There was a time, in the relatively recent past, when private healthcare was largely unregulated. But from April 2010, in England it will be subject to the same regulatory system as the NHS.
It was only in 1998 that the Action for the Proper Regulation of Private Hospitals was set up by a group of families whose relatives had died or been injured as a result of inadequate care in independent facilities. The pressure they brought on the government led to the Care Standards Act (2000), which private healthcare providers are required to meet today.
Independent providers were also regulated by the same body as the NHS, the Healthcare Commission, but in a different way. Private providers registered with the regulator and had to comply with the National Minimum standards to maintain registration. Meanwhile, NHS providers registered against a single requirement relating to infections but also had to meet Standards for Better Health.
From April 2010, all health services in England, whether they are NHS or private, big or small, will be regulated in the same way.
The change has come about with the introduction of the new super-regulator, the Care Quality Commission (CQC), which came into force on 1 April 2009.
CQC was created under the Health and Social Care Act 2008 and brings together the work previously carried out by three inspectorates - the Healthcare Commission, the Mental Health Act Commission and the Commission for Social Care Inspectorate - giving it a broader remit than healthcare. It will check there is a consistent standard across health and adult social care services, whether provided by the NHS, local authorities, private companies or the voluntary sector.
For GPs, this means they can refer to independent providers with peace of mind, since they will be subject to the same rigorous regulatory system as the NHS.
For the first time next April, NHS and independent providers will be legally required to register their services in order to practice what the Department of Health (DH) classifies as a ‘regulated activity'.
In healthcare, regulated activity includes treatment for drug and alcohol misuse, surgical procedures, diagnostic procedures, treatment of disease or injury, services in slimming clinics, maternity and midwifery services and termination of pregnancy.
Since April 2009, every NHS trust that provides healthcare directly to patients must be registered with CQC on the basis of their performance in infection control. In April 2010, this will be broadened out to include new regulations that will apply to all healthcare and adult social care. From then, healthcare organisations must be registered with CQC before they can treat members of the public.
The only exemptions to the registration requirements are NHS GP practices and high street dentists. The DH expects registration for GPs to begin between April 2011 and April 2012.
To register with the CQC, providers will have to show they meet a generic set of registration requirements, which will replace the current standards in place for the independent sector and NHS.
The registration requirements are based on safety and quality standards, with a focus on achieving outcomes rather than ensuring processes are in place.
Providers need to show the safety and suitability of their premises and equipment, and management of medicines and medical devices. They also need to demonstrate cleanliness and infection control. They must provide evidence of risk management procedures and record-keeping. Staff qualifications and skills are also checked, together with arrangements for further training and professional development.
The new inspectorate places the service user firmly at the centre of its regulation. After all, a patient has the right to expect the same high quality of care regardless of whether they are treated in the NHS or independent sector. So registration requirements also include the care and welfare of service users, consent to care and treatment and respecting and involving patients.
In June, CQC launched a consultation on guidance that makes it clear to providers what they need to do to meet the registration requirements. The guidance focuses on what constitutes a good outcome for a patient and what services should be doing to achieve it. The consultation closes on 24 August 2009.
Once an independent healthcare provider is registered with the inspectorate, it is held on a database accessible to the public and professionals. A GP or patient can search the database and view the information held on them by CQC, including inspection reports.
Following registration, providers are subject to ongoing inspection to ensure standards are maintained. This is done via an annual self-assessment whereby providers mark their services against the registration requirements and provide evidence of their claims. If CQC thinks there is insufficient evidence, it will request more.
All providers will be inspected at least once every five years. Those that CQC considers to be at risk of failing to meet the standards will be inspected more frequently and monitored for improvement.
CQC has enforcement powers and sanctions to ensure compliance. These build on those applicable to independent providers under the Care Standards Act, which gave the regulator the ability to impose, change or remove conditions, cancel registration and to prosecute for offences.
The additional powers given to CQC under the Health and Social Care Act are the ability to issue a public warning notice, give a penalty notice in lieu of prosecution and to suspend registration.
In 2009/10, before the registration framework comes into force, independent providers will continue to be monitored and liable to sanctions under the current system.
CQC expects all providers of health and adult social care to be registered under the new system by 1 October 2010.