Sticking to the day job

9 Jun 09
The new mega-regulator for health and social care has a huge task ahead, licensing a wide range of providers and ensuring standards of care. It will need to avoid mission creep and stay focused, argues Anna Dixon

By Anna Dixon

8th May 2009

The new mega-regulator for health and social care has a huge task ahead, licensing a wide range of providers and ensuring standards of care. It will need to avoid mission creep and stay focused, argues Anna Dixon

The UK’s new health and social care regulator, the Care Quality Commission, represents a world first in its size and scope. The CQC, which became fully operational on April 1, was formed from the merger of the Healthcare Commission, the Mental Health Act Commission and the Commission for Social Care Inspection.

Its inaugural chair, Baroness (Barbara) Young, has big ambitions for the body, saying it will ‘focus on improvement, not just bear witness to poor performance’. Speaking at the King’s Fund on April 23, she said she would lead an organisation that was not simply in the business of ‘naming and shaming’ or ‘punishing failure’ but one that was about helping the service to improve its service to patients.

The super-regulator takes on its responsibilities at a particularly difficult time. The quality and safety of care are prominent in the public’s mind following 90 deaths from the C-difficile superbug at Maidstone & Tunbridge Wells NHS Trust, the harrowing story of Baby P and the failures in care at Stafford Hospital.

Beyond the public services, financial regulators have come under fire for their lack of oversight of the financial and banking sector, raising doubts about the effectiveness of ‘light touch’ regulation.

So, how will this new regulator assure the public, patients and users that health and social care providers are safe and of high quality? How will it ensure it builds on the strengths of its predecessors and integrates regulation across the different sectors? How will it establish its authority in the complex and crowded arena of health care regulation? And how will it ensure that regulation is effective without being too heavy-handed?

The first major test for the new organisation will be to bring together the work of the three different regulators, harmonising their regulatory approaches and establishing common methodologies for risk profiling, assessment and inspection.

Given the tighter public spending environment, it is likely that the trend for reducing the size and cost of arm’s-length government bodies will continue. The CQC will have to make efficiency savings and prioritise its activities if it is to survive.

Yet even before it opened for business, it was given the extra task of assessing commissioners’ performance, in an amendment to the Health and Social Care Bill. And in its own documents, the CQC sets out an ambitious view of what it aims to do, including: giving patients the information to make choices and exercise greater control; identifying poor practice; giving information on the quality of care to help commissioners and providers improve services; and providing an independent account of commissioner and provider performance.

There is a danger that activities such as publishing data on hospital performance will detract from the regulator’s fundamental task, which is to license providers to guarantee that minimum standards of safety and quality are being met. Indeed, the government is investing significant money elsewhere to make this information available to patients through NHS Choices. The public will want to know an organisation is CQC-registered but beyond that there are other places where they can and should go for easy-to-digest data on their day-to-day concerns or questions about services. Patient information is not the commission’s job.

Under the Act creating the CQC, all providers of health care in England, including independent companies, will have to register with the commission from April 2010.

From 2011, this requirement will extend to primary care, including GPs, who have not previously been subject to such regulation. The case for bringing them into the regulatory system is based on perceived variation in service quality and a recognition that the policy of moving services out of hospitals and into community-based settings has increased the complexity of some primary care services.

The registration framework, which the government has already consulted on, demonstrated just how difficult it is to establish common standards across these diverse sectors. There is a danger in trying to develop a single framework and set of standards that they will be meaningless when applied in practice. Even within health care it is hard to envisage a common approach that can adequately cover large and complex multi-speciality providers such as acute tertiary hospitals as well as small private clinics and general practice.

The concern for those in social care – and mental health – is that they will take second place to health care and in particular the NHS. It will be a challenge for the regulator to demonstrate that it is giving sufficient focus to these areas of care, which have traditionally played second fiddle to the NHS. Political and media pressure will always focus on keeping hospitals clean and doctors surgeries accessible. The CQC will have to resist the temptation to follow the media gaze and public attention and keep focusing on areas that pose the greatest risk to the greatest number.

On the other hand, the providers of social care and primary care are much more numerous and so it will require an enormous logistical effort to get them registered. For an idea of the scale of the job, there are 8,000 GP practices, more than 18,000 care homes and a social care workforce of 1.6 million people.

The CQC will also be required to carry out performance reviews of all NHS trusts and foundation trusts and of care provided and commissioned by primary care trusts in England – termed ‘periodic reviews’. The main concern for providers is the likely burden of regulation and inspection, both in terms of data collection and reporting requirements.

Across government, there is an ambition to develop a more rational approach to regulation. The principles of this approach were set out by the Better Regulation Task Force and have been applied to the NHS. A specific aim has been to develop a ‘lighter touch’ approach that achieves a better balance between the costs imposed by regulation and the hoped-for benefits. This requires regulation to be risk-based, ie, more intense where risks are higher and vice versa.

The Healthcare Commission, one of the three predecessor bodies, introduced this sort of approach in 2005 – a more selective inspection regime, combined with self-certification of data returns by NHS providers. However, such regimes rely on the validity of the data submitted. In addition, the current financial crisis has exposed the weaknesses of relying on systems to ‘self-regulate’ with only minor interference from watchdogs and might suggest the need to find a different balance.

The CQC is expected to use a variety of data and intelligence through routine sources, the media, patient surveys and so on to build profiles of each organisation. However, it is likely to still do some on-site inspections in order to ‘sniff the breeze’ or ‘wipe our finger round the toilet bowl’ as Young phrased it. Under the Healthcare Commission, top performing trusts could earn the right to be inspected only every five years. But surely a regulator must carry out a minimum amount of physical inspection to maintain confidence in a service’s performance levels?

Getting the balance right between these regulatory tools will be the key to a good relationship between the new regulator and service providers. Too little involvement and situations such as at Mid Staffordshire could go unchecked; too much and the regime becomes too onerous for staff and becomes resented for taking time and resources away from the business of providing care.

These relationships will also be sensitive to the way the CQC uses its sanctioning powers. The regulator can issue warning notices, and penalty notices that impose fines and require organisations to remedy problems within a set time. If trust boards fail to comply with any enforcement action, then the secretary of state or, in the case of foundation trusts, Monitor, will have the power to intervene.

While the CQC’s message is that use of these sanctions will be seen as a failure on its part, it must be prepared to use them. Providers might fail to meet standards for many reasons but some are structurally flawed and closures might be necessary. There needs to be clarity about how the exercise of the CQC’s powers links with the recovery and failure regimes proposed recently by the Department of Health.

We will have to wait to see quite how willing the new body is to use those powers and whether they provide a sufficient threat to focus boards’ minds on quality as much as the consequences of financial failure.

There are different views about the role and ambition of the new regulator. Is a regulator there to set, monitor and enforce minimum standards or does its role extend to improving the quality of care? The CQC’s chair has made it abundantly clear that she thinks improvement in quality is at the heart of the CQC’s role. Indeed, included in the CQC’s ‘mission statement’ is an objective ‘to drive improvement and stamp out bad practice’.

But the Department of Health has described the registration function as the regulator’s ‘principal role’. The department clearly sees quality improvement as a major responsibility for strategic health authorities and primary care trusts. Health minister Lord Darzi’s review has strengthened SHAs’ role as the guardians and drivers of quality in the system and as performance managers of PCTs. Meanwhile, PCTs themselves will have to ensure quality through contracts and local intervention. It will be vital to align these activities with those of the CQC.

The creation of the commission and the task it aims to take on is hugely ambitious. So its focus needs to be very clear to stop it trying to be everything for everybody and spreading itself too thin. It must have regard to the context in which it will work, the roles of other actors and the cost-effectiveness of its action.

How will it fit with other players on what is already a crowded pitch? The existing concordat has not reduced the burden of regulation in the way that was hoped. There is now a real danger of history repeating itself, with all those involved in regulation, performance management and patient information bumping into one another as they jostle for position, with resulting duplication and confusion.

A vital first job for the new regulator is defining its relationship with other bodies working with the NHS to maintain standards. The CQC must seek quickly to build constructive relationships with these organisations. And, because it is the only body whose specific role is to assure the quality and safety of care for the public and patients, it must make this its first and foremost job.

Suitable case for treatment: the regulatory story

In health care, as in other parts of the economy, regulation was initially introduced to protect service users from incompetent practitioners. When medical licensing was introduced in 1858, the focus was on individuals. Regulators both licensed doctors and dealt with cases of malpractice reported to them — a responsive rather than a proactive role. This will change with the introduction of new requirements for doctors to be relicensed every five years.

From 1999 onwards, with the establishment of the Commission for Health Improvement, regulation began to focus on the performance of organisations. This followed the investigations into the failures at Bristol Royal Infirmary, which found that poor quality of care often reflected factors outside the control of an individual. Unlike the practitioner regulators however, the CHI inspected trusts with the aim of identifying places where clinical governance fell short. At the same time, the Health Act 1999 strengthened the responsibilities of the trust board to ensure that proper systems were in place. The role of the board/employer in relation to quality of care was new to health care but not to the wider economy, where responsibility for identifying and dealing with poor professional performance has always been a corporate responsibility.

The government introduced further changes to the regulatory structure by establishing the Commission for Healthcare Audit and Inspection (known as the Healthcare Commission. This brought together the NHS quality regulation role of the Commission for Health Improvement, the health value-for-money work of the Audit Commission and the private sector health care role of the National Care Standards Commission.

CHAI’s creation was intended both to strengthen regulation and to reduce the burden it imposed on providers. But pressures developed for further cuts in the number of regulators and, following reviews by the government and Department of Health, the Care Quality Commission was born.

Anna Dixon is director of policy at the King's Fund


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