Consultation outcome

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

Updated 13 July 2023

Background

The Care Quality Commission (CQC) was established under the Health and Social Care Act 2008 (2008 Act) as an independent regulator of health and adult social care providers of ‘regulated activities’, in England. The ‘regulated activities’ are prescribed in schedule 1 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

The 2008 Act and the associated regulations set out below provide CQC with the powers to register, monitor, inspect and regulate provision of health and adult social care services to ensure they meet fundamental standards of quality and safety. Where CQC issue ratings, providers are given an overall rating of ‘outstanding’, ‘good’, ‘requires improvement’ or ‘inadequate’.

The associated regulations (‘the Regulations’) this report covers are:

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

These regulations include a statutory requirement for the Secretary of State for Health and Social Care to carry out a post-implementation review. The review provisions are set out in the corresponding regulations: 2009 Regulations (PDF, 14KB), 2014 Regulations and 2018 Regulations.

Introduction

The Department of Health and Social Care (DHSC) conducted a post-implementation review (PIR) of the Regulations to determine:

• whether they 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

As part of the PIR, DHSC sought feedback by way of a survey from all providers of a regulated activity that are registered with CQC in England, including:

• NHS bodies
• adult social care providers
• local authorities
• independent providers (in this report, independent providers includes independent contractors providing NHS services)
• voluntary sector organisations

Individual providers with more than one location registered with CQC were asked to submit one response per registration. The survey ran from 29 June to 22 July 2022. This PIR report summarises the information that DHSC received. It will consider the responses to the survey and whether a further piece of work needs to be undertaken to look at amending regulations relating to CQC.

Summary of results

The survey contained 49 questions and was posted on CQC’s registered provider notice board, enabling over 51,000 CQC registrants in England to have access to the survey. 86 responses were received. The small sample size should be taken into account when interpreting these results. In particular, the results may not be representative of the health and social care sector as a whole, but are indicative of those who responded.

Section 4 of the survey, on resourcing, included additional questions to assist with informing work on any future impact assessment of amendments to the Regulations. The information collected in this section of the survey will not be used to make an assessment on whether the Regulations met their overall objectives.

A summary of the responses to the survey is provided below. The number of respondents in the tables reflect the number of providers that provided an answer to each question. Very few questions were answered by all respondents.

Some of the tables below contain very small numbers and so present a risk of disclosure. Two steps have been taken to address this. Firstly, organisations in categories with a low response rate have been grouped into an ‘other’ category. Secondly, the majority of the tables in this report have been rounded to the nearest multiple of 5, in line with DHSC guidance on disclosure control.

Where respondents have given a reason for their answers, the totals in these tables may not always tally with the number of respondents who have answered the survey. This is due to respondents giving more than one reason for their answer.

What type of health and/or social care services does your organisation provide?

Aggregated services	Number of respondents
Acute services	10
Ambulance services	6
Care homes	12
Community services	13
Doctors	25
Domiciliary care services	9
Other (local authorities, voluntary sector and other responses)	11
Total	86

What sector do you work in?

Organisation type	Responses
Independent providers	41
NHS providers	36
Other	9
Total	86

Section 1: Care Quality Commission (Registration) Regulations 2009

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

Organisation type	Strongly agree	Agree	Disagree	Strongly disagree	Total
Independent providers	0	20	15	5	40
NHS providers	0	20	5	10	35
Other	0	5	0	0	5
Total	0	45	20	15	80

Summarised reasons given by respondents	Number of comments
Agree that regulations meet their objectives	20
Raising concerns with how inspections are conducted	20
GPs raising concerns about inspections	5
Regulations require amendment and expansion	10
Other	10
Total respondents	45

Note: the total includes where some respondents gave more than one reason for their answer.

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

Organisation type	Strongly agree	Agree	Disagree	Strongly disagree	Total
Independent providers	0	20	10	5	35
NHS providers	0	15	10	15	40
Other	0	5	0	0	5
Total	0	40	20	20	80

Summarised reasons given by respondents	Number of comments
Agree that regulations are appropriate	5
CQC registration process is inflexible and inspections are too onerous	10
Each type of service should have clear inspection guidance, which is consistently applied	10
Negative comments on inspection process and consistency of outcomes	15
Other	15
Total respondents	40

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

Organisation type	Strongly agree	Agree	Disagree	Strongly disagree	Total
Independent providers	0	20	10	5	35
NHS providers	0	10	15	15	40
Other	0	5	0	0	5
Total	0	35	25	20	80

Summarised reasons given by respondents	Number of comments
Agree that regulations are proportionate	10
Regulations applied inconsistently between providers	10
Inspections burdensome and/or difficult to achieve in working hours	15
Other inspection issue	10
Other	5
Total respondents	40

Note: the total includes where some respondents gave more than one reason for their answer.

Overall, around 60% of respondents agreed that the 2009 Regulations meet their original objectives. 50% of respondents agree they are appropriate in carrying out its objectives. Around 60% of respondents either disagree or strongly disagree that the 2009 Regulations are proportionate.

The original objectives of the 2009 Regulations were to:

• enable CQC to set and maintain registration requirements
• enable 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 CQC
• set out provisions in relation to compliance with the Regulations and offences
• contain provisions for providers to notify CQC of certain incidents

The main concerns raised about whether the 2009 Regulations are proportionate or appropriate were in relation to the inspection process and the burden it creates on providers.

In May 2021, CQC published its new strategy for the changing world of health and social care that reflects CQC’s learning from the past 5 years. CQC’s new strategy combines its learning and experience and has been developed with valuable contributions from the public, service providers and its partners in order to ensure that CQC’s function is more relevant to the way care is now delivered, reflecting how the health and care environment continues to evolve.

Part of CQC’s new strategy includes a focused and targeted approach to risk, lessening the burden on health and social care providers. The new approach uses a mix of on-site and off-site methods, based on a variety of sources including data and patient feedback. This information is used to target emerging service risks as well as responding to service failures. It allows CQC to regulate in a more dynamic and flexible way, with more regulatory contact and frequent engagement with providers and people who use their services. Alongside this approach, CQC undertakes ongoing monitoring of services to identify where it may need to take further action to ensure people are receiving safe care.

CQC will offer support to registered providers by developing collaborative relationships, helping them to find a route to improvement. CQC has an ambition to support providers to improve through guidance, best-practice and connecting with other providers and organisations that can offer advice and support. Providers will be able to see their ratings and where they benchmark against other providers. CQC is also encouraging feedback from people who access health and care services to get a better view on the services providers deliver.

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

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?

Organisation type	Yes	No	Don’t know	Total
Independent providers	15	20	5	40
NHS providers	10	20	5	35
Other	5	5	0	10
Total	30	45	10	85

Summarised reasons given by respondents	Number of comments
Scope of regulated services should be expanded	15
CQC inspection standards too onerous	5
Other	15
Total respondents	30

Note: the total includes where some respondents gave more than one reason for their answer.

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?

Organisation type	Yes	No	Don’t know	Total
Independent providers	15	10	15	40
NHS providers	5	15	15	35
Other	5	5	0	10
Total	25	30	30	85

Summarised reasons given by respondents	Number of comments
Regulations are appropriate	5
Identified additional services requiring regulation (of which: home care or direct payments: 5, medical support or first aid at events or cosmetic procedures: 5, other: 10)	25
Total respondents	30

Feedback on the proportionality of the 2014 Regulations and whether the 2014 Regulations need to be expanded provided a mixture of responses, with a number of respondents agreeing that the 2014 Regulations are proportionate and cover all activities defined as ‘regulated activities’. However, a larger number of respondents disagreed and commented that the 2014 Regulations are disproportionate because CQC’s inspection process is too onerous and the 2014 Regulations need to be expanded to cover other activities. This was also reflected in the responses on whether there are activities not currently covered by the 2014 Regulations, with a larger number of respondents agreeing that the Regulations do not cover all health and social care activities where there is a possible risk to patient safety or service users.

CQC’s inspection process being too onerous was a common theme in the feedback received for both the 2009 and 2014 Regulations. As previously mentioned, CQC has now moved from its routine inspections to a risk-based approach using a mix of on-site and off-site methods, based on data and patient feedback. CQC’s risk-based approach means that it will only inspect providers on-site where it identifies a serious patient safety issue, and moves away from CQC’s previous approach where all providers were routinely inspected. Making on-site inspections where CQC identifies risk will lessen the burden on providers. On-site inspections will also happen where providers have been rated as ‘requires improvement’ or ‘inadequate’ or where services are for vulnerable patients, such as mental health services.

A number of respondents commented that the activities the 2014 Regulations cover need to be expanded. As part of the PIR process, DHSC is working with CQC to discuss and identify whether there are activities being carried out by providers that are not included in the 2014 Regulations but may fall within CQC’s remit.

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

Organisation type	Yes	No	No relevant experience	Total
Independent providers	5	25	10	40
NHS providers	0	25	10	35
Other	5	5	0	10
Total	10	55	20	85

Summarised reasons given by respondents	Number of comments
Unwarranted variation in inspection outcomes between different inspection teams	15
Inconsistent approach between types of providers	30
Inspections should be proportionate for small organisations and can be burdensome	5
Bias against ethnic minority doctors and those serving ethnic minority communities	5
Other	15
Total respondents	50

Note: the total includes where some respondents gave more than one reason for their answer.

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

Organisation type	Yes	No	No relevant experience	Total
Independent providers	5	20	15	40
NHS providers	5	20	10	35
Other	5	5	0	10
Total	15	45	25	85

Summarised reasons given by respondents	Number of comments
Inconsistent approach and unwarranted variation in outcomes between inspection teams	15
Bias against ethnic minority providers and those serving ethnic minority communities	5
Inconsistent approach and unwarranted variation in outcomes between organisations	10
Other	15
Total respondents	40

Note: the total includes where some respondents gave more than one reason for their answer.

Feedback showed that a number of respondents felt that providers are treated unfairly, highlighting inconsistent approaches between types of providers, unwarranted variations between inspection teams and bias against ethnic minority doctors and those serving ethnic minority communities. In January 2023, CQC will replace its current 4 assessment frameworks with a single assessment framework, which it will use to assess quality in all service types at all levels, including local authorities and integrated care systems (ICS). This will help CQC to avoid duplication and streamline its approach across the system.

CQC is aware that GP practices led by GPs who qualified overseas might have disproportionately more challenges in meeting CQC requirements due to various factors such as being located in inner city areas or working in single-handed practices. In February 2021, CQC started a programme of work to focus on these inequalities and how its own regulatory approach affects ethnic minority-led GP practices and how CQC can improve its regulatory approach to address any inequalities it identifies. The outcomes from this programme of work are being fed into CQC’s new approach to regulation.

CQC will take account of this PIR report when developing its approach of assessing ICSs and will assess how well health and social care partners within an area are working together to:

• deliver high quality care to meet people’s needs and improve outcomes
• reduce inequalities
• improve access

In doing this, CQC will look to address where local systems need to provide more support to ensure that primary care meets the needs of everyone in their population.

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

Organisation type	Yes	No	Don’t know	Total
Independent providers	15	15	5	35
NHS providers	10	20	5	35
Other	10	0	0	10
Total	35	35	10	80

Summarised reasons given by respondents	Number of comments
Regulations encourage improvement in quality and safety of care	15
Organisation provides a quality service, little additional benefit to patient care	10
CQC inspections are bureaucratic and time consuming and/or distracts from patient care	15
CQC should support rather than punish organisations	5
Other	10
Total respondents	45

Note: the total includes where some respondents gave more than one reason for their answer.

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

Organisation type	Strongly agree	Agree	Disagree	Strongly disagree	Total
Independent providers	10	30	0	0	40
NHS providers	0	20	10	5	35
Other	0	5	0	0	5
Total	10	55	10	5	80

See CQC fundamental standards

Summarised reasons given by respondents	Number of comments
The regulations clearly set out the outcomes of the fundamental standards	15
Regulations unclear and/or clearer, objective, practical, operational guidance needed	10
Inconsistent approach when implemented by inspection teams	10
Other	5
Total respondents	30

Note: the total includes where some respondents gave more than one reason for their answer.

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

Organisation type	Yes	No	Total
Independent providers	15	30	45
NHS providers	10	25	35
Other	5	5	10
Total	30	60	90

Summarised reasons given by respondents	Number of comments
Clearer guidance on implementation and specific standards including: a list of expectations and requirements	10
Regulations should include safe discharge, patient-centred care and commissioning	5
Inspections should take account of local factors, both organisational and socio-economic	5
Other	10
Total respondents	25

Note: the total includes where some respondents gave more than one reason for their answer.

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

Organisation type	Strongly agree	Agree	Disagree	Strongly disagree	Total
Independent providers	5	20	15	5	45
NHS providers	0	10	10	10	30
Other	0	5	0	0	5
Total	5	35	25	15	80

Summarised reasons given by respondents	Number of comments
CQC’s guidance is clear and easy to follow	5
CQC’s guidance is open to interpretation	10
CQC’s guidance is complex and requires streamlining. It needs to offer more support and clearer terms and definitions	20
Other	10
Total respondents	40

Note: the total includes where some respondents gave more than one reason for their answer.

Responses were equally divided on whether the 2014 Regulations have encouraged improvement, with 35 respondents agreeing that the 2014 Regulations have encouraged improvement and 35 respondents disagreeing. Some of those who disagreed stated that CQC inspections are bureaucratic and time-consuming or distract from patient care. As mentioned previously, CQC has now revisited its inspection process with the ambition of making it less burdensome for providers. CQC will monitor the progress of this ambition through its stakeholder surveys.

The large majority of respondents, 81%, agreed that the 2014 Regulations clearly set out the outcomes of the fundamental standards that providers of regulated activities are expected to meet and/or avoid, with some stating that the 2014 Regulations clearly set out the outcomes.

Responses showed that 67% of respondents do not think anything is missing from the 2014 Regulations that could help providers of regulated activities improve quality and safety. However, some respondents commented that more could be included in the 2014 Regulations to help improve quality, including clearer guidance on specific standards, safe discharge, patient-centred care and commissioning and inspections taking account of local factors. It is clear the health and social care landscape has changed since CQC was established. The Health and Social Care Act 2022 gave CQC the power to assess integrated care systems. Once commenced, CQC will look at whether local authorities are delivering their duties under the Care Act 2014.

Responses were divided on whether CQC’s guidance to the fundamental standards is easy to follow, with around half agreeing and half disagreeing. Some respondents stated the fundamental standards are clear and easy to follow, while others stated the guidance is open to interpretation and is too complex.

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

Organisation type	Strongly agree	Agree	Disagree	Strongly disagree	Total
Independent providers	5	25	5	0	35
NHS providers	0	15	10	5	30
Other	0	5	0	0	5
Total	5	45	15	5	70

Summarised reasons given by respondents	Number of comments
Agree that CQC’s guidance is clear	5
Guidance is unclear. What constitutes a notifiable safety incident is inconsistent across settings and providers	15
Other	5
Total respondents	25

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

Organisation type	Strongly agree	Agree	Disagree	Strongly disagree	Total
Independent providers	10	25	5	0	40
NHS providers	0	20	10	5	35
Other	0	5	0	0	5
Total	10	50	15	5	80

Summarised reasons given by respondents	Number of comments
Agree that it’s clear what providers must do when a notifiable incident occurs	5
Doesn’t agree or it’s not clear what providers must do when a notifiable incident occurs	5
Other	5
Total respondents	15

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

Organisation type	Strongly agree	Agree	Disagree	Strongly disagree	Total
Independent providers	5	20	10	5	40
NHS providers	5	20	10	0	35
Other	0	5	0	0	5
Total	10	45	20	5	80

Summarised reasons given by respondents	Number of comments
Agree that the duty of candour requirement has helped when things go wrong	10
Duty of candour is ineffective, wider changes required	10
Providers do this anyway	5
Other	5
Total respondents	30

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?

Organisation type	Strongly agree	Agree	Disagree	Strongly disagree	Total
Independent providers	5	20	5	5	35
NHS providers	0	15	15	5	35
Other	0	5	0	0	5
Total	5	40	20	10	75

Summarised reasons given by respondents	No of Comments
Agree that the requirement has helped the organisation	5
Disagree that the requirement has helped the organisation	10
Provider would be appointing the right individuals without CQC regulation	10
Regulations don’t apply to my organisation – Regulation 19 applies to all employees of providers of regulated activities under 2014 Regulations. In respect of Regulation 5: FPPR: directors, it applies to all providers other than if they are an individual or a partnership in which case Regulation 4)	5
Other	10
Total respondents	30

Note: the total includes where some respondents gave more than one reason for their answer.

It was generally agreed, by 71% of respondents, that it was straightforward to identify whether something qualifies as a notifiable incident.

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

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

Providers of services that are excluded from CQC 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.

Organisation type	Strongly agree	Agree	Disagree	Strongly disagree	Total
Independent providers	5	10	10	15	40
NHS providers	5	10	15	10	40
Other	0	0	5	0	5
Total	10	20	30	25	85

Summarised reasons given by respondents	Responses
Disagree that the above mentioned excluded providers should not be rated. They should be rated (included in CQC’s regime)	20
Agree that the above mentioned excluded providers should not be rated	5
Dental Services and cosmetic surgeries procedures should be rated	10
Other	10
Total respondents	40

Note: the total includes where some respondents gave more than one reason for their answer.

How many people does your organisation currently employ?

Organisation type	Fewer than 10 people	Between 10 and 49 people	Between 50 and 249 people	250 people or more	Total
Independent providers	10	20	10	5	45
NHS providers	0	25	5	5	35
Other	0	0	0	5	5
Total	10	45	15	15	85

Approximately 65% of respondents disagreed that the providers of services listed in the survey should be excluded from CQC’s ratings.

While considering changes to the ratings regime, DHSC identified that it would be beneficial to broaden the scope of CQC’s ratings regulations so that, with some exceptions, all providers of regulated activities could be 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 CQC too infrequently to make a rating meaningful

As previously stated, DHSC is working with CQC to discuss and identify whether there are non-regulated activities being carried out by providers that are not included in the 2014 Regulations. This will also include looking into whether some of the above-mentioned excluded providers need to be included in CQC’s ratings and whether an amendment is needed to be made to the 2018 Regulations. Any proposed amendment to the Regulations will go through an appropriate consultation process.

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

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

DHSC received information from only a sub-section of respondents to this question. Due to the small sample size, this information is not suitable to present in table form.

Note: we did not receive much feedback on the resources it takes for providers to comply with the 2009 regulations. However, we have included below cost estimates we may use to inform a future impact assessment.

The mean cost estimate from this small sample was £10,000 with a wide degree of variation. The median cost estimate was £2,000. Around two thirds of the responses analysed had costs below £5,000.

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

Organisation type	Yes	No	Don’t know	Total
Independent providers	25	10	0	35
NHS providers	25	10	0	35
Other	5	0	0	5
Total	55	20	0	75

Summarised reasons given by respondents	Responses
New location	15
Additional services or service changes	10
New manager and/or change of partner	15
Other	10
Total respondents	40

Note: the total includes where some respondents gave more than one reason for their answer.

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

DHSC received information from only a small subsection of respondents to this question. Due to the small sample size, this information is not suitable to present in table form.

Note: we did not receive much feedback on the resources it takes for providers to comply with the 2009 regulations. However, we have included below cost estimates we may use to inform a future impact assessment.

The mean cost estimate from this small sample was £1,250 with a wide degree of variation. The median cost estimate is £350. Around two thirds of the responses analysed had costs below £500.

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

Organisation type	Yes	No	Total
Independent providers	25	10	35
NHS providers	20	15	35
Other	5	5	10
Total	50	30	80

Summarised reasons given by respondents	Number of comments
Requirements are clear	5
Process is overly complicated and lengthy	10
Other	5
Total respondents	20

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

Organisation type	Yes	No	Total
Independent providers	10	25	35
NHS providers	5	30	35
Other	0	5	5
Total	15	60	75

Summarised reasons given by respondents	Number of comments
Reviews are demanding and time-consuming, welcome streamlined approach	20
Duplication in review and/or registration process	5
Burden too high for small providers and/or inspections should be proportionate	5
Other	10
Total respondents	40

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

DHSC received information from only a small subsection of respondents to this question. Due to the small sample size, this information is not suitable to present in table form.

Note: we did not receive much feedback on the resources it takes for providers to comply with the 2009 regulations. However, we have included below cost estimates we may use to inform a future impact assessment.

The mean cost estimate from this small sample was £750 with a wide degree of variation. The median cost estimate was £400. Around two thirds of the responses analysed had costs below £500.

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?

Organisation type	Strongly agree	Agree	Disagree	Strongly disagree	Total
Independent providers	0	25	15	0	40
NHS providers	0	20	15	0	35
Other	0	5	5	0	10
Total	0	50	35	0	85

Summarised reasons given by respondents	Responses
Requirements are clear	5
Process is overly complicated and lengthy	10
Other	5
Total respondents	20

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

DHSC received information from only a small subsection of respondents to this question. Due to the small sample size, this information is not suitable to present in table form.

Note: we did not receive much feedback on the resources it takes for providers to comply with the 2009 regulations. However, we have included below cost estimates the department may use to inform a future impact assessment.

The mean cost estimate from this very small sample was £4,000. The median cost estimate was £2000.

Thinking about your most recent onsite inspection, who was involved in facilitating the inspection in your organisation?

DHSC received information from only a small subsection of respondents to this question. Due to the small sample size, this information is not suitable to present in table form.

Note: we did not receive much feedback on the resources it takes for providers to comply with the 2009 regulations. However, we have included below cost estimates the department may use to inform a future impact assessment.

The mean cost estimate from this very small sample was £2,000. The median cost estimate was £1,250.

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

DHSC received information from only a small subsection of respondents to this question. Due to the small sample size, this information is not suitable to present in table form.

Note: we did not receive much feedback on the resources it takes for providers to comply with the 2009 regulations. However, we have included below cost estimates the department may use to inform a future impact assessment.

The mean cost estimate from this very small sample was £2,500. The median cost estimate was £1,750.

Conclusion

The PIR was promoted on CQC’s provider notice board and therefore all registered providers had the opportunity to respond to the survey. However, the response to the survey was low and therefore the findings are only representative of those who responded and not of all registered providers. Responses to questions on all 3 sets of regulations that were covered by the survey raise both positives and negatives on how the Regulations meet their specific objectives.

There were responses to the survey that suggested that there are health and social care services being carried out that are currently out of scope of regulation and that CQC’s inspection process is disproportionate. As mentioned in the summary of responses, CQC’s new strategy strengthens its regulatory approach, moving to a more flexible approach for collecting information on providers enabling CQC to respond to risk and where people’s experience of care is poor, moving away from routine inspections and reducing the burden on providers.

Due to the low number of responses to the survey, it is not possible to conclude that the views provided in the responses to the survey are indicative of the whole health and social care sector.

However, in terms of the 2009 and 2014 Regulations, there is not sufficient evidence in the responses to suggest whether or not the objectives of both sets of regulations remain appropriate and whether there is an alternative system of regulation that imposes less regulation of the health and social care sector.

Responses relating to the 2018 regulations showed that the majority of respondents disagreed that the listed providers should be excluded from CQC’s ratings. DHSC is working with CQC to discuss whether there are some providers that need to be included in CQC’s ratings and whether an amendment is needed to be made to the 2018 Regulations to widen the scope of their requirement.

Providers’ responses to the PIR survey on all 3 sets of the Regulations will be fed into a wider piece of work DHSC will do to review and assess proposals to amend regulations relating to CQC’s oversight of regulated activities. If it is decided that amendments need to be made to secondary legislation, these will follow the applicable Parliamentary process, including an appropriate consultation.

DHSC would like to thank all the health and social care providers that took the time to complete the PIR survey, especially those providers that took the time to test the draft survey to ensure the questions were drafted in the right way.