blood transfusion abstract and papers

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Blood Transfus DOI 10.2450/2012.00??????© SIMTI Servizi Srl

Blood Transfus 12, Supplement no. 2, February 2014 - ISSN 1723-2007

w w w. b l o o d t r a n s f u s i o n . i tEdizioni SIMTI

Offi cial journal ofSocietà Italiana di Medicina Trasfusionale e Immunoematologia - SIMTI

Associazione Italiana dei Centri Emofi lia - AICE Hrvatsko društvo za hematologiju i transfuzijsku medicinu - HDHTMSociedad Española de Transfusión Sanguínea y Terapia Celular - SETS

16th International Haemovigilance SeminarBarcelona (Spain), 5-7 March 2014

GUEST EDITORS: Eduardo Muñiz-Diaz (Local chairman), Erica Wood (IHN President), Paula Bolton-Maggs, Jean-Claude Faber, Martin Schipperus, Peter Tomasulo, Jo Wiersum-Osselton, Lydia Blanco, Azucena Castrillo, Carmen Fernández, Joan R. Grifols, Salvador Oyonarte, Mikel Pérez-Vaquero, Ramón Pla, Gloria Rivero

ABSTRACT BOOK

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2014

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Editor-in-ChiefClaudio [email protected]

Associate EditorsGiovanni Di MinnoMassimo FranchiniIrena Jukić Giancarlo M LiumbrunoPier Mannuccio MannucciDaniele PratiRoberto ReverberiLuisa RomanòGiuseppe TagarielloTomislav VukAlberto Zanella

Affi liated Society EditorsMaria Helena Gonçalves, APIHAlice Maniatis, HSBTMassimo Morfi ni, AICEEduardo Muñiz-Diaz, SETSAna Planinc Peraica, HDHTM

Executive DirectorStefano Antoncecchi

FounderLorenzo Lapponi

Past Editors-in-ChiefLorenzo Lapponi, 1956-1964Carlo Alberto Lang, 1965-1966Roberto Venturelli, 1967-1968Rosalino Sacchi, 1969-1978Giorgio Reali, 1979-2006

Editorial Offi ce Luisa SteaVia Desiderio, 21 - 20131 Milano

Websitewww.bloodtransfusion.it

Printing Grafi ca Briantea SrlVia per Vimercate, 25/27 - 20040 Usmate (MI)

International Editorial BoardJean-Pierre Allain, United KingdomGiuseppe Aprili, ItalyLydia Blanco, Spain Ines Bojanić, CroatiaPietro Bonomo, ItalyDialina Brilhante, PortugalMaria Domenica Cappellini, ItalyJean-Pierre Cartron, FranceGiancarlo Castaman, ItalyFrancine Décary, CanadaJosè António Duran, PortugalWilly A Flegel, United States of AmericaGilles Folléa, The NetherlandsZulmira Fonseca, PortugalGabriella Girelli, ItalyGiuliano Grazzini, ItalyAna Hećimović, CroatiaGiancarlo Icardi, ItalySyria Laperche, FranceLuis Larrea, SpainFranco Locatelli, ItalyAurelio Maggio, ItalyMichael Makris, United Kingdom Ivanka Mihaljević, CroatiaManuel Muñoz, SpainMario Muon, PortugalAlessandro Nanni Costa, ItalySalvador Oyonarte, Spain Arturo Pereira, SpainFlora Peyvandi, ItalyPaolo Rebulla, ItalyAngiola Rocino, Italy Elena Santagostino, Italy Dorotea Šarlija, CroatiaErhard Seifried, GermanyPaul FW Strengers, The NetherlandsCees L van der Poel, The NetherlandsJonathan H Waters, United States of AmericaAlessandro Zanetti, Italy

ISSN 1723-2007

Edizioni SIMTI© SIMTI Servizi Srl

The journal is indexed in PubMed-MEDLINE, Google Scholar, Embase and Scopus and PubMed Central

Blood Transfusion articles are indexed in Journal of Citation Reports (JCR) for Impact Factor determination. Impact Factor 2012: 1,858.

Associated with USPI Unione Stampa Periodica Italiana

Offi cial journal of:Società Italiana di Medicina Trasfusionale e Immunoematologia, SIMTI

Associazione Italiana dei Centri Emofi lia, AICE Hrvatsko društvo za hematologiju i transfuzijsku medicinu, HDHTM Sociedad Española de Transfusión Sanguinea y Terapia Celular, SETS

Affi liated Societies of the journal:Associação Portuguesa de Imuno-Hemoterapia, APIH - Hellenic Society of Blood Transfusion, HSBT

Tribunale di MilanoAuthorisation n° 380, 16th June 2003This number is published in 300 copies.Printed in February 2014Euro 7,00 each

CONTENTS

Blood Transfus 2014; 12 Suppl 2 DOI 10.2450/2014.S2© SIMTI Servizi Srl

INVITED LECTURES S407

ORAL PRESENTATIONS S453

POSTER PRESENTATIONS ORGANISATIONAL ASPECTS S460CLINICAL ASPECTS S470

AUTHORS S487

Citation of the manuscripts published in this volume should be as follows

Author(s). Title. Journal year; Volume (Suppl 2): abstract number.

E.g.: Muñiz-Diaz E. Pasado, presente y futuro de la Hemovigilancia en España. Blood Transfus 2014; 12 (Suppl 2): INV-01.

INVITED LECTURES

s409

16TH INTERNATIONAL HAEMOVIGILANCE SEMINARINVITED LECTURES

Blood Transfus 2014; 12 Suppl 2

INV-01PASADO, PRESENTE Y FUTURO DE LA HEMOVIGILANCIA EN ESPAÑAMuñiz-Diaz E.Coordinador de Hemovigilancia de Cataluña. Miembro del Comité Científico para la Seguridad Transfusional, Ministerio de Sanidad, Madrid, Spain

El sistema de Hemovigilancia en España es la suma de los 17 sistemas de Hemovigilancia que las respectivas comunidades autónomas (CCAAs) han establecido. La estructura política y administrativa de nuestro país, donde además las competencias sanitarias están transferidas desde el gobierno central a las CCAAs, hacía necesaria la creación de una red de Hemovigilancia de estas características. En 1998, el Ministerio de Sanidad, como autoridad competente en Europa, creó un grupo de trabajo de Hemovigilancia constituido por siete especialistas en medicina transfusional. Los objetivos de este grupo fueron el diseño de un modelo de programa de Hemovigilancia adaptado a las características territoriales y administrativas de nuestro país y la elaboración de los documentos de trabajo necesarios para la notifi cación de efectos adversos. En ambos casos se trataba de impulsar el desarrollo de la Hemovigilancia en España y de proponer a las CCAAs ambas herramientas como punto de partida. El trabajo realizado por el grupo, incluyendo una amplia difusión de la utilidad e interés de los sistemas de Hemovigilancia, favoreció la creación en 2003 de los primeros sistemas de Hemovigilancia autonómicos que adoptaron los documentos de trabajo proporcionados por el Ministerio. En 2004, con la fi nalidad de seguir promoviendo desde todos los ámbitos posibles la creación de sistemas de Hemovigilancia en las comunidades que todavía no disponían de él, el Ministerio de Sanidad estableció un acuerdo de colaboración con la Sociedad Española de Medicina Transfusional (SETS) y la asociación Española de Hematología (AEHH) de tres años de duración. En este periodo se creó el sistema estatal de Hemovigilancia y se presentó en Europa (6th European Haemovigilance Seminar, Zürich, Switzerland, 2004) el primer informe sobre Hemovigilancia en España. No obstante, aunque 2004 es considerado ofi cialmente como el año de implantación en España de un sistema de Hemovigilancia de ámbito estatal, hubo que esperar hasta 2009 para poder completar la red de Hemovigilancia en nuestro país.El sistema estatal de Hemovigilancia está organizado en tres niveles: 1) Local. Constituido por los centros y los servicios hospitalarios de transfusión donde existe un responsable de Hemovigilancia encargado de la notifi cación al registro autonómico; 2) Autonómico. Liderado por un coordinador de Hemovigilancia responsable de la colección y análisis de las reacciones e incidentes. Cada comunidad autónoma elabora su propio informe anual e informa a la Unidad de Hemovigilancia del Ministerio de Sanidad; y 3) Estatal. Representada por la Unidad de Hemovigilancia que elabora un informe anual de ámbito estatal a partir de la información aportada por las CCAAs. La Unidad trabaja de forma coordinada con los responsables autonómicos y convoca periódicamente reuniones con los mismos en aras de mantener la máxima homogeneidad posible en las defi niciones de las reacciones y efectos adversos, en el tratamiento de la información y en el diseño de las recomendaciones y de las medidas correctoras que el análisis de la información aconseja en cada momento. Por otra parte, la normativa vigente obliga a España, como miembro de la Unión Europea, a la notifi cación anual de las reacciones y

efectos adversos graves a la Comisión Europea (Directiva 2002/98/CE de la Comisión, transpuesta mediante la Orden SCO/322/2007). Esta acción también es ejecutada por la Unidad de Hemovigilancia que, además, colabora con otras instituciones y organismos internacionales (Consejo de Europa, OMS).La Hemovigilancia española abarca actualmente a toda la cadena transfusional y se registran las reacciones y los errores (incidentes y casi incidentes o incidentes sin efecto) de la transfusión, las complicaciones de la donación, y los efectos adversos ligados a la calidad y a la seguridad de los componentes sanguíneos. Las reacciones y los errores de la transfusión se notifi can con arreglo a los formularios de: reacción febril, reacción alérgica, reacción hemolítica, edema pulmonar cardiogénico, lesión pulmonar aguda relacionada con transfusión (LPA-RT), púrpura postransfusional (PPT), enfermedad del injerto contra el huésped relacionada con transfusión, (EICH-RT), hemosiderosis, infección vírica transmitida por transfusión, infección parasitaria transmitida por transfusión, infección bacteriana transmitida por transfusión, errores en la administración de componentes sanguíneos, y casi incidentes. La notifi cación de las complicaciones de la donación se efectúa con el formulario correspondiente diseñado de acuerdo con las defi niciones elaboradas en 2008 por el "Working Group on Complications Related to Blood Donation" de la ISBT. Finalmente, los efectos adversos ligados a la calidad y a la seguridad de los componentes sanguíneos se notifi can de acuerdo con la propuesta de la propia Comisión Europea que exige su clasifi cación en función de la fase de la cadena en que se han producido (extracción, verifi cación, procesamiento, almacenamiento, distribución, materiales) indicando, además, en cada caso si se trata de errores humanos, de un fallo en los equipos, o de componentes sanguíneos que no reúnen los requisitos de calidad y de seguridad exigidos por la normativa.La Hemovigilancia española tiene algunos retos pendientes como son alcanzar un nivel de notifi cación más homogéneo entre las diferentes CCAAs, la consolidación de la fi gura del/la enfermero/a de Hemovigilancia, la trazabilidad total e inequívoca de los componentes sanguíneos y el uso óptimo o adecuado de estos componentes sanguíneos. En relación con el uso óptimo, la Unidad de Hemovigilancia del Ministerio de Sanidad está decidida a impulsar esta práctica solicitando a los servicios de transfusión la necesaria información en base a indicadores de uso óptimo bien defi nidos.Transcurridos más de quince años desde que la Hemovigilancia en España dio sus primeros pasos, el balance es positivo y, hoy en día, constituye una herramienta totalmente integrada en el conjunto de actividades desarrolladas por los centros y servicios hospitalarios de transfusión.

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INV-02 TRANSFUSIÓN SANGUÍNEA EN ESPAÑA:MAPA DE RIESGOSPérez M., Arrieta R., Moro E.Unidad de Hemovigilancia. Dirección General de Salud Pública, Calidad e Innovación. Ministerio de Sanidad, Servicios Sociales e Igualdad, Madrid, Spain

La Hemovigilancia es una actividad, que aunque sin tal denominación, se venía realizando en España tanto en hospitales como en centros de transfusión años antes de su regulación por parte de las autoridades europeas. La publicación de la Directiva 2005/61/EC sobre trazabilidad de los componentes sanguíneos y la notifi cación de reacciones adversas y efectos adversos graves de la transfusión, incorporada al ordenamiento jurídico interno a través de la Orden Ministerial SCO/322/2007, supone un empuje defi nitivo en la consolidación y desarrollo de la red de Hemovigilancia. Dicha Orden, incorpora a su vez la notifi cación de reacciones adversas en los donantes y los errores en la administración de componentes, no contemplada como tales por la Directiva.La red transfusional en España la integran 24 Centros de Transfusión (posiblemente 20 en un futuro inmediato,) y 368 Servicios Hospitalarios de Transfusión dependientes de las 17 Comunidades autónomas. Anualmente se solicita a nivel central (Ministerio) información relativa a la actividad de los Centros y Servicios a través de una encuesta que recoge, entre otras, información relativa al número de donantes y donaciones, pruebas de seguridad relativas a enfermedades infecciosas, así como número de unidades transfundidas, información toda ella utilizada en la valoración de posibles riesgos. La información recogida en Hemovigilancia se realiza a través de cuestionarios de notifi cación comunes en todo el país. La información recogida es la de todos los Centros de Transfusión, y en torno al 60 % de los servicios hospitalarios, los cuales abarcan prácticamente el 90% de actos transfusionales. Los casos notifi cados son a su vez refl ejados en un informe anual que se discute en el seno del Comité Científi co para la Seguridad Transfusional (órgano asesor del Ministerio de Sanidad en materia transfusional), y se envía a los coordinadores de Hemovigilancia de cada comunidad además de ser publicado en la web del Ministerio. El ámbito de la Hemovigilancia integra todos los eslabones de la cadena transfusional: desde la selección del donante hasta el seguimiento clínico del paciente transfundido. Es así como los incidentes registrados pueden dividirse en tres grupos: incidentes en la donación, en la preparación de componentes e incidentes en la propia transfusión. Los incidentes relativos a la transfusión comprenden: notifi cación de reacciones adversas, errores en la administración de componentes (EAC) y los incidentes sin efecto/casi incidentes. La tasa de notifi cación en los últimos años se ha incrementado de 9 por 10,000 unidades transfundidas (2007) hasta 15,5 (2012). Esta tasa varía de forma notoria entre las Comunidades Autónomas en un rango que va de 4 a 37 notifi caciones por 10,000.El estudio de las reacciones y errores concluye con la asignación de un grado de gravedad (G) y de un grado de imputabilidad (I). Los posibles niveles de gravedad contemplados son los siguientes: 0: sin manifestaciones clínicas, 1: signos inmediatos sin riesgo vital y resolución completa, 2: signos inmediatos con riesgo vital, 3 morbilidad a largo plazo, 4: muerte del paciente. La imputabilidad hace referencia a la probabilidad de que la reacción adversa sea atribuible a la transfusión y

no a otras causas. Los grados de imputabilidad defi nidos son los siguientes: NE: No Evaluable, 0: Excluida/improbable, 1: Posible, 2: Probable, 3: Seguro.En el periodo 2007-2012 se han transfundido en España casi 12 millones de componentes (concentrados de hematíes, dosis terapéuticas de plaquetas y plasma fresco congelado). En estos 6 años se han notifi cado 24 casos de exitus con un grado de imputabilidad elevado (I≥2): ocho debidos a Reacción Hemolítica Transfusional (RHT) (incompatibilidad ABO, EAC), siete casos de Lesión Pulmonar Aguda Relacionada con la transfusión (LPART/TRALI), cuatro de Edema Pulmonar Cardiogénico (EPC), tres de Reacción hemolítica transfusional (no-ABO) y dos de Infección Bacteriana (IBTT). En resumen suponen 1 exitus por cada 490,000 unidades transfundidas.La frecuencia de aparición de los incidentes citados con anterioridad para el grupo de pacientes que ha sufrido una reacción grave (G=2-4) con imputabilidad alta (I≥2) han sido: EPC: 1/93,000, TRALI: 1/95,000, RHT: 1/150,000 e IBTT: 1/1,000,000.En relación a incidentes en la Donación se han referido, durante el año 2012, 139 complicaciones por 10,000 en caso de donaciones de Aféresis y 41 por 10,000 de donaciones de sangre. Las complicaciones más frecuentes han sido síntomas generales de tipo vasovagal en caso de donación de sangre, y complicaciones con síntomas locales, en caso de las Aféresis (86% y 66% respectivamente). La mayoría de los incidentes fueron de carácter leve.En lo que se refi ere a los efectos adversos ligados a la calidad y seguridad de los componentes, los notifi cados son en su mayoría "casi incidentes", detectados a través de los sistemas de calidad. La baja incidencia de efectos adversos graves ligados a la calidad y seguridad de los componentes (como pueden ser la transmisión de enfermedades infecciosas) es refl ejo del alto nivel de seguridad y calidad alcanzado por parte de los Centros en nuestro país.Los datos refl ejan margen de mejora en incidentes inicialmente prevenibles como el EPC y aquellos que se producen como consecuencia de errores, datos acorde con las experiencias de otros sistemas de hemovigilancia.Transcurrido este tiempo de consolidación del sistema de Hemovigilancia, se considera de interés profundizar en el control del uso óptimo de los componentes, entendido como un uso seguro, efi ciente y clínicamente efi caz, centrado en el paciente. Este será nuestro próximo objetivo.

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INV-03 LA HEMOVIGILANCIA EN AMÉRICA LATINATorres O.W.1, León de Gonzalez G.2

1Transfusion Medicine Service, Hospital Materno Infantil "Ramón Sardá"/Haemophilia Unit. William Osler Institute, City of Buenos Aires, Argentina; 2Jefe del Banco de Sangre del Intituto Diagnóstico, Caracas, Venezuela

IntroducciónAmérica Latina (AL) es una región de aproximadamente 20 millones de km2 que se extiende desde México hasta Chile y Argentina. Está conformada por 18 países de habla hispana y uno de habla portuguesa. Aunque tenemos muchas características en común por nuestra vinculación histórica, cada país tiene sus particularidades desde el punto de vista geográfi co, cultural, social, económico y político. En algunos países, la legislación vigente en Medicina Transfusional exige desde hace algunos años, la notifi cación obligatoria de las reacciones adversas a la transfusión. Sin embargo, es desde hace aproximadamente una década cuando comienzan a desarrollarse acciones sobre hemovigilancia (HV) de magnitud variable.

ObjetivoDescribir la actual situación de la hemovigilancia en América Latina.

MétodoRealizamos una encuesta utilizando un cuestionario de 7 preguntas, cinco cerradas y dos abiertas. Según las respuestas obtenidas en tres de las cerradas, se debía llenar una tabla con opciones de respuesta dicotómicas o con datos cuantitativos (valores numéricos y porcentuales). En dos de las cerradas se dejó espacio para comentarios.

ResultadosContestaron 13/19 países (68.42%) contactados. En el 100%, el Ministerio de Salud, recoge datos de la actividad de los servicios de sangre de forma periódica, usualmente mensual, con formatos estandarizados electrónicos (61.53%), manuales (7.69%) o ambos (23%); uno de los países no respondió (7.69%). En cinco países, el 100% de los servicios de sangre nacionales informa a las autoridades sanitarias, en tres, informa entre el 80-99% de ellos, en uno el 40% y en tres se desconoce el porcentaje de servicios que lo hace; 1 país no respondió. Solo Brasil y Colombia tienen un programa de HV nacional estructurado implementados desde 2006 y 2009 respectivamente; Cuba tiene un programa piloto regional de HV (desde 2003) en vías de expandirlo a todo el país; Chile, Guatemala y Venezuela registran y notifi can algunos datos de HV que se exigen de forma obligatoria en el informe mensual general, pero solo informados por instituciones aisladas. Chile está mejorando su red de comunicaciones para extenderlo a nivel nacional. En Venezuela, el organismo ofi cial no mostró interés en implementar un proyecto nacional, presentado por la Sociedad Científi ca en 2011; de hecho, lo poco que se reporta no se refl eja en el informe anual nacional. Argentina y Honduras registran algunos datos de forma voluntaria. Costa Rica, Ecuador y Perú lo hacen en forma local pero no informan al organismo ofi cial porque no lo exige.Causas de la falta de implementación de un sistema de HV:1 - Políticas: inexistencia de un Programa de Sangre operativo

o de una normativa nacional; falta de voluntad política;

no se considera importante; falta de centralización de los procesos; no se ha desarrollado aún el programa.

2 - Recursos: insufi ciencia de recursos humanos (en general y/o especializado para funciones específi cas) y fi nancieros.

3 - Cultura de la responsabilidad: temor por acciones punitivas.El 36.36% de los países sin sistema nacional de HV, no tiene planes de implementación a corto plazo; el 18.18% desconoce si existe, el 45.45% tiene planes de mejorarlo o de implementarlo próximamente. El 54.54% respondió que las Sociedades Científi cas podrían tener un papel relevante en esta implementación, pero en coordinación con el organismo ofi cial; el 45.46% respondió negativamente (tres países no tienen Sociedad Científi ca y uno respondió que sus sugerencias no infl uyen en las decisiones sanitarias).Obstáculos para implementar la HV:1 - no hay una norma ofi cial que exija que se realice ese tipo

de actividades;2 - en los que existe la norma: falta voluntad institucional

y personal suficiente para llevar a cabo las diversas actividades; no hay comités de transfusión hospitalaria; hay desidia de los profesionales de la salud para generar registros e informes; no existe interrelación entre el médico que valora al paciente con una reacción y el banco de sangre; no hay defi nición de funciones hospitalarias ni autoridad para que se cumplan; carencia de personal y de formación de los involucrado; falta de automatización en los procesos;

3 - indefensión jurídica.Finalmente se solicitó datos de reacciones adversas a la transfusión (RAT) y a la donación. Todos señalaron que hay subregistro.

ConclusiónEn AL existe una insipiente actividad de HV. Aunque hay países que cuentan con un sistema estructurado ofi cial y otros en vías de extenderlos a nivel nacional, la mayoría registra datos en forma institucional ya que no es exigido por las autoridades sanitarias. Son múltiples los factores que inciden en la falla en la implantación del sistema de HV en la Región que comienza en algunos casos por la inexistencia de un Programa Nacional de Sangre. Sin embargo, en casi todos hay conciencia de la necesidad de su implementación aunque no siempre existe la voluntad política. La OPS, las Sociedades y Organizaciones Científi cas, y los profesionales del área están llamados a unir esfuerzos para demostrar y convencer a las autoridades sanitarias sobre la importancia de la HV para la seguridad transfusional y para orientar y buscar soluciones que minimicen los obstáculos que impiden su implementación e implantación, con acciones concretas adaptada a las realidades de los países.

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INV-04COMPLICACIONES PULMONARES DE LA TRANSFUSIÓN SANGUÍNEA: TRALI Y TACOFernández Álvarez C.Hospital de Cabueñes, Gijón, Spain

IntroducciónSólo un órgano o sistema se menciona por su nombre en la nomenclatura de los efectos adversos transfusionales: el cardiopulmonar. Esto es así porque el tejido pulmonar es el más vulnerable a la respuesta infl amatoria aguda, teniendo que soportar constantes cambios de volumen, altísimos fl ujos de presión y un intenso tráfi co circulatorio. Los receptores de componentes sanguíneos (CS) pueden sufrir diferentes grados de edema pulmonar. Los más agudos y severos son una demostración del devastador potencial infl amatorio de los CS, que afortunadamente, pocas veces se manifi esta.

Defi nición y criterios diagnósticosEl diagnóstico es difícil, especialmente el TRALI, pues se basa fundamentalmente en el juicio clínico del médico. En la práctica diaria no siempre disponemos de los métodos necesarios de monitorización, y la interpretación de los hallazgos radiológicos tiene un gran componente de subjetividad. También existe amplia variabilidad en los métodos de estudio inmunohematológico.TRALI (transfusion-related acute lung injury): el daño pulmonar agudo relacionado con la transfusión, se defi ne como una situación de hipoxemia, acompañada de la aparición de edema pulmonar sin signos de sobrecarga circulatoria, en las 6 horas siguientes a una transfusión, para la que no hay una explicación alternativa. El edema lo causa un aumento de la permeabilidad vascular. TACO (transfusion-associated circulatory overload): el edema agudo de pulmón cardiogénico, es un cuadro de descompensación cardiorespiratoria propiciado por la transfusión. Se produce por un mecanismo hidrostático. Los informes de hemovigilancia (HV) ponen de manifi esto su importancia, así como su frecuente asociación con un error en la determinación de hemoglobina que conduce a la administración de transfusión innecesaria. TAD (transfusion-associated dyspnoea): aunque no universalmente aceptada, esta entidad se defi ne como la aparición de disnea en las 24 horas siguientes a una transfusión que no cumple criterios de TRALI o TACO. Diferentes grupos han establecidos criterios diagnósticos, aunque dispares, se incluyen los del Nacional Heart, Lung and Blood Institute.

TRALI En pacientes sin factores de riesgo para sufrir daño pulmonar agudo ALI- Desarrollo brusco de hipoxia (Saturación de Oxihemoglobina

inferior 90% respirando aire ambiental).- Infi ltrados pulmonares bilaterales en la radiografía o TAC

de tórax, sin elevación de la presión venosa central (presión oclusión en la arteria pulmonar inferior a 18 mm de Hg).

- Desarrollado en un intervalo no superior a 6 horas tras la transfusión.

En pacientes con factores asociados de daños pulmonar agudo (ALI)- Los criterios anteriores.- Los signos anteriores se agravan y se relaciona con la

transfusión, no habiendo otro factor identifi cable para el empeoramiento.

Tabla II - Porcentaje de las RAD.País Reacciones

inmediatasReacciones

tardíasReacciones

localesReacciones vasovagales

Otras

ArgentinaN: 26,805 1.66 0.16 0.63 1.52 0.007

Costa RicaN: 2,890 0.65 0.28 0.10 1.24 --

CubaN: 272,379 0.25 -- 0.04 0.21 --

ChileN: 279,107 -- -- -- 1.58 0.55

PerúN: 100,000 0.62 -- 0.46 0.72 --

VenezuelaN: 43,993 0.38 0.06 0.81 1.01 0.009

Tabla I - Frecuencia absoluta y relativa de las RAT inmediatas, infecciosas y tardías.

País RAT inmediatas

Infecciosas* RAT tardías

Total

ArgentinaN: 45,097

1,167(99.91%)

1(0.08%) -- 1,168

(100%)

BrasilN: 3,567,720

5,279(98.78%)

12(0.22%)

53(0.99%)

5,344(100%)

ColombiaN: 900,640

1,16897.41%

171.5%

131.09%

1,198(100%)

Costa RicaN: 1,930

19(90.47%)

1(4.76%)

1(4.76%)

21(100%)

CubaN: 176,269

781(97.38%)

14(1.74%)

7(0.87%)

802(100%)

ChileN: 380,870

1,020(90.50%) -- 107

(9.49%)1,127

(100%)GuatemalaN: 171,244

48(100%) -- -- 48

(100%)PerúN: 210,000

38(97.43%)

1(2.56%) -- 39

(100%)VenezuelaN: 484,449

449(97.39%)

9(1.95%)

3(0.65%)

461(100%)

*Incluye las infecciones transmisibles por transfusión y la contaminación bacteriana.

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TACOAparición o empeoramiento de al menos tres de los siguiente signos o síntomas, en las 6 horas posteriores a la transfusión: distress respiratorio; signos de sobrecarga, elevación de los niveles de péptido natriurético; signos radiológicos de edema pulmonar; signos de fallo ventricular derecho; elevación de la presión venosa central.

FisiopatologíaLa fi siología del TRALI es compleja debiendo referirnos a características del componente y del receptor, siendo en ocasiones estas últimas las determinantes. La teoría ha ido evolucionando desde la hipótesis basada exclusivamente en la presencia de anticuerpos antileucocitarios, a la teoría de los dos pasos, en la que factores clínicos predisponentes se asocian con los inmunes. Los conocimientos actuales demuestran la posible implicación de otras muchas sustancias. En todo caso, resulta determinante el reclutamiento y secuestro de leucocitos en la vasculatura pulmonar, su activación y migración al espacio intersticial, desencadenando un aumento de la permeabilidad capilar. Igualmente la manifestación aguda del daño no siempre es tal, admitiéndose el daño pulmonar reiterado y subagudo.A continuación se relacionan los posibles mecanismos involucrados, inmunes y no inmunes.- Relacionados con la presencia de anticuerpos o reacciones

cruzadas (componente y receptor): anticuerpos anti HLA clase I y II, anti HNA, reacciones medidas por plaquetas.

- No relacionados con la presencia de anticuerpos. Componente : sus tanc ias en los sobrenadantes

(lisofosfatidilcolina; CD40 ligando soluble; citoquinas; micropartículas, cristales de colesterol), lesión de almacenamiento (pérdida de deformabilidad eritrocitaria y de expresión antigénica Duffy).

Receptor: TRALI. Patología/lesión pulmonar previa; cirugía reciente; sepsis; paciente crítico. TACO. Edades extremas: muy avanzada o neonatos; género femenino; cardiopatía previa; insufi ciencia renal; niveles de hemoglobina muy bajos (menos 50 gr/L); shock hemorrágico; balance positivo de fl uidos: transfusión masiva, transfusión de plasma.

IncidenciaEstá infraestimada, existiendo gran variabilidad según se obtenga de los informes de HV o de estudios prospectivos "ad hoc". Los casos menos graves no se investigan o comunican, y algunos graves no se diagnostican adecuadamente. Varios estudios lo han demostrado mediante la revisión retrospectiva y la implantación de medidas proactivas de detección. Todos los informes de HV coinciden en señalar al TRALI y al TACO como los principales responsables de la mortalidad transfusional. Así, los datos 2004-2011 de la FDA indican que el TRALI fue responsables del 43% de la mortalidad. En España la incidencia reportada de TRALI es 0.1-0.2/10,000 componentes transfundidos (considerando cualquier grado de imputabilidad), y un poco superior para TACO, con una mortalidad 2006-2012 del 38%. La disminución del TRALI, comunicada en otros países no se observa en España, quizás por el aumento de sospechas clínicas y notifi caciones.

Tratamiento y medidas preventivasLas medidas preventivas del TACO: identifi cación de receptores de riesgo, transfusión de menores volúmenes y administración de diuréticos, son muy efi caces. El tratamiento es el habitual de la insufi ciencia cardiaca. Para el TRALI no existe ningún

tratamiento específi co, salvo las medidas de soporte. Diferentes medidas implementadas en los últimos años están contribuyendo a la reducción de los casos. Medidas propuestas o aplicadas a los donantes y componentes: escrutinio de anticuerpos anti HLA y anti HNA en mujeres con antecedentes gestacionales, selección de plasma para transfusión sólo de donantes varones, sustitución del plasma fresco congelado por plasma tratado con solvente detergente, fi ltración prealmacenamiento, mayor desplasmatización de hematíes y plaquetas, selección de componentes de menor tiempo de almacenamiento para colectivos de riesgo. Medidas propuestas o aplicadas a los receptores: uso óptimo de todos los componentes y en particular del plasma fresco congelado.

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INV-05LECCIONES QUE DEBEMOS APRENDER DE LOS ERRORES EN LA ADMINISTRACIÓN DE COMPONENTES SANGUÍNEOSLópez Soques M.Hospital del Mar, Barcelona, Spain

IntroducciónDesde la infancia, la humanidad aprende del error. Por tanto, ocultar y desoír el error es injusto porque equivale a impedir el "benefi cio" derivado del error. La mejor manera de reducir el error es darlo a conocer. En la cultura del error, atendemos al error trayéndolo a la luz para renovar nuestra estrategia. De esta manera, mediante el tratamiento adecuado del error, se puede prevenir la reiteración del mismo error y proteger a los pacientes.Existen errores de muchos tipos en la vida cotidiana que no son diferentes de los errores en el medio sanitario: errores de cálculo, errores de identifi cación, errores de procedimiento… Todos cometemos errores. Es importante conocer con precisión los puntos negros en la administración de transfusiones, así como se publican los puntos donde se producen más accidentes de tránsito, para prevenir los fallos mediante barreras preventivas específi cas. Este es un deber ético para con los receptores de sangre.

El error humanoAfortunadamente, los incidentes en la administración de sangre son infrecuentes. Por ello, de forma similar al control del error en la aviación civil, es importante aprovechar los " near misses", o errores sin incidente, o errores humanos en que casi se produjo un incidente pero que alguien detectó a tiempo. Estos errores que no llegan al paciente se denominan casi incidentes.Tanto los incidentes como los casi incidentes se pueden clasifi car al igual que es posible clasifi car las reacciones transfusionales adversas. Una correcta clasifi cación permite seleccionar el tratamiento apropiado, tal como sucede por ejemplo con las enfermedades infecciosas y el antibiótico correspondiente.En 1998 el equipo del Dr.H.Kaplan publicó en la revista Transfusion un trabajo pionero para la clasifi cación del error transfusional, denominada MERS-TM (Medical Events Reporting System -Transfusion Medicine). Según éste, en la clasifi cación del error humano se distinguen 3 grandes grupos: los lapsus o fallos de concentración, los fallos de verifi cación, y los fallos de conocimiento:1 - En un fallo de concentración, una persona realiza una

tarea y pierde la concentración por otro encargo o urgencia concomitante.

2 - En un fallo de verifi cación, una persona realiza una tarea y abrevia, omitiendo un paso obligatorio.

3 - En un fallo de conocimiento, una persona realiza una tarea sin disponer de la formación sufi ciente para responder a cualquier desviación.

En una cuarta categoría, el error humano de causa externa, una persona comete un fallo que depende de un factor totalmente ajeno a su actuación. En cada error, conviene clasifi car el error humano en una de estas categorías y pasar a preguntarse el por qué de tal error humano, como indica el apartado siguiente.

Análisis causal del error humanoLos profesionales encargados de analizar un error deben preguntar y preguntarse por qué sucedió el error, e identifi car las causas o circunstancias subyacentes que se denominan errores

latentes o errores del sistema. El análisis causal permite enfocar el tratamiento apropiado. Si preguntamos adecuadamente el por qué, podremos detectar el error latente. Habitualmente, el fallo latente suele ser múltiple. En la clasifi cación MERS-TM, el grupo de causas subyacentes o errores latentes incluye los fallos tecnológicos, los fallos de sistema de la institución, y los fallos fuera del alcance de la institución:1 - El fallo tecnológico es el error que hay que considerar en

primer lugar en el análisis de las causas subyacentes de un error humano. Se debe tratar para prevenir reincidencias.

2 - En segundo lugar, al analizar las causas de un error humano se debe valorar si hubo un fallo del sistema, entendiendo como sistema el diseño de la rutina o la forma de trabajar. Se han descrito cuatro grandes grupos de errores del sistema: los errores debidos a la cultura del servicio, los errores por fallos de transmisión de conocimiento, los errores de priorización, y los errores de protocolos.

3 - Cada servicio y centro de transfusión decide su forma de funcionamiento y sus procedimientos de trabajo. La cultura de la empresa puede primar la imagen por encima de otros valores, por ejemplo. La empresa puede no tener canales de organización de la formación de los profesionales. Un servicio puede priorizar ciertas actividades analíticas por encima de otras, como la dotación de plantilla, al decidir el destino del presupuesto económico. Los procedimientos normalizados de trabajo pueden ser demasiado simples o excesivamente complicados, pueden estar ausentes en ciertas actividades o pueden estar anticuados. Todo ello origina una sistemática de trabajo propia y precisa de cada empresa o servicio.

4 - En un error de causa externa, las condiciones dependen de factores externos que el propio servicio no puede controlar. Se trata de factores económicos o jerárquicos externos que condicionan el sistema de trabajo. Los fallos de sistema fuera del alcance de la institución se deben reconocer para informar a los responsables en jerarquías superiores.

Tratamiento Si en un hospital se detectan lapsus o errores de concentración, es importante establecer una política de concentración, silencio y orden en la atención a pacientes. Puede ser necesario intercalar una verifi cación en algún procedimiento hospitalario y revisar la dotación de plantilla. Todos los profesionales deben ser notifi cados de los lapsus sucedidos, de manera que comprendan y acepten nuevas políticas de seguridad.Si en un hospital se detectan errores por incumplimiento, conviene revisar los procedimientos correspondientes y posiblemente cambiar la sistemática de trabajo; esto puede signifi car "adelgazar" el sistema, revisando verifi caciones quizá inútiles y añadiendo algún punto de verifi cación. Es necesario fl exibilizar la redacción de protocolos de forma de que 1) existan para cada punto de importancia, 2) sean comprensibles, 3) sean realizables, y 4) sean conocidos y aceptados por el personalSi en un centro se detecta un error humano de conocimiento, se debe revisar la sistemática de formación, tanto el adiestramiento inicial como el mantenimiento de la formación. Si el análisis del error humano y de los posibles errores latentes o subyacentes se realiza correctamente, el cambio en el sistema se asocia al éxito. Desaparecerá el error humano si desaparecen los factores causales.

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INV-06ASPECTOS CONTROVERTIDOS EN LA HEMOVIGILANCIA DE LAS ENFERMEDADES TRANSMISIBLESOyonarte S.Centro de Transfusión de Sevilla y Huelva, Sevilla, Spain

Los siguientes aspectos debemos abordarlos al hacer un acercamiento de la Hemovigilancia al área de cribado de los marcadores infecciosos:

1. Investigación retrospectiva o look-back de donaciones efectuadas por donantes que han seroconvertidoEl contenido del Anexo IV del Real Decreto1 1088/2005, supone un cambio de la forma de tratar los resultados anormales de serología. Hasta su publicación nos guiábamos por lo establecido en la Orden2 de 2 de Julio de 1999, según la cual solo se informaba a los centros receptores de productos anteriores a las seroconversiones en los casos de resultados positivos de las pruebas de confi rmación, mientras que en caso de resultados indeterminados se informaba únicamente al centro de tratamiento del plasma. El RD 1088/2005, en cambio, establece que se debe informar a los centros receptores de productos anteriores a las seroconversiones "cuando una muestra resulte repetidamente reactiva en las pruebas de cribado o las pruebas de confi rmación sean positivas o no concluyentes". Las consecuencias de esta indicación, poco práctica y difícil de cumplir, que puede deberse al cambio de una conjunción copulativa ("y") por la primera conjunción distributiva ("o") de la frase entrecomillada, han sido tratadas con detalle y sentido común en un boletín de la SETS3.Siguiendo la idea de este trabajo, debemos comunicar solo las conversiones, es decir, los resultados repetidamente reactivos en las pruebas de cribado de serología con pruebas complementarias y/o NAT positivas. Según la prueba alterada y el tipo de componente, se puede actuar como sigue:a) Plasma. Ajustarse a las normas de Grifols. Comunicar las conversiones "en un periodo no superior a una semana desde que se detecta el hecho que lo motiva" y "todas las unidades de plasma obtenidas de un donante en los doce meses anteriores a la última donación negativa". Se comunican las conversiones de VHB, VHC y VIH, pero no las de sífi lis. La expresión "en un periodo no superior a una semana desde que se detecta el hecho que lo motiva", ahora han bajado a cinco días, se presta a interpretación; para poder cumplir el plazo hay que considerar que el hecho que lo motiva es una prueba de cribado repetidamente positiva que se acompaña de una prueba NAT discriminatoria positiva. O cuando tomamos por referencia la prueba serológica de confi rmación, se entiende que es a partir del resultado de esta última prueba.b) Hematíes con pruebas de VHB, VIH y VHC alteradas. Hacer look-back de los hematíes de la última donación negativa. No es necesario extender la investigación a la donación inmediatamente anterior a la última negativa en los casos de donación de sangre total.c) Para las conversiones de marcadores de introducción reciente (Chagas, HTLV, malaria), hay que hacer look-back desde la donación inmediatamente anterior a la conversión hasta encontrar una donación cuyos receptores sean negativos.

2. Con respecto al denominado trace-back o seguimiento de los donantes de componentes trasfundidos a paciente que ha seroconvertido para el marcador de una infección susceptible de ser transmitida por la sangrea) Considerar que los donantes que tienen una donación negativa posterior a la implicada, con un intervalo superior a la duración del periodo ventana, no han podido transmitir la infección.

b) Por tanto, se cita solo a los donantes que no tienen donaciones posteriores a la implicada. A estos donantes se les debe pedir las pruebas de cribado de una donación, pero no directamente pruebas complementarias tipo inmunoblot, que pueden dar resultado dudoso con pruebas de cribado negativas. En caso de trace-back por hepatitis B supuestamente postransfusional, debe pedirse anti-HBc además de HBsAg y ADN de VHB.c) Sobre la utilización de muestras de seroteca, no tiene sentido usar estas muestras para repetir pruebas que ya se habían hecho. Puede valorarse el repetir con muestra individual una prueba hecha en mini-pool.

3. Protocolo para seguimiento de receptores de productos correspondientes a donantes con hepatitis B ocultaConsideraremos que un donante tiene hepatitis B oculta (HBO) si en su sangre se detecta ADN del VHB pero no HBsAg, pudiendo presentar o no HBcAc y/o HBsAc. La concentración de ADN de VHB es inferior a 200 UI/mL4. En España la prevalencia de HBO está alrededor de un caso por cada veinte mil donaciones. Las donaciones que tienen estas características deben considerarse infecciosas4, pero los datos sobre su capacidad de transmisión del virus de la hepatitis B (VHB) son escasos y basados en estudios con un número de receptores pequeño5,6.Hacer un seguimiento solo de la donación inmediatamente anterior a la conversión del donante es la decisión más discutible de las que se han tomado para elaborar este protocolo. En USA no está contemplado el look-back para VHB7 y en España la investigación retrospectiva está defi nida en el Anexo IV del RD 1088/2005. A pesar de que este apartado ha planteado problemas de interpretación, de su contenido se deduce que debe hacerse look-back de las donaciones de donantes con HBO, aunque no delimita el tiempo. El grupo ETT de la SETS decidió limitar la investigación retrospectiva por HBO a la donación inmediatamente anterior a la donación positiva para ADN de VHB. a - Estudio de las donaciones y seguimiento del donanteA todas las donaciones con serología de donante negativa y NAT+, se les determinará HBcAc, HBsAc y prueba de discriminación NAT. a.1. A las donaciones cuyo único marcador positivo sea ADN

de VHB, se les hará una cuantifi cación del mismo.- a.1.1. Si el resultado es inferior a 200 UI/mL (<1,000

geq/mL), lo más probable es que el donante presente una hepatitis B oculta seronegativa. Se citará al donante para comprobación.

- a.1.2. Si el resultado es superior a 200 UI/mL (>1,000 geq/mL), probablemente el donante no presenta una HBO, siendo obligatorio descartar una infección reciente en periodo de ventana serológica. Se citará al donante dos meses después de la donación, con objeto de que sea más probable encontrar HBsAg positivo.

a.2. A las donaciones HBcAc y/o HBsAc positivo con ADN de VHB positivo, también se les hará una cuantifi cación de este último, así como determinación de HBcAc IgM (si es HBcAc positivo) y de HBeAc.- a.2.1. Si los únicos marcadores de VHB son ADN y

HBsAc, hay que descartar que se trate de una infección aguda en una persona vacunada frente a VHB.

- a.2.2. Si el resultado es inferior a 200 UI/mL (<1,000 geq/mL), lo más probable es que el donante presente una hepatitis B oculta seropositiva. Se habrán desechado todos los productos de la donación y se citará al donante.

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- a.2.3. Si el resultado es superior a 200 UI/mL (>1,000 geq/mL), hay que descartar una infección por mutantes de escape del gen S de VHB4.

b) Estudio y seguimiento de los receptores (look-back)b.1. Después de diagnosticar HBO en un donante, se averigua

el destino de los componentes de su última donación. Si se envió algún producto a la industria fraccionadora, se le comunica. La comunicación a los hospitales debe ir acompañada de una explicación sobre la baja probabilidad de transmisión y la conveniencia de que extraigan muestras al receptor.

b.2. A la muestra del receptor se le deben hacer ADN de VHB, HBsAg, HBcAc y HBsAc. Si el ADN es positivo, hay que hacer cuantifi cación, genotipo y secuenciación para establecer identidad con el VHB del donante. Puede ser necesario hacer además HBcAc IgM, HBeAc y HBeAg.

b.3. Para considerar que una donación ha transmitido el VHB debe establecerse una identidad entre los virus del donante y del receptor por secuenciación7. Si se detecta algún caso se comunicará a los centros a los que se enviaron los componentes de la donación y al sistema de hemovigilancia, además de hacer look-back con los componentes de la donación inmediatamente anterior.

AgradecimientosDr. Manuel Álvarez, CTS de la Comunidad Valenciana. El texto y protocolos descritos han sido extraídos de las actas del grupo de enfermdedades tranmisibles por transfusión (ETT) de la Sociedad Española de Transfusión Sanguínea (SETS).

Referencias1) Real Decreto 1088/2005, de 16 de septiembre, por el que se

establecen los requisitos técnicos y condiciones mínimas de la hemodonación y de los centros y servicios de transfusión. BOE 2005; 225: 31288-304 (20 de septiembre de 2005).

2) Orden de 2 de julio de 1999, por la que se actualizan las condiciones de exclusión de los donantes de sangre y se establecen los criterios de interpretación de las pruebas para la detección de agentes infecciosos en las donaciones de sangre. BOE 1999; 168: 26792-3 (15 de julio de 1999).

3) Monsalve Gil-Fournier F, Jiménez del Bianco A. El algoritmo para la interpretación de las pruebas para la detección de agentes infecciosos en las donaciones de sangre. SETS 2009; 21 (3): 20-21.

4) Raimondo G, Allain J-P, Brunetto MR, Buendia M-A, Chen D-S, Colombo M et al. Statements from the Taormina expert meeting on occult hepatitis B virus infection. J Hepatol 2008; 49: 652-7.

5) Satake M, Taira R, Yugi H et al. Infectivity of blood components with low hepatitis B virus DNA levels identifi ed in a look-back program. Transfusion 2007; 47: 1197-205.

6) Hollinger FB. Hepatitis B virus infection and transfusion medicine: science and the occult. Transfusion 2008; 48: 1021-6.

7) Hollinger FB, Dodd RY. Hepatitis B virus traceback and lookback: factors to consider. Transfusion 2009; 49: 176-84.

INV-07LOS RETOS PENDIENTES: LA ENFERMERA DE HEMOVIGILANCIA, LA FORMACIÓN Y CAPACITACIÓN, EL USO ÓPTIMOAlba Bosch M.Hospital de Sant Pau, Barcelona, Spain

Los sistemas de Hemovigilancia permiten conocer los riesgos y los efectos adversos de la transfusión sanguínea. En el del Reino Unido la información recogida, presentada y publicada anualmente desde 1996, ha cristalizado en diversos cambios de la práctica transfusional, obteniendo como resultado una mejoría en la seguridad del paciente con reducción de los efectos adversos y de la mortalidad. También ha estimulado muchas otras iniciativas como la auditoría nacional de transfusión y estrategias educacionales aprobadas por las autoridades gubernamentales dirigidas a reducir los riesgos e incrementar la seguridad transfusional. Dentro del Estado Español, Cataluña es una de las comunidades autónomas que dispone de un sistema de Hemovigilancia más consolidado, con 10 años de experiencia, que le permite conocer de forma clara cuales son los riesgos actuales de la transfusión sanguínea. Igual que en otros países los riesgos están fundamentalmente asociados a los errores en la administración de componentes sanguíneos, más concretamente a los errores de identifi cación de los pacientes que son responsables de reacciones hemolíticas agudas con un alto grado de morbilidad y mortalidad. Únicamente detectando y estudiando los errores y el origen de los mismos es posible implementar medidas pertinentes. En este sentido, el estudio y reconocimiento de los errores latentes resulta imprescindible para la seguridad transfusional. Y, además, la participación del paciente empieza a ser urgente en nuestro objetivo de seguridad.Hemos visto que algunas posibles soluciones pasan por: 1) conseguir la máxima difusión de los informes de Hemovigilancia haciéndolos llegar a los médicos prescriptores y al personal de enfermería; y 2) insistir en la formación y capacitación del personal que lleva a cabo la transfusión, sin olvidar la formación continuada del personal veterano.La creación o la consolidación de la fi gura del enfermero o enfermera de Hemovigilancia, puede ser determinante en la reducción o eliminación de estos errores. Su presencia permite aumentar la calidad y la seguridad de la transfusión, y los hospitales que disponen de ella ya están marcando una diferencia notable respecto al resto, tal como ha sucedido en Irlanda y el Reino Unido. Ha llegado el momento de plantearnos el dar un paso adelante y avanzar en la temática del buen uso de la sangre, y del uso adecuado o correcto de los componentes sanguíneos. El propio sistema de Hemovigilancia ya nos está informando en parte de este buen o mal uso a través de la transfusiones erróneas, inapropiadas o innecesarias, o de aquellas en las que no se cumplen los requisitos previstos, pero el reto es todavía mayor, y debemos entrar más activamente en las indicaciones clínicas de la transfusión y de los diferentes componentes sanguíneos. En esta presentación revisaremos algunas de las iniciativas que se han llevado a cabo en España, en general, y en Cataluña, en particular, en cuanto a lo que consideramos retos pendientes del sistema de Hemovigilancia: 1) la formación y capacitación del personal que realiza la transfusión, 2) la creación de la fi gura de la enfermera/o de Hemovigilancia, y 3) el uso óptimo de la sangre.

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En los últimos años en Cataluña se han realizado varios estudios en relación al uso de la sangre de los cuales daremos una breve pincelada: 1) el estudio epidemiológico de la transfusión que nos informa de las características de los pacientes que transfundimos, así como de las patologías y procedimientos que más componentes sanguíneos consumen; 2) un análisis comparativo entre varios hospitales de la variabilidad en las indicaciones de transfusión en diferentes patologías, y 3) una auditoría multicéntrica sobre la adecuación del uso de los componentes sanguíneos.Actualmente disponemos de unos componentes sanguíneos muy seguros, como jamás lo han sido, y el reto es conseguir que la transfusión sanguínea, y que todo el proceso que acontece en el ámbito hospitalario, llegue a ser tan segura como nuestros componentes.Hoy en día se está hablando de un nuevo modelo, que no contempla únicamente el uso óptimo de la sangre, sino que se centra en la valoración global de las necesidades terapéuticas del paciente, de forma multidisciplinar y contando con el propio paciente: el "Patient Blood Management". Avanzar en seguridad transfusional requiere trabajar de forma coordinada unifi cando esfuerzos, mediante la mejora de la formación y de las competencias, desde la prescripción médica hasta la administración de la transfusión.

INV-10WHO ARE THE PATIENTS WE ARE TRANSFUSING?ARE THE PREVENTIVE MEASURES SUITABLE FOR THE EPIDEMIOLOGICAL PROFILE OF OUR PATIENTS?Grifols J.R.Banc de Sang i Teixits, Barcelona/Hospital Germans Trias i Pujo, Spain

Transfusion of blood and blood components is one of the most common medical procedures performed in the developed world. More than 10% of patients admitted to hospitals were transfused and this is one of the most frequently employed procedures among discharge codes recorded for hospital inpatients. Despite this common use, transfusion practice continues to be dogged by controversies.While blood collection, blood establishments and hospital transfusion services are highly regulated, transfusion, as part of a therapeutic strategy in sick persons, its current use and the monitoring and study of them are elements of "patient care" and thus beyond the reach of most regulatory arms. Despite the known potential risk of unnecessarily transfusions, blood component therapy is estimated to have saved over a billion lives around the world since the mid-twentieth century representing one of the greatest achievements in patient care throughout history. However, the decision to transfuse or not to transfuse is one of the more complex decisions made by medical practitioners. Historically many studies about correct blood components prescription have focused on the comparative analysis of conservative vs liberal transfusion practices, usually focusing on the classic question of how many units should be necessary to transfuse without regarding the patient's characteristics. The transfusion decision, rather than on clinical evidence, relies often on numbers, a very restrictive and punitive regulatory framework, the prescriber's fear against potential claims or an excess of expectations generated in the society in case to be transfused. The prescriber decision should consider individual patient characteristics including age, sex, weight, comorbidity, whole blood volume, etc., estimating the specifi c benefi t/risk in the specifi c patient of blood component administration. This decision is enough complex and important to be based just on a few numbers and must always weigh the risks and benefi ts associated with transfusion against those related with anemia, thrombocytopenia or clotting factor disorders. In the absence of more uniform standards consensus guidelines will be the only element in which we may base our transfusion decision. It urges the establishment of policies and management guidelines based on evidence and focused on the patient in order to clearly defi ne the indications on the use of blood components and to identify and reduce those possible situations that behave bad indication or improper use of these.Correct and safety blood component transfusion should be based on: - it's an individualized decision for a specifi c patient;- proper transfusion indication;- selection of the most suitable blood component according to

the patient's needs;- accurate dosage of the prescribed component;- correct blood component administration by qualifi ed staff.These factors support the need to promote safe and evidence-based clinical transfusion practice. The introduction of patient blood management (PBM), defi ned as (Professional defi nition)

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the timely application of evidence-based medical and surgical concepts designed to maintain hemoglobin concentration, optimize hemostasis and minimize blood loss in an effort to improve patient outcome or (Public description) the scientifi c use of safe and effective medical and surgical techniques designed to prevent anemia and decrease bleeding in an effort to improve patient outcome, shows that the need for transfusion can be minimized in many patients by implementation of thoughtful processes often beginning days or even weeks before the actual decision to transfuse or not is being made. Transfusion medicine is moving from a component safety emphasis to patient-centered decision making, focusing on holistic patient management, including methods to minimize transfusion requirements and therefore decrease the risk of transfusion-related adverse events. In this context, the focus has now shifted to the benefi t side of the equation risk/benefi t in blood component transfusion. Are the assumed benefi ts of transfusion universal or are they limited to only a well-defi ned population of patients? What triggers should be used to administer blood components and when should transfusions occur? What component dose is suffi cient and/or necessary to confer clinical benefi t? The answers to these questions have been sought in multiple randomized clinical trials. The next step of this process is to translate this information into widely adopted and consistent practice through the development of clinical practice guidelines that can become a part of comprehensive PBM.There are relatively few studies focused on the epidemiologic characteristics of blood recipients and these could improve the utilization of transfusion resources:- to determine the detailed profi le of the demographic and

clinical features of blood recipients;- to know the relative utilization by specifi c clinical conditions

and diagnostic or therapeutic procedures;- to help the prediction of long-term needs for blood

transfusion;- to provide information that can be useful in contingency

planning for blood shortages;- to allow the assessment of the potential impact that either blood

conservation techniques or changes in the case mix of transfused patients will have on the demand for blood components;

- to benchmark with other Blood Transfusion Services in order to achieve more appropriate use of blood transfusion resources.

It's important to know about patients we transfuse:- demographic and clinical features of recipients of blood

components;- immediate medical reason behind the need for transfusion;- product mix received by transfused patients;- identify transfusion practices susceptible of improvement;- derive population-based estimates useful both to predict the

future demand for blood transfusion and to better characterize the public health impact of transfusion safety measures.

Epidemiological profi les are a still photograph of the blood component transfusion. It would be necessary to repeat these cross-sectional surveys to have a dynamic view of blood component utilization and to capture the most relevant trends. Meanwhile it should be necessary to evaluate the clinical appropriateness of individual transfusions which would be very valuable to improve transfusion practices. Long-term predictions based only on demographic profi les are subjected to several sources of uncertainty. Estimations about the future population mix are intrinsically uncertain and do not take into account future changes in the patient case mix and transfusion practices. Despite those uncertainties, predictions of future

transfusion needs may prove to be a valuable aid for the long-term planning of blood supply.

References1) Ansari S, Szallasi A. Blood management by transfusion triggers:

when less is more. Blood Transfus 2012; 10 (1): 28-33.2) Bosch MA, Contreras E, Madoz P, et al. The epidemiology

of blood component transfusion in Catalonia. Transfusion 2011; 51: 105-16.

3) de Vries RR, Faber JC, Strengers PF, Board of the International Haemovigilance Network. Haemovigilance: an effective tool for improving transfusion practice. Vox Sang 2011; 100 (1): 60-7.

4) Ditomasso J, Liu Y, Heddle NM. The Canadian Transfusion Surveillance System: what is it and how can the data be used?. Transfus Apher Sci 2012; 46 (3): 329-35.

5) Engelbrecht S, Wood EM, Cole-Sinclair MF. Clinical transfusion practice update: haemovigilance, complications, patient blood management and national standards. Med J Aust 2013; 199 (6): 397-401.

6) Epstein JS. Alternative strategies in assuring blood safety: An overview. Biologicals 2010; 38 (1): 31-5.

7) Goodnough LT, Levy JH, Murphy MF. Concepts of blood transfusion in adults. Lancet 2013; 381 (9880): 1845-54.

8) Goodnough LT , Sh ieh L , Hadhazy E , e t a l . Improved blood utilization using real-time clinical decision support. Transfusion 2013; DOI: 10.1111/trf.12445.

9) Hillyer CD, Blumberg N, Glynn SA, Ness PM, NHLBI Working Group in Transfusion Recipient Epidemiology and Outcomes Research. Transfusion recipient epidemiology and outcomes research: possibilities for the future. Transfusion 2008; 48 (8): 1530-7.

10) Hohmuth B, Ozawa S, Ashton M, Melseth RL. Patient-centered blood management. J Hosp Med 2014; 9 (1): 60-5.

11) Klein HG. How safe is blood, really? Biologicals 2010; 38 (1): 100-4.

12) Kuehn BM. Guideline tightens transfusion criteria. JAMA 2012; 307 (17): 1788-9.

13) Leahy MF, Mukhtar SA. From blood transfusion to patient blood management: a new paradigm for patient care and cost assessment of blood transfusion practice. Intern Med J 2012; 42 (3): 332-8.

14) Roback JD. Evidence-based guidelines for blood transfusion. J Infus Nurs 2012; 35 (3): 187-90.

15) Shander A, Gross I, Hill S, et al. A new perspective on best transfusion practices. Blood Transfus 2013; 11 (2): 193-202.

16) Spahn DR, Shander A, Hofmann A. The chiasm: transfusion practice versus patient blood management. Best Pract Res Clin Anaesthesiol 2013; 27 (1): 37-42.

17) Szczepiorkowski ZM, Dunbar NM. Transfusion guidelines: when to transfuse. Hematology Am Soc Hematol Educ Program 2013; 2013: 638-44.

18) Vamvakas EC, Blajchman MA. Blood still kills: six strategies to further reduce allogeneic blood transfusion-related mortality. Transfus Med Rev 2010; 24: 77-124.

19) Venkatesh V, Khan R, Curley A, et al. How we decide when a neonate needs a transfusion. Br J Haematol 2013; 160 (4): 421-33.

20) Vincent JL. Transfusion triggers: getting it right!. Crit Care Med 2012; 40 (12): 3308-9.

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INV-11WHAT IS MORE DANGEROUS:THE ANAEMIA OR THE BLOOD TRANSFUSION?Vincent J.L.Erasme Hospital, Université Libre de Bruxelles, Belgium

Some degree of anaemia is common in critically ill patients with about one fourth of intensive care unit (ICU) admissions having a haemoglobin concentration <9-10 g/dL1-4. The aetiology of the anaemia is multifactorial, including haemorrhage from trauma, surgery, gastro-intestinal bleeding; phlebotomy losses; blunted erythropoietin production; abnormalities in iron metabolism; and altered proliferation and differentiation of bone marrow erythroid precursors5. In most patients, several mechanisms will be involved. Multiple studies have demonstrated that severe anaemia is associated with worse outcomes, both in terms of increased risks of complications, such as delayed wound healing and increased incidence of cardiac arrhythmias, but also increased short and long-term mortality rates3,6,7. Importantly, however, tolerance to anaemia is highly patient dependent and will also be related to the degree of anaemia present and the speed with which it has developed. Elderly patients and patients with co-morbid ischemic heart disease or heart failure will tolerate anaemia less well than other patients; and normovolemic dilutional anaemia is tolerated better than anaemia in hypovolemic states (e.g., acute bleeding)5. In general ICU practice, as many as one third of ICU patients will receive a red blood cell (RBC) transfusion during their ICU stay1,2,8, generally in the belief that this intervention will help restore and maintain oxygen delivery, and thus optimize a patient's chance of survival. However, RBC transfusion may not always improve oxygenation: for example, by increasing haemoglobin concentration, viscosity may increase, potentially reducing microcirculatory fl ow to the tissues; and in sepsis, altered oxygen extraction capabilities and RBC deformability may reduce the degree of oxygen downloaded from haemoglobin to the tissues. Moreover, risks of transmission of certain infectious diseases and development of immunosuppression remain a concern. Several observational studies and meta-analyses have suggested increased morbidity and mortality in patients who receive a blood transfusion during their ICU stay1,2,9; however others have suggested no effect or a benefi cial effect on outcomes3,8,10. The now relatively old randomized TRICC study (11), showed that a restrictive transfusion practice (transfusion if haemoglobin level <7g/dL) was not associated with higher mortality rates than a more liberal strategy (transfusion if haemoglobin level <10 g/dL) in all patients, that patients with APACHE II <20 and those aged <55 years of age may have fared better with the restrictive approach11, and that patients with ischaemic heart disease had higher mortality rates if managed according to the restrictive strategy12. Indeed the heart is of particular concern as the increased cardiac output associated with higher myocardial contractility and faster heart rate may increase myocardial oxygen demand when the arterial oxygen content is reduced. More recent studies comparing transfusion strategies in specifi c groups of patients have given confl icting results13 such that it is not possible to identify an "ideal" transfusion trigger for all and diffi cult to clearly specify an "at risk" group of patients.So, the question, "What is more dangerous: the anaemia or the blood transfusion?" cannot be answered by a simple either/or response. It is not possible to say which is more dangerous in all patients. The risks of anaemia and of transfusion will vary according to the individual patient being treated, such

that in one patient the benefi ts of transfusion will outweigh the potential risks, while in another, the risks will push the balance in the other direction. Unfortunately, we have few tools to help determine the adequacy of tissue oxygenation, which could help in assessing the likely benefi t of transfusion in individual patients: cardiac output, venous oxygenation, oxygen extraction, and blood lactate levels can give some indication of global oxygenation but offer little information about regional tissue oxygenation. Techniques to monitor the microcirculation may prove useful but are still experimental at present. Patient factors (including age, co-morbid disease [especially cardiovascular], current disease process, proposed intervention), clinical examination, and global oxygenation parameters must, therefore, be taken into account when deciding whether or not to transfuse each individual patient14,15.

References1) Vincent JL, Baron JF, Reinhart K, et al: Anemia and blood

transfusion in critically ill patients. JAMA 2002; 288: 1499-507.2) Corwin HL, Gettinger A, Pearl RG, et al. The CRIT Study:

Anemia and blood transfusion in the critically ill--current clinical practice in the United States. Crit Care Med 2004; 32: 39-52

3) Sakr Y, Lobo S, Knuepfer S, et al. Anemia and blood transfusion in a surgical intensive care unit. Crit Care 2010; 14: R92.

4) Nguyen BV, Bota DP, Melot C et al: Time course of hemoglobin concentrations in nonbleeding intensive care unit patients. Crit Care Med 2003; 31: 406-10.

5) Lelubre C, Vincent JL: Red blood cell transfusion in the critically ill patient. Ann Intensive Care 2011; 1: 43.

6) Carson JL, Poses RM, Spence RK, et al. Severity of anaemia and operative mortality and morbidity. Lancet 1988; 1: 727-9.

7) Mudumbai SC, Cronkite R, Hu KU et al. Association of admission hematocrit with 6-month and 1-year mortality in intensive care unit patients. Transfusion 2011; 51: 2148-59.

8) Vincent JL, Sakr Y, Sprung C, et al. Are blood transfusions associated with greater mortality rates? Results of the Sepsis Occurrence in Acutely Ill Patients study. Anesthesiology 2008; 108: 31-9.

9) Marik PE, Corwin HL. Effi cacy of red blood cell transfusion in the critically ill: a systematic review of the literature. Crit Care Med 2008; 36: 2667-74.

10) Park DW, Chun BC, Kwon SS, et al. Red blood cell transfusions are associated with lower mortality in patients with severe sepsis and septic shock: a propensity-matched analysis. Crit Care Med 2012; 40: 3140-5.

11) Hebert PC, Wells G, Blajchman MA, et al. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med 1999; 340: 409-17.

12) Deans KJ, Minneci PC, Suffredini AF, et al. Randomization in clinical trials of titrated therapies: unintended consequences of using fi xed treatment protocols. Crit Care Med 2007; 35: 1509-16.

13) Vincent JL, Sakr Y, Lelubre C. The future of observational research and randomized controlled trials in red blood cell transfusion medicine. Shock 2013; in press.

14) Vincent JL. Transfusion triggers: getting it right! Crit Care Med 2012; 40: 3308-09.

15) Vincent JL. Indications for blood transfusions: too complex to base on a single number? Ann Intern Med 2012; 157: 71-2.

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INV-12PROPOSED INCLUSION OF BLOOD IN THE PROJECT NOTIFY LIBRARY AS A MEDICAL PRODUCT OF HUMAN ORIGIN: A REPORT FROM THE BLOOD TRANSFUSION WORKGROUP OF THE WHO CONSULTATION FOR VIGILANCE AND SURVEILLANCEWhitaker B.AABB, Bethesda, MD, USA

BackgroundThe WHO Global Consultation for Vigilance and Surveillance of Organs, Tissues and Cells, has developed Project Notify as part of an international effort to promote the sharing of published vigilance information for didactic purposes and for greater public transparency. The Notify Library is an open access online compendium and review of information already available from other sources. The original scope included organs, tissues and cells used in transplantation or in assisted reproduction therapies, addressing adverse events and outcomes in both recipients and living donors. Expansion to include blood (haemovigilance) in the library as the most frequently used Medical Product of Human Origin (MPHO) was proposed at the Project Notify meeting in Brasilia, December 7-9, 2013. This proposal refl ects the WHO approach to considering all MPHO in a manner that acknowledges the ethical and safety risks associated with their exceptional nature.

MethodsThe subject matter experts of the Blood Transfusion Working Group proposed taxonomies for blood as a substance and for transfusion adverse incidents that integrate with the Notify Library taxonomic structure. The library of adverse transfusion incidents is intended to describe all types of reactions or events that might have didactic value and might assist in the estimation of risk.

ResultsSeparate taxonomies were developed for blood as an MPHO and for serious adverse events and serious adverse reactions. For each reaction or event type, at least one reference source will be sought and the project's collaborating international experts will develop structured analyses that include alerting signals and imputability.

ConclusionIn order to assure comprehensive didactic content for the Notify Library, the Blood Transfusion Working Group requests support from the International Haemovigilance Network Community so as not to duplicate efforts while making available key resources for the global initiative.

INV-13BENCHMARKING BLOOD DONOR SAFETY PRACTICES: A FIRST EXPERIENCEFolléa G.1, Tiberghien P.2

1European Blood Alliance, Brussels, Belgium; 2Etablissement Français du Sang, Saint Denis, France

BackgroundDonor safety is of paramount importance, particularly for blood establishments (BE) collecting blood and blood components from voluntary non-remunerated donors. Although recent scientifi c studies have helped assessing and improving donor safety in BEs, important variations in practices regarding blood donor safety seem to persist between BEs.

ObjectiveThe objective was, on a voluntary basis, to benchmark practices implemented at Etablissement Français du Sang (EFS) for donor safety, to get an appreciation from international experts on EFS practices, to identify ways of improvement, both for EFS and other BEs of the European Blood Alliance (EBA).

Material and methodsEFS prepared a set of data relating to donor safety and presented it to a panel of experts from 4 other countries (Germany, Finland, Netherlands, United Kingdom). This occurred fi rst in a visit of a fi xed collection site in Paris and then in a one day workshop with 3 sessions focusing respectively on i) means to prevent adverse donor reactions; ii) means to cure/manage donors with adverse reactions; iii) donor vigilance. All sessions were attended by EFS managers involved in donor safety. Visit and discussions, facilitated by the EBA, were focused on identifying best practices and ways to improve donor safety. The Executive summary and minutes of these benchmarking actions were written so one could clearly identify strengths, weaknesses and actions to develop to improve blood donor safety. They have been reviewed and approved by all participants.

ResultsThe following main ways forward have been identifi ed. - Qualifi cation needed for pre-donation interviewers: it was

diffi cult to objectively identify best practice for pre-donation interviewer qualification (medical doctor or not). EFS should pursue its project to introduce qualifi ed nurses for pre-donation interviews.

- Donor questionnaire archiving: the EFS procedure (only donor consent is track recorded) seemed medically acceptable, but could raise legal issues in case of need of lookback. EFS should work on this issue.

- Whole blood donation volumes: deferring donors if the collected volume would exceed 15% of blood volume, as refl ecting the Council of Europe Guide recommendations, and as practiced in FR and UK, has been identified as good practice. This practice is not implemented in BEs collecting 450 mL in donors weighing 50 kg. BEs elsewhere in Europe not doing so yet should implement the related recommendations of the Council of Europe Guide (<15% blood volume).

- Prevention of cardiovascular decompensation: studies to assess the potential value of blood pressure and pulse rate for donor safety should be envisioned (also in the perspective

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of EU Blood Directives revision). All the other criteria implemented at EFS for preventing this type of risk for donors should be considered by all BEs. EFS will make its SOP on this point available in English.

- Prevention of vaso-vagal (VV) reactions: as all participating countries have implemented some form of hydration and, except for France, muscle tension as well, EFS was encouraged not to wait too long to perform its study on effectiveness of isotonic hydration and muscle tension. Based on preliminary data from NL, EFS was advised to add to its study Hb level as a new parameter which could potentially infl uence the VV reaction rate in donors.

- Hemoglobin measurement and level: EFS has a different approach as compared to all other EU countries, mainly inspired from previous scientifi c studies in Germany1, 2. Their justifi cation (accepted by the French national Competent Authority) is that it complies with normal ranges for Hb in normal individuals and Hb measurement on a venous sample at each donation is offering donors good safety conditions. The international experts agreed on this approach but deemed it not feasible in their countries for legal/regulatory reasons. EFS was encouraged to submit its experience for publication in a peer reviewed journal, particularly with regard to donor safety.

- Staff training and qualifi cation: EFS should make available to other EBA members its staff training and qualifi cation procedures, much appreciated by the international experts (already available in English).

- Self-assessment system to reduce risks: the system developed at EFS, facilitating continuous improvement by means of self-assessment, was much appreciated by the international experts. EFS was thus encouraged to submit its experience for publication in a peer reviewed journal and to fi nd out a second country accepting to implement an equivalent system (with the necessary adaptations) to further assess and validate the method.

- Donor vigilance: all acknowledged diffi culties met to deduce donor safety measures from the current vigilance data. Regular analysis and discussion of donor safety issues at national level (as already done at EFS and other countries) should be encouraged.

ConclusionsThe international experts appreciated the efforts of EFS and the method used for this benchmarking exercise. They expressed confi dence in the system and measures implemented by EFS for donor safety. The benchmarking method set up for this meeting on donor safety proved to be effective in identifying practice variation and for a number of good practice items. With the vision recently developed for benchmarking applied to transfusion medicine activities3, a follow up of the outcomes from this benchmarking has been organised to encourage implementation of identifi ed good practices and to assess if this benchmarking exercise succeeded in inducing changes in practices, and beyond in improving donor safety.

AcknowledgementsHarald Klüter (DE), Johanna Castrén (FI), Wim de Kort (NL), Gail Mifl in (UK) as well as participating EFS colleagues are deeply acknowledged for their very valuable contribution to this benchmarking exercise.

References1) Lotfi R, Wernet D, Starke U et al. A noninvasive strategy for

screening prospective blood donors for anemia. Transfusion 2005, 45: 1585-92.

2) Ziemann M, Steppat D, Brockmann C et al. Selection of whole-blood donors for hemoglobin testing by use of historical hemoglobin values. Transfusion 2006, 46: 2176-83.

3) Heddle NM, Barty R. Benchmarking: applications to transfusion medicine. ISBT Science Series 2013, 8: 93-9.

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INV-14THE SPANISH HAEMOVIGILANCE SYSTEMVesga M.A.Ministry of Health, Spain

The organisation of Blood Transfusion in SpainThe organisation of health in Spain is highly decentralised. The Ministry of Health, from Madrid, coordinates the functions of the whole structure and logically works as the competent authority for many common responsibilities. However, it is the regional authorities who are actually in charge of managing the health systems, including Transfusion Services and Blood Establishments.There are 17 regional governments in charge of their own Health Services and they work as competent authorities as part of the National Network of Blood Establishments and Hospital Transfusion Services. Although these institutions operate in specifi c regions, they are linked and work together towards common goals. They are public services that are coordinated to meet the national transfusion needs, self-suffi ciently. In short, there are 24 centres that collect and supply blood components to around 380 Hospital Transfusion Units. The former (called Blood Establishments) draw and test human blood and its components, whatever the destination, and is in charge of its treatment, storage and distribution when transfusion is required. The latter (Hospital Transfusion Services) are care units located in hospitals linked to a Blood Establishment where blood and blood components are stored for transfusion, where compatibility tests on blood and blood components can be conducted to be used exclusively in their facilities, including hospital transfusion.The Ministry of Health is the competent authority for, amongst other things, relationships with the European Union, so its role in the Spanish and European Haemovigilance System is crucial.

The Spanish Haemovigilance SystemThe Spanish Haemovigilance System is a compulsory surveillance programme for incidents and adverse effects of blood donation and transfusion. Its framework of reference is the Spanish law, according to the transposition of the Commission Directives on blood and blood component technical requirements, and on traceability and reporting of reactions and severe adverse effects.This regulatory framework especially focuses on aspects included in said Directives, such as: Identifi cation and defi nition of the key Haemovigilance concepts, requirements, specifi cations and traceability data record, procedures to report reactions and severe adverse effects, procedures to draft periodic reports and information exchange, defi nition of severity levels and imputability or standardised reporting forms.There are currently 16 standardised questionnaires in the Spanish Haemovigilance System:1) Donation-related incident report.2) Transfusion-related incident report.3) Component preparation incident report.4) Error in component administration.5) Haemolytic reaction.6) Allergic reaction.7) Bacterial contamination.8) Transfusion-related acute lung injury.9) Transfusion-associated circulatory overload.10) Post-transfusion purpura.11) Graft-vs-host disease.

12) Transfusion-transmitted viral infection.13) Transfusion-transmitted parasitic infection14) Febrile reaction/hypotension.15) Transfusion haemosiderosis.16) Incidents with no effect/near incidents.

Spanish Haemovigilance Programme StructureThe structure is organised in parallel with the Spanish transfusion administrative organisation. That is, there are Haemovigilance networks in the 17 regions which come together in the Ministry of Health's Haemovigilance Unit. There are, therefore, three levels of action.- Locally: Transfusion Centres and Hospital Services take part,

led in both cases by a doctor who specialises in Haematology and Haemotherapy, directly in charge of the local collection, transfusion, surveillance, detection and reporting policies.

- Regionally: Led by a Regional Haemovigilance Coordinator who unites the regional structure, collects and studies reports from local stakeholders and interrelates with the Ministry of Health's National Haemovigilance Unit.

- Nationally: The Haemovigilance Unit in charge of the defi nition of the general surveillance policies, information standardisation and management, coordination with regional experts and coordinators, preparation of annual reports and collaboration with international organisations: European Commission, European Council, World Health Organisation. All the activity and documentation is available on the accessible website of the Ministry of Health/Haemovigilance.

http://www.msssi.gob.es/profesionales/saludPublica/medicinaTransfusional/publicaciones/publicaciones.htm

Scientifi c Committee for Transfusion SafetyThe Committee is integrated into the public health structure and is the main technical/scientifi c body of the Spanish Transfusion System. It is made up of six experts from the different Transfusion Medicine fi elds, appointed by the Competent Authority and the transfusion-related Scientifi c Societies. This organ establishes objectives and methods, and assesses the Haemovigilance System globally. It analyses the results of the programme, of alerts and of periodic reports, and recommends and/or suggests or informs the health authorities in order to promote preventive or corrective action, depending on the results.http://www.msssi.gob.es/profesionales/saludPublica/medicinaTransfusional/recomendaciones/acuerdosRecomen.htm

References1) Royal Decree 1088/2005, of 16 September, which establishes

the technical requirements and minimum conditions for blood donation and transfusion centres and services. Spanish Offi cial Gazette (BOE) no 225, Tuesday, 20 September 2005.

2) Order SCO/322/2007, of 9 February, which establishes the requirements of traceability and reporting of reactions and severe adverse effects of the blood and blood components.

3) Haemotherapy Unit / Ministry of Health Haemovigilance. Available at: http://www.msssi.gob.es/profesionales/saludPublica/medicinaTransfusional/home.htm.

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INV-15TEN YEARS OF HAEMOVIGILANCE IN SPAINMuñiz-Diaz E., Pérez M., Moro E.Hemovigilance Unit, Ministry of Health, Social Services and Equality, Madrid, Spain

The National Haemovigilance System in Spain is the result of the 17 systems existing in the corresponding autonomous regions (AR) that constitute our country. The political and administrative structure of our country where law development and implementation of domestic health matters have been transferred from the central government to the AR demanded the creation of such a Haemovigilance network. In 1998 the Ministry of Health established a Working group of Haemovigilance constituted by 7 blood transfusion specialists. The aims of this group were to design a system adapted to our special structure and to elaborate the documents necessary for the notifi cation of adverse effects. These two objectives were designed to promote the development of Haemovigilance in Spain and to provide the AR with tools to start work. The work carried out led to the creation in 2003 of the fi rst Haemovigilance systems in some AR that adopted the documents elaborated by the Working group.In 2004 in line with the aim of promoting the Haemovigilance systems in the AR, the Ministry of Health reached an agreement to constitute a pilot Haemovigilance program with the Spanish Society of Blood Transfusion (SETS) and the Spanish Association of Hematology (AEHH) for three years. During this period the National Haemovigilance System was created in the form of a Haemovigilance Unit in the Ministry of Health and the fi rst report on Haemovigilance in Spain was presented in Europe. The publication of the Directive 2005/61EC on "Traceability requirements and notifi cation of serious reactions and events" boosted the development and consolidation of the Spanish Haemovigilance Network. However, it was necessary to wait until 2007 to complete the Spanish Haemovigilance Network with the incorporation of the last AR to the national program. The Haemovigilance Unit is coordinated with the AR and regularly holds meetings with the respective coordinators in order to maintain the maximum homogeneity of criteria in the defi nitions of reactions and adverse events, in the management of information and in the design of the recommendations and preventive measures. Moreover, the Haemovigilance Unit reports every year the serious reactions and adverse events to the European Commission (EC) and collaborates with other international bodies.Our transfusion network at present consists of 24 Blood Transfusion Centers (BTC) (possibly 20 in the near future) and 368 Hospital Transfusion Services (HTS) belonging to the 17 autonomous regions (AR). The information collected currently encompasses the whole blood transfusion chain and registers the reactions and errors (incidents and near misses) of transfusion, complications of blood donation and serious adverse reactions and events (SARE) which may be attributable to the quality and safety of blood components. The most recent collected data belongs to 100% of the BTC, and to about 60% of HTS which account for almost 90% of the transfusions performed. The cases reported are included in the annual report delivered to the Scientifi c Committee for Transfusion Safety as the body of the Ministry of Health responsible for advice on transfusion matters. After discussion, the report is sent to the coordinators of each AR.

The rate of reporting in recent years has increased from 9 per 10,000 units transfused to 15.5 in 2012. This rate varies considerably among the AR, oscillating between 4 and 37 notifi cations per 10,000 units transfused.In the period 2007-2012 nearly 12 million blood components (red cells, therapeutic doses of platelets and plasma) were transfused. In the last 6 years, 24 deaths were reported with a high degree of imputability (I≥2) due to: 8 cases of Hemolytic Transfusion Reaction (HTR) due to ABO incompatibility, 4 cases of TRALI, 4 cases of TACO, 3 more cases of HTR non-ABO and 2 cases of transfusion-transmitted bacterial infection (TTBI). In summary, this represents 1 death per 490,000 blood components transfused.The incidence of the aforementioned reactions in patients who suffered from a severe reaction (G≥2) with a high degree of imputability (I≥2) was: 1/150,000 for HTR, 1/95,000 for TRALI, 1/93,000 for TACO and 1/1000,000 for TTBI. Our data as those of other Haemovigilance systems show considerable room for improvement in complications that can be generally preventable as in the case of TACO and in the group of errors leading to the transfusion of an incorrect blood component. As for the complications of blood donation in 2012, there were 41 notifi cations per 10,000 blood donations and 139 notifi cations per 10,000 apheresis donations. The most frequent complications were: vasovagal reactions with general symptoms among blood donors (86%), and complications with local symptoms among apheresis donors (66%), most of them being mild.As regards SARE which may be attributable to the quality and safety of blood components most of them were near misses detected through the quality systems implemented by BTC. The low incidence of serious effects due to the quality and safety of our blood components such us transmission of infectious diseases refl ects the high level of quality and safety of the BTC in our country.In addition to the specifi c information on HV the Ministry of Health demands additional information about the transfusion activity in the different regions: number of donors and blood donations, the results of tests concerning transfusion transmitted diseases as well as the number of units transfused. All this information allows us to determine the risks of blood transfusion and blood donation in Spain. Nevertheless, some objectives such us the attainment of a homogeneous level of reporting between the different AR, the consolidation of the transfusion Haemovigilance offi cer fi gure, the total traceability and the optimal use of blood components remain to be fulfi lled. As for the optimal use, the Haemovigilance Unit of the Ministry of Health decided to promote this practice demanding new information from the HTS on the basis of well defi ned indicators.Fifteen years after the initiation of Haemovigilance in Spain, we can say that the balance is positive and today Haemovigilance constitutes a tool that is fully integrated into the activities carried out by the BTC and HTS.

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INV-16DONOR COMPLICATIONS OUTSIDE THE DONATION ROOM AND THEIR IMPACT ON DONOR RETURNNomen-Calvet N., Ortiz-Murillo P., Pastoret-Pascal C., Pellejero-Gómez J.A., Cortel-Mañè G., Castellà-Cahiz D., Profi tós-Tuset J., Sánchez-Villegas J.M., Contreras-BarbetaE., Salinas-Argenté R., Bosch-Llobet A., Massuet-Bosch L.l., Grifols-Ronda J.R., Argelagués-Vidal E., Puig-Rovira Ll., Muñiz-Díaz E.Represent the group: Fidelitzación- Hemovigilancia-Donación BST*, Banc de Sang i Teixits, Barcelona, Spain

IntroductionThere are several factors that infl uence whether or not a fi rst-time donor will donate again, such as demographic characteristics, family tradition, psychological approach, treatment received by staff during the donation itself and the following days, and adverse reactions as a result of the donation. Immediate adverse reactions, those that happen during the extraction, are better known and easier to analyze. However, it is more diffi cult to document Delayed Adverse Reactions (DAR), those that happen beyond the control and vigilance of the donation staff.

BackgroundTo evaluate the extent and characteristics of the DAR and its impact on fi rst-time donor loyalty.

Materials and methodsWe initiated a fi rst-time donor phone follow-up in February 2012. Our goal was twofold: To increase loyalty and to detect any DAR that happened during the following 24 hours after the donor left the transfusion center. Those follow-ups were executed by members of the transfusion center (TC) utilizing a specifi c questionnaire, 15 days after the donation. For this study, we analyzed the impact in donors' loyalty during a 3-month period and whether they returned for a second donation in the following 12 months. We used a descriptive study of the variables and studied the relationship between those variables with the χ2 Pearson test.We calculated donors' loyalty as a percentage of donors that donated again during the following 12 months, based on the total number of original donors.We fi nally developed a multiple regression model between the probability of donating again and the existence of a DAR. We considered a p<0.05 as statistically signifi cant. We developed the model with SPSS software, version 19.0.

ResultsBetween 02-27-2012 and 05-31-2012, we analyzed 77,501 donors. 19,742 of them were fi rst-time donors (25.5%).We contacted 4,389 donors (22.23%), 2,112 of them (48.1%) came back during the following 12 months, while 2,277 (51.9%) did not return during this period (Table I).Donors' loyalty was signifi cantly high (48.1%) for those involved in the study, as opposed to those donors with whom we didn't proceed with any follow-up (24.8%). We can see that there are almost no differences in loyalty among sex and age. There are two main variables that affect loyalty: Type of donation center and DAR.The participants that enjoyed a follow-up experience were on average 36 years old (standard deviation of 12.4). 53.5% of them were women and 62.7% of them did the

donation in a fixed center concluding that the return of donors from mobile centers was greater (52.1%) than those who donated at a fixed center (45.8%) (p<0.001). 4,357 donors answered the DAR questionnaire. 420 of them answered that they had a DAR with a 9.6% of prevalence. 21% of the DAR was related to arm injury (hematoma, arm pain) and 79% were general (fainting, dizziness, nausea and/or vomiting, asthenia). - DAR strongly affects loyalty, as 49% of the donors that didn't

have any DAR come back, as opposed to the donors that did, with 41% of them coming back.

- Loyalty among donors that come to a mobile center is 52%, as opposed to 46% for those that come to a fi xed center (p<0.001).

Table II - Characteristics of donor groups and not returning for a second donation.

Subsequent donation

No subsequent donation

Total donors

Sex n=2,112 n=2,277 n=4,389Male 977 (46.3%) 1,065 (46.8%) 2,042 (46.5%)Female 1,135 (53.7%) 1,212 (53.2%) 2,347 (53.5%)Age 1st donation<30 years 720 (34.1%) 762 (33.5%) 1,482 (33.8%)30-44 803 (38.0%) 905 (39.7%) 1,708 (38.9%)>45 years 589 (27.9%) 610 (26.8%) 1,199 (27.3%)Center type**Fixed center 1,259 (59.6%) 1,492 (65.5%) 2,751 (62.7%)Mobile unit 853 (40.4%) 785 (34.5%) 1,638(37.3%)

DAR** n=2,103 n=2,254 n=4,357No 1,932 (91.9%) 2,005 (89.0%) 3,937 (90.4%)Yes 171 (8.1%) 249 (11.0%) 420 (9.6%)DAR type**Arm injury 43 (2.0%) 45 (2.0%) 88 (2.0%)General 128 (6.1%) 204 (9.1%) 332 (7.6%)**p<0.05.

Donors that didn't have any DAR have a 45% higher probability of returning than those that did have a DAR. We deduce that as we can see an OR of 1.45 when evaluating the relationship between having DAR and the probability of coming back. For those donors that had a local DAR, 48.9% of them came back as opposed to 38.6% for those that had a general DAR. We have an OR of 0.64 for general DAR, thus the probability of coming back for a donor that had experienced a general DAR is 36% lower than those that had not suffered it.

Table I - Phone call and loyalty.

Phone call Loyalty Total

subsequent donation

no subsequent donation

No 3,803 (24.8%) 11,550 (75.2%) 15,353 (100%)

Yes 2,112 (48.1%) 2,277 (51.9%) 4,389 (100%)

Total 5,915 13,827 19,742

**p<0.001.

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Table III - Multiple regression analysis, for different factors related to coming back.

Adjusted OR (IC 95%)DAR*Yes 1No 1.45 (1.18-1.79)SexMale 1Female 1.04 (0.92-1.17)Age of 1st donation<30 130-44 0.94 (0.82-1.09)≥45 1.05 (0.9-1.23)Center type*Fixed center 1

Mobile unit 1.31 (1.16-1.49)

Table IV - OR adjusted based on DAR type.Adjusted OR (IC 95%)

DAR*No 1Arm injury 0.94 (0.6-1.4)General 0.63 (0.5-0.8)

ConclusionWe increased loyalty by doing a personal follow-up and acknowledging our donors.General DAR strongly reduces the probability of coming back for 1st time donors.

*Group Fidelización-Hemovigilancia-DonaciónAlbert-López A., Arcos-Rivera S., Argelagués-Vidal E., Bobet-Garcés A., Bosch-Llobet A., Carpio-Caniego F., Castellà-Cahiz D., Claret-Roset R., Contreras-Barbeta E., Cortel-Mañé G., Dalmau-Vergé C., Delgado-Torres S., Diaz-Von-Der Fecht C., Grifols-Ronda J.R., Izquierdo-Costa M., Maspons Castells A., Massuet-Bosch LL., Mingo-Sanchez A., Morlans-Boldu M., Muñiz-Diaz E., Nomen-Calvet N., Ortiz-Murillo P., Pastoret-Pascal C., Pellejero-Gomez J.A., Perucho-Manjón M., Pla-Fernandez N., Pleguezuelos-Hernández V., Profi tós-Tuset J., Puig-Rovira LL., Roldán-Tiscar T., Sáez-Bruguera M., Salinas-Argente R., Sánchez-Villegas J.M., Sanfeliu-Riera E., Sillué-Bagués C., Tarifa-Chicano M., Tejedor-Pagés S., Vallejo-Genaro E., Vilanova-Cabayol N.

INV-17PREVENTING TRANSFUSION-TRANSMITTED INFECTIOUS DISEASES IN SPAIN:IS OUR BLOOD SAFE ENOUGH?Sauleda S.Banc de Sang i Teixits, Barcelona, Spain

Blood safety is achieved by means of adequate donor selection, sensitive blood screening tests and pathogen reduction technologies. These three factors are combined into a diffi cult equation where other variables are also included: cost-effectiveness, legal requirements, available technology, social perception of the risk, local epidemiology, emerging threats, etc. From the past history of HIV and hepatitis C transmission, the blood safety equation has been designed to prevent by all possible means transmission of HIV, hepatitis B and hepatitis C virus. In Spain as in many other countries, all blood donations are screened for HIV RNA, HCV RNA and HBV DNA by ultrasensitive nucleic acid amplifi cation technologies (NAT). NAT screening is aimed to prevent viral transmission through donations in serological window phase (WP). When HCV NAT was implemented for the fi rst time, there were concerns about the cost-effectiveness of the measure. After more than ten year experience in Spain, NAT screening has interdicted 32 HCV WP (1 in 550,000 donations), 38 HIV-1 WP (1 in 390,000) and 60 HBV WP (1 in 190,000) (Data from the TTID-working group of the Spanish Society of Blood transfusion, updated to December 2012). Spanish blood centers have a ten-fold higher NAT yield cases as compared to Northern Europe and North America. In our Regional Transfusion Center in Catalonia, we could calculate the residual risk of HCV, HIV and HBV transmission after NAT implementation that was set in 1 per 32 millions donations for HCV, 1 per 1.6 million donations for HIV and 1 in 200,000 donations for HBV. Therefore, the theoretical residual risk of viral transmission might be considered negligible for HCV, moderate for HIV and still high for HBV. Undisclosed risk factors for HIV and HBV acquisition during the pre-donation interview may explain the higher risk. Another effect of NAT screening is the identifi cation of donors that carry occult hepatitis B infection. In Spain, anti-HBc screening is not mandatory and, as a consequence, ultrasensitive NAT identifi es low level HBV DNA replication in anti-HBc positive blood donors. Since HBV NAT implementation, 497 blood donors with occult hepatitis B infection have been identifi ed (1 in 22,000 donations). Most of them are regular donors, otherwise healthy subjects, and the infectivity of the previously transfused blood components is still controversial. Chagas disease is also an issue for blood safety in Spain, due to the massive arrival of Latin America immigrants during the past decade. Chagas disease is caused by a zoonotic parasite, Trypanosoma cruzi, that is endemic to Central and South America, especially Bolivia. Contrary to HIV/HCV/HBV NAT and serology screening, anti-T. cruzi screening is performed only in at-risk donors, defi ned by the Spanish regulation (RD 2005/1088) as being born or resident in endemic areas or whose mother was born in endemic areas. Chagas screening is therefore an example of selective testing based in donors' questionnaire. Since 2005, when Chagas testing became mandatory, the Spanish Hemovigilance system has reported 3 cases of post-transfusion Chagas disease. Failure to correctly identify at-risk donors during the pre-donation interview may have fatal consequences to immunosuppressed blood recipients.Blood safety is compromised by globalization. Chagas disease

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is a good example but also any infectious disease outbreak that appears locally can be transported rapidly to any other place in the world within hours. Therefore, we all need to be prepared for an unknown infectious agent to cause a major disruption in blood supply because, applying the precautionary principle, blood transmission is always to be suspected. And the outbreaks are more frequent every year. We all remember the Chikungunya virus epidemic in Reunion Island back in 2006 or the West Nile Virus (WNV) rapid spread in North America in 1999. The Chikungunya virus and WNV virus appeared recently in Northern Italy, causing seasonal outbreaks coinciding with the mosquitoes activity. Every year we need to react to different epidemiological threats coming from all over the world and closing the circle around Spain and other European countries. Two WNV clinical cases were identifi ed in South Spain in 2010, and WNV has become endemic to Northern Italy, Greece, Romania and many former Soviet Republics. Dengue virus is widely spread in the Caribbean Islands and many regions in South America and caused an outbreak in Madeira in 2012. It is paramount to deal rapidly with the risk and modify donors' selection criteria accordingly. In our experience, one month deferral to donors traveling outside the European countries helps deal with most viral outbreaks (Dengue, Chikungunya, WNV). Nevertheless, during the summer season, weekly updates must be distributed to the blood collection facilities in order to deal with the outbreaks within Europe. Emerging infections are not the only threat to blood safety. Concerns have risen recently regarding hepatitis E virus and its relevance in blood safety. There are a few cases of proven post-transfusion hepatitis E infections, described mainly in Asian countries. Recent studies report consistent data on high HEV exposure and evidence of HEV active infection among European blood donors. Immunosuppressed patients, such a solid organ recipients, may carry chronic hepatitis E infection leading to severe liver damage. In view of this situation, some voices have already demanded that blood is screened for HEV. In any case, there is need of more studies to assess the true impact of HEV transmission through blood component and plasma derivates. The Hemovigilance system in Spain has reported only a few post-transfusion infections in the past years. However, in view of the threats, the old ones and the new ones, the circle around blood safety is still open.

INV-18POST-DONATION INFORMATION: AN IMPORTANT ELEMENT OF DONOR HAEMOVIGILANCEJimenez-Marco T.Fundació Banc de Sang i Teixits de les Illes Balears, Majorca; Balearic Islands Hemovigilance Division (BIHVD), Majorca, Spain

IntroductionDonor haemovigilance can be defi ned as the systematic monitoring of adverse reactions and incidents in blood donor care with a view to improving quality and safety for blood donors1. Early post-donation information (ePDI) is also an essential element of donor haemovigilance since it helps to monitor the safety in donor screening process through medical interview. ePDI notifi cation can be defi ned as deferrable medical history or donor behaviour not disclosed at the time of donation, but it is subsequently notifi ed by the blood donors or by other reliable source before the following donation2. Blood donors are usually encouraged by the Blood Bank staff to report any symptoms of disease that appear within the next days after donation or condition that was forgotten to notify during the medical interview.

AimDuring the years 2005 and 2012, we analyzed the number and the categories of ePDI that were voluntary reported by the blood donors or by other reliable source early after the donation.

MethodsThe ePDI rates between 2005 and 2012 were obtained from the Balearic Island Hemovigilance Division (BIHVD).The BIHVD designed a system to register any information reported voluntary by the donors in the fi rst days after giving blood and before a future donation. A post-donation information sheet with post-donation recommendations was giving by the Blood Bank nurses to all donors in each donation. In order to facilitate the donors'notifi cation, a Blood Bank e-mail account and 24-hour available phone number were listed in the post-donation information sheet. The ePDI were classifi ed in the following categories: mild infections as fl u, cold and gastrointestinal infections; high-risk-sexual behaviour; high-risk-nonsexual behaviour as having close contact with a person viral hepatitis, having a tattoo, ear or skin piercing, acupuncture or coming into contact with someone else's blood; travelling history to or being born in an endemic area either for parasite diseases as malaria and Chagas disease or for other infectious disease such as HTLV I/II infection and Creutzfeldt-Jacob disease, and a deferrable medical history as cancer or epilepsy, etc.; deferrable medical treatment as fi nasteride, isotretinoin, etc.; and blood diseases as bleeding disorders.

ResultsDuring the years 2005 to 2012, an average of 24,403 blood donors gave annually 41,202 donations in the Balearic Islands Blood Bank community. In the same period, 188 ePDI reports were reported to the BIHVD. This means that annually around 0.09% of the donors voluntary performed an ePDI report. More than a half of the ePDI reports were due to mild infections (52.2 %). High-risk-nonsexual and high-risk-sexual behaviour reports represented 15.9% and 12.7%, respectively. Travelling to or being born in an endemic country for malaria, Chagas disease or other infectious diseases (7.5%), medical history (4.3%) and medical treatment (3.7%) and blood diseases (3.7%) were the ePDI less frequently reported (Table I).

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ConclusionsIn our experience, the ePDI notifi cation can be considered a very useful tool for monitoring medical interview accuracy .The most common ePDI notifi cation is the mild infections symptoms reported by donors few days after giving blood. It is likely that donors donate blood during the asymptomatic incubation period of the infection. In order to prevent from using their donation for transfusion it is important to encourage donors to contact with the Blood Bank staff early after donation as soon as infection's symptoms appear.Other interesting aspect that needs to be investigated is the reason why some donors either forgot or intentionally fail to give information about their high-risk-nonsexual, high-risk-sexual behaviours and other conditions during the medical interview at the time of the donation.

References1) Wiersum-Osselton JC, Marijt-van der Kreek T, L.A.M.

de Kort W. Donor vigilance: What are we doing about? Biologicals 2012; 40: 176-9.

2) Wilkinson S L, Steele W R, High P.H, et al. Characteristic of post donation information donors and comparison with appropriately deferred donors. Transfusion 2011; 51: 1503-10.

Table I - Donor Haemovigilance: Early Post-Donation Information, 2005-2012.

Years 2005 2006 2007 2008 2009 2010 2011 2012 Total

Donations 40,835 39,475 38,602 41,185 43,869 43,414 42,181 40,054 329,615

Donors 21,563 22,540 22,486 25,006 27,722 26,121 25,294 24,490 195,222

ePDI 23 28 20 15 27 20 29 23 188

Mild Infections (%) 14 13 6 8 16 14 13 14 98

High-risk-sexual (%) 2 5 3 3 1 7 3 24

High-risk-nonsexual (%) 5 5 7 4 5 3 1 30

Travel to or born in an endemic country (%) 5 1 2 1 1 3 1 14

Medical history (%) 2 3 2 1 8

Medical treatment (%) 2 1 2 1 1 7

Blood disease (%) 1 2 1 3 7

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INV-19THE HAEMOVIGILANCE NURSE IN SPAINCarpio CLa Fe University Hospital, Valencia, Spain

While Haemovigilance is a well-known control program during the transfusion process, the procedures for its implementation in a Transfusion Service are not so clear. It depends on several factors. Perhaps the most important factors are related to the transfusion activity at the individual hospital, the type of pathology involved and the coverage of the Transfusion health care outside the hospital.Our centre has 900 beds. Every year nearly 50,000 blood components are transfused, 160 transplants of hematopoietic progenitors (of which 60% are allogeneic), and 250 organ transplants are performed. In addition we attend to home blood transfusions in adult and pediatric patients, some local dialysis centers and also to medium and long stay patients in another hospital.In this scenario, we have implemented a program of Haemovigilance that includes health professionals in the Blood Bank. In 2000 we started collecting reports in accordance with the rules of the Spanish Commission of Haemovigilance, these data including: adverse reactions, errors related to blood component administration (IBCT) and near miss events (NME). The majority of reactions were allergic or febrile and of a mild character. Only a minority had serious reactions, non-cardiogenic pulmonary edema (LPART), bacterial contamination (IBTT), purple postransfusional and haemolytic reactions. In the following years with the preventive measures introduced: universal leucodepletion, administration of fresh frozen plasma from donor males and the automation of all the analytical tests, the number and the gravity of reactions has decreased. There is a special type of hemolytic reaction, where no preventive measures have been taken, especially the hemolytic reaction due to Incorrect Blood component transfused (IBCT).In 2006 the research in the trasfusional process phase in which the error may have occurred in cases of IBCT and Near-Miss events, caused us to rethink the methodology to be followed, and the staff involved in prevention. In 2006 the present Haemovigilance team was formed and it is still the same today. There is a part time medical professional, who is ultimately responsible, and also two nurses and a technician both full time.Every day in the morning there is a short meeting with the Haemovigilance team and the doctor and nurses responsible for all the areas of the Blood Bank: transfusion, inmunohaematológic and apheresis. We analyze the incidents that have happened in the last 24 hours, the workers implicated, the transfusion phase errors implicated and which is the best way to prevent errors. The Haemovigilance team then prepares a note of non-compliance with the service concerned and holds a meeting to explain detailed of the error. Simultaneously, a presentation is given recalling the steps most important in the transfusion process and the dangers of breaking the rules. The presentations have two parts, one general about all the procedures and one specifi c for the particular errors occurring. A tour of the Blood Bank is given following the presentation so that the procedures are fully understood. Other professionals from the service where the error occurred are also invited to a similar presentation and tour. At present there is a two month waiting list.The meeting also discusses all the possible errors that may have occurred by tracing the components given to the patients, the units send for transfusion, returned, unused or broken, and

component bags whole o empty accompanying patients from their hospital of origin. There is a daily control of all units entering or leaving the Blood Bank.On the other hand, we are convinced that if the established procedures are followed, errors will not occur. We therefore, undertook audits to ensure compliance with the procedures. These audits are performed by the Haemovigilance team and other voluntary part-time nurses that collaborate with the team. The audits are made fi rst in the transfusions areas responsible of the Blood Bank nurses, and then nurses in other departments involved in transfusions. There are two types of audits; one revises all the procedures related to the transfusion process from the sample extraction for compatibility tests to blood transfusion at the bed side. The other audit is to review records from when we received a request until return of the empty bags to the Blood Bank and the form with the complete transfusion information. For the audit we use a checklist previously defi ned which allows us to compare results with other audits.These audits are carried out with the permission of the hospital management and allow us to identify areas of non-compliance and establish corrective actions. These corrective measures are always dealt with in training and information sessions. We have never taken punitive measures. Our goal is to make aware among all professionals involved the importance of quality and safety in blood transfusion.

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INV-20SAFE ADMINISTRATION OF BLOOD COMPONENTSSanz C. Clinic Hospital, Barcelona, Spain

Transfusion is a complex multistep process involving members of several professional groups, including doctors, nurses, laboratory technicians, clerk assistants, as well as patients and blood donors. Such complex and multitask structure results in many opportunities to human error and serious deviations from the standard procedure that endanger patients' health. Human error arises as a consequence of the omission of essential checks (short cuts), the assumption that someone else has performed or will perform such checks and, more generally, from involuntary gaps."Transfusion safety" should be distinguished from "blood safety". The latter concerns the quality of the blood component, and is largely the responsibility of blood collectors. It has been a primary focus of both regulatory agencies and standard-setting organizations in the blood industry. Transfusion safety, in contrast, focuses on the overall process that results in the delivery of transfusion therapies to patients. Transfusion safety includes blood safety but also involves additional critical steps related to the medical use of blood components and patient's outcome. Transfusion safety is close to clinical activities and lies largely within the responsibility of hospitals. We have seen terrifi c improvements in blood safety over the past few decades. Large quantities of resources, either fi nancial, intellectual or technological, have been spent in improving the quality of collected blood. Much of this effort was the result of the political, judicial and medical aftermath of the transfusion-transmitted HIV and HCV epidemics. A more careful scrutiny of donors, increasingly sensitive enzyme immunoassays, nucleic acid-based testing, leukocyte reduction, the widespread application of good manufacturing practices in blood component preparation, chemical pathogen inactivation, and the new methods to decrease the risk of bacterial contamination have all resulted in a signifi cant reduction in the rate of transfusion-transmitted infections.While we have achieved a remarkable improvement in "blood safety", that is, the quality of blood as a component, we must also admit the lack of progresses in "transfusion safety", including the noninfectious hazards and the risks related to the hospital-based process of delivering transfusion to patients.The three focal points in the process of blood transfusion most in need of improvement are the medical decision making leading to transfusion, the collection of the patient's blood samples, and the bedside administration of blood components. More than 80% of all mistakes occur in the patient environment, out of the direct control of the compatibility testing laboratory. The rate of blood unit-patient mismatched transfusion ranges from 1:12,000 to 1:19,000 blood units in most industrialized countries. It should be noted that such fi gures come from voluntarily reported systems and increase nearly 10-fold when active tracking or systematic audits were done. Recently, a new philosophy of error management has been proposed. The approach considers that humans are fallible and errors are to be expected, even in the best organizations. Countermeasures should be based on the assumption that we cannot change the human condition but we can change the conditions of human work. Systems and processes must be re-engineering taking into account human factors and weaknesses. Organizational changes, intensive use of the information and communication technologies, team work, and a fair dose of

common sense should result in a more safe transfusion process. The newly designed transfusion process must be strongly resilient to cope with the avatars of the clinical practice and must give people the opportunity to learn while they work in the process. Finally, it is worth remembering that transfusion safety is not the duty of only transfusion specialists but must be shared with other medical specialties, nurses, hospital managers, government institutions, and patient advocacy organizations.

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INV-21HAEMOVIGILANCE IN LATIN AMERICATorres O.W.1, León de Gonzalez G.1

1Transfusion Medicine Service, Hospital Materno Infantil "Ramón Sardá"/Haemophilia Unit. William Osler Institute, City of Buenos Aires, Argentina; 2Jefe del Banco de Sangre del Intituto Diagnóstico, Caracas, Venezuela

IntroductionLatin America (LA) is a region of approximately 20 million km² that extends from Mexico to Chile and Argentina. It consists of 18 Spanish-speaking countries and a Portuguese-speaking one. Although we have a lot of characteristics in common for historical reasons, each country has its own special features in geographic, cultural, social and economic terms.In some countries, current legislation in Transfusion Medicine has required mandatory reporting of adverse transfusion reactions. However, Haemovigilance (HV) activity of varying magnitude started developing only a decade ago.

ObjectiveTo describe the current situation of Haemovigilance in Latin America.

MethodologyWe conducted a survey using a questionnaire of 5 close-ended questions and 2 open-ended ones. According to the responses obtained in 3 of the close-ended questions, participants were asked to fi ll out a table with dichotomous responses or quantitative data (numerical and percentage values). In two of the close-ended ones, room was allowed for comments.

ResultsOut of 19 countries reached, only 13 answered. (68.42%). In all the countries (100%) the Ministry of Health periodically (usually monthly) collects data of the activity of blood services in standardized formats: electronic (61.53%), manual (7.69%) or both (23%). One of the countries did not respond (7. 69%)In fi ve countries, 100% of national blood services report to the health authorities; in three 80-99%; in one 40%; three countries do not know the percentage of services involved and one country did not respond.Only Brazil and Colombia have implemented, structured, national HV plans since 2006 and 2009 respectively; Cuba has a regional pilot plan (since 2003), on the way of nationwide expansion; Chile, Guatemala and Venezuela keep records and notify HV data that is mandatory in the general monthly report, though very few institutions comply with the reporting. Chile is improving its communication network to extend it nationwide. In Venezuela the offi cial agency showed no interest in developing a national plan presented by the Scientifi c Society in 2011; in fact little is reported and thus not refl ected in the annual national report. Argentina and Honduras record some data voluntarily. Costa Rica, Ecuador and Peru do it locally but do not report to the government agency because it is not mandatory.

Causes of lack of implementation of a HV system1 - Political: either absence of an operative blood programme

or of national legislation; lack of political initiative; HV importance is underestimated; non-existent centralized processes; a programme has not been developed yet.

2 - Resources: insuffi cient human resources (general and/or specialized for specifi c functions) and funding.

3 - Culture of responsibility: fear of punitive actions.

We observed that 36.36% of the countries with no national HV system do not have a short-term implementation plan; 18.18% are not aware of its existence; 45.45% intend to improve it or implement it in the short run; 54.54% claimed that Scientifi c Societies could play a signifi cant role in this implementation, provided that they work in coordination with government agencies; 45.46% responded negatively (three countries do not have Scientifi c Societies and one claimed that they do not even have a say in health decisions).

Obstacles to HV implementation1 - No regulations demanding this kind of activities.2 - In those where there are, there is no institutional commitment

and not enough staff to carry out the various activities involved; lack of hospital transfusion committees; health professionals have no interest in keeping records or writing reports; there is no interrelationship between the physician who assesses a reaction in a patient and the blood bank; there are neither assignments of hospital tasks, nor authorities to enforce them; lack of staff and the training involved and absence of automated processes.

3 - No legal protection.Finally, data of adverse transfusion reactions (ATR) and donation was requested. All respondents indicated that there is underreporting.

Table I - Relative and absolute frequency of immediate, infectious and late ATR.

Country TAR immediate

Infectious* Delayed ATR

Total

ArgentinaN: 45,097

1,167(99.91%)

1(0.08%) -- 1,168

(100%)BrazilN: 3,567,720

5,279(98.78%)

12(0.22%)

53(0.99%)

5,344(100%)

ColombiaN: 900,640

1,16897.41%

171.5%

131.09%

1,198(100%)

Costa RicaN: 1,930

19(90.47%)

1(4.76%)

1(4.76%)

21(100%)

CubaN: 176,269

781(97.38%)

14(1.74%)

7(0.87%)

802(100%)

ChileN: 380,870

1,020(90.50%) -- 107

(9.49%)1127

(100%)GuatemalaN: 171,244

48(100%) -- -- 48

(100%)

PeruN: 210,000

38(97.43%)

1(2.56%) -- 39

(100%)

VenezuelaN: 484,449

449(97.39%)

9(1.95%)

3(0.65%)

461(100%)

Table II - ATR percentages.

Country Immediatereactions

Delayedreactions

Local reactions

Vasovagal reactions

Others

ArgentinaN: 26,805 1.66 0.16 0.63 1.52 0.007

Costa RicaN: 2,890 0.65 0.28 0.10 1.24 --

CubaN: 272,379 0.25 -- 0.04 0.21 --

ChileN: 279,107 -- -- -- 1.58 0.55

PeruN: 100,000 0.62 -- 0.46 0.72 --

VenezuelaN: 43,993 0.38 0.06 0.81 1.01 0.009

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ConclusionIn LA, HV activities are just emerging. Even though some countries count on an offi cial, structured system and others are on the way of expanding it nationwide, most of them record data only at an institutional level, since it is not demanded by health authorities. There are numerous factors that affect the consolidation of the HV system in the region; some of them stem from the absence of a National Blood Programme. However, in all the countries, there is a growing awareness of the need of its implementation, despite the lack of political initiative. The PHO, the Scientifi c Societies and Organizations and professionals in the fi eld are invited to work jointly in order to demonstrate and persuade health authorities of the importance of HV for transfusion safety and to guide them and seek solutions aimed at minimizing the obstacles that are preventing its implementation and deployment by means of concrete actions tailored to the possibilities of each country.

INV-22SCREENING FOR TRANSFUSION TRANSMISSIBLE INFECTIONS IN LATIN AMERICACruz J.R.1, Otani M2

1Ashburn, VA, United States of America; 2Hemocentro do Sao Paulo, Brazil

BackgroundThe screening for transfusion-transmissible infections (TTI) in Latin America -Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela- is based on the Working Standards for Blood Services, published by the Pan American Health Organization (PAHO) in 1999, 2005 and 2011. The spirit of these Standards was originally defi ned by the PAHO Member States in 1999. The agreement was to screen all blood units for HIV, HBV, HCV and syphilis markers, and for Trypanosoma cruzi antibodies where there is risk for its transmission through transfusion, whether endemic areas or areas where signifi cant numbers of infected individuals might have migrated. Laboratory testing plays a very important role in Latin America because blood donation is mostly done as a requisite of the hospitals for patients to be either admitted into or treated at hospitals. In 2011, for instance, on 41% of donations were from voluntary, altruistic donors. To guarantee the accuracy of the screening results, region-wide programmes for external evaluation of performance were to be instituted. As an initial step towards hemovigilance, groups of patients at high-risk of TTI were to be monitored for HCV incidence. National data provided to PAHO would be the basis to assess progress of blood services at the regional level.

Materials and methodsNational data for 1994, 1995, 1997, 1999 and 2000-2011 summarized by PAHO, offi cial documents of its Directing Council, and articles published in peer-reviewed journals were used to assess the coverage of the screening and the prevalence of markers of TTI among blood donors. Reports of the Regional Programme for External Evaluation of Performance, run by the Hemocentro do Sao Paulo, were employed as a proxy to gain understanding of the quality of the screening results.

Results

Table I - Regional coverage of screening for TTI in Latin American countries, 1994-2011.

Year Countries Coverage (%) of screening

HIV HBV HCV T. cruzi

1994 11 86.41 85.67 51.24 51.27

1995 13 91.30 90.79 72.28 76.78

1997 14 99.26 98.07 91.42 70.54

1999 17 99.66 99.63 97.82 97.88

2001 18 99.90 99.85 99.13 82.11

2003 19 99.93 99.86 99.59 88.08

2005 19 98.90 98.82 98.85 87.97

2007 17 99.65 98.61 98.75 86.23

2009 19 99.98 99.98 99.98 96.82

2010 19 99.59 99.58 99.59 97.48

2011 19 99.71 99.71 99.69 97.78

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Table II - Regional prevalence (median, low and high) of TTI markers among blood donors, 1994-2011.

Year Prevalence (%) of TTI markersHIV HBV HCV T. cruzi

1994 0.015(0.002-0.070)

0.081(0.038-0.146)

0.042(0.006-0.093)

0.137(0.013-2.024)

1995 0.012(0.003-0.050)

0.060(0.037-0.150)

0.0385(0.010-0.096)

0.100(0.003-1.370)

1997 0.145(0.010-0.360)

0.485(0.150-1.020)

0.445(0.130-1.660)

1.15(0.130-1.720)

1999 0.150(0.040-0.540)

0.600(0.240-1.700)

0.330(0.120-0.930)

0.680(0.100-45.460)

2001 0.200(0.01-0.42)

0.525(0.05-1.70)

0.560(0.07-1.08)

0.670(0.05-9.91)

2003 0.280(0.01-0.87)

0.430(0.012-1.40)

0.560(0.01-1.22)

0.63(0.13-7.65)

2005 0.250(0.006*-0.80)

0.390(0.03-1.66)

0.600(0.01*-0.99)

0.61(0.01*-8.61)

2007 0.280(0.02-0.82)

0.390(0.02-1.33)

0.660(0.17-0.99)

0.590(0.06-3.75)

2009 0.240(0.02-0.61)

0.270(0.13-1.08)

0.540(0.12-1.56)

0.730(0.12-3.08)

2010 0.250(0.024-0.54)

0.240(0.02-1.07)

0.410(0.03-1.34)

0.4100.04-3.13)

2011 0.220(0.02-0.98)

0.250(0.02-0.98)

0.440(0.03-0.65)

0.460(0.18-2.96)

*Confi rmed as positive.

From 2005 to 2011, 29 laboratories from 16 countries participated in the twice-a-year surveys of the programme for external evaluation of performance. Six centres were enrolled in 2006 and three began their participation in mid 2007. Six centres missed one survey, one did not respond to three surveys and one centre was temporarily suspended for three years. Overall, in the 371 reports, there were 165 (1.7%) false-reactive results for HIV, 137 (1.5%) for HBsAg, 164 (1.9%) for HCV, and 36 (0.3%) for T. cruzi. On the other hand, there were 2 (0.1%) false non-reactive results for HIV, 36 (1.2) for HBsAg, 8(0.2%) for HCV and 29 (0.7%) for T. cruzi. Two centres did not report any erroneous results; thirteen of them reported fewer than 20, while one laboratory reported 121 discordant fi ndings. Discordant fi ndings, however, tended to diminish in time.

DiscussionThere has been a signifi cant improvement in the coverage of screening for TTI in Latin America in the last 20 years. Except for 2005, coverage of screening for HIV was above 99% since 1997 (Table I). In the case of HBV and HCV, however, coverage reached 99% for the fi rst time in 1999 and 2001, respectively but never attained levels similar to those of HIV. In 2011, over 26,000 units of blood were not screened for any of the three viruses. Median prevalence rates of HBV markers were the highest before 2003, when HCV markers became the most prevalent viral maker among the blood donors. Nevertheless, rates tended to decrease for both HBV and HCV during the last 12 years. Observations in Brazil have shown that a prevalence of 0.47 of anti-HCV antibodies among donors represents a residual risk of 1:19,300 donations. In 2009, ten countries had prevalence rates higher than 0.47; 10 and eight countries, respectively, did so in 2010 and 2011. In the case of T. cruzi, coverage never attained 98%. The median prevalence rates of its marker also diminished during the 21st century but, except

for 2007, were the highest of all markers tested for. Increased coverage, decreased prevalence of markers and, probably, and better quality of testing have contributed to the production of safer blood products in Latin America. There are, however, opportunities for improvement. Better oversight (including regular inspection of blood services, evaluation or reagents and equipment, and data collection and analyses) by the local health authorities, coupled with more active support (including continued competence development and assessment among staff, programs of external evaluation of performance and blood service accreditation) from professional associations, will further contribute to improving the safety of the blood transfusions in Latin America.

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INV-23SIDE EFFECTS OF BLOOD DONATION BY APHERESISVrielink H.Sanquin Blood Supply, Amsterdam, The Netherlands

IntroductionMedical complications in donors are seen only in a small percentage of donations. Side effects during and / or after blood donation can have follow-on consequences for both donor and blood bank. Unpleasant experiences and medical problems may lead to donors not returning for donation. The blood bank loses donors who have been extensively tested, sometimes with rare erythrocyte blood type antigens, HLA and/or HPA types, etc. Furthermore, a very special donation might be lost due to a problem during the donation. Therefore, all staff at donor centers and involved in all variations of blood donations should be able to recognize an imminent side effect in a blood donor and intervene to attempt to prevent it or minimize the consequences.

Registration/Documentation of adverse reactionsAdverse reactions related to blood donations must be documented very carefully. The origin of a side-effect can be found in donor-related issues, errors made by operators, mechanical and/or equipment-related problems, in the administration of anticoagulant solutions or in harness (disposable) problems. Environmental factors can also play a role, for instance in the risk of collapsing. Busy collection centers, long waiting periods and high temperature or humidity all increase the tendency for a donor to collapse. Blood establishments should record donation side effects, both in the interests of individual donor care and in order to monitor, perform trend analysis and attempt to minimize their occurrence.Registration of complications and other problems is important in monitoring the quality of equipment, disposables and operators. Changes in the mean frequency of complications can be an indication that standard operating procedures are not being adhered to or performance had deteriorated. Besides registration of all adverse reactions in a database, a record of medical problems during or after the blood donations must be accessible in the donor's fi le. The type of side-effect should be documented, and in the case of serious medical problems also the recovery and follo w-up. All information should be available at the next donation in order to take adequate preventive measures. Knowing the medical history of a donor can be helpful in deciding whether or not to give medical approval for blood donation. Also in the event of insurance claims it can be in the blood bank's interest to document complications as completely as possible.

Possible medical problems during an (apheresis) donationCollapse/dizziness (tendency to collapse)An (imminent) vasovagal reaction is the most frequent adverse reaction during and after whole blood and apheresis donations. Vasovagal reactions have been related to an inappropriate reaction from the hypothalamus to stress factors, like fear, pain or injury. An imbalance in the autonomic nerve system has been suggested, causing an extremely low pulse together with peripheral vasodilatation especially of the muscles of the arterioles. The result is a decreased cardiac output and increasing hypotension. Finally one loses consciousness. Prior to the collapse, prodromal symptoms can be observed. A complete loss of consciousness with collapse can also be seen without any warning. Usually the donor indicates that he or she is not feeling well.

HyperventilationHyperventilation can occur as a reaction to an anxious situation.

In fact there is a situation of overbreathing. As a consequence the CO2 level in the blood decreases and the pH increases (alkalosis). Many symptoms can be seen, diffi cult to distinguish from many other adverse reactions. Usually the donor complains of dizziness, anxiety, a "band" feeling around the chest, tingling/paraesthesiae in the hands and around the mouth. The donor may sigh continuously. Also hyperventilation might cause collapse or convulsions.- Bleeding and puncture problems.- Hematoma.- Thrombophlebitis.- Arterial puncture.- Puncture of a peripheral nerve.- Stroke.- Epilepsy.- Angina pectoris/myocardial infarction.

Specifi c complications in apheresis proceduresBesides the described adverse events during a whole blood donation, side effects specifi cally related to apheresis procedures can occur.

Hemodynamic consequencesThe extra corporeal volume (volume of the disposable may be from 120-300 mL) plus the volume of harvested blood components can be a substantial part of the donor's total blood volume, especially in small donors. This increases the risk of hypotensive reactions, especially if the donor is on anti-hypertensive drugs.

Citrate intoxicationUsually, in apheresis procedures tri-sodium citrate solutions are applied as anticoagulant. Citrate blocks calcium-dependent clotting factor reactions by binding ionized/free calcium in the blood component. Since citrate also binds magnesium, side effects can also be caused by hypomagnesemia.

Clotting problemsWhen citrate is used in an apheresis procedure, no disturbance of the donor's clotting system is expected. In the case of heparin use some prolongation of the clotting time is possible.

HematomaAs a consequence of the mechanical return of blood components during an apheresis procedure, hematomas are more frequent and may be more severe.

HemolysisDue to kinks in the lines of the apheresis disposable or other mechanical obstructions, red blood cells can be damaged. If hemolysis is observed, the apheresis procedure must be stopped and the donor must be informed about the possibility of red coloring of the urine (hemoglobinuria).

Air embolismAir embolism is a very rare potential complication.There must be also attention for long term effects from apheresis donations. A plateletapheresis donor may lose 80-100 mL of blood, both in the harness and by blood sampling at each donation. Reports of decreased ferritin levels in repeat apheresis donors with over 20 donations per year are published. Also low immunoglobulin levels in frequent plasmapheresis donors are described. Since compromised bone mineral densities at the lumbar spine in frequent plateletapheresis donors are described, there is also a concern regarding the long-term effects of frequents increased PTH levels caused by apheresis, although the clinical consequence remains open.

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INV-24 & 30HEMOVIGILANCE IN HEMATOPOIETIC CELL TRANSPLANTATIONMiller J.P.National Marrow Donor Program, Minneapolis, MI, United States of America

In hematopoietic cell transplantation (HCT), reporting and investigation of adverse events related to donation and recipient infusion, as well as product complaints related to product handling/transport, are essential to ensure donor and recipient safety. The risks of adverse events and product integrity issues are different for donors of bone marrow, peripheral blood stem cells (PBSC) and for cord blood units (CBU). As the incidence of hematologic diseases treated by HCT (e.g., leukemia and lymphoma) increases with age, related sibling donors may have different risks of donation due to coexisting medical conditions. PBSC have higher cell concentrations than marrow and viability may be more adversely affected by transport temperature and time/distance from the transplant center1. Cryopreserved CBU are susceptible to product integrity issues such as bag leakage and breakage and arriving thawed. Finally, PBSC, marrow and cord blood have different patient safety profi les. Therefore, hemovigilance for these cellular therapy products needs to monitor the entire product lifecycle from donor selection, screening, donation, handling and transport, product infusion and post-transplant clinical outcomes.Hemovigilance in HCT faces some unique challenges in comparison to the monitoring of adverse events related to the transfusion of blood components. Tracking, trending and the analysis of adverse events are limited by the smaller number of allogeneic HCT transplants, with approximately 25,000 transplants occurring annually worldwide. The donation risks are different; donors of marrow may experience adverse events related to tissue injury or anesthesia and PBSC donors may experience adverse events related to the mobilizing agent, the apheresis procedure or the use of a central venous catheter if one is needed. Many products are shipped over long distances (including cryopreserved CBU); approximately 50% of HCT products are shipped to a patient in a different country, making global reporting of adverse events essential. Finally, clinical judgment may be necessary to determine the attribution of a possible recipient adverse event to the product rather than other events in the clinical course of a HCT patient.Reporting of donor and product adverse events occurs via several mechanisms worldwide to advance donor and recipient safety and to meet specifi c global mandates, regulations of national competent authorities, requirements of professional organizations and donor registries and for use in research. The World Marrow Donor Association (WMDA) has established a global system of vigilance for unrelated donor Serious Adverse Events and Reactions (SEAR) and hematopoietic stem cell products (SPEAR)2. This system allows data collection, analysis, distribution and reacting to these serious adverse events and reactions. Participation is mandatory for accredited registries and information about reporting adverse events may be found at the WMDA website: www.worldmarrow.org. National registries have mechanisms in place for reporting of adverse events. The National Marrow Donor Program (NMDP) and the Center for Blood and Marrow Transplant Research (CIBMTR) have developed automated systems for reporting serious donor and recipient adverse events and product complaints. Although electronic reporting is preferred, adverse events may still be submitted by phone or email. Information submitted on recipient adverse events includes clinical toxicity criteria (CTCAE), assessment of whether

the event is serious and/or unexpected and the likely attribution of the event to the product (defi nitely, probably, possibly, unlikely or not related). Adverse events associated with products collected under an IND are investigated by the sponsor (e.g. NMDP) or by the manufacturer of a licensed CBU.Serious adverse events in HC donors are rare. Pulsipher and colleagues reported that marrow and PBSC donors may experience similar mild to moderate symptoms associated with their donation including skeletal pain, fatigue, insomnia, anorexia, nausea, vomiting, dizziness, local site reactions, skin rash, fever and syncope3. These symptoms are similar for PBSC and marrow donors, but they occur at different time points; either during PBSC mobilization or shortly following marrow collection. Female donors and those with high BMI were at higher risk of these donation related adverse events and marrow donors experienced longer recovery times. Serious adverse events were more common in marrow donors (2.38%) compared to PBSC donors (0.56%). Life-threatening complications were seen more often in marrow donors (0.26%) than in PBSC donors (0.03%), as was persistent disability (0.5% vs 0.06%, respectively). There was no difference in the incidence of cancer or autoimmune disease. Deaths have been reported in HPC donors. In an EBMT survey of 338 transplant teams in 35 predominantly European countries, Halter reported fi ve deaths in related donors; one associated with marrow donation and 4 with PBSC donation4. At least fi ve other deaths are known to have occurred5.Hematopoietic cell transplantation is used to treat an ever-increasing number of patients with malignant and non-malignant diseases and it would not be possible without the altruistic donors of PBSC and marrow. Accordingly, a careful medical assessment of donors to identify increased risks of donation is an integral part of the donation process. Although serious adverse events from donation and receipt of marrow and PBSC are uncommon, it is important to have robust reporting of these events to further promote donor and recipient safety. Efforts have been made to enhance harmonization of reporting, which will improve the ability to analyze adverse event data and take the steps necessary to further the safety of HC donors and HCT recipients6.

References1) Kao GS, Kim HT, Daley H, et al. Validation of short-term

handling and storage conditions for marrow and peripheral blood stem cell products. Transfusion 2011; 51 (1); 137-47.

2) Shaw BE, Chapman J, Fechter M, et al. Towards a global system of vigilance and surveillance in unrelated donors of haematopoietic progenitor cells for transplantation. Bone Marrow Transplantation 2013; 48: 1506-9.

3) Pulsipher MA, Chitphakdithai P, Logan BR, et al. Acute toxicities of unrelated bone marrow versus peripheral blood stem cell donation: results of a prospective trial from the National Marrow Donor Program. Blood 2013; 121: 197-206.

4) Halter JP, Kodera, Y, Ispizua AU, et al. Severe events in donors after allogeneic hematopoietic stem cell donation. Haematologica 2009; 94: 94-101.

5) Confer DL, Stylianou C, Costa M, et al. Adverse Reactions in Donors. Available at: http://www.sohovs.org/soho/fi le.php/1/NOTIFY_-_report_Part_B.pdf.

6) Halter JP, van Walraven SM, Worel N, et al. Allogeneic hematopoietic stem cell donation - standardized assessment of donor outcome data: A consensus statement from the Worldwide Network for Blood and Marrow Transplantation (WBMT). Bone Marrow Transplantation 2013; 48: 220-5.

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INV-25FOLLOW-UP OF HEALTHY DONORS RECEIVING GRANULOCYTE COLONY-STIMULATING FACTOR FOR PBSC MOBILIZATION AND COLLECTION. RESULTS OF THE SPANISH DONOR REGISTRY De la Rubia J.Hematology Service, University Hospital La Fe, Valencia;Universidad Católica de Valencia, Valencia, Spain

IntroductionPeripheral blood is currently the main source of hematopoietic stem cells for patients requiring an allogeneic transplantation1. Granulocyte colony-stimulating factor (G-CSF) is the cytokine administered most frequently to healthy donors as part of the regimen to mobilize progenitor cells into the peripheral blood for collection and has been administered to thousands of related and unrelated donors worldwide2. Although the short-term toxicity of G-CSF in this population has been analyzed exhaustively3-9, data on the long-term impact of G-CSF in normal donors are scarce, and only a few series, involving small numbers of donors, have addressed this point10-13. It is important to understand the side effects of G-CSF administration in this population more comprehensively in order to provide consistent information for the long-term follow-up of G-CSF-primed donors of peripheral blood progenitor cells. The development of nation-based donor registries can help in recruiting a suffi cient number of donors with adequate follow-up to study the long-term effects of G-CSF in donors. In 1998, Spain developed a multicenter national donor registry involving the main transplant centers with the primary aims, among other objectives, of improving the effi ciency of cell mobilization and harvesting techniques, as well as exploring the short- and long-term biological and clinical effects of G-CSF in normal donors. Since January 1998 more than 1,600 healthy donors undergoing mobilization procedures in 23 Spanish centers are registered and assessed for short-term side effects14.

Data collectionInformation about peripheral blood progenitor cell mobilization and harvesting is prospectively collected and monitored by means of a standardized data sheet. Detailed, written informed consent is obtained from each donor before the start of the procedure. Informed consent is obtained from guardians of minors.

Donor registrationAt the time of the initial assessment (baseline), general donor information includes age, sex, and grade of HLA matching. Complete blood counts and biochemistry surveys are performed. Blood chemistry data includes the concentrations of glucose, urea nitrogen, creatinine, uric acid, total bilirubin, alkaline phosphatase, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, and g-glutamyl transferase. Donors are also questioned about side effects observed during G-CSF administration. Adverse events are recorded and graded according to the duration of symptoms, and whether the donors require medication for pain or symptom relief.

Long-term follow-up protocol designAs mentioned above, one of the main objectives of the registry is to collect information about the long-term side effects of G-CSF administration with special emphasis on the development of severe complications such as neoplastic diseases. To achieve this

goal, donors undergo several follow-up controls after donation. The fi rst one (control #1) is performed within 4 to 6 weeks after mobilization. At that time, the complete physical examination and hematological and chemistry profi les performed at baseline are repeated. The remaining fi ve controls (control #2 to control #6) are planned to be done annually for 5 consecutive years. To evaluate possible changes in hematologic parameters, the same variables measured at baseline are measured at every follow-up control. Likewise, a complete physical examination is performed at the center responsible for harvesting the peripheral blood progenitor cells, or is done by a general practitioner for donors who had to travel a long distance to the mobilization service. Controls consisting of only mail or telephone calls are not accepted as follow-ups.

DiscussionThere are limited data on the long-term safety of G-CSF administration to healthy volunteer donors at present. Because G-CSF receptors are present in cells of myeloid lineage, the main theoretical risk is assumed to be the late development of MDS or leukemias. In this regard, reports about the diagnosis of acute leukemias or non-Hodgkin lymphomas in healthy donors15 have initiated a controversial debate about the risk of G-CSF administration to normal donors. It is well known that family members have an at least doubled incidence of hematologic malignancies than the general population and these observations must be set in this context of a higher predisposition for hematologic malignancies within families. On the other hand, in many studies, the small sample size, the relatively short follow-up time, and the lack of an adequate control group for comparison mean that no defi nitive conclusions can be made on the long term adverse health effects, if any, of G-CSF on healthy donors. Finally, our data, as well as those from other stem cell donor registries do not suggest an increased risk of hematologic malignancy in donors who receive G-CSF14,16,17. Finally, a longitudinal study examining the ratio of observed disease incidences in subjects to expected disease incidences in a population must also take into account that disease incidences vary by age, sex, and race. This will invariably require even larger cohorts to maintain a satisfactory level of statistical power. In addition, if a substantial proportion of subjects are lost to follow-up, the validity of the study's conclusion is called into question. Therefore, monitoring the long-term safety of G-CSF administration to healthy volunteer donors is challenging, and any benefi ts derived from such a monitoring should take into consideration the costs and the benefi ts associated with it.Since 1999, we have observed fi ve cases of solid tumors, a rate that is consistent with the age-adjusted Spanish incidence of cancer in adults during this period14. Originally, a 5-year follow-up was recommended for our registry. However, we note that in two of the fi ve donors who developed a solid tumor, cancer was diagnosed after the initially scheduled 5-year follow-up (61 and 64 months), raising the questions of whether 5 years is long enough and whether these donors should undergo annual follow-ups for the rest of their lives. Obtaining valid informed consent from healthy donors receiving G-CSF is made diffi cult by the fact that data on the long-term safety of G-CSF are not fully understood at present and will remain unknown for some time due to diffi culties in designing effective prospective cohort studies. Donor centers must therefore be extremely diligent in accurately conveying the known risks to donors and be straightforward about what risks remain unknown when G-CSF is administered to donors.

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It is crucial, therefore, that transplant physicians and donor registry organizations reach consensus on what is an acceptable risk for G-CSF-stimulated donors, realizing that the acceptable risk may be different for related and unrelated donors. To reach these goals, it will be necessary to 1) perform detailed studies in selected donors, 2) limit cytokine exposure (doses and/or courses) wherever possible accepting that it is impossible to defi ne what the lower limit should be at the present time, and 3) provide donors with up-to-date information so they can effectively judge and balance the risks of donation.

References1) Passweg JR, Baldomero H, Gratwohl A, et al. The EBMT activity

survey: 1990-2010. Bone Marrow Trans 2012; 47: 906-23. 2) Horowitz MM, Confer DL. Evaluation of hematopoietic stem

cell donors. Hematology American Society of Hematology Education Program Book 2005; 469-75.

3) Stroncek DF, Clay ME, Petzoldt ML, et al. Treatment of normal individuals with granulocyte-colony-stimulating factor: donor experiences and the effects on peripheral blood CD34+ cell counts and on the collection of peripheral blood stem cells. Transfusion 1996; 36: 601-10.

4) Waller CF, Bertz H, Wenger MK, et al. Mobilization of peripheral blood progenitor cells for allogeneic transplantation: effi cacy and toxicity of a high-dose rhG-CSF regimen. Bone Marrow Transplant 1996; 18: 279-83.

5) Anderlini P, Przepiorka D, Seong C, et al. Clinical toxicity and laboratory effects of granulocyte-colony-stimulating factor (filgrastim) mobilization and blood stem cell apheresis from normal donors, and analysis of charges for the procedure. Transfusion 1996; 36: 590-5.

6) Anderlini P, Przepiorka D, Champlin R, Korbling M. Biologic and clinical effects of granulocyte colony-stimulating factor in normal individuals. Blood 1996; 88: 2775-9.

7) Murata M, Harada M, Kato S, et al. Peripheral blood stem cell mobilization and apheresis: analysis of adverse events in 94 normal donors. Bone Marrow Transplant 1999; 24: 1065-71.

8) De la Rubia J, Martínez C, Solano C, et al. Administration of recombinant human granulocyte colony-stimulating factor to normal donors: results of the Spanish National Donor Registry. Bone Marrow Transplant 1999; 24: 723-8.

9) Confer D, Haagenson M, Anderlini P. Collection of rhG-CSF mobilized stem cells from 395 unrelated donors. Bone Marrow Transplant 2002; 29 (Suppl): S17.

10) Sakamaki S, Matsunaga T, Hirayama Y, et al. Haematological study of healthy volunteers 5 years after G-CSF. Lancet 1995; 346:1432-3.

11) Cavallaro AM, Lilleby K, Majolino I, et al. Three to six years of follow-up of normal donors who received recombinant human granulocyte colony-stimulating factor. Bone Marrow Transplant 2000; 25: 85-9.

12) Anderlini P, Chan FA, Champlin RE, et al. Long-term follow-up of normal peripheral blood progenitor cell donors treated with fi lgrastim: no evidence of increased risk of leukemia development. Bone Marrow Transplant 2002; 30: 661-3.

13) Tassi C, Razzari PL, Bonifazi F, et al. Short- and long-term haematological surveillance of healthy donors of allogeneic peripheral haematopoietic progenitors mobilized with GCSF: a single institution prospective study. Bone Marrow Transplant 2005; 36: 289-94.

14) de la Rubia J, de Arriba F, Arbona C, et al. Follow-up of healthy donors receiving G-CSF for peripheral blood progenitor cell mobilization and collection. Results of the Spanish Donor Registry. Haematologica 2008; 93: 735-40.

15) Halter J, Kodera Y, Urbano Ispizua A, et al. Severe events in donor after allogeneic hematopoietic stem cell donation. Haematol 2009; 94: 94-101.

16) Anderlini P, Chan FA, Champlin RE, et al. Long-term follow-up of normal peripheral blood progenitor cell donors treated with fi lgrastim: no evidence of increased risk of leukemia development. Bone Marrow Transplant 2002; 30: 661-3.

17) Hölig K, Kramer M, Kroschinsky F, et al. Safety and effi cacy of hematopoietic stem cell collection from mobilized peripheral blood in unrelated volunteers: 12 years of single-center experience in 3928 donors. Blood. 2009; 114: 3757-63.

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INV-27TRANSFUSION REACTIONS AND ERRORS IN CHILDRENNew H.V.ICHT/NHSBT, London, United Kingdom

An understanding of the frequency and signifi cance of transfusion reactions and errors in children is needed as part of risk-benefi t transfusion decisions. For neonates in particular, there is enormous variation in transfusion practice (Guillén et al., 2012; Stanworth et al., 2009) and ongoing uncertainty as to appropriate indications for transfusion despite recent studies (Whyte and Kirpalani 2011; Venkatesh et al., 2013). Plasma transfusions are given in many cases for coagulopathy alone (Stanworth et al., 2011) and if there were better understanding of potential adverse outcomes, more inappropriate transfusions might be avoided. Children should be considered as a distinct group of recipients when analysing transfusion reactions and errors. Preterm neonates are a vulnerable and highly transfused paediatric population and, partly due to immunological immaturity, may react differently to transfusion, with more subtle signs. Sub groups such as haematology/oncology and cardiac patients are a signifi cant proportion of non-neonatal paediatric transfusion recipients (New et al., 2014) and many of these children have other co-morbidities creating a complex clinical picture in which transfusion reactions may be overlooked.Many countries have special components for neonates (New et al., 2009), and laboratory or clinical errors may result in the incorrect component being used. Moreover, neonatal pre-transfusion compatibility testing needs to take account of maternal serological results, increasing the chance of laboratory errors. Administration of blood components to neonates and small children often involves the use of specifi c giving sets and pumps, and also of precise volume calculations. These may be subject to clinical error, with some patients receiving signifi cantly different volumes than intended, and resulting morbidity. Paediatric patients are often part of shared care arrangements, with communication errors over clinical special requirements such as irradiation.The UK Serious Hazards of Transfusion Scheme (SHOT) reports paediatric cases separately from adults. The fi rst 9 years' data were analysed by Stainsby et al. (2008) with 10% cases in children, showing a disproportionate number of adverse outcomes of transfusion in children (in particular infants) compared with adults. The majority of paediatric cases were errors resulting in the "incorrect blood component transfused", highlighting the need for paediatric transfusion education and good communication. The numbers of paediatric reports appear to have plateaued since 2009 (Bolton-Maggs et al., 2012), and in the most recent publication (Bolton-Maggs et al., 2013) they were 6.7% (110/1,645) of total SHOT reports. A number of other haemovigilance organisations also report paediatric data, including the Netherlands (TRIP) and the Irish Blood Service. Although it can be diffi cult to compare reporting patterns precisely between countries, by collaborating together we are likely to understand more about the nature of adverse outcomes of transfusion in children in the future.Haemovigilance reporting systems do not capture all adverse outcomes of transfusion. Some are recognised elsewhere in the literature, for example reports of hyperkalaemia and cardiac arrest following large volume transfusions (Vraets et al., 2011; Lee et al., 2014), or of morbidity and mortality associated with neonatal exchange transfusions (Ip et al., 2004; Smits-Wintjens et al., 2008), including catheter-related problems. However, there is a concern that neonatal adverse reactions could be

being missed; for SHOT data the majority of reports in the neonatal/infant group are errors rather than reactions. Modifi ed defi nitions may be needed in order to capture the full incidence and range of neonatal transfusion reactions.There are several areas of ongoing research, including the recent suggestion that early red cell transfusion may be an independent risk factor for neonatal intraventricular haemorrhage (Baer et al., 2011). A more longstanding discussion has been over the relationship between red cell transfusions and some cases of necrotising enterocolitis (NEC), a devastating condition of intestinal infl ammation and necrosis in neonates with a high morbidity and mortality. It has recently been postulated that transfusion-associated NEC could be the gut equivalent of transfusion-related acute lung injury (TRALI; Blau et al., 2011). However, most information is from retrospective observational studies and the same causal factor could lead to both anaemia triggering the transfusion and NEC. In a recent meta-analysis, although observational studies showed an association between transfusions and NEC, for the few randomised controlled trials of neonatal red cell transfusion that included NEC in the outcomes there was a tendency for more NEC in the restrictively transfused group rather than the liberal, the opposite of what might be expected if NEC were causally associated with transfusion (Kirpalani and Zupanicic, 2012). There is a need for further prospective studies in this area. Adverse cardiorespiratory outcomes of neonatal and paediatric transfusion in particular may be under-recognised. There have been no reports to SHOT of TRALI in neonates or infants, and only occasional cases of transfusion-associated circulatory overload (TACO) or respiratory symptoms. However, one study of neonatal TRALI described a 15% incidence according to their defi nition in the 6 hours following transfusion (Joshi et al., 2006), and a more recent retrospective study showed persistent post-transfusion changes in oxygen support or mean airway pressure in 7.8% patients (Rashid et al., 2013). A UK prospective observational study has shown cardiorespiratory changes following neonatal transfusion (Venkatesh et al., manuscript in preparation) and there is a need for further studies with control groups. Gauvin et al. (2013) highlighted in a paediatric population on intensive care that the number of patients with positive criteria for TACO varied signifi cantly depending on the criteria used, and that none was reported to the Quebec haemovigilance system by the attending clinicians. In summary, transfusion reactions and errors in children and neonates need separate consideration due to the population-specifi c reasons for adverse outcomes in these patients. Ongoing programmes of education for professionals involved in paediatric transfusions are required in order to minimise the chance of transfusion errors. For reactions, there is a need for increased clinical awareness, further research into their true incidence, and review of appropriate defi nitions.

References1) B a e r V L , L a m b e r t D K , H e n r y E , e t a l .

Among very-low-birth-weight neonates is red blood cell transfusion an independent risk factor for subsequently developing a severe intraventricular hemorrhage? Transfusion 2011; 51: 1170-8.

2) Blau J, Calo JM, Dozor D, et al. Transfusion-related acute gut injury: necrotizing enterocolitis in very low birth weight neonates after packed red blood cell transfusion. J Pediatr. 2011; 158: 403-9.

3) Bolton-Maggs PHB (Ed) and Cohen H on behalf of the Serious Hazards of Transfusion (SHOT) Steering Group.

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The 2011Annual SHOT Report (2012). Available at: http://www.shotuk.org/wp-content/uploads/2012/07/SHOT-Summary_FinalWebVersion2012_06_261.pdf.

4) Bolton-Maggs PHB (Ed), D Poles, A Watt, D Thomas and H Cohen on behalf of the Serious Hazards of Transfusion (SHOT) Steering Group. The 2012 Annual SHOT Report (2013). Available at: http://www.shotuk.org/wp-content/uploads/2013/08/SHOT-Annual-Report-2012.pdf.

5) Gauvin F, Lefebvre E', Jarlot C, et al. Transfusion-associated circulatory overload in a paediatric intensive care unit: different incidence rates with different interpretation of the same defi nition. Transfusion Medicine 2013; 23 (s1): 19.

6) Guillén U, Cummings JJ, Bell EF, et al. International survey of transfusion practices for extremely premature infants. Semin Perinatol 2012; 36: 244-7.

7) Ip S, Chung M, Kulig J, et al; American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. An evidence-based review of important issues concerning neonatal hyperbilirubinemia. Pediatrics. 2004; 114: e130-53.

8) Joshi VH, Joshi PV, Webert K, et al. Does transfusion-related acute lung injury (TRALI) occur in newborns? J Canadian Paed Soc 2006; 11 Suppl SB. Available at: http://www.pulsus.com/cps2006/abs/042.htm.

9) Kirpalani H, Zupancic JA. Do transfusions cause necrotizing enterocolitis? The complementary role of randomized trials and observational studies. Semin Perinatol 2012; 36 (4): 269-76.

10) Lee AC, Reduque LL, Luban NL, et al. Transfusion-associated hyperkalemic cardiac arrest in pediatric patients receiving massive transfusion. Transfusion 2014; 54: 244-254.

11) New HV, Stanworth SJ, Engelfriet CP, et al. Neonatal transfusions. Vox Sang 2009; 96: 62-85.

12) New HV, Grant-Casey J, Lowe D, et al. Red blood cell transfusion practice in children: current status and areas for improvement? A study of the use of red blood cell transfusions in children and infants. Transfusion 2014; 54: 119-127.

13) Rashid N, Al-Sufayan F, Seshia MM, Baier RJ. Post-transfusion lung injury in the neonatal population. J Perinatol. 2013; 33: 292-6.

14) Smits-Wintjens VE, Walther FJ, Lopriore E. Rhesus haemolytic disease of the newborn: Postnatal management, associated morbidity and long-term outcome. Semin Fetal Neonatal Med 2008; 13 (4): 265-71.

15) Stainsby D, Jones H, Wells AW, Gibson B, Cohen H; SHOT Steering Group. Adverse outcomes of blood transfusion in children: analysis of UK reports to the serious hazards of transfusion scheme 1996-2005. Br J Haematol 2008; 141: 73-9.

16) Stanworth SJ, Clarke P, Watts T, et al; Platelets and Neonatal Transfusion Study Group. Prospective, observational study of outcomes in neonates with severe thrombocytopenia. Pediatrics 2009; 124: e826-34.

17) Stanworth SJ, Grant-Casey J, Lowe D, et al. The use of fresh-frozen plasma in England: high levels of inappropriate use in adults and children. Transfusion 2011; 51: 62-70.

18) Venkatesh V, Khan R, Curley A, et al. How we decide when a neonate needs a transfusion. Br J Haematol 2013; 160: 421-33.

19) Vraets A, Lin Y, Callum JL. Transfusion-associated hyperkalemia. Transfus Med Rev 2011; 25: 184-96.

20) Whyte R, Kirpalani H. Low versus high haemoglobin concentration threshold for blood transfusion for preventing morbidity and mortality in very low birth weight infants. Cochrane Database Syst Rev 2011; 9 (11): CD000512.

INV-28VARIATION IN RATES OF REPORTED TRANSFUSION REACTIONS IN HOSPITALS: IS A HIGH REPORTING RATE AN INDICATOR OF SAFER TRANSFUSION?Wiersum-Osselton J.C.TRIP National Hemovigilance and Biovigilance Foundatio, The Hague, The Netherlands

Background and objectives Hospitals ask how many reports of transfusion reactions they should expect to see if their hemovigilance activity is running well. It is thought that a high rate of reported transfusion reactions is "good" and that patients receiving a blood transfusion in those hospitals are probably safer than in hospitals which see fewer reports. SHOT (Serious Hazards of Transfusion, the United Kingdom hemovigilance system) in 2009 reported a decline in cases of serious transfusion-related morbidity and stated, "These trends are the hallmark of an effective vigilance system, in that the participation in the scheme, and thus total reports, increases as users become engaged with the process while the number of serious incidents declines"1. We evaluated this assumption at the hospital level in the database of TRIP (Transfusion and transplantation reactions in patients) National hemo- and biovigilance offi ce, taking reported incorrect blood component transfused as a proxy for unsafe transfusion2.

MethodsReports from 2006-2010 and annual numbers of transfused blood components from the 103 hospitals were analysed. The rate of transfusion reactions per 1,000 blood components was calculated per hospital. Logistic regression analysis was performed between reporting of at least one incorrect blood component and tertile of transfusion reaction rate.

Results Out of the 103 hospitals, 101 had complete data in some and 93 in all fi ve years. The rate of transfusion reaction reporting by hospitals tended to be consistent from year to year, with approximately 55% of variance in the rate of reporting transfusion reactions being explained by the rates in the previous years after adjustment for level of blood component use. In all, 72 hospitals had reported at least one incorrect blood component transfused; this was associated with blood use level and also with rate of reported transfusion reactions: odds ratio 4.2 (95% confi dence interval 1.3-13.7) in the highest vs the lowest tertile after adjustment for blood use level.

DiscussionThis study showed that the hospitals which detected and sent in higher numbers of reports of febrile and other reactions also reported more cases of incorrect blood component transfused. The data do not support that hospitals with a higher rate of transfusion reaction reports are safer. The results would be consistent with not all errors being detected or reported in hospitals with a less strong reporting culture.Hemovigilance reporting serves for surveillance of adverse reactions and of errors and incidents. The act of reporting is not an intervention to actually reduce risks, although the assumption is that feedback on what is happening, combined with recommendations for practice, should lead to improvements in safety both within the hospital itself and from the aggregate national and international reporting. The Dutch data show no decline in the numbers of reported incorrect transfusions or

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of the most serious subgroup, that of the ABO-incompatible transfusions3. This is in contrast to the United Kingdom and to France where there have been declining trends of the reported ABO incompatible transfusions4,5. No country has seen widespread introduction of electronic technology for the prevention of errors so any improvements are the result of less specifi c changes in practices6. Avoiding incorrect transfusions is highly important but only part of transfusion safety. Much considered is the safety of the actual components. In the Netherlands there are very low infectious risks from blood components, with 1-2 confi rmed or probable transfusion-transmitted bacterial infections per year and fewer than 1 case of viral transmission annually on average since reporting started in 2003. Other relevant domains are optimising component selection and care of patients receiving blood transfusion as well as sparing use of blood transfusion, which is important for both for donors and for patients. As yet it is not known whether certain (preferably easy to collect) hemovigilance data may be valid indicators of safe practice. At present hemovigilance reporting only covers the occurrence of transfusion reactions or incidents and no data is collected on patient outcomes. Studies of relevant outcomes are needed in different groups of patients in order to investigate the impact of transfusion reactions and monitor the effect of changes in practice.

ConclusionHospitals in The Netherlands which reported more transfusion reactions per 1,000 units in 2006-2010 were also more likely to have reported incorrect blood component transfused. A higher rate of transfusion reaction reports cannot be used as an indicator for safer transfusion. Future work should focus on maximizing the learning effect from reported events, both within the hospital itself and from the aggregate national and international reporting.

References1) SHOT Annual Report 2009. Available at: http://www.shotuk.

org/shot-reports/report-and-summary-2009/. Accessed on 19 January 2014.

2) Wiersum-Osselton JC, van Tilborgh-de Jong AJ, Zijlker-Jansen PY, et al. Variation between hospitals in rates of reported transfusion reactions: is a high reporting rate an indicator of safer transfusion? Vox Sang 2013; 104 (2): 127-34. doi: 10.1111/j.1423-0410.2012.01642.x.

3) Transfusion Reactions in Patients (TRIP) Dutch National Hemovigilance Offi ce on behalf of the TRIP board: annual reports available at: https://www.tripnet.nl/pages/en/publicaties.php. Accessed on 19 January 2014.

4) SHOT Annual Report 2012 available at: http://www.shotuk.org/wp-content/uploads/2013/08/SHOT-Annual-Report-2012.pdf. Accessed on 19 January 2014.

5) Agence Nationale de sécurité du médicament et de produits de santé. Rapport d'activité d'hémovigilance 2011. Available at: http://ansm.sante.fr/var/ansm_site/storage/original/application/94eaed87fcb1d3c9d2187f4945256875.pdf. Accessed on 19 January 2014.

6) Murphy MF, Stanworth SJ, Yazer M. Transfusion practice and safety: current status and possibilities for improvement. Vox Sanguinis 2011; 100: 48-59.

INV-29HOW COMPREHENSIVE SHOULD THE INFORMATION PUBLISHED ABOUT COMPLICATIONS OF BLOOD DONATION BE?Cárdenas J.M.Centro Vasco de Transfusion y Tejidos Humanos, San Sebastian, Spain

1914-2014 One hundred years have elapsed since the beginning of World War I when the big starting jump of blood transfusion practice took place1. During this period of time blood donors have evolved from the war front soldier's spirit of comradeship helping others, going through other subsequent types of donors such as voluntary donors, paid donors, family or replacement donors, compulsory donors, up to altruistic blood donors. According to Titmuss' classical book The Gift Relationship published in 19702, only a voluntary community donor base is suitable in order to meet patient's transfusion needs in terms of quality and quantity. The Red Cross3, the ISBT5, the WHO4 and other International institutions did endorse this statement. Donors should comply with two quality requirements: to be altruistic and to be regular5. Twelve years later at the beginning of aids pandemic, another donor quality requirement was added: responsibility. The donor had to be involved in his own selection process and had to judge by himself if his blood was adequate or not for transfusion. As demonstrated in a striking paper published in 19916 by Busch, Young, and Samson, it was possible with this sole preventive measure carried out in the AIDS pre-testing era, to cut by ninety percent the probability of AIDS transmission via blood transfusion in San Francisco area. For many years the donor's role had been perceived as merely passive, but nowadays Transfusion Medicine professionals are conscious regarding the prominent and active role of blood donors in the transfusion process. Politicians too. EU Blood Transfusion Directives7 require blood establishments to provide a lot of information for the prospective donor in order to make him/her able to participate in the decision of giving blood. In this setting we are driven to the subject of this presentation: which is the nature of the information to be provided? If we set apart everything related to possible effects on the recipient (discussed elsewhere), we should focus on information regarding the potential consequences of giving blood.

Let's see fi rst the objectiveThe idea is primarily to make the donor aware of the risks related to blood donation prior to give his/her informed consent for the procedure. Blood establishments take measures to control untoward effects of blood donation such as prevention of vasovagal reactions or iron depletion. A good deal of these measures requires the donor's collaboration. This is another important objective of the information to be provided.

Second, review which are the real risks associatedThose related to drawing the blood (currently8 classifi ed as local, generalized, apheresis related, and others) or those related to repeated blood donations. Recent papers9,10,11,12,13 stress the higher than expected occurrence of facts such as fainting off-site, or iron depletion incidence in particular donors with high variability among donors. Donor somatic characteristics and specifi c tests are being sought in order to determine which signals detect donors at risk. Communicating tests results may be also a cause of concern (remember the era of ALT screening!). Errors may affect donors in other ways as may

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happen in case of inappropriate data protection systems. The description of a list of potential adverse effects is only a fi rst step. It should be followed by a risk analysis taking into account the real situation in this particular blood establishment. A good haemovigilance system put in place is an invaluable tool for this to be true. Just to close this subject, the EU Directive mentioned above establishes the following information to be provided to the donors: 4. The reasons why individuals are not to make donations which may be detrimental to their health. 5. Specifi c information on the nature of the procedures involved in the donation process and their respective associated risks.

Third, how the information should be presentedAdverse effects always have a negative alarming connotation. In addition simple raw information could be misguiding. It should be well explained and coupled with information regarding control measures put in place for minimizing their effects or for lowering their occurrence. Remember that blood agencies are notorious for being quite often in the focus of public attention, presenting both chances and risks. Their conduct and their image must be properly managed. ISO 26000 provides guidance related to Social Responsibility and may give us some light, in particular items 4.3 Transparency and 4.4 Ethical behaviour. Both principles should be included in the communication policy.

References1) Diamond LK. A history of blood transfusion. In Wintrobe

MM Blood Pure and Eloquent. pp 679. New York 1980.2) Titmuss RM. The Gift Relationship. From Human Blood to

Social Policy. pp 75-89. London 1970.3) League of Red Cross and Red Crescent Societies. Third

colloquium on recruitment of voluntary donors, Hanover august 1990.

4) World Health Organization. Recommendation: Developing a national policy and guidelines on the clinical use of blood. Transfusion Today 1998; 37: 3.

5) ISBT General Assembly, Vienna, July 2000. A code of ethics for blood donation and transfusion. Vox Sang 2002; 82: 165-6.

6) Busch MP, Young MJ, Samson SM et al. Risk of human immunodeficiency virus (HIV) transmission by blood transfusions before the implementation of HIV-1 antibody screening. Transfusion 1991; 31: 4-11.

7) European Union. Commission Directive 2004/33/EC of 22 March 2004 regarding certain technical requirements for blood and blood components. Annex II Part A) 4-5. Brussels, Offi cial Journal of European Union 30-3-2004.

8) ISBT working party on Haemovigilance. Standard for surveillance of complications related to blood transfusion. 2008.

9) Kamel H et al. Delayed adverse reactions to blood donation. Transfusion 2010; 50: 556-65.

10) Wiersum-Osselton JC, van der Kreek TJ, de Kort W. Donor vigilance: progress and challenges. ISBT Science Series 2012; 7: 251-5.

11) Inaba S et al. Analysis of a questionnaire on adverse reactions to blood donation in Japan. Transfus Apher Sci 2013; 48: 21-34.

12) Kiss JE et al. Laboratory variables for assessing iron defi ciency in REDS-II Iron status evaluation (RISE) blood donors. Transfusion 2013; 53: 2766-75

13) Waldvogel-Abramovski S et al. Iron and transfusion medicine. Blood Reviews 2013; 27: 289-95.

INV-31DO WE SELECT DONORS THINKING ESPECIALLY ABOUT DONOR WELFARE? ARE MORE EFFORTS NEEDED TO PROTECT DONOR HEALTH?Tomasulo P.Blood Systems, Scottsdale, AZ, USA

Blood donation is an extraordinarily safe and inexpensive way for a person to do something good for others, to perform an altruistic act which saves lives. Blood programs should encourage more individuals to donate and they should enlarge the donor base. With a larger donor base it will be possible to improve the effectiveness and safety of healthcare by having the right donor and the right component for each patient. With more blood donors, we could provide ABO identical blood components to all patients and provide HLA-matched or compatible blood components more rapidly for alloimmunized or potentially alloimmunized patients. With more blood donations, we could signifi cantly reduce the risk of TRALI, allergic reactions and other adverse events associated with donor characteristics and we could reduce the risk of transmitting infectious disease, e. g. malaria, West Nile Virus and Chagas disease which are transmitted mostly by donors who live in or travel to areas where these diseases are prevalent by deferring donors who might have increased risk. Most important, if we had many more blood donors, we would not have to rely as heavily as we do on donors who might have a slightly increased risk of adverse events from blood donation.

Reactions associated with decreased blood pressureCaucasian, female, fi rst-time donors, whole blood donors and donors who give more than 13% of their estimated blood volume (EBV) have higher risk of fainting. Donors who faint are at risk of injury. Very few hypotensive reactions occur before the venipuncture. During the whole blood donation process the risk of fainting increases until the time the needle is removed and after the needle is removed, fainting is associated with the assumption of the upright position. Most injuries associated with whole blood donation occur after the needle is removed. The donor characteristics which are most associated with fainting after blood donation are high percent of EBV donated and female gender, but youth and FT donor status are also risk factors.

Injuries produced by venipunctureVery little is known about the risk factors for needle-related injuries (NRI) and about the mechanism to prevent them. Hematoma, tendon injury and nerve injury make up the bulk of the NRI and muscle injury and arterial injuries are the rarest. NRI occurs more frequently with apheresis donations than with whole blood donations and though VVR are far more common than NRI in whole blood donation, they occur at a similar frequency in apheresis donations. The donor characteristic most associated with NRI is low weight. There is a strong association between the occurrence of a VVR and the occurrence of a NRI.

Systemic adverse eventsWhen one donates a unit of red cells, one loses about 250 mg of iron. A male would have to absorb >5 mg/of iron per day to recover in 56 days (North American guideline) or >3.5 mg of iron per day to recover in 90 days (3 months). These rates of iron absorption are higher than normal. Based on recent observations it appears that the average fi rst time American blood donor

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recovers hemoglobin level in 20-28 weeks and this varies with the donation type and gender. Recovering the hemoglobin level is not necessarily an indication that iron level has been restored. In spite of these observations, it is clear that many blood donors have patterns of blood donation and iron metabolism which suit them well and they do not become iron defi cient. A male or female with average iron stores who donates blood twice each year is not likely to become defi cient. The factors which might play a role in determining iron defi ciency and net iron balance are the level of iron stores, history of blood donation, gender, frequency of blood donation (interval between donations), effectiveness of iron absorption, degree of daily iron loss, etc. It has been observed that a greater proportion of the population, especially the young female population, is iron defi cient than was previously thought and that non-anemic iron defi ciency might be clinically signifi cant during pregnancy and possibly during the adolescent years. Countries with very restrictive guidelines on the frequency of blood donation have not eliminated iron defi ciency in their blood donors, suggesting that detection of donors at risk is important.During apheresis donations, citrate is infused into the donor in varying amounts depending on the technology used and on the donation procedure chosen. Rapid citrate infusion can cause acute citrate reactions. Donors and blood service staff have become used to these reactions and they are managed in a fashion which is satisfactory to the donor and the staff. Nevertheless there are still concerns about citrate infusion. The biggest concern is that the blood services staff might attach a citrate bag in a fashion so that citrate is infused instead of an electrolyte solution meant to maintain the donor's fl uid balance. When this happens, donors can receive large volumes of citrate which can, depending on donor size and metabolism, cause severe morbidity and possibly mortality. This is an extremely rare event, but effective preventative measures have not been implemented even though this complication has been apparent for years. Finally, there has been some concern that chronic administration of citrate might adversely affect bone metabolism because it binds calcium and mobilizes calcium from bone. An impact on bone metabolism has been studied and the preliminary thought is that this is not a major worry, though defi nitive research results are needed.

Actions to be takenDonor centers must educate donors about the risks involved in blood donation in a frank and effective way. Because donation is safe and adverse events are rare, full disclosure should include putting facts into perspective to reduce the danger of producing inappropriate fear. The communication must accomplish more than simple education because reducing risk from blood donation requires donor action. Donors can reduce the risk of fainting by performing muscle tensing exercises and eating a high salt diet before and after the blood donation. They can reduce the risk of iron defi ciency by replacing the iron lost from each blood donation before the next blood donation.In many jurisdictions, there is a movement to recruit adolescent blood donors because most adolescents have a desire to help others and there is hope that a lifelong habit of blood donation can be formed. Unfortunately adolescent donors are more subject to iron defi ciency because of periods of rapid growth and the onset of puberty. They are at greater risk of fainting because they are smaller than middle aged adults and because they are unfamiliar with the donation process. It is likely that both iron defi ciency and fainting from blood donation are

completely preventable. More than explaining risks to blood donors, the goal of the communication and education is to empower the donor with the skills and knowledge necessary to nearly eliminate risk. Unfortunately it appears that donors are reluctant to take the actions necessary to prevent fainting and iron defi ciency. Donor centers must increase the effort to teach and engage adolescent blood donors so that risk can be minimized. If they are not effective in empowering the donors with the necessary tools, more restrictive donor recruitment strategies may be necessary.

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INV-32ANXIETY AND FEAR:PSYCHOLOGICAL ASPECTS OF BLOOD DONATION Van Dongen A.Sanquin Research, Amsterdam, The Netherlands

Anxiety and fear are among the most commonly named barriers to donating blood, even for regular blood donors1-5. These emotions can take many forms, like fear of needles, general nervousness, anxiety about reduced health after donating, or fear of fainting. For the sake of clarity, we use fear for an acute stage of fright (the phlebotomist putting a needle to your arm to pierce your skin and vein), whilst anxiety is a lingering feeling of nervousness and tension about blood donation in general. It is a common belief that anxiety and fear are deterrents to blood donation. This is probably true for people who are not blood donors. Lemmens et al (2005) found that non-donors report higher levels of fear and anxiety than already registered blood donors. More specifi cally, non-donors with a low intention to sign up as a blood donor also report higher levels of fear and anxiety than non-donors with higher intentions to take up donation3.Until recently, no study had found a direct effect of fear or anxiety in already registered donors on continuing blood donation. Several studies have shown that pre-donation anxiety is associated with experiencing vasovagal reactions9-12. Since vasovagal reactions have been shown to decrease return for another donation6-8, anxiety is an indirect determinant of donation behaviour. This could be explained by the fact that anxiety increases needle pain, and needle pain subsequently increases vasovagal reactions13. Another indirect relation of anxiety to donation is via attitude towards blood donation14,15 and intention to donate blood13. Both attitude toward donation (does the donor see the benefi ts of donating blood?) and intentions to donate (is the donor planning to donate blood again?) have been shown to be associated with continuous blood donation16. To study the direct effects of fear (of needles) and anxiety (general nervousness, anxiety about feeling faint) on continuing blood donation, we have conducted two studies. In the fi rst study we measured fear and anxiety in new blood donors who had just signed up. We asked them to what extent they were afraid of needles, to what extent they felt nervous and/or tense about blood donation, and to what extent they were afraid of feeling faint or fainting at the blood donation. We asked them the same questions after the fi rst donation (1-2 months later). We found that anxiety increased after the fi rst donation. However, when we looked at whether or not these donors had made a second donation, neither the level of increase nor the anxiety scores themselves were associated with subsequent donation17. In the second study we looked at the effect of fear and anxiety on retention in regular donors. We asked the same questions as in the previous study, this time to donors who made their fi rst donation one year previous. In this group, we did fi nd that the scores on fear and anxiety were related to subsequent donations18. This is in line with a recent study by France et al. (2013), who found no effect of anxiety on donation in fi rst time donors, but they did fi nd an effect of anxiety on donation in regular donors19. Therefore, if blood banks want to increase retention by decreasing anxiety and fear in donors, regular donors will most likely be infl uenced by these retention strategies. Anxiety and fear are not the only affective factors that can infl uence donation behaviour. In our fi rst study, we also

looked at the level of subjective distress that was caused by a physical reaction. We asked donors who had experienced a physical reaction (vasovagal reactions, needle reactions or fatigue) to rate how unpleasant they found the occurrence of the physical reaction. The results showed that regardless of the severity of the physical reaction, the level of subjective distress experienced by the donor infl uenced future donation behavior. Therefore, teaching donors how to cope with physical reactions could also infl uence retention. These coping strategies could incorporate passive distraction, for example getting the donor to read a book or magazine, or making tablets available. Another strategy could be to get the donor to reappraise their negative emotion (stress), by emphasizing that the negative event has a positive outcome20. Studies by Ferguson and colleagues show that that feelings of "warm glow" (e.g. donating blood because it makes one feel good) are a strong motivator for blood donation; stronger than feelings of reciprocity or altruism21,22. If we can get donors to reappraise their feelings of fear, anxiety and distress by emphasizing that they may feel a bit bad now, but they are actually saving a life and therefore should feel proud and good about themselves, we may lose less donors to negative emotions associated with blood donation.

References1) Oswalt RM. A review of blood donor motivation and

recruitment. Transfusion 1977; 17: 123-35. 2) Piliavin JA. Why do they give the gift of life? A review of

research on blood donors since 1977. Transfusion 1990; 30: 444-59.

3) Lemmens KP, Abraham C, Hoekstra T, et al. Why don't young people volunteer to give blood? An investigation of the correlates of donation intentions among young nondonors. Transfusion 2005; 45: 945-55.

4) Masser BM, White KM, Hyde MK, Terry DJ. The psychology of blood donation: current research and future directions. Transfusion Medicine Review 2008; 22: 215-33.

5) Bednall TC, Bove LL. Donating blood: A meta-analytic review of self-reported motivators and deterrents. Transfusion Medicine Review 2011; 25: 317-34.

6) France CR, France JL, Roussos M, Ditto B. Mild reactions to blood donation predict a decreased likelihood of donor return. Transfusion Apheresis Science 2004; 30: 17-22.

7) France CR, Rader A, Carlson B. Donors who react may not come back: analysis of repeat donation as a function of phlebotomist ratings of vasovagal reactions. Transfusion Apheresis Science 2005; 33: 99-106.

8) Newman BH, Newman DT, Ahmad R, Roth AJ. The effect of whole-blood donor adverse events on blood donor return rates. Transfusion 2006; 46: 1374-9.

9) Meade MA, France CR, Peterson LM. Predicting vasovagal reactions in volunteer blood donors. Journal of Psychosomatic Research 1996; 40: 495-501.

10) Labus JS, France CR, Taylor BK. Vasovagal reactions in Volunteer Blood Donors: Analyzing the Predictive Power of the Medical Fears Survey. International Journal of Behavioral Medicine 2000; 7: 62-72.

11) Ditto B, France CR. Vasovagal symptoms mediate the relationship between predonation anxiety and subsequent blood donation in female volunteers. Transfusion 2006; 46: 1006-10.

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12) Viar MA, Etzel EN, Ciesielski BG, Olatunji BO. Disgust, anxiety, and vasovagal syncope sensations: A comparison of injection-fearful and nonfearful blood donors. Journal of Anxiety Disorders 2010; 24: 941-5.

13) France CR, France JL, Wissel ME, et al. Donor anxiety, needle pain, and syncopal reactions combine to determine retention: a path analysis of two-year donor return data. Transfusion 2013; 53: 1992-2000.

14) Masser BM, White KM, Hyde MK, et al. Predicting blood donation intentions and behavior among Australian blood donors: testing an extended theory of planned behavior model. Transfusion 2009; 49: 320-9.

15) Clowes R, Masser B. Right here, right now: the impact of the blood donation context on anxiety, attitudes, subjective norms, self-efficacy, and intention to donate blood. Transfusion 2012; 52: 1560-5.

16) Ferguson E, France CR, Abraham C, et al. Improving blood donor recruitment and retention: integrating theoretical advances from social and behavioural science research agendas. Transfusion 2007; 47: 1999-2010.

17) Van Dongen A, Abraham C, Ruiter RAC, Veldhuizen IJT. The infl uence of adverse reactions, subjective distress, and anxiety on retention of fi rst-time blood donors. Transfusion 2013; 53: 337-43.

18) Van Dongen A, Ruiter R, Abraham C, Veldhuizen I. Predicting blood donation maintenance: the importance of planning future donations. Transfusion 2013; doi: 10.1111/trf.12397.

19) France CR, France JL, Carlson BW, et al. Fear of blood draws, vasovagal reactions, and retention among high school donors. Transfusion 2013. doi: 10.1111/trf.12368.

20) Webb TL, Miles E, Sheeran P. Dealing with feeling: A meta-analysis of the effectiveness of strategies derived from the process model of emotion regulation. Psychological Bulletin 2012; 138: 775- 808.

21) Ferguson E, Atsma F, de Kort W, Veldhuizen I. Exploring the pattern of blood donor beliefs in fi rst-time, novice, and experienced donors: differentiating reluctant altruism, pure altruism, impure altruism, and warm glow. Transfusion 2012; 52: 343-55.

22) Ferguson E, Taylor M, Keatley D, et al. Blood donors' helping behavior is driven by warm glow: more evidence for the blood donor benevolence hypothesis. Transfusion 2012; 52: 2189-200.

INV-33 & 36UPDATE ON ISTARE: RECENT FINDINGS IN RECIPIENTS AND FUTURE ORIENTATION OF THE INTERNATIONAL DATABASE ON HAEMOVIGILANCEPolitis C.1, Wiersum-Osselton J.C.2

1Coordinating Haemovigilance Centre (SKAE), Athens Hellas, Greece; 2TRIP National Hemovigilance and Biovigilance Foundation, The Hague, The Netherlands

BackgroundThe IHN established ISTARE (International Surveillance of Transfusion-associated Reactions and Events) in 2008 in order to unify the collection of haemovigilance data on all adverse reactions (ARs) and adverse events (AEs) associated with the donation and transfusion of blood components, irrespective of severity, from any country or region that gathers detailed haemovigilance data. ISTARE's ultimate goal is to maximize the safety of donors and transfusion recipients through the sharing of haemovigilance data and preventive measures in various parts of the world. Participants provide confi dential aggregated data following IHN/ISBT standards. The early pilot studies led eventually in 2012 to a web-based database developed by the ISTARE Working Group (current members: C. Politis, P. Renaudier, C. Richardson, P. Robillard, J. Wiersum) in collaboration with Stefi con Ltd (http://www.ihn-org.com/haemovigilance-databases/istare-2), which has recently been enhanced in the light of users' experience.

MethodsISTARE contains data entry forms for: ARs by component, imputability and severity; donor complications; errors-incorrect blood component transfused (IBCT); and general and specifi c denominator data (blood units issued and transfused, etc.) which are necessary for the automatic calculation of rates.

Data management, analysis and disseminationThe ISTARE Working Group coordinates the project on behalf of IHN and in consultation with its board; the working group are responsible for giving expert technical and haemovigilance input, providing support and technical advice to the data contributors, carrying out the data analysis and producing reports and other documents. Areas to be covered by the analysis include: data on contributing systems/sites (% coverage); rates of events per 100,000 units issued/transfused, overall and by product type, type of reaction and total/severe/deaths; distributions of types of event; averages for global regions; trends overall and by subcategory. If the national haemovigilance system does not record events according to product subtype, the user has the option of submitting the total for each main type of component. The data are disseminated anonymously. Interactive graphs compare country data with total data. Additional graphs, new in 2014, show donor aphaeresis reactions separately from whole blood and stratify by severity of reactions. Each country's data are marked in tables and diagrams by a code number allocated by the coordinators. The country's code number is known to its representative but not to the representatives of other countries. Instructions and defi nitionsInstructions and information are provided online as well as defi nitions which are the ISBT /IHN standard defi nitions for donor and recipient ARs. The Help facility has been enhanced recently.

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ResultsParticipation has increased steadily. For the reporting years up to 2012, 25 countries and regions from Europe, North America, Africa, Asia/Pacifi c and Australia had submitted a total of 103 reports, covering 111.5 million blood components issued for transfusion. ARs in recipients now stand at 74.5 per 100,000 units issued, annual numbers of reports having increased by almost 30% as more countries join and the completeness of reporting, especially of non-severe ARs (75% of reports), increases. Three quarters of reported ARs were not severe, 20.8% were severe, 4.1% life-threatening and 0.4% fatal. The three respiratory ARs were responsible for 60% of deaths: TACO 25.8%, TRALI 22.3% and TAD 11.7%. The most recent results will be included in the presentation. The reporting of donor complications has increased from 6 countries in 2006 in the pilot that preceded the full operation of the database (55% of participating countries in that year) to 17 countries (81%) who reported 110,000 complications in 19.6 million donations in 2011 giving an overall rate of 0.6%. 76% were vasovagal: 84% of whole blood reports, 58% of those relating to apheresis. However not all countries were able to provide data separately according to collection type. Severe complications represented 2.4% of the whole blood and 2.2% of the apheresis reports. Improvements to the data collection forms and charts were made in 2013 and reports for 2012 data are expected to exceed the previous year's yield with new participating countries.

ConclusionsThe ISTARE web-system initiates new prospects for the future of haemovigilance.ISTARE differs from other data collection systems in its holistic approach, aiming for surveillance of all ARs and AEs, and not only of the severe ones. As the time spanned by the records in the database increases, it is becoming possible to obtain important information on trends. Reports from new participating countries are expected to further increase data on recipients for 2012. Apart from improved data export and other technical improvements, further development of ISTARE is expected to include information on transfusion-associated iron overload and emerging transfusion transmitted infections, as well as additional data on component specifi cations. Enhanced calculation capabilities and deeper analysis of the results are also planned.

INV-34HOW TO DO A REALLY EFFECTIVE AUDIT: AUDITS IN PATIENT IDENTIFICATION AND BLOOD TRANSFUSION POLICYAndreu G.Consultant, Dijon, France

An audit is a systematic examination to determine whether actual activities comply with planned activities and achieve objectives. It is the way to test compliance with a frame of reference, consisting of regulation, guidelines, and professional standards.Audit can:- improve understanding of current practice (descriptive audit);- give information about compliance with guidelines

(compliance audit);- give information about the cause of an identifi ed problem

(diagnostic audit). Audit can be sized from a single hospital ward to a national level. Whatever its size is, an audit requires to be done in a favourable environment and in rigorous conditions to be successful.

The need for a favourable environment Audit should be considered as a priority by the board of directors of your institution, so that it is encouraged and supported.The existence in your institution of a structure dedicated to audits that coordinates this activity is an additional success factor.

Rigorous organization of the auditWe can recognize fi ve different steps to be completed in order to manage a full audit cycle.

Stage 1: PreparationRelevance of the topics for the institutionPatient identifi cation is a cross-disciplinary topic considered in all healthcare organization as a major challenge. It will be easy to convince that an audit in this key factor for patient safety will be useful for the institution. However, auditing all the aspects related to patient identifi cation is a very complex task, and you can make the choice to restrict the audit to the patient identifi cation in the blood transfusion process.Transfusion policy, which covers safety as well as clinical indication is also considered as important for most hospital boards of directors, who may hope that mastering the use of blood components will contribute not only to a better patients care, but also to an improved control of hospital costs.

Identifi cation of relevant frame of reference related to the selected topicsAlthough there may be different situations according to countries, these two topics will be generally covered by national regulation and guidelines.

Stage 2: Selection of audit review criteriaIn the audit jargon, a "criterion" is a principle or standard by which something may be judged or decided.Local criteria developed in the institution should be used as the basis for audit, as they are more likely to be clearly present in the hospital documentation in paper or electronic format. Audit criteria are explicit statements defi ning an outcome to be measured. They will ensure that the data you collect are precise and that you collect only essential information.

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Choice of method:Prospective audit Information is collected during the process of care. Its advantage is that it permits more complete data collection since errors can be corrected in real time. However, its disadvantage is that practice could be altered if personal are aware that their data are collected.

Retrospective audit Data are collected from records of discharged patients. Although it is more diffi cult to obtain complete data on every subject in the sample, retrospective audit may provide information that is more representative of day-to-day practice, which is a main target for auditing patient identifi cation and transfusion policy.

Stage 3: Measure of the performanceData collection The number of patients to be included and excluded in the audit, the way they are selected and the time period over which the criteria apply should be defi ned.

Data analysis Most criteria in the fi eld of patient identifi cation and transfusion policy should be met in 100% of the fi les investigated. However, criteria for transfusion prescription may be complex in some clinical situation, and if this specifi c fi eld is included in the audit, the analysis will benefi t of selected case review by independent investigators to conclude that criteria are met or not.The audit results are presented and discussed with the directly involved personal and whoever else in the hospital the audit is relevant to as well.

Stage 4: Search for improvementImplement changeBased on the results, an action plan for improvement should be built, with the participation of the personal involved. Actions may include dissemination of educational materials, modifi cation of documentation or SOPs when necessary, sensitizing tools such as tutorials, regular reminders, etc.

The Audit reportThe audit report should include the following sections:- Objectives.- Participants.- Organisation and methodology.- Frame of reference and timeline from planning to report.- Both positive fi ndings and issues requiring improvement- Agreed action plan for improvement.- Annexes (audit protocol, user manual, reference sources).

Stage 5: Sustaining improvementsThis stage verifi es whether the changes implemented have had an effect.The classical action is to repeat the audit using the same methodology to ensure it is comparable to the initial. The repeat audit will hopefully show that changes have been implemented and improvements made, all the analysis being included in a fi nal audit report.

Available tools to help building a blood transfusion auditAn EU initiative: the Optimal Blood Use ProjectThe Optimal Blood Use website1 is a resource for improving safety and effectiveness of the clinical transfusion process. The

project, promoted by the European Commission, was conducted between 2008 and 2010 by representatives of 18 countries, coordinated by the Scottish Blood Transfusion service.The manual has been translated into French, German, Greek, Italian, Polish, Portuguese and Spanish.It may help all of those wishing to organize an audit by providing a full chapter on this topic2. More specifi cally, different frames for auditing transfusion policy, patient wristband management, patient blood sampling and blood component administration practice, are proposed3.

Frame from the French Haute Autorité de Santé The French Health Authority «Haute Autorité de Santé» has published a tool to audit patient identifi cation, transfusion data traceability, and relevance of clinical indication of red blood cell concentrates in surgical situation4. This website is useful for those who can read French.

Publications For the audit methodology, we can recommend two publications5,6. The following recent publications refer to either compliance with safety guidelines in a single institution7, time to blood availability in emergency conditions8, compliance with clinical guidelines in a single institution9-12, at a regional13 and national level14.

ConclusionConducting an audit in Blood transfusion may imply different independent structures such as hospital, blood transfusion centre, independent laboratory, etc. adding complexity to its realization. However, the existing available documentation will enable every motivated team to implement successful audits in this fi eld.

Special thanks to the following members of the EU Optimal Blood Use Project: Margarida Amil, Shubha Allard, Riin Kullaste, Brian McClelland, Simon Stanworth, Vincenzo de Angelis and Rene R.P. de Vries.

References1) http://www.optimalblooduse.eu/.2) http://www.optimalblooduse.eu/content/9-audit. 3) http://www.optimalblooduse.eu/sites/optimalblooduse.eu/

fi les/12_EU%20OBUP%20Audit%20Forms.pdf.4) http://www.has-sante.fr/portail/jcms/c_417448/fr/

transfusion-en-anesthesie-reanimation?xtmc=&xtcr=1.5) Benjamin A. Audit: how to do it in practice. BMJ. 2008 May

31; 336 (7655): 1241-5.6) Haspel RL, Uhl L. How do I audit hospital blood product

utilization? Transfusion 2012; 52 (2): 227-30. 7) Gallagher-Swann M, Ingleby B, Cole C, Barr A. Improving

transfusion practice: ongoing education and audit at two tertiary speciality hospitals in Western Australia. Transfus Med 2011; 21 (1): 51-6.

8) Pottle J, Staves J, Curry N. Transfusion delays: an audit of transfusion practice for major blood loss in a UK teaching hospital. Transfus Med 2012; 22 (1): 71-2.

9) Gutsche JT, Kornfi eld ZN, Speck RM, et al. Impact of guideline implementation on transfusion practices in a surgical intensive care unit. J Cardiothorac Vasc Anesth 2013; 27 (6): 1189-93.

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10) Cohn CS, Welbig J, Bowman R, et al. A data-driven approach to patient blood management. Transfusion 2013; doi: 10.1111/trf.12276.

11) Wolfenden H, Shefl er A, Stanworth S, et al. Are we following a restrictive red cell transfusion practice? A multi-centre audit of paediatric transfusion practice in PICU. Transfus Med 2013; 23 (4): 274-5.

12) Jackson GN, Snowden CA, Indrikovs AJ. A prospective audit program to determine blood component transfusion appropriateness at a large university hospital: a 5-year experience. Transfus Med Rev 2008; 22 (2): 154-61.

13) Tinmouth A, Thompson T, Arnold DM, et al. Utilization of frozen plasma in Ontario: a provincewide audit reveals a high rate of inappropriate transfusions. Transfusion 2013; 53 (10): 2222-9.

14) Qureshi H, Lowe D, Dobson P, et al; National Blood Service/Royal College of Physicians National Comparative Audit of Blood Transfusion programme. National comparative audit of the use of platelet transfusions in the UK. Transfus Clin Biol 2007; 14 (6): 509-13.

INV-35TOTAL TRACEABILITY: HOW IS THIS MANDATORY INSTRUCTION BEING IN EUROPE? IMPLEMENTED STRATEGIES TO CONTROL THE FINAL DESTINY OF BLOOD COMPONENTSEscoval M.A.A., Condeço J., Ramoa A.Portuguese Blood and Transplantation Institute/Portuguese Haemovigilance System, Lisbon, Portugal

IntroductionTraceability and notifi cation of serious adverse events and reactions are the essential requirements of an haemovigilance system, representing as well fundamental tools for transfusion safety.In many legal contexts haemovigilance and traceability progressed from desirable to mandatory. The strategy to attain and maintain effective traceability comprises all activities associated with process planning, design and management.European Union (EU) Blood Safety Directive (2002/98/EC)1 applies to all European countries since February 2005 and ensures health protection by setting standards of quality and safety for the collection, testing, processing, storage and distribution of blood. Directive 2005/61/EC2 implements Directive 2002/98/EC as regards traceability. According to this, blood components must be traceable from donor to recipient and vice versa. Member States (MS) must implement unmistakable identifi cation procedures, record maintenance and an appropriate labeling system. The regulations require also the evidence of the fi nal destiny of all blood components. This traceability information should be kept for at least 30 years. Currently in Europe and all around the world, relatively little is known about traceability and no comprehensive synopsis of traceability status in the different countries is available on medical literature. The percentage of blood products confi rmed as having been transfused or destroyed in hospitals is unknown.

AimTo assess the implementation of traceabilty status at a global level, capture information about current practices and evaluate the compliance for confi rming the fi nal destination of blood components.

MethodsA survey was designed and the 28 EU MS Competent Authorities as well as Norway and 28 ISBT haemovigilance working party members, from different countries outside Europe, have been invited to contribute. The questionnaire was divided into sections: respondents, blood supplier, haemovigilance system, full traceability, identifi cation procedures, labelling system requirements, record of data on goods traceability procedures. The survey was available online, from 2 December 2013 to 15 January 2014.

ResultsIn order to facilitate data analysis, presenting Norway a similar profi le to the EU countries, it was decided to include the Norway data in this group.25 answers were received from 24 countries, 17 answers from EU countries (Croatia, Cyprus, Czech Republic, Denmark, Estonia, France, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden) and 8 answers from 7 non-EU countries ((Argentina, Japan, Qatar, Saudi Arabia, South Africa, Sri Lanka, USA) with an answer rate of 59% for EU countries and 25% for non EU countries. In EU countries 70.6% of the survey respondents were involved with regulatory agencies/competent authorities and 11.8% national haemovigilance offi ces.

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In 76% of the respondent countries there was more than one blood supplier and 84% of the respondent countries had an haemovigilance system, amongst whom all the European countries. In all the EU MS, the European Directives have been transposed into national law between 2005 and 2007. All the respondent countries outside Europe but one, has some regulation or national law on traceability requirements.In 88% of the countries there are procedures/ guidelines in place to trace each blood donation and its components from the donor to its fi nal destination and vice-versa. Countries classify the degree of full components traceability as in Table I.

Table I - Degree of full components traceability.

Degree of full components traceability

EU Countries Non EU Countries

100% 10 290% 3 480% 3 170% 1 -60% - 1

This classifi cation is based in collected data (52% of the respondent/64.7% of EU countries), in offi cial reports (2 countries) and in the remaining cases in estimated data.48% of the respondent (52.9% of the European countries) answered that they have in place procedures/guidelines to receive information that each unit issued has been transfused to the intended recipient. If the unit has not been transfused 60% of the countries (70.1% of the European countries), have a procedure to verify its subsequent disposal, and 36% (29%) answered that some Hospital Blood Banks (HBB) and Blood Establishments (BE) have.All the respondent country BE and facilities record data comprising identifi cation procedures. For blood units not transfused, confi rmation or subsequent disposition is recorded by 84% (82.4% at EU level).In table II, data from component labeling is summarized.

Table II - Information in component labels.

Information present in label EU Countries

Non EU Countries

Single national coding system for blood components

76.5% 62.5%

Offi cial name of the component 100% 100%Volume, weight or number of cells in the component

88.2% 87.5%

Unique numeric or alphanumeric donation identifi cation

100% 100%

Name of producing establishment 100% 100%ABO group 100% 100%Rh D group 100% 100%Date or time of expiry 100% 100%Storage temperature 88.2% 75.0%Name, composition and volume of anticoagulant and/or additive solution

100% 62.5%

Data record on traceability is kept by quality management system or quality policy in 76% and in the other cases by IT systems. The data storage is organized both in paper and electronic forms in 83.3% of the countries (70.6% EU countries).In what concerns to procedures for the traceability of goods from receipt to issue, 75% of the countries (93.8% EU) have documental procedures to maintain records of stock requisitions received and dispatched 66.7% (68.8 EU countries) for non-stock requisitions and 87.5% for delivery notes (81.3% EU countries).

Discussion and conclusionAlthough a bias, related to the fact that the survey respondents may be the countries with the largest implementation of traceability procedures, can be present, our survey shows that blood components are majority traceable from donor to recipient and vice versa through unmistakable identifi cation requirements and procedures, record maintenance and appropriate labeling systems.However the critical point on traceability is the fact the legal requirement to confi rm the fi nal destination of blood components is currently not always met. We can fi nd a lack of evidence of the implemented strategies in place to control the fi nal destiny of blood components. A more detailed survey is needed to obtain insight into the various methods used by hospital blood banks. The information collected in this survey will help in the design of strategies to maintain effective haemovigilance systems. The same way as the reporting system for adverse reactions and events, offi cial reports on traceability, should also be disclosed.

AcknowledgmentsThe authors gratefully acknowledge to all the respondent survey contributors (Dr Vanja Nikolac, Mrs Sappho Michael, Dr Turek Petr, Dr Jorgen Georgsen, Professor Triin Naadel, Dr Imad Sandid, Professor Constantina Politis, Inspector Richard Forde, Dr Giuseppina Facco, Dr Paul Courrier, Dr Oystein Flesland, Professor Ryszard Poglod, Dr Irena Bricl, Mrs Katja Mohorcic, Dr Miguel Angel Vesga, Mrs Helena Strom, Dr Carlos Gonzalez, Professor Hitoshi Okazaki, Dr Aysha Almaki, Dr Salwa Hindawi, Dr Neo Moleli, Dr Senarath Jayasekara, Dr Peter Tomasulo, Dr Barbee Whitaker) and in particular Dr Jo Wiersum-Osselton, Dr Eduardo Muñiz-Diaz and Dra Gracinda de Sousa for the support and advice.

References1) European Commission: Directive 2002/98/EC of the European

Parliament and of the council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components; 2003. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:2003:033:0030:0040:en:pdf.

2) European Commission: Directive 2005/51/EC of the European Parliament and of the Council as regards traceability requirements and notifi cation of serious reactions and events; 2005. Available at: http://eur-lex.europa.eu/LexUriServ.do?uri=OJ:L:2005:256:0032:0040:EN:PDF.

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INV-37VIGILANCE OF MEDICAL DEVICES. STATE OF THE ARTRuiz-Villar C.Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, Spain

Medical devices are currently used on blood donations, blood processing, and blood procedures; therefore like Haemovigilance systems, a strong Vigilance System of Medical Devices plays also an important role to protect health and safety of patients, users and others. The majority of products used in blood procedures are general medical devices like needles, blood lines, etc, or in vitro diagnostic medical devices. Both of them defi ne by the European Directives as:Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifi cally for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation

of disease,- diagnosis, monitoring, treatment, alleviation of or

compensation for an injury or handicap,- investigation, replacement or modifi cation of the anatomy or

of a physiological process,- control of conceptionand which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.In vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:- concerning a physiological or pathological state, or- concerning a congenital abnormality, or- to determine the safety and compatibility with potential

recipients, or- to monitor therapeutic measures.Recent events in the fi eld of medical devices, as PIP breast implant crisis or metal on metal hip implant alerts, have demonstrated even more the importance of having a well defi ned Medical Device Vigilance System implemented to avoid or reduce any risk when a medical device is used. The occurrence of these events, has caused a re-evaluation of the existing medical device legislations and procedures by competent authorities.The objective of the Medical Device Vigilance System is the protection of health and safety of patients, users and others by reducing the reoccurrence of incidents. As a common understanding, this is to be achieved by the evaluation of incidents and in some cases through the dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such incidents. The health effects that may result from non-compliance, failure or defi ciency of information that accompanies a medical device can be very serious, even more if you consider that the product can be use worldwide.

Internationally, different groups as the International Medical Device Regulators Forum (IMDRF) based on the previous group the Global Harmonization Task Force (GHTF), has been created to accelerate international medical device regulatory harmonization and convergence to promote an effi cient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety. IMDRF work covers different fi elds of medical devices like pre market, clinical investigations, post market, etc. Regarding vigilance of medical devices a National Competent Authority Report Exchange Program (NCAR) was created to facilitate timely information exchange of relevant post market safety information on medical devices with global distribution.At a European level a guidelines document (MEDDEV 2.12-1 rev. 8) was created to facilitate the uniform application and implementation of the Medical Device Vigilance System requirements of the European legislation, by manufactures and Notifi ed Bodies, and also by the National Competent Authorities charged with safeguarding public health. These guidelines describe the European system for the notifi cation and evaluation of incidents and Field Safety Corrective Actions (FSCA) involving medical devices and facilitate an early and harmonized implementation of the FSCA in all member states where a specifi c medical device is used rather than country by country. Based on the work already done by the GHTF, a European vigilance network on medical devices was created to exchange information.Finally, besides manufacturers and competent authorities which have a key role on the Medical Device Vigilance System, we must not forget that health professional participation is essential for a satisfactory performance of this system. Therefore it's important to encourage professionals to report all incidents to occur as soon as possible to the manufacturer and / or the Competent Authority in accordance with national regulations and to assist in the adoption of the recommended measures.

References1) Directive for Medical Devices (MDD), 93/42/EEC.2) In Vitro Diagnostic Medical Devices Directive (IVDD),

98/79/EC.3) Guidelines on a Medical Devices Vigilance System

MEDDEV 2.12-1 rev 8, January 2013.4) GHTF/SG2/N54R8:2006. Medical Devices Post Market

Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices.

5) GHTF/SG2/N79R11:2009. Medical Devices Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form.

6) MDRF/MC/N1FINAL:2013. IMDRF Terms of Reference.

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INV-38INDICATIONS AND SIDE EFFECTS OF PLASMA AND PLASMA PRODUCTSSchipperus M.R.1, Saadah N.2

1TRIP National Hemovigilance and Biovigilance Foundation, The Hague; 2Department of Epidemiology, Leiden University Medical Center, Leiden, The Netherlands

Plasma transfusions are indicated in cases of massive bleeding, warfarin reversal, thrombotic thrombocytopenia purpura (TTP), hemolytic-uremic syndrome (HUS), liver disease, defi ciencies in clotting factors for which concentrates do not exist (e.g. Factor V), and a few other disease states. The two most commonly used forms of plasma for transfusion are quarantine fresh frozen plasma (Q-FFP) and solvent/detergent-treated plasma (SDP). Q-FFP is a one-donor to one-recipient product in which the donor is fi rst tested (for HIV, HBV, HCV, syphilis and, in the case of fi rst-time donors, HTLV I/II) before the plasma is frozen for six months. Following this quarantine period, the donor is retested (given the window period of the concerned pathogens) before the product is released for use. SDP, on the other hand, is a pooled product made from around a thousand units of FFP wherein the donors do not undergo secondary testing. Thus it must endure a robust pathogen reduction process to ensure its safety.Indications for plasma transfusions generally suffer from a lack of a strong evidence base. Only the treatment of thrombotic microangiopathies (such as TTP and HUS) via plasma transfusions carry a GRADE* ranking of A (high quality evidence) while all other indications achieve only a ranking of C (low quality evidence)1. This is partly due to the acute settings in which plasma transfusions tend to take place. Data on plasma usage are diffi cult to come by, but a 2008 plasma transfusion audit performed over fi ve days within seventy-six hospitals in the province of Ontario, Canada confi rms that over half of all plasma transfusions occur in an acute setting (surgery or rapid reversal of warfarin) .

Table I - Indications for FFP transfusions - Ontario, Canada.

Procedure/clinical indication Percentage of FFP transfusions

Surgery 33.3%

Warfarin reversal 20.2%

Other coagulopathy 14.3%

Before invasive procedure 5.9%

Bleed 8.4%

Massive transfusion 7.3%

Plasma exchange 3.8%

Trauma 0.3%

Miscellaneous 6.3%

Source: Tinmouth, A. et al (2013). Utilization of frozen plasma in Ontario: a province-wide audit reveals a high rate of inappropriate transfusions. Transfusion, 53 (10), 2222-9.

Given that much of the evidence base for plasma transfusions has expert opinion as opposed to concrete data as its source, in comes as little surprise that research into plasma transfusion appropriateness tends to reveal a high proportion of unnecessary transfusions. Indeed the same audit reporting the above data on plasma use concluded that only 55% of plasma transfusions could

be qualifi ed as appropriate based on internationally agreed-upon indications, with fully 28% qualifying as inappropriate and the remainder as indeterminate2.Despite being generally well tolerated, plasma transfusions, like those of any blood product, occasionally lead to adverse events. The most commonly observed side effects to plasma transfusion are febrile non-hemolytic transfusion reactions (FNHTRs) and allergic transfusion reactions. More serious reactions to plasma transfusions include anaphylactic reactions, acute haemolytic reactions and septic reactions. In addition, both TACO (transfusion-related circulatory overload) and TRALI (transfusion-related acute lung injury) can occur following plasma transfusions.The last decade has seen a slow but steady shift from Q-FFP to SDP on the part of most European countries as the advantages of pathogen reduced, pooled plasma over frozen plasma are realized. In addition to decidedly more consistent plasma protein levels, SDP has demonstrated markedly decreased incidences of allergic/anaphylactic reactions, FNHTRs and septic transfusion reactions, and to date there has yet to be a confi rmed report of TRALI following transfusion with SDP3. However the pathogen reduction process starkly diminishes the levels of some plasma proteins, notably protein S and α2-antiplasmin, leading some researchers to conclude that SDP carries a higher risk of both venous thromboembolism (due to low protein S levels)4,5,6 and hyperfi brinolysis (due to low α2-antiplasmin levels)7,8. Indeed while provisionally approving the use of SDP in the United States for the fi rst time in over a decade, the FDA insisted studies investigating these two risk factors be done before fi nal approval is given9.As SDP has demonstrated a reduced risk of recognized transfusion-related adverse events, hemovigilance organizations the world over are now turning their attention to attenuating the risk of emerging pathogens, most notably prion diseases. Octapharma now offers OctaplasLG, a prion-reduced version of its pooled plasma Octaplas, and the Netherlands is in the process of switching to Omniplasma, a prion reduced form of SDP made exclusively from Dutch donors, following a ten-year hiatus from pooled plasma brought on specifi cally by the fear of prion transmission10. The classifi cation of adverse events, particularly FNHTRs and allergic/anaphylactic reactions, varies by country often making their incidences diffi cult to report and compare (e.g. the threshold for the temperature rise associated with a FNHTR varies from 1o to 2o). In addition, given the acute setting in which most plasma transfusions take place and the comparatively subtle manifestations of FNHTRs and allergic transfusion reactions, these two, unarguably the most commonly observed, often go unnoticed or unreported11. TRIP (Transfusion Reactions In Patients), the national hemovigilance organization of the Netherlands, recently began a three-year study (the FROSTED** study) designed to more accurately investigate and quantify the risks and incidences of plasma transfusion related adverse events. Given that the study is taking place during the transition from Q-FFP to SDP, it should allow accurate comparisons of these two products with regard to safety, effi ciency, and cost effectiveness within a representative country.

*Grading of Recommendations Assessment, Development and Evaluation Working Group.**Fresh frozen plasma, Omniplasma, and SDP comparison of Transfusion reactions, Effi cacy and DVT.

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References1) Liumbruno G, Bennardello F, Lattanzio A, Piccoli, et al.

Recommendations for the transfusion of plasma and platelets. Blood Transfusion 2009; 7 (2): 132-50.

2) Tinmouth A, Thompson T, Arnold D, et al. Utilization of frozen plasma in Ontario: a provincewide audit reveals a high rate of inappropriate transfusions. Transfusion 2013; 53 (10), 2222-9.

3) Krusius T, Auvinen M-K, Tuimala J. Introduction of Octaplas in clinical use decreased the rate of serious adverse reactions. Vox sanguinis 2010; 99 (Suppl. 1): 461.

4) Flamholz R, Jeon HR, Baron JM, Baron BW. Study of three patients with thrombotic thrombocytopenic purpura exchanged with solvent/detergent-treated plasma: is its decreased protein S activity clinically related to their development of deep venous thromboses? Journal of clinical apheresis 2000; 15 (3): 169-72.

5) Yarranton H, Cohen H, Pavord SR, et al. Venous thromboembolism associated with the management of acute thrombotic thrombocytopenic purpura. Br J Haematol. 2003; 121 (5): 778-85.

6) Coignard BP, Colquhoun SD, Nguyen GT, et al. Intra-operative deaths in liver transplant recipients associated with the use of solvent/detergent plasma. Hepatology 2002; 36 (4 (2)), 209A.

7) De Jonge J, Groenland THN, Metselaar HJ, et al. Fibrinolysis during liver transplantation is enhanced by using solvent/detergent virus-inactivated plasma (ESDEP). Anesthesia and analgesia 2002; 94 (5): 1127-31.

8) Magner JJ, Crowley KJ, Boylan JF. Fatal fibrinolysis during orthotopic liver transplantation in patients receiving solvent/detergent-treated plasma (Octaplas). Journal of cardiothoracic and vascular anesthesia 2007; 21 (3): 410-3.

9) Food and Drug Administration (FDA). (2012). Clinical Review Memo - Octaplas - Food and Drug Administration [Memo]. Retrieved from: http://www.fda.gov/downloads/Bio log icsBloodVacc ines /B loodBloodProduc t s /ApprovedProducts/LicensedProductsBLAs/UCM339691.pdf.

10) Christine, Kramer. "Omniplasma: extra veiligheid in vele stappen." Sanquin Avond. Sanquin. Sanquin Blood Supply, Amsterdam, the Netherlands. 31 Jan 2013. Lecture.

11) Vamvakas, Eleftherios C. "Allergic and Anaphylactic Reactions." Transfusion Reactions (4th Edition). By Mark A. Popovsky. Bethesda, MD: AABB 2012: 106-7.

INV-39EDUCATION AND TRAINING TO IMPROVE TRANSFUSION SAFETYBranigan B.Beaumont Hospital and Bon Secours Hospital, Dublin, Ireland

BackgroundWe have had blood transfusion education programmes for over a decade, arising from the national and international Haemovigilance movements. Transfusion education is mandatory for all members of staff involved in blood transfusion. We have annual Accreditation from external.

MethodsI will give a general description of the educational standards which we have in the hospitals and the effects they have had on blood transfusion safety. We have used different teaching methods including e-learning, formal lectures, informal talks and introduction of protocols on Red Cell prescribing.

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INV-40WHAT'S THE HOLD UP?DELAYED AND INADEQUATE TRANSFUSIONBolton-Maggs P.H.B., Ball J.On behalf of the SHOT steering group, Serious Hazards of Transfusion, Manchester, United Kingdom

Haemovigilance schemes have focused on adverse reactions and events in donors and recipients following transfusion of blood and its components. However, patients may also suffer adverse consequences if transfusion does not take place in a timely manner or is inadequate. The UK National Patient Safety Agency (NPSA) was set up in 2001 to identify trends and patterns in patient safety problems through a national reporting and learning system (NRLS)1. Hospitals were encouraged to report any unintended or unexpected incident that could have or did lead to harm. This scheme issued national warnings and alerts from sentinel events. Between 2005 and 2010 reports were received of 11 deaths and 83 incidents in which patients were harmed as a result of delayed provision of blood in an emergency. A "Rapid Response Report" followed in October 20102 with immediate action by hospitals to be completed by April 2011, including review of major haemorrhage protocols (MHP) and reporting any incidents of death or harm to the NPSA and the haemovigilance scheme, SHOT (Serious Hazards of Transfusion).Hospitals were advised to review their local practices for requesting and obtaining blood in an emergency (guidance available on Department of Health website3,4). This should include training and regular drills similar to training for cardiac arrest calls. The protocol should be activated using an easily recognised trigger phrase, and a local team member nominated to co-ordinate communication. Hospital transfusion committees are recommended to review all incidents to ensure activation is appropriate and effective. Major haemorrhage packs (usually 4 units of red cells with 4 units of fresh frozen plasma (FFP), this together with platelets in a second pack), are now advocated for management of severe bleeding on the basis of good results in military settings where the principle is early and adequate transfusion for major trauma. However, local audit5 has shown that the majority of MHP calls in the civilian setting are not triggered by major trauma (11%) but by other serious bleeding events - 31% gastrointestinal bleeding, 23% obstetric haemorrhage and 21% vascular bleeding or surgery. Overall, the use of the emergency pack resulted in signifi cant wastage of FFP (118 units in 31 cases, 14.3% all FFP); 50% of cases used 0-4 units of red cells, and 20% used greater than 9 units (audit data collected by the NW Regional Transfusion Committee5). A recent meta-analysis of plasma to red cell ratios in trauma has demonstrated that a ratio of 1:2 is as good as 1:16.SHOT now collects data through an online database from the beginning of 2010, and reports of delays or inadequate transfusion are invited since then. Currently more than 98% UK National Health Service hospitals report to this scheme. Although the NPSA recommendation related only to emergency transfusion, the SHOT scheme will accept any report where the clinician noted "delay", for example delay resulting from reluctance to transfuse overnight despite clear clinical indications. Emergencies are also associated with other SHOT-reportable adverse events such as sample mix ups, poor labelling and ultimately, wrong components transfused including incompatible ABO red cells.Reports to SHOT of delayed or inadequate transfusion have increased each year, 2 in 2010, 12 in 2011, 21 in 2012 and 34 in 2013 (ages ranged from birth to 86 years of age). These are seriously ill patients with a high mortality (21/69, 30.4%) and in some cases 10/69 (14.5%) this was related to the delayed transfusion. The majority of these events were emergencies. A death in 2011 resulted from inadequate transfusion after obstetric haemorrhage

in a 34 year old woman. In this instance 6 units of blood were available within 5 minutes, the bleeding was quickly controlled and the MHP stood down, but there was failure to recognise and correct the large volume haemorrhage that had occurred, compounded by shift changes and confusion over who was in charge. In two cases reported in 2013 junior doctors did not recognise and act on basic signs of haemorrhagic shock, resulting in death in one case and cardiac arrest followed by serious brain damage in the other. Reports of inadequate transfusion (n=3) related to suboptimal volumes of fresh frozen plasma transfused for coagulopathies.Key features identifi ed from these 69 cases included lack of knowledge about MHPs (location, how to trigger), but also serious errors: short cuts in procedures resulting in failure to correctly identify patients, poor sample labelling so that repeat samples were required, selection of wrong blood components and transfusion without the fi nal bedside checks. Poor communication between clinical and laboratory staff contributed to delay when the laboratory staff did not know that this was an emergency. Delay resulted from poor handover where patients were transferred between departments and hospitals. A patient with acute myeloid leukaemia was admitted with a Hb of 40g/L, but the unit of blood prescribed in the emergency department was not administered for 28 hours because the ward and then tertiary hospital to which he was transferred assumed that it had been given. There were unexpected lessons. A major bleeding event began during an interventional radiology procedure which revealed that none of the radiology medical or other staff knew about MHPs and none had received any transfusion training. Indeed transfusion training was not included in the national training programme for interventional radiology. There were 2 unrelated incidents where the MHP was activated but fi re alarms involving the laboratory meant no laboratory facilities were available. These reporters were put in touch with each other and shared their root cause analyses and solutions with benefi t.It is clear that further education and training is needed, particularly to ensure junior medical staff can recognise haemodynamic compromise and are facilitated to escalate to senior colleagues. The initiation and operation of MHPs will improve patient care because a structured approach can reduce panic and errors from cutting corners. However, to be effective appropriate training and drills are required in all areas of medical and surgical practice. Transfusion laboratories must receive clear notifi cation of urgent requests in order to prioritise their work and make available appropriate components, and also be informed when the MHP is stood down.

References 1) NRLS. The National Reporting and Learning Service - Seven steps

to patient safety. www.nrls.npsa.nhs.uk/. 2) NPSA. NPSA Rapid Response Report RRR017. The transfusion

of blood and blood components in an emergency. Rapid Response Report [Internet]. 2010 21 February 2012. Available at: http://www.nrls.npsa.nhs.uk/resources/?entryid45=83659&p=4.

3) Management of major haemorrhage http://www.transfusionguidelines.org.uk/index.aspx?Publication=BBT&Section=22&pageid=1342.

4) North West Regional Transfusion Committee (NWRTC) toolkit on the management of major haemorrhage http://www.transfusionguidelines.org.uk/Index.aspx?pageid=7675&section=28&publication=RTC.

5) NWRTC MHP Audit results December 2011 to February 2012 http://www.transfusionguidelines.org.uk/docs/pdfs/rtc-nw_2013_07_P_mh_audit_pres.pdf.

6) Bhangu A, Nepogodiev D, Doughty H, Bowley DM. Meta-analysis of plasma to red blood cell ratios and mortality in massive blood transfusions for trauma. Injury. 2013; 44 (12): 1693-9.

ORAL PRESENTATIONS

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16TH INTERNATIONAL HAEMOVIGILANCE SEMINARORAL PRESENTATIONS


O-01DONOR ADVERSE REACTIONS DUE TO CITRATE INFUSION DURING AUTOMATED COLLECTIONSKamel T.1, Bravo M.1, Kempin S.1, Tomasulo P.1, Custer B.2

1Blood Systems, Inc., Scottsdale, AZ; 2Blood Systems Research Institute, San Franscico, CA, United States of America

Background Automated blood separation devices and anticoagulation solutions reduce but do not eliminate the incidence of adverse events due to citrate infusion.Aim To quantify and characterize citrate reactions (CR) in a multicenter blood collection operation.Method Donors, donations and CR data for automated collections (AC) made between Jan 18, 2010 and Jan 17, 2013 were analyzed. We calculated CR rates and performed multivariable analysis (MVA) to identify variables associated with increased or decreased likelihood of CR. The fi nal statistical model included donor age, gender, blood volume (BV), hemoglobin (Hb), residence altitude, experience, donation's site, collection type, device used and blood center.Results We observed 541 CR in 634,634 AC (9 per 10K AC); 11% of CR were not considered mild and 12 cases required outside medical care. The rate of CR was 25 and 4 per 10K AC in females and in males, respectively CR rates decreased as donor weight, BV, BMI and Hb increased. Eighty nine percent of CR occurred in 31% of AC procedures where platelets were the target component. MVA showed increased likelihood of CR with component collection type E (platelets, plasma and RBC), C (platelets and plasma), B (platelets and RBC) and A (platelets) compared to type R (2-RBC): Odds Ratios (95% Confi dence Intervals) 12.1 (5.8-25.2), 7.7 (4.3-13.7), 5.5 (3-9.8) and 3.8 (2.1-6.8), respectively (Table). Compared to male, female donors were more likely to have a CR, OR=3.2 (2.4-4.2). Collections on Amicus devices were associated with CR compared to Trima devices, OR=4.4 (3.0-6.5). Donors residing at altitude >6,000 feet were more likely to have CR than donors living at 0-2,000 feet, OR=7.8 (4.2-14.7).Conclusions CRs are strongly associated with AC of platelets and with female gender. The association of CR with donors living in high altitude warrants further investigation to understand the physiologic basis.

O-02UPPER LIMB VENOUS THROMBOSIS COMPLICATING BLOOD DONATIONBell B.M., Pink J.M., Keller A.J.Australian Red Cross Blood Service, Alexandria, Australia

Background Upper limb venous thrombosis (ULVT) is a rare but serious complication of blood donation and necessitates additional medical care, absence from employment, signifi cant fi nancial expenditure and litigation risk. There are only 3 published case reports of ULVT in blood donors. Aims To identify risk factors and complications of ULVT in blood donors.Methods We retrospectively reviewed ULVT reported between 1/10/2010 to 30/11/2013. Donors were interviewed to identify risk factors. Only donors with confi rmed venous thrombosis of the brachio-basilic vein, with or without axillary vein involvement, were included. Where investigations and outcomes information was missing, donors were contacted.Result In 4,232,239 collections there were 20 reports of ULVT during the study period. 75% occurred in females (a frequency of 1:282,149 donations); mean age was 44.9 years (range 23-67). Frequency in males was 1:846,448; mean age 53.4 years (range 37-60). Axillary vein thrombosis occurred in 5 females, complicated by pulmonary embolus in 1 donor, reporting repetitive arm exercise post-donation as the only possible risk. Factor V Leiden mutation was present in 3 donors - a 37 year old male, and 2 females aged 33 and 37 years, both taking the oral contraceptive pill (OCP). Failed or diffi cult phlebotomy was reported in 10 donors (2 males, 8 females), 2 of whom were also taking OCP/hormone replacement therapy (HRT). A further 4 donors were taking OCP/HRT. Only 2 donors reported no risk factors. No long term sequelae were reported.Conclusions Phlebotomy problems manifest by slow fl ow and requiring frequent needle manipulation are potentially preventable causes of ULVT. Early abandonment of problematic phlebotomy would reduce the risk of ULVT Female gender, use of OCP/HRT and the presence of thrombophilia increase risk of ULVT but are less amenable to preventative interventions.

O-03AABB VALIDATION STUDY OF THE CDC NATIONAL HEALTHCARE SAFETY NETWORK'S HEMOVIGILANCE MODULE ADVERSE EVENTS DEFINITIONS PROTOCOLAubuchon J.P.1, Fung M.2, Whitaker B.3, Malasky J.3

1Puget Sound Blood Center, Seattle, WA; 2Fletcher Allen Health Care, Burlington, VT; 3AABB, Bethesda, MD, United States of America

Background The utility of a hemovigilance system depends on appropriate, reproducible application of system defi nitions. This is even more important when submissions are not reviewed by an adjudicating body. We sought to determine how participants would code adverse reactions at institutions that had or had not received training on the application of defi nitions used in the CDC's National Healthcare Safety Network Hemovigilance Module (HVM).Methods Facilities that were (11) or were not (11) submitting adverse reaction data to the HVM reviewed 36 hypothetical cases containing elements of 37 case defi nitions from 12 different diagnostic groups. Respondents were required to

Table I

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determine the type of adverse event, if any, and assign a case defi nition (diagnostic probability), severity, and imputability using the January 2013 HVM Surveillance Protocol defi nitions. Those submitting HVM data had access to an instructional slide set prepared by CDC using similar hypothetical cases. Concordance with expert analysis was determined for the two groups of respondents.Results The frequencies of agreement with the expert assessment were not different according to prior training exposure in any of the diagnostic groups, and results were tallied across both groups. Response accuracy varied by type of categorization (adverse event type: 72.1%, match with case defi nition: 76.5%, severity: 69.6%, imputablity 64.4%) and by type of adverse event. Categories with the lowest expert assessment concurrence for event type were transfusion-association dyspnea and circulatory overload, delayed serologic and acute hemolytic reactions and transfusion-transmitted infections. A common problem appeared to be substitution of medical experience in making a diagnosis instead of applying the specifi c criteria of the HVM adverse event defi nitions.Conclusion Despite delineated defi nitions, considerable variability in responses was seen, and this was not reduced by the available training. This degree of inconsistency in application of the surveillance defi nitions could degrade the utility of comparative reports.

O-04EVALUATION OF ABO MISMATCHED TRANSFUSION IN IRAN FROM SEPTEMBER 2009 TO SEPTEMBER 2013Jalali Farahani F., Zolfaghari Anaraki S., Rajabpour Niknam F., Faranoush M.F, Pourfathollah A., Balali M.B, Hadad Deilami A., Raeisi Shad E., Rasouli M.Iranian Blood Transfusion Organization Research Center, Tehran, Iran

Background Blood transfusion saves thousands of lives annually, but transfusion errors can harm patient health and cause death. In addition transfusion errors carry a fi nancial burden.Aims We aimed to identify the specifi c causes of transfusion errors in order to help develop preventive measures to ensure safe transfusion for blood recipients.Methods In Iran about 31% of hospitals have a haemovigilance system and report transfusion adverse reactions to haemovigilance offi ce. Using this data base we evaluated and analysed ABO mismatched transfusions from September 2009 to September 2013.Results There were 2,469 reported transfusion complications from 278 hospitals in four years of which 28 were ABO mismatch events. Erroneous administration was observed for 21 of 100,000 RBC units administered. All of these events were due to human error; 13 cases happened at the patient's bedside and out of the blood banks due to lack of proper bedside patient identifi cation. 7 cases were caused by blood bank errors, including clerical and technical (lack of blood group testing or wrong technique), and 8 cases were related to both blood bank and non-blood bank errors including issue the wrong unit followed by lack of proper bedside checks before transfusion. Three cases led to death. The most common signs were chills, fever, agitation and dyspnea. There was not a signifi cant correlation between the severity of complications and the volume of transfused product, (P>0.05). (Table I).Conclusions ABO transfusion mismatch remains a serious hazard of transfusion in our country. The most frequent error

leading to transfusion of ABO incompatible blood was failure of patient identifi cation. To decrease ABO-incompatible RBC transfusions a focus on nurse training and implementation of additional measures for patient and blood sample identifi cation should be one of our major national priorities.Keywords Incompatible blood, Iran, haemovigilance, RBC, ABO Mismatched Transfusion.

Table I - Sources of transfusion - associated errors in Iran, Sep 2009 through Sep 2013.

O-05BLOOD DONOR SAFETY: THE PREVENTION OF VASOVAGAL REACTIONS LIES IN A PSYCHOLOGICAL APPROACH TO FIRST-TIME DONORSPagliariccio A.1, Marinozzi M.2, Vavic N.3

1Ospedali Riuniti Ancona, Italy, Ancona, Italy; 2Independent practitioner in Psychotherapy, Ancona, Italy; 3Blood Transfusion Institute, Belgrade, Serbia

Background The task and responsibility of transfusion medicine is to prevent any complication that might jeopardise donor safety. Vasovagal reaction (VVR) is rather insidious and may occur despite careful constant monitoring of donors. Due to its potential fatal consequences, delayed VVR is a serious problem. It is now widely accepted that emotional status negatively infl uences fi rst blood donation. As we demonstrated1, and as recently confi rmed2,3, there is a strict correlation between anxiety at fi rst donation and subsequent onset of VVR.Aims This study aims to demonstrate that a psychological approach prevents VVR at fi rst donation. Methods Among 1,202 voluntary and non remunerated new donors, 882 received a psychological approach and 320 a standard procedure to check eligibility for donation. A specifi cally-trained doctor implemented a bespoke methodology for fi rst-time donors. This method, based on psychodynamics and integrating some elements of short strategic psychotherapy, is used to deal with the emotional-affective dynamics of donation-related fears. Results Seven (0.8%) psychologically approached donors had minor transient symptoms such as pallor or some non-specifi c feeling of discomfort (99% CI 0-10.9). In the other group, 62 (19.4%) donors experienced VVR (99% CI 18.7-26), of whom 14 (4.37%) lost consciousness. In the experimental group, 53 (6%) donors never returned (99% CI 5.2-13.5) to donate compared to 143 (44.69%) donors in the control group (99% CI 41-53). Rate of returns was 94% in the psychologically approached donors compared to 55.3% in the other group.

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system is a powerful reporting and analyzing tool providing data at various levels of detail to support surveillance reporting, business metrics, and research.

Summary/Conclusion The adoption of a psychological approach led to a drastic reduction in the number and intensity of VVR, also in donors who are highly anxious about fi rst donation. This demonstrates that VVRs are psychosomatic symptoms connected with the fears of donation. It should therefore be acknowledged that dissipating fears is a key factor in preventing these potentially life-threatening reactions.References1) Pagliariccio A, Marinozzi M. Avoiding vasovagal reactions

in fi rst time donors through a psychological approach. Full proceeding 11th Colloquium on the recruitment of voluntary, non remunerated blood donors. Cairo Egypt 12-8 January 2009.

2) France CE et al. How afraid are you having drawn from your arm? A simple fear question predicts vasovagal reactions without causing them among high school donors. Transfusion 2013; 53 (2): 315-21.

3) France CE et al. Fear of blood drawn, vasovagal reactions, and retention among high school donors. Transfusion 2013; doi: 10.1111//trf.12368.

O-06LAYERED DATA REPORTING ALLOWS DONORHART™ TO MEET A VARIETY OF DONOR VIGILANCE NEEDS: THE FIRST ANNUAL REPORT OF THE AABB US DONOR HEMOVIGILANCE SYSTEMLand J.1, Whitaker B.I.2, Erraguntla M.3, Tomasulo A.1

1Blood Systems Inc, Scottsdale, AZ; 2AABB, Bethesda MS; 3KBSI, College Station, TX, United States of America

Background Recognizing the importance of donor health and the absence of a standardized national surveillance system, the AABB Inter-organizational Task Force on Biovigilance established a Donor Hemovigilance Working Group in 2007 with representation from blood and plasma industries, government, military, and database developers.Aim Develop a donor hemovigilance system available to all US blood collection facilities (Facilities) as a voluntary, confi dential, non-punitive reporting service, focused on improving donor safety.Methods The Donor Hemovigilance Analysis & Reporting Tool (Donor HARTTM) software was developed by KBSI with expertise support from the working group; and was funded by the US federal government, with oversight from AABB. This public-private partnership developed objective standardized data elements required for blood donation-related adverse reaction reporting, taking into consideration existing national and international defi nitions. Most data elements were made optional, ensuring that all Facilities could participate. Facilities were asked to adopt the data elements and to report as much data as possible given their existing resources. Aggregate denominator data elements were also developed allowing for univariate, bivariate, and multivariate analysis, depending on levels of data provided.Results Five Facilities reported suffi cient 2012 numerator and denominator data to be included in the fi rst annual report. All Facilities provided age, donation history, donation type, donor gender, and procedure type for 1,171,906 individual donations. Other data elements were reported to varying degrees. From this rich data set, reaction rates with confi dence intervals and other comparisons were determined (Table I).Conclusion Use of DonorHARTTM in the US yielded donor hemovigilance results consistent with published reports while allowing facilities to benefi t locally from drill down analytics to better understand and support donor health. The DonorHARTTM

Table I - Unadjusted odds ratios and confi dence intervals.

O-07DONOR VIGILANCE IN BLOOD TRANSFUSION SERVICES, PAKISTAN INSTITUTE OF MEDICAL SCIENCESWaheed U., Zaheer H.A.Safe Blood Transfusion Programme, Government of Pakistan, Islamabad, Pakistan

Background In Pakistan, the blood transfusion system relies predominantly on "Family Replacement Donors" with very little contribution from Voluntary Blood Donors. However, in times of emergencies and national crises, tremendous response from voluntary blood donors is observed. The adverse events during blood donation are not documented due to lack of documentation system and lack of awareness of the staff involved. Aims The current study was initiated to improve the safety standards of blood donation by monitoring all adverse events in the blood donor section at Pakistan Institute of Medical Sciences (PIMS), Islamabad, a premier tertiary care hospital of the country.Methods This is a prospective study conducted from June-December, 2013, at the Donor Management Section of PIMS, Islamabad. A pre-tested standardized reporting form was developed to collect the data.Results Out of 14,137 donors, 92 donors experienced adverse events which included 701 signs and symptoms. The majority of the adverse events were mild. The adverse events included fainting 11.4% (n=80), pallor skin 13.1% (n=92), low BP 13.1% (n=92), slow pulse 13.1% (n=92), sweating 11.5% (n=81), drowsiness 10.2% (n=72), vomiting 8.7% (n=61), cold extremities 8.4% (n=59) nausea 7.8% (n=55), weakness 0.8% (n=6), restlessness 0.8% (n=6), anxiousness 0.6% (n=4) and bruising 0.1% (n=1).Conclusion Donor haemovigilance systems allow monitoring of donor safety and assessment of the success of interventions designed to further improve donor safety. There is need to provide specifi c information cards to donors at the time of an adverse event detailing immediate management and preventative actions relevant to subsequent donations. It is crucial that all blood banks adopt a systematic approach to monitor the rates of donor adverse reactions. The current pilot study, supported by the Pakistan Haemovigilance Network, needs to be emulated, to bring about a general improvement in the functioning of the blood transfusion services in Pakistan.

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O-08ENCOURAGING LABORATORIES TO IMPROVE PRACTICE - UK INITIATIVESMistry H.1, Glencross H.2, Chaffe B.3, Bolton-Maggs H.1

1Serious Hazards of Transfusion, Manchester; 2Queen Alexandra Hospital, Portsmouth; 3National External Quality Assessment Scheme, Kent, United Kingdom

Background Laboratory errors in transfusion practice continue to put patients at risk. The United Kingdom Transfusion Laboratory Collaborative (UKTLC) was formed in 2006. Following national surveys it published recommended minimum standards for hospital transfusion laboratories in 2009. These encouraged appropriate staffi ng, their training, knowledge and skills, and the use of computer information systems. The intention was to reduce laboratory errors reported to the national haemovigilance scheme, Serious Hazards of Transfusion (SHOT) by 50% by 2012.Aim Repeat the laboratory surveys to examine current practice and review SHOT reports to see whether the target error reduction had been met.Method New surveys were sent to all transfusion laboratories registered with the national external quality assessment scheme (NEQAS) in 2011 and 2013, to be completed by the lead scientist on specifi ed working days. Annual SHOT data were reviewed to see if the error rate had reduced.Results SHOT data showed that although % errors had reduced (200/1,040, 19% of reports in 2008 to 247/1,516, 16% in 2012) this was not by 50% and the absolute number had increased. The number of responding laboratories in both surveys (162/322 responding, 50% in 2011 and 188/304, 62% in 2013) revealed a low level of senior staff with appropriate qualifi cations (44% in 2011, 47% in 2013). Between 2011 and 2013 there was a signifi cant drop in numbers of staff spending >75% time in transfusion. Lack of funding adversely affected full implementation of automation. Funding for education and training was also reduced resulting in fewer staff with current competency assessments.Conclusions The 50% target for reduction in laboratory errors was not achieved. The 2013 survey showed implementation of the UKTLC recommendations was incomplete. The UKTLC has revised its recommendations into standards. All laboratories are encouraged to comply with these standards for the safety and security of provision of transfusion services.

O-09HAEMOVIGILANCE PROGRAMME OF INDIABisht A.1, Singh S.2, Marwaha N.3

1Indian Pharmacopoeia Commission, Uttar Pradesh; 2National Institute of Biologicals, Noida; 3Postgraduate Institute of Medical Education and Research, Chandigarh, India

Background National haemovigilance programmes have yielded signifi cant data to implement blood safety initiatives. India has 2,545 blood banks, one-third each in public, charitable and private healthcare sectors and annual blood collection of 7-8 million. Given the diversity of blood bank management, setting up a national programme was a complex task.Aim To set up a national haemovigilance programme in India.Method The Ministry of Health and Family Welfare (MoHFW), Govt. of India had launched the Pharmacovigilance Programme of India (PvPI) in 2010, with oversight by the Indian Pharmacopoeia Commission (IPC). After the successful launch of PvPI, the MoHFW, initiated the haemovigilance programme, as a collaboration between IPC and National Institute of Biologicals (NIB), with the co-ordinating centre at NIB. The broad organizational structure of the programme is as follows; reports will be generated in the medical institution based blood banks - submitted online to NIB - reports will be reviewed by the National Advisory Committee which will make recommendations to IPC for onward transmission to the regulatory authority - the Central Drugs Standards Control Organization to formulate safety related regulatory changes and communicate to all stakeholders in blood transfusion services for compliance.Results The initial focus is on reporting adverse transfusion reactions as defi ned by the Working Party of the International Society of Blood Transfusion, reporting is voluntary and a Guidance Document and Transfusion Reaction Reporting Form have been made available to reporting centres. The reporting is online through a software - Haemo-Vigil accessible on the NIB website. In 11 months since the programme commenced 765 reports of adverse reactions have been submitted, majority of the reactions comprise of febrile non-haemolytic reactions and allergic reactions. Nine awareness workshops have already been organized.Conclusion A well-structured programme of haemovigilance has been initiated in India and is now in a phase of expansion.

POSTER PRESENTATIONS

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16TH INTERNATIONAL HAEMOVIGILANCE SEMINARPOSTER PRESENTATIONS - ORGANISATIONAL ASPECTS


ORGANISATIONAL ASPECTS

P-1-01PUTTING PATIENT SAFETY FIRST:HOW TO DO IT IN A TERTIARY CARE HOSPITAL?Bosch M.A.1, Bolibar I.2, Moral M.V2., Dalmau C.1, Catala P.2, Sanchez J.M.2, Muñoz C.2, Medina L.1, Muñoz R.M.2, Domeque M.11Banc de Sang i Teixits de Catalunya, Barcelona; 2Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Background Current advances in hemovigilance and patient safety are new challenges for the functions and organization of the Transfusion Committee.Aims To present the actions engaged in recent years by our Transfusion Committee aimed at improving patient transfusion safety.Methods Three key actions were undertaken at our tertiary care hospital: 1) incorporation of a hemovigilance offi cer with the role of linking the activity of the Blood Bank with the hospital transfusion at the bed side, 2) to initiate a reporting system of patient safety incidences, and 3) to start coordinated actions with the Patient Safety Committee of the hospitalResults - Continuous education and training on safety and optimal use

of blood products.- Audit and promotion of safe clinical practices relating to blood

products: analysis of appropriate transfusions, guidelines for blood transfusion, the patient blood management program, nurse procedures for blood administration and massive transfusion protocol.

- Management of adverse transfusion incidents, root cause analysis of the sentinel events with implementation of new corrective actions approved by the hospital Director, i.e. implementation of Radio Frequency Identifi cation (RFID) technologies.

Summary/Conclusion Multidisciplinary actions engaged in recent years by our Transfusion Committee have improved the management of patient transfusion safety.

P-1-02CLINICAL MANAGEMENT OF DONORS IN SANT'ANDREA HOSPITAL ROMEBove M.Azienda Ospedaliera Sant'Andrea, Roma, Italy

Background All donors that refer to our SIT are examined and checked periodically as required by Legislative Decree of 3 March 2005.Aims The controls related to clinical problems during donation or post donation. Methods The controls are carried out in two steps: the fi rst step is during interviews for the eligibility and the second is performed in the validation phase. Results In our SIT we examined these issues from May 2012 to May 2013. During donations 173 have been found unfi t (80 periodic donors and 93 occasional donors). Most are temporary unfi tnesses. The anaemia in periodic donors (23/52) are investigated here. In the second step the problems related to serology are performed quickly calling the donor back for the repetition of the test. For other problems the communication is written. In this phase, you get a correspondence of 100% for the

controls on serological tests, while of the 149 donors retrieved from a total of 1,669 (8.9%) who have made the donation in the same period, only 16/149 (11%) have returned to repeat sampling. The most common problems encountered in this phase were: 45 alterations in cholesterol and/or triglycerides (values>300 mg/dL repeats examination, values between 200-300 mg/dL is recommended diet; variations within 50 mg/dl no control and no diet), increased ALT 25: the bag has been eliminated in 16 of 27 cases and the donor is followed in follow-up; 11 thrombocytopenia; 48 anaemia (18 donors with decreases in ferritin perform iron therapy, while 30 with decreased haemoglobin perform tests for iron metabolism); 18 alterations of white blood cells. But the is causes a lengthening of the time between donations and the decrease donations per year:1,25. Summary: Furthermore, sending the examinations by mail lengthens the time of communication making it diffi cult for clinical control to take place, especially for occasional donors.

P-1-03NATIONAL HEMOVIGILANCE PROGRAMME:EXPERIENCE IN MALAYSIASivasambu T., Wan Salleh A., Hassan R., Ayob Y., Abd Karim F.National Blood Centre, Kuala Lumpur, Malaysia

Background Transfussion Error is monitored as part of National Quality Assurance programme (NEQAP) of the Ministry of Health (MOH) since 1985. In 2003, National Haemovigilance Programme (NHP), a voluntary programme provides comprehensive monitoring and evaluation of errors and any deviation in the process within the transfusion chain.Objective To collect and review information on all haemovigilance reports from 2003 to 2012.To clarify weakness and strength in the system.To recommend initiatives to prevent recurrence of adverse event errors and to improve patient care.Methods Data were collected from 2004 till 2012 from all MOH hospitals. The data is assessed on the basis of predefi ned standard and in accordance to the defi nitions set by the International Society of Blood Transfusion (ISBT). These reports were compiled and reported to the National Transfusion Committe at the MOH.Results Data from 2003 to 2012 were evaluated but 2003 reports were omitted due to diffi culty in verifying data. A total of 81 of 122 MOH hospitals (66.4%) responded in the fi rst year and there was an increment to 100% respondents by 2007. There were 1,467 case reports received in 2004 and increased to 2,860 cases by 2012 (195%). The commonest events were febrile non haemolytic transfusion reaction and allergic rash making more than 85% of the annual reports. Incorrect blood component transfusion was less than 0.9%. There were 8 cases of TRALI reported (1 in 482,854 transfusion), 6 cases of bacterial contamination or septic transfusion reaction and 4 cases of TA-GVHD reported but all these cases were not confi rmed.Conclusion There is improvement in reporting. However,not all reactions are reported due to failure to recognise transfusion reaction. Inability to verify TRALI, TA-GVHD, Septic transfusion reaction remain a challenge. Remedial measures such as CME, HTC involvement and human resource development need to be strengthened.

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P-1-04TRAINING AS A TOOL FOR IMPROVING TRANSFUSIONSVaquero I.V.B., Peñalver M., Lujano S., Solves P.S.A., Carpio N.Hospital La Fe, Valencia, Spain

Background The analysis of adverse effects of transfusions in our Centre detected two ways of improving outcomes: Promotion of technological development in each transfusion step and implementation of training for staff involved in transfusions. Aim We analysed the impact of training in the prevention of adverse effects.Methods We analyzed the errors that occurred last year, after implementing a special Haemovigilance program, wich were compared with the errors reported in 2007. Our current Haemovigilance activity includes a daily meeting with the Haemovigilance team and nurses of the Blood Bank. We analyzed the incidents of the last 24 hours and when workers were implicated. The Haemovigilance team prepares a non-compliance report for the service concerned and a meeting is held to explain the error in detail. An oral presentation is given recalling the most important steps in the transfusion process. The presentation has two parts, one general about all the procedures and one specifi c for the particular errors occurring. Professionals attending also make a visit to the Blood Bank.. Other professionals of the service are also invited to the training session.Results From 2012, 190 nurses of the hospital attended 16 meetings. The level of satisfaction measured by a score of 0-10, has been 8.7. Table I shows the number of blood components transfused in the years 2007 and 2013, and the errors occurring in each phase of the transfusion process.Conclusion Training is an important tool to improve and prevent transfusion errors. Health workers attending this training program have a high degree of satisfaction.

supply, monitors the transfusions and coordinates the local haemovigilance system. This study aims to evaluate the prevalence and characteristics of acute transfusion reactions (ATR) that was reported and investigated in the period of 10 years (2004 to 2013). All ATRs reported are evaluated immediately by a hematologist and if necessary laboratory investigation is carried out according to established protocol. A preliminary classifi cation according to the established conventions of the AABB was made and after the fi nal classifi cation was repeated by author based on registered records. A total of 317,415 blood components were transfused during the study period (68% RBCs, 24% FFP and 8% PLTs) and 1,998 acute transfusion reactions (ATRs) have been reported (625 per 100,000 transfusions). The most frequently reported are febrile non-hemolytic and mild/moderated allergic reactions. Serious ATRs such as anaphylaxis, TRALI and intravascular hemolytic transfusion reactions occur, but are rare. Four incidents of transfusion associated bacterial sepsis (TAS) have been identifi ed, all related with platelet transfusion and two cases with fatal evolutions. The third most frequent ATRs was Transfusion-Associated Circulatory Overload (TACO) (48 cases, 15 per 100,000 transfusions) and we observed in the last 5 years increasing these notifi cations triggered by educational activities. Our data are comparable with data from others tertiary hospitals. Increased knowledge of haemovigilance among physicians and nurses can lead to improve the notifi cations of ATRs and transfusion safety.

P-1-06CONTRIBUTION OF INFORMATION TECHNOLOGY IN HAEMOVIGILANCE SYSTEM IN AREA VASTA ROMAGNA TERRITORY IN EMILIA ROMAGNA REGIONBiguzzi R., Chicchi R., Moretti D., Boetti L.AUSL della Romagna, Cesena, Italy

Background information An effective surveillance method for the registration of all necessary data in haemovigilance, must be able to cover the whole transfusion chain. A real time and simple way data collection improved quality process, better if computerized. The aim is to provide a tool for the recording of the data and to prevent the loss, in two features; blood collection and recipients of blood components, which usually take place outside of the blood transfusion service,responsible, in accordance with the current legislation, for recording data haemovigilance and in order to correct their cause and prevent recurrence.Methods With regard to the blood collection, we worked, creating in database of our Transfusion Information System (TIS), a table that contains the coded adverse events in donors as present in "Sistema Informativo dei Servizi TRAsfusionali" (SISTRA), the national form proposed for notifying adverse reactions, while in our computerized transfusional order entry system we computing a mask that in case of transfusion reaction must necessarily be compiled according to SISTRA.Results The data collected came from four Transfusion Structures (ST) of Area Vasta Romagna territory in Emilia Romagna Region; in 2013, 657 adverse events in blood donors were reported, which is equivalent to 1.1 reactions/100 units collected. This method is the tool to analyse the relevance of adverse events in blood donors, the outcome of the donors, the type of collection involved, and some vital parameters such as blood pressure and the number of previous donations.Conclusion This method permits standardization between the different ST and we worked actively to analyse data to increase safety and quality of the entire transfusion process.

Table I

P-1-05HAEMOVIGILANCE SYSTEM AT THE TERTIARY CARE HOSPITAL COMPLEX IN BRAZIL:A TEN YEARS EXPERIENCEAddas-Carvalho M.State University of Campinas, UNICAMP, Campinas, Brazil

The practice of transfusion medicine has become complex in recent decades and despite the technical progress, transfusions are not without risk and may trigger acute reactions. Haemovigilance consists of voluntary reporting transfusion reactions in order to prevent their recurrence and to lower the risk associated with transfusions. The University Hospital Complex of UNICAMP is formed by 3 units with high complexity of medical care, totaling about 550 beds. The Blood Center ensures the blood

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P-1-08ABO INCOMPATIBLE RED BLOOD CELL TRANSFUSION IN ITALY (2009-2012)Facco G., Pupella S., Catalano C., Piccinini P.L., Grazzini G.Centro Nazionale Sangue, Rome, Italy

Background Wrong transfusion due to errors (WTE) can lead to severe adverse reactions (AR), such as death or major morbidity caused by ABO incompatible red blood cell (RBC) transfusion. Systematic data collection, analysis and reporting are of paramount importance to reduce error occurrence and improve transfusion safety. Aims In Italy, data from the national Haemovigilance (HV) system has recently allowed to evaluate WTE rate and severity, suggesting the introduction of new preventive measures. Methods Data concerning AR and WTE was retrieved from the national HV database. Results From January 2009 to December 2012 a total of 13,455,146 blood components (BC) were transfused to 2,517,054 patients and 6,050 AR were reported (449/millionBC transfused). In the same period 9,972,971 RBC were transfused and 3,919 resulted in AR (393/millionRBC transfused). Fifty-one AR were due to WTE (36 ABO incompatible, 15 ABO compatible), with an estimated rate of 5.1/millionRBC transfused. Among the 36 ABO incompatible RBC transfusions, 4 cases had a fatal outcome (1 death/2,493,243 RBC transfused). Among the 32 non-fatal cases: i) in 1 case intensive care treatment was required; ii) in 19 cases specifi c therapeutic treatment was required; iii) 5 cases were symptomatic but did not require specifi c therapeutic interventions; iv) 7 cases were reported as asymptomatic. Thirty/36 (83%) ABO incompatible transfusions were due to errors in the bedside check; 3/36 (8.3%) were due to mislabeled pre-transfusion samples; in 3/36 (8,3%) cause was not reported. Thirty-fi ve/36 (97%) errors occurred in clinical wards, 1 (3%) in a blood bank's outpatient clinic.Conclusions Based on the analysis of the WTE reported in a four-year period, in Italy bedside double-check procedures, as well as specifi c training and re-training of healthcare staff, will be made mandatory by law. Introduction of electronic barrier devices is advocated, but its cost/benefi t shall be carefully evaluated.

P-1-09PLATELET INVENTORY MANAGEMENT:THE NAMIBIAN EXPERIENCELohrke B.1, Chipare I.2, Alphen G.2

1Ministry of Health and Social Services, Windhoek; 2NAMBTS, Windhoek, Namibia

Background Namibia (Area 880,000 km2, Population 2.1 million) has 1 platelet apheresis centre with 2 apheresis machines. Platelet donors (85) donate in Windhoek, where fi nal processing takes place at NAMBTS. Platelets are available to 46 hospitals on an offi cial request for a specifi c patient only.Perceived problems with platelet inventory management were: The short shelfl ife and variable demand leading to shortages requiring extra efforts from staff while putting patient's lives at risk, but over-production resulted in discards and wasted production costs.Aims This study needed to verify the present platelet inventory management policy by NAMBTS and compare it internationally.Methods Data available from the NAMBTS computerized

database: number of donors bled , products made i.e. Adult (PLCA1) and Paediatric (PLCA2) platelet concentrate, and products issued.Additional information was captured by blood bank staff on a record form (Table I) from November 2011 to May 2013. Data collected: number and type of platelets requested, medical doctor to discuss each platelet request with requesting doctor , date and time request received and issued.Results Platelet requests show a linear increase but demand is highly variable for both products. Average percentage of discards in PLCA1 is 5% and PLCA2 (a side product) 33% during the 18 months.Demand and supply statistics on platelet requisitions from Windhoek and outlying hospitals show an average of 57% immediate issues, 27% issued between 2-15 hours, 8% next day, and 8% of orders reduced or cancelled.Conclusion NAMBTS is doing well in platelet inventory management as compared to discards internationally. Improvements suggested are the following: Encourage more active communication between blood bank and apheresis clinic. Extend Time Till Outdating (TTO) by early release of platelets by relocating TTI testing back to Windhoek from February 2014. Strict observance by medical personnel is mandatory as this often decreases platelet requests.

P-1-10TEN YEARS OF HAEMOVIGILANCE IN CATALONIALópez M, Bosch A, Sanz C, Gómez D, Álava F, López LL, Davins J, Muñiz-Diaz E.Haemovigilance Commission, Barcelona, Spain

Background The Haemovigilance system was created in Catalonia in 2002 and since then it has been working to analyse transfusion reactions, adverse incidents and near misses events and to elaborate recommendations in a yearly report. In 2009, electronic notifi cation was made available to hospital Haemovigilance Offi cers.Aims To analyse the 10-year data of Haemovigilance in Catalonia.Results In 10 years, 3,556,579 blood components were administered and 6,309 notifi cations were collected: 74% corresponded to transfusion reactions, 6% to adverse incidents and 20% to near misses. Nine deaths were reported: 4 were associated with TRALI (2003-2004), 1 with an anaphylactic reaction, 1 with Transfusion Associated Cardiac Overload

Table I

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(TACO) and 3 with an acute ABO incompatible haemolytic reaction.In 6 cases the level of imputability was probable or defi nite. In 2007, a selective "male plasma only" policy was implemented to reduce TRALI incidence. Comparing two periods, 2002-2007 and 2008-2012, the incidence of TRALI was reduced from 2,7 to 0,6/100,000 blood components transfused. Among cardiovascular complications (n=259), 50% corresponded to TACO (n=121) with a high level of severity and imputability (≥2) in 44% of cases. Most patients were old patients with cardiovascular risk factors which were not considered in medical orders. Only 4 infectious reactions were fully documented: 3 bacterial infections and 1 case of Hepatitis B transmission in 2005. Among incidents, identifi cation errors were most frequent (40%) followed by prescription errors (22%). Most near misses also corresponded to patient identifi cation errors at sampling (52%) and prescription (22%). In 2010 a patient safety national campaign was launched from the Commission to enforce identifi cation practices.Conclusions The most severe risks detected in the fi rst 10 years of Haemovigilance corresponded to acute haemolytic reactions related to ABO incompatibility, TRALI and TACO. TACO appears as an old but re-emerging severe complication of blood transfusion.

P-1-11FIVE YEAR TREND ANALYSIS ON INCORRECT BLOOD COMPONENTS TRANSFUSED IN SOUTH AFRICAMoleli N.K., Muthivhi T., Ingram C., Ledwaba F.South African National Blood Service, Roodepoort, South Africa

Background information Incorrect Blood Components Transfused (IBCT) refers to all reported episodes where a patient was transfused with a blood component or plasma product that did not meet the appropriate requirements or that was intended for another patient. These incidents are almost completely preventable because they are ascribed to human error.Aims and objectives To analyse the trend of Incorrect Blood Components Transfused (IBCT) cases over fi ve years from 2008-2012 in South Africa.Methods Data that was submitted to the National Haemovigilance Offi ce on IBCT events from 2008-2012 was analysed. All cases that resulted in major sequelae such as; haemolysis and mortalities and cases without any sequelae were included. Near miss events have been excluded since they were detected before the component was transfused.Results Over the 5 years, a total of 99 IBCT events occurred contributing 2.7% of all 3,611 transfusion adverse events. Of all 99 events, 25.2% cases were due to ABO or Rhesus incompatibilities, 7.1% due to missed antibodies and 67.7% cases were due to patient misidentifi cations or misdirected transfusions. Errors by blood bank technicians contributed 29.3% and 70.7% errors were committed by hospital personnel. There were no mortality cases as a result of IBCT.The overall rate of IBCT over a period of 5 years is 1.93 per 100,000 units issued. The rate has increased from 1.05 in 2008 to 2.63 per 100,000 unit issued in 2012. Conclusion The increase in number and rates of errors noted is a concern since this occurs despite all measures to improve the transfusion practice. However it should be noted that this may partly be related to more accurate and improved reporting. Further investigation, ongoing trend monitoring and more detailed root cause analysis of these incidents is planned for 2014.

P-1-13CROATIAN HAEMOVIGILANCE REPORT 2012Štimac R., Šarlija D., Vuk T., Jukic I.Croatian Institute of Transfusion Medicine, Zagreb, Croatia

Background Croatian haemovigilance report includes adverse reactions, adverse events, and donor reactions and complications.Methods Data from Croatian institutions performing transfusion are collected and processed at Systematic Surveillance of Transfusion Treatment (SSTT) at Croatian Institute of Transfusion Medicine. Reactions and events are classifi ed according to the Proposed Standard Defi nitions for Surveillance of Non Infectious Adverse Transfusion Reactions ISBT Working Party on Haemovigilance. Number of units issued for transfusion is used as a denominator to present the frequency of reactions to transfusion. Reactions related to blood donation are classifi ed according to the Standards for Collecting and Reporting Data on Reactions Related to Blood Donation (EHN, ISBT) and frequency is expressed per number of blood units collected.Results A total of 354 adverse reactions or 1.17/1,000 blood components issued for transfusion were reported. On report reassessment, 23 adverse reactions or 0.08/1,000 blood components issued for transfusion were characterized as serious adverse reactions: 1 AHTR, 5 DHTR, 1 DSTR, 10 anaphylactic reactions, 2 TRALI, 1 PTP and 3 TACO. There were 134 adverse events reported, and on report reassessment, 78 were characterized as serious adverse events, including 2 product failures, 58 human errors (4 IBCT) and 18 events characterized as "other". There were 2,238 or 13.6/1,000 reactions/complications related to blood donation, including 1,782 vasovagal reactions (9 with injuries), 387 hematomas, 2 thrombophlebitis, 1 nerve injury and 7 symptoms of painful arms. Fifty-nine reactions to citrate were recorded during apheresis procedures. Fourteen reactions or 0.09/1,000 blood donation were characterized as serious.Conclusion Additional effort is still needed to improve recognition and reporting of reactions and events. Continuous education of all staff included in haemovigilance chain and modifi cation of the reporting form are needed to ease the reporting and evaluation of reactions and events.

P-1-14ROOT CAUSE ANALYSIS: WHAT DOES IT TELL US ABOUT TRANSFUSION PRACTICE? Sweeney J.E., Brady R., Healy S., Scanlon J., Byrne D.,Ni Loingsigh S.Irish Blood Transfusion Service, Dublin, Ireland

Background European Commission Directive2005/61/EC necessitates root cause analysis (RCA) of serious adverse events (SAE). The Irish National Haemovigilance Offi ce (NHO) implemented RCA in 2007 with the aim of collecting, classifying and analysing events that could affect transfusion safety.Aim To review RCAs of SAEs reported between 2007-2012 and examine corrective and preventative actions proposed.Materials and methods Reports were examined for site of fi rst error and attributed causes. Discovery data and corrective/preventative actions to prevent reoccurrence were also reviewed.Results More than half the errors reported occurred and were

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discovered outside the clinical area. Of note, reporting of clinical errors to the EU commission is not mandatory. On RCA of SAEs, human failure accounted for 83% of errors: common causes included "failure to adhere to policies/procedures" (28%) followed by "lack of verifi cation" (14%). Of the 17% of errors caused by system failures, 28% were due to policy issues and 11% were attributed to lack of managerial prioritisation of transfusion issues. Encouragingly, at least 1 corrective/preventative action was identifi ed in most reports.Table I - Summary of Findings.Conclusion RCA of errors aid recognition of underlying transfusion risks and result in measures to prevent recurrence of SAEs.

issue to hospitals was 3,294. Screening of 12,672 female serum samples allows to reveal 276 (2.2%) positive samples with HLA antibodies.Conclusion The investigation of appropriate strategies to decrease immune TRALI gives the opportunity to minimize usage of female plasma (only rhesus-negative and AB group). The necessary amount of female therapeutic plasma units should be screened for HLA antibodies as 2.2% units are unsuitable for clinical use.

P-1-16PROCESS MAPPING HAEMOVIGILANCE REPORTING AND EXPERT REVIEW PROCESSES IN AUSTRALIAWood E.M.1, Bielby L.1, Arnold E.2, Stevenson L.1, Glazebrook B.1, Beard P.1

1Department of Health Victoria and Australian Red Cross Blood Service, Melbourne; 2National Blood Authority, Canberra, Australia

Background The Blood Matters Serious Transfusion Incident Reporting (STIR) haemovigilance system covers four Australian jurisdictions. Hospitals are encouraged to report serious adverse reactions and events. Following initial notifi cation, hospitals complete detailed investigation forms which undergo validation by independent expert review.Australia's National Blood Authority (NBA) is developing a nationally consistent, complete and validated haemovigilance system. With NBA assistance and expertise, detailed mapping of STIR activities outlined seven key processes end-to-end. The aim was to illustrate and understand the processes and system interfaces currently in place and identify gaps, resources and areas for improvement.Methods and results Complex activities in each process were deconstructed. The seven key process maps provide visual representations of the reporting and expert review pathways, exposing processes not immediately apparent. Triggers, scenarios, dependencies, exceptions and resources were identifi ed for each map, demonstrating relationships between core business areas. The mapping provided opportunities to document complexities, such as the number of steps involved in each process documented in the end to end process across the seven maps, which ranges from six to 27 steps. Additionally process metrics were measured, such as time from "event" to "notifi cation" (average 40 days) and from "investigation request" to "investigation returned to STIR" (average 49 days). Delays in data completeness were most often observed at the expert review stage.The results also illustrate the dependency on STIR Secretariat and Data Management to manually oversee workfl ows, required in 68% of all processes (n=27/40).Conclusion The mapping process reinforced the time-consuming and resource-intensive nature of the expert review process; however this is essential for quality assurance and is one of STIR's strengths in enabling comparisons between hospitals and jurisdictions. A number of areas in the STIR process requiring refi nement and future system development were also identifi ed.

Table I - Summary of Findings (n=991).

P-1-15TRANSFUSION-RELATED ACUTE LUNG INJURY: CURRENT STRATEGY OF PREVENTIONSvirnouskaya E.1, Khulup H.2, Novik A.2, Klimovich O.3, Semenov G.2, Pasiukov V.2, Svirnovski A.2

1Minsk; 2Republican Scientific and Practical Center for Transfusiology, Minsk; 3City Blood Center, Minsk, Republic of Belarus

Background All blood components which contain plasma may be implicated in transfusion-related acute lung injury (TRALI). This serious complication of blood transfusion is recently reported as the most frequent cause of transfusion-associated death. Antibodies against human leukocyte antigens (HLA class I and class II) and human neutrophil antigens (HNA)are characteristic for TRALI pathogenesis. Leukocyte antibodies are most commonly revealed in the multiparous female donor plasma. ThereforeTRALI avoidance or preventionmay be achieved by using HLA and HNA antibody negative blood components (may be possible in future) or by rejection of female plasma clinical use.Aim In the present study we evaluated the possibility to limit female donor plasma for therapeutic use in order to prevent large majority of TRALI cases.Methods During 2012 the distribution of collected plasma issued from quarantine was retraced concerning its usage for transfusion therapy or fractionation. We analyzed 63,360 units of plasma including 12,672 units from female donors who had been tested for antibodies against class I HLA antigens. Supply of rhesus-negative and AB group plasma that should be in stock in every hospital was under study.Results The amount of therapeutic plasma and plasma for fractionation was 46% and 54%, respectively. Rhesus-negative female plasma units of O, A, B blood groups and rhesus-positive and rhesus-negative female plasma of AB group were in total 26%. The number of female plasma units needed for

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P-1-17IMPROVEMENT PROGRAM FOR UNSAFE TRANSFUSIONSBravo Augue A.1, Muñoz Lopez M.2, Reyes Martin C.2, Mauri Herrero C.2, Ortega Sanchez S.1

1Banc de Sang i Teixits, Barcelona; 2Hospital de Viladecans, Viladecans, Spain

Background Unsafe transfusions (UTs) are red blood cells concentrates (RBC) performed too fast (increased circulatory overload risk) or too slow (bacterial contamination risk).Inexperienced staff, usually external of transfusion service (TS), may negatively infl uence to this matter.Aims Analyze the corrective actions impact introduced from mid 2012 with the aim of avoiding UTs in our hospital.Methods Blood components infusions in Viladecans Hospital are performed by trained personnel not belonging to the TS.The target population mainly consists of elderly patients, frequently with renal/cardiac failure; meaning 82% may get profi t from RBC aliquots (RBCa) or slower transfusions.Hospital transfusion committee (HTC) detected high rate of UTs in 2012, so it motivated the design of corrective measures.The recommendations for a safe transfusion were: minimum of 2 hours for patients with risk factors and 90-120 minutes (45-60 drops/minute) for the rest. Transfusion cannot last more than 4 hours in any case.Action plan:1. Supervisor nurse for root causes analysis.2. Blood component administration protocol review and spread it.3. Two months awareness campaign by deliver instructions

guide joined with RBCs.4. The results obtained are periodically transmitted to the staff.5. Educational plan for new personnel/retraining staff.6. UT as a new quality indicators.Results 1. Lack of knowledge; underestimating risk of UT; and two

or more people implicated in the same transfusion; were handicaps.

2. Emphasize main important items.3. Instant information.4. Personnel are involved and aware about importance of

transfusing.5. 100% of the staff trained.6. Table I.Conclusion The fi rst time requested more RBCa than RBC.It has been an evidence decrease of UTs due to the action plan. The implication of HTC has proven to be a useful tool to combat this risk. Although, RBC UT slow remain equally.The current challenge is to keep working in this way, trying to avoid those dangerous transfusions.

P-1-18THE NATIONAL HEALTHCARE SAFETY NETWORK HEMOVIGILANCE MODULE:EFFORTS TO INCREASE RECIPIENT HEMOVIGILANCE PARTICIPATION IN THE UNITED STATESHarvey A.R., Kuehnert M.J.Centers for Disease Control and Prevention, Atlanta, GA, United States of America

Background In 2007, the Centers for Disease Control and Prevention (CDC), in collaboration with transfusion medicine experts groups convened by AABB, designed a surveillance system to monitor transfusion-related adverse events. The result was the Hemovigilance Module, which is operated within the National Healthcare Safety Network (NHSN), an internet-accessible surveillance system used by US healthcare facilities to report healthcare-related patient safety outcomes. From 2010-2012, over 5,000 adverse reactions and 30,000 process incidents were reported. However, CDC determined that many facilities were not adhering to protocol requirements nor reporting consistently due to the reporting burden. In 2013, following consultation with transfusion medicine experts, a revised protocol that reduced reporting requirements by half, through elimination of required reporting of minor allergic reactions and process errors not resulting in patient harm, was released. We report the results of efforts to increase participation.Methods Baseline facility enrollment for 2010-2012 was recorded by reviewing NHSN data. Facility enrollment in 2013 and expected enrollment in 2014, following modifi cations to the surveillance requirements, were analyzed.Results From the initial release of the Hemovigilance Module in 2010 through 2012, 120 of approximately 4,800 (2.5%) eligible healthcare facilities had enrolled. Of these, 54/120 (45%) actively reported data. In 2013, since reduction of reporting requirements, enrollment has increased to 167 (3.5%) facilities with 72/167 (43.1%) actively reporting data. In 2014, an additional 70 facilities will enroll due to a mandate by the Massachusetts Department of Public Health for facilities to report to the Hemovigilance Module.Conclusion Increasing recipient hemovigilance participation in the United States requires a multi-faceted approach. Reducing reporting burden and building partnerships has been temporally associated with modestly increased national participation and mandated reporting by one state health department. Continued improvements to the utility and effi ciency of reporting and engagement with additional partners are planned.

P-1-19IMPLEMENTATION OF HAEMOVIGILANCE SYSTEM AT UNIVERSITY HOSPITAL, JEDDAH, KSAHindawi I., Damanhouri A., Badawi M., Raj T., Gholam A.KAUH, Jeddah, Saudi Arabia

Background Implementation of hemovigilance systems is an effective way of collecting data that would defi ne areas requiring improvement to enhance outcomes of both donors and recipients of labile blood products. This is a summary of two years (2012- 2013) experience in implementation of Haemovigilance System for the improvement of quality and safety of blood transfusion services at University Hospital (KAUH).Methods KAUH is a tertiary care academic center with 760 bed capacity. Services offered by the Transfusion Services include collection of whole blood preparing of labile blood components,

Table I

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pre transfusion testing and issuing blood components. Data were prospectively collected through documents quarterly and reported to Hospital Transfusion committee as quality Indicators data Including Donor reaction, Transfusion reaction, Incidents as wrong blood sampling and FFP In date wastage.Results The donor population during the study period consisted of 23,132 donors, including 21,659 (93.6%) males. Overall 144 donor reactions were reported resulting in an overall donor reactions rate of 0.62%.Out of 82 reported transfusion reactions, 34 (41.46%) were FNHTR, 48 (58.54%) allergic reactions no severe reactions were reported.Overall an error is associated with approximately 1·4% of total no of samples/request forms. Overall FFP In date wastage is 21.3% of total wastage. Table I shows the results of 2012-2013 for all haemovigilance data.Conclusions We conclude that there are under reporting of transfusion reaction and an action plan for all haemovigilance reports put in place for further improvement of blood transfusion safety.Our data were reviewed by Hospital Transfusion Committee on regular basis. There is an evidence of Improvement between 2012 and 2013 of Donor reaction, Incident reporting and FFP In date wastage.Availability of haemovigilance data at our hospital has given the transfusion services a clear understanding of problems associated with transfusion that to be solved and help in continuous improvement.

Only one adhesive label is printed with ER, it must be removed from the blood order paper sheet and put it on blood sample tube. No previous printed patient labels are circulating in hospital services.We analyze IE's detected from one year before SAP and one year with SAP completely implemented.Results See Table I.Conclusions The use of electronic request for pre-transfusional tests has decreased IE's to less than half. This reduction is not signifi cant in services without this option.It proves that ER andthe lack of previous printed labels into patient's fi les are important tools to face this error.ER is not the solution for everything, in any case. It continues to be essential extra vigilant staff when labeling blood samples prior to send to laboratory.

Table I - Haemovigilance data of year 2012 and 2013.

P-1-20ELECTRONIC BLOOD COMPONENTS REQUEST AS A TOOL TO DECREASE PATIENT IDENTIFICATION ERRORSOrtega Sanchez S., Verdugo Valle M., Gracia Brinquis E., Bravo Augué A., Ramoneda Novas R., Massuet Bosch L.Blood and Tissue Bank of Catalonia, Barcelona, Spain

Background Transfusion process needs to be performed according with protocols and standard operating procedures (SOP's) in use. All staff involved in transfusion should be reminded that they have a professional responsibility to practice safely. However errors exist and some of the most relevant have to do with an incorrect patient identifi cation. Transposed labels in blood samples for transfusion tests are one of the most frequently reported procedural error in transfusion process.Trained personnel are essential in order to avoid identifi cation errors (IE). Other helpful tools are: continuous retraining and check lists.Aims The aim of this study is to compare the incidence of IE before and after the electronic request (ER) was implemented in our Hospital.Methods SAP Logon computer system was initiated on June'2010 for pre-transfusion tests, except for haematology and oncology services (belonging to another hospital) which still perform manual blood order forms.

Table I

P-1-21STEPS FOR A BETTER PRACTICE IN AN IMMUNOHEMATOLOGY LABORATORY -1 YEAR EXPERIENCEVasconcelos E.1, Rasteiro P.2, Oliveira I.2, Encarnacao F.2, Sousa G.1

1Instituto Portugues do Sangue e da Transplantacao, Lisboa; 2Laboratorio Laura Ayres, Faro, Portugal

Background The Blood Establishment (BE) of Laura Ayres Laboratory is responsible for processing and analysis of WB collected by 2 Hospital Collection Sites (HCS) of Algarve. In January 2013, Instituto Portugues do Sangue e Transplantação (IPST) was commissioned by the Ministry of Health to take responsibility for its management.Aim to describe past and current state of routine donor Immunohematology tests and steps taken for a better practice during 2013.Methods There was an evaluation of how WB/tubes were checked on reception and reconciliated against donor sessions data. Ortho-Autovue-Innova was used for routine donor testing (ABO, RhD, Rhphenotype and antibody-screening). Grifols-WADiana-Compact, the back-up, was out of service for lack of reagents. Procedures were analysed. Samples with reproducible discrepant results began to be sent to Reference Lisbon Laboratory (RLL) and RBC retained until resolution. IPST informatics-reporting-system (IRS) was introduced and

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occurrences sent to staff, Quality-Department and HCS, when applicable. Training and a no-blame policy were implemented.Results 14,046 WB were received. Missed/wrong identifi cation (n=3) or absence of WB/tubes (n=2), labels with unreadable barcodes (n=112) or collection date not matching records (n=31) were reported. WADiana was validated and used for 1rst-time-donors blood group confi rmation. WeakD test moved from manual to Autovue but a 6% false-positive rate was found, the cause being overcentrifugation of tubes in preanalytical phase. A case of wrong-blood-in-tube was identifi ed through comparison of tube/historic/RBC-segment data. An ABO discrepancy was reported after RBC release, as donor was previously grouped in HCS as B but result from RLL was AwB1. No harm occurred to patient.Conclusion Changes occurred in BE would not succeed without staff commitment for improvement. IRS was a starting point for dysfunctions recognition, that except for unreadable barcodes all had human origin. Continuous training is a key factor. Nevertheless, human errors are likely to occur at any process.

P-1-22PRESCRIBING BLOOD TRANSFUSION:PHYSICIAN ASSISTANTS TOO?Zijlker-Jansen P.Y., van Tilborgh-de Jong A.J.W., Wiersum-Osselton J.C.TRIP National Hemovigilance and Biovigilance Offi ce, The Hague, The Netherlands

Background and aim In December 2011 an amendment to the Law on practitioners in health care was passed in the Dutch Parliament. This amendment legally allows for reallocation of certain medical tasks to physician assistants (PAs) and nurse practitioners for a trial period of 5 years. The legal amendment does not specifi cally name transfusion, but can be read to allow prescription of blood components by PAs. TRIP National hemovigilance and biovigilance offi ce has received some reports of adverse events relating to PAs prescribing blood components. Dutch hospitals were surveyed regarding employment of PAs and their tasks relating to blood transfusion prescription.Method Added to the TRIP annual 2012 survey of blood component use all Dutch hospitals were asked:a) if they employed PAs;b) if PAs prescribed blood transfusions.The survey was done by means of a password protected online form.Results Out of the 98 Dutch hospitals 67 employed PAs (68%), 27 did not employ PAs and 4 did not reply. Out of the 67 hospitals employing PAs, 19 (28%) allowed PAs to prescribe blood transfusions; in 34 hospitals (51%) prescribing transfusion by PAs is not allowed. Twelve hospitals (18%) replied PAs were allowed to prescribe transfusion in certain specialties or situations. In one hospital the blood transfusion committee had not yet reached a decision on prescription of blood components by PAs; one hospital did not specify the PAs tasks.Conclusion The majority of Dutch hospitals employ physician assistants. However the scope of their responsibilities relating to prescription of blood components is not uniform. It is advisable for hospitals to clearly lay down responsibilities of PAs in their institution and to ensure that PAs receive appropriate training for prescribing blood transfusion.

P-1-23TRENDS OF TRANSFUSION ASSOCIATED ADVERSE REACTIONS IN GREECE: THE SIGNIFICANCE OF STANDARDIZATION OF DEFINITIONS.A REPORT FROM OVER THE PERIOD 2008-2012 Politis C.1, Richardson C.2, Zervou E.3, Marantidou O.3, Kavallierou L.3, Martinis G.3, Hatzitaki M.H.3,Koumarianos S.4, Asariotou M.A.4

1Hellenic Center for Disease Control and Prevention, Athens; 2Panteion University of Social and Political Sciences, Athens; 3Blood Transfusion Services, Ioannina; 4Coordinating Haemovigilance Centre, Athens, Greece

Background A national haemovigilance database for the surveillance of adverse reactions (ARs) and adverse events (AEs) in donors and recipients of blood components is an accepted tool for data management, trend analysis and benchmarking. Standardized defi nitions for donor and recipient adverse reactions and internationally accepted scales of severity and imputability are required to avoid misinterpretation and allow comparisons. We present trends in transfusion- associated total ARs in recipients in Greece in 2008-2012.Methods Aggregate data on total ARs were analyzed by type, severity and imputability. Trends were studied by linear regression analysis.Results SKAE recorded 4,917 ARs (6.7% serious) in 3,194,352 blood components issued for transfusion by a large number of hospitals (prevalence 1:650). The commonest serious ARs, in 2012 were anaphylactic/allergic (28.1%), TACO (15.6%), TAD (13%), febrile non- haemolytic (10.9%) and TRALI (9.4%).Two deaths occurred: one attributed to ABO incompatibility due to incorrect blood component transfused and another to septicaemia due to contamination of red cells by Serratia.Trends over the period 2008-2012 showed statistically signifi cant average yearly changes in the incidence of febrile ARs +7.2 (p=0.001), allergic/anaphylactic +5.1 (p=0.029), incorrect blood component transfused -ABO -0.2 (p=0.009) and TAD +1.5 (p=0.007). Changes were not statistically signifi cant for TACO +0.5 (p=0.28) and TRALI +0.1 (p=0.13).Deeper analysis for the three respiratory tract related ARs (TACO, TRALI, TAD) showed inadequate knowledge of differential diagnosis for these ARs.Conclusions This study demonstrates high incidence of the three respiratory ARs and the signifi cance of standardization of ARs defi nitions as well as the need for continuous training of medical and nursing staff of the clinical departments. Hospital Transfusion Committees should pay special attention to the non-product-related ARs.

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P-1-24COSTS OF TRANSFUSION REACTIONS:A PRELIMINARY ANALYSISWiersum-Osselton J.C.1, Bergers M.S.E.1, van Tilborgh-de Jong A.J.W.1, De Vooght K.M.K.2, Van EmpelJ.3, Van Grootveld G.4, Van Pampus E.C.5, Janssen M.P.61TRIP Hemovigilance and Biovigilance Office, The Hague; 2Universitair Medisch Centrum Utrecht, Utrecht; 3St Anna Ziekenhuis, Geldrop; 4Ziekenhuis St Jansdal, Harderwijk; 5Radboud Universitair Medisch Centrum, Nijmegen; 6Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands

Background and aim Costs of possible measures to improve transfusion safety are a barrier to their implementation but could partly be recouped through reduction of reactions and incidents. The costs and the potential preventability of transfusion reactions were investigated; costs of errors and incidents will be investigated in a further project.Methods A list was compiled of additional investigations and components of care when a transfusion reaction occurs. 2013 standard hospital and laboratory tariffs were used to derive costs. Numbers of reactions reported to the hemovigilance system were used to calculate total annual national costs.Volunteer hospital professionals were asked to state, for each transfusion reaction, whether each item was always performed or in a lower percentage of cases. This was done separately for non-serious and for serious reactions. Costs to patients and increased future care costs were not included. The experts also estimated the proportion of each type of transfusion reaction which they considered potentially preventable with currently available means, as well as a plausible minimum and maximum.Results In all, 14 experts participated. Costs were estimated at € 167 average per non-serious reaction and € 3,054 per serious reaction. The total annual costs of reactions were estimated at € 640,000. Experts stressed that the real amount is probably higher owing to underreporting of reactions and possibly also of investigations. Of all reactions 25% was judged to be potentially avoidable, corresponding to reduction of 33% of costs from serious and 15% from non-serious reactions.Conclusion This preliminary analysis estimated that approximately € 640,000 of additional costs arise in the Netherlands annually as a result of transfusion reactions. True costs are likely to be higher, as not all reactions may have been reported. Experts estimated that approximately 25% of the costs might be avoided with currently available means.

P-1-25THE X FACTOR IN HEMOVIGILANCE- HUMAN ERRORCodaty J., Arumugam A.Fortis Malar Hospital, Chennai, India

Introduction Blood Transfusion is a life saving process associated with complications, both incidental to the process and manmade. World Statistics of hemovigilance largely put the blame on human error. Machines can be repaired, processes can be rewritten and personnel trained, but what about human error? Our aim is not to open the door to infi nite wisdom but to set a limit to infi nite error.Methodology Deviations are identifi ed on the basis of recorded data, either by supervisory staff or by self reporting. Analysis reveals that these can be broadly classifi ed into:1. mistakes in entry - ignored in this analysis;2. errors in entry that can lead sentinel events;3. errors due to machine failure.

The fi nger points to Human error. Our personnel are qualifi ed, well trained, motivated and content. Yet, errors happened.We grouped errors by more than one person on more than one occasion. We inserted barriers in our process:- daily cards with pre calculated expiration dates of each product;- a chain of evidence signature with timing at every step of the

process;- returning of used blood bags to the blood bank along with

feedback forms;- double check at every point of discard.Result Our record of deviations of 2013 is lesser than of 2012. Our work with barriers helped. Results are in Table I.Conclusion Human conditioning cannot be changed but the conditions in which humans work can be. Every process has inherent weak points as per James Reason's Swiss Cheese analysis. Errors happen when an act of man can penetrate these holes. By inserting barriers this act is defl ected. Our experiment has reduced the number of errors. Refer Figure 1 below.But errors will continue to happen when dealing with humans.Hemovigilance is a continuous process and requires an eagle eye to catch and correct errors.

Table I

Figure 1 - Reason's Swiss Cheese Model.

P-1-26RESIDUAL AMOTOSALEN IN INTERCEPT TREATED PLATELET CONCENTRATES AT MINIMUM CAD TIME (4H AND 6H)de Valensart N.1, Cellier N.2, Lambermont M.2, Najdovski T.2

1Suarlée; 2Service du Sang, Croix-Rouge de Belgique, Namur, Belgium

Background With pathogen reduction technology INTERCEPT Blood System® (CERUS) for platelet concentrates (PC), residual amotosalen is adsorbed by a compound adsorption device (CAD). A concentration <2μM is the limit specifi ed

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by French and German Health Authorities for product release. CERUS requires CAD incubation times from 4h to 16h (Small Volume sets, SV) and from 6 h to 16 h (Large Volume sets, LV) targeting a [amotosalen] of 0,5μM.Aims Measure [amotosalen] in pathogen reduced PC at 4h and 6h CAD time respectively for SV and LV sets in order to reduce release time.Methods PC prepared by pooling 6 buffy-coats with SSP+ (280 mL) met volume requirements for SV (255-325 mL, N=15) and LV sets (300-420 mL, N=15). Treatment according to routine procedures was repeated with 3 batches of sets. Samples taken at : 4, 6 and 8h were stored at −80 °C before measurements by HPLC.Results Table I shows the results obtained with SV and LV sets. After 4h, [amotosalen] in SV sets ranged from 0,37 to 0,99 μM. 5 out 15 PC showed results ≤0,5 μM. After 6h, [amotosalen] in LV sets ranged from 0,34 to 0,78 μM. 9 out 15 PC showed results ≤0,5 μM.Conclusion PC treated with SV and LV sets consistently meet the limit <2 μM of [amotosalen] and can be released after respectively 4 and 6h CAD time. Robustness of the adsorption process is confi rmed with 3 batches of sets. The [amotosalen] achieved is <1 μM representing 50% of limit specifi ed by Health Authorities. With CAD times of 4h and 6h respectively for SV and LV sets, the results for residual amotosalen are compatible with data observed by other Blood establishments but a majority of the PC do not reach the level <0.5 μM as claimed by CERUS.

emergency stocks of 0 Rhesus negative RBCs in hospital strategic locations; 4) time synchronization between urgent orders and transport 24/7; 5) improved stock management system of blood bank; 6) updated transfusion guidelines, accessible at time of order, and 7) information, communication campaign to all health personnel, including training videos In addition, a telephone help-line was opened during the fi rst three months of implementation.The results of the fi rst four months of implementation from June to September 2013, have shown several positive effects. Comparing to the same period in 2012, the proportion of ordered blood products which have been transfused has increased from 44% to 73%. The number of orders of blood products decreased by 38%, partly due to increased confi dence in the blood supply system, and decrease in precautionary orders of blood products to store at the bedside. The requests for transport of blood products increased by 29%, but the "Extremely Urgent requests" were reduced by 75%: from 1,337 down 349 comparing the same periods in 2012 and 2013.A full assessment of the effects of the new quality management of the blood supply system introduced would require the analysis of data of at least one year of full program implementation.

P-1-28WRONG BLOOD IN TUBE ERROR IN DONOR BLOOD SAMPLES: CAUSES AND FREQUENCYVuk T., Cipek V., Hecimovic A., Jukic I.Croatian Institute of Transfusion Medicine, Zagreb, Croatia

Background Although the error known as Wrong Blood In Tube (WBIT) has been well documented in the hemovigilance system, it has hitherto applied only to the one end of the transfusion chain, i.e. to the patient. To our knowledge, this is the fi rst study on WBIT errors in donor blood samples.Methods Data of the Croatian Institute of Transfusion Medicine (CITM) Department of QA were used in the study. WBIT frequency in donor blood samples, the causes of their occurrence and trends over years were retrospectively analyzed for a 12-year period (2002-2013).Results During the study period 955,218 blood donations with two samples each were collected at CITM. WBIT was recorded in 19 (0.0020%) donations (in 12 error episodes in total). In 15 donations, WBIT was detected in both test samples, whereas in 4 donations only one test sample proved questionable. Thus, WBIT was recorded in 34 (0.0018%) samples. In 50% (6/12) error episodes, mismatching of the donation form and panel of donation ID numbers occurred after blood bag labeling. Comparison of the proportion of errors occurring at the institution and at mobile sessions as well as between less experienced and more experienced workers showed no statistically signifi cant difference. Seven (58%) of 12 blood donation sessions where errors occurred were sessions characterized by excessive workload (9-11 donors per worker per hour). Decrease in the freqency of WBIT errors correlates with abolishing the function of phlebotomist's assistant and full implementation of automated scale mixers.Conclusion Study results pointed to a relatively low frequency of WBIT errors in donor blood samples. Investigating these errors, however, greatly interferes with regular work, is time-consuming, etc. Besides its relevance in immunohematologic testing, WBIT may hamper trace-back and look-back procedures, and result in erroneous conclusions.

Table I - Residual amotosalen results for SV and LV sets.

P-1-27IMPACT OF THE NEW QUALITY MANAGEMENT OF THE BLOOD SUPPLY SYSTEM AT THE GENEVA UNIVERSITY HOSPITALPizzi Bosman L., Preynat-Seauve O., Haller G., Rigal E., Hadji Guer L.Hopital Cantonal Universitaire Geneve, Geneve, Switzerland

Every year approximately 400,000 units of blood products are transfused in Switzerland, 5% are transfused at the Geneva University Hospital (21,473 units in 2012). In 2011 a multidisciplinary review of the blood supply management identifi ed as main problems: 1) suboptimal delivery systems; 2) storage of blood products above the recommended temperatures; 3) expiry and wastage; 4) wrong ordering patterns.A new quality management system was implemented in May 2013, which includes the following key elements: 1) simplifi ed criteria for ordering; 2) supply of blood products in refrigerated cool boxes to the surgery blocks; 3) placement of multiple

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16TH INTERNATIONAL HAEMOVIGILANCE SEMINARPOSTER PRESENTATIONS - CLINICAL ASPECTS


CLINICAL ASPECTS

P-2-01THE RISK OF TRANSFUSION TRANSMITTED BACTERIAL INFECTIONS IN CROATIA - RESULTS OF FOURTEEN-YEAR SURVEYVuk T., Ocic T., Batarilo I., Balija M., Šarlija D., Jukic I.Croatian Institute of Transfusion Medicine, Zagreb, Croatia

Background In spite of continuous improvement in the quality and safety of blood products (BP), transfusion transmitted bacterial infections (TTBI) remain one of the leading causes of mortality associated with transfusion therapy. The aim of the study was to assess the risk of this adverse reaction in patients treated with BP prepared at the Croatian Institute of Transfusion Medicine (CITM), and to identify the advantages and drawbacks of the TTBI investigation.Methods Reports of suspected TTBI from clinical departments using BP from CITM were retrospectively analyzed for the 2000-2013 period.Results During the study period, 40 reports of suspected TTBI were received, i.e. 14 (35%) for red cell concentrates (RCC) and 26 (65%) for platelet concentrates (PC). Testing performed at CITM confi rmed with certainty association between transfusion and patient reaction in only two cases. Reports of TTBI caused by PC were reduced from ½,000 issued platelet products in the 2000-2002 period to 1/35,000 in the 2011-2013 period, and those of TTBI caused by RCC from 1/98,000 to 1/122,000 in the respective periods. In case of PC, this reduction showed negative correlation with the proportion of fi ltered PC (r=−0.82), whereas for RCC the level of correlation with fi ltration was signifi cantly lower (r=−0.19). As the suspicion of bacterial contamination of BP was not confi rmed in the majority of cases, reduction in the number of febrile non-hemolytic reactions (FNHTR) due to increased proportion of fi ltered BP, could not be excluded either. This was supported by the fact that 26 (65%) reports of suspected TTBI were related to unfi ltered products.Conclusion Along with upgrading the microbiological safety of BP, additional effort should be invested in standardization of testing for suspected TTBI because of the many problems and diffi culties encountered in their implementation (lack or inadequate information, discrepant results, inappropriate samples, etc.).

P-2-02RELATIVE BLOOD VOLUME:THE BEST PREDICTIVE FACTOR ASSOCIATED TO VASOVAGAL BLOOD DONOR REACTIONS?Bertrand O.1, Benoît A.B.2, Govaerts B.2, Rapaille A.1, Deneys V.1, Lambermont M.1, Gillet P.1

1Service du Sang, Namur; 2ISBA, Université Catholique de Louvain, Louvain-la-Neuve, Belgium

Background Factors associated with blood vasovagal donor reactions (VVDR) are well known: gender, age, weight and donor status. Reducing VVDR rate is essential to improve the safety of donors.Methods All donations were recorded from January 2010 to December 2012. VVDR were classifi ed as none, mild, moderate or severe.Odds ratios (with 95% CI) were computed for gender, age, donor status and relative blood volume (RBV=blood collection volume/estimated total blood volume).

A logistic regression model was used to assess the effect of covariates (donor status, RBV, age, weight and gender) on the occurrence of a VVDR. A manual stepwise selection based on the Bayesian information criterion was performed to determine the best combination of covariates.Results On 523,024 procedures, the overall VVDR prevalence was 0.82%. Table I shows the data on associated factors to VVDR. 508,815 observations were included in the logistic regressions.The selected model included the covariates donor status and RBV as well as their interaction. The risk of a VVDR was higher for fi rst time donors compared to regular (p<.0001) and with higher RBV (p<.0001).Estimated probability of VVDR with respect to donor status and relative blood volume is shown in Figure 1.Conclusion OR and CIs confi rm that donor status, age, RBV and gender are associated with VVDR in our donor population. However the stepwise analysis highlights that when RBV and donor status are included in the model, there is no statistically signifi cant gain of adding gender and age.In consequence, it is essential to identify the upper limit of RBV for all donors and especially in the fi rst time donor population and to evaluate on a regular basis the occurrence of VVDR.

Figure 1 - Estimated probability and associated observed proportions of VVDR with respect to donor status and relative blood volume.

Table I - Individual OR of associated factors to VVDR.

P-2-03ADVERSE EVENTS IN THE MALTA NATIONAL BLOOD TRANSFUSION SERVICEBorg-Aquilina D., Abela MA, Scerri R., Aquilina A.A.National Blood Transfusion Service, G'mangia, Malta

Haemovigilance is a relatively new domain in the fi eld of Transfusion Medicine, covering all aspects of the transfusion chain, including blood collection. Malta started the donor haemovigilance programme as a consequence of Directive 2005/61/EC. This local programme records adverse events (AE) occurring at all donation sites. This survey aimed to

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analyse whether there was a difference between reporting of donor adverse events captured in the national donor vigilance programme and when donors were specifi cally asked about AE in a retrospective survey.Blood donors were subjected to all routine pre-donation assessments and encouraged to drink water. Post-donation, donors were ushered to the refreshment area and were advised to stay for a minimum of ten minutes. Donors consenting to take part in the survey were asked to complete the questionnaire during this post-donation time. Results were analysed using a spreadsheet programme.The majority of donors were male, 67.75%, vs 31.62% females. A total of 276 AE (32.13%) were described by donors who donated at least once before. AE were categorised under dizziness, tingling, bruising and others. Bruising and dizziness were the commonest fi ndings (both at 40% of AE). This result is in contrast with data collected by the national haemovigilance programme, where the incidence of AE is reported at 2.8%. Dizziness is by far the commonest adverse event (83.10%) on site, and no bruising reported.AE are commoner than initially thought and captured by the haemovigilance programme, (2.8% of donors on site vs 32.1% of donors in the survey). This kind of study has never been done locally and will serve as a benchmark for further studies and to improve on donor care.Another survey assessing the rate of donors returning to donate after experiencing an adverse event is also being undertaken as this may have an impact on the blood supply.

P-2-04DONOR ENGAGEMENT IN INTERVENTIONS TO REDUCE VASOVAGAL REACTIONS: SURVEY RESULTSBravo M.D.1, Kamel H.1, Tomasulo P.1, Custer B.2

1Blood Systems, Inc, Scottsdale, AZ; 2Blood Systems Research Institute, San Francisco, CA, United States of America

Background Studies support physiologic benefi ts of fl uid replacement (FR), applied muscle tensing (MT) and salt intake (SI) to prevent vasovagal reactions (VVR).Aim This analysis evaluates donor perception and adoption of these interventions at several blood centers.Methods Surveys were sent in 2 periods (January-May 2012 and January-May 2013) to donors in pilot centers (PC) and control centers (CC) in the United States. PC were randomly selected to provide oral and written educational materials to donors regarding FR, SI and MT and prescribed amounts of fl uids and salty snacks to be consumed prior, during and after donation. CC followed current practices (pre-donation hydration and routine donor safety materials). To evaluate awareness, a 31-item survey (Survey Monkey, Palo Alto, CA) was emailed to donors with successful donation at both PC and CC. Response proportions regarding MT, SI and FR were compared and stratifi ed by fi rst-time (FT) or repeat donor status within and between the PC and CC.Results 18,276 (8% FT) from PC and 25,400 (9% FT) from CC allogeneic whole blood donors completed the survey (overall response rate: 16% for PC and 18% for CC). More FT donors indicated receiving materials, discussing and performing MT and SI in both PC and CC (Table I). All donors from PC had higher reported MT compared to CC donors. More FT donors reported consuming all salty snacks provided with CC having even better donor compliance. FR was reported with good compliance in all groups.

Summary/Conclusion Some aspects of interventions in PC were voluntarily adopted by CC. Provision of fl uids and availability of salty snacks engaged the donor in the desired FR and SI behaviors. Use of MT is less than optimal but education measures in the PC centers and increased adoption by FT donors suggest donors are receptive to learning VVR prevention skills.

Table I - Donor reaction survey results (% Yes) by donor status and intervention group.

P-2-05DONOR VIGILANCE- WE CARE!Codaty J., Arumugam A.Fortis Malar Hospital, Chennai, India

Introduction A vibrant community requires a healthy donor. Donor hemovigilance assures this. Sound ethical and medical practices at pre, during and postdonation ensure his safety. Innovative and individualistic attention builds donor pools.Methodology Our center is 3 years old. We follow established medical practices with TLC for donor care. Our value additions are listed below:Talks in small groups help remove misconceptions about blood donation including self exclusion - a sensitive topic in India.Pre donation concerns Follow up of anemia every 3 months with nutritional correction yields good results. A repeat reading after 15 minutes eliminates the whitecoat effect. Persisting hypertension is advised treatment.During or post donation: Donors carry a post donation instruction leafl et with telephone numbers to call. "How are you

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doing?" call the next day enhances a feel good experience in a donor with the simplest of adverse events.TTI positive donors are counseled and free consultation offered by our internist.They are free to call us at any time.Thanking our repeat donors in a public function on WBD day.Result Our rates of deferral, temporary or permanent, are lower than our own fi gures of 3 years back. 15-20%, of our donors return to donate blood, someseveral times.Conclusion Hemovigilance to us is sound medical practices with a caring attitude. Our donor friendly methods of willingness to answer questions, caring for thembefore, during or after donation ensures a feel good atmosphere ensuring hemovigilance. Our programs of counseling anemic donors and those with hypertension, calling after the smallest of adverse events result in positive feedback of, "You care. None call to check on us." Our TTI positive donors remain our friends and refer friends for blood donation.

P-2-06REVERSE NEEDLE STICK A NEW CATEGORY OF DONOR ADVERSE EVENT? Moore N.Irish Blood Transfusion Service, Cork, Ireland

Background This is the fi rst reported incidence of a "Reverse Needlestick Injury"to our knowledge.The European Haemovigilance Network collates fi gures for donor adverse events within the "Standard for Surveillance of Complications Related to Blood Donation"to which the IBTS submits annually.This describes complications related to blood donation as Local, Generalized, Apheresis and other.Description This is an observational report of 2 incidents of "Reverse Needlestick" i.e. where the donor is exposed to staff members blood, with a review of Donor Adverse Events for the time period 24/06/2008-17/04/2013 at our Centre. In 2008 a Further Education and Training Awards Council (FETAC) Donor Attendant, under supervision accidentally contaminated the pack needle by piercing left thumb prior to donor venepuncture, noted on removing gloves. In 2013, a recently appointed RGN immediately post phlebotomy, noted bleeding from a puncture wound to her left thumb. Neither staff member was aware of the "reverse needlestick"occurring.Phlebotomies performed totalled 268,276 for the time period 24/06/2008 - 17/04/2013 in the Munster Region of the IBTS. i.e. Plateletapheresis, Whole Blood, Unsuccessful Draw, Samples Only for - Virology Follow Up, New Donor, Anti D Recipient. 215,479 donations were procured with 680 signifi cant complications recorded.Conclusion Reverse Needlestick is not mentioned in the categories in "The Surveillance of Complications Related to Blood Donation". Nurse led clinics introduced in the IBTS in 2008, with Nurses and FETAC trained Donor Attendants undertake phlebotomy previously performed by a Medical Offi cer or Medical Offi cer with Nursing Support. Both cases involved relatively inexperienced staff performing donor procurement in busy clinics.The purpose of the poster highlights this as complication of donation.

P-2-076 YEARS OF EXPERIENCE USING THE HEMOCOD TRANSFUSION SAFETY SYSTEMViejo A.Hospital Universiatorio La Paz, Madrid, Spain

Introduction The component Administration to the untargeted patient remains a signifi cant source of mortality and morbidity in the western world. Aims The scope of the presented system is to securely track and crosscheck drug administration. The system can be confi gured to securely identify the samples taken from the patient at bedside and relating it with the doctor prescription. The system will be use to positively match the patient with the blood to be administered. Furthermore the system allows for a complete and detailed traceability and monitoring of all blood products that leave the local blood bank. This traceability and monitoring capability reaches from the assignment of the product up to the actual administration at bedside.Methods The HemoCod system is based on a specifi c software suite, which links a database with mobile computer devices (PDA's), also some special transfusion bands are used to uniquely ID the patient and the samples. While the PDA's are deployed in the different hospital departments, they have access to the central software suite. At bedside any information related to the samples, the patient and the actual blood unit can be collected using the PDA's. The method of data collection it is based on linear barcode readings. After personalized assignment of specifi c blood products, the products will be sent to the hospital departments, where the receipt can be tracked as well. Finally scanning both, the patient and the assigned blood product at bedside will provide a check for the compatibility.

Figure 1

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P-2-08SCREENING OF INFECTIOUS DISEASES IN BLOOD DONORS: 10 YEARS OF HAEMOVIGILANCE IN ASTURIAS (SPAIN)Muñoz M.C.1, Garcia Gala J.M.2, San Roman F.1, Seco C.1, Corbillon L.3, Fernandez C.4, Martínez E.2, Bernardo A. 3, Rozada S.5, Chamorro C.6

1Centro Communitario de Sangry y Teidos de Asturias, Oviedo; 2Hospital Universitario Central de Asturias, Oviedo; 3Hospital Cruz Roja Española, Gijón; 4Hospital Cabueñes, Gijón; 5SESPA, Oviedo; 6Hospital del Oriente de Asturias, Arriondas, Spain

Background The aim of this paper is to analyze the positive fi ndings of infectious diseases that have been detected at Community Blood and Tissue Center of Asturias (Northern of Spain) in the last 10 years (2004-2013).Methods All donations were tested for HIV, HCV, HBV (serology PRISM-ABBOTT + NAT CHIRON until 2008, COBAS-ROCHE since 2008 to present time) and LUES (RPR until 2011, IgG+IgM ARCHITECT-ABBOTT 2011-2013). Donors who come from endemic areas or had travelled to the same were analyzed for Malaria and Chagas disease. Since 2012, donors from endemic areas for HTLV I/II or whose sexual partners were from this areas were tested for HTLV I/II. OBI (occult infection by HBV) is defi ned as HBSAg negative + NAT positive.Results Positive cases detected are shown in Table I.The prevalence for HBV in donors was 16.18 per 100,000 donors (1.46 seroconversions per 100,000 donors), for HCV was 19.12 per 100,000 donors (1.84 seroconversions per 100,000 donors) and for HIV, 8.46 per 100,000 donors (3.6 seroconversions per 100,000 donors). Syphilis prevalence shows 18.7 cases per 100,000 donors. 2% of offered - donors from endemic areas were positive for malaria and 0.23% for Chagas disease.The 3 HTLV I positive donors were from Central and South-America. Look-back studies have revealed no transmission to patients. Only one of the fi ve OBI detected was transmitted to an oncohematologic patient.Conclusions Except for an occult hepatitis B, there has not been documented any transmission to patients, which confi rms the reliability of the laboratory tests used in screening, specially after introduction of routine NAT technology. However, transmission of OBI supports the capacity of this entity to be infectious especially when the receiver is an immunocompromised patient.

P-2-09ENSURING TRACEABILITY OF ALL ACTIVITIES AT BLOOD COLLECTION IN ORDER TO ANALYZE ADVERSE EVENTS AT BLOOD DONORS IN TRANSFUSION CENTER OF GENERAL HOSPITAL CELJE Pajk J.P.General Hospital Celje, Celje, Slovenia

Background In GH Celje we established a haemovigilance system supported by transfusion information system Datec and a systematic follow-up of adverse events.Aims The aim is to discuss about data of adverse events at blood donors.Methods Data collection: 2009-2013. Every donation is carried out by a well-trained nurse, responsible for the whole donation process. During donation all important data is recorded on the donor list. At any adverse events or reactions the physician is called and further useful information is recorded. The withdrawal of blood is carefully monitored on the chip of the scales.Results In the period 2009-2013 there were 49,408 donations of whole blood, out of which 280 cases of adverse events are reported (0.57% of all donations). The most frequent was P 1- collapse after donation, without loss of conscience (58,9%), the second was I 1 - collapse at donation, without loss of conscience (21,7%); the third was P 2 collapse after donation, with partly loss of conscience (14,2%).Conclusions Analyzing the collected data can lead to prompt effective actions in order to ensure greater safety and quality of treatment. Keeping detailed records is essential, as they may represent an important source of information in lawsuits.

Table I - Positive donors.

Table I - Number of events at donors from 2009 to 2013.

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P-2-10NURSING ACTIVITY IN MANAGEMENT OF ADVERSE REACTIONS DURING BLOOD DONATIONPena C., Gómez R., Coll N., Mingo A., Pujolràs C., Millan A.BST Girona, Girona, Spain

Background Though blood donation is a safe process and it is highly regulated, adverse effects can occur during this activity. Due the importance of Haemovigilance in blood components obtaining, Banc de Sang i Teixits in Girona nursing staff developed a record to evaluate nursing activity in high dependency adverse effects (HDAE: serious dizziness with consciousness, seizures or vomits).Primary aim To evaluate nursing activity in HDAE.Secondary aim To analyze risk factors of HDAE.Methods All HDAE occurred between January 2010 and September 2013 in blood drives in Girona are recorded. Nursing activities carried out to all fi rst donation donors are water intake and elevation of extremities. All donors are classifi ed depending on the HDAE risk factors.Results 167 HDAE out of 113,063 blood donations were registered. 42 (0.4%) of 10,297 new donors and 124 (0.12%) of 102,766 usual donors presented AEHD. The most prevalent risk factor among donors presenting HDAE is anxiety (40%), which appears in 18% of fi rst donations and in 39% of usual donors.Conclusion Nursing activities on fi rst donations do not clearly prove to avoid HDAE. The most important risk factor on HDAE is anxiety. More studies on HDAE risk factors are necessary.

P-2-11PRE DONATION HEMOGLOBIN CONTROL EFFICACY IN FRANCE: RESULTS OF A WHOLE YEAR STUDYPy J-Y1, Ounnoughene N.2, Pillonel J.3, Auroy Y.4, Joussemet M.2, Carlier M.5

1EFS Centre-Atlantique, Orleans; 2ANSM, Saint-Denis; 3InVS, Saint-Maurice; 4HIA Val de Grâce, Paris; 5Centre Hospitalier, Châlons en Champagne, France

Background and aims Capillary or venous pre donation hemoglobin control is only mandatory in France for new donors or donors without donation since 2 years or more. It is not done for other donors if their last donation hemoglobin measure is normal. Due to some cases of donors found highly anemic, a national study was launched to evaluate effi cacy of that scheme.Methods Retrospective data of the year 2010 were collected in all French blood transfusion centers databases. Whole blood donations only were taken into account.Results Hemoglobin measures were done on whole blood donations made by 1,081,354 women and 1,254,515 men. Results below the French mandatory levels of 12 g/dL for women and 13 g/dL for men concerned respectively 3.33% and 0.74% of donations. Two third of the anemic donations were made without a pre donation hemoglobin control and one third after a valid one.35,067 donors were refused because of a low pre donation hemoglobin control. The French scheme sensibility (i.e. refusal of an anemic donor) and specifi city (i.e. donation of a non-anemic donor) were respectively 0.307 and 0.993.Summary/Conclusion There is a real need to improve sensibility of the pre donation hemoglobin control in France. It means at least to enlarge its indications, if not consider to generalize it. Use of noninvasive methods may be a future way to do it without a dramatic workload increase. It can also solve some technical errors met with invasive methods.

P-2-12INCIDENCE AND PREDICTIVE FEATURES FOR SYSTEMIC REACTIONS DURING AND AFTER WHOLE BLOOD DONATION IN CASTILLA Y LEON, SPAINSala Cano N.1, Bahillo Ruiz E.1, Perez Gonzalez P.1, Sierra San Nicolas S.2, Salas Villasur H.1, Blanco Peris L.1, Fernández Castro C.1, Ramos N.1

1Chemcyl, Soria; 2Navarra University, Pamplona, Spain

Background Blood donation is an altruistic and well tolerated act in which side reactions are possible.An adverse reaction is an unexpected sign-symptom during or after donation. Usually a transitory, self-limited event, although a few cases might lead to permanent damage.Aims To detect possible causes of adverse reactions in the blood-donating process and to establish guidelines to be followed, in such an event.Material and methods Data were collected in a questionnaire by nurse and medical staff. It includesAdverse reactions were classifi ed as:- Minor: lasting<15 minutes. Such as dizziness with paleness,

blurred vision.- Moderate: lasting>15 minutes. Such as vomiting, transient

loss of consciousness.- Serious: loss of consciousness possibly leading to a crisis

with convulsions, injuries.33,835 donors participated in the study, in two periods: February-March 2013 and July-August 2013.A SPSS 21 software package was used for statistical analysis.Results Donors experienced an adverse effect 0,73% and 0,61% during the fi rst and the second periods respectively.There is an arising pattern of adverse reaction:First time period: females, fi rst donation, blood drive location, anxiety, insuffi cient liquid intake, fasting over 4 hours. Adverse reactions were mild.Second time period: males, occasional donor, blood drive location, anxiety, heat at extraction or refreshment area, previous cases of dizziness while donating and insuffi cient liquid intake. Adverse reactions were mild.Conclusions The main causes determined for an adverse reaction are anxiety, insuffi cient fl uids intake and heat in summer season.The study proves the importance of ensuring donors drink liquids prior to donation and of informing them on the process to reduce anxiety experienced during donation, such as, applying tension to the major muscle groups, encouraging conversation with the donor, etc.The work of health staff is crucial in predicting and avoiding that these circumstances may arise.

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P-2-13ADVERSE REACTIONS AND EVENTS OBSERVED DURING PERIPHERAL BLOOD STEM CELLS COLLECTIONSSpínola A.I., Bernardo A.P., Silva A., França M., Carneiro R., Reis C., Sousa S., Roncon S.Instituto Português Oncologia do Porto Francisco Gentil, EPE, Porto, Portugal

Background Collection of peripheral blood stem cells (PBSC) by leukapheresis is generally a safe procedure. Nevertheless, all health care professionals involved have the responsibility to recognize the risks and ensure that donors are fully informed and have access to clinical attention in case of an adverse reaction (AR) or adverse event (AE). We aimed to evaluate immediate ARs and AEs detected during leukapheresis since the implementation of our single center biovigilance system in 2011.Methods We analyzed retrospectively 189 individuals who underwent PBSC harvest and had ≥1 AR and/or AE. Demographic and patient data, mobilization and collection, AR and AE were reviewed.Results Our study population was 102 autologous-donors, 62 unrelated-donors and 25 related-donors (68 males, 121 females), with a median age of 47 years (2-70) and a median weight of 68 kg (7.5-123). They were mobilized with G-CSF, median dose 15.3 μg/kg/day, and underwent 257 leukapheresis, 57% by peripheral vein, 33% femoral access and 10% central venous catheter. A total of 333 ARs and 3 AEs were registered. From the ARs, 58% were anticoagulant-related, 20% leukapheresis-related, 7.5% venipuncture-related and 3% mobilization-related; all were non-serious, 68% with a minor impact on the donor and 76% with defi nite imputability to the collection. All the AEs were due to equipment failure with insignifi cant impact on the donor.Discussion The most common AR was due to the anticoagulant used (generally mild and easily treated by calcium supplementation); others are less common, but also must be recognized and treated. None of them were reported to our National Regulatory Agency. Knowing all the AR and AE associated with PBSC collections, we can prevent them, ensuring donor's safety and preserving PBSC products quality.

P-2-14ANTI-D ALLOIMMUNIZATION AFTER RH INCOMPATIBLE PLATELETS TRANSFUSIONS: RESULTS FROM THE HAEMOVIGILANCE PROGRAM AT LA FE UNIVERSITY HOSPITALSolves P., Carpio N., Balaguer A., Vaquero I., Moscardo F., Sanz MALa Fe University Hospital, Valencia, Spain

Introduction Platelet concentrate (PC) transfusions have greatly increased during recent years. Platelets concentrates contain red blood cells that can produce recipient alloimmunization against Rh antigens. Prophylaxis with gammaglobulins has been proposed in order to avoid this complication.Objective Our objective was to review the incidence of anti D alloimmunization after Rh positive platelet transfusions in Rh negative patients.Material and methods The Haemovigilance program in our Hospital started in January 2000. Since then, all immunisation events have been recorded in a database. A positive antibody screening test and positive identifi cation of an antibody against

Figure 1

Figure 2

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red blood cell antigens was considered an immunisation event. We analysed the type of PC involved, specifi city of the antibody and imputability degree. The policy of our blood bank is restrictive, the administration of anti D gammaglobulin is only given to young women that do not require long term platelet support.Results From January to December 2013, 89,430 PC and 16,868 unitary platelets were transfused. During this 14-year period, 3,634 adverse events related to transfusions have been registered, of which 2,354 (64.7 %) corresponded to alloimmunization. Only in 12 patients (0.5 %) was anti D alloimmunization due to D positive platelet transfusions: 4 women and 8 men who developed anti-D (9 cases) and anti-D + anti-C (3 cases) antibodies. Diagnosis was liver transplantation (4), myelodisplastic syndrome (3), heart disease (1), enolic cirrhosis (1), acute myeloid leukaemia (2) and multiple myeloma (1). All these patients had a previous negative antibody screening, and received a mean of 4 (1-25) PC transfusions. In all cases, PC was responsible for the alloimmunization.Conclusions Anti-D alloimmunization after Rh incompatible platelets transfusion is a rare event in our hospital. Our results support the selective and strict administration of anti D gammaglobulin only to young women not requiring long term platelet support.

P-2-15IMPROVEMENT OF THE BLOOD TRANSFUSION SAFETY BY MEANS OF CONTINUOUS EVALUATION OF THE TRANSFUSION PROCESS AND CONTINUING TRAININGAranda A.1, Hernández I.1, Subirà M.2, Cano M.1

1Hospital Sant Joan Despí Moisès Broggi, Barcelona; 2Banc de Sang i Teixits, Barcelona, Spain

Background Moises Broggi Hospital opened in 2010. The staff came from different hospitals where different blood transfusion methods were applied. Haemotherapy and haemovigilance committee (HHC) was created to ensure the correct functioning of the blood transfusion practice with the aim to defi ne the transfusion procedure, the haemovigilance records and incidences and the continuing staff training.Aim To assess the results of the measures promoted by HHC to ensure the safety of the transfusion practice.Methods Since the opening, continuous evaluation of the transfusion process have been made by trimestral checks of 100 transfusion practice samples, reviewing the transfusion request form, the hemodynamic and transfusion reaction control sheet, the delay in the blood transfusion start, the duration of the transfusion and the correct verifi cation of the ABO blood group at the patient's. The results in 2010 enabled the detection of the weak points, leading to the implementation of the following measures: 1) Blood transfusion safety sessions; 2) Leafl et describing the steps to follow during the blood transfusion and what to do in front of adverse event; 3) Posters about blood transfusion safety installed in the treatment room.Results Improvements have been verifi ed from 2010 up to 2013: 1) 99% of hemodynamic and transfusion reaction control sheet correctly fi lled vs 96% in 2010; 2) 84% of ABO blood group correctly done vs 34% in 2010; 3) 80% of transfusion request forms correctly fi lled vs 50% in 2010. The average time delay and the duration of the transfusion have not presented any signifi cant change.Conclusion The continuing training and the easy and quick access to the information through visual means and the constant evaluation of the blood transfusion process are essential to maintain the safety levels and to identify the steps that shall be improved in the overall blood transfusion chain.

P-2-16TRANSFUSION ERRORS, A FOUR YEAR REPORT GRUPO DE HEMOVIGILANCIA DEL PRINCIPADO DE ASTURIAS (GHAS) SPAIN Fernandez Alvarez C.1, Garcia Gala J.M.2, Martínez Revuelta E.2, Martínez Turrillas C.3, Bernardo Alvarez A.4

1Hospital de Cabueñes, Gijón; 2Hospital Central de Asturias, Oviedo; 3Centro Comunitario de Sangre y Tejidos de Asturias, Oviedo; 4Hospital Cruz Roja, Gijón, Spain

Background Asturias is a Spanish region with a population of over 1 million inhabitants. Thirteen hospitals, all of them having standard operating procedures, participate in the Haemovigilance Group with a common reporting system. Our aim was to analyse transfusion errors reported to GHAS in a 4 year period (2010-2013). Methods All errors reported were reviewed. The following items were assessed: patient gender and age, hospital area and staff involved, error category, causes and patient outcome. Results A total of 212,953 blood components were transfused and 19 errors were notifi ed. Patients characteristics: 12 male, 7 female, mean age 67.1 (34-90). Hospital area in which the error occurred: ward 15; emergency room 1; operation theatre 1. Staff involved: ward nurses 5, transfusion service nurses 9; transfusion service technician 1; physicians 3. Error categories, clinical consequences and patient outcome are shown in Table I. The likelihood of an error occurring was 1/11,208 delivered blood components. An error involving the administration of a wrong component or the transfusion of a recipient other than the intended one was observed in 1/35,492, being ABO incompatible 1/33,013 red blood components transfused.Conclusions This study gives us a scope on the transfusion safety in our region. We identifi ed that the weakest points in the transfusion chain were: sampling collection and recipient identifi cation. It is remarkable that 40% of the errors resulted in a patient receiving a component not clinically indicated, based on wrong analytical results (diluted samples, out dated results and laboratory errors). Despite of having applied corrective actions the transfusion error rate is not decreasing in our region. More regional initiatives, technical and educational, are needed to reinforce transfusion safety.

Table I

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P-2-17NEAR- MISS: 5 YEARS OF EXPERIENCE IN A REGIONAL HAEMOVIGILANCE SYSTEMGarcia Gala J.M.1, Martinez Revuelta E.1, Fernandez Alvarez C.1, Muñoz Turillas C.2, Corbillon L.3, Bernardo A.3, Medina Rodriguez J.4, Taboada F.5, Rozada S.6

1Hospital Universitario Central de Asturias, Oviedo; 2Centro Communitario de Sangry y Teidos de Asturias, Oviedo; 3Hospital Cruz Roja, Gijon; 4Hospital San Agustin, Aviles; 5Hospital Carmen y Severo Ochoa, Cangas de Narcea; 6SSCC SESPA, Oviedo, Spain

Background Analysis of near-miss in transfusion allows knowing if there is any deviation from standard operate proceedings (SOP) before an error occurs. Therefore is important to register and analyze this type of events in order to improve transfusion safety. We describe near-miss reported in a regional haemovigilance system during 5 years.Methods We reviewed near-miss reported to our regional haemovigilance system during 2008-2012.Results A total of 266,661 units were transfused during this period. There were 43 near-miss reported. 23 of them (53.5%) were detected during collect of specimen for pretransfusional tests, 10 (23%) were detected in laboratory and 6 of them (14%) affected to prescription.The most frequent near-miss reported was the incorrect use of pre-printed labels (46.5% of all near-miss reported). In 7 cases (16%) there were a clerical mistyped. In 4 cases (9%) prescription were based in an incorrect analysis.Conclusions Use of pre-printed labels is the most frequent near-miss reported so it is important to establish a system for avoiding the use of this type of labels.Another important point are mistyped errors. This could be prevented with a complete informatization of transfusion services Analysis of near-miss allows developing measures in order to improve safety and qualitu in transfusion.

P-2-18TEN YEARS OF A HOSPITAL HAEMOVIGILANCE SYSTEMLopez-Villar O., Nieto-Gonzalez M.J.University Hospital, Salamanca, Spain

Background An haemovigilance system is required by Spanish law since 2005. Two years before, in our institution such a system was initiated. It is not only a legal requirement but also a useful tool to ameliorate the clinical practice and to detect problems that can be afterwards solved. The aim of this study is to show the results of the haemovigilance system in our hospital for a ten year period.Methods From January 2003 until December 2012 the adverse events occurred during or after transfusion of blood components in our institution were collected. After 2004 the offi cial recording sheets provided by the Ministry of Health were used, from that moment the severity and the imputability were recorded. Adverse reactions, incidents and near misses were taken into account. The number of adverse events is related to the number of blood components transfused in order to obtain the percentage and to compare it to the national statistic.Results In this ten year period the total number of blood components that have been transfused in our institution is 169,358. The total number of adverse events is 572 (0.33%),

the range of this percentage of adverse events: 0.20-0.40%. The most frequent adverse event type are adverse reactions is 322 (56%). The number of incidents is 88 (15%) and the number of near misses is 162 (28%). 84% of adverse reactions are allergic and febrile non hemolytic reactions. 23% of incidents were related to the fact that patients requiring irradiated red blood cell transfusion have received a non-irradiated component.Conclusions Our hospital haemovigilance system is well established. It is a useful tool to reach a deeper knowledge of our transfusion practice and it helps us to fi nd the steps that require an improvement in the safety of patients.

P-2-19EVALUATION OF THE CLINICAL TRANSFUSION PRACTICES, USING A FEEDBACK REPORTING FORMDo Nascimento M.F.R., Soares F.M.T., Oliveira C., Gomes P.D., Soares M.L., Ferreira J.Hemovida Lda, Lisboa, Portugal

Background and aim Education of in pre-transfusion procedures is essential to avoid the human errors, a frequent cause of serious adverse reactions. After the implementation of these procedures, we used the transfusion feedback reporting form, to evidence that the blood units were transfused to the intended patients, to evaluate the clinical part of the transfusion process.Material and methods The forms received corresponding to the transfusion of Red Blood Cell Concentrates (RBC), in two consecutive months (September-October 2013), in fi ve private hospitals were analysed.Results 1,869 RBC units were transfused and 1,869 (100%) reporting forms were received. Nevertheless, some forms were not totally completed. It was not available 2.5% (48) of the period of time between the reception of the unit and the beginning of the transfusion; 0.85% (16) of the verifi cation of the units conditions as well as the conformity of the blood group of the units with the blood group of the patient; 0.8% (15) of the patients' basic vital parameters before, during and after the transfusion and 2.03% (38) of the duration of the blood transfusion.From the available data, 75.2% of the units started to be transfused within the fi rst hour after arriving to the ward; in 98.8% the integrity of the unit and the conformity of the blood group with the patient blood group were verifi ed; in 98.7% the patient basic vital parameters were assessed and 97.9% of the RBC units were transfused in less than 4 hour. During this period 3 adverse reactions were reported.Conclusion The users recognised the importance of the feedback reporting form. Time between the reception and the start of transfusion shall decrease. The education and training sessions shall continue to achieve better results.

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P-2-20EVALUATION OF THE EXTERNAL QUALITY CONTROL PROGRAM (EQCP) IN MEXICAN BLOOD BANKSRojo-Medina J., Ibáñez-Cervantes G., Fernández-Sánchez V.Centro Nacional de la Transfusión Sanguínea, Mexico City, Mexico

Background The NCBT applies twice a year an EQCP in the 559 blood banks of the country. Objective To assess the prevalence rate of false negative (FNR) and false positive results (FPR) for the mandatory serologic tests. Methods The percentage of FPR and FNR reported from the blood banks of the country were evaluated in 2012.Results Only 366 (73%) blood banks participated, with 12.86% FPR, 21. 89%FNR for HBV; T. pallidum 15.15% FPR and 9.5% FNR; T. cruzi 2.42% FPR and 3.24% FNR, HIV 6.72% FPR and 3.45% FNR; HCV 1.35% FPR and 5.03% FNR. Conclusions There is a correlation with the decrease of HIV with supported clinic evaluation of replacement blood donors. The vaccination for hepatitis B has a correlation with the decrease in its prevalence in the last years. The HCV results correlate with the increasing of reported cases. An increase in FNR in Syphilis and Chagas tests were observed, this was related to the use of rapid tests. For syphilis, 66% FNR were reported by private banks. The banks that reported more erroneous results were from Baja California State and Mexico City, which correlates with the highest number of reported syphilis cases. As for Chagas, 65%FNR were from public banks, attributed to diverse methods or commercial kits used; screening was not mandatory on that period and was usually not carried out. The state with more erroneous results was Michoacán (one of the states with highest number of cases) and Mexico City where blood banks are mostly concentrated. The NCBT informs the results to the blood banks with recommendations. The upgrade of regulatory policies in Mexico in December 2012, establishes the participation in the EQCP and the T. cruzi screening as mandatory, so for the coming year a 100% of participation is expected. Further studies should be done in order to compare the different screening tests.

P-2-21ESTABLISHING RED BLOOD CELL QUALITY THROUGH MEMBRANE MECHANICAL FRAGILITYTarasev M., Chakraborty S., Alfano K.Blaze Medical Devices, Ann arbor, MI, United States of America

Introduction Logistically-necessitated storage times (ST) and associated storage lesion can result in reduced RBC effi cacy, particularly dangerous for massively transfused and chronic anemia patients. Today's blood inventory management makes ST the de-facto metric of blood quality. However, RBC units' effi cacy may vary due to various time-independent factors. Mechanical Fragility (MF) of RBC can potentially provide a more physiologically relevant metric. Unlike auto-hemolysis, MF refl ects sub-lethal cell damage and could be more relevant to cells performance in vivo. It was shown previously to vary signifi cantly, and to be largely independent of ST even for units from similar donors.Methods Mechanical stress was applied using a bead mill with oscillation at 50Hz over durations varying from 0.5 to 60 minutes. Packed RBC samples were tested in AS3 storage medium supplemented when necessary with 40g/L albumin. MF profi les were described in terms of percent hemolysis following stresses of specifi ed durations.

Results MF varied among RBC units, with anticipated in-vivo cell survival dependent on chemical environment. Albumin was shown to decrease, and fatty-acids (in plasma) to increase, RBC MF. Incubation with methyl-b-cyclodextrin or diamide resulted in higher MF. Incubation at temperatures from 4 to 45 oC did not result in changes of MF, however MF increased signifi cantly at 48-50 oC with elevated auto-hemolysis at 50 oC but not 48 oC. Conclusions These fi ndings indicate potential sensitivity of this testing method, and illustrate that sub-lethal membrane damage and damage responsible for auto-hemolysis are not necessary well correlated. Together with previously published data on unit-to-unit RBC variability, these results suggest MF as an alternative metric for assessing RBC effi cacy - to be clinically verifi ed. Overall effi cacy increase, previously modelled at up to 15% if applied to inventory management, could potentially translate to fewer units transfused in multi-unit transfusions and longer intervals between transfusions for chronic anemia patients.

P-2-22NATIONAL SURVEY OF QUALITY INDICATORS FOR THE HOSPITAL TRANSFUSION CHAINZijlker-Jansen P.Y.1, Janssen M.P.2, Wiersum-Osselton J.C.1

1TRIP National Hemovigilance and Biovigilance office, The Hague; 2Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht, The Netherlands

Background and aim The revised 2011 Dutch blood transfusion guideline published quality indicators for the hospital transfusion chain. These seven quality indicators (4 structural and 3 process indicators) aim to measure guideline compliance with regard to organisational aspects of transfusion safety, observance of transfusion triggers and mandatory traceability of blood components.Method By means of an online password protected form a national voluntary survey of indicators was conducted in all Dutch hospitals in 2011 and 2012. In 2012, additional questions focussed on the practical administrative traceability procedure in the hospitals.Results In 2012 78% of all Dutch hospitals (76/98) responded (2011: 78/100). Of these, 96% had instated a transfusion committee and 89% employed a transfusion safety offi cer. However, only 23% of these complied both with the recommended minimum of four annual transfusion committee meetings and 8 hours' weekly employment of a transfusion safety offi cer. The ability to generate process indicator data using laboratory information systems varied widely and did not correlate with the actual provision of data. Of responding hospitals, 38-54% provided data for one or more of the process indicators. Of responding hospitals 90% met the indicator for red cell transfusion in >80% of their transfusions. The indicator regarding platelet transfusion showed wide variation, 42% of hospitals had a compliance of less than 80%. Complete traceability of transfusions was achieved by 24% of responding hospitals. Proper administrative procedures for recording traceability were in place in 33% of responding hospitals whereas 16% merely assumed that issued blood components had been transfused if they were not returned. Results for 2011 were largely comparable.Conclusion It is feasible to monitor aspects of the hospital transfusion chain and transfusion guideline compliance in a nationwide survey. The results can be used for (inter)national benchmarking of blood transfusion practice.

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P-2-23SUCCESFULLY IMPLEMENTATION OF A PROGRAME TO REDUCE ALLOGENIC BLOOD TRANSFUSION IN TOTAL KNEE ARTHROPLASTY Asbert R., Morales M., Anglès F., Alvarez del Castillo M.Hospital Universitari Mútua Terrassa, Terrassa, Spain

Allogenic blood transfusion (ABT) is a scarce and expensive therapy associated with immunological effects, infectious transmission and allergic reactions, but multiple surgical treatments need blood transfusion.Total knee and hip arthroplasties are common surgical procedures by long life expectancy of our citizens and high quality of life.Total Knee Arthroplasty (TKA) is a procedure associated with important blood loss. The optimum strategy for reducing Allogenic Blood Transfusion (ABT) is not established. Preoperative Haemoglobin (Hb) value is the most important predictive factor for ABT. We implemented a programme to reduce allogenic blood transfusion in TKA.We compared transfusional rate, volume and stay in hospital as a quality programme developed in three steps.Patients were distributed in four groups with regard to their preoperative Hb value and received preoperative treatment with iron and /or erythropoietin to increase preoperative Hb level. Minimally invasive surgical techniques, and the use of antifi brinolitic drugs improve the process.Multidisciplinary teamwork between staff, nursing and physician and hospital management from preoperative time til the postoperative period, results in a successfully implementation of the programme.Haemoglobin and haematocrit value was obtained in preoperative period before and after treatment and in the early postoperative period, fi rst day after surgery and discharge day. We analysed this data and we compared among the groups.Results We included seven hundred and thirty-six consecutive patients in the program. One hundred and twenty-seven patients were included in Control Group, four hundred and thirty eight in treatment group, and one hundred and seventy-one in tranexamic group. We didn't record any adverse effect due to the treatment.Conclusions The progressive implementation of a programme to reduce allogenic blood transfusion with iron iv, rhEPO and tranexamic acid has diminished the transfusional rate in 45.6%, the transfusional volume in 45.7% and the duration of hospital stay in 2,7 days, without adverse effects.

P-2-24APPROPRIATENESS OF RED CELL USAGE IN MATER DEI HOSPITAL, MALTABorg-Aquilina D.1, Attard D.2, Scerri R.1, Laspina S.2

1National Blood Transfusion Service, G'mangia; 2Mater Dei Hospital Blood Bank, Msida, Malta

Background Mater Dei Hospital (MDH) is the major public hospital in Malta, catering for the absolute majority of transfusions in the country. The aim of this audit is to obtain a more realistic picture of the appropriateness of red cell (RC) usage.Methodology Data collection was performed by tracking all units issued by the MDH blood bank from the period 10th June till 10th August, 2013, and looking up the relevant information in patientfi les. Data was collected in episodes, i.e. number of units transfused before the next haemoglobin (Hb) check

or within 24 hours. Data was analysed using a spreadsheet program. Neonatal and paediatric transfusions were omitted as numbers were too small forsignifi cant results. An appropriate trigger for transfusion was deduced according to Hb level,age, comorbidities, acute blood loss and symptoms of anaemia. A patient was deemed to beovertransfused when the post-Hb level (taken within 24 hours of transfusion) was more than 2g/dL above the appropriate transfusion trigger.Results To date 68% of data has been collected (719 episodes analysed). Gender distribution of RC transfusions was 48% to males and 52% to females, with over 70% of transfusions taking place in patients older than 60 years. Two units RC were transfused in 343 episodes. 21% oftransfusions were found to be not appropriate according to the pre-defi ned criteria, and 24% of patients were overtransfused. 27% of patients had no post-transfusion Hb check within 24 hours of transfusion.Conclusion The above fi gures show that considerable amounts of transfusion are inappropriate and consequently patients overtransfused. A substantial amount of patients had no post-transfusion Hb check, thus the fi gure for overtransfusion is possibly higher. These fi ndings highlight signifi cant differences in practices between specialties. This audit will thus serve as an educational tool for hospital physicians as well as a benchmark for future audits.

P-2-25THE ONGOING VARIABILITY IN BLOOD TRANSFUSION PRACTICES: ANYTHING TO DO?Bosch M.A.1, Ortiz P.1, Pereira A.2, Carrion J.1, Lopez I.1, Argelagues E.1, Castella D.1, Centerdirectors Board1, Puig L.L.11Banc de Sang i Teixits de Catalunya, Barcelona; 2Hospital Clinic, Barcelona, Spain

Background Blood utilization has been under considerable scrutiny for many years. Variability in transfusion practice has led to recommendations regarding standardization within countries. However, big differences in clinical blood utilization rates still remain.Aims To compare the blood transfusion practices in the major hospitals of our region, as the fi rst step of the Optimal Use of Blood Program.Methods Patient-specifi c transfusion data from 10 hospitals were linked within the national database of hospital inpatient episode data (CMBD), by patient ID and both transfusion and discharge dates. 221,968 inpatient episodes and 205,376 blood components transfused were included. Transfusion rates were calculated for each Diagnostic Related Group (DRG). Detailed analysis for some surgical procedures such as hip replacement (HipR), Total knee arthroplasty (Tknee A), Cardiac surgery (CVS), and Gastrointestinal bleeding (GI) were made.Results Transfusion rate variability is found between centers for each clinical condition studied. (Table I): the probability of being transfused for patients' ongoing hip replacement range from 26% to 65%; 9 to 27% for total knee arthroplasty and 62-90% for cardiovascular surgery. Fewer differences were found in the average of number of units transfused in every condition: average of 2,1-2,7 RBC in hip replacement, 1,6-2,4 RCB in total knee arthroplasty and 3,3 to 9,2 RBC units in cardiac surgery.Conclusion Knowing the transfusion rate (probability to be transfused) for the main clinical conditions is a useful tool to make progress in optimal use of blood. Benchmarking allows

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identifi ng the best practices as well as the "out-layers". Optimal use of blood should begin by studying the reasons for the variability (why do we transfuse?) and monitor and manage the effectiveness of the interventions applied.

P-2-27E.U. OPTIMAL BLOOD USE PROJECT IN CLINICAL HAEMATOLOGY: AN INITIAL APPROACH TO THE SAFE, EFFECTIVE AND EFFICIENT USE OF PLATELETSLopez S., Johansson B., Ferraro P., Ancochea S., Raya H., Carrasco R., Besses R.Hospital del Mar, Barcelona, Spain

Background The health authority distributed the "U.E. Optimal Blood Use" manual to hospital transfusion services in 2012.Aims As a starter application, we measured safety, effectiveness and effi ciency in platelet transfusion.Methods In a 400-bed hospital, the Hospital Transfusion Committee implemented platelet transfusion guidelines in 2008. The standard platelet product was the pre-storage leucodepleted pool of 4 donations. A computer physician order entry system (CPOE) was available from 2008. We reviewed utilization analyzing all consecutive requests of platelets from the Clinical Haematology service in the database from January 2012 to December 2013. We studied safety ("frequency of adverse reactions, incidents, and appropriateness"), effectiveness ("presence of 1h. posttransfusion counts"), and effi ciency ("frequency of prophylactic platelet double doses in compliance with the guidelines").Results We analysed 392 platelet requests for a total 579 platelet pools transfused. Most (75%) corresponded to prophylactic indications, 20% to pre-invasive procedures, and 5% to active haemorrhage. Safety: 11 transfusion reactions were recorded (11 per 579 pools, 0,2%), all with severity grade 1. One near miss and no incidents were reported. The indication of platelets was appropriate in 68% of pre-invasive procedures, 85% of prophylactic transfusions, and 100% of active bleeding requests. Effectiveness: 2,6% of patients had 1 hour post transfusion platelet counts. Effi ciency: in 59% of the prophylactic requests, haematologists prescribed elevated doses of platelets (2 units). Patient's body weight was stated in 38% of the requests. Some (young) haematologists prescribed a single unit in 90% of their requests, while other (senior) doctors requested almost always a double dose (90% of their requests).Conclusions All patients should have their body weight recorded and available for prescription. A certain degree of variability in prescription among haematologists, leading to overtransfusion, should be addressed. The haemovigilance offi cer could develop a routine strategy to assess effectiveness in platelet transfusion.

P-2-28COMPLICATIONS OF THERAPEUTIC PLASMA EXCHANGE IN LIVER DISEASE PATIENTSBajpai M., Rajani P., Daman R.Institute of Liver and Biliary Sciences, New Delhi, India

Background Therapeutic plasma exchange (TPE) is used as a bridging modality in acute liver failure. The risk of complications is much higher in patients with liver disease as these patients have underlying coagulopathy. They usually have deranged renal function and dysregulated calcium (Ca++) metabolism.Aims To study and analyze complications/ adverse events during TPE in liver disease patients to understand the adverse events and take precautions to reduce them and manage the complications in a better manner.Methods A retrospective compilation and analysis of data on complications/adverse events during TPE in liver disease patients was done over a period of 3 years.

Table I - Transfusion rates per Diagnostic Related Group (Transfused discharges %).

P-2-26RATIONALE CLINICAL USE OF BLOOD IN A TERTIARY HEALTH CENTER IN A DEVELOPING COUNTRYFasola F.A., Shokunbi W.A.College of Medicine, University of Ibadan, Ibadan, Nigeria

Background Blood safety is still a major concern of developing countries particularly in the African Region and emphasis is often on transfusion transmissible infection because of their prevalence. However, audits of practice also indicate that poor hospital transfusion practice is frequent. Therefore a pilot study was carried out.Aim to assess the blood utilization and appropriateness in transfusion practice.Methodology: A prospective study was conducted in a hospital based blood bank. Questionnaires were used to assess the prescribers' transfusion practice in line with the response of the blood bank in terms of how the requests were handled.Results A total of 116 units of blood and blood products were transfused to 60 patients, of which 103 (88.8%) and 13 (11.2%) were from homologous and autologous donors respectively. The main reason for transfusion was anaemia in 43.3% who had a pre -transfusion packed cell volume (PCV) of 15% or less with 10% having a PCV of 30% or more. The average pre -transfusion PCV was 19.7%.The response of the blood bank to blood prescription shows that 2/3 of the request for packed cells received packed cells while the remaining 1/3 were given whole blood. All the request for fresh frozen plasma were met but half of the request for platelet concentrate and cryoprecipitate received fresh whole blood respectively due to breakdown of the cold centrifuge. Thirteen units of blood issued were returned because surgery was with minimal blood loss (30%), excess of need (45%), blood transfusion reaction (15%) and no response for 10%.Conclusion In view of the perennial shortage of blood, training of blood prescribers in rationale clinical use of blood will reduce unnecessary crossmatching and issuing of blood. Back up equipment in the blood bank when available one breaks down will foster judicious use of the limited blood supply.

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Results During the study period from January 2011 to December 2013 over 33 TPE were done on 16 patients. The underlying diagnosis was acute on chronic liver failure in 5 patients, acute liver failure in 3 patients, Wilson's disease in 2 patients, acute hyperlipidemic pancreatitis in 2 patients and other liver diseases in two patients. During the work-up prior to TPE, 9 of the patients had low platelets (platelet count below 50,000) while 10 patients had an INR (international normalized ratio) above 1.5 (range 1.6 to 4.12). Three patients had Ca++ below 1.15 mmols/L. All procedures were done in the Intensive care unit setting. During the procedure 10 patients had low plasma Ca++ and were given intravenous Ca gluconate. Eight patients had signs of cardiovascular instability such as fl uctuating blood pressure or alterations in heart rate. Fluid overloading was also a signifi cant complication in these patients due to a precarious fl uid balance.Conclusion Liver disease patients are high risk patients as far as TPE is considered due to the inherent risks associated with their underlying condition. They require intensive monitoring during TPE procedure with an emphasis on Ca++ levels and extra precautions regarding coagulation and fl uid status.

P-2-29QUALITY MANAGEMENT IN IMMUNOLOGY AND TRASFUSION MEDICINEBove M.Azienda Ospedaliera Sant'Andrea, Roma, Italy

In Italy, the State-Regions Agreement 16.12.2010 decides about the organizational, structural and technological health activities of the Transfusion Services. The management has therefore organized an internal auditing programme (UNI EN ISO 19011:2012, Guidelines for auditing management systems) in the period June-July/2013 to carry out the fi rst checks on the transfusion activities. In the same period through (July 8-7 September 2013) organizational changes. The agreement at point 3.1 issues that there "should be a documented system to keep track of changes that may be introduced in the process of collection…" In our SIT, in fact, there is not a place for the collection of blood and a space dedicated to delivery of therapeutic treatments, but the various activities are spread throughout the day. In this way the same room used for donors in the morning in the afternoon is dedicated to the activities of transfusion medicine (section structural requirements: 3.3 and 3.10 of the agreement). During the summer the changes introduced have interrupted service accessibility in the afternoon hours, and the distributing all the health activities in the morning hours. During this period there have been 24 episodes in which donors and patients were cared for at the same time. Donors were subjected to donation simultaneously with 15 patients undergoing therapeutic apheresis, 5 patients at therapeutic phlebotomy and 4 patients in autologous blood sampling. Fortunately, during the 24 episodes only 2 patients undergoing therapeutic to apheresis showed mild complications. In the audit performed in July at the audite representatives' site, this evidence has not been mentioned (P.6.4.4). In conclusion, the lack of adequate space in our SIT makes it diffi cult to organize activities in general, which must include foresight. Any change must therefore be assessed in an appropriate way, the risks must be meticulously recorded and reported in detail to the staff.

P-2-30INCIDENCE AND CHARACTERISTICS OF SERIOUS ADVERSE EFECTS (SAES) RELATED TO TRANSFUSIONSCarpio N., Solves P., Vaquero I., Balaguer A., Moscardo F., Lujano M., Sanz M.A.La Fe University Hospital, Valencia, Spain

Background Blood component transfusion can lead to undesirable side effects ranging from mild complications to life-threatening reactions. Data from serious adverse events related to transfusion are required to implement preventive strategies. Aim The aim of this study is to analyze the serious adverse events after blood component transfusions.Materials and methods Between January 2000 and December 2013 all side effects related to transfusions were recorded. The adverse events were analyzed according to the severity and their relationship to transfusions. The following side effects were analyzed: long term-morbidity (severity 2), direct life-threatening (severity 3) or death (severity 4) and that could be explained by the transfusion procedure (grade 2 association) or the transfusion was the defi nitive cause (grade 3 association).Results During the analyzed period, 506,144 blood components, (329,583 red blood cell, 106,298 platelets and 40,263 fresh frozen plasmas) were transfused. The incidence of serious adverse events was 0.01%. The incidence of SAEs was higher for platelet transfusions as compared to red blood cell transfusions (P<0.00005). The type of SAEs and blood components are showed in the Table I below.The majority of SAEs (77%) were of grade 2 severity. Three cases were grade 3 severity and four patients died due to TRALY (2), septic shock, and CMV infection. The mortality rate was of 0.0007% (1/126,536 component transfused).Conclusion The incidence of SAEs is low and the mortality is related to platelet transfusion. Control of platelet transfusion indications is important to reduce transfusion related mortality.

Table I

Table I

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P-2-31TRANSFUSION RELATED ACUTE LUNG INJURY (TRALI) BEFORE AND AFTER IMPLEMENTATION OF PREVENTIVE MEASURE IN SWITZERLANDJutzi M.P., Amsler L.Swissmedic, Bern, Switzerland Background To prevent TRALI, the production of quarantine-fresh-frozen-plasma (qFFP) in Switzerland was restricted in 2007 to donations from men or from women never having been pregnant or tested negative for anti-human-leukocyte-antigen-I/II/human-neutrophil-antigen-Antibodies (Anti-HLAI ⁄ II ⁄HNA-Antibodies)1.Aims To compare TRALI-frequency before and after implementation of the preventive measure.Methods Based on units issued and adverse events reported, we compare TRALI-occurrence in Switzerland for the periods 2002-2007 and 2008-2012.Results Previous to the implementation of specifi c selection criteria for donors of plasma for transfusion to prevent TRALI in recipients, 2.373 million blood components, including 435,000 units of FFP were issued in Switzerland between 2002 and 2007. Twenty-eight reports of TRALI, 22 following transfusions that included plasma, were received. Ten cases were considered proven or probable TRALI, whereas 11 were categorised as possible TRALI and 1 report did not meet the criteria for TRALI. Between 2008 and 2012, among 1.993 million blood components, 298,000 qFFP were issued and 14 cases of TRALI were reported. Two of the three cases following plasma transfusions were proven/probable, the third a possible TRALI. Total reporting frequencies for TRALI amount to approximately 1:85,000 and 1:140,000 respectively and the occurrence of TRALI possibly attributable to plasma transfusion was of 1:20,000 and 1:100,000 units at most. When excluding possible cases, the risk for TRALI due to plasma transfusion decreased from 1:45,000 to 1:150,000 qFFP after implementation of preventive measures. Conversely, TRALI after transfusion of blood components other than plasma was reported more frequently (1:155,000) after implementation of the prevention strategy than before (1:325,000).Summary/Conclusion Our fi gures support effectiveness of the described prevention strategy. Given the higher TRALI rate in the second period for transfusions other than plasma, underreporting causing the observed decrease in plasma-related TRALI seems unlikely.

P-2-32THE INCIDENCE OF ALLERGIC REACTIONS WITH METHYLENE BLUE TREATED PLASMA.A FIVE-YEAR EUROPEAN RETROSPECTIVE STUDYLarrea L.1, Castrillo A.1, Politis C.2, Nussbaumer W.3

1Centro de Transfusion de Galicia, Valencia, Spain; 2Coordinating Haemovigilance Centre, Athens, Greece; 3Central Institute for Blood Transfusion and Department of Immunology, University, Innsbruck, Austria

Background The main objective of this study was to evaluate the safety of Plasma photoinactivated with Methylene Blue (THERAFLEX MB-Plasma system), assessing the incidence of Allergic Adverse Reactions (AAR) registered in some countries, over the period 2007-2011.Methods The number of transfused units, AAR, severity grade, year and country were retrospectively collected from different

haemovigilance reports: in Spain, Centro de Transfusión de Galicia and Centro de Transfusión de la Comunidad Valenciana; in Greece, the Oral Communication by Prof Dr C Politis et al., presented at the IPFA/PEI 19th International Workshop 2012 - Budapest, Hungary; in Austria, from the Central Institute for Blood Transfusion, University Clinic of Innsbruck; from the United Kingdom, the Serious Hazards of Transfusion Annual Reports; the Agence Fédérale des Médicaments et des Produits de Santé (AFMPS) of Belgium and the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM, previously Afssaps) of France.Results A total sample of 1,547,105 units was evaluated from six European countries. The incidence of AAR remained proportional to the transfused units per year. In France, the rate of Grade 3-4 AAR was signifi cantly higher than expected in 2008 and 2009 compared to 2011 (p<0.05); that kind of differences were not found in any other country. The rates of AAR Grade 3-4 rates reported from 2007 to 2011 in the different countries were signifi cantly higher in France (7.6/100,000 units) than in Greece, Spain and Belgium (0-2.8/100,000 units). When the 2007 year data were excluded from the analysis, the AAR rates comparisons were maintained signifi cantly higher in France than in Greece, Spain and Belgium. Conclusion The incidence of Allergic/anaphylactic Adverse Reactions were signifi cantly more frequent in France than in the other countries, being signifi cantly higher than expected in 2008 and 2009.

P-2-33INTERFERENCE TEST IMMUNOHAEMATOLOGICAL FOR THE DETECTION OF ANTIBODIES TO HIV 1/2: ANALYSIS OF A CLINICAL CASEMininni V., Bencivenga L., Giaquinto A., Mottola M.M., Zuccarelli B.A.O.R.N. Ospedali dei Colli, Napoli, Italy

Background On 13 November 2013 a sample of blood was sent to our SIT from the cardiac surgery department of A. O. Monaldi within the blood transfusion safety program which requires presurgery serological tests.Aims The sample has tested positive for HIV 1/2 performed on the instrument Vitros ECiQ Immunodiagnostic System (Ortho Clinical Diagnostic), immunometric method, with a value of 4.64 (positive>1.0). From patient anamnesis, aged 65, are deduced two myocardial infarctions in 2010 and 2013 treated with percutaneous coronary intervention, a chronic obstructive pulmonary disease, diabetes mellitus II, dyslipidemia, hypertension, not precised drug allergies. No other diseases are reported to occur in other organs. Furthermore, the patient reports having received the fl u vaccine in late October.Methods Further investigations were needed at the hospital Cotugno in Naples. On the sample of serum, HIV testing bioMerieux VIDAS method ELFA (Enzyme Linked Fluorescent Assay) for detecting HIV p24 Ag, as well as for anti-Ab HIV 1+2 was carried out. The test gave a negative result. As from the protocol, the confi rmation test RIBA HIV 1+2 (Inno-Lia HIV 1/2 Score) with immunoblot assay on the strip, for the detection of anti-HIV 1+2 Ab:gp120, gp41,HIV-2 peptide, p31, gp 24/p26 has followed. The confi rmation test was negative as well.Results In the present case, given the discrepancy in results between the two instruments, positive on Vitros ECiQ and negative on VIDAS, a further explanatory investigation

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was necessary which experts identifi ed in the immuno-blot technique. Testing in our case gave negative result, therefore excluding the possibility of an actual infection by HIV virus.Conclusion Among the tests for the detection of HIV, the ELISA method can give false positive results while the RIBA test has a greater specifi city. Concerning our patient,we can assume that the fl u vaccine administered approximately two weeks before the test may have infl uenced the outcome and that a transient false positive could be related to the presence of IgM present in the circulation in response to the vaccine.

P-2-34HEMOVIGILANCE ANALYSIS OF INTERCEPT TREATED VERSUS NON TREATED PLATELETS IN TWO GENERAL HOSPITALS 2008-2013Pajares Herraiz A.L.1, Barea Garcia M.L.1, Eguia Lopez B.1, Solano Ramos F.2, Flores Sanz M.V.1

1Centro Regional de Transfusion Castilla La Mancha Área Toledo-Guadalajara, Toledo; 2Hospital Nuestra Señora del Prado, Talavera, Spain

Background Hemovigilance studies have shown that the treatment of platelet concentrates (PC) with amotosalen and UVA light (PCA) in the INTERCEPT process is associated with decreased in the frequencies of Adverse Transfusion Reactions (ATR).Aim To compare the rate of ATR of PCA vs non treated PC (PCN) in two hospitals of our county and to compare ATR frequencies with previously published data.Methods We performed a retrospective analysis of Hemovigilance data for all reports on transfused platelet concentrates between January 2008 and October 2013. Data were registered in a data base according to Spanish Hemovigilance System requirements. Statistics were performed utilizing SPSS for p-values (from Fisher's exact Test).Results In the study period, 11,483 PC were transfused, (1,568 PCA (13.65%)). Table I shows that ATR were reported for 31 patients, all of them receiving PCN: 19 men (age of 64.6 ±18.3) and 12 women (60.33±18.8). 97% had a transfusion background with only 3 patients without such background (2 men,1 woman). 42% of women with ATR had previous obstetric records. 3 of 31 ATR (9.67%) were severe, 1 shock and 2 angioneurotic edemas, none of them fatal. Not a single ATR was reported for the PCA group giving a statistical difference between PCN and PCA with a p-value of 0.017. No documented cases of transfusion-related sepsis or any other transfusion-transmitted infection was reported.. Of the ATR 48.2 % were allergic, 22.3% febrile, 23% hypotensive and 6.5% anaphylactic or hipersensitivity reactionsConclusion Treatment of PC with the INTERCEPT system has been shown to be safe and to be associated with decreased rates of ATR. The overall rate of ATR was lower than in other studies probably due to aslight underreporting and a not yet optimal hemovigilance program in our hospitals.

P-2-35VASOVAGAL ADVERSE REACTIONS IN BLOOD DONORS: A TEN YEAR EXPERIENCE IN A SINGLE BRAZILIAN CENTERAmorim L.M.A.F., Ferreira N.A., Lopes M.E.D.HEMORIO, Rio de janeiro, Brazil

Background Surveillance of adverse donor reactions is now part of the global hemovigilance system. It represents a step ahead on the protection of blood donors, contributing to prevent this complication. Aims The aim of this study is to present a ten year survey of vasovagal reactions in whole blood donors in a single center and to evaluate the main risk factors leading the donors to present this problem. Methods We reviewed the electronic fi les of 850,000 blood donors (who donated from January 2004 through December 2013), searching for vasovagal reactions reports. The reactions were divided according to the type of symptoms and to the severity. We then correlated the frequency of these reactions to some risk factors: gender, age and season of donation. Results There were 840,000 whole blood donations during the study period; 4,851 (0.58%) out of these donors presented per and/or post donation symptoms due to a vasovagal reactions. These donors presented the following symptoms: fainting (1,237, or 25.5% of vasovagal reactions), pallor (1,632 or 33.6%), dizziness (1,026 or 21.1%) abnormal sweating (567 or 11.7%), nausea (271 or 5.59%), hypotension (194 or 4%) and vomiting (122 or 2.51%). 1,553 reactions were classifi ed as severe (32% of vasovagal reactions and 0.18% of all blood donations). The risk for this vasovagal reaction was associated with male gender (p<0.05), age (donors aged with less 30 years old having a statistically signifi cant greater risk, p<0.01, and donors older than 60 years bearing the lesser risk, p<0.01). The season where the donation was done had no infl uence on the incidence of vasovagal reactions. Conclusions Our study was one of the fi rst studies to show the symptoms of vasovagal reactions in a very large set of donors; it did confi rm some previous reports about risk factors for vagal reactions in blood donors.

P-2-36POOLED SOLVENT-DETERGENT PLASMA IS ASSOCIATED WITH FEWER TRANSFUSION REACTIONS THAN STANDARD FRESH FROZEN PLASMATinegate H.N.1, Bolton-Maggs P.2, Ball J.2, Poles D.2

1NHSBT, Newcastle; 2SHOT, Manchester, United Kingdom

Cumulative SHOT (Serious Hazards of Transfusion) haemovigilance data show that allergic reactions, including anaphylaxis, are more frequently seen with plasma transfusions than with red cell transfusions. In the UK, most plasma units are untreated and from male donors, whilst it is standard practice to transfuse individuals born in or after 1996 with imported methylene blue treated plasma. Pooled solvent-detergent plasma (S-D FFP) is recommended by the British Committee for Standards in Haematology (BCSH) for the treatment of thrombotic thrombocytopenic purpura (TTP) in all age groups.SHOT data on acute transfusion reactions (ATRs) from 2010-2012 include fi ve reactions to S-D FFP, 103 to standard plasma and three to cryoprecipitate. Using UK issue data,

Table I - Platelet concentrates.

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the incidence of febrile reactions is shown to be low with both standard and S-D FFP, whilst the incidence of allergic reactions is signifi cantly higher (7.6 reactions/100,000 units issued, 95% CI 6.2-9.3) with standard plasma compared to S-D FFP (2/100,000, 95% CI 0.5-5.2).When interpreting these data, it is important to recognise that clinical indications for standard and S-D FFP differ. S-D FFP is recommended for patients undergoing plasma therapy for TTP, whilst SHOT ATR data show that the majority of patients reacting to standard plasma were being transfused for haemorrhage. The age profi le of recipients reported to SHOT also differs. For SD-FFP cases the median age is 18 years (1-36) whilst for standard plasma and cryoprecipitate it is 50 years (0-90). Nevertheless, our fi gures do suggest that the incidence of allergic and anaphylactic reactions to SD-FFP is signifi cantly reduced compared with standard plasma.

P-2-37ADVERSE EVENTS IN THALASSAEMIA PATIENTS AT THE PAKISTAN INSTITUTE OF MEDICAL SCIENCES, ISLAMABADZaheer H.A., Waheed U.Safe Blood Transfusion Programme, Government of Pakistan, Islamabad, Pakistan

Background Thalassaemia, with a prevalence rate of 5-8%, is a major health care challenge in Pakistan and the biggest consumer of its transfusion services. The transfusion services to the affected patients are provided by the public, private and NGO sector blood banks and hospitals. There are, however, some public sector hospitals which have large Thalassaemia Centers including Pakistan Institute of Medical Sciences (PIMS), Islamabad.Aims The current study was carried out to develop a haemovigilance system and determine the incidence of adverse transfusion reactions occurring at the PIMS Thalassaemia Centre.Methods This prospective study was conducted from June-December 2013, at the Thalassaemia Centre, PIMS, Islamabad. A pre-tested standardized reporting form was used to collect data.Results 5,924 transfusions took place at the Thalassaemia Centre including 3,910 Packed Red Cells, 17,50 FFPs and 264 platelet concentrates. 119 patients suffered a total of 414 immediate transfusion reactions in the seven months and none of the reactions caused death. The reactions included 119 cases (28.7%) of febrile non-haemolytic ATR, 119 cases (28.7%) of allergic rashes, 40 cases (9.66%) of restlessness, 35 cases (8.45%) of cannula blockage, 30 cases (7.24%) of abdominal pain, 27 cases (6.52%) of bruising, 27 cases (6.52%) of hematoma, 15 cases (3.62%) of cold extremities and 2 cases of respiratory distress (0.48%) classifi ed as possible TRALI. In 32 cases, multiple pricks were performed to transfuse and in 65 cases, premedication (Avil/Solocortef) was given. All transfusions were monitored by the doctor or nurse.Conclusion The majority of the patients had suffered with febrile non-haemolytic ATR and allergic reactions. The adverse events observed were generally mild and immediate. The study can serve the purpose of promoting haemovigilance in thalassaemia care set-ups as such Centers are heavily dependent on the support and cooperation of the blood banks.

P-2-38WEST NILE VIRUS (WNV) IN GREECE IN 2010-2013:SURVEILLANCE IN BLOOD DONORS AND HAEMOVIGILANCE FINDINGS IN RECIPIENTS OF BLOOD COMPONENTSPolitis C.1, Pappa A.2, Stamoulis K.3, Hassapopoulou H.4, Varachlioti R.4, Theodossiadis G.4, Richardson C.5, Pervanidou D.1, Dadiotis L.4, Baka A.1, Tsakris A.6, Hatjichristodoulou Ch.71Hellenic Center for Disease Control and Prevention, Athens; 2Reference Laboratory for Arboviruses, Aristoteleion University, Thessaloniki; 3National Blood Centres, Athens;4Blood Transfusion Services, Thessaloniki; 5Panteion University of Social and Political Sciences, Athens; 6Athens University Microbiology Department; 7University of Thessaly, Thessaly, Greece

Background We present the general epidemiological situation of the 4-year WNV outbreak in Greece, which has the highest prevalence in Europe, data on transfusion-related WNV neuroinvasive disease (WNND) and other haemovigilance fi ndings. Methods Enhanced surveillance of WNV infection in humans and animals, comprehensive vector control, and blood safety and haemovigilance measures were implemented. Measures include 28 days' deferral of blood donors who spent at least one night in affected areas, and NAT testing for WNV-RNA with ID-NAT or MP-NAT using respectively Procleix WNV Assay and Cobas Taqscreen WNV test in the affected areas. Results Of 609 laboratory-diagnosed cases in the general population, 71% were WNND including 71 deaths with highest case fatality rate 18.3% in 2010. Sequencing revealed WNV lineage 2 of the Nea Santa - Greece strain containing H 242 P substitution in the NS3 protein.Screening of 192,997 blood units detected 18 positive for WNV-RNA (1:10,722 varying from 1:3,389 in 2010 to 1:24,045 in 2011). Eleven of these donors remained asymptomatic but4 presented with symptoms of non-WNND 1-4 days after donation. Two had concealed high fever, skin rash, headache and malaise around the time of donation. Haemovigilance in 2012 detected one WNND case acquired through transfusion of whole blood derived platelets. A patient suffering from liver failure transfused with plasma derived from the same blood unit was infected but did not develop symptoms. Both transfusions took place before the year's fi rst WNV diagnosis triggered blood safety measures.Discussion-Conclusions Blood safety measures including haemovigilance were very effective. Only one WNNV case in 4 years was associated with the transfusion of an untested blood component. Nevertheless look-back studies in thalassaemic patients in 2010 demonstrated WNV transmission in two patients before the implementation of NAT testing of blood. Both these patients as well as the plasma recipient remained asymptomatic.

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P-2-39INCORRECT BLOOD COMPONENTS TRANSFUSED (IBCT). TWELVE YEARS OF EXPERIENCE AT OUR CENTREBalaguer A., Carpio N., Solves P., Vaquero I.N.M., Moscardo F., Lujano M., Sanz M.A.Hospital La Fe, Valencia, Spain

Background A transfusion is a complex procedure which includes different stages from the blood component request to the transfusion. Mistakes at any level can lead to severe consequences for the patient.Aim The objective of our study is to evaluate the results of our Haemovigilance program in the area of IBCT over a period of 12 years at our institution.Materials and methods All errors implicated in cases of IBCT were in our Haemovigilance program. General transfusion procedures included: patient identifi cation with a wrist band carrying a specifi c code before sample collection, registration using transfusion software, automatic compatibility tests, on-line transmission of the results, component selection and fi nal administration with bedside checking of blood component labels and patient wrist bands. Mistakes were classifi ed according to the transfusion phase and the component implicated. Clinical consequences of all mistakes were analysed.Results Between January 1st 2002 and December 31th 2013, 458,550 blood components were transfused and 142 errors in 132 IBCT were detected (1/3,474). 40% of the mistakes were related to component selection, 26% to bed side transfusions and 24% to the request phase. Table I shows the types of IBCT, their severity and type of component.Conclusion In our Centre cases of IBCT were not severe. Most of the mistakes were related to the selection phase, especially for sending non irradiated components to patients when required and also components without specifi c requirements.

P-2-40TRANSFUSION TRANSMITTED CYTOMEGAROVIRUS (TT-CMV) - SUSPECTED CASES IN JAPANGoto G., Furui Y., Igarashi S., Hino H., Tadokoro K.Japanese Red Cross Society Blood Service Headquarters, Tokyo, Japan

Background CMV infection may cause severe, even fatal disease in immunocompromised patients. The risk of transfusion transmission can be reduced by using CMV seronegative blood or leukodepletion as CMV is latent to leukocytes. Japanese Red Cross Society (JRCS) has been supplying CMV seronegative blood by request from a medical institution since 1991. JRCS then introduced universal leukodepletion in 2007. The national guideline of transfusion medicine also recommends the use of CMV seronegative or leukodepleted blood for patients at risk.Despite these safety measures, suspected TT-CMV cases are reported to JRCS from medical institutions every year.Aims To analyze 22 suspected TT-CMV cases which were reported by medical institutions from January 2004 to September 2013.Methods Information sources are 1) Case Report Forms including recipient's/mother's CMV markers obtained from medical institutions 2) Test results of CMV DNA and CMV antibodies performed by JRCS using repository samples from implicated blood donations and recipients' samples.Results Of all 22 recipients, 18 were preterm infants including 13 extremely low-birth-weight infants (<1,000 g). There was no confi rmed case of TT-CMV from the test results of repository samples from implicated donations. In 21 cases, leukodepleted blood components or bedside leukodepletion fi lters were used. CMV seronegative blood was requested in only one case. CMV markers from the mothers of the recipients were provided only in 6 cases and were all seropositive.Summary/Conclusion There was no confi rmed case of TT-CMV. Most of suspected TT-CMV cases were of extremely or very low-birth-weight infants who received leukodepleted blood without a request of CMV seronegative blood. Following this result, JRCS distributed a leafl et to medical institutions with neonatal intensive care unit to inform that CMV seronegative blood is available on request from medical institutions and CMV seronegative blood should be transfused to very low-birth-weight infants in accordance with the national guideline.

P-2-41AUDIT OF BLOOD REQUEST FORMS AS A TOOL OF HEMOVIGILANCEJunaid A., Ijaz S., Khan M.N., Ahmed M.Shifa International Hospital, Islamabad, Pakistan

Background Physician's requesting document is of utmost importance for appropriate and timely delivery of any blood component. Flawless requesting form is crucial in transfusion chain as it provides, important information about the patient, diagnosis, indication for transfusion and identity of the phlebotomist. Completely fi lled forms also apprise about special needs like irradiation or cell wash. We are working as a hospital transfusion service for a 500 bedded tertiary care facility. The hospital function as huge transplant setup (renal, liver and bone marrow), besides running heavy dialysis service, obstetrics clinics and cardiac bypass surgeries. Specifi c delivery to this varied demand list is only possible if requests are vigilantly

Table I

1RBC: red blood cells; 2FFP: fresh frozen plasma; 3PT: platelets.

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and completely documented. Casual and careless entries would seriously delay or default the supply line.Aims As a part of preventing serious issuance and release mishaps, we planned an internal audit of these request forms, in order to improve requisition and receiving practices.Methods We scrutinized documentation of our requisition forms for 6 consective months (July to December 2013). We chose fi ve parameters as quality indicators including patient's demographics, name & identity of requesting physician and phlebotomist drawing blood specimen for grouping & crossmatch. We also checked the documents for entry of receiving time, date and staff at blood bank.

Results We found out that among patients demographics name and medical record number had 100% compliance but parameters like age and sex showed 62% and 85% entries respectively. 36% of the forms identifi ed the phlebotomist. Patient's blood group was documented on 56% of forms. Complete receiving was documented on 93% of the requests.Conclusion Appropriate and timely counseling of the staff has improved our documentation. Receiving time documentation had major impact on timely processing of the request. We plan to expand our internal audit of issuance documents, as next step of hemovigilance activity.

AUTHORS

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16TH INTERNATIONAL HAEMOVIGILANCE SEMINARAUTHORS


ABD KARIM F. P-1-03ABELA MA P-2-03ADDAS-CARVALHO M. P-1-05AHMED M. P-2-41ALAVA C. P-1-10ALFANO K. P-2-21ALBA BOSCH M. INV-07ALPHEN G. P-1-09ALVAREZ DEL CASTILLO M. P-2-23AMORIM L.M.A.F. P-2-35AMSLER L. P-2-31ANCOCHEA S. P-2-27ANGLÈS F. P-2-23AQUILINA A.A. P-2-03ARANDA A. P-2-15ARGELAGUES-VIDAL E. INV-16ARGELAGUES-VIDAL E. P-2-25ARNOLD E. P-1-16ARRIETA R. INV-02ARUMUGAM A. P-1-25 ARUMUGAM A. P-2-05ASARIOTOU M.A. P-1-23ASBERT R. P-2-23ATTARD D. P-2-24AUBUCHON J.P. O-03AUROY Y. P-2-11AYOB Y. P-1-03BADAWI M. P-1-19BAHILLO RUIZ E. P-2-12BAJPAI M. P-2-28BAKA A. P-2-38BALAGUER A. P-2-14BALAGUER A. P-2-30BALAGUER A. P-2-39BALALI M.B O-04BALIJA M. P-2-01BALL J. INV-40BALL J. P-2-36BAREA GARCIA M.L. P-2-34BATARILO I. P-2-01BEARD P. P-1-16BELL B.M. O-02BENCIVENGA L. P-2-33BENOÎT A.B. P-2-02BERGERS M.S.E. P-1-24BERNARDO A. P-2-08BERNARDO A. P-2-13BERNARDO A. P-2-17BERNARDO ALVAREZ A. P-2-16BERTRAND O. P-2-02BESSES R. P-2-27BIELBY L. P-1-16BIGUZZI R. P-1-06BISHT A. O-09BLANCO PERIS L. P-2-12BOETTI L. P-1-06BOLIBAR I. P-1-01BOLTON-MAGGS P.H.B. INV-40BOLTON-MAGGS P.H.B. O-08BOLTON-MAGGS P.H.B. P-2-36BORG-AQUILINA D. P-2-03BORG-AQUILINA D. P-2-24BOSCH L. INV-16 BOSCH L. P-1-10BOSCH M.A. P-1-01 BOSCH M.A. P-2-25BOVE M. P-1-02 BOVE M. P-2-29BRADY R. P-1-14BRANIGAN B. INV-39BRAVO M. O-01BRAVO M. P-2-04

BRAVO AUGUÉ A. P-1-17BRAVO AUGUÉ A. P-1-20BYRNE D. P-1-14CANO M. P-2-15CÁRDENAS J.M. INV-29CARLIER M. P-2-11CARNEIRO R. P-2-13CARPIO N. INV-19CARPIO N. P-1-04CARPIO N. P-2-14CARPIO N. P-2-30CARPIO N. P-2-39CARRASCO R. P-2-27CARRION J. P-2-25CASTELLA D. INV-16 CASTELLA D. P-2-25CASTRILLO A. P-2-32CATALA P. P-1-01CATALANO C. P-1-08CELLIER N. P-1-26CHAFFE B. O-08CHAKRABORTY S. P-2-21CHAMORRO C. P-2-08CHICCHI R. P-1-06CHIPARE I. P-1-09CIPEK V. P-1-28CODATY J. P-1-25CODATY J. P-2-05COLL N. P-2-10CONDEÇO J. INV-35CONTRERAS-BARBETA E. INV-16CORBILLON L. P-2-08CORBILLON L. P-2-17CORTEL-MAÑÈ G. INV-16CRUZ J.R. INV-22CUSTER B. P-2-04CUSTER B. O-01DADIOTIS L. P-2-38DALMAU C. P-1-01DAMAN R. P-2-28DAMANHOURI A. P-1-19DAVINS M. P-1-10DE LA RUBIA J. INV-25DE VALENSART N. P-1-26DE VOOGHT K.M.K. P-1-24DENEYS V. P-2-02DO NASCIMENTO M.F.R. P-2-19DOMEQUE M. P-1-01EGUIA LOPEZ B. P-2-34ENCARNACAO F. P-1-21ERRAGUNTLA M. O-06ESCOVAL M.A.A. INV-35FACCO G. P-1-08FARANOUSH M.F O-04FASOLA F.A. P-2-26FERNANDEZ ALVAREZ C. INV-04FERNANDEZ ALVAREZ C. P-2-08FERNANDEZ ALVAREZ C. P-2-16FERNANDEZ ALVAREZ C. P-2-17 FERNÁNDEZ CASTRO C. P-2-12FERNÁNDEZ-SÁNCHEZ V. P-2-20FERRARO P. P-2-27FERREIRA J. P-2-19FERREIRA N.A. P-2-35FLORES SANZ M.V. P-2-34FOLLÉA G. INV-13FRANÇA M. P-2-13FUNG M. O-03FURUI Y. P-2-40GARCIA GALA J.M. P-2-08 GARCIA GALA J.M. P-2-16GARCIA GALA J.M. P-2-17

GHOLAM A. P-1-19GIAQUINTO A. P-2-33GILLET P. P-2-02GLAZEBROOK B. P-1-16GLENCROSS H. O-08GOMES P.D. P-2-19GOMEZ F. P-1-10GÓMEZ R. P-2-10GOTO G. P-2-40GOVAERTS B. P-2-02GRACIA BRINQUIS E. P-1-20GRAZZINI G. P-1-08GRIFOLS J.R. INV-10HADAD DEILAMI A. O-04HADJI GUER L. P-1-27HALLER G. P-1-27HARVEY A.R. P-1-18HASSAN R. P-1-03HASSAPOPOULOU H. P-2-38HATJICHRISTODOULOU CH. P-2-38HATZITAKI M.H. P-1-23HEALY S. P-1-14HECIMOVIC A. P-1-28HERNÁNDEZ I. P-2-15HINDAWI I. P-1-19HINO H. P-2-40IBÁÑEZ-CERVANTES G. P-2-20IGARASHI S. P-2-40IJAZ S. P-2-41INGRAM C. P-1-11JALALI FARAHANI F. O-04JANSSEN M.P. P-1-24JANSSEN M.P. P-2-22JIMENEZ-MARCO T. T. INV-18JOHANSSON B. P-2-27JOUSSEMET M. P-2-11JUKIC I. P-1-13JUKIC I. P-1-28JUKIC I. P-2-01JUNAID A. P-2-41JUTZI M.P. P-2-31KAMEL H. P-2-04KAMEL T. O-01KAVALLIEROU L. P-1-23KELLER A.J. O-02KEMPIN S. O-01KHAN M.N. P-2-41KHULUP H. P-1-15KLIMOVICH O. P-1-15KOUMARIANOS, S. P-1-23KUEHNERT M.J. P-1-18LAMBERMONT M. P-1-26LAMBERMONT M. P-2-02LAND J. O-06LARREA L. P-2-32LASPINA S. P-2-24LEDWABA F. P-1-11LEÓN DE GONZALEZ G. INV-03 LEÓN DE GONZALEZ G. INV-21LOHRKE B. P-1-09LOPES M.E.D. P-2-35LOPEZ-VILLAR O. P-2-18LOPEZ I. P-2-25LOPEZ S. P-1-10LOPEZ S. P-2-27LOPEZ V. P-1-10LÓPEZ SOQUES M. INV-05LUJANO M. P-2-30LUJANO M. P-2-39LUJANO S. P-1-04MALASKY J. O-03MARANTIDOU O. P-1-23

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MARINOZZI M. O-05MARTÍNEZ E. P-2-08MARTÍNEZ REVUELTA E. P-2-16MARTÍNEZ TURRILLAS C. P-2-16MARTINIS G. P-1-23MARWAHA N. O-09MASSUET BOSCH L. INV-16MASSUET BOSCH L. P-1-20MAURI HERRERO C. P-1-17MEDINA L. P-1-01MEDINA RODRIGUEZ J. P-2-17MILLAN A. P-2-10MILLER J.P. INV-24MILLER J.P. INV-30MINGO A. P-2-10MININNI V. P-2-33MISTRY H. O-08MOLELI N.K. P-1-11MOORE N. P-2-06MORAL M.V. P-1-01MORALES M. P-2-23MORETTI D. P-1-06MORO E. INV-02MORO E. INV-15MOSCARDO F. P-2-14MOSCARDO F. P-2-30MOSCARDO F. P-2-39MOTTOLA M.M. P-2-33MUÑIZ-DIAZ E. INV-01MUÑIZ-DIAZ E. INV-15MUÑIZ-DIAZ E. INV-16MUÑIZ-DIAZ E. P-1-10 MUÑOZ C. P-1-01MUÑOZ M.C. P-2-08MUÑOZ R.M. P-1-01MUÑOZ LOPEZ M. P-1-17MUÑOZ TURILLAS C. P-2-17MUTHIVHI T. P-1-11NAJDOVSKI T. P-1-26NEW H.V. INV-27NI LOINGSIGH S. P-1-14NIETO-GONZALEZ M.J. P-2-18NOMEN-CALVET N. INV-16NOVIK A. P-1-15NUSSBAUMER W. P-2-32OCIC T. P-2-01OLIVEIRA C. P-2-19OLIVEIRA I. P-1-21ORTEGA SANCHEZ S. P-1-17ORTEGA SANCHEZ S. P-1-20ORTIZ P. P-2-25ORTIZ-MORILLO P. INV-16OTANI M. INV-22OUNNOUGHENE N. P-2-11OYONARTE S. INV-06PAGLIARICCIO A. O-05PAJARES HERRAIZ A.L. P-2-34PAJK J.P. P-2-09PAPPA A. P-2-38PASIUKOV V. P-1-15PASTORET-PASCAL C. INV-16PELLEJERO-GÓMEZ J.A. INV-16PENA C. P-2-10PEÑALVER M. P-1-04PEREIRA A. P-2-25PEREZ M. INV-02PEREZ M. INV-15PEREZ GONZALEZ P. P-2-12PERVANIDOU D. P-2-38PICCININI P.L. P-1-08PILLONEL J. P-2-11PINK J.M. O-02

PIZZI BOSMAN L. P-1-27POLES D. P-2-36POLITIS C. INV-33POLITIS C. INV-36POLITIS C. P-1-23POLITIS C. P-2-32POLITIS C. P-2-38POURFATHOLLAH A. O-04PREYNAT-SEAUVE O. P-1-27PROFITÓS-TUSET J. INV-16PUIG L.L. INV-16PUIG L.L. P-2-25PUJOLRÀS C. P-2-10PUPELLA S. P-1-08PY J-Y P-2-11RAEISI SHAD E. O-04RAJ T. P-1-19RAJABPOUR NIKNAM F. O-04RAJANI P. P-2-28RAMONEDA NOVAS R. P-1-20RAMOA A INV-35RAMOS N. P-2-12RAPAILLE A. P-2-02RASOULI M. O-04RASTEIRO P. P-1-21RAYA H. P-2-27REIS C. P-2-13REYES MARTIN C. P-1-17RICHARDSON C. P-1-23RICHARDSON C. P-2-38RIGAL E. P-1-27ROJO-MEDINA J. P-2-20RONCON S. P-2-13ROZADA S. P-2-08ROZADA S. P-2-17RUIZ-VILLAR C. INV-37SAADAH N. INV-38SALA CANO N. P-2-12SALAS VILLASUR H. P-2-12SALINAS-ARGENTÉ R. INV-16SAN ROMAN F. P-2-08SANCHEZ-VILLEGAS J.M. INV-16SANCHEZ-VILLEGAS J.M. P-1-01SANZ C. INV-20SANZ C. P-1-10SANZ M.A. P-2-14SANZ M.A. P-2-30SANZ M.A. P-2-39ŠARLIJA D. P-1-13ŠARLIJA D. P-2-01SAULEDA S. INV-17SCANLON J. P-1-14SCERRI R. P-2-03SCERRI R. P-2-24SCHIPPERUS M.R. INV-38SECO C. P-2-08SEMENOV G. P-1-15SHOKUNBI W.A. P-2-26SIERRA SAN NICOLAS S. P-2-12SILVA A. P-2-13SINGH S. O-09SIVASAMBU T. P-1-03SOARES F.M.T. P-2-19SOARES M.L. P-2-19SOLANO RAMOS F. P-2-34SOLVES P. P-1-04SOLVES P. P-2-14SOLVES P. P-2-30SOLVES P. P-2-39 SOUSA G. P-1-21SOUSA S. P-2-13SPÍNOLA A.I. P-2-13

STAMOULIS K. P-2-38STEVENSON L. P-1-16ŠTIMAC R. P-1-13SUBIRÀ M. P-2-15SVIRNOUSKAYA E. P-1-15SVIRNOVSKI A. P-1-15SWEENEY J.E. P-1-14TABOADA F. P-2-17TADOKORO K. P-2-40TARASEV M. P-2-21THEODOSSIADIS G. P-2-38TIBERGHIEN P. INV-13TINEGATE H.N. P-2-36TOMASULO A. O-06TOMASULO P. INV-31TOMASULO P. O-01TOMASULO P. P-2-04TORRES O.W. INV-03TORRES O.W. INV-21TSAKRIS A. P-2-38VAN DONGEN A. INV-32VAN EMPEL J. P-1-24VAN GROOTVELD G. P-1-24VAN PAMPUS E.C. P-1-24VAN TILBORGH-DE JONG A.J.W. P-1-22VAN TILBORGH-DE JONG A.J.W. P-1-24VAQUERO I. P-1-04 VAQUERO I. P-2-14VAQUERO I. P-2-30VAQUERO I. P-2-39VARACHLIOTI R. P-2-38VASCONCELOS E. P-1-21VAVIC N. O-05VERDUGO VALLE M. P-1-20VESGA M.A. INV-14VIEJO A. P-2-07VRIELINK H. INV-23VUK T. P-1-13VUK T. P-1-28VUK T. P-2-01WAHEED U. O-07WAHEED U. P-2-37WAN SALLEH A. P-1-03VINCENT J.L. INV- 11WHITAKER B.I. INV-12WHITAKER B.I. O-03WHITAKER B.I. O-06WIERSUM-OSSELTON J.C. INV-28 WIERSUM-OSSELTON J.C. INV-33WIERSUM-OSSELTON J.C. INV-36WIERSUM-OSSELTON J.C. P-1-22WIERSUM-OSSELTON J.C. P-1-24WIERSUM-OSSELTON J.C. P-2-22WOOD E.M. P-1-16ZAHEER H.A. O-07ZAHEER H.A. P-2-37ZERVOU E. P-1-23ZIJLKER-JANSEN P.Y. P-1-22ZIJLKER-JANSEN P.Y. P-2-22ZOLFAGHARI ANARAKI S. O-04ZUCCARELLI B. P-2-33

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