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England’s healthcare safety watchdog, the Healthcare Safety Investigation Branch (HSIB), has published its maternity investigations programme’s 2022/23 annual review. The report highlights HSIB’s recent work to identify and alert the healthcare system to significant patient safety concerns identified from more than 1,380 recommendations in 700 maternity investigations arising from brain injuries to babies, and maternal and neonatal deaths.
What is HSIB’s maternity investigations programme?
HSIB’s maternity investigation programme was set up in April 2018 to support national efforts to improve safety in maternity care. Since April 2019 HSIB has worked with all 122 NHS trusts which provide maternity care. NHS trusts must refer to HSIB all maternity incidents which meet HSIB’s specific eligibility criteria. When HSIB accepts a referral which meets its criteria and agrees to investigate the incident, their investigation replaces the NHS trust’s own investigation. HSIB’s maternity investigation report is not published but is shared with the injured patient’s family and with the NHS trust which is responsible for implementing any safety recommendations that are made in the report. Alongside investigations related to harm caused to individual mothers and babies, HSIB’s maternity team identify and analyse recurring themes from these investigations, so that they can be explored via their national investigations programme and the lessons shared across the healthcare system to encourage learning and improvements in maternity services.
HSIB’s national investigation reports arising from maternity safety concerns in 2022/23 included ‘The assessment of venous thromboembolism risks associated with pregnancy and the postnatal period’, ‘Assessment of risk during the maternity pathway’ and a review of maternal collapses and maternal deaths at Royal Derby Hospital. HSIB continues to explore maternity safety themes via its national investigations, with reports currently awaited on ‘Factors affecting the delivery of safe care in midwifery units’ and ‘Perimortem caesarean section during the management of cardiac arrest’.
What maternity safety incidents are eligible for HSIB investigation?
HSIB’s maternity investigation programme investigates:
- Maternal deaths, where a pregnant woman/person (mother) dies within 6 weeks of the end of their pregnancy from any pregnancy-related cause, but not accidental/incidental causes or suicide.
HSIB also investigates incidents where ‘term’ babies born at or after 37 full weeks of pregnancy suffer:
- intrapartum stillbirth, where the baby was alive at the start of labour but was born with no signs of life;
- early neonatal death, where the newborn baby died within the first week of life;
- severe brain injury, diagnosed within the first week of life, involving either a diagnosis of grade III hypoxic ischaemic encephalopathy (HIE), treatment with therapeutic cooling, or decreased central tone (floppiness), loss of consciousness and seizures (fits or convulsions).
Since the pandemic, HSIB has not investigated cases where, after cooling, the baby’s MRI scan or neurological examination reveals no obvious evidence of ongoing brain injury, unless the family or the NHS trust request an investigation.
How many maternity safety investigations did HSIB carry out in 2022/23?
HSIB’s 2022/23 review of the maternity investigation programme reveals that between April 2022 and March 2023, they received 1,070 referrals arising from birth-related serious brain injury, stillbirth, or the newborn baby’s or mother’s (maternal) death. 399 of the referred cases were not investigated, either because they did not meet HSIB’s criteria or the family declined an investigation.
HSIB’s maternity investigations programme completed 702 investigations, in line with similar figures from previous years. HSIB report a decrease in the number referrals involving brain-injured babies with abnormal MRI results or ongoing neurological damage. Their report (and limited investigation remit) does not consider the more subtle neurological disability which may develop later in childhood or adolescence in babies who suffered a severe brain injury but have subsequently been ‘cooled’ successfully.
Of the incidents which were investigated by HSIB, 52% (351) were brain-injured/cooled babies, 26% (173) were stillbirths, 13% (84) were neonatal (newborn) deaths and 9% (63) were maternal deaths. Whilst annual reviews look for trends in these figures which provide statistical evidence of improvement, it is vital that the unacceptable level of harm caused by maternity care failings in these tragic and often avoidable cases is not minimised or normalised by positive comparison with the harm from past years. Each incident represented the devastating, life-changing injury to a child, or the tragic, irreplaceable loss of a child or mother to their partner or family.
Themes arising from HSIB maternity investigations
Between April 2022 and March 2023, HSIB’s maternity programme made more than 1,380 safety recommendations to NHS trusts and other healthcare organisations. HSIB’s safety recommendations are made when an investigation reveals a safety issue which contributed to the patient’s tragic outcome. It is the NHS trust or other organisation’s responsibility to act on the recommendation, so that the standard of maternity care is improved for other patients. HSIB’s former Chief Investigator, Keith Conradi, recently shared his frustrations that HSIB is largely dependent on cooperation from NHS England to support and enforce HSIB’s efforts to improve patient safety, as HSIB currently has no power to compel NHS trusts or other organisations to implement their recommendations.
HSIB’s analysis of their safety recommendations reveals recurring themes in maternity safety. These often occur in combination and must be understood and addressed to ensure safe maternity care. In 2022/23, HSIB’s safety recommendations most commonly related to clinical assessment, guidance, fetal monitoring, clinical oversight, risk assessment, escalation and communication. HSIB are working to understand how these and other common themes interact, and how combined improvements could lead to safer maternity care environments.
Escalation in maternity safety investigations
HSIB and other professional reviews have highlighted recurring failure to recognise when a pregnant mother’s condition is deteriorating and escalate her care. Escalation was found to be a common theme in the care of pregnant mothers with diabetes, and is often related to failings in clinical assessment, clinical oversight and communication. In 2022/23, HSIB issued 32 letters raising urgent concerns or highlighting emerging themes.
HSIB has supported the development of a standardised escalation process to enable their own maternity investigation teams to escalate serious and significant safety concerns which they identify during an investigation but which require immediate action. The process also supports healthcare staff and managers in making decisions to share these concerns with external regulatory bodies or other authorities.
Risk assessment in maternity safety investigations
Risk assessment failure is another common theme in HSIB maternity investigations, which led to the publication in March 2023 of HSIB’s report, ‘Assessment of risk during the maternity pathway’.
Triage in labour
Triage involves assessing the urgency of a patient’s need for treatment when they call or arrive at the hospital. HSIB has identified recurring failings and variations in the triage care of pregnant mothers in early labour, often linked to issues with training, guidance, clinical assessment, clinical oversight, escalation and staffing. HSIB found that in many NHS trusts no record was kept of a pregnant mother’s previous calls to the triage service, resulting in the mother’s ongoing concerns remaining unrecognised.
Pregnant mothers in established labour were sometimes assessed as ‘not in labour’ if their cervix was only 3 cm dilated which, under the hospital’s guidance, prevented them from being admitted to the labour ward and being denied pain relief or monitoring for the pregnant mother and unborn baby. Local guidelines stated that they should not be reassessed for four hours, during which time they will have been sent home and returned to the hospital only when labour is far more advanced, missing the opportunity for fetal monitoring at a critical time for an unborn baby who might be compromised and need an urgent or emergency delivery.
Racial inequality theme
In response to the findings in reports by HSIB, MBRRACE and other organisations, highlighting racial differences in maternity outcomes, HSIB has formed a race equality group to analyse further their data from investigations and understand the impact of racial diversity on experiences, access to care, and outcomes.
HSIB say that they contacted all families who consented to being contacted during their maternity safety investigation. 86% agreed to take part in the investigation. 14% of families declined an HSIB investigation. Their reasons for declining included wanting to ‘move on’ or seeing no value in an investigation, being happy with the care they received or having a positive prognosis, preferring an investigation by the NHS trust or the coroner (in fatal cases), feeling too distressed to discuss the events or not wanting HSIB to access their medical records.
HSIB explored families’ needs before and during their investigations so that the process could be adapted if needed to ensure the families’ access and inclusivity. HSIB identified that families had needs in 30% of all investigations. 57% of the needs involved communication, most commonly for interpretation/translation or lack of access to technology. 32% had health and wellbeing needs, most commonly for mental health concerns or the effects of trauma. 11% had social needs, most commonly involving the protection of a child or issues relating to housing. HSIB’s review does not specify whether families were asked about financial needs arising from the injury or loss to their mother or child.
HSIB provided interpretation/translation services on 670 occasions and translated explanatory information about investigations into 36 languages. The watchdog is now seeking feedback from families about their experiences of their investigations and working to add value to their post-investigation tripartite meetings which bring together HSIB, the hospital and the family. HSIB’s report does not clarify whether the ‘next steps’ discussed at these meetings include advising families about their rights to seek independent specialist legal advice if referred to NHS Resolution’s Early Notification Scheme (ENS).
What’s next for maternity safety investigations?
In October 2023, HSIB will become the HSSIB and will no longer carry out maternity safety investigations. The most recently announced plans are for the maternity investigations programme to continue investigating incidents based on current eligibility criteria as the Maternity and Newborn Safety Investigations Special Health Authority (MNSI) and be hosted by the Care Quality Commission (CQC).
If you or your partner or child have suffered severe injury as a result of medical negligence or have been contacted by HSIB/HSSIB/MNSI/CQC or NHS Resolution, you can talk to a solicitor, free and confidentially, for advice about how to respond or make a claim by contacting us.
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