This article relates to the CQC key question: Is your practice well-led?
The CQC has had several questions on our inspections from practices asking how the fundamental standards of care regulations apply to general practice.
The inspection of GP practices is underpinned by the Health and Social Care Act 2008. On 1 April 2015, new fundamental standards of care were introduced which existing registered providers and managers, and those applying for registration, must comply with to ensure they are meeting the following two groups of regulations:
- Health and Social Care Act 2008 (HSCA 2008) (Regulated Activities) Regulations 2014 (as amended)
- Care Quality Commission (Registration) Regulations 2009 (Part 4)
The new regulations underpin our approach to inspecting and regulating GP practices and replace the essential standards of quality and safety – ‘the old regulations’.
These are the standards everybody has a right to expect when they receive care. They form part of changes to the law recommended by Sir Robert Francis following his inquiry into care at Mid Staffordshire NHS Foundation Trust.
What must practices do to ensure they meet the fundamental standards?
The new regulations are more focused and clearly define standards below which care must not fall, they are:
- Care and treatment must be appropriate and meet people's needs and preferences (Regulation 9)
- People must be treated with dignity and respect (Regulation 10)
- Care and treatment must only be provided with consent (Regulation 11)
- Care and treatment must be provided in a safe way (Regulation 12)
- People must be protected from abuse and improper treatment (Regulation 13)
- People's nutritional and hydration needs must be met (Regulation 14)
- All premises and equipment used must be clean, secure, suitable and properly used, maintained and located (Regulation 15)
- Complaints must be appropriately investigated and appropriate action taken in response (Regulation 16)
- Systems and processes must be established and used to ensure compliance with regulatory requirements (Regulation 17)
- Sufficient numbers of suitably qualified, competent, skilled and experienced staff must be deployed (Regulation 18)
- Staff must be of good character, qualified and able to do their job (Regulation 19)
I have already covered the requirement to display your ratings, the Fit and Proper Persons Requirement and the Duty of Candour in previous articles.
We have published guidance on our website to help existing registered providers and managers, and those applying for registration, understand how they can meet the regulations, including the fundamental standards. Regulation 21 of the HSCA 2008 says that registered persons "must have regard" to this guidance.
The guidance does not attempt to describe in detail how the regulations apply to each type of service registered with CQC, but we will be proportionate in how we apply the regulations to practices. We will consider the size and type of services and the relevance of the regulation to the regulated activity provided. For example, when inspecting GP practices and considering how they are meeting the regulation on premises and equipment (Regulation 15) we will be proportionate in how we do this and will consider what services the practice provides, for example whether they provide minor surgery or not.
For each regulation the guidance includes:
- a summary of the intention of the regulation
- the text of the regulation
- guidance on the requirements of specific components of the regulation
- links to relevant legislation
- links to other guidance, categorised by service type where appropriate.
If you are a prospective provider or manager applying for registration, you must demonstrate that you will be able to meet the requirements set out in these regulations and, once registered, that you will continue to meet them.
The Health and Social Care Act 2008 says that CQC must take this guidance into account when we make our regulatory decisions. We will therefore use this guidance when deciding whether a provider of GP services or manager meets the requirements of the regulations when we consider an application for registration. If a prospective provider is not able to demonstrate that they will meet the requirements of the regulations from their first day of business, we may refuse the application.
If you are already registered with the CQC as a provider or manager, it is important that you read and consider the guidance in relation to the regulated activities you provide, as it will help you to understand what you need to do to meet the regulations.
You are responsible for meeting the regulations and deciding how to do this. It is not CQC's role to tell practices or managers what they must do to deliver their services. When registered providers and managers do not follow this guidance, we will ask them to provide evidence that their approach enables them to meet the requirements of the regulations.
Professor Nigel Sparrow is senior national GP advisor and responsible officer at the CQC
More CQC resources
- View the full CQC Essentials series on Medeconomics
- CQC's recommended reading to help practices meet regulations and prepare for an inspection