Responsibility for setting standards

Accepted.
The Department of Health will shortly consult on new regulations that will provide for fundamental standards of care. 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 consultation will include engagement events with professionals and the public to ensure that a wide a spectrum of views is collected. Subject to Parliament, these will come into force during 2014.
In Patients First and Foremost19 the Government confirmed that the Care Quality Commission would work with stakeholders to draw up a set of simpler fundamental standards to 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. The consultation engaged 5,154 individuals and 4,500 organisations, plus 41 consultation events. Respondees included the medical and nursing Royal Colleges and the Nursing and Midwifery Council. The professional bodies were also part of a stakeholder advisory group with the Care Quality Commission. 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 is using the responses to this consultation to develop its new draft regulations.
Through the Chief Inspector of Hospitals, the Care Quality Commission will consult on guidance for hospital providers on how they should comply with the requirements in the regulations. In December 2013 the Care Quality Commission will set out information in more detail in guidance, so that there is transparency in how it will rate acute hospitals. This will build on the proposals in A new start by providing more detail on:
• what the five questions that the Care Quality Commission inspects* will cover
• the definition of each level of the rating scale (outstanding, good, requires improvement inadequate)
• key lines of enquiry that will always be followed to ensure consistent ratings
• indicators and data that contribute to the rating, and any methods or rules for aggregating them
• how judgements are made from inspection findings and data, to place a provider in a ratings band.
While the focus is on hospital services in the first instance, new Chief Inspectors of General Practice and Adult Social Care, who took up post in the Care Quality Commission in October 2013, will extend and develop guidance on the regulations for providers in their respective sectors. The Deputy Chief Inspector of Mental Health will report to the Chief Inspector of Hospitals on how this applies to mental health services. Together they will ensure that the Care Quality Commission is providing assurance that health and adult social care services join up seamlessly from the perspective of people who use services.
*Is the service safe? Is the service effective? Is the service caring? Is the service responsive? Is the service well-led?

As noted by the Thirlwall Inquiry, fundamental standards were implemented via the Health and Social Care Act 2008 (Regulated Activities)) Regulations 2014 as amended. The fundamental standards are set out in regulations 8 to 20A. These fundamental standards set the level below which care must not fall.

Between January and April 2014, the Department of Health consulted on new fundamental standards regulations. The Care Act 2014 received Royal Assent in May 2014 and these will come into force for all providers of health and social care in April 2015. The consultation response was published in July 2014.

New Fundamental Standards regulations come into force for all providers of health and social care in April 2015.The fundamental standards are:

• care and treatment must be appropriate and reflect service users’ needs and preferences.
• service users must be treated with dignity and respect.
• care and treatment must only be provided with consent.
• care and treatment must be provided in a safe way.
• service users must be protected from abuse and improper treatment.
• service users’ nutritional and hydration needs must be met.
• all premises and equipment used must be clean, secure, suitable and used properly.
• complaints must be appropriately investigated and appropriate action taken in response.
• systems and processes must be established to ensure compliance with the fundamental standards (good governance).
• sufficient numbers of suitably qualified, competent, skilled and experienced staff must be deployed.
• persons employed must be of good character, have the necessary qualifications, skills and experience, and be able to perform the work for which they are employed.
• A health service body must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity (Duty of Candour).

In July 2014, the Care Quality Commission published a consultation on guidance for providers meeting the fundamental standards and on the Care Quality Commission’s enforcement powers. The consultation closed on 17 October 2014. The Care Quality Commission is considering the responses and will publish its new guidance prior to April 2015.

To meet the fundamental standard for good governance, providers must have oversight of planning, delivery and monitoring of all care and treatment. It must know what action is taken to mitigate risks to the quality and safety of care and treatment, and what action is taken in response to issues raised by monitoring activities. This includes ensuring that it has access to all relevant information about its service(s), including information about the experience of service users and others. The provider must also take timely and appropriate corrective action where there is a risk of a regulatory breach occurring, or where a regulatory breach has occurred. Additionally, the provider must securely maintain appropriate and accurate records as follows:

• Records about all aspects of the care and treatment of each service user.

• Relevant records about persons it employs for designing and delivering care and treatment.

• Any other records which may be appropriate for managing the carrying on of regulated activities.

The provider must also continually evaluate and make improvements to the systems and processes that are used to achieve the above. The three Chief Inspectors will use the insights of people who use services to guide, inform and influence the inspection process and the judgements that come out of it. Information on the new inspection model programme and the Care Quality Commission consultation are given under recommendation 14.

From April 2014, the Care Quality Commission began rating hospitals’ quality of care in bands ranging from outstanding to inadequate. The full roll out of ratings for hospitals, and ratings for social care and GPs began to be used from October 2014. Ratings give patients and the public a fair, balanced and easy to understand assessment of how well a provider is performing. Ratings will give patients and the public a fair, balanced and easy to understand assessment of how well a provider is performing.

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.

The Care Quality Commission undertook a public consultation before drawing up the standards, engaging with both individuals and organisations including the medical and nursing Royal Colleges and the Nursing and Midwifery Council. The Department of Health also consulted on the regulations implementing fundamental standards.