Open consultation

Changes to regulations relating to the Care Quality Commission

Published 26 April 2024

Applies to England

Introduction

The Health and Social Care Act 2008 requires all providers of ‘regulated activities’ in England to register with the Care Quality Commission (CQC) and to comply with the requirements and fundamental standards.

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (‘the 2014 regulations’) set out the scope of these regulated activities and the fundamental standards.

In April 2015, amending regulations inserted a provision into the 2014 regulations meaning that the 2014 regulations would expire automatically after 31 March 2022.

Following a public consultation in July 2021 and Parliamentary debates in both Houses in March 2022 it was decided to extend the expiry date of the 2014 regulations to after 31 March 2025 to allow time for the Department of Health and Social Care (DHSC) to undertake a full review of CQC regulations.  

The full review was paused to enable DHSC to meet its statutory requirement to complete a post implementation review (PIR) of these CQC regulations. The PIR was completed and results published in July 2023.

The PIR was promoted on the CQC bulletin to target providers registered with CQC, so registered providers had the opportunity to respond to the PIR. However, the response rate to the PIR was too low to make an assessment on whether the responses received were indicative of the sector as a whole. There were no responses to the PIR that suggested the Care Quality Commission (Registration) Regulations 2009 (‘2009 regulations’), 2014 regulations and Care Quality Commission (Reviews and Performance Assessments) Regulations 2018 did not meet their original objectives and regulation could be carried out in another way.

Now DHSC has completed the PIR of 3 sets of regulations relating to CQC, which included the 2014 regulations and the 2009 regulations, it will seek views on proposals to amend the CQC regulations. One of these proposals is to remove the expiry date within the 2014 regulations and insert a review clause so that reviews will take place every 5 years following the date of the PIR (as required by section 28 of the Small Business, Enterprise and Employment Act 2015).

Purpose of the consultation

This consultation will run from 26 April 2024 to 21 June 2024. The purpose of this consultation is to gather views on:

• whether, now DHSC has carried out a PIR of the 2014 regulations, it is appropriate to remove the expiry date for those regulations and replace it with a 5-yearly review. The purpose of removing the expiry date is to ensure CQC continues to have regulatory oversight of the health and care sector and maintain the requirements for providers of regulated activities to meet fundamental standards in respect of those activities. Inserting a 5-yearly review clause would mean regular reviews of the 2014 regulations take place to ensure they remain fit for purpose

• DHSC’s proposal in respect of the exceptions relating to:

  • treatment in a sports ground or gymnasium (including associated premises) where it is provided for the sole benefit of persons taking part in, or attending, sporting activities and events

  • the provision of treatment under temporary arrangements to deliver healthcare to those taking part in, or attending, sporting or cultural events

• DHSC’s proposal in respect of the notification of the use of restraint for people with a learning disability and autistic people. DHSC is proposing an amendment to the regulations which will apply to all patients being assessed or treated for a mental health disorder in a mental health unit (and not only people with a learning disability and autism)

Removing the expiry date of the 2014 regulations

The 2014 regulations apply to all providers of a regulated activity including NHS bodies (for example, NHS trusts and NHS foundation trusts), adult social care providers, independent providers and voluntary sector organisations. The 2014 regulations were made on 6 November 2014 and commenced fully for all registered providers on 1 April 2015. They are due to expire after 31 March 2025. DHSC carried out a PIR in July 2022 and is intending to make regulations to remove the expiry date of the 2014 regulations, to ensure that providers will continue to be bound by the requirements set out in the 2014 regulations.

Post implementation review of the 2014 regulations

The 2014 regulations provide for the regulations to be reviewed. The purpose of this review was to assess whether the objectives of the 2014 regulations have been achieved and, if so, whether they remain appropriate.

DHSC carried out the PIR in July 2022 and published the results in July 2023. The results of the PIR did not provide sufficient evidence to suggest whether or not the objectives of the 2014 regulations remain appropriate and whether there is an alternative system of regulation that imposes less regulation of the health and social care sector.

DHSC wants to make sure the health and care sector continues to be bound by regulation that ensures that health and care providers of specified activities are required to meet fundamental standards in the provision of those activities under the oversight of CQC. To continue to amend expiry dates for the 2014 regulations raises the risk of the regulations expiring, which would remove the legal basis for CQC to carry out its regulatory function in respect of providers of regulated activities. Removing the expiry date will also create certainty among providers as there will be no risk of the regulations expiring.

Setting an expiry date requires government and Parliamentary resourcing. As no risk has been identified that the 2014 regulations create too high a burden or do not meet their original objectives, it is DHSC’s view that the expiry date clause is disproportionate and should be removed.

The landscape of the health and care sector is constantly evolving. We propose to insert a review clause, as required under the Small Business, Enterprise and Employment Act 2015, requiring a 5-yearly review to assess the extent to which the objectives of the 2014 regulations are achieved, assess whether those objectives remain appropriate and if so, assess the extent to which they could be achieved in another way involving less onerous regulatory provisions.

Question

Do you agree or disagree that DHSC proceed with its proposal to remove the expiry date and replace it with a 5-yearly review provision?

• Agree

• Disagree

• Don’t know

Question

What alternatives, if any, should DHSC consider?

• A further 3-year extension of the expiry date

• A further 5-year extension of the expiry date

• Other

Question

If you have additional information in relation to the proposal to remove the expiry date, please provide this (do not include any personal information). (maximum 300 words)

This could include information to inform the analysis of this proposed amendment. Or you can raise concerns or highlight potential unintended consequences of this proposed amendment.

Temporary cultural and sporting events and sporting activities exceptions

Background

Following the Manchester Arena Inquiry (MAI) volume 2 report (recommendations 132 to 134), it was recommended DHSC should consider:

• the standard of provision of healthcare at events
• this standard being contained in statutory regulation
• enforcement by a regulator

Additionally, CQC is aware of significant risk in the provision of independent medical care at temporary sporting and cultural events. It is concerned that continuing to have unregulated care in these settings and others (for example, sporting activities) will have a negative effect. This unregulated care has, in some cases, resulted in serious harm to individuals receiving treatment.

In line with the objectives of the MAI recommendation, DHSC is proposing to make an amendment to the 2014 regulation. This seeks to remove 2 exceptions which, in their current form, mean that the following activities relating to the treatment of disease, disorder or injury (TDDI) are not within CQC’s regulatory remit:

• the provision of treatment in a sports ground or gymnasium (including associated premises) where it is provided for the sole benefit of persons taking part in, or attending, sporting activities and events, as set out in schedule 1. paragraph 4, sub-paragraph (3)(f) of the 2014 regulations
• the provision of treatment under temporary arrangements to deliver healthcare to those taking part in, or attending, sporting or cultural events as set out at schedule 1, paragraph 4, sub-paragraph (3)(g) of the 2014 regulations

Removing these exceptions will bring these activities in scope of the regulated activities set out at schedule 1 to the 2014 regulations, ensuring providers carrying out the regulated activity of TDDI for the purposes of a sporting or cultural event site needs to register with CQC and will, therefore, be subject to regulation.

The above proposal will also bring the regulated activity of TDDI where it is provided for the sole benefit of persons taking part in, or attending, sporting activities at a sports ground or gymnasium into scope. This is necessary due to concern that continuing to have unregulated care in this setting will have a negative effect. As noted above, this unregulated care has, in some cases, resulted in serious harm to individuals receiving treatment and should be regulated in order to improve safety and quality of healthcare provision.

Proposal for consultation

Under the 2014 regulations, TDDI is listed as a regulated activity (see paragraph 4 of schedule 1 to the 2014 regulations). Accordingly, a provider will, as a general rule, be required to register with CQC and will be subject to CQC regulation when carrying out that activity (and any other regulated activity listed in the 2014 regulations).

However, currently within the 2014 regulations, there are exceptions which mean in certain specified cases TDDI is not a regulated activity and therefore not within CQC’s remit.

The result is that a provider who only ever carries out activity covered by these exceptions need not register with CQC and will fall outside its regulatory remit. By contrast, where a provider carries out activity that falls within an exception but also carries out other activities that are not excepted then that provider will have to register with CQC and will be subject to regulation. To note, this is only so far as its non-excepted activities are concerned.

This proposal is focused on the removal of 2 of these exceptions. These can be found in sub-paragraphs 4(3)(f) and 4(3)(g) of schedule 1 to the 2014 regulations.

Removal of the exceptions and impact 

Removing these exceptions will enable regulation of TDDI in the above cases. There have been multiple reports of unsafe practice, sexual assault and deaths arising from shortcomings in care from unregulated providers at temporary events. There is concern that continuing to have unregulated care in all settings in the exceptions has a negative effect.

Removal of the exceptions will also provide clarity for providers that all TDDI on an event site is regulated. There is currently a lack of clarity around this, as the conveyance of a patient to hospital by ambulance is a regulated activity. It will also make it easier for CQC to monitor providers.

Schedule 2 to the 2014 regulations includes a general exception for the provision of first aid (9(a)(b)(c)). We are not proposing to remove this exception and the proposed removal of the exceptions to the regulated activity of TDDI will not alter that. First aid remains out of scope of CQC’s remit due to schedule 2, paragraph 9 of the 2014 regulated activities which includes a general exception for first aid, that applies in whatever circumstances it is provided.

There is a cross reference to the exceptions in schedule 1, paragraph 4 (3)(f) and (g), within another exception at schedule 1 paragraph 9(3) which relates to transport services provided within the confines of the site or venue being used for sporting activities or events, or cultural events. We are not proposing this exception is removed because it would have wider unintended consequences, such as, for example, regulating transport services which might involve only a single journey across an event site. However, this cross reference will no longer work and new wording will be needed to ensure that transport services provided at a location used for the activities and events currently referred to in sub-paragraph 4(3)(f)(g)) continue to be excepted by the amended regulations.

Schedule 2 to the 2014 regulations includes a general exception for medical and dental services provided under arrangements made by a service user’s employer (5(1)(a)). The proposed changes do not affect this exception, and it will remain the case that the care and treatment provided to professional athletes and sports people under arrangements made by their employer remains out of scope.

DHSC has commenced separate but linked work developing a standard for the provision of healthcare at events. CQC will consider this standard, once published, when regulating the medical care (TDDI) at events following the removal of these exceptions.

We anticipate we will implement this change in the 2025 to 2026 financial year, and are considering appropriate transitional arrangements to ensure there is a sufficient lead-in time.

Question

Do you agree or disagree with the proposal to remove the exception relating to treatment in a sports ground or gymnasium (including associated premises)?

This is where treatment is provided for the sole benefit of persons taking part in, or attending, sporting activities and events.

• Agree

• Disagree

• Don’t know

Please explain your answer. (Do not include any personal information.) (maximum 300 words)

This answer could include information to inform the analysis of this proposed amendment. Or it could be an opportunity to raise concerns or highlight potential unintended consequences of this proposed amendment.

Question

Do you agree or disagree with the proposal to remove the exception relating to treatment at cultural and sporting events?

This is where treatment is provided under temporary arrangements. It’s provided for those taking part in or attending events.

• Agree

• Disagree

• Don’t know

Please explain your answer. (Do not include any personal information.) (maximum 300 words)

This answer could include information to inform the analysis of this proposed amendment. It could also be an opportunity to raise concerns or highlight potential unintended consequences of this proposed amendment.

Question

Are you a provider of medical treatment (not first aid) at local cultural or sporting events?

• Yes

• No

Are you an organiser of local cultural or sporting events?

• Yes

• No

Question

Do you agree or disagree that there will be an effect on sporting activities or local cultural and sporting events as a result of the outlined proposal?

• Agree

• Disagree

• Don’t know

Question

Do you agree or disagree that there will be a disproportionate effect on small businesses as a result of the proposal outlined?

• Agree

• Disagree

• Don’t know

Please explain your answer. (Do not include any personal information.) (maximum 300 words)

Notification of use of restraint, segregation and seclusion (RSS)

This proposal is a response to CQC’s request to be notified of use of the most serious types of restrictive practices by health and social care providers. This first step focuses on mental health providers and seeks approval to amend the current CQC regulations, so that providers registered with CQC who operate mental health units are required to notify CQC within 72 hours so far as reasonably practicable when they use any of the following forms of restrictive practice: physical, mechanical chemical restraint, and isolation (which includes seclusion and segregation), as defined in the Mental Health Units (Use of Force) Act 2018. We will consider whether the amendment is more appropriate as an amendment to the 2009 regulations or the 2014 regulations as part of the drafting process.

DHSC accepted the recommendations from CQC’s thematic review of RSS published in 2020 including, subject to Parliamentary approval, introduction of a requirement for providers to notify CQC when a person is put into segregation. DHSC made a commitment to take forward the proposed regulation change in its response to Baroness Hollins’ report: My heart breaks - solitary confinement in hospital has no therapeutic benefit for people with a learning disability and autistic people (November 2023). This commitment was for segregation to be a notifiable event to CQC for people with a learning disability and autistic people in mental health units.

DHSC is, however, proposing that this requirement applies to all patients being assessed or treated for a mental disorder in a mental health unit (not only people with a learning disability and autism) and to all forms of restraint. This would:

1. be in line with recommendation 11 of CQC’s Out of Sight, who cares? report, which called for better oversight of the use of specific restrictive practices in mental health hospitals
2. ensure alignment with the requirement to keep a record of restrictive practices in section 6 of the Mental Health Units (Use of Force) Act 2018 (which has not yet been commenced)

Consistency with section 6 of the 2018 Act would enable the submission of notifications by providers to be administratively simpler. The regulation change would apply to mental health units where the provider is registered with CQC.

NHS and independent hospitals providing NHS-funded care already submit data on the use of force to the NHS Digital Mental Health Services Data Set (MHSDS). However, there is no legal requirement to do this and CQC only receives this information 3 months after the reported event occurs. The MHSDS data requires suppression to address the data disclosure risk inherent in the presentation of small numbers of cases so most of CQC cannot see individual cases and have to wait to intervene until more than 5 people have experienced restrictive interventions at a particular provider which prevents prompt intervention. Current arrangements mean that CQC is unable to react promptly where there is potentially inappropriate and unsafe use of restrictive practice in mental health settings on the basis of the MHSDS data.

The proposed changes to the CQC regulations (which would be subject to Parliamentary approval) would improve timely reporting and notifications by providers to CQC on use of restrictive practices, by imposing a legislative requirement to report restrictive practices within 72 hours so far as reasonably practicable, allowing the regulator to take prompt action where it considers this to be an indicator of poor-quality care or practice.

Examples of actions CQC may take in response to the information provided to them include:

• a decision to inspect
• a requirement for an action plan to reduce the use of restrictive practices
• issuing a warning notice to the provider

This would enhance the safety of people using these services and improve accountability and transparency about the use of force in mental health units. We would expect this to lead to a reduction in use of force.

DHSC proposes bringing this new requirement into force in April 2025 or as close as possible after that date.

This new reporting requirement would be based on core aspects of the requirement to record use of force as imposed by section 6(5) of the Mental Health Units (Use of Force) Act 2018.

We expect that section 6 of the Mental Health Units (Use of Force) Act 2018 would be commenced ahead of any new reporting requirement.

We anticipate that the requirement for providers to report uses of restrictive practice to CQC within a specific timeframe (72 hours, so far as reasonably practicable) will add new burdens to providers. We expect to minimise burdens by only asking them to report a subset of information required by section 6 of the Use of Force Act 2018 to CQC. These are the data items that CQC considers they need in order to effectively monitor and regulate providers’ use of the most severe restrictive interventions. We consider that extending the reporting requirement to all of the information required by section 6 would add unnecessary burden to both providers and CQC and would introduce challenges within the 72-hour timeframe.

We welcome views from providers on how burdensome they consider the proposed regulation to be and its potential impacts. We welcome views on mitigations.

As part of the new reporting requirement, the following information, which is a subset of information required by section 6(5) of the Mental Health Units (Use of Force) Act 2018, would need to be submitted to CQC:

• the reason for the use of force

• the place, date and duration of the use of force

• the type, or types of force used on the patient

• name of the patient on whom force was used

• the relevant characteristics of the patient (if known)

• whether the patient has a learning disability or autistic spectrum disorder

• whether the patient died or suffered any serious injury as a result of the use of force 

• any efforts made to avoid the need for use of force on the patient

In the list above, ‘the relevant characteristics of the patient’ are:

• the patient’s age

• whether the patient has a disability, and if so, the nature of that disability 

• the status regarding marriage or civil partnership

• whether the patient is pregnant

• the patient’s race

• the patient’s religion or belief

• the patient’s sex

• the patient’s sexual orientation

Under the new proposal, the personal data of patients would be disclosed to CQC, including the patient’s name.

CQC would issue statutory guidance in due course which will set out how data required under the proposed amendment to regulations is to be classified and reported and how the data should be transmitted.

Question

Do you agree or disagree with the proposal?

• Agree

• Disagree

• Don’t know

Please explain your answer. (Do not include any personal information.) (maximum 300 words)

Question

Do you agree or disagree with the proposal that the regulations should apply to all patients in CQC-registered mental health units?

• Agree

• Disagree

• Don’t know

Please explain your answer. (Do not include any personal information.) (maximum 300 words)

Question

Do you agree or disagree that this proposal will affect providers registered with CQC who operate mental health units?

• Agree

• Disagree

• Don’t know

Please explain your answer. (Do not include any personal information) (maximum 300 words)

If you said ‘Agree’, please explain how you think the proposal will affect providers.

Question

If you have any suggestions for how these impacts can be mitigated, please give details. (Do not include any personal information.) (maximum 300 words)

Question

Do you agree or disagree that mental health units have the capacity to record and report this information to CQC within 72 hours?

• Agree

• Disagree

• Don’t know

Question

Do you have any suggestions for how units can be supported to do this? (Do not include personal information.) (maximum 300 words)

Question

If you have any additional information in relation to the proposal on notification of the use of RSS, please provide this. (Do not include any personal information.) (maximum 300 words)

This could include information to inform the analysis of the impact of this proposed amendment to the regulations. Or it could be an opportunity to raise concerns or highlight potential unintended consequences of this proposed amendment.

Equalities

It is anticipated that the matters considered in this consultation will not produce an adverse impact on the duty to advance equality of opportunity or foster good relations between different groups because any change to the CQC regulations are anticipated to ensure the safety and quality of services providing treatment and care in England to all those who access it, irrespective of disability, sex, gender reassignment, age, sexual orientation, religion or belief, race, pregnancy and maternity, and marriage or civil partnership.

The proposal to remove the expiry date will ensure that all providers are required to comply with the fundamental standards, which will ensure the continuation of safety and quality of services, benefiting all the general public, including those who share protected characteristics.

The proposal is to regulate the provision of medical care in the following settings:

• a sports ground or gymnasium (including associated premises) where it is provided for the sole benefit of persons taking part in, or attending, sporting activities and events
• under temporary arrangements to those taking part in, or attending, sporting or cultural events

This would benefit the general public, irrespective of any protected characteristics. The change in regulation is expected to result in safer and better quality of care in the above settings, because providers of medical care will be required to register with CQC for that regulated activity and comply with CQC’s fundamental standards, such as safety and safeguarding from abuse.

DHSC’s proposed regulation change in respect of the notification of the use of restraint for people with a learning disability and autistic people, could have a positive effect on certain groups with protected characteristics, for example, people detained under the Mental Health Act and those in mental health units. It is anticipated that improved monitoring and oversight of the proposal to require reporting of specific restrictive practices of restraint, seclusion and segregation would ensure such practices are proportionate and allow as much as possible, free mixing with peers for an individual’s wellbeing.

With better data, CQC would be able to react promptly where there is potentially inappropriate and unsafe use of restrictive practice in mental health settings and thereby ensure safeguarding of individuals in these settings where historically there have been cases of closed cultures leading to abuse and harm of residents.

How to respond to the consultation

Please respond using the online survey.

We prefer you to use the online form to respond to this consultation. This will ensure the analysis of the responses to the consultation remains consistent. If you need a postal response form, email 2014regulations@dhsc.gov.uk.

This consultation opens on 26 April 2024 and will close at 11.59pm on 21 June 2024.

DHSC policy officials will consider all responses to the consultation questions received during this period. They will consider these in the final decision on how to proceed as a result of the outcome of this consultation.

After the closing date of this consultation, DHSC policy officials will aim to analyse the replies and publish a response document within 12 weeks of the consultation or provide an explanation as to why this is not possible.

The consultation response will set out the main findings resulting from the submissions made to the consultation. The response will also confirm the finalised policy decision, pending debate of any draft amendment regulations in both Houses of Parliament.

If you have concerns or comments relating specifically to the consultation process itself, please email: 2014regulations@dhsc.gov.uk.

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Information provided will be managed in accordance with the DHSC privacy notice. It explains your rights under the Data Protection Act 2019 and the United Kingdom General Data Protection Regulation (UK GDPR).