S.L. 483.2 Art. 2Interpretation.

In these regulations unless the context otherwise requires:

"the Act" means the Human Blood and Transplants Act;

"autologous transfusion" means transfusion in which the donor and the recipient are the same person and in which predeposited blood and blood components are used; "blood" means whole blood collected from a donor and processed either for transfusion or for further manufacturing; "blood component" means a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods; "blood component release" 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;

"blood establishment" means any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion. This does not include hospital blood banks;

"blood product" means any therapeutic product derived from human blood or plasma;

"computerised system" means a system including the input of data, electronic processing and the output of information to be used either for reporting, automatic control or documentation "deferral" means suspension of the eligibility of an individual to donate blood or blood components, such suspension being either permanent or temporary; "distribution" means the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusions; good practice" means all elements in established practice that collectively will lead to final blood or blood components that consistently meet predefined specifications and compliance with defined regulations "haemovigilance" 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;

"hospital blood bank" means a hospital unit 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; "inspection" means formal and objective control to identify problems in accordance with standards adopted to assess compliance with these regulations;

"mobile site" means a temporary or movable place used for the collection of blood and blood components which is in a location outside of but under the control of the blood establishment; "processing" means any step in the preparation of a blood component that is carried out between the collection of blood and the issuing of a blood component; "qualification" as part of validation, means the action of verifying that any personnel, premises, equipment or material works correctly and delivers the expected results

"qualified health professional" includes a doctor and a nurse; "quality assurance" means all the activities from blood collection to distribution made with the object of ensuring that blood and blood components are of the quality required for their intended use; "quality control" means part of a quality system focussed on fulfilling quality requirements; "quality management" means the co-ordinated activities to direct and control an organisation with regard to quality at all levels within the blood establishment; "quality system" means the organisational structure, responsibilities, procedures, processes, and resources for implementing quality management;

"quarantine" means the physical isolation of blood components or incoming materials/reagents over a variable period of time while awaiting acceptance, issuance or rejection of the blood components or incoming materials/reagents; "serious adverse event" means 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;

"specification" means a description of the criteria that must be fulfilled in order to achieve the required quality standard;

"standard" means the requirements that serve as the basis for comparison;

"trace-back" means the process of investigating a report of a suspected transfusion-associated adverse reaction in a recipient in order to identify a potentially implicated donor; "validation" means the establishment of documented and objective evidence that the pre-defined requirements for a specific procedure or process can be consistently fulfilled; "written procedures" means controlled documents that describe how specified operations are to be carried out; "serious adverse reaction" means an unintended response in donor or in patient associated with the collection or transfusion of blood and blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity.