Organ and tissue donation: agreement between the Crown Office and Procurator Fiscal Service and the Scottish Donation and Transplant Group

Terms of Agreement

General

2.1 In any case of proposed donation after circulatory death, once a decision to withdraw life-sustaining treatment has been reached, the PF should be consulted in advance of proposed treatment withdrawal if there is reason to believe that the death would need to be reported to the PF^[4]. Similarly, if the death of a brain-stem dead potential donor needs to be reported to the PF, the death must be reported before any organ or tissue donation can take place.

2.2 The Specialist Nurse for Organ Donation (SNOD), Specialist Requester (SR) or Tissue Donor Coordinator (TDC) will have checked whether the person had joined the NHS Organ Donor Register, or otherwise given express authorisation during his or her lifetime, for the donation of organs and/or tissue after death. If such express authorisation does not exist, there needs to be discussion with family members or friends to establish whether authorisation can be deemed or (if the potential donor is in an excepted group) to obtain authorisation for donation from the nearest relative. A valid authorisation is required to permit donation to proceed and express, deemed, and nearest relative authorisation are all equally valid types of authorisation.

2.3 The 2019 Act permits the sharing of a person's donation decision recorded in the register, or the fact of the absence of such a recorded decision, with certain people. Aside from the potential donor's family members or others consulted about their views, this information may only be shared with certain people to carry out functions under the Act which relate to the removal and use of a body part for the purpose of transplantation. These are registered medical practitioners, retrievers or health workers carrying out enquiries about the potential donor's views.

2.4 Organs must be retrieved soon after death if they are to be viable. Medical authorities must inform the PF of any potential organ donation in appropriate cases as soon as possible after either brain-stem death is confirmed or the decision is reached to withdraw life sustaining treatment, seeking a decision at the earliest possible moment.

2.5 Corneas can be donated up to 24 hours after death, while tendons, heart valves and other tissue can be donated up to 48 hours after death.

2.6 The PF will consider whether the retrieval should proceed. In order to make an informed decision, the PF may instruct the police to make enquiries into the circumstances, so that they may decide whether to consent to the retrieval following death. The PF may also wish to discuss the circumstances with the doctor in charge, the SNOD or TDC, or the on-call pathologist.

2.7 Where no objection is made to organ and/or tissue retrieval, it is the responsibility of the PF to ensure that sufficient evidence is available for any subsequent criminal proceedings or Fatal Accident Inquiry. This includes ensuring that the time of death can be confirmed followed by confirmation of the time of the retrieval operation commencing. This will ensure confirmation that the donor's death has not been caused, or contributed to, by the retrieval procedure.

2.8 If there is uncertainty as to whether, subsequent to death, the retrieval operation could affect evidence, the PF shall ask the SNOD and/or TDC to put him or her in touch with the senior retrieval surgeon on the organ retrieval team or tissue retrieval staff to discuss the operation plans and ensure cooperation with any requirement for pathological investigation.

2.9 If it is felt that discussions should be assisted by involving a pathologist, the on-call forensic pathologist should be contacted for advice.

2.10 Organ donors may also donate tissues post-organ retrieval. Such a tissue retrieval process takes place in a separate second procedure at a later time point, usually in the mortuary. The tissue retrieval staff will also be able to provide any information that may be required by the PF pathologist if there are any queries about findings at the tissue retrieval procedure.

DBD

2.11 The following is the procedure adopted in hospitals:

• The retrieval procedure will not be commenced until the brain-stem death of the potential donor has been established by two senior doctors independent of the transplant team.
• These doctors will, if required, give evidence to that effect, to provide proof that the death of the donor was not caused by the retrieval operation; and
• The retrieval surgeon will detail the operative procedure and any other findings in the patient's medical records, which will be available for the autopsy pathologist should they wish to see them. The retrieval surgeon will also be available for court purposes, if required.

2.12 The above procedure ensures that if the PF then decides that a post-mortem examination is necessary, evidence will be available to prove that the retrieval operation did not contribute to the death of the donor.

DCD

2.13 Anyone dying in hospital is a potential DCD organ and/or tissue donor unless they have a medical contraindication or there is no authorisation for donation (either deemed or from the individual or their nearest relative). The PF's consent for DCD organ donation is required before death occurs. This does not apply in the case of tissue donation, as tissue can be retrieved up until 48 hours (24 hours for cornea donation) after death so the PF's consent for tissue donation can be obtained either before or after death, but before the retrieval procedure starts.

2.14 In the majority of cases, patients will have been admitted to an Intensive Care Unit and given full life support. After hours or even days of care, it may become clear that further treatment is not in the patient's overall best interests. With the agreement of the family (or occasionally the patient themselves), a decision may then be taken to withdraw all life-sustaining treatment. Once life-sustaining treatment has been withdrawn, cardio‑respiratory arrest will occur after an interval, following which death will be pronounced. The circumstances will have been discussed with the PF in appropriate cases. The retrieval team will have been alerted and will be present/available to preserve or retrieve organs and/or tissue.

2.15 It is for Emergency Medicine or Critical Care teams to identify all potential patients for DCD donation and contact the SR, SNOD or TDC.

• The SR/SNOD will confirm that there are no medical contraindications to donation. This will assist the decision as to whether the death should be reported to the PF in advance;
• Because of the need to commence organ preservation or donation immediately after death in the case of DCD, it is essential to discuss the circumstances with the PF in advance whenever the death has to be reported to the PF. It is also good practice to do this in the case of tissue donation. In general, a PF, after suitable enquiry, will be able to give a view as to whether or not consent will be given to organ or tissue retrieval after death, assuming there is no change in relevant circumstances. Medical authorities must inform the PF of any proposed retrieval operation in appropriate cases as soon as possible;
• Thereafter, the case will proceed to donation if consent is given by the PF in terms of section 5 of the Human Tissue (Scotland) Act 2006.
• As for DBD donors, the retrieval surgeon (or team in the case of tissue donation) will detail the operative procedure and any other findings in the patient's medical records, which will be available for the autopsy pathologist should they wish to see them. The retrieval surgeon or team will also be available for court purposes, if required.

Paediatric and Neonatal Donation

2.16 It is also possible for organ and/or tissue donation to occur from children and even babies from the age of at least 36 weeks corrected gestational age^[5]. Like adults, children and babies can potentially be either DCD or DBD donors and the procedures to be followed in seeking consent from the PF for paediatric or neonatal donation to proceed are the same as those set out above for adult potential donors.

2.17 However, in some cases, particularly in the case of neonates, it may be more likely that a death needs to be reported to the PF as the cause of the baby's death/ anticipated death is unclear. In such cases, it may not be possible for the PF to consent to donation proceeding where it is considered likely that the retrieval procedure may make it impossible to confirm the cause of death at post-mortem examination, depending on the details of the individual case. The PF will nonetheless consider the individual circumstances in each case.

How to contact the Procurator Fiscal

2.18 The Scottish Fatalities Investigation Unit (SFIU) is a specialist unit within the Crown Office and Procurator Fiscal Service (COPFS). SFIU has responsibility for receiving reports of deaths occurring in Scotland which are sudden, suspicious, accidental or unexplained.

2.19 There are three SFIU teams in Scotland based in the North, East and West. Each team comprises of a number of legal and administrative staff.

2.20The SFIU North team has staff located in Dundee, Aberdeen and Inverness. The SFIU East team is based in the Procurator Fiscal's office in Edinburgh and the SFIU West team is based in the Procurator Fiscal's office in Glasgow.

2.21 The death should be reported to the SFIU team in whose area the significant event leading to the death occurred. Annex 1 provides contacts for each team. Please note that where a death or expected death needs to be reported out of normal office hours, the homicide out of hours Procurator Fiscal should be contacted. SNODs/SRs can provide the relevant contact details.

2.22 Information for bereaved relatives on the role of PF in the investigation of deaths can be found on the COPFS website^[6].