Recommendation 28

Zero tolerance of fundamental standards

Accepted
Zero tolerance: A service incapable of meeting fundamental standards should not be permitted to continue. Breach should result in regulatory consequences attributable to an organisation in the case of a system failure and to individual accountability where individual professionals are responsible. Where serious harm or death has resulted to a patient as a result of a breach of fundamental standards, criminal liability should follow and failure to disclose breaches of these standards to the affected patient (or concerned relative) and a regulator should also attract regulatory consequences. Breaches not resulting in actual harm but which have exposed patients to a continuing risk of harm to which they would not otherwise have been exposed should also be regarded as unacceptable.

The government agrees that decisive action must be taken in response to a failure of quality of care and just as there is a clearly defined end point for hospitals that are financially unsustainable, the same principle must apply for those that are clinically unsustainable. This process must ensure problems can be rectified quickly while allowing essential services to continue and without compromising patient safety.

The Care Quality Commission has clear legal powers to take swift and decisive action if patients are at immediate risk of harm, ensuring that the service or ward in question is closed immediately until the risk is addressed. New fundamental standards will be introduced which will set the level below which standards of care should not fall. Where the Care Quality Commission finds an NHS trust or foundation trust to be failing systematically, for example with serious or repeated breaches of the fundamental standards, it will issue a warning notice requiring the provider to improve within a fixed period. If problems persist, the NHS Trust Development Authority, for an NHS trust, or Monitor, for an NHS foundation trust will intervene.  Levels of service performance and standards of care quality form part of Monitor’s regular risk assessment of foundation trusts including Care Quality Commission judgements on the quality of care provided. Monitor also expects licence holders to notify them in the event of any incident, event or report that may raise potential concerns over compliance with the licence. Breaches of licence conditions will attract enforcement action that can range from informal action, imposition of special licence conditions, removal or suspension of directors and revoking provider’s licence.

In instances where, but not limited to, the Chief Inspector of Hospitals considers that standards of care quality are inadequate the Care Quality Commission may recommend that the NHS Trust Development Authority or Monitor place the trust into special measures. Special measures provides a framework for action where it is not thought probable that the Trust leadership can secure the necessary improvements in quality without intensive intervention. Such interventions would be led by Monitor or the NHS Trust Development Authority and can include formal partnering with a high performing trust to share best practice and guidance, a full leadership capability review including the ability to replace directors, creation of a public ‘Improvement Plan’, and the appointment of an Improvement Director to oversee progress. Typically the chief inspector will re-inspect the trust after a year to ascertain whether the required improvements are being made.

Ultimately, if it proves impossible for an NHS trust or an NHS foundation trust to turn their performance around, Monitor, or the NHS Trust Development Authority (through a recommendation to the Secretary of State), will be able to place the organisation into 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. As a backstop, if the Care Quality Commission considers that Monitor or the NHS Trust Development Authority has erred in not placing a trust into special administration it will be able to compel them to initiate the process.

The Department of Health will revise the requirements for registration with the Care Quality Commission so that they will include fundamental standards. Under the revised registration requirements the intention is that it will be possible to prosecute providers in the most serious cases of poor care without the need for an advance warning notice. These new powers will build on and be compatible with powers already provided to the Care Quality Commission under the provisions of the Mental Health Act 1983 (as updated and amended by the Mental Health Act 2007) and supported by the code of practice to the Mental Health Act 2012 to monitor the use of the Mental Health Act and protect the interests of people whose rights are restricted under that Act.

For individual healthcare providers, Monitor and the NHS Trust Development Authority have a range of intervention powers. For example, Monitor is able to remove, suspend or replace NHS foundation trusts’ governors or directors. The NHS Trust Development Authority is able to remove directors in NHS trusts. The Department of Health has also consulted on proposals that will allow the Care Quality Commission to hold board members to account for the provision of poor care, which could result in them being removed from their posts. The Care Quality Commission does not have the power to take action against individuals. However, in instances where an individual is found to have caused death or serious harm, existing legislation can be used by the appropriate authority to hold them to account, as has happened with staff who were charged with neglect or ill-treatment at Winterbourne View. In addition, the government agrees with Professor Don Berwick’s recommendation that there should be legal sanctions where individuals or organisations are guilty of wilful neglect or mistreatment of patients. This will help ensure there is ultimate accountability for those guilty of the most extreme types of poor care. The government will seek to legislate on this, and will work with stakeholders beforehand to determine the details of this measure, and will consult on proposals for legislation as soon as possible.

Professional regulators can take a decision to remove clinical practitioners through the fitness to practice processes. The Nursing and Midwifery Council has responded to say that it will undertake a comprehensive review of its current code in the light of the recommendations in the inquiry report to explore how key messages can be strengthened and developed. This will include ensuring that a duty to comply with any relevant national fundamental standards is addressed in the revised code. The General Medical Council is undertaking a programme to reform its fitness to practice processes including speeding up investigations work, modernising and streamlining the adjudication procedures and strengthening confidence in the independence of its adjudication function. The latter has resulted in the launch of the Medical Practitioners Tribunal Service in June 2012.

Update

From April 2015, along with the introduction of new fundamental standards, the Care Quality Commission will have new enforcement policy for all providers. The key difference is that the new policy will allow the Care Quality Commission to take the most appropriate action straight away. For example, the Care Quality Commission will be able to prosecute a provider without first issuing a warning notice, if that is the right thing to do. The Care Quality Commission will use these new arrangements to protect people who use regulated services from harm and the risk of harm and to hold providers and individuals to account for failures in how the service is provided.

The changes to the Care Quality Commission’s enforcement policy do not mean that the principles that underpin effective enforcement will change. The effective use and deployment of the Care Quality Commission’s powers are achieved through robust evidence gathering at the outset, consideration of the range of enforcement tools available and taking action that is proportionate to the concerns identified and the impact on people who use services.

The Care Act 2014 has created an additional form of warning notice specifically for NHS Trusts and Foundation Trusts. The Care Quality Commission will issue these where it judges that a trust requires significant improvement. When there are failures in the quality of care within NHS trusts the Care Quality Commission works closely with Monitor and the NHS Trust Development Authority. This warning notice can lead to the provider entering the failure regime.

Further progress has been made in ensuring more robust accountability for individuals.  A new fit and proper person test for directors of NHS Trusts was put in place in November 2014, and in April 2015 will be extended to all providers of health and adult social care registered with the Care Quality Commission. This test is being introduced as a new requirement for registration and places a requirement on providers to take steps to ensure that their Board level Directors are fit to perform the role to which they are appointed, and provides the Care Quality Commission with a power to insist on the removal of Directors that it considers do not meet the fitness requirement.

Professional regulation is also being strengthened. From 31 March 2015, nurses and midwives registered in the UK must practise in line with an updated Code of professional standards of practice and behaviour. This revised code will replace the 2008 Nursing and Midwifery Council Code. The 2015 Code has been updated to reflect changes in contemporary professional nursing and midwifery practice, and wider societal expectations of health and social care, in order to drive continuous improvement in the quality and safety of care. The Nursing and Midwifery Council has also produced guidance for Fitness to Practise panel members called ‘Guidance for decision makers on insight, remediation and risk of reoccurrence’ which has explicit requirements in relation to candour and near misses.

The Government has also introduced an Order under Section 60 of the Health Act 1999, which came into force on the 11 December 2014 and makes amendments to the Nursing and Midwifery Order 2001. This will enable the Nursing and Midwifery Council to carry out its fitness to practise processes more efficiently. This is set out in more detail in the update to recommendation 228.

As the next step in the General Medical Council’s programme of reform to its fitness to practise procedures, the Department is working with them to develop legislation to establish the Medical Practitioners Tribunal Service in statute and modernise the fitness to practise procedures involving doctors. This includes a number of measures to make the fitness to practise procedures at the adjudication stage swifter and more effective. The intention is that an Order under Section 60 of the Health Act 1999 will amend the grounds on which the Professional Stands Authority for Health and Social Care can refer a fitness to practise panel decision to the higher courts and introduce a corresponding new right of appeal for the General Medical Council.