6 The future of regulation
Regulating the system: the future
of the CQC and Monitor
173. The Francis inquiry report revealed that the
decision of Monitor to authorise Foundation Trust status for Mid
Staffs in 2008 was made in ignorance of the serious concerns raised
by the Healthcare Commission, the predecessor organisation of
the CQC, about quality standards within the Trust.
174. The failure of Monitor and the Healthcare Commission
to establish a proper basis of cooperation in the case of the
Mid Staffordshire Trust led Robert Francis to propose that there
should be greater institutional links between the two organisations.
In particular he recommended that:
There should be a single regulator dealing both
with corporate governance, financial competence, viability and
compliance with patient safety and quality standards for all trusts.[123]
He spelt out his recommendation in greater detail
in his oral evidence:
My proposal is that one regulator, in assessing
the safety of the hospital or the compliance with standards of
the hospital, should be considering both what have up to now been
called the quality outcomes but also the financial corporate governance
that makes that compliance possible under one roof. That is not
to say that the expertise that Monitor have in relation to looking
at those matters is not absolutely valid—it is—but
what we saw here was that dealing with them separately, under
separate organisations, meant that one did not talk to the other.
It might be said, "You can sort that out by getting one to
talk to the other," but I think you need the teams who do
these things to be working together so that the perspective of
each in the course of their investigations and so on feeds off
each other so that we no longer have the issues of corporate governance
being dealt with without people thinking to themselves, "How
is this in itself impacting on patient safety?"
Therefore, I would envisage initially much the
same people who do this in Monitor continuing to do it. It is
simply that I believe they ought to have the same boss, if you
like. I have not suggested one way or the other whether that means
you get rid of Monitor or you amalgamate them, because there are
other functions that Monitor perform. I see this as—and
I said it should be—an evolutionary process because we have
to keep such regulations as we have going while we do this. [
. . . .] [T]he important point is simply that this should be work
that is done together for the benefit of patients rather than
separating off the system bit from the outcome bit.[124]
The Government's response
175. The Government has indicated that it does not
intend to accept this recommendation for a single regulator of
provider quality and financial performance. Instead the Government
proposes to establish a "single failure regime" which
would treat failures in care quality as seriously as failures
in financial performance. The Government's proposals were outlined
in Patients First and Foremost:
In delivering this regime, the Care Quality Commission,
Monitor and the NHS Trust Development Authority will work closely
with each other and with commissioners, who will have a role in
driving improvement and service change. We are mindful that this
approach should not increase the overall level of regulatory burden,
and in developing the regime we will consider the recommendations
from the NHS Confederation's Review of Bureaucratic Burdens.[125]
The single failure regime is to operate as follows:
The single failure regime will deliver a clear
and co-coordinated regulatory approach to identifying and tackling
failures of quality. There will be three elements to the proposed
failure regime:
· It is essential that there is a common
understanding of provider performance amongst regulatory bodies
and commissioners - a 'single version of the truth'. There will
be a single rating of providers led by the Chief Inspector of
Hospitals at the Care Quality Commission which draws on information
and assessments from Monitor and the NHS Trust Development Authority
on finance. The Chief Inspector of Hospitals will champion excellent
care. The regulatory bodies and the NHS Commissioning Board will
agree a single national definition of quality, consistent with
the Mandate and the NHS Outcomes Framework. This agreed quality
framework will include consistent use of data to support assessment.
The application of the national method will take account of the
need to reflect, and not crowd out, local commissioner priorities.
The Care Quality Commission will have an increasingly prominent
role in Quality Surveillance Groups in assessing the quality of
providers.
· Where quality is poor, the Chief Inspector
will require the board of the provider with its commissioners
to improve, within a fixed period. But the Care Quality Commission
will not then be responsible for making it happen. The principle
that responsibility for dealing with the problem lies with the
provider, rather than external bodies, will not change. If the
provider is unable to resolve the situation in partnership with
commissioners, and problems persist, Monitor or the NHS Trust
Development Authority would step in, potentially following a request
from the Chief Inspector. Monitor and the NTDA retain their current
ability to intervene at their discretion if urgent regulatory
action is required. The same level of intervention will
be possible in response to quality failings as for finance and
governance failings.
· In some cases, however, it may become
clear that more fundamental issues prevent an NHS foundation trust
or NHS trust from making the necessary improvements in quality
of care. For these rare cases of clinically unsustainable providers,
we will ensure there is a suitable mechanism to ensure that the
local population can access a comprehensive range of safe, sustainable
health services.[126]
176. The proposed primary legislation to achieve
the single failure regime and align the respective responsibilities
of the CQC and Monitor has been included in Part 2 of the Care
Bill [Lords]. The Bill was accompanied by a joint statement
from the CQC, Monitor, NHS England and the NHS Trust Development
Authority about how the newly aligned regime would operate.[127]
177. The Secretary of State argued in evidence to
the Committee that the effect of the proposed single failure regime
would be that where a hospital breached fundamental standards
the regime would make it "impossible for the system not to
sort out the problem. There will be a time-limited period within
which any of those breaches have to be sorted out, and if they
are not, the hospital will go into administration."[128]
178. The Committee is sceptical that any failure
regime can make it "impossible for the system not to sort
out the problem". The causes of failure within a major care
provider are often numerous and complex; the Committee expects
that the new model of inspection on which the CQC is presently
consulting, and the operation of the single failure regime across
all regulators, will require continual examination and tightening
to ensure that both regulators are working effectively together.
179. The Committee does not support further major
institutional change to the relationship between Monitor and the
CQC. The Committee recommends that the two organisations continue
to develop closer working arrangements to deal with cases of provider
failure and shall seek evidence about the effectiveness of these
arrangements from both organisations through its programme of
annual accountability hearings with them.
180. Little of the detail of the regime set out in
Patients First and Foremost and explained in greater detail
in the quadripartite statement accompanying the Care Bill will
be included in primary legislation, and although the policy approach
has been set out, the detail of how it is to be achieved will
be carried in secondary legislation. The changes to be made to
the inspection functions of the CQC and its registration requirements
are to be enacted through secondary legislation under the Health
and Social Care Act 2008. While such legislation should pass through
the affirmative procedure, enabling a form of debate before approval
by each House, in practice secondary legislation laid before Parliament
for enaction through this route is unamendable. There is substantial
public interest in ensuring scrutiny of any draft before the Government's
proposed draft is formally laid for approval.
The Committee recommends that the Government publish
for comment, prior to its formal introduction to Parliament, a
draft of the legislation under which it is proposed to alter the
inspection regime of the Care Quality Commission and the functioning
of the single failure regime for Trusts and Foundation Trusts.
181. The Government has suggested that "outstanding"
hospitals, as rated by the Chief Inspector, will be given "greater
freedom from regulatory bureaucracy." In the CQC's consultation
document on its proposed new inspection and ratings regime, it
is proposed that the following criteria will have to be met for
a hospital to achieve an "outstanding" rating:
· No breaches of fundamental standards
· No inadequate services, with most services
rated as 'Good' or 'Outstanding'
· Any breaches in expected standards are
acted on quickly and effectively by the provider
· There is a range of evidence that the
service is sustaining high-quality care (e.g. through consistently
meeting NICE quality standards or achieving Royal College standards
through clinical peer review) over time across most services in
the organisation, with evidence of innovation
· No governance or finance issues from Monitor
or the NHS Trust Development Authority.[129]
182. The CQC proposes that inspection frequencies
should be risk-adjusted: hospitals with an 'outstanding' rating
should be inspected every three to five years, 'good' hospitals
every two to three years, hospitals 'requiring improvement' at
least once per year and 'inadequate' hospitals as and when needed.[130]
183. The Committee welcomes the principle of ensuring
that inspections are targeted and based on risk assessment, but
believes that the CQC will need to continue to develop its thinking
about the application of these principles based on evidence and
experience. It has not been demonstrated to the Committee that
proposals for the frequency of inspections have been based on
such evidence. The Committee therefore recommends that these proposals
should be supported by effective monitoring arrangements which
will trigger an immediate inspection in cases where standards
are alleged to be falling.
Inspecting the system: a Chief
Inspector of Hospitals
184. In his response to the Francis Report, the Prime
Minister indicated that he had asked the CQC to establish a Chief
Inspector of Hospitals, to head a hospital inspectorate team within
CQC. This was not one of the recommendations made by Robert Francis,
though he indicated to the Committee on 12 February 2013 that
he was not opposed to the idea.
185. The CQC has now recruited a Chief Inspector
of Hospitals. Professor Sir Mike Richards is to begin the inspection
of providers in the autumn of 2013. The CQC has also appointed
Andrea Sutcliffe as Chief Inspector of Adult Social Care and Professor
Steve Field as Chief Inspector of General Practice. Each inspector
is to lead national teams of inspectors specialised in relevant
aspects of care.
186. In respect of the Chief Inspector of Hospitals,
the Government has indicated that the inspection team at the CQC
will actively engage with other organisations "including
Monitor, the NHS Trust Development Authority and the NHS Commissioning
Board as a pivotal part of the single failure regime and the national
ratings for hospitals."[131]
The role of the Chief Inspector of Hospitals will be crucial in
establishing the credibility of a hospital inspectorate within
the CQC which commands public confidence. The inspectorate must
be adequately resourced: while the Secretary of State indicated
to the Committee that the inspectorate function would receive
"as much money as they need in order to do this job properly",
he was unable to indicate the additional funding to be allocated
to the CQC to support the inspectorate.
187. The Government indicated that the Chief Inspector
of Hospitals would be "the nation's whistleblower",
able to inspect hospitals without fear or favour and empowered
to root out instances of poor care.[132]
As such, the Committee expects the Chief Inspector to play a significant
role in driving openness and transparency across the NHS, not
least by inspecting and reporting on the culture encountered in
providers.
188. The Committee notes that the Chief Inspector
of Hospitals is an official of the Care Quality Commission, leading
the hospital inspection function of that organisation: although
new methods of hospital inspection may be introduced, the CQC
retains overall responsibility for hospital inspection. The Committee
hopes that the substance of the role and the way it is exercised
by its first incumbent justifies the rhetoric with which it has
been introduced.
Regulating professionals
189. Robert Francis examined the role of professional
regulators in his inquiry, both in terms of the regulatory oversight
of professionals operating in the Mid Staffs Trust but also in
terms of their general systems of professional oversight. He made
this observation in oral evidence:
I have said they should be more responsive by
way of not just sitting back waiting for a complaint to come in—and,
of course, they must react to complaints—but, where they
become aware, as they will do, of concerns about a system, they
should be alert to considering proactively whether those deficiencies,
which are being brought to light or of which they are made aware
of, are due to a failing on the part of someone who is accountable
to them and a breach of whatever their code of conduct is. That,
I think, requires a different approach from the one that they
have been undertaking to date. It requires in real life, I am
sure, much closer co-operation with the systems regulator and
possibly joining them in their investigations so that, if an investigation
is taking place of a particular place, the professional regulators
are involved in that.[133]
190. The Committee proposes to examine the response
of both the General Medical Council and the Nursing and Midwifery
Council to the Francis recommendations in the course of its programme
of annual accountability hearings, when it will consider the extent
to which professional regulators ought to intervene when they
have concerns about the operation of the regulatory system as
opposed to concerns about the practice of their individual registrants.
Death certification reform
191. Reforms to the system of death certification,
which were recommended by the report of the Smith Inquiry into
the activities of Harold Shipman, were enacted in chapter 2 of
the Coroners and Justice Act 2009 but have not yet been brought
into force.
192. The reforms provide for an independent medical
examiner to examine the cause of death of each individual and
to enter the cause of death on the death certificate. Presently
the examining doctor may enter the cause of death on the certificate,
a procedure which has been shown to provide insufficient assurance
that the cause of death has been effectively recorded.
193. Under the 2009 Act, primary care trusts were
to be responsible for the establishment of independent medical
examiners. As a consequence of the abolition of primary care trusts
in the Health and Social Care Act 2012, responsibility for appointing
medical examiners has been passed to local authorities, to be
exercised once the provisions of the 2009 Act have been brought
into force.
194. Recognising that the independent medical examiner
system is not yet in effect, Robert Francis nevertheless made
a number of recommendations on reform of the coronial and death
certification system, particularly concerning the independence
and resourcing of independent medical examiners and their approach
to examining causes of death.
195. In addition Mr Francis recommended that healthcare
providers should be under a duty to provide all relevant information
to a coroner to enable him to perform his functions, unless there
was a clear public interest justification for not doing so: this
requirement, recommended as a condition of registration, should
establish a duty of candour for a provider in respect of a coroner
as well as in respect of a patient or relative.
196. Implementation of the medical examiner system
following the transfer of responsibility to local authorities
was to take place in April 2014. In itself this represents a delay
of some five years since the enactment of the primary legislation,
and comes over ten years since the report of a review of the system
undertaken following the first report of the Shipman Inquiry.[134]
197. The Secretary of State conceded to the Committee
that the timetable for implementation has now slipped, citing
issues in relation to the charging regime and cooperation with
local authorities: the Permanent Secretary indicated that there
had been delays in drafting the relevant regulations as a precursor
to consultation on them.[135]
The Secretary of State later wrote to confirm agreement with the
Local Government Association that the new system would be implemented
in October 2014, following public consultation in the summer of
2013 and Parliamentary approval for the relevant secondary legislation
early in 2014. He indicated that the Department proposed to include
in its consultation measures to implement the further reforms
proposed by Francis.[136]
198. The Committee regrets the continued delay
to implementation of the reform of death certification—a
necessary reform to protect the public. The Committee notes the
commitment of the Government to implementation of the new system
in October 2014, and urges the Government to ensure that the timetable
does not slip further.
199. Robert Francis has made some recommendations
to the reform of death certification which do not depend on the
implementation of the independent medical examiner regime, such
as the duty of candour which providers should owe to coroners
and the requirement that a consultant in charge of the treatment
of a patient who dies in hospital should be personally responsible
for certifying the cause of death. Implementation of these recommendations
should not have to await the delayed date for introducing medical
examiners.
200. The Committee recommends that the Government
give early effect to the recommendations of Robert Francis in
respect to coroners and death certification which do not depend
on the introduction of the independent medical examiner system.
123 Francis Report, recommendation 19, chapter
10 Back
124
Q47 Back
125
Patients First and Foremost, Cm 8576, para 3.10 Back
126
Ibid., para 3.11 Back
127
The regulation and oversight of NHS trusts and NHS foundation
trusts: joint policy statement to accompany Care Bill quality
of services clauses, may 2013, available at https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/200446/regulation-oversight-NHS-trusts.pdf Back
128
Q535 Back
129
Care Quality Commission, A new start: Consultation on changes
to the way CQC regulates, inspects and monitors care, July
2013, p. 30 Back
130
Ibid., p. 31 Back
131
Patients First and Foremost, Cm 8576, para 2.9 Back
132
Ibid., para 12 Back
133
Q58 Back
134
Death Certification and Investigation in England, Wales and
Northern Ireland: The Report of a Fundamental Review 2003,
Cm 5831, June 2003 Back
135
Q573 Back
136
Ev 94 Back
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