Recommendation 19

Merger of system regulatory functions

There should be a single regulator dealing with both corporate governance, financial competence, viability and compliance with patient safety and quality standards for all trusts.

We agree with the principle that there should be a single regulatory process with clearly defined responsibilities across governance, finance and compliance with safety and quality standards. It is important that the system is able to identify and act quickly where there are potential risks to service users and, in ensuring this, that there are clear roles and responsibilities for all those involved in that process.

Patients First and Foremost stated that the Care Quality Commission, Monitor and the NHS Trust Development Authority would establish a single failure regime that would further clarify the separate functions of the Care Quality Commission and Monitor across health and social care.  This will ensure that the role of inspecting trusts is kept clearly separate from the responsibility for the turnaround of failing organisations, and there can be no conflict of interest in assessing quality.  It also allows us to address, more fully, the Inquiry’s concerns regarding the potential impact on the whole system of rapid changes to the quality regulator.

The Care Bill lays the framework for a simple, flexible process for tackling quality failures in NHS trusts and foundation trusts. It will remain the primary responsibility of the board of a trust, working with their commissioners, to ensure the provision of good quality care.

The Care Quality Commission will not exercise its enforcement powers, beyond issuing a new warning notice outlined in the Care Bill, in respect to trusts unless patients and service users are at immediate risk of harm, in which case it will be able to act immediately. Where intervention is required it will be the role of Monitor (for foundation trusts) and the NHS Trust Development Authority (for NHS trusts) to take action.Ultimately, if it proves impossible for an NHS trust or foundation trust to turn their performance around, the organisation may be placed into Trust special administration on quality grounds. Special administration will provide a framework for determining how best to secure a comprehensive range of high quality services that are both financially and clinically sustainable. In very serious cases, the Care Quality Commission (subject to Parliamentary approval) will have the power to prosecute a provider for a breach of fundamental standards of care.

The Care Quality Commission, Monitor and the NHS Trust Development Authority will work together to publish further guidance on how they work together to address risks to quality. This will include details of how concerns, including immediate concerns, will be addressed; how and when special measures and the single failure regime could be triggered; and what guidance and support would be made available to the public in the event of large scale, significant failure.  This guidance will build on the joint policy statement, The Regulation and oversight of NHS Trusts and Foundation Trustspublished by the Care Quality Commission, Monitor, the NHS Trust Development Authority, NHS England and the Department of Health.


The Care Quality Commission and Monitor work together to assess the capability of a Foundation Trust and/or its leadership to ensure safe and quality care. Monitor makes this assessment from the Board down, the Care Quality Commission from the ward up. The Care Quality Commission and Monitor have a new single, overarching framework for judging whether or not an organisation and/or service are well-led. The Care Quality Commission and Monitor use the framework to help inform their assessments and inspections.

The framework is used during the routine inspection of Foundation Trusts where the Care Quality Commission requests information from Monitor in preparation for an inspection. The Care Quality Commission’s inspection provides a judgement on the quality of services and Monitor will then take action where necessary to support improvement. The Chief Inspector of Hospitals can also recommend that a Foundation Trust be put in special measures. As part of this, Monitor provides intensive support, including appointing an Improvement Director. The Care Quality Commission will then re-inspect and recommend whether the Foundation Trust should be kept in, or taken out of, special measures.

For example in July 2013, after the Care Quality Commission inspection identified significant concerns about the quality of care, the Chief Inspector of Hospitals recommended that North Lincolnshire & Goole NHS Foundation Trust be placed in special measures. Monitor initially used its powers to agree a programme of work with the Foundation Trust to address issues in governance, clinical effectiveness, patient safety and experience. Monitor subsequently oversaw the Foundation Trust’s delivery of this programme, resulting in the quality issues being addressed. Following a recommendation from the Chief Inspector, the Foundation Trust was removed from special measures in July 2014.

The Care Quality Commission, Monitor and the NHS Trust Development Authority have jointly developed and published guidance on how the special measures programme worked for NHS trusts and Foundation Trusts. The Care Quality Commission and Monitor have also published a joint working agreement document setting out how they will work together.