Policy paper

Government response to the findings of the independent investigation into the death of Elizabeth Dixon

Published 11 May 2023

Applies to England

Ministerial foreword

Patients and their families rightly expect safe and effective care from the health systems that treat them. They expect information about their care to be openly provided and for their concerns to be listened to.

An investigation into the death of 11-month-old Elizabeth Dixon in 2001 was commissioned in June 2017 by the former Secretary of State for Health and Social Care, the Right Honourable Jeremy Hunt MP, and was led by Dr Bill Kirkup. Its report, published in 2020, looked at a series of failures in Elizabeth’s care and the subsequent concealment of facts about her death.

I thank Dr Kirkup and all those involved in the investigation for their work uncovering the circumstances in which both Elizabeth and her family were failed.

The multiple failures in Elizabeth’s care and the struggle for her family to understand what went wrong remains distressing. It is imperative that Elizabeth’s death is not treated in isolation, but instead viewed as an indication of wider failures and the need for improvements across the healthcare system.

Like the Paterson inquiry, the Ockenden review, and the recent investigation into maternity and neonatal services in East Kent, where concerns were raised about patients and families not being given information they needed, this investigation pointed to the fact that Elizabeth’s family were not listened to when they raised concerns.

The recommendations of the report are informed by past events but describe improvements the report has identified as necessary today. The report’s first recommendation speaks directly to clinicians caring for infants and children. Other broader recommendations are equally applicable to the entire healthcare system, including maternity care, as well as to the criminal justice system.

The government response to the Dixon investigation demonstrates our determination to learn from this tragedy. Patient safety remains a top priority for the government, and we continue to place enormous emphasis on making our NHS as safe as possible for patients.

In the last decade, the government has introduced substantial measures to support the NHS in England to reduce patient harm and improve the response to harmed patients, including:

• a statutory duty of candour
• legal protections for whistle-blowers
• legislation to establish the Health Services Safety Investigations Body and medical examiners across the NHS

We believe that the Health Services Safety Investigations Body will play an important part in stimulating a culture of openness and transparency to encourage people to come forward without fear, resulting in thorough investigations that focus on learning and improving – not blaming.

We have also introduced the NHS Patient Safety Strategy, with substantial programmes underway to advance patient safety and create a safety-focused learning culture across the NHS. The strategy was published in 2019 and updated in 2021 to reflect learning from the coronavirus (COVID-19) pandemic, and includes new work to address patient safety disparities.

The first Patient Safety Commissioner, Dr Henrietta Hughes, who commenced work in September 2022, will act as a champion for patient safety and help to make sure patient voices are listened to within the healthcare system specifically with regard to medicines and medical devices.

All these important steps have been taken since Elizabeth and her family were failed. But the government is not complacent. Recent investigations into maternity care, including the Ockenden report into Shrewsbury and Telford Hospitals and East Kent, have shown that there is still more to do to improve care and safety in maternity services as well as improving the quality of investigations where harm occurs.

The government is as committed as ever to ensuring that the learning from this investigation is used to improve the healthcare system and prevent future harms. As set out in this response, the government and the relevant healthcare organisations are committed to making the progress that is needed.

In particular, this means a willingness in the NHS to be candid about failures and promote a culture of learning so that patients and their families feel listened to. This will help to ensure failures within the healthcare system do not again go unacknowledged and are thoroughly investigated.

Maria Caulfield MP, Parliamentary Under Secretary of State (Minister for Mental Health and Women’s Health Strategy), Department of Health and Social Care

Introduction

It is vitally important that we do not lose sight of the problems raised by the life and death of Elizabeth Dixon, and its aftermath. Elizabeth was one child, but the failures that affected her care at every stage are not unique.

Dr Bill Kirkup, chair of the independent investigation

The Dixon investigation was commissioned in June 2017 by the then-Secretary of State for Health and Social Care, the Right Honourable Jeremy Hunt MP. The investigation, led by Dr Bill Kirkup, was tasked with investigating concerns about the death of 11-month-old Elizabeth Dixon in 2001, while under the care of a private nursing agency commissioned by the local health authority.

Elizabeth Dixon was a child with special health needs. She had been born prematurely at Frimley Park Hospital on 14 December 2000. Following treatment and care at Great Ormond Street Hospital and a children’s hospice, she was nursed at home under a care package. As a result of a failure to clear a tracheostomy tube, she asphyxiated and was pronounced dead at Frimley Park Hospital on 4 December 2001.

This historical and tragic case has been subject to various processes over many years including:

• General Medical Council and Nursing and Midwifery Council proceedings
• a civil suit against the private nursing agency
• a police inquiry into potential charges against individuals for gross negligence manslaughter

The Dixon investigation report The life and death of Elizabeth Dixon: a catalyst for change was published on 26 November 2020. It made 12 recommendations to a number of organisations (see Annex A below). While we have reproduced the recommendations in full as drafted in the original report of the investigation, we have sought to clarify the specific organisation that has taken or will take action in response to each recommendation, according to its remit.

Many of the recommendations are addressed to NHS England and NHS Improvement. Since July 2022, the provisions of the Health and Care Act 2022 saw NHS Improvement become part of NHS England. For this reason, the response only references NHS England.

This report sets out the government’s response to the independent investigation’s conclusions and recommendations. The response has been informed by discussions with key partners across government and the healthcare and justice systems, including regulators, the NHS and those involved in policing. Where recommendations have been addressed to specific bodies, the response has been agreed with these bodies. Where, for simplicity, the response uses the term ‘we’, the response has been agreed by the government and the relevant system partners.

Response to the recommendations

1. Hypertension in infants

Recommendation 1

Hypertension (high blood pressure) in infants is a problem that is under-recognised and inconsistently managed, leading to significant complications. Its profile should be raised with clinicians; there should be a single standard set of charts showing the acceptable range at different ages and gestations; and a single protocol to reduce blood pressure safely. Blood pressure should be incorporated into a single early warning score to alert clinicians to deterioration in children in hospital.

Addressed to:

National Institute for Health and Care Excellence, Care Quality Commission, Royal College of Paediatrics and Child Health, Department of Health and Social Care

The problem of hypertension in infants is under-recognised and inconsistently managed across the healthcare system, and its profile needs to be raised with clinicians.

Hypertension in infants was considered for a National Institute for Health and Care Excellence (NICE) guideline in 2018 and discussed with NHS England, but the conclusion was that a NICE guideline was unlikely to add value in this area. While a NICE guideline may help in the management of hypertension in infants once the condition is recognised, it probably would not improve detection where a patient comes in to be diagnosed for the first time, which is the core issue that needs addressing.

Instead of a guideline, the Royal College of Paediatrics and Child Health and the Royal College of Nursing have supported a multi-professional, cross-organisation National Delivery Board. The board focused on development of a national paediatric early warning system (PEWS) in England, led by the Children and Young People’s Transformation Team at NHS England. Monitoring blood pressure and consideration of published hypertension ranges in paediatric scientific literature have been included in discussions involving senior paediatricians and members of the board from the early stages of the NHS System-wide Paediatric Observation Tracker programme development.

PEWS charts for inpatient children’s services that were trialled in pilot sites across England are currently being evaluated, with rollout expected in 2023. The set of charts (one for each age range: 0 to 11 months, 1 to 4 years, 5 to 12 years and 13 years and over) include blood pressure in the early warning score, and other observations such as heart and respiration rate. They also include escalation linked to parental concern, even when the early warning score itself would not trigger escalation for review from a more senior clinician.

This work will be supported by the NHS, with the development of a specification for a digital tool (ePEWS) underway. The aims of the development of the wider System-wide Paediatric Observation Tracker programme include greater use of this tool across the system, including in emergency departments, ambulance services and primary care.

In addition, the Care Quality Commission’s (CQC) current health assessment framework is also looking at how risks to patients are assessed, and their safety is monitored and managed. This includes the use of early warning scores and escalation processes. The identification and management of risks in individual service users will remain an integral part of the key lines of enquiry in CQC’s new single assessment framework for providers, local authorities and integrated care systems. The new framework will:

• allow CQC to target more frequent inspections at the worst-performing providers
• enable inspectors to spend more time talking to patients and their carers

In conclusion, had PEWS charts been in existence when Elizabeth was born, it is likely that her medical condition (hypertension) would have been more easily identified, and the concerns voiced by her parents would also have resulted in escalation or a review by a more senior clinician.

2. Community care

Recommendation 2

Community care for patients with complex conditions or conditions requiring complex care must be properly planned, taking into account and specifying safety, effectiveness and patient experience. The presence of mental or physical disability must not be used to justify or excuse different standards of care.

Addressed to:

NHS England and Improvement, Care Quality Commission, Department of Health and Social Care

The government is committed to the same standards of care regardless of disability or complex conditions. In the last decade, there has been new legislation and work from NHS England to address this and ensure the same high standards of care for all.

Legislation to address inequalities

Under the Equality Act 2010, health and social care organisations have to make reasonable adjustments so that people with a disability are not disadvantaged. Similarly, the NHS Constitution for England states that the presence of mental or physical disability must never be used to justify different standards of care. 

Avoiding discrimination in care is part of Regulation 13 in the Health and Social Care Act 2008 (Regulated Activities) Regulation 2014. However, avoidance of discrimination is not enough. The fundamental standards introduced by amendments to the Health and Social Care Act 2008 in 2014 require providers to have due regard to protected characteristics of people using services, including disability (and to make reasonable adjustments so that patients with a disability have the same quality of care as others). Where providers do not do this, and care is unsafe, this is a breach of Regulation 12 – safe care and treatment.

The Health and Care Act 2022 provides that relevant NHS organisations should consider the wider effect of decisions on health disparities as part of the ‘triple aim’, which includes the impact on the health and wellbeing of people in England. They should also consider the quality of services provided or arranged by NHS organisations and other relevant bodies, and the sustainable and efficient use of resources by both themselves and other relevant bodies.

The act also introduces a requirement for NHS England to publish a statement containing a description of certain NHS bodies’ powers to collect, analyse and publish information relating to inequalities in patient access to, and outcomes from, health services, together with NHS England’s view on how those powers should be exercised. In turn, those bodies are required to review and publish in their annual report the extent of their compliance with NHS England’s view.

Research has shown that some groups have a worse experience than others when accessing health services and this can negatively impact their health outcomes. The amended duties on reducing inequalities are designed to capture all common forms of health inequalities. Therefore, the act explicitly includes patient experience as well as the quality and safety of services, as part of the duties on NHS England and integrated care boards in relation to the reduction of inequalities.

Work in the NHS

Since 2016, all NHS organisations and local authorities are required to comply with the Accessible Information Standard, which sets out a consistent approach to identifying, recording, flagging, sharing and meeting the information and communication support needs of patients, service users, carers and parents with a disability, impairment or sensory loss.

The NHS Long Term Plan advocates reducing health disparities and improving community-based support. The plan recognises the need for a more fundamental shift in how the NHS works alongside patients and individuals to deliver more person-centred care, recognising – as National Voices has championed – the importance of ‘what matters to someone’ rather than just assessing ‘what’s the matter with someone’.

As with any healthcare service, NHS England expects the service provider to proactively monitor and assess risks to patient safety. Patient safety incidents should be identified and recorded. Reviewing relevant records can generate insight in relation to reducing future risks and support effective and sustainable improvements in the safety of services. The NHS Standard Contract 2022 to 2023 requires providers to comply with local “transfer of and discharge from care protocols”, and relevant requirements and guidance.

In addition, CQC reviews a range of evidence to see if care is person centred for each patient. This includes reviewing care plans and feedback from people using a service. CQC’s equality objectives under the new single assessment framework will also enable it to identify risks to good quality care for people with a disability more easily. It also allows CQC to take regulatory action where appropriate, challenging providers regarding deviations from expected pathways of care. This includes a focus on:

• gathering experiences from people more likely to have poor care
• analysing data sets, where possible, by equality characteristics, including disability

In conclusion, the focus of the Health and Care Act 2022 on reducing health disparities will assist in ensuring better outcomes for people with complex care needs in the community. Additionally, CQC’s new equality objectives will enable it to more easily identify risks to good quality care for people with a disability and then take regulatory action where appropriate.

3. Commissioning and clinical governance

Recommendation 3

Commissioning of NHS services from private providers should not take for granted the existence of the same systems of clinical governance as are mandated for NHS providers. These must be specified explicitly.

Addressed to:

NHS England and Improvement

The same high standards of clinical governance should be expected from both private providers and NHS providers. A number of mechanisms already exist to ensure that services from private providers meet the appropriate standards, including those related to clinical governance. The work responding to the Paterson inquiry has led to further improvements in this respect.

Healthcare regulation sets out the fundamental standards that must be maintained in health and all patients have the right to expect. These are statutory requirements against which CQC assesses services to ensure compliance. Independent providers must register with CQC and adhere to these standards in the same way as NHS providers. These fundamental standards include:

• the need for good governance to check on the quality and safety of care
• the requirement that providers must have enough suitable qualified, competent, and experienced staff
• that providers have strong recruitment procedures to ensure they only employ fit and proper staff

CQC will continue to assess the strength and implementation of clinical governance in providers as part of its regulatory activity, including in its ongoing revision of assessment frameworks and methodology.

The independent sector itself is also taking steps to set high standards for clinical governance. The Independent Healthcare Providers Network published a ‘refresh’ of its Medical Practitioners Assurance Framework (MPAF) in September 2022. Initially launched in October 2019, the framework, developed with the former National Medical Director at NHS England Sir Bruce Keogh, seeks to improve consistency around effective clinical governance across the sector. It makes it clear that independent providers are responsible for the quality of care in their facilities, regardless of how the staff are engaged. The ‘refresh’ framework is designed to further improve the safety and quality of care that independent providers deliver to patients.

In commissioning non-NHS providers to deliver NHS services, there are 2 key mechanisms for assurance of the standards of those providers:

• the NHS provider licence
• the NHS Standard Contract

The NHS provider licence is the main tool the NHS uses for regulating providers of NHS services. It sets out conditions that providers must meet to help ensure the health sector works for the benefit of patients. These conditions give the NHS the power to:

• set prices
• enable integrated care
• safeguard patient choice
• protect essential services if a provider gets into financial difficulties

The NHS Standard Contract is the mechanism through which those who commission NHS services from independent providers specify the quality requirements of the services. The contract is mandated by NHS England for use by commissioners for all contracts for healthcare services other than primary care. The conditions of the contract include terms relating to compliance with regulatory requirements, service standards and safety. In respect of the quality and safety of their services, the national terms of the contract place the same requirements on non-NHS providers as on NHS trusts. This applies equally where care is subcontracted by an NHS provider, as was the case for Elizabeth Dixon. These are then monitored by commissioners at a local level. Contracts can be, and are, terminated when providers fail to meet these conditions.

Many aspects of, and requirements under, the NHS Standard Contract relate to using the contract to manage the quality of services provided and how this is governed. These cover a number of aspects, such as:

• clinical audit
• consent forms
• complaint procedures
• patient safety incidents
• information monitoring and improvement

As of the 2022 to 2023 version of the contract, a new condition has been added that non-NHS providers must have regard to the MPAF. This embeds the requirement to commit to high standards of clinical governance into contracting for services with non-NHS providers.

Together, the NHS Standard Contract and MPAF ensure the same high standards of clinical governance from both private providers and NHS providers.

4. Communication between clinicians

Recommendation 4

Communication between clinicians, particularly when care is handed over from one team or unit to another, must be clear, include all relevant facts and use unambiguous terms. Terms such as palliative care and terminal care may be misleading and should be avoided or clarified.

Addressed to:

Royal Colleges, Health Education England

Clear and effective communication between clinicians is important and training has a crucial role in achieving this. Terms such as ‘palliative care’, ‘terminal care’ and ‘end of life care’ are clinical terms^{[footnote 1]} widely understood by healthcare professionals, yet it is necessary to have an agreed understanding of these terms in various settings. The NHS has identified that ineffective communication among healthcare professionals is one of the leading causes of error and patient harm (PDF, 923KB).

The document One chance to get it right, developed by the Leadership Alliance for the Care of Dying People, contains definitions for ‘palliative care’ and ‘end of life care’ that are now embedded within healthcare systems.

Clear communication around handovers or transfers of care and consistent use of terminology generally should be understood as core skills and embedded in curricula. This is critical to patient safety. We expect General Medical Council (GMC), Nursing and Midwifery Council (NMC), and the Royal Colleges and faculties who set curricula for undergraduate and postgraduate medical education to remind their members of this.

The NHS is committed to improving communications between patients and clinicians, as set out in universal personalised care. In addition, under the NHS Long Term Plan, 75,000 clinicians will be trained in shared decision-making conversations through the Personalised Care Institute, which is hosted by the Royal College of General Practitioners. The aim of the training is to help patients become more involved in decisions about their care.

NHS England’s national patient safety team has also led a programme of work examining patient safety and spoken communication. This has helped identify the elements of spoken communication that should be considered when assessing activity to improve the reliability of this very social and dynamic process.

NHS England seeks to enhance personalised end of life care by using the comprehensive model of personalised care to support increased choice and control at the end of life, and better experience of care. This model includes:

• earlier identification of people who are likely to die within 12 months
• better conversations for people to identify their needs and preferences
• better sharing of information with those involved in their care
• integrated services that cover their health and care needs

Advance care plans

Advance care plans, created by individuals and their families, aim to improve communication between clinicians as well as to provide clear, concise and shared documentation across health, social and education settings. This is particularly the case when care is handed over from one hospital to another or to other care providers. Medical Royal Colleges strongly support advance care planning for all, as it is good practice for anyone of any age with a life-limiting condition to undertake such planning.

One example of an advance care plan is the children and young person’s advance care plan. This is a nationally recognised advance care plan for children and young people with life-limiting or life-threatening conditions. It sets out an agreed plan of care to be followed when a child’s condition deteriorates.

The children and young person’s advance care plan is compliant with recent NICE guidelines on end of life care for infants, children and young people and helps promote a unified approach for children and families where the family is comfortable with the idea of such a plan being in place.

The NICE guideline [NG61] on end of life care for infants, children and young people with life-limiting conditions: planning and management also states that every child or young person with a life-limiting condition should have a named medical specialist who leads on and co-ordinates their care.

A key part of effective communication is ensuring that there are better processes in place for handovers of care. The Academy of Medical Royal Colleges has stated that:

When using the terms palliative and end of life care (EOLC) in relation to handover of information when transferring a patient from one team to another, specific consideration should be given to the context and narrative of the patient’s expected condition, status of their care – for example, whether a patient’s condition is anticipated to be progressive or complex or stable or reversible. Importantly, if a patient is known to palliative or EOLC services, and death is NOT expected, this should be explicitly covered with guidance.

The Royal Colleges of Paediatrics and Child Health, Physicians, and General Practitioners have agreed to highlight this distinction to their members through their work and when guidance is next reviewed.

GMC’s generic professional capabilities framework also emphasises the importance of good communication within the multidisciplinary team by:

• exploring and resolving diagnostic and management challenges or differences
• applying management and team-working skills appropriately, including influencing, negotiating, continuously re-assessing priorities and effectively managing complex dynamic situations
• ensuring continuity and co-ordination of patient care through the appropriate transfer of information
• demonstrating safe and effective handover, both verbally and in writing

Finally, NMC’s standards outline the importance of assessing needs and planning care. This includes identifying and assessing the needs of people and families for care at the end of life and palliative care, and decision-making related to treatment and care preferences. Communication and relationship management skills are also included in the standards, recognising that effective communication is central to the provision of safe and compassionate person-centred care.

In conclusion, had an advance care plan been developed for Elizabeth, it would have benefitted both clinicians and the family. By following best practice and sense-checking the final version before distribution, it would have been very clear that her cancer was not progressive or in itself life limiting. After her unfortunate death, this would have alerted those who reviewed the situation to the fact that an incorrect presumption had been made and left unchallenged.

5. Training in clinical error

Recommendation 5

Training in clinical error, reactions to error and responding with honesty, investigation and learning should become part of the core curriculum for clinicians. Although it is true that curricula are already crowded with essential technical and scientific knowledge, it cannot be the case that no room can be found for training in the third-leading cause of death in western health systems.

Addressed to:

General Medical Council, Nursing and Midwifery Council

The government endorses the importance of training in patient safety and demonstrating the right behaviours. This is recognised in the NHS Patient Safety Strategy along with the creation and implementation of the NHS’s first Patient Safety Syllabus, which is a vital part of the strategy.

The strategy includes a commitment to establish training and education for all NHS staff, including doctors and nurses, in the essentials of patient safety, as well as providing opportunities for more in-depth patient safety training and education. There is an explicit intention to ensure more detailed training and education are provided in this area in both clinical and non-clinical undergraduate and postgraduate healthcare education and continuing professional development.

The syllabus was published in May 2021 and forms the basis for the preparation of detailed curricula and training modules designed for specific levels of the NHS. Training in levels 1 (essentials for patient safety, including specific training for boards and senior leadership teams) and 2 (access to practice) became available as e-learning modules in October 2021.

There are currently over 800 patient safety specialists working in the NHS who will be fully trained in the syllabus when all training modules become available.

The role of regulators

The importance of understanding clinical error is also recognised by GMC and NMC. Both professional regulators agree that training on how to respond to patient safety incidents is paramount, and healthcare professionals must have the values and skills to react openly and honestly when things go wrong. They also recognise that there must be support in place for professionals to learn from mistakes and put that learning into practice.

Over the last few years, both professional regulators have updated their education and training standards to include how professionals respond to, and learn from, clinical error. NMC now has a specific patient safety lead.

GMC’s guidance sets out the knowledge, skills and standards that both new UK medical graduates and their education providers are expected to meet. These include the promotion of:

• acting with honesty and openness
• learning from errors without blame
• raising concerns

The following 5 guides are particularly relevant:

• Good medical practice
• Outcomes for graduates
• Promoting excellence
• Generic professional capabilities framework
• Raising and acting on concerns about patient safety

NMC also focuses on how its registrants can address, reflect on and learn from clinical error. The NMC Code and associated standards of proficiency ensure individuals assess, identify and reflect on any risk to patient safety to improve their practice while appropriately escalating concerns.

To make sure that NMC-approved education institutions and their partners learn from mistakes, obligations are placed on them through the standards framework for nursing and midwifery education. Although NMC does not mandate approved education institutions’ curricula, all programmes must meet its standards.

A range of support is available outlining the standards for student supervision and assessment. This helps to create the right culture so that students are supported and supervised in being open and honest in line with the professional duty of candour. Revalidation requirements ensure knowledge is consistently developed and a culture of learning is embedded throughout a professional’s career.

In partnership with the Academy of Medical Royal Colleges, the Conference of Postgraduate Medical Deans and the Medical Schools Council, GMC has developed guidance that emphasises the importance of medical professionals reflecting on their practice to drive learning, and improve quality and patient safety within organisations.

GMC has since worked with a number of other healthcare regulators to develop additional advice on the Benefits of becoming a reflective practitioner and added learning materials to their website to provide more practical support in this area.

GMC and NMC both recognise that just and learning cultures are critical in supporting people to raise concerns, and ensuring that those concerns are heard, responded to, addressed and learnt from. The government will continue to:

• work with GMC and NMC towards changing the wider system approach to patient safety
• evaluate the impact of existing guidance on behavioural change
• monitor the ways in which their guidance and standards are met through their quality assurance of education and training

6. Clinical error

Recommendation 6

Clinical error, openly disclosed, investigated and learned from, must not be subject to blame. Conversely, there should be zero tolerance of cover up, deception and fabrication in any health care setting, not least in the aftermath of error.

Addressed to:

NHS England and Improvement, General Medical Council, Nursing and Midwifery Council, Ministry of Justice

Patient safety incidents – when openly disclosed, investigated and learned from in accordance with the statutory and professional duties of candour – must not subject those involved to blame and fear. A just and learning culture is key, as is the need for all those involved in the management and delivery of care to take responsibility for their actions.

Improving the quality of investigations

Significant progress has been made over the last 2 decades in promoting a just and learning culture through improving how patient safety incidents are investigated at a national and local level.

The Healthcare Safety Investigation Branch was established in 2017 to conduct independent safety investigations into serious patient safety concerns across NHS-funded care. The Health Services Safety Investigations Body is expected to be fully operational in October 2023 and to continue the work of the Healthcare Safety Investigation Branch as an independent arm’s length body under provisions in the Health and Care Act 2022.

To encourage the spread of a culture of learning within the NHS by conducting investigations that promote learning, not blaming, the Healthcare Services Safety Investigations Body will conduct investigations under a statutory ‘safe space’, which prohibits the unauthorised disclosure of protected material. These investigations will take a no-blame approach to encourage participants, including patients, families and staff, to share information in confidence.

The Healthcare Services Safety Investigations Body will also promote better standards for local investigations in the NHS and the independent sector by providing advice, guidance and training to NHS bodies when approached, and the programme of family-centred, high-quality maternity investigations will also continue.

In order to improve local responses to, and investigations of, patient safety incidents, NHS England published its Patient Safety Incident Response Framework (PSIRF) in August 2022, which replaced the Serious Incident Framework. The new framework:

• improves the experience for those affected by patient safety incidents, emphasising the importance of engagement, involvement and support of patients, families and carers, as well as staff, during the incident response
• promotes the need for openness and transparency, as well as the importance of a just culture where staff are supported after incidents occur

The PSIRF was published in March 2020 and tested by 24 early adopters for 2 years. Secondary care organisations are now preparing for the transition to PSIRF, which we expect to be complete by autumn 2023.

Promoting a just and learning culture

Openness and transparency, as part of a just culture, contribute to patient safety.

This is recognised as one of the foundations for the NHS Patient Safety Strategy published in 2019. The strategy commits to a range of activities to promote an open, transparent and just patient safety culture, including work to identify and promote the use of safety culture metrics, and identify and implement evidence-based interventions that can support the development of that culture.

When a notifiable patient safety incident occurs in the course of a patient’s care, NHS organisations are legally required under a statutory duty of candour to:

• act openly and transparently
• provide patients with an accurate account of what happened
• apologise

When reviewing trusts, CQC looks at culture, and how and whether this duty is being delivered. CQC can take enforcement action against a provider for breaching the regulations.

NHS Resolution has highlighted the need for a restorative and just learning culture in its 2019 report Being fair: supporting a just and learning culture for staff and patients following incidents in the NHS and, more recently, in its animation about the duty of candour, which emphasise the importance of being open and honest. The duty of candour animation explains the statutory and professional duties of candour, and reiterates that saying sorry is not an admission of liability. The animation was launched on the NHS Resolution website in March 2022 and is also publicised on GMC’s website.

This makes the case for a move away from ‘fear and blame’ to balance equity, fairness and justice to ensure learning from incidents. ‘Being fair’ advocates a positive learning culture and is supported by a ‘just and learning culture charter’ that states:

Clinical incidents have a real and deep impact on people’s lives. Patients (or their partners or relatives) who have been affected have a right to explanations and to seek apologies, assurances and/or financial compensation for injuries caused where appropriate.

We need to take the blame out of failure. This means changing the mindset and the language associated with safety – from blame to learning. However, this does not mean an absence of accountability. Accountability is about sharing what happened, working out why it happened, and learning and being responsible for making changes for the future.

Patient safety culture in maternity settings

GMC and NMC are members of the NHS England Culture Working Group and regional perinatal oversight groups to shape and improve the culture in maternity services. They have piloted a joint programme of ‘professional behaviour patient safety’ sessions for targeted maternity units. These sessions are designed to work together with others to help improve workplace cultures in healthcare environments.

The report of the Ockenden review of maternity services at the Shrewsbury and Telford Hospital NHS Trust, published in December 2020, states that trust boards must:

• have oversight and understanding of their maternity services
• ensure that they listen to and hear local families and their own staff

Helping people and employers speak up when things go wrong

The government supports the right of staff working in the NHS to speak up and raise concerns. Speaking up is vital for ensuring patient safety and improving the quality of services.

In response to a recommendation of the Sir Robert Francis Freedom to Speak Up review, published in 2015, the government established an independent National Guardian to help drive positive cultural change across the NHS so that speaking up becomes business as usual. The National Guardian provides support and leadership to a network of over 800 local Freedom to Speak Up Guardians, covering every trust in England, whose role is to help and support staff who want to speak up about their concerns. The government has put in place other measures to support staff to raise a concern, including legal protections for whistle-blowers to prohibit discrimination against employees and job applicants who have spoken up, as well as the Speak Up Direct helpline and website.

GMC and NMC acknowledge that professional healthcare regulators have a part to play in tackling the blame culture that currently exists in the health sector. It is vital that regulators encourage environments that are inclusive and supportive, and promote a speaking up culture to eradicate the fear of blame and reprisal when things go wrong.

In addition to the statutory duty of candour, GMC and NMC have issued joint guidance on the professional duty of candour that requires every healthcare professional to be open and honest with patients when something goes wrong with their treatment or care. Healthcare professionals must also:

• be open and honest with their colleagues, employers and regulators
• raise concerns where appropriate
• take part in reviews and investigations when requested

GMC and NMC also agree that there must be zero tolerance of cover-ups, deception and fabrication in all healthcare settings, as any of these seriously undermines patient safety and damages public trust in healthcare professions. They expect registrants to follow guidance. Both professional regulators will investigate or act:

• if a healthcare professional’s actions fall seriously or persistently below the standards expected
• where they think a healthcare professional could harm patients or public confidence in the profession

GMC’s outreach teams regularly engage with doctors and employers to promote its guidance or tools, embed learning, and support local clinical governance systems in creating a culture that promotes openness and learning. As part of GMC’s review into its core guidance ‘good medical practice’, GMC is proposing changes to emphasise the importance of openness and transparency in patient communication. GMC has also launched a Speaking up hub that contains advice and tools to help doctors follow its guidance, and be more confident in raising concerns effectively.

In addition, NMC has created an employer resource hub to support employers to manage concerns locally, where appropriate, which includes guiding principles for local investigations. The Employer Link Service also provides support to employers on managing concerns, just culture and speaking up.

Finally, NHS Resolution’s Practitioner Performance Advice service offers impartial and expert advice, support, interventions and training to employing and contracting organisations about responding to concerns with regards to practitioners’ performance, including clinical, conduct, behavioural or health concerns.

Fitness to practise processes

GMC and NMC have both made improvements to their fitness to practise processes as part of promoting an open and learning culture.

GMC has taken forward work to better understand human factors when things go wrong, and make sure contextual and system factors are appropriately considered during an investigation into a doctor’s practice. It will also be reviewing its guidance for decision-makers to include more information on how issues relating to systems may influence doctors’ performance so that these can be taken into account when making decisions about a doctor’s fitness to practise.

NMC has also improved the way in which it considers context in its fitness to practice processes by looking beyond the actions of an individual, and understanding the role of the culture, environment and system they were working in when something went wrong. It has provided training and support to colleagues to help them understand contextual factors more clearly, and ensure a consistent approach is taken where concerns are raised.

Addressing fear of the regulator

The consequences of being candid can weigh heavily on some healthcare professionals when they are deciding whether to raise and act on concerns.

In 2021, the government consulted on proposals to reform the legislation of all healthcare professional regulators including GMC and NMC. The proposed changes will provide all professional regulators with broadly consistent powers to carry out their functions of:

• registration
• fitness to practise
• education and training
• governance

The consultation response was published in February 2023 and sets out the policy approach for future reform. It includes more information on the timing and sequencing of these reforms, which, from 2024, will see physician and anaesthesia associates brought under the regulation of GMC under the new framework.

One of the key changes of the reforms will be to modernise the regulators’ fitness to practise processes. This will introduce fitness to practise procedures that are less adversarial, and will support and facilitate the safe and quick conclusion of many cases without the need for expensive and lengthy panel hearings. Regulators will have greater:

• discretion to determine which fitness to practise complaints should be investigated
• scope for resolving complaints through a process of agreed outcomes without the need for formal panel or tribunal hearings

GMC’s power to appeal decisions of the Medical Practitioners Tribunal Service will also be removed.

In 2018, in its The reflective practitioner: guidance for doctors and medical students, GMC voluntarily committed to never require a doctor to share their reflective notes as part of a fitness to practise process – the planned legislative changes will also formally remove GMC’s power to do this.

7. Providing false evidence to an inquiry

Recommendation 7

There should be a clear mechanism to hold individuals to account for giving false information or concealing information relating to public services, and for failing to assist investigations. The Public Authority (Accountability) Bill drawn up in the aftermath of the Hillsborough Independent Panel and Inquests sets out a commendable framework to put this in legislation. It should be re-examined.

Addressed to:

Ministry of Justice

Although the recommendation has been addressed to the Ministry of Justice, this is a wider government issue that extends beyond health and social care or indeed any single department.

The Inquiries Act 2005 provides a statutory framework for the establishment of public inquiries that require formal powers – for example, the ability to take evidence under oath – and sets out associated penalties for non-compliance.

It makes it an offence to commit acts that intend to have the effect of distorting, altering or preventing evidence from being given to a statutory inquiry. It is also an offence to intentionally suppress, conceal or destroy a relevant document.

The Coroners and Justice Act 2009 provides for similar offences in relation to evidence to coronial inquests.

Transparency in healthcare

The government recognises the importance of honesty by professionals when things go wrong, and expects all healthcare professionals and others involved in the commissioning, management or delivery of healthcare to co-operate fully with patient safety investigations, whether at local, regional or national level.

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 introduced a statutory duty of candour for every health and social care provider that CQC regulates. The duty of candour requires registered providers and managers (known as ‘registered persons’) to act in an open and transparent way with people receiving care or treatment from them.

The Care Act 2014 introduced a new offence in relation to the provision of false or misleading information. The offence applies to those care providers who:

• falsify certain types of management and performance information
• supply false or misleading information either deliberately or because of a lack of due diligence

The types of information in scope are specified in the False or Misleading Information (Specified Care Providers and Specified Information) Regulations, which came into force in May 2015.

The regulations apply the offence only to providers of publicly funded NHS secondary care services. Social care providers, GPs and other non-hospital services are not in scope of these regulations. The offence also applies to the information listed in the regulations, which includes:

• Commissioning Data Sets
• NHS Quality Accounts
• national Cancer Waiting Times Data Collection
• Maternity Services Data Set

Providers that are prosecuted could be subject to a remedial order, publicity order and/or an unlimited fine. Directors or other senior individuals who consent or connive in (or are negligent in relation to) that offence could be subject, on conviction, to unlimited fines, custodial sentences of up to 2 years, or both.

GMC’s professional standards guidance and curricula and NMC’s professional standards of practice and behaviour are also clear that professionals on their registers must act with honesty and integrity at all times, and follow the laws of the country in which they are practising.

Healthcare professionals are expected to co-operate with investigations or audits relating to themselves or others. NMC guidance also outlines that professionals must co-operate with requests to act as a witness in any hearing that forms part of an investigation.

NMC’s policy principles underpinning its approach to fitness to practise are clear that deliberately covering up when things go wrong runs counter to patient safety and damages public trust in the professions. In its guidance Serious concerns which are more difficult to put right, NMC is clear that breaching the professional duty of candour to be open and honest when things go wrong – including but not limited to covering up and falsifying records – can lead to regulatory action such as suspension or removal from the register.

GMC’s Good medical practice guidance is also clear that doctors must be honest and trustworthy when giving evidence to courts or tribunals, and that information given should be complete and not misleading. GMC will investigate and may take action if a doctor’s actions fall seriously or persistently below the standards expected, or where they think a doctor could harm patients or public confidence in the medical profession.

Police investigations

The Home Office introduced a duty of co-operation for police officers in 2020 in the amended standards of professional behaviour in the Police (Conduct) Regulations 2008. The duty of co-operation provides clarity on the level of co-operation required by an officer where they are a witness in an investigation, inquiry or other formal proceedings.

Since 2013, significant steps have been made by the government and the police to improve the systems that are in place to ensure police officers account for their actions. These include:

• the publication in 2014 of the College of Policing’s Code of Ethics
• the introduction of independent legally qualified chairs in disciplinary hearings in 2015
• reforms to the Independent Police Complaints Commission in 2018 – now the Independent Office for Police Conduct

Bishop James Jones’s report on Hillsborough

Regarding the response to Bishop James Jones’s report on the experiences of the Hillsborough families, work has been underway within the relevant departments and organisations to carefully consider and address those points of learning directed at the government.

The government will address the points of learning related to equality of arms at inquests and the duty of candour as part of the full response, and remains committed to engaging with the Hillsborough families prior to publication of its full response in due course.

Legal help at inquests

Under the Legal Aid, Sentencing and Punishment of Offenders Act 2012, legal aid is available for advice and assistance (legal help) to members of the deceased’s family for all inquests, but legal aid for representation at an inquest is generally not available.

However, in certain circumstances, legal representation for bereaved families at inquests may be funded through the exceptional case funding scheme. As of January 2022, there is no longer a means test for an exceptional case funding application in relation to representation at an inquest for families.

The Ministry of Justice has recently consulted on a proposal to remove the means test for legal help when the inquest relates to a possible breach of rights under the European Convention on Human Rights (within the meaning of the Human Rights Act 1998), or where there is likely to be a significant wider public interest in the individual being represented at the inquest. The review has been published alongside a full consultation on legal aid means testing, which closed in June 2022. The Ministry of Justice plans to publish a response to the Legal Aid Means Test Review consultation in 2023, which will set out final proposals.

In conclusion, there have been several changes – both legislative and by professional regulatory bodies – that have been put in place and some pre-date the investigation. Many of the mechanisms described above address concerns about accountability, and will apply to future investigations, inquiries and inquests.

8. Clinical expert witnesses

Recommendation 8

The existing haphazard system of generating clinical expert witnesses is not fit for purpose. It should be reviewed, taking into account the clear need for transparent, formalised systems and clinical governance.

Addressed to:

Ministry of Justice, Department of Health and Social Care

The Dixon investigation report highlighted mistakes by the police in their appointment of an expert witness. As is stated in the report, investigations of this kind necessarily deal with matters of a technical and clinical nature that are outside the expert knowledge of lawyers and police. The use of clinical expert witnesses to inform police investigations and judicial processes demands the use of individuals with the right knowledge, training or experience working within an appropriate framework of clinical governance.

A great deal of guidance and support to ensure the effective appointment of clinical expert witnesses has been put in place since the police investigation of the circumstances of baby Elizabeth Dixon’s death in 2001. This includes:

• changes to the Criminal Procedure Rules 2020 (Crim PR), which cover criminal court procedures within a range of court settings
• guidance for healthcare professionals acting as an expert or professional witness (see more detail in the ‘Use and conduct of clinical expert witnesses’ section below)

Therefore, in view of the positive work that has been undertaken and is set out below, the government does not consider that any further action is necessary at this stage.

Selection of clinical expert witnesses

Clinical expert witnesses are individuals usually appointed by the police and sometimes on the advice of the Crown Prosecution Service. They should be selected on the basis that they are currently practising in or have recent and directly relevant clinical expertise and knowledge of the area under investigation. This enables the individual to provide an objective and unbiased opinion on the matters being investigated. 

The role of an expert witness is to assist the court on specialist or technical matters within their expertise, with their duty to the court overriding any obligation to the person who is instructing or paying them.

The National Crime Agency holds an Expert Advisers Database, which is used to identify and source those experts who can add value to law enforcement investigations.

Use and conduct of clinical expert witnesses

The use of expert witnesses in a criminal court setting is governed by the Crim PR. These rules were created in part as a consequence of recommendations made in the 2005 report Forensic science on trial, published by the House of Commons Science and Technology Committee. The report expressed concern that expert opinion evidence was being admitted in criminal proceedings with insufficient scrutiny, with the potential to produce, on rare occasions, miscarriages of justice.

This report prompted the Law Commission to publish a report titled Expert evidence in criminal proceeding in England and Wales in 2011.

The government’s 2013 response to the Law Commission’s report suggested taking forward changes to the Crim PR. Part 19 of the Crim PR sets out the duties and requirements of expert witnesses giving evidence. This includes the requirement for the expert witness to:

• provide details of their qualifications, relevant experience and accreditation
• include such information as the court may need to decide whether the expert’s opinion is sufficiently reliable to be admissible as evidence

Since 2015, this has included an obligation on experts to only provide opinions on matters within their expertise and to state if another expert is needed to provide opinion on any matter raised. Expert witnesses are in a better position than investigators to decide what expertise is needed in a particular case.

Failure to comply with the Crim PR could mean that the expert witness is not called to give evidence in proceedings. This ensures a robust system is in place to guarantee the reliability of expert witnesses.

Relevant guidance

Further resources such as the National Police Chiefs Council’s 2021 Major Crime Investigation Manual and 2015 Senior Investigating Officer’s Guide to Investigating Unexpected Death and Serious Harm in Healthcare Settings also provide guidance relating to expert witnesses.

This includes information on the Special Crime and Counter Terrorism Division whose lawyers have particular expertise in medical and corporate manslaughter prosecutions. They can provide early investigative advice in these cases, and assist senior investigating officers with planning a case strategy and selecting experts, including preparation of terms of reference.

Major crime investigative support at the National Crime Agency also manages the National Injuries Database, which provides support and advice for serious crime investigations involving all forensic medical issues. It is available to the police, and forensic and medical practitioners, and sources and facilitates independent expert medical and forensic opinions.

Additionally, Part 35 of the Civil Procedure Rules 1998 sets out additional rules governing the use of experts and assessors. This is complemented by Practice Directions and guidance from the Civil Justice Council to apply to a range of court environments.

Achieving best evidence in criminal proceedings guidance on interviewing victims and witnesses, and guidance on using special measures was released earlier this year. This guidance includes expert witnesses, and how their role fits into witness and victim care.

In response to the recommendations set out in the Williams review into gross negligence manslaughter in healthcare settings, the government has been working with relevant bodies^{[footnote 2]} to update a Memorandum of Understanding. The updated Memorandum of Understanding will:

• establish a common understanding of the respective roles and responsibilities of the organisations involved
• support effective liaison and communications
• cover what is expected of clinical expert witnesses – this includes requiring the expert witness to particularly consider the role of systems and employ an understanding of human factors to examine the provision of healthcare

In addition, in response to the Williams review, the Academy of Medical Royal Colleges has produced guidance on acting as an expert or professional witness, which has been endorsed by the key healthcare professional organisations. The guidance is aimed specifically at healthcare clinical professionals who provide an expert opinion or act as professional or expert witnesses in courts or tribunals. It is produced by clinical professional organisations, and sets out the standards and conduct expected of a clinician acting in the role of a witness.

Hamilton review

The report of the Hamilton review in 2019 into gross negligence manslaughter, commissioned by the GMC, recommended in recommendation 11 that those providing expert witness reports and evidence should be required to:

• state in a specific section of their report the basis on which they are competent to provide an expert opinion or evidence on the matters contained within the report, and where their views fit on the spectrum of possible expert opinion within their specialty
• calibrate their reports to indicate whether an individual’s conduct was, in all the circumstances, within the standards that could reasonably have been expected, using a grading system. They should also give their reasons for the views reached

The Hamilton review also recommended that doctors should only provide expert opinion to the coroner, procurators, fiscal, police, Crown Prosecution Service, GMC or criminal court on matters that occurred while they were in active and relevant clinical practice.

In response, GMC has completed a review of expert witness reports and processes, and has made appropriate amendments in line with the gross negligence manslaughter review (Standards for GMC experts (PDF, 114KB) and Expert report template (PDF, 158KB)). This includes confirming that experts can only comment on incidents that occurred while they were in active clinical practice.

GMC carefully considered recommendation 11 in the Hamilton review and decided not to take the classification of conduct proposal forward. GMC currently use a system that classes conduct as ‘not below’, ‘below’ and ‘seriously below’ the standard. Experts give detailed reasoning as to why acts or omissions are classed as such, together with an overall conclusion using the same grading. By giving full reasoning as well as classifying conduct, the expert draws out the full extent and seriousness of the act or omission. While introducing a classification of ‘exceptionally below’ might suggest gross negligence manslaughter, it is not strictly necessary for fitness to practise purposes. This is because fitness to practise considers whether misconduct was ‘serious’.

Finally, guidance on the duties and responsibilities of expert witnesses is also available from expert witness bodies, such as the Academy of Experts, the Expert Witness Institute and from professional bodies. While the academy, the Royal Colleges and other professional bodies are not able to regulate or enforce compliance with this guidance, any healthcare professional acting as a witness who fails to meet the standards set out in the guidance is not considered to be meeting the expectations or demonstrating the values of their profession.

Since Elizabeth Dixon’s death in 2001, there have been several guidance documents issued that together set out the expectations on the use of, and conduct of, expert witnesses within various settings. This provides clarity of the standards and values expected of expert witnesses involved in any future investigations, inquiries and court proceedings.

9. Systemic failure

Recommendation 9

Professional regulatory and criminal justice systems should contain an inbuilt ‘stop’ mechanism to be activated when an investigation reveals evidence of systematic or organisational failures, and which will trigger an appropriate investigation into those wider systemic failures.

Addressed to:

Home Office, Ministry of Justice, Department of Health and Social Care, General Medical Council, Nursing and Midwifery Council

It can often take a long time for the various investigations into patient safety incidents to complete, and the Dixon family faced an unacceptably long wait. However, professional regulatory action and criminal prosecutions will always take priority in the interests of justice and in order to deal promptly with health professionals, where there are concerns over their fitness to practise.

Professional regulators have a statutory duty to investigate the conduct of individual practitioners where there are grounds for concern. Delays to fitness to practise proceedings have a significant negative impact on patients and all those involved.

When specific events are being investigated, it is essential that wider systemic issues are identified, concerns are shared and lessons are learned. The government recognises the importance of identifying system learning as quickly as possible.

The effective sequencing of investigations and ensuring that parallel investigations can be undertaken, wherever possible, is critical to this. For example, the new independent Healthcare Services Safety Investigation Body will investigate and share learning without the need for fitness to practise processes being paused. It will have the powers and independence to conduct investigations into these incidents with a view to identifying patient safety risks, and facilitating the improvement of systems and practices in the provision of healthcare services in England. Investigation reports will make recommendations and require organisations to publicly respond to these measures within a specified timescale.

Both GMC and NMC have a formal mechanism to place cases on ‘hold’ pending the outcomes of third-party investigations (such as a criminal investigation or an investigation being undertaken by another organisation into systemic concerns). However, given the impact this has on all parties involved in a case, both professional regulatory bodies will only place a case on hold where there are clear and compelling reasons, and it is in the public interest. Additionally, NMC has updated its Investigating at the same time as other organisations guidance in light of the investigation’s recommendation.

Furthermore, there are a range of early warning systems that aim to share data across the healthcare system on emerging concerns. CQC, GMC and NMC acknowledge that there is a need for more effective collaboration on wider system failures. The 3 regulators started using a shared data platform last year to build a joint understanding of risk in maternity services.

The establishment of a shared data platform marks a very significant shift in a cross-regulatory approach to data-sharing. If the approach is sustained over time, it could transform the way in which regulators reach a common understanding of risks from a joint regulatory concern. The intention is that the shared data platform will not be limited to maternity and the 3 regulators will explore its expansion to other areas.

NHS Resolution’s Healthcare Professional Alert Notices (HPANs) allow NHS bodies and others to be informed of healthcare professionals who may pose a risk of harm to patients, staff or the wider public. HPANs are usually used while the regulator is considering the concerns. Although NHS Resolution is not a safety regulator, the HPAN system provides an important additional safeguard during the pre-employment-checking process.

NHS Resolution’s Practitioner Performance Advice service (of which HPANs are a part) also plays a part in the system of dealing with safety concerns by providing a range of services to healthcare organisations to effectively manage and resolve concerns raised about the practice of individual doctors, dentists and pharmacists. This service includes advice, assessment and intervention, training courses and insights publications.

Inquests

In most cases, an inquest will take place after completion of other investigations as these will yield relevant evidence for the coroner to consider. Under the Coroners and Justice Act 2009, a coroner’s investigation must be suspended until after the criminal trial when someone has been charged with a criminal offence such as murder or manslaughter. The investigation may also be suspended where a public inquiry established under the Inquiries Act 2005 and chaired by a judge is considered likely to adequately investigate the cause of death.

Section 32 and Schedule 5 of the Coroners and Justice Act 2009, in addition to Regulation 28 of the Coroners (Investigations) Regulations 2013, outline the duty of a coroner to issue a prevention of future deaths report when they consider operations or policies revealed in an investigation could be reviewed or changed to save lives in the future.

The purpose of prevention of future deaths reports is to raise the systemic importance of individual deaths and the learning derived from them. These reports are the means by which a coroner can publicly call for a government department, organisation or other body to consider its practices to avoid loss of life in future.

10. Scrutiny of deaths

Recommendation 10

The scrutiny of deaths should be robust enough to pick up instances of untoward death being passed off as expected. Despite changes to systems for child and adult deaths, concern remains that, without independent review, such cases may continue to occur. The introduction of medical examiners should be reviewed with a view to making them properly independent.

Addressed to:

Department of Health and Social Care

It is important to ensure that robust systems are in place to scrutinise deaths. Independent scrutiny of cause of death is critical in order to improve patient safety and for wider learning across the health system.

The medical examiner system will ensure independent scrutiny of all deaths that are not referred to the coroner. Medical examiners will improve the quality and accuracy of medical certificates of cause of death, which will, in turn, improve national data on mortality and patient safety.

Through medical examiners, bereaved people will be offered the opportunity to raise concerns with an independent doctor, thereby increasing transparency. This additional scrutiny will help identify and deter criminal activity and poor practice. Medical examiners will also use their training and skills to better identify deaths that should be notified to coroners, in line with the Notification of Death Regulations 2019, therefore contributing to a more efficient process. Importantly, medical examiners will also refer deaths for more detailed review under existing clinical governance processes.

The appointment of medical examiners by NHS bodies will facilitate their access to patient information in order to scrutinise the proposed cause of death but will not impact on their independence. While medical examiners will be employed by the NHS, they will perform their functions independently and this will be set out in regulations.

Medical examiners are senior doctors and will not scrutinise deaths where they have provided care for the patient or have a connection with the patient. The government believes that the statutory medical examiner system will provide independent scrutiny of non-coronial deaths. 

Child death reviews

Under the provisions of the Children Act 2004 (as amended), the child death review process in England began in April 2008. The legislation is supported by the statutory guidance Working together to safeguard children. The current child death review process is robust, independent and includes the family’s voice throughout.

There is a statutory requirement for the child death review process to be delivered by integrated care boards and local authorities. The Child death review: statutory and operational guidance, together with the Safeguarding accountability and assurance framework, lay out in detail the processes to be followed when a child up to 18 years of age dies. This includes:

• immediate decision-making
• multi-agency discussion
• information collection, including discussion with the parents and family

The Kennedy guidelines on sudden unexpected death in infancy and childhood explicitly mention the unexpected death of a child with a life-limiting condition and recommend that an immediate joint agency response is considered in such cases.

The joint agency response is carried out jointly by a paediatrician (or other healthcare professional) and the police. It includes a full interview with the family to understand what happened in the previous 48 hours before death, and a full medical and family history. This ensures that all information is gathered quickly and discussed in a multi-agency setting to ensure appropriate professional challenge. A keyworker is assigned to the family to provide them with support and signposting.

In the days following death, every professional who had contact with the child during its life is asked to contribute information via a standardised form. A local child death review meeting takes place, attended by such professionals, and the family are invited to submit questions and comments or concerns through their keyworker or another professional.

The next stage is an independent child death overview panel review. Child death overview panels have a statutory role to review the deaths of all children normally resident in the relevant local authority area and, if they consider it appropriate, the deaths of non-resident children in that area. These panels conduct an anonymised secondary review of each death informed by the draft analysis form from the child death review meeting.

In summary, had the statutory medical examiners system and the child death review process been in place when Elizabeth Dixon died, there would have been a significantly greater opportunity to detect the problems that the investigation has highlighted.

11. Responding to local complaints and clinical governance

Recommendation 11

Local health service complaints systems are currently subject to change as part of wider reform of public sector complaints. Implementation of a better system of responding to complaints must be done in such a way as to ensure the integration of complaints into NHS clinical governance as a valuable source of information on safety, effectiveness and patient experience.

Addressed to:

NHS England and Improvement, Care Quality Commission

Good complaint handling provides a direct and positive connection between those who provide services and the people who use them. Complaints offer a rich source of learning to help improve services for everyone.

The Parliamentary and Health Service Ombudsman (PHSO) has worked across the NHS sector^{[footnote 3]} to build a better, more coherent approach to responding to complaints, using learning from feedback to improve services. Its core aim is to:

• build best practice and consistency in complaints handling, which includes promoting a just and learning culture
• focus on how every NHS organisation can better integrate complaints insight into its governance and oversight systems to ensure patient safety and continuous improvement

The government – alongside NHS bodies including NHS England, NHS Resolution and CQC – is supporting PHSO in this work.

Following the launch of the NHS Complaint Standards in 2021, PHSO carried out a pilot to co-create and test supporting materials and training with a wide range of NHS organisations, which aimed to help staff embed the standards in their local complaints processes. The pilot successfully concluded at the end of 2022, and PHSO has started to roll out its supporting materials across the NHS from April 2023.

Clinical governance is the system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which clinical excellence will flourish. It is therefore critical that learning from complaints and patient safety incidents is an integral part of clinical governance to improve safety, effectiveness and patient experience.

The integration of complaints in the way set out in this recommendation links closely to the ‘Safety through learning’ theme of the CQC strategy. As part of its regulation of hospitals, CQC reviews complaints to identify themes and trends or specific areas where there may be regulatory breaches. This may generate either a monitoring call, where the regulator would seek assurance from the provider, or an inspection, depending on the issues in the complaint. CQC has begun work with PHSO to understand how the new complaints standards can be reflected in its new regulatory model and single assessment framework.

NHS Resolution’s 2018 report Behavioural insights into patient motivation to make a claim for clinical negligence also offers important learning. A key finding was that the response following an incident and the handling of any complaint made at the time featured highly in decisions to make a claim for compensation.

NHS Resolution continues to support ongoing work across the health system to improve the management of incidents and learning from complaints, including from PHSO’s development of the NHS Complaint Standards framework. This work is important so that families wishing to make a complaint have confidence in the handling and outcomes of complaints processes.

12. Complexity of landscape for families

Recommendation 12

The approaches available to patients and families who have not been treated with openness and transparency are multiple and complex, and it is easy to embark inadvertently on a path that is ill-suited to deliver the answers that are being sought. There should be clear signposting to help families and the many organisations concerned.

Addressed to:

NHS England and Improvement, Department of Health and Social Care

The Dixon report demonstrated the significant difficulties faced by the family in seeking answers. Recent investigations into patient safety incidents have highlighted similar difficulties faced by patients and their families when seeking to complain about poor care and seek redress.

The government and health organisations have taken steps to address calls for greater transparency and signposting of redress routes for patients, their families and carers. This point was also highlighted in several other investigations, including the Morecambe Bay investigation, Gosport Independent Panel and, more recently, the Paterson inquiry, the Ockenden review and the East Kent investigation reports.

Support and signposting in the NHS

The report of the Ockenden review in December 2020 recommended that an Independent Senior Advocate role be created across England to provide support to families. One of the elements of the role of the advocate would be to:

• provide support to families attending follow-up meetings with clinicians where concerns about maternity or neonatal care are discussed, particularly where there has been an adverse outcome
• signpost to other services that could provide more expert advocacy where needed

NHS England is taking forward work to implement this recommendation as part of the Maternity Transformation Programme. A framework for services, recruitment processes and training requirements are being co-produced with stakeholders led by NHS England.

More generally, the NHS has published clear information setting out:

• how the complaints process works in the NHS
• how patients can access it
• what patients can expect to happen during the process

This information is intended to familiarise patients with the complaints system, and help them decide whether or not it is the most appropriate route to pursue their concerns and obtain the answers they seek.

The independent NHS Complaints Advocacy Service provides assistance at all stages of the complaints process, and can provide support such as attending meetings with patients and reviewing information they are given during the complaints process. If a complainant is not satisfied with the outcome, they have the right to refer their complaint to PHSO.

The first ever Patient Safety Commissioner, Dr Henrietta Hughes, began work in September 2022. The role of the commissioner will add to and enhance existing work to improve patient safety by acting as a champion for patients so that patients’ voices are heard and acted upon. The commissioner will use patients’ insight to help the government and the healthcare system in England listen and respond to patients’ views, and promote patient safety, specifically with regard to medicines and medical devices.

Other health system organisations are also working to help patients and their families and carers to navigate the complaints process.

NMC has launched a referrals helpline for patients and the public. This helps to explain who the regulator is and whether it is the right avenue for the concern to be raised. NMC has also updated information on its website on raising concerns, including signposting to appropriate organisations.

NMC is clear that concerns should be raised locally first but, where this has failed or the issue warrants regulatory action, it will offer guidance through that process. In addition, its Public Support Service offers support to anyone who has raised concerns about a registered nurse, midwife or nursing associate that NMC has decided to investigate, and will guide people through the investigation process.

GMC has also made several changes to improve how it deals with complaints and supports patients and their families through the process. Building on the introduction of its Patient Liaison Service, which gives complainants the opportunity to hear about how their concerns are being investigated and to ask questions, GMC has also developed a new resource to help complainants identify the right place to raise their complaint, so they get the most appropriate response first time. GMC has also published a charter for patients, relatives and carers that sets out its commitments to those who raise concerns.

Finally, GMC and NMC have made arrangements together for Victim Support, an independent charity, to provide emotional support via a helpline to those affected by the issues being investigated and the impact the process may have on them. Through this service, people may also be signposted to other organisations that can help.

Support and signposting in the judicial system

In January 2020, the Ministry of Justice published the refreshed Guide to coroner services to help bereaved people understand the inquest process, their rights and responsibilities, and what they can do if they feel these are not being met.

The guide includes information about where the bereaved can find emotional and practical support – not just with the inquest process but also to cope with bereavement.

Support for claimants

One of the areas of focus for NHS Resolution to 2025 is on achieving fair and timely resolution, wherever possible, keeping patients and healthcare staff out of formal processes. This is in line with its strategy Advise, Resolve and Learn: Our strategy to 2025.

The use of dispute resolution techniques, including mediation, and initiatives such as the Early notification scheme established in 2017 are ways in which NHS Resolution is working to improve the experience for claimants and healthcare staff who are involved in a claim.

The Early notification scheme is a national programme led by NHS Resolution for the early reporting of babies born with a potential severe brain injury following term labour (meaning at least 37 completed weeks of gestation). Its purpose is to contribute to improvements in the safety of maternity care, while also responding to the needs of families where clinical negligence is identified, including the early admission of liability or breach of duty where appropriate.

NHS Resolution’s claims mediation service and use of dispute resolution initiatives are designed to support patients, families and NHS staff in working together towards the resolution of incidents, legal claims and costs disputes, and to avoid the potential emotional stress and expense of going to court. They can also provide a helpful forum for candid conversations, explanations and apologies to patients and their families. NHS Resolution will continue to expand the use of dispute resolution initiatives across core services to ensure systematic deployment of the right intervention on the right case at the right time.

In summary, there has been a lot of work to ensure there is clear information on complaints procedures and signposting to patient support, including guidance, and improving the mediation and compensation systems available.

Conclusion

The recommendations in the Dixon report are intended to improve the current system in order to help prevent similar tragedies occurring and to ensure that, where harm occurs, it is swiftly and thoroughly investigated.

The recommendations cover several themes that echo other recent inquiries into patient safety incidents. For example, recommendations 5, 6 and 7 are based upon a call for significant organisational and professional culture change that has been made by previous inquiries and investigations, starting with the Mid-Staffordshire NHS Foundation Trust public inquiry, the Morecambe Bay investigation and, more recently, the Paterson inquiry, Ockenden review, and the investigation into maternity and neonatal services in East Kent.

We believe that many of the recommendations are already addressed by suitable provisions put in place since this tragic case and its aftermath, and that progress has already been made in several areas highlighted in the report.

The NHS Patient Safety Strategy is being implemented with substantial programmes underway to create a safe, learning culture across the NHS work to address patient safety disparities. Other important measures to reduce patient harm and improve the response to harmed patients include:

• a statutory duty of candour
• legal protections for whistle-blowers
• medical examiners across the NHS
• the Healthcare Services Safety Investigation Body, which we intend to be established in October 2023

However, there is still work to be done in other areas. We are committed to the following actions highlighted in the recommendations as follows:

Recommendation 1

National paediatric early warning system charts for inpatient children’s services have been developed, which include blood pressure in the early warning score and escalation criteria linked to parental concern. The charts are being trialled in pilot sites across England with rollout due by summer 2023.

Recommendation 2

The focus of the Health and Care Act 2022 on reducing health disparities will assist in ensuring better outcomes for people with complex care needs in the community.

CQC’s new equality objectives will enable CQC to identify risks to good-quality care for disabled people more easily and then take regulatory action where appropriate.

Recommendation 3

The Independent Healthcare Providers Network published its Medical Practitioners Assurance Framework in 2019, with a refreshed version planned to be published this year.

As of the 2022 to 2023 version of the NHS Standard Contract, a new condition has been added that non-NHS providers must have regard to the MPAF. This embeds the requirement to commit to high standards of clinical governance into contracting for services with non-NHS providers.

Recommendation 4

The Royal Colleges of Paediatrics and Child Health, Physicians, and General Practitioners have agreed to highlight the distinction between ‘palliative care’ and ‘end of life care’ to their members through their work and when guidance is next considered.

Recommendation 5

The first NHS Patient Safety Syllabus was published in May 2021 and forms the basis for the preparation of detailed curricula and training modules.

Training in Levels 1 (Essentials for patient safety, including specific training for boards and senior leadership teams) and 2 (Access to practice) became available as e-learning modules in October 2021.

There are currently over 800 patient safety specialists working in the NHS who will be fully trained in the syllabus when all training modules become available.

Recommendation 6

The Healthcare Services Safety Investigations Body will promote better standards for local investigations in the NHS and the independent sector by providing advice, guidance and training to NHS bodies, when approached, and the programme of family-centred, high-quality investigations continue.

GMC and NMC acknowledge that regulators have a part to play in tackling blame culture in medicine, and will encourage environments that are inclusive, supportive and promote a speaking up culture to eradicate the fear of blame and reprisal that registrants may have when things go wrong.

GMC and NMC joint guidance on the professional duty of candour makes clear that every healthcare professional must be open and honest with patients when something goes wrong with their treatment, or their care causes (or has the potential to cause) harm or distress. The guidance covers raising concerns and taking part in investigations when requested, with zero tolerance of cover-up, deception and fabrication.

Recommendation 7

The government is committed to engaging with the Hillsborough families prior to publication of its full response to Bishop James Jones’s report on the experiences of the Hillsborough families in due course.

Recommendation 8

The Academy of Medical Royal Colleges has produced guidance on expert witnesses endorsed by the key healthcare professional organisations.

The government is working with relevant bodies to update a Memorandum of Understanding on investigating deaths in healthcare settings.

In response to the Hamilton review in 2019, GMC has completed a review of expert witness reports and processes, and has made appropriate amendments in line with the gross negligence manslaughter review (introducing standards for GMC experts and an expert report template). This includes confirming that experts can only comment on incidents that occurred while they were in active clinical practice.

Recommendation 9

Professional regulatory action and criminal prosecutions will always take priority in the interests of justice and in order to deal promptly with health professionals where there are question marks over their fitness to practise. It is essential that wider systemic issues are identified, concerns are shared and lessons are learned.

NMC has updated its guidance on investigating at the same time as other organisations in light of the investigation’s recommendation.

Recommendation 10

While medical examiners will be employed by the NHS, they will perform their functions independently and this will be set out in the regulations.

In addition, there is a statutory requirement for the child death review process to be delivered by integrated care boards and local authorities. The child death review statutory and operational guidance lays out in detail the processes to be followed when a child up to 18 years of age dies.

Recommendation 11

Following the launch of the NHS Complaint Standards in 2021, the Parliamentary and Health Service Ombudsman (PHSO) carried out a pilot to co-create and test supporting materials and training with a wide range of NHS organisations, which aimed to help staff embed the standards in their local complaints processes. The pilot successfully concluded at the end of 2022. PHSO has started to roll out its supporting materials across the NHS from April 2023.

Recommendation 12

The NHS, Ministry of Justice and professional regulators have worked to ensure there is clear information on complaints procedures and signposting to patient support, including guidance, and improving the mediation and compensation systems available.

In addition, work on setting up an Independent Senior Advocate role is also being taken forward as part of NHS England’s work and the Maternity Transformation Programme.

The Patient Safety Commissioner, Dr Henrietta Hughes, who commenced work in September 2022, will use patients’ insight to help the government and the healthcare system in England listen and respond to patients’ views, and promote patient safety, specifically with regard to medicines and medical devices.

Next steps

We will continue to work closely with other government departments, our arm’s length bodies and other system partners to implement the independent investigation’s recommendations.

As part of this, we will ensure that the momentum described in this response is maintained and that we keep progress under review.

Annex A: summary of the recommendations in the investigation report

Recommendation 1

Hypertension (high blood pressure) in infants is a problem that is under-recognised and inconsistently managed, leading to significant complications. Its profile should be raised with clinicians; there should be a single standard set of charts showing the acceptable range at different ages and gestations; and a single protocol to reduce blood pressure safely. Blood pressure should be incorporated into a single early warning score to alert clinicians to deterioration in children in hospital.

Addressed to:

National Institute for Health and Care Excellence, Care Quality Commission, Royal College of Paediatric and Child Health, Department of Health and Social Care

Recommendation 2

Community care for patients with complex conditions or conditions requiring complex care must be properly planned, taking into account and specifying safety, effectiveness and patient experience. The presence of mental or physical disability must not be used to justify or excuse different standards of care.

Addressed to:

NHS England and Improvement, Care Quality Commission, Department of Health and Social Care

Recommendation 3

Commissioning of NHS services from private providers should not take for granted the existence of the same systems of clinical governance as are mandated for NHS providers. These must be specified explicitly.

Addressed to:

NHS England and Improvement

Recommendation 4

Communication between clinicians, particularly when care is handed over from one team or unit to another, must be clear, include all relevant facts and use unambiguous terms. Terms such as palliative care and terminal care may be misleading and should be avoided or clarified.

Addressed to:

Royal Colleges, Health Education England

Recommendation 5

Training in clinical error, reactions to error and responding with honesty, investigation and learning should become part of the core curriculum for clinicians. Although it is true that curricula are already crowded with essential technical and scientific knowledge, it cannot be the case that no room can be found for training in the third-leading cause of death in western health systems.

Addressed to:

General Medical Council, Nursing and Midwifery Council

Recommendation 6

Clinical error, openly disclosed, investigated and learned from, must not be subject to blame. Conversely, there should be zero tolerance of cover up, deception and fabrication in any health care setting, not least in the aftermath of error.

Addressed to:

NHS England and Improvement, General Medical Council, Nursing and Midwifery Council, Ministry of Justice

Recommendation 7

There should be a clear mechanism to hold individuals to account for giving false information or concealing information relating to public services, and for failing to assist investigations. The Public Authority (Accountability) Bill drawn up in the aftermath of the Hillsborough Independent Panel and Inquests sets out a commendable framework to put this in legislation. It should be re-examined.

Addressed to:

Ministry of Justice

Recommendation 8

The existing haphazard system of generating clinical expert witnesses is not fit for purpose. It should be reviewed, taking into account the clear need for transparent, formalised systems and clinical governance.

Addressed to:

Ministry of Justice, Department of Health and Social Care

Recommendation 9

Professional regulatory and criminal justice systems should contain an inbuilt ‘stop’ mechanism to be activated when an investigation reveals evidence of systematic or organisational failures, and which will trigger an appropriate investigation into those wider systemic failures.

Addressed to:

Home Office, Ministry of Justice, Department of Health and Social Care, General Medical Council, Nursing and Midwifery Council

Recommendation 10

The scrutiny of deaths should be robust enough to pick up instances of untoward death being passed off as expected. Despite changes to systems for child and adult deaths, concern remains that, without independent review, such cases may continue to occur. The introduction of medical examiners should be reviewed with a view to making them properly independent.

Addressed to:

Department of Health and Social Care

Recommendation 11

Local health service complaints systems are currently subject to change as part of wider reform of public sector complaints. Implementation of a better system of responding to complaints must be done in such a way as to ensure the integration of complaints into NHS clinical governance as a valuable source of information on safety, effectiveness and patient experience.

Addressed to:

NHS England and Improvement, Care Quality Commission

Recommendation 12

The approaches available to patients and families who have not been treated with openness and transparency are multiple and complex, and it is easy to embark inadvertently on a path that is ill-suited to deliver the answers that are being sought. There should be clear signposting to help families and the many organisations concerned.

Addressed to:

NHS England and Improvement, Department of Health and Social Care

1. ‘Palliative care’ is an approach that improves the quality of life of patients (adults and children) and their families who are facing problems associated with life-threatening illness. It prevents and relieves suffering through the early identification, correct assessment and treatment of pain and other problems, whether physical, psychosocial or spiritual. ‘End of life care’ is usually defined as care provided to people in the last year of their life. ↩

2. CQC, the Crown Prosecution Service, the Health and Safety Executive, all healthcare professional regulators overseen by the Professional Standards Authority, the Healthcare Safety Investigation Branch, the National Police Chiefs Council and NHS England. ↩

3. See the PHSO report Making Complaints Count: Supporting complaints handling in the NHS and UK Government Departments, published 15 July 2020, for more details. ↩