Guidance

Chapter 16: adverse incidents relating to transplantation

Updated 21 May 2024

Individuals involved in the transplantation of organs, tissues and cells should remain vigilant for the possibility of transmission of infection from donors. The identification of the possibility of transmission of a pathogen may occur at any point in the donation and transplant process. Once an actual or potential risk is identified there is a legal obligation to report that risk to the appropriate supervisory organisation.

In view of the time pressures implicit in organ transplantation, and the possibility of a multi-organ donor also being a tissue donor, laboratory testing of tissues may identify an infection risk to recipients of organs that have already been transplanted. It is also possible that an adverse incident arising from an organ transplant may identify an infectious risk not known at the time tissues were retrieved. There are cases of transmission of disease that could have been prevented had an adverse event in an organ recipient been linked appropriately to involved tissues from the same donor.

Where an infection in a transplant recipient indicates potential transmission from the donor, it is the duty of the clinician looking after the transplant recipient to ensure that this information is communicated to the relevant supervisory organisation in order that this information is disseminated to clinicians caring for the recipients of other organs, cells and tissues from the same donor.

In the setting of solid organ transplantation, it is mandatory to inform the duty office (hub) at the Directorate for Organ Donation and Transplantation (ODT), NHS Blood and Transplant (NHSBT). They will assist in ensuring that all relevant clinicians and tissue establishments are informed as well as co-ordinate central quality control processes and microbiological advice. Any involved tissue establishment must in addition undertake a risk assessment of tissues from the donor held in their inventory or, where these have been issued to clinicians, contact the clinicians and, if the tissues have not already been transplanted, undertake a tissue recall.

Where a donor-derived infection is detected in a tissue recipient, or there is concern about the potential transmission of donor-derived infection, the tissue establishment must inform all other tissue establishments where tissues or cells from the same donor have been processed in order to initiate, where necessary, a tissue recall, and, where the tissue donor also donated organs, the ODT duty office must be informed in order to assist in informing all relevant clinicians.

Where a potential for transmission exists, appropriate follow-up of all recipients must be undertaken:

1. It is essential that confirmatory testing be undertaken on the donor sample to confirm specificity of the serological reactivity and the likelihood of transmission.
2. A risk assessment should be undertaken to assess the susceptibility of the recipient to infection and to disease.
3. Advice should be sought and appropriate monitoring and or post-exposure prophylaxis administered to recipients.
4. Prophylaxis should also be considered for close contacts of the recipient where secondary transmission is possible.

It is good medical practice to make an appropriate referral for assessment of an infected living donor and close contacts of an infected donor, living or deceased.

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