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Introduction to Haemovigilance Services at UHW: European Blood Directive 2002/98/EC
The European Communities (Quality and Safety of Human blood and Blood Components) Regulations 2005 Statutory Instrument (SI) No. 360 of 2005 became effective for the purpose of regulations on 8 November 2005 and transposed in to Irish Law August 2006.The Directive governs the activities of Blood Transfusion Service and Hospital Blood Banks in all EU member states:
- Setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components
- Mandates full traceability of all blood/ blood components (Article 14)
- Mandates reporting of all serious adverse reactions and events to blood/ blood components (Article 15)
Definitions As Defined in EU Directive 2002/98/EC
Haemovigilance: shall mean a set of organized surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients and the epidemiological follow up of donors.
Serious Adverse Event: shall mean any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in or prolongs hospitalisation or mobidity.
Serious Adverse Reaction: shall mean an unintended response in donor or inpatient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs hospitalisation or morbidity.
Traceability: means the ability to trace each individual unit of blood or blood component derived there of from the donor to its final destination, whether this is a recipient , a manufacturer of medicinal products or disposal and vice versa.
Haemovigilance Services in University Hospital Waterford
The Haemovigilance Service in University Hospital Waterford is facilitated by the Consultant Haematologists and Haemovigilance Officers, liaising with the Chief Medical Scientist and Quality Officer for blood transfusion on a daily basis and when the need arises.
Purpose of the Haemovigilance Officer(s) in University Hospital Waterford
To act as a resource for all health care workers, by offering expert care, advise and support in Haemovigilance in consultation with the Consultant Haematologist. The Haemovigilance Officer(s) embrace the five core concepts of the Haemovigilance role including :
Clinical focus, patient advocacy, education and training, audit and research and consultancy, to ensure the provision of high quality, holistic and integrated service for all patients in University Hospital Waterford. This involves ensuring adherence to the EU Blood Directive 2002/98/EC and the ISO Standard 15189 throughout the entire blood transfusion process, assessing current treatments, improving the management and clinical outcomes of care, monitoring cost effectiveness in care provision and supporting practice development and education in Haemovigilance care in order to facilitate the development of competencies within the specialty.
It is the responsibility of each professional in University Hospital Waterford to practice Haemovigilance safely, competently and effectively fulfilling his/ her professional responsibility.
Reporting Relationships
- Consultant Haematologist Responsible for Blood Transfusion
- Chief Medical Scientist – Blood Transfusion Laboratory
Working Relationships
- Quality Officer – Blood Transfusion Laboratory
Contact Numbers :
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