23. We accept this recommendation in principle. A new national, Independent
Patient Safety Investigation Service will supplement existing practice.
24. The Investigation found that there were a substantial number of missed
opportunities to uncover and address the problems at Morecambe Bay. The quality
of investigations carried out into serious incidents was found to be poor, and this
contributed to the ongoing failures to learn and improve, and also resulted in the
system having an overly optimistic view of performance in the midwifery unit.
25. On mandatory reporting and standardised reviews of perinatal deaths, the
Department is working with NHS England, the Scottish, Welsh and Northern Irish
health departments along with the Royal College of Midwives and the Royal College
of Obstetricians and Gynaecologists and Sands (the leading stillbirth charity) to
consider how standardised reviews for all perinatal deaths might be introduced. We
will keep in mind this recommendation when developing this work.
26. MBRRACE-UK (Mothers and Babies – Reducing Risk through Audits and
Confidential Enquiries across the UK) currently collects information on:
• all late fetal losses, stillbirths and neonatal deaths;
• characteristics of mothers whose babies are stillborn or die in the first 28 days
after birth;
• all mothers in the UK who die during pregnancy or in the 12 months after
giving birth.
27. They conduct confidential enquiries on topics related to aspects of stillbirth,
infant deaths, and neonatal deaths. They also conduct confidential enquiries into all
maternal deaths and topic specific serious maternal morbidity.
28. Data is anonymised and the confidential enquiry expert assessors review the
care provided and compare the quality of care with national agreed “best practice”
standards to identify where improvements could be made. Based on their findings,
MBRRACE-UK makes national recommendations about how care for mothers and
babies across the UK can be improved in future.
29. While reporting is not mandatory, MBBRACE-UK collects surveillance
information about mothers and babies that die directly from hospital trusts via
hospital medical records, including reports and test results; letters and medical
records from other doctors (ie GPs); a description from local staff about the care
provided to the woman and her baby in the form of written statements. MBBRACE­
UK is confident that they identify all maternal deaths and compliance with the
confidential enquiry is mandated in England through “Quality Accounts” and for
doctors through General Medical Council best practice requirements.
30. As well as acknowledging the importance of using data and standardised
reviews to improve maternity services specifically, the Government believe that clear
standards should be drawn up for incident reporting and investigations in relation to
all serious incidents, not just maternity.
31. in line with this recommendation, the Secretary of State for Health asked Mike
Durkin, Director of Patient Safety at NHS England, to develop and publish clear
standards and guidelines for incident reporting.
Following this, NHS England
published a revised Serious Incident Framework in March 201512. This requires all
unexpected or avoidable deaths, including those of mothers or babies, which may
have been or were the result of failings in health care, to be reported to the relevant
commissioner(s) and to be investigated as serious incidents. It is not always initially
clear if a failure in health care has occurred and has directly led to a death. In these
circumstances, providers and commissioners are expected to discuss the incident, to
investigate it appropriately and to let the investigation decide. If a serious incident is
initially declared but further investigation reveals no serious incident occurred, the
incident can be downgraded.
32. In addition, the Care Quality Commission is conducting a thematic review into
the quality of investigations in a sample of NHS Trusts and Foundation Trusts. This
review will seek to understand the quality of investigations and to identify areas for
improvement. This work will report later in 2015.
33. There is further scope to improve the quality of investigations into serious
incidents in the NHS and there is much to be learned from other safety-conscious
sectors such as the airline industry.
34. We will therefore, as indicated elsewhere in this document, establish a new,
Independent Patient Safety Investigation Service that will conduct independent,
expert-led investigations into patient safety incidents from 1 April 2016. It will be
selective about the incidents it investigates to ensure optimum effectiveness, and it
will focus on incident types that signal systemic or apparently intractable risks within
the local health care system. For example, incidents that lead to high cost litigation
claims, certain never events and incident types such as medication errors. There
may be some capacity to examine cross cutting themes from these investigations.
35. The Service will have the capacity to investigate only a small proportion of the
many safety incidents that occur each year, and therefore a key part of its wider role
will be to champion the need for good quality local investigations and lead on
12 http://www.england.nhs.uk/ourwork/patientsafety/serious-incident/
approaches that will enhance the capabilities of providers to conduct their own
investigations.
36. We have said that an important principle of this new Service will be its ability to
exercise independence and operate without fear or favour irrespective of its location
in order to get to the bottom of any patient safety incident that it examines. To ensure
that its processes, practices and outputs are transparent and subject to external
scrutiny.
Openness and transparency: 24-27