Paper No: / 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.
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.
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.
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 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.
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.