European Communities (Human Blood and Blood Components Traceability Requirements and Notification of Serious Adverse Reactions and Events) Regulations 2006
Source: Iris Oifigiúl 2006-11-14

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paragraphs: These Regulations may be cited as the European Communities (Human Blood and Blood Components Traceability Requirements and Notification of Serious Adverse Reactions and Events) Regulations 2006.
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paragraphs: These Regulations shall come into operation on 25 October, 2006.
Interpretation
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paragraphs: (1) In these Regulations-
‘facilities’ means hospitals, clinics, manufacturers, and bio-medical research institutions to which blood or blood components may be delivered;
‘imputability’ means the likelihood that a serious adverse reaction in a recipient can be attributed to the blood or blood component transfused or that a serious adverse reaction in a donor can be attributed to the donation process;
‘issue’ means the provision or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient;
‘recipient’ means someone who has been transfused with blood or blood components;
‘reporting establishment’ means the blood establishment, the hospital blood bank or facilities where the transfusion takes place that reports serious adverse reactions and/or serious adverse events to the competent authority;
‘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 hospitalization or morbidity;
‘serious adverse reaction’ means an unintended response in a donor or a patient associated with the collection or transfusion of blood or blood components that is fatal, life threatening, disabling or incapacitating, or which results in, or prolongs hospitalization or morbidity;
‘traceability’ means the ability to trace each individual unit of blood or blood component derived thereof from the donor to its final destination, whether this is a recipient, a manufacturer of medicinal products or disposal, and vice versa.
(2) A word or expression that is used in these Regulations and is also used in the Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 has, unless the contrary intention appears, the same meaning in these Regulations as it has in Directive 2002/98/EC.
Traceability
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paragraphs: Each blood establishment, hospital blood bank and facility shall ensure the traceability of blood and blood components through accurate identification procedures, record maintenance and an appropriate labelling system.
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paragraphs: Each blood establishment shall ensure that it has in place a traceability system such as enables the tracing of blood components to their location and processing stage.
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paragraphs: Each blood establishment shall ensure that it has in place a system to uniquely identify each donor, each blood unit collected and each blood component prepared, whatever its intended purpose, and the facilities to which a given blood component has been delivered.
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paragraphs: Each facility shall have a system in place to record each blood unit or blood component received, whether or not locally processed, and the final destination of that received unit, whether transfused, discarded or returned to the distributing blood establishment.
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paragraphs: Each blood establishment shall have a unique identifier that enables it to be precisely linked to each unit of blood that it has collected and to each blood component that it has prepared.
Verification procedure for issuing blood or blood components
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paragraphs: Each blood establishment and hospital blood bank shall have in place a procedure, when it issues units of blood or blood components for transfusion to verify that each unit issued has been transfused to the intended recipient or if not transfused to verify its subsequent disposition.
Record of data on traceability
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paragraphs: Each blood establishment and hospital blood bank and facility shall retain the data set out in the First Schedule hereto for at least 30 years in an appropriate and readable storage medium in order to ensure traceability.
Notification of serious adverse reactions
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paragraphs: Each facility where transfusion occurs shall have procedures in place to retain the record of transfusions and to notify blood establishments without delay of any serious adverse reactions observed in recipients during or after transfusion which may be attributable to the quality or safety of blood and blood components.
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paragraphs: (1) Each reporting establishment shall have procedures in place to communicate to the Irish Medicines Board as soon as known all relevant information about suspected serious adverse reactions. The notification thereof shall be in the formats set out in Part A and Part C of the Second Schedule hereto.