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.

Human Intramuscular Hyperimmune Gamma Globulin (hIHGG) Anti-SARS-CoV-2-Characteristics of Intermediates and Final Product.

This study aims to characterize the intermediates, and the final product (FP) obtained during the production of human intramuscular hyperimmune gamma globulin anti-SARS-CoV-2 (hIHGG anti-SARS-CoV-2) and to determine its stability. : hIHGG anti-SARS-CoV-2 was fractionated from 270 convalescent plasma donations with the Cohn method. Prior to fractionation, the plasma was inactivated (Theraflex MB Plasma).

Assessing quality of blood components derived from whole blood treated with riboflavin and ultraviolet light and separated with a fully automated device.

Background: Combining pathogen reduction and automated separation of whole blood (WB), together with the use of improved additive solutions, may increase reproducibility and extend shelf-life of blood components.

Materials And Methods: Forty WB units were collected from volunteer donors and randomised 1:1 into two groups: 1) pathogen reduction with riboflavin and ultraviolet light (PRT); or 2) no treatment (Control). After two hours (h) at room temperature, all units underwent fully automated separation into red blood cell concentrate (RBCC), plasma and leukopack components.

Plasma pooling in combination with amotosalen/UVA pathogen inactivation to increase standardisation and safety of therapeutic plasma units.

Objectives: Assessment of the impact of pooling five single-donor plasma (SDP) units to obtain six pathogen-reduced therapeutic plasma (PTP) units on standardisation and the retention of labile coagulation factors.

Background: SDP shows a high inter-donor variability with potential implications for the clinical treatment outcome. Additionally, there is still an existing risk for window-period transmissions of blood borne pathogens including newly emerging pathogens.

Identification and follow-up of pregnant women with platelet-type human platelet antigen (HPA)-1bb alloimmunized with fetal HPA-1a.

Introduction: Pregnant women negative for human platelet antigen 1a (HPA-1a) are at risk of alloimmunization with fetal HPA-1a antigen inherited from the father, and their offspring may develop fetal and neonatal alloimmune thrombocytopenia (FNAIT). The aim of this study was to analyze the frequency of HPA-1a alloimmunization in pregnant Polish women, the feasibility of using maternal platelets for intrauterine transfusions in women subjected to diagnostic fetal blood sampling (FBS) and to discuss potential consequences of alloimmunization.

Material And Methods: Fifteen thousand two hundred and four pregnant women were typed for HPA-1a; HPA-1a negative were screened for anti-HPA-1a.

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.

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.

Hemovigilance survey of pathogen-reduced blood components in the Warsaw Region in the 2009 to 2013 period.

Background: In 2009 the Mirasol Pathogen Reduction Technology (PRT) was introduced to the routine blood component production of the Regional Blood Transfusion Center in Warsaw (RBTCW). The goal of this study was to investigate the safety of Mirasol-treated blood components.

Study Design And Methods: The accumulated passive hemovigilance data of Mirasol-treated blood components collected at the RBTCW are presented and compared to historical and contemporary data.

Introducing Pathogen Reduction Technology in Poland: A Cost-Utility Analysis.

Background: Mirasol® pathogen reduction technology (PRT) uses UV light and riboflavin to chemically inactivate pathogens and white blood cells in blood components. In the EU, Mirasol PRT is CE-marked for both plasma and platelet treatment. In Poland, the decision to introduce PRT treatment of the national supply of fresh frozen plasma has spurred interest in evaluating the cost-effectiveness of this strategy.

Analysis of leucocyte antibodies, cytokines, lysophospholipids and cell microparticles in blood components implicated in post-transfusion reactions with dyspnoea.

Background And Objectives: Post-transfusion reactions with dyspnoea (PTR) are major causes of morbidity and death after blood transfusion. Transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO) are most dangerous, while transfusion-associated dyspnoea (TAD) is a milder respiratory distress. We investigated blood components for immune and non-immune factors implicated in PTR.

Methods of freezing cord blood hematopoietic stem cells.

Background: Cord blood (CB) is a valuable source of hematopoietic stem cells (HSCs). Extended storage of CB is possible provided that validated cryopreservation procedures are used. The study objective was to determine optimal methods of CB cryopreservation.

Lysophosphatidylcholines: bioactive lipids generated during storage of blood components.

Transfusion-related acute lung injury (TRALI) is suggested to be a "two hit" event, resulting from priming and activation of pulmonary neutrophils. It is known that neutrophil activation may result from infusion of lysophosphatidylcholines (LysoPCs) accumulated during storage of blood components. The aim of our study was to verify whether the LysoPCs are released into the storage medium of blood components.

Inventory management.

A critical aspect of blood transfusion is the timely provision of high quality blood products. This task remains a significant challenge for many blood services and blood systems reflecting the difficulty of balancing the recruitment of sufficient donors, the optimal utilization of the donor's gift, the increasing safety related restrictions on blood donation, a growing menu of specialized blood products and an ever-growing imperative to increase the efficiency of blood product provision from a cost perspective. As our industry now faces questions about our standard practices including whether or not the age of blood has a negative impact on recipients, it is timely to take a look at our collective inventory management practices.

[Comparison of platelet and leukocyte content in platelet concentrates obtained from CS-3000 and third generation (CS-3000 plus and Cobe-Spectra) cell separators].

Platelet concentrates (PCs) obtained using old generation of cell separators contain high number of leukocytes. White cell (WBC) contamination and platelet (Plts) number in PCs obtained from separator II-nd generation CS-3000 and separators III-rd generations CS-3000 plus and Cobe-Spectra have been determined. PCs from new separators contain the same Plts number as PCs from CS-3000.

[Comparison of platelet concentrates obtained using blood cell separators with continuous flow: CS-3000 and Cobe-Spectra].

During a platelet apheresis procedure on CS-3000 the platelet concentrate (Pc) is centrifugated for about 1.5 h. In the Cobe system Pc is gradually collected in a container located outside the machine.