Impact assessments before structural change

Accepted.
The Care Quality Commission has consulted on fundamental standards of care, which the Department of Health will reflect in regulations. While the focus is on hospital services in the first instance, a new Chief Inspector of General Practice and Chief Inspector of Adult Social Care took up post in the Care Quality Commission in October 2013 and will extend and develop guidance on the regulations for providers into their respective sectors.
Attention will be given to how the fundamental standards of care are presented to providers and especially to the public, in particular so as to clarify the relationship to rights under the NHS Constitution and consumer rights, and to present their relationship to other standards and to the Care Quality Commission’s own broader ratings of quality. The Care Quality Commission’s three Chief Inspectors will engage with the public, providers and professionals to develop guidance that makes clear for all sectors what compliance with the regulations involves and how it joins up with other rights and entitlements, other standards, and the Care Quality Commission’s broader assessment of the quality of services.
In June 2013, the Care Quality Commission issued A new start – Consultation on changes to the way Care Quality Commission regulates, inspects and monitors care. This document started the public discussion on what the fundamental standards of care should be. The consultation engaged 5,154 individuals and 4,500 organisations, plus 41 consultation events. The Department will consult shortly on draft regulations in October 2013 which will specify the fundamental standards as outcomes that must be avoided. Subject to Parliament, these will come into force during 2014.
The Department has revised the NHS Constitution to give greater prominence to NHS values, and it will consider further revision to the NHS Constitution to reflect this response to The Inquiry.
NHS England has agreed with the National Institute for Health and Care Excellence that the concept of enhanced standards is represented by the existing quality standards, which are developed by the National Institute for Health and Care Excellence and endorsed by NHS England. The Care Quality Commission will use (enhanced) quality standards to inform their quality ratings of providers. The National Institute for Health and Care Excellence will also include ‘developmental’ standards within quality standards, where there are emergent evidence-based technologies with the potential to drive widespread improvements.

The NHS Constitution provides that the NHS aspires to the highest standards of excellence and professionalism and to provide high quality care that is safe, effective and focused on patient experience.

The Constitution sets out the six core NHS values. These include a commitment to quality of care and working together for patients.

NHS values and standards are set at the highest level by the Department of Health and Social Care through the NHS Constitution and the Government’s Mandate to NHS England.

CQC introduced fundamental standards of care from 2015 as part of its regulatory framework. The standards set the level below which care must not fall. Where providers fail to meet these standards CQC can use its enforcement powers to protect patients and service users from the risks of poor care - including prosecuting providers where a failure to meet a fundamental standard results in avoidable harm to a patient or service user, or a significant risk of such harm. A statutory duty of candour on all providers (regulated by the CQC) and a fit and proper person requirement for directors of NHS bodies are in force. DHSC works in several ways to ensure clinical involvement in patient safety decisions in several ways. This includes working closely with the National Director of Patient Safety and his National Patient Safety Team. More recently the investigation undertaken by Lord Darzi in 2024 included an assessment of patient safety.

Between January and April 2014, the Department of Health consulted on new fundamental standards regulations which will come into force for all providers of health and social care in April 2015. The response to the consultation was published in July 2014.

The draft regulations are also laid in Parliament.

Between 09 April and 04 June 2014, the Care Quality Commission consulted on how it planned to change the way it regulates, inspects and rate care services and published consultation handbooks for different types of provider. The handbooks cover hospitals, specialist mental health services, community health services, adult social care, and GP and out of hours services.

The National Institute for Health and Care Excellence has adapted its development processes to introduce developmental statements in its quality standards where appropriate. The National Institute for Health and Care Excellence consulted on its updated quality standards process guide that makes detailed proposals for how developmental statements will be identified and produced. The consultation document is also available online.

The Government has passed legislation that will put in place new fundamental standards as requirements for registration with the Care Quality Commission. These fundamental standards set the level below which care must not fall. Where providers fail to meet these standards the Care Quality Commission will be able to use its enforcement powers to protect patients and service users from the risks of poor care – including prosecuting providers where a failure to meet a fundamental standard results in avoidable harm to a patient or service user, or a significant risk of such harm.

The fundamental standards will come into force for all providers registered with the Care Quality Commission in April 2015. Two new regulations introducing a duty of candour for NHS bodies and a fit and proper person requirement for directors of NHS bodies came into force in November 2014

In July 2014, the Care Quality Commission consulted providers, health care professionals and other key stakeholders on proposed guidance on meeting the new regulations. The Care Quality Commission published final guidance ahead of the fundamental standards coming into force in November 2014 on duty of candour and the fit and proper person requirement for NHS bodies.

The Care Quality Commission has also recently published a series of provider handbooks that will sit alongside the guidance on the regulations and describe the end to end inspection process, including how the Care Quality Commission will judge what good quality care looks like and how the Care Quality Commission will rate providers. The handbooks cover hospitals, specialist mental health services, community health services The Care Quality Commission is also producing targeted information for the public on the new 11 fundamental standards and standards of care people have a right to expect.

This recommendation was accepted by the Government.

In the January 2014 Hard Truths report, the Government said that the Care Quality Commission had consulted on the fundamental standards of care, and that attention would be given to how they are provided to providers and the public. The concept of enhanced standards was to be represented by the existing quality standards developed by the National Institute for Health and Care Excellence, with developmental statements to be included where appropriate. The Care Quality Commission’s three Chief Inspectors were to engage with the public, providers and professionals to develop guidance to make it clear what compliance with the regulations involved and how it joined up with other rights, entitlements and standards.

Th Government said it had revised the NHS Constitution was revised to give greater prominence to NHS values.

In the February 2015 Culture Change report, the Government said the Department of Health had consulted on the fundamental standards regulations between January and April 2014, and the Care Quality Commission had consulted on proposed guidance on meeting the regulations in July 2014. The Government also said the Care Quality Commission had published a series of provider handbooks to sit alongside the guidance on the regulations.