I represent the , and am instructed by Bevan Brittan solicitors. The Care Quality Commission came into being on 1 April 2009, immediately after the period with which your Inquiry is primarily concerned, and was created from the merger of three previous regulators – the Commission for Healthcare, Audit and Inspection, known as the , the Commission for Social Care Inspection and the Mental Health Act Commission. The Healthcare Commission no longer exists but the CQC is its statutory successor body. We and the CQC are working closely with Miss Eleanor Grey and Mills & Reeve solicitors, who are facilitating the provision of evidence from, and supporting former employees of the Healthcare Commission, under the umbrella of the CQC, and this opening statement is made in conjunction with them and with their assistance.

The Healthcare Commission itself had been established on 1 April 2004 by the Health and Social Care (Community Health Standards) Act 2003, to promote improvement in the provision of healthcare through a variety of activities set out in the Act. Its predecessor, the Commission for Health Improvement, had existed from 2000 to 2004 but had a different role to that of the Healthcare Commission, being largely concerned with whether the principles of good clinical governance were in place in trusts.

Details of the functions of the Healthcare Commission have been outlined in two provisional statements already submitted to the Inquiry, which were referred to by Counsel to the Inquiry on Tuesday. These are the statements provided by Anna Walker, former Chief Executive of the Health Care Commission, and the statement of Sir Ian Kennedy, the Health Care Commission’s former Chairman. They explain how independent regulation of the healthcare sector’s quality of care, both public and private, was introduced for the first time with the establishment of the Commission on 1 April 2004, supplementing the regulation of professions involved in healthcare with the regulation of organisations. The Healthcare Commission was responsible for assessing approximately 400 NHS Trusts and 2000 independent sector organisations.

The statements set out the details of the HCC’s statutory functions and its approach to carrying these into practice. Its general responsibility was described in section 48 of the 2003 Act as “encouraging improvement in the provision of healthcare by and for NHS bodies” which went on to provide that the HCC was to be concerned, in particular with the availability of and access to healthcare, the quality and effectiveness of healthcare, the economy and efficiency of the provision of healthcare and the availability and quality of information provided to the public about healthcare. Its main statutory functions, in relation to trusts, were to review the performance of each NHS trust and award an annual rating, to investigate serious service failures in the NHS, to carry out reviews of the provision of healthcare in the NHS and to consider complaints that had not been resolved locally.

The Healthcare Commission began the process of developing ways of consulting patients to obtain their views on NHS trusts, conducting surveys to ascertain patients’ own experiences of care. Over time, the Healthcare Commission was increasingly engaging with clinicians and groups of patients to interpret and develop the standards laid down for it by the Department of Health so that they would increasingly reflect what, in the view of those in the system, really led to improvements in care. This process was still ongoing at the time of the Healthcare Commission’s abolition in 2009.

The Healthcare Commission was required by statute to assess the performance of NHS Trusts annually against two criteria, the Government’s targets and, for the first time, also against the Government’s standards for NHS organisations. Over time, the Healthcare Commission added further performance indicators which were intended to shift the emphasis to outcomes of care (which was in line with the expressed views of both patients and clinicians as to what was important) and also to measure patients’ experiences and how well the organisation was managed. The criteria for these annual assessments (known as the Annual Health Check) had to be agreed with government and were an assessment of performance over the previous year.

These annual checks were supplemented by specific reviews into areas of concern and by investigations where it was considered that an in-depth examination was needed of an organisation. That, of course, was the function the Healthcare Commission was performing when it carried out its investigation into the Trust resulting in the report of March 2009.

The Care Quality Commission’s functions and powers are set out in Part 1 of the Health and Social Care Act 2008, which provides a single legislative framework for CQC to operate within. They differ significantly from the functions and powers of the Healthcare Commission. The 2008 Act provides that the CQC’s main objective in performing its functions is to protect and promote the health, safety and welfare of people who use health and social care services. This is in addition to CQC’s other functions of encouraging improvement which mirror the functions which the Health Care Commission previously had in relation to the NHS. The CQC is also specifically required by the 2008 Act to encourage the provision of health services in a way that focuses on the needs and experiences of people who use those services.

The 2008 Act sets out further specific matters to which the CQC must have regard, and it may be helpful to set those out at this stage to demonstrate the significance accorded by the Act, and by the CQC, to the views and experiences of patients, their families and friends, and the public. The first four of those matters are: a. views expressed by or on behalf of members of the public about health services; b. Experiences of people who use health services and their families and friends; c. Views expressed by local involvement networks about the provision of health services in their areas; d. The need to protect and promote the rights of people who use health services.

Section 5 of the 2008 Act imposed on the CQC a specific obligation to publish a statement describing how it proposed to promote awareness among service users and carers of its functions, to promote and engage in discussion with service users and carers about the provision of health services and about the way in which it exercises its functions, and to ensure that proper regard is had to the views expressed by service users and carers. To meet that obligation, in June 2009 the CQC published its statement “Voices into Action, How the Care Quality Commission is going to involve people” following detailed consultation. That document, and the consultation report, are available on the CQC website and can be provided to the Inquiry. Of course, the CQC has responsibilities not only in relation to services provided to people who may be described as “patients”, but also to social care services where this would not be an appropriate term, hence the use of the statutory umbrella term “service users”.

Further details of the CQC’s functions and powers are set out in a provisional statement, also referred to in Counsel to the Inquiry’s opening statement, submitted to the Inquiry jointly by Dame Jo Williams, Chair of the CQC, and Cynthia Bower, Chief Executive.

In it they explain that the CQC’s functions and powers in relation to the regulation of NHS trusts differ significantly from those of the Healthcare Commission, and it will no doubt be important for this Inquiry to consider in some detail those differences, and their significance for the identification and resolution of serious failings in the provision of clinical care.

The CQC’s first year of operation, from April 2009 to March 2010, was a transitional period in which it operated a hybrid system of regulation, delivering the legacy approaches of the Healthcare Commission, including its Annual Check, alongside developing the CQC’s new approaches, including registration. Therefore, CQC has only been operating its own, new systems of regulation since April 2010. When the Inquiry comes to considering, as its terms of reference require, the lessons to be drawn as to how in the future the NHS and the bodies which regulate it can ensure that failing and potentially failing hospitals or their services are identified as soon as is practicable, and having regard to the fact that the regulatory systems differ significantly from those in place previously and the need to consider the situation both then and now, it may be that it will be most helpful to the Inquiry to consider the CQC’s systems and how they have operated from 1 April 2010, which is when the NHS came to be registered under the new statutory regime for regulation.

The CQC takes an outcome-based approach to regulation that uses the direct experiences of people using services as a primary source of information, amongst other information and substantial sources of data. Whereas under the previous regime for regulation the DoH set out the standards to be met, the current system has required the CQC to consult upon and develop the Essential Standards of Safety and Quality to apply to all regulated health services. These were developed after extensive consultation with people using services, and are written in terms of what people who use services should experience. They are designed as the central feature of CQC's systems of regulation and how they operate.

The CQC’s activities are focused on registration, enabling it to build a single integrated approach to regulation. On-going compliance with essential standards is checked through a dynamic process of assessing services on a continuous basis, rather than an annual process as under the Annual Health Check. The CQC’s processes for accumulating and assessing information, its Quality and Risk Profiles, are built around the views of patients and the public, as well as taking account of information from other sources, including a substantial number of national data sets. But patients’ experiences are central. There is also an emphasis on gathering intelligence on risks and concerns locally from people using services and from staff. When information comes to light, from whatever source, it is weighted and fed into the continuous assessment process, so that risk can be assessed on the basis of current information. The CQC places substantial emphasis on unannounced visits, and there is a strong focus on talking to patients and their relatives, and to junior as well as senior staff and management.

The CQC’s wide range of enforcement powers, which derive from its core registration role, enable there to be a swift and effective response to concerns. For example, where a service is found to be failing, or deteriorating, conditions can be imposed on the service’s continued registration, mandating effective action by the trust concerned. Failure to comply with conditions is a criminal offence under section 33 of the Health and Social Care Act 2008, for which both trusts and individuals such as board members and senior managers may be prosecuted in appropriate circumstances. Ultimately, in addition to the power to bring criminal proceedings, the CQC has powers to suspend or close services if it considers that there is a direct risk to safety and wellbeing or systematic failure of services.

By way of further example, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 set out, in regulations 9 to 24, detailed requirements as to the quality and safety of service provision. Those regulations cover issues such as taking proper steps to ensure that each patient is protected against the risks of receiving care or treatment that is inappropriate or unsafe, protecting against identifiable risks of acquiring health care associated infections, protecting from the risks of inadequate nutrition and hydration and having an effective system in place for dealing with complaints. Breach of any of these requirements is a criminal offence.

In addition, the Care Quality Commission Registration Regulations 2009 impose on health bodies various reporting requirements, for example to report deaths that would not have been expected to occur with appropriate care or treatment either to the CQC or the National Patient Safety Agency, with a description of the circumstances of the death, and to report any significant injuries to patients and any abuse or allegation of abuse in relation to a patient. Any breach of these requirements is also a criminal offence.

It should be clear from what I have said that the CQC has very real powers to enforce meaningful, detailed obligations to which NHS providers are subject, obligations relating directly to the issues of patient care and safety that concern this Inquiry.

The CQC recognises the importance of there being coordination between those statutory bodies with responsibilities for regulation of NHS services and, to that end, has developed very close links and improved lines of communication with Monitor, SHA’s and PCT’s, in addition to working together under a tightly defined early warning system defined by the National Quality Board. In the provisional statement submitted on behalf of CQC it was said that there are weekly conversations between CQC and Monitor in relation to those applying for registration, and this was relayed by Mr Kark in his opening statement. There is a small error in that, which I need to correct. There are, in fact, weekly conversations in relation to those trusts that already have foundation trust status, and monthly conversations in relation to those trusts that are applying for foundation trust status.

The CQC is a young organisation which is keen to learn and adapt its regulatory approach to address the different risks to patients and people using services. The regulatory approach developed so far by CQC has sought to address the issues raised in previous investigations and reports on Mid-Staffordshire. However, the wide range of experience and expertise available to this Inquiry will inevitably result in further developments and recommendations, and the CQC looks forward to assisting the Inquiry in this process.

The CQC is acting to enable and support the participation of employees of the former HCC to participate in this Inquiry, whether now employed by CQC or not. I have already referred to the fact that provisional statements have been submitted by Sir Ian Kennedy and Anna Walker of the HCC. These statements have suggested further and more detailed lines of investigation for the Inquiry, in relation to events at Mid-Staffordshire. Work by the legal team is ongoing on these matters. In particular, the CQC now holds the HCC’s documentation, and work is in hand to ensure that all relevant material is available to the Inquiry. In addition, a number of key members of the former HCC’s staff, who are in a position to speak directly about the HCC’s work in relation to events at Mid-Staffordshire, have been identified, and work is currently underway to assist them in providing statements, in addition to statements to be provided by CQC staff. If further lines of investigation are uncovered, they will be explored under the overall supervision of the Inquiry. The CQC welcomes the Inquiry and, in particular, the representation as core participants of so many patient bodies, which will enable the Inquiry to have a uniquely broad perspective on the issues it is to consider. It is essential that patients, and their experiences of care, be at the heart of everything that the NHS does, not only in the provision of services, but also in the assessment of standards, the investigation of failings and the making of improvements for the future.

The Inquiry, and all the Core Participants and wider members of the public who have an interest in the findings and recommendations of the Inquiry, can be assured that the CQC and former members of the HCC alike are committed to ensuring that this Inquiry is placed in the best position to fulfill its Terms of Reference, and can make recommendations based on the lessons to be learnt from the tragic events at Mid Staffordshire.