90 The Review Group is aware of the important need to distinguish between the hospital and the Fiscal post-mortem examination, as well as to ensure that the two types of examination are treated similarly, so far as issues relating to organ retention are concerned. It is pleased to have had the opportunity to look again at this topic. The Review Group believes that a proper understanding of the Fiscal post-mortem examination system is essential to the restoration of public confidence, which in turn is needed in order to achieve an appropriate number of hospital post-mortem examinations in Scotland.
BACKGROUND
91 We indicated in our Preliminary Report (published 6 February 2001) that we had concerns about the confusion in the public mind between hospital and Fiscal post-mortem examinations, and that everything possible should be done to remove that confusion. The Preliminary Report also highlighted the need for improvements in respect of the handling of Fiscal post-mortem examinations, particularly in terms of communications with families. It identified two main areas where there was lack of clarity about the roles of hospital and Fiscal staff. One was communicating with families where a death in hospital might require a Fiscal post-mortem examination. The other was communication between Fiscals and pathologists in respect of retention of organs and tissue.
92 The Preliminary Report, therefore, contained a series of recommendations addressed to the Lord Advocate. These were referred formally to him by the then Minister for Health & Community Care on 9 May 2001. The Lord Advocate replied on 13 June 2001, indicating that the recommendations had been considered, and revised guidance would be issued.
93 As the Crown Office and Procurator Fiscal Service (COPFS) leaflet for bereaved relatives explains, the Procurator Fiscal has a duty to investigate all sudden, suspicious, accidental, unexpected and unexplained deaths and any deaths occurring in circumstances which give rise to serious public concern. Where a hospital doctor or GP is unable to determine the cause of death, he or she will report the death to the Procurator Fiscal. If the Fiscal decides that a post-mortem examination is necessary to determine the cause and circumstances of death, he or she can instruct the carrying out of that examination. The authorisation of the relatives is not required. This is one of the key distinguishing factors between the Fiscal post-mortem examination and the hospital post-mortem examination. Fiscal post-mortem examinations are carried out by pathologists acting on the instructions of the Fiscal, regardless of the basis on which they are employed.
94 This section of the Review Group's report concentrates on three main issues:
COMMUNICATIONS WITH RELATIVES
95 In paragraph 86 of its Preliminary Report, the Review Group noted that the Crown Office was revising the information which should be made available to bereaved relatives about post-mortem examinations instructed by the Procurator Fiscal. COPFS has provided the following update:
96 In paragraph 87 of its Preliminary Report, the Review Group pointed out that when a post-mortem examination is instructed by the Procurator Fiscal, the question of seeking the relatives' authorisation did not arise. However, this did not diminish the need to make sure that relatives are informed, as fully as is consistent with the Fiscal's role in the administration of justice, of the nature and purpose of the post-mortem examination. Verbal information should always be supplemented by written information which relatives can take away with them. All members of staff involved in informing relatives of post-mortem procedure should possess the skills necessary to conduct sensitive discussions. They should have had appropriate training in Fiscal post-mortem procedures and in dealing with the bereaved, and should have sufficient relevant experience to support this. The role of relatives' support groups in providing such training should be borne in mind, and the physical surroundings in which such discussions take place should be appropriate to the sensitivity of the situation.
97 COPFS have provided the following update in respect of these recommendations:
* A number of training events have been organised for legal staff including:
98 In paragraph 88 of its Preliminary Report, the Review Group recommended that the Fiscal should explain to the family the reasons for requiring a post-mortem examination, including which organs will or may be removed and/or retained, as soon as this is known. Where relatives object, the Fiscal should explain clearly why the post-mortem must proceed. When objections are made, the Fiscal needs to be clear whether these are based on religious belief, and, if so, to decide the extent to which those beliefs can be accommodated, given the circumstances of the particular case. If the relatives wish, the Fiscal should be prepared to hold a meeting with them to explain the need for a post-mortem examination. In particular, it is the Fiscal's responsibility to make clear that organs can only be retained after a Fiscal post-mortem examination for the purposes of determining the cause of death and other related matters. Fiscals should make clear to relatives what will be done with these organs once this process is completed and should inform relatives clearly about disposal options, including the possibility of returning the organs to the relatives and delaying funeral arrangements in order to permit the retained organs to be reunited with the body. Where appropriate it should be made clear to relatives that continued retention of organs, blocks and slides may be necessary for legal purposes.
99 COPFS have provided the following update on these recommendations:
100 In paragraph 89 of its Preliminary Report, the Review Group noted that Regional Fiscals already have a role in auditing the practices of individual Fiscals, and indicated that it would consider it to be an inherent part of that responsibility that the provision of information to relatives should be standardised and included in this audit. In addition, we re-iterated our commendation of the involvement of the pathologists, as in Glasgow, in meeting with relatives and assisting in the explanation of procedures and process.
101 COPFS have pointed out that:
102 The Review Group notes these changes, and understands the need for some degree of flexibility. However, it also recommends that this situation is closely monitored and audited. We return to this at paragraph 108.
103 In paragraph 90 of its Preliminary Report, the Review Group drew attention to the fact that one of the main lessons to be learned from past practice was that there is clearly a communication gap, which needs to be closed, at the point when the Fiscal decides that organs retained at post-mortem examination are no longer required for his/her purposes. The Review Group, therefore, felt that a system needed to be put in place to ensure both that Procurators Fiscal are notified explicitly and promptly where organs are retained and that the Procurator Fiscal in turn makes sure that the pathologist in possession of the organs is made aware when retention for the Fiscal's purposes is no longer necessary. Appropriate arrangements need to be made to ensure that disposal of the organs then takes place in accordance with the wishes of the next of kin. The Procurator Fiscal should ensure that systems are in place to obtain such information from them.
104 The COPFS response is that:
105 In paragraph 91 of its Preliminary Report, the Review Group suggested that two key steps needed to be taken to avoid any blurring of the distinction between hospital and Fiscal post-mortem examinations. Where the post-mortem examination has been instructed by the Fiscal in respect of a child, and it is conducted in a hospital paediatric pathology department, the Fiscal must take particular pains to make relatives aware of the fact that s/he has instructed the post-mortem and that it is being conducted by a pathologist retained by the Crown Office. Where hospital staff find themselves in the position of having to explain to relatives that a Fiscal post-mortem examination has been instructed, the Fiscal needs to provide a form of words which the hospital staff can use to give the relatives an initial explanation which does not interfere with the proper discharge of the Fiscal's responsibilities.
106 The COPFS response is:
107 The Review Group welcomes the work which the COPFS has undertaken as a result of its recommendations. There are, however, a number of matters which it considers require further attention, and these are dealt with in the following paragraphs.
108 The Review Group remains firmly of the view that communication with those closest to the deceased should be every bit as sensitive in Fiscal cases as it is intended it should be in relation to hospital post-mortem examinations. As we have already said, in this report, we have used expressions such as 'family', 'relatives' and 'next-of-kin'. However, these are a form of shorthand, and should not be taken literally. They should be understood as also including, in appropriate cases, those who were closest in life to the deceased and who are most affected by the death. This approach is reflected in COPFS guidance and procedures. Guidance to Procurators Fiscal also notes that in some cases this will mean communicating with more than person. The Review Group notes the detailed guidance that has been provided to Procurators Fiscal on the issues raised in the earlier report, but reiterates that it is important to ensure that the guidance is followed routinely and that there is consistency of approach so far as possible across the country. The Review Group, therefore, recommends that the COPFS should some time in the next 12-18 months arrange for an audit of the effectiveness of the arrangements it has now put in place. This could possibly be done through independent research. Whatever methodology is adopted, the views of families, as users of the service, must be canvassed.
109 The Review Group recommends that there should be a designated person in each area Fiscal's office with responsibility for dealing with families, along the model of the death unit co-ordinator in Edinburgh. This person would be able to ensure that the final diagnosis was communicated to the family, whether or not the diagnosis had changed, and would be responsible for finding out the family's wishes regarding ultimate disposal of any retained organs. In discussing disposal, they should bear in mind that retention may be an option.
110 The Review Group notes that the size of Fiscal Area Offices varies, and that some of the smaller offices may find it difficult to adopt the death unit co-ordinator model. It would therefore accept that the smaller offices may need to collaborate in order to provide such an arrangement. The essential thing from the Review Group's perspective is that the model, or a variant of it, should cover every Fiscal office across Scotland. It notes that there may be a role for VIA here.
111 The Review Group re-iterates its recommendation (paragraph 87 of its Preliminary Report) as to the importance of training, and the potential role of relatives' support groups in providing that training. COPFS already involves some of these groups in training events. The Review Group considers this to be good practice, and recommends that COPFS should be willing to expand the range of groups involved in such work in future.
112 The Review Group considers that training is also important for medical professionals, including doctors who certify deaths and those who carry out post-mortem examinations. The General Medical Council's pamphlet The New Doctor indicates in its section 'Professional Training' that one of the topics which must be covered through in-service training is:
'(h) The duties of doctors under the law:
death certification;
dealing with coroner/Procurator Fiscal;
procedures for cremation;
statutory notifications.'
The Review Group recommends that in taking forward his work with the Deans of Medical Schools, the CMO should pay particular attention to whether or not such training is indeed available, and its quality. Any Medical Schools not offering such training should be reminded of its importance, and required to ensure its availability.
113 The Review Group also considered whether relatives should have a statutory right of appeal against the decision to refer a case to the Fiscal, as well as against the instruction of a post-mortem examination by the Fiscal. In relation to a right of appeal against a decision to refer a case to the Fiscal, the Review Group had concerns about the delay this would cause, and also was worried about the fact that relatives with a criminal interest could be expected to object strongly to a post-mortem examination. It notes that instructions to Procurators Fiscal include a requirement to accommodate the families' wishes, concerns and religious and cultural beliefs where possible in making decisions about post-mortem examinations. On balance, therefore, it does not recommend that a statutory right of appeal against the decision to refer to the Procurator Fiscal should be created. The Review Group prefers an approach based on more informal methods of representation by relatives to the Fiscal, coupled with these instructions.
114 In relation to the creation of a statutory right of appeal against a Fiscal's decision to instruct a post-mortem examination, the Review Group is aware that certain states in Australia (Victoria, Western Australia and New South Wales) have legislation which permits formal objection to the carrying out of a medico-legal post-mortem examination.
115 The Review Group was not, however, aware of any evidence to suggest that would commend the creation of such a right of appeal in Scotland. As we have already noted, the guidance issued to Fiscals covers the question of dealing with relatives' concerns and taking them into account as far as possible, as well as explaining the purpose of a Fiscal post-mortem examination and the role of the Fiscal in the investigation of deaths. Additionally, we understand that there are some concerns in Australia about the delays which result from this right of appeal. These can compromise the outcome of the post-mortem examination, especially of a baby. The Review Group therefore does not recommend the creation of such a right of appeal.
116 The Review Group notes that it may not always be necessary to carry out a full post-mortem examination, involving dissection, in order for pathologists to issue a death certificate. The procedure, known as 'view and grant', involves an external examination of the deceased's body and a consideration of medical notes. In some natural cause deaths, pathologists are able to issue certificates following such examination. This avoids, from the relatives' perspective, the distress that might be occasioned by a full post-mortem examination and the Review Group is attracted to this. The Group is aware that practice in this area varies among pathologists and across the country. It also understands that the assessment of what is required in a post-mortem examination is a matter for the professional judgement and expertise of pathologists, but believes that pathologists should be reminded of this possibility.
117 A COPFS-led consultative forum in the Spring of 2003 led to the production of a discussion paper which recommends, inter alia, that a Scottish Advisory Committee for Forensic Pathology (SACFP) be established to oversee the provision of forensic pathology services in Scotland; establish best practice for the speciality; and encourage the development of the profession through the training of practitioners. The paper further recommends that SACFP should set up committees to develop systems for training, accreditation and standards.
118 The Review Group would support this recommendation and further recommends that SACFP, or another appropriately constituted body, should consider the practice of 'view and grant' post-mortem examinations and develop standards and guidance for its use by appropriately qualified pathologists. The Group recognises that there may be an educational and training role for relevant professional bodies such as the Royal College of Pathologists and the British Association of Forensic Medicine.
119 The Review Group believes that some further improvements can be made to the information about organ retention and disposal contained in the COPFS leaflet for relatives. The COPFS leaflet, Advice for bereaved relatives, discusses the possibility of retention of organs, tissue blocks and slides at post-mortem examination and the options available to the family for disposal once diagnosis is complete. This is supplemented by instructions to Procurators Fiscal to communicate directly with families in cases where organs do require to be retained for diagnostic purposes, to explain this and discuss how they wish to deal with disposal of retained organs once diagnosis is complete. The Review Group commends this approach, which is intended to promote an appropriate and supportive approach, but it has heard some anecdotal concerns about the way in which this communication is handled from time to time. The Review Group has noted that the information on the possibility of organ retention for diagnostic purposes is not replicated in the more detailed leaflet produced by COPFS - What happens when a death is reported to the Procurator Fiscal - and is concerned that there is potentially scope for confusion here. The Review Group recommends that steps should be taken at the first opportunity to ensure that any such confusion is removed. The Review Group notes that the relevant leaflet is under review and recommends that steps are taken by COPFS to include more information on the possibility of organ retention and the options open to the family for disposal of organs once these are no longer required for diagnostic purposes.
120 The coming into operation on 27 June 2003 of the Cremation (Scotland) Amendment Regulations 2003 will put beyond doubt the ability to have body parts cremated. This should be taken account of in COPFS information leaflets. The option of educational, audit or research use of organs, tissue blocks and slides is dealt with in the next section of this chapter.
121 The Review Group is aware that, in homicide cases where criminal proceedings have commenced, the defence may wish to arrange for its own post-mortem examination to take place. This will inevitably delay the release of the body to the family. It is also technically possible, although the Review Group is not aware of any instances where this has occurred, that the defence pathologist would wish to retain material for further analysis. The consent of the Procurator Fiscal to any such retention would be required. The Review Group considers it to be important that, where relevant, families are advised of the defence post-mortem procedure. It is also vital that, in the unlikely event that tissues/organs are retained in these circumstances, similar procedures in relation to informing the family and arranging for disposal will be applied. Overall responsibility for what happens to a body once the Fiscal has instructed a post-mortem examination rests with the Fiscal, who has control of the body until s/he formally releases it. Any material required for the defence post-mortem examination remains subject to that control. The Review Group has been advised that the COPFS leaflets are under review and that a dedicated leaflet for families where criminal proceedings or a fatal accident inquiry take place is under preparation. The Review Group therefore recommends that information about the potential impact of a defence post-mortem examination is included in future versions of the material which COPFS makes available to relatives.
DEATHS IN HOSPITAL WHERE THE ROLE OF HOSPITAL AND FISCAL STAFF IN RELATION TO COMMUNICATION WITH RELATIVES REQUIRES CLARIFICATION
122 Deaths in hospital which should be reported to the Fiscal include:
123 Deaths which could be the result of a medical mishap raise specific issues about communication with relatives. The doctor who is potentially at fault in respect of this death will naturally be cautious about what information he or she gives to the family, and may not be the appropriate person to discuss matters with them. As a matter of course, no-one from the Fiscal's office will be on hand in the hospital. Clearly, someone needs to be on hand to speak to the relatives after such a death in hospital. The Review Group's Preliminary Report (paragraph 82, second bullet point) suggested that consideration should be given to the creation of the post of Bereavement Officer.
Our further work, and that of NHS Quality Improvement Scotland, has strongly underlined the importance of, and our commitment to, this type of appointment. The duties of the Bereavement Officer should be clearly defined to include this type of forensic case. These responsibilities point to the need for the Bereavement Officer to be essentially independent of the Trust and the Area Fiscal's Office. Until such appointments are made, it is important, once such a death has been reported to the Procurator Fiscal, that there is a clear point of contact in the Fiscal's office to whom the relatives can speak. In the meantime, however, hospitals should give immediate consideration as to who should most appropriately discuss such a case with relatives.
124 The Review Group takes the view that, in addition, there is a need for training of hospital doctors about the deaths that require to be reported to the Procurator Fiscal. Improved awareness and understanding of the Procurator Fiscal's role and the types of death that should be reported may help to reduce the number of cases referred to the Fiscal, since anecdotal evidence suggests that doctors may be referring cases to the Fiscal unnecessarily. This emphasises the need for further education of hospital staff about the Fiscal's role in the investigation of deaths, and exposes a further educational/training need. The attention of hospital staff should be drawn to the COPFS leaflet, Death and the Procurator Fiscal, which is designed to give doctors guidance in this area. The Review Group notes that this publication is under review and recommends that once that process is complete it is re-issued and publicised among medical professionals.
125 In relation to the Review Group's original recommendation (paragraph 72 of the Preliminary Report) regarding the need to audit all cases where doctors think a post-mortem examination might be required, the reasons and basis for referring a death to the Fiscal should be recorded by the hospital. This will allow a proper audit to be carried out which can identify any inconsistent patterns in referral practice, both within and between hospitals.
126 Some cases, for example, those where the person has been in hospital for a period such as a week and then dies unexpectedly, may raise a medical education issue in respect of the process of death certification. The Review Group in its Preliminary Report recommended firmly that responsibility for considering the need for referral to the Fiscal should lie with the consultant and not a junior doctor, which should reduce the number of cases in which it was felt necessary to make such contact. The consultant should also take account of the relatives' wishes where the death was clearly natural, in order to avoid causing them further distress. We repeat our commitment to each of these recommendations.
127 It is important that, where information is known about the deceased's attitude towards post-mortem examination, or where it is feasible to make inquiries on the subject, that information should be passed to the Fiscal's office, especially where the information relates to religious views. Each Trust should therefore liaise with its local Fiscal's office to ensure that procedures are in place for the communication of information about the deceased's attitude to post-mortem examination, where these have been voiced or can be discovered. This information, and details of its transfer to the Fiscal, should be recorded in the patient's medical notes. The police may also have such information, and should always include it in any report to the Fiscal.
128 In this context it will be important to bear in mind what is acceptable to the relevant Registrar of Births, Marriages and Deaths in terms of what appears on the death certificate. There needs to be agreed guidelines on the writing of the death certificate. There should, therefore, be further discussion with the Registrar General's Office about the requirements for certification purposes, although the Review Group is aware that the whole process of death certification will be affected by the Report of the Shipman Inquiry.
129 The Discussion Paper on Pathology Services suggests (paragraph 6.2) that the Scottish Executive Health Department should consider 'whether mechanisms could be devised for the certification of natural causes deaths that do not require investigation by the Procurator Fiscal, in particular having regard to the discussion around availability of an independent medical intermediary to assist doctors in certifying such deaths and mechanisms to facilitate the conduct of hospital post-mortem examinations in such cases'. The Review Group understands that a working group is being set up by the Scottish Executive Health Department to prepare a consultation paper on a general modernisation of burial and cremation legislation, and that the remit of that working group will take account of recent developments in England and across the UK in respect of death certification (in particular Death Certification: the report of a fundamental review and Shipman III - Death Certification and investigation of deaths by coroners). The Review Group would expect that working group to take account of its concerns about death certification, as well as the points made in the Discussion Paper on Pathology Services.
130 Consideration of this category of case reinforces the Review Group's original proposition that they should be handled at consultant level, and that further medical education and training are needed in relation to death certification and the post-mortem examination processes. The Review Group is aware that the Chief Medical Officer has already put in hand work with the Deans of the Medical Schools and Trust Medical Directors in order to take this work forward (paragraph 33). The nature of this work must be clarified and publicised, and its implementation speeded up. In any event, consultants should be encouraged to contact the Fiscal if they are concerned about any particular case, rather than simply assuming that it must be referred to the Fiscal. This further underlines the need for greater awareness of the list of cases which must be referred to the Fiscal, and those where discretion may be exercised.
131 Overall, the issues raised in this section point to the need for closer liaison between, and training, of doctors and Fiscals as a way of avoiding the problems of the past. The Review Group recommends that the Health Department and COPFS, in conjunction with the Royal Colleges and NHS Education for Scotland, should consider organising joint seminars on a regular basis to promote mutual understanding of medico-legal post-mortem examinations.
RETENTION AND USE OF TISSUES AND ORGANS FOR EDUCATION AND RESEARCH FOLLOWING A FISCAL'S POST-MORTEM EXAMINATION
132 One of the main lessons from past post-mortem examination
practice is that there needs to be complete clarity about the purpose for which
material is being retained from a Fiscal's post-mortem examination. First and
foremost, retention will be for the Fiscal's purposes in seeking to determine
the cause, mode and related circumstances of the death. There are also reasons
for retaining the material where the diagnosis is in doubt, and future tests
may be devised which would help to determine the diagnosis. This applies to
tissue blocks and slides in Sudden and Unexplained Deaths in Infancy/Sudden
Infant Death Syndrome cases (SUDI/SIDS), where the diagnosis is unclear.
It may also apply in other cases, such as unsolved criminal cases which may
need to be looked at again. There is general agreement on the importance of
having access to archived material in this context, but this should properly
be regarded as a matter of future diagnosis rather than research. No authorisation
is, therefore, required from relatives in respect of retention for these purposes.
133 The Review Group understands that it is current practice for tissue blocks and slides to be retained routinely following such post-mortem examinations. It is uncertain of the present basis for such retention, in cases other than those mentioned in the previous paragraph, once the Fiscal's examination has been completed, since no authorisation to do so has been given by the relatives. The Review Group, however, recognises the undoubted potential value of retaining such material as part of the medical record, for research, audit of forensic practice or educational purposes. It therefore considered how such practice could be placed on a proper footing, consistent with its overall approach to the retention of organs and tissue.
134 One approach would be to include a provision in the proposed legislation which would deem such tissue blocks and slides to be part of the medical record. They would then automatically become available for use for purposes such as research, medical education, training and audit. Such an approach might be seen to put at a disadvantage the families of those who had been the subject of a Fiscal post-mortem examination, as there would be no place in such a system for families to have control over any part of the process. The tissue blocks and slides would have been prepared without the families' authorisation, and their use for purposes other then the Fiscal's would have no reference to the families' wishes. That would be inconsistent with the whole basis of the Review Group's approach. In particular, families would not be placed in a position equivalent to those who have authorised the use of tissue blocks and slides following a hospital post-mortem examination.
135 The Review Group therefore takes the view that families should be given the opportunity to authorise the wider use of retained tissue blocks and slides derived from a Fiscal post-mortem examination, in the same way, and for the same purposes, as can be authorised following a hospital post-mortem examination.
136 In making this recommendation, the Review Group acknowledges the need for clarity about the process involved. Tissue blocks and slides will automatically be created as the end-product of a properly-conducted post-mortem examination performed on the instructions of the Fiscal. If these are to be retained further for the Fiscal's purposes, no authorisation from the families is required, as we have already noted at paragraph 132. Once the Fiscal's purposes are complete, however, we consider that the blocks and slides should be regarded as part of the deceased's medical record, since they complete his or her medical history. What must be clearly understood, though, is that in the case of the Fiscal post-mortem examination, a separate authorisation of the use of the blocks and slides is required, since the family will have had no opportunity to consider and authorise their retention or use. That is the basis on which we have devised the authorisation forms for use in the Fiscal context. Only once the form has been completed giving authorisation can the blocks and slides be used for purposes such as medical education, training, audit and research.
137 The Review Group is also clear that no wider use of any retained organs is permissible unless the deceased had or the family has specifically authorised this, irrespective of the nature of the post-mortem examination. The Isaacs Report indicated that, in the past, arrangements existed which allowed brains (and other organs) to be retained from coroners' autopsies in England and Wales for research purposes without the relatives knowing about this, let alone being asked for consent or authorisation. The Review Group reiterates its position that such practice is unacceptable. Arrangements are now clearly in place to prevent this happening in Scotland but the Isaacs Report further underlines their importance.
138 The Review Group noted in its Preliminary Report that even those families most traumatised by the revelations about organ retention - and the majority of representations received by the Review Group from relatives about post-mortem practice related to Fiscal cases (paragraph 56 of Preliminary Report) - maintained their support for medical research. This was based not just on the benefits they themselves might obtain in terms of future reproductive and other choices, but also in recognition of the wider benefits to society which could result. That support has been embodied in the arrangements introduced with effect from 18 October 2002 allowing research to be undertaken, subject to certain conditions, on archived tissue obtained under past post-mortem examination practice. The arrangements apply equally to material obtained from hospital or Fiscal post-mortem examinations.
139 The importance of research following Fiscal post-mortem examination cases is beyond doubt. In many of them, further investigation could lead to a clearer understanding of the disease from which the patient died, and to the development of better diagnostic methods. For example, examination of the brain in HIV-infected drug users who have died suddenly has often revealed the presence of unsuspected severe brain disease.
140 In putting in place a mechanism which would allow relatives to authorise the use, for educational and/or research purposes, of organs, tissue blocks and slides retained originally for the Fiscal's purposes but no longer required for them, the Review Group is anxious to ensure that this mechanism should operate so as to cause as little additional distress to relatives as possible. The Review Group is also aware that such arrangements require clear communication between Fiscal offices and pathologists to establish when material is no longer needed for the Fiscal's purposes. In addition, the wider public interest in the research importance of this material should not be compromised by the very process of seeking authorisation. The mechanism must be as clear and simple as possible.
141 The Review Group notes that there are two distinct situations in which authorisation for the research, educational or other legitimate use of material derived from a post-mortem examination will need to be sought. First, in deaths from certain causes, into whose pathology an existing research project is under way (for example in relation to CJD), it may be desirable that material additional to that which is strictly necessary for the purposes of the post-mortem examination itself is also removed and retained. In this situation, authorisation will need to be sought before the post-mortem examination takes place. Second, it may be regarded as important that material removed at post-mortem be retained for research, education or audit. More commonly, authorisation for this will be sought after the examination, at the point at which the Fiscal has completed his or her investigation. A specific form for this authorisation in both sets of circumstances is included in Appendix 3, in both adult and child versions. They are consistent with the hospital post-mortem examination authorisation forms.
142 In either situation, when retention for research or other purposes is desired, a suitable authorisation form must be given to the relatives which they should be invited to consider. They should also be given an information leaflet which explains the purposes of the removal, retention or use, and which supplements any verbal explanation provided as part of the process of seeking authorisation.
143 The Review Group gave considerable thought as to who should take responsibility for seeking authorisation for research or other purposes, and providing information for relatives, in a way which does not disrupt Fiscal practice. It is not a duty which Fiscal staff should be expected to perform, but they need to be aware of the possibility of authorisation, and information about this should be included in COPFS leaflets for relatives. Ideally, the responsibility for seeking authorisation should rest with the bereavement officers whose appointment we have already recommended (paragraph 123). Until then, it is not clear who should have this responsibility. It could be argued that those best placed to seek authorisation are the researchers themselves, but this raises a number of practical issues. In the normal course of events, University forensic departments have no point of contact with families, and the introduction of a new person could in itself cause families additional distress. Families will, however, have already had contact with a police administration officer or mortuary technicians, who are skilled in dealing with bereaved families. It might therefore best be left to each institution or department to establish the most appropriate person to fulfil this task. There is also the question of where and how the authorisation form is to be completed. Options would be for the person seeking authorisation to visit the family, or to arrange a meeting elsewhere, or to contact the family to find out if it would be acceptable to post the form to them, supplemented by communication with the contact person, or a pathologist if required. Each of these approaches has drawbacks, so, given the importance of this work to families and society as a whole, we recommend that views should be sought on these practicalties, with the aim of finding the approach which best meets the needs of research without causing families unnecessary additional distress.
144 The Review Group recommends that the research and education authorisation forms and information leaflets included in Appendix 3 should be adopted for use across the country as a whole.
145 A potential conflict arises in relation to post-mortem examinations where relatives may be under suspicion of being implicated in the death. For instance, there is an urgent need for research in cases such as non-accidental injury in children, but there are likely to be constraints on approaching relatives for authorisation in such circumstances. These complications need not prevent relatives' authorisation being sought for research after Fiscal post-mortem examinations where no such suspicion exists. But in cases where the person who would give authorisation is under suspicion in respect of a death which is thought to be criminal or unnatural, there may be circumstances in which the interests of justice should perhaps allow research to take place without specific authority. As this runs counter to the Review Group's general commitment to the rights of families, we recommend that there should be consultation on this point.
STANDARDS FOR FISCAL POST-MORTEM EXAMINATIONS
146 Another main recommendation in the Review Group's Preliminary Report was that the Clinical Standards Board for Scotland should include amongst its generic standards one relating to the conduct of the post-mortem examination (recommendation q). We accept that professional standards are matters for the relevant medical bodies, and we have already recommended that training and education of medical personnel in this area should be reviewed. However, in terms of our remit, the standards to which we refer are those which relate to the operational manner in which such procedures are carried out. Standards of this sort were published by NHS Quality Improvement Scotland, within which the Clinical Standards Board was subsumed on 1 January 2003. When the Board (as it then was) considered that recommendation, it came to the conclusion that there was a need for a separate set of standards relating to Fiscal post-mortem examinations.
147 The section of the NHS QIS report dealing with Overarching Principles makes the following point:
While the standards only apply to NHS services, the Project Group recognise that most post-mortem examinations are carried out by the Fiscal service, which is outwith the NHS. No authorisation is required for a Fiscal post-mortem examination, nor for the retention of material, including organs, tissue blocks and glass slides taken for evidential purposes. The standards are therefore highly commended to the Crown Office to be applied when post-mortem examinations are carried out under the jurisdiction of a Procurator Fiscal to establish the cause of death. The members of the Project Group stressed the importance of ensuring that relatives will be given as much information as possible.
148 Concern regarding the lack of quality assurance for medico-legal post-mortem examinations is expressed in many reports, including the Isaacs Report and the Review of Coroners. The lack of quality assurance programmes for Coroner or Fiscal post-mortem examinations means that much evidence regarding poor quality post-mortem examinations is anecdotal or highlighted only in specific cases. The Review of Coroners does highlight the Confidential Enquiries into maternal and post-operative deaths which found 'a significant proportion of [post-mortem reports done for coroners] to be below standard'.
149 A National Sentinel Clinical Audit of Epilepsy-Related Deaths
(SUDEP Report) reviewed the quality of the post-mortem examination in these
deaths (based on the post-mortem examination reports) all of which had been
undertaken at the instruction of the Coroner or Procurator Fiscal.
The pathology panel looked at four.htmects of the post-mortem examination: the
external examination, internal examination, the further investigations undertaken
and the certification of death and broke down the analysis by country. Less
than 13% of the post-mortem examinations were considered adequate (England 13%,
Scotland 9%, Wales 7%). In Scotland, the problems lay not with the technical
.htmects of the post-mortem examination (external and internal examinations)
which were all satisfactory (in contrast to England where 8% and 31%, respectively
were inadequate), but with the extent of the further investigations (36% inadequate)
and the certification of death (52% inadequate). Thus, while there may be some
reassurance that in Scotland the examination was conducted to comply with RCPath
guidelines, epilepsy deaths are one of the types of death where further investigations
are essential and poor certification is always a concern.
150 A system of audit for all forensic pathology work must be established. The Review Group noted in its first report that there was a need for fundamental changes in the culture of NHSScotland, particularly in relation to medical education and training in respect of post-mortem examinations and associated issues such as death certification. As indicated earlier in this Report (paragraph 130), the work which the Chief Medical Officer is undertaking with the Deans of Scotland's Medical Schools and with Medical Directors requires further effort.
151 The development of standards is intended to ensure consistency of approach across the country as a whole to key elements of post-mortem examinations, specifically in respect of communication with relatives. Lack of consistency of approach has been one of the issues which has most troubled the families affected by past post-mortem examination practice, whether in the hospital or Fiscal context.
152 The Discussion Paper on Pathology Services noted (paragraph 3.2.12) that there was widespread agreement on the need for objective standards, and that this would be a suitable task for the proposed Scottish Advisory Committee on Forensic Pathology. The Review Group felt that since it might be some time until that Committee could be established, the adaptation of the hospital post-mortem examination standards should be one of the sub-group's main tasks. Its membership deliberately included some of those who had been involved in the preparation of the original standards, and assistance was also provided by NHS Quality Improvement Scotland staff. The suggested Fiscal post-mortem examination standards are set out in Appendix 2.
153 This approach is not to be taken as implying that the Fiscal post-mortem examination is simply a variation of the hospital post-mortem examination. Fiscal post-mortem examinations can be divided (at least) into those deriving from the Fiscal's function to investigate sudden or unexpected deaths, and those directed at investigation of criminality. In the latter case, the main concern is the way in which the evidence will stand up in court, and hospital-based standards have little to do with that. These considerations have been borne in mind in producing the standards for Fiscal post-mortem examinations.
154 The Review Group takes the view that these standards are a public document, rather than merely protocols for professionals. This means that they require to be self-standing, and should therefore include general material on post-mortem examinations, not just material specific to Fiscal post-mortem examinations. The draft standards included in this report are commended to the Minister for Health & Community Care, the Lord Advocate and the Minister for Justice to consider how best they can be taken forward, bearing in mind the potential role of the proposed Scottish Advisory Committee on Forensic Pathology. Whatever mechanism is devised needs to take account of the fact that the standards potential apply to a number of agencies, including COPFS, NHS staff and the police, as well as pathologists providing forensic pathology services to the Crown. The Review Group recommends that all relevant agencies should be consulted on the draft with a view to producing an agreed set of standards, for which each can feel a sense of ownership.
155 The Review Group recommends that arrangements should be made to review performance against those standards, taking account of the recommendations of the Review Group.
156 The Review Group considered the question of whether the list of cases to be reported to the Fiscal should be included in statute. This would make it easier to find them, and would make it easier for medical and other professionals to be aware of those cases which the Fiscal would require to investigate. Such a step would, however, make it much more difficult to take account of unforeseen changes and the emergence of new categories. The Review Group therefore does not recommend that the list should be included in primary legislation, but recommends that some other way be found to make this information available in the public domain and readily accessible. The Review Group felt that including the list in Regulations was not only impracticable, given the absence of any regulation-making power, but also unnecessary. It recommends, however, that views on this point should be canvassed in any consultation on this Report.