As of April 2010 the Care Quality Commission introduced a new regulatory system which aims to ensure that people can expect services to meet essential standards of quality and safety that respect their dignity and protect their rights.

These standards apply wherever care is provided: in someone’s home, in a community setting, in a hospital, however it is funded (private or public); and whether it is acute care or longer residential care there will be a single set of standards of quality and safety.

NHS trusts that provide regulated activities (including PCTs as providers) are required by law to be registered from 1st April 2010. Providers of adult social care and independent healthcare must be registered under the new system from 1st October 2010. Dental services need to be registered by April 2011 and GP practices by April 2012.

Under transition orders there may be time limits for providers new to registration to have a full application submitted to CQC during which they will be exempt from prosecution for carrying on as an unregistered service.

The CQC has published the final list of requirements for NHS trust registration. To register with the CQC, providers will have to show that they meet these standards which replace The Standards for Better Health and National Minimum Standards that currently apply to NHS and adult social care/independent sector providers, respectively.

The registration of providers of adult social care and independent healthcare currently registered under the Care Standards Act 2000 ends on 30 September 2010 and, there will be no automatic transfer to the new system.

All existing independent providers who are within the scope of the new regulation system will need to register and will need to make a new application for each of the regulated activities they provide.

There is a risk to all providers if these timescales are not met but a specific business risk to independent providers as activity may be compromised if the provider fails to register. Failure to achieve registration may result in limited or complete withdrawal of service provision.

The unique challenge for the independent sector is the widening of the scope from the Care Standards Act 2000 where providing “regulated activities” is defined by the Health and Social Care Act 2008.  This will require many providers to register with the CQC for the first time.  Although the deadline is 1 October 2010, new providers that are now in scope are required to submit their completed application to the CQC by 1 August 2010.

Specific examples of areas of change/impact

Some areas that are changing from 1 October 2010, which the CQC describes in its guidance in particular the regulation of Class 3B and Class 4 lasers and intense pulsed lights (IPLs).  For example, there are instances where a beautician using lasers in specific circumstances currently registered under the Care Standards Act 2000 will not now have to register under the new regime.  

Any provider which operates a private doctor service or operates an establishment which is now classed as carrying out services within the scope of registration is also required to register as the previous exemption for doctors in independent practice will not apply.

The regulatory burden has shifted significantly towards self assessment and declaration requiring a rigorous approach and objective review of actual rather than theoretical practice.

Providers will be required to list locations where regulated activities are performed, but it is the ‘main address’ where the activity is carried on (such as a hospital, care home or domiciliary care agency). The responsibility of ensuring compliance at each location now lies with the main provider and not with the individual site. The term location is important because providers will self-assess and declare compliance against each regulated activity at each location. Monitoring this declaration is an important part of how the CQC make judgements about continuing compliance with the essential standards of quality and safety.

Inevitably there will be an influx of applications and a potential back-log of requests requiring to be processed by the CQC. Any delay at either the CQC or provider side will result in possible negative impacts on both business and service delivery if registration is delayed.

Although the application process for registration is relatively straight-forward, additional resource may be required to undertake the self assessment, gap analysis, definition and implementation of identified improvement measures. This may prove a challenge for smaller NHS and independent providers who are not familiar with the regulatory compliance process. This is a new regime and therefore requires a fresh review of plans for registration.

Time scales are tight and consequences of failing to register can present a significant risk to your business. Now is the time to check that suitable resources are in place to support your plans for application.