Sanquin Bloodbank Southwest Region Rotterdam, Rotterdam, The Netherlands 2

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1 Original article Reporting transfusion-incidents: two-year s experiences of haemovigilance in the Southwest region of the Netherlands Erik AM Beckers 1, Rob B Dinkelaar 2, Peter AW te Boekhorst 3, Huub E van Ingen 4, Dick J van Rhenen 1 1 Sanquin Bloodbank Southwest Region Rotterdam, Rotterdam, The Netherlands 2 Albert Schweitzer Hospital, Laboratory of Clinical Chemistry, Dordrecht, The Netherlands 3 Erasmus Medical Center, Department of Haematology, Rotterdam, The Netherlands 4 Ruwaard van Putten hospital, Laboratory of Clinical Chemistry, Spijkenisse, The Netherlands Background. Haemovigilance may be defined as a surveillance system for standardized collection and analysis of data concerning adverse effects associated with the collection and transfusion of blood components, aiming at improving the safety and quality of blood transfusion. Despite strong recommendations by the Dutch Health Care Inspectorate, a national haemovigilance system was not effective in the Netherlands till Objective. In the Southwest region of the Netherlands with an estimated population of 3.5 million a regional initiative was undertaken to assess the importance of reporting transfusion incidents. Material and Methods. From January 1st, 2001 all regional hospitals and the bloodbank itself participated in a scheme of reporting transfusion incidents in patients. Adverse events were registered anonymously in thirteen different categories. Each incident was recorded on a standardized report. Results. The yearly number of bloodproducts issued was approximately 155,000 (120,000 red blood cell concentrates; 10,000 random donor platelets; 25,000 fresh frozen plasma). In the second year of registration the number of reports doubled. In the first year reporting hospitals accounted for 68% of all bloodproducts, which increased to 83% in the second year. Number of incidents in categories (2001/2002): Incorrect bloodcomponent transfusion 9/12; Temperature rise 1-2 C 14/27; Non-haemolytic fever 36/65; Acute haemolytic transfusion reaction 3/6; Delayed haemolytic Introduzione L'emovigilanza si può definire come un sistema di sorveglianza per la raccolta, la registrazione e l'analisi delle complicanze che possono essere attribuite alla trasfusione di sangue. Un programma di emovigilanza dovrebbe contemplare qualsiasi caso in grado di interferire con la sicurezza della trasfusione, dal donatore al paziente e viceversa. Lo scopo del programma è quello di migliorare sempre più qualità e sicurezza della pratica trasfusionale. La sua importanza consiste nella possibile identificazione dei connessioni, anche le più labili, con l'intera catena trasfusionale per garantire una più sicura utilizzazione dei prodotti ematici. Nonostante le molte raccomandazioni delle autorità sanitarie del Paese, sino al febbraio 2003 non era operativo, in Olanda, un sistema nazionale di emovigilanza, quale quello francese (AFSSAPS, Agence Française de Securité Sanitarie des Produits de Santé) 1 o quello del Regno Unito (SHOT, Serious Hazards Of Transfusion) 2. La carenza di un'attiva rete nazionale che riportasse gli incidenti sui pazienti, ha condotto a una iniziativa da parte della Banca del Sangue della regione Sud-Ovest dell'olanda che ha coinvolto 22 Ospedali nel territorio. Lo scopo primario dell'ufficio regionale di emovigilanza è stato quello di realizzare un sistema, standardizzato e uniforme, per la segnalazione degli incidenti trasfusionali nei pazienti. Vengono qui riferiti i risultati e le esperienze dei primi due anni di attività di tale programma. Received: 3 December Revision accepted: 24 December 2003 Correspondence: Dr. Erik AM Beckers Sanquin Bloodbank Southwest Region Rotterdam Wytemaweg CN Rotterdam, The Netherlands erik.beckers@bloodrtd.nl Metodi Il Consiglio medico della Banca del Sangue regionale ha organizzato un working party, al quale hanno partecipato 379

2 EAM Beckers et al. transfusion reaction 17/39; Posttransfusion purpura 0/ 0; Allergic reactions 11/16; Transfusion transmitted infections 3/5; Transfusion Associated Graft versus Host Disease 0/0; Transfusion Related Acute Lung Injury 1/3; Near-miss 6/5; Product incidents 19/59; unclassified 0/ 6. Total 2001/2002: 119/243. Conclusion. Transfusion incidents are probably underreported. Despite all safety measures, severe adverse events still do occur. The improved awareness of the importance of reporting transfusion incidents in patients and ongoing education, including benchmarking contributed to the remarkable increase in reports of transfusion incidents. A well-functioning program for haemovigilance contributes to the knowledge about transfusion incidents, and thereby to a safer transfusion practice. Key words: haemovigilance, adverse events, transfusion practice Introduction Haemovigilance can be defined as a surveillance system for the collection, registration and analysis of complications that can be attributed to blood transfusion. All events that might interfere with the safety of blood transfusion from blood donor to patient and vice versa should be included in a haemovigilance programme. The aim of such a programme is to further improve the quality and safety of the practice of blood transfusion. Its importance lies in the possible identification of the weakest links in the whole chain of blood transfusion to ensure a safer use of blood products. Despite all recommendations by national health authorities a national haemovigilance scheme, such as the registration by the AFSSAPS (Agence Française de Securité Sanitaire des Produits de Santé) in France 1 or the SHOT (Serious Hazards Of Transfusion) scheme in the UK 2, was not operational in the Netherlands till February The lack of a nationally active network of reporting transfusion incidents in patients led to a regional initiative supported by the regional Bloodbank, in which 22 hospitals in the Southwest region of the Netherlands participated. The primary goal of the regional bureau of haemovigilance was to implement a standardized and uniform system of reporting transfusion incidents in patients. The results and experiences of reporting transfusion incidents in patients in the first and second year of regional haemovigilance are reported. 380 tutti gli Ospedali del territorio e dove è stato proposto un modello uniforme su cui segnalare, su base volontaria, gli incidenti trasfusionali. Per quanto riguardava la classificazione di tali incidenti, è stato scelto il modello utilizzato dallo SHOT. Inoltre, le gravi reazioni febbrili e/o allergiche sono state registrate separatamente e sono stati anche classificati separatamente gli incidenti riguardanti le attività produttive (product incidents in tabella I). Le reazioni trasfusionali rispecchiano i sintomi clinici pertinenti. La severità delle reazioni sono state riportate in gradi, opzionali, da 0 a 5 (Tabella II). È stata anche valutata la probabilità del nesso fra reazioni e trasfusione (Tabella III). I referti sono stati compilati dagli addetti ospedalieri all'emovigilanza, responsabili per le registrazioni degli incidenti trasfusionali nei loro Ospedali. Tutte le segnalazioni erano volontarie e registrate in forma anonima. Gli incidenti riportati non venivano sottoposti a verifica, come è, invece, imperativo negli altri programmi di emovigilanza. Lo scopo precipuo di questa iniziativa è stato, infatti, quello di catalogare i vari tipi di incidenti trasfusionali avvenuti nella regione sud-occidentale dell'olanda. Risultati Dal 1 gennaio 2001, data d'inizio del programma regionale di emovigilanza, sono state registrate, nel primo e nel secondo anno, rispettivamente, 119 e 243 segnalazioni, che hanno riferito non soltanto reazioni trasfusionali sintomatiche ma anche errori, mancanze e i cosiddetti near-misses (cioè, "sbagli, per caso non accaduti"). Ogni anno la Banca del Sangue regionale distribuisce, approssimativamente, emocomponenti ( concentrati eritrocitari, concentrati piastrinici e unità di plasma fresco congelato). Non si riesce, invece, a determinare l'esatto numero di emocomponenti trasfusi in realtà ai pazienti. Benché tutti i 22 Ospedali siano rappresentati nel Consiglio medico, i rapporti sugli incidenti trasfusionali sono giunti da 11 Ospedali nel primo anno e da 18 nel secondo. Erano, comunque, rappresentate le differenti strutture (cioè, gli Istituti universitari e gli Ospedali di grande e di piccola dimensione) Il primo anno è stato riferito sul 68% e il secondo sull'83% del totale degli emocomponenti distribuiti. Come riportato in tabella IV, gli incidenti sono stati classificati in 13 categorie. Una descrizione dettagliata di ogni incidente è elencata in tabella V. Non essendosi potuto stabilire il quantitativo degli emocomponenti trasfusi (il denominatore), non è stata condotta alcuna analisi statistica.

3 Experiences in reporting transfusion incidents Table I - Descriptions of transfusion-incidents Category Incident Description I Incorrect bloodcomponent transfused (IBCT) All cases in which the patient was transfused with a blood product, which did not meet all requirements needed for this patient, or that was intended for an other patient, without the occurrence of a transfusion reaction. II Temperature rise: 1-2 C All cases of mild temperature rise without relevant complaints or symptoms, for which no other causes than blood transfusion could be found. III Febrile non-haemolytic transfusion reaction (>2 C) All cases of a severe temperature rise, which necessitated a (FNHTR) temporary or definite interruption of the transfusion. The hereafter performed diagnostic evalution did not show haemolysis. IV Acute haemolytic transfusion reaction (AHTR) All reactions any time up to 24 hours following transfusion, which are caused by haemolysis. V Delayed haemolytic transfusion reaction (VHTR) All cases with immunohaematological evidence for a secondary immune respons leading to haemolysis with or without clinical symptoms, occurring more than 24 hours following transfusion. VI Post-transfusion purpura (PTP) Thrombocytopenia arising 5-12 days following transfusion of red cells, associated with the presence in the patient of alloantibodies directed against the HPA (human platelet antigen) system. VII Allergic reactions Mild allergic symptoms treated by antihistaminics. Lifethreatining acute allergic transfusion reaction such as anaphylaxis, caused by antibodies in the patients serum against plasma proteins of the donor. VIII Transfusion transmtted infections (TTI) Microbiologically shown bacterial septicaemia, which can be related to the administration of a blood product, or suspected transfusion transmitted viral, or other non-bacterial infections. IX Transfusion associated The development of the classical symptoms of fever, rash, Graft-versus-Host-Disease (TA-GvHD) liver dysfunction, diarrhoea and pancytopenia occurring 1-6 weeks following transfusion, without other apparent cause. X Transfusion associated acute lung injury (TRALI) Acute dyspnoea with hypoxia and bilateral pulmonary infiltrates occurring during or in the 6 hours after transfusion, with no other apparent cause. XI Near-miss Any mistake or error, which if undetected, could have resulted in a wrong blood group, the selection of an incorrect bloodcomponent, but which was recognised before transfusion. XII Product incidents Any recall procedure of blood components, which did not meet all requirements for clinical use, but were issued to hospitals. If administered, transfusion reactions did not occur. XIII Unclassified Any other report which could not be classified in the other categories. Table II - Grades of transfusion reactions Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 No reactions No immediate danger, small morbidity, e.g. allergic reactions, FNHTR Long term some morbidity, might be life threatening, e.g. alloimmunisation, viral infections Immediate life threatening, e.g. AHTR, TA-GvHD, TRALI, septicaemia Mortality caused by transfusion Table III - Likelihood relation transfusion and clinical symptoms Possible, suspected Probable Definite, proven Clinical symptoms, not confirmed by laboratory results Clinical symptoms, inconclusive laboratory results Clinical symptoms, conclusive laboratory results 381

4 EAM Beckers et al. Table IV - Reports about transfusion incidents in 2001 and 2002 Category Incident 2001 % 2002 % I IBCT II T 1-2ºC III FNHTR (T>2ºC) IV AHTR V DHTR VI PTP VII Allergic reactions 11 9, VIII T T I IX TA-GvHD X TRALI XI Near-miss XII Product incident XIII Unclassified Total IBCT: incorrect bloodcomponent transfused; FNHTR: Febrile non-haemolytic transfusion reaction; AHTR: acute haemolytic transfusion reaction; DHTR: delayed haemolytic transfusion reaction; PTP: post-transfusion purpura; TTI: Transfusion transmitted infections; TA-GvHD: transfusion-associatedgraft-versus-host-disease; TRALI: transfusion-related-acute-lung-injury Table V - Descriptions of transfusion incidents in 2001 and 2002 Category Incident 2001 Description 2002 Description transfusion transfusion incident incident I IBCT 8 - ABO incompatible: 3x. 70 ml red cells 12 - RhD-incompatible, occurrence type B to O patient; 50 ml red cells alloanti-d: 5x. type B to A patient; 300 ml fresh - Mistyping: 1x. RhD antigen incorrectly frozen plasma type O to??? typed as positive by clerical error. - Alloantibodies not properly identified - Emergency transfusion of S+ uncrossmatched or mistakenly overlooked: 3x. Anti- units to patient with anti-s, E; anti-c and anti-jk a. not known at the time: 1x - Passive transmission of alloantibodies by - Misidentification, ABO-compatible: 3x. fresh frozen plasma units: 2x. Anti-Wr a. - Transfusion of cek-nontyped unit in IBCT incidents were reported without a patient who should have had cek clinical symptoms. compatible blood: 1x. - Failure to irradiate HLA-compatible platelets: 1x. II Temperature rise: 1-2 C 14 - Buffy-coat depleted red cell 27 concentrate: 1x. - Leucocyte-depleted red cell concentrate: 7x. - 5 random donors platelets: 6x. III FNHTR (>2 C) 36 - Buffy-coat depleted red cell 65 concentrate: 18x. - Leucocyte-depleted red cell concentrate: 11x. - 5 random donors platelet concentrate: 7x. IV AHTR 3 - ABO-incompatible: 1x. Red blood cells 6 type A to patient type O, perioperatively. Uneventful clinical course after intensive treatment. - Unexplained: 2x. Clinically and biochemically AHTR; definite immunohaematological cause not found. - Leucocyte-depleted red cell concentrate: 26x. - Leucocyte-depleted 5-donors platelets: 1x. - Leucocyte-depleted red cell concentrate: 54x. - Leucocyte-depleted 5-donors platelets: 8x - SD plasma: 2x. - Unknown: 1x. - ABO-incompatible: 2x. Red blood cells type to patient type 0 (20 ml and 100 ml respectively). - Acute hemolysis after cross-match negative transfusion due to anti-do a : 1x - Transfusion of 6 units of SD plasma type B to patient type A: 1x. - Unknown immunohaematological cause: 2x. Two episodes of increased haemolysis and fever in the same patient in the presence of autoantibodies. There were no transfusion related deaths. 382

5 Experiences in reporting transfusion incidents Category Incident 2001 Description 2002 Description transfusion transfusion incident incident V DHTR 18 - Boostering of one antibody: 12x Boostering of two antibodies: 6x. Antibodies involved: anti-e 6x, anti-c 2x, anti-c w, 3x, anti-jk a 7x, anti-fy a 2x, anti-fy b 1x, anti-k 1x, anti-s 1x, anti-private 1x. - Boostering of one antibody: 29x. - Boostering of two antibodies: 9x. - Boostering of three antibodies: 1x Antibodies involved: anti-d 1x, anti- C 5x, anti-c 3x, anti-e 13x, anti-e 4x, anti-fy a 5x, anti-fy b 1x, anti-jk a 10x, anti-jk b 5x, anti-k 2x, anti- Le a 1x. VI PTP 0 0 VII Allergic reactions 11 - grade I (erythema, urticaria, pruritus): 9x grade II (hypotension, bradycardia and facial redness): 1x. - grade III (generalized erythema, bronchospasm and hypotension, ICU treatment): 1x. VIII T T I 3 - Septicaemia by bacterial contamination 5 (B. cereus) of 5 random donor platelet concentrates: 2x. - Unconfirmed report of bacterial contamination of red blood cell concentrate: 1x. Str. parasanguinis, N. sicca, and Streptococcus species were cultured in the patient. - grade 1: 13x - grade 2: 3x - Bacterial contamination suspected, but not definitely proven: 4x. Involved products were red cell concentrates: 3x; combination RBC/FFP/platelets 1x. - Viral transmission suspected, but not proven: 1x CMV infection de novo after cardiac surgery. Product involved was a non-leucocyte depleted RBC. IX TA-GvHD 0 0 X TRALI 1 TRALI was clinically diagnosed. HLA 3 antibodies were found in one of the involved donors. Antibodies against granulocytes were not identified. XI Near-miss 6 - Positive cross match: 2x. Anti-Jk a 5 identification failed, unit was Jk a +; exchange of serum from two patients. - Wrong labelling: 3x. Blood group typing did not match historical results. - Confusion of patient data from ER to OR discovered by discrepancies in second blood group typing: 1x. XII Product incidents 19 Recall procedures after implementation 59 of routine bacterial screening of 5 random donors platelet concentrates: 19x. XIII Unclassified 6 In two cases TRALI was clinically diagnosed. In one of these, HLA antibodies in the patient and a positive crossmatch between donor leucocytes and patient serum was found. One report of suspected TRALI was redrawn after St.aureus septicaemia was diagnosed. - Analytical errors: 2x. - Wrong labelling: 2x. - Failure of ID check on request form: 1x. - Recall procedures after implementation of routine bacterial screening of 5 random donors platelet concentrates: 55x. - Wrong labelling of bloodproducts: 2x ABO(!); 1x K. Red cells were not transfused - Non-irradiated HLA-matched platelets: 1x. These cases included: heartfailure, cyanosis, clinical deterioration, refractoriness to random platelets, cold fever, isolated hyperbilirubinemia. All complaints occurred during transfusion. Total IBCT: incorrect bloodcomponent transfused; FNHTR: Febrile non-haemolytic transfusion reaction; AHTR: acute haemolytic transfusion reaction; DHTR: delayed haemolytic transfusion reaction; PTP: post-transfusion purpura; TTI: Transfusion transmitted infections; TA-GvHD: transfusion-associated-graft-versus-host-disease; TRALI: transfusion-related-acute-lung-injury 383

6 EAM Beckers et al. Methods A working party of the medical advisory council of the regional bloodbank, in which all hospitals were represented, was instituted. A proposal for reporting transfusion incidents using uniform registration forms on a voluntary basis was done. The British SHOT (Serious Hazards Of Transfusion) scheme was regarded as a desirable example. The classification of the transfusion incidents was primarily based on SHOT. In addition, mild or severe febrile reactions and allergic reactions were separately registered. Also, reports involving incidents in the production process (product incidents) were classified. Table I lists all categories and their definitions, in which transfusion incidents were reported. Transfusion reactions reflect the clinical symptoms involved in transfusion incidents. The severity of transfusion reactions were optionally reported in grades 0-5 (Table II). The likelihood that the reactions were transfusion related could be stated as well (Table III). Reports were done by hospital haemovigilance officers, who were responsible for the registration of transfusion incidents in their hospitals. All reports were voluntary submitted and registered anonymously. The reported incidents were not verified, as is mandatory in other haemovigilance programmes. The primary goal of this initiative was to make an inventory of the kind of reports concerning transfusion incidents occurring in the Southwest region of the Netherlands. Results From the start of the regional haemovigilance programme on 1 January 2001, a total of 119 and 243 reports were registered in the first and second year, respectively. Not only symptomatic transfusion reactions, but also errors, mistakes and near-misses were reported. Approximately, a total of 155,000 blood components (120,000 red cell concentrates; 10,000 platelet concentrates and 25,000 units of fresh frozen plasma) were distributed by the regional bloodbank each year. The exact number of blood components, which were actually administered to patients, could not be determined. Although all 22 hospitals were represented in the medical advisory council, the reports about transfusion incidents came from 11 in the first year and from 18 in the second year. University hospitals, large regional teaching hospitals and small local hospitals were represented. The joint amount of blood components which was accounted for was 68% in the first year and 83% in the second year. The reports were classified in 13 different categories and are Discussione Due anni dopo l'introduzione del sistema regionale di emovigilanza, la consapevolezza, in molti Ospedali, dell'importanza di segnalare gli incidenti trasfusionali è evoluta sino al livello di registrare ogni reazione avversa. La quantità delle segnalazioni è raddoppiata nel secondo anno, come riflesso di un avvenuto apprendimento. Anche l'esperienza maturata in altri Paesi ha dimostrato un incremento nel numero delle segnalazioni nei primi anni che hanno seguito l'introduzione dei sistemi di emovigilanza 3-6. La positiva realizzazione del programma nel Sud-Ovest dell'olanda è dipesa da numerosi fattori. Uno dei più importanti è relativo alla volontà degli Ospedali regionali di riferire sulle reazioni avverse. Altrettanto importanti sono stati: il fatto che tali incidenti venivano segnalati in maniera anonima, la tempestività della presentazione dei risultati, la immissione dei rapporti in un metodo di valutazione e l'organizzazione di sessioni illustrative nelle quali veniva sottolineata l'importanza dell'emovigilanza. Anche l'impiego di moduli standardizzati e preventivamente impostati, nonché l'attitudine "a noncolpevolizzare-ma-a-insegnare" hanno contribuito ad aumentare il numero delle segnalazioni. Una comparazione fra i risultati qui presentati e i dati provenienti da altri programmi di emovigilanza viene ostacolata dai differenti metodi di registrazione e dalle diverse definizioni degli incidenti trasfusionali. La più alta frequenza di incidenti (2,3 ogni emocomponenti) si riscontra in Francia 3, la maggior parte dei quali, peraltro, di lieve entità. Nel Regno Unito vengono registrati soltanto incidenti trasfusionali ben definiti e confermati, e di entità tale da essere considerati gravi: la frequenza è molto più bassa (0,1 su emocomponenti) 4. Nello sviluppare l'iniziativa di emovigilanza nella nostra regione abbiamo adottato il sistema di definizione SHOT. Eravamo, comunque, interessati anche alle reazioni di lieve entità. Nel secondo anno, la frequenza totale è stata di 1,5 per emocomponenti nella regione sud-occidentale dell'olanda, il che ci avvicina alle frequenze francesi. È necessario che venga effettuata una valutazione internazionale della gravità degli incidenti trasfusionali (da lieve, a moderata, a severa), così da poter paragonare i vari modelli nazionali di emovigilanza. Nel 1998, è stato fondato l'ehn (European Haemovigilance Network), con lo scopo di permettere e facilitare scambi di informazioni attendibili 7. I benefici di un programma di emovigilanza sono da attendersi non soltanto a lungo ma anche a breve termine. Dopo due soli anni di attività, si sono potuti fare alcune interessanti osservazioni. Il numero di modesti aumenti 384

7 Experiences in reporting transfusion incidents summarized in Table IV. A detailed description of each incident is listed in Table V. Statistical analysis was not performed because the amount of blood components transfused, the denominator, could not be established. Discussion Two years after the introduction of a regional haemovigilance scheme, the awareness in many hospitals of the importance of reporting transfusion incidents has evolved to a level at which adverse events are routinely registered. The amount of reports doubled in the second year of registration, which reflected the learning curve of haemovigilance. The experiences with haemovigilance systems in other countries had also showed an increase in the number of reports during the first few years following implementation 3-6. The successful implementation of the haemovigilance program in the Southwest of the Netherlands depended on several factors. The willingness of the regional hospitals to report adverse events is one of the most important ones. Equally important were the fact that incidents were reported anonymously, the timely presentations of results, the feed-back of reports by the method of benchmarking and educational sessions in which the importance of haemovigilance was underlined. Also, the use of standardized, pre-formatted reports and "a-notto-blame-but-to-learn" attitude contributed to the rise of reported transfusion incidents. A comparison of the presented results with the data from other haemovigilance schemes is hampered by differences in registrations and by different definitions of transfusion reactions. In France, a high frequency (2.3 reports/1,000 blood components) of incidents, of which the majority consists of mild reactions, is reported 3. In the UK, however, only specifically defined and verified transfusion incidents that are considered serious hazards are registered, resulting in a much lower frequency (0.1 report/1,000 blood components) 4. For the development of the regional haemovigilance initiative in our region we had adopted the SHOT definitions of transfusion reactions. In addition, we were also interested in the occurrence of only mild transfusion reactions. In the second year, the overall frequency of reporting transfusion incidents in the Southwest region of the Netherlands was 1.5/1,000 blood components, which approached the observed incidence in France. An international evaluation of the definitions and verification of transfusion incidents, from mild to moderate and serious, is necessary in order to compare national haemovigilance schemes. The European Haemovigilance Network was founded in 1998 to facilitate della temperatura corporea e delle reazioni febbrili non emolitiche è rimasto invariato nei due anni. Si deve, tuttavia, sottolineare che, a partire dalla fine del 2001, tutti gli emocomponenti cellulari distribuiti in Olanda erano leucodepleti: l'introduzione della leucodeplezione totale non ha determinato un abbassamento delle reazioni febbrili, come è stato anche riferito da altri 8,9. Una seconda conclusione che si può trarre da un'analisi superficiale è che, anche se non si sono verificate reazioni fatali, intervengono ancora incidenti gravi, nonostante tutte le misure di sicurezza. La catena trasfusionale è complessa e formata da numerosi anelli. Un'analisi più approfondita rivela, in molti casi, la presenza di errori umani prevenibili, che comprendono anche gravi reazioni trasfusionali per incompatibilità ABO. Si potrebbe concludere che né i donatori né i luoghi di produzione degli emocomponenti né i laboratori sono l'anello debole, ma piuttosto la pratica trasfusionale nei reparti ospedalieri. Sembra raccomandabile (se non addirittura imperativo) un insegnamento sul comportamento da seguire per il personale medico e, soprattutto, per quello infermieristico, più coinvolto nella somministrazione degli emocomponenti. Dalla nostra esperienza (così come da quella di altri), si può arguire che la sicurezza della pratica trasfusionale si ottiene migliorando le procedure trasfusionali a livello ospedaliero piuttosto che a quello produttivo Si è anche rilevato un numero relativamente alto di reazioni emolitiche ritardate (DHTR, Delayed Haemolytic Transfusion Reactions). Secondo la nostra definizione, si considera la possibilità di una DHTR, quando i risultati immunoematologici indicano una risposta immunologica (presenza di all'anticorpi nel siero e nell'eluato, test diretto all'antiglobulina positivo, trasfusione recente). La Banca del Sangue regionale mette a disposizione degli Ospedali un laboratorio di sierologia eritrocitaria, il che facilita la segnalazione di possibili DHTR. Non sempre sono state eseguite le ricerche cliniche e biochimiche relative a una sintomatologia emolitica nei pazienti. Tuttavia, 8 pazienti su 12, indagati a questo scopo, hanno mostrato evidenze di modesta emolisi (Hb diminuita, LDH aumentata e iperbilirubinemia). Gli alloanticorpi coinvolti in questi casi erano: anti-d, anti-c, anti-c, anti-e, anti-k, anti-jk a (2 casi), anti-fy a (risultati non mostrati). Questi dati concordano con quelli dello SHOT e indicano che i metodi di screening anticorpale non sono così sensibili come si pensava un tempo 4. Ovviamente, si debbono attendere segnalazioni future prima di trarre conclusioni definitive. Infine, nel 2002 vi è stato un sensibile incremento di frequenza degli incidenti relativi agli emocomponenti, il che può essere attribuito alla introduzione, a partire dal 1 ottobre 385

8 EAM Beckers et al. and to allow an efficient exchange of reliable information 7. The benefits of haemovigilance programs are not only to be expected in the longterm, but also in the short-term. After only two years some interesting findings were observed. The number of mild temperature rises and FNHTR's remained equal in the first two years. However, it must be noted that by the end of 2001, all cellular blood components were leucodepleted in the Netherlands. The introduction of general pre-storage leucodepletion did not result in a lower incidence of febrile reactions, which is also reported by others 8,9. A second conclusion, which might be drawn after short-term analysis, is that although fatal accidents did not happen, serious adverse events still do occur, despite all safety measurements. The practice of blood transfusion is complex and the blood transfusion chain consists of many links. A more detailed investigation of the reported incidents revealed in many cases preventable human errors, including serious mistakes as ABO-incompatible transfusions. It might be concluded that not the donor, nor the production site or the transfusion laboratory are the weakest links, but rather the practice within the hospitals wards. Ongoing education of doctors and especially of nurses, who are mainly in charge of the administration of blood components, seems to be desirable if not mandatory. From our experiences, as well as from others, it might be argued that the safety of blood transfusion is currently better served by putting more emphasis on improving hospital transfusion procedures than on blood component safety procedures Another remarkable finding was the relatively high number of reports concerning DHTR's. By our definition the possibility of DHTR was considered when immunohaematological results indicated a booster alloimmune respons (alloantibodies detectable in serum and eluate, a positive direct antiglobulin test, recent transfusion). The regional bloodbank provides a red cell serology laboratory service to the hospitals, which facilitated the reporting of possible DHTR's. Clinical or biochemical investigations of haemolysis in these patients were not always performed. However, 8 out of 12 patients, who were investigated, showed evidence of mild haemolysis (Hb drop, LDH rise or hyperbilirubinemia). The alloantibodies that were involved in these cases were: anti- D, anti-c, anti-c, anti-e, anti-k, anti-jk a (2x) and anti-fy a (results not shown). These data are in agreement with the reports of the SHOT scheme and support the idea that antibody screening methods might not be as sensitive as once was thought 4. Obviously, future reports must be awaited before definite explanations can be given. Finally, 2001, dello screening sull'inquinamento batterico di tutti i concentrati piastrinici (CP). Campioni provenienti dai CP vengono posti in coltura per 7 giorni. I CP sono, tuttavia, distribuiti sulla base di una politica di "negativo-almomento", senza richiedere il tempo minimo della coltura. Ciò ha portato a riesaminare emocomponenti già distribuiti, quando lo screening batterico risultava positivo. Nel 2001 sono stati segnalate 2 setticemie da Bacillus cereus, dopo trasfusione di CP contaminati. Dopo l'introduzione dello screening sistematico, ci sono stati 4 casi di sospetto inquinamento batterico. Tuttavia, nessuno di questi casi si è potuto ricondurre a uno specifico donatore o a uno specifico emocomponente. In conclusione, il programma regionale di emovigilanza è stato introdotto con successo nel Sud-Ovest dell'olanda. L'iniziativa ha contribuito alla attuazione, nel 2003, del programma nazionale olandese di emovigilanza, noto come TRIP (Transfusion Reactions In Patients). Un sistema di emovigilanza ben funzionante contribuisce alle conoscenze sugli incidenti trasfusionali 13. È necessario educare sul comportamento da tenersi in caso di reazioni trasfusionali, sulla loro prevenzione e sul loro trattamento, al fine di migliorare ulteriormente sicurezza e qualità della trasfusione di sangue 14. Riassunto L'emovigilanza può essere definita come un sistema di sorveglianza per la raccolta standardizzata e l'analisi dei dati concernenti le reazioni avverse associate al prelievo e alla trasfusione di emocomponenti,al fine di migliorare sicurezza e qualità della trasfusione di sangue. Nonostante le raccomandazioni dell'ispettorato olandese della Salute, un metodo nazionale di emovigilanza in Olanda non si è reso effettivo sino al Nella regione sud-occidentale del nostro Paese (che conta una popolazione stimata di 3 milioni e mezzo di abitanti), è stata presa l'iniziativa rivalutare l'importanza di segnalare gli incidenti trasfusionali. A partire dal 1 gennaio 2001, tutti gli ospedali della regione nonché la Banca del Sangue hanno partecipato al sistema di segnalare gli incidenti trasfusionali verificatisi nei pazienti. Le reazioni sfavorevoli sono state segnalate in maniera anonima, suddivise in 13 categorie. Ogni incidente è stato registrato su di un modello standardizzato. Centocinquantacinquemila sono, approssimativamente, gli emocomponenti distribuiti ogni anno ( concentrati eritrocitari, concentrati piastrinici random, unità di plasma 386

9 Experiences in reporting transfusion incidents there was a remarkable rise in the frequency of product incidents in 2002, which can be attributed to the implementation from 1 October 2001 of routine bacterial screening of all platelet concentrates. Samples from platelets concentrates were cultured for 7 days after production. However, platelets were issued on a negativeto-date policy, without the requirement of a minimum culturetime. This resulted in recall procedures of already issued blood components, of which the bacterial screening became positive. In 2001 there were 2 reports about septicaemia by B. cereus after transfusion of contaminated platelet concentrates. After the implementation of bacterial screening there were 4 suspected cases of bacterial contamination. However, none of these could be reduced to a specific donor or bloodcomponent. In conclusion, a regional haemovigilance scheme was succesfully implemented in the Southwest region of the Netherlands. This initiative has contributed to the foundation of the Dutch national haemovigilance scheme "TRIP" (Transfusion Reactions In Patients) in A wellfunctioning system for haemovigilance contributes to the knowledge of transfusion incidents 13. Ongoing education about transfusion reactions, their prevention and treatment, are necessary for further improving the safety and quality of blood transfusion 14. fresco congelato). Il numero delle segnalazioni si è raddoppiato nel secondo anno.nel primo anno le segnalazioni riguardavano il 68% degli emocomponenti distribuiti,con un incremento all'83% nel secondo anno. Le reazioni nel 2001/2002 sono state le seguenti: trasfusioni non corrette 9/12; aumento della temperatura corporea di 1-2 C 14/27; reazioni febbrili non emolitiche 36/65; reazioni emolitiche acute 3/6; reazioni emolitiche ritardate 17/39; porpora post-trasfusionale 0/0; reazioni allergiche 11/16; trasmissione di malattie infettive 3/5; GvHD trasfusionali 0/8; TRALI 1/3; near-misses 6/ 5;incidenti con plasmaderivati 19/59; non classificabili 0/6, per un totale di 119 nel 2001 e di 243 nel Gli incidenti trasfusionali non sono probabilmente tutti segnalati. Nonostante tutte le misure di sicurezza, avvengono ancora reazioni gravi. La migliorata consapevolezza dell'importanza di segnalare gli incidenti trasfusionali che colpiscono pazienti e gli insegnamenti sul modo di comportarsi,ivi compresi i metodi di valutazione, hanno contribuito ad accrescere sensibilmente le segnalazioni. Un programma di emovigilanza funzionante aumenta le conoscenze sugli incidenti trasfusionali e concorre, quindi, a una maggiore sicurezza. References 1) Rouger P, Noizat-Pirenne F, Le Pennec PY. Haemovigilance and transfusion safety in France. Vox Sang 2000; 78 Suppl 2: ) Williamson LM, Love EM. Reporting serious hazards of transfusion: the SHOT program. Transf Med Reviews 1998; 12: ) Debeir J, Noel L, Aullen J, et al. The French haemovigilance system. Vox Sang 1999; 77: ) The SHOT writing group. Serious hazards of transfusion annual report ISBN : 2002, SHOT office, Manchester Blood Centre, Manchester UK. 5) Engelfriet CP, Reesink HW. Haemovigilance systems. International Forum. Vox Sang 1999; 77: ) Robillard P, Itaj NK. Incidence of adverse transfusion reactions in the Quebec s hemovigilance system Transfusion 2003; 43 Suppl: 22a. 7) Faber JC. Haemovigilance in Europe: the European haemovigilance network. Transf Clin Biol 2001; 8: ) Seghatchian J. Universal leucodepletion: an overview of some unresolved issues and the highlights of lessons learned. Transfus Apheresis Sci 2003; 29: ) Castella D, Pujol M. Non-hemolytic febrile transfusion reactions: its incidence in buffycoat-depleted and pre-storage leukocyte filtered components. Transfusion 2003; 43 Suppl: 115a. 10) Dzik WH. Emily Cooley lecture 2002: transfusion safety in the hospital. Transfusion 2003; 43: ) Williamson LM. Using haemovigilance data to set blood safety priorities. Vox Sang 2002; 83 Suppl 1: ) Todd A. Haemovigilance: closing the loop. Vox Sang 2002; 83 Suppl 1: ) Cahill MR, Joyce S, O Brien N, Casey M. Haemovigilance is associated with decreased use and improved appropriateness of blood transfusion. Vox Sang 2003; 85: ) Michlig C, Vu DH, Wasserfallen JB, et al. Three years of haemovigilance in a general university hospital. Transfus Med 2003; 13: