All NHS provider organisations will need to submit applications for full registration with the Care Quality Commission ("CQC") between 4 and 29 January 2010 as the regulator takes the next steps towards a single regulatory system across both the public and independent health sectors.
A separate regime applies to adult social care and independent healthcare providers. They will need to apply for registration under the Health and Social Care Act 2008 from April 2010 onwards to obtain registration from 1 October 2010.
Preparation for registration
In preparation for this process, trusts will need to undertake three main steps:
(1) Identify the scope of registration required
Draft Regulations (The Draft Health and Social Care Act 2008 (Regulated Activities) Regulations 2009) were laid before Parliament on 29 October 2009 which set out the different “regulated activities” which will each require separate registration with the CQC. Providers need to be registered for each of the regulated activities they provide at each location from which they provide them. Carrying on an activity without being registered for it is an offence potentially punishable upon conviction by an unlimited fine and/or up to 12 months in prison. Prosecutions can be brought against individual directors and managers as well as the organisation and it is important that providers get this right.
NHS providers will need to look closely at the way these regulated activities are defined to see which services they need to register. Excluding any services already registered under the Care Standards Act 2000 (which will transfer to the new Act separately in October 2010), each trust should prepare an inventory of regulated activity services provided at each of its sites to form the basis of the application process. This is likely to be a major piece of work and may give rise to uncertainties as to whether certain services fall within registration or not, and if they do, under what category. The range of activities provided may also be subject to change as services are restructured amongst NHS bodies under Transforming Community Services.
(2) Gather evidence of compliance with the new standards
To date, NHS providers’ registrations with the CQC since April 2009 have only been in relation to healthcare associated infections. From April 2010, however, NHS providers’ registrations will be subject to the full range of essential safety and quality standards (“Registration Requirements”) set out in the Regulations.
This means that, when applying for registration, NHS providers will need to make a declaration around compliance with each of the new Registration Requirements. Careful consideration will need to be given to the precise terms of the Registration Requirements in making declarations about compliance, taking into account the updated Compliance Guidance and judgment tool to be published by CQC in December 2009. Although the layout of the application forms is not yet known, trusts will need to be in a position to make declarations for each regulated activity at each location at which it is provided. NHS providers may need to adapt their systems to ensure they are designed to capture outcome information in order to demonstrate compliance with the new regulatory standards.
Given the timescale for making applications, NHS providers won’t have much time to carry out their scoping exercise and to decide on what to declare about compliance with these new requirements. In instances where there are shortfalls against standards, NHS providers will need to submit an action plan and satisfy CQC that all reasonable steps are being taken to address the issue.
(3) Identify Nominated Individual(s)
NHS providers should identify who will be the individual “responsible for supervising the management of the regulated activity” and act as the main point of contact with CQC about that activity. Whilst the CQC guidance appears to anticipate there will only be one individual per trust, it is possible that different individuals could be nominated for different activities. The individual should be a director or senior manager employed by the trust and should have an appropriate CRB Check and have the necessary qualifications skills and experience to supervise the management of the activity.
It is essential that NHS providers, and in particular their Board members, understand what services will need to be registered and how compliance will be judged, both as part of the application process and following registration, assuming it is granted. CQC has published guidance for NHS trusts on how to apply and on the scope of registration to assist with this process.
In practice, it is unlikely that a trust will have its application refused. It is more likely that where there are significant concerns, a trust will be registered but subject to strict ‘compliance conditions’ to put things right. A failure to comply with any such condition would be grounds for enforcement action including prosecution so the safest position is to avoid a condition being imposed in the first place if at all possible. The guidance indicates that trusts will be able to make representations and appeal against refusals of registration or conditions imposed by CQC.
Future Compliance and Enforcement
Once registered, each trust will be subject to the full raft of CQC enforcement powers, including warning notices, suspension of registration and fixed penalty notices. There is also the risk of being prosecuted for breaching the Regulations or conditions, with a maximum fine of £50,000 per offence and all the reputational damage that would entail.
Much is at stake and it will be essential for trusts to take all necessary steps to demonstrate compliance with the new Registration Requirements as part of the application process and thereafter on a continuing basis. After all, no trust will want to be the first to be prosecuted by CQC for breaches of the Regulations or conditions or be the subject of possible intervention by Monitor or the Secretary of State. Compliance with the Registration Requirements is one of the terms of authorisation with Monitor. In addition, there could be contractual remedies arising out of non-compliance, as well as redress issues from claims brought in negligence.
Bevan Brittan is unique in having in-depth expertise in health regulation compliance to enable rapid, effective and informed advice to be delivered to NHS organisations. Further details of our work in these areas, as well as contact details for our specialist lawyers, are set out below.
We would be delighted to discuss with you, and in particular with your proposed nominated individual and your Board, how you might best meet the challenge of the new regulatory system given that applications need to be submitted in January 2010.
We have unrivalled experience of dealing with the regulation of care services under the Care Standards Act 2000 and are fully conversant with the regulatory reforms to be carried forward by the Care Quality Commission from April 2010 under the Health and Social Care Act 2008. Our work covers not only enforcement action, in terms of prosecutions, tribunal appeals and urgent applications to magistrates, but also advice upon the appropriate structure of businesses, the making of applications for registration, achieving compliance, and regulatory due diligence. In addition, we have considerable experience of other regulatory regimes including Health and Safety, the Medicines Act, the Misuse of Drugs Act, and the Data Protection Act.