The regulation the health and social care sector has never been as much in the public eye, for example the attention given to the failings at the Mid Staffordshire Foundation Trust. There is also a new regulator, the Care Quality Commission (“CQC”), for the first time charged with ensuring essential levels of safety and quality across the entire health and social care sectors.
Shortly, the CQC will be implementing a new regulatory scheme, which will be applying new requirements and standards to an increasing range of services. It is important for all providers to be aware of the changes, particularly as accountability rests not just with the organisations but also their senior officers.
From April 2010 onwards, CQC will extend the scope of its regulatory remit over providers of health and adult social care services in both the public and independent sectors. All providers who undertake “regulated activities” will be required to be properly registered under the Health and Social Care Act 2008 (“the 2008 Act”). The key changes will be:
- NHS Providers: registration which, to date, has been based solely on compliance with the Code of Practice on Healthcare Associated Infections (HCAIs), will be extended and measured against a new set of requirements and standards governing all aspects of the running of the organisation. These requirements will replace the Standards for Better Health.
- Social Care and Independent Healthcare Providers: from October 2010 services will require registration under the 2008 Act, rather than the Care Standards Act 2000.
This will mean:
- A wider scope of services requiring registration
- The need to comply with a new set of registration requirements and guidance, in place of the existing regulations and National Minimum Standards.
This new system is intended to create a level playing field, where all providers of regulated activities are required to register with the CQC and comply with a common set of requirements, whether they are NHS, local authority, private or third sector providers.
Failure to Register
It will be unlawful to carry on regulated activities without being registered with CQC. In order to gain and maintain their registration, providers will need to demonstrate an ongoing ability to meet the registration requirements. These will be a single set of requirements focused on the safety and quality of care which will apply to the entire health and social care sectors.
CQC will have a range of new powers to enforce compliance with the requirements including:
- Prosecutions (with fines up to £50,000 per offence)
- Issuing penalty notices
- Suspending services
Proposed Scope of Registration
The proposed scope of “regulated activities” which will trigger the need for registration include:
- Personal care;
- Accommodation for persons who require nursing or personal care, or treatment for substance misuse;
- Accommodation and nursing or personal care in the further education sector;
- Treatment of disease, disorder or injury (by or under the supervision of a healthcare professional);
- Assessment or medical treatment for persons detained under the Mental Health Act 1983;
- Surgical procedures;
- Diagnostic procedures;
- Management and supply of blood and blood derived products;
- Patient Transport services, triage and medical advice provided remotely;
- Maternity and midwifery services;
- Termination of pregnancies;
- Services in slimming clinics; and
- Nursing care
A range of services not previously regulated under the Care Standards Act will now be subject to registration. For example: some family planning services, such as fitting of intrauterine devices (IUDs) and contraceptive caps, will come within scope of registration, under ‘nursing care’.
GP Practices and Dentists
It is proposed that from 2011/12, primary medical and dental care providers will be required to register with the CQC. This means that, for the first time, all 8500 GP practices and 9000 high street dental practices will be subject to independent registration, regardless of whether they provide solely private services, solely NHS services, or a mixture of both.
National Minimum Standards and the Standards for Better Health will be in force until services are required to register.
It is expected that the CQC will register Providers of “Regulated Activities” in stages:
By 1 April 2010:
All NHS providers, including PCTs that provide services, and NHS
Blood and Transplant.
(N.B. NHS Providers will be required to have declared their compliance with the new registration requirements and guidance in January 2010)
By 1 Oct 2010:
All providers of adult social care services, and independent providers of healthcare services.
From April 2011:
Other providers, including primary medical and dental practices.
We have unrivalled experience of dealing with the regulation of care services and are fully conversant with the regulatory reforms to be carried forward by the CQC. 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.
If you require any advice as to how the new regulatory regime will impact upon your organisation, we would be happy to discuss this with you.
We are also running two free training sessions on Preparing for the New Regulatory system at our London office on 15 October 2009 and our Birmingham office on 20 October 2009.