Organ/part organ that cannot be transplanted into the intended recipient
When an organ is referred to in this paper we mean organ/part organ.
Issue date: 27 July 2011
HTA policy on the steps to take to prepare for when an organ/part organ cannot be transplanted into the intended recipient.
1. There are rare circumstances in which a living donor organ cannot be transplanted into the intended recipient.
2. The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplant Regulations) 2006 (the Regulations) are silent on the options available.
3. If a donor has not consented to donate the organ to another person the organ would have to be re-implanted or disposed of.
4. Whilst these cases are extremely rare (two cases in the last ten years), they have the potential to prove a risk to the organ donation programme, as the organ could be perceived to be wasted when it could have successfully been transplanted into an alternative recipient. This same risk exists for living liver lobe donors.
5. Legal advice was sought and four potential options were identified for cases where the organ cannot be transplanted into the intended recipient:
• organ can be transplanted into an alternative recipient;
• organ can be re-implanted into the donor (not appropriate for liver lobes);
• organ can be used for research; or
• organ can be disposed of.
6. The Authority has delegated the function of statutory approval for this group of cases, where the primary intention is for the donation to be directed, to the Executive.
7. Prior to this delegation, a panel of Members would have been required to assess these cases, as this type of donation would have been defined as a non-directed altruistic donation.
8. Legal advice indicated that this function could be delegated as it is the primary intention of the donor in these cases to direct their organ.
9. Under Section 5 of the Human Tissue Act 2004, 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 fine. In May 2011 we communicated this information to surgeons. In July 2011 we implemented changes to the Online Submission System (the secure system in which Independent Assessors submit reports to the HTA).
10. We have requested that all living organ donation units implement a new process to ensure that all living donors are asked their wishes on the alternate use of the organ in advance of surgery. The intended purpose of implementing this process is to ensure that organs are not “wasted”.
11. Surgeons should be aware of the donor’s choice prior to surgery and must follow this in the rare event that an organ cannot be transplanted into the intended recipient.
12. We have been in regular contact with NHS Blood and Transplant (NHSBT) throughout this process and the changes we have asked units to implement are supported by NHSBT.
Non-directed altruistic donors
13. In cases of non-directed altruistic donation, as the donor is not aware of the identity of the intended recipient prior to surgery, it would not be significant or change the classification of the donation, if the organ needed to be redirected to an alternative recipient. Where the donor is a non-directed altruistic donor, there is no requirement that this process is followed.
14. Advice and guidance has been provided to all transplant units detailing the steps to take to prepare for when an organ cannot be transplanted into the intended recipient.
15. This policy will be reviewed annually.