Human Tissue Authority

The regulator for human tissue and organs

Serious adverse events and serious adverse reactions (SAEARs) in relation to quality and safety of organs intended for transplantation

Please see below for a number of frequently asked questions from a specific category. Simply select one of the questions of interest, the answer will then appear below. For the complete list of categories please visit the main FAQs page.

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.

Although not directly licensed by the HTA, any SAEAR in relation to donor or organ characterisation which involves a testing laboratory must be reported. It is the responsibility of the licence holder to report SAEARs directly to NHSBT; however, laboratories are also able to report to NHSBT.

Please note, systems for reporting SAEs and SARs are not intended to replace existing local reporting requirements.

All SAEARs must be reported, and licence holders are expected to collaborate fully in the investigation of a suspected SAEAR.

Detailed information on the statutory requirements relating to SAEARs can be found in the HTA documentary framework.

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 incapacitating conditions to patients; or which results in, or prolong, hospitalisation or morbidity.

SAEs that may influence the quality and safety of an organ, and that may be attributed to the testing, characterisation, procurement, preservation and transport of organs must be reported.

A serious adverse reaction (SAR) is defined in the Regulations as ‘an unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation, that is fatal, life-threatening, disabling, incapacitating or which results in or prolongs hospitalisation or morbidity’.

SARs observed during or after transplantation, which may be connected to the testing, characterisation, procurement, preservation and transport of organs must be reported.

The system of reporting and investigating SAEARs is managed by NHSBT on behalf of the HTA as an assisted function. All suspected SAEARs must be reported to NHSBT using the online incident reporting system.

Further information on how to report SAEARs can be found in NHSBT's procedure on Reporting an Organ Donation or Transplantation Incident or the HTA guidance for reporting SAEARs for organs intended for transplantation

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. Urgent notification is required in cases where there are potential implications for other recipients, for example.

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 licensing.enquiries@hta.gov.uk. In cases where a conflict of interest is confirmed, the HTA may take on the responsibility for overseeing the investigation.

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:

  • damage to an organ during retrieval;
  • the event could have implications for other patients or donors because of shared practices, services, supplies or donors;
  • transmission of a communicable disease.

Examples of reportable SAEs are given at the bottom of this FAQ.

Events which are commonly referred to as ‘near misses' should be reported as SAEs if any of the above criteria are met.

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:

  • an unnecessary procedure performed on an organ recipient;
  • transmission of a communicable disease;
  • damage to vessel during retrieval from living donor;
  • surgical removal of a transplanted organ.

Examples of reportable serious adverse reactions are given at the bottom of this FAQ.

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 and preventative actions are reviewed. A member of the SAEARs team may advise if any further actions are required.

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).

  • reportable as a suspected SAE as an unlabelled organ box was not accepted for transport resulting in extended CIT. Following delay, the organ was unsuitable for transplantation.

Incorrect perfusion fluid.

  • reportable as a suspected SAE as the use of incorrect perfusion fluid resulted in an organ being unsuitable for transplantation.

A cytomegalovirus (CMV) test result was reported incorrectly as negative when the actual test result was positive.

  • reportable as a suspected SAE as at the time of implantation in a CMV negative recipient the transplant surgeon was unaware that the donor test was CMV positive.

An organ recipient was anesthetised in preparation for an organ transplant.

  • reportable as a suspected SAR as on inspection of the organ, the surgeon following a risk/benefit analysis found the organ was unsuitable for transplantation and the procedure was aborted.

An organ damaged during retrieval was repaired and implanted.

  • reportable as a suspected SAR as following implantation, the recipient developed complications associated with the transplant and the organ had to be removed.

Damage to vessel during retrieval from a living donor.

  • Reportable as a suspected SAR as the living donor required unplanned surgical intervention following retrieval of an organ.