Healthcare safety watchdog, HSIB, have published their annual review, looking back at their work to improve patient safety from April 2022 to March 2023. HSIB currently expect this to be their final review before their planned change of status and operating procedures as HSSIB, and handover of maternity investigations to MNSI in October this year. Who are HSIB? The Healthcare Safety Investigation Branch (HSIB) was established in April 2017 to conduct independent investigations into patient safety incidents and concerns in NHS-funded care across England, with the aim of improving patient safety. HSIB is funded by the Department of Health and Social Care (DHSC) and is hosted by NHS England, but operates independently. In contrast to many hospitals’ and trusts’ investigations of serious incidents involving harm to their patients, which often focus on an individual’s mistakes or negligent actions, HSIB’s investigations focus on issues within the healthcare systems and processes which cause or contribute to harm suffered by patients. HSIB works to improve patient safety by making safety recommendations to individual organisations and helping the NHS to learn by sharing their findings across the wider healthcare system. Currently HSIB has no power to enforce the implementation of their recommendations. HSIB pride themselves on their expertise in safety science and human factors and their investigative approach which differs from the variable quality and defensiveness of serious incident investigations carried out in NHS trusts, and liability investigations carried out by the NHS’s legal defence organisation, NHS Resolution. HSIB’s investigation programmes HSIB’s investigations are carried out under its national investigations programme or its maternity investigations programme, depending on the area of healthcare in which the patient suffered harm. Both types of investigation involve the injured patients and families in the investigation process, and both avoid apportioning blame or attributing liability to individual healthcare staff. Recurring themes from these investigations may also form the basis for further investigations. HSIB’s national investigations do not replace an NHS trust’s own investigation into an individual patient safety incident, but review the risk to patients across the entire healthcare system arising from the safety issues. National investigation reports are then published on HSIB’s website. Since 2018, HSIB’s maternity investigation programme has investigated the causes and contributing factors which have led to severe injury to pregnant women/people, mothers and babies in very specific circumstances, as part of the national effort to improve patient safety in maternity care. These include stillbirths of babies who were alive at the start of labour, deaths of newborn babies or mothers (maternal death) from pregnancy-related causes, and severe HIE brain injury to babies either with ongoing evidence of brain injury after cooling or at the parents’ or trust’s request. HSIB’s maternity investigations replace NHS trusts’ own serious incident investigations and aim to include the parents whilst helping trusts learn from incidents and make changes to improve their patient care. At system level, HSIB’s maternity teams identify and raise concerns about recurring maternity safety themes and trusts which are not providing safe maternity care. Maternity investigation reports are not published but are shared with the family and the trust. Statistics from HSIB’s Annual Review 2022/23 HSIB report that since their launch in 2017, their national investigations programme has completed 84 national reports and issued 236 national safety recommendations, 210 safety observations and 59 safety actions to 57 organizations. Between 2018 and March 2023, their maternity investigation team have made 6,998 maternity safety recommendations arising from 2,949 reports into severe harm caused by maternity safety incidents. Last year (April 2022 to March 2023), HSIB published 16 national investigation reports and issued 36 safety recommendations to 13 organisations, including DHSC, NHS England, the National Institute for Health and Care Excellence (NICE) , the Care Quality Commission (CQC), MHRA and professional bodies including the General Medical Council (GMC) and the Association of Anaesthetists. In addition, HSIB published four interim reports highlighting emergent risks which required an urgent response from the system. HSIB’s national investigation reports have highlighted patient safety concerns related to topics including ambulance handover delays, delayed diagnosis of neonatal jaundice, risks of life-threatening injury from incorrect use of arterial lines and central venous catheters, maternal death, lack of guidance on the management of premature twin births, and risks associated with poor communication. National reports also highlighted themes in maternity care, including risks of venous thromboembolism (VTE) in pregnancy and postnatally. In the same period from 2022 to 2023, HSIB’s maternity investigation programme received 1,070 referrals and completed 702 reports, a similar number to previous years. HSIB issued more than 1,380 maternity safety recommendations to healthcare organisations. Throughout the year there were always approximately 355 active investigations. 399 referrals did not proceed, either because they did not meet HSIB’s referral criteria or the family did not agree to an investigation. HSIB commented that their maternity referrals suggest that there has been ‘a sustained decrease in babies with abnormal MRI results or neurological damage’, but it is unclear from their report whether this observation assumes that many babies with HIE have been ‘cured’ by cooling without consideration of the longer term impact of more subtle neurological disability which can remain ‘under the radar’ and unrecognised until the child experiences problems in later childhood and teenage years. Family engagement in HSIB’s maternity safety investigations All the families were contacted where consent was given and 86% agreed to participate in their investigation. Those who refused to participate gave reasons which included: wanting to move on, having a positive prognosis or being happy with the care they received, preferring a trust or coroner’s investigation, feeling too distressed to discuss the events or refusing HSIB access to their medical records. HSIB’s efforts to engage families in the investigations included providing translation and interpretation services on 670 occasions and translating explanatory information about the investigation process into 36 languages. HSIB also gathered information about any specific needs which might affect the family’s ability to access or engage in the investigation, so that the process could be adapted as needed. HSIB identified family needs in nearly a third (30%) of investigations, with the most common including language barriers or lack of access to technology, mental health concerns or the effect of trauma, concerns relating to child protection or housing matters. The review does not specify whether families were asked about financial hardship after the mother or baby’s death or serious injury. Maternity safety themes from HSIB’s 2022/23 Annual Review HSIB identified that the most common themes in their maternity safety investigations were clinical assessment, guidance, fetal monitoring, clinical oversight, risk assessment, and escalation. In the last year, HSIB issued 32 escalation letters of concern to trusts, and has been working to develop a standardised process of escalation to ensure that healthcare staff who are concerned about a patient’s condition can more easily call for assistance from senior staff. Following multiple reports by HSIB and others highlighting racial inequalities in maternity outcomes, HSIB have formed a race equality group to understand the impact of racial diversity on healthcare experiences, outcomes and access to care. What will happen to patient safety investigations under HSSIB and MNSI? From October 2023, HSIB’s investigations programmes will be handled by two separate organisations. HSIB will become a Non-Departmental Public Body established under the Health and Care Act 2022 and will change its name to the Health Services Safety Investigations Body (HSSIB). The new HSSIB will continue the national investigations programme with enhanced powers to compel NHS trusts to disclose information and comply with the investigation, open access to patients’ medical records (without their prior consent), and the highly controversial use of ‘safe space’. Following the government’s announcement in March 2023, it is now expected that when HSIB changes status, the maternity investigation programme will be hosted by the CQC and will be known as the Maternity and Newborn Safety Investigations (MNSI) programme. HSIB’s review says that ‘further details are still being worked out’, but initially they expect the criteria for maternity investigations to remain the same as in 2022/2023. If you have suffered severe injury in an accident or 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.