Strengthening of the Blood Safety System in the National Blood Transfusion Service - Implementation of the European Union IPA Project - at the Institute for Transfusion Medicine of the Republic of Macedonia

Authors

  • Rada M. Grubovic Institute for Transfusion Medicine of the Republic of Macedonia, Vodnjanska 17, 1000 Skopje
  • Emilija Velkova Institute for Transfusion Medicine of the Republic of Macedonia, Vodnjanska 17, 1000 Skopje
  • Primoz Rozman Blood Transfusion Center of Slovenia, Ljubljana
  • Henk W. Reesink Academic Medical Center, Amsterdam

DOI:

https://doi.org/10.3889/oamjms.2014.091

Keywords:

blood supply, blood transfusion, quality, blood components, haemovigilance, Republic of Macedonia.

Abstract

The Safety of the Blood Supply in any country is of utmost importance to safeguard patients from serious adverse events of blood transfusion. Implementation of a Quality System in the Blood Transfusion Service, with support of Government and Ministry of Health is a key element to guarantee safe blood. The IPA TAIB 2009 project - Strengthening of the Blood Safety System executed in 2013/14 provided the means to start implementing a Quality System in the Institute for Transfusion Medicine of the Republic of Macedonia. This project aimed to ultimately bring the Blood Transfusion Service to European Union standards, allowing the exchange of blood components and all other types of collaboration with other European Union countries in future. The project put the basis for unification of blood transfusion standards and operating procedures in the whole country as well as set up essential education of blood transfusion personnel.

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References

WHO: Blood Transfusion Safety. http://www.who.int/bloodsafety/en/

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 European Union, L33 of 08/02/2003]

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 European Union L256 of 1/10/2005]

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 European Union L256 of 1/10/2005].

Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components [Official Journal of European Union L91 of 30/3/2004].

Commission Directive 2009/135/EC of 3 November 2009 allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic [Official Journal of European Union L288 of 4/11/2009]

WHA63.12. Availability, safety and quality of blood products: resolution, 2010.

WHA28.72: National blood services based on voluntary unpaid blood donors, 1975.

Recommendation No R(88)4 of the Committee of Ministers to Member States on the responsibilities of Health Authorities in the field of Blood Transfusion [07/03/1988, Council of Europe]

Recommendation No R (95)15 of the Committee of Ministers to Member States on the preparation, use and quality assurance of blood components [18/10/1995, Council of Europe].

Law on Safety in Blood Supply of the Republic of Macedonia [Official Journal of the Republic of Macedonia no. 110 of 14/07/2007].

The Guide to the preparation, use and quality assurance of blood components, EDQM, Council of Europe, 17th edition, 2013.

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Published

2014-09-15

How to Cite

1.
Grubovic RM, Velkova E, Rozman P, Reesink HW. Strengthening of the Blood Safety System in the National Blood Transfusion Service - Implementation of the European Union IPA Project - at the Institute for Transfusion Medicine of the Republic of Macedonia. Open Access Maced J Med Sci [Internet]. 2014 Sep. 15 [cited 2024 May 2];2(3):506-9. Available from: https://oamjms.eu/index.php/mjms/article/view/oamjms.2014.091

Issue

Section

E - Public Health

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