Establishment of Hemovigilance for the Testing, Storage, Distribution, Transport, and Issuing of Blood and Blood Components: The Example of Greece

Hemovigilance: An Effective Tool for Improving Transfusion Safety

Volumn , Issue , 2012, Pages 52-60

  Politis, Constantina ^a,b  

^a UNIVERSITY OF ATHENS   (Greece)

^b SKAE Hellenic Coordinating Haemovigilance Centre   (Greece)

Author keywords

Blood group serology compatibility; Coordinating haemovigilance centre (SKAE in Greek); Epidemiological protocol for TTIs surveillance; Flow chart of information; Hemovigilance for testing storage transport, example of Greece; Issuing of blood components; Release of blood components; Transfusion component, and transfusion service personnel; TTIs

Indexed keywords

EID: 84887159904     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118338179.ch6     Document Type: Chapter

References (15)

1. European Union, 2003, Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Official Journal of the European Union 8.2.2003: L33/30.
2. European Union, 2005, Commission Directive 2005/ 61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events. Official Journal of the European Union 1.10.2005: L256/32.
3. Council of Europe, 2008, Guide to the Preparation, Use and Quality Assurance of Blood Components, Recommendation R (95) 15. 14th edition. Council of Europe Publishing, Strasbourg.
4. Centre for Disease Control and Prevention, 2001, Ministerial Resolution Y1/5028, Official Journal of Hellenic Government 831. Internal operational regulation.
5. Greek Government, 2011, Ministerial Resolution 261/17-Feb-2011, Definition of conditions and procedures for the notification of adverse events to the National Blood Centre (EKEA) and the Centre of Disease Control and Prevention (KEELPNO) through the haemovigilance system.
6. Politis C, Richardson C, Damaskos P, et al., 2010, Hellenic Coordinating Haemovigilance Centre, Summary report Epidemiological Surveillance of Transfusion Transmitted Infections (TTIs) (1996-2009); Surveillance of adverse reactions (ARs-TR) and adverse events (AEs-TR) associated with blood transfusion (1997-2009), Surveillance of adverse reactions (ARs- DN) and adverse events (AEs-DN) during or after donation (2003-2009), Athens.
7. Politis C, Kavallierou L, Asariotou M, et al., 2010, Surveillance of transfusion transmitted infections in 1996-2008 in Hellas: The impact of individual NAT testing on blood safety. Vox Sang 99: 279.
8. Politis C, Richardson C, Damaskos P, et al., 2011, Risk behaviours with an impact on blood donor management in Hellas. Blood Transf 9(Suppl 1): 29.
9. Politis C, Asariotou M, Koumarianos S, et al., 2009, Look back programme for HIV seropositive blood donors in Hellas. Vox Sang 96(1): 142.
10. National Blood Centre (EKEA), 2009, Guidelines for pre-transfusion testing and other technical requirements.
11. McClelland DBL, Pirie E, and Franklin IM, 2010, Manual of Optimal Blood Use, Support for safe, clinically effective and efficient use of Blood in Europe. EU Optimal Blood Use Project.
12. ISBT, 2011, Proposed standard definitions for surveillance of non-infectious adverse transfusion reactions. http://www.isbtweb.org/fileadmin/user upload/WP on Haemovigilance/ISBT definitions final 2011 4 .pdf [accessed February 22, 2012] 13 European Union, 2005, Presidential decree 25/2008 implementing Directives 2005/61/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events and 2005/62/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments. Official Journal of the European Union 1.10.2005: L256/1.
13. European Union, 2005, Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments. Official Journal of the European Union 1.10.2005: L256/41.
14. European Union, 2003, Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Official Journal of the European Union. 14.10.2003: L262/22-25.
15. National Law 3402/2005-Restructuring the blood transfusion system.