Written evidence submitted by Healthcare Safety Investigation Branch (MSE0044)
Health and Social Care Committee: Safety of Maternity Services in England
Healthcare Safety Investigation Branch submission
The Healthcare Safety Investigation Branch (HSIB) conducts independent investigations into patient safety concerns in NHS funded care across England. Formed in April 2017, we are funded by the Department of Health and Social Care (DHSC) and hosted by NHS England and NHS Improvement, but we operate independently. HSIB’s safety investigations identify the contributory factors that have led to harm or have the potential to cause harm to patients. Our safety recommendations aim to improve healthcare systems and processes to reduce risk and improve patient safety in the NHS. We work closely with patients, families and healthcare staff affected by patient safety incidents and we never attribute blame or liability.
1.1. HSIB welcomes the Health and Social Care Committee’s inquiry, Safety of Maternity Services in England, including the role and work of the Healthcare Safety Investigation Branch (HSIB) in improving the safety of maternity services. Our submission provides an overview of our maternity investigation programme, the outputs and impact of our work to date at local level with trusts, regionally and nationally across the NHS. We explain our positive impact on NHS safety culture including through our family engagement model, our just culture approach to investigations and our collaborative approach with trusts and staff. We also discuss our ambitions and recommendations for improving HSIB’s impact and furthering our positive contribution through investigations that enhance patient safety in NHS maternity services.
1.2. HSIB would be pleased to discuss HSIB’s submission with the Committee; for further information contact Cassandra Cameron, Head of Policy and Strategy, email@example.com and C.I.Office@hsib.org.uk.
2.1. The HSIB maternity programme was fully operational in all 130 trusts by end-March 2019 and had commenced 1421 investigations by end-July 2020, of which 977 had been completed and 444 at varying stages of completion. Timescales for HSIB investigations are decreasing as the programme evolves, in response to feedback from families and trusts and through refining our processes.
2.2. HSIB investigations have identified recurring themes in maternity safety incidents; among the most frequent are issues relating to effective escalation, clinical oversight, clinical assessment and monitoring, and appropriate use of guidance. HSIB has established a system of engagement with trusts to ensure safety risks are rapidly shared and escalated, and our ongoing presence through investigations aids our understanding about how effectively a trust is responding to address the risks.
2.3. HSIB, although only one part of the national system for safety of maternity care, has unique insight into local maternity services which informs our work at local, regional and national level to support joined-up learning. We are contributing to national maternity safety improvement programmes and have begun publishing national learning reports on key safety themes identified through our investigations to date.
2.4. HSIB’s positive impact on safety culture is demonstrated through family and staff feedback showing that they value professional, independent maternity investigations, and the importance of HSIB’s commitment to a just culture approach based on safety science. HSIB’s commitment to transparency and continuous improvement has been central to achieving this impact.
2.5. The maternity programme is beginning to produce valuable system level learning and positive safety impact, and HSIB’s commitment to professionalising patient safety investigation will further support this work. However, it needs more time and benefits could be increased through changes to the Each Baby Counts criteria, developing the maternity safety champion role in trusts, reducing duplication for trusts, and HSIB’s full statutory independence.
3.1. On 27 November 2017, in an update to the National Maternity Safety Strategy, the then-Secretary of State for Health and Social Care, Jeremy Hunt announced in Parliament that from April 2018 onwards, “every case of a stillbirth, neonatal death or suspected brain injury that is notified to the Royal College of Obstetricians and Gynaecologists’ Each Baby Counts Programme - that is about 1,000 incidents annually” - would become the responsibility of HSIB instead of the local trust. In addition, HSIB’s new programme would investigate the death of any woman while pregnant or within 42 days of the end of her pregnancy, from any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes and excluding suicides. The programme was formally established with the HSIB Maternity Directions 2018.
3.2. The Secretary of State’s decision was prompted by recent national reports which demonstrated that the same types of safety incidents in maternity care were reoccurring in services across the NHS, leading to significant harm and suffering and very high litigation costs. These reports also conveyed persistent variation in the quality, transparency and impact of local trust patient safety investigations in maternity services, and workplace cultures in some trusts that perpetuated blame and cover-up and denied patients and families a voice. For example, the RCOG’s Each Baby Counts Programme report in 2015 noted the poor standard of local NHS maternity safety investigations, with 66 percent that excluded the family from involvement in the investigation and 76 percent of incidents with a potentially different outcome given different care. The intention was for HSIB’s investigatory expertise to bring a standardised, learning-oriented and person-centred approach to safety investigations that would produce insight to help reduce maternity safety incidents across the NHS. HSIB maternity investigations:
3.3. The maternity programme has important differences from the national, system-level investigations that HSIB was established to provide. Unlike our national investigations, for eligible maternity cases HSIB replaces the local trust serious incident investigation. Trusts are still encouraged to complete an initial (72-hour) review to identify any immediate safety risks and act appropriately. Confidentiality of all staff and families is protected in line with our ‘just culture’ approach, but the investigations are not subject to ‘safe space’ provisions.
Operations of the HSIB maternity programme
3.4. The maternity programme is overseen by HSIB’s Executive Director of Investigations and jointly managed by the Associate Director of Maternity Investigation Programme and the Clinical Director for Maternity. HSIB’s maternity investigators are recruited with prior experience of safety investigation in healthcare or other professional environments; a significant number are NHS staff on secondment from their local trust. Upon starting with HSIB, all investigators undergo a three-week training course for developing their investigatory skills in maternity services and knowledge of safety science. This bespoke professional development approach is maintained with ongoing internal training and learning opportunities. Including the programme’s senior leadership team, about 160 staff work in HSIB’s maternity programme.
3.5. There are 130 acute trusts in England that provide maternity services, and the programme was implemented with the trusts from April 2018 using a 12-month phased approach across 14 regions. The first maternity investigations commenced in May 2018 in the South East region and all 14 regions were fully operational in every NHS maternity unit by end-March 2019. Trusts refer to HSIB any maternity incidents (‘cases’) which appear to meet the EBC criteria or MBRRACE maternal death through a secure website portal.
3.6. Once a referral is received, an HSIB investigation team from the relevant region will contact the trust within 24 hours to ensure the case meets all criteria for investigation and obtain the family’s contact details. HSIB cannot commence an investigation without family consent to access the mother and baby’s healthcare records; we aim to obtain this within five working days of the referral. The investigation team then scopes the case, working with the family and trust to establish the investigation's terms of reference. The investigation progresses in accordance with the allocated pathway (‘complex’ or ‘non-complex’) on a timescale aimed to complete within six months, and the investigation team ensures that the family and the trust remain updated throughout. The investigation pathways are provided at Appendix 3. Ongoing communication with trusts during the investigations also ensures that any early learning from investigations is rapidly shared to support safer care.
3.7. In addition to the acute trusts, throughout an investigation HSIB works as needed with other providers of health and social care including ambulance trusts, general practitioners, social services, charities and mental health providers who may have been involved in the care of a mother or baby. In cases of maternal or neonatal death, HSIB has engaged with coroners at national and local level to support the requirements of inquest hearings. All HSIB’s maternity investigations engage relevant clinical and safety science experts as needed for the individual case.
4.1. When the Covid-19 pandemic struck in March 2020, HSIB had just completed one year of full operation. In line with NHS-wide efforts to reduce pressures on trusts, HSIB (with DHSC’s agreement) made amendments to the programme - trusts would continue to refer all cases in line with the existing criteria, but HSIB would temporarily cease investigations of cases relating to Hypoxic Ischemic Encephalopathy (HIE) where the baby had received cooling therapy and there was no apparent neurological injury. This adjustment has reduced the investigations caseload by 17.45% between March and end-July 2020.
4.2. From April 2018 until end-July 2020 (our latest figures), HSIB received a total of 2061 referrals from trusts, which is broadly in line with the approximately 1000 investigations per annum that the programme was expected to deliver under the referral criteria. Of these 2061 referrals:
Progress of referrals
4.3. Of the 1421 referrals that have progressed to investigation, 977 (69%) investigations have now been completed, meaning that the final report has been provided to the family and the trust. The remaining 444 cases at end-July 2020 were at varying stages of completion:
Categories of referrals
4.4. Referrals accepted for investigation across the four main criteria categories for the programme are set out in Figure 1, below. Referrals not investigated due to our Covid-19 adjustment are also displayed, categorised as ‘Covid-19 rejections’. The diagrams show that in the first two years of the programme, ‘cooled babies or babies diagnosed with brain injuries’ was the largest category and continues to be into the current year, although their numbers have declined in relative percentage of overall referrals. Of notable significance is the increase in intrapartum stillbirths and maternal deaths, which have occurred at a greater pro-rata rate from April-July 2020, compared with the previous years of the programme’s operation. HSIB has commenced work in the national investigations programme to identify any systemic factors which may account for the rise in these cases.
Figure 1: categories of accepted referrals to HSIB’s maternity investigations programme
4.5. The timescales for HSIB investigations have been progressively reducing as our methodology and processes mature, and the collaborative approach with trusts becomes embedded into the operations of the programme. As figure 2 below shows, the number of investigations exceeding the 6-month timescale set in the Maternity Directions is rapidly decreasing. This has been a priority focus area for HSIB as we are aiming for there to be no cases exceeding the six-month timescale by November 2020.
Figure 2: Progress of active cases against the six-month timescale
5. Recurring safety themes identified by HSIB maternity investigations
5.1. Our investigations have, over time, provided HSIB with a unique insight on the safety, risks and culture on individual maternity units, and the recurrent safety themes at trust level and across the country. This has enabled us to identify themes which highlight both high number of occurrences, and events that occur less regularly but have significant impact. We have made over 2,500 safety recommendations to trusts addressing a wide array of issues. Among the most frequently recurring themes that we have addressed include:
Problems with effective escalation
5.2. Issues relating to escalation can have a significant impact on the outcome of mothers and babies. This can relate to timeliness, the environment, anticipation of events and communication within and outside of the clinical team. Escalation problems can occur at any point during the pregnancy pathway, such as:
5.3. The care a mother and baby receive involves multiple clinical staff who often may only be involved at particular stages during the pregnancy. Effective documentation and communication are necessary to ensure the mother and clinical teams remain up to date with any changes to care plans. When complications occur and there is no coordination of care this creates confusion and results in individual specialities working in silos. This can also occur when care is delivered across multiple healthcare providers, with a reliance on the mother or family to update the clinical teams. For a mother with complex conditions, the importance of allocating responsibility to a consultant obstetrician and their team is often underestimated. Without this approach care can be uncoordinated with an ineffective multidisciplinary approach.
Clinical assessment and monitoring
5.4. The clinical assessment of mothers and babies incorporates many factors which influence their ongoing monitoring and can affect subsequent actions taken as part of their care. The initial monitoring of a mother using a track and trigger tool, the interpretation of cardiotocograph (CTG) monitoring or assessment of progress in labour are just a few of multiple examples. Each represents a decision point that provides opportunities for different choices regarding pathways of care, escalation for senior review or transfer from one location to another. Poorly informed decisions can adversely influence both the outcome and experience for all involved. For families this can mean significant changes for their current home situation or decisions made in subsequent pregnancies. For staff this may impact on their career pathway or ability to work within a particular environment.
Appropriate use of guidance
5.5. The effective and appropriate use of national policy and guidance to support staff to provide care to mothers and babies is variable. There is a significant volume of national guidance available, and at times this can be unclear or conflicting. For example, we have recently written to NICE regarding updates to Induction of Labour guidance. Our investigations often identify that local guidance does not reflect the national perspective or the interpretation for local context is insufficiently clear. Where a trust has multiple sites, the guidance may be different between each site, which can be confusing for staff. In addition, where a trust has implemented guidance without a coordinated approach, staff can struggle to practice care safely by adhering to it.
6. HSIB’s engagement processes with trusts
6.1. Close collaboration with the trusts is necessary for the programme to be effective, and its operational structure ensures that every trust has a close relationship with a team of HSIB staff. This team includes a regional midwifery advisor, a regional team leader, a designated lead investigator to oversee the relationship, and other maternity investigators for that region who may undertake investigations in the trust. We share the intelligence from our investigations with trusts through an ongoing programme of meetings and communications which are designed to facilitate rapid response to any safety risks that require urgent attention, awareness of emergent and recurring themes, and to communicate effectively with frontline staff about risks and support their learning from HSIB’s work. Our methods include:
6.2. Any significant areas of concern are shared as soon as HSIB identifies them to ensure critical safety risks are mitigated as soon as possible. This is usually by telephone call to the Head of Midwifery followed up in writing to support action prior to completion of an investigation report. We have received positive feedback on this approach, and on completion of an investigation the final report can reflect the actions already taken by the trust. For example:
6.3. These regular updates to the trust’s head of midwifery include details about progress of ongoing investigations, delays or missing information for cases, HSIB’s experience with staff interviews (whilst protecting staff confidentiality) and provide insight into safety issues that may be factored into other safety management activity for the maternity unit.
Quarterly Review Meetings
6.4. Each trust has a scheduled quarterly review meeting (QRM) with their HSIB regional team leader and lead maternity investigator. At the QRM the HSIB team presents the data relating to all referrals and review cases from the previous three months, identifying evolving and recurrent themes along with any evidence of safety improvement based on previous HSIB recommendations. This information remains with the trust for them to share internally or with CCG’s. If necessary, such as for more serious safety concerns or when HSIB considers there to be insufficient urgency in the trust’s response to previously identified issues, senior HSIB staff also attend to provide additional support for discussions between trusts and HSIB team members. Trusts are encouraged to send a senior executive or board level representative to the QRM if the trust has experienced a recent case or multiple cases of more serious concern. These are welcome opportunities to reinforce the importance of visible trust leadership for patient safety. For example:
6.5. To support improvement in local maternity units, our investigations have also tackled challenges that are presented by care pathways that cross multiple boundaries. This can mean internally within trusts across clinical settings such as intensive care, haematology, radiology, oncology services, and operating theatres. It also includes local system partners such as general practice, ambulance trusts, and external services for social care, pregnancy termination, substance misuse, learning disabilities, mental health and police forces. For example:
7.1. A trust that is responding effectively to HSIB’s investigations will keep their HSIB team informed and updated on actions being taken to address recommendations. Similarly, trusts will be open with their CCGs and use HSIB reports to reinforce their prioritisation of safety actions. For example:
7.2. It is HSIB’s experience that most trusts welcome our reports and act promptly to demonstrate responsiveness to our recommendations. However, this is not always the case – for various reasons, some trusts have struggled to recognise the information we are presenting to them or to prioritise the actions necessary to address the risks. We understand the many pressures on trusts and that maternity services are a product of systems not all within the full control of individual organisations; sometimes solutions do not appear easily achievable. HSIB has a duty under the Maternity Directions to ensure that identified patient safety risks are known to relevant parties, including to escalate these issues when there is evidence that the risks may, for whatever reason, be persisting.
7.3. As discussed in our recently published report for the DHSC, it was necessary for HSIB to implement our escalation policy with East Kent University Hospitals NHS Foundation Trust. From December 2018, HSIB engaged frequently with the Trust to present evidence of recurrent patient safety concerns in its maternity services relating to CTG interpretation, neonatal resuscitation, recognition of deterioration and timely escalation of concerns and responses. Despite repeatedly raising these concerns with the Trust, HSIB investigators continued to see the same themes reoccurring. In August 2019, HSIB asked the Trust to self-refer themselves to their CCG and the CQC and followed up directly with these external authorities to ensure they were aware.
8.1. The landscape of maternity safety in the NHS is complex, with many organisations at all levels working to deliver on government commitments and support the safer delivery of maternity services. HSIB is only one part of the national system to improve safety of maternity services, but an advantage of our function is the perspective our role provides us. We have unique insight into local maternity services, working across multiple organisations and pathways of care at local, regional and national level. This approach gives HSIB’s maternity investigators nuanced and detailed knowledge of the safety risks and culture of the trusts they work with, and this aids HSIB’s contribution to national activity in a joined-up way.
How HSIB engages the NHS system of maternity safety
8.2. Nationally, we are involved in the following activities led by NHS bodies:
8.3. HSIB has also become increasingly involved in the national Maternity Transformation Programme which implements the five-year vision for maternity services set out in the ‘Better Births’ report. We are working collaboratively with the representative group of stakeholders to support national learning and prevent duplication and burden to trusts. This work includes:
8.4. HSIB is also engaged with Local Maternity Systems (LMS), Maternity Clinical Networks and Neonatal Operational Delivery Networks. Through this ongoing work we are also building productive relationships with the NHSE/I regional chief midwives.
8.5. Our local trust investigations can also produce outcomes that have an impact at national level. For example:
9.1. The Maternity Directions require HSIB to produce thematic reports that draw together the overarching themes and aggregate points of learning from our investigations and, where appropriate, make recommendations for the purposes of securing continuous improvement in the quality of services. The first of these reports was published in March 2020, using data and evidence from our investigations conducted from April 2018-December 2019, and identified eight key themes for learning. Six themes will be explored further through HSIB National Learning Reports (three have already been published), and another two themes have progressed to national investigations, both of which are underway. Recent and upcoming publications from the maternity programme are listed, with links to the published reports, below.
10.1. The benefits of the HSIB maternity programme extend beyond learning and change for safer NHS maternity care. Improvements to NHS safety culture are also being supported through HSIB’s family engagement model, our learning focus in safety investigations which enables staff to speak freely about their experiences, and the unique insight our approach provides on the relationship between engaged leadership and positive safety culture at trust level.
HSIB’s family engagement model
10.2. HSIB recognises that meaningful engagement with families during an investigation delivers better learning, higher-quality reports and an improved experience of the investigation for all involved. Family engagement is therefore embedded throughout our entire investigation process, providing an environment where a family’s insights can inform the investigation, their questions answered within the boundaries of an investigation, and they can be signposted to further support if required.
10.3. HSIB defines ‘family engagement’ as: the prompt, effective liaison between a family and an investigation to ensure the family is integral to the investigation and is treated professionally, respectfully and according to their individual needs. For this purpose, ‘family’ is defined widely, to include patients, mothers, partners, parents, siblings, children, guardians and others who had a direct and close relationship with the individual concerned. This ensures HSIB’s family engagement approach can be tailored and nuanced appropriately with every case.
10.4. Participation rates are high – 88 percent of families engaged with HSIB’s maternity investigations during 2019/20, compared with 34 percent involved in trust investigations according to the RCOG EBC report. Feedback has shown that our family engagement approach has been widely welcomed, offering improved learning and a better experience for both families and trusts when compared with the scope of engagement that most trusts can offer through their local investigations. Families have described how HSIB investigations have helped them to fully understand the circumstances of their case; to trust that the knowledge generated has been fair, transparent and independent; and to feel reassured that they have been an important part of the investigation. Non-English-speaking families have benefited from HSIB’s inclusive approach – we have produced our information resources in 19 other languages, used interpreters and translated 57 investigation reports into the family’s native language. In addition, we will produce reports in other formats such as audible to support a family's request. Some illustrative quotes about HSIB’s positive impact with families are provided at Appendix 5.
10.5. HSIB is keen to support improved family engagement across the NHS. In September 2020 we will publish a national learning report explaining our methodology in detail along with key outcomes from family engagement undertaken across both our national and maternity investigation programmes. We hope that many organisations will find HSIB’s experience and approach to offer useful guidance and insight.
10.6. Other work we have undertaken to promote family engagement includes contributing to the Learning from adverse events in maternity services course by Baby Lifeline training; to a serious incident investigation training programme at Northumbria Healthcare NHS Foundation Trust; and participating in the Strengthening the disclosure of harm in maternity care in the NHS (DISCERN) study. We are also collaborating with the Bradford Institute for Health Research and the University of Leeds on a National Institute of Health Research (NIHR)-funded research project to co-design processes and resources for supporting patients and families participating in serious incident investigations, which is due for completion in 2022.
Shifting the blame culture – HSIB’s approach to interviewing staff
10.7. The way that safety incidents are investigated sets a powerful tone for how healthcare staff interpret the safety culture of their organisation. Research has shown that most harm in healthcare results from problems within the systems and processes that determine how care is delivered. However, many staff still fear that they will be individually blamed for errors, and they too can experience significant psychological harm when involved in a patient safety incident. To support the shift away from blame to learning, HSIB takes a systems approach to investigations, focusing on identifying and understanding the contextual and contributory factors about what, why and how an incident occurred . Ensuring staff are signposted to appropriate support is also essential. Medical defence organisations have supported HSIB’s approach, and staff are reporting a positive experience; some feedback examples are provided at Appendix 6. HSIB will also publish a National Learning Report in early 2021 which will share our insight about how NHS staff are most effectively supported by their organisations following incidents and during HSIB investigations, helping to promote the spread of stronger safety and learning cultures in the NHS.
Encouraging positive safety culture at Trust level
10.8. Trusts have embraced HSIB with differing levels of confidence. Most have been collaborative and keen to work with us; some have required greater effort to build relationships that are open, engaged and beneficial to learning. Visible engagement from senior leaders is a strong signal that a trust is willing to recognise the safety issues we have identified and respond to our safety recommendations.
10.9. Trusts that have engaged fully and with enthusiasm have supported HSIB to understand what ‘works well’ for both organisations and have actively shaped our approach, helping us improve the programme’s processes for sharing healthcare records and how we support their staff with our interviews. The programme’s establishment inevitably created some complex administrative and logistical challenges that took effort and patience to resolve. Trusts that value HSIB’s contribution have proactively adapted in ways that reduced additional burden on their patient safety and governance teams and aided our improvement.
10.10. Furthermore, not all trusts felt that HSIB’s investigations have improved upon their own serious incident processes and we recognise that some trusts had well-developed and effective investigations already in place. Producing timely outputs has been a challenge, especially at early stages of the programme’s implementation. As a new and learning organisation, we have proactively sought trusts’ feedback and listened to their concerns, adapting and refining our methodology, reports, and communications to continuously improve the usefulness of our work to them. Earlier in 2020 we surveyed trusts and interviewed staff for their experiences and views about the programme, and will soon be communicating with them about our actions taken in response to their feedback.
10.11. The regular information we produce for trusts about our local investigations has helped to improve the flow of patient safety communication across midwifery, obstetrics, and neonatology teams. We encourage trusts to share the information we provide about safety risks and investigation outcomes with frontline maternity services staff, patient safety and governance teams and the board. Where feasible we now also conclude investigations with tripartite meetings involving both the trust and family – this is to support ongoing constructive relationships, as families are often continuing to access care at the trust. Our family engagement approach is being embraced by growing numbers of trusts as a model for their own organisations. The result is that now, every qualifying maternity incident is subject to an independent professional safety investigation which is consistent across England with the resultant learning available to all other trusts.
11.1. Despite the rapid pace at which the programme was introduced, it has taken time for the necessary systems, processes, relationships, and ways of working to embed. With more time to achieve our development ambitions and some recommended adjustments to policy and legislation (discussed below), we are confident the full potential of the programme can be realised. However, sustained national support and stability for the programme will be necessary for this to happen.
Continuous improvement of HSIB’s investigations approach
11.2. As a learning organisation HSIB seeks to continuously improve its investigation process. We have identified the importance of clinical expertise, investigation science, and the application of human factors and ergonomics to maternity investigations. Any future programme of maternity safety investigation will need to ensure that access to this expertise is available in equal measure.
11.3. HSIB investigations produce considerable amounts of data on maternity safety. We are working with academic partners to understand how to use this qualitative data to identify themes or trends which require further evaluation. There is considerable potential to use advanced data processing techniques, such as natural language processing and artificial intelligence, to provide HSIB with areas for further investigation and insights into areas of focus for national health care bodies.
Professionalising patient safety investigations
11.4. It is a key ambition for HSIB to provide expert advice, guidance, and training to NHS organisations to support safety investigations. We have recently appointed an acting Head of Investigation Education, Learning and Development who is developing standards, curriculum, and competencies for the professionalisation of healthcare safety investigators. We are launching the curriculum of training later this year for our own staff, and this will evolve into external training. The curriculum’s development draws heavily on our training for maternity investigators and will rely on ongoing learning through our work with trusts for the maternity programme. In addition, we are contributing to the curriculum of training for the NHS patient safety specialists to ensure they are appropriately knowledgeable and skilled in investigation science, particularly regarding maternity services.
Developing the trust maternity safety champions
11.5. We consider there to be greater scope for the contribution of trust’s board level maternity safety champions, to have executive oversight of the local action plans from HSIB findings and recommendations. HSIB is working with DHSC and NHSR to explore how this can be incorporated into the 2021 maternity incentive scheme.
System level changes needed to support improved maternity safety
11.6. Currently (excluding the changes made to NHSR reporting during the Covid-19 pandemic) trusts are required to report certain maternity incidents to several bodies – HSIB, NHSR, and MBRRACE. Development of a single reporting portal would minimise administration time for trusts and prevent the same data needing to be entered onto multiple different portals. Trusts have told us that this is a change they would welcome, and we are working with key stakeholders to explore the optimal approach to achieve this.
Refining criteria for the maternity investigation programme
11.7. HSIB’s work to date has demonstrated there is a clear long-term need for a maternity safety investigation programme in the NHS. Emerging evidence of historic failures in local providers, high levels of public concern and the longer-term effects on litigation costs all indicate this. The programme should be given more time to build on the progress HSIB has made over the last two years, and modifications should be considered based on learning from the programme’s implementation to date.
11.8. It is apparent to HSIB and trusts that the current criteria for the programme do not ensure HSIB is always investigating the maternity cases that offer the greatest potential for learning. Many current investigations into low harm events may not need to continue, and we have evidence that our adjustments made during Covid-19 have been welcomed by families. Some events which currently fall outside the programme but have high levels of harm or potential harm, or where there are significant levels of parental concern, could usefully be included. HSIB is keen to maximise the maternity programme’s positive impact on NHS patient safety more broadly, and further work will clarify how professional safety investigation could be effectively introduced for other clinical services in healthcare in the future. We would also like to explore learning from events where trusts have adapted and adjusted, and it has been possible to intervene to prevent harm – a safety II approach.
HSIB’s need for full statutory independence
11.9. Feedback to HSIB from parents, families and members of trust staff has highlighted the importance of HSIB’s demonstrable independence. Parents and families are more inclined to trust and accept the findings of an investigation that is independent of the provider involved and of the wider NHS. Staff have repeatedly told us that they are willing to disclose information to HSIB investigators that they would not have felt safe divulging to investigators from their trusts or from national NHS bodies.
11.10. However, we have also received feedback that HSIB’s current uncertain status, with a requirement to function independently but with accountability to NHSE/I, still inhibits some staff from feeling they can speak openly without fear of recrimination, and trusts doubt our ability to remain separate from the regulatory environment. Such fears can limit the scope of useful information obtained through our investigations. Engagement with patients and families is also often hampered and delayed, because GDPR requirements and our current legal status mean that HSIB cannot approach families directly but must do this through trusts. HSIB are required to obtain consent from families prior to accessing healthcare records. This causes inevitable but unnecessary delays to initiating investigations and in producing reports. The maternity programme’s ongoing uncertain status has also negatively impacted the recruitment and retention of our own staff.
11.11. HSIB’s full statutory independence would provide reassurance to families, NHS staff and the broader healthcare system that the government’s commitment to shifting the blame culture, which HSIB’s creation was intended to serve, still stands.
Appendix 1: Comparison table for national and maternity investigations
Programme began in April 2017.
Programme began in April 2018.
Number of investigators
Number of investigations
We were set the task of carrying out up to 30 investigations per year.
We were set the task of completing around 1,000 investigations per year that meet the criteria.
Training for investigators
Investigators attend an intensive three-week training programme as soon as they join, and they attend regular professional development workshops throughout the year.
All investigators attend an intensive three-week training programme and additional training and updates are provided throughout the year.
Any person, group or organisation can refer a patient safety concern to the HSIB through our website. We also identify issues for investigation through research.
Individual NHS trusts refer incidents to us that meet the criteria.
Criteria for investigations
We evaluate patient safety issues against our own criteria and decide whether to go ahead with an investigation.
We investigate maternity healthcare safety incidents that meet the criteria set out in Each Baby Counts or MBRRACE-UK.
Our investigation does not replace the local trust’s investigation into the patient safety incident (also known as the ‘reference event’).
Our investigation replaces the trust’s investigation into the maternity incident for those investigations that meet the criteria.
We publish all our national investigation reports on our website.
Maternity investigation reports are shared with the family and trust. They are not published.
We make safety recommendations to relevant named organisations. We ask organisations to respond to the recommendations within 90 days and we publish the responses on our website. We may also make safety observations (where we consider our findings warrant attention but there is not enough information on which to make a recommendation) and identify safety actions that have been taken during an investigation to immediately improve patient safety.
We make safety recommendations for learning to the trust. The trust is responsible for putting them into action.
We gather information about themes arising from our investigations to share learning across the health sector.
APPENDIX 5: Family feedback about HSIB maternity investigations
“The investigation has given us an opportunity to turn a negative into something positive for future patients. It’s allowed us time to work through the event and feel listened to which will hopefully make a difference to those in the future.”
The investigation process has allowed me to make sense of what went wrong, what couldn't have been changed and will give me an opportunity to know how the trust will rectify any issues I encountered so in the future no other families suffer in this way.”
“The best part of the investigation was I was able to know what actually happened that day while I was not in the state of mind to grasp everything or understand the situation while in labour. Also that the small errors/ mistakes that happened on that day would hopefully will be rectified and won’t be repeated with future moms and babies.”
“They helped us understand and rationalise so much of what happened to us on the day in question. That, coupled with their compassion was incredible.”
“Just knowing that someone nonbiased was looking into what happened to my daughter and I. I felt the hospital were covering their backs. Also reading the report to finally realise it wasn’t my fault as I’ve had a lot of self-blame.”
“The HSIB investigation offered an invaluable service to us. It meant that a thorough and unbiased investigation was carried out into the circumstances surrounding the birth of my daughter without us having to push for or ask for this to happen. Following the birth, we were in shock and traumatised and knowing that this investigation was being done was reassuring and a weight off our minds. The investigators were really kind and considerate of how we were feeling and took all our comments and recollections into account. I appreciate that they did a walk-through of our journey into the hospital and delivery suite and got a really good understanding of what we went through.”
“Great to see the end findings as this has helped a lot with my feelings and memories about my labour and pregnancy. Feel more confident in going forward with a second birth. Very happy that a thorough investigation was undertaken.”
“We found it very helpful that the investigators came to our home in the early days after it had happened when the shock was still very raw and we did not feel up to leaving the house. That we could contact the investigator at any point and know that we would get a prompt response and be listened to. The report was detailed and helped us to build a fuller picture about what happened throughout the labour process which helped towards the initial incorrect feelings of self-blame that we experienced. Having an impartial investigation was helpful because we knew that it wasn't going to be biased.”
APPENDIX 6: Trust and staff feedback about HSIB maternity investigations
‘The interviewers were great throughout, they made me feel at ease, explained all fully and gave me time to speak without rushing or feeling like I was being judged, just listened to. It made a stressful event much easier especially with them being healthcare professionals. They were calm, respectful and actually seemed to care about how I felt. This enabled me to be open and honest with them.’
‘I felt well supported by HSIB, but not by the senior management at my trust.’
‘It came from a learning perspective and not a blame one. it was acknowledged that it had been a difficult and traumatising experience and it was supportively handled.’
‘Overall the whole experience was positive. I felt I was treated with respect and kindness. I didn’t feel like it was trying to appoint blame. I felt they understood how distressed I was about the subject I was discussing and how difficult I found it and were empathetic.’
‘…knowing that an outside investigation was being conducted to ensure everyone was treated fairly and hopefully improve safety in the long term.’
‘I feel the investigation will improve the health and safety of the mothers and babies on the neonatal unit.’
‘I am now able to offer reassurance to other colleagues if they need to attend an HSIB investigation.’
‘As a Trust we have felt that engagement with HSIB has been very positive and provides an independent review of these cases.’
‘From a Trust perspective we would like maternity HSIB reviews to continue and would like to see sharing of learning from other Trusts across the NHS.’
‘Concerns raised regarding the triage software for cord prolapse and for shoulder dystocia are being raised at a national meeting in March to make changes to improve care for women.’
‘…[HSIB investigation reports] are very focused on giving clear explanations to parents and individuals in trust and commissioning that would have limited knowledge of maternity care and services, which is positive.’
‘The reports are written well for families to be able to navigate complex terminology.’
HSIB submission, Safety of Maternity Services in England, p.20
 A full description of the criteria is included in the HSIB Maternity Directions.
 The National Health Service Trust Development Authority (Healthcare Safety Investigation Branch) (Additional Investigatory Functions in respect of Maternity Cases) Directions 2018.
 This includes reports from MBRRACE-UK, the RCOG Each Baby Counts Programme, the Report of the Morecambe Bay investigation, and NHS Resolution's reviews of litigation claims.
 Just culture balances learning and accountability to give people the confidence to report safety issues knowing that they won’t be unfairly blamed for error, but undesirable performance won’t be tolerated (Dekker, S. Just Culture (3rd edn), 2017).
 ‘Safe space’ refers to the full protection and prohibited disclosure of an individual’s identity regarding information they disclose during a safety investigation.
 A table explaining differences between the two programmes is provided at Appendix 1.
 A diagram of the programme structure is provided at Appendix 2.
 For these cases, HSIB still contacts the family to establish whether they have concerns about the care they received or if they wish the investigation to be conducted.
 The main reason why families do not consent to HSIB investigating is because they are satisfied with the care they received and do not wish to revisit the incident.
 The timescales for reports are influenced by processes involving trust and family review which sits outside HSIB’s control.
 See letter provided at Appendix 4.
 Dekker, Sidney (2017). Just Culture: Restoring Trust and Accountability in Your Organisation (3rd edn).
 For further information about HSIB’s approach to interviewing staff: www.hsib.org.uk/maternity/information-trusts-and-staff/
 The Medical Protection Society’s statement to its members is provided at Appendix 7.