Those with long memories will have read The Francis Report with a sense of déjà vu. The Report, published on February 6th 2013, contained echoes of recommendations made in the Kennedy Report into children’s heart surgery at the Bristol Royal Infirmary in 2001. Both reports were the culmination of many months of investigating and sifting of evidence, and both made a large number of recommendations – 198 in the Kennedy Report, and 209 in the Francis Report. Although the Bristol Inquiry was concerned with specialist cardiac services for babies and children, and the Francis Inquiry covered a much broader area of secondary healthcare, both Reports refer to a “culture” in which there was little transparency and some members of staff felt too intimidated to voice their concerns. What is particularly dispiriting, is the fact that if lessons had been learned from events at Bristol at the end of the twentieth century, and some of the recommendations made by Sir Ian Kennedy been acted upon, the tragic events that occurred more recently in Mid Staffordshire might never have materialised. There is a long tradition in the NHS of a commitment to learning from mistakes, but in too many instances the evidence of the Francis Inquiry is that far from learning, staff continued to bury mistakes, and the culture of openness recommended in the Kennedy Report had never came into existence. What is still more significant is that the Francis Report is simply the latest in a long series reports on failures in NHS patient care, dating from the Report of the Ely Hospital Inquiry in the late 1960s, all of which have reached similar conclusions. As the King’s Fund response to Francis points out:
“This shows that the real challenge is not the diagnosis and prescription for the problem, it is ensuring that the remedy is administered effectively”.
After 31 months of investigation, the Francis Report concluded that the culture of poor care, secrecy and inadequate leadership at Mid Staffs NHS Trust had resulted in the deaths of between 400 and 1,200 patients. The evidence revealed an appalling lack of care, failure to listen to the concerns expressed by relatives and patients, and a culture in which meeting targets was placed before compassion. As was identified during the first inquiry, Mid Staffs NHS Trust, as an entire organisation, lacked insight into the reality of the care provided to its patients. It reacted defensively to criticisms and lacked openness about errors with patients, the public and external agencies. As the responsibilities of external agencies were ill-defined, there was a general failure to investigate warning signs, and organisations operated in silos, without further consideration of the wider implications of their role. Ineffective communication across the healthcare system in sharing information and concerns exacerbated the situation, and a central plank in the overall system failure was lack of openness, transparency and candour in information emanating from the Trust, and over-reliance by others on the Trust’s own information. This situation was complicated by the constant reorganisation of NHS structures, often leading to the loss of corporate memory and misunderstandings about functions and responsibilities.
It would be impossible to cover in depth all the events and recommendations made in the Francis Report, and the intention in this summary is to deal with the recommended “Duty of Candour”
The Proposed Duty of Candour
The Kennedy Report had contained the following observation:
“Even in the case of a mistake which might bring legal liability there is a duty of candour. This duty is part of and grows out of the culture of openness which we have called for. It is also a duty that is implicit in the notions of respect and honesty in dealings with patients.
With specific regard to an unplanned event which results in harm to the patient, the duty of candour should still apply even when mistakes are not immediately apparent and come to light later. This is so particularly when the patient may otherwise be unaware.
It is also vital that healthcare services routinely seek direct feedback from patients. This is not something to be feared but to be embraced.”
Ironically, twelve years later, among the key proposals in the Francis Report is the creation of a new ‘duty of candour’, a legal requirement for NHS staff to inform patients’ families if they believe that harm has been done.
The Department of Health had, however, already accepted the concept of a duty of candour in its publication that followed the Kennedy recommendations, entitled “Making Amends,” in which Sir Liam Donaldson mooted the possibility of the introduction of a statutory Duty of Candour. Recommendation 12 of Making Amends stated:
“A duty of candour should be introduced together with exemption from disciplinary action when reporting incidents with a view to improving patient safety.”
Although no such statutory duty was ever implemented, later developments could have raised the false hope that it might not have been necessary, as the recommendation was concerned in the main with improving safety, and in practice, reporting of safety concerns and incidents has been encouraged within internal systems in NHS organisations and is required to be made to external bodies such as the National Patient Safety Agency (NPSA), whose key functions were transferred to the NHS Commissioning Board Special Health Authority on June 1st 2012. NHS organisations now report safety incidents to the National Reporting and Learning System (NRLS), but this requirement is not currently supported by any direct criminal sanctions for failure to report. Moreover, the commentary accompanying the proposal in Making Amends makes it clear that it is intended to apply to disclosure to patients, and there is no guarantee under the present system in England that this will happen.
In 2009, the “Being Open” initiative was introduced, following guidance issued in 2005 by the NRLS on communicating effectively with patients when things go wrong. However, this was no more than a best practice framework for healthcare staff, including boards, clinicians and others, explaining the basic principles behind the guidance and advising on how to communicate with patients, their families and carers following incidents of harm.
“Open and honest communication with patients is at the heart of health care. Research has shown that being open when things go wrong can help patients and staff to cope better with the after effects of a patient safety incident……
Being open is the right thing to do, and should encourage NHS boards to make a public commitment to openness, honesty and transparency”.
NHS organisations dutifully produced and published “Being Open” policies, supported by recommendations made by the Ombudsman, but such aspirational rhetoric did not prevent the situation that developed in Mid Staffordshire, despite the following statement in the Trust’s own annual Report for 2007-8:
“The Trust’s complaints procedure aims to deliver the six good practice values set out in the “Principles for Remedy” published by the Parliamentary and Health Service Ombudsman in March 2007.
- Getting it right;
- Being customer focused;
- Being open and accountable;
- Acting fairly and proportionately;
- Putting things right and
- Seeking continuous improvement”
In Wales, the implementation of a system of NHS Redress does go some way to improving this situation, Coroners’ reports suggest that defensive practices and a lack of openness continue to pervade the NHS in both England and Wales, and successive Ombudsman’s reports indicate that many and various kinds of communication e rror in general lie at the heart of mistakes and poor practice in healthcare.
NHS staff have continued to act defensively for fear of repercussions for themselves if mistakes come to light, and from concern that an apology might amount to an admission of guilt. Yet the professional regulatory bodies advise otherwise, and the General Medical Council and healthcare defence organisations have encouraged open disclosure of errors for many years.
Moreover, the Compensation Act 2006 s 2, which does not only apply to healthcare organisations, aims to reassure those who are urged to apologise following an accident of any kind, stating:
“An apology, an offer of treatment or other redress, shall not of itself amount to an admission of negligence or breach of statutory duty”.
The Francis Report suggests that there is a need to close the gap between the advice provided by the Regulatory authorities in healthcare and the requirements of law, commenting that it should be recognised that there are some cases which are so serious that criminal sanctions are required, even where a charge of individual or corporate manslaughter cannot be sustained, and taking the view that:
“The argument that the existence of a criminal sanction inhibits candour and cooperation is not persuasive. Such sanctions have not prevented improvements in other fields of activity”.
The Francis Report on openness, transparency and candour
The Francis recommendations on openness reach beyond the proposed duty of candour into the entire culture of NHS organisations. The recommendations are for a common culture characterised by openness to be shared throughout the system , so that concerns can be raised and disclosed freely and without fear; by transparency which would enable valid information about performance and outcomes to be shared with staff, patients and the public; and candour, to ensure that patients who are harmed by a healthcare service (or their relatives where appropriate), are informed of the facts and that an appropriate remedies are offered -whether or not a complaint has been made or a question asked.
The Francis Report recommends that organisations and their leaders should be completely truthful in any statements made to regulators, and should not mislead by omission, and that public statements should be clear, truthful and not misleading. There is a further recommendation that the NHS Constitution, which applies only in England and was first introduced in 2010, should include a clear obligation to comply with these principles. The most recent iteration of the NHS Constitution already emphasises the importance of whistleblowing in the NHS, and includes a pledge that NHS organisations will support their staff who raise concerns by investigating them fully, and ensuring that staff who raise concerns about safety, malpractice or other wrong-doing suffer no detriment. However, such pledges have little legal force except in so far as they are already supported by law, though NHS organisations in England do have a responsibility “to enforce the constitution”, and a legal duty to “take note” of the constitution when performing their duties.
In recognition of the complexities of the situation and the need to embed a new culture in the NHS, the Francis Report makes an overarching recommendation that:
“The common culture of caring requires a displacement of a culture of fear with a culture of openness, honesty and transparency, where the only fear is the failure to uphold the fundamental standards and the caring culture”
NHS staff, in common with those in other professions, are encouraged to report events which they consider might endanger patients, and are protected by the Public Interest (Disclosure) Act 2008 from suffering any detriment in their employment as a result. Yet despite the introduction of this Act, and even with “Whistleblowing” policies in place in all NHS organisations in England and Wales, there is continuing evidence that staff are reluctant to speak out against colleagues, as the Francis Report demonstrates.
A statutory obligation backed up by criminal sanction
The most forceful recommendation made by the Francis report in connection with candour is that there should be a statutory obligation imposed on NHS healthcare providers, registered medical and nursing practitioners to observe the duty of candour, and on directors of healthcare organisations to be truthful when providing information given to a regulator or commissioner.
“There should be a statutory duty on all directors of healthcare organisations to be truthful in any information given to a healthcare regulator or commissioner, either personally or on behalf of the organisation, in compliance with a statutory obligation on the organisation to provide it. It should be made a criminal offence for any registered medical practitioner, or nurse, or director of an authorised or registered healthcare organisation:
- Knowingly to obstruct another in the performance of these statutory duties;
- To provide information to a patient or nearest relative intending to mislead them about such an incident;
- Dishonestly to make an untruthful statement to a commissioner or regulator knowing or believing that it is likely to rely on the statement in the performance of its duties”.1
The recommendation for the creation of this criminal offence is interesting and has been welcomed by bodies such as Action against Medical Accidents, (AvMA),, but it might not be sustainable in practice, especially as it is recommended that the enforcement of these duties should be the responsibility of the Care Quality Commission (CQC). The Francis Report identified the failings of the CQC itself as playing a part in the situation that arose in Mid Staffs:
“The evidence received by this Inquiry does not suggest that the CQC is a happy environment to work in. The massive upheaval that has taken place in its creation has led at least some elements of staff, from the frontline to the Board, to express concerns and to believe they have not received an adequate response. While it is clear that the CQC aspires to be an organisation which welcomes constructive comment, the Inquiry has seen evidence of a defensive institutional instinct to attack those who criticise it, however honestly and reasonably those criticisms are made. A healthcare regulator needs to be a model of openness and therefore welcome constructive criticism”.2
Despite this, the Francis Report recommended:
“Observance of the duty should be policed by the Care Quality Commission, which should have powers in the last resort to prosecute in cases of serial non-compliance or serious and wilful deception. The Care Quality Commission should be supported by monitoring undertaken by commissioners and others”
In response to the obvious point that fear of prosecution could deter people from being candid, the Francis Report argues that criminal sanctions have not prevented improvements in other fields of activity, especially if they are only used proportionately and in cases where no improvements are made, or the deficiencies are particularly serious, commenting:
“It is likely that nothing will focus the minds of a board or trust leaders more on avoiding serious breaches of safety requirements than the possibility of prosecution. Clearly, it should be a last resort, sparingly used, but it undoubtedly has its place in maintaining public confidence in the system and preserving proper standards of service”
The Implications for Wales
Although the Francis Report concerned events at an English NHS Trust, Welsh Health Minister Lesley Griffiths promised that lessons will be learnt in Wales from the Inquiry into what she described as “appalling” neglect at Stafford Hospital, cautioning against complacency and c ommenting that everything must be done to make sure that the same level of systemic failing does not occur in Wales.
There are now very significant differences between England and Wales in the structure and delivery of healthcare services, and the Francis Report, which focuses on secondary care, must be considered in the context of these. The NHS in England3 is currently in a state of some turmoil and uncertainty following yet another recent restructuring exercise, while in Wales the position is settled after reforms which have had time to stabilise. In addition to the broader aspects of change, it is possible to identify numerous smaller points of difference between the two countries since devolution. For example, patients are given a voice in Wales through Community Health Councils, which have been abolished in England, and through extended advocacy arrangements. A new system has been introduced for handling concerns, complaints and lower value claims4. The two countries have different inspectorates, different targets, different approaches to treating more patients in the community5.
Under a far more straightforward healthcare system than England’s, seven Local Health Boards in Wales now have overall responsibility for the delivery of all healthcare services to the population within their geographical areas, from care provided in all primary care and community settings, to that which is delivered in hospitals. But despite its simplicity, this system has the potential for mistakes to be buried more easily, as it is difficult to monitor all care wherever it is given, from patients’ homes to secondary services, and within the Health Boards strenuous efforts are made, though clinical governance, to identify and learn from past failings.
In terms of the duty of candour, Wales has already made some progress towards the implementation of a degree of openness in the healthcare setting, with the implementation of its NHS Redress Measureand the introduction of the related programme entitled “Putting Things Right”, which links concerns, complaints and claims, and urges patients, their friends, relatives and staff to report errors and other incidents. Information gained, and lessons learned, are fed back into the system in order to improve the care that is provided to patients. The emphasis is on communication between staff and patients to provide explanations when errors are made. However, there is no room for complacency, and it is not surprising therefore that the Francis Report has already been the subject of intense discussion among members of Welsh Healthcare Boards.
Ministers, NHS inspectorates and regulators and the newly established NHS Commissioning Board are already debating the merits of the many Francis recommendations and it will surely be necessary to introduce reforms to the NHS as soon as possible. However, even legislation is sometimes unable to bring about cultural change, and the UK Government’s health secretary Jeremy Hunt has already commented that the biggest challenge to the NHS is the crisis in standards of care at a time of rising demands on services when budgets are tight and efficiency savings are necessary.
The Francis Report calls for the recommendations to be implemented, and for implementation progress to be evaluated within 12 months, which is all the more urgent in the light of the astonishing announcement that on the day that the Francis Report was published, an investigation began into excessively high mortality rates at five further NHS Trusts. It is essential that the Report should not be allowed to gather dust as other reports have done in the past, and for its recommendations to be taken seriously in England and Wales alike. Admittedly, even the implementation of a large number of the recommendations made in the Report cannot guarantee the proposed change in the culture of the NHS, but it would be sensible to embark upon the introduction of the proposed duty of candour as soon as possible, not least to engage with the rhetoric of the “dignity and respect” agenda that is already being developed in the NHS.
Vivienne Harpwood is a Professor of Medical and Healthcare Law.
1 Francis Report Para 22.164
2 Francis Report Summary para 1.74
3 Health and Social Care Act 2012
4 The NHS Redress (Wales) Measure 2008
5 “Setting the Direction – Primary and Community Care in Wales” 2010