Involve patients and relatives in incident investigation

37. We accept this recommendation. A duty of candour has been introduced. 38. A lack of openness and honesty at Morecambe Bay was a fundamental cause of both the distress of the families, and of the inability of the Trust to learn from serious incidents. At a regulatory, provider and professional level action is being taken to increase the involvement of patients/relatives in investigation of serious incidents. 39. All providers must now comply with a new legal requirement for openness – the duty of candour – as a condition of their registration with the Care Quality Commission and hence a condition of their providing care. Providers must now inform patients where there has been a significant failure in their care or treatment and set out what further enquiries will be undertaken into the incident and to inform patients of the outcome of such enquiries. Registered providers must also seek and act on feedback from patients in order to improve services. We believe that these requirements address the recommendation. However, we will keep the effectiveness of the duty of candour under review and will consider whether further changes are needed in due course. 40. The new NHS England Serious Incident Framework, published on 27 March 2015, also requires providers to: comply with national requirements and guidance in relation to being open with patients or their representatives when things have gone wrong; support and enable staff in disclosing incidents to patients and their representatives; and involve patients and families/carers in investigations, sharing findings and facilitating specialist support where appropriate. 41. In addition, all healthcare professionals including doctors, nurses and midwives have an individual professional duty of candour, which is a responsibility to be open and honest. This responsibility is set out in their respective professional codes of conduct. In October 2014, the Department welcomed a joint statement by eight of the statutory regulators of healthcare professionals, including the General Medical Council and the Nursing and Midwifery Council, reaffirming that every healthcare professional must be open and honest with patients when something goes wrong with their treatment or care. Similarly, the Department is pleased to note that the General Medical Council and the Nursing and Midwifery Council launched their new joint guidance on the professional duty of candour on 29 June 2015, which includes advice on apologising to patients when things go wrong. 42. The Government fully expect both individuals and organisations to comply with these processes; and will also seek further advice from the expert group considering the national investigations capability on: • how any new investigation function can ensure a genuine commitment to openness, transparency and engagement with patients and their families/carers throughout the investigation process; and, • whether this can be made an integral objective of any investigative process.

The Thirlwall Inquiry has noted action taken in response to this recommendation.

In 2021, new guidance was published on involving patients in safety which sets out patient involvement in the response to a patient safety incident including any investigation.

All healthcare professionals have an ongoing professional duty of candour.

The statutory duty of candour requires registered providers and registered managers (known as ‘registered persons’) to act in an open and transparent way with people receiving care or treatment from them. In December 2023, the Government announced a review of the statutory duty of candour. The review is ongoing.

As committed to in the Kings’ Speech on 17 July 2024 the Government will bring forward legislation to establish a Hillsborough Law ahead of the next anniversary of the Hillsborough Disaster. This will establish a duty of candour on all public servants and officials with criminal sanctions for those who do not comply.

Safety through learning is one of four ambitions in CQC’s strategy (from 2021). A key aspect of this ambition is ‘involving everybody’ which recognises the need for staff and leaders to involve people in their own safety and take into account their rights. The quality statement for ‘learning culture’ under the new single assessment framework, to which there is a direct link to the Duty of Candour regulation, states: “We have a proactive and positive culture of safety based on openness and honesty, in which concerns about safety are listened to, safety events are investigated and reported thoroughly, and lessons are learned to continually identify and embed good practices”.

The Health Services Safety Investigations Body (HSSIB) also aims to involve patients and families affected by safety incidents in their investigations. They set out how patients and families are involved on their website.

Compassionate engagement and involvement of those affected by patient safety incidents, including patients, families and staff, is central to NHS England’s Patient Safety Incident Response Framework (PSIRF). The framework aims to ensure they are treated with compassion and are effectively and compassionately supported to be involved in patient safety incident investigations to the extent that they wish to be.

In 2022, NHS England, in partnership with HSIB and Learn Together published supporting guidance on engaging and involving patients, families and staff following a patent safety incident.

In 2021, new guidance was published on involving patients in safety which sets out patient involvement in the response to a patient safety incident including any investigation.

The Government introduced a statutory duty of candour on organisations in response to the Mid Staffordshire NHS Foundation Trust Public Inquiry, and this is regulated as part of the Care Quality Commission inspection regime. Providers must ensure that they have processes in place to ensure staff are supported to deliver the duty of candour and have a system in place to identify and deal with possible breaches by registered staff. There are currently no plans to make further changes to these regulations.

The General Medical Council and the Nursing and Midwifery Council produce professional duty of candour guidance that registered doctors, nurses and midwives must follow.

Tom Kark QC in his Review into the Fit and Proper Persons Test suggested that compliance with the duty of candour should be included in the core competencies of directors to sit on the board of any health providing organisation. NHS England and NHS Improvement are currently considering how best to bring forward this proposal as part of the NHS People Plan.

Department of Health response (July 2015):

New Duty of Candour

“A duty of candour has been introduced … All providers must now comply with a new legal requirement for openness – the duty of candour – as a condition of their registration with the Care Quality Commission and hence a condition of their providing care.” (p. 73)

New Serious Incident Framework

“The new NHS England Serious Incident Framework, published on 27 March 2015, also requires providers to: comply with national requirements and guidance. (p. 73)

NHS England Webpage

“… in August 2022 … [NHS England] published the new Patient Safety Incident Response Framework (PSIRF), which will replace the current Serious Incident Framework. There will be a 12-month period where organisations prepare for the transition to PSIRF, which we expect to be completed by Autumn 2023.”

Professions regulating duty of candour

“Duty of candour … responsibility is set out in their respective professional codes of conduct. Department is pleased to note that the General Medical Council and the Nursing and Midwifery Council launched their new joint guidance … on 29 June 2015.” (p. 74)