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BACKGROUND: With blood component therapy becoming the standard of care in transfusion medicine globally, the quality control (QC) of these components has become a routine and mandatory program in all blood centers. Extensive utilization of blood components has been observed in our multidisciplinary tertiary care hospital. We use quadruple bag systems and automated component extraction facilities for collection and processing of whole blood (WB). In this study, we analyzed our data relating to QC of all blood components which we prepare and issue for transfusion. MATERIALS AND METHODS: The retrospective 5-year study comprised 47,430 WB collections which were separated into blood components using quadruple bags and automated component extraction machine. A total of 90 units of WB were processed into blood components for the machine calibration and validation. Routine use of the system was started once the calibration and validation results were acceptable. At least 1% of each component prepared was subjected to QC as per departmental standard operating procedures. Statistical analysis was done using the SPSS statistical package. RESULTS: The mean volume, hematocrit (Hct), platelet (PLT), and white blood cell (WBC) in 350 and 450 mL WB units were 394.63 mL, 39.43%, 0.93 × 1011, and 3.12 × 109 and 507.75 mL, 40.72%, 1.13 × 1011, and 3.45 × 109, respectively, with mean recovery of PLT and WBC in buffy coat being 95.54% and 68.63% and 97.87% and 74.51%, respectively. As high as 89.91% RBC recovery was noted in the packed red blood cell units which were subjected to QC. QC of random donor platelets was performed in 979 (2.36%) units with acceptable results. The mean fibrinogen and FVIII values were estimated to be 469.17 mg and 217.34 IU (1.07 IU/mL) and 600.21 mg and 273.39 IU (1.11 IU/mL) in fresh frozen plasma units prepared from 350 and 450 mL WB, respectively. A total of 578 (1.62%) units of cryoprecipitate were investigated for QC with favorable results. CONCLUSION: We conclude that QC data generated in this study will provide invaluable information about the performance of the latest blood collection systems. QC of all blood components under study complied with both national and international standards. We opine that all blood centers should establish a complete QC program and adhere to departmental protocols and manufacturer's instructions for its execution and effective outcome.

BACKGROUND: With blood component therapy becoming the standard of care in transfusion medicine globally, the quality control (QC) of these components has become a routine and mandatory program in all blood centers. Extensive utilization of blood components has been observed in our multidisciplinary tertiary care hospital. We use quadruple bag systems and automated component extraction facilities for collection and processing of whole blood (WB). In this study, we analyzed our data relating to QC of all blood components which we prepare and issue for transfusion. MATERIALS AND METHODS: The retrospective 5-year study comprised 47,430 WB collections which were separated into blood components using quadruple bags and automated component extraction machine. A total of 90 units of WB were processed into blood components for the machine calibration and validation. Routine use of the system was started once the calibration and validation results were acceptable. At least 1% of each component prepared was subjected to QC as per departmental standard operating procedures. Statistical analysis was done using the SPSS statistical package. RESULTS: The mean volume, hematocrit (Hct), platelet (PLT), and white blood cell (WBC) in 350 and 450 mL WB units were 394.63 mL, 39.43%, 0.93 × 1011, and 3.12 × 109 and 507.75 mL, 40.72%, 1.13 × 1011, and 3.45 × 109, respectively, with mean recovery of PLT and WBC in buffy coat being 95.54% and 68.63% and 97.87% and 74.51%, respectively. As high as 89.91% RBC recovery was noted in the packed red blood cell units which were subjected to QC. QC of random donor platelets was performed in 979 (2.36%) units with acceptable results. The mean fibrinogen and FVIII values were estimated to be 469.17 mg and 217.34 IU (1.07 IU/mL) and 600.21 mg and 273.39 IU (1.11 IU/mL) in fresh frozen plasma units prepared from 350 and 450 mL WB, respectively. A total of 578 (1.62%) units of cryoprecipitate were investigated for QC with favorable results. CONCLUSION: We conclude that QC data generated in this study will provide invaluable information about the performance of the latest blood collection systems. QC of all blood components under study complied with both national and international standards. We opine that all blood centers should establish a complete QC program and adhere to departmental protocols and manufacturer's instructions for its execution and effective outcome. [ABSTRACT FROM AUTHOR]

Background and Objectives ISO standards for blood bags do not adequately define and control the dimensions of blood bag transfer tubing. This lack of standardization presents potential difficulties when making sterile connections between the wide range of tubing that has evolved in the absence of such standards. We aim to validate the suitability of the TSCD-II and provide a minimum standard for assessing the suitability of sterile connections (welds) between dissimilar tubing. Materials and Methods The Terumo TSCD-II was used in this study to connect by hermetic welding seven tubing types with a wide range of dimensions from five suppliers. Thirty sterile connections were made between each combination split between dry/dry, wet/wet and dry/wet connections. Welds were assessed for visual defects, by tensile stress test (TST) and pressure tests. Results All welds passed visual inspection and pressure tests. All welds had a minimum tensile strength of greater than 40 N and mean of greater than 45 N. Conclusion Successful connections have been made between dissimilar tube types and this work does not support the requirement for ‘tight’ tubing dimensional specifications. We have recommended to the ISO Technical Committee 76 Work Group 1 that ISO 3826-1 be revised and should include a minimum standard validation protocol for joining dissimilar tubing. [ABSTRACT FROM AUTHOR]