Blood Transfus 12, Supplement no. 2, February 2014

Transcription

Blood Transfus 2014; 12 Suppl 2
Official journal of
Società Italiana di Medicina Trasfusionale e Immunoematologia - SIMTI
Associazione Italiana dei Centri Emofilia - AICE
Hrvatsko društvo za hematologiju i transfuzijsku medicinu - HDHTM
Sociedad Española de Transfusión Sanguínea y Terapia Celular - SETS
ABSTRACT BOOK
16th International Haemovigilance Seminar
Barcelona (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
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 t
Edizioni SIMTI
Blood Transfus DOI 10.2450/2012.00??????
© SIMTI Servizi Srl
1
ISSN 1723-2007
Edizioni SIMTI
Official journal of:
Società Italiana di Medicina Trasfusionale e Immunoematologia, SIMTI
Associazione Italiana dei Centri Emofilia, AICE
Hrvatsko društvo za hematologiju i transfuzijsku medicinu, HDHTM
Sociedad Española de Transfusión Sanguinea y Terapia Celular, SETS
Affiliated Societies of the journal:
Associação Portuguesa de Imuno-Hemoterapia, APIH - Hellenic Society of Blood Transfusion, HSBT
Editor-in-Chief
Claudio Velati
[email protected]
Associate Editors
Giovanni Di Minno
Massimo Franchini
Irena Jukić
Giancarlo M Liumbruno
Pier Mannuccio Mannucci
Daniele Prati
Roberto Reverberi
Luisa Romanò
Giuseppe Tagariello
Tomislav Vuk
Alberto Zanella
Affiliated Society Editors
Maria Helena Gonçalves, APIH
Alice Maniatis, HSBT
Massimo Morfini, AICE
Eduardo Muñiz-Diaz, SETS
Ana Planinc Peraica, HDHTM
Executive Director
Stefano Antoncecchi
Founder
Lorenzo Lapponi
Past Editors-in-Chief
Lorenzo Lapponi, 1956-1964
Carlo Alberto Lang, 1965-1966
Roberto Venturelli, 1967-1968
Rosalino Sacchi, 1969-1978
Giorgio Reali, 1979-2006
Editorial Office
Luisa Stea
Via Desiderio, 21 - 20131 Milano
Website
www.bloodtransfusion.it
Printing
Grafica Briantea Srl
Via per Vimercate, 25/27 - 20040 Usmate (MI)
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.
International Editorial Board
Jean-Pierre Allain, United Kingdom
Giuseppe Aprili, Italy
Lydia Blanco, Spain
Ines Bojanić, Croatia
Pietro Bonomo, Italy
Dialina Brilhante, Portugal
Maria Domenica Cappellini, Italy
Jean-Pierre Cartron, France
Giancarlo Castaman, Italy
Francine Décary, Canada
Josè António Duran, Portugal
Willy A Flegel, United States of America
Gilles Folléa, The Netherlands
Zulmira Fonseca, Portugal
Gabriella Girelli, Italy
Giuliano Grazzini, Italy
Ana Hećimović, Croatia
Giancarlo Icardi, Italy
Syria Laperche, France
Luis Larrea, Spain
Franco Locatelli, Italy
Aurelio Maggio, Italy
Michael Makris, United Kingdom
Ivanka Mihaljević, Croatia
Manuel Muñoz, Spain
Mario Muon, Portugal
Alessandro Nanni Costa, Italy
Salvador Oyonarte, Spain
Arturo Pereira, Spain
Flora Peyvandi, Italy
Paolo Rebulla, Italy
Angiola Rocino, Italy
Elena Santagostino, Italy
Dorotea Šarlija, Croatia
Erhard Seifried, Germany
Paul FW Strengers, The Netherlands
Cees L van der Poel, The Netherlands
Jonathan H Waters, United States of America
Alessandro Zanetti, Italy
Tribunale di Milano
Authorisation n° 380, 16th June 2003
This number is published in 300 copies.
Printed in February 2014
Euro 7,00 each
Associated with USPI
Unione Stampa Periodica Italiana
CONTENTS
INVITED LECTURES
S407
ORAL PRESENTATIONS
S453
POSTER PRESENTATIONS
ORGANISATIONAL ASPECTS
CLINICAL ASPECTS
AUTHORS
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.
Blood Transfus 2014; 12 Suppl 2 DOI 10.2450/2014.S2
S460
S470
S487
INVITED LECTURES
16TH INTERNATIONAL HAEMOVIGILANCE SEMINAR
INVITED LECTURES
INV-01
PASADO, PRESENTE Y FUTURO DE LA
HEMOVIGILANCIA EN ESPAÑA
Muñiz-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 notificación 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 finalidad 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 oficialmente 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 notificación 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 definiciones 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 notificación 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 notifican 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 notificación de las complicaciones de la
donación se efectúa con el formulario correspondiente diseñado
de acuerdo con las definiciones 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 notifican de
acuerdo con la propuesta de la propia Comisión Europea que
exige su clasificación en función de la fase de la cadena en
que se han producido (extracción, verificación, 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 notificación más homogéneo
entre las diferentes CCAAs, la consolidación de la figura 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 definidos.
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.
s409
INVITED LECTURES
INV-02
TRANSFUSIÓN SANGUÍNEA EN ESPAÑA:
MAPA DE RIESGOS
Pérez 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 notificación 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 definitivo en la consolidación y desarrollo de
la red de Hemovigilancia. Dicha Orden, incorpora a su vez la
notificación 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 notificación 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 notificados son a su
vez reflejados en un informe anual que se discute en el seno
del Comité Científico 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:
notificación de reacciones adversas, errores en la administración
de componentes (EAC) y los incidentes sin efecto/casi
incidentes. La tasa de notificación 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
notificaciones 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 definidos 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 notificado 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 refiere a los efectos adversos ligados a la calidad
y seguridad de los componentes, los notificados 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 reflejo del alto
nivel de seguridad y calidad alcanzado por parte de los Centros
en nuestro país.
Los datos reflejan 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, eficiente y clínicamente eficaz, centrado en el
paciente. Este será nuestro próximo objetivo.
s410
INVITED LECTURES
INV-03
LA HEMOVIGILANCIA EN AMÉRICA LATINA
Torres O.W.1, León de Gonzalez G.2
1
Transfusion 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
Introducción
América 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 geográfico, cultural,
social, económico y político.
En algunos países, la legislación vigente en Medicina
Transfusional exige desde hace algunos años, la notificación
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.
Objetivo
Describir la actual situación de la hemovigilancia en América
Latina.
Método
Realizamos 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.
Resultados
Contestaron 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 notifican 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 oficial no mostró
interés en implementar un proyecto nacional, presentado
por la Sociedad Científica en 2011; de hecho, lo poco que se
reporta no se refleja 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 oficial 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: insuficiencia de recursos humanos (en general
y/o especializado para funciones específicas) y financieros.
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 Científicas podrían tener un papel relevante en
esta implementación, pero en coordinación con el organismo
oficial; el 45.46% respondió negativamente (tres países no
tienen Sociedad Científica y uno respondió que sus sugerencias
no influyen en las decisiones sanitarias).
Obstáculos para implementar la HV:
1 - no hay una norma oficial 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 definición 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.
Conclusión
En AL existe una insipiente actividad de HV. Aunque hay
países que cuentan con un sistema estructurado oficial 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 Científicas, 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.
s411
INVITED LECTURES
Tabla I - Frecuencia absoluta y relativa de las RAT
inmediatas, infecciosas y tardías.
País
RAT
inmediatas
Infecciosas*
RAT
tardías
Total
Argentina
N: 45,097
1,167
(99.91%)
1
(0.08%)
--
1,168
(100%)
Brasil
N: 3,567,720
5,279
(98.78%)
12
(0.22%)
53
(0.99%)
5,344
(100%)
Colombia
N: 900,640
1,168
97.41%
17
1.5%
13
1.09%
1,198
(100%)
Costa Rica
N: 1,930
19
(90.47%)
1
(4.76%)
1
(4.76%)
21
(100%)
Cuba
N: 176,269
781
(97.38%)
14
(1.74%)
7
(0.87%)
802
(100%)
Chile
N: 380,870
1,020
(90.50%)
--
107
(9.49%)
1,127
(100%)
Guatemala
N: 171,244
48
(100%)
--
--
48
(100%)
Perú
N: 210,000
38
(97.43%)
1
(2.56%)
--
39
(100%)
Venezuela
N: 484,449
449
(97.39%)
9
(1.95%)
3
(0.65%)
461
(100%)
*Incluye las infecciones transmisibles por transfusión y la contaminación
bacteriana.
Tabla II - Porcentaje de las RAD.
País
Argentina
N: 26,805
Costa Rica
N: 2,890
Cuba
N: 272,379
Chile
N: 279,107
Perú
N: 100,000
Venezuela
N: 43,993
Reacciones Reacciones Reacciones Reacciones Otras
inmediatas
tardías
locales
vasovagales
1.66
0.16
0.63
1.52
0.007
0.65
0.28
0.10
1.24
--
0.25
--
0.04
0.21
--
--
--
--
1.58
0.55
0.62
--
0.46
0.72
--
0.38
0.06
0.81
1.01
0.009
INV-04
COMPLICACIONES PULMONARES DE LA
TRANSFUSIÓN SANGUÍNEA: TRALI Y TACO
Fernández Álvarez C.
Hospital de Cabueñes, Gijón, Spain
Introducción
Sólo 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 inflamatoria aguda, teniendo
que soportar constantes cambios de volumen, altísimos flujos
de presión y un intenso tráfico 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 inflamatorio de los CS,
que afortunadamente, pocas veces se manifiesta.
Definición y criterios diagnósticos
El 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 define 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 manifiesto 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
define 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).
- Infiltrados 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 identificable para el
empeoramiento.
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INVITED LECTURES
TACO
Aparición 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.
Fisiopatología
La fisiología 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: sustancias 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; insuficiencia renal; niveles de hemoglobina muy
bajos (menos 50 gr/L); shock hemorrágico; balance positivo
de fluidos: transfusión masiva, transfusión de plasma.
tratamiento específico, 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, filtración 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.
Incidencia
Está 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 notificaciones.
Tratamiento y medidas preventivas
Las medidas preventivas del TACO: identificación de receptores
de riesgo, transfusión de menores volúmenes y administración
de diuréticos, son muy eficaces. El tratamiento es el habitual
de la insuficiencia cardiaca. Para el TRALI no existe ningún
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INVITED LECTURES
INV-05
LECCIONES QUE DEBEMOS APRENDER DE
LOS ERRORES EN LA ADMINISTRACIÓN DE
COMPONENTES SANGUÍNEOS
López Soques M.
Hospital del Mar, Barcelona, Spain
Introducción
Desde la infancia, la humanidad aprende del error. Por tanto,
ocultar y desoír el error es injusto porque equivale a impedir
el "beneficio" 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 identificación, 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
específicas. Este es un deber ético para con los receptores de
sangre.
El error humano
Afortunadamente, 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 clasificar
al igual que es posible clasificar las reacciones transfusionales
adversas. Una correcta clasificación 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 clasificación del error
transfusional, denominada MERS-TM (Medical Events
Reporting System -Transfusion Medicine). Según éste, en la
clasificación del error humano se distinguen 3 grandes grupos:
los lapsus o fallos de concentración, los fallos de verificación, 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 verificación, 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 suficiente 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 clasificar el error
humano en una de estas categorías y pasar a preguntarse el por
qué de tal error humano, como indica el apartado siguiente.
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 clasificación 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 verificación en algún procedimiento hospitalario
y revisar la dotación de plantilla. Todos los profesionales
deben ser notificados 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
significar "adelgazar" el sistema, revisando verificaciones quizá
inútiles y añadiendo algún punto de verificación. Es necesario
flexibilizar 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 personal
Si 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.
Análisis causal del error humano
Los profesionales encargados de analizar un error deben
preguntar y preguntarse por qué sucedió el error, e identificar las
causas o circunstancias subyacentes que se denominan errores
s414
INVITED LECTURES
INV-06
ASPECTOS CONTROVERTIDOS EN LA
HEMOVIGILANCIA DE LAS ENFERMEDADES
TRANSMISIBLES
Oyonarte 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 seroconvertido
El 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 confirmación, 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
confirmación 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 sífilis. 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 confirmación, 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 sangre
a) 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 oculta
Consideraremos 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 definida 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 donante
A 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 cuantificación 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 cuantificación 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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INVITED LECTURES
-
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 cuantificación, 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.
Agradecimientos
Dr. 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).
Referencias
1) 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 identified
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-07
LOS RETOS PENDIENTES: LA ENFERMERA
DE HEMOVIGILANCIA, LA FORMACIÓN Y
CAPACITACIÓN, EL USO ÓPTIMO
Alba 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 identificación 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 figura 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
figura de la enfermera/o de Hemovigilancia, y 3) el uso óptimo
de la sangre.
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INVITED LECTURES
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
unificando esfuerzos, mediante la mejora de la formación
y de las competencias, desde la prescripción médica hasta la
administración de la transfusión.
INV-10
WHO 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 specific benefit/risk in
the specific 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 benefits
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 define 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 specific 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 qualified staff.
These factors support the need to promote safe and evidencebased clinical transfusion practice. The introduction of patient
blood management (PBM), defined as (Professional definition)
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INVITED LECTURES
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 scientific
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 benefit side of the equation risk/benefit
in blood component transfusion. Are the assumed benefits
of transfusion universal or are they limited to only a welldefined population of patients? What triggers should be used
to administer blood components and when should transfusions
occur? What component dose is sufficient and/or necessary to
confer clinical benefit? 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 profile of the demographic and
clinical features of blood recipients;
- to know the relative utilization by specific 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 profiles 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 profiles 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 longterm planning of blood supply.
References
1) 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) G o o d n o u g h L T , S h i e h L , H a d h a z y 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. Patientcentered 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-11
WHAT 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 flow 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 beneficial 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 specific
groups of patients have given conflicting results13 such that it is
not possible to identify an "ideal" transfusion trigger for all and
difficult 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 benefits 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 benefit 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.
References
1) 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. Efficacy 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 fixed 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-12
PROPOSED 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
SURVEILLANCE
Whitaker B.
AABB, Bethesda, MD, USA
Background
The 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 reflects the WHO approach to considering all
MPHO in a manner that acknowledges the ethical and safety
risks associated with their exceptional nature.
Methods
The 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.
Results
Separate 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.
Conclusion
In 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-13
BENCHMARKING BLOOD DONOR SAFETY
PRACTICES: A FIRST EXPERIENCE
Folléa G.1, Tiberghien P.2
1
European Blood Alliance, Brussels, Belgium; 2Etablissement
Français du Sang, Saint Denis, France
Background
Donor safety is of paramount importance, particularly for blood
establishments (BE) collecting blood and blood components
from voluntary non-remunerated donors. Although recent
scientific studies have helped assessing and improving donor
safety in BEs, important variations in practices regarding blood
donor safety seem to persist between BEs.
Objective
The 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 methods
EFS 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 first in a visit of a fixed 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.
Results
The following main ways forward have been identified.
- Qualification needed for pre-donation interviewers: it was
difficult to objectively identify best practice for pre-donation
interviewer qualification (medical doctor or not). EFS
should pursue its project to introduce qualified 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
reflecting 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 influence 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 scientific studies in Germany1, 2. Their
justification (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 qualification: EFS should make available
to other EBA members its staff training and qualification
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 find 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 difficulties 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.
References
1) 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.
Conclusions
The international experts appreciated the efforts of EFS
and the method used for this benchmarking exercise.
They expressed confidence 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 identified
good practices and to assess if this benchmarking exercise
succeeded in inducing changes in practices, and beyond in
improving donor safety.
Acknowledgements
Harald Klüter (DE), Johanna Castrén (FI), Wim de Kort (NL),
Gail Miflin (UK) as well as participating EFS colleagues are
deeply acknowledged for their very valuable contribution to this
benchmarking exercise.
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INV-14
THE SPANISH HAEMOVIGILANCE SYSTEM
Vesga M.A.
Ministry of Health, Spain
The organisation of Blood Transfusion in Spain
The 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
specific regions, they are linked and work together towards
common goals. They are public services that are coordinated to
meet the national transfusion needs, self-sufficiently. 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 System
The 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: Identification and
definition of the key Haemovigilance concepts, requirements,
specifications and traceability data record, procedures to report
reactions and severe adverse effects, procedures to draft periodic
reports and information exchange, definition 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)
13)
14)
15)
16)
Transfusion-transmitted viral infection.
Transfusion-transmitted parasitic infection
Febrile reaction/hypotension.
Transfusion haemosiderosis.
Incidents with no effect/near incidents.
Spanish Haemovigilance Programme Structure
The 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
definition 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
Scientific Committee for Transfusion Safety
The Committee is integrated into the public health structure and
is the main technical/scientific body of the Spanish Transfusion
System. It is made up of six experts from the different Transfusion
Medicine fields, appointed by the Competent Authority and the
transfusion-related Scientific 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
References
1) Royal Decree 1088/2005, of 16 September, which establishes
the technical requirements and minimum conditions for
blood donation and transfusion centres and services. Spanish
Official 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.
s422
INVITED LECTURES
INV-15
TEN YEARS OF HAEMOVIGILANCE IN SPAIN
Muñiz-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 notification 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 first 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 first report on Haemovigilance in Spain
was presented in Europe. The publication of the Directive
2005/61EC on "Traceability requirements and notification
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 definitions
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 Scientific 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
notifications 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 notifications per 10,000 blood donations and 139
notifications 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 reflects the high level of quality and safety of the BTC
in our country.
In addition to the specific 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 officer figure,
the total traceability and the optimal use of blood components
remain to be fulfilled. 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
defined 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.
s423
INVITED LECTURES
INV-16
DONOR COMPLICATIONS OUTSIDE THE DONATION
ROOM AND THEIR IMPACT ON DONOR RETURN
Nomen-Calvet N., Ortiz-Murillo P., Pastoret-Pascal C.,
Pellejero-Gómez J.A., Cortel-Mañè G., Castellà-Cahiz D.,
Profitós-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
Introduction
There are several factors that influence whether or not a
first-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 difficult to document Delayed Adverse
Reactions (DAR), those that happen beyond the control and
vigilance of the donation staff.
Background
To evaluate the extent and characteristics of the DAR and its
impact on first-time donor loyalty.
Materials and methods
We initiated a first-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
specific 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 finally 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 significant.
We developed the model with SPSS software, version 19.0.
Results
Between 02-27-2012 and 05-31-2012, we analyzed 77,501
donors. 19,742 of them were first-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 significantly 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
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.
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 fixed 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=4,389
Male
977 (46.3%)
1,065 (46.8%)
2,042 (46.5%)
1,135 (53.7%)
1,212 (53.2%)
2,347 (53.5%)
Female
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%)
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%)
Center type**
DAR**
n=2,103
n=2,254
n=4,357
No
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.
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INVITED LECTURES
Table III - Multiple regression analysis, for different factors
related to coming back.
Adjusted OR (IC 95%)
DAR*
Yes
1
No
1.45 (1.18-1.79)
Sex
Male
Female
1
1.04 (0.92-1.17)
Age of 1st donation
<30
1
30-44
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
1
Arm injury
0.94 (0.6-1.4)
General
0.63 (0.5-0.8)
Conclusion
We 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-Donación
Albert-López A., Arcos-Rivera S., Argelagués-Vidal E., BobetGarcés 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., PastoretPascal C., Pellejero-Gomez J.A., Perucho-Manjón M., PlaFernandez N., Pleguezuelos-Hernández V., Profitós-Tuset J.,
Puig-Rovira LL., Roldán-Tiscar T., Sáez-Bruguera M., SalinasArgente R., Sánchez-Villegas J.M., Sanfeliu-Riera E., SilluéBagués C., Tarifa-Chicano M., Tejedor-Pagés S., VallejoGenaro E., Vilanova-Cabayol N.
INV-17
PREVENTING 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 difficult
equation where other variables are also included: costeffectiveness, 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 amplification technologies (NAT).
NAT screening is aimed to prevent viral transmission through
donations in serological window phase (WP). When HCV NAT
was implemented for the first 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 predonation interview may explain the higher risk.
Another effect of NAT screening is the identification of donors
that carry occult hepatitis B infection. In Spain, anti-HBc
screening is not mandatory and, as a consequence, ultrasensitive
NAT identifies 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
identified (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, defined 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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INVITED LECTURES
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 identified 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-18
POST-DONATION INFORMATION: AN IMPORTANT
ELEMENT OF DONOR HAEMOVIGILANCE
Jimenez-Marco T.
Fundació Banc de Sang i Teixits de les Illes Balears, Majorca;
Balearic Islands Hemovigilance Division (BIHVD), Majorca,
Spain
Introduction
Donor haemovigilance can be defined 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 postdonation 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 notification
can be defined as deferrable medical history or donor behaviour
not disclosed at the time of donation, but it is subsequently
notified 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.
Aim
During 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.
Methods
The 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 first 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'notification,
a Blood Bank e-mail account and 24-hour available phone number
were listed in the post-donation information sheet. The ePDI were
classified in the following categories: mild infections as flu, cold
and gastrointestinal infections; high-risk-sexual behaviour; highrisk-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 finasteride, isotretinoin, etc.; and blood diseases as
bleeding disorders.
Results
During 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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INVITED LECTURES
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
5
1
2
1
Travel to or born in an endemic country (%)
Medical history (%)
Medical treatment (%)
2
2
1
Blood disease (%)
2
1
1
3
1
30
1
3
1
14
3
2
1
8
1
3
1
2
7
7
Conclusions
In our experience, the ePDI notification can be considered a
very useful tool for monitoring medical interview accuracy .The
most common ePDI notification 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.
References
1) 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.
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INVITED LECTURES
INV-19
THE HAEMOVIGILANCE NURSE IN SPAIN
Carpio C
La 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 noncompliance 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
specific 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 first 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 defined 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 noncompliance 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-20
SAFE ADMINISTRATION OF BLOOD COMPONENTS
Sanz 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 standardsetting 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 terrific improvements in blood safety over
the past few decades. Large quantities of resources, either
financial, 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 significant
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 figures 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 reengineering 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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INVITED LECTURES
INV-21
HAEMOVIGILANCE IN LATIN AMERICA
Torres O.W.1, León de Gonzalez G.1
1
Transfusion 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
Introduction
Latin 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.
Objective
To describe the current situation of Haemovigilance in Latin
America.
Methodology
We 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 fill 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.
Results
Out 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 five 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 official agency showed no interest in developing
a national plan presented by the Scientific Society in 2011; in
fact little is reported and thus not reflected 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 system
1 - 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: insufficient human resources (general and/or
specialized for specific 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 Scientific Societies could
play a significant role in this implementation, provided that they
work in coordination with government agencies; 45.46% responded
negatively (three countries do not have Scientific Societies and one
claimed that they do not even have a say in health decisions).
Obstacles to HV implementation
1 - 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
Argentina
N: 45,097
1,167
(99.91%)
1
(0.08%)
--
1,168
(100%)
Brazil
N: 3,567,720
5,279
(98.78%)
12
(0.22%)
53
(0.99%)
5,344
(100%)
Colombia
N: 900,640
1,168
97.41%
17
1.5%
13
1.09%
1,198
(100%)
Costa Rica
N: 1,930
19
(90.47%)
1
(4.76%)
1
(4.76%)
21
(100%)
Cuba
N: 176,269
781
(97.38%)
14
(1.74%)
7
(0.87%)
802
(100%)
Chile
N: 380,870
1,020
(90.50%)
--
107
(9.49%)
1127
(100%)
Guatemala
N: 171,244
48
(100%)
--
--
48
(100%)
Peru
N: 210,000
38
(97.43%)
1
(2.56%)
--
39
(100%)
Venezuela
N: 484,449
449
(97.39%)
9
(1.95%)
3
(0.65%)
461
(100%)
Table II - ATR percentages.
Country
Argentina
N: 26,805
Costa Rica
N: 2,890
Cuba
N: 272,379
Chile
N: 279,107
Peru
N: 100,000
Venezuela
N: 43,993
Immediate Delayed
Local
Vasovagal Others
reactions reactions reactions reactions
1.66
0.16
0.63
1.52
0.007
0.65
0.28
0.10
1.24
--
0.25
--
0.04
0.21
--
--
--
--
1.58
0.55
0.62
--
0.46
0.72
--
0.38
0.06
0.81
1.01
0.009
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INVITED LECTURES
Conclusion
In LA, HV activities are just emerging. Even though some
countries count on an official, 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 Scientific Societies and Organizations and professionals in
the field 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-22
SCREENING FOR TRANSFUSION TRANSMISSIBLE
INFECTIONS IN LATIN AMERICA
Cruz J.R.1, Otani M2
1
Ashburn, VA, United States of America; 2Hemocentro do Sao
Paulo, Brazil
Background
The 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 defined 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 significant
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 methods
National data for 1994, 1995, 1997, 1999 and 2000-2011
summarized by PAHO, official 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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INVITED LECTURES
Table II - Regional prevalence (median, low and high) of TTI
markers among blood donors, 1994-2011.
Year
Prevalence (%) of TTI markers
HIV
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
0.680
(0.120-0.930) (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)
0.410
0.04-3.13)
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)
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.
*Confirmed 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 findings.
Discordant findings, however, tended to diminish in time.
Discussion
There has been a significant 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 first 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
s432
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INV-23
SIDE EFFECTS OF BLOOD DONATION BY APHERESIS
Vrielink H.
Sanquin Blood Supply, Amsterdam, The Netherlands
Introduction
Medical 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 reactions
Adverse reactions related to blood donations must be documented
very carefully. The origin of a side-effect can be found in donorrelated 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 file. 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) donation
Collapse/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.
Hyperventilation
Hyperventilation 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, difficult 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.
Specific complications in apheresis procedures
Besides the described adverse events during a whole blood donation,
side effects specifically related to apheresis procedures can occur.
Hemodynamic consequences
The 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 intoxication
Usually, 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 problems
When 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.
Hematoma
As a consequence of the mechanical return of blood components
during an apheresis procedure, hematomas are more frequent
and may be more severe.
Hemolysis
Due 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 embolism
Air 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 longterm effects of frequents increased PTH levels caused by apheresis,
although the clinical consequence remains open.
s433
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INV-24 & 30
HEMOVIGILANCE IN HEMATOPOIETIC CELL
TRANSPLANTATION
Miller 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 profiles. 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 specific 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 (definitely, 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 five deaths in related donors; one
associated with marrow donation and 4 with PBSC donation4. At
least five other deaths are known to have occurred5.
Hematopoietic cell transplantation is used to treat an everincreasing 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.
References
1) 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/file.
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-25
FOLLOW-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
Introduction
Peripheral 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 shortterm 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 sufficient number of donors with adequate followup 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 efficiency of cell mobilization and
harvesting techniques, as well as exploring the short- and longterm 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 collection
Information 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 registration
At 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 design
As 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 first one (control #1) is performed within 4 to 6 weeks after
mobilization. At that time, the complete physical examination
and hematological and chemistry profiles performed at baseline
are repeated. The remaining five 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 followup 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.
Discussion
There 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 definitive 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 benefits derived from such a monitoring should take into
consideration the costs and the benefits associated with it.
Since 1999, we have observed five 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 five 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 difficult 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 difficulties 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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INVITED LECTURES
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 define 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.
References
1) 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: efficacy and toxicity of a high-dose rhGCSF 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 rhGCSF 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 followup of normal peripheral blood progenitor cell donors treated
with filgrastim: 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 followup of normal peripheral blood progenitor cell donors treated
with filgrastim: 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 efficacy
of hematopoietic stem cell collection from mobilized
peripheral blood in unrelated volunteers: 12 years of singlecenter experience in 3928 donors. Blood. 2009; 114: 3757-63.
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INV-27
TRANSFUSION REACTIONS AND ERRORS IN
CHILDREN
New H.V.
ICHT/NHSBT, London, United Kingdom
An understanding of the frequency and significance of transfusion
reactions and errors in children is needed as part of risk-benefit
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 significant 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 specific giving sets and pumps, and also of precise
volume calculations. These may be subject to clinical error, with
some patients receiving significantly 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 first 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 difficult 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. Modified
definitions 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 inflammation 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 definition 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 significantly
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 populationspecific 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 definitions.
References
1) 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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4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
17)
18)
19)
20)
The 2011Annual SHOT Report (2012). Available at: http://
www.shotuk.org/wp-content/uploads/2012/07/SHOTSummary_FinalWebVersion2012_06_261.pdf.
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.
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 definition. Transfusion Medicine 2013; 23 (s1): 19.
Guillén U, Cummings JJ, Bell EF, et al. International survey
of transfusion practices for extremely premature infants.
Semin Perinatol 2012; 36: 244-7.
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.
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.
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.
Lee AC, Reduque LL, Luban NL, et al. Transfusion-associated
hyperkalemic cardiac arrest in pediatric patients receiving
massive transfusion. Transfusion 2014; 54: 244-254.
New HV, Stanworth SJ, Engelfriet CP, et al. Neonatal
transfusions. Vox Sang 2009; 96: 62-85.
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.
Rashid N, Al-Sufayan F, Seshia MM, Baier RJ. Posttransfusion lung injury in the neonatal population. J Perinatol.
2013; 33: 292-6.
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.
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.
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.
Stanworth SJ, Grant-Casey J, Lowe D, et al. The use of freshfrozen plasma in England: high levels of inappropriate use
in adults and children. Transfusion 2011; 51: 62-70.
Venkatesh V, Khan R, Curley A, et al. How we decide when a
neonate needs a transfusion. Br J Haematol 2013; 160: 421-33.
Vraets A, Lin Y, Callum JL. Transfusion-associated
hyperkalemia. Transfus Med Rev 2011; 25: 184-96.
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-28
VARIATION 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 office, taking reported incorrect blood component
transfused as a proxy for unsafe transfusion2.
Methods
Reports 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 five 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% confidence interval 1.3-13.7) in the highest vs the
lowest tertile after adjustment for blood use level.
Discussion
This 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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INVITED LECTURES
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
specific 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 confirmed 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.
Conclusion
Hospitals 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.
References
1) 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, ZijlkerJansen 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): 12734. doi: 10.1111/j.1423-0410.2012.01642.x.
3) Transfusion Reactions in Patients (TRIP) Dutch National
Hemovigilance Office 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-AnnualReport-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/appli
cation/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-29
HOW 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 first the objective
The 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 associated
Those related to drawing the blood (currently8 classified 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 offsite, or iron depletion incidence in particular donors with high
variability among donors. Donor somatic characteristics and
specific 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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INVITED LECTURES
happen in case of inappropriate data protection systems. The
description of a list of potential adverse effects is only a first
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. Specific
information on the nature of the procedures involved in the
donation process and their respective associated risks.
Third, how the information should be presented
Adverse 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.
References
1) 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,
Official 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
deficiency 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-31
DO 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 significantly 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 pressure
Caucasian, female, first-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 venipuncture
Very 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 events
When 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 first time American blood donor
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INVITED LECTURES
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 deficient. A male or
female with average iron stores who donates blood twice each
year is not likely to become deficient. The factors which might
play a role in determining iron deficiency 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 deficient than
was previously thought and that non-anemic iron deficiency
might be clinically significant during pregnancy and possibly
during the adolescent years. Countries with very restrictive
guidelines on the frequency of blood donation have not
eliminated iron deficiency 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 fluid
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
definitive research results are needed.
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 deficiency. 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.
Actions to be taken
Donor 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 deficiency 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 deficiency 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 deficiency and fainting from blood donation are
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INVITED LECTURES
INV-32
ANXIETY 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 specifically, 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 benefits 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 first
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 first donation (1-2 months
later). We found that anxiety increased after the first 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 first donation one year previous. In this group, we
did find 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 first time donors, but they did find 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 influenced by these retention
strategies.
Anxiety and fear are not the only affective factors that can
influence donation behaviour. In our first 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 influenced future donation
behavior. Therefore, teaching donors how to cope with
physical reactions could also influence 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.
References
1) 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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INVITED LECTURES
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 influence of adverse reactions, subjective distress, and
anxiety on retention of first-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 metaanalysis 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 first-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 & 36
UPDATE ON ISTARE: RECENT FINDINGS IN
RECIPIENTS AND FUTURE ORIENTATION
OF THE INTERNATIONAL DATABASE ON
HAEMOVIGILANCE
Politis C.1, Wiersum-Osselton J.C.2
1
Coordinating Haemovigilance Centre (SKAE), Athens Hellas,
Greece; 2TRIP National Hemovigilance and Biovigilance
Foundation, The Hague, The Netherlands
Background
The 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 confidential aggregated data following IHN/ISBT
standards. The early pilot studies led eventually in 2012 to a webbased database developed by the ISTARE Working Group (current
members: C. Politis, P. Renaudier, C. Richardson, P. Robillard, J.
Wiersum) in collaboration with Steficon Ltd (http://www.ihn-org.
com/haemovigilance-databases/istare-2), which has recently been
enhanced in the light of users' experience.
Methods
ISTARE contains data entry forms for: ARs by component,
imputability and severity; donor complications; errors-incorrect
blood component transfused (IBCT); and general and specific
denominator data (blood units issued and transfused, etc.) which
are necessary for the automatic calculation of rates.
Data management, analysis and dissemination
The 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 definitions
Instructions and information are provided online as well as
definitions which are the ISBT /IHN standard definitions for
donor and recipient ARs. The Help facility has been enhanced
recently.
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INVITED LECTURES
Results
Participation has increased steadily. For the reporting years up
to 2012, 25 countries and regions from Europe, North America,
Africa, Asia/Pacific 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.
INV-34
HOW TO DO A REALLY EFFECTIVE AUDIT:
AUDITS IN PATIENT IDENTIFICATION AND BLOOD
TRANSFUSION POLICY
Andreu G.
Consultant, Dijon, France
Conclusions
The 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 specifications. Enhanced
calculation capabilities and deeper analysis of the results are
also planned.
Rigorous organization of the audit
We can recognize five different steps to be completed in order
to manage a full audit cycle.
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 identified 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.
Stage 1: Preparation
Relevance of the topics for the institution
Patient identification 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 identification is a very complex task,
and you can make the choice to restrict the audit to the patient
identification 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.
Identification of relevant frame of reference related to the
selected topics
Although 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 criteria
In 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 defining 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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INVITED LECTURES
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 difficult 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 identification and
transfusion policy.
Stage 3: Measure of the performance
Data 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 defined.
Data analysis
Most criteria in the field of patient identification and transfusion
policy should be met in 100% of the files investigated. However,
criteria for transfusion prescription may be complex in some
clinical situation, and if this specific field is included in the audit,
the analysis will benefit 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 improvement
Implement change
Based 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,
modification of documentation or SOPs when necessary,
sensitizing tools such as tutorials, regular reminders, etc.
The Audit report
The audit report should include the following sections:
- Objectives.
- Participants.
- Organisation and methodology.
- Frame of reference and timeline from planning to report.
- Both positive findings and issues requiring improvement
- Agreed action plan for improvement.
- Annexes (audit protocol, user manual, reference sources).
Stage 5: Sustaining improvements
This stage verifies 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
final audit report.
Available tools to help building a blood transfusion audit
An EU initiative: the Optimal Blood Use Project
The 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 specifically, 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 identification, 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.
Conclusion
Conducting 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 field.
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.
References
1) http://www.optimalblooduse.eu/.
2) http://www.optimalblooduse.eu/content/9-audit.
3) http://www.optimalblooduse.eu/sites/optimalblooduse.eu/
files/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, Kornfield 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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INVITED LECTURES
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, Shefler 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-35
TOTAL TRACEABILITY: HOW IS THIS MANDATORY
INSTRUCTION BEING IN EUROPE? IMPLEMENTED
STRATEGIES TO CONTROL THE FINAL DESTINY
OF BLOOD COMPONENTS
Escoval M.A.A., Condeço J., Ramoa A.
Portuguese Blood and Transplantation Institute/Portuguese
Haemovigilance System, Lisbon, Portugal
Introduction
Traceability and notification 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 identification procedures, record maintenance
and an appropriate labeling system. The regulations require also
the evidence of the final 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 confirmed
as having been transfused or destroyed in hospitals is unknown.
Aim
To assess the implementation of traceabilty status at a global
level, capture information about current practices and evaluate the
compliance for confirming the final destination of blood components.
Methods
A 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,
identification procedures, labelling system requirements, record of
data on goods traceability procedures. The survey was available
online, from 2 December 2013 to 15 January 2014.
Results
Inordertofacilitatedataanalysis,presentingNorwayasimilarprofileto
theEUcountries,itwasdecidedtoincludetheNorwaydatainthisgroup.
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 offices.
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INVITED LECTURES
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 final 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
2
90%
3
4
80%
3
1
70%
1
-
60%
-
1
This classification is based in collected data (52% of the
respondent/64.7% of EU countries), in official 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 identification procedures. For blood units not
transfused, confirmation 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
Single national coding system for blood
components
EU
Countries
Non EU
Countries
76.5%
62.5%
Official name of the component
100%
100%
Volume, weight or number of cells in the
component
88.2%
87.5%
Unique numeric or alphanumeric donation
identification
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 conclusion
Although 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 identification requirements
and procedures, record maintenance and appropriate labeling
systems.
However the critical point on traceability is the fact the
legal requirement to confirm the final destination of blood
components is currently not always met. We can find a lack
of evidence of the implemented strategies in place to control
the final 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, official reports on traceability, should also be disclosed.
Acknowledgments
The 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.
References
1) 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 notification 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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INVITED LECTURES
INV-37
VIGILANCE OF MEDICAL DEVICES. STATE OF THE ART
Ruiz-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 define 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 specifically 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 modification of the anatomy or
of a physiological process,
- control of conception
and 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 field 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
defined 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
deficiency 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 efficient
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 fields 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 Notified Bodies, and also by the National Competent
Authorities charged with safeguarding public health. These
guidelines describe the European system for the notification
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 specific 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.
References
1) 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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INVITED LECTURES
INV-38
INDICATIONS AND SIDE EFFECTS OF PLASMA AND
PLASMA PRODUCTS
Schipperus M.R.1, Saadah N.2
1
TRIP 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, deficiencies 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 first tested (for HIV, HBV, HCV, syphilis and, in the case of
first-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 difficult to come by, but a 2008 plasma transfusion
audit performed over five days within seventy-six hospitals in
the province of Ontario, Canada confirms 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 qualified 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 confirmed 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
hyperfibrinolysis (due to low α2-antiplasmin levels)7,8. Indeed
while provisionally approving the use of SDP in the United
States for the first time in over a decade, the FDA insisted
studies investigating these two risk factors be done before final
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 specifically by the fear of
prion transmission10.
The classification of adverse events, particularly FNHTRs and
allergic/anaphylactic reactions, varies by country often making
their incidences difficult 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, efficiency, 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, Efficacy and DVT.
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INVITED LECTURES
References
1) 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. Intraoperative 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/
B i o l o g i c s B l o o d Va c c i n e s / B l o o d B l o o d P r o d u c 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-39
EDUCATION AND TRAINING TO IMPROVE
TRANSFUSION SAFETY
Branigan B.
Beaumont Hospital and Bon Secours Hospital, Dublin, Ireland
Background
We 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.
Methods
I 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.
s450
INVITED LECTURES
INV-40
WHAT'S THE HOLD UP?
DELAYED AND INADEQUATE TRANSFUSION
Bolton-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 significant 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 identified 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
final 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 fire 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 benefit.
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 notification 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)
2)
3)
4)
5)
6)
NRLS. The National Reporting and Learning Service - Seven steps
to patient safety. www.nrls.npsa.nhs.uk/.
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.
Management of major haemorrhage http://www.transfusionguidelines.
org.uk/index.aspx?Publication=BBT&Section=22&pageid=1342.
North West Regional Transfusion Committee (NWRTC)
toolkit on the management of major haemorrhage http://www.
transfusionguidelines.org.uk/Index.aspx?pageid=7675&sectio
n=28&publication=RTC.
NWRTC MHP Audit results December 2011 to February
2012 http://www.transfusionguidelines.org.uk/docs/pdfs/rtcnw_2013_07_P_mh_audit_pres.pdf.
Bhangu A, Nepogodiev D, Doughty H, Bowley DM. Metaanalysis of plasma to red blood cell ratios and mortality in massive
blood transfusions for trauma. Injury. 2013; 44 (12): 1693-9.
s451
ORAL PRESENTATIONS
ORAL PRESENTATIONS
O-01
DONOR ADVERSE REACTIONS DUE TO CITRATE
INFUSION DURING AUTOMATED COLLECTIONS
Kamel T.1, Bravo M.1, Kempin S.1, Tomasulo P.1, Custer B.2
1
Blood 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 final 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% Confidence Intervals) 12.1 (5.8-25.2), 7.7 (4.313.7), 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.
Table I
O-02
UPPER LIMB VENOUS THROMBOSIS
COMPLICATING BLOOD DONATION
Bell 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, significant
financial 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 confirmed 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 2367). 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 difficult 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 flow
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-03
AABB VALIDATION STUDY OF THE CDC
NATIONAL HEALTHCARE SAFETY NETWORK'S
HEMOVIGILANCE MODULE ADVERSE EVENTS
DEFINITIONS PROTOCOL
Aubuchon J.P.1, Fung M.2, Whitaker B.3, Malasky J.3
1
Puget 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 definitions. 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 definitions 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 definitions from 12
different diagnostic groups. Respondents were required to
s455
ORAL PRESENTATIONS
determine the type of adverse event, if any, and assign a case
definition (diagnostic probability), severity, and imputability
using the January 2013 HVM Surveillance Protocol definitions.
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
definition: 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 transfusionassociation 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 specific criteria of the HVM adverse event definitions.
Conclusion Despite delineated definitions, considerable
variability in responses was seen, and this was not reduced
by the available training. This degree of inconsistency in
application of the surveillance definitions could degrade the
utility of comparative reports.
O-04
EVALUATION OF ABO MISMATCHED TRANSFUSION
IN IRAN FROM SEPTEMBER 2009 TO SEPTEMBER 2013
Jalali 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 financial burden.
Aims We aimed to identify the specific 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
office. 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 identification. 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 significant
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 identification. To decrease ABO-incompatible RBC
transfusions a focus on nurse training and implementation of
additional measures for patient and blood sample identification
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-05
BLOOD DONOR SAFETY: THE PREVENTION OF
VASOVAGAL REACTIONS LIES IN A PSYCHOLOGICAL
APPROACH TO FIRST-TIME DONORS
Pagliariccio A.1, Marinozzi M.2, Vavic N.3
1
Ospedali 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 influences first blood donation. As we demonstrated1,
and as recently confirmed2,3, there is a strict correlation between
anxiety at first donation and subsequent onset of VVR.
Aims This study aims to demonstrate that a psychological
approach prevents VVR at first 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
specifically-trained doctor implemented a bespoke methodology
for first-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-specific
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.
s456
ORAL PRESENTATIONS
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 first
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.
References
1) Pagliariccio A, Marinozzi M. Avoiding vasovagal reactions
in first 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.
system is a powerful reporting and analyzing tool providing
data at various levels of detail to support surveillance reporting,
business metrics, and research.
O-06
LAYERED DATA REPORTING ALLOWS
DONORHART™ TO MEET A VARIETY OF DONOR
VIGILANCE NEEDS: THE FIRST ANNUAL REPORT OF
THE AABB US DONOR HEMOVIGILANCE SYSTEM
Land J.1, Whitaker B.I.2, Erraguntla M.3, Tomasulo A.1
1
Blood Systems Inc, Scottsdale, AZ; 2AABB, Bethesda MS;
3
KBSI, College Station, TX, United States of America
O-07
DONOR VIGILANCE IN BLOOD TRANSFUSION
SERVICES, PAKISTAN INSTITUTE OF MEDICAL
SCIENCES
Waheed U., Zaheer H.A.
Safe Blood Transfusion Programme, Government of Pakistan,
Islamabad, Pakistan
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, confidential,
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 publicprivate partnership developed objective standardized data elements
required for blood donation-related adverse reaction reporting,
taking into consideration existing national and international
definitions. 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 sufficient 2012 numerator and
denominator data to be included in the first 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 confidence 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 benefit locally from drill down analytics to
better understand and support donor health. The DonorHARTTM
Table I - Unadjusted odds ratios and confidence intervals.
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 JuneDecember, 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 specific 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.
s457
ORAL PRESENTATIONS
O-08
ENCOURAGING LABORATORIES TO IMPROVE
PRACTICE - UK INITIATIVES
Mistry H.1, Glencross H.2, Chaffe B.3, Bolton-Maggs H.1
1
Serious 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 staffing, 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 specified 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 qualifications (44% in
2011, 47% in 2013). Between 2011 and 2013 there was a significant
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-09
HAEMOVIGILANCE PROGRAMME OF INDIA
Bisht A.1, Singh S.2, Marwaha N.3
1
Indian Pharmacopoeia Commission, Uttar Pradesh; 2National
Institute of Biologicals, Noida; 3Postgraduate Institute of
Medical Education and Research, Chandigarh, India
Background National haemovigilance programmes have
yielded significant 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 defined 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.
s458
POSTER PRESENTATIONS
POSTER PRESENTATIONS - ORGANISATIONAL ASPECTS
ORGANISATIONAL ASPECTS
P-1-01
PUTTING 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.1
1
Banc 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 officer 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 hospital
Results
- 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 Identification (RFID)
technologies.
Summary/Conclusion Multidisciplinary actions engaged in
recent years by our Transfusion Committee have improved the
management of patient transfusion safety.
P-1-02
CLINICAL MANAGEMENT OF DONORS IN
SANT'ANDREA HOSPITAL ROME
Bove 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 first
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 unfit (80
periodic donors and 93 occasional donors). Most are temporary
unfitnesses. 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 difficult for
clinical control to take place, especially for occasional donors.
P-1-03
NATIONAL HEMOVIGILANCE PROGRAMME:
EXPERIENCE IN MALAYSIA
Sivasambu 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 predefined standard
and in accordance to the definitions 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 difficulty in verifying data. A total of 81
of 122 MOH hospitals (66.4%) responded in the first 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 TAGVHD reported but all these cases were not confirmed.
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-1-04
TRAINING AS A TOOL FOR IMPROVING
TRANSFUSIONS
Vaquero 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 noncompliance 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 specific 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.
Table I
P-1-05
HAEMOVIGILANCE SYSTEM AT THE TERTIARY
CARE HOSPITAL COMPLEX IN BRAZIL:
A TEN YEARS EXPERIENCE
Addas-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
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 classification according
to the established conventions of the AABB was made and after
the final classification 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 identified, 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 notifications 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 notifications
of ATRs and transfusion safety.
P-1-06
CONTRIBUTION OF INFORMATION TECHNOLOGY
IN HAEMOVIGILANCE SYSTEM IN AREA VASTA
ROMAGNA TERRITORY IN EMILIA ROMAGNA REGION
Biguzzi 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.
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P-1-08
ABO 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 specific therapeutic
treatment was required; iii) 5 cases were symptomatic but did
not require specific 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-five/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 specific training and re-training of healthcare staff, will
be made mandatory by law. Introduction of electronic barrier
devices is advocated, but its cost/benefit shall be carefully
evaluated.
P-1-09
PLATELET INVENTORY MANAGEMENT:
THE NAMIBIAN EXPERIENCE
Lohrke B.1, Chipare I.2, Alphen G.2
1
Ministry 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 final
processing takes place at NAMBTS. Platelets are available to
46 hospitals on an official request for a specific patient only.
Perceived problems with platelet inventory management were:
The short shelflife 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.
Table I
P-1-10
TEN YEARS OF HAEMOVIGILANCE IN CATALONIA
López 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 notification was made available to hospital
Haemovigilance Officers.
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 notifications 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
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(TACO) and 3 with an acute ABO incompatible haemolytic
reaction.In 6 cases the level of imputability was probable or
definite. 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, identification
errors were most frequent (40%) followed by prescription
errors (22%). Most near misses also corresponded to patient
identification errors at sampling (52%) and prescription (22%).
In 2010 a patient safety national campaign was launched from
the Commission to enforce identification practices.
Conclusions The most severe risks detected in the first 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-1-11
FIVE YEAR TREND ANALYSIS ON INCORRECT BLOOD
COMPONENTS TRANSFUSED IN SOUTH AFRICA
Moleli 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 five years from
2008-2012 in South Africa.
Methods Data that was submitted to the National
Haemovigilance Office 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 misidentifications 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-1-13
CROATIAN HAEMOVIGILANCE REPORT 2012
Štimac 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
classified according to the Proposed Standard Definitions 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 classified 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
modification of the reporting form are needed to ease the
reporting and evaluation of reactions and events.
P-1-14
ROOT 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 Office
(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
first 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
s463
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 verification" (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 identified 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.
Table I - Summary of Findings (n=991).
P-1-15
TRANSFUSION-RELATED ACUTE LUNG INJURY:
CURRENT STRATEGY OF PREVENTION
Svirnouskaya E.1, Khulup H.2, Novik A.2, Klimovich O.3,
Semenov G.2, Pasiukov V.2, Svirnovski A.2
1
Minsk; 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 rhesuspositive and rhesus-negative female plasma of AB group were
in total 26%. The number of female plasma units needed for
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-1-16
PROCESS MAPPING HAEMOVIGILANCE REPORTING
AND EXPERT REVIEW PROCESSES IN AUSTRALIA
Wood E.M.1, Bielby L.1, Arnold E.2, Stevenson L.1,
Glazebrook B.1, Beard P.1
1
Department 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 notification, 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
identified 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 "notification" (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 workflows, required
in 68% of all processes (n=27/40).
Conclusion The mapping process reinforced the timeconsuming 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 refinement and future system development
were also identified.
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P-1-17
IMPROVEMENT PROGRAM FOR UNSAFE
TRANSFUSIONS
Bravo Augue A.1, Muñoz Lopez M.2, Reyes Martin C.2, Mauri
Herrero C.2, Ortega Sanchez S.1
1
Banc 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 influence 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
profit 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 first 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.
Table I
P-1-18
THE NATIONAL HEALTHCARE SAFETY NETWORK
HEMOVIGILANCE MODULE:
EFFORTS TO INCREASE RECIPIENT HEMOVIGILANCE
PARTICIPATION IN THE UNITED STATES
Harvey 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 modifications 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 efficiency of reporting and
engagement with additional partners are planned.
P-1-19
IMPLEMENTATION OF HAEMOVIGILANCE
SYSTEM AT UNIVERSITY HOSPITAL, JEDDAH, KSA
Hindawi 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 define 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,
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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
significant in services without this option.
It proves that ER andthe lack of previous printed labels into
patient's files 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
Table I - Haemovigilance data of year 2012 and 2013.
P-1-20
ELECTRONIC BLOOD COMPONENTS REQUEST AS
A TOOL TO DECREASE PATIENT IDENTIFICATION
ERRORS
Ortega 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
identification. 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 identification 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.
P-1-21
STEPS FOR A BETTER PRACTICE IN AN
IMMUNOHEMATOLOGY LABORATORY 1 YEAR EXPERIENCE
Vasconcelos E.1, Rasteiro P.2, Oliveira I.2, Encarnacao F.2,
Sousa G.1
1
Instituto Portugues do Sangue e da Transplantacao, Lisboa;
2
Laboratorio 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 identification
(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 confirmation. 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 identified 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-1-22
PRESCRIBING BLOOD TRANSFUSION:
PHYSICIAN ASSISTANTS TOO?
Zijlker-Jansen P.Y., van Tilborgh-de Jong A.J.W., WiersumOsselton J.C.
TRIP National Hemovigilance and Biovigilance Office, 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 specifically name transfusion, but can be read to allow
prescription of blood components by PAs. TRIP National
hemovigilance and biovigilance office 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-1-23
TRENDS 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
1
Hellenic Center for Disease Control and Prevention, Athens;
2
Panteion University of Social and Political Sciences, Athens;
3
Blood 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 definitions 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
significant 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 significant
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 significance of standardization of
ARs definitions 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-1-24
COSTS OF TRANSFUSION REACTIONS:
A PRELIMINARY ANALYSIS
Wiersum-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.6
1
TRIP Hemovigilance and Biovigilance Office, The Hague;
2
Universitair Medisch Centrum Utrecht, Utrecht; 3St Anna
Ziekenhuis, Geldrop; 4Ziekenhuis St Jansdal, Harderwijk;
5
Radboud 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-1-25
THE X FACTOR IN HEMOVIGILANCE- HUMAN ERROR
Codaty 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 infinite wisdom but to set a limit to infinite error.
Methodology Deviations are identified on the basis of recorded
data, either by supervisory staff or by self reporting. Analysis
reveals that these can be broadly classified 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 finger points to Human error. Our personnel are qualified,
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 deflected. 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-1-26
RESIDUAL 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
1
Suarlée; 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 specified
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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 confirmed with 3 batches of sets. The [amotosalen]
achieved is <1 μM representing 50% of limit specified 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.
Table I - Residual amotosalen results for SV and LV sets.
P-1-27
IMPACT OF THE NEW QUALITY MANAGEMENT
OF THE BLOOD SUPPLY SYSTEM AT THE GENEVA
UNIVERSITY HOSPITAL
Pizzi 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 identified 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) simplified
criteria for ordering; 2) supply of blood products in refrigerated
cool boxes to the surgery blocks; 3) placement of multiple
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 first three
months of implementation.
The results of the first 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 confidence 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-1-28
WRONG BLOOD IN TUBE ERROR IN DONOR BLOOD
SAMPLES: CAUSES AND FREQUENCY
Vuk T., Cipek V., Hecimovic A., Jukic I.
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 first 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 significant 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 timeconsuming, etc. Besides its relevance in immunohematologic
testing, WBIT may hamper trace-back and look-back
procedures, and result in erroneous conclusions.
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POSTER PRESENTATIONS - CLINICAL ASPECTS
CLINICAL ASPECTS
P-2-01
THE RISK OF TRANSFUSION TRANSMITTED
BACTERIAL INFECTIONS IN CROATIA - RESULTS OF
FOURTEEN-YEAR SURVEY
Vuk T., Ocic T., Batarilo I., Balija M., Šarlija D., Jukic I.
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 confirmed 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 filtered PC (r=−0.82), whereas
for RCC the level of correlation with filtration was significantly
lower (r=−0.19). As the suspicion of bacterial contamination
of BP was not confirmed in the majority of cases, reduction in
the number of febrile non-hemolytic reactions (FNHTR) due
to increased proportion of filtered BP, could not be excluded
either. This was supported by the fact that 26 (65%) reports of
suspected TTBI were related to unfiltered 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
difficulties encountered in their implementation (lack or inadequate
information, discrepant results, inappropriate samples, etc.).
P-2-02
RELATIVE 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
1
Service 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 classified 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 first 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 confirm 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
significant 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 first time donor population
and to evaluate on a regular basis the occurrence of VVDR.
Table I - Individual OR of associated factors to VVDR.
Figure 1 - Estimated probability and associated observed
proportions of VVDR with respect to donor status
and relative blood volume.
P-2-03
ADVERSE EVENTS IN THE MALTA NATIONAL
BLOOD TRANSFUSION SERVICE
Borg-Aquilina D., Abela MA, Scerri R., Aquilina A.A.
National Blood Transfusion Service, G'mangia, Malta
Haemovigilance is a relatively new domain in the field 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 specifically 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 findings (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.
Summary/Conclusion Some aspects of interventions in
PC were voluntarily adopted by CC. Provision of fluids 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-2-04
DONOR ENGAGEMENT IN INTERVENTIONS TO
REDUCE VASOVAGAL REACTIONS: SURVEY RESULTS
Bravo M.D.1, Kamel H.1, Tomasulo P.1, Custer B.2
1
Blood Systems, Inc, Scottsdale, AZ; 2Blood Systems Research
Institute, San Francisco, CA, United States of America
Background Studies support physiologic benefits of fluid
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 fluids 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 stratified by first-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.
P-2-05
DONOR 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 leaflet 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 figures 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-2-06
REVERSE NEEDLE STICK A NEW CATEGORY OF
DONOR ADVERSE EVENT?
Moore N.
Irish Blood Transfusion Service, Cork, Ireland
Background This is the first reported incidence of a "Reverse
Needlestick Injury"to our knowledge.
The European Haemovigilance Network collates figures 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 significant
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
Officer or Medical Officer 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-2-07
6 YEARS OF EXPERIENCE USING THE HEMOCOD
TRANSFUSION SAFETY SYSTEM
Viejo A.
Hospital Universiatorio La Paz, Madrid, Spain
Introduction The component Administration to the untargeted
patient remains a significant 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 configured
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 specific 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 specific 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-2-08
SCREENING 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
1
Centro Communitario de Sangry y Teidos de Asturias, Oviedo;
2
Hospital 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
findings 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 defined 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 SouthAmerica. Look-back studies have revealed no transmission to
patients. Only one of the five 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 confirms 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-2-09
ENSURING 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 1collapse 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 - Number of events at donors from 2009 to 2013.
Table I - Positive donors.
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P-2-10
NURSING ACTIVITY IN MANAGEMENT OF
ADVERSE REACTIONS DURING BLOOD DONATION
Pena 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 first donation donors are water intake
and elevation of extremities. All donors are classified 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 first donations and in 39% of usual donors.
Conclusion Nursing activities on first 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-2-11
PRE DONATION HEMOGLOBIN CONTROL EFFICACY
IN FRANCE: RESULTS OF A WHOLE YEAR STUDY
Py J-Y1, Ounnoughene N.2, Pillonel J.3, Auroy Y.4, Joussemet
M.2, Carlier M.5
1
EFS 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 efficacy 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 specificity (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-2-12
INCIDENCE AND PREDICTIVE FEATURES FOR
SYSTEMIC REACTIONS DURING AND AFTER WHOLE
BLOOD DONATION IN CASTILLA Y LEON, SPAIN
Sala 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
1
Chemcyl, 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 includes
Adverse reactions were classified 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 first and the second periods respectively.
There is an arising pattern of adverse reaction:
First time period: females, first donation, blood drive location,
anxiety, insufficient 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 insufficient liquid intake.
Adverse reactions were mild.
Conclusions The main causes determined for an adverse
reaction are anxiety, insufficient fluids 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-2-13
ADVERSE REACTIONS AND EVENTS OBSERVED
DURING PERIPHERAL BLOOD STEM CELLS
COLLECTIONS
Spínola 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
Figure 1
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% leukapheresisrelated, 7.5% venipuncture-related and 3% mobilization-related;
all were non-serious, 68% with a minor impact on the donor and
76% with definite imputability to the collection. All the AEs were
due to equipment failure with insignificant 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-2-14
ANTI-D ALLOIMMUNIZATION AFTER RH
INCOMPATIBLE PLATELETS TRANSFUSIONS:
RESULTS FROM THE HAEMOVIGILANCE
PROGRAM AT LA FE UNIVERSITY HOSPITAL
Solves P., Carpio N., Balaguer A., Vaquero I., Moscardo F.,
Sanz MA
Figure 2
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 identification of an antibody against
s475
red blood cell antigens was considered an immunisation event. We
analysed the type of PC involved, specificity 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-2-15
IMPROVEMENT OF THE BLOOD TRANSFUSION
SAFETY BY MEANS OF CONTINUOUS EVALUATION
OF THE TRANSFUSION PROCESS AND CONTINUING
TRAINING
Aranda A.1, Hernández I.1, Subirà M.2, Cano M.1
1
Hospital 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 define
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 verification 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) Leaflet 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 verified from 2010 up to 2013: 1)
99% of hemodynamic and transfusion reaction control sheet correctly
filled vs 96% in 2010; 2) 84% of ABO blood group correctly done
vs 34% in 2010; 3) 80% of transfusion request forms correctly filled
vs 50% in 2010. The average time delay and the duration of the
transfusion have not presented any significant 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-2-16
TRANSFUSION 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
1
Hospital 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 notified. 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 identified that the weakest points in
the transfusion chain were: sampling collection and recipient
identification. 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-2-17
NEAR- MISS: 5 YEARS OF EXPERIENCE IN A
REGIONAL HAEMOVIGILANCE SYSTEM
Garcia 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
1
Hospital Universitario Central de Asturias, Oviedo; 2Centro
Communitario de Sangry y Teidos de Asturias, Oviedo;
3
Hospital Cruz Roja, Gijon; 4Hospital San Agustin, Aviles;
5
Hospital 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-2-18
TEN YEARS OF A HOSPITAL HAEMOVIGILANCE
SYSTEM
Lopez-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 official
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 find the steps that
require an improvement in the safety of patients.
P-2-19
EVALUATION OF THE CLINICAL TRANSFUSION
PRACTICES, USING A FEEDBACK REPORTING FORM
Do 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 five 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 verification 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 first 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 verified; 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-2-20
EVALUATION OF THE EXTERNAL QUALITY CONTROL
PROGRAM (EQCP) IN MEXICAN BLOOD BANKS
Rojo-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-2-21
ESTABLISHING RED BLOOD CELL QUALITY
THROUGH MEMBRANE MECHANICAL FRAGILITY
Tarasev 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 efficacy,
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'
efficacy 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 reflects sub-lethal cell damage and could be more relevant
to cells performance in vivo. It was shown previously to vary
significantly, 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 profiles were described in terms of percent hemolysis
following stresses of specified 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 significantly at
48-50 oC with elevated auto-hemolysis at 50 oC but not 48 oC.
Conclusions These findings 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 unitto-unit RBC variability, these results suggest MF as an alternative
metric for assessing RBC efficacy - to be clinically verified.
Overall efficacy 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-2-22
NATIONAL SURVEY OF QUALITY INDICATORS FOR
THE HOSPITAL TRANSFUSION CHAIN
Zijlker-Jansen P.Y.1, Janssen M.P.2, Wiersum-Osselton J.C.1
1
TRIP 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 officer.
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 officer. 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-2-23
SUCCESFULLY 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
antifibrinolitic 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, first 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-2-24
APPROPRIATENESS OF RED CELL USAGE IN
MATER DEI HOSPITAL, MALTA
Borg-Aquilina D.1, Attard D.2, Scerri R.1, Laspina S.2
1
National 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 patientfiles. 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 forsignificant 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-defined criteria, and
24% of patients were overtransfused. 27% of patients had no
post-transfusion Hb check within 24 hours of transfusion.
Conclusion The above figures show that considerable amounts
of transfusion are inappropriate and consequently patients
overtransfused. A substantial amount of patients had no posttransfusion Hb check, thus the figure for overtransfusion is
possibly higher. These findings highlight significant 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-2-25
THE 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.1
1
Banc 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 first step of the Optimal Use of
Blood Program.
Methods Patient-specific 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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identifing 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.
Table I - Transfusion rates per Diagnostic Related Group
(Transfused discharges %).
P-2-26
RATIONALE CLINICAL USE OF BLOOD IN A TERTIARY
HEALTH CENTER IN A DEVELOPING COUNTRY
Fasola 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.
P-2-27
E.U. OPTIMAL BLOOD USE PROJECT IN CLINICAL
HAEMATOLOGY: AN INITIAL APPROACH TO THE
SAFE, EFFECTIVE AND EFFICIENT USE OF PLATELETS
Lopez 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 efficiency 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 efficiency ("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. Efficiency: 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 officer could develop
a routine strategy to assess effectiveness in platelet transfusion.
P-2-28
COMPLICATIONS OF THERAPEUTIC PLASMA
EXCHANGE IN LIVER DISEASE PATIENTS
Bajpai 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.
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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 fluctuating blood pressure or
alterations in heart rate. Fluid overloading was also a significant
complication in these patients due to a precarious fluid 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 fluid status.
P-2-29
QUALITY MANAGEMENT IN IMMUNOLOGY AND
TRASFUSION MEDICINE
Bove 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 first 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 difficult 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-2-30
INCIDENCE AND CHARACTERISTICS OF SERIOUS
ADVERSE EFECTS (SAES) RELATED TO TRANSFUSIONS
Carpio N., Solves P., Vaquero I., Balaguer A., Moscardo F.,
Lujano M., Sanz M.A.
Background Blood component transfusion can lead to
undesirable side effects ranging from mild complications to lifethreatening 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 definitive 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-2-31
TRANSFUSION RELATED ACUTE LUNG INJURY
(TRALI) BEFORE AND AFTER IMPLEMENTATION
OF PREVENTIVE MEASURE IN SWITZERLAND
Jutzi M.P., Amsler L.
Swissmedic, Bern, Switzerland
Background To prevent TRALI, the production of quarantinefresh-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/humanneutrophil-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 specific 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 figures 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-2-32
THE INCIDENCE OF ALLERGIC REACTIONS WITH
METHYLENE BLUE TREATED PLASMA.
A FIVE-YEAR EUROPEAN RETROSPECTIVE STUDY
Larrea L.1, Castrillo A.1, Politis C.2, Nussbaumer W.3
1
Centro de Transfusion de Galicia, Valencia, Spain;
2
Coordinating Haemovigilance Centre, Athens, Greece;
3
Central 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 significantly 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 significantly 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 significantly higher in France
than in Greece, Spain and Belgium.
Conclusion The incidence of Allergic/anaphylactic Adverse
Reactions were significantly more frequent in France than in
the other countries, being significantly higher than expected in
2008 and 2009.
P-2-33
INTERFERENCE TEST IMMUNOHAEMATOLOGICAL
FOR THE DETECTION OF ANTIBODIES TO HIV 1/2:
ANALYSIS OF A CLINICAL CASE
Mininni 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 flu 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 confirmation 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 confirmation 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 identified 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 specificity. Concerning our patient,we can
assume that the flu vaccine administered approximately two
weeks before the test may have influenced 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-2-34
HEMOVIGILANCE ANALYSIS OF INTERCEPT
TREATED VERSUS NON TREATED PLATELETS IN
TWO GENERAL HOSPITALS 2008-2013
Pajares Herraiz A.L.1, Barea Garcia M.L.1, Eguia Lopez B.1,
Solano Ramos F.2, Flores Sanz M.V.1
1
Centro 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 transfusionrelated 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 reactions
Conclusion 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.
Table I - Platelet concentrates.
P-2-35
VASOVAGAL ADVERSE REACTIONS IN BLOOD
DONORS: A TEN YEAR EXPERIENCE IN A SINGLE
BRAZILIAN CENTER
Amorim 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 files 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 classified
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 significant 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 influence on the
incidence of vasovagal reactions.
Conclusions Our study was one of the first studies to show the
symptoms of vasovagal reactions in a very large set of donors;
it did confirm some previous reports about risk factors for vagal
reactions in blood donors.
P-2-36
POOLED SOLVENT-DETERGENT PLASMA IS
ASSOCIATED WITH FEWER TRANSFUSION
REACTIONS THAN STANDARD FRESH FROZEN
PLASMA
Tinegate H.N.1, Bolton-Maggs P.2, Ball J.2, Poles D.2
1
NHSBT, 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 five reactions to S-D FFP, 103 to standard
plasma and three to cryoprecipitate. Using UK issue data,
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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 significantly 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 profile 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 figures do suggest that the
incidence of allergic and anaphylactic reactions to SD-FFP is
significantly reduced compared with standard plasma.
P-2-37
ADVERSE EVENTS IN THALASSAEMIA PATIENTS
AT THE PAKISTAN INSTITUTE OF MEDICAL
SCIENCES, ISLAMABAD
Zaheer 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 JuneDecember 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%) classified 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-2-38
WEST NILE VIRUS (WNV) IN GREECE IN 2010-2013:
SURVEILLANCE IN BLOOD DONORS AND
HAEMOVIGILANCE FINDINGS IN RECIPIENTS OF
BLOOD COMPONENTS
Politis 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.7
1
Hellenic Center for Disease Control and Prevention,
Athens; 2Reference Laboratory for Arboviruses, Aristoteleion
University, Thessaloniki; 3National Blood Centres, Athens;
4
Blood 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
findings.
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 first 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.
s484
P-2-39
INCORRECT BLOOD COMPONENTS TRANSFUSED
(IBCT). TWELVE YEARS OF EXPERIENCE AT OUR
CENTRE
Balaguer A., Carpio N., Solves P., Vaquero I.N.M., Moscardo F.,
Lujano M., Sanz M.A.
Hospital La Fe, Valencia, Spain
P-2-40
TRANSFUSION TRANSMITTED
CYTOMEGAROVIRUS (TT-CMV) - SUSPECTED
CASES IN JAPAN
Goto G., Furui Y., Igarashi S., Hino H., Tadokoro K.
Japanese Red Cross Society Blood Service Headquarters,
Tokyo, Japan
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 identification with a wrist band
carrying a specific code before sample collection, registration
using transfusion software, automatic compatibility tests, online transmission of the results, component selection and final
administration with bedside checking of blood component labels
and patient wrist bands. Mistakes were classified 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 specific requirements.
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
confirmed case of TT-CMV from the test results of repository
samples from implicated donations. In 21 cases, leukodepleted
blood components or bedside leukodepletion filters 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 confirmed case of TTCMV. 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 leaflet 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 lowbirth-weight infants in accordance with the national guideline.
Table I
RBC: red blood cells; 2FFP: fresh frozen plasma; 3PT: platelets.
1
P-2-41
AUDIT OF BLOOD REQUEST FORMS AS A TOOL OF
HEMOVIGILANCE
Junaid 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 filled 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. Specific delivery to this
varied demand list is only possible if requests are vigilantly
s485
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 five
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 identified 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.
s486
AUTHORS
AUTHORS
ABD KARIM F.
ABELA MA
ADDAS-CARVALHO M.
AHMED M.
ALAVA C.
ALFANO K.
ALBA BOSCH M.
ALPHEN G.
ALVAREZ DEL CASTILLO M.
AMORIM L.M.A.F.
AMSLER L.
ANCOCHEA S.
ANGLÈS F.
AQUILINA A.A.
ARANDA A.
ARGELAGUES-VIDAL E.
ARGELAGUES-VIDAL E.
ARNOLD E.
ARRIETA R.
ARUMUGAM A.
ARUMUGAM A.
ASARIOTOU M.A.
ASBERT R.
ATTARD D.
AUBUCHON J.P.
AUROY Y.
AYOB Y.
BADAWI M.
BAHILLO RUIZ E.
BAJPAI M.
BAKA A.
BALAGUER A.
BALAGUER A.
BALAGUER A.
BALALI M.B
BALIJA M.
BALL J.
BALL J.
BAREA GARCIA M.L.
BATARILO I.
BEARD P.
BELL B.M.
BENCIVENGA L.
BENOÎT A.B.
BERGERS M.S.E.
BERNARDO A.
BERNARDO A.
BERNARDO A.
BERNARDO ALVAREZ A.
BERTRAND O.
BESSES R.
BIELBY L.
BIGUZZI R.
BISHT A.
BLANCO PERIS L.
BOETTI L.
BOLIBAR I.
BOLTON-MAGGS P.H.B.
BOLTON-MAGGS P.H.B.
BOLTON-MAGGS P.H.B.
BORG-AQUILINA D.
BORG-AQUILINA D.
BOSCH L.
BOSCH L.
BOSCH M.A.
BOSCH M.A.
BOVE M.
BOVE M.
BRADY R.
BRANIGAN B.
BRAVO M.
BRAVO M.
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BRAVO AUGUÉ A.
BRAVO AUGUÉ A.
BYRNE D.
CANO M.
CÁRDENAS J.M.
CARLIER M.
CARNEIRO R.
CARPIO N.
CARPIO N.
CARPIO N.
CARPIO N.
CARPIO N.
CARRASCO R.
CARRION J.
CASTELLA D.
CASTELLA D.
CASTRILLO A.
CATALA P.
CATALANO C.
CELLIER N.
CHAFFE B.
CHAKRABORTY S.
CHAMORRO C.
CHICCHI R.
CHIPARE I.
CIPEK V.
CODATY J.
CODATY J.
COLL N.
CONDEÇO J.
CONTRERAS-BARBETA E.
CORBILLON L.
CORBILLON L.
CORTEL-MAÑÈ G.
CRUZ J.R.
CUSTER B.
CUSTER B.
DADIOTIS L.
DALMAU C.
DAMAN R.
DAMANHOURI A.
DAVINS M.
DE LA RUBIA J.
DE VALENSART N.
DE VOOGHT K.M.K.
DENEYS V.
DO NASCIMENTO M.F.R.
DOMEQUE M.
EGUIA LOPEZ B.
ENCARNACAO F.
ERRAGUNTLA M.
ESCOVAL M.A.A.
FACCO G.
FARANOUSH M.F
FASOLA F.A.
FERNANDEZ ALVAREZ C.
FERNÁNDEZ CASTRO C.
FERNÁNDEZ-SÁNCHEZ V.
FERRARO P.
FERREIRA J.
FERREIRA N.A.
FLORES SANZ M.V.
FOLLÉA G.
FRANÇA M.
FUNG M.
FURUI Y.
GARCIA GALA J.M.
GARCIA GALA J.M.
GARCIA GALA J.M.
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GHOLAM A.
GIAQUINTO A.
GILLET P.
GLAZEBROOK B.
GLENCROSS H.
GOMES P.D.
GOMEZ F.
GÓMEZ R.
GOTO G.
GOVAERTS B.
GRACIA BRINQUIS E.
GRAZZINI G.
GRIFOLS J.R.
HADAD DEILAMI A.
HADJI GUER L.
HALLER G.
HARVEY A.R.
HASSAN R.
HASSAPOPOULOU H.
HATJICHRISTODOULOU CH.
HATZITAKI M.H.
HEALY S.
HECIMOVIC A.
HERNÁNDEZ I.
HINDAWI I.
HINO H.
IBÁÑEZ-CERVANTES G.
IGARASHI S.
IJAZ S.
INGRAM C.
JALALI FARAHANI F.
JANSSEN M.P.
JANSSEN M.P.
JIMENEZ-MARCO T. T.
JOHANSSON B.
JOUSSEMET M.
JUKIC I.
JUKIC I.
JUKIC I.
JUNAID A.
JUTZI M.P.
KAMEL H.
KAMEL T.
KAVALLIEROU L.
KELLER A.J.
KEMPIN S.
KHAN M.N.
KHULUP H.
KLIMOVICH O.
KOUMARIANOS, S.
KUEHNERT M.J.
LAMBERMONT M.
LAMBERMONT M.
LAND J.
LARREA L.
LASPINA S.
LEDWABA F.
LEÓN DE GONZALEZ G.
LEÓN DE GONZALEZ G.
LOHRKE B.
LOPES M.E.D.
LOPEZ-VILLAR O.
LOPEZ I.
LOPEZ S.
LOPEZ S.
LOPEZ V.
LÓPEZ SOQUES M.
LUJANO M.
LUJANO M.
LUJANO S.
MALASKY J.
MARANTIDOU O.
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P-2-25
P-1-10
P-2-27
P-1-10
INV-05
P-2-30
P-2-39
P-1-04
O-03
P-1-23
s489
AUTHORS
MARINOZZI M.
MARTÍNEZ E.
MARTÍNEZ REVUELTA E.
MARTÍNEZ TURRILLAS C.
MARTINIS G.
MARWAHA N.
MASSUET BOSCH L.
MASSUET BOSCH L.
MAURI HERRERO C.
MEDINA L.
MEDINA RODRIGUEZ J.
MILLAN A.
MILLER J.P.
MILLER J.P.
MINGO A.
MININNI V.
MISTRY H.
MOLELI N.K.
MOORE N.
MORAL M.V.
MORALES M.
MORETTI D.
MORO E.
MORO E.
MOSCARDO F.
MOSCARDO F.
MOSCARDO F.
MOTTOLA M.M.
MUÑIZ-DIAZ E.
MUÑIZ-DIAZ E.
MUÑIZ-DIAZ E.
MUÑIZ-DIAZ E.
MUÑOZ C.
MUÑOZ M.C.
MUÑOZ R.M.
MUÑOZ LOPEZ M.
MUÑOZ TURILLAS C.
MUTHIVHI T.
NAJDOVSKI T.
NEW H.V.
NI LOINGSIGH S.
NIETO-GONZALEZ M.J.
NOMEN-CALVET N.
NOVIK A.
NUSSBAUMER W.
OCIC T.
OLIVEIRA C.
OLIVEIRA I.
ORTEGA SANCHEZ S.
ORTEGA SANCHEZ S.
ORTIZ P.
ORTIZ-MORILLO P.
OTANI M.
OUNNOUGHENE N.
OYONARTE S.
PAGLIARICCIO A.
PAJARES HERRAIZ A.L.
PAJK J.P.
PAPPA A.
PASIUKOV V.
PASTORET-PASCAL C.
PELLEJERO-GÓMEZ J.A.
PENA C.
PEÑALVER M.
PEREIRA A.
PEREZ M.
PEREZ M.
PEREZ GONZALEZ P.
PERVANIDOU D.
PICCININI P.L.
PILLONEL J.
PINK J.M.
O-05
P-2-08
P-2-16
P-2-16
P-1-23
O-09
INV-16
P-1-20
P-1-17
P-1-01
P-2-17
P-2-10
INV-24
INV-30
P-2-10
P-2-33
O-08
P-1-11
P-2-06
P-1-01
P-2-23
P-1-06
INV-02
INV-15
P-2-14
P-2-30
P-2-39
P-2-33
INV-01
INV-15
INV-16
P-1-10
P-1-01
P-2-08
P-1-01
P-1-17
P-2-17
P-1-11
P-1-26
INV-27
P-1-14
P-2-18
INV-16
P-1-15
P-2-32
P-2-01
P-2-19
P-1-21
P-1-17
P-1-20
P-2-25
INV-16
INV-22
P-2-11
INV-06
O-05
P-2-34
P-2-09
P-2-38
P-1-15
INV-16
INV-16
P-2-10
P-1-04
P-2-25
INV-02
INV-15
P-2-12
P-2-38
P-1-08
P-2-11
O-02
PIZZI BOSMAN L.
POLES D.
POLITIS C.
POLITIS C.
POLITIS C.
POLITIS C.
POLITIS C.
POURFATHOLLAH A.
PREYNAT-SEAUVE O.
PROFITÓS-TUSET J.
PUIG L.L.
PUIG L.L.
PUJOLRÀS C.
PUPELLA S.
PY J-Y
RAEISI SHAD E.
RAJ T.
RAJABPOUR NIKNAM F.
RAJANI P.
RAMONEDA NOVAS R.
RAMOA A
RAMOS N.
RAPAILLE A.
RASOULI M.
RASTEIRO P.
RAYA H.
REIS C.
REYES MARTIN C.
RICHARDSON C.
RICHARDSON C.
RIGAL E.
ROJO-MEDINA J.
RONCON S.
ROZADA S.
ROZADA S.
RUIZ-VILLAR C.
SAADAH N.
SALA CANO N.
SALAS VILLASUR H.
SALINAS-ARGENTÉ R.
SAN ROMAN F.
SANCHEZ-VILLEGAS J.M.
SANCHEZ-VILLEGAS J.M.
SANZ C.
SANZ C.
SANZ M.A.
SANZ M.A.
SANZ M.A.
ŠARLIJA D.
ŠARLIJA D.
SAULEDA S.
SCANLON J.
SCERRI R.
SCERRI R.
SCHIPPERUS M.R.
SECO C.
SEMENOV G.
SHOKUNBI W.A.
SIERRA SAN NICOLAS S.
SILVA A.
SINGH S.
SIVASAMBU T.
SOARES F.M.T.
SOARES M.L.
SOLANO RAMOS F.
SOLVES P.
SOLVES P.
SOLVES P.
SOLVES P.
SOUSA G.
SOUSA S.
SPÍNOLA A.I.
P-1-27
P-2-36
INV-33
INV-36
P-1-23
P-2-32
P-2-38
O-04
P-1-27
INV-16
INV-16
P-2-25
P-2-10
P-1-08
P-2-11
O-04
P-1-19
O-04
P-2-28
P-1-20
INV-35
P-2-12
P-2-02
O-04
P-1-21
P-2-27
P-2-13
P-1-17
P-1-23
P-2-38
P-1-27
P-2-20
P-2-13
P-2-08
P-2-17
INV-37
INV-38
P-2-12
P-2-12
INV-16
P-2-08
INV-16
P-1-01
INV-20
P-1-10
P-2-14
P-2-30
P-2-39
P-1-13
P-2-01
INV-17
P-1-14
P-2-03
P-2-24
INV-38
P-2-08
P-1-15
P-2-26
P-2-12
P-2-13
O-09
P-1-03
P-2-19
P-2-19
P-2-34
P-1-04
P-2-14
P-2-30
P-2-39
P-1-21
P-2-13
P-2-13
STAMOULIS K.
STEVENSON L.
ŠTIMAC R.
SUBIRÀ M.
SVIRNOUSKAYA E.
SVIRNOVSKI A.
SWEENEY J.E.
TABOADA F.
TADOKORO K.
TARASEV M.
THEODOSSIADIS G.
TIBERGHIEN P.
TINEGATE H.N.
TOMASULO A.
TOMASULO P.
TOMASULO P.
TOMASULO P.
TORRES O.W.
TORRES O.W.
TSAKRIS A.
VAN DONGEN A.
VAN EMPEL J.
VAN GROOTVELD G.
VAN PAMPUS E.C.
VAN TILBORGH-DE JONG A.J.W.
VAN TILBORGH-DE JONG A.J.W.
VAQUERO I.
VAQUERO I.
VAQUERO I.
VAQUERO I.
VARACHLIOTI R.
VASCONCELOS E.
VAVIC N.
VERDUGO VALLE M.
VESGA M.A.
VIEJO A.
VRIELINK H.
VUK T.
VUK T.
VUK T.
WAHEED U.
WAHEED U.
WAN SALLEH A.
VINCENT J.L.
WHITAKER B.I.
WHITAKER B.I.
WHITAKER B.I.
WIERSUM-OSSELTON J.C.
WOOD E.M.
ZAHEER H.A.
ZAHEER H.A.
ZERVOU E.
ZIJLKER-JANSEN P.Y.
ZIJLKER-JANSEN P.Y.
ZOLFAGHARI ANARAKI S.
ZUCCARELLI B.
P-2-38
P-1-16
P-1-13
P-2-15
P-1-15
P-1-15
P-1-14
P-2-17
P-2-40
P-2-21
P-2-38
INV-13
P-2-36
O-06
INV-31
O-01
P-2-04
INV-03
INV-21
P-2-38
INV-32
P-1-24
P-1-24
P-1-24
P-1-22
P-1-24
P-1-04
P-2-14
P-2-30
P-2-39
P-2-38
P-1-21
O-05
P-1-20
INV-14
P-2-07
INV-23
P-1-13
P-1-28
P-2-01
O-07
P-2-37
P-1-03
INV-11
INV-12
O-03
O-06
INV-28
INV-33
INV-36
P-1-22
P-1-24
P-2-22
P-1-16
O-07
P-2-37
P-1-23
P-1-22
P-2-22
O-04
P-2-33
s490

Blood Transfus 12, Supplement no. 2, February 2014

Transcription

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