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              Studies on the procurement of blood coagulation factor VIII in vitro studies on blood components prepared in half-strength citrate anticoagulant.

              The effect of replacing a standard citrate anticoagulant with one containing half the amount of citrate on the in vitro properties of components prepared from blood donations was investigated. This resulted in a significant improvement in factor VIII stability such that there was little loss during overnight storage, and this was reflected in the factor VIII yield in cryoprecipitate. The quality of cellular components in red cell units stored up to 35 days or platelet concentrates stored up to 7 days was not adversely affected. Although initial levels were similar to those in standard anticoagulant, the extent of fibrinopeptide A generation and complement C3 breakdown in red cell units stored for 35 days in half-strength citrate was somewhat increased.

                Author and article information

                Asian J Transfus Sci
                Asian J Transfus Sci
                Asian Journal of Transfusion Science
                Medknow Publications & Media Pvt Ltd (India )
                Jul-Dec 2015
                : 9
                : 2
                : 217-218
                [1] Department of Transfusion Medicine, Medanta-the Medicity, Gurgaon, Haryana, India
                [1 ] Department of Transfusion Medicine and Laboratory Services, Medanta-the Medicity, Gurgaon, Haryana, India
                Author notes
                Correspondence to: Dr. Aseem Kumar Tiwari, Department of Transfusion Medicine, Medanta-The Medicity, Sector-38, Gurgaon - 122 001, Haryana, India. E-mail: aseem.tiwari@ 123456medanta.org
                Copyright: © Asian Journal of Transfusion Science

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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