Select Committee on Health Written Evidence


Memorandum by the Care Quality Commission (PS 41)

PATIENT SAFETY

EXECUTIVE SUMMARY:

    —  The Care Quality Commission ("CQC") is the new regulator of quality in health and social care services. It will become a legal body in October 2008, and commences its functions in April 2009.

    —  CQC has a range of regulatory and enforcement tools and powers which it will use in fulfilling its duties to promote care quality.

    —  These tools and powers, combined with CQC's remit, which covers the whole of health and social care, both public and private, mean it has a unique opportunity to promote improvement across the system.

    —  CQC will operate using a broad definition of quality and safety. This will include not just avoiding incidents and promoting clinical outcomes, but will also consider the relationship between safety, patient experience and quality of life.

INTRODUCTION:

  1.  The terms of reference for the Committee's enquiry include, at section 2(d), an intent to investigate the effectiveness of national bodies, including the Care Quality Commission, in ensuring patient safety.

  2.  This submission outlines the Care Quality Commission's role, provides a general guide to its emerging regulatory approach, and highlights the potential these have to improve safety and quality of care. It also includes thoughts on how safety might be viewed within a broad and integrated model of quality care.

  3.  CQC will become a legal body on 1st October 2008 and will commence its functions on 1st April 2009. Although necessarily high-level at this stage, the thinking outlined here will be developed rapidly in the coming months.

SECTION 1: THE CARE QUALITY COMMISSION

  4.  CQC was created by the Health and Social Care Act 2008. CQC brings together the role and functions of the Healthcare Commission, Commission for Social Care Inspection and Mental Health Act Commission. CQC's challenge is to build on the excellent work of these Commissions, combined with the increased tools and powers granted in the Act, to improve care quality across the whole health and social care system.

  5.  CQC's vision is of high quality health and social care which supports people to live healthy and independent lives, which empowers individuals, families and carers in making informed decisions about their care, and which is responsive to individual needs. CQC's vision, values and approach are set out in an initial manifesto, issued in August 2008. This is enclosed as an annex to this submission and will soon be available online.

CQC's unique position

  6.  CQC is one of the few organisations whose remit genuinely spans all of health and social care, both public and private. This will allow it to act across the boundaries of organisations providing and commissioning care, and to take a perspective which embraces the whole of a particular patient experience. This is in contrast to previous regulators, whose remit has been constrained by organisational boundaries.

  7.  This wide remit will allow CQC to consider, for example, the interdependencies between organisations which are crucial to patient safety. For example, healthcare associated infections need to be managed not only by hospitals, but also by care homes and General Practitioners. Failure to provide appropriate care for HCAI sufferers in care homes, or inappropriate antibiotic prescribing by GPs will impact on the level of risk carried by the hospital sector. Another example would be medicines management, where hospitals prescribe new medicines, which are administered by care home staff, with changes being monitored by GPs. All players need to observe safe practice, and to communicate in order for risks (and re-admission) to be avoided.

  8.  CQC will also be able to address the particular risks which arise from transfer between services. For example, discharge summaries to GPs may not contain all relevant information, or GPs may not have appropriate systems to update prescriptions or check for drug duplication. When someone is discharged to a care home, information may not be sent regarding their infection status or how to care for them if they are infected.

  9.  CQC will be able to look at pathways between organisations and test out that all parties are transferring patients, and information about them, in a way that promotes safety. It will be able to focus its work across the whole spectrum of health and care, thereby taking a comprehensive view of risk across the system.

  10.  In time, legislative changes will also give CQC the ability to address safety issues within primary care—an area where risks are considerable but unquantified, and where the Healthcare Commission is unable to effectively address safety issues because its powers are limited.

  11.  Research has estimated that between 1 in 800 and 1 in 8000 consultations in general practice involve an error or incident. The volume of incidents is therefore potentially huge—but only 2,150 incidents were reported from general practice to the NPSA last year. Prescribing medicines and diagnosing disease involve huge risks in themselves. On top of this, many GPs are now also taking responsibility for care previously delivered by the secondary care sector.

  12.  CQC must push for general practice to be brought within the scope of regulation as soon as is manageable, and for appropriate powers to properly assess safety.

SECTION 2: DELIVERING CQC'S PROGRAMMETOOLS AND POWERS

  13.  The Act prescribes a number of tools which CQC will use to deliver its programme. Unlike previous legislation, most of these tools do not differentiate between health and social care, or between public and private providers.

  14.  The provisions of the Act are complex meaning that the following section is necessarily a simplification. However, it should serve as a guide both to the methods available to CQC, and how it will use them to increase care quality across the system.

Registration

  15.  Registration is the central plank of CQC's regulation of care providers. From 2010, almost all health and social care providers (and in some cases individual managers) must be registered with CQC in order to legally provide services. Registration is dependent on fulfilling a range of quality criteria (the "compliance criteria"). Details of the compliance criteria are yet to be determined, but will have a strong emphasis on safety as necessary building block of good quality care.

  16.  Currently, social care and independent health providers must register with their respective regulators, but registration will be a completely new process for NHS providers.

  17.  Operating without registration, or, in the case of registered services, failing to continue to fulfil the compliance criteria, is an offence which leaves the provider open to enforcement action.

  18.  Registration will bring common core quality and regulatory standards to the whole care system. This will ensure minimum standards and go some way to driving out substandard practice. However, CQC will use registration not only for this purpose, but also to engage care providers in a process of continuous improvement. Registration will form the start of discussions about service improvement, with the aim that even the best services continue to get even better.

  19.  Registration standards should therefore go further than is currently proposed. This would allow registration to promote better attention to safety and ensure that organisations put systems in place to continuously improve it.

  20.  Currently, two proposed registration requirements address safety in general.

  21.  The proposed registration requirement 13 says organisations must:

    —  "|Have systems in place to manage, assess and report upon the safety and quality of care and treatment provided, and do so regularly

    —  systematically, identify and assess risks and take action to manage risks to health, safety and welfare

    —  use reports about the quality of care and treatment provided and learn from events to inform decisions about action needed to secure people's health, safety and welfare."

  22.  The first registration requirement says that safety must be taken into account when assessing, planning and delivering care for individual patients. This includes where care is unsafe for a person's needs, or errors of omission, when services fail to respond to that person's needs.

  23.  As currently worded, these requirements are in some ways not as comprehensive as the Standards for Better Health, which not only require organisations to learn from ALL patient safety incidents, but also explicitly require organisations to act upon national learning. The bar for registration requirements and standards must be set so as to be stretching and drive improvement, requiring organisations to put proper safety systems in place.

Assessments

  24.  CQC will publish periodic assessments of both providers and commissioners. These assessments will not only be intended for the sector, including providers and commissioners and performance managers. They will be published in an accessible format with the aim of informing the general public about the quality of local services and helping them make choices about their care.

  25.  Assessments encourage providers to improve, by providing benchmarking information to allow providers to see their performance in comparative terms, through the "naming and shaming" effect of poor assessments and the desire to attract business through ever-higher ratings, where care is provided in a competitive setting.

  26.  Assessment of commissioners will highlight where commissioning could be improved. This will include both the effectiveness and value for money of commissioning decisions and the ability of commissioners to hold providers accountable for the quality of the care they provide.

Reviews, reports and studies

  27.  CQC will carry out periodic reviews assessing the state of health and social care, and the monitoring of the Mental Health Act. It also has the power to carry out "special reviews", which may be cross-cutting or thematic. Such reviews may look across organisational boundaries and focus on issues of specific interest to patients and the public. This might include safety issues such as incident or infection rates, or whether a "safety culture" is developing in provider organisations or boards.

  28.  CQC will focus its efforts on producing a small number of influential reports, and will ensure they are both followed up and integrated with other aspects of regulation. This will ensure that they have maximum chance of effecting real change in the service.

Enforcement action

  29.  The Act gives CQC a range of enforcement powers against non-compliance with registration criteria.

  30.  CQC will use its enforcement powers proportionately, and may be able to resolve concerns through informal approaches such as informal notification of concerns or increased monitoring and/or inspection.

  31.  When needed, formal enforcement powers include formal warning notices, prosecution for breach of registration requirements, or a penalty notice (of up to £4,000) in lieu of prosecution. CQC can also impose conditions on, temporarily suspend, or cancel, a provider's registration. This will constrain the services they are able to provide (in case of conditions), or prevent them from operating altogether. Cancellation can be regarded as the ultimate sanction as it makes a provider unviable.

Action against healthcare associated infection (HCAI)

  32.  CQC's systems of registration, review and enforcement will apply fully from April 2010. However, a more limited system will apply from 2009 in relation to Healthcare Associated Infection ("HCAI").

  33.  From April 2009, NHS bodies will register under an interim registration arrangement, with enforcement powers applying to registered bodies in relation to HCAI only.

  34.  Although it will be very different from the full regulatory system, registration and enforcement against HCAI will provide a first test of CQC's methods and effectiveness in what is a vital area for both patient safety and public confidence.

SECTION 3: APPROACH TO QUALITY AND SAFETY

  35.  CQC will promote patient safety within an overall regulatory and quality framework. CQC's manifesto identifies five "dimensions" of quality:

    —  safety,

    —  access to care services,

    —  quality of outcomes including clinical outcomes,

    —  quality of people's experience of services,

    —  the contribution that care makes to preventing illness and promoting ongoing healthy, independent living and wellbeing.

  36.  This broad conception of quality will inform all of CQC's work, including the full range of its regulatory activity. Crucially, CQC will not only look at these aspects in isolation, but will also consider how they interact. Thus safety will not be restricted to clinical incidents or to eradicating unsafe "episodes", but will include wider aspects related to the care of patients and people who use services. In many ways, clinical incidents and accidents are, whilst very important, merely the most visible and easily addressed forms of unsafe care.

  37.  Importantly, CQC's conception of safety will also be shaped by people who use services, their carers, families, and the wider public. This forms part of CQC's commitment to put user involvement at the heart of regulatory activity as well as fulfilling a legislative duty to "promote and engage in discussion with service users" and "ensure that proper regard is had to their views".

  38.  A broader view of safety ties it in with the other four dimensions of quality. For example, malnutrition or inappropriate feeding will adversely affect patients' reported experience of hospital care, but may also impair their recovery or treatment with as much severity as would be caused by a clinical incident. Potential conflict between safety and other key aspects of quality is also a key factor. For example, replacing carpets in care homes with hard floors would reduce the risk of infection. However, by reducing both the perception and the appearance of the facility as the "home" of those resident there, infection control comes into conflict with their rights to dignity and respect. A sensitive balance therefore needs to be struck between the provision of safe care and the place where a person lives.

  39.  CQC will therefore adopt a risk-based approach to safety, in relation to both other aspects of quality and, importantly, individual choice. Personalisation, through both service flexibility and, importantly, individual budgets, means that freedom of choice will in many cases be balanced against at least some safety risk.

SECTION 4: CONCLUSION

  40.  CQC's remit, tools and powers, building on the excellent work of the existing Commissions, give it a comprehensive opportunity to promote safety, as part of wider care quality, across the whole health and care system.

  41.  CQC will take a broad view of safety. This will be integrated within an overall regulatory model which recognises all five aspects of quality, and which takes a risk-based view of potential issues.

  42.  This is necessarily a high-level view of CQC's emerging regulatory model and policies. More information will be available in the coming months as thinking proceeds.

September 2008






 
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