Human Tissue Authority

The regulator for human tissue and organs

Organ/part organ that cannot be transplanted into the intended recipient

Below are the steps transplant units should take to prepare living organ donors for the very rare possibility that their organ/part organ (which is otherwise transplantable), cannot be transplanted into the intended recipient. The purpose of this process is to ensure that living donor organs are not “wasted”.

The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplant Regulations) 2006 (the Regulations) requires the donor’s consent for a specified purpose. 

Under Section 5 of the Human Tissue Act 2004 (the HT Act), if a surgeon proceeds to redirect an organ to an alternative recipient without the consent of the donor, this may be a criminal activity. A person guilty of an offence under Section 5 is liable to imprisonment for up to a year and/or a Where a donor has not consented to donate the organ to an alternate recipient, or to research, the organ would have to be re-implanted or disposed of. This is because consent would not be in place for the re-direction to occur.  Whilst this situation is extremely rare there is a potential risk to the living organ donation programme, as viable organs could be wasted where the donor’s decision is not known in advance of the surgery.

 

All transplant units should ensure that living donors are asked their wishes on the alternative use of the organ in advance of surgery. The donor’s wishes must be documented in section five of the statutory referral letter. Transplant Units must ensure that their discussion with the donor is clear and explains that this specifically relates to the scenario where the organ, which is otherwise transplantable, however, cannot be transplanted into the intended recipient.

 These are the available options:

  • organ can be transplanted into an alternative recipient waiting for a transplant on the national waiting list;
  • organ can be re-implanted into the donor (this option is not appropriate for liver lobes; In addition, paired/pooled donors and non-directed altruistic donors are advised that this may not always be possible if their organ is already being transported);
  • organ can be used for research or
  • organ can be disposed of.

Surgeons must follow the donor’s wishes in the rare event that the organ cannot be transplanted into the intended recipient.

The donor’s wishes are also discussed during the interview with the Independent Assessor (IA) and recorded in the report submitted to HTA. If the donor has not made a decision or was not provided with the relevant information the LDC (Living Donor Coordinator) should be informed before the interview.  It is not the IA’s responsibility to provide information to donors about the options available. LDCs should ensure, where possible, that the donor has made a decision in advance of their interview. If a donor is undecided about their wishes at the time of referral this should be documented under section five of the referral letter. If the donor is still undecided following the interview with the IA, the IA should document this in their report to the HTA.

In cases of NDAD, the donor has already given consent for their organ to go to an unknown recipient. The HTA considers it unlikely for a NDAD to choose any other option other than re-direction of their organ to another recipient.  As good practice, transplant teams should also seek consent from the donor to use their organ for research if the organ is damaged during retrieval and cannot be transplanted. The consent must be filed in the donor’s medical notes. This is important to ensure that where the organ cannot be utilised for transplantation, there is valid consent in place for it to be used for research.

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