Notifying adverse events and reactions
Serious adverse events may occur in any phase of the process - from the time of donor identification through to transplantation of donated tissues. Adverse effects may occur in any of the facilities involved in the process.
Serious adverse reactions concern living donors and tissue recipients and are of major importance to both the Harvesting and Transplantation Centres.
A serious adverse event is any negative event in someway linked to the harvesting, assessment, processing, storage and distribution of tissues that may cause the onset of transmissible disease, death or life-threatening situations, invalidity or incapacity of the patient, or a diseased state requiring or prolonging patient hospitalisation.
A serious adverse reaction is an undesired response of the donor or recipient, including the onset of transmissible diseases occurring in connection with the harvesting or implantation into a human being of tissue that causes death, life- threatening conditions, invalidity or incapacity of the patient, or a diseased state requiring or prolonging patient hospitalisation.
Surgeons, receiving facilities and operators carrying out the harvesting of living donor tissue - in the person of the Healthcare Director - must notify the TTBF of any reaction or presumed serious adverse reaction. Intra-operative reactions must be reported on the Traceability Report and sent via fax to the Foundation. The form entitled ‘Notification of Severe Adverse Reactions' should indicate any adverse reactions occurring in the post-operative phase. The two forms are provided when the tissue is first delivered.
The TTBF staff member responsible will assess the notification and, if s/he considers it necessary, will immediately communicate the situation to the National Transplantation Centre (NTC) and the Regional Referral Centre (RRC).The same TTBF staff member will also open an enquiry in collaboration with the laboratory and the Logistics Dept. to identify the causes and implications of the serious adverse events/reactions notified. The enquiry conclusions, subsequent follow-up and corrective measures will all be recorded in the form entitled ‘Conclusions regarding Serious Adverse Reactions' or in the form entitled ‘Conclusions regarding Serious Adverse Events'. These reports will be sent both to the NTC and the RRC.