Agenda
Paper No:
DRAFT
Response to our consultation proposals
for the Judgement framework and
Enforcement policy
10
CM/01/12/10
Annex E
Contents
Introduction ................................................................................. 3
Responses to the consultation .................................................. 6
Points raised that were not included in the consultation ......... 9
Responses to consultation questions ..................................... 12
Judgement framework .............................................................. 20
Enforcement policy ................................................................... 22
Regulatory Impact Assessment ............................................... 24
Equality Impact Assessment .................................................... 26
Appendix 1: Organisations that responded ........................... 28
2
Introduction
Since April 2010 the Care Quality Commission (CQC) has brought 22,000
regulated providers of health and social care services into the new regulatory
framework introduced by the Health and Social Care Act 2008. We have
registered these providers against essential standards of quality and safety
within extremely challenging timescales. Since registration, we have
inspected, and continue to inspect thousands of care services to judge how
well they continue to meet those standards.
During this time, we have listened to what providers and the public have told
us about some of the challenges of our current regulatory model. In addition,
as part of the process of reforming the NHS, the government has sought to
strengthen our role to ensure we focus on our core business. This is to
monitor and inspect providers to make sure that essential standards are being
met and to take swift action where they are not.
We are now simplifying and strengthening our regulatory model to reflect this
focus, and to build on what we have learned in the last two years.
We will continue to be focused on outcomes for people who use care
services; risk-based in line with the principles of Better Regulation; intelligent,
using the wealth of information that CQC inspectors and analysts have at their
disposal; and responsive, ensuring that we act quickly to take regulatory
action when we identify that essential standards are not being met.
However, we will inspect most services more often, our inspections will be
more targeted, and where we find that providers are not meeting their legal
requirements we are clear that swift action will follow.
These refinements are not about toughening our approach or about ‘raising
the bar’; our aim is to be clear about whether a provider is meeting the
standards or not and, where they are not, what regulatory action will follow.
Because some of these refinements affect our key guidance, we held a
consultation to give providers, the public, commissioners and other
stakeholders the opportunity to comment. This document sets out our
response to that consultation.
We are grateful to everyone who took the time to respond to the consultation.
We intend to introduce the changes to our regulatory model from the 1st of
April 2012, we will communicate with providers about these changes and
information will be made available on our website.
We are also improving the way we publish information for the public to make
sure it is clear, accessible and supports choice. We believe these
improvements will give the public and providers greater clarity about whether
or not providers are meeting essential standards. Together with the
establishment of Healthwatch England as a committee of CQC, they will
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continue to ensure that the voices of people who use services are always at
the centre of our work.
CQC will play its role to ensure essential standards are met, but there are
22,000 regulated providers of 37,000 registered services in England and
expectations of regulation must be realistic. Every part of the system - from
providers, to commissioners, to professional regulators - has a duty to make
sure that poor care is identified and addressed. All of those involved in
providing care - senior management, boards of governors, medical
professionals and frontline staff – have a part to play in stopping or reporting
poor care whenever they see it. If poor care is happening, someone,
somewhere knows about it and should act.
The key features of our improved regulatory model
Under the Health and Social Care Act 2008, health and social care providers
have a legal responsibility to make sure their services meet essential
standards of quality and safety. The public has a right to expect these
whenever or wherever they receive care.
Our core business is to register providers against essential standards of
quality and safety to monitor and inspect them to make sure they continue to
meet the standards.
We will continue to carry out scheduled, responsive and themed inspections
of services, and they will continue to be unannounced unless there is a good
reason to let the service know we are coming. We will inspect most social
care, independent healthcare services, and most NHS hospitals at least once
a year. By NHS hospitals we mean all NHS hospitals which provide acute
services and all NHS Ambulance Trusts. We inspect at least one type of
service1 in all other Trusts. We will inspect dental services at least once every
two years.
Our inspections are more targeted to take account of the nature of the care
a service provides, the level of information we currently have about it, the
risks to people, and the approach relevant to the sector regulated. We focus
our resources on acting swiftly when we identify that essential standards are
not being met. We do not necessarily inspect all 16 essential standards every
year but we target our inspections by focusing on a smaller number of
standards.
We no longer ask the provider to send us information before an inspection,
but during or after an inspection we may ask to see further information if
necessary to provide evidence of compliance.
In between inspections, our inspectors and analysts will continue to monitor
information we hold about services against all 16 essential standards and
1
Further information about service types can be found on pages 14-31 in our Guidance about
compliance: Essential standards of quality and safety
http://www.cqc.org.uk/publications.cfm?fde_id=15413
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build up a profile of each service (Quality and Risk Profile) to decide where
there is a risk of poor care.
To support these improvements to our regulatory model, we proposed to
refine some of the key guidance that underpins it – our Judgement
Framework, Setting the Bar and Enforcement Policy. The consultation set out
those refinements and sought views on them. There were also a number of
broader consultation questions. This document sets out our response to the
consultation.
In summary the proposals were:







Proposal 1: Removal of improvement actions
Proposal 2: Focus on non-compliance
Proposal 3:Judge impact ‘after’ judgement of non-compliance
Proposal 4: Remove the assessment of a providers level of confidence
Proposal 5: Escalating scale of enforcement action
Proposal 6: Remove the likelihood factor
Proposal 7: Publication of a summary of a Warning Notice
For each of these proposals we have set out what we consulted on, what
people said and what our response is.
In addition to consulting on the above the format and the layout of the
guidance documents were amended. The sector-specific case studies have
been removed from stage 4 of the Judgement framework and will be made
available on our website.
Stage 4 has been replaced with setting the bar as it was more appropriate to
incorporate this into the body of the Judgement framework.
The Judgement framework we consulted on included illustrative examples
that described minor, moderate and major impact. We have removed these
from the final version as some respondents commented that they did not
provide the necessary level of detail. The sector specific case studies which
will be made available on our website and updated as we collect more
examples from our work will provide the clarity, context and detail that some
respondents requested.
5
Responses to the consultation
The consultation ran from the 13th of September until the 9th of December,
with the consultation documents available on our website, and highlighted in
our provider e-bulletin in September, October and November 2011, over
30,000 people receive this e-bulletin.
Five focus groups were also held with our Speakout Network and Experts by
Experience to ensure we fully engaged with people who use services. The
details of the groups we engaged with and the numbers of people who
attended are listed in the table below.
Number Speakout Network
attending
11
Asian Disabled Association
10
Harrow Association of Somali Voluntary Organisations (HASVO)
6
Brent Advocacy Concern: Adults who have a disability
5
British Association of Visually Impaired People (BAVIP)
Number Experts by Experience
attending
18
Choice Support: Adults with a learning disability
We invited members of LINKs, and the various groups that we work with as
part of Experts by Experience, to respond to the consultation, including, Help
the Aged, Challenging Behaviour Foundation, Alcohol and Drug Service
(ADS) /Oxfordshire User Team (OUT), The Daffodil Advocacy Project, EQuality Voices Group. Due to the complexity and technical nature of this
consultation accessible versions were also produced (Easy Read, a mid and a
full version, as well as an Equality Impact Assessment).
We received 174 responses to the consultation. The respondents included
many of the key stakeholders for each sector. Figure 1 shows a breakdown of
responses by sector group.
6
Figure 1: Respondents by sector group
Consultation responses were recieved from
70
69
60
Number
50
40
42
35
30
20
21
10
7
0
CQC
National
body
Other body
Person using
a service/
carer/ public
Provider
Sector group
The sector groups can be broken down further to show the number of
responses received for each sector group. See below:
Table 1: Responses by sector for ‘person using service/carer/public’
group
Sector group
Person using service /
carer / public
Sector
No of responses
Person using health or adult
social care services
31
Carer
2
Member of the public
9
7
Table 2: Responses by sector for ‘Provider’ group
Sector group
Provider
Sector
No of responses
Independent healthcare
5
Adult social care
32
Dentist
1
Primary medical services
1
Ambulance service
1
NHS organisation
29
Table 3: Responses by sector for ‘National body’ group
Sector group
National body
Sector
No of responses
Professional body
6
Government
2
Other national body
13
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Points raised that were not included in the consultation
The responses made reference to the 7 proposals and consultation questions
as well as other issues that were not specifically consulted on. Where those
issues were raised by several respondents we have set out responses below:
Assessing quality over and above the essential standards
One of the key issues that many respondents raised was CQC’s approach of
focusing on whether services are meeting essential standards, but no
assessment of quality above or beyond these standards.
The responses, particularly from social care providers highlighted the potential
impact this approach could have on the quality of services and people who
use services. Some respondents felt that this approach meant that
commissioners and people choosing services did not have useful information
to inform their decision making, and some people felt that this model would
not motivate compliant providers to strive to provide better care.
Under the Care Standards Act 2000 the Commission for Social Care
Inspection (CSCI) introduced a quality rating scheme for adult social care
providers. In the summer of 2011 CQC consulted on proposals for a
voluntary excellence award. The proposals were rejected by the sector and
the scheme abandoned. The Department of Health has been working with
CQC, providers of services and other partners to design a quality
improvement framework that provides relevant and up to date information to
help people make decisions and choices about the type of care setting that
will best meet their needs.
Quality assurance and consistency
A significant number of respondents identified supporting mechanisms that
need to be robust and operational to ensure that the proposed changes to the
model will work effectively.
Under the new model services will either be compliant or not. This raised
concerns from some people about the possibility of our inspectors being more
stringent when making decisions. A number of people raised the need for
CQC to have a robust quality assurance system to ensure consistency and
proportionality. Several people said that CQC should publish details of this
system.
We know we must have a robust quality assurance system and to continue to
strive for consistency. However, it must also be recognised that our
judgements and regulatory response will vary depending upon the
circumstances of the provider, the nature of the service they provide and the
circumstances of the people who use the service. Therefore we can ensure
consistency in our judgements, but our regulatory response will vary
according to circumstances,
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The quality assurance process currently used by CQC is being reviewed.
Mechanisms will be put in place to validate and audit judgements to ensure
consistency and support learning across the organisation. Information about
our quality assurance approach will be made available on our website.
Our focus on inspection
Several respondents commented about our greater focus on inspection
activity and welcomed this. Inspection is just one of the tools we use to
monitor compliance with the essential standards. Our inspectors continually
monitor all the information we hold about services against all of the essential
standards.
Since July 2011 we have been running a national pilot which has seen us
inspect more frequently. The feedback from the pilot has been positive and
we intend to roll out this model fully from April 2012. Our inspections will not
usually inspect all 16 essential standards but will focus on a smaller number,
a minimum of 5 for most service types, one from each of the key outcome
areas in the essential standards. Inspectors are not restricted to this number
of outcomes, they are free to use their professional judgement and will
broaden out the inspection if they feel more outcomes need to be inspected.
We will continue to have three types of inspection, scheduled, responsive and
themed. More guidance about our approach to inspections will be made
available on our website.
Following up on our regulatory response
A number of people noted the importance of CQC following up on compliance
and enforcement action swiftly to both ensure compliance had been achieved
and to enable the updating of the website to provide accurate and up to date
information. Some people said that follow up checks of regulatory action
should always be done via a site visit.
We have considered this issue and agreed that all enforcement action and
many compliance actions will be followed up through a visit.
However in some cases where a compliance action has been issued a
desktop review could provide the evidence required to assure us that the
service is now compliant. For example if we needed to see evidence that staff
had attended a particular training course, the provider could send us copies of
certificates. This ensures we are being proportionate and not overly
burdensome in our action.
We recognise the potential reputational impact on providers who have been
judged non-compliant and have made a commitment to follow up on
compliance and enforcement action in a timely manner. We will continue to
follow our existing policy which is on our website:
Any cross on your profile page is an indication of non-compliance with one or
more of the essential standards. If you have been required to produce an
action plan stating by what date you expect to become compliant, we will
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review your service again within three months of you declaring your action
plan complete. If at that time we judge you to be compliant, your profile page
will be updated when we publish the findings from that review of compliance.
The Provider Compliance Assessment (PCA)
Several respondents asked about the future of the Provider Compliance
Assessment (PCA) particularly as our inspections will be unannounced,
unless there is good reason to let the service know in advance that we will be
coming. We have also made clear that we will not ask for information in
advance of an inspection.
However, we recognise that the PCA is a useful tool that many providers
choose to use to monitor their own quality assurance, although it’s use is not
mandatory and providers may choose to use a different system. We also
recognise that many providers have invested time and effort into integrating
the PCA into their assurance mechanisms.
On this basis the PCA will continue to be made available to providers as an
optional quality assurance tool, if providers wish to use an alternative quality
assurance system that is perfectly acceptable. In line with our principles of
inspections being unannounced and not seeking information in advance we
will only ever ask to see the PCA during or after an inspection to help us
triangulate our evidence, we will not ask for it in advance.
Judgements around non-compliance with safeguarding
In terms of safeguarding the refined judgement framework set out that any
breach in relation to safeguarding would be classed as a major impact. The
introduction of zero tolerance for this essential standard would mean any
breach of this regulation would result in enforcement action being taken as it
would always be deemed a major impact on people using the service. Some
respondents expressed concern about low level breaches that would not
result in a major impact on people using services.
In view of these comments we have consulted with experts in safeguarding.
We have agreed that minor and moderate impact should be retained in
relation to safeguarding to enable CQC to respond in a proportionate way and
take regulatory action that is appropriate to the breach.
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Responses to consultation questions
In this section of the document we set out the consultation questions and
proposals, what people said about those questions and proposals and what
our response is. For each proposal and question we set out in full the text of
the consultation document.
1. Do you agree with the improvements we propose to make
to the judgement framework?
Of the 174 responses we received, only 35 respondents disagreed with the
improvements we proposed to the judgement framework with 78 people
agreeing, 61 responses did not directly respond to this question. However,
issues were raised in relation to specific proposals.
Proposal 1: removal of improvement actions
Following an inspection or review, we will judge providers to be either
compliant or non-compliant.
We will take no action if providers are compliant. Where a provider is
compliant, our inspectors will have the opportunity to make comments that
may be useful to the provider and to the public about minor improvements
that could be made, but there will be no improvement actions or regulatory
follow-up.
Where providers are non-compliant, compliance actions are the precursor
to formal legislative enforcement action.
How is this different?
Currently, a provider can be compliant but with some concerns for which we
set improvement actions. The change will make it very clear whether a
provider is compliant or non-compliant, and help us to target non-compliance
more effectively.
What people said
People that commented specifically on this proposal were divided 40:60
respectively against and in favour of the proposal. Respondents supporting
the proposal found it simpler, clearer and easier to understand. Generally the
responses noted the removal of the judgement ‘compliant but with some
concerns’ made it clearer for the public and people using services.
The responses that did not support the proposal raised concerns about the
lack of distinction between a provider that is ‘fully compliant’ compared to a
provider that is ‘compliant but with some concerns’ and argued that this
provides limited information to assist people when making a decision about
what services to use.
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Some of the respondents misunderstood what improvement actions were.
They thought that they were actions to encourage the provider to improve
above and beyond the essential standards.
It was also noted by some that removing improvement actions meant we
would no longer be encouraging services to improve as set out in the Health
and Social Care Act 2008.
Our response
It is important to note that improvement actions are not about encouraging
services to improve the quality of care above essential standards, but to
encourage services to make changes that ensure they continue to meet
essential standards.
We will no longer set improvement actions that require the provider to submit
an action plan detailing how they will maintain compliance and require our
staff to monitor the progress of that action plan.
Our inspectors will make comments in inspection reports about minor
improvements that could be made. This will be useful to the provider,
commissioners, people choosing services and the public. Inspectors will be
able to report on any action that was taken in response to our comments
during the next inspection.
Proposal 2: focus on non-compliance
Our inspections will be focused on identifying areas of non-compliance, rather
than focusing on compliance. Where we see non-compliance we will continue
to triangulate our evidence to reach a judgement. If we see compliance, our
judgement will be that the provider is compliant.
How is this different?
Currently, we look for specific evidence of compliance during our reviews, so
this is a shift in focus to finding evidence of non-compliance rather than
compliance.
What people said
The majority of responses were not in favour of this proposal. It was felt this
would be biased, negative and encourage inspectors to seek out for noncompliance rather than taking a holistic view of the care and support offered
to people using the service. People felt it would provide limited information to
the public and people deciding what services to use as well as to
commissioners. Learning about and sharing best practice would not be
possible as our reports would provide no detail about how services are
demonstrating compliance. It was noted a focus on non-compliance would
accentuate the impact of the loss of the excellence scheme and drive the level
of quality down further.
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One respondent noted that it would be impossible for a service to be
compliant with all the prompts in the essential standards all the time and
therefore services would always be non-compliant.
Our response
We recognise how strongly respondents felt about this issue and we will
report compliance where we see it. Our inspections will focus on identifying
non-compliance but where we see compliance we will describe it to ensure we
provide a balanced view when reporting our findings. This also ensures that
we are providing useful information to the public and commissioners to inform
choice and decision making when selecting a service.
Providers do not need to be compliant with all the prompts in the essential
standards. They need to be compliant with the regulations. The prompts set
out what compliance might look like, providers are free to use other
approaches, but they must demonstrate compliance with the regulations.
Proposal 3 & 6
Proposal 3: judging the impact after we have reached a
judgement of non-compliance
Where we judge that a provider is non-compliant with one or more of the
regulations, the level of impact on people who use the service (minor,
moderate or major) will inform the regulatory response we make. We will
judge the level of impact on people who use the service after we have
reached a judgement of non-compliance with a regulation.
How is this different?
Currently, we judge a level of concern before we make a judgement as to
whether the provider is compliant or non-compliant. A concern can be
graded as minor, moderate or major. We reach this judgement by
considering the impact on people who use the service and the likelihood of
it happening. Under these proposals, we will no longer refer to a level of
concern, and we will consider the impact on people after we have made a
judgement of non-compliance.
Proposal 6: removing the likelihood factor
We will judge the level of impact on people who use the service, including
the degree of risk to which they have been exposed, for each one of the
regulations where we have identified non-compliance. We will assess
whether the impact of this risk is minor, moderate or major, and this will
influence our regulatory response.
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How is this different?
Currently, inspectors make a risk assessment of concerns that have been
identified to determine whether it is a minor, moderate or major concern. The
current risk assessment takes account of the impact on people using the
service (low, medium or high) as well as the likelihood that the impact will
recur (unlikely, possible, almost certain).
What people said
Respondents that supported this proposal felt it was a logical and fairer
approach to reach a decision about compliance prior to risk assessing what
the impact would be.
In contrast respondents that disagreed with these proposals felt that by
removing the assessment of likelihood and deciding the level of impact on
people who use services after reaching a decision about non-compliance we
are not taking account of all the circumstances or considering all relevant
information. They felt the introduction of these proposals would mean we were
not being proportionate or helping to reduce the burden on services. There
was also concern that this would result in a greater focus on processes and
inputs rather than outcomes for people.
Our response
In deciding what regulatory response to make the impact on people is the
most important thing for us to consider. For example an unsecured fire exit
on the fourth floor of a care home for people with dementia could have a
significant impact on an individual if they were to fall from it. But, if that floor
was not accessible to people using the service the likelihood of that
happening is greatly reduced. We will take into account all relevant
circumstances including the likelihood of potential or actual harm when
deciding on our regulatory response. This approach enables the principles of
proportionality, consistency and reasonably practicable to be embedded in our
work and therefore we propose this is implemented as part of the new model.
Proposal 4: removing assessment of level of confidence
Our level of confidence in the provider’s capability will not directly affect our
regulatory response. Our regulatory response will be primarily based on the
significance of the non-compliance and its impact on people who use
services.
How is this different?
Currently, our level of confidence in the provider (combined with the level of
concern and the number of concerns) directly affects our judgement of
compliance or non-compliance as well as our regulatory response. With this
proposal, inspectors would instead take capability into account alongside
other factors when determining the appropriate response.
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What people said
There was confusion regarding this proposal. Respondents requested clarity
regarding the meaning of ‘taking capability into account’. Respondents
expressed concern about CQC not taking account of a provider’s level of
confidence when deciding what regulatory action to take as this information
helps to ensure CQC is propionate in its decisions. Generally the consensus
was that a provider’s commitment to make improvements was important
information to consider.
Our response
We propose that we need to take into account a range of factors when
deciding upon our regulatory response to breaches of compliance including
their capacity and circumstances, this enables us to be proportionate. We
appreciate that some people struggled to understand what we meant by
‘capability’. We mean the providers capacity to make the changes, for
example financial resources or competent staff. To resolve any confusion we
propose to refer to this as capacity not capability. This means we should take
into account all of the providers circumstances including their capacity, their
individual circumstances, and the circumstances of the people using the
service.
2. By using the revised judgement framework will CQC be
able to regulate and take action to help eliminate poor
quality care more effectively?
What people said
Just under half (70) of the respondents agreed that the revised judgement
framework would help eliminate poor quality care, whilst 40 respondents
disagreed and 64 did not answer. Although not specifically consulted on some
people raised concerns about limiting our inspections to a smaller number of
outcomes. Some people argued that it would be difficult for us to help
eliminate poor quality care if we are not looking at all the essential standards.
In contrast many respondents supported reducing the number of essential
standards inspected as this ensures a more robust and targeted approach as
well as being less burdensome.
Our response
During inspections we will focus on a smaller number of outcomes but
inspection is only one part of what we do. Our inspectors and analysts will
continue to monitor compliance across all 16 essential standards by
continually reviewing the information we hold, including the Quality and Risk
Profile.
Inspecting a smaller number of outcomes enables us to be less burdensome,
risk based, proportionate and targeted. It allows inspectors to scrutinise
essential standards that are highlighted as potentially failing in greater depth.
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3. Do you agree with the improvements we propose to make
to the enforcement policy?
81 of the 174 responses agreed with the improvements to the enforcement
policy, while 67 did not answer. Only 25 respondents did not agree with the
proposals and 68 respondents did not answer the question.
Some respondents were concerned about the focus on non-compliance and
that the approach with the new enforcement escalator would result in CQC
being more stringent. The need for a robust quality assurance process was
re-iterated in many of the responses to prevent inappropriate regulatory action
being taken because of an inconsistent judgement being reached.
Proposal 5: escalating scale of enforcement action
The escalating scale of enforcement action will help inspectors decide
which regulatory response to take. We will follow a clearer, more
transparent escalation process to ensure providers achieve compliance,
referred to as the enforcement escalator. We will not normally issue a
second compliance action to follow up a compliance action. We will not
normally extend the timescales we give providers to achieve compliance.
Failure to respond to compliance or enforcement actions will usually result
in an escalation of enforcement activity. However, we will always be
proportionate in the action that we take and we will retain our discretion to
take individual circumstances into account.
How is this different?
Currently, we may extend deadlines to enable providers to meet compliance
actions, or we may set consecutive compliance actions to enable providers to
become compliant. The enforcement escalator will be much clearer and more
transparent in setting out which regulatory response will be applied.
What people said
The majority of respondents that referred specifically to proposal 5 agreed
with the change. The responses referred to the new escalator table providing
a clear framework of what regulatory responses we have available to us and
how these will be used. They considered it transparent and agreed it would
support a timely and effective response to non-compliance by services.
Where a service is non-compliant it allows them to identify the type of action
that will be taken if they do not make the necessary improvements.
The challenges to the proposal, although limited (4 responses), referred to
possible unwanted effects by having an automated approach to moving up the
escalator. It was highlighted that there is a need to consider each case on its
own merit so as not to fetter discretion through rigidly applying the escalator
where it is not appropriate.
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Our response
We agree that the enforcement escalator may not always be used in
sequence and CQC has the right to exercise discretion where it deems
appropriate. The enforcement escalator is set out as a guide to help promote
consistency, it is not an absolute.
We have also recognised that calling the flow chart the ‘enforcement
escalator’ is potentially misleading. This is because the range of options open
to us includes compliance actions. Compliance actions are not enforcement
action but a precursor to enforcement action. Therefore we have renamed
the enforcement escalator the ‘regulatory response escalator’ and this is what
it will be referred to from now on.
Proposal 7: publishing a summary of warning notices
Where we issue a warning notice for non-compliance with a regulation, we
will publish a summary of the notice and refer to the warning notice in the
compliance report, unless representations about that notice are received and
upheld. Where the provider does not comply with this notice, evidence on
which the notice was based can be considered again and used as a basis for
further action if compliance is not achieved.
How is this different?
Currently any warning notice served is not mentioned in the compliance
report. This means that people who use services are unaware of any action
being taken on a provider or manager. This can be of major concern to
people who use services where it appears that we are not acting upon
information received.
What people said
Overall there was support for the proposal to publish a warning notice
summary. Respondents agreed with the concept that this information should
be made available to the public as it supports the principle of being open and
transparent as well as ensuring the public are fully informed about any action
we have taken.
The concerns raised by a small number of respondents (4), was relating to the
opportunity for a service to challenge any decision relating to a warning notice
and the time taken to update our findings when improvements have been
implemented by the service.
One provider highlighted that where there are multiple locations and
regulatory action is being taken, it is important to make it clear which location
the non-compliance relates to for accuracy and reputational purposes.
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Our response
It is important to note that the representations process for warning notices is
around the publication of the notice and not the judgement made within it. The
process that we follow prior to a warning notice being issued ensures the
evidence the inspector is reliant upon is robust and should not be open to
challenge. The Health and Social Care Act 2008 has no provisions for an
appeals process for warning notices.
There is a factual accuracy check of the inspection report, which is the
services opportunity to challenge the written report and the accuracy of
evidence used by the inspector. If a service can demonstrate evidence used
to reach a judgement was inaccurate, this system enables those concerns to
be resolved prior to publication.
We agree that it is important for any warning notice and associated press
release to identify the location at which it was served and we have included
this in our guidance for publishing warning notices.
4. By using the revised enforcement policy will CQC be able
to regulate and take action to help eliminate poor quality
care more effectively?
What people said
There were 67 responses in support of this statement with only 28 in
disagreement and 79 respondents not answering. The definitive line between
compliance and non-compliance and the regulatory response escalator were
the key principles that respondents highlighted in ensuring the new model will
help to eliminate poor practice.
Generally respondents viewed the enforcement policy as clearer and more
transparent. The regulatory response escalator clearly demonstrates next
steps showing a clear escalation where services continue to fail to comply
with the essential standards. This ensures that the public, as well as services
understand the implications of non-compliance.
Several respondents stated that they want to see CQC use these documents
more effectively to eradicate poor care but had reservations about our
capacity and the skills and numbers of inspectors. A few respondents
requested a more open culture of support and did not see the new policy as
being helpful in this way.
Our response
Guidance that supports the judgement framework and enforcement policy
such as the case studies on our website should provide additional support to
services that require more detail.
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Our inspectors will be fully trained on the refined model and comprehensive
guidance will be available to support them. We are recruiting more inspectors
to enable us to carry out more frequent inspections
Judgement framework
5. Do you understand the processes our inspectors will
follow to make judgements based on the revised
Judgement framework?
What people said
There was a positive response to this consultation question. Only 11
respondents did not understand the process our inspectors would follow to
make judgements, while over half (91) of our respondents stated they did and
72 respondents did not answer. To clarify the process further it was
suggested that the definitions for reasonably practicable and proportionate
should be simplified.
Examples of compliance and what evidence can be used to demonstrate
compliance were also requested by some respondents to provide further
clarity of the process and how judgements are reached.
Our response
We have simplified the definitions of reasonably practicable and proportionate
to aid understanding.
Compliance is described in the Guidance about Compliance: Essential
standards of quality and safety, this document will always be used alongside
the judgement framework by inspectors and should be used as the main
compliance benchmark by services. In addition we have guidance available
on our website that describes what outcome evidence can be used to
demonstrate compliance.
We have removed the case studies that were previously in the judgement
framework and will be putting these on the website. These case studies will
provide additional guidance about where the bar is set for minor, moderate
and major impact. We will update the case studies as we undertake further
regulatory work.
6. Do you think that the process and associated guidance is
clear?
What people said
Approximately half of respondents (69) were positive about this question and
felt the guidance and process was clear, while 23 respondents stated they did
not and 82 respondents did not answer. It was felt the guidance contained
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jargon and was quite complex in parts for a member of the public or other
interested parties to understand. The main concern raised about the clarity of
the guidance was the lack of detail about the operational aspects of an
inspection such as timescales, the responsibility of the inspector and the
provider and the publication process.
Some respondents were unsure who the guidance was targeting, because of
this it was suggested that an easy read version would be helpful.
Our response
The judgement framework and the enforcement policy will be used
predominantly by inspectors; and as such are targeted towards them.
However, there is a need for the public and providers to understand our
methods as well as to ensure openness and transparency. A review of the
documents, to simplify where possible, has been completed and we will
consider producing an easy read version.
It is important that people understand the inspection process and information
and guidance will be made available on our website. The judgement
framework and enforcement policy detail the process used to reach a
judgement rather than the inspection process itself, so we will not include this
information in these documents.
7. Do you think that the revised Judgement framework will
enable us to be more consistent in implementing our
judgements?
What people said
The majority of responses given to this question (69) were positive and
agreed that the revised and simplified judgement framework would enable
more consistency in judgements reached by our inspectors, only 35
respondents said no and 70 did not answer. However, there was a focus on
the need for a robust quality assurance process that is made public to ensure
openness and transparency. There was also an issue raised about the need
for sufficient, consistent and detailed training for all inspectors so they have
the necessary skills to apply the model consistently.
Our response
As set out earlier in this document we are reviewing our quality assurance
processes and will publish information about this in due course.
There is a full training programme planned for our inspectors to ensure they
have the skills and understanding to implement the refined model in a
consistent way.
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Enforcement policy
8. Do you understand what our enforcement powers are and
how we can use them?
What people said
Out of 174 responses 98 agreed that they understood our powers, only 8
respondents disagreed and 68 did not answer. The majority of the responses
that disagreed had concerns about the removal of minor and moderate impact
for outcome 7 safeguarding. This has been addressed and the changes made
to the judgement framework.
Some respondents highlighted the advantage of including examples
describing scenarios where particular types of regulatory action would be
taken.
It was also highlighted that CQC need to consider the implications of a
change in policy through the removal of ‘compliant with some concerns’ and
what the effect will be on the services with this judgement.
Our response
Case studies will be included on the website that will illustrate the different
judgements we have made to provide a benchmark. In addition all judgements
and regulatory action will be published on our website which will provide
ongoing up to date examples where different regulatory action has been
taken.
For services that are currently judged as ‘compliant with some concerns’ we
will follow up any improvement actions in line with existing methodology and
at the next inspection a new judgement will be reached and published in line
with the new methodology. If providers have made the improvement identified
previously they should now be compliant.
9. Do you think that our process of escalating action in
response to non-compliance is clear?
What people said
Over half of the respondents were in agreement with this question (92) with
17 saying no and 65 not responding. However issues were raised about some
aspects of the regulatory response escalator that appeared ambiguous.
Respondents questioned how an inspector would decide between a
compliance action or a warning notice when a moderate impact was identified.
Where there are multiple breaches and a moderate impact, four options are
available to an inspector when deciding what regulatory action to take.
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Some people commented that the levels of fines were too high and should be
reduced, particularly for small providers.
Our response
The judgement framework clarifies when an inspector would choose between
a compliance action and a warning notice when responding to noncompliance with a moderate impact. However, the regulatory response
escalator has been reviewed and amended to clarify the flow where multiple
breaches have been identified.
CQC is given the power to charge fines under legislation and to do so within a
framework of policy decided by the government. We have no power to reduce
the amounts set in the fines table for small providers as the levels are set by
government not CQC.
10. Do you understand the implications of non-compliance?
What people said
There was strong support for this question, with 101 respondents agreeing
that they understood the implications of non-compliance, 3 saying no and 70
respondents not answering. However, approximately a third of the
respondents (54) raised concerns regarding this question.
One issue related to clarification about whether poor care identified during an
inspection is as culpable as poor care that occurred prior to an inspection.
The potential for the new model to be more stringent resulting in more
services being identified as non-compliant was also raised. People identified
the need for an effective and transparent process to make representations
and appeals.
Our response
Where non-compliance is identified, the time at which the breach occurred
does not lessen the action we take. All relevant information will be considered
and taken into account to determine an appropriate and proportionate
response.
CQC has a representations process and guidance is available on our website
which describes the process for representations. Details about the appeals
process are also available from the first-tier tribunal.
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11. Does the ‘enforcement escalator’ help you to understand
the range of action that is available to us where providers
are non-compliant with the regulations?
What people said
The final question relating to the changes in the enforcement policy had 92
respondents agreeing they understood the range of action we can take in
response to non-compliance, while 14 said no and 70 did not respond.
Respondents wanted to be assured that we would not use the escalator in a
numerical order.
Some respondents requested we provide time frames between the different
enforcement steps.
Several respondents asked that the enforcement escalator be presented in a
more user friendly format.
Our response
We now refer to the enforcement escalator as the regulatory response
escalator.
As all enforcement actions are individual to the risk and impact on people who
use services it would be disproportionate to be prescriptive when using the
regulatory response escalator. CQC has the discretion to take appropriate
action dependent on the risk and circumstances presented in line with the
better regulation principles of proportionality.
Fixed timeframes for each step have not been included as the timeframe is
dependent on the issue and the change needed to achieve compliance. Each
regulatory action is individual to the risk and situation and is judged
accordingly within the judgement framework and enforcement policy.
We have made the regulatory response escalator clearer in both the
judgement framework and the enforcement policy by using a simplified
diagrammatical format.
Regulatory Impact Assessment
12. Does the regulatory impact assessment accurately
represent the impact of implementing the guidance to
providers of regulated activities and others?
13. Does the regulatory impact assessment accurately reflect
all the benefits associated with implementing this
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guidance for providers of regulated activities and people
who use services?
What people said
Overall, most respondents that answered the first question (62), agreed the
impact assessment accurately represents the impact and benefits of
implementing the guidance for both services and people who use services, 25
respondents said no and 87 did not answer.
Many of the comments from those that disagreed often included opinions
concerning regulatory and policy issues that lie outside the scope of either the
impact assessment or the consultation. In general, it can be observed that
whilst 25 respondents disagree with the impact assessment they often do so
for very different reasons.
On the second question 66 respondents agreed, 24 said no and 84 did not
answer.
Of those respondents that agreed with the impact assessment, many
commented that the description of the anticipated impact and benefits,
especially on services, reflected their own assessment of the likely
consequences of implementing the changes. A few key stakeholders queried
the estimates of costs and the percentage of providers (9%) who will be
affected by the new judgement framework.
Our response
It is recognised and acknowledged that these estimates represent the best
available estimates at this stage and that these might change during and after
implementation.
These estimates are based on our current use of improvement actions which
can be set when:
a) a provider is compliant and our judgement is that they need to make
improvements to maintain compliance or
b) a provider is not compliant but the concern is minor and we have
confidence that they can make the necessary improvements
Therefore some providers will remain compliant under the new model as they
will have made the changes to remain compliant. Some providers will have
needed to make changes to become compliant, and if they have not made
those changes they would be non-compliant under the new model.
In line with best practice, CQC has indicated that it will carry out a post
implementation review of the new regulatory model within two years of its start
date.
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Equality Impact Assessment
14. Are there any proposals contained in the Judgement
framework or Enforcement policy that might have an
adverse impact on race, disability, gender (including
gender reassignment), sexual orientation, religion or
belief, or age equality for you or for people who use
services?
Of the 174 responses, 12 felt there might be an adverse impact on race, 18
on disability, 11 on gender, 11 on sexual orientation, 13 on religion or belief
and 15 on age equality
What people said
Some respondents were concerned about the expertise inspectors have
across the different sectors and in recognising equality, diversity and human
rights (EDHR) issues. Concern was raised about how we involve service
users; give weight to their views and the skills of inspectors to communicate
with service users with communication difficulties or challenging behaviour.
Some concern was also raised about focusing on non-compliance and that
the removal of improvement actions, meant ‘direction of travel’ would not be
shown and this could damage the ability for people to make choices. This has
been highlighted and discussed in the relevant section of this response
document.
It was also noted that the equality and human rights impact assessments
(EHRIAs) did not include the protected grounds of pregnancy and maternity or
marriage and civil partnership nor did it include an analysis of the specific
issues for different protected groups to help inform judgements. Feedback
was also received about progress on the areas that we want to explore
(identified in the EHRIA).
Our response
To support inspectors there is EDHR guidance and case studies available on
our website that provide real-life examples to benchmark against. CQC staff
also undertake equality and diversity training.
Our approach is outcome focused and places the views and experiences of
people who use services at its centre. The vast majority of our time on an
inspection is spent observing care, talking to users (individually or in groups),
relatives and staff with a minimal amount of time checking records, this
enables us to focus on outcomes and whether or not quality, safe care is
being delivered. Guidance is available for inspectors about accessible
communication, including the ‘Short Observational Framework for Inspection
2’ (SOFI 2) which enables us to assess the experience of people with
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dementia and more complex learning disabilities. Our guidance recommends
that we speak with people with different needs including people from minority
groups; the Equality Voice network helps us consider our approach more
broadly. When necessary, inspectors can use translation services and
encourage the use of third parties to translate and mediate with users of
services. Our Acting Together project (details are available on our website)
enables us to involve people who have experience of using health or social
care services in our inspections. Feedback is triangulated with evidence
gathered during our inspection. The Judgement framework promotes
consistency in judgement; it is not a substitute for the professional judgement
of our staff, and we have ensured that the Guidance about Compliance has
equality, diversity and human rights issues included throughout, this is
because they are an intrinsic element of quality, safe care, not an add on.
We have updated the EHRIAs to include all protected characteristics.
Inspectors would use the judgement framework to inform their specific
judgements, the case studies and also use the equality, diversity and human
rights (EDHR) guidance to highlight what they should be looking for in relation
to EDHR issues, therefore an analysis of the specific issues for different
protected groups has not been included in the EHRIA. Due to the services
that we regulate any change in the way that we regulate is likely to have a
greater impact on disabled people and older people. However these changes
are intended to have a positive impact on ensuring providers meet essential
standards and so we believe that they will have a positive impact on these
groups. Our evaluation of Equality in reviews of compliance currently under
way, may pick up more specific impacts across any protected characteristic,
for example, in relation to where we currently tend to use improvement
actions. Action planning to address any necessary changes to methodology
will flow from this evaluation. The outcome of the review will inform ways that
we can monitor and enhance quality assurance in relation to EDHR.
Our enforcement policy has been amended to make it clear that we will take
account of any ethnic or cultural requirements of individuals when initiating
regulatory action.
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Appendix 1: Organisations that responded
Name of organisations that responded
Ashford and St Peter’s NHS Foundation Trust
Abbeyfield Society
Age UK
Airedale NHS FT
Alzheimer’s Society
Asian Disability Association
Athena care
Avon and Wiltshire Mental Health Partnership NHS Trust
Barnet Learning disability Partnership Board
BCHA
Bexley Council
Binoh of Manchester
Birmingham and Solihull Mental Health NHS Foundation Trust
Birmingham Community Healthcare NHS Trust
Bradford Association of Visually Impaired People
Bradford Teaching Hospitals NHS Foundation Trust
Brent Advocacy Concerns
British Association of Visually Impaired People (BAVIP)
British Dental Association
British Medical Association (BMA)
BUPA
Calderdale MBC
Camden and Islington NHS Foundation Trust
Care Management Group
Central and North West London NHS Foundation Trust
Centre for Public Innovation
Choice Support
Christian Science Committee on Publication
City Hospitals Sunderland NHS Foundation Trust
CLS Care Services
Colchester Hospital University NHS Foundation Trust
Coventry and Warwickshire NHS Partnership Trust
Coventry City Council
Coverage Care Services
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Name of organisations that responded
Care Quality Commission
Crossroads Care Association
Cumbria Partnership NHS Foundation Trust
Department of Health
Derbyshire Healthcare
Derbyshire Healthcare NHS Foundation Trust
Devon County Council
Dimensions
Dorset County Council
Durham County Council
English Community Care Association
Equality and Human Rights Commission
eQuality Voices
Foundation Trust Network
General Medical Clinics
Gloucestershire Hospitals NHS Foundation Trust
Greensleeves Homes Trust
Hampshire County Council
Harrow Association of Somali Voluntary Organisations
Health and Safety Executive
Healthcare Landscape Solutions Ltd
Henford Nursing home, Yeovil Somerset, Aurora Ltd
Heredfordshire Public services
Heritage Care
Hertfordshire Partnership NHS Foundation Trust
HL Consultancy
Hopscotch Asian Women's Centre
Independent Healthcare Advisory Services (IHAS)
Jan-Net Ltd
Joseph Rowntree Housing Trust
Kisimul Group Ltd
Lancashire Care Association
Langton Care Ltd
Leeds City Council
Leicester City Council
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Name of organisations that responded
Leicester City Council
Leonard Cheshire Disability
Living Options Devon
Luton and Dunstable Hospital NHS Foundation Trust
Margaret House
Mencap
Metropolitan Support Trust
Midland Heart Limited
Monitor
National Care Forum (NCF)
Netherwood
Newcastle City Council
NHS Bedfordshire and Luton
NHS Confederation
NHS Sussex
NHS Wakefield District
Norfolk and Waveney Mental Health NHS Foundation Trust
Northumberland, Tyne and Wear NHS Foundation Trust
Northwood
Nursing and Midwifery Council
Outlook care
Oxfordshire PCT
Oxfordshire User Team
Parliamentary & Health Service Ombudsman
Priory
Queen Victoria Hospital NHS FT
RCPA
Registered Nursing Home Association
Rochdale Metropolitan Borough Council
Royal College of Nursing
Royal College of Radiologists
Section 12 Office, East Midlands and Yorkshire and the Humber
self advocacy group for adults with a learning disability within The London
Borough of Redbridge
Sense
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Name of organisations that responded
South Essex Partnership University NHS Foundation Trust (SEPT)
Sheffield Teaching Hospitals NHS Trust
South Staffordshire and Shropshire Healthcare NHS FT
South Western Ambulance Service NHS Foundation Trust
Stonewall
Sue Ryder
Surrey County Council
Sussex Community NHST
Sustainable Development Unit
The Association of Directors of Adult Social Services (ADASS)
The Association of National Specialist Colleges
The British Psychological Society
The Challenging Behaviour Foundation
The Daffodil Advocacy Project
The Disabilities Trust, including the Brain Injury Rehabilitation Trust
The Fremantle Trust
the Patients Association
The Royal Masonic Benevolent Institution (RMBI)
Turning Point
United Kingdom Accreditation Service (UKAS)
United Kingdom Homecare Association (UKHCA)
University Hospitals Bristol NHS Foundation Trust
VODG (Voluntary Organisations Disability Group)
Walton Centre NHS FT
Wenham Holt Nursing Home ltd
West Sussex County Council
Wolverhampton City PCT
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