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A serious adverse event (SAE) is defined in the Regulations as ‘any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation, that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or...
Licence holders are required to notify NHSBT of serious adverse events (SAEs) or serious adverse reactions (SARs) within 24 hours of discovery. Establishments should take note that a full investigation of an event or reaction is not required for the purposes of initial reporting.
Staff at HTA-licensed establishments should refer to the Governance and Quality Systems section of the HTA’s Code of Practice B on Post-mortem Examination.
All information relating to donor and organ characterisation must be kept for a period of 30 years from the date of retrieval of the organ.
The HTA regulates organ donation and transplantation under The Quality and Safety of Organs Intended for Transplantation Regulations 2012 and the Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014.
The HTA’s remit does not extend to Scotland in terms of consent for organ and tissue donation.
In Northern Ireland, the removal, storage and use of organs or part organs from a deceased person for transplantation is governed by the Human Tissue Act 2004.
Consent must always be given expressly by the potential donor before their death, or by a nominated representative or a person in...
Since December 2015, a deemed consent system has been operational in Wales. The Human Transplantation (Wales) Act 2013 allows for consent to deceased organ and tissue donation to be deemed to have been given when a person both lived and died in Wales; there are however a number of exceptions to...
Since May 2020, a deemed consent system has been operational in England.
The Organ Donation (Deemed Consent) Act 2019 allows for consent to deceased organ and tissue donation to be deemed to have been given when a person both lived and died in England. There are however a number of...
The NHS Organ Donor Register operates throughout the UK and allows you to record your donation decision. It allows you to state whether you wish to donate all of your organs and tissues (opt in), some of your organs and tissues (opt in), or none of your organs or tissues (opt out).