4. Part Two

1. The following brief summaries of each chapter in Part Two set out the principal issues. Further reading of the chapters is necessary to understand the detail.

Chapter 31: Implementation of recommendations of inquiries

2. The first detailed work carried out by this Inquiry was a review of all recommendations made in all inquiries into the NHS in the last 30 years. The review shows that, whilst some significant changes have been introduced in response to inquiry recommendations over the last 30 years, most have not been implemented.
3. Even where recommendations are accepted, there is no clear or easily accessible mechanism to track their progress or enforce their implementation over a reasonable period of time. The problem is exacerbated in the NHS because of repeated structural change. Several other reasons can be identified for the failure to implement recommendations: first, the sheer number of recommendations made; second, lack of clarity about who is responsible for implementation; and third, lack of political will.
4. In September 2024, the House of Lords Statutory Inquiries Committee recommended that the House of Commons Liaison Committee facilitate the formation of a joint committee of Parliament to ensure that inquiry recommendations are followed up and implemented. Provided the committee is given sufficient time, resources and flexibility to carry out this work, this could and should work.
5. Within government, there is a need for effective independent monitoring of the implementation of recommendations from statutory inquiries. I recommend that responsibility for auditing the implementation of the recommendations of statutory inquiries into NHS bodies should be given to the National Audit Office.

Chapter 32: Medical examiners

6. In July 2003, Dame Janet Smith DBE, in her third report of the Shipman Inquiry, recommended a system whereby there would be an effective cross-check on the account given by a doctor in respect of the death of a patient. The government of the day proposed a system of medical examiners and the proposal stood still. In February 2013, Sir Robert Francis KC expressed his support for a system of medical examiners. The statutory system of medical examiners came into effect on 9 September 2024. It should have been introduced a decade earlier, by mid-2014 at latest, ten years after it had been agreed.
7. The statutory scheme provides for medical examiners – doctors independent from the primary, treating physician – to review those deaths not taken for investigation by the coroner. Part of the role of medical examiners is to identify patterns of poor care, including care that is negligent or deliberately harmful. They should operate as an early warning system, identifying any issues and referring them to the coroner, clinical governance processes or the National Medical Examiner, as appropriate. This is a positive development. The NHS should review the adequacy of funding for medical examiners, including whether the funding should be ring-fenced. I also make a number of recommendations as to how the system could be improved.
8. The Rt Hon. Jeremy Hunt MP, former Secretary of State for Health, was of the opinion that the medical examiner system would have prevented a number of the deaths at the Countess. The deaths of Baby A, Baby C, Baby D and Baby I were reported to the coroner and post-mortems were ordered and received, so the medical examiner would probably not have been involved. However, it may well be that the medical examiner would have been informed of, or otherwise become aware of, the unusual rise in the number of neonatal deaths. The system would also have allowed the clinicians to talk about their concerns with someone external to the Trust. Such discussions would probably have led to action to protect babies by May 2016.

Chapter 33: CCTV and monitoring

9. From the outset of the Inquiry, Core Participants and witnesses were asked for their view on whether the Inquiry should make recommendations about CCTV monitoring of neonatal units. I summarise some of the responses provided in Chapter 33. The parents were firmly of the view that CCTV would protect babies on the neonatal unit. I agree. Parents of very young babies will find this reassuring. It will also deter those rare people who seek to harm babies. I am not persuaded that the cost, training and ‘workload’ implications outweigh those benefits, if those implications are of any real weight at all. I am sure that all cots and incubators in all neonatal units should be fitted with in-cot cameras with live streaming video, so that parents may observe the baby remotely at any time. The modest funding required for this should be centrally managed and ring-fenced.

Chapter 34: Insulin

10. Letby poisoned Baby F and Baby L by administration of insulin. Insulin poisoning is a method of deliberate harming and killing of people in hospital. The cases of Beverly Allitt, Victorino Chua and Colin Norris are some more examples in the UK. It was one of the methods of killing discussed by the RCPCH review team in September 2016.
11. Insulin is not a controlled drug and so not subject to the tight processes and procedures applied to controlled drugs. No one suggests it should be. However, it is agreed that there should be effective systems to prevent and detect unauthorised access to, and use of, insulin. There was broad support amongst Core Participants for expanded use of technology for these purposes.
12. NHS England has taken steps to achieve this. In January 2026, the NHS issued a Getting It Right First Time guide called GIRFT Neonatology: Guide to safe insulin use. This sets out a delivery checklist for safe access, storage, handling, prescription, administration and disposal of insulin. This includes individually identifiable and auditable access controls, and locked fridges or cupboards. It mandates two-person checking for insulin preparation and administration, and working towards implementing ‘closed loop’ administration systems.
13. I recommend that digital devices be used to restrict access to authorised people and to record access to insulin storage units. All neonatal units should meet the requirements set out in the Getting It Right First Time guide by 31 March 2027. Until access is restricted by biometric data (and so prevents card swapping), each Trust should install a CCTV camera focused on the insulin storage cupboard or unit, storing recordings for at least 28 days.
14. I welcome the October 2025 publication of the Getting It Right First Time laboratory handling guidance for high insulin low C-peptide results. The guidance directs that local protocols be set up for when high insulin low C-peptide is found. I suggest that serious consideration be given to producing a single step-by-step template protocol. The protocol should explicitly mandate immediate discussion between laboratory and treating clinicians and between the laboratory head and the medical director of the hospital. Senior managers must inform NHS England and CQC and, in the absence of a complete explanation for the finding, the police must be contacted.

Chapter 35: Data – reading the signals

15. The increase in the number of neonatal deaths at the Countess in 2015 was significant data. It was sufficient to generate an alert signal. The alert signal is clearly found in the crude and stabilised and adjusted mortality rates for babies born at the Countess in 2015, as recorded in MBRRACE-UK (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries) surveillance data. However, the MBRRACE-UK data analysis for 2015 was not reported until June 2017, by which time the police had been contacted. The figures for 2016 were reported in June 2018. The utility of the alert signal provided by the data was lost to time.
16. When it comes to the early detection of a member of staff causing deliberate harm, it is real-time monitoring or continuous monitoring that will be of most value. In 2019, MBRRACE-UK provided all NHS Trusts with access to a real-time or continuous data viewer, enabling more immediate and ongoing monitoring of the stillbirths and neonatal deaths reported to it. The multiplicity of electronic systems within the NHS, many of which do not talk to each other, continues to complicate real-time data reporting. I recommend that NHS England and/or DHSC undertake to provide, by 31 March 2027, a clear and timed route to ensuring that computer systems are harmonised across the NHS, so that by December 2028 data relating to babies and neonates in hospital may be entered and reviewed in a timely manner and on a continuous monitoring basis.

Chapter 36: The NHS

17. The NHS is a large, complex constellation of organisations, which together provide a national healthcare service. It has undergone successive reorganisation, with all the attendant upheaval. Countless resources have been expended on tasks and documents that ultimately make no difference to the quality of patient care. Time (managerial, medical, nursing or other) and money should not be devoted to any task that does not improve patient care, or at least maintain it to a good standard. That is true of administrative reform (which should not be pursued for its own sake), targets mandated (which are too many in number) and documents circulated (which people spend too much time producing and reading). The practical abolition of NHS England should also include a significant reduction in the number of regulatory bodies. An informed analysis of what they all do should be prepared and reviewed. Decisions should be taken about which bodies are necessary, which can be amalgamated and which can be abolished so that those working in them may be directed to those parts of the NHS that need their skills to improve patient care.

Chapter 37: Training and regulation of managers

18. The core purpose of a hospital is to diagnose accurately and treat effectively patients with illnesses, conditions and diseases, and to care for those patients with kindness and respect. The role of senior managers in a hospital is to make sure the core purpose of the hospital is achieved. Managers need to understand what people working in the hospital actually do, and collaborate with them to make sure the hospital is fit to meet its core purpose. Recruitment and training of managers must reflect this. At present there are too many managers who do not meet the standards that should be expected of them. The need to improve the quality of people recruited and to retain excellent managers is urgent.
19. The Terms of Reference require me to consider whether, and if so how, the accountability of senior managers should be strengthened. One way to do this is to regulate. The question as to whether to regulate managers has been considered, ignored and reconsidered for decades.
20. The Inquiry heard ample evidence of the ‘revolving door’ employment provided for NHS managers about whom serious concerns had been raised. The NHS must be prepared to dismiss senior managers for serious misconduct. Such managers should not be able to secure employment as a manager in the NHS again. Those are basic propositions. The time for profound change is long overdue.
21. The current government proposal on regulation is to introduce a statutory barring system for board-level directors and their direct reports. Whilst a barring system may go some way to removing offending and poorly performing NHS managers, the current proposal has limitations. It is not clear how regulating only the most senior managers will help professionalise NHS leaders generally.
22. More fundamentally, the fact that full professional standards are not, and under the government proposals will not be, required for NHS managers should ring alarm bells. The essential step is to raise standards. A statutory barring system for managers should be introduced but, having been introduced and operated, it should be reviewed with a view to moving to a full statutory regulation system.

Chapter 38: Duty of candour

23. All NHS organisations owe a statutory duty of candour. The statutory duty does not apply to individuals, although organisations inevitably discharge their duty through the actions of their staff and directors. Clinical staff who are registered healthcare professionals have a professional duty of candour, overseen by their respective professional regulators, such as the GMC, the Nursing and Midwifery Council and the General Dental Council. Non-clinically qualified managers owe no equivalent duty.
24. The government’s response to the consultation on proposals to regulate managers failed to deal with the question of introducing a professional duty of candour for NHS managers. So does the NHS Leadership and Management Framework Code, published in July 2026. I am in no doubt that non-clinical managers should be subject to a duty of candour. Hospital managers control all the resources and make decisions that affect all aspects of the running of the hospital and patient care. An individual duty should be imposed on managers, mirroring the duty on nurses, doctors and other healthcare professionals.

Chapter 39: Culture of the NHS

25. Culture has been a repeat theme of inquiries into the NHS in the last two and a half decades. A heavy focus has been placed on improvement in NHS culture. Despite this, patients have still suffered avoidable harm through the actions of NHS staff and shortages of resources.
26. The move towards a ‘no blame’ culture in the NHS, starting in 2000, was a mistake. The focus on system faults rather than the failings of individuals, coupled with a learning culture that omitted acknowledging responsibility or blame, meant difficult conversations about conduct were avoided. This undermined patient safety.
27. Fundamentally, the concept of ‘culture’ is limited. It is behaviours that need to change. The starting point for everyone must be patient safety. It must be the top priority for all managers. Managers looking to drive up standards must be guided by the fundamental principle that patients are at the centre of all that is done in a hospital.

Chapter 40: Freedom to Speak Up Guardians

28. Freedom to Speak Up (FTSU) Guardians work alongside Trust leadership teams to ensure staff have the capability to speak up effectively and are supported appropriately. They became part of the standard NHS contract in 2017, following Sir Robert Francis’s 2015 Freedom to Speak Up Review. The National Guardian’s Office (NGO) came into being in 2016. It provided mandatory training, offered support calls to Guardians and collected anonymised data. It was a small organisation, with limited resources and powers. The NGO was abolished at the end of June 2026 and its functions transferred to NHS England.
29. There is significant variability in how individual Trusts operate their FTSU Guardian system. There are still many NHS staff who do not feel it is possible to raise patient safety concerns without experiencing a detrimental effect on their careers, including threat of referral to a regulator and threat of disciplinary proceedings. This occurred at the Countess. It is in that context that there remains a need for a national oversight body. The NGO’s functions should be taken over by the Parliamentary and Health Service Ombudsman in England. The Ombudsman’s powers must be increased to include: (a) investigating complaints that whistleblowing in the NHS has not been dealt with adequately; and (b) assisting whistleblowers by referring their concerns to the relevant NHS bodies and overseeing the response.

Chapter 41: Patient safety, safeguarding and employment law

30. In the Countess in 2016, patient safety and safeguarding concerns were relegated below a flawed HR investigation of Letby’s grievance. This was wrong. Where safeguarding or other concerns about patient safety are raised in good faith, the balance to be struck by a responsible NHS employer, between the risk of an employment claim and the risk to patient safety, comes down firmly in favour of protecting the patient.
31. Where concerns about or suspicions of deliberate harm are raised against healthcare staff, the most usual and correct response is to move the person about whom the concern has been expressed to a post where they can do no harm, or to suspend them altogether while the matter is investigated. This is a neutral act essential to protect patient safety.
32. If suspicions of murder have been raised in a hospital, the police must also be called. Where there is insufficient information to lead to suspicion, but there is an emerging concern, the ideal way forward would be to take the concern to a suitable expert or experts from another hospital, who can review the case and give their views. They must be provided with full and frank disclosure of the concern and the material required to consider it.
33. Serious consideration should be given by DHSC to the setting up of a panel of independent experts from all specialties to be called upon in situations where there are emerging concerns about an individual and harm to a patient or patients. A team from any specialty or combination of specialties would be drawn from the panel to conduct a swift, technical investigation into the concerns raised. This may most often be necessary where there are concerns that harm is being or has been caused inadvertently. The precise make-up of the panel should be determined by DHSC but could include, for example:
    • two doctors and two nurses from each clinical specialty
    • four senior managers
    • paediatric and perinatal pathologists
    • other experts as decided by DHSC.

Where necessary, a small team (always including clinicians from the relevant specialty/specialties) would be drawn from the panel to carry out an independent investigation into clinical concerns. Such investigations should always include safeguarding considerations (including contacting the police). In addition to reporting their findings to the Trust and DHSC, the experts would be available to be called as witnesses in any proceedings which may follow.

34. The Inquiry heard evidence about the lack of clarity in employment policies for handling serious concerns. All employment policies should include a clearly stated overriding objective, which is the safety of patients. Trusts should be required to embed the Suspicion of Deliberate Harm Protocol and guidance (see Recommendation 9 in Chapter 45). No member of staff, clinical or managerial, should be in any doubt about what to do when suspicions are raised that a member of staff (or any other person) has caused harm to a child.

Chapter 42: Care Quality Commission

35. CQC’s purpose is to ensure that health and care services provided are safe, effective, compassionate and of a high quality. This includes a duty to conduct inspections of health and social care service providers and publish a report of their findings.
36. CQC initially took a generalist approach to inspections. This changed in 2013 to inspecting and rating NHS hospitals, using larger and more specialist teams of inspectors. The change was triggered by several high-profile failures of care. In 2015, The Report of the Morecambe Bay Investigation was published by Dr Bill Kirkup CBE. It found there was significant organisational failure on the part of CQC. This ought to have alerted CQC to the urgent need to ask more questions, and to probe the answers given, during their inspections, including that of the Countess in 2016. Such an approach may well have uncovered the rise in the mortality rate on the neonatal unit at the Countess.
37. Further changes in CQC strategy followed in 2016 and 2021. In October 2024, Dr Penny Dash published her review into the operational effectiveness of CQC. Dr Dash found significant failings in the internal working of CQC, which had led to a substantial loss of credibility and a deterioration in CQC’s ability to identify poor performance. In the same month, Professor Sir Mike Richards published his review of CQC’s 2021 strategy. The report found that the changes had major adverse consequences and failed to deliver the benefits that were intended. CQC accepted these findings.
38. CQC has not often achieved its purpose since it was set up in 2009. It now needs to focus on its core purpose and develop teams who work to achieve that purpose. The new Chief Executive must be an exceptional leader and manager, who is supported by an outstanding team. CQC must not be allowed to fail again.

Chapter 43: The Health Services Safety Investigations Body

39. The Health Services Safety Investigations Body (HSSIB) was established under the Health and Care Act 2022. Their role is to carry out independent investigations that identify risks to patients and facilitate the improvement of systems and safety practices in the provision of healthcare services in England. Investigations are focused on patient safety issues that occur in multiple places across the country, and on issues where HSSIB consider they can add value and address inequalities. Learning lessons about safety is prioritised over individual accountability.
40. The issue at the Countess was one of concern about a particular nurse on a particular unit. However, as set out elsewhere in this Report, the Inquiry has revealed issues at the Countess that were almost certainly more widespread. Staff and managers misunderstood, and failed to follow, guidance and procedures. There was inadequate training about what to do when concerns were raised about a member of staff harming a child. Staff did not feel able to raise concerns. Doctors, with good reason, feared disciplinary action or referral to the GMC. The need for an external body such as HSSIB remains. HSSIB continue to fulfil a needed function and require the resources and staff to carry on doing this effectively.

Chapter 44: Memorandum of Understanding

41. A Memorandum of Understanding (MoU) is meant to establish a formal framework for effective cooperation and communication between public agencies. An MoU entitled ‘Investigating patient safety incidents involving unexpected death or serious untoward harm: a protocol for liaison and effective communication between the National Health Service, Association of Chief Police Officers and Health & Safety Executive’ was published in February 2006. It appears to have fallen out of use at about the time the Association of Chief Police Officers was replaced by the National Police Chiefs’ Council in 2015.
42. In December 2024, a new MoU was agreed between a number of police, criminal justice and healthcare bodies. It applies when more than one of the signatories needs to investigate any incident where there is reasonable suspicion that a criminal offence has or may have been committed by an individual who is providing healthcare services, which leads to or significantly contributes to the death or serious life-changing harm of a patient or service user. The MoU provides useful and comprehensive guidance. However, it is aimed at executives or senior managers in the signatory organisations. It is not directed at, and does not provide useful information to, healthcare professionals who may have suspicions of their colleagues. It is also premised on the ability of internal reporting processes to identify those concerns that trigger further response. For the MoU to be effective, hospital executives must be respectful of clinicians’ genuinely held views.
43. The current MoU reflects no input in respect of safeguarding but I understand that is to be remedied. Nor does it contain explicit advice that it is best practice to make early contact with the police. This too should be remedied. I also consider an accompanying, shorter document is essential to guide those faced with one of the situations identified in the MoU.