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Blood and Blood Components

​The Health Care Services Standards Directorate is committed to ensuring that there are effective quality systems in place that guarantee consistent quality and the safety of blood transfusion throughout the whole transfusion chain from the recruitment of blood donors, the processing of blood and blood products, the transfusion of blood and blood products and follow-up of the recipients and donors. Standards for the quality and safety of blood and blood components are enshrined in Maltese law through the Human Blood and Transplants Act  (Chapter 483) and its subsidiary legislation.

The Blood Quality and Safety Regulations of 2006 (L.N. 272 of 2006)​​​ implement the requirements of three EU Directives: Directive 2002/98/EC (setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components), Directive 2004/33/EC (implementing Directive 2002/98/EC as regards certain technical requirements for blood and blood components) and Directive 2005/62/EC​ - implementing Directive 2002/98/EC as regards Community standards and specifications relating to a quality system for blood establishments).

L.N. 273 of 2006 (Traceability Requirements and Notification of Serious Adverse Reactions and Events Regulations, 2006) transposes Directive 2005/61/EC (implementing Directive 2002/98/EC as regards traceability requirements and notification of serious adverse reactions and events).

Maltese Legislation​

  1. Blood and Transplants Act (Chapter 483)
  2. Blood (Quality and Safety) Regulations (S.L. 483.02)
  3. Traceability Requirements and Notification of Serious adverse Reactions and Events Regulations (S.L. 483.03)
  4. Blood Supply (Temporary Derogations to Eligibility Criteria) regulations (S.L. 483.05)
  5. Human Blood and Transplants (Fees) Regulations (S.L. 483.09)​

EU Directives
  1. Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components
  2. Directive 2004/33/EC implementing Directive 2002/98 EC as regards certain technical requirements for blood and blood components
  3. Directive 2005/61/EC implementing Directive 2002/98/EC as regards traceability requirements and notification of serious adverse reactions and events
  4. Directive 2005/62 amending Directive 2002/98/EC as regards Community standards and specifications relating to a quality system for blood establishments
  5. Directive 2016/1214 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments
  6. Directive 2009/135 allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid sown in Annex III to Directive 2004/33 in the context of a risk of shortage caused by the Influenza A (H1N1) pandemic
  7. Directive 2011/38 amending Annex V to Directive 2004/33 with regards to maximum pH values for platelets concentrates at the end of shelf life
  8. Directive 2014/110 amending Directive 2004/33 as regards temporary deferral criteria for donors of allogenic blood donations


Standards
National Standards for Blood Transfusion​​​​

Haemovigilance
The aim of haemovigilance is to detect and to analyse all untoward effects of blood transfusion in order to correct their cause and prevent recurrence and to improve the safety of blood transfusion.

Haemovigilance is defined as: as 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 Reactions
A Serious Adverse Reaction is defined as ‘an unintended response in a donor or in a patient that is 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 hospitalisation or morbidity’

Serious Adverse Events
A serious adverse event is defined as: ‘any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood or 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.’

Reporting Forms
The Haemovigilance Unit within the Health Care Services Standards, on behalf of the Competent Authority, is responsible for the collection of both serious adverse events (SAEs) and serious adverse reactions (SARs) to blood and blood components. Blood establishments and hospital blood banks are reminded to notify the the Haemovigilance Unit of SAEs using the Blood SAE Reporting Form. Hospital blood banks, and all other facilites to which blood or blood components may be delivered e.g. hospitals, clinics, manufacturers and bio-medical research institutions, are reminded to notify the Haemovigilance Unit of SARs using the Blood SAR Reporting Form​.

Application Forms
Blood Establishment Variation Application Form​​​