Abstract
Abstract
Patient safety is enhanced by harnessing multiple sources of data, including sources external to the organization – such as the coroner. Following an inquest, the coroner can make a report under the Coroner's Rule 43 to any statutory body or organization when it is identified at inquest that similar fatalities could be prevented if lessons are learnt from the findings of the inquest. An exploratory study was undertaken, using qualitative methodology to investigate the characteristics of organizational learning following recommendations of the coroner under Rule 43 in one district health economy. The role of the coroner was not clear even to the most senior interviewees. There was little evidence of organizational learning generated or shared in the organizations involved in this study from the recommendation of the coroner after a comiogenic (iatrogenic) death. There was evidence of a lack of clarity in both structure and function in the handling of and learning from coroner's recommendations both within and between the organizations involved in this study. The role of Rule 43 reports should be explored at national level and standardized tools developed in order to facilitate learning within and between NHS organizations.
Introduction
The worldwide acknowledgement 1,2 that thousands of patients each year die and many others suffer serious injury as a result of medical error, has resulted in patient safety being central to both the political and research healthcare agendas of states and nations worldwide. In England and Wales, for example, there have been over 10 government 3–11 and independent reports 12 published since 1998, that provide a contextual framework for the patient safety agenda in the NHS.
There is a great impetus, for both practical and academic reasons, to increase our understanding of the contributory reasons for iatrogenic (also known as comiogenic) morbidity and mortality associated with healthcare systems and their artefacts. A variety of information sources and techniques (reporting patient safety incidents [NPSA website]); 13 safety culture assessment; 14,15 and rule-related behaviour 16,17 have been used for these purposes.
Despite the fact that there is now a proliferation of studies investigating the epidemiology and causality of iatrogenic/comiogenic error, the nature and extent of patient safety incidents causing death or permanent disability remain poorly defined. It is estimated that, for instance, reporting systems fail to capture up to 96% of errors. 18,19 One of the most under-used sources of information, in patient safety terms, is that which is available when a patient has died as a result of the care/treatment that they have received. This information could be raw internally generated mortality statistics or information passed on to the care provider by an external source, for instance a relative through a complaint or another statutory agency, for instance, the coroner.
The role of the Coroner and Coroner's Inquests
It is important to understand the scope and indeed the limitations of a Coroner's Inquest. The purpose of an Inquest, as set out in the Coroners Act 198820 and the Coroners Rules 1984,
21
is to establish who the deceased was, and how, when and where he or she came by his or her death (Section 11).
11(5) An inquisition – … (b) shall set out, so far as such particulars have been proved – (i)who the deceased was; and (ii)how, when and where the deceased came by his death;
The Coroners Rules expressly forbid a coroner from expressing any opinion on any other matters (Rule 36).
Neither the coroner nor the jury shall express any opinion on any other names.
The Rules also forbid a coroner from appearing to determine any question of criminal liability of the part of a named individual or civil liability.
No verdict shall be framed in such a way as to appear to determine any question of – (a) criminal liability on he part of a named person (b) civil liability
The Coroner and Rule 43
Following an inquest, the coroner can make a report under the Coroners Rule 43 to any statutory body or organization when it is identified at inquest that similar fatalities could be prevented if lessons are learnt from the findings of the inquest. Rule 43 of the England and Wales Coroners Rules states:
A coroner who believes that action should be taken to prevent the recurrence of fatalities similar to that in respect of which the inquest is being held may announce at the inquest that he is reporting the matter in writing to the person or authority who may have power to take such action and he may report the matter accordingly.
There is a similar provision in Rule 23 of the Northern Ireland Rules.
In a review of death certification and investigation in England, Wales and Northern Ireland 22 the use of Rule 43 was explored. It was found that, on average, reports were made following just less than one inquest in 50 (op. cit. Chapter 8, paragraphs 41–46). However, the sample size is not specified in the 2003 document, so it is difficult to know how authoritative the survey was.
Other findings are summarized below:
The recommendation rate per inquest was roughly the same as between full-time and part-time coroners; Among coroners overall there were marked discrepancies – about one-third of the coroners in the sample made no recommendations at all during the previous year and one had made 60; The main agencies to which the recommendations were addressed were local road and health bodies; Almost half the recommendations had led within a year to some remedial action; In one-quarter of cases the results were unknown or still under review; In the remaining quarter the recommendation had been rejected or the coroner felt that the response had been inadequate.
These reports can provide a potentially valuable source of information for the NHS. Anecdotally, coroners in the past have identified problems with healthcare that standard mortality data collection within the NHS had missed (e.g. neonatal deaths following the insertion of long lines 23 ). However, in order for the reports made under Rule 43 to have an effect, NHS organizations need to reflect and learn from them.
A further impetus for NHS organizations to consider and act upon these reports may come from Coronial Reform. There is not currently any legal requirement for the reports made under Rule 43 to be made publicly available (and some coroners have been criticized for making their reports available to people other than to those to whom the report is addressed); however, a draft Bill for coroner reform was published in June 2006, which supported the wider dissemination of Rule 43 reports.
Organizational learning
In their extensive review of the literature concerning change management in the NHS, Iles and Sutherland 24 described organizational learning as a transformational process that seeks to help organizations develop and use knowledge to change and improve themselves on an ongoing basis.
The concept of organizational learning has previously been linked to patient safety by those attempting to measure the patient safety culture of healthcare organizations. For instance, through a wide literature review (including literature from health and industry) and consultation with field experts, 25 identified organizational learning following a patient safety incident (or prevented patient safety incident) as one of the nine key dimensions of patient safety culture in primary care in the NHS.
The characteristics and the value of the learning that can be derived from a coroner's recommendation is poorly understood but worth exploring.
An overview of the study
An exploratory study was undertaken, using qualitative methodology (interviews and case studies), to investigate the characteristics of organizational learning following recommendations of the coroner under Rule 43 in one district health economy. Twelve semi-structured interviews were undertaken with a purposefully sampled range of NHS managers who had operational responsibility for organizational learning within two NHS Trusts, one primary care trust (PCT) and one providing Acute Services. The local coroner was also interviewed.
A thematic analysis of the interview data was undertaken. The findings of the case studies were used to provide illustrative examples of any organizational learning triggered by the recommendations of the coroner.
It was anticipated that the findings of the study would provide a valuable insight into the process, the amount and the quality of organizational learning occurring and that recommendations would be made to influence practice based on the analysis of the data collected.
Results
Overall there was little evidence of organizational learning generated or shared in the organizations involved in this study from the recommendation of the coroner after a comiogenic death. On one hand, the Trusts (especially the one providing acute services) did have relatively robust systems for dealing with information about problems with patient care generated internally (for instance from complaints or as a result of a Serious Untoward Incident Report). On the other hand, they did not react in a structured way towards information generated from an external source such as the coroner.
Four central themes emerged from the qualitative data obtained that provide an explanatory framework for this overall finding. These were:
the organization: structures and functions; information processing: systems and anecdote; organizational culture; leadership.
The latter two themes were identified as exerting the most influence on the quality of any organizational learning that occurred. The former themes were portrayed as manifestations of the culture of and the leadership within the organizations.
The organization: structures and functions
Organizational clarity
There was evidence of a lack of clarity in both structure and function in the handling of and learning from coroners' recommendations both within and between the organizations involved in this study. This evidence emerged from both the interview data and the case studies. There was a lack of consistency in how recommendations were dealt with and the learning was managed.
The structure of the Coronial system itself and the function of the Coroner were not always clear to the participants who worked in the NHS. On the one hand, the coroner was seen as a public advocate:
‘He's there so the public can have their say.’
And on the other hand, was seen to be influenced by national priorities:
‘He's only resonating with the national agenda.’
The remit of Rule 43 itself was seen as being at best subjective and at worst obtuse. There was a general attitude among those working in the two Trusts that much of the coroner's work was open to interpretation:
‘He just sees what he wants to see, or what he needs to see to satisfy the public or the media so what eventually comes out from him probably would have been really different from another coroner so I guess you could question the significance of it to us.’
The recommendations of this and other coroners appeared to be subject to their personal decision-making and interpretation, thus compounding any issues of uncertainty and clarity about the structure and function of the Coronial system.
It is perhaps a lack of understanding about the role of the coroner, the scope of their responsibility and the limitations of what a coroner (or coroner's jury where there is one) may and may not do, that contribute in part to the opinions expressed by NHS managers during this study.
The coroner himself acknowledged that Rule 43 itself was open to interpretation:
‘One of those requirements is where there is a likelihood of a repetition of the same problem re-occurring, and affecting the public at large or a significant proportion of them, well really if you think about it the death of everybody affects potentially a group of the public, I always find that rather difficult to determine and the same goes with Rule 43 letters you could write one after every inquest, its just a balance.’
In the Trusts, where the study was undertaken the clinical governance function was seen by the most senior managers as the single most important structure related to organizational learning from coroners' recommendations:
‘It gets under the auspices of governance.’
The ‘Governance people’ (i.e. those both at Trust and divisional level with responsibility for developing and managing the Clinical Governance agenda in the Trusts) were seen as those within the organization whose role it was to identify the learning and drive the process forward. However, the case studies revealed that Clinical Governance managers were not consistently made aware of coroners' recommendations to the Trust, especially when their division was not directly involved.
Any possible structural approaches to addressing the recommendations were much clearer in the Acute Trust than the PCT. In the PCT most managers interviewed did not know that coroners could make recommendations to organizations about problems with care and had never had experience of dealing with them. Indeed, the Chief Executive of the PCT, when approached to be interviewed, declined with an indication that he ‘did not have anything to do with the Coroner’.
Interface issues, lateral relationships and collaborative processes
A Rule 43 letter of recommendation from a coroner is essentially a mechanism by which the interface between two different organizations both with different structures and functions is spanned.
There was evidence of a perception of an imbalance of power between the coroner and the NHS Trusts, especially at the time of an inquest:
‘Staff need to be prepared for what can be a very bruising experience, he [the coroner] can get them there and stand them up in front of everybody and they have no support, no protection.’
The perceived power of the coroner over staff was directly related to their level of exposure to the Coronial system and the support available to them. On the other hand, the coroner was not certain of the consistency of the organizational response to his letter of recommendation:
‘One of two things happens either I get a letter, a slightly sort of placating patronising letter: “Thanks for referring us to this, we have looked at it” or you get the letter which says genuinely thank you for referring, we have looked at it and this is what we are doing about it and I think in that situation it is worth it. But I don't really know what happens to them.’
This uncertainty may be related to the fact that the coroner does not have any power of enforcement of his recommendations, apart from placing them in the public domain.
This imbalance of power probably contributed to the fact that there was only occasional evidence of attempts at shared understanding:
‘So what we need to do is educate him about what we are doing as in MRSA does not equal dirty hospital.’
The coroner was seen as not fully understanding the process of care delivery in its entirety:
‘He has no medical training, he doesn't know what it is like working here, how could he?’
The role of the coroner was seen as being distinct from trusts, not as a true collaborator. This was partly because the role was not a medical one:
‘Well he's not medical is he?’
But also because the coroner had to remain impartial to do his job:
‘It's just a different role, completely separate from what we are doing, he has to be impartial.’
Information processing and anecdote
Participants generally agreed that there were established processes within the organizations to inform staff about problems with patient safety, in particular when the information was derived from a serious untoward incident report or a complaint. However, the recommendations made by the coroner were not managed using the same processes.
The findings from the qualitative data and the case study material both served to illustrate that there were no formal ways of processing information gleaned from the Rule 43 recommendations of a coroner in either Trust. The coroner in respect of his letters said:
‘I don't know what happens to them.’
Neither the coroner nor the NHS staff interviewed identified specific organizational structures to address his recommendations that gave them any status within the organization:
‘Well, like everything, it is all a bit hit and miss.’
Any information processing that did occur was characterized by single direction flows with very tenuous feedback loops. This processing was evident in the case studies in both formal (letters and minutes of meetings) and informal ways:
‘Well, I just went and had a chat with […] about it and we sort of developed the action plan from there.’
This single direction flow processing with a combination of formal and informal communication was not seen to facilitate information sharing between divisions or professional groups:
‘So I said will we get this sent out in a letter or something and she said no I am telling you about it here and it is up to you to go and share it within your division.’
There was evidence of informal communication between the coroner's office and the Acute Trust:
‘I think sometimes we get a call before the inquest is called even, just to let us know what is happening.’
This informal channel of communication was dependent entirely on the individuals involved.
Another characterization of the information processing was the time it took from the death of the patient to the coroner's report being addressed within the Trust. The time taken for this:
‘It just takes so long, like since […] happened we have brought in Essence of Care and Agenda for Change, so changes have been made anyway.’
These changes were made in response to national directives rather than the recommendations from the coroner and were not specifically designed to address the identified problem.
Organizational culture
The culture of, and the leadership within, the organizations were viewed by most participants as the central influence on the previous two themes.
There was evidence of a general reluctance to accept fully the recommendations of an external body by the trusts. This was related to the perception of an imbalance of power and also the lack of shared understanding discussed previously. The reluctance was, however, probably more closely related to the defensiveness of the participants uncovered during the interviews. The participants from the Acute Trust were defensive of their staff:
‘We, as managers, have to protect staff from a lot of this.’
They were also defensive of the quality of the care provided within their division:
‘We rarely have problems, and I would be very surprised if the coroner told me something I didn't already know.’ ‘Well, not to be complacent, but we operate pretty much at a gold standard level. We are constantly scrutinised so the information is an added burden.’
This general defensiveness was also apparent in the PCT though exhibited in a different way as there had been no exposure of the participants to the coroner's recommendations. The participants from this sector of healthcare spoke about how professionals working in primary care, especially GPs, would be unlikely to accept recommendations from a coroner:
‘I think that would cause all sorts of problems, what about professional judgement? What about decision-making when you don't have all the information? It's alright for him – he can criticize after the event with all the information. That is not what it's like when you are there trying to do your very best for a patient.’
A culture of organizational defensiveness was also apparent in the fact that responding to the coroner's recommendations was perceived by many participants as purely a paper exercise to avoid further comeback:
‘You do what you have to, to make sure the right box is ticked, then it is filed away and done with. Then if you are ever audited, not that we are for this, you are ready with your defence.’
The central barrier to ‘closing the loop’ and addressing organizational learning following coroner's recommendations was identified as competing organizational priorities. National targets were the priorities most readily identified, as were other targets that the performance of the organization was measured against:
‘When you have your four-hour wait, et cetera, et cetera, that you can make measurable progress against then you focus on that, learning is difficult to measure especially if you are learning about a one off event that probably won't happen again.’
The Clinical Governance Leads and Facilitators were seen as having the responsibility for managing any organizational learning following coroners' recommendations in the Acute Trust. At the time of the study, there were limited forums for the Clinical Governance staff to share ideas and learning:
‘We used to get together, you know, a few times a year, and if you had had a problem at an inquest you could share it with those in other divisions and vice versa. That was really useful, but that doesn't happen anymore.’
There was no evidence in the case studies that the recommendations were fed into any other existing teams or processes unless the incident had been recognized and reported prior to the inquest.
Leadership
There was a perceived lack of consistency among the approaches taken by different senior managers to recommendations made by the coroner:
‘Well, it depends whose desk it lands on, that is what really decides how it is dealt with.’
This inconsistency was evident from two different perspectives. The first was that the priorities of senior managers in terms of the quality and spread of organizational learning were perceived to be different especially if the incident was seen as a ‘one off’:
‘It is closing the book, you know it's not going to happen again. Well at least the odds are that it won't so let's do what we have to do and get on.’
The more senior managers, however, related difficulty in engaging their more junior counterparts in thorough evaluated action planning:
‘So you get to the point where you think, well, I have fed this back in so many different ways, and I have told them we need an evaluation of what they have done, not just a box ticked to say they have an action plan, so you think you have to let them get on with it, me going on about it makes no difference, they have to prioritize their work.’
The inconsistencies of the approach of leadership towards organizational learning following coroners' recommendations can be seem to stem from both the priorities of the more junior managers and those of the leaders themselves. While leadership was viewed as an important independent influence on the scope and quality of organizational learning, it is clear that the culture of the organization has an important impact upon the leadership of the organizations.
Conclusion
A systematic approach to collecting data about patient safety incidents is key to improving patient safety in any healthcare system. While developing national reporting systems represents a step in this process, it could be argued that this approach will not capture or utilize all the data that is readily and publicly available. The central role of a coroner in providing an impartial investigation into the cause of death has been a constant through recent times and across many countries. It is, therefore, interesting to note that in the draft World Health Organization international guidelines for reporting patient safety incidents, the value of information generated externally to healthcare organizations, for example, from coroners and from patient complaints, is neglected. Safety-focused systems that are capable of addressing, harnessing and analysing multiple sources of patient safety data need to be developed.
The role of the coroner was not clear even to the most senior interviewees. This lack of clarity had a great impact on the attitudes of the healthcare professionals towards both providing the information the coroner requested and in acknowledging and acting upon the recommendations that were made. This represents a fundamental barrier to the healthcare organizations collaborating with the coroner to identify and learn from patient safety incidents that may have contributed to the death of a patient.
A contributory factor to the lack of clarity among healthcare professionals is the lack of consistency of application of Rule 43 reports. The role of these reports should be explored at national level and standardized tools developed in order to achieve consistency in its application.
The importance of the safety culture of healthcare organizations should not be underestimated, especially in terms of organizational learning and communication. A defensive organization will not learn from reports made to them by an external body. If the safety culture of an organization is assessed, then potential levers and/or strategies for change in the current structures could then be identified.
If enacted, the changes to the coronial system in the Department of Constitutional Affairs Coroners Service Reform 26 and the introduction of medical examiners to the process of death certification 27 will make the Rule 43 letters more effective. The coroner will have medical advice from the medical examiner. Because the examiner is employed by the PCT, they, as commissioners, will have a greater interest and responsibility in ensuring shortcomings in healthcare services are addressed.
The letters of recommendation of a coroner are a key patient safety resource and the way such information and knowledge is generated and distributed should be a valuable component of attempts to reduce the incidence of error and system failure in the NHS.