Are you registered

From October, all diagnostic labs will have to register with the Care Quality Commission, Linda Hutchinson tells us why

The Care Quality Commission (CQC) is introducing a new system of registration, which brings NHS, independent healthcare and adult social care under a single set of essential standards of quality and safety.

This brings with it significant changes for independent stand-alone or private medical laboratories, as they will need to register with the CQC for the first time in order to legally practice from 1 October 2010.

The Health and Social Care Act 2008 outlines the scope of registration. The Department of Health has set out new regulations in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and Care Quality Commission (Registration) Regulations 2009.

Previously, different types of services were regulated under different Acts, with different regulations and standards.

The new registration system makes sure that essential standards of quality and safety apply across the whole care sector, creating a level playing field for providers.  It means that people can expect services to meet the same essential standards across the care sector and that their safety, dignity and rights are protected and respected.

The essential standards have a legal status. We have a wider range of strong new enforcement powers including imposing conditions on registration, fines, and in extreme cases, cancellation of registration. We will use these to ensure registered providers comply with the regulations.

After initial registration, we will continuously monitor whether providers are meeting essential standards, as part of a new, more dynamic system of regulation that places the views and experiences of people who use services at its centre.

CQC is working with UKAS (United Kingdom Accreditation Service) to set out an agreement on sharing information to assist this monitoring process. The agreement aims is to prevent unnecessary duplication of gathering information on performance. UKAS and CQC are in discussions that will enable CPA (Clinical Pathology Accreditation) to share its expertise and knowledge about medical laboratory services with CQC to establish systems that will help avoid any additional assessments falling on medical laboratories if they are already accredited by CPA.

The key differences between the new registration system and the old one are as follows:
•    Registration will be at provider level, rather than at the location of individual services or establishments. By ‘provider’, we mean the legal entity that provides the service to people, whether this is an individual, partnership or organisation;
•    A single set of essential standards introduces much needed parity across the sector, making it easier for one provider to be compared to another and for providers to work together make sure care services are joined up across health and social care;
•    It focuses primarily on outcomes – the experiences we expect people to have as a result of the care they receive – rather than on systems and processes.
•    We are making better use of – and constantly updating – information we have about providers. This information comes from a wide range of sources including: providers; people who use services; representative organisations; and other regulators;
•    We will continually monitor compliance so that we identify concerns quickly and work with providers to improve. We have a wider range of strong enforcement powers that allow us to take swift action where services are failing people.

The new registration system is being introduced gradually across all health and adult social care services. NHS trusts were first to enter registration in April 2010, meaning all trusts that directly provide laboratory services are now registered to provide this activity.

Independent healthcare providers, adult social care providers and those coming into the system for the first time – such as independent laboratories – will come into registration from 1 October 2010.

From April 2011, all independent ambulance providers and all primary dental care providers (NHS, private and mixed practice) will have to be registered, and from April 2012, primary medical services commissioned by primary care trusts, such as GP practices and out-of-hours services, will have to register.

Independent stand-alone or private medical laboratories need to register with CQC if they examine tissue, cells or fluids from the body for the purpose of discovering the presence, cause or extent of disease, disorder or injury.

However, there are some exemptions. Laboratories that only carry out analysis for genetic purposes, or research and analysis associated with a national cancer screening programme, will not need to register.  

For further detail on which laboratories need to register, providers can refer to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and Care Quality Commission (Registration) Regulations 2009.

Providers will be required to pay fees associated with registration. There will be no fee for the application providers to enter the new registration system; however, all providers will be required to pay an annual registration fee after they are registered. We have recently consulted on the interim fees that independent healthcare providers, (including laboratories), and adult social care providers will need to pay, relating to their registration from October 2010 to the end of March 2011. The consultation document also provides important information about the fees arrangements that will be in place as we move from the current system of registration to the new one.

The interim fees scheme for NHS trusts in 2010/2011, and those we will put in place for adult social care and independent healthcare providers from October 2010 will not provide a blueprint for future fees. From April 2011, we will have developed a single fees policy for all providers to replace all former or interim schemes, and we will be consulting widely on our proposals for this later this year.

The application process is open and independent or private laboratories are advised to submit an application on or before 1 August 2010. If CQC receives the application by this date, then they are able to continue to operate legally after 1 October 2010 even if CQC has not yet processed its application.

To prepare for registration, providers can familiarise themselves with CQC’s Guidance about compliance documents, which make clear the outcomes we expect people to experience if a provider is compliant with the regulations and how we judge compliance.  There is also an online interactive version which enables you to collect and print out the guidance that applies to your particular type of service. This is available at www.cqcguidanceaboutcompliance.org.uk

CQC has also made available an e-learning module, which guides providers step-by-step through the application process, and a ‘How to complete the application form’ guidance document that explains how to complete the form. Both of these are available on our website – www.cqc.org.uk/registration.