Consultation outcome

Post-implementation review of regulations relating to the Care Quality Commission

Updated 13 July 2023

Applies to England

Introduction

The Department of Health and Social Care (DHSC) is conducting a post-implementation review of 3 sets of regulations made in exercise of powers under the Health and Social Care Act 2008 to determine:

• whether all 3 regulations meet their original objectives
• whether their scope is still appropriate and proportionate
• their impact on providers
• whether any changes are required to achieve those objectives with a system that imposes less regulation or to change what the regulations prescribe

These regulations are:

• Care Quality Commission (Registration) Regulations 2009
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
• Care Quality Commission (Reviews and Performance Assessments) Regulations 2018

As part of this review, we are seeking feedback from all providers of a regulated activity that are registered with the Care Quality Commission (CQC) in England, including:

• NHS bodies
• adult social care providers
• independent providers, including independent contractors providing NHS services
• voluntary sector organisations

To submit feedback please complete the online survey by 22 July 2022.

We are asking individual locations registered with the CQC to submit a response. Please coordinate with relevant team members within your organisation, including the individual who acts as your registered manager (where this role exists) with the CQC, and finance lead to submit one response per registration.

All feedback received will be summarised and published in a post-implementation review report. The published report will have full regard for the anonymity of all respondents.

Note, all questions are optional. Please answer as many questions as you can to the best of your knowledge, providing estimates where necessary.

Section 1: Care Quality Commission (Registration) Regulations 2009

The Care Quality Commission (Registration) Regulations 2009 (‘the 2009 Regulations’) requires all providers of regulated activities to register with the CQC. Regulated activities are defined in section 8 of the Health and Social Care Act 2008 and the list of regulated activities is specified in Schedule 1 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

The policy objective of the 2009 Regulations was to achieve the integration and alignment of health and adult social care regulation across all types of providers – whether public, private or third sector. This is to ensure, for example, that the NHS, private and voluntary healthcare sectors are subject to common regulatory procedures and standards. The 2009 Regulations:

• enable the CQC to set and maintain registration requirements
• enable the CQC to directly collect information from providers about the services they provide
• ensure providers of regulated activities meet these registration requirements to become and remain registered with the CQC
• set out provisions in relation to compliance with the regulations and offences
• contain provisions for providers to notify the CQC of certain incidents

Question

Do you agree or disagree that the 2009 Regulations meet their original objectives?

• strongly agree
• agree
• disagree
• strongly disagree

Please explain your answer.

Question

Do you agree or disagree that the 2009 Regulations are appropriate in carrying out their objectives?

• strongly agree
• agree
• disagree
• strongly disagree

Please explain your answer.

Question

Do you agree or disagree that the 2009 Regulations are proportionate in carrying out their objectives?

• strongly agree
• agree
• disagree
• strongly disagree

Please explain your answer.

Section 2: Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

The Health and Social Care Act 2008 requires all providers who carry out ‘regulated activities’ in England to register with the CQC and to comply with the requirements set out in regulations made under that act.

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (‘the 2014 Regulations’) are made in exercise of powers under the Health and Social Care Act 2008. The 2014 Regulations set out the regulated activities in Schedule 1 and the fundamental standards that all registered providers must comply with.

Overarching objectives

The 2014 Regulations prescribe the activities that providers should register with the CQC and set fundamental standards, below which care should not fall. We would like your feedback to understand whether the 2014 Regulations meet their objectives in ensuring that they require all health and/or adult social care providers that present a risk to the safety of patients or service users to be registered and help to maintain fundamental standards.

Question

To the best of your knowledge, are the 2014 Regulations proportionate by regulating only activities, services and providers where there is a risk to the safety of patients and/or service users?

• yes
• no (please explain)
• don’t know

If no, please explain your answer.

Question

Are there activities not currently defined as ‘regulated activities’ in the 2014 Regulations where there is a possible risk to patient safety or service users?

• yes
• no
• don’t know

Please explain your answer.

Question

In your experience, are different providers (for example, NHS, adult social care, independent providers, and voluntary sector healthcare providers) treated fairly and equally by the CQC under the 2014 Regulations?

• yes
• no
• cannot answer – no relevant experience

Please explain your answer.

Question

In your experience, are providers treated fairly and equally by the CQC under the 2014 Regulations across settings (for example, acute hospital, community care, mental health and primary care)?

• yes
• no
• cannot answer – no relevant experience

Please explain your answer.

Question

Have the 2014 Regulations encouraged improvement in quality and safety in the service you provide?

• yes
• no
• don’t know

Please explain your answer.

The fundamental standards

The 2014 Regulations set out the statutory minimum standards, below which care must never fall. We would like your feedback on the Fundamental Standards.

They cover person-centred care, dignity and respect, consent, safe care and treatment, safeguarding from abuse and improper treatment, meeting nutritional and hydration needs, premises and equipment, receiving and acting on complaints, good governance, staffing, fit and proper persons, duty of candour, and display of performance assessments.

Question

Do you agree or disagree that the 2014 Regulations clearly set out the outcomes of the Fundamental Standards providers of regulated activities are expected to meet and/or avoid?

• strongly agree
• agree
• disagree
• strongly disagree

Please explain your answer.

Question

Do you think anything is missing from the 2014 Regulations that could help providers of regulated activities improve quality and safety?

• Yes
• No

If you answered yes to the above question, please provide some detail about the reason for your answer.

Please explain your answer.

Question

Do you agree or disagree that the CQC’s guidance for complying with the Fundamental Standards is clear and easy to follow?

• strongly agree
• agree
• disagree
• strongly disagree

Please explain your answer.

Duty of candour

We would like your feedback on a specific aspect of the Fundamental Standards, called the duty of candour (Regulation 20).

The duty of candour places a legal duty on all health and/or social care providers to be open and transparent with people using services in relation to their treatment and care. It also sets out some specific actions that providers must take when a notifiable safety incident occurs. These include:

• informing the relevant person affected about the incident
• providing reasonable support
• providing an account that is, to the best of their knowledge, true of all the facts known
• an apology
• a written record that is kept secure

Question

Do you agree or disagree that it is straightforward to identify whether something qualifies as a notifiable safety incident?

• strongly agree
• agree
• disagree
• strongly disagree

Please explain your answer.

Question

Do you agree or disagree that it is clear from the 2014 Regulations what we must do if a notifiable safety incident is identified?

• strongly agree
• agree
• disagree (please explain)
• strongly disagree (please explain)

Please explain your answer.

Question

Do you agree or disagree that the duty of candour requirement has helped us ensure people receiving care receive a proper apology (an expression of sorrow or regret) when things go wrong?

• strongly agree
• agree
• disagree
• strongly disagree

Please explain your answer.

Fit and proper person requirement for directors

We would like your feedback on the fit and proper person requirement for directors.

This ensures that providers take the necessary steps to ensure that all directors are appropriate and fit for their role.

Question

Do you agree or disagree that the fit and proper person requirement has helped your organisation take appropriate steps to ensure your directors are fit and proper for their role?

• strongly agree
• agree
• disagree
• strongly disagree

Please explain your answer.

Section 3: Care Quality Commission (Reviews and Performance Assessments) Regulations 2018

The Care Quality Commission (Reviews and Performance Assessments) Regulations 2018

The CQC began ratings of providers in October 2014. However, it was limited to specific settings to allow time for the CQC to build capacity. Subsequently, we consulted on proposals to expand the scope of the CQC’s duty to extend performance assessments and ratings to a variety of additional providers, including many of the independent sector providers, who carry out regulated activities.

While considering changes to the ratings regime, DHSC and the CQC concluded that it would be beneficial to broaden the scope of the CQC’s ratings regulations so that, with some exceptions, all providers of regulated activities are rated. The small number of providers who are excluded from ratings are, however, subject to the fundamental standards of care and to inspections. The reasons for exclusion are:

• the number of providers is so small that ratings would not contribute to consumer choice
• the service providers are already regulated by other agencies so a CQC rating could confuse the public
• the sector is relatively low risk and is inspected by the CQC too infrequently to make a rating meaningful

Providers that were excluded from ratings are primary dental care, minor cosmetic surgery services, national screening programmes, health and justice services, hyperbaric chambers, blood and transplant services, services licensed by the Human Fertilisation and Embryology Authority and independent pathology laboratories, independent podiatry services and children’s homes undertaking regulated activities.

Question

Do you agree or disagree that the above mentioned providers should not be included in the CQC’s ratings regime?

• strongly agree
• agree
• disagree
• strongly disagree

Please explain your answer.

Section 4: Resource needed to comply with the Care Quality Commission (Registration) Regulations 2009

The Care Quality Commission (Registration) Regulations 2009

Questions in this section will be used to help us understand what level of resources are required to comply with 3 aspects of the regulations:

1. registration with the CQC
2. completing provider information returns
3. facilitating inspections

The answers should only relate to the individual location registered with the CQC. Please do not include any information on your wider group or parent organisation, if you belong to one.

Question

How many people does your organisation currently employ?

We are looking for the number of full-time equivalent (FTE) staff in the organisation covered by your CQC registration.

• less than 10 people
• between 10 and 49 people
• between 50 and 249 people
• 250 people or more

Registration with the CQC

We would like to collect information on the average cost of completing a CQC registration to ensure the process is not too burdensome for providers.

Question

Who worked on your organisation’s original application to register with the CQC?

Please include job titles, full time (gross) annual salary and estimated hours each individual spent on your initial application.

Question

Has your organisation updated any aspect of its registration since it was first registered (for example, to register a new location that was opened)?

• yes
• no
• don’t know

Please explain your answer.

Question

Please provide information on who worked on your organisation’s most recent registration update with the CQC.

Please include job titles, full time (gross) annual salary and estimated hours each individual spent on most recent registration update.

Question

Are the registration requirements for health and social care providers clear?

• yes
• no

Please explain your answer.

Question

Is the regulatory burden placed on your organisation by the 2009 Regulations as low as possible?

• yes
• no

Please explain your answer.

Provider information returns

The CQC asks for information about the services you provide each year, including any changes that have been made and how your organisation ensures the service is safe, effective, caring, responsive and well-led. This is known as a provider information return (PIR).

Question

Who worked on your organisation’s most recent provider information return?

Please include job titles, full time (gross) annual salary and estimated hours each individual spent on this PIR or assessment.

Inspections

In response to the COVID-19 pandemic, the CQC carried out remote inspections to lessen the burden on providers and has subsequently changed the way it carries out inspections by taking a more intelligence-led and risk-based approach. As a result, we are aware that some providers may not have had an on-site inspection for at least 2 years.

The following questions relate to the pre-COVID-19 pandemic inspection regime based on routine programme of on-site inspections. Where these questions ask you to think about your most recent inspection, please answer with reference to your most recent on-site inspection.

Question

Do you agree or disagree that DHSC understands that the work you do, when an inspection occurs, can be broken down into 3 phases: preparation for an inspection, facilitating the inspection, and the post-inspection follow-up work?

• agree
• disagree

Please explain your answer.

Question

Thinking about your most recent on-site inspection, who carried out any preparatory work required in your organisation?

Please include job titles, full time (gross) annual salary and estimated hours each individual spent on inspection preparation.

Question

Thinking about your most recent on-site inspection, who was involved in facilitating the inspection in your organisation?

Please include job titles, full time (gross) annual salary and estimated hours each individual spent on facilitating inspection.

Question

Thinking about your most recent on-site inspection, who was involved in any post-inspection follow up work in your organisation?

Please include job titles, full time (gross) annual salary and estimated hours each individual spent on post inspection follow up work.

Data protection

Data controller

The Department of Health and Social Care (DHSC) is the data controller.

What personal data we collect

We collect and process the following personal data:

• whether you are responding as an individual or on behalf of an organisation and information about your area of work or your organisation where appropriate
• (if responding online) your internet protocol (IP) address (this is for security purposes and will not be attached to your survey response)

If volunteered:

• your email address or your organisational email address (if confirming DHSC can contact you about your response)
• any other personal data you volunteer by way of evidence or example in your response to open-ended questions in the survey

How we use your data (purposes)

Your data will be treated in the strictest of confidence.

We collect your personal data as part of the call for evidence process:

• for statistical purposes, for example, to understand how representative the results are and whether views and experiences vary across demographics
• so that DHSC can contact you for further information about your response

A summary of the responses to this consultation will be published in a post-implementation review report. Responses will be aggregated, summarised, and anonymised prior to publication to ensure that data relating to your specific organisation will not be identifiable in our report.

Legal basis for processing personal data

Under Article 6 of the United Kingdom General Data Protection Regulation (UK GDPR), the lawful basis we rely on for processing this information is Article 6(1)(a): ‘Your consent’; Article 6(1)(e): ‘Necessary task in the public interest or controller’s official authority’.

Data Processors and other recipients of personal data

All responses to the call for evidence will be seen by:

• professional analysts and policy leads working on the Care Quality Commission regulations made under the Health and Social Care Act 2008 (or overlapping areas) in DHSC
• DHSC’s third-party supplier (SocialOptic), who is responsible for running and hosting the online survey

International data transfers and storage location(s)

Storage of data by DHSC is provided via secure computing infrastructure on servers located in the European Economic Area (EEA). Our platforms are subject to extensive security protections and encryption measures.

Retention and disposal policy

DHSC will only retain your personal data for as long as either:

• it is needed for the purposes of the call for evidence
• the law requires us to

This means that personal data will be held by DHSC for a minimum of 1 year and a maximum of 8 years.

Data retention will be reviewed on an annual basis. Anonymised data will be kept indefinitely.

How we keep your data secure

DHSC use appropriate technical, organisational and administrative security measures to protect any information we hold in our records from loss, misuse, unauthorised access, disclosure, alteration and destruction. We have written procedures and policies which are regularly audited and reviewed at a senior level.

SocialOptic is Cyber Essentials certified.

Your rights as a data subject

By law, data subjects have a number of rights and this processing does not take away or reduce these rights under the EU General Data Protection Regulation (2016/679) and the UK Data Protection Act 2018 applies.

These rights are:

1. the right to get copies of information – individuals have the right to ask for a copy of any information about them that is used

2. the right to get information corrected – individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected

3. the right to limit how the information is used – individuals have the right to ask for any of the information held about them to be restricted, for example, if they think inaccurate information is being used

4. the right to object to the information being used – individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case

5. the right to get information deleted – this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case

Comments or complaints

Anyone unhappy or wishing to complain about how personal data is used as part of this programme, should contact data_protection@dhsc.gov.uk in the first instance or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

Anyone who is still not satisfied can complain to the Information Commissioners Office. Their postal address is:

Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Automated decision making or profiling

No decision will be made about individuals solely based on automated decision making (where a decision is taken about them using an electronic system without human involvement) which has a significant impact on them.

Changes to this policy

This privacy notice is kept under regular review and was last updated on 4 July 2022.