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All things Pharma

Three become one: healthcare’s new monitoring body

It is hoped that a single system for monitoring healthcare will streamline the process across different sectors. Thoreya Swage takes a closer look at the new regulatory body – the Care Quality Commission.

The Government is up to its favourite pastime of re-arranging the NHS landscape. This time it is not the structures that commission or provide services, instead, it is the organisations that monitor the quality of healthcare.

The arguments put forward for this reorganisation are that there needs to be greater coherence in the approach to the regulation of health and social care across all the sectors, to strengthen assurance about the quality and safety of services and, of course, to save public money through the integration of three of the public service inspectorates.

The current system for the regulation of the differing care sectors is provided by three separate organisations; the Healthcare Commission, for healthcare providers; the Commission for Social Care Inspection, for social care providers and the Mental Health Act Commission, to ensure compliance with the Mental Health Act. In addition to having differing regulatory functions, these three bodies have differing powers of registration and enforcement.

Work is underway to establish a single body, the Care Quality Commission, to streamline the regulatory and registration processes for the different care sectors. The plan is to set up the Commission in a shadow form in October 2008 and will go live in April 2009 under the Health and Social Care Bill.

What will the Care Quality Commission do?

The Care Quality Commission will be responsible for regulating health and social care services that spend over £100 billion of public money and involve about 2.9 million people, employed in over 2,500 settings.

The aim of the Care Quality Commission is to have a consistent approach and use one regulatory framework across the sectors.

Proposed functions of the Care Quality Commission

• Register healthcare organisations, including NHS providers (currently only independent sector healthcare providers have to be registered).
• Register social care providers.
• Monitor compliance with registration requirements.
• Have greater enforcement powers to ensure that all service providers meet their registration obligations.
• Assess the performance of commissioners, including the PCT commissioning functions.
• Assess the performance of providers and publish information about public accountability and help people make choices about services.
• Review regularly the Mental Health Act.
• Reduce the burden of regulation by implementing a proportionate and single approach, e.g. use information from existing resources.
• Conduct service reviews.
• Publish an annual report on the activities described above.

Current consultation on set up of the Care Quality Commission

There is a current consultation underway (due to close on 17th June 2008) which is seeking views on a number of key areas. These include: which health and social care services should need to be registered, the requirements for registration, when should registered providers have to have in place a registered manager and the inclusion of GP and dental services.

The requirements for registration

• A single set of high level requirements for registration covering all health and adult social care services.
• The current standards, Standards for Better Health (which apply to healthcare) and the National Minimum Standards (which apply to social care and independent sector providers), will be replaced by the ‘registration requirements’ which are set by the government in secondary legislation.
• The key requirements are to demonstrate that services are safe, that people are not put at risk of harm and that essential levels of service quality are maintained.
• Registration is granted when providers can meet the registration requirements.
• Registration is maintained by continuing demonstration to meet the registration requirements.
• Failure to comply with the registration requirements may mean sanctions (including fines), restriction or closure of the services.

The scope of registration is wider than the original requirements of the predecessor organisations and the new system will come into effect from April 2010 (the exception being the enforcement of the regulations for the NHS on healthcare associated infections which come into effect during 2009/10).

The principles for registration centre on risk to users of the service and broad categories of services, rather than type of service provided.

Scope of registration

• Services that include activities with the greatest inherent risk of harm are priorities for regulation by the Care Quality Commission.
• Most of the current services covered by the Commission for Social Care Inspection and the Healthcare Commission will continue to be included.
• NHS organisations are to be registered for the first time (including primary care).
• Activities rather than individual services are the main emphasis for registration.
• The list of activities to be registered are to be reviewed as new services are developed by the provider.
• Account will be taken of the increasing integration between health and social care.
• Greater clarity on when registration is required by potential providers.

How will the Care Quality Commission be set up and work?

The new Commission has its work cut out; it needs to maintain the work of the three predecessor bodies, whilst establishing a new registration process and absorbing the cultures of these organisations. It also needs to clarify its role in relation to that of Monitor, the Foundation Hospitals’ regulatory body, as there may be duplication of effort when it comes to intervening with a failing Foundation Trust.

The shadow organisation already has an indentified chair, Baroness Young, who has stated that her priorities are to set up the Care Quality Commission and to maintain the momentum of the three current bodies. Some of the new functions will be phased in, such as the enforcement powers for healthcare associated infections (2009/10), the new registration system (2010/11) and registration of primary care providers possibly in 2011/12. In addition, the review work will not commence in the first year of operation.

Once the Commission is established, there will be further consultation on the actual methodology to be adopted and identification of the criteria for assessing the compliance of providers with the registration requirements. There are plans to establish an advisory committee to include regulated providers and service users to help the Commission develop its methodologies.

Impact on the pharmaceutical industry

The impact of these proposed changes could be both direct and indirect. By widening the scope of services to be registered, some pharmaceutical company sponsored services, e.g. homecare delivery services, will come under the same umbrella. This may mean a requirement to have a registered manager who is responsible for the day-to-day running of the service and who can demonstrate continued competence to do so. This may place a greater administrative burden and cost to the company that is providing such a service.

The healthcare associated infections enforcement powers will mean that failing providers will need to improve their performance in infection control. This may be an opening for the industry to help a provider assess and implement better measures for managing infections, the greater use of hand washing products and prescribing more appropriately.

Much of the information for assessing compliance with the registration requirements will be through self-assessment and demonstrating good, effective and safe practice will be essential. Here, the industry can help registered providers develop evidence-based safe practice and, in so doing, influence the use of more effective drug interventions.

Although the true impact of the Care Quality Commission is yet to be seen, it will certainly have a greater influence over how the industry works compared to its predecessor organisations.

Dr Thoreya Swage is the Clinical Lead for new projects at the Commercial Directorate at the DH, responsible for transfering the clinical knowledge and experience acquired from the Independent Sector Treatment Programme to the wider NHS. She has worked as both clinician (psychiatry) and senior manager in various NHS organisations. She can be contacted at t.swage@btinternet.com.

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