Impact of the new medical examiner role on patient safetyBMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5166 (Published 14 December 2018) Cite this as: BMJ 2018;363:k5166
- Alan Fletcher, medical examiner and consultant in emergency medicine1,
- Joanne Coster, research fellow2,
- Steve Goodacre, professor of emergency medicine2
- 1Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
- 2School of Health and Related Research, University of Sheffield, Regent Street, Sheffield S1 4DA, UK
- Corresponding author: S Goodacre
The current death certification system in England and Wales has not changed in over 50 years (box 1). The government recently announced its intention to introduce a system of medical examiners that, from April 2019, will deliver a more comprehensive system of assurances for all deaths not referred to the coroner in England and Wales.1 This provides an unprecedented opportunity to develop a system that tackles concerns about avoidable hospital deaths, that works in partnership with families and carers, and that identifies deaths due to problems in care. We draw on our experience and ongoing research to describe the new role of medical examiner and how it could improve patient safety.
Current system for examining deaths in England and Wales
A registered medical practitioner who has attended the dead person before death must complete a medical certificate of cause of death (MCCD) to the best of their knowledge and belief. If the cause of death is unknown or the death is thought to be unnatural in any way, the death must be referred to a coroner, who is an independent judicial officer with legislated powers. There is no second check of the cause or circumstances of death unless the body is to be cremated. The National Mortality Case Record Review programme aims to introduce a standardised method for reviewing case records of adults who have died in acute general hospitals in England and Scotland, but this detailed review is likely to be feasible for only a proportion of hospital deaths.RETURN TO TEXT
What is a medical examiner?
The role of medical examiner was developed from recommendations in the 2003 Home Office Fundamental Review of Death Certification and Investigation2 and in response to concerns raised by Janet Smith in the third report of her investigation into the murders committed by English general practitioner Harold Shipman.3 This recommendation was endorsed by Robert Francis in his investigation into avoidable deaths at the Mid Staffordshire NHS Foundation Trust4 and Bill Kirkup in the review of deaths and patient safety at Morecombe Bay Hospitals.5
A medical examiner is an independent senior doctor who will be accountable to the national medical examiner.6 The role is to manage three matters related to the cause of death and relevant documentation, taking the views of bereaved relatives into consideration. First, where an MCCD is completed, the medical examiner will ensure that the content is as accurate as possible. Second, where a case needs to be notified to a coroner, the medical examiner will make sure it is undertaken as quickly and accurately as possible. Finally, the medical examiner will detect and report clinical governance concerns as early as possible.
This is different from the role of the North American medical examiner, who investigates deaths occurring under unusual or suspicious circumstances, performs postmortem examinations, and may initiate inquests.
What will a medical examiner do?
Medical examiners will become involved immediately after a death, with the support of appropriately qualified medical examiner officers (another new role). To date, most of the medical examiners in pilot studies have focused on hospital deaths, but a few consider community cases. In all cases not investigated by a coroner, the medical examiner must carry out a proportionate review of medical records (focusing on the last hospital admission, selected investigation results, correspondence, and interventions), discuss the case with the qualified attending practitioner completing the MCCD, interact with bereaved relatives to clarify whether they have any concerns or questions regarding the cause or circumstances of death, and review the MCCD. All these steps must be completed before the death is registered, and the target standard is to achieve this within 24 hours of the medical examiner’s office having received the records. Standards for delivering the medical examiners service have been published by the medical examiners committee of the Royal College of Pathologists.7
The Coroners and Justice Act 20098 provides legal provision for medical examiners, but this has not yet been enacted owing to the complexity of legislation concerning several government departments and uncertainty around funding. The planned implementation of the initial non-statutory medical examiner system will be focused on acute hospitals from April 2019, but some locally determined places will consider primary care deaths. The full statutory system is planned to be implemented within 18-24 months to include all deaths not investigated by a coroner, including primary care.
Impact of medical examiner assessment
Since 2008, medical examiners have been established in several pilot sites across the UK to help the Department of Health and Social Care refine their policy plans and establish the key functions of a medical examiner system. In 2016 the department reported data from over 23 000 medical examiner reviews of deaths at pilot sites in Sheffield and Gloucester, showing that the referrals to the coroner were more consistent and appropriate than referrals before medical examiners were involved, rejection of the MCCD by the registrar was eliminated (compared with historical rejection rates), and input from relatives occurred in every case.9 The pilot sites also identified some potential problems (box 2).
Potential problems identified from the medical examiner pilots
Half a day was added to the time from records being provided after death to the MCCD being released, compared with time taken before introduction of medical examiners
The provision of an out-of-hours service was restricted by lack of funding
The proposed funding model was not fully tested
Attending doctors were initially circumspect
There was a perception in some areas that the medical examiner told the attending doctor what to write, which would be inappropriate
A small number of bereaved relatives were initially puzzled about the purpose of contact from the medical examiner
A parallel study by the Office for National Statistics to examine the effect of medical examiners on the confirmed cause of death on the MCCD found that the International Classification of Diseases coding was changed in 12% of cases and less fundamental changes were made in a further 10%.10 MCCDs are known to contain inaccuracies and incomplete information,111213 which was corrected by the medical examiners. If replicated in a national system, this has major implications for epidemiology, public health, and allocation of resources. It is also important for bereaved people to have death certificates that accurately describe the cause of death.
The 2016 review also found that independent scrutiny of medical records, supplemented by discussions with bereaved relatives, was a consistent source of high quality information about the quality of care, irrespective of the nature of the problem or the type of organisation providing care (hospitals, general practice, social care, and so on). This indicates that medical examiners reviewing deaths could have a role in improving patient safety.
Improving patient safety
In December 2016 the Care Quality Commission reported that learning from deaths was not being given sufficient priority in some NHS organisations and that valuable opportunities for identifying and making improvements were being missed.14 It identified the need to engage families and carers and to recognise their insights as a vital source of information. The Care Quality Commission now requires all acute hospital trusts to be able to “say something about every death.” In March 2017 NHS England launched the Learning from Deaths initiative,15 which required acute hospitals to undertake case record reviews on selected cases based on criteria most likely to yield opportunities for learning, reflection, and improvement. NHS England did not stipulate any particular method for case record review, but recommended structured judgment review.16 This uses a standardised clinical judgment based method and involves trained clinical reviewers making explicit quality and safety judgments, scores, and comments about the care provided, using a phase of care approach.
Medical examiners could help to meet these requirements. Their scrutiny of cases could be used to ensure that every death is examined and that families and carers are engaged, while allowing additional structured judgment review to focus on cases with clinical governance concerns. Early identification of clinical governance concerns provides opportunities to reduce avoidable deaths, as well as reducing complaints or litigation if bereaved relatives have their concerns recognised.
Estimating preventable death rates
Medical examiner review is intended to identify causes for concern requiring further investigation. Unlike structured reviews of hospital deaths, it is not intended to determine preventability. Studies using structured judgment review have estimated that up to 5.2% of deaths are probably avoidable.171819 But judgments regarding levels of preventability vary between observers,17 so each case requires agreement between independent reviewers. Uncertainty around this judgment has led many to conclude that structured judgment review is better used to identify themes in causes for concern rather than preventability in individual cases.
Unpublished data from the pilot of medical examiners (A Fletcher, personal communication, see supplementary file) show that, of 3875 consecutive deaths, the medical examiner identified 153 cases with clinical governance concerns, where attending doctors were unaware of the issues. Examples include medical or surgical mishaps potentially leading to premature death, delays in giving correct treatments, and bereaved relatives drawing attention to system failures. This indicates that medical examiner screening before structured judgment review could substantially reduce the number of reviews required. Valuable lessons from structured judgment review could, however, be missed if medical examiner assessment is too superficial or the threshold for clinical governance notification is too high. We currently have no data to determine how appropriately medical examiner assessment identifies threats to patient safety, although it serves the requirement to know something about every death.
The National Institute for Health Research’s policy research programme has funded a study that will compare the findings of medical examiner assessment and structured judgment review as used in the National Mortality Case Record Review Programme at pilot sites.2021 These two processes are intended to be complementary, so inconsistencies are expected and neither should be considered the gold standard. The study will provide valuable insights into how these two processes work alongside each other and determine how medical examiner screening influences the workload and yield of information from structured judgment review.
Hospital trusts needing to learn from all deaths may be tempted to use medical examiner screening to select cases for structured judgment review, but they must recognise the current lack of data to support this approach. Until findings from the research in progress are available, trusts should at least augment this approach with additional reviews selected using an alternative process.
The timescale for implementing the medical examiner system is tight. Both the examiners and officers will come from a limited pool of senior clinicians who already face substantial demands, and they must have the correct skills and attributes. Key attributes include up to date knowledge of clinical medicine, the healthcare system, and general matters; pragmatism; good communication skills; and the ability to work in a team. New medical examiners will need training and existing medical examiners will need ongoing updates to ensure consistent quality of assessments. We need new data collection systems that can be linked to existing systems.
The initial plan for funding the system is to use fees for the second part of the cremation form, which poses logistical challenges—principally that cremation forms mandate an examination of the deceased in all cases, which can take up a considerable amount of time, and that applying this funding model to community deaths will be difficult. Introduction of the medical examiner system may also increase the workload of clinical governance and coroner services. The pilot sites were mainly based in hospital care so extending the system to primary care is likely to involve additional and potentially unforeseen problems.
Medical examiners must be independent and able to make potentially critical assessments of NHS care, but ensuring independence—alongside the need for accountability and practical matters such as resources and data protection—will be challenging. The national director for patient safety recently announced that medical examiners will be employed by NHS trusts, but they will have a separate reporting line to NHS Improvement and the national medical examiner. Ensuring that the many different stakeholders understand the changes resulting from the medical examiner system will be a communications challenge.
The next steps in implementation include appointing the national medical examiner; organising funding streams (including from central government); publishing a national reporting system; establishing a digital system for data entry, sharing, and analysis; releasing updated e-learning modules; providing face to face training from the Royal College of Pathologists; and providing communication events and material to all stakeholders. The concurrent rollout of the National Mortality Case Record Review programme provides a system for more detailed investigation of cases identified by the medical examiner.
Medical examiner assessment and structured judgment review have different origins, purposes, and methods, so we should expect different results. But aligning these two important policy measures to give a robust independent system that is protected by statute has the potential to make the mortality review system in England and Wales the best in the world.
Medical examiners provide independent scrutiny of medical records, supplemented by discussions with bereaved relatives, for all hospital deaths
This assessment can improve recording of the cause of death, fulfil the need to say something about every death, and identify threats to patient safety
Medical examiner assessment is not intended to make a judgment about preventability of death but to identify causes for concern
Research is underway to determine how medical examiner assessment can work alongside case record review to provide a robust mortality review system
Contributors and sources: AF is chair of the medical examiners committee of the Royal College of Pathologists and used this role and his position as a medical examiner to write the first draft of the paper and provide key content. JC is project manager for the Safety for Patients Through Quality Review study (Evaluation of medical examiners’ review to identify potentially avoidable deaths due to problems in care) and was project manager for research developing structured judgment review. She used her involvement on these projects to contribute to drafting the paper. SG is chief investigator for the Safety for Patients through Quality Review study. He used his involvement in this project and expertise as a senior investigator at the National Institute for Health Research to contribute to drafting the paper. All authors approved the final draft. SG is guarantor for the paper.
Patient and public involvement: Two representatives have been involved with the project since its inception. They are members of the Safety for Patients Through Quality Review study’s advisory group and attend regular meetings with the study team to support and advise the project.
Competing interests: AF is chair of the medical examiners committee of the Royal College of Pathologists and medical examiner at Sheffield Teaching Hospitals NHS Foundation Trust. All three authors are investigators on the Safety for Patients Through Quality Review study. SG is chair of the NIHR health technology assessment clinical evaluation and trials board. The views and opinions expressed by authors in this paper are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the Policy Research Programme, or the Department of Health.
Funding: This paper was written as part of the Safety for Patients Through Quality Review study, which was funded by the NIHR policy research programme (project number PR-R16-0516).