Agenda
Paper No:
9
CM/01/12/08
Annex B
OUR REGULATORY MODEL EXPLAINED
Introduction
This paper is designed to provide a description and explanation of how the CQC regulates
Health and Social Care in England. It is designed to be viewed alongside the CQC’s
Business Plan for 2012/13. It does not include all the detail of our regulatory model. This
information can be found in various documents on the CQC’s website, including the
following:



The Scope of Registration – December 2011
Guidance about Compliance – Essential Standards of Quality and Safety – March
2010
Guidance about compliance – Judgement Framework – March 2010.
Our approach is outcome focussed and it places the views and experiences of people who
use services at the centre of regulation. We achieve this in a number of ways, including:

The continual monitoring of activities undertaken by providers

An emphasis on seeing, hearing, observing and describing services through a
number of methods, including regular, timely inspection

Considering the views and experience of people who use services in the decisions
that we take

The use of information and intelligence to inform our decisions and judgements

We take timely action to identify and address poor practice. We use our
enforcement powers proportionately
What does CQC regulate
We derive our principal powers to regulate from the Health and Social Act 2008 and the
regulations made under the Act. We do this through a system which hinges on a number
of regulated activities, the registration of particular types of providers in various sectors of
the market, and identifying where services are provided. The legislation makes it an
offence to provide these activities to members of the public without being registered with
the CQC.
Regulated Activities
The CQC organises its regulatory system around specific Regulated Activities. These are
specified in the regulations and relate to 15 activities that providers must register for in
order to provide services. These services are outlined in The Scope of Registration –
2011. Activities that are subject to regulation range from Personal Care to the Treatment of
Disease Injury and Disorder.
Page 1 of 8
Agenda
Paper No:
9
CM/01/12/08
Annex B
The sectors of the market that we regulate
Providers in the health and social care sector who are subject to CQC regulation include:

Social Care Providers (such as care homes, nursing homes, and domiciliary care
agencies). This is the largest area of regulation by volume.

NHS providers (including hospitals, NHS Trusts and Foundation Trusts, community
services etc).

Independent Health Care providers and hospitals.

Private GPs

Dentists

Out of Hours GPs and GPs providing services to NHS patients will be brought into
registration by March 2013.
Where health and social care happens - Providers and locations
Providers must register each location in which they carry out regulated activities. This
ensures that the CQC and the public are clear where and when regulated activities are
taking place, rather than a provider who runs multiple services simply registering all
services from an office or headquarters address. This is important as one of the principal
ways we monitor compliance is by going out and looking at services for ourselves.
How does the CQC regulate
The CQC continually monitors the quality of provider services. Key to this is the work of
the Registration Assessors, who assess whether or not providers should be registered to
provide services, and the compliance inspectors who monitor the ongoing quality of
services once services have been brought into the scope of registration.
We use a number of methods for gathering, analysing and understanding information,
which helps us to identify the risks of poor care.
We operate a generic model which provides a single system of regulation. The regulations
provide the legal basis for what is regulated and how. These give rise to a set of Essential
Standards which represent a way to help providers and the public understand how
compliance can be achieved.
Of the 21 outcomes, 16 are specifically related to the safety and quality or services. The
outcomes are expressed in clear and easily understood language and they focus on what
people who use services should expect from providers. They are written to focus on safety
and quality in a way that can be applied to all providers and organisations, irrespective of
sector or specialty.
Page 2 of 8
Agenda
Paper No:
9
CM/01/12/08
Annex B
Additional powers and responsibilities
In addition to our core regulatory functions, the CQC also has responsibilities for the
visiting, monitoring and reporting of the conditions of the assessment and treatment of
patients detained under the Mental Health Acts. These are described in Section 120 of the
Mental Health Act 1983.
The four key functions
The way we deliver our regulation of health and social care is to use four key functions.
These are:




Registration
Monitoring and compliance checking
Enforcement
Publication
Registration
Service providers apply to register with the CQC for the provision of regulated activities in
one or more location. Within this process the provider is asked to state whether or not they
are compliant with all the Essential Standards.
These applications are initially scrutinised by the registrations team at the CQC’s National
Customer Service Centre. The CQC considers each application on the basis of risk. This
may differ according to specific issues related to the provider or to risks within particular
sectors. The regulations require the CQC to make its own judgement as to whether or not
the provider should be registered. The CQC considers all the information in the
application. If there is intelligence or co-lateral information which calls this into question, if
the provider did not meet all the requirements for registration, or if the provider declared
that they were not fully compliant with the Essential Standards or regulations, then a
Registration Assessor would perform a detailed assessment before making a judgement.
The registration assessors are a national team, but they are regionally based and work
closely with compliance colleagues. They are experts in the field of registration, and what
is required of providers.
The Registration Assessor can either agree that the provider should be registered, they
can reject the application, or they can recommend registration but with specific conditions
that have to be met or certain restrictions to regulated activities.
In some cases a decision will be taken to eliminate risk to those using services at the point
of registration. For others, the judgement may be to manage risk as part of the compliance
process. In order to do this the risk may be better managed within registration.
Monitoring and Compliance Checking
The process of monitoring compliance, risk and quality in order to continue to meet the
Essential Standards and regulations is constant and ongoing. The Compliance Inspector
has the responsibility for this ongoing monitoring. They have a variety of ways of checking
compliance, including the use of inspection.
Page 3 of 8
Agenda
Paper No:
9
CM/01/12/08
Annex B
Each Compliance Inspector has a designated portfolio of providers and this will usually be
a mixed group across the sectors.
There are two principles available to us that help our ongoing monitoring. We use the
information and intelligence. In both the planning of compliance monitoring and responding
to more immediate concerns that might arise at any time, the CQC gathers information
from a number of sources. These include:

A suite of information contained with an intelligence based system called the
Quality and Risk Profile (QRP). This processes large amounts of data from
numerous sources (from individual concerns to national gathered
comparative information sources such as minimum data sets, Dr Foster
mortality information etc).We do not make a judgement about this
information. Rather inspectors take this into account when making their
decisions. This information is routinely shared with the provider themselves
in order to develop a common understanding of risk, safety and compliance.

The Outliers Programme. Mortality and other information which lies outside of usual
parameters is scrutinised and influences our reviews of compliance of particular
providers.

Local information – Compliance Inspectors use information from local organisations
to understand how well providers are doing in terms of risk, safety and compliance.
Information specifically comes from Local Involvement Networks (LINks), the
Overview and Scrutiny Committees of Local Authorities, concerns from
commissioners and Strategic Health Authorities, service user groups and their
representatives, the Governors of Foundation Trusts, and other local bodies with
an interest in health and social care.

Thematic Reviews – The CQC conducts a number of reviews on specific subjects.
These might relate to areas such as pressure areas, midwifery services, or delayed
discharges. This information is reviewed and analysed as a central function of the
CQC. The results of these reviews identify providers where there might be specific
problems these results help drive our programme of inspections.

Mental Health Act Commissioners – As part of the CQC’s functions related to the
Mental Health Act, Commissioners regularly and routinely visit hospitals that are
able to detain people under this legislation. Where the Commissioner identifies a
matter which might relate to compliance with the Essential Standards, this
information is conveyed to the relevant compliance inspector.
All of this information assists the Compliance Inspector, in conjunction with their
Compliance Manager, in making decisions on how to respond to risk and concerns. This is
in line with the Hampton Principles of Better Regulation, which advocates a risk based
approach and a proportionate response based on directing regulatory activity where it is
most required, and applying a “lighter touch” where it is not.
The review of risk, intelligence and information is only part of the picture when it comes to
our monitoring of compliance. We have found that inspection also provides a useful way of
assessing compliance. In particular we have found that there is no substitute for an
inspector looking at those services, talking to people who receive services and the staff
that provide these services. This is not a “paper work” based system, designed for
Page 4 of 8
Agenda
Paper No:
9
CM/01/12/08
Annex B
providers to demonstrate evidence of compliance, but is more reliable in allowing a skilled
and experienced inspector to observe care and describe what they see. Where they have
concerns in particular areas then they can. Investigate in more detail.
We visit locations frequently because we understand that this is a necessary component of
both:

Addressing poor care from a provider quickly and effectively, and

Acting as a deterrent. Our experience shows that where providers know that they
will be inspecting frequently this means that they are more likely to ensure that
standards are maintained. This experience is borne out by the research in this area.
We consider these to be the ways we can have the most impact on ensuring that services
meet the Essential Standards.
We intend to visit most Health and Social care providers at least annually. This includes
NHS and private hospitals and care homes. We aim to visit dentists and general
practitioners at least once every two years.
The CQC recently piloted some revised methods on how to provide the most efficient and
effective way of looking at services. As we have said, each compliance inspector is
responsible for the scrutiny and review of all 16 Essential Standards. When they visit each
inspector will examine in greater detail a minimum of five essential standards. There is no
maximum number and so they may make a judgement to inspect all 16. The minimum five
are drawn from different aspect of the Standards, and will always include Outcome 4 which
relates to the “Care and Welfare of People who use services”. The reason for this is that
this particular standard relates to many key aspects of quality, safety and risk.
Our piloting of the methodology has shown that it is better to allow inspectors the
discretion to inspect along whichever Essential Standard they feel is most appropriate
given the information they have available when planning their inspections. When they are
on site and their direct observation leads them to look at specific areas which bear greater
scrutiny, they need the freedom to pursue whichever line of enquiry which seems
appropriate to them.
Inspectors are encouraged, not only to look at areas of non compliance but also to
“describe what they see”, in order to give a broad balanced picture of how a provider is
meeting the essential standards.
On occasions where inspectors need to assess and describe regulated activities in even
greater detail then they can use bespoke methods of observing practice, such as
observing meal times, or the use of SOFI 2 (a specific methodology for observing the care
of people with dementia, which has been developed using the principles of Dementia Care
Mapping).
We have found that the three processes of i. ongoing scrutiny and review, ii.
understanding intelligence information, and iii. directly observing services and more in
depth enquiry through talking to those who both use services and work in them, are the
most effective ways of ensuring the compliance of providers and quality and safety for the
public.
Page 5 of 8
Agenda
Paper No:
9
CM/01/12/08
Annex B
We have three main forms of inspection available to us:

Planned compliance inspections, which are scheduled as part of the ongoing review
of compliance

Responsive Reviews, where compliance inspectors can go in, often at short notice,
and inspect because of a specific and immediate concern

Thematic Inspections. These are inspections on particular themes, such as Dignity
and Nutrition, Learning Disabilities Services or Domiciliary Care. As well as
providing an in depth review of at least five Essential Standards, these inspections
have an element of the Essential Standards that remains constant for all
inspections. Inspections take place across a sample of providers in a particular
sector. This enables us to both look at the compliance of the particular provider as
well as giving us a view across the sector of thematic issues.
We use one or all of these inspection methods to contribute to our annual or twice yearly
schedule of inspections.
If inspections use a generic model, how do you deal with specialist areas.
This is addressed in two ways. First it is right to say that most inspections are conducted
using a generic model. This was a deliberate policy choice at the inception of the CQC to
ensure that issues of compliance, risk and safety could be easily understood across all
care areas and are readily understandable to the public.
However, there are certain areas where the CQC conducts specialist inspections. These
include the visiting of patients detained under the Mental Health Act, pharmacy
inspections, inspections relating to specific regulations on ionising radiation, joint
inspections relating to children, and inspections of Defence Medical Services.
The second use of specialist advice relates to our generic compliance inspections. The
Essential Standards are sufficiently broad in their approach to enable a generic
compliance inspector to undertake an inspection in most area of health and social care.
The inspector is supported by a range of guidance notes and training materials on the
different sectors and methodologies. There are occasions where more specialist clinical
and social care professional advice and involvement is necessary. On these occasions the
CQC’s National Professional Advisors are available for this purpose and if necessary they
will accompany the inspector on an inspection. To strengthen this approach a bank of
clinical and professional associates is being developed on a regional basis.
Professional Experts are routinely involved as part of our themed inspections. An example
of this is the involvement of senior nurses as part of the Dignity and Nutrition Inspections.
How does the CQC use the expertise of people who use services when checking
compliance ?
As well as using what people tell us about services in deciding where and how to target
our regulatory activity, the CQC uses the expertise of people who use services in our
inspections.
Page 6 of 8
Agenda
Paper No:
9
CM/01/12/08
Annex B
They are known as “Experts by Experience”. Our experts by experience are trained and
supported to accompany our compliance inspectors. These experts have a range of
experiences and knowledge. We ensure that Experts by Experience are used in all types
of our inspections. We have found their involvement in themed inspections particularly
useful. They support CQC in developing its inspection methods to ensure that we take into
account the views and experiences of people who use services. In Mental Health Act
Commissioner visits there is a programme joint inspections with people who have
experience of using services. These are known as “Acting Together” visits.
Enforcement
The CQC, unlike its predecessor commissions has a variety of enforcement actions,
statutory powers and if necessary, sanctions available to it where providers are found to
not be complying with the Essential Standards and the regulations that underpin them. We
share information with those who commission services and with other with responsibility
for ensuring quality and safety in health and social care systems (such as other
regulators).
We have the ability to set compliance actions where a provider is not compliant, but we
consider that services are not affected to the degree of being unsafe. We monitor the
implementation of a provider’s action plan. If we consider that the provider has returned to
be compliant with the Essential Standards and the regulations we will take no further
action. If the provider remains non-compliant we will consider further action. We have the
ability to escalate our actions where necessary.
If the breach of the regulation is more serious, or there are several or continual breaches,
we have a range of actions we can take using the civil and criminal procedures contained
in the Health and Social care Act 2008 and the relevant regulations. These enforcement
actions include:



Issuing a Warning Notice,
Restricting or suspending the services a provider can offer, or the number of people
it can care for,
Issuing fines and formal cautions in lieu of prosecution,
and, in more extreme cases:


Cancelling a provider or managers registration
Prosecuting a provider of manager.
When we exercise these powers we do so in a proportionate way, considering the effect
on the public and those who use services. This suite of powers enable us to take swift,
targeted action where services are failing people who use them.
Publication
We consider the timely and up to date reporting and publication of information as a vital
part of our regulatory activity. It is of paramount importance to the public and those who
use services which we regulate that they have access to relevant information about
providers.
We will inform the public about our regulatory work by:
Page 7 of 8
Agenda
Paper No:
9
CM/01/12/08
Annex B

Publishing information about our regulatory judgements, the evidence that supports
them and the regulatory action taken

Publishing the Provider Profile on our website, in order to give a balanced picture of
each provider’s compliance

Whenever we inspect, we publish a report as quickly as possible

Detailing what the inspector observed and heard during the inspection, including
what the users of services told us

Updating information about providers in order to keep the public informed and to
hold providers to account.
As well as publishing information about our regulatory judgements related to specific
providers, we also publish wider information including:

The guidance and documents we use in making our regulatory judgements, so that
the public and providers are clear about the criteria we use in making our
judgements, and these are known about in advance of any regulatory monitoring or
inspection. We think this is an important element of our transparency as a regulator.
In effect there should be “no surprises” in terms of the criteria we use in reaching
our regulatory judgments

Broader thematic reports which arise from thematic inspections

Information on the use of the Mental Health Act in the form of an Annual Report

Information on the use of Deprivation of Liberty Safeguards in the form of an Annual
Report

Our report to Parliament describing the State of Health Care and Adult Social Care
Services in England (often known as the State of Care report).
Page 8 of 8