After Francis: making a difference - Health Committee Contents

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 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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© Parliamentary copyright 2013
Prepared 18 September 2013