Health Insurance (Quality Assurance Activity – Australian Vigilance and Surveillance System for Organ Donation for Transplantation) Declaration 2021
1ADefinitions
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1A Definitions
In this Schedule:
SAER (short for serious adverse event or reaction) means:
(a) a serious adverse event; or
(b) a serious adverse reaction.
serious adverse event means any undesired or unexpected occurrence associated with any stage of an organ donation and transplantation process (from the donation of the organ to the transplantation of the organ) that might:
(a) lead to:
(i) the transmission of a communicable disease to the transplantation recipient; or
(ii) the death of, or a life‑threatening, disabling or incapacitating condition for, the transplantation recipient; or
(b) result in, or prolong, hospitalisation or morbidity for the transplantation recipient.
serious adverse reaction means any unintended response of an organ transplantation recipient, including a communicable disease in the transplantation recipient, that:
(a) might be associated with any stage of the organ donation and transplantation process (from the donation of the organ to the transplantation of the organ); and
(b) either:
(i) is fatal, life‑threatening, disabling or incapacitating for the transplantation recipient; or
(ii) results in, or prolongs, hospitalisation or morbidity for the transplantation recipient.