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.
CRIMINALLY NEGLIGENT PRACTICE
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.
STANDARDS ON CARE AT THE END OF
LIFE
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.
THE NATIONAL PATIENT SAFETY AGENCY
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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