The last few weeks have seen the launch of two consultations which map out the forthcoming wholesale re-design of the regulation of the health and social care sector in the wake of the Mid Staffordshire Inquiry and the scandal at Winterbourne View:
- A New Start – a CQC consultation was published on 17 June 2013
- Strengthening corporate accountability in health and social care – a Department of Health consultation was published on 4 July 2013.
The CQC consultation is open until 12 August 2013 and the DH consultation until 6 September. The consultations propose extensive changes to how CQC will operate which impact, in different ways, not only on the NHS but the entire health and adult social care sector. All care providers are encouraged to respond to the consultations to ensure their voices are heard in the design of the new regulatory system.
Issues covered by the consultations include:
- The new standards of care CQC will apply;
- A new 'fit and proper person' test for all directors of health and social care providers;
- CQC’s proposals for surveillance and monitoring of quality and safety of care;
- The move to more expert inspection teams;
- New enforcement powers;
- The introduction of care ratings.
The consultations map out an extremely ambitious programme and some changes will take up to three years to implement. However, the changes will be introduced in phases:
- From July 2013 - changes will be made to introduce a more robust test, at the time of initial registration, for providers whose ability to deliver quality care is less clear. CQC state this will initially be introduced from July 2013 for providers wishing to offer services to people with learning disabilities (and from October 2013 for other providers applying for registration). The CQC consultation states that providers will be required, at the point of registration, to make a commitment to “deliver safe, effective, compassionate, high-quality care” and that named directors or leaders of providers will be personally held to account for that commitment. Part of this is likely to include a greater focus on quality governance at the point of registration. However, the consultation is not clear how CQC proposes to hold individual directors to account in this way.
- From October 2013 - CQC will begin introducing changes in the way it inspects acute hospitals (in both the NHS and independent sectors) – part of this will include publishing quality ratings in shadow form (from December 2013) pending the passing of legislation by Parliament.
- In 2014/15 - CQC will introduce changes to the way it inspects all services for people with learning disabilities and mental health issues. It is presumed that there will be a further consultation regarding these changes. However, unlike for adult social care services, CQC has not expressly set out a proposal to consult separately upon its plans to inspect and regulate mental health services.
- Also in 2014/15 CQC will change the way it inspects adult social care services (including the introduction of quality ratings). CQC have indicated they will consult separately upon their proposed regulatory approach to the adult social care sector in Autumn 2013.
- From April 2014 the requirements regarding 'fit and proper' directors will come into force.
- In 2015/16 – CQC will make changes to its inspection (and introduce ratings) of community healthcare and ambulance trusts.
CQC state that they have not yet decided whether they will introduce ratings systems for dental practices and providers of cosmetic surgery, although a ratings system will be developed for general practice.
The changes to the required standards which CQC propose will be applicable to all services regulated by CQC from the largest NHS acute trusts to small domiciliary care providers.
As part of his report in the Mid Staffordshire Inquiry, Robert Francis QC called for a reform of CQC’s Essential standards of quality and safety which he described as beaurocratic and not being of sufficient relevance to clinicians or patients. Robert Francis set out a call for the introduction of what he called “fundamental standards”, below which the standards of care should never fall, to be expressed in language both the public and professionals understand.
CQC are implementing Robert Francis’ recommendation and proposing to introduce what they call 'Fundamentals of care'. However, in addition to the 'Fundamentals of care', CQC also propose to introduce a new set of 'Expected standards' and, for the purpose of preparing ratings, to have regard to standards of 'High-quality care'.
There is a danger, therefore, that the standards used by the regulator will not be quite as simplified a picture as Robert Francis envisaged. However, in terms of what standards are legally required, CQC propose that this will be limited to the 'Fundamentals of care' and 'Expected standards'. In contrast, standards of 'high-quality care' will be matters of good practice, developed by organisations such as NICE and the Royal Colleges, which CQC will take into account in setting quality ratings, but which will not result in enforcement action for non-compliance.
It is worth considering what the CQC consultation says about the legally required standards a little further:
Fundamentals of care
Drawing on Robert Francis’ recommendations in the Mid Staffordshire Inquiry, CQC state that these represent "a clear bar below which standards of care should not fall” and that “anyone should be able to recognise a breach of the fundamentals of care, even in the absence of specific guidance”. Also in line with Robert Francis’ recommendations, CQC propose that breaches of the 'fundamentals of care' will enable it to bring a prosecution of the provider without the need to issue a prior warning notice. In terms of the content of the 'fundamentals of care' CQC expand upon the list suggested by Robert Francis and propose the following standards:
- I will be cared for in a clean environment
- I will be protected from abuse and discrimination
- I will be protected from harm during my care and treatment
- I will be given pain relief or other prescribed medication when I need it
- When I am discharged my on-going care will have been organised properly first
- I will be helped to use the toilet and to wash when I need it
- I will be given enough food and drink and help to eat and drink if I need it
- If I complain about my care, I will be listened to and not victimised as a result
- I will not be held against my will, coerced or denied care and treatment without my consent or the proper legal authority.
CQC are proposing a move from their current 16 Key Outcomes to a system of inspecting every service against five key questions:
- Is it safe?
- Is it effective?
- Is it caring?
- Is it responsive to peoples’ needs?
- Is it well-led?
CQC will develop, and consult upon, guidance as to how they will reach their judgements on these five questions and indicate that this guidance will be tailored to the differing needs of the different sectors it regulates. It needs to be borne in mind, however, that the way in which this consultation is drafted has a very acute sector focus:
- Safe – CQC state that “by safe, we mean that people are protected from physical, psychological or emotional harm”. It is notable that no reference is made here to the possibility of financial harm/abuse but, presumably, CQC will take such matters into account when inspecting the social care sector. Matters which CQC will take into account in deciding whether services are safe include rates of hospital-acquired infections and whether there are sufficient qualified, skilled and experienced staff to meet peoples’ needs – it is of course a recommendation of the Mid-Staffs Inquiry and the government’s response that judgements on staffing levels will be informed by evidence based guidance.
- Effective - CQC state that this means ensuring that “peoples’ needs are met, and their care is in line with nationally-recognised guidelines and relevant NICE quality standards”.
- Caring - this will involve ensuring “people are treated with compassion, respect and dignity and that care is tailored to their needs”. CQC state that their approach to monitoring caring services will be informed by the extent of compliance with the Department of Health’s and NHSE’s policy “Compassion in Practice”.
- Responsive - CQC state that this means that “people get their treatment and care at the right time, without excessive delay, and that they are listened to in a way that responds to their needs and concerns”. In the context of acute services, this question may be largely dependent upon waiting times. However, an example of the way in which the questions will be tailored differently to different sectors can be seen in that, for primary medical services, CQC may consider whether, for example, a surgery is open at times to suit the needs of the local population whereas, in care homes, the question of responsiveness may be determined by, for instance, ensuring residents’ care plans properly address their personal preferences and changing care needs.
- Well-led - CQC state that this means that “there is effective leadership, governance (clinical and corporate) and clinical involvement at all levels of the organisation, and an open, fair and transparent culture that listens and learns from peoples’ views and experiences to make improvements”.
CQC indicate that they will issue draft guidance on how to meet to expected standards, when the Department of Health issues draft regulations to incorporate these standards, in the autumn. However, it appears that there will be no 'tick box' approach to compliance and regulation will be based more on professional judgements made against the five key questions.
Failure to comply with the “Expected standards” will result in CQC taking action to require improvements to be made. In the context of NHS providers, the consultation also sets out some further detail of the single failure regime by which, if services fail to improve following input from the trust, and subsequently Monitor/the NHS Trust Development Authority, CQC will be able to require the appointment of a special administrator over the providers’ services.
Perhaps the most striking shift in the proposed move from the 16 Key Outcomes to the five key questions is the CQC’s increasing focus upon governance (both quality governance and corporate governance) within provider organisations. Providers should expect far greater scrutiny of their governance systems and to be able to evidence those systems, with particular focus upon engagement with staff and patients, openness and transparency, and appropriate supervision and training of staff. It is also clear that, in future, providers will be well advised to devise their quality assurance systems around CQC’s five key questions.
Fit and Proper Person Test
The Department of Health consultation proposes to increase accountability of individual directors by the introduction of a 'fit and proper person' test. DH state that they are proposing to introduce an amendment to the CQC registration requirements so that all directors appointed to the "Board” of any care organisation regulated by CQC are suitable for the job. This begs a number of questions upon which the consultation seeks input including:
- How to define which positions these new requirements will apply to (should it only relate to Board directors or other officers within the provider?).
- What is meant by a “fit and proper person”? The consultation points out that this could include not only matters relating to financial background and honesty and integrity, but also issues of the individual’s competence and capability.
The proposals in the Department of Health consultation are that CQC would enforce the 'fit and proper' person test by deeming certain individuals to be unfit, and then action would be taken against the provider on the basis of a breach of registration requirements. Further, it is proposed that CQC would be able to impose conditions of registration requiring the provider to remove an 'unfit' director. However, the consultation states that, although CQC will keep a record of decisions taken, “an individual would not be deemed to be universally unfit and while unfit in one role may be fit in another”; it is unclear whether this simply means that an individual deemed 'unfit' to be a director may be fit to work in some more junior role, or whether, despite being deemed to be 'unfit' to be a director of one organisation, an individual may be regarded as fit to hold a director's post in another organisation. Although it is far from clear, it appears that the consultation may envisage the latter which would mean that there would be no definitive list of individuals who are regarded as 'unfit' to be directors of CQC registered providers.
In contrast, and as a further level of complexity, for NHS trusts and foundation trusts, the Department of Health is proposing to introduce a barring scheme which will prevent senior NHS managers and leaders moving to new positions elsewhere within the NHS system.
How CQC will inspect and regulate Acute Hospitals
Section 3 of the CQC consultation sets out CQC’s proposals for its on-going monitoring and surveillance, and issuing of ratings, in relation to NHS and independent sector acute hospitals. CQC propose to use three tiers of indicators with their primary monitoring of services being based upon the “Tier 1” indicators. The Tier 1 indicators comprise a range of qualitative and quantitative data such as mortality rates, never events, and certain results from NHS staff and patient surveys, as well as information from whistleblowers, members of the public, and information shared at Quality Surveillance Groups.
If CQC become aware of a concern as a result of a Tier 1 indicator, this will prompt them to review a wider range of intelligence (Tier 2 indicators) such as information from National Clinical Audits, further patient and staff survey results and information from accreditation schemes. CQC will use this information to help them understand issues raised by the Tier 1 indicator and decide upon key lines of enquiry for any further inspection they may carry out.
This part of the consultation is of particular relevance to NHS acute providers as CQC set out their proposed Tier 1 indicators for acute NHS trusts at the annex to their consultation document. It remains to be seen, however, what indicators are proposed in relation to independent sector acute hospitals and mental health services.
Expert inspection teams
Another of the outcomes from the Mid Staffs Inquiry was a recommendation that CQC should move away from generic inspectors to more expert inspection teams. CQC is adopting this proposal and going further through the appointment of a number of Chief Inspectors. Professor Sir Mike Richards has already been appointed as the Chief Inspector of Hospitals, and CQC is in the process of recruiting Chief Inspectors for Social Care and General Practice.
The CQC consultation makes it clear that, as part of the move towards more expert inspection, there will be a number of practical changes. These include:
- Carrying out inspections at nights and at weekends in services that provide 24 hour care, as CQC is concerned there is often less supervision and people can experience poorer care at these times.
- In mental health services – greater alignment between CQC’s inspection activity and Mental Health Act activity, and more involvement of the Experts by Experience in Mental Health Act monitoring.
- An increasing focus on the Mental Capacity Act - to ensure that "its principles are promoted and people with mental capacity issues receive care of the same standard as anyone else”.
In addition to providing some details of the three stage single failure regime to be applied to NHS providers, the CQC consultation also highlights ways in which CQC’s enforcement powers will be extended for all providers across the health and social care sector. These include:
- Direct prosecution of providers breaching 'fundamentals of care';
- Accountability for Board members failing to provide safe, high-quality care. The consultation states that the Department of Health will shortly publish a separate consultation providing details of the proposed changes, including the introduction of a new 'fit and proper person' test for directors of boards.
- A statutory duty of candour - the consultation makes it clear that, once the statutory duty of candor is introduced by the Government as a CQC registration requirement, CQC will have the power to prosecute an organisation for breaching the duty, without having to issue a Warning Notice first.
The CQC consultation sets out CQC’s proposed timetable for the introduction of quality ratings as follows:-
- From December 2013 - acute service providers (NHS and independent sector);
- During 2014 - mental health trusts;
- 2014/15 - adult social care aervices;
- 2015/16 - community healthcare and ambulance trusts and primary medical care
The consultation gives the first insight into how CQC’s care ratings system will work albeit specifically in relation to NHS acute trusts. It remains to be seen to what extent the ratings system will differ for other types of services although, in order to provide clear information for the public, it is presumed a similar approach will be followed in the ratings awarded to services in other sectors.
It is stated that CQC’s ratings will be primarily based upon its inspectors’ judgements on the five key questions (safe, effective, caring, responsive and well-led) but may also use information from accreditation schemes, findings of clinical audits, or inspections by other organisations such as the Royal Colleges.
CQC is proposing a four point rating scale (from 'Inadequate' to 'Outstanding') and, for acute trusts, it is proposing to issue a rating against each of the five key questions at the level of each individual service, as well as at a hospital and whole trust level. It is interesting to note that CQC acknowledge that breaches of 'fundamentals of care' will not prevent a 'good' rating at a hospital or trust level, as long as those breaches are rare and arise from isolated human error as opposed to a systemic failure within a service.
It is proposed that the hospital-level rating will determine the minimum frequency of inspection with “'outstanding' hospitals receiving inspections every three – five years; 'good' hospitals every two – three years; hospitals where 'improvements are required' at least once a year; and those rated as 'inadequate' as and when needed”.
These consultations mark an extremely important moment in defining the nature of quality regulation right across the health and social care sector. All providers in the care sector are encouraged to respond to ensure their voices are heard in the way the new regulatory system is designed.
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