A.8.4. NOTIFICATION OF SERIOUS ADVERSE EVENTS
1. An adverse event can be detected at any stage in the process from donation to transplantation. Competent authorities will not want to be informed about every deviation from an SOP within a TE. Only serious adverse events should be reported to the CA.
2. Seriousness might relate to potential severity of an adverse reaction if the event had not been discovered or to the severity of an adverse reaction that might occur due to a repetition of the event in another place or time.
3. Deviations from standard operating procedures in TEs, or other adverse events, which have implications for the quality and safety of tissues and cells should result in SAE reporting to the competent authority when one or more of the following criteria applies:
a) Inappropriate tissues / cells have been distributed for clinical use, even if not used;
b) The event could have implications for other patients or donors because of shared practices, services, supplies or donors;
c) The event resulted in loss of any irreplaceable autologous tissues or cells or any highly matched (i.e. recipient specific) allogeneic tissues or cells;
d) The event resulted in the loss of a significant quantity of unmatched allogeneic tissues or cells.
4. Thus, where the criteria listed above are met, the adverse event can be considered as posing a serious risk to patient health and in those circumstances it should be reported to the CA. Events that are commonly referred to as ‘near misses’ are included in the above mentioned categories. In the case of assisted reproduction, any type of gamete or embryo misidentification or mix-up is considered to be a serious adverse event and should be notified to the CA.