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The HTA regulates establishments in England, Wales and Northern Ireland that conduct licensed activities under the Human Tissue Act 2004 (HT Act).
• Designated Individuals in the Human Application sector • Licence contacts in the Organ Donation and Transplantation sector
They should hold:
An organ recipient was anesthetised in preparation for an organ transplant.
An organ was inadvertently damaged during retrieval.reportable as a suspected SAE as the damage associated with retrieval resulted in an otherwise transplantable organ being unsuitable for transplantation.
Extended cold ischaemic time (CIT).
When the HTA receives notification of an SAE or SAR, a member of the serious adverse events and reactions (SAEARs) team will review the information provided in the initial report and contact NHSBT if further information is required. Once NHSBT has submitted the follow-up report the corrective...
Any serious adverse reaction in a living donor which may influence the quality and / or safety of organs must be reported. A suspected SAR must also be reported when one or more of the following applies:
Events which are commonly referred to as ‘near misses' should be reported as SAEs if any of the above criteria are met.
A serious adverse event (SAE) can occur at any stage from donation to transplantation to post transplantation. A suspected SAE must be reported when one or more of the following applies: