Fundamental Standards

Closed 4 Apr 2014

Opened 23 Jan 2014

Results Updated 8 Jul 2014

This consultation has now closed.  Our response is available at the link below, alongside the final regulations, which have now been laid before Parliament.



This consultation sets out proposed amendments to CQC's registration requirements in order to introduce Fundamental Standards of care.

Our proposals to amend the CQC registration requirements are part of a wide-ranging set of changes designed to improve the regulation of health and social care providers, and provide assurance that service users receive safe, quality care and treatment.

Our plans to introduce Fundamental Standards were originally set out in Patients First and Foremost - The Initial Government Response to the Report of The Mid Staffordshire NHS Foundation Trust Public Inquiry, published in March 2013.

Over the summer, CQC’s consultation A New Start - consultation on changes to the way CQC regulates, inspects and monitors care included a number of specific questions about Fundamental Standards. 

This document provides our response to those questions, and asks further consultation questions on the draft regulations (see link below), and on the impact of our proposals.

This consultation does not cover the proposed new Duty of Candour or the Fit and Proper Persons requirement for Directors of providers registered with CQC.

We will consult separately on each of these proposals, although the intention is to introduce these measures alongside the Fundamental Standards as part of the same set of regulations.

Why We Are Consulting

The legislative changes we are proposing have several aims.  These are covered in more detail in the full consultation document (see the link at the bottom of this page), and outlined below. 

Aim 1: To introduce Fundamental Standards

The Francis Inquiry report recommended the introduction of new Fundamental Standards of safety and quality below which care should never fall. The Department committed to incorporate these in to the requirements for registering with CQC.

The Fundamental Standards are intended to be common-sense statements that describe the basic requirements that providers should always meet, and set out the outcomes that patients or care-service users should always expect. All care providers registered with CQC will have to meet them. 

They are set out in the draft regulations, and CQC will produce guidance that explains how they will judge whether providers are complying with them.

Aim 2: To make regulations more effective and improve enforcement against them

The existing registration requirements were brought in to force in 2010 and set out 16 essential standards of quality and safety that all providers should meet.  The Francis Inquiry report noted that:

“The current outcomes are over-bureaucratic and fail to separate clearly what is absolutely essential from that which is merely desirable.”

The report also criticised them for a “lack of clarity”, and recommended that Fundamental Standards should be introduced as registration requirements, and that compliance with these should be monitored by CQC.

The current requirements contain a lot of detail and as a consequence, it is not always clear what the overall intended effect is. It is also not obvious what a breach of the overall requirement would entail. 

We have tried to rectify this lack of clarity by redrafting the current registration requirements so that they become Fundamental Standards – clear outcomes that providers need to meet, and that are widely accepted to be the core of a good service.

We want the new requirements to be more precise than the present versions, with the outcomes we expect providers to achieve or avoid clearly stated.  This means it should be easier for people to judge what must be done to meet them, and for CQC to take effective and timely enforcement action where they identify poor care.

The complexity of the existing regulations means that CQC is currently required to issue a warning notice explaining what the provider has done wrong and giving them time to rectify the issue before they can bring a prosecution against a provider. This makes it hard for CQC to prosecute providers in cases where the seriousness of the breach might warrant such action.  As a result, CQC is sometimes prevented from taking the most appropriate course of enforcement action, and providers may not always be fully held to account. Revising the requirements to make them clearer will mean that for those cases that CQC considers serious enough to warrant prosecution, it will not need to issue a warning notice before bringing a prosecution.

This will help us meet another recommendation from the Francis Inquiry - that the regulations should be clearer and that stronger enforcement action should be available where necessary.

Aim 3: To reduce the burden on business

The new regulations should be easier for providers to understand, and we believe that this will help reduce the burden associated with the regulations.  We intend to do this in two ways – firstly by clearly stating the outcome we expect to see, and secondly by removing some of the detailed references to specific actions that providers are currently required to take to meet the requirements. 

Our impact assessment for the changes goes in to more detail on the reduction of burden, and we are interested in gathering views that will help us make a more accurate judgement about the impacts and benefits of these changes.   

What Happens Next

In this document we have set out our aims and intentions in detail, shared our reasoning for the proposals we have made, and alongside it we have published a set of draft regulations.

We will use the responses to this consultation to further develop the draft regulations, which will then be laid before parliament and debated. 

We intend for these regulations to come in to force in October 2014.


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