Duty to report external investigation findings

43. We accept these recommendations. A new national, Independent Patient Safety Investigation Service will improve local standards of investigation and openness. 44. During the 10-year period in which serious incidents were occurring at Morecambe Bay, the Investigation found that there had been external reviews conducted into operational aspects of the Trust, that were not brought to light in a timely or transparent way and that had regulators been sighted on the Fielding report earlier, action might have been taken sooner to address concerns. 45. NHS Trusts and Foundation Trusts are already required to notify the Care Quality Commission and Monitor and the NHS Trust Development Authority of certain events, such as serious incidents or third party investigations or reports. However we also believe that there is a strong case for requiring providers to notify regulators - both the Care Quality Commission and Monitor or the NHS Trust Development Authority - when they commission external investigations. The Government will consult on proposals to extend the regulations that set out requirements for notifications to cover the commissioning of external investigations. 46. In the meantime, Monitor and the Care Quality Commission will continue to use their respective statutory information-gathering powers to require NHS Trusts and Foundation Trusts to notify them of both the commissioning and the conclusions of relevant external investigations. 47. Trusts also have to report in their Quality Account on the number and where available, the rate of patient safety incidents reported within the reporting period, and the number and percentage of such patient safety incidents that resulted in severe harm or death. There is also a requirement to report on whether they have taken part in any reviews or investigations by the Care Quality Commission under section 48 of Health and Social Care Act 2008. We will consider what more can be done to improve awareness and accessibility of this information. 48. There are several existing mechanisms for reporting and sharing learning from serious incidents: • NHS bodies are already required to notify the Care Quality Commission and the National Reporting and Learning System, currently overseen by NHS England, where serious incidents have happened, including those which prompt investigations. Reports to the National Reporting and Learning System are analysed by expert clinicians to identify common hazards, and can result in recommendations being made to local NHS organisations to mitigate these risks and improve the safety of patient care. • The NHS England Serious Incident Framework recommends that providers collaborate with external scrutiny and investigations, including the full and open exchange of information with other investigatory agencies (such as the police, the Health and Safety Executive, Coroner and local safeguarding boards). It also recommends publishing information about serious incidents including data on the numbers and types of incidents, excluding material that would compromise patient confidentiality, within annual reports, board reports and other public facing documents. 49. The Government have accepted the recommendation of Sir Robert Francis QC that national expertise on patient safety should be based within a single organisation that can provide strategic leadership across the whole healthcare system. The Government intend to bring under the single leadership of Monitor and the NHS Trust Development Authority responsibility for leading the patient safety functions that currently sit with NHS England. The new Independent Patient Safety Investigation Service will also be brought under the single leadership of Monitor and the NHS Trust Development Authority. A core element of that role would be supporting the NHS to learn from service failures. Responsibility for disseminating learning from external investigations would best sit with the body that has the lead role on patient safety.

The Academy of Royal Colleges published their invited review framework in March 2022. CQC contributed to the update, which included strengthening information sharing with regulators. The framework should lead to an improvement in the disclosure of reports to CQC and escalation of issues. Principle 14 of the framework sets out that healthcare organisations will be responsible for addressing patient safety risks and being open and transparent about them. This includes bringing risks identified in the review to the attention of the CQC and other appropriate regulatory bodies.

Organisations are required under the Health Act 2009 and subsequent Health and Social Care Act 2012 to produce Quality Accounts if they deliver services under an NHS Standard Contract, have staff numbers over 50 and NHS income greater than £130k per annum. Guidance published by the Healthcare Quality Improvement Partnership requires that this contains details of the Trust’s clinical audit participation for each of the national audits, enquiries and quality improvement programmes they participate in, along with information related to improvements responding to clinical audit report recommendations.

National Health Service trusts are asked to submit details of the commissioning and conclusion of relevant external reviews or investigations undertaken in the previous 12 months and describe key outcomes to the Care Quality Commission (CQC) as part of the Routine Provider Information Return.

NHS England and NHS Improvement have agreed to establish an advisory function for independent reviews which they sponsor, commission or oversee. This will advise on the establishment and best practice management of these types of reviews.

The CQC does not have a system for disseminating learning to other trusts. However, Local Maternity Systems (LMSs) and Clinical Networks have a role in sharing learning from reviews and investigations. A recent review of LMSs suggests this is working well with systems for shared learning embedding.

Department of Health response (July 2015):

In its response, the Department of Health noted that there are already existing obligations on NHS Trusts within this recommendation:

• Disclose to the Care Quality Commission of serious incidents.
• Monitor and the Care Quality Commission use their respective statutory information-gathering powers to require NHS Trusts and Foundation Trusts to notify them.
• Trusts also have to report in their Quality Account on the number of patient safety incidents. However also mentioned introduction of “a new national, Independent Patient Safety Investigation Service. The Government intend to bring under the single leadership of Monitor and the NHS Trust Development Authority responsibility for leading the patient safety functions that currently sit with NHS England.” (p. 76)