Blood – How We Monitor Safety
The implementation of legislation ensures high standards of quality and safety, nationally and across EU Member States.
Role of Blood Establishments
Blood Establishments are required to:
- Comply with the requirements laid down in relevant Legislation.
- Apply to the HPRA for a blood establishment authorisation as per Regulation 6 of S.I. 360 of 2005.
- Undergo inspections by the HPRA in order to obtain authorisation and regular inspections thereafter.
- Notify the HPRA of any substantial changes it intends to make in the prescribed activities it undertakes through the submission of a variation to a blood establishment authorisation.
As per Article 9 paragraph 4 of S.I. 360 of 2005 all Blood Establishments must maintain records in relation to the prescribed activities for which they are responsible. This information, in addition to activities undertaken by the blood establishment where it operates as a hospital blood bank, should be submitted to the HPRA annually by 1st March in the Blood Establishment Annual Activity Report Form.
Role of the HPRA with Blood Establishments
The HPRA has been designated as the Competent Authority for the purposes of the Legislation.
As a result the HPRA is obliged to:
- Authorise all activities relating to the collection, testing, processing, storage and distribution of human blood and blood components.
- Organise inspections and appropriate control measures to ensure that the requirements of the directives are complied with.
Role of the Hospital Blood Bank
Hospital Blood Banks are required to:
- Comply with the requirements laid down in relevant Legislation
- Submit a Hospital blood bank annual report to the HPRA by the 1st March as per Regulation 12 of S.I. 360 of 2005.
- Operate to International Standard ISO 15189 (Medical laboratories – Particular requirements for quality and competence) of the International Organisation for Standardisation
- S.I. No. 360 of 2005 requires that all hospital blood banks gain ISO 15189 accreditation. The Irish National Accreditation Board (www.inab.ie) is the accrediting body for ISO 15189 in Ireland. As ISO 15189 does not fully meet the requirements of the Blood Directives in the areas of Traceability and Haemovigilance, an Expert Group on Blood and Blood Components was established to provide guidance for ensuring that hospital blood banks comply with the requirements of Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of Directive 2002/98/EC. The ‘Minimum Requirements for Blood Bank Compliance with Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of EU Directive 2002/98/EC’ document was prepared by this group in order to provide such guidance. Further information is available here
Role of the HPRA with Hospital Blood Banks
The HPRA may inspect hospital blood banks with a view to ensuring that -
- hospital blood banks and persons responsible for the management of hospital blood banks comply with the requirements of S.I. No. 360 of 2005,
- problems relating to compliance with those requirements are identified
Haemovigilance is the process of monitoring the safety of blood and blood components from collection of the pre-transfusion sample to completion of the transfusion process.
The National Haemovigilance Office (NHO) was established in 1999 by the Department of Health to operate a national haemovigilance system. As such, while the HPRA is the Competent Authority for implementation of legislation relating to blood and blood components, the NHO will provide assistance to the HPRA through the continued collection, collation and evaluation of Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs), as provided for in national legislation.
A ‘serious adverse event’ is defined as 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 morbidity.
A ‘serious adverse reaction’ is defined as an unintended response in donor or in patient 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.
Reporting establishments are considered to have complied with their reporting requirements if they submit details of SARs and SAEs to the NHO, who will in turn submit relevant data to the HPRA. In its role as Competent Authority, the HPRA will forward the annual reports of SARs and SAEs received to the European Commission.
The NHO and the HPRA meet regularly to discuss cumulative data and reporting trends.
Further information and report forms are available from the NHO website.
The HPRA is the Competent Authority for medicinal products (including blood-derived medicinal products) and is responsible for the national pharmacovigilance system for collection and evaluation of information relevant to the benefit-risk balance of medicinal products. Suspected adverse reactions associated with blood-derived medicinal products should be notified to the HPRA, in addition to NHO reporting requirements. For further information on adverse reaction reporting, see product safety section here
or contact the Pharmacovigilance Section at the HPRA.