Spanish Hemovigilance System Results 2007-2012

1. Data of the Spanish population were obtained from the National Institute of Statistics
Data on blood donation, blood component transfusion, and hemovigilance were retrived from the Spanish Ministry
of Health and Consume.
At Spain, the Ministry of Health has defined Hemovigilance as “set of organized surveillance procedures relating to
effects or adverse reactions that may appear throughout the transfusion chain, from extraction of blood and
components to monitoring of recipients, all in order to prevent and/or treat its occurrence or recurrence”.
An Annual Report is being published since 2007. These reports are or public domain and available at:
http://msc.es/profesionales/saludPublica/medicinaTransfusional/indicadores/indicadores.htm
We have reviewed public data accumulated over a six-year period (2000 – 2012).
Hemovigilance in Spain (2007 – 2012)
José Antonio García-Erce1
, Arturo Campos2
, Esther Chica3
,
Victoria González5
, Antonio Pérez Ferrer3
1Hospital San Jorge, Huesca; 2University Hospital “Virgen de la Victoria”, Málaga; 3University Hospital “La
Paz”, Madrid; 4 Hospital Getafe, Madrid; 5 Hospital “Miguel Servet”, Zaragoza;
INTRODUCTION & OBJECTIVE
MATERIAL & METHODS
RESULTS
Hemovigilance is a powerful tool to improve the safety and quality of the whole transfusion process.
The increased rate of case notification probably reflects an increasing compromise of professional and
authorities in improving blood transfusion safety.
However, regional differences invite us to continue improving Transfusion Medicine in Spain .
CONCLUSIONS
During the study period, overall blood component transfusion increased by 61.146 units (3.3%)
Incidence of adverse events increased by 80,2%, from 8.6 to 15,5 cases per 10 thousands units transfused,
though with huge differences among Autonomous Communities (Regions), ranging from <5 to >20 (Figure).
Voluntary notifications to the hemovigilance system increased by 93,8%.
The number of hospital notifying at least one case per year increased from 172 (41%) to 226 (54%). Once again,
there are huge regional differences: from 10.5% of hospitals to 100% of hospitals, depending on the region.
8
www.awge.org
2006 2007 2008 2009 2010 2011 2012
Febril Hypotensive Reaction 527 618 582 764 623 753 864
Allergic Reaction 462 449 445 556 522 579 685
Hemolytic Reaction 52 49 61 59 68 61 52
Transfusion Cardiac Overload 28 39 29 50 38 59 63
TRALI 32 32 30 30 35 48 43
Alloimmunization 23 24 43 85 216 208 273
Bacterial Infection 15 17 17 16 10 11 11
Viral or Parasit Infection 1 3 1 2 0 0 0
Transfusion Iron Overload 2 3 15 10 10 16 10
Others 2 8 70 55 70 61 65
Adverse Events 1144 1242 1293 1627 1592 1796 2066
Error/Mistakes 114 134 165 167 147 171 179
Near-miss AE 243 246 304 458 578 604 664
Total 1501 1622 1762 2252 2317 2571 2909
2006 2007 2008 2009 2010 2011 2012 ∆ 06-12 (%)
Adverse Events (AE) 1144 1242 1293 1627 1592 1796 2066 922 80,59
Error/Mistakes 114 134 165 167 147 171 179 65 57,02
Near-miss AE 243 246 304 458 578 604 664 421 173,25
Total 1501 1622 1762 2252 2317 2571 2909 1408 93,80
Rate (1/10.000) 8,6 9,1 9,2 12,1 12,4 13,8 15,5 6,9 80,23
Deaths 5 7 3 3 4 3 4 -1 -20,00
Hospitals (of 419) 172 179 181 198 200 226 224 52 30,23
Infections: Three cases of Chagas, one case of VHC and two of VIH; but none of CJD or VHB were confirmed.
Deaths: 29 cases confirmed: 9 ABO hemolytic reactions; 3 no-ABO; 3 TACO, 10 TRALI and 3 bacterial
contaminations. The overall rate: 2.49 cases per million unit transfused.