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.