After Francis: making a difference - Health Committee Contents

4  The NHS and its patients

Fundamental standards of healthcare

97. A significant number of Robert Francis' recommendations are devoted to the establishment of fundamental standards of healthcare across the NHS. The establishment of fundamental standards "for which there is zero tolerance of non-compliance, backed up by rigorous actions" was identified by Mr Francis as one of the overarching themes in his recommendations. He recommended that these fundamental standards should be accompanied by a governance system designed to ensure both compliance with them and the publication of accurate information about compliance.

98. In his report Mr Francis analysed the multiple sources of norms and standards which currently apply in the health sector. He identified Nolan principles, standards for GMC and NMC registrants, standards for other registrants with the Health and Care Professions Council, and standards for healthcare support workers, health service managers, Foundation Trust governors and board directors and NHS directors. Underpinning these standards are the "core values" of the NHS Constitution, a document which he believes has not yet had the impact it should in establishing those values.

99. Mr Francis recommended the establishment of an integrated hierarchy of standards, with clarity of status and purpose, coherence throughout the system and a clearly understood mechanism for setting and developing both the standards themselves and effective compliance arrangements.

    [Healthcare] standards should be divided into:

·  Fundamental standards of minimum safety and quality - in respect of which non?compliance should not be tolerated. Failures leading to death or serious harm should remain offences for which prosecutions can be brought against organisations. There should be a defined set of duties to maintain and operate an effective system to ensure compliance;

·  Enhanced quality standards - such standards could set requirements higher than the fundamental standards but be discretionary matters for commissioning and subject to availability of resources;

    Developmental standards which set out longer term goals for providers - these would focus on improvements in effectiveness and are more likely to be the focus of commissioners and progressive provider leadership than the regulator.

All such standards would require regular review and modification.[80]

100. In oral evidence Mr Francis explained that previous regulatory standards had been perceived, to a greater or lesser extent, as having been "handed down" to the health service by Government, meaning that there had not been a proper sense of ownership of standards of care. He indicated what he meant by fundamental standards of minimum safety and quality:

    What we need is a set of standards that are the result of a consensus between the public who are being served and the professionals who have to provide the service according to these standards, and then endorsed by Government. The sorts of things I have in mind [ . . . ] are that it should be regulated that it is unacceptable that a patient should be left in filth; it should be unacceptable that a patient is left without food and water; and it is unacceptable that a patient should not receive medication that has been prescribed. I am talking about extraordinarily basic things of that nature which we would all think would be provided day in day out in our hospitals but manifestly were not on some, at least, of the wards of Stafford.[81]

101. He clarified that he intended these standards to be ones which patients could recognise and establish whether they were being observed, rather than technical standards:

    What I am talking about as a standard I call a "fundamental standard", which is something that no sane person would ever accept not to be provided. If you have a minimum standard, a core standard, or whatever, I am afraid that evidence tends to suggest that that is what people work to and that is all they provide. I am talking about things that we used to assume were provided but we now know were not. They are things that a patient can recognise are not being provided, a member of staff there can recognise are not being provided, and, therefore, both can immediately take action to do something about it. My impression of the current standards regulated by the Care Quality Commission is that it may be that the Care Quality Commission understands, by going round, whether there is a breach of them or not, but you or I wandering around a ward would not know.[82]

102. A failure to meet fundamental standards for a healthcare service would mean that the service in question was no longer being provided safely and should be closed:

    In times of economic challenge, it must be even more important to protect patients and their safety by ensuring that there is openness and honesty in the system, and by that I mean that there is genuine honesty about what can and cannot be done. The reason I have concentrated on [ . . . ] the fundamental standard is that the very least we can expect of a national health service is that those who run it, at any level, tell us when something cannot be done safely and, therefore, we can no longer do it, and to re-order whatever the service is accordingly.[83]

    There is no point in us providing a service to patients that does them harm, which is a grim truth, and it is awful to have to say it. So we need to provide a service that does not do that, and, if we cannot do that, we need to think again.[84]

Responses to the proposal

103. The Government has accepted the principle of defined fundamental standards, and has begun work with the CQC, Monitor, the Trust Development Agency, NHS England and NICE to develop "a small number of fundamental standards focusing on key areas of patient care".[85] It has suggested that the scope of such standards should include :

·  whether patients are getting the medicines they have been prescribed at the right time and the right dose, including appropriate pain relief;

·  whether patients are getting food and water, and help to eat and drink if they need it;

·  whether patients are being helped when they need it to go to the lavatory and not left in wet or soiled clothing or beds;

·  whether patients are being asked to consent to treatment and all staff communicate with patients effectively about their care and treatment; and

·  whether the environment is clean and hygienic.

104. The CQC has issued a consultation paper on its approach to setting and inspecting standards in healthcare providers. The consultation envisages three levels of standard against which providers will be assessed:

·  Fundamental standards—a legal requirement for any provider to operate a service

·  Expected standards—standards of care which users should expect as a matter of course

·  High-quality care—standards set by bodies such as NICE with the purpose of driving and measure priority quality improvements in providers

105. The CQC proposes that there will be "immediate, serious consequences" for the healthcare services it inspects where care falls below the fundamental standards, including the possibility of prosecution. As Robert Francis recommended, the fundamental standards should be drafted so that anyone should be able to recognise a breach of them.

106. The CQC has proposed a debate on the formulation of fundamental standards of care, suggesting as examples the following:

·  "I will be cared for in a clean environment.

·  "I will be protected from abuse and discrimination.

·  "I will be protected from harm during my care and treatment.

·  "I will be given pain relief or other prescribed medication when I need it.

·  "When I am discharged my ongoing care will have been organised properly first.

·  "I will be helped to use the toilet and to wash when I need it.

·  "I will be given enough food and drink and helped to eat and drink if I need it.

·  "If I complain about my care, I will be listened to and not victimised as a result.

·  "I will not be held against my will, coerced or denied care and treatment without my consent or the proper legal authority."

107. The CQC proposes that the regulations establishing fundamental standards should allow the CQC to pursue breaches of fundamental standards without first having to serve a warning notice on the provider. It proposes that expected standards should be enforced through registration requirements and that the CQC should require providers who do not meet expected standards to implement improvements as a condition of continued registration.

108. The report of the Berwick Review recognises the importance of regulation based on fundamental standards, but suggested that quality improvement in health services would not be achieved solely through a reliance on regulation based on technical standards:

    Regulation, especially using intelligent inspection by experts, does have an important role in setting out what is expected, monitoring the extent to which those expectations are met, and taking action when they are not met. Clear and prompt response to alarming signals [. . .] is crucial for quality control.

    However, regulation alone cannot solve the problems highlighted by Mid Staffordshire. Neither quality assurance nor continual improvement can be achieved through regulation based purely on technically specific standards, particularly where a blunt assertion is made that any breach in them is unacceptable.

    In the end, culture will trump rules, standards and control strategies every single time, and achieving a vastly safer NHS will depend far more on major cultural change than on a new regulatory regime.[86]

The Committee's view

109. The Committee agrees in principle with the proposal to establish a set of clear and unambiguous fundamental standards in such a way that patients, their relatives, clinical and auxiliary staff and NHS managers can immediately recognise unacceptable care and take appropriate action.

110. The expectation in establishing such standards is of course that they will not be breached, and that consequences will follow if breaches occur. Providers will no doubt adopt systems which minimise the risk of such standards being breached and which alert staff to any risk that the standards might be breached. It is important in establishing a fundamental standards regime that providers and the CQC are alert to the risk that a rigid adherence to measures designed to avoid breaches of fundamental standards may lead to perverse consequences elsewhere.

111. Even on well-managed wards, health professionals are properly expected to prioritise their effort according to clinical need. It is inevitable that occasions will arise where a coincidence of higher clinical priorities which require urgent attention of staff will be a greater priority than the temporary discomfort caused to some patients when fundamental standards are unavoidably breached as a consequence. Above all, fundamental standards should not distort clinical priorities such that they put patients at risk.

112. The Committee believes that once it has been established that a breach of a fundamental standard has occurred, it is axiomatic that it is treated seriously, reported accordingly and investigated thoroughly. Regulatory consequences—including unannounced CQC inspections—may follow from breaches, but it is important that any regulatory action should be proportionate to the breach that has occurred, and that it concentrates on analysis and remedy of the circumstances which have led to the breach.

113. The Committee expects to examine the CQC's progress in developing the full range of standards identified in paragraph 104 of this report in the course of its regular programme of accountability hearings.


114. The Government proposes that where the Chief Inspector of Hospitals, working within the CQC, identifies criminally negligent practice in hospitals, the CQC should refer the matter to the Health and Safety Executive to consider whether criminal prosecution of providers or individuals is necessary.[87] The Health and Safety Executive (HSE) will receive additional resources to enable it to take on the task of examining criminal breaches of fundamental standards in hospitals. The Committee notes that the HSE has recently commenced a criminal prosecution of the Mid Staffordshire NHS Foundation Trust under Section 3(1) of the Health and Safety at Work Act 1974 in relation to the death of a patient in April 2007, a case examined by Robert Francis.

115. The Berwick Review has recommended that in cases of demonstrably severe and wilful misconduct which result in "egregious acts or omissions that cause death or serious harm", providers and individuals alike should be subject to criminal sanction. The proposed criminal offence of wilful or reckless neglect or mistreatment which Berwick recommends is modelled on a similar provision in the Mental Capacity Act 2005. While the Committee understands the relevance of this proposal and the issue it is intended to address, it is aware that there may already be provision in statute which enables such behaviour to be prosecuted as a criminal offence.

116. The Committee agrees that serious breaches of fundamental standards which risk harming patients, or which are directly responsible for the death or serious injury of patients, should be treated as criminal matters.

117. The Committee notes the recommendation of the Berwick Review that an offence of wilful or reckless neglect or mistreatment, applicable both to organisations and individuals, should be introduced. It considers that the proposal should be examined to determine whether egregious acts or omissions on the part of individuals or providers that cause death or serious injury to patients can be prosecuted as offences under existing criminal statutes.


118. Robert Francis did not, in the report of his latter inquiry, make specific recommendations on standards for care of the dying. Extracts from witness statements and independent case note reviews presented in the report of his first inquiry indicate that at Stafford General Hospital during the period under investigation there were several instances where patients who were dying received care which was below an acceptable standard.

119. The issue of care for the dying in NHS care has been analysed in greater detail by the team led by Baroness Neuberger established to review the use of the Liverpool Care Pathway. The report of the review[88] made a number of detailed recommendations on which the Committee has not taken evidence and which are still under consideration by the Department of Health, NHS England and the relevant regulators.

120. The Neuberger Review found that a number of the stories in the press and broadcast media about the use of the Liverpool Care Pathway (LCP) which had prompted the commissioning of the review appeared to have much in common not only with the complaints which had led to the establishment of the two inquiries into Mid Staffs, but also with several other media stories about the way elderly patients in acute hospitals had been treated. The review concluded that

    Plenty of evidence received [. . .] shows that, when the LCP is used properly, patients die a peaceful and dignified death. But the Review Panel is also convinced, from what it has heard and read, that implementation of the LCP is not infrequently associated with poor care.[89]

121. The Neuberger Review recognised the positive contribution which the Liverpool Care Pathway and similar approaches to end of life care have made to clinical decision-making.

    The Review panel fully recognises the valuable contribution that approaches like the LCP have made in improving the timeliness and quality of clinical decisions in the care of dying patients. It is therefore vital that the comments which follow [. . .] do not result in clinicians defaulting back to treating dying patients as though they are always curable, for fear of censure.[90]

122. The review has, however, raised wider issues about standards of care which are applied to dying patients. The review report observes that all doctors, nurses and healthcare staff should aim to provide care with compassion to all people at the end of their lives, and that "exceptional standards" of care are required in the care of people with co-morbidities, people in pain and people who are frightened, as well as in the care of distressed and anxious relatives: "yet exceptional standards are all too often noticeable by their absence".[91]

123. The Neuberger Review has recommended the establishment of a "system-wide, strategic approach" to the improvement of care for the dying, to entail close cooperation between the GMC, the NMC, the medical Royal Colleges, the CQC, NHS England and the National Institute for Health and Care Excellence. This coalition of bodies should created and deliver a knowledge base, education, training, skills and commitment "to make high quality care for dying patients a reality".[92]

124. As part of this approach the Review recommends that the CQC should collaborate with patient groups to define standards for good-quality end of life care services, and then inspect against those standards. It is also recommended that:

·  the CQC incorporate end of life care into the new inspection programme established by the Chief Inspector of Hospitals

·  the CQC carry out a thematic review of the treatment of dying patients across all the healthcare settings it inspects

·  NHS England and clinical commissioning groups work to drive up standards of care for the dying by improving their commissioning practices.

125. The evidence of poor care at end of life in the NHS which has emerged from the Mid Staffs inquiries, the review of the Liverpool Care Pathway and other press and broadcast media coverage is deeply disturbing. The Committee recommends that the National Institute for Health and Care Excellence should establish specific standards for end of life care designed to ensure that dying patients receive all the care they require to minimise their suffering.


126. The National Patient Safety Agency, established in 2001 as a Special Health Authority, had the core function "to improve the safety of NHS care by promoting a culture of reporting and learning from adverse events", which it largely achieved through a Patient Safety Division, which operated the National Reporting and Learning Systems arrangements for recording and learning from patient safety incidents.

127. In April 2012 the National Patient Safety Agency was abolished as part of the Department of Health's review of its arm's-length bodies. Leadership on patient safety policy transferred to the NHS Commissioning Board Authority (now NHS England); the National Reporting and Learning System (NRLS) database of patient safety incidents transferred to Imperial College NHS Trust for a two year period from 1 April 2012 and was to be commissioned by NHS England; the National Clinical Assessment Service transferred to the National Institute of Health and Clinical Excellence (now the National Institute for Health and Care Excellence); the National Research Ethics Service was taken into the newly established Health Research Authority, and the commissioning of the three Clinical Outcome Review Programmes (formerly known as National Confidential Enquiries) transferred to the Healthcare Quality Improvement Partnership, a charitable body.

128. At the time, the Department explained that, as the NHS Commissioning Board was expected to provide national leadership on commissioning for quality improvement, the essential functions supporting this role undertaken by other agencies, including the NPSA, should be brought together within the mainstream work of the Board "to exploit the leverage that commissioning would provide in placing quality and safety at the heart of patient care."[93] The NPSA's functions, while still considered necessary within a system supporting wider quality and safety improvement, were not considered necessary to be delivered by an arm's-length body and could be delivered elsewhere in the system.

129. The Secretary of State suggested that the Department's commitment to patient safety remained, despite the decision to eliminate the agency which had as its principal focus the monitoring of patient safety in the NHS: he indicated that the change was intended to "mainstream" a commitment to quality through the NHS system.[94]

130. The Committee is not convinced by this argument. While a commitment to patient safety needs to be promoted throughout the NHS, and is part of the role of the Commissioning Board, responsibility for operating the database of patient safety incidents has been in effect outsourced to an academic institution on a commissioning arrangement which will require renewal at regular intervals.

131. Robert Francis was himself critical of the present arrangements for the patient safety function:

    Safety is such a crucial aspect of protecting patients, it is questionable whether it should be controlled by a body under pressure to ensure the delivery of economic and financial objectives as well as quality ones. Wherever the function resides, its resources need to be well-protected and defined.

    Consideration should be given to the transfer of this valuable function to a semi-independent arm of the systems regulator.[95]

132. The purpose of establishing the NPSA as a separate organisation was to create a single focus for concern about patient safety—as one key domain of clinical quality. It was an institutional reflection of the old principle of good medicine—"first do no harm". Although the abolition of the NPSA reflects a welcome desire to reduce the number of regulatory and quasi-regulatory bodies in an over-crowded field, the effect of the present arrangements has been to give the appearance that the overall significance of patient safety in health policy has been downgraded and that the effectiveness of the patient safety function has been compromised. In particular the location of legacy responsibility with NHS England, as the main commissioner of care, rather than with the CQC as the principal regulator, appears surprising.

133. The Committee has recommended before that prime responsibility for monitoring of patient safety practice and data should be a core responsibility of the CQC.[96] It repeats this recommendation in this report in order to re-establish the principle that this responsibility should be demonstrably at arm's length from both the Department and from NHS England. The Committee further notes that the definitions of patient safety incidents used by the National Reporting and Learning System focus only on incidents in taxpayer-funded healthcare. The definitions should be amended to cover patient safety incidents in private healthcare and taxpayer-funded social care services, both of which fall within the CQC's responsibility.

Feedback and complaints

134. The Government has made few recommendations on reform to the NHS complaints system, pending the report of the review being undertaken by Rt Hon Ann Clwyd MP and Professor Tricia Hart. The Committee expects that the Government will, in its full response to Francis, consider the progress on relevant recommendations made in its 2011 report on Complaints and Litigation, as well as the recommendations relevant to the NHS which emerge from the present inquiry into complaint handling being undertaken by the Public Administration Select Committee.

135. Robert Francis was keen to stress the role which NHS commissioners should play in the complaints process, both as a matter of principle and as a means of checking that a proper service is being provided in return for the public money disbursed to providers. Information from individual complaints should therefore be available to commissioners as a matter of course: "if we have commissioners who are buying services, then they must have the means to check that those services have been delivered according to the specification that they have agreed with the relevant trust".[97]

136. Mr Francis considered the complaints system operated by the Mid Staffs Trust and concluded that it paid only lip service to good practice. Complaints were responded to, but often partially and inadequately. Where action plans were provided, there was little evidence that any action had followed from it: more often no action followed, " because we then see six months later the same thing happening in the same ward and the same sort of letter coming out with the same sort of action plan."[98] Mr Francis concluded that greater transparency in the handling of complaints was the key to greater effectiveness in the system:

    [ . . . .T]he substance of the complaints needs to be shared with the commissioners, the Care Quality Commission and—I see no reason why not in a suitably anonymised form—with the public. There would be visibility then as to what is happening about these things. If we are seeing a repeat of elderly patients breaking their legs because they have been falling over in a particular ward because no one was there to help them to the toilet, and that has happened two or three times, we will be beginning to wonder whether this is a hospital capable of maintaining fundamental standards and, therefore, whether the service of this particular ward, or whatever the service was, should be allowed to continue. That is a commissioner's job, it seems to me, as well as the regulator's job. Between them, you have two organisations, at least, and in the background the public through patient involvement groups or whatever, being able to bring pressure to bear to make sure these things are done. I am not sure that changing the structure is necessarily the answer. There may be tweaks that could be made to it. It is about ensuring that the structure we have is acted on properly.

137. Mr Francis also recommended that Trusts make greater use of independent investigators to examine complaints, a practice which might help Trusts identify systemic issues which needed to be rectified: "if you do that, you get a report from an outsider who sets out things, one would hope, in a systematic way, and you have a report that may well identify systemic issues where they arise. That can be shared with the commissioner, the regulator and so on."[99]

138. The Committee agrees with Robert Francis that proper complaints handling is vital if organisations are to ensure that services are change for the better.

139. Robert Francis recognised that patients are often not willing to complain about poor care, for fear of adverse consequences, particularly if the complainant is bed-bound or in a similarly vulnerable position:

    You have the nurses there, you have the patient there, and unless you change the culture and root out [intimidatory] behaviour—and that requires responsibility on the part of those running it—it is quite difficult to see the answer to that [issue]. The one answer I will give is that [a] PALS [Patient Advisory and Liaison Service] does not work in this context. It has its value, but its value is to do with facilitating communications, perhaps, and advice of that nature, rather than anything else. It is too intrinsic to the trust itself to be of help. You need more transparency. Part of what I have said is about being more welcoming to families and their involvement in what is going on, and the more people you have—the force of numbers—occasionally overcomes the vindictive nurse, one would hope. In so far as they exist—and we know they exist; they did at Stafford—it is, I am afraid, the duty of those around them to root that out. I cannot see any other answer to that.

140. Providers of NHS services should be alert to this issue. The Committee recommends that NHS providers should promote a culture of openness to complaints and receptiveness to feedback throughout their organisations, and they should also develop channels which allow patients and their families to make observations about poor standards of care in the confidence that there will be no detriment to the patient and will be taken seriously by the organisation. Any staff who deliberately treat patients poorly as a consequence of complaints being made should be held to be in breach of a fundamental standard of NHS care, and liable for the consequences.

80   Francis Report, recommendation 13, chapter 21 Back

81   Q14 Back

82   Q17 Back

83   Q35 Back

84   Ibid. Back

85   Patients First and Foremost, Cm 8576, para 3.22 Back

86   A promise to learn - a commitment to act, p. 11  Back

87   Patients First and Foremost, Cm 8576, para 25 Back

88   Independent Review of the Liverpool Care pathway, More care, less pathway: a review of the Liverpool Care Pathway, July 2013 Back

89   Ibid., p 19 Back

90   Ibid., para 1.38 Back

91   Ibid., p 38 Back

92   Ibid., recommendation 39, para 3.6  Back

93   Liberating the NHS: Report of the arm's-length bodies review, Department of Health, July 2010, para 3.57 Back

94   Q474 Back

95   Francis Report, paras 17.123 and 17.124 Back

96   Health Committee, Seventh Report of Session 2012-13, 2012 accountability hearing with the Care Quality Commission, HC 592, para 19 Back

97   Q32 Back

98   Q72 Back

99   Q74 Back

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Prepared 18 September 2013