Introduction of EUBIS standards to upgrade inspections of blood establishments to improve the safety of blood transfusion: The Polish experience.

BACKGROUND AND OBJECTIVES: The competent authority (CA) responsible for external inspections of Polish blood establishments (BEs) and supervision of the quality system is the Institute of Haematology and Transfusion Medicine (IHTM). Before the implementation of the European Blood Inspection System (EuBIS) classification of non-compliance, the IHTM inspections were conducted according to national guidelines and the non-compliance-related recommendations were based on the inspectors' own experience and interpretation of the observed problems. Since 2009, IHTM inspections were already performed according to EuBIS guidelines. The study assessed the impact of the EuBIS classification on the IHTM recommendations. We assumed that the implementation of consistent assessment criteria contributed to the upgrading of the quality of BE inspections. MATERIALS AND METHODS: BE-inspection protocols; 30 from 2009 to 2010 and 61 from 2016 to 2019. Non-compliance-related recommendations were classified according to the seriousness of non-compliances (critical, major, other significant, and observation) and also to the area of BE activity (documentation, organisation of work, qualification and validation, pathway from donor qualification to blood component-issue, quality control of blood components, adverse events and reactions). RESULTS: The recommendations mostly referred to document-keeping and work organisation and were distributed as follows: 2009-2 critical (others unclassified), 2010-1-13 major, 4-25 other significant and 1-7 suggestions, 2016-2019-3-9 critical, 90-196 major, and 157-297 other significant as well as 14-22 suggestions. CONCLUSION: Polish BEs still require: integrated document management, analysis of IHTM recommendations, implementation of corrective and preventive measures and personnel training in identifying similar non-compliances in other procedures.

Quality control of riboflavin-treated platelet concentrates using Mirasol® PRT system: Polish experience.

BACKGROUND: The quality of platelet concentrates (PCs) is affected by preparation, storage, the type of container, and pathogen reduction technology (PRT). The Mirasol® Pathogen Reduction Technology (PRT) system (Terumo BCT Inc., Lakewood, USA), which uses riboflavin and ultraviolet (UV) light, has recently been proven effective against bacteria, viruses, parasites, and leukocytes. OBJECTIVES: The aim of the study was to evaluate the effect of the Mirasol® PRT system, based on riboflavin and UV light exposure, on the most common in vitro platelet quality parameters of PCs prepared from whole blood-derived buffy coats. MATERIAL AND METHODS: The study included 15 trials (n = 15). For each trial, 2 PCs were used: 1 for treatment with the Mirasol® PRT system (M) and 1 for a control (C). In the M group, PCs were illuminated. In the C group, saline solution was added. PCs from groups M and C were stored at 20-24°C, with agitation. Samples were collected on days 1, 3 and 5 to determine platelet concentration, total platelet count/unit, mean platelet volume (MPV), power of hydrogen (pH), glucose and beta-thromboglobulin concentration (BTG), hypotonic shock response (HSR), aggregation, CD42b and CD62P expression, pCO2, and pO2. RESULTS: No significant differences in HSR or CD42b expression were observed between groups M and C. All pH values were stable during the whole storage period (7.1-7.5). On storage day 1, CD62P expression in group C was significantly higher than in group M. In the Mirasol® group, significantly higher glucose consumption was noted on storage days 3 and 5. On day 5, a 2-3-fold increase in BTG was observed in both groups as compared to day 1; on day 5, BTG concentration was 32% higher in group M than in group C. On all storage days, pCO2 was comparable in groups M and C; lower pO2 values were reported for group M. CONCLUSIONS: In vitro results demonstrated that pH, HSR, aggregation, CD42b antigen expression, and MPV and platelet count parameters were comparable in groups M and C.

Study of CD69 antigen expression and integrity of leukocyte cellular membrane in stored platelet concentrates following irradiation and treatment with Mirasol® PRT System.

BACKGROUND: Leukocytes in transfused blood components, particularly residual lymphocytes, have been shown to contribute to the occurrence of various adverse reactions. One of the most severe is transfusionassociated graft versus host disease (TA-GvHD) following transfusion of blood components contaminated with immunocompetent T lymphocytes. Irradiation is a routine method for protection against TA-GvHD. According to the literature, some pathogen reduction methods have also been proven effective for the inactivation of T lymphocytes, and so they may be considered as an alternative to irradiation. OBJECTIVES: Comparison of CD69 antigen expression and the integrity of the leukocyte cellular membrane in stored platelet concentrates (PCs) following irradiation with the Gammacell 3000 Elan (Nordion Inc., Ottawa, Canada) and treatment with the Mirasol® Pathogen Reduction Technology (PRT) System (Terumo BCT, Lakewood, USA). MATERIAL AND METHODS: The study included seven experiments. For each experiment we used 3 PCs, for Mirasol® PRT System treatment (M), for Gammacell 3000 Elan irradiation (R), and for the control (C). 7-amino-actinomycin D (7-AAD, Becton Dickinson, Franklin Lakes, USA) permeability was used to determine lymphocyte viability while CD69 antigen expression was the marker of lymphocyte activation. Analyses of 7-AAD and CD69 antigen expression were performed in a FACS Canto I flow cytometer (Becton Dickinson, USA). RESULTS: During 6 storage days, viable lymphocyte count decreased to 28% (p = 0.001) in the Mirasol® PRT System treated PCs and to 65% (p = 0.004) in the irradiated PCs. A statistically significant increase in CD69 expression in the irradiated PCs was observed; 1.3-fold on day 3 and 1.5-fold on day 6. In the Mirasol ® PRT System treated PCs, no statistically significant increase was observed. CONCLUSIONS: The in vitro results suggest that the Mirasol® PRT System is as effective as irradiation due to donor leukocyte inactivation capacity.