S.L. 483.3 Art. 2Interpretation.

For the purposes of these regulations, unless the context otherwise requires: "the Authority" means the Superintendent of Public Health; "facilities" means hospitals, clinics, manufacturers and biomedical 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 of blood or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient; "recipient" means a person 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, which reports serious adverse reactions and, or serious adverse events to the Authority; "traceability" means the ability to trace each individual unit of blood or blood component derived therefrom, from the donor to its final destination, whether this is a recipient, a manufacturer of medicinal products or disposal thereof, or vice versa.