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HTA licensed establishments in the Post Mortem sector are required to report incidents to the HTA - we call these HTARIs - and those in the Human Application and Organ Donation and Transplantation sectors are required to report serious adverse events or...
• Designated Individuals in the Human Application sector • Licence contacts in the Organ Donation and Transplantation sector
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:
There is no requirement for licence holders to report directly to the HTA; however, if the licence holder or any party involved in a SAEAR has concerns relating to a potential conflict of interest involving NHSBT they can contact the HTA directly by emailing email@example.com.
In cases where an urgent notification is required the establishment must telephone ODT Hub Operations on 0117 9757580 immediately upon discovery. The telephone call must be followed up by an online submission of a report form detailing any immediate actions taken.