The nature of standards

Accepted.
The Department of Health, the National Institute for Health and Care Excellence, NHS England and the Care Quality Commission are working on a new framework of standards. New regulations setting out fundamental standards of care will come into effect during 2014, and will apply to all providers of health and social care required to register with the Care Quality Commission. Through its Chief Inspectors, the Care Quality Commission is engaging with providers, professionals and the public on what guidance it should publish on complying with these regulations and how they should relate to the Care Quality Commission’s broader assessments of the quality of health and care services.
In Patients First and Foremost13 the Government confirmed that the Care Quality Commission would work with stakeholders to draw up a set of simpler fundamental standards that would make explicit the basic standards, and set a clear bar below which care should never fall. In June 2013, the Care Quality Commission issued A new start – Consultation on changes to the way the Care Quality Commission regulates, inspects and monitors care. This document started the public discussion on what the fundamental standards of care should be. On 17 October 2013, the Care Quality Commission published the responses to the consultation in A new start: Responses to our consultation on changes to the way the Care Quality Commission regulates, inspects and monitors care services, which showed that there is broad agreement with the new approach. The Department will consult shortly on the draft regulations; these will set in legislation the fundamental standards of care as outcomes that providers must meet. The final set of standards is likely to cover areas such as: care and safety of patients and service users; abuse, including neglect; respecting and involving service users; nutrition; consent; governance; cleanliness and safety of premises and equipment; staffing; fitness of directors; and duty of candour.
The Care Quality Commission will issue succinct guidance on meeting the regulations’ requirements, which it will take into account when considering prosecutions. This guidance will sit alongside the broader handbook that the Care Quality Commission will issue on how it decides ratings of providers and services.
The fundamental standards of care will be part of the regulatory system in their own right, alongside the Care Quality Commission’s broader assessments of the overall quality of a provider’s services. This will start initially in the hospital sector, but also alongside new Chief Inspectors of General Practice and Adult Social Care, who will extend and develop the approach for their respective sectors over time. The Care Quality Commission will keep guidance for their sectors under review and will advise Ministers if changes to the regulations are needed.
The National Institute for Health and Care Excellence has an existing programme of production of quality standards that define what high quality care should look like in a defined care or service area. Topics in healthcare are referred by NHS England to the National Institute for Health and Care Excellence, and the National Institute for Health and Care Excellence provides guidance for commissioners to help them to commission for quality improvement within these areas. Enhanced quality standards are set out for commissioners in the National Institute for Health and Care Excellence quality standards, which in future will also specify developmental standards.

CQC is the independent regulator of health and adult social care in England. They monitor, inspect and regulate services to ensure health and social care services are safe, effective, compassionate and providing high quality care. Where a registered provider of healthcare services is found to have breached the fundamental standards as set out in the Health and Social Care 2008 (Regulated Activities) Regulations 2014, CQC can bring civil enforcement action or a criminal prosecution. The highest level of civil enforcement action available is to cancel a providers registration.

All organisations are required under the Health Act 2009 to produce Quality Accounts if they deliver services under an NHS Standard Contract.

Guidance published by the Healthcare Quality Improvement Partnership sets out that the legislation governing Quality Accounts requires details of the trust’s clinical audit participation for each of the national audits, enquiries and quality improvement programmes they participate in. They also require information related to improvements responding to clinical audit report recommendations.

In addition to the CQC’s fundamental standards, the NHS Oversight Framework (2024) set NHS England’s approach to oversight of NHS providers and ICBs. This includes oversight metrics to indicate issues.

The NHS provider licence included a condition covering provider governance (FT4) that required organisations to meet specific standards as set by DHSC, Monitor, CQC or NHS England.

The Code of governance for NHS provider trusts (2023) sets out the expectation that the board of directors will establish procedures that manage risk.

The National Institute for Health and Care Excellence has introduced developmental statements in its quality standards where appropriate. Between June and September 2014 it published NICE quality standards - the process guide a consultation on its updated quality standards process guide which made detailed proposals for how developmental statements would be identified and produced.

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 a minimum 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 in to force in November 2014.The Care Quality Commission published guidance for providers on the duty of candour for NHS bodies and the fit and proper person requirement for directors of NHS bodies regulations to help providers meet the requirements of the regulations.

The Care Quality Commission has also recently published a series of provider handbooks. These 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, adult social care, and GP and out of hours services.

This recommendation was accepted by the Government.

Fundamental standards were implemented via the Health and Social Care Act 2008 (Regulated Activities)) Regulations 2014, regs. 8 to 20A, in force from April 2015. Twelve fundamental standards. Every registered healthcare provider of NHS services required to comply with these requirements.

In the January 2014 Hard Truths report, the Government considered that enhanced quality standards were already provided by guidance published by the National Institute for Health and Care Excellence.

In the February 2015 Culture Change report, the Government said that the National Institute for Health and Care Excellence had published a consultation on its updated quality standards process which made detailed proposals for how developmental standards would be identified and produced, and that the National Institute for Health and Care Excellence had introduced developmental statements in its quality standards where appropriate.