Department of Health
Friday, 10 June, 2016

This consultation seeks views on proposed changes to the death certification process and accompanying draft regulations. These changes include the introduction of independent medical examiners who will confirm cause of all deaths that do not need to be investigated by a coroner. The consultation also seeks views about making changes to cremation regulations – the current role of the medical referee, who authorises cremations at a crematorium, will be abolished when medical examiners are introduced.

In this consultation the Ministry of Justice seeks views on introducing a statutory duty on registered medical practitioners to report deaths in prescribed circumstances to the coroner for investigation.

The Welsh Government has devolved powers for appointing medical examiners and the funding mechanism for medical examiner services in Wales; an additional consultation will be published in Wales in due course.

Response to Department of Health Introduction of Medical Examiners and Reforms to Death Certification in England and Wales: Policy and Draft Regulations

The Royal College of Physicians of Edinburgh (the College) is pleased to respond to the call for views on the Department of Health’s Introduction of Medical Examiners and Reforms to Death Certification in England and Wales: Policy and Draft Regulations consultation.

1: Do you agree that an individual should be prescribed in legislation as being responsible to pay, or to arrange to have paid, the medical examiner fee?

Yes – the College suggests that this is the informant who registers the death.

Question 2: Should the person prescribed be the individual that collects the MCCD from the medical examiner, or the death registration informant?

The College suggests that this is the informant at time of death registration as this would align payment to an administrative process.

Question 3: Should the regulations exempt an official or employee who acts as an informant, from being responsible to pay, or to arrange to have paid the medical examiner fee?

An official or employee of a hospital should be exempt from being responsible to pay if there is no informant for the deceased.

Question 4: Should there be a 28 day or three month period for payment of the medical examiner fee?
28 days.

Question 5: As a local funeral service would you be willing to collect the medical examiner fee on behalf of a local authority, for a small administrative charge? The bereaved would see the fee itemised in the funeral director’s bill.

The Colleges suggests that the collection of the medical examiner fee is undertaken at point of registration, so this would not be relevant.

Question 6: Do you believe the provision of “administrative and clinical information” set out in schedule 1 is necessary and sufficient for all deaths, either for a medical examiner’s scrutiny or for a coroner’s investigation? If not, what would you add or delete and why?

The information in schedule 1 is comprehensive. However, some specific aspects of the schedule are impractical for a death occurring in hospital. Requirement (h) to complete last occupation of the deceased person is frequently impractical to obtain for older people who may not have undertaken employment for many years. This group comprises the majority of inpatient deaths. If previous occupation has a direct relevance to death, the death would be notified to the Coroner and not follow the medical examiner process.

Information requirements 1(l) and (m) seek the address and telephone number of the qualified attending practitioner and any person responsible for the nursing or care of the deceased prior to death. The College would recommend that ambiguity is reduced for hospital settings by making the requirement that this is the organisational address.

Question 7: Do you agree that the medical examiner should have discretion about whether an independent non-forensic external examination of the body is necessary?

Yes:  this would reduce the workload of the medical examiner and reduce the potential for delays in release of the body to the informant if the medical examiner is satisfied from the information provided that the death was from unnatural causes. The concern would be that if this delegation is to a medical qualified practitioner in hospital, this requirement will increase delays in providing information to the medical examiner. In a high intensity clinical environment both in hospital and in general practice, urgent clinical care provision will take precedence over availability to attend mortuary or similar facility to conduct a non-forensic external examination.

Question 8: In your view, are there sufficient safeguards if a person without a medical qualification but with suitable expertise and sufficient independence carries out a non-forensic external examination of the body on behalf of the medical examiner?

There should be greater clarity on who these individuals are if the purpose of the external examination is to exclude unnatural cause of death. For example, what qualifications and experience are these individuals to have? Who will be their employer and regulator? What training and appraisal requirements are to be in place for these individuals?

Question 9: Under regulation 26, do you agree that the medical examiner process should be suspended during a period of emergency?

Yes: the College agrees under the definition of a period of emergency defined in the Act.

Question 10: Do you agree that during a period of emergency any registered medical practitioner could certify the cause of death in the absence of a qualified attending practitioner?

Yes.

Question 11: Are the proposed certificates and medical examiner forms set out in schedules 2- 7 fit for purpose? If not, please say why.

Schedule 2: Attending Practitioners Certificate; Medical Certificate of Cause of Death - the draft certificate requests that the registered medical practitioner confirms one of the following three options; a) externally examined after death by me, b) externally examined after death on my behalf by: Name….GMC No… c) not examined after death by me or on my behalf. This wording is changed from existing certificate whereby the practitioner states if the body has been seen. We would seek clarification on whether the new wording requires an extensive (non-forensic) external examination? If so, the form is contradictory to proposals that it is at the medical examiner’s discretion whether a thorough (non-forensic) external examination of the body (Process Section 2.10) is undertaken.

Under existing regulations, the purpose of this declaration is to confirm that deceased is dead and a qualified medical practitioner has seen the body of the deceased to confirm death. We would suggest reverting the wording to current certificate ‘seen after death by me’.

The proposed new process also allows for a non-medically qualified individual to perform external examination. These individuals will not have GMC registration; therefore the box requiring this information is incompatible with this and we suggest changing this to a space for noting their role.

Schedule 3: Recommend amendments as above for Schedule 2.

Schedule 4: No amendments suggested.

Schedule 5: As per Schedule 2, if there is to be a delegated role for a non-medically qualified individual to perform the external examination, the requirement for GMC number to be included on the form should be deleted and replaced with information on the role of the individual undertaking this examination.

Schedule 6: As above for Schedule 5.

Schedule 7: No amendments suggested.

Question 12: In relation to regulation 5 of the NME regulations, what other aspects should standards cover for monitoring medical examiners’ levels of performance?
Review of the proportion of MCCD referred back for review as a consequence of the medical examiner scrutiny to determine if this proportion falls within the national range or is an outlier. Further review of process of the medical examiner should result if there is evidence of insufficient challenge following scrutiny or if excessive referrals for review are occurring which could delay process for the bereaved.

We agree that the lead College should determine markers for performance for both medical examiner and NME.

Question 14: Do you agree that a death should be notifiable if it is “otherwise unnatural”?

Yes: all deaths where there is no identified natural cause should be notifiable.

Question 15: Do you believe there is sufficient understanding between members of the medical and coronial professions as to the meaning of “unnatural” and that further definition is not required? If not, we would be grateful for suggestions as to what the guidance may include.

Yes: current understanding of the term is adequate and long established. Guidance of categories to consider remain relevant.

Question 16: Do you agree that provision needs to be made with regard to poisoning, given that cases of poisoning are rare?

We agree that provision with regard to poisoning should still be included, particularly in relation to poisoning attributable to controlled drugs, and in respect to the Psychoactive Substances Act.

Question 17: Do you believe that “poisoning, the use of a controlled drug, medicinal product or toxic chemical” sufficiently covers all such circumstances of death? If not, should the guidance be broadened?

Yes

Question 18: Do you believe there is a sufficient understanding of “neglect”? If not, should this be made clearer in the draft regulations rather than guidance?

Yes: there is sufficient understanding of the term, enhanced by safeguarding legislation. If safeguarding concerns have been raised prior to death, this should be notifiable to the Coroner.

Question 19: Do you agree that regulation 3(2)(e) - “occurred as a result of an injury or disease received during, or attributable to, the course of the deceased person’s work” - is clear that it includes any death that has occurred as a result of current or former work undertaken by the deceased, including cases such as mesothelioma or other asbestos related cases? If not, we would be grateful for alternative suggestions.

We suggest a revision of the text to include ….’attributable to, the course of the deceased person’s current or former work”

Question 20: Do you agree that it should be possible to make notifications orally, but that where an oral notification is made the information must be recorded in writing and confirmed?

Yes:  notifications should be made orally. Specification of where the information is recorded should be determined.

Question 21: Do you agree that regulation 3(6) should prevent duplication of notification? We would be particularly grateful for views on how this would work in a surgical environment.

We would appreciate clarification on why duplication should occur. Following death, the registered medical practitioner should review the medical records in advance of discussion either with the medical examiner, or the Coroner and have established if a notifiable death has occurred.

Question 22: Do you have any other comments about the draft Regulations?

We would appreciate clarification of a number of aspects:

There is ambiguity in absolute requirement for an external examination of the body under current proposals. Certification forms indicate that an external examination has occurred, and that this has been by a medically qualified individual. Draft regulations separately indicate this could be conducted by a non-medically qualified individual, but do not provide specifics on who this individual would be, their regulation, training or appraisal. In practical terms, if death has been confirmed by a qualified medical practitioner and there is no reasonable concern that death was unnatural, that the medical examiner can use their discretion as to whether a full external examination is undertaken. Otherwise, additional delays in releasing the body to the bereaved may occur.

There is little recognition in the legislation that the majority of death certification work is undertaken in secondary care by relatively newly qualified doctors. The additional steps which will result from the requirement for a proportion of the MCCD certificates to be rewritten following medical examiner discussion and scrutiny will impact on time to release of the body in the context of the conflicting clinical priorities faced by this cohort of the healthcare workforce who are already under considerable work pressures.

There is an absence of specific guidance in relation to patients who have a Deprivation of Liberty Safeguard authorisation in place. These cases are notifiable to the Coroner as currently the guidance from the Chief Coroner is that the death of a person subject to a DOL should be the subject of a coroner investigation ‘because that person was in state detention’. Experience in England is that a significant and increasing proportion of older people who die within hospital or care home are subject to DOLS. We recommend that the medical advisor holds the initial discussion with the qualified attending practitioner to make a determination if a referral to the Coroner is indicated for this group of patients; the overwhelming majority die from natural causes in the context of underlying progressive dementia syndromes that lead to death and are the indication for the DOLS authorisation. We recommend review of the definition that a person subject to a DOLS authorisation in these circumstances should be regarded as being in state detention.

Question 23: In relation to the guidance, do you agree with the examples used under each category of death? If not, we should be grateful for further examples or suggestions for definitions.

The College has no specific comment on this question.

Question 24: Also in relation to the guidance, do you agree that no specific reference is needed as to whether certain deaths will be subject to jury inquests or not (such as those that have occurred under state detention)?

Clarification of which deaths should be subject to jury inquests would be helpful. Specifically, consideration of a review of the linkage between DOLS authorisation and a view that these individuals are in ‘state detention’. Currently the experience of geriatricians is that this view is a disproportionate response to the majority of people who are subject to DOLS authorisation.

Question 25: Do you have any other comments about the guidance?

The new role of Medical Examiner will be pivotal in fulfilling the stated aims of strengthening safeguards for the public and making the process simpler.

The Medical Examiner should be suitably experienced and qualified to undertake the role. The response of the RCPE to the Scottish Government on 7 May 2013 (Death Certification: Secondary Legislation - Medical Reviewer) outlines a range of appropriate qualifications and experience that would be appropriate to replicate for the role of Medical Examiner.

Critical to confidence in the reformed system is that the Medical Examiner is impartial and independent. They will need to be both suitably experience and qualified for the role (recommendations as outlined above) and be subject to a robust annual appraisal process for the role. This could be aligned to existing hospital Trust appraisal processes whereby another medical qualified practitioner and trained appraiser would appraise the medical examiner against this aspect of their scope of practice.

Proposed legislation indicates the potential for the Medical Examiner to arrange for external examination of the body to be carried out by someone else. (Process 2.10). In order to maintain independence in the process, greater clarity on the experience and qualifications of any individual delegated by the medical examiner to perform thorough (non-forensic) external examination of the body is recommended. A delegated individual would need to have direct experience in the external examination of the body to exclude suspicious and unnatural deaths, neglect or abuse.

Process 2.10 indicates that this examination would determine whether the medical examiner agrees with the cause of death. Such a non-forensic external examination could not be expected to fulfil this requirement. This examination has a greater role in helping exclude suspicious and unnatural death. Establishing cause of death will be the resultant of review of the information provided in the MCCD including relevant detail leading up to death and relevant past medical history.

The opportunity for doctors to obtain advice from a medical examiner on medical circumstances and causes of apparently natural deaths for which the cause is known but not clear is welcomed and will assist more newly qualified doctors in providing accurate information on cause of death.

Following scrutiny by the medical examiner, it should be recognised that requests to reissue the MCCD will result in additional delay in provision of this document to the informant as employment patterns for qualified attending practitioner may result in the doctor who prepares the MCCD being unavailable to complete a revised MCCD immediately following discussion with medical examiner.

Many older people who die in hospital have extensive hospital records linked to preceding illness and comorbidities which have a bearing on the cause of death. A requirement that copies of the relevant hospital records accompany the written summary available to the medical examiner is likely to be burdensome to secondary care providers due to the large quantity of medical records which may need to be copied. Practically, therefore, it would be appropriate to require a review of the written medical record by the medical examiner at their discretion, rather than a mandatory requirement following review of the written summary. To reduce delays in the process, it is likely that the medical examiner will need to attend the hospital where the death occurred to review the written medical records if they determine this is necessary to formulate a decision on MCCD.

Question 26: After the changes are brought in, there will be no provision for medical examiners to be involved in the certification of the cremation of body parts. Do you agree that the requirement to complete a statutory application form and provide a registration document and a certificate from the hospital trust or other authority holding the body parts will provide sufficient scrutiny prior to the cremation of body parts? If not, what further scrutiny do you think would be needed, in the absence of medical referees?

The College has no specific comment on this question.

Question 27: Do you agree that this proposal will provide a sufficient level of scrutiny in stillbirth cases? If not, what further scrutiny do you think would be needed, in the absence of medical referees?

The College has no specific comment on this question.

Question 28: Do you agree that investigation and clearance for cremation by a coroner provides sufficient assurance for cremation to take place without a further check by a medical referee based at the crematorium? If not, what further scrutiny do you think would be needed, in the absence of medical referees?

The College has no specific comment on this question.