The transfusion of human blood and blood components is used extensively in various therapeutic situations in hospitals from the replacement of blood loss following surgery or haemorrhage to the treatment of blood and cancer related diseases. This widespread use requires that the quality and safety of human blood and blood components is ensured to protect human health, and in particular, to prevent the transmission of diseases. A blood component is a therapeutic constituent of blood, such as, red cells, white cells, platelets and plasma. Blood Establishments which are responsible for the collection, testing, processing, storage and distribution of blood components and Hospital Blood Banks, which are also known as blood transfusion laboratories, and perform compatibility testing between blood components and patients fall within the scope of the legislation for which the HPRA is responsible.
HPRA Role in Regulating Blood
The HPRA role is:
- Competent authority for blood legislation
- Implementation legislation
- Inspection and authorisation of blood establishments
- Oversight of blood banks and facilities. Interaction with the NHO regarding haemovigilance, particularly serious adverse reactions and events (SAR/E)
Requirements relating to quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components are regulated under Statutory Instrument No. 360 of 2005 (Quality and Safety of Human Blood and Blood Components) Regulations.
These Regulations apply to Blood Establishments and to Hospital Blood Banks which are defined as follows:
A ‘blood establishment’ is any structure or body involved in any aspect of the collection, testing, processing, storage and distribution of blood and blood components.
A ‘hospital blood bank’ is a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities.
Blood establishments are required to be authorised by the HPRA for the activities which are carried out. In order to obtain authorisation, blood establishments must apply to the HPRA for blood establishment authorisation and demonstrate compliance with the requirements of relevant Regulations. To ensure that compliance with these requirements are maintained, inspectors monitor compliance through regular on-site inspections.
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.