Clear standards for incident reporting in maternity

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 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.

The Thirlwall Inquiry has noted action taken in response to this recommendation. In 2020 the Patient Safety Incident Response Framework (PSIRF) was published by NHS England. The PSIRF outlines how providers should respond to patient safety incidents and how and when a patient safety investigation should be conducted.

The Maternity and Newborn Safety Investigations Programme (MNSI) investigates early neonatal deaths, intrapartum stillbirths and severe brain injury in babies born at term following labour in England, and maternal deaths in England.

The programme was established in 2018 as part of the Healthcare Safety Investigation Branch (HSIB) and has been hosted by the Care Quality Commission (CQC) since 2023.

Safety Action 10 of the Clinical Negligence Scheme for Trusts (CNST) Maternity Incentive Scheme for year six asks Trusts to report all qualifying incidents to MNSI and the Early Notification Scheme for investigation. Safety Action 1 of the Maternity Incentive Scheme also asks Trusts whether they are using the National Perinatal Mortality Review Tool to review perinatal deaths.

The Perinatal Mortality Review Tool (PMRT) supports Trusts to carry out standardised perinatal mortality reviews across NHS maternity and neonatal units in England. The PMRT is used to investigate a wider remit of cases, including all stillbirths where the baby is born from 24+0 weeks gestation showing no signs of life, or if the gestation is not known, where the baby is over 500g. The PMRT recommends that an external member, who is a relevant health professional and is external to the Trust and health board, participate in review panels to provide a ‘fresh eyes’, independent and robust view of the care provided.

In 2020 the Patient Safety Incident Response Framework was published by NHSE. The PSIRF outlines how providers should respond to patient safety and how and when a patient safety investigation should be conducted. https://www.england.nhs.uk/wp-content/uploads/2020/08/200312_Introductory_version_of_Patient_Safety_Incident_Response_Framework_FINAL.pdf

Safety Action 10 of the CNST Maternity Incentive Scheme for year four asks Trusts to report 100% of qualifying cases to HSIB and the NHS Resolution Early Notification Scheme: https://resolution.nhs.uk/wp-content/uploads/2022/05/MIS-year-4-relaunch-guidance-May-2022-converted.pdf

In July 2019, NHS Improvement published a new NHS Patient Safety Strategy. The strategy commits the National Health Service to developing a new Patient Safety Incident Response Framework (PSIRF), which will replace the Serious Incident Framework (published in March 2015) and support clinicians to identify insights at the point of care.
In April 2018, the Healthcare Safety Investigations Branch (HSIB) began rolling out its new maternity investigation approach, which investigates cases of unexplained severe brain injury, term intrapartum stillbirths and early neonatal deaths (all cases notifiable to the Royal College of Obstetricians and Gynaecologists under the 'Each Baby Counts' programme) and maternal deaths in England. Since 1 April 2019 HSIB has completed its roll out of investigations to all 130 trusts with maternity services in England.

Department of Health response (July 2015):

‘We accept this recommendation in principle. A new national, Independent Patient Safety Investigation Service […] that will conduct independent, expert-led investigations into patient safety incidents from 1 April 2016.’

‘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.” (p.71)

“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 2015.” (p.72)

Healthcare Safety Investigation Branch (HSIB)

The Independent Patient Safety Investigation Service is now the HSIB which started running in 2016.

“IPSIS Expert Advisory Group was set up to make recommendations on how the new Independent Patient Safety Investigation Service would work. Following feedback from the group and others, the function’s name was changed to the Healthcare Safety Investigation Branch (HSIB).”

Introduction and development of the national Perinatal Mortality Review Tool

Perinatal Mortality Review Tool (PMRT) was consequently developed and started in February 2017. (p. 1)