Organ and tissue donation: COPFS and SDTG agreement

Terms of Agreement

General

In any case of proposed donation after circulatory death, once a decision to withdraw life-sustaining treatment has been reached, the Procurator Fiscal 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 Procurator Fiscal (see Annex 1, which gives details of which deaths, or prospective deaths, must be reported to the Procurator Fiscal). Similarly, if the death of a Brain Stem Dead donor needs to be reported to the PF, the death must be reported before any organ donation can take place.

DBD

It is not essential that the cornea, tendons, heart valves or skin be removed immediately upon death and no special procedure is necessary in this case.

• Organs must be removed very soon after death if they are to be viable. Medical authorities must inform the Procurator Fiscal of any proposed retrieval procedure in appropriate cases as soon as possible after death is confirmed, seeking a decision at the earliest possible moment.

Where there is doubt about the appropriate Procurator Fiscal, the initial contact will be with the District Procurator Fiscal for the District in which the hospital is situated. Contact numbers and an organisational chart are given in Annex 2. The Procurator Fiscal will then either:

decide whether the retrieval should proceed; or make enquiry to establish who is the appropriate Procurator Fiscal to consider the retrieval request.

Procurators Fiscal will immediately instruct any necessary enquiry by the police into the circumstances, so that they may decide whether to consent to the retrieval when death occurs.

Where no objection is made to organ retrieval, it is the responsibility of the Procurator Fiscal to ensure that sufficient evidence is available for any subsequent criminal proceedings or Fatal Accident Inquiry.

It will be necessary to take steps to ensure it can be established that the death has not been caused, or contributed to, by the retrieval procedure.

If there is uncertainty as to whether the retrieval operation could affect evidence, the Procurator Fiscal shall ask the Specialist Nurse for Organ Donation (SN-OD) to put him or her in touch with the senior transplant surgeon on the organ retrieval team to discuss the operation plans and co-operate with any requirement for pathological investigation.

If it is felt that discussions should be assisted by involving a pathologist, the on-call forensic pathologist should be contacted and may attend the retrieval if required.

The following procedure should be adopted in hospitals:

• The retrieval operation will not begin until the 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.
• 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.

The above procedure ensures that if the Procurator Fiscal 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

Anyone dying in hospital is a potential DCD organ or tissue donor unless they have a medical contraindication or there is no authorisation for donation. The Fiscal'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 24 hours (exceptionally 48 hours) after death.

Category II DCD

The following information is taken from the policy document underpinning the pilot programme in NHS Lothian, with the intention that it should be adopted in other parts of Scotland in due course. The fundamental principles underlying the pilot are:

• It relates only to those aged between 16 and 70 who have a witnessed cardiac arrest, for whom all attempts at resuscitation prove unsuccessful and for whom it is subsequently found that authorisation for organ donation exists;
• There is complete separation of the resuscitation process from any consideration of organ donation;
• The donation pathway is triggered only after referral is made by Emergency Department staff and the Fiscal gives consent in terms of section 5 of the HT(S) 2006 Act; and,
• The surgical team will attend the donor only after death is pronounced by the ED consultant in charge.

Should organ donation not prove possible, existing arrangements for tissue donation in the Emergency Department at the RIE will go ahead in appropriate circumstances.

There may be cases where resuscitation is successful initially, and the patient is transferred to an Intensive Care Unit (ICU). Should treatment in the ICU subsequently prove futile, the patient might then go on to become a Category III DCD donor, in which case the arrangements below will apply.

The following is the procedure adopted in hospitals:

• The retrieval procedure will not be commenced until the death of the potential donor has been established by medical staff independent of the transplant team;
• The medical staff will, if required, give evidence to prove 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 pathologist in the event of a post-mortem examination, should the pathologist wish to see them. The retrieval surgeon will also be available for court purposes, if required.

The above procedures ensure that if the Procurator Fiscal then decides to request a post mortem; evidence will be available to prove that the retrieval operation did not contribute to the death of the potential donor.

Category III DCD

In the majority of these cases, patients will have been admitted to an Intensive Care Unit (ICU) and given full life support. After hours or days of care, it may become clear that further treatment is futile and therefore not in the patient's best interests. With the agreement of the family, 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 can be pronounced. The Specialist Nurse-Organ Donation (SNOD) will have checked whether the person had put his or her name on the NHS Organ Donor Register, or otherwise given self-authorisation during his or her lifetime for the donation of organs or tissue after death. If such self-authorisation does not exist, there can be discussion with the nearest relative to obtain authorisation for donation. The circumstances will have been discussed with the Procurator Fiscal in appropriate cases. The retrieval team will have been alerted and will be present to preserve or remove organs or tissue.

It is for Emergency Medicine or Critical Care teams to identify all potential patients for DCD donation and contact the SN-OD. Guidance on legal issues relevant to DCD, as set out in CMO Letters (2010)11 and (2012)08 should be followed.

• The SN-OD 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 Procurator Fiscal 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 Procurator Fiscal in advance whenever the death has to be reported to the Procurator Fiscal. It is also good practice to do this in the case of tissue donation. In general, a Procurator Fiscal, after suitable enquiry, will be able to give a view as to whether or not consent will be given to organ retrieval after death, assuming there is no change in relevant circumstances. Medical authorities must inform the Procurator Fiscal of any proposed retrieval operation in appropriate cases as soon as possible. Where there is doubt about the appropriate Procurator Fiscal, the initial contact will be with the District Procurator Fiscal for the District in which the hospital is situated. Contact numbers and an organisational chart are given in Annex 2. That Procurator Fiscal will then either:
  • decide whether the retrieval should proceed; or
  • make enquiry to establish who is the appropriate Procurator Fiscal to consider the retrieval request.
• Thereafter, the case will proceed to donation if consent is given by the Fiscal in terms of section 5 of the Human Tissue (Scotland) Act 2006.