22. Death certification is a long established and necessary requirement of the process by which we deal with bereavement in Scotland. Each year around 56,000 people die in Scotland. It is important that bereaved families have the opportunity to know and understand the cause of death of their relative and to have confidence in the scrutiny and robustness of the processes associated with the certification of that death.
23. The Burial and Cremation Review Group was tasked with reviewing the current death certification process in Scotland, not only as a consequence of the findings of the Shipman Inquiry, but also to reflect modern society, facilitate electronic transfer of information, storage and use of data for public health purposes, to improve the quality and safety of healthcare services and, importantly, to ensure that the processes we put in place in Scotland can, as far as possible, meet the needs of the nearest relatives and reflect our needs as a multi-cultural and multi-faith society.
24. The Review Group recommended a new process for the certification of death which is intended to improve the quality of death certification and deter any abuses of the certification system in both hospital and community settings. It would also introduce a new uniform process of certification regardless of the method of disposal of the body i.e. the same process would in future apply regardless of whether an individual was buried or cremated or an alternative form of disposal was used.
25. This consultation paper sets out two options put forward by the Review Group. Both options would address potential weaknesses in the current system for certifying death which were identified by the Shipman Inquiry. The proposals represent a transparent, proportionate and consistent response in order to provide better protection and reassurance to the public, improve the quality and accuracy of death certification, improve public health surveillance and remove current inequalities in the way that burials and cremations are dealt with. Any new procedure would need to be integrated into Crown Office and General Register Office for Scotland ( GROS) procedures and legislation. For GROS this would mean the Registration of Births Deaths and Marriages (Scotland) Act 1965 as amended. The Crown Office produced information and guidance for medical practitioners in October 2008 which deals with the process of referrals to the Procurator Fiscal and requirements for post mortem examinations called Death and the Procurator Fiscal and this can be viewed at http://www.copfs.gov.uk/Publications/1998/11/DeathandthePF.
26. An overview of the current system and the options are set out below.
Overview of Current System
27. The Medical Certificate of Cause of Death ( MCCD) Form (Form 11) has three purposes. The first is the legal requirement to record the fact and cause of death and information on the deceased such as name to enable disposal of the body to take place. The second is to enable the registration of the death by a Registrar of Births, Deaths and Marriages. The third is to provide information on the cause of death which may be used for the purposes of national statistics on mortality. The MCCD can only be completed by a registered medical practitioner. The MCCD must be presented within 7 days of the death to a suitably qualified informant, for example a relative of the deceased. That person has a statutory obligation within 8 days of the death to inform a Registrar of Births, Deaths and Marriages in order to enable the death to be registered (not to do so is an offence). The Registrar will then issue an Extract of an Entry in a Register of Deaths (commonly called a 'death certificate'). This Extract is legal proof of the death. The abbreviated Extract (death certificate) is provided free of charge (a full Extract may be provided for a fee). These arrangements are governed by the Registration of Births, Deaths and Marriages (Scotland) Act 1965 (the 1965 Act).
28. For deaths in Scotland, it is currently a requirement under the 1965 Act that any registered medical practitioner who was in attendance on the deceased during his last illness has a duty to complete the MCCD (Form 11). Following the move to practice based patient lists with the Primary Medical Services (Scotland) Act 2004 and GP practices withdrawing from the responsibility for out of hours arrangements, in most areas it would be expected that a medical practitioner from the patient's practice would be asked to sign the certificate. Any registered practitioner could, subject to adequate information such as the case notes, make a decision based on best clinical judgement. They would not have to view the body. In the event that the GP or registered medical practitioner felt that they had insufficient information at their disposal to complete the declaration on the MCCD this would be referred to the Procurator Fiscal in accordance with current practice. In both the proposed new systems, initially a Medical Investigator or Medical Examiner would consider the facts surrounding the death and they would then refer to the Procurator Fiscal if appropriate.
29. The contents of the MCCD comply with the World Health Organisation ( WHO) recommendations to ensure comparability for epidemiological purposes. The information recorded on the certificate includes the name of the deceased, the date and place of death, when they were last seen alive by the certifying doctor, the cause of death and any contributory factors. The MCCD and its accompanying notes are prescribed in secondary legislation under Section 24 of the 1965 Act. The MCCD Statutory Instrument ( SI) can be found at the following link: http://www.opsi.gov.uk/si/si1998/19982285.htm(the MCCD is at Schedule 2 to the SI).
30. After the death is registered by the Registrar for Births, Deaths and Marriages, a form (Form 14) is issued confirming the registration of the death. In normal practice it is only after a Form 14 has been issued that a burial may proceed, but it is possible to do so on the basis of the MCCD (Form 11) alone. A cremation may not proceed without the registration of the death.
31. Additional procedures are required to enable cremation to proceed. Two forms (B and C) must be completed by separate doctors who are paid fees totalling around £142. This cost is met by the nearest relative. The completion of forms B and C should in theory constitute two separate checks which are totally independent of each other. However, the Review Group acknowledged that this is often not the case in practice.
32. In addition, when a body is cremated, a third doctor, the medical referee at the crematorium, performs the final check on the papers. The medical referee, who must be of at least 5 years medical standing, has the power to refuse the cremation if there is any suspicion around the death. He also has the power to order a post mortem examination of the body. The cremation authority pays the medical referee a fee which is recouped through the cremation fee which is charged by the authority to the nearest relative.
33. The logic of these more rigorous checks for cremation dates back to the early 20th century when such checks were introduced as safeguards, as it was considered that the exhumation of a buried body would allow further investigations which would not be available after cremation. However, experts are of the view that exhumation of buried bodies yields very little forensic information, particularly if the body is exhumed after a significant length of time.
Disposal following Inconclusive Post Mortem
34. With regards to disposal where cause of death cannot be ascertained even after post mortem, there appears to be inconsistency of practice about what happens next. While this matter was not discussed by the Review Group, it has since been brought to our attention and we are therefore seeking views on this through this consultation.
In cases where the cause of death is undetermined, even after a post mortem has been carried out, what measures should be put in place to allow the disposal of the body?
Should disposal of the body where cause of death is undetermined be restricted to burial or are there circumstances where cremation or other methods should be permitted?
Proposals for Change
35. The Review Group agreed that the current system of death certification lacked thorough independent scrutiny and needed to be replaced by a more robust system. Initially the Review Group considered the monitoring and assurance system contained in the recommendations of the Shipman Inquiry's 3rd report and a model was devised which would fit in with the distinctive Scottish legal system and the role of the Crown Office Procurator Fiscal Service. However, the Review Group raised reservations about this model and learned that the UK Government had rejected the Shipman recommendations on the grounds that they did not offer good value for money and would add significant delay to the release of the body for funeral and disposal. In light of these developments the Review Group reconsidered the matter and suggested two alternative models - the Medical Investigator model and the Medical Examiner model.
36. Both models are set out on the following pages. The preliminary view of the Scottish Government is that the Medical Investigator model is to be preferred. Our reasons for this are set out first below.
37. The Medical Investigator and the Medical Examiner models have some similarities. Both propose to undertake comprehensive checks in 1-2% of cases which are random and 'for cause'. The causes can include someone raising a concern surrounding the circumstances of death, or arise from audit and statistical processes highlighting unusual variances related to individual doctors or particular locations, such as care homes. The management of the death certification data would be undertaken by an independent specialist statistician (Deaths Investigator), common to both models. This is intended to have a deterrent effect as well as providing public reassurance.
38. Both models would do away with the need to have a medical referee at crematoria, although it is recognised that given these individuals' experience they would make ideal candidates to fulfil the roles of either Medical Investigator or Medical Examiner.
39. The Medical Investigator model in particular would rely on existing sound clinical governance within the NHS. Annex A sets out an explanation of current clinical governance in the NHS. Sound and thorough scrutiny of death certification and investigation by the relevant authority of any unusual variances would be a significant enhancement on the current system (which relies on a number of MCCD forms signed by a doctor). This option would provide robust, transparent procedures and reassurance to the public on the efficacy of the process.
40. The Medical Examiner model diverges from the Medical Investigator model by providing a superficial paper based scrutiny of all deaths, undertaken by administrative staff, before sign-off by a second doctor.
41. We do not believe that requiring such basic checks by clerical staff on all deaths would necessarily provide any additional degree of reassurance and scrutiny on the appropriateness of the circumstances of the death. They may in fact add to a false sense of security over what will be in effect an additional layer of administration which could lead to delays in the process. We also note that most of the basic checks proposed under this model are already undertaken by the Registrar, for example incomplete forms and incorrect details.
42. The Medical Investigator model also aims to provide additional reassurance by linking the reports of the 'Deaths Investigator' (statistician) to the health boards' clinical governance structures, whereas the Medical Examiner model aims to be independent of health boards. We consider the former to be a significant advantage of this model, allowing for triangulation of performance and activity information from other sources in the health boards, such as complaints, prescribing patterns and appraisals. This additional information and intelligence should help to highlight inconsistent behaviours or deviations from normal practice, possibly in more than one area. Such unusual variances by individual doctors or in certain locations or situations could then be investigated in detail by the relevant health board or the relevant regulatory organisations, such as the Care Commission in relation to care homes.
43. Given the concerns about the Medical Examiner model outlined above, the preliminary view of the Scottish Government is that the Medical Investigator model is to be preferred. It is clear that there must be a balance between a robust process, value for money and public confidence, without introducing undue delays into the system. We believe the Medical Investigator model would seem to best meet these requirements. This model provides a proportionate response and sound investment of public money by delivering a robust process embedded in sound clinical governance, while also ensuring that administrative arrangements are sufficiently streamlined to keep to a minimum the delays and bureaucracy involved in issuing a death certificate. Fuller information on both models is set out below, including estimated costs.
The Medical Investigator Model
44. This model involves the appointment of Medical Investigators whose function will be to carry out a comprehensive paper based scrutiny of a 1% random sample of all deaths and of all deaths where concerns have been expressed (which is estimated to be a further sample of up to 1% of all deaths). In this model only one signature will be required to certify death, apart from those deaths which have been subject to comprehensive scrutiny where the MCCD will require to be countersigned by the Medical Investigator.
45. This model will involve the appointment of a small number of Medical Investigators who will probably be recruited from GPs, pathologists, forensic physicians and consultant grade doctors who have additional qualifications and / or experience in pathology / forensics, and crematoria Medical Referees. This is estimated at 4 whole time equivalent ( WTE) Medical Investigator posts along with 4 ( WTE) Administrative Assistant posts. They will be totally independent of the 14 NHS health boards and can be employed by a national organisation such as NHS National Services Scotland ( NSS) or NHS Quality Improvement Scotland ( QIS). The posts will be located in different areas in Scotland to facilitate access to the Investigators and minimise any delays.
46. This system will require Medical Investigators to carry out a comprehensive scrutiny of 1% of all deaths, selected randomly. In addition, the Medical Investigators will be required to carry out a comprehensive scrutiny of any death reported to them by any person who has legitimate concerns about the cause of death. Those entitled to make such requests will include Registrars of Births, Deaths and Marriages (who are already required to refer certain deaths to the Procurator Fiscal), funeral directors and any interested person who has had recent close contact with the deceased such as a nearest relative, a health care professional, an informal or formal carer or a neighbour. It is estimated that such requests will not be made in respect of more than 1% of all deaths.
47. The role of the Medical Investigator when undertaking comprehensive scrutiny will be to carry out a paper based investigation into the death. This will include viewing the appropriate medical records and taking evidence from the nearest relative and / or those who provided care, including medical care, to the deceased. If any doubt is raised about a particular death this will be reported to the Procurator Fiscal. The Investigator will have the power to view the body but it is not expected that the need to do so will occur often. The Medical Investigator will have to sign the MCCD of those deaths that he had investigated in order to permit the disposal of the body.
48. It is also recommended that a new Deaths Investigator be appointed (based at the General Register Office for Scotland ( GROS) or the Information Services Division ( ISD) of NHS National Services Scotland. The Deaths Investigator will be a statistician whose role will be to carry out a statistical check on all Scottish death data. Specific reports can be run at set periods from this collected death data, for example monthly, to identify unusual results. It is envisaged that once this system had been set up there will only be a requirement for one statistician and administrative support to carry out this work. Locating these individuals in a pre-existing organisation is also recommended to minimise costs associated with buildings, IT support and the like.
49. The Medical Investigator will consider the results from the statistical checks of the Deaths Investigator. These may not necessarily indicate a high proportion of deaths, but can indicate where forms had been poorly completed or data is missing. However, the data will also identify e.g. GP practices with an unusually high number of deaths or where the number of deaths has sharply increased for a particular doctor or an increased frequency of a particular cause of death. Given the numbers of deaths, patterns of behaviour can be established over time, for both individual doctors and at a GP practice level or a hospital team.
50. Data from these statistical checks will also be analysed for each NHS board and sent to the Medical Director of the board for action. An executive member of the clinical governance committee e.g. the Medical Director will decide whether the highlighted issue is significant in the context of other information available to him/her and will then decide what further action will be appropriate. In the majority of cases action will be likely to improve the existing training of doctors in completion of the MCCD forms. In any case which raises serious concerns the Medical Director can refer the case to the "Poorly Performing Professional" process or appropriate authorities such as the Procurator Fiscal. The Medical Director can also request more detailed reports to be provided by the Deaths Investigator or ask the Medical Investigator to look into other records of the patients of a particular GP or hospital doctor if there were causes for concern. There will be strong and useful links with clinical governance processes.
51. Delay: This model will not increase the delays between death and disposal in around 98% of deaths, irrespective of the method of disposal. There will in fact be a slight reduction in the delays where cremation is the mode of disposal (around 60% of disposals), as the requirement for additional forms for cremation to be completed by two doctors and the involvement of the crematorium medical referee will both be abolished.
52. In the remaining up to 2% of deaths subject to comprehensive scrutiny there will be an increase in the delay in the timescale for approval to dispose of the body, especially out of hours and in sparsely populated areas. The typical delay between time of death and cause of death being certified is expected to be 24-48 hours. Where death occurs in an urban area during the working week, a further delay of 24-48 hours for scrutiny by the Medical Investigator will occur. For a death in the community at the weekend or in sparsely populated areas there may be an additional delay of up to 60 hours. Therefore, in the worst case scenario, a total delay of 6.5 days may occur.
53. Cost: The total financial cost of this model is estimated at £1,473,000 to which there should be added the unquantifiable emotional and religious cost of the slightly longer delay involved between death and disposal of the body in the up to 2% of deaths subject to a comprehensive scrutiny. The staff costs for the 4 WTE medical staff and 4 WTE administrative assistants, along with the cost of the Deaths Investigator and his/her assistant (statistical analysis) is estimated at £425,000. Assuming that these Investigators are recruited from existing GPs and are subsequently replaced then their training / replacement costs is likely to be in the region of £250,000 each giving a total cost of £1m. Location costs are estimated at £41,000 and IT and stationery costs around £7,000 which make up the total costs of £1,473,000. A full cost benefit analysis accompanied the Burial and Cremation Review Group Report and can be viewed on the Scottish Government website.
54. The training costs / replacement costs will arise as and when existing Investigators leave the post. This is unlikely to be an annual cost but instead it is assumed that Investigators will remain in post for 5-10 years. Hence it can be assumed that the training / replacement cost of £1m will be recurring.
Is the Medical Investigator model your preferred model?
If yes, why?
What do you view as its potential strengths over the existing system?
What do you view as its potential weaknesses?
Do you think it offers best value for money?
The Medical Examiner Model
55. The other proposed model involves the appointment of Medical Examiners whose function will be to carry out a basic scrutiny of all deaths and a comprehensive scrutiny of 1-2% of these deaths. The MCCD form in all deaths will be required to be countersigned by the Medical Examiner.
56. This model will involve the appointment of a larger number of Medical Examiners and supporting administrative assistants (estimated at 4 WTE Medical Examiners to carry out comprehensive scrutiny of up to 2% of deaths and a further 6 WTE Medical Examiners who will have similar qualifications to the Medical Investigator model, along with 20 WTE administrative assistants, to carry out basic scrutiny of the remaining 98% of deaths). Medical Examiners, who will be entirely independent of health boards, will be required to countersign all deaths although the basic scrutiny of all deaths can be performed by administrative staff.
57. The Medical Examiners will have assistants to carry out some of the tasks involved in the basic scrutiny including scrutinising the MCCD form, checking paperwork (medical records), talking to the certifying doctor and talking to relatives where required. Basic scrutiny does not include viewing the body. All certificates, including those scrutinised by assistants, will be countersigned by the Medical Examiner.
58. While every death will be subject to basic scrutiny by a second doctor, although only 1-2% of deaths will be subject to a comprehensive scrutiny: 1% random and an estimated further 1% 'for cause', the same as in the Medical Investigator model. Each Medical Examiner will be set a target number for checking of both 'for cause of death' and random checks. Any comprehensive scrutiny will need to be completed as speedily as possible in order to minimise distress to families and allow disposal of the body to take place as soon as possible. It will include, for example, looking at the deceased's medical records and the results of investigations or autopsies, discussing the circumstances of the death with the doctor signing the MCCD and any other clinicians involved in the deceased's care and, where necessary, with the family of the deceased. If the Examiner is satisfied that all is in order, he or she can issue an authorisation to the family of the deceased which will enable them to register the death and make arrangements for disposal of the body.
59. Under this model the new Deaths Investigator (statistician) will still be appointed to generate death data (see above).
60. Delay - This model will not increase the delays between death and disposal where cremation is the mode of disposal (around 60% of disposals) and the deaths are not included in the up to 2% of deaths subject to comprehensive scrutiny. In all other cases there will be an increase in delay due to the need for countersignature by the Medical Examiner albeit only slight where disposal is by burial (around 40% of disposals) and the death is not subject to comprehensive scrutiny.
61. In the up to 2% of deaths subject to comprehensive scrutiny there will be an increase in the delay in the timescale for approval to dispose of the body, especially out of hours and in sparsely populated areas. The typical delay between time of death and cause of death being certified is expected to be 24-48 hours. Where death occurs in an urban area during the working week, a further delay of 24-48 hours for scrutiny by the Medical Examiner will occur. For a death in the community at the weekend or in sparsely populated areas there may be an additional delay of up to 60 hours. Therefore, in the worst case scenario a total delay of 6.5 days may occur.
62. Costs - The total financial cost of this model is estimated at £3,838,600 to which there should be added the unquantifiable emotional and religious cost of the slightly longer delay involved between death and burial (around 40% of deaths) and the significantly longer delay involved where there is a comprehensive scrutiny of the death (of up to 2% of deaths). This model will require 10 WTE Medical Examiners and 20 WTE administration assistants. If it is assumed that each Medical Examiner will require to be supported by two administrative assistants, along with the cost of the Deaths Investigator and his/her assistant (statistical analysis), the total staff costs for this model will be £1,184,000. Assuming that the Investigators are recruited from existing GPs and subsequently replaced then their training / replacement costs are likely to be in the region of £2,500,000. Location costs are estimated at £147,600 and IT and stationery costs around £7,000 which make up the total costs of £3,838,600. A full cost benefit analysis accompanies the Burial and Cremation Review Group Report and can be viewed on the Scottish Government website.
63. The training costs / replacement costs will arise as and when existing Investigators leave this post. This is unlikely to be an annual cost but instead it is assumed that Investigators will remain in post for 5-10 years. Hence it can be assumed that the training / replacement cost of £2.5m will be recurring.
Is the Medical Examiner model your preferred model?
If yes, why?
What do you view as its potential strengths over the existing system?
What do you view as its potential weaknesses?
Do you think it offers best value for money?
Review of Forms and Certificates
64. In addition, current forms and certificates are being reviewed to improve the quality of the data captured. For example, the Medical Cause of Death ( MCCD) (Form 11) requires a doctor's name or identity and signature to be recorded but this is often difficult for the Registrar to read. To address this, the form will be adapted so that each doctor has a unique identifier number (such as the General Medical Council Registration Number) which will be used when completing the form. This will enable the identification of the doctors certifying the death.
DEATH CERTIFICATION IN OTHER PARTS OF THE UK
65. In England and Wales the Coroners and Justice Bill received Royal Assent in November 2009. The Coroners and Justice Act 2009 is introducing new legislative measures on death certification to deliver against the recommendations of the Shipman Inquiry. The Act will require that in future all death certificates are signed off by two doctors, following a check of the paperwork by administrative staff. A random sample of cases will be subject to a more in-depth scrutiny by the second doctor (Medical Examiner). These measures (due to take effect from 2012) do not include the role of independent Deaths Investigator proposed for Scotland, who would carry out statistical checks on all Scottish death data. In England and Wales any statistical checks will be undertaken by the second doctor, the Medical Examiner.
66. Under the new system in England and Wales public fees will be applied to cover the cost of the new governance process for death certification. Fee levels will not be set until after draft regulations have been consulted on at the beginning of 2011 and will reflect the findings of pilots currently underway in England and Wales. It is expected that the fees will be less than the £160.50 fee currently paid to authorise cremations in England. Those opting for burial will also incur the fee, so that the costs of death certification will be spread equitably across all deaths that occur whatever the method of disposal of the body. The net financial impact on the NHS will therefore be zero. The introduction of this unified death certification system will also address potential areas of discrimination identified in the Equality Impact Assessment carried out for the Coroners and Justice Bill: a common level of assurance, a common timetable and a common level of fee, removing the differential in charges between cremations and burials.
67. The Devolved Administration in Northern Ireland is currently reviewing the process of death certification and hopes to consult on any proposals emerging from the review during 2010. While it is not possible to pre-empt the content of that consultation, it is likely that any proposed model will require the death certificate to be scrutinised by another doctor.
FUNDING INCREASED GOVERNANCE
68. The Review Group recommended that relatives should not have to pay for the forms required for the disposal of the body. At present no fee is payable for the Medical Certificate of Cause of Death ( MCCD) (Form 11) which must be completed to enable the disposal of the body and allow the death to be registered. Registration is undertaken by the Registrar of Births, Deaths and Marriages who issues free of charge both a Form 14 (confirmation of registration) and an Abbreviated Death Extract (legal proof of the death). We propose that the issue of both these forms remains free of charge.
69. Burials currently proceed without further scrutiny by a medical practitioner but because there are additional costs associated with the further checks required to authorise a cremation (see paragraphs 31-32), families opting for cremation currently incur fees of £142 plus the Medical Referee's fee. These fees would be swept away and replaced by new arrangements for resourcing the costs of the scrutiny processes proposed in this consultation (there will of course continue to be further costs associated with each funeral irrespective of the method chosen for disposal, such as the services provided by an undertaker).
70. The principle that the deceased's family or estate should reimburse the costs of additional checks required to authorise disposal of the body has been applied in relation to cremations for some time. As noted at paragraphs 65 and 66, in England and Wales the preferred option for funding the costs of new scrutiny arrangements is to apply a single fee in relation to all deaths, irrespective of whether death is followed by burial or cremation. This fee is likely to be lower than the current fee charged for cremations. This will end the potentially discriminatory situation currently existing whereby cremations incur fees while burials avoid any such charge.
71. In Scotland approximately £4.9m was incurred for cremation fees in 2008. We estimate that the proposals contained in this consultation could be delivered at a reduced overall cost while providing additional protection for the public against criminal activity or poor practice. Both the models put forward by the Review Group would cost significantly less overall than the total currently charged in cremation fees, even though they would be spread across all deaths that occur in Scotland.
72. Therefore, if Scotland were to apply a fee to the public to cover these costs, irrespective of whether the death is followed by burial or cremation, we predict the fee would be lower than the fee currently paid by the two thirds of families who opt for cremation. Such an arrangement would also create a consistency in approach between burials and cremations, fairly reflecting the additional scrutiny required irrespective of the method of disposal and avoiding any potential for a discriminatory situation to arise between the two methods. In England and Wales fee levels will be considered carefully and sensitively following the pilots they are currently undertaking to test new arrangements, and we would be keen to consider further the potential application of fees in Scotland in light of these pilots.
Should bereaved families or the deceased's estate pay a moderate fee to cover the cost of introducing increased scrutiny by a Medical Investigator or Medical Examiner?
Can you suggest any other ways of funding increased governance, bearing in mind the current constraints on public spending?
If a fee were to be levied, should it be set at the same level irrespective of the method of disposal of the body?
A fee could potentially be levied at the point of disposal (i.e. included as part of the fee currently collected by local authority, burial or cremation authorities) or by private burial and cremation companies when charging for provision of their services. Are there any practical issues which need to be taken into account in considering these options?