Published on 19 October 2022, the report of the investigation into maternity and neonatal services at East Kent Hospitals NHS Foundation Trust revealed a series of serious patient safety failings between 2009 and 2020, which resulted in avoidable harm to patients and deaths. The investigation found that if nationally recognised standards had been followed, the outcome could have been different in 97 of the 202 cases reviewed.
In this article, Patient Safety Learning analyses the findings of this report from a broad patient safety perspective, focusing on five key themes that are consistent with many other serious patient safety inquiries and reports in recent years. It sets these in their wider context and highlights the need for a fundamental transformation in our approach to patient safety if similar scandals are to be prevented in the future.
Commissioned by the Department of Health and Social Care (DHSC) in February 2020, the Independent Investigation into East Kent Maternity services published its report last month highlighting patient safety failings in maternity and neonatal care services from 2009–2020 at two hospitals: Queen Elizabeth The Queen Mother Hospital at Margate and the William Harvey Hospital in Ashford.
This is another devastating report detailing cases of serious avoidable harm and preventable deaths in the NHS, stating that it found that:
“... those responsible for the services too often provided clinical care that was suboptimal and led to significant harm, failed to listen to the families involved, and acted in ways which made the experience of families unacceptably and distressingly poor.”
It is a harrowing read, with its findings echoing many of the problems we have seen highlighted in other maternity care inquiries and reports in recent years, such as the Morecambe Bay Investigation and the Independent Review of Maternity Services at the Shrewsbury and Telford Hospital NHS Trust. 
The aspects of this report specific to maternity and neonatal care have recently been explored in more detail by charities such as Sands, Tommy’s, Baby Lifeline and Birthrights.    In this article, we will analyse this report from a broader patient safety perspective, focusing on five key themes that are consistent with many other serious patient safety inquiries and reports in recent years:
- Failing to listen to patients.
- Still not learning from investigations.
- Poor behaviour and a corrosive blame culture.
- Lack of effective leadership for patient safety.
- Absence of an effective regulatory framework.
Having considered each of these issues in their wider context, we will then consider the recommendations made by this report, what we think needs to happen to prevent similar scandals in the future and the need for a fundamental transformation in our approach to patient safety.
Failing to listen to patients
A common theme that comes up repeatedly in inquiries and reports into serious patient safety failings is a failure to listen to patients when they raise concerns about care. At Patient Safety Learning we believe that patient engagement is key to improving patient safety and identify this as one of the six foundations of safer care in our report, A Blueprint for Action. Patients should be engaged for safety at the point of care, if things go wrong, in improving services, advocating for changes and in holding the system to account.
It is clear from the East Kent Maternity services investigation that too often this was not the case, with it stating that:
“An overriding theme to have come from the listening sessions is the tendency of midwives and doctors to disregard the views of women. In fact, in a significant number of cases, the Panel found compelling evidence that women and their partners were simply not listened to when they expressed concern about their treatment in the days and hours leading up to the birth of their babies, their concerns often dismissed or ignored altogether. In at least some of these cases, the Panel was able to draw a connection between that failure to listen and an adverse outcome.”
The report highlights cases of patients being dismissed or ignored in a range of separate ways: being excluded and marginalised immediately after serious events, an unwillingness to engage with families in investigations, failures to explain risks and ensure patients were informed, and distressing incidents showing a basic lack of kindness and compassion. It also highlights that these issues only received full investigation thanks to the tenacious campaigning efforts of patients and family members themselves, noting that:
“In common with other investigations, the trigger for regulatory scrutiny and the commissioning of this Independent Investigation came from individual families who had been failed by the Trust. It was their persistence and determination to get to the truth that has led us to where we are now. It is disappointing that families continue to have to do this to substitute for ineffective safety monitoring by trusts and regulators.”
There are no detailed recommendations in the report relating to improvements in this area, apart from a proposal for the DHSC to consider “bringing forward a bill placing a duty on public bodies not to deny, deflect and conceal information from families and other bodies”. However, nationally this is acknowledged by the NHS as an area for improvement, with the importance of patient engagement and involvement set out in the NHS Patient Safety Strategy. The NHS also published last year a new Framework for involving patients in patient safety to guide improvements in this area.
Although this includes a number of commendable ideas, translating these principles into practice remains the key challenge. This requires resources, commitment and a willingness to proactively seek the insights of those with lived experience to be successful. Healthcare needs to restore the trust of patients and families so they can be assured that safety is a core purpose with their voices and experience being heard and ensuring that lessons are learned and applied to prevent future harm.
We are closely monitoring the implementation of the framework and await the subsequent evaluation of its impact on patients and families and safety improvement.
Still not learning from investigations
Patient safety incident investigations are an important source of patient safety learning, providing an opportunity to identify what went wrong and the actions needed to prevent a similar incident taking place in the future. However, too often in the NHS we still see examples of investigations not resulting in learning and improvement. This is a theme that also emerges from the East Kent Maternity services investigation, with it stating:
“Safety investigations were often conducted narrowly and defensively, if at all, and not in a way designed to achieve learning. The instinct was to minimise what had happened and to provide false reassurance, rather than to acknowledge errors openly and to learn from them.”
The report noted that investigations could be inadequate, failing to identify where practice could be improved and that, as mentioned in the previous section, there was a reluctance to involve families in these processes. This problem is not specific to East Kent, with poor quality investigations also being a major theme in the Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust published earlier this year. Describing the approach to root cause analysis (RCA) investigations at Shrewsbury and Telford, it said:
“It also identified that there was no culture of shared learning, that the RCAs often focused on the wrong issues, lacked system wide actions and focused instead on non-specific actions such as ‘share report widely’ and ‘learn from events’. There was no documentation that action plans were completed and recommendations often focused on individuals, rather than recommendations for system changes.”
There are no detailed recommendations in the East Kent report about the need for improvements in safety investigations. However, this issue was picked up in the review of maternity services at Shrewsbury and Telford as an area for improvement, with it emphasising that “families must be involved in the investigative process and that lessons must be learned and implemented in a timely way to prevent further tragedies”.
NHS England has also identified the need for improvement in patient safety investigations. This year they have published a new Patient Safety Incident Response Framework (PSIRF), setting out their approach to developing and maintaining effective systems and processes for responding to patient safety incidents for the purpose of learning and improving patient safety. This new framework makes a welcome acknowledgement of the importance of engaging patients and families as part of the investigation process and ensuring that investigations result in a clear understanding of the causal factors of harm and actions needed to deliver safety improvements.
As with new initiatives around patient involvement, it is too early to say whether PSIRF will bring about significant changes to address the issue of poor-quality investigations highlighted in both the East Kent and Shrewsbury and Telford reports. It proposes a complex innovation in the NHS’s approach to incident investigation and review. We believe that its success will depend on having the right leadership and resources to support this transition, enabling organisations to move towards a learning culture with quality improvements designed and implemented to prevent future harm. This should ultimately be the judge of PSIRF’s success.
Poor behaviour and a corrosive blame culture
It is vital that organisations have an open and fair culture that enables patient safety issues to be raised, discussed and addressed. However, the presence of a blame culture, which results in people covering up errors that lead to avoidable harm rather than report them, comes up as a consistent theme in major patient safety scandals. This has been highlighted in the Mid-Staffordshire Inquiry in 2013, the Independent Medicines and Medical Devices Safety Review in 2020 and most recently in the Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust.  
This is also a key concern in the East Kent Maternity services investigation. The report notes that a poor culture existed between obstetricians and midwives at the Trust, that there was a fear of speaking up about patient safety issues, a reluctance to listen to staff concerns and a bullying and blame culture when things went wrong. It appears that some of these issues were recognised internally at the Trust, but that efforts to tackle this proved ineffective:
“The Panel was told that there were “about three” cultural change programmes at the Trust that failed because of a lack of direction and leadership, and that the Trust paid lip service to cultural change but this was not sufficient. There was not enough commitment or engagement from leaders of the organisation.”
“A consultant told the Panel: “The Trust thinks if you send someone on a three-day training course in human factors, that their personality will change forever but that’s not going to happen.” Another clinician expressed having limited confidence in the behaviour and competence of certain obstetricians.”
Poor behaviour was not restricted to clinicians but also seen at senior leadership and governance levels too:
“The Panel further heard of poor behaviours of non-executive directors at the Trust Quality and Safety Committee: “The behaviour of the non-executive directors was appalling, rude, bullying. It was shameful.”
In our report published earlier this year, Mind the implementation gap: The persistence of avoidable harm in the NHS, we highlighted that despite similar issues of blame culture coming up in multiple patient safety scandals over the past 20 years, currently the NHS still only has an outline of proposed activity to tackle this problem.
The importance of having a just culture that supports patient safety is highlighted as a key aim of the NHS Patient Safety Strategy, and since the publication of the East Kent report the National Patient Safety Team has recently published new examples of good practice in this area. However, three years into the Strategy we are yet to see more specific and robust measures proposed to address this. For instance, there are no specific proposals around organisations publishing and reporting on goals to change culture or steps for intervention when poor behaviours are identified.
This is not an issue limited to Trusts with serious patient safety scandals. The results of the NHS Staff Survey over the last three years show that too many staff still do not feel safe to speak up about errors, patient safety incidents and near misses.  
Disappointingly, this report makes no recommendations on this issue, perhaps considering it beyond the scope of the investigation. However, Patient Safety Learning believes that this is a theme that must be considered a high priority in the DHSC’s response to this report.
Lack of effective leadership for patient safety
Issues around organisational culture, as highlighted above, are interlinked with the importance of leadership for patient safety. Good leadership can drive patient safety performance, support learning from unsafe care and put in place clear governance processes to enable this. It is another of the six foundations of safer care identified in our report, A Blueprint for Action.
The East Kent Maternity services investigation consistently highlights a failure at a leadership level to identify and prevent avoidable harm to patients and deaths at the Trust, including:
- Governance structures that were “not sufficiently robust to allow assurance from ward to Board”.
- An impression by regulators that the Trust did not actively look for problems and issues to be resolved but waited for them to be pointed out.
- Poor Board relationships between the executive and non-executive directors.
- Lack of external benchmarking of performance and serious incidents.
The report makes two specific recommendations in relation to these issues:
- Trusts be required to review their approach to reputation management and to ensuring there is proper representation of maternity care on their boards.
- NHS England reconsider its approach to poorly performing trusts, with particular reference to leadership.
We support both these recommendations. However, we also believe that further urgent action is needed by the DHSC and NHS in relation to the report’s leadership findings, which have much in common with other recent inquiries and reports into serious patient safety failings.
We believe that there needs to be a more effective leadership and governance for patient safety in both the NHS and independent sector. There should be high standards and behaviours set for our leaders and they should be supported by specialist patient safety, organisational development and governance experts. As with the other key themes considered here, this is not a blank slate that requires new research and analysis. A useful starting point would be for the DHSC and NHS England to revisit the recommendations of the review of the Fit and Proper Person Test by Tom Kark QC and Jane Russell, published in 2019, which in its first recommendation called for:
“All directors (executive, non-executive and interim) should meet specified standards of competence to sit on the board of any health providing organisation. Where necessary, training should be available.”
Organisations also need clear and published goals for patient safety with Board focus and effective oversight on reducing patient harm. A key part of our work around the development of patient safety standards for healthcare organisations is focused on strengthening patient safety leadership and governance in organisations as an integral part of a safety management systems approach (read more about this in the next section).
Absence of an effective regulatory framework
The East Kent Maternity services investigation gives a significant amount of attention to the Trust’s relationship with regulators during this period. The picture it paints is one of a system failing to act quickly or effectively in response to serious patient safety concerns, stating:
“We have found that the Trust was faced with a bewildering array of regulatory and supervisory bodies, but the system as a whole failed to identify the shortcomings early enough and clearly enough to ensure that real improvement followed.”
The Trust was overseen by a range of different organisations, including:
- Care Quality Commission
- General Medical Council
- Its local Clinical Commissioning Group
- Healthcare Safety Investigation Branch
- Monitor (former NHS regulator whose functions are now part of NHS England)
- NHS England
- Nursing and Midwifery Council
- Royal College of Obstetricians and Gynaecologists
- Royal College of Midwives
The report suggested that “the plethora of regulators and others served to deflect the Trust into managing those relationships and away from its own responsibility”.
As with the other themes highlighted in this article, these concerns about the effectiveness of the regulatory framework are not a new issue. In a 2018 report, Opening the door to change, the CQC described the current system as “confused and complex, with no clear understanding of how it is organised and who is responsible for what”. Similar issues have also been highlighted in reports and inquiries such as the independent inquiry into the issues raised by Paterson and the Independent Medicines and Medical Devices Safety Review. 
The Professional Standards Authority for Health and Social Care (PSA) have also recently discussed this in their report Safer Care for All, stating:
“Large-scale failures of care still occur frequently, and inquiries and reviews highlight similar themes and issues, with the system seemingly unable to prevent their recurrence. Each body looks at the problems principally through the lens of its own remit, often prejudging the nature of the solutions as a result. We need a new framework focused on safety that spans organisational and sectoral boundaries.”
The East Kent report makes no specific recommendations about these system-level failures. However, Patient Safety Learning believes this is another issue the DHSC must consider as part of their response to this report. We need a joined-up and effective regulatory framework for patient safety that identifies problems at an early stage and facilitates and coordinates interventions and improvements.
Now turning to the East Kent Report’s recommendations, in his introduction Dr Bill Kirkup states that he has opted not to make a series of specific policy recommendations. Setting out the rationale for this, the report states:
“NHS trusts already have many recommendations and action plans resulting from previous initiatives and investigations, and we have no desire to add to their burden with further detailed recommendations that would inevitably repeat those made previously, or conflict with them, or both. We take those previous recommendations and the resulting policy initiatives as a given."
Instead, it sets out four broad areas describing the deep-rooted reform required to address the issues highlighted in the report. These are summarised below:
- Creating a Task Force to drive the introduction of valid maternity and neonatal outcome measures for mandatory national use.
- Reports to be commissioned on how compassionate care can best be embedded into practice and sustained through lifelong learning, alongside commissioning reports considering the oversight of clinicians, with national agreed standards of professional behaviour and sanctions for non-compliance.
- Reports to be commissioned on how teamworking in maternity and neonatal care can be improved and how this can be supported in the employment and training of junior doctors.
- Considering a new Government bill which would place a duty on public bodies not to deny, deflect or conceal information from families and other bodies. Alongside this, Trusts should be required to review their approach to reputation management, ensure there is maternity care representation on their Boards and for NHS England to reconsider its approach to poorly performing Trusts.
Action needed for a systems approach to patient safety
We support these recommendations, but also note the concern highlighted by Dr Kirkup about the effectiveness of inquiry recommendations in reducing avoidable harm. He states that:
“… this approach has been tried by almost every investigation in the five decades since the Inquiry into Ely Hospital, Cardiff, in 1967–69, and it does not work. At least, it does not work in preventing the recurrence of remarkably similar sets of problems in other places.”
We concur with the disheartening sentiment. As set out in our report earlier this year, Mind the implementation gap, such recommendations are often eagerly received, with associated commitments to learn lessons from the past, but their implementation remains inadequate and patchy and their impact left unmonitored and often unevaluated.
However, as we make clear in this article, there are several overarching patient safety themes which the East Kent Maternity service investigation raises, in common with previous patient safety inquiries and reports, where there is a clear need for action. Some of these are not covered by the East Kent report’s recommendations.
Given that these are system-wide issues, not specific to one specialism or type of trust, we believe that the DHSC response to this report needs to consider these in their wider context, and account for the broader trends from reports and inquiries from the last 20 years. We need a holistic and joined up approach to these issues – not simply another commitment to ‘learn lessons’ without the necessary follow through.
As recently discussed in more detail in an interview with Keith Conradi on the hub, a key element of this is learning from other high-risk industries and moving towards the creation of a safety management system in healthcare, which he describes as follows:
“The basics of any safety management system is to have safety objectives, so you set out what you want to achieve. This requires assessment of the hazards and risks and the mitigation to those risks and these need to be transparent. You need an assurance process that constantly monitors the safety performance of the organisation and investigates incidents when they occur. This in turn will drive learning which will further improve safety and crucially embed a safety culture amongst all staff. All of this needs to be recognised at Board level, continually stretching the organisation’s safety objectives."
While the NHS Patient Safety Strategy talks about moving towards “a patient safety system, across all settings of care”, in our view there is currently no overlapping approach to this and this needs to be urgently addressed.
At Patient Safety Learning we believe that the persistence of avoidable harm is the result of our failure to address complex systemic causes. In our report A Blueprint for Action we identify six foundations of safer care for patients and practical actions to address them. Central to this is the need for a transformation in our approach to patient safety, ensuring that this is treated as a core purpose of health and social care, not one of several competing strategic priorities to be traded off against each other.
Patient safety needs to be seen as everyone’s responsibility, from the DHSC, policy makers, patient safety experts, system and professional regulators, leaders, those developing and providing guidance on good practice, academics and to individual healthcare professionals. We need to operate as an effective Safety Management System with everyone working in partnership, aligned with patient safety at the core.
- Independent Investigation into East Kent Maternity Services, Maternity and neonatal services in East Kent – the Report of the Independent Investigation, 19 October 2022.
- Dr Bill Kirkup CBE, The Report of the Morecambe Bay Investigation, March 2015.
- Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, Ockenden Report: Findings, conclusions and essential actions from the independent review of maternity services at The Shrewsbury and Telford Hospital NHS Trust, 30 March 2022.
- Sands and Tommy’s Joint Policy Unit, Responding to the independent report on East Kent maternity and neonatal services, 19 October 2022.
- Sands and Tommy’s Joint Policy Unit, We need a renewed approach to improving the safety of maternity services, 21 October 2022.
- Baby Lifeline, The East Kent Report: In summary, 19 October 2022.
- Birthrights, Birthrights responds to the independent investigation into East Kent maternity services, 2 November 2022.
- Patient Safety Learning, The Patient-Safe Future: A Blueprint for Action, 2019.
- NHS England, The NHS Patient Safety Strategy, 2019.
- NHS England and NHS Improvement, Framework for involving patients in patient safety, 29 June 2021.
- NHS England, Patient Safety Incident Response Framework, Last Accessed 8 November 2022.
- The Mid Staffordshire NHS Foundation Trust Public Inquiry, Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry, 6 February 2013.
- The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020.
- Patient Safety Learning, Mind the implementation gap: The persistence of avoidable harm in the NHS, April 2022.
- NHS England, Safety Culture: learning from best practice, 15 November 2022.
- Patient Safety Learning, Results of the NHS Staff Survey 2019, 18 February 2020.
- Patient Safety Learning, Tackling the blame culture? NHS Staff Survey Results 2020, 22 March 2021.
- Patient Safety Learning, Safe to Speak up? NHS Staff Survey Results 2021, 31 March 2022.
- Tom Kark QC and Jane Russell, A review of the Fit and Proper Person Test, 6 February 2019.
- CQC, Opening the door to change: NHS safety culture and the need for transformation, 2018.
- The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020.
- PSA, Safer care for all – solutions from professional regulation and beyond, 6 September 2022.
- Patient Safety Learning, Why healthcare needs to operate as a safety management system: In conversation with Keith Conradi, 24 October 2022