Abstract
Every six months, the Ministry of Justice publishes a summary of coroners' Rule 43 reports. There are many references to clinical medicine and this article describes the document content, its' relevance to clinical risk management and the implications for healthcare governance. This article discusses the history of Rule 43 and also its future. We discover that there are many valuable lessons learned from coroner inquests, that application of Rule 43 varies depending on jurisdiction, and that a recurring theme of similar problems runs through successive Ministry summaries.
Introduction
Have you ever received a Rule 43 report? If so, the report will have featured as a statistic in the Ministry of Justice summary of reports of responses published every six months. At inquest, the prospect of a Rule 43 report is usually regarded as a terrifying sanction, a headmasterly ticking off that barristers petition vigorously to avoid. But is a Rule 43 report really so bad? This article considers the provenance of the Rule, implications arising, and provides an analysis of the latest instalment of reports and responses under Rule 43 of the Coroners Rules published by the Ministry of Justice in March 2011. 1
The current Rule 43
The Coroners (Amendment) Rules amended Rule 43 of the Coroners Rules 1984 with effect from 17 July 2008.
2
The legislation somewhat wordily describes,
‘Where a coroner is holding an inquest into a person's death; the evidence gives rise to a concern that circumstances creating a risk of other deaths will occur, or will continue to exist, in the future; and in the coroner's opinion, action should be taken to prevent the occurrence or continuation of such circumstances, or to eliminate or reduce the risk of death created by such circumstances, the coroner may report the circumstances to a person who the coroner believes may have power to take such action.’
From a public perspective, one welcomes such a power that has the laudable intention of preventing future deaths. Furthermore, the provision of the Rule to require the recipient of the report to send the coroner a written response within 56 days, detailing the action to be taken, is a powerful safeguard against apathy. There is of course the opportunity for the recipient to write with an explanation of why no further action needs to be taken, but such a course of action would seem brazen brinkmanship. If further death occurs, would not the recipient be in a particularly difficult position?
The coroner must provide interested persons at the inquest and the Lord Chancellor with both a copy of the report and the response. No doubt the properly interested persons at the inquest consider both documents carefully. The Lord Chancellor, receiving over 300 reports and around the same number of equivalent responses per year, will probably be more selective in his reading, given all the other statutory duties he must undertake. Nevertheless, a summary of the reports and responses is published at the Lord Chancellor's discretion every six months and makes for an interesting read.
Summary of Reports and Responses under Rule 43 March 2011
In 2010, 230,600 deaths were reported to coroners in England and Wales (47% of all registered deaths). 3 Of these, inquests were opened in 31,000 deaths. Between 1 April and 30 September 2010, however, coroners issued a Rule 43 report in just 175 inquests. This rare instrument is used no more frequently nor less than in previous years.
The statistical summary continues the theme seen in previous years that the most common category for a Rule 43 report is that of deaths arising in hospital, accounting for 46 (26%) reports. Nearly all of these concerned clinical procedures and medical management. A further 21 reports (12%) were in connection with community health care and emergency services related deaths, 14 concerned mental health related deaths, six for drug medication related deaths, and 11 for care home deaths. The remainder are fairly evenly spread between the categories of road deaths, accidents at work, deaths in custody, service personnel deaths, police procedure related deaths, product related deaths, and railway related deaths.
It is conspicuous that 98 reports (56%) span the health and social care system in England and Wales, providing further evidence (if it were required) that our health and social care system can be fatally dangerous. The recipients of 72 reports were NHS hospitals and Trusts, by far the largest category, with individual Ministers and central government departments in second place with 44 reports. Local authorities and the police and emergency services received 22 reports each, and care and nursing homes received six.
The Ministry of Justice names and shames the 10 organizations which the Ministry have been notified as having not responded to the coroner within the 56 day timeframe (or applied for an extension). The details of the reports to these 10 are not provided and one wonders about the purpose of naming them in this way.
The summary provides an interesting insight into the variation in coroners' practice. We know there is a wide variation in inquest rate between jurisdictions: between 5% of reported deaths (Boston and Spalding, Gwent) and 26% (Birmingham and Solihull, Sunderland), with the national average at 13% in 2010. 3 By no means did all coroners write Rule 43 reports and some are evidently more ready than others to put pen to paper. There are some coroners who interpret the law differently from their colleagues, which leads to three jurisdictions that stand out: in third place, Cheshire with 10 reports, in second place Greater Manchester South with 11 reports, and in first place, Staffordshire South (including Mid Staffordshire NHS Foundation Trust) with 12 reports. Such variation cannot be accounted for by chance alone, and further study may provide an explanation.
So where do hospitals and NHS organizations go wrong? The summary makes the telling point that the trends identified in the three previous Rule 43 summary reports, remain the main themes in the first six months of 2010. It is not surprising to me that the gravest concerns centre on staff training, absence of procedures and protocols (or failing to follow such procedures and protocols), deficiencies in record-keeping, and concerns about communication in particular. Communication problems are consistently raised between different hospital departments or specialties, at handover between different staff involved in the patient's care, with patients and their families, and through to community colleagues following discharge. Many reports describe incidents where there were insufficient staff numbers with appropriate training and also failure to learn from critical incidents and share lessons learned if investigations were conducted. Health and safety concerns spanned the entire spectrum of reports.
Such grim reading has two possible interpretations. Seen optimistically, the continued provision of Rule 43 reports is a mechanism to highlight hitherto unrecognized hazards that should be embraced as vital for patient safety. On the other hand, if the trend is no different and human failure is as prevalent as ever, do these reports really make a difference? One could cynically take the view that no matter how seriously an organization takes a Rule 43 report, the real proof in reducing clinical risk is whether or not further incidents have truly been prevented as a result of learning and actions taken from the report.
The summary includes a short paragraph that describes the content of responses to Rule 43 reports. This sets out the Ministry's pleasure that many organizations take the concerns brought to their attention seriously, and indicate that lessons have been learned and appropriate action taken, but how do we know? In the brief summaries of the detail of individual reports provided as an appendix, I cannot see any that make reference to a concern raised in a prior Rule 43 report to the same organization.
Turning to the detail of individual reports, there is certainly a wide variation in the precision of the recommendations. Some reports, especially those relating to road deaths, for example, go to the level of the precise location of a particular road sign on an individual road. Others are much more general in nature such as ‘to consider introducing a nationally agreed protocol or algorithm to ensure that all appropriate questions are answered and considered when junior doctors seek advice from on-call consultants’.
Herein, I suspect, lies the Lord Chancellor's conundrum. It is doubtful that there is much merit in all organizations seeing the detail for all reports. Nevertheless, there are some reports concerning matters which are definitely not unique to an individual hospital or Trust. There is a missed opportunity here to share the information gained at an inquest in one jurisdiction with organisations with similar problems. Patients, services, treatments, and systems are much the same wherever one is in the UK. One hospital's Rule 43 report may describe a matter that is a disaster waiting to happen to some poor soul elsewhere in the country. ‘There but for the grace of God’ is a motto to be adopted when reading others' Rule 43 reports and if, by understanding where systems went wrong elsewhere and making a change, just one life is saved, this surely justifies close attention to these reports. At the moment, I doubt the information buried within appendices of the Ministry of Justice summary document achieves a high profile at patient safety or clinical governance committees at local organizations.
The Ministry of Justice shares the detail of responses to selected reports where there are wider cross organizational implications. This detail is interesting in its own right but perhaps more so is the tone in which the responses are worded. One suspects lawyers have been through the words very carefully and it is disappointing to encounter a defensive theme of ‘it wasn't our fault’. In these circumstances, it is very difficult to know what the coroner can do: he certainly cannot hold another inquest or become embroiled in a protracted exchange of letters. I suspect most coroners when faced with such responses would shrug their shoulders and carry on with the next case.
One of the cases described in more detail, shows how important a Rule 43 letter can be in highlighting a previously unrecognized problem. This case describes the reaction a patient with idiopathic primary pulmonary hypertension suffered after receiving the drug Silaxsentan. The ensuing liver damage was clearly significant. The coroner's Rule 43 letter to Pfizer asked that the drug safety profile be considered once more. Although a panel of experts initially concluded that no action needed to be taken, subsequent further reports of liver damage elsewhere in the world lent weight to the coroner's letter and the drug was withdrawn.
The future of Rule 43
I am a supporter of the principle of Rule 43. I am relieved that the Coroners and Justice Act 2009 makes provision for continuing the same safeguards, albeit in slightly different and simplified words. A concern is the dependence of Schedule 5(7) of the Act on the establishment of the office of the Chief Coroner, 4 which of course has recently been controversially disregarded. Regulations have yet to be laid and they cannot be realistically expected until at least 2014, so whilst a careful eye must be kept on the destiny of this coronial power, the status quo prevails, at least for now.
One of the most prominent recent Rule 43 reports followed the inquest into the deaths of 7 July 2005. Lady Justice Hallett wrote an extensive report addressed to a wide range of very high profile organizations, including the Secretary of State for the Home Department, the Director General of Security Service, the London Resilience Team, Transport for London, the London Ambulance Service, the Secretary of State for Health, and the Barts and London NHS Trust. 5 This has prompted a carefully considered and timely response from each of the addressees. It is testimony to democracy and the independence of the coronial system that we have seen steps taken to prevent difficulties, should such an atrocity ever occur again.
A Rule 43 report usually takes the form of a letter. It is peculiarly and delightfully British that in the circumstances of discovering a matter of serious concern, one should be moved to write or expect a letter. Even more British is to take that letter seriously, act accordingly and respond in kind. If only we were able to dismiss perception of a blame culture and enable these reports to make a real difference, nationally this would complete the circle.
Rule 43 reports are an eclectic mix of independent judgements that can make our world safer, especially in healthcare. At present, we do not take full advantage of findings and the Ministry of Justice summary report is just a start in the information sharing required to allow all of us to learn from others' mistakes.
Footnotes
Acknowledgements
I confirm there are no conflicts of interest.
The views expressed are my own and not necessarily those of the Department of Health or Sheffield Teaching Hospitals NHS Foundation Trust.
