Organ and tissue donation - authorisation requirements: guidance

Chapter 1: Introduction

1. Deceased organ and tissue donation is a unique act of generosity which has the potential to greatly enhance or save the life of a person receiving a transplant. The donation system relies on public trust and confidence in order for it to function and provide the life-saving and life-enhancing transplants it has the potential to. Key to this is the lawful fulfilment of the donor's decision, but also sensitive support of the donor's family who are involved as part of end of life care.

2. A core principle in current good practice, enshrined in the new duty to inquire under the Human Tissue (Authorisation) (Scotland) Act 2019^[1] ("the 2019 Act"), is that health workers should make every effort to establish the decision or views of the potential donor, and then to support their decision being fulfilled.

3. Each scenario surrounding a donation is unique and it is impossible to be prescriptive about precisely what should happen in every case. It is the role of practitioners to balance the information available to them and reach a judgement about whether it is lawful and appropriate for donation to proceed. This guidance makes clear that the presence of authorisation permits organ and tissue donation to take place, but does not mandate that it must. Sometimes a clinician will reach the judgement that although the legal basis to proceed with donation is in place, the broader considerations involved mean that it should not go ahead.

4. Further, in limited circumstances, the risks to public confidence in the donation process may outweigh the benefits of proceeding with donation. In these limited circumstances, this guidance outlines that donation should not proceed even though the law permits it.

Purpose and scope of this guidance

5. In Scotland, deceased donation is governed by the Human Tissue (Scotland) Act 2006^[2] ("the 2006 Act"). The 2006 Act was amended by the 2019 Act, the primary aim of which was to introduce a system of deemed authorisation for transplantation and to provide clarity on the approach to authorisation and carrying out of medical procedures to facilitate transplantation (known as 'pre-death procedures'). References in this guidance to the "HTS Act" are to the 2006 Act, as amended by the 2019 Act. This guidance applies from 26 March 2021 when the 2019 Act comes into effect.

6. Before organs and tissue can be removed and used for any of the purposes^[3] set out in the HTS Act, and before a pre-death procedure may be carried out, authorisation for that activity must be in place. This guidance advises practitioners on how to ensure the necessary authorisation is in place for such activity to be undertaken in accordance with the HTS Act.

7. This guidance is not intended to be prescriptive about what should happen in every scenario. It provides guidance about the HTS Act and aims to assist the reader in making an assessment of whether authorisation for donation activities is in place and whether other relevant legal requirements have been fulfilled.

8. This guidance relates to the removal and use of organs and tissue for deceased donation only and relates only to Scotland. This guidance should be read in conjunction with the HTS Act. It is not, and is not intended to be, a comprehensive description of the Act, nor a substitute for seeking legal advice in complex cases.

Who this guidance is for

9. This guidance is for those involved in the donation process, particularly those involved in the authorisation process, who will be Specialist Nurses for Organ Donation (SNODs), Specialist Requestors (SRs) or Tissue Donor Coordinators (TDCs, also sometimes referred to by NHS Blood and Transplant (NHSBT) as "Specialist Nurses for Tissue Donation"). It is also relevant to those who are carrying out, or authorising others to carry out, pre-death procedures and those carrying out retrieval of organs and tissue. Guidance for those who refer potential donors is also included.

Interpretation and navigation

10. An interpretation section is included at Annex A, which details some of the terms used throughout this guidance.

11. The guidance includes the following chapters which cover the key stages in the donation process, as relevant to the HTS Act, shown in figure 1.

Figure 1: Outline of key stages in the donation process, as relevant to the HTS Act

• Checking whether authorisation is in place for donation
• Checking the potential donor's latest views about donation and abou pre-death procedures
• Seeking authorisation for donation and pre-death procedures (where applicable)
• Carrying out pre-death procedures
• Retrieval of organs/ tissue

Chapter 1 – Outlines broad principles and the purpose and scope of this guidance

Chapter 2 – Provides guidance on the new principles introduced by the 2019 Act.

Chapter 3 - Provides an overview on the role of the potential donor's family and the relevance of faith and beliefs in the context of the HTS Act, as well as details of different types of donation.

Chapter 4 – Referral is not part of the HTS Act, but for completeness, chapter 4 provides information on the process for those areas of the NHS which might refer potential donors.

Chapter 5 – Explains how donation can be expressly authorised and how opt-out declarations are made.

Chapter 6 – Provides guidance on establishing whether or not donation is authorised, including on establishing whether authorisation can be deemed under the HTS Act. It also provides guidance on establishing the views of the potential donor.

Chapter 7 – Provides guidance on the circumstances in which authorisation may be given on behalf of the potential donor.

Chapter 8 – Provides guidance on the legal requirements around the authorisation and carrying out of pre-death procedures.

Chapter 9 – Provides guidance on the requirements which must be fulfilled before retrieval can take place and the related offences.

Annex A – Explains various terms in the HTS Act

Role of the Crown Office and Procurator Fiscal

12. There is an existing agreement^[4] between the Crown Office and Procurator Fiscal Service and the Scottish Donation and Transplant Group in relation to Organ and Tissue Donation regarding the Procurator Fiscal's role in consenting to organ and/or tissue donation proceeding in cases where a patient's death needs to be reported to the Procurator Fiscal. This agreement reflects the 2019 Act and should be referred to for more details.

Principles

• Where there is reason to believe that a death should be reported to the Procurator Fiscal, no parts of a body may be removed without the Procurator Fiscal's prior consent.^[5] Where consent has been given verbally, this should be confirmed in writing, for example by email, as soon as is reasonably practicable. The guidance entitled 'Reporting deaths to the Procurator Fiscal - Information and Guidance for Medical Practitioners' provides details of the categories of deaths which must be reported to the Procurator Fiscal.^[6]
• The Procurator Fiscal will normally permit removal of organs and/or tissue, subject to the need to ensure that sufficient evidence is available for any criminal proceedings or Fatal Accident Inquiry.
• In any case of proposed organ (and tissue) donation after circulatory death (DCD), 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.
• Similarly, if the death of a brain-stem dead organ donor or a tissue only donor needs to be reported to the Procurator Fiscal, the death must be reported before any donation can take place.

Points to consider

13. The SNOD/SR/TDC or hospital medical staff must inform the Procurator Fiscal of any potential organ and/or tissue donation in appropriate cases as soon as possible.

14. The Procurator Fiscal may wish to discuss the particular circumstances of the case with the doctor in charge, the SNOD/SR/TDC or the crown/fiscal pathologist.

15. If there is uncertainty as to whether, subsequent to death, the retrieval operation could affect evidence, the Procurator Fiscal may ask the SNOD/SR/TDC to put him or her in touch with the senior retrieval surgeon on the organ retrieval team and/or tissue retrieval staff to discuss the procedure/operation plans and ensure co-operation with any requirement for pathological investigation.

How to contact the Crown Office and Procurator Fiscal Service

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

17. There are three SFIU teams in Scotland. The 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. The death should be reported to the SFIU team in whose area the significant event leading to the death occurred:

North

Telephone: 0300 020 2387

Email: SFIUNorth@copfs.gov.uk

East

Telephone: 0300 020 3702

Email: SFIUEast@copfs.gov.uk

West

Telephone: 0300 020 1798

Email: SFIUWest@copfs.gov.uk

18. Where a death or expected death needs to be reported out of normal office hours, the homicide out of hours Fiscal should be contacted. SNODs/SRs can provide the relevant contact details. For more information on the Crown Office and Procurator Fiscal Service.

Use of organs and tissue outside of Scotland

19. The use of organs and tissue for transplantation or other purposes in other parts of the UK or elsewhere is regulated by legislation in those respective jurisdictions. Organs and tissue retrieved lawfully in Scotland in accordance with the HTS Act - including those retrieved on the basis of deemed authorisation - may be transported to other parts of the UK or elsewhere and utilised there, provided that any relevant statutory and regulatory requirements are met in the relevant jurisdiction. Subject to those same conditions, organs and tissue lawfully retrieved in other parts of the UK or elsewhere are able to be used in Scotland for the purposes specified in the HTS Act.