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Public law and Regulation

Case reports and guidance on public law and professional regulation issues

15 APR 2013

The Francis Report – what next for healthcare regulation?

The publication of the Francis Report on 6 February 2013 was awaited with significant apprehension across the medical community. The first report was scathing about the care received by those individuals who suffered as a result of the dreadful care they received in Mid-Staffordshire NHS Foundation Trust from 2005 to 2009. This second inquiry was designed to look more broadly at the events surrounding this episode, and encompassed management not just within the hospital but also the role of the regulatory bodies involved, from the Care Quality Commission (CQC) to the regulatory bodies of the medical professions. Crucially, Robert Francis QC has noted that the scandal of Stafford Hospital suggest that similar events could occur elsewhere, such that fundamental intervention is required at all levels of the NHS.

This article will focus on Francis' findings and recommendations in relation to these bodies, but the report goes much further. In his 290 recommendations, Francis recommends root and branch changes to patient care. He places significant emphasis on the culture of care which should exist within the NHS and which has, sadly, at times been found to be lacking. His recommendations cover all levels within the NHS, from the healthcare assistant to the hospital board; from entry-level requirements in nursing to potential criminal liability for managers; in his own words, ‘from porters and cleaners to the Secretary of State'.

Regulatory bodies - problems identified by the Francis Report

The key concern Francis identifies in relation to regulators is their inability to communicate effectively, both between themselves and with other bodies involved in healthcare provision, and their lack of pro-active engagement with issues relating to patient care. The responsibilities of what should be complementary agencies were not well defined, leaving gaps in regulation. The organisations concerned include the CQC, the General Medical Council (GMC) and the Royal College of Nursing (RCN). Francis notes that the ‘warning signs' that something was deeply wrong within Mid-Staffordshire were rarely communicated between the bodies responsible for regulating those concerns. There were multiple opportunities for warnings to be made and action to be taken, including the downgrading of the Trust's rating by the Healthcare Commission (HCC), worrying peer reviews, auditors' reports revealing serious concerns about management and damning patient surveys. Perhaps of greatest concern should be the formal investigation conducted by the HCC, described by Francis as ‘an unusual event, only embarked upon where there was serious cause for concern.' Even though this clearly raised issues which should have interested other regulatory and oversight bodies, they chose to await the outcome of the investigation, rather than taking steps to ascertain the state of patient care and whether any action should be taken on their part. In short, although the warning signs of system problems within the Trust existed, those responsible for regulation and oversight failed to take any form of pro-active measure in relation to this. Information was not shared on a sufficiently regular basis, and when it was it related only to matters of concern, preventing those responsible from building a wider picture of what was happening within the Trust. Too great comfort was taken in the sense that others were responsible for the emerging problems.

Francis also considers the role of both regulators and their regulatees in greater detail. Although its role is now played by the CQC, it is important to note the criticisms made of the HCC, as these form the background of Francis' assessment of the CQC and recommendations made in relation to it. The HCC has already been subject to much criticism and the CQC was established under very different terms, but Francis makes a number of remarks which will be important for the future formulation of regulatory structures and standards.

The core standards used by the HCC in assessing hospitals are criticised on the basis that they were simply handed down by Government, and lacked input from those to whom they would apply and be enforced by. This led to disengagement between the assessment process and hospital staff when, to be effective, regulation requires involvement and endorsement. The standard-setting should be more transparent and capable of being understood by patients, staff, the public and those who apply them. Furthermore, a more independent approach to standard-setting would minimise the appearance of the system as being too closely linked to the Department of Health. The structure of the standards also came in for criticism, both for being a ‘confusing mixture of the general and the specific' and for over-extending themselves in their ambition to provide a minimum standard, target particular areas of Government interest and provide benchmarks to allow the public to make comparisons between providers. The assessment process should not have relied on self-assessment and self-declaration, as this quite clearly left too much room for problems to be overlooked. Francis describes the system as having ‘discouraged intervention' and notes that the central collection of information allowed smaller pieces of crucial information to be overlooked.

Francis also examines the CQC, successor to the HCC (as well as the Commission for Social Care Inspection and Mental Health Act Commission). This new regulatory model is described as ‘encouraging', particularly due to new methods of dealing with information, but there is still room for improvement. The practical difficulties of transferring the roles and responsibilities of three organisations to one body, at the same time as setting up a new system of registration and monitoring, seems to have cast a shadow over the work of the CQC. It is said to have trouble dealing with concerns raised internally, and is described as having a ‘defensive institutional instinct' where it should be open to constructive criticism. In terms of the regulatory structure, Francis recognises improvements in the pro-active nature of reviews, but finds that the CQC is not sufficiently responsive to patient information and feedback, which are not given enough importance as sources of information.

The standards it is guardian of still suffer from difficulties: the combination of different concepts such as ‘welfare' and ‘safety' into one regulatory requirement clouds the aims of the standards. Perhaps as a result of this, they are said not to attract a great deal of attention on the frontline of healthcare. Francis criticises the current standards on the basis that they are ‘over-bureaucratic and fail to separate clearly what is absolutely essential from that which is merely desirable'. More fundamentally, the perception that they form a ‘top down' system is damaging; there is a need for greater patient and clinician involvement, which again links to the importance of engagement and participation.

As regards GPs, he notes that local doctors only raised concerns about the hospital once the HCC investigation had been announced. Whilst he is careful to note that they were under no duty to do so and should not be subject to criticism, he suggests that in future GPs should be expected to monitor local facilities in this way. He notes that ‘a GP's duty to a patient does not end on referral to hospital, but is a continuing relationship', adding that ‘they have a role as an independent, professionally qualified check on the quality of service, in particular in relation to an assessment of outcomes.'

The professional regulatory bodies come in for criticism too. Their isolated way of working, with entirely separate standards and sanctions means that one incident of poor patient care could lead to different systems dealing with different parties and potentially inconsistent outcomes. In the case of Mid-Staffordshire hospital there was a lack of referrals to the regulatory bodies, either from the Trust itself or from patients. As such, it would be desirable for the regulatory bodies to have greater capacity to launch investigations even where no individual has been referred to them.

Recommendations

Francis makes a number of overarching recommendations which should impact on the work of the various regulatory bodies. First and foremost is the emphasis on openness, transparency and candour at all levels. Francis recommends that this should be underpinned by a statutory obligation and a new criminal offence of obstructing performance of these duties or dishonestly or recklessly making an untruthful statement to a regulator. Also key is the need for information to be accessible and useable by those within healthcare organisations, bodies dealing in regulation and oversight, patients and the public more generally, with greater weight being given to complaints. The CQC would have responsibility for monitoring the accuracy of information published by providers and commissioners in relation to standards and compliance.

Of particular relevance to regulators is the key recommendation of regulatory simplification. That regulatory bodies have overlapping functions but nevertheless operate within silos between which there is little effective communication is a key problem to emerge from the report, and Francis recommends that the regulation of the governance of healthcare providers and fitness to be a director, governor or equivalent should become the sole responsibility of the CQC, rather than awkwardly split between the CQC and Monitor. The CQC would be able to impose a code of conduct upon healthcare managers, who would have to demonstrate that they were ‘fit and proper' to hold their positions. It would also take on responsibility for overseeing governance and financial sustainability. Importantly, he is careful to stress that this should not be seen as an excuse for cutting the resources available in this area. Furthermore, it is also recommended that the CQC take over responsibility for bringing prosecutions from the Health and Safety Executive.

Another key suggestion is the commitment to one set of common values throughout the healthcare system, to be found in the NHS Constitution, which should also refer to the professional standards and codes of conduct applicable across the NHS. For the sake of clarity, there should be three categories of standards: fundamental standards to govern all services and providers; enhanced quality standards to be defined and enforced by the commissioners of services; and developmental standards to regulate longer term goals. As suggested by the criticisms discussed above, standards should be developed through a ‘bottom up' approach to bolster confidence in them, with the involvement of healthcare professionals and patients. The CQC would also have the power to take immediate protective action in the interests of patients' safety.

For professional regulatory bodies the emphasis is on ensuring that information is both widely available and acted on promptly and pro-actively. Patient safety must be the key focus of training and education. The GMC and NMC should both have policies as to when they should be informed of generic complaints, and there should be greater liaison with the CQC. Procedures should be put in place to allow for a common independent tribunal to determine fitness to practise cases where an issue has implications across the professions.

For regulatees, the most significant change is perhaps the recommendation that a failure to comply with a standard which then results in death or serious harm should be capable of being prosecuted as a criminal offence. This is in addition to the new offence of failing to fulfil the duty of candour, noted above.

Francis also makes recommendations as to the internal workings of the professional regulatory bodies: he suggests that the NMC introduce a revalidation system like that already in use at the GMC, requiring nurses to show on a regular basis that they remain fit to practise. A further recommendation is for an aptitude test for registered nurses to allow consideration of their capacity for care and compassion, and that nurses' training be more practical. There should also be a new category of registered older person's nurse, in response to the particular considerations of caring for the elderly. The RCN is encouraged to separate its trade union and professional representation functions. Significantly, Francis recommends that healthcare workers should be subject to registration requirements.

Next steps

The Government has responded positively to the report of the Francis Inquiry. In a statement to the Commons, the Prime Minister stated that the government will study the recommendations and respond in detail next month. In the meantime though, action should be taken on the three core areas identified by the report: patient care, accountability and defeating complacency. David Cameron made a number of commitments to immediate action. Most relevant to this article is his commitment to ask the Law Commission, already undertaking a significant review of the regulation of health and social care professionals, to advise on reforming the ‘outdated and inflexible' decision-making process of the NMC. He promised to look closely at the recommendation to transfer the right to conduct criminal prosecutions from the Health and Safety Executive to the CQC.

That the Prime Minister, rather than the Secretary of State, responded to the report in this way illustrates just how seriously the government are taking this matter. It is to be hoped that this is a good omen for a positive and inclusive approach to putting the recommended reforms in place.

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