Memorandum by the Care Quality Commission
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.
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
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
10. In time, legislative changes will also
give CQC the ability to address safety issues within primary carean
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
hugebut 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
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
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.
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
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
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.
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
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
35. CQC will promote patient safety within
an overall regulatory and quality framework. CQC's manifesto identifies
five "dimensions" of quality:
access to care services,
quality of outcomes including clinical
quality of people's experience of
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
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.