Memorandum of Understanding between the Care Quality Commission (CQC) and the National Institute for Health and Care Excellence (NICE) Introduction
Introduction
1. This Memorandum of Understanding (MoU) sets out the framework to support the working relationship between the Care Quality Commission (CQC) and the National Institute for Health and Care Excellence (NICE). The MoU describes the nature of the joint working to safeguard the wellbeing of the public receiving health and social care in England.
2. The working relationship between CQC and NICE is part of the maintenance of a regulatory system for health and adult social care in England. The regulatory system promotes patient safety and high-quality care.
3. This MoU describes how both organisations will work together, in a co-ordinated way, to drive improvement in the quality and safety of care. It covers the guidance, advice and other products that NICE provides for the health and care system. It covers the support CQC provides for the development and implementation of NICE guidance, quality standards and indicators. The MoU covers the support NICE provides to CQC in order for CQC to fulfil its role in the regulation of health and social care services.
4. CQC is the independent regulator of health and social care in England. NICE’s core purpose is to improve health and wellbeing by putting science and evidence at the heart of health and care decision making. The responsibilities and functions of CQC and NICE are set out in Annex 1. Both organisations share a concern for the quality and safety of health and care services. CQC and NICE recognise that the development of models of health and care service delivery requires closer co-operation between the two organisations.
5. CQC's powers apply to England. This MoU applies in respect of the exercise of NICE's functions in England.
6. This MoU describes the circumstances in which CQC and NICE will aim to constructively engage and co-operate when carrying out their respective functions. The MoU also describes the processes through which both organisations will co-operate.
7. This MoU does not override the statutory duties, responsibilities, functions and reporting rights of CQC and NICE and is not enforceable in law. This MoU does not place extra legal responsibilities on either organisation. This MoU does not imply any transfer of responsibility from one organisation to the other, nor sharing of statutory functions or accountabilities. However, CQC and NICE are committed to working in ways that are consistent with the principles of this MoU.
Principles of co-operation
8. This MoU is a statement of principle, which supports our focus on promoting patient and public safety and wellbeing. Both organisations will develop more detailed operational protocols and guidance as required.
9. CQC and NICE intend that their working relationship be characterised by the following principles:
a. Able to make decisions which promote the delivery of safe and high- quality care.
b. Mutually supportive, respecting the statutory status and independence of both organisations.
c. Valued at the highest levels of both organisations, with visible leadership, clear lines of accountability, and a coherent corporate approach.
d. Open and transparent, with both organisations sharing information, where legally able to do so, to inform good decision-making and to minimise risk.
e. Efficient, with business processes designed to deliver outputs quickly, facilitate rapid communication between both organisations and to enable a collaborative approach to change and develop.
f. One that maintains public confidence in the two organisations.
Areas of co-operation and joint priorities
10. There are several areas of work where CQC and NICE need to work closely together to support safe, high-quality health and social care. The areas listed below cover core areas of ongoing work. Both organisations will continue with these areas, unless agreed otherwise (see section below on agreeing priorities).
Alignment to support achievable standards for high quality care
11. CQC issues guidance (as required by section 23(1) of the Health and Social Care Act 2008). This guidance sets out what providers can do to meet their obligations under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and the Care Quality Commission (Registration) Regulations 2009.
12. CQC makes independent, objective and evidence-based assessments about whether care is safe, effective, compassionate, responsive to people's needs and whether the organisation delivering that care is well led. CQC must conduct reviews of providers, assess their performance and publish a report of its assessment. Assessments rate providers on a four point scale of outstanding, good, requires improvement and inadequate.
13. To enable CQC to make robust and accurate assessments CQC has developed approaches to using and monitoring intelligence, inspections involving clinical and professional experts as well as experts by experience, and robust assessment frameworks that detail the key lines of enquiry used to gather the evidence. CQC and NICE will work together to ensure, where appropriate, there is alignment between NICE guidelines, interventional procedures guidance and quality standards, with the CQC's assessment frameworks. This will encourage achievable improvements in the provision of safe and high quality care and treatment.
Further detail is included in the joint statement in Annex 2.
Supporting the development of NICE guidance
14. NICE will work with key system stakeholders to identify priority areas across its portfolio to keep updated and develop new recommendations. CQC will contribute to the process, as a key stakeholder, as appropriate.
15. NICE's guidance and quality standard development processes includes many stages of stakeholder consultation. CQC will provide comments, as a key stakeholder, at these stages as appropriate.
Supporting assessment and improvement in the quality of care
16. CQC and NICE will work together to understand strengths and weaknesses in current practice and service provision. Both organisations will work together, in the exercise and co-ordination of their respective activities, to drive improvement where it is most needed. CQC provides:
- information from State of Care reports and thematic activity about current practice that help to inform guidance scoping, review and development.
- information from State of Care reports and thematic activity about current practice that help to inform reports on the uptake and use of NICE guidance, technology appraisals and standards and implementation issues.
17. NICE guidance, quality standards and associated measures will inform the CQC's existing methodology and assessment of providers. Information from NICE is referenced in CQC’s Guidance for providers on meeting fundamental standards. It is also included in provider and inspector handbooks and resources relevant to the regulation of services.
18. CQC and NICE will identify opportunities to collaborate on matters relating to risk and improvement at national, regional and system level, for example in relation to current Quality Surveillance Groups, Health and Wellbeing Boards and in future with other organisations as required (for example, Integrated Care Systems).
19. CQC and NICE will identify opportunities for potential collaboration on matters relating to environmental sustainability (ES). These will have a focus on assessing and supporting health and care providers in planning and acting to minimise the environmental impact of care delivery. For example, including ES objectives in NICE guidance which CQC may use to support its assessments of compliance with relevant requirements.
20. All Information sharing will be lawful and proportionate. Both organisations recognise that all processing of personal data (including the sharing of personal data) must be carried out under:
- the General Data Protection Regulation 2016
- the Data Protection Act 2018
- section 79 of the Health and Social Care Act 2008
- CQC’s Code of Practice on Confidential Personal Information (CPI) is published in accordance with section 80 of the Health and Social Care Act 2008
- the Human Rights Act 1998 and
- all relevant legislation and applicable Codes of Practice, frameworks or policies relating to confidential personal information and information sharing issues.
Both organisations agree that the sharing of personal data will be considered on a case-by-case basis and carried out in a manner consistent with the Data Sharing Code of Practice published by the Information Commissioner’s Office.
21. Both organisations recognise their responsibilities under the Freedom of Information Act 2000. Where either organisation receives a request under the Act for information received from the other, both organisations agree to take reasonable steps to consult on the proposed disclosure and the application of exemptions. But both organisations recognise the responsibility for disclosure lies with the organisation that received the request.
External communications
22. CQC and NICE will seek to give each other adequate warning of any planned announcements to the public, related to operating in accordance with this MoU. This includes any relevant and adequate information about planned announcements.
23. CQC and NICE will respect the confidentiality of any documents shared in advance of publication. CQC and NICE will not act in any way that would cause the content of those documents to be made public ahead of the planned publication date.
Cross-referral of concerns
24. Where CQC or NICE encounters a serious concern which it believes falls within the remit of the other, they will promptly convey the concern and relevant information to a named individual with relevant responsibility in the other organisation (see Annex 3). The receiving organisation will provide feedback on any action taken. This is to improve how CQC and NICE work together to improve the quality of care.
Agreeing Joint Priorities
25. In addition to the core ongoing areas of work described above, NICE and CQC will also build an annual discussion into the business planning cycle to review priorities. Both organisations will consider any new areas of work and the resources available to take them forward. Key areas that will form part of these additional joint priorities might include:
- data and Information (including artificial intelligence and digital health technologies)
- patient safety
- evolving models of care
- environmental Sustainability, CQC and NICE will identify opportunities for potential collaboration on matters relating to environmental sustainability (ES)
- health inequalities, CQC and NICE will identify opportunities for potential collaboration on matters relating to health inequalities (HI)
26. Both organisations will identify and share developments which may impact on existing areas of joint working as listed above. Both organisations will also discuss and identify new potential areas of joint working that may emerge from associated initiatives. This will be as part of the monitoring and arrangements for engagement described below.
27. NICE and CQC will endeavour to take into account the work of other Arm’s Length bodies and key national organisations. Both organisations will include these in setting priorities and areas of joint work.
Monitoring and Arrangements for Engagement
28. The Chief Executives of NICE and CQC will meet on an annual basis to consider strategic issues. They will review the operation of the MoU and matters of relevance to strategic business planning.
29. NICE and CQC Strategic Oversight Group will meet at least twice a year. Members of the group will include;
- CQC Deputy Chief Inspectors (relevant Deputy Chief Inspectors, as required)
- CQC Director of Policy and Strategy and
- NICE Director of Health and Social Care.
30. The NICE and CQC Strategic Oversight Group will review plans and address any issues arising from each organisation. From this meeting NICE and CQC will identify specific areas of joint work. NICE and CQC will take forward identified work via task and finish groups, convened of members from one or both organisations.
31. The NICE and CQC Strategic Oversight Group will facilitate any new contacts required and generally seek to coordinate links. The group will agree a programme of meetings. The relevant lead contact persons in each organisation will put these meetings in place.
32. Other regular meetings and information exchanges relating to individual products or programmes can take place on an ad hoc basis. Either NICE or CQC may complete exceptional meetings or information exchanges to address a particular concern.
Resolution of disagreement
33. In the first instance, CQC and NICE will resolve any disagreement between the two organisations at appropriate working levels. If this is not possible, each organisation may make a referral through those responsible for the management of this MoU. This includes up to and including the Chief Executives of CQC and NICE. They will then be jointly responsible for ensuring a mutually satisfactory resolution.
Duration and review
34. This MoU commences on the date of the signatures below. It is not time-limited and will continue to have effect unless the principles described above need to be altered and/or cease to be relevant.
35. This MoU will routinely be reviewed every two to three years. CQC and NICE may review this MoU at any time at the request of either party. However, any alterations to the MoU will need both parties to agree.
36. It is however acknowledged that both organisations are at a crucial stage in the development of new strategies. It is proposed that an extra review is undertaken within the first 12 months. This will ensure alignment in the context of these new strategic directions.
37. Our aim for this agreement is to have an enduring document, which describes how we intend to conduct our relationship. We will add to this via the annual planning process, and the strategic planning process, described above.
38. Both organisations have identified a person responsible for the management of this MoU (known as ‘Relationship Leads’). Their contact details are set out in Annex 3. Relationship Leads will liaise as required to ensure that:
a. this MoU remains up to date
b. they identify any emerging issues in the working relationship between the organisations
c. they resolve any questions that arise about the interpretation of this MoU.
Signatures
Original document signed by:
Ian Trenholm
Chief Executive
Care Quality Commission (CQC)
Gillian Leng
Chief Executive
National Institute for Health and Care Excellence (NICE)
Date: 29 April 2021
Annexes
Annex 1: Responsibilities and functions of CQC and NICE
Care Quality Commission
The Care Quality Commission (CQC) is the independent regulator of health and adult social care in England. It also monitors the use of the Mental Health Act 1983 and protects the interests of vulnerable people including those whose rights are restricted under that Act. Its purpose is to make sure health and social care services provide people with safe, effective, compassionate, high-quality care and to encourage them to improve.
CQC does this by:
- registering
- monitoring
- inspecting
- rating regulated services
- issuing enforcements against regulated services and registered persons where required
- using our Independent Voice to publish reports and highlight major issues and
- regulating the following health and care services
- hospitals (including acute, mental health, community health and ambulance services)
- adult social care services
- dental practices
- general practices and doctors
- other care services in England.
This is to make sure they meet fundamental standards of quality and safety. We set out what good and outstanding care looks like. We make sure services meet these standards, which care must never fall below. We take action to hold registered persons to account and to drive improvements in quality and safety.
To do these things CQC:
- registers providers against national standards of quality and safety. These are the standards that providers have a legal responsibility to meet and people have a right to expect whenever or wherever they receive care.
- regulates, monitors and inspects providers against those standards, carrying out inspections regularly, at any time in response to concerns. CQC also carries out themed inspections, themed reviews and specialist investigations based on particular aspects of care.
- takes action if a provider is failing to meet the standards, using a range of civil and criminal enforcement powers. These include:
- using requirement notices or warning notices to set out what improvements the care provider must make and by when
- making changes to a care provider's registration to limit what they may do, for example by imposing conditions for a given time
- placing a provider in special measures, where we closely supervise the quality of care while working with other organisations to help them improve within set timescales
- hold the care provider to account for their failings by
- issuing simple cautions
- issuing penalty notices (fines)
- prosecuting cases where people are harmed or placed in danger of harm.
- involves people by working with local groups, national organisations and the public. This is to make sure that the views and experiences of people are at the centre of what CQC does.
- publishes information and ratings on:
- the quality and safety of services
- national reports on key themes and
- reports on the state of care.
CQC reports publicly on what it finds. This includes performance ratings for care providers, to help people choose care and encourage providers to improve. CQC also reports annually to Parliament. The annual report is on the overall state of health and adult social care in England.
National Institute for Health and Care Excellence
NICE was established as a non-departmental public body in the Health and Social Care Act 2012. Their statutory role and responsibilities are set out in 2013 Regulations.
Over the past 21 years NICE has established itself as an international leader in technology evaluation, guideline development and evidence synthesis. Their work today spans three ecosystems (life sciences, guidelines, and information) that involve close working with partners to ensure patients have access to the latest technologies, advice and guidance.
In 2021, NICE published a new strategy that sets out their strategic priorities for the next five years with respect to:
- rapid, robust, and responsive technology evaluation: providing independent, world-leading assessments of new treatments at pace, quickening access for patients, and increasing uptake
- dynamic, living guideline recommendations: creating and maintaining up-to-date guidance that integrates the latest evidence, practice, and technologies in a useful and useable format
- effective guidance uptake to maximise our impact: working with our strategic partners to increase the use of our guidance, monitor adoption and measure impact on health outcomes and health inequalities
- leadership in data, research, and science: becoming scientific leaders by driving the research agenda, using real world data to resolve gaps in knowledge and drive forward access to innovations for patients
Annex 2: Joint working statement
In its regulatory approach, CQC considers evidence of how registered persons have met the fundamental standards. In doing this, the CQC will consider the processes providers have to ensure that they are following NICE guidelines, quality standards and interventional procedures guidance to improve the quality and safety of care they provide, both within their organisations and across the systems in which they work.