Thematic report on organ retention

Investigation of Deaths by the Procurator Fiscal

1.1 One of the three strategic objectives of COPFS^[2] is to investigate deaths which require further explanation. This includes all sudden, suspicious, unexpected and unexplained deaths and any deaths occurring in circumstances which give rise to serious public concern. In other parts of the United Kingdom, the Coroner^[3] may investigate such deaths. The primary purpose of the investigation is to ascertain a cause of death although there are a number of other aims of the investigation including:

• to ensure any criminality is discovered and prosecuted
• to allay public anxieties about particular deaths
• to alert family members to any genetic causes of death which may be avoidable
• to maintain accurate death statistics

1.2 COPFS' objectives in the investigation of deaths include:

• securing the confidence of diverse communities
• prioritising the prosecution of serious crime
• providing services that meet the information needs of nearest relatives
• ensuring that all reported deaths are investigated properly in a reasonable time

1.3 Deaths are most commonly reported to the Procurator Fiscal by hospital doctors, General Practitioners (GP) and the police. Once a death has been reported, the Procurator Fiscal has legal responsibility for the deceased's body, usually until a death certificate is provided by a doctor. If initial investigations do not identify a cause of death, or if a cause of death is believed to be known but there are other concerns surrounding the death, a post-mortem examination (also known as an 'autopsy') may be instructed by the Procurator Fiscal.

1.4 Post-mortems instructed by COPFS fall into two different categories - forensic or non-forensic post-mortems. A non-forensic post-mortem examination is generally performed to confirm the cause of death due to natural causes and where no court proceedings are likely. Forensic post‑mortem examinations are carried out where it is suspected that the death is not from natural causes (e.g. accidental, homicidal, suicidal, where there is evidence of violence) and in cases, including death by natural causes and death while under medical care, where a prosecution or Fatal Accident Inquiry (FAI) may be pursued through the courts. The examination may take different forms. The most common types of post-mortems are:

• A non-invasive visual examination by a pathologist taking account of the deceased's medical history and the known circumstances of the death. This is commonly referred to as 'a view and grant'.
• A full post-mortem which examines all parts of the body including internal areas conducted by a single pathologist.
• A full post-mortem conducted by two pathologists. This is often referred to as a 'double doctor' or 'two doctor' post-mortem and is most likely to be conducted in cases where there is suspicion that the cause of death is of a criminal nature and there is a likelihood of criminal proceedings.

1.5 If a forensic post-mortem is instructed, it will be performed by two pathologists.

1.6 COPFS deals with the investigation of on average 12,000 deaths^[4] every year and over the last five years has on average instructed a post-mortem examination in 49%^[5] of cases reported.

1.7 In most cases, the post-mortem examination involves the retention of tissue samples or fluids for laboratory examination and in a few cases it may be necessary for the pathologist to retain a whole organ for more detailed or specialist examination. In a very small percentage of such cases, it may be necessary to retain the organ for further examination after the deceased's body has been released.

1.8 It is the procedures and governance arrangements in cases where an organ or organs have been retained for further examination, after the deceased's body has been released, with which this report is concerned. In such cases COPFS will rely upon the pathologist's expertise and professional judgement. The consent of the nearest relative is not required to remove or retain organs or human tissue following a post‑mortem examination instructed by the Procurator Fiscal. This differs from NHS hospital instructed post-mortems.

Hospital Post-Mortems

1.9 This review only covers post-mortem examinations instructed by the Procurator Fiscal. Other post-mortem examinations, commonly referred to as 'hospital' post-mortem examinations, are not considered in this report. Hospital post-mortems are normally undertaken to provide information on potential genetic disorders in the interests of the nearest relatives. Such post-mortems are regulated by the Human Tissue (Scotland) Act 2006 (The Act). The Act sets out the purposes for which a hospital post-mortem examination may be undertaken^[6] and provides a framework designed to ensure that all such post-mortems and retention of tissues and organs are only carried out with proper authorisation being obtained^[7]. Undertaking a post-mortem without proper authorisation can constitute a criminal offence^[8].

Aims and Objectives

1.10 The aims and objectives of this inspection were:

• To review and assess the governance and accountability arrangements regarding the retention of organs.
• To assess compliance with legal and agreed policies and protocols including arrangements for liaison with nearest relatives.
• To scrutinise the audit processes to ensure they are sufficiently robust and that the system is fit for purpose.
• To identify any weaknesses in the systems governing organ retention within COPFS and associated pathology laboratories and make recommendations.

Methodology

1.11 The review was carried out using a number of accepted techniques including:

• A review of all relevant legislation.
• A review of relevant departmental internal and external protocols and guidance.
• Visits and interviews with all COPFS pathology service providers.
• Interviews of relevant persons involved in the investigation of deaths within COPFS.
• Examination of case papers.
• Visits and interviews with those involved with the provision of pathology services in other jurisdictions including the Forensic Pathology Unit at the Home Office and the State Pathologist in Northern Ireland.

Acknowledgement

1.12 We are grateful to everyone who facilitated our visits and shared their experiences and current procedures regarding the removal, use of and disposal of human tissue and organs.