Consultation outcome

Government response to the results of the consultation on changing regulations relating to the CQC

Updated 18 December 2024

Introduction

This is the analysis by the Department of Health and Social Care (DHSC) of responses to their consultation to amend the Health and Social Act 2008 (Regulated Activities) Regulations 2014 (the ‘2014 regulations’).

The consultation ran from 26 April to 21 June 2024. The easy read version ran from 13 August to 27 September 2024.

The consultation was open to members of the public and providers of regulated activities.

The core survey had 189 responses, which was relatively small in number compared to broader consultations. However, this included responses from 8 umbrella bodies and associations representing groups of event medical care and sports organisations who provided additional comments by email regarding their views on the temporary events and sporting activities.

The easy read version had 33 responses.

The core survey contained 7 closed-ended and 4 open-ended questions.

The easy read version contained a shorter list of questions equivalent to the core survey (see annex for details).

Responses from the easy read survey have been combined with those of the core survey to produce a single set of results. In the very few cases where respondents left a question blank, unless otherwise stated, we have excluded these from the analysis. Percentages may not add up to exactly 100% due to rounding.

We would like to thank all respondents for taking time to provide their views.

Background

On 24 April 2024, DHSC published a consultation document to gather views on:

• whether, now that DHSC has carried out a post-implementation review of the 2014 regulations, it’s appropriate to remove the expiry date for those regulations and replace it with a 5-yearly review
• the purpose of removing the expiry date which 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 which would mean regular reviews of the 2014 regulations take place to ensure they remain fit for purpose

DHSC proposed to make an amendment to the 2014 regulation to remove 2 exceptions which, in their current form, mean that the activities relating to the treatment of disease, disorder or injury (TDDI) are not within CQC’s regulatory remit. These exceptions are 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
• under temporary arrangements to deliver healthcare to those taking part in, or attending, sporting or cultural events

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

DHSC also proposed changes to the CQC regulations which require timely reporting and notifications by providers to CQC on use of restrictive practices, including a legislative requirement to report restrictive practices within 72 hours, so far as reasonably practicable. This would allow the regulator to take prompt action where it considers this to be an indicator of poor-quality care or practice. This requirement would apply 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.

Overview of respondents

This section summarises the 189 responses to the demographic questions at the beginning of the consultation. The easy read version did not ask demographic questions.

Table 1: proportion of individual and organisation responses

Response	Proportion of responses
An individual sharing personal views and experiences (such as a patient or carer or member of the public)	10%
An individual sharing their professional view	56%
On behalf of an organisation	34%

Table 2: proportion of responses by age of individual

Response	Proportion of responses
Under 18	1%
18 to 25	2%
26 to 30	6%
31 or above	57%
Not answered	34%

Table 3: proportion of responses by sex

Response	Proportion of responses
Female	24%
Male	38%
Prefer not to say	4%
Not answered	34%

Expiry date clause

This section covers analysis of questions relating to the proposal to remove the expiry date clause within the existing regulations.

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?

There were 219 responses to the question on whether the expiry date should be removed - 187 from the non-easy read version and 32 from the easy read version.

The responses to the closed question on the 5-year review were:

• 70% agreed
• 9% disagreed
• 21% didn’t know

Question

What alternatives, if any, should DHSC consider?

Table 4 shows how the 222 responses answered this question.

Table 4: proportion of responses to the closed question on alternatives

Response	Proportion of responses
5-year extension	12%
3-year extension	24%
Blank	63%
Other	1%

Additional information on alternatives

For the free-text question which allowed respondents to add more detail, 85% did not respond. For 95% of all answers, themes could not be identified. Of those that did, the themes identified are below.

Concerns around the fitness for purpose or rationale of the proposal

Some responses noted the possibility that regulation changes might be needed outside the 5-yearly review, for example where concerns are highlighted and warrant urgent review, or if there are changes to other regulations that could impact on the way providers operate (such as in the area of mental health). However, responses also noted that any regulation changes would still need thorough consideration to reduce the likelihood of unintended consequences occurring.

Some respondents were concerned that removing the expiry date clause would reduce the incentive for DHSC or CQC to comprehensively review the regulations, despite 5-yearly reviews.

Broader issues with CQC

Some respondents raised broader concerns with CQC, which were not directly related to the proposed regulation amendment but provided additional context behind their response. 

Government response

There was broad support for this proposed amendment to the 2014 regulations and we intend to proceed with removing the expiry date and replacing it with a 5-yearly review provision when Parliamentary time allows.

We note some respondents have concerns that the 5-yearly review might be a barrier to instances that warrant ad-hoc and urgent review of a particular regulation, for example, if operational or policy reasons warrant it. That is not our intention and CQC regulations will continue to be amended when the need arises and when Parliamentary time allows.   

Broader concerns with CQC, that are outside the scope of these proposed amendments to the regulations are being robustly addressed. Between May and September 2024, Dr Penny Dash conducted a review into the operational effectiveness of CQC, with her report published on 15 October 2024. The report uncovered significant failings in the internal workings of the organisation, although Dr Dash recognised the dedication of CQC staff. The findings of the report demonstrated that significant action was required to ensure that we have regulation that is fit for purpose. CQC have developed an approach to recovery that supports addressing the recommendations in the Dash report. This includes a review of their single assessment framework (SAF) to allow them to produce better reports that are clearer about judgments and ratings. They commissioned Professor Sir Mike Richards to carry out a review into the SAF, which was also published on 15 October 2024.

Temporary events and sporting activities exceptions

This section covers analysis of questions relating to removing the exemptions in the 2014 regulations that mean that some treatment at temporary cultural and sporting events and sporting activities is not within CQC’s regulatory remit.

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)?

There were 220 responses to the question on whether the exemption should be removed in sports grounds or gymnasiums (and associated premises) - 187 from the non-easy read version (including the 8 who provided additional comments by email) and 32 from the easy read version. There were 55 ‘don’t know’ responses (25%).

Of the responses to the closed question on treatment in a sports ground or gymnasium:

• 56% agreed
• 19% disagreed
• 25% didn’t know

Additional information on treatment in a sports ground or gymnasium

For the free-text question which allowed respondents to add more detail, roughly half did not respond and for 70% of all answers, themes could not be identified. Of those that did, including the 8 respondents who provided additional comments by email, the themes identified are below.

The proposal being a positive change

Most of the responses with detailed comments noted the importance of the proposed change in regulations as they had witnessed or were aware of suboptimal care provided at events. In addition, some respondents noted the importance of the proposed change due to the high-risk nature of some events with currently unregulated healthcare provision. These included types of events such as certain sports, events where children are in attendance (sometimes unaccompanied), and events where there is a possibility that some attendees could be inebriated.

Clarification around purpose and rationale

Some respondents felt that the existing exemptions were appropriate, and the proposed change was not required. Respondents also raised some questions about whether CQC have the relevant resource to begin regulating the TDDI in sports grounds and gymnasiums, given these settings are different to the usual healthcare settings in which CQC regulates TDDI. Some respondents felt more clarification was needed on the proposed changes, including the definition of TDDI, and whether certain professions such as physiotherapists would be regulated under this change. There were also some questions around if regulating TDDI at a sports ground or gymnasium could lead to providers choosing to provide first aid instead (an unregulated activity), therefore lowering the standard of healthcare at these events.

Potential added costs or burden

Some respondents raised that the proposed change to regulations may remove some businesses from the market or reduce the amount of events able to take place due to the potential added cost burden on healthcare providers or event organisers. A potentially heightened cost burden was also raised with regard to events that rely on volunteers to provide medical treatment.

Regulation and enforcement were another theme that was identified. However, there was not much free-text information.

Question

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

There were 219 responses to the question on whether the exemption should be removed at cultural and sporting events - 187 from the non-easy read version (including the 8 who provided additional comments by email) and 32 from the easy read version. There was a high proportion of ‘don’t know’ responses (25%).

The proportion of responses to the closed question on cultural and sporting events were:

• 55% agreed
• 20% disagreed
• 25% didn’t know

Additional information on cultural and sporting events

For the free-text question which allowed respondents to add more detail, 60% did not respond. For 80% of all answers, themes could not be identified. Of those that did, including the 8 respondents who provided additional comments by email, the themes identified are below.

Potential added costs or burden

Some respondents raised the potential cost burden on volunteers and small businesses, whether CQC have relevant resource, and the potential for some events to lower their standards of care due to the regulatory or financial burden.

Regulation and enforcement

There were some additional insights under regulation, such as responses highlighting there could be more businesses in this field than previously anticipated and also requests for clarification on who or what type of premises would be regulated (in other words, the healthcare provider or the sports ground).

Other themes that were identified with less free-text information were:

• this proposal was a positive change
• concerns around the fitness for purpose of the proposal

Question

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

There were 189 responses to this question through the online consultation. This question had no easy read equivalent and therefore no additional responses.

On this question about whether respondents were providers of medical treatment at events:

• 66% answered ‘no’
• 34% answered ‘yes’

Question

Are you an organiser of local cultural or sporting events?

There were 189 responses to this question through the online consultation. This question had no easy read equivalent and therefore no additional responses.

On this question about whether respondents are organisers of events:

• 86% answered ‘no’
• 14% answered ‘yes’

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?

There were 214 responses to this question - 183 from the non-easy read version (including the 8 who provided additional comments by email) and 31 from the easy read version. Around a third of responses didn’t know whether there would be an impact, which may be reflective of respondents responding to the consultation primarily to provide their views on one of the other proposals. This question does not distinguish whether that impact would be positive or negative.

On this question about an effect on sporting or cultural events from the proposal:

• 56% agreed
• 11% disagreed
• 33% didn’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?

There were 189 responses to the question on whether small businesses would be disproportionately affected by the removal of the exemption, including the 8 who also provided additional comments by email. This question had no easy read equivalent and therefore no additional responses.

The proportion of responses to the closed question on a disproportionate effect on small businesses from the proposal is:

• 31% agreed
• 30% disagreed
• 39% didn’t know

Additional information relating to the proposal’s effect on small businesses

For the free-text question which allowed respondents to add more detail, 60% did not respond. For 80% of all answers, themes could not be identified. Of those that did, including the 8 respondents who provided additional comments by email, the themes identified are below

The proposal being a positive change

A number of responses recognised that there might be an impact on smaller business but noted that removing the exemption would drive up standards by improving patient safety, and that public safety should be prioritised.

Potential added costs or burden

A potential additional cost and burden on smaller businesses was raised by some respondents. It was noted these businesses typically have smaller profit margins. Some respondents highlighted that smaller businesses may close and/or costs may be passed on to higher ticket prices for events, which could cause unintended consequences like events being cancelled or lower sport participation rates.

Clarification on proposed changes

Some respondents welcomed further detail around impacts of the proposed changes, highlighting that the impact on small businesses was not certain. There were also some questions around the requirements for regulation (for example, appropriateness, amount of and type) and who would be regulated (for example, event size, event organisers, promoters, first aiders and so on).

Regulation and enforcement were another theme that was identified. However, there was not much free-text information.

Government response

Ensuring the health and safety of the public is a priority, which includes the provision of good healthcare at events. The proposed changes to remove the temporary cultural and sporting events and sporting activities exceptions to CQC regulations are part of this plan to ensure that the provision of TDDI meets the standards that both the public and event organisers expect.

The majority of respondents who gave a response to the questions agreed that both exceptions should be removed, with 56% agreeing that the exception relating to treatment in a sports ground or gymnasium should be removed, and 55% agreeing that the exception relating to treatment at cultural and sporting events should be removed. There were however a significant proportion of ‘Don’t know’ answers to each question. Discounting the ‘Don’t know’ answers, 75% and 73% agreed with the proposals respectively.

Some respondents gave further detail to their answers. For example, some respondents said that the existing regulatory position was appropriate for the sector, and that no regulatory changes were required. In contrast, CQC has reported multiple concerns around the standard of independent medical care at sporting and cultural events which has, in some cases, resulted in serious harm to individuals receiving treatment. This can be seen in CQC’s The state of care in independent ambulance services report. Following the Manchester Arena Inquiry volume 2 report, it was recommended that DHSC should consider the standard of provision of healthcare at events. Removing the exceptions with relation to events aims to fulfil the inquiry’s recommendation and improve the provision and safety of TDDI at events.

Some respondents stated that the proposed changes may not be the most effective way to address healthcare shortcomings at events and that the government should consider which body would be the most effective regulator of the sector. The government is clear that our first priority is to keep the public safe, and it is important that healthcare is regulated effectively. As CQC is the independent regulator of health and social care in England the government believes that they are best placed to regulate healthcare in this sector.

CQC are taking a number of steps to ensure any legislative changes taken forward following this consultation are implemented in a way that are appropriately moderated, and any regulation is communicated effectively to businesses and events groups. The regulations will also link closely to the forthcoming event healthcare standard (the ‘standard’). The standard will define what level of healthcare should be provided at events and will be used by CQC to measure and regulate effective healthcare arrangements. The standard is being written by an authorship group comprised of clinical experts, those working within event healthcare and CQC representatives. 

Some comments from respondents expressed confusion around the definitions of TDDI, which professions would require registration, and whether the proposed changes would include the regulation of first aid. CQC gives a definition of TDDI and further information about qualifying professions and those that do not fall into scope. TDDI does not include first aid, which remains an unregulated activity and does not fall in scope of the proposed amendments.   

There were also comments that providers may choose to provide first aid instead of TDDI (as the provision of first aid will remain an unregulated activity), therefore potentially lowering the quality of care at events. DHSC has started separate but linked work developing a standard for the provision of healthcare at events. CQC will consider this standard, once published, when regulating TDDI at events should these exemptions be removed. DHSC will then consider whether the standard should become a statutory requirement.

Furthermore, some respondents said that changes to the regulations or the requirement to register with CQC may lead to increased costs on providers or organisers and therefore disproportionality impact small businesses and volunteers. While financial implications to providers were risks, as acknowledged in the regulatory impact assessment published with the initial consultation, we also recognise that doing nothing about the inadequate levels of event healthcare as set out in the Manchester Arena Inquiry and through CQC is not in the public interest and that regulatory oversight of this sector is needed to ensure safe provision of services. 

In summary, the responses to the consultation on removing the regulation exceptions were broadly positive. DHSC remains committed to ensuring the provision of healthcare at temporary and sporting events is to a high standard and that it is appropriately moderated. DHSC will continue to work with CQC, healthcare providers, event organisers and the wider public to address these concerns as far as is practicable. DHSC will take a measured approach, considering the cost to businesses and working with CQC to communicate changes to those providing TDDI and managing events, while committing to its aims of improving the standard of healthcare at events.

The government will also work with CQC to ensure that any amendments to regulations align with wider improvements of CQC.

Notification on the use of restraint

This section covers analysis of questions relating to the introduction of a new requirement to notify CQC of the use of restraint, segregation and seclusion in mental health units.

Question

Do you agree or disagree with this proposal?

There were 217 responses to the question on whether respondents agree with the proposal on the reporting of restraint - 189 from the initial consultation and 28 from the easy read version. There was a high proportion of ‘Don’t know’ responses (29%). Table 5 highlights the full distribution of responses.

Of the 189 who responded to the initial consultation^{[footnote 1]}, 34% were responding on behalf of organisations, 56% were responding as professionals and 10% were responding with personal views. Of those responding on behalf of an organisation, the net agreement score^{[footnote 2]} was –1, compared to 41 for professionals and 61 for those with personal views.

Table 5: the proportion of responses to this closed question on reporting restraint

Response	Overall	Organisations	Professionals	Personal experience
Agree	51%	25%	60%	72%
Disagree	20%	26%	19%	11%
Don’t know	29%	49%	21%	17%

Additional information on reporting restraint

Respondents were given the chance to provide a free-text response to support their answer to whether they agree or disagree with the proposal to introduce a requirement for CQC-regulated mental units to notify the CQC of any use of restraint, segregation or seclusion within 72 hours of it occurring.

Of those who responded to the free-text question, the following broad themes were identified:

• the proposal is a positive change, encouraging safe working practices
• concerns about the length of the time window to report
• unanticipated burden upon staff
• concerns around CQC’s ability to process reports
• clearer guidance required on the evidence behind the proposed changes and how the changes will be practically applied

Positive change or sentiment

Many respondents shared an overall positive sentiment that the changes would be a step forward in reducing inequalities, improving safer working practices and encouraging scrutiny of the use of restraint. Some responses acknowledged the change’s potential to facilitate learning that would improve practices and prevent unnecessary use of restraint.

Time window concerns

There were numerous concerns regarding the proposal for a 72-hour window to report the use of restraint. These concerns were primarily related to the potential compromise of patient care due to the reallocation of resources to this urgent administrative task. Some worries also related to how the 72-hour limit might jeopardise UK General Data Protection Regulation (UK GDPR) and data safety protocols. It was noted that either data would need considerable scrutiny to remove identifiable information or protected characteristics before reports were shared with the CQC, or consent to share information would be required from family members. Respondents stated that both processes would be difficult to carry out within 72 hours.

Burden on staff

Some respondents expressed fears that the mandate could create a burden for healthcare providers, straining their resources or capacity. A few respondents noted that administrative tasks and monitoring or evaluation could reduce time with or divert focus away from patients, while some highlighted the possibility of duplicate work being carried out. A considerable number of respondents attributed their concerns about the staff burden to the confined 72-hour reporting window.

Concern with CQC processing ability

Apprehension was raised about CQC’s ability to process and review all reports effectively, with some remarks that CQC may not be agile enough. Some respondents also brought to attention a lack of understanding about how CQC would act upon the information from incoming reports.

Clearer guidance required

Respondents also indicated the need for greater clarity about the purpose of the change and evidence in support of it. There were prompts for further guidance about how both CQC and care practice in organisations would enact and manage the changes. A small proportion of respondents highlighted the necessity for clearer definitions of restrictive force, conveying worries that information could be withheld or misreported without clarity.

Question

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

There were 215 responses to the question on whether the rules should apply to all patients in CQC-registered mental health units - 189 from the initial consultation and 26 from the easy read version. There was a high proportion of ‘Don’t know’ responses (27%). Table 6 highlights the full distribution of responses.

Of those who responded to the initial consultation^{[footnote 1]} on behalf of an organisation, the net agreement score^{[footnote 2]} was 37, compared to 47 for professionals and 67 for those with personal views.

Table 6: proportion of responses to the closed question on all patients in CQC-registered mental health units

Response	Overall	Organisations	Professionals	Personal experience
Agree	60%	46%	63%	78%
Disagree	13%	9%	16%	11%
Don’t know	27%	45%	21%	11%

Additional information on all patients in CQC-registered mental health units

Respondents were given the chance to provide a free-text response to support their answer to whether they agree or disagree with the plan that the new rules should apply to all patients within CQC-registered mental health units.

Of those who responded to the free-text question, the following broad themes were identified:

• widespread agreement of regulations applying to all patients in mental health settings and suggestions of expansion to other care settings
• considerations for the complexity of a patient’s condition or circumstances when imposing regulations on restraint
• concerns about the richness and accuracy of data
• opinions that current practices are already safe and recommendations of other ways to improve outcomes

Agreement and expansion to other settings

There was substantial consensus that the regulations should apply to all patients in mental health units, reflecting the belief that the changes will have a productive effect on reducing the use of restraint. Many respondents asserted that the scope of the plan should extend further than mental health hospitals to include social care settings, acute hospitals, community settings and independent healthcare.

Consideration of diagnosis complexity

Some respondents emphasised that the complexity of a patient’s condition should be taken into consideration when applying the new plan. It was recognised that some patients with a learning disability or autistic patients may be undiagnosed or misdiagnosed, leading to the unnecessary use of restrictive practices. While others remarked that restrictive practices are vital in challenging circumstances.

Data accuracy

In a few responses, it was speculated that the wider the scope of the proposal, the more difficult it would become to collect high-quality data. There was also the suggestion that data collection and processing could be misinterpreted by the CQC due to the organisations lack of first-hand involvement in mental health practice and patient care.

Current restraint practices are safe

Some respondents felt that current restraint practices were already safe, suggesting that the level of impact from the proposal would not justify the resources needed to comply. Respondents also advised on other practices they believed would be more successful in regulating restraint, such as staff training and encouragement of whistleblowing.

Question

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

There were 216 responses to the question on whether the change will affect mental health hospitals that have to follow the new regulation - 189 from the initial consultation and 27 from the easy read version. There was a high proportion of ‘Don’t know’ responses (31%). Table 7 highlights the full distribution of responses.

Of those who responded to the initial consultation^{[footnote 1]} on behalf of an organisation, the net agreement score^{[footnote 2]}  was 49, compared to 42 for professionals and 61 for those with personal views.

Table 7: proportion of responses to the closed question on providers

Response	Overall	Organisations	Professionals	Personal experience
Agree	57%	52%	58%	72%
Disagree	12%	3%	16%	11%
Don’t know	31%	45%	26%	17%

Additional information on providers

Respondents were given the chance to provide a free-text response to support their answer to whether they agree or disagree that the change will affect mental health hospitals that have to follow CQC rules. Respondents were also asked if they had any suggestions for how these proposals could be mitigated.

Of those who responded to the above free-text questions regarding the effects on CQC-regulated mental health hospitals and how to mitigate them, the following broad themes were identified:

• optimism and belief that the changes are achievable
• concerns about the burden of additional work, and appeals for additional funding
• inquiry into the data reporting and processing systems that will be used and concerns over their effectiveness
• the importance of staff training
• further guidance required regarding the enforcement of regulations

Positive and achievable proposal

Many respondents believed that the change was achievable and a positive step forward in increasing scrutiny on care providers, and thereby improving care provision.

Burden of additional work

There were frequent concerns about the burden of additional work due to the lengthy process of completing reports. Queries and appeals were raised about the funding and supply of resources for such administrative tasks, and suggestions of extending the reporting window to longer than 72 hours were made. These concerns largely surrounded the impact of the burden on care provision.

Data and reporting systems

Uncertainties were raised about data quality and the misinterpretation of data at different stages of its collection, processing, and reporting. To ease some of the effects of data collection, there was a strong demand for robust and straightforward reporting systems, with some respondents suggesting online and digital systems. While some respondents suggested the utilisation of existing systems or datasets to avoid duplication.

Staff training

Several respondents stressed the importance of training staff on the appropriate use of restraint, seclusion and segregation. Many of such respondents believed this would mitigate the effects of the proposal on CQC-regulated mental health hospitals by minimising the number of incidents or overall use of restraint, thereby reducing the number of reports required.

Further guidance on enforcement

There were questions focused on the enforcement of regulations and an urge for greater clarity on the actions or sanctions that CQC would implement. Implementation proposals were made for increased and/or unannounced visits from the CQC, guidance for best practices and expansion of the scope of regulations.

Question

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

There were 216 responses to the question on whether participants agree or disagree with the proposed 72-hour reporting period - 189 from the initial consultation and 27 from the easy read version. There was a high proportion of ‘Don’t know’ responses (36%). Table 8 highlights the full distribution of responses.

Of those who responded to the initial consultation^{[footnote 1]} on behalf of an organisation, the net agreement score^{[footnote 2]}  was –12, compared to 20 for professionals and 50 for those with personal views.

Table 8: proportion of responses to the closed question on reporting within 72 hours

Response	Overall	Organisations	Professionals	Personal experience
Agree	40%	17%	45%	67%
Disagree	25%	29%	25%	17%
Don’t know	36%	54%	30%	17%

Additional information on reporting within 72 hours

Respondents were given the chance to provide a free-text response to support their answer to whether they agree or disagree with the mandated 72-hour reporting window, proposed by the CQC.

Of those who responded to the open-text question, the following broad themes were identified.

• suggestion this is achievable, but more clarity is required regarding how CQC will use the data
• some concerns about the capacity or resource to manage the 72-hour reporting window alongside caring duties
• suggestion of changes to the length of the reporting window
• emphasis on implementing effective and efficient reporting systems

Achievable, but more guidance required

Some respondents remarked that the proposal can be achievable if there were clear expectations and guidance about how and when to report restraint, as well as the actions CQC would take using the information they have received. This includes clarity on the potential sanctions CQC would enforce.

Concerns with care provider’s capacity or resource

There were frequent concerns about care provider’s capacity or resource to manage the requirement of reporting the use of restraint within the mandated 72-hour time frame and appeals for additional funding in support. Some respondents feared the impact that this might have on patient care.

Changes to reporting window

Many respondents prompted for a longer reporting window than 72 hours to ease the burden placed on staff that was not previously accounted for in resourcing. There were also comments that there was little evidence on the impact on patient safety due to this shorter time frame. However, it should be noted that there were a minority of respondents that separately called for a shorter reporting window, stating that restraint should be reported as soon as possible to facilitate investigation of whether it was appropriately used.

Reporting systems

There were recommendations for a robust and user-friendly reporting system, with some respondents suggesting it should be online or electronic. A reoccurring emphasis was placed upon how it could be adapted to reduce the administrative burden, with some suggestions of using pre-existing systems.

Further information provided by respondents

A final free-text question was asked which allowed respondents to provide any additional information that they hadn’t raised elsewhere during the consultation in relation to regulating the use of restraint. A small minority of respondents supplied further details about their opinions, from which the following themes were identified

Expansion of the legislation

A few respondents encouraged a wider rollout of the legislation to other settings, and some advocated for more data to be collected and utilised by the CQC. However, there were also concerns that CQC might have difficulty acting upon all reports, due to the amount of data they are likely to receive.

Exploring other initiatives

Among those that provided additional feedback, there were suggestions for alternative initiatives to regulate the use of restraint. This included increasing staff training on the safe use of restraint and working with other professional bodies going forward. The necessity for considering accessibility requirements when designing a reporting system was also noted.

UK GDPR and data safety

Some respondents highlighted the importance of maintaining UK GDPR and data safety protocols in the practice of the legislation.

Concerns about burden upon care providers

Further concerns were emphasised regarding the burden the legislation may have upon staff, service provision and patient care.

Government response

The proposed changes to the CQC regulations are regarding the regulation of restrictive practices, in which CQC-regulated mental health hospitals would be required to report any use of restrictive practice within 72 hours of it occurring. The changes were suggested on the basis of CQC’s ‘Out of sight, who cares?’ report, which asserts that restrictive practices have no therapeutic benefit to patients with a mental health condition and/or learning disability or autistic people, and may even harm attempts at rehabilitation. The report also detailed examples of restrictive practices being used inappropriately and called for better oversight of the use of such practices in mental health hospitals. Baroness Hollins’ report: My heart breaks - solitary confinement in hospital has no therapeutic benefit for people with a learning disability and autistic people highlighted similar concerns about the use of restrictive interventions on people with a learning disability and autistic people. The proposal was made in response to this. The proposed changes were intended to enhance the safety of people using these services and improve accountability and transparency of the use of force in mental health units.

Across the easy read and non-easy read consultations, 51% of all respondents agreed with the proposed changes to the CQC regulations, requiring reporting of restrictive practices within 72 hours of its use. However, of those responding on behalf of an organisation, only 25% agreed, compared to 60% of professionals and 72% of those with personal views. More support was recorded for the plan to apply the new rules upon the care of all patients within CQC-registered mental health units, with 60% of all respondents stating they agree to the plans. However, caution is advised in interpreting consensus, as 29% of respondents reported they were unsure about the proposed changes, and 27% were unsure about applying them universally in mental health units.

Further insights about respondent’s opinions were collated from the open-text questions. Many reported that the proposals were a progressive step in improving safer working practices and encouraging scrutiny of the use of restraint, aligning with the legislation’s aim to improve accountability and transparency of the use of force in mental health units. As such, there were numerous suggestions that the scope of the plan should be expanded further than mental health hospitals alone, to include other regulated care settings. In contrast to this, some respondents said that current practices are already safe and suggested that other practices could be utilised to regulate restraint, such as staff training or encouragement of whistleblowing.

There were also reoccurring issues, including concerns that the mandate could create a burden on the healthcare providers capacity and resources. Worries were raised that the 72 hour reporting window could potentially compromise patient care by diverting focus away from patients and towards urgent administrative tasks. This extended to concerns regarding the potential jeopardy of UK GDPR and data safety protocols due to the proposed 72-hour limit. Further apprehensions were raised about the ability of the CQC to manage the large amount of data received, and the need for clarity about how CQC would act upon incoming reports, was highlighted.

 There were opposing perspectives about whether the rule should apply to all patients and without exception, as many respondents highlighted the necessity to consider a patient’s specific needs when regulating restraint. For example, in defence of restraint, some respondents noted that restraint can be a crucial procedure during difficult circumstances of mental healthcare. Contrastingly, some stated that restraint is unjustifiably used in misdiagnosed or undiagnosed patients. Some also cautioned that wider application of these rules could make it harder to collect accurate, meaningful data. There was limited agreement on the mandated 72-hour reporting window, with 40% of respondents agreeing with the proposed time limit, while 25% disagreeing and 36% stating they didn’t know whether they agreed or disagreed. Some felt the deadline was feasible with clear guidance, but many suggested a longer timeframe to reduce staff burden. Recommendations including additional funding for resources, a user-friendly reporting system and preference for electronic or existing systems to prevent duplication.

In a final open-ended question, respondents recommended exploring collaboration with other professional bodies and reinforced concerns about data security, staff capacity and expanding regulations to other settings.

Throughout all consultation questions, those responding on behalf of organisations were less supportive than professionals or those with personal views. This aligns with many respondents agreeing that this regulation change would be a positive change with benefits to patient outcomes and safer use of restraint, despite practical implementation challenges such as staff burden and data reporting processes.

While there was broad agreement for the proposed amendment from people responding giving personal views and from professionals, only 25% of those responding on behalf of an organisation said that they agreed with the proposal. In summary, consultation responses indicate that while there is support for the proposed changes to the notification of restraint, segregation and seclusion require further policy development work is required on practical implementation before this requirement can be introduced. 

Next steps

Consultation responses were broadly supportive of the policy intention of the proposals described above. Out of the 3 proposals we consulted on, we have concluded that 2 require further policy and operational consideration.

The government’s next step is to pass secondary legislation to remove the expiry date clause in the 2014 regulations and inserting a 5-yearly review provision.

Further development work will be taken forward on the proposal to require CQC-registered mental health providers to notify the CQC within 72 hours, as far as reasonably practicable, of the use of restraint, seclusion and segregation and the proposal relating to regulating treatment at temporary sporting and cultural events or at associated premises.

We published a regulatory impact assessment on these 3 policy proposals with the initial consultation on 26 April 2024. As this assessment shows, the removal of the expiry date clause does not impose any direct costs to business. If the 2 other proposals are taken forwards in the future, we will update the assessment accordingly.

Annex: survey questions

The table below sets out the questions asked in the core survey, and how these map across to the questions asked in the easy read version.

Core survey question	Easy read survey 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?	Do you think we should review our rules every 5 years instead of having an end date?
What alternatives, if any, should DHSC consider? If you have additional information in relation to the proposal to remove the expiry date, please provide this (do not include any personal information).	Are there any other choices for reviewing the rules? Please say more about your answer in this box.
Do you agree or disagree with the proposal to remove the exception relating to treatment in a sports ground or gymnasium (including associated premises)?	Should organisations who give healthcare at sports venues and cultural events register with CQC? Please tell us more about your answer in the box.
Do you agree or disagree with the proposal to remove the exception relating to treatment at cultural and sporting events? Please explain your answer (do not include any personal information).	Should organisations who give healthcare at temporary sports venues and sports and cultural events register with CQC? Please tell us more about your answer in the box.
Are you a provider of medical treatment (not first aid) at local cultural or sporting events?	Not asked
Are you an organiser of local cultural or sporting events?	Not asked
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?	Do you think our plans will make it more difficult for organisations to provide help to people who become injured or unwell at sports events? Please tell us more about your answer in the box.
Do you agree or disagree that there will be a disproportionate effect on small businesses as a result of the proposal outlined?	Not asked
Do you agree or disagree with the proposal?	Do you think all use of restraint as we have described should be reported to CQC? Please tell us more about your answer in the box.
Do you agree or disagree with the proposal that the regulations should apply to all patients in CQC-registered mental health units?	Do you agree or disagree with the plan that the new rules should apply to all patients in mental health hospitals? Please tell us more about your answer in the box.
Do you agree or disagree that this proposal will affect providers registered with CQC who operate mental health units? (Additional question on suggestions to mitigate any effects)	Do you think the change will affect mental health hospitals that have to follow CQC’s rules? Please tell us ways we can help mental health hospitals do this.
Do you agree or disagree that mental health units have the capacity to record and report this information to CQC within 72 hours?	Do you think mental health hospitals should report information to CQC within 72 hours? Please tell us ways we can help mental health hospitals do this.

1. Demographic questions were not asked in the easy read consultation, so we can only provide these breakdowns for the non-easy read consultation respondents. ↩ ↩² ↩³ ↩⁴

2. The net agreement score is calculated by subtracting the proportion of those who disagreed from the proportion of those who agreed, therefore discounting those who selected ‘Don’t know’. ↩ ↩² ↩³ ↩⁴