Impact of the new medical examiner role on patient safety

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).

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.

Potential challenges

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.

Next steps

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.