Thematic report on organ retention

2.1 We examined the number of deaths reported to COPFS and the number of different types of post-mortem examinations conducted over the past five years. Chart 1^[9] illustrates that the number of death reports received by COPFS has decreased since 2009. In 2009, there were 13,321 reports. This has steadily decreased to 10,226 in 2013. However, the number of invasive post‑mortems as a percentage of deaths reported has increased from 44% in 2009 to 59% in 2013. Part of the explanation may be due to the downward trend in the number of 'view and grant' examinations from 2009 to 2012 as illustrated in Chart 2.

Chart 1: Death reports received

Chart 2: Type of examination

2.2 We also examined data where organs were retained after the body had been released, including the number of cases, type of death, and type of organs retained as shown in Charts 3 to 5^[10].

2.3 The data shows that organs have been predominantly retained in two types of death - homicide and Sudden Unexpected Death in Infancy (SUDI)^[11].

2.4 What is evident from the data is that the number of organs retained following a post-mortem is extremely low. In recent years, the highest number of organs retained was five, in 2007.

2.5 Organs are more usually retained following a double doctor post-mortem with the brain being the most commonly retained, but even in double doctor post-mortems, they are retained in a very small proportion of cases each year (less than 1%) and none were retained in 2012.

Chart 3: Number of cases with organs retained

Chart 4: Type of death with organ retained

Chart 5: Type of organ retained

Chart 6: Number of organs retained compared to number of double doctor post-mortems

2.6 To place the extent of organ retention in context, in 2013 there were 5,105 post-mortems authorised by Procurators Fiscal. Of these 853 were forensic post-mortems. There were only three cases where organs were retained representing 0.351% of forensic post-mortems and 0.059% of all post-mortems conducted in 2013.

Recommendation 1

To ensure transparency COPFS should publish annually the number of organs retained after the deceased's body has been released. This information should be included in their publication scheme.

Legal Obligations

2.7 Prior to the Human Tissue (Scotland) Act 2006 coming into force^[12], the law on organ retention was vague and unsatisfactory for both medical practitioners and bereaved relatives. Public concern over the practice of organ retention resulted in an Independent Review Group on the Retention of Organs at Post-Mortem being established in 2000, chaired by Professor Sheila McLean, Professor of Law and Ethics in Medicine at Glasgow University. The Review Group published two reports containing a number of recommendations. A key recommendation in the final report was that the Human Tissue Act 1961 should be radically overhauled and replaced by new legislation. This resulted in the enactment of the Human Tissue (Scotland) Act 2006^[13] which remains the primary legislation governing the retention and use of organs following a post-mortem. The Act is supplemented by a number of regulations and orders^[14].

2.8 The Act deals with three distinct uses of human tissue: donation for transplantation, research, education or training and audit; the removal, retention and use following post-mortem examination; and for the purposes of the Anatomy Act 1984. The Act, recognising the importance for diagnostic and other purposes of retaining organs and tissue in post‑mortems instructed by the Procurator Fiscal, did not alter COPFS practices in instructing post-mortems.

2.9 The Act introduced the concept of authorisation for using tissue and organs no longer required for the purposes of the functions, or under the authority, of the Procurator Fiscal.

2.10 The Act provides that on receipt of notification^[15] from the Procurator Fiscal that a tissue sample is no longer required for the purposes of the functions of the Procurator Fiscal, it falls to be retained as part of the medical records of the deceased person^[16]. As such, nearest relatives will not routinely be asked about their preferences for disposal of tissue. Tissue samples can be used for the purposes of education, training or research, but only if specific authorisation from the nearest relatives has been obtained^[17].

2.11 Similarly, an organ no longer required for the purposes of the functions, or under the authority, of the Procurator Fiscal cannot be used for any other purpose, including research, without authorisation from the nearest relatives^[18].

2.12 The Act further provides that tissue samples and organs acquired from a Procurator Fiscal post-mortem prior to 1 September 2006 could continue to be used for the purposes of education, training and research without the need to obtain authorisation^[19].

Definition of an Organ

2.13 The Act clarifies that 'tissue' includes skin, a cornea and bone marrow and that 'tissue sample' includes any derivative of skin^[20] (which appears to include hair and nails) but it does not provide a definition of what constitutes an organ. To obtain some clarification, we referred to guidance and relevant documentation issued by other medical bodies^[21].

2.14 Taking account of the guidance, there is no dubiety that organs include any significant part of the body, including the brain, lungs and heart. There is less clarity, however, regarding the retention of limbs and parts of limbs.

2.15 The distinction in the Act between tissue and organs is perhaps reflective of the different emotional significance that they can have for nearest relatives. Applying that reasoning, we are of the view that significant parts of bones or limbs, not retained in paraffin blocks, would have similar emotional significance to organs for nearest relatives and given that retention of such parts is extremely rare, the best approach is to include limbs and parts of limbs within the definition of an organ. Whether bones and parts of limbs are included within any definition, there should be an agreed written understanding between COPFS and the pathology service providers on what constitutes an 'organ' requiring to be notified to the nearest relatives.

Recommendation 2

There should be an agreed written definition of what constitutes an 'organ' between pathology service providers and COPFS.

Retention of an Organ or Organs

2.16 In this report, all references to organ retention refer to the retention of an organ after the deceased's body has been released on the authority of the Procurator Fiscal. In other words, the deceased's body released for burial or cremation is not intact.

2.17 This should be distinguished from what has been described as 'temporary or short-term removal'. There are some cases where, as part of the post‑mortem examination, it is necessary for the pathologist to remove an organ from the body for a more detailed examination or specialist examination by another pathologist. In most cases the organ will be reunited within the body prior to the body being released to the nearest relative.

2.18 In certain circumstances, it may be necessary to retain both the body and organ for a longer period of time. The most common scenario is where there is suspected criminality and there may be a requirement for a defence post-mortem. Another possibility is where the nearest relative has requested that an organ is examined by a specialist, perhaps to establish if there are any genetic implications for other members of the family. The removal of the organ for examination in these circumstances has been described and recorded as 'temporary or short-term removal or retention'.

2.19 The use of such terminology is in our view unhelpful and can result in confusion. The removal of the organ for the purpose of further examination to assist in determining the cause of death is a necessary part of the pathologist's examination. The pathologist records the examination undertaken in every post-mortem and produces a post‑mortem report. Any specialist examination should either be referred to in the post-mortem report or in a supplementary report detailing the nature and findings of the examination.

2.20 It is very much the exception for an organ to be transported to a laboratory or mortuary other than where the post-mortem is held. If, however, it is required, all of the pathology service providers have outlined their transportation and audit arrangements and confirmed that in all such cases the location of any organ at any point will be tracked and recorded on their system.

2.21 If the further examination is likely to take more than a few days, the reason for the delay should be explained to the nearest relatives but if the organ is not retained separately from the deceased's body, it should not be categorised as a case in which an organ has been retained.

2.22 If, however, the nearest relatives express a preference for the body to be released without the organ being reunited with the body, perhaps for religious or cultural reasons, then the retention of the organ should be classified as organ retention and all the authorisation, notification and recording procedures completed.

Forensic Pathology

2.23 A significant finding of this review is the consensus among the pathology service providers that organ retention is now only likely to occur exceptionally. The overriding aim is to complete any examination of an organ prior to the deceased's body being released to the nearest relatives.

2.24 There are two factors underpinning the significant reduction in organs being retained. The first is cultural. Following heightened public concern over the retention of organs at Alder Hey Children's Hospital in Liverpool and the subsequent Inquiry, the distress caused to nearest relatives by retaining organs was plainly evident. As a consequence, the medical profession will only seek to retain an organ where it is necessary either to provide a direct benefit for the nearest relatives, for example to ascertain if there is any genetic disorder, or for the wider public interest, the most common situation being where there is a suspected homicide.

2.25 The second and more significant factor is advances in forensic pathology. Traditionally the main organs retained were lungs, hearts and brains. Lungs were retained to investigate whether the death was industrially related. However, samples from the lung are now sufficient for diagnostic purposes of this nature.

2.26 More recently, the two main groups of organs that have been retained are brains, particularly in relation to blunt force potential homicide and Sudden Unexpected Death in Infancy (SUDI) cases, and hearts, predominantly in relation to sudden cardiac deaths of children and young adults. The purpose of retaining hearts for cardiological screening is to investigate whether there are any genetic issues and to provide the nearest relatives with as much information as possible. Again, due to advances in forensic pathology, guidelines on Autopsy Practice issued by the Royal College of Pathology, including guidance on deaths with likely cardiac pathology, now emphasise and advocate retaining samples rather than retaining the whole heart for specialist examination^[22].

2.27 The most commonly retained organ is the brain for neuropathology examination. The main reason for retaining the brain was that it required a prolonged period of 'fixation'^[23] of usually four to six weeks prior to examination. However, medical developments have significantly reduced the time required for 'fixation' and for deaths where there is suspected criminality, the examination of the brain can now be undertaken within a considerably shorter time frame and in almost all cases within a three-week period. Given that there is likely to be a defence post-mortem in such cases, the examination can now be completed and the brain reunited with the body prior to it being released.

2.28 In non-criminal cases where the examination is to assist with establishing the cause of death, forensic pathologists and neuropathologists have worked together and developed excellent communication channels which have enabled samples to be taken for histological and other specialist examination within 24 hours of the brain being retained in 'fixative'^[24]. Accordingly, there is no need to retain the brain in such cases.

2.29 Greater awareness of cultural sensitivities and medical advances has significantly reduced the need in most cases to retain a whole organ following the release of the deceased's body and should result in the retention of organs authorised by COPFS occurring only in exceptional cases.

COPFS Guidance

2.30 Following the commencement of the 2006 Act, COPFS issued a circular^[25] to all staff. The circular summarised the main provisions of the Act, reminded staff of existing guidance and practices and reinforced procedures to be undertaken if an organ is retained following the deceased's body being released for cremation or burial.

2.31 This supplemented a circular^[26] issued in 2002 which provided specific guidance on communicating with bereaved relatives in deaths reported to the Procurator Fiscal and a summary of information relating to the retention of organs and tissue blocks with the options for their disposal.

2.32 In addition to the circulars, there is an abundance of COPFS guidance outlining appropriate procedures and best practice on dealing with nearest relatives when a death is reported to the Procurator Fiscal and detailed and specific guidance if a post-mortem is required and an organ has to be retained. The guidance has been regularly reviewed and updated and is available to staff on the COPFS Knowledge Bank^[27] .

2.33 Specifically, the Book of Regulations^[28] provides detailed information on various aspects of the investigation of deaths including organ retention. It states:

"Procurators Fiscal have a right and a duty to control the disposal of the body of any person who has died within Scottish jurisdiction while they make enquiries into the death. Where there is a requirement to retain an organ for further enquiry the nearest relative must be informed and arrangements must be made to provide for the disposal of the organ in accordance with the nearest relative's wishes."

"It is the duty of the Procurator Fiscal to provide services which meet the information needs of nearest relatives."

2.34 A 'Deaths Manual of Practice' provides additional legal and practical guidance on procedures to be adopted if it is necessary to retain an organ. It provides that:

• Arrangements should be put in place with local pathology service providers to ensure that the Procurator Fiscal is notified promptly in all cases where an organ is retained in the course of a post-mortem and where tissue blocks/slides are made. The Procurator Fiscal should be informed of the reason for the retention and an estimate of how long an organ will require to be retained.
• Liaison arrangements between the Procurator Fiscal and pathology service providers must be put in place to ensure that the Procurator Fiscal is notified, in writing, as soon as the analysis of any retained material has been completed.
• Thereafter, the Procurator Fiscal should confirm to the pathologist that the material is no longer required for the purposes of the investigation and authorise its release or continued retention, as appropriate, again in writing.
• In the case of organs, disposal should be in accordance with any reasonable wishes of the nearest relative.

Scottish Fatalities Investigation Unit (SFIU)

2.35 There has been a progressive move towards greater specialisation in the investigation of deaths in COPFS since 2010. Historically, such investigations were undertaken in every Procurator Fiscal office across Scotland under the direction of the local District Fiscal.

2.36 In 2010, the SFIU was launched. It is the national specialist unit responsible for investigating all sudden, suspicious, accidental and unexplained deaths. When launched, in its initial form in 2010, it assumed responsibility for policy at a national level with the investigation of deaths still managed at local level under the direction of SFIU.

2.37 In April 2012, as part of the restructuring^[29] of COPFS, SFIU assumed national responsibility for all matters related to deaths and post-mortems, including the initial investigation which previously would have been the responsibility of the local Procurator Fiscal. Within the new structure there are dedicated and knowledgeable staff situated in three geographic COPFS Federations - SFIU North, SFIU East and SFIU West.

2.38 SFIU deals with all non-suspicious deaths from the death being reported to COPFS to the point of closure. Their role is to investigate and prepare all death reports to the highest possible standard, to apply policy and practice consistently and to ensure that appropriate and timely decisions are taken in every case. Throughout their investigation SFIU will liaise with bereaved relatives to keep them fully informed of progress.

2.39 SFIU also delivers training on the role of the Procurator Fiscal in the investigation of deaths to various external stakeholders including the Police, Scottish Ambulance Service and newly qualified doctors.

2.40 To raise awareness of the role of COPFS in the investigation of deaths and to provide greater understanding of the duty of the Procurator Fiscal and, in particular, its interaction with those with 'protected characteristics' as defined in the Equality Act 2010^[30], the COPFS National Federation Equality Network held a conference in October 2013 on 'Communicating with the Procurator Fiscal in the Investigation of Sudden Deaths' for staff and external participants, including community groups. A session delivered by the Head of SFIU addressed organ and tissue retention. The conference received favourable feedback and the intention is to hold such conferences bi-annually.

2.41 There has been positive feedback from a number of stakeholders on the creation of specialist units to deal with deaths reported to the Procurator Fiscal. They report that there has been an improvement overall in the service they have received and, in particular, highlighted the advantages of having a dedicated point of contact.

Training

2.42 It is important that all staff dealing with the investigation of deaths and organ retention are fully familiar with the relevant guidance and approved practices.

2.43 There are a number of training modules provided by COPFS which contain guidance on organ retention. These include:

• 'Deaths 2'
• 'Retention of Organs and Samples Power Hour'
• 'Managing Communication with the Bereaved'
• 'On Call Homicide and On Call General'^[31]

2.44 The main training module referring to organ retention is the 'Deaths 2' module. It covers all areas including:

• When retaining organs may be necessary
• Liaison with the Pathologist
• How long organs are likely to be kept
• Authorising release of organs
• Liaison with nearest relatives
• Disposal options
• Paediatric post-mortems
• Human Tissue (Scotland) Act 2006
• Transplantation
• Consideration of public interest and preservation of evidence
• Consideration of cultural and religious needs

2.45 The 'Retention of Organs and Samples Power Hour' PowerPoint is compiled from relevant sections of the 'Deaths 2' module and was designed to be delivered at local offices. It provides an overview of issues relating to organ retention and is in a format to enable it to be delivered easily to all legal staff that provide on call cover and work in homicide units within the Federations.

2.46 With the exception of 'Managing Communication with the Bereaved', which is delivered by CRUSE Bereavement Care, training is delivered by experienced COPFS legal trainers, using real-life examples to provide a greater understanding of the issues that can arise.

2.47 Under the existing contracts between COPFS and the pathology service providers, there is a provision for pathologists to provide training to COPFS staff but this does not occur on a regular basis.

Good Practice

There should be a pathology input into training provided to SFIU.

2.48 The 'Deaths 2' module commenced in May 2009 and is designed for legal and precognition staff actively involved in, or who within the near future anticipate being involved in, the further investigation of deaths up to and including the preparation and conduct of Fatal Accident Inquiries. The course has received favourable feedback from those who have attended.

2.49 The 'Managing Communication with the Bereaved' course aims to assist staff to respond appropriately to family members' reaction to loss. Feedback from the evaluation of the course has indicated that a counselling element to the training would be helpful to enable staff to provide better support to nearest relatives at difficult meetings^[32].

2.50 Attendance on the courses is not mandatory but agreed by individual members of staff with their line managers.

2.51 Table 1 provides a breakdown of SFIU staff attendance on the two main courses up to April 2014.

Table 1: Attendance at training courses

2.52 As shown, only 44% of the SFIU legal staff have attended the 'Deaths 2' course and 37% of all SFIU staff have attended the 'Managing Communication with the Bereaved' course.

2.53 Given the specialist nature of the investigation of deaths, it is essential that all members of SFIU and other specialist units that deal with fatalities, such as the Health and Safety Division, are fully informed and equipped to deal with such work and that those involved in the investigation of homicides should have an awareness of the main issues.

Recommendation 3

Attendance on the 'Deaths 2' module and the 'Managing Communication with the Bereaved' course should be mandatory for all staff in the Scottish Fatalities Investigation Unit (SFIU) and other specialist units that deal with fatalities, such as the Health and Safety Division. The training should be completed by legal staff within three months of joining SFIU or other specialist unit.

Good Practice

Completion of the 'Retention of Organs and Samples Power Hour' should be included as a specific personal development objective within performance agreements for all legal staff who deliver on-call services and work in homicide teams.