Definition serious adverse reaction (SAR):
An unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.
Definition serious adverse event:
Any untoward occurrence associated with the procurement, storage and distrubution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-greatening, disabling or incapacitating conditions for donors or patients or which might result in, or prolong, hospitalisation or morbidity.
STEP 1: ASSESSING LIKELIHOOD OF OCCURRENCE/RECURRENCE OF SAR
| 1 | Rare | |
| 2 | Unlikely | |
| 3 | Possible | |
| 4 | Likely | |
| 5 | Probably |