The Blood Safety and Quality Regulations 2005

means a solution specifically formulated to maintain beneficial properties of cellular components during storage.

means blood and blood components collected from an individual and intended for transfusion to another individual, for use in medical devices or as starting material or raw material for manufacturing into medicinal products.

means a method of obtaining one or more blood components by machine processing of whole blood in which the residual components of the blood are returned to the donor during or at the end of the process.

means—

means blood and blood components collected from an individual and intended solely for subsequent autologous transfusion or other human application to that same individual.

means a transfusion in which the donor and the recipient are the same person and in which pre-deposited blood or blood components are used;

means any body which carries out biomedical research;

means whole human blood collected from a donor and processed either for transfusion or for further manufacturing;

means a therapeutic constituent of human blood (red cells, white cells, platelets and plasma) that can be prepared by various methods;

means a process which enables a blood component to be released from a quarantine status by the use of systems and procedures to ensure that the finished product meets its release specification;

means any person who carries out any of the activities specified in regulation 3(2) which require an authorisation by virtue of that regulation;

means any therapeutic product derived from human blood or plasma;

means a blood component prepared by centrifugation of a unit of whole blood, and which contains a considerable proportion of the leucocytes and platelets.

means the European Commission;

means Commission Directive 2005/62/EC of 30th September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments;

means a plasma component prepared from plasma, fresh-frozen, by freeze-thaw precipitation of proteins and subsequent concentration and re-suspension of the precipitated proteins in a small volume of the plasma.

means prolongation of the storage life of blood components by freezing.

means suspension of the eligibility of an individual to donate blood or blood components, such suspension being either permanent or temporary;

means the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood products, other than the issuing of blood or blood components for transfusion;

means a registered medical practitioner;

means a person who has passed both the written and practical examinations of the NHS Blood and Transplant (Gwaed a Thrawsblaniadau'r GIG), the Scottish National Blood Transfusion Service, the Northern Ireland Blood Transfusion Service or the Welsh Blood Service in the care of blood donors and who holds a current certificate of competence, awarded by that body, in the care of blood donors;

means— (a) a hospital, (b) any other facility or service owned or managed by a health service body, (c) a care home, (d) an independent clinic, (e) a manufacturer, or (f) a biomedical research institute;

means a concentrated suspension of granulocytes obtained by apheresis.

means a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors;

means— (a) a...

means a hospital owned or managed by a health service body;

means a health service hospital or an independent hospital;

means any unit within a hospital which stores and distributes, and may perform compatibility tests on, blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities;

means any of the following constituents of human blood: red cells, white cells, platelets and plasma.”

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;

means formal and objective control to identify problems in accordance with standards adopted to assess compliance with these Regulations;

means a person appointed by the Secretary of State to carry out inspections pursuant to regulation 15(10);

means the provision of blood or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient;

means a person who— (a) holds a licence under section 8(2) of the Medicines Act 1968 to manufacture medicinal products;

means a registered nurse or registered midwife;

means— (a) in the case of hospital blood bank located in a hospital managed by a health service body, that body, and (b) in the case of an independent hospital, the registered person;

means— (a) in the case of a hospital, facility or service which is owned or managed by an NHS body, that body, (b) in the case of an independent hospital, an independent clinic or a care home, the registered person, (c) in the case of a manufacturer or a biomedical research institution, the manufacturer or biomedical research institution;

means a blood establishment, the person responsible for the management of a facility or the person responsible for the management of a hospital blood bank;

means the liquid portion of the blood in which the cells are suspended.

means a plasma component prepared from a unit of plasma, fresh-frozen.

means the supernatant plasma separated from a whole blood donation or plasma collected by apheresis, frozen and stored.

means a concentrated suspension of blood platelets obtained by apheresis.

means a concentrated suspension of blood platelets, obtained by apheresis, and from which leucocytes are removed.

means a concentrated suspension of blood platelets, obtained by processing of whole blood units and pooling the platelets from the units during or after separation.

means a concentrated suspension of blood platelets, obtained by processing of whole blood units and pooling the platelets from the units during or after separation, and from which leucocytes are removed.

means a concentrated suspension of blood platelets, obtained by processing of a single unit of whole blood.

means a concentrated suspension of blood platelets, obtained by processing of a single whole blood unit from which leucocytes are removed.

means— (a) a doctor;

means the co-ordinated activities to direct and control an organisation with regard to quality at all levels within the blood establishment or hospital blood bank;

means the organisational structure, responsibilities, procedures, processes, and resources for implementing quality management and, for this purpose, “quality management” means the co-ordinated activities to direct and control an organisation with regard to quality at all levels within the blood establishment or hospital blood bank;

means a person who has been transfused with blood or blood components;

means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed.

means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed.

means the red cells from an apheresis red cell donation.

means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed.

means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed.

means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed, and from which leucocytes are removed.

means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed, and from which leucocytes are removed.

means— (a) in England, the person registered as manager under Chapter 2 of Part 1 of the Health and Social Care Act 2008 in respect of regulated activities (within the meaning of that Part) carried on in an independent hospital, a care home or an independent clinic;...

means the blood establishment, the hospital blood bank or the facility where the transfusion takes place;

means the period of twelve months ending on 31st March;

means 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;

means an unintended response in a donor or in 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 hospitalisation or morbidity;

means a method of quality control of a product or a process that relies on a system of analysis of an adequate sample size without the need to measure every product of the process.

means Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components;

means— (a) in relation to the import of blood or blood components into Great Britain, a country other than the United Kingdom;

means the ability to trace each individual unit of blood or blood component from the donor to its final destination (whether this is a recipient, a manufacturer of medicinal products or disposal) and from its final destination back to the donor;

means the establishment of documented and objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

means a process of removing plasma or storage medium from cellular products by centrifugation, decanting of the supernatant liquid from the cells and addition of an isotonic suspension fluid, which in turn is generally removed and replaced following further centrifugation of the suspension.

means a single blood donation.