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BOARD MEETING - 14 September 2011
Regulatory Model Review Group - final report
PURPOSE
1. This paper presents the final report from the Regulatory Model Review Group,
chaired by Martin Marshall.
RECOMMENDATION
2. The Board is asked to:
 NOTE the content of the report
 AGREE next steps for making the report public and following up agreed actions.
BACKGROUND
3. Following discussions at the Board a time limited task group, chaired by Martin
Marshall, was set up involving members of the executive team and a small
number of external experts. The purpose of this group was to review the
regulatory model focusing on strategic issues about the focus and effectiveness
of the model.
4. An interim paper from the group was presented to the Board in June 2011, which
summarised the issues raised by the group and their recommendations. The
paper was debated by the Board which resulted in a number of agreed actions.
The final report from the review summarises the issues raised, the conclusion
from the discussions and the priorities agreed for action. The final report is
attached.
KEY ISSUES
5. The review provided an opportunity to critique the fundamental assumptions and
principles that underpinned the regulatory model which led to discussions about
the capacity and sustainability of the regulatory model. In considering the issues
raised, the review group and the Board were satisfied that a model which aims to
be risk-based, targeted and proportionate, but which recognises the inherent risks
within regulated sectors, remains the correct approach. The difficulties that the
review highlighted were related to implementation of the principles, rather than
the principles themselves.
6. The review identified a number of environmental and organisational risks which
might impact on the effectiveness of the regulatory model or which could result in
the need for more extensive focusing.
7. The review group identified aspects of the model where review would be of
benefit and where clarity or adaptations could improve the model’s effectiveness.
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These analyses resulted in the group prioritising three areas that need to be
addressed to improve the regulatory model. These were:
 Having a clear understand of risk and a risk-based approach;
 The approach to enforcement; and
 Communication about the regulatory model and about regulatory judgements.
8. In terms of risk, the review group considered that a clear and embedded
understanding of risk is needed to set consistent internal and external expectations
about essential standards and to drive regulatory activity. Suggestions for
improvement included: reviewing the strategic view of risk; assessing the need to
build on skills and competencies in risk assessment; reviewing the approach to
planned and responsive compliance reviews; and assurance for the Board that
QRPs are effective as a mechanism for helping identify risk.
9. In considering these challenges, the CQC Board identified two main areas where
the organisation’s approach to risk should be improved:
 The way that risk is used as the main mechanism for targeting regulatory
activity; and
 Recognising the varying nature of risk in different sectors.
The agreed actions are being followed up by the compliance workstream of the
internal implementation review.
10. In relation to enforcement, the review group highlighted that improvement and
enforcement powers should be used in an effective way to protect people from
care that does not meet essential standards and to drive improvement across the
system. Key issues raised by the review group included: how best to balance
regulatory action with the need to be proportionate to the level of risk; whether
CQC should take a harder line on tackling non-compliance; legal barriers to
publishing enforcement information as hindering CQC’s strength as a regulator;
insufficient understanding about the responsibilities of the different stakeholders
responsible for assertive action to address poor standards of care.
11. CQC is prioritising action to clarify its focus on failing providers and to ensure
consistency in its approach to enforcement and in September will be consulting
publicly on guidance to assist inspectors to make judgements and where
applicable, to take regulatory action.
12. In relation to communication, the review group emphasised the need to provide
further clarity about the regulatory model and ensure that published information
about CQC’s role and the quality of services is meaningful, accessible and helps
promote choice and transparency.
13. The CQC Board agreed that developing the public messages about the model
was a priority, particularly to help manage expectations. Work is underway to
develop CQC’s communication strategy and plan to raise awareness of our role
and to facilitate better engagement.
14. In addition to more general advice about issues that should be considered as the
regulatory model is developed and evolves, the review group highlighted
evaluation as a critical area to focus on. The CQC signalled its full support for this
recommendation and work has begun to develop an agreed schedule of internal
evaluation and benefits realisation activities.
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15. The review group made a number of recommendations for action to improve the
regulatory model that the CQC Board has considered and, as appropriate, has
started to action.
RESOURCE AND RISK IMPLICATIONS
16. All actions will be followed up within existing workstreams or directorates. There is
a risk to CQC’s reputation if agreed actions are not delivered; implementation of
agreed actions is expected to improve the effectiveness of the regulatory model.
NEXT STEPS
17. The proposals for next steps are:
 Circulation of the final report to all who contributed and to other interested
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parties
Publication of the report on the CQC website
Follow up of the agreed actions through [six monthly/quarterly] progress
reports to CQC’s executive team and the Board
Discuss within the Board an appropriate stage at which the issues within the
report could be re-visited .
RECOMMENDATION
18. The Board is asked to:
 NOTE the content of the report
 AGREE next steps for making the report public and following up agreed
actions
Martin Marshall
CQC Commissioner
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Care Quality Commission Regulatory Model Review:
Final Report
1. Background
1.1 Context for developing CQC’s regulatory model
In 2009, the Care Quality Commission (CQC) was established as the single
regulator of health and adult social care in England. The following year, CQC
introduced a new regulatory system, so that for the very first time regulated
health, adult social care and independent healthcare providers were subject to
a single system of registration and are assessed against the same set of
essential standards of quality and safety. The new system was based on the
best available evidence, better regulation principles and on the experience
and learning from previous regulators – the Healthcare Commission, the
Commission for Social Care Inspection and the Mental Health Act
Commission. It was implemented within the context of the requirement to
reduce regulatory burden and costs – with around two thirds of the budget that
had been allocated to the three predecessor organisations –and against a
series of fixed Parliamentary deadlines for registration.
Since the introduction of the new system, CQC has registered the NHS (April
2010), independent health and adult social care (October 2010), dental and
independent ambulance services (April 2011) with out-of-hours primary
medical services due for registration in 2012 and all other primary medical
services in 2013. CQC continues to process high volumes of new providers
and variations to existing registrations alongside monitoring compliance with
its essential standards of quality and safety for registered providers, which will
ultimately amount to around 44,000 regulated locations once the final phases
of registration are complete.
1.2 CQC’s regulatory model
CQC’s overall objective as an organisation is to ‘make care better for people’.
The Health and Social Care Act 2008 outlines three organisational functions;
 Registration, compliance monitoring and enforcement
 Reviews and investigations
 Functions under the Mental Health Act.
CQC’s regulatory model is risk based and concerns the registration of health
and adult social care providers of regulated activities and the checking of their
compliance with essential standards of safety and policy. The regulatory
cycle involves: gathering information in order to analyse risk of non
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compliance with essential standards; using the assessment of risk to target
regulatory activity to address any non compliance; triangulating evidence and
using this to make regulatory judgements. A summary of the key components
of the regulatory model can be found in Annex B.
As appropriate, enforcement powers and investigations can be used in
relation to providers that do not comply with the essential standards, while
information from reviews and CQC’s monitoring of the Mental Health Act are
used to inform the wider compliance monitoring of regulated providers.
1.3 Impetus for the review
The stringent timetable for introducing the new system of registration and
compliance monitoring and the other pressures and restrictions on the
organisation allowed limited opportunity for piloting the regulatory model
before it was introduced. CQC also recognised that as the regulatory system
was new, that it would need to review and adapt the model in the light of
experience, any changes to the remit of the organisation or the external
context. Therefore, in January 2011, nine months after the launch of the first
phase of registering NHS organisations and four months after registering
independent healthcare and adult social care organisations, CQC decided to
establish a time limited group to review the regulatory model.
The Regulatory Model Review Group comprised members of CQC’s executive
team and board with significant input from a number of external experts in the
health and social care fields (see Annex A for membership). The group was
chaired by one of the CQC Commissioners, Professor Martin Marshall,
Clinical Director and Director of Research and Development at The Health
Foundation. The review was carried out on behalf of the CQC board with the
external experts acting in an advisory capacity.
1.4 Focus of the review
The review focused on strategic issues relating to the effectiveness of CQC’s
regulatory model. Operational matters remained the responsibility of an
established internal working group. The review group was kept up to date with
the work of this internal group and any operational matters that arose from the
strategic review were referred to this group.
The terms of reference for the review group were:
1. To review the design of the CQC regulatory model to determine
whether it is delivering CQC's objectives and the regulatory benefits
that were anticipated.
2. To use this information to identify those elements of the regulatory
model that require further attention and to clarify by whom and when
this work will be carried out.
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3. To consider the impact of the CQC regulatory model on the quality of
care in the regulated sector.
The review group considered not only the original design of the model, but
also the principles underpinning the model and the factors that influenced
(and in some cases constrained) the design of the model.
The review group also acknowledged and strongly affirmed four of the
important principles that underpin the model:
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Focusing on outcomes and experiences of people who use services rather
than policies and procedures
Using a person-centred approach and listening to the views of people who
use services, carers, local groups and staff
Being proportionate, targeted, transparent and consistent
Working in partnership with other regulators and monitoring organisations
to minimise burden and reduce duplication.
Given the centrality of these principles to the model, the review group kept
them in mind when considering the themes and the challenges related to the
effectiveness of the model.
1.5 Process of the review
An interim paper from the group was presented to the CQC Board in June
2011, setting out a summary of the issues raised by the group and suggesting
ways of addressing them. The issues and recommendations were debated by
the CQC Board, resulting in a series of agreed actions. This report
summarises the issues raised, the conclusions from the discussions and the
steps CQC is now taking to progress the priorities for improvement that were
identified through the review.
1.6 Report structure
The rest of this report is structured as follows:
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
Section 2 summarises the environmental and organisational risks
associated with the regulatory model
Section 3 outlines the three priority areas that the review group identified
as the key strategic challenges to the regulatory model, the conclusions
drawn by the discussion of these issues with the CQC board and the
actions CQC is taking or needs to take to address the issues that were
identified
Section 4 highlights the review group’s more general advice about issues
for CQC to consider as the regulatory model is developed and the group’s
thoughts on the importance of evaluation to demonstrate the impact that
regulation has on the quality and safety of the care that people receive
Section 5 summarises the key findings and section 6 acknowledges the
contribution of the review to the work of CQC.
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2. Risks and challenges to the regulatory model
The review provided an opportunity to critique the fundamental assumptions
and principles that underpinned the regulatory model. Although in general, the
review group considered that the principles on which the model is built are
sound, questioning the assumptions led to a more challenging discussion
about the capacity and sustainability of the regulatory model. The review
group recognised that operational delivery had been particularly stretched
because of the significant transition registration programmes that CQC has
been required to implement alongside the businesses as usual functions. The
group was not convinced that these pressures would be much relieved in the
near or medium future. The group suggested that the CQC Board would
therefore need to continue to be vigilant about the capacity of the regulatory
model to deliver effectively and consistently, given the available resources
and the expectations of stakeholders.
The opportunity to discuss this fundamental challenge was welcomed by the
CQC Board. It was felt to be both timely and appropriate for the Board to
assure itself that the approach to regulation is appropriate. In considering this
issue, there was recognition of the demands that had been put on CQC and
the speed with which the regulatory system had been set up, which have
contributed to many of the difficulties faced by CQC.
The review group and the Board were satisfied that a model which aims to be
risk-based, targeted and proportionate, but which recognises the inherent
risks within regulated sectors, remains the correct approach. The difficulties
that the review highlighted are more related to implementation of the
principles, rather than the principles themselves. Further, experience of
implementing the model has indicated that the information and intelligence
gathered to monitor compliance with essential standards might need to be
supplemented by increased inspector visibility, albeit in line with the need for
proportionality. Exactly how this should be achieved needs to be explored.
That said, the review group acknowledged that there were a number of risks
that might impact on the effectiveness of the regulatory model and that there
were areas in which improvements could be made which would help to
mitigate these.
2.1 External risks
The review group identified three main issues which might impact on the
effectiveness of the regulatory model but which were largely outside of CQC’s
control:
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The scope of regulated services, which is large and could get larger
The available resources, which are unlikely to change significantly and
therefore the portfolio sizes for compliance staff will increase as the scope
of registration is expanded
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
Challenges to the generic set of standards and methods that are used
across all regulated sectors, including the generic operations workforce
which results in front line CQC staff having mixed portfolios of providers.
The group also identified a number of potential risks which could result in the
need for more extensive refocusing of the regulatory model, including:
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The current model failing to identify a provider’s non compliance with
essential standards in a timely way or action to address identified non
compliance not being sufficiently swift
A view amongst some regulated providers that the current model is not
adding value or is less relevant to their sector
A willingness on the part of government to increase the scope of regulation
and/or the responsibilities of CQC but not to increase the resources
available
Changes in the structure, governance and operations in the health and
social care sectors as a result of reform that change the nature of what
needs to be regulated and the local oversight mechanisms that exist
Failure to convey the agreed role of CQC in the overall landscape
Lack of clarity about the relative roles of different regulators
2.2 Internal factors
The review group identified examples of how the delivery pressures on CQC
could impact negatively on its effectiveness as a regulator and its ability to
have the desired impact on the quality of care. The group identified the four
issues which presented the most significant internal challenges as being:
 The regulations governing CQC are complex as these are based on
regulating by activity, multiplied by location, which creates a significant
number of transactions. Within the scale and the demanding timetable for
implementing registration across different sectors, difficulties have been
experienced with new and transition registrations creating delays and
frustration for providers and damaging CQC’s credibility.

A high proportion of time and resources is being diverted to dealing
organisations or services with consistently poor standards. As a result, the
level of planned compliance activity is lower than expected. This suggests
that the expectations of the model and the balance it sets out between
planned and responsive activity may be unrealistic and unsustainable.
This, in turn, links to the risk based approach to regulation.

From the perspective of social care providers in particular, there has been
a perception that enforcement has been used differently across sectors,
with a view that a stronger approach has been applied in social care
particularly compared to the NHS. CQC’s analysis of the use of
enforcement does not concur with this perception, indicating that different
enforcement powers have been used to reflect the context of different
sectors such that there has been a greater use of warning notices within
adult social care whilst compliance action has been more prevalent for the
NHS. However, the review group highlighted that the rationale for this has
not been clear to providers which could lead to a perception that CQC is
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not setting a level playing field. The lack of public information about
planned but unfinished enforcement action could also create a perception
that CQC are insufficiently tough on non-compliance; this could reduce its
broader ability to lever improvement through the ‘threat’ of regulation.

There is insufficient clarity among some stakeholders about the role of
CQC and how the regulatory model works. Expectations about what CQC
can and cannot achieve through regulation are often unrealistic,
particularly in relation to an improvement role.
3. Key strategic challenges to the regulatory model
These analyses resulted in the group prioritising 3 areas that need to be
addressed in order to improve the regulatory model. These were:



Having a clear understanding of risk and a risk-based approach
The approach to enforcement
Communication about the regulatory model and about regulatory
judgements
Theme 1 - Risk
A clearer and embedded understanding of risk is needed to set consistent
internal and external expectations about essential standards and to drive
regulatory activity.
3.1 Risk issues
The review group identified the main challenges of implementing the current
regulatory model under this theme as being:

A clear view of risk is necessary to ensure providers understand their
responsibilities when meeting essential standards. It should also help
challenge the prevailing acceptance of poor quality care in some settings;
for example, where some providers focus on short term financial gains at
the expense of even adequate care. The strategic view of risk should be
reviewed to ensure it is clear and appropriate and promotes consistency
when assessing compliance. Issues that should be considered include:
how to measure risk that outcomes are not met; risk relating to vulnerable
groups
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The success of the regulator hinges on how effective it is at assessing
risks to help prevent failings and how it holds providers to account for
correcting failings. On an ongoing basis, it is important for CQC to assess
whether greater emphasis is needed on building skills and competencies
in risk assessment. This could include reviewing the approach to ensure
front line staff:

have confidence about the risk information they have
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
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are developing local partnership working
have support to develop their understanding of inherent risk (i.e. risk
which cannot be managed or transferred away - for example, the risk
attributable to an organisation by virtue of the kind of care being
provided and/or the characteristics of the people receiving care) and
contextual risk (i.e. those internal and external factors which may
influence the performance of an organisation, affect outcomes or
access to care including the organisational, social and practice
contexts)
adopt a flexible approach that focuses on high risk activities

It will take time to embed the model and efficiency is likely to improve as
this happens, particularly once initial registration has been completed.
However, the review highlighted that sustaining the current approach to
planned and responsive compliance reviews, and delivering future
aspirations for compliance, could present challenges, particularly in light of
increasing scope and static resources. It is important that CQC articulates
these pressures in order to manage expectations about the level of
compliance activity. The CQC Board may also provide some strategic
thinking about how planned activity should be driven by contextual risk,
local knowledge and intelligence, particularly qualitative information about
people’s experience of services

The review acknowledged and supported the use of intelligence to inform
a risk-based model and it applauded the innovative work being done on
the Quality and Risk Profiles (QRP). CQC recognises that the QRP has
been based on ten years of development in health care and because of
this and the greater availability of national data, that current QRPs are
further developed for the NHS compared with adult social care and
independent healthcare where they are more in their infancy. However, the
review group recommended that the CQC Board is assured that QRPs are
effective as a mechanism for helping to identify risk, in conjunction with
other approaches such as direct feedback from people who use services,
representative groups, whistleblowers, and intelligence gained through
inspection activity. Particular focus might be given to: how outcomes and
views of people who use services are reflected in QRPs; any consistency
issues across different sectors; whether there are any explicit ‘red flags’
that are always unacceptable and should trigger a response
3.2 Areas for improvement: risk
Having considered these challenges, the CQC Board identified two main
areas where the organisation’s approach to risk should be improved:

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The way that risk is used as the main mechanism for targeting regulatory
activity; and
Recognising the varying nature of risk in different sectors
CQC believes that action to improve both of these areas would help to
increase the effectiveness of its regulatory system as well as encouraging
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more realistic use of limited resources. This is particularly important in relation
to compliance activity.
3.3 Action to support improvement: risk
The CQC Board has asked the compliance workstream of the internal
implementation review to follow this up and to:
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Be explicit about the organisation’s overall appetite for risk
Ensure there is adequate understanding of different types of risks –
inherent, contextual and quality risks
Consider whether CQC should be more flexible and responsive to different
types of risk in different sectors. This might be reflected in the frequency or
focus of inspections
Develop a risk framework that enables and equips: inspection staff to
assess providers effectively and to understand the risks they will come
across in different sectors; regional intelligence staff to manage risks
across a portfolio of providers
Consider the implications of different distributions and mixes of risk across
inspectors’ caseloads
Consider whether CQC challenges providers sufficiently on the assurance
they have about their own approach risk management systems, such as:
Do they know what their risks are? How do they assess them? How do
they mitigate them?
Much of this work is underway and progress reports should be submitted to
the CQC Board on a quarterly basis.
CQC has also begun a national pilot to test out a new methodology for
carrying out planned reviews of compliance. Instead of requiring a check of all
16 quality outcomes on every visit, this new methodology involves inspections
starting with a focus on a smaller number of outcomes. These ‘scheduled
inspections’ should enable inspectors to more quickly identify non-compliance
through visiting more locations and more direct observation of people’s
experience of care. The initial outcomes selected will differ according to the
type of service being inspected, with fewer outcomes checked for those
service types where there is deemed to be less risk. The pilot will run until the
end of September and will be evaluated. Responsive reviews (where a
significant risk is identified) and thematic reviews (such as the Dignity and
Nutrition review) will continue alongside the pilot.
In addition to this, CQC is actively reviewing the workload and the size of the
portfolios of inspection staff with a view to reducing these. The current drive to
recruit to front line inspection posts will enable the organisation to achieve
this. Reduced inspection portfolios and a more targeted approach to
scheduled inspections will also support the identification of possible risks
within services.
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Theme 2 - Enforcement
Improvement and enforcement powers should be used in an effective way to
protect people from care that does not meet essential standards and to drive
improvement across the system.
3.4 Enforcement issues
The main challenges of implementing the current regulatory model under this
theme included:
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Within the approach to enforcement to date, whether an effective balance
has been struck between the imperative to take appropriate regulatory
action to address non compliance with the need to be proportionate to the
level of risk. Similarly, the review group thought it important that the CQC
Board determines what the right balance is between supporting providers,
ensuring continuity of services for users and enforcing standards
CQC is clear that as an organisation it is focused on essential standards
rather than on promoting high quality. However, if CQC is the regulator of
the essential standards, should it be more prepared to enforce them, more
willing to label non-compliance when it is identified and does it need to
take a harder line on tackling non-compliance? The review group believed
that the expectation on CQC is that it must fulfil the ‘regulator’ role as a
priority, and must focus on tackling failing providers as this is what it will be
held to account for
Legal barriers to publishing information about unfinished enforcement
action reduce the specific and broader improvement impact of those
enforcement actions. They can also affect perceptions about the
transparency of CQC and its strength as a regulator
It is unclear whether the different responsibilities of the various
stakeholders responsible for assertive action to address poor standards of
care and treatment are fully understood. Feedback also suggested that
there are mixed messages about what is and what is not acceptable when
the quality of care hovers around the line of compliance
3.5 Areas for improvement: Enforcement
In developing its approach to enforcement, the review highlighted that CQC
should:
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Review the types and patterns of enforcement action to determine if there
have been differences across sectors, and if so, the extent to which this is
appropriate
Make it clearer that it is the responsibility of providers, not CQC, to ensure
that standards are met
Ensure that implementation and communications are unambiguous and
set realistic expectations about the priority for CQC being on tackling
failing providers, both to the services and to CQC’s own staff
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
Articulate the barriers to publishing information about performance so that
CQC can defend its record on tackling non compliance and ensure
transparency
3.6 Action to support improvement: Enforcement
The review group is confident that CQC is prioritising action to clarify its focus
on failing providers and to enable greater consistency and clarity in its
approach to enforcement. The action that is being taken is as follows: within
its compliance review workstream, CQC has been reviewing the principles
that underpin its approach to making judgements, where it sets the bar in
terms of compliance and its enforcement policy. In September, CQC will be
consulting on the guidance document to assist inspectors to make judgements
and where applicable, to take regulatory action. This guidance will reflect
changes in the approach to judging compliance and enforcement in that:
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Providers will be judged either compliant, or non compliant with the
essential standards. CQC will take no action if providers are compliant (i.e.
no improvement actions)
The emphasis will be on evidence of non compliance - if inspectors
consider that they have enough evidence, and that there is no evidence of
non compliance, CQC will judge them to be compliant
Where CQC assesses that a provider is non compliant, the level of impact
on people who use services (either minor, moderate or major) will inform
what regulatory action is taken. CQC will no longer refer to a level of
concern
There will be an enforcement escalator to help inspectors decide which
regulatory response to take, and an escalation process to follow
The executive team should provide a progress report to update the Board at
least quarterly.
Theme 3 - Communication
The regulatory model should be clearer to all and published information about
what CQC does and about the quality of care services should be more
accessible in order to promote choice and transparency.
3.7 Communication issues
The main challenges of implementing the current regulatory model under this
theme include:

Despite considerable efforts, there remains a mixed stakeholder
understanding about the role of CQC and where it fits in the wider health
and social care landscape. Clearer communication is needed about the
functions and the regulatory model. Indeed, the meaning of the term
‘regulatory model’ remains unclear to most people. In particular, the review
group suggested that CQC could review its communications to further
reinforce the focus on compliance with essential standards in order to
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manage expectations about what CQC can and cannot achieve through
regulation

There is recognition that the complex registration system can create
difficulties when trying to communicate regulatory judgements in a
coherent way, particularly for people who use services. When reviewing
the progress on provider profiles, the review group advised that CQC
should give specific attention to:
 the way in which compliance reviews are presented
 the overall statements about quality of care at a location or provider
 the way in which people’s views are presented; timeliness of reporting
 and to ensuring transparency about how decisions have been made

The level of information about the quality of care coming from the
regulator, particularly for social care, is less comprehensive than in the
past, chiefly because of the tighter focus of the regulator. To empower
service users and promote choice more effectively, it would be useful to
consider improving the signposting to other relevant resources and also
working with partners to encourage greater openness and transparency
about quality within the sector
3.8 Areas for improvement: Communication
The CQC Board consider the priorities are to develop the public messages
about the model and its ability to describe the model clearly and succinctly.
The sector are demanding a consistent and clear message about CQC’s role
and approach must be addressed to ensure that the organisation’s reputation
is protected, that it is effective in safeguarding standards in care services and
that it is seen as a useful and trusted source of assurance and information for
people who use services and the public.
CQC recognises that the messages it sends must manage expectations about
its role. In light of the pressures it faces, clearly articulating CQC’s role as a
‘regulator’ is important. In doing so, the Board considered a priority was
making it clear that CQC’s focus must be on protecting people from risk of
poor quality care, and as such the organisation cannot be expected to occupy
both a regulatory and an “improvement” space. Therefore CQC must also be
able to describe its fit within the system alongside other supervisory and
improvement agencies.
3.9 Action to support improvement: Communication
CQC needs to develop clear messages about the regulatory model. Work is
on-going in this area, led by the Strategic Marketing and Communications
Directorate and includes:

Developing CQC’s communications plan with a focus on how the
organisation will communicate with providers and other stakeholders to
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increase an understanding of its role and how it inspects and judges
services
Holding some stakeholder events to raise awareness of how CQC
operates at provider level
Developing CQC’s communications strategy to ensure better engagement
with providers
Producing a ‘regulation made easy’ guide which will be the main vehicle
for communicating these messages
The executive team should provide a progress report to update the Board at
least quarterly.
4. General issues to support the further development of the
regulatory model
4.1 General considerations
The review group gave some more general advice about issues that should
be considered as the regulatory model is developed and evolves, including
the importance of:





A clear strategic direction from the CQC Board and executive team in
order to address the pressures CQC faces
Re-stating the principles underpinning the regulatory model
Having clarity about the organisation’s strategic priorities and to allocate
resources accordingly
CQC’s experience of implementing the model so far may direct which
questions need to be considered, and help to identify trade-offs that might
be necessary. For example: how realistic it is for CQC to balance an
emphasis on outcomes for people who use services if it also needs to
focus on the process measures that help to identify poorly performing
providers? Is effective regulation more important than consistent regulation
across different providers? In what circumstances and to what extent might
the regulator have to compromise on quality in order to maintain continuity
of services?
CQC considering its position as part of the quality landscape, including the
extent to which the organisation should be positioned publicly as ‘the’
authoritative provider of information about essential standards and use its
position to challenge government policy or highlight risks to the quality of
services.
4.2 Evaluating the impact and benefits of the regulatory model
In addition to the three key themes and the broader strategic challenges
facing CQC, the review group highlighted evaluation as a critical area for the
organisation to focus on. The group reflected that the true test of the
regulatory model is how effective it is in assuring and protecting people who
use services from care that does not meet essential standards. The ability for
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CQC to evaluate its impact is also particularly important given the policy
emphasis on testing the value of regulators and regulations; greater openness
is therefore very important.
The review group did not give recommendations about what evaluation should
look like, but did identify issues for consideration when determining the
approach to evaluation:

Evaluation needs to form a more central part of the regulatory model, and
greater focus could be given to the work that is underway on benefits
realisation work. However, this work needs to be simplified so that it can
be presented publicly

CQC needs to be clear about how it wants to be judged. At the same time
consideration should be given as to how others, including providers,
commissioners, government, service users and the public, will judge CQC.
Key questions to consider are:





What is the desired impact of CQC’s regulation? What ‘benefits’ should
be realised?
Which regulatory principles or objectives are so fundamental that they
should be tested when evaluating implementation and impact of the
model? For example, based on the current model, the review group
highlighted the outcomes focus, person centred approach and meeting
better regulation principles as principles that could be benchmarked
Is compliance the important threshold or is it possible to encourage
improvement in quality at the same time?
What does better care for people look like and how can it be
measured?
What are the markers of an efficient and effective regulatory process?
Does CQC offer value for money to the public and regulated services in
delivering its regulatory model and ensuring agreed priorities are met?
These questions should be considered when developing the approach to
evaluation and any associated performance measures that are used.
Collection of data about effectiveness and impact should also be routinely
built into regulatory processes. This is likely to include a variety of
management information, key performance indicators and indicators of
impact. In particular, front line staff should be more engaged in gathering
evidence about the impact their activity makes to regulated services and to
the people who use them. An approach that combines such a process-based
evaluation with a more objective outcomes-oriented one is more likely to
engage providers and should also support operations staff to demonstrate the
difference they make and also to challenge and improve the way they work.
The review group suggest that an independent group is established to provide
oversight for this work.
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The CQC Board signalled its full support for the group’s recommendation that
greater focus should be given to evaluating the impact of CQC’s regulatory
model. In response to this recommendation, CQC has begun work to:
 Develop its understanding of other regulators’ approach to evaluation
 Map out all current and planned evaluation activity within the organisation
as a basis for developing an agreed schedule of internal evaluation and
benefits realisation activities
 Scope the need for commissioning external evaluation of its impact
 Establish an independent steering group to oversee and coordinate this
work.
5. Summary
The process described in this report has made a significant contribution to
CQC’s understanding of the challenges of implementing their regulatory
model and has helped to clarify where it needs to take action to improve the
model’s effectiveness. The CQC Board has acknowledged the need to give
ongoing consideration to the key questions posed by the review, particularly
the need to continue to seek assurance that the model, the processes and
ways of working that underpin the model, are safe.
The review group made a number of recommendations for action to improve
the regulatory model that the CQC Board has considered and, as appropriate,
has started to action. In particular, this has focused on the specific challenges
and recommendations made in relation to the issues of risk, enforcement and
communication and evaluation. Action taken or being taken to address the
issues raised by the review includes:
 Developing CQC’s approach to identifying possible risks
 Piloting a new methodology for scheduled inspections
 Action to reduce the portfolio size of front line inspection staff
 Resetting ‘the bar’ in terms of compliance so that providers will be judged
as either compliant or non-compliant with essential standards
 Redrafting guidance for CQC staff on the approach to judging compliance
and enforcement (which will be published for public consultation) to better
support inspection staff to make judgements and, where applicable take
regulatory action
 Developing CQC’s communications plan and strategy to help increase
understanding of its role and to support better engagement with providers
 Developing CQC’s approach to evaluation.
The detailed actions are as follows:
Action to support improvement: risk


Be explicit about the organisation’s overall appetite for risk
Ensure there is adequate understanding of different types of risks –
inherent, contextual and quality risks
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



Consider whether CQC should be more flexible and responsive to different
types of risk in different sectors. This might be reflected in the frequency or
focus of inspections
Develop a risk framework that enables and equips: inspection staff to
assess providers effectively and to understand the risks they will come
across in different sectors; regional intelligence staff to manage risks
across a portfolio of providers
Consider the implications of different distributions and mixes of risk across
inspectors’ caseloads
Consider whether CQC challenges providers sufficiently on the assurance
they have about their own approach risk management systems, such as:
Do they know what their risks are? How do they assess them? How do
they mitigate them?
Progress reports should be submitted to the CQC Board on a quarterly basis.
Action to support improvement: Enforcement
The guidance document to assist inspectors to make judgements and where
applicable, to take regulatory action will reflect changes in the approach to
judging compliance and enforcement in that:




Providers will be judged either compliant, or non compliant with the
essential standards. CQC will take no action if providers are compliant (i.e.
no improvement actions)
The emphasis will be on evidence of non compliance - if inspectors
consider that they have enough evidence, and that there is no evidence of
non compliance, CQC will judge them to be compliant
Where CQC assesses that a provider is non compliant, the level of impact
on people who use services (either minor, moderate or major) will inform
what regulatory action is taken. CQC will no longer refer to a level of
concern
There will be an enforcement escalator to help inspectors decide which
regulatory response to take, and an escalation process to follow
The executive team should provide a progress report to update the Board at
least quarterly.
Action to support improvement: Communication



Developing CQC’s communications plan with a focus on how the
organisation will communicate with providers and other stakeholders to
increase an understanding of its role and how it inspects and judges
services
Holding some stakeholder events to raise awareness of how CQC
operates at provider level
Developing CQC’s communications strategy to ensure better engagement
with providers
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
Producing a ‘regulation made easy’ guide which will be the main vehicle
for communicating these messages
The executive team should provide a progress report to update the Board at
least quarterly.
Action to support improvement: Evaluation




Develop its understanding of other regulators’ approach to evaluation
Map out all current and planned evaluation activity within the organisation
as a basis for developing an agreed schedule of internal evaluation and
benefits realisation activities
Scope the need for commissioning external evaluation of its impact
Establish an independent steering group to oversee and coordinate this
work.
CQC recognises that it will take time to embed its approach and is committed
to ongoing review and evolution of its regulatory model to improve its
efficiency and effectiveness. In the last 10 years there have been five different
regulators in health and social care. This degree of change destabilises the
regulator, confuses the public and places a burden on providers. The
government commitment to the future of CQC and to making it a more
effective regulator offers an important opportunity for continuity in regulation
and will enable the ongoing development of a meaningful regulatory model.
CQC is confident that the changes it is making as a response to the regulatory
model review will help to improve its effectiveness as a regulator and will
enable the organisation to have a greater impact on the quality of care for
people who use the services that it regulates.
6. Acknowledgements
CQC would like to acknowledge the invaluable contribution of members of the
regulatory model review group, in particular the external members, to
providing constructive challenge and helpful advice on how the regulatory
model can be improved.
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ANNEX A – Regulatory model review group membership
Martin Marshall (chair)
Cynthia Bower
Jill Finney
Peter Hay
Amanda Hutchinson
Linda Hutchinson
Sir Ron Kerr
Barbara Laing
Sir Neil McKay
Lucy Robbins
Amanda Sherlock
Kieran Walshe
CQC Commissioner
CQC Chief Executive
CQC Director of Strategic Marketing &
Communications
Strategic Director Adults and Communities,
Birmingham City Council
CQC Interim Director of Regulatory Development
(Head of Better Regulation until April 2010)
CQC Director of Regulatory Development (until
April 2010)
Chief Executive – Guy’s and St Thomas’ NHS FT
Non Executive Director for Social Care
Chief Executive – East of England SHA
CQC Operations Programme Director
CQC Director of Operations
Professor of Health Policy and Management
Manchester Business School
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ANNEX B - REGULATORY MODEL – a summary
CQC functions
19. The overall objective as an organisation is to ‘make care better for people’.
The Health and Social Care Act 2008 outlines three main functions which
can be used by CQC:
- Registration, compliance monitoring and enforcement
- Reviews and investigations
- Functions under the Mental Health Act
Strategic priorities
20. The two strategic priorities that the Board has agreed CQC should focus
on are:
- Priority 1 - Acting swiftly to help eliminate poor quality care.
- Priority 2 - Ensuring care is centred on people’s needs.
Regulatory principles
This section outlines the principles of the model considered by the regulatory
model review group. Some aspects may therefore change as a result of their
recommendations
Regulatory model principles
Regulatory cycle involves:
gathering information in order to
analyse risk; assessment of risk is
used to target regulatory activity;
evidence is triangulated and used
to make regulatory judgements.
Using a person-centred approach
Registration and compliance monitoring
 Registration cycle: Nine steps (2 linked
cycles) make up the cycle of registration
and compliance monitoring which follows
the same flow as the generic regulatory
cycle.

Key registration documents and tools, such
as the Essential standards of quality and
safety and the Judgement Framework were
developed in consultation with key
stakeholders, are person-centred and focus
on outcomes and experiences.

Inspection and observation tools and
products should enable staff to focus on
outcomes and take account of peoples’
views within when making regulatory
judgements.
Listening to the views of people
who use services, carers, local
groups and staff

Mechanisms are in place to gather and take
account of user voice and information from
local groups.
Regulatory model principles
Being proportionate and targeted
Registration and compliance monitoring
 Assessment tools should enable operations
Focusing on outcomes and
experiences of people
Protecting people’s rights and
promoting equality and diversity
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Regulatory model principles
Registration and compliance monitoring
staff to undertake proportionate and
targeted regulatory activity that is focused
where concerns are identified or where
there are gaps in information.
 All providers have a planned compliance
review against all 16 Essential Standards at
least every two years. Responsive reviews,
targeted at areas of concern only, can
occur at any time. Compliance reviews
consider all information about quality and
risks and can involve a site visit if required.
This model seeks to examine both
compliance at a point in time and judge
whether compliance is likely to be
sustained.
 A Quality and Risk Profile (QRP) for each
provider holds all information to enable
operations staff to evaluate risks and target
activity.
Using information to identify risk
and target activity
Being transparent and consistent

Quality assurance systems ensure that
enforcement or improvement action is
consistent and transparent.
Publishing reliable and accessible
information

Using generic regulation expertise,
with access to specialist advice
when required

Compliance reports for every review are
published as soon as possible; information
provided should emphasise the views of
people who use services. Once launched,
provider profiles published on the CQC
website will give up to date information
about registration status and recent
compliance reviews.
Analytical support and specialist advice
enables more in-depth review where
required.
Using unannounced visits
wherever possible

Working in partnership with other
regulators and monitoring
organisations to minimise burden
and reduce duplication

Minimise administrative burden for
providers and provide effective
customer service.

Site visits are unannounced wherever
possible. Other site visits are done at short
notice.
Key partnerships with other regulators and
supervisory organisations enable effective
information sharing, early identification of
concerns and appropriate system response
to failures.
New registration and variation processes
should be easy to follow, streamlined and
timely.
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