[Show abstract][Hide abstract] ABSTRACT: Administration of pathogen-specific T-cell lines can reconstitute the cellular immune function of immunocompromised patients. Selection and expansion of specific T cells for reinfusion pose unique challenges owing to the fact that good manufacturing procedures must be implemented. Cytokine secretion-based methods can identify and select specific T cells. We showed here that it is possible to combine this method with procedures for cell handling performed in a sealed, unbreached system from start to end. Peripheral blood mononuclear cells, obtained from blood samples and processed in a sealed system, were stimulated in Teflon bags with a library of selected CD4 and CD8 peptides derived from the immunodominant cytomegalovirus protein pp65. The stimulated T cells were labeled with reagents for interferon-gamma surface capture and selected on a magnetic column using a sealed system connected to the Teflon bags. Elution and final expansion were also performed with an unbreached protocol with preservation of sterility even if the steps were run on the bench top. Expanded cells exhibited the appropriate functions. The use of this unbreached procedure proves that safety of cellular products generated in a good manufacturing procedures facility can be further improved. Similar sealed protocols can also be applied for T-cell therapies directed against tumor antigens.
[Show abstract][Hide abstract] ABSTRACT: Drug-induced immune hemolytic anemia (DIIHA) is a well-known complication of drug treatment. Sensitization can occur, due to interaction of the drug and/or its metabolites with cells of the immune system, after the first drug administration, while the hemolytic crisis generally occurs after repeated administration of a drug. This event occurred in the case described here of acute hemolysis due to the administration of corticosteroids.
To define the etiopathogenesis of the hemolytic crisis, immunohematologic screening and specific tests were performed to identify antibodies against a possible drug-red cell (RBC) complex and circulating drug-anti-drug antibody immune complexes. Six drugs administered to the patient were tested and results were confirmed by test repetition using other types of corticosteroids.
Indirect antiglobulin test performed with the patient's serum sample on 22 RBC samples from commercial panels was strongly positive, while it was negative on RBCs from ABO-compatible donors. The same test repeated on commercial RBCs after washing was negative. Specific tests were negative for five of the six tested drugs, while RBCs incubated with hydrocortisone strongly reacted with the patient's serum. The same tests performed using other types of corticosteroids confirmed a reaction with the same positivity score on all tested molecules.
The positive reaction observed each time the patient's serum sample was incubated with RBCs in the presence of corticosteroids suggested that the triggering cause of hemolysis was an immune-mediated mechanism and the drug responsible for DIIHA was hydrocortisone.
[Show abstract][Hide abstract] ABSTRACT: The monitoring of near miss errors, in other words events that cannot be classified as substantial errors, but whose occurrence suggests that there is probably a critical point in a working procedure, can be useful in order to prevent these 'almost errors' from occurring again or to prevent them evolving into 'relevant errors'.
The methods for picking up and studying near miss errors use widely tested systems that have recently also been applied to medicine. These systems are based on the process of identifying the risk through spontaneous notifications of events (incident reporting). In our Service of Immunohaematology and Transfusion Medicine (SIMT) these reports were assessed using root cause analysis, allowing us to introduce corrective actions to eliminate or reduce the risk.
We report the distribution, type and frequency of near miss errors, divided according to the stage of the working procedure in which they occurred, and for each of them describe the possible causes and corrective actions identified. We show how the possibility of an error, with potentially harmful consequences for the patient, is present throughout the whole transfusion chain. Near miss errors in Transfusion Medicine can be included in the wider field of 'clinical risk, a problem that concerns not only SIMT, but also numerous other sectors of health care.
The instruments identified through this study can lower the threshold of clinical risk in a Transfusion Service.
[Show abstract][Hide abstract] ABSTRACT: Since 2002, Liguria has been part of the Interregional Agreement on Plasma Derivatives (AIP) stipulated among some Regions of north Italy with the aim of contributing to self-sufficiency of the interregional system through exchanges between the facilities lacking products and those with an excess. In Liguria , the management of plasma derivates is entrusted to the Regional Centre for Co-ordination and Compensation (CRCC) which, with strategies of compensation, tries to guarantee that the needs for plasma derivates are covered in the hospitals in its territory. The Services of Immunohaematology and Transfusion Medicine (SIMT) have a goal of increasing the production of plasma in order to participate actively in achieving regional self-sufficiency.
The SIMT of the G. Gaslini Institute introduced some strategies aimed at reaching this goal. The increase in the number of donations made with a cell separator, the introduction of multicomponent donations of plasma and platelets and the collection of high concentration platelet concentrates led to a considerable increase category A plasma sent for fractioning. Finally, the implementation of shared guidelines on the use of blood components enabled the clinical use of the plasma collected to be kept under control.
The analysis of the trends of consumption of the most widely used plasma derivatives showed an increase in the overall demands, which can be attributed to the paediatric focus of our hospital and to its highly specialised wards. ON THE BASIS OF THE INDUSTRIAL TECHNICAL YIELD, IT WAS POSSIBLE TO CALCULATE THE THEORETICAL COVERAGE OF THE REQUIREMENTS FOR PLASMA: this highlighted a better theoretical coverage for albumin but a shortfall of intravenous immunoglobulins. The amount of plasma necessary to meet the theoretical needs was calculated for each plasma derivative, revealing that the derivative requiring the greatest volume of plasma is intravenous immunoglobulins. This finding confirms the change in the "driving product": it is now the consumption of intravenous immunoglobulins that determines the amount of plasma that is sent for industrial processing.
[Show abstract][Hide abstract] ABSTRACT: Introduzione Uno degli obiettivi prioritari di un Servizio di Immunoematologia e di Medicina Trasfusionale (SIMT) consiste nel ricercare il massimo vantaggio sia per l'utente/ paziente sia per l'utente/donatore, non perdendo di vista il rapporto costo/efficienza. In particolare, per le caratteristiche dei pazienti trattati, il SIMT di un ospedale pediatrico deve perseguire l'ottimizzazione della resa delle aferesi produttive di plasma e piastrine attraverso la produzione di unità piastriniche a elevato contenuto: riuscire a ottenere da un donatore più subunità idonee a ripetuti eventi trasfusionali permette di garantire a un singolo paziente un supporto con più unità dello stesso donatore, riducendo, in tal modo, il rischio infettivologico. Un Servizio Trasfusionale deve anche potenziare l'efficacia delle raccolte di emocomponenti con lo scopo di procurarsi prodotti qualitativamente migliori, senza diminuire però il comfort del donatore: ridurre la durata delle donazioni e gli effetti dell'infusione di anticoagulante è un obiettivo importante per incentivare la donazione mediante separatore cellulare. Nel migliorare la qualità di un emocomponente, un ulteriore, ma non meno importante, compito di un SIMT è quello di monitorare il rapporto costo/efficienza: ridurre il costo di un prodotto a parità di qualità è sicuramente un obiettivo suggerito dall'economia aziendale. In questo scenario è da considerare come, presso il SIMT dell'Istituto Giannina Gaslini, vengano utilizzati dal 2003, per la donazione combinata di plasma e piastrine da unico donatore, due diversi separatori cellulari a flusso discontinuo (Trima Accel Gambro e Haemonetics MCS 3p). Per individuare il separatore che meglio risponde alle esigenze del Servizio Trasfusionale, abbiamo effettuato una One of the tasks a Transfusion Medicine Service is to optimise the yield of platelets obtained from productive platelet apheresis, while considering the advantages for the patient and the donor, as well as the cost/efficiency ratio. With this aim, we compared some parameters related to multicomponent procedures of platelet and plasma apheresis, carried out using two different discontinuous flow cell separators. The results are based on data from a similar number of procedures carried out with a Trima Accel (Gambro) cell separator and a Haemonetics MCS 3p system. The analysis of these data enabled us to define the efficacy of the two separators and identify which performed better, in terms of duration of the procedures, yield of collected platelets and running costs.