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The Report
Volume III
Part Two
Chapter 44

Chapter 44. Memorandum of Understanding

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Chapter 43
The Health Services Safety Investigations Body
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Contents

Background

  1. A Memorandum of Understanding (MoU) was published in February 2006 with the title ‘Investigating patient safety incidents involving unexpected death or serious untoward harm: a protocol for liaison and effective communications between the National Health Service, Association of Chief Police Officers and Health & Safety Executive’.1 It seems to have fallen out of use at about the time the Association of Chief Police Officers was dissolved in 2015 and replaced by the National Police Chiefs’ Council. It was nine years before a new MoU was published, arising out of the work of Professor Sir Norman Williams in 2018.

The Williams Report

  1. The Williams Report, published in June 2018, was a rapid policy review of gross negligence manslaughter in healthcare. It was motivated by a concern amongst healthcare professionals that simple errors and accidents could result in prosecution for gross negligence manslaughter.2 Sir Norman found that the objective risk of being prosecuted for gross negligence manslaughter was small, and the chance of prosecution was even smaller still.3 However, the concern was primarily that investigations can “cast a long shadow”,4 and the fear of those investigations was higher given the poor understanding of the law on gross negligence manslaughter.5
  2. Sir Norman recommended the development of a new MoU between all relevant agencies.6 This document would:
    “set out the respective roles of the police, CPS [Crown Prosecution Service], HSE [Health and Safety Executive] and health service bodies (such as the Care Quality Commission, the Healthcare Safety Investigation Branch and healthcare professional regulators) in investigating unexpected deaths in healthcare settings in order to ensure that patient safety lessons can be understood and acted upon”.7
  3. Sir Norman recommended that, as a minimum, the roles and responsibilities of the organisations should be defined, and that there should be effective liaison and communication between them. Expectations of expert witnesses should be clear. The MoU must be disseminated “in order to promote a greater understanding of legal issues among healthcare professionals and of healthcare issues (including systemic and human factors) among prosecuting authorities, the police and coroner services”. It is expressly hoped that “this would help support the development of a ‘just culture’ in healthcare”.8

The current MoU

  1. The current document, ‘Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm’, was published in December 2024, during the Inquiry hearings.9
  2. Under the subtitle ‘A memorandum of understanding (MoU) between regulatory, investigatory and prosecutorial bodies’, there was a list of signatories as follows:
    • Care Quality Commission (CQC)
    • Crown Prosecution Service (CPS)
    • Health and Safety Executive (HSE)
    • National Police Chiefs’ Council (NPCC)
    • NHS England
    • General Medical Council (GMC)
    • Nursing and Midwifery Council (NMC)
    • General Dental Council (GDC)
    • Health and Care Professions Council (HCPC)
    • General Pharmaceutical Council (GPhC)
    • General Optical Council (GOC)
    • General Chiropractic Council (GCC)
    • General Osteopathic Council (GOsC).10
  3. The guidance applies, in England only,11 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 any individual who is providing healthcare services in health or care settings, which leads to or significantly contributes to the death or serious life-changing harm of a patient or service user.12
  4. The MoU gives the following guidance on the types of incident that may prompt an NHS organisation to involve the police. It is incidents that display one or more of the following characteristics:
    1. where there is reasonable suspicion that the actions leading to harm were intended to cause harm
    2. where there is reasonable suspicion of ‘gross negligence’ and/or ‘recklessness’.13
  5. The guidance makes no reference to safeguarding, and in particular the safeguarding of children. In such a situation the police would become involved at the point of any concerns being raised.
  6. I pause to note that the threshold of ‘reasonable suspicion’ is higher than that applied by the police (see paragraph 26.59(b), Chapter 26). In my view, this risks setting the bar for referral too high. Instead, in my view, the threshold should be one of ‘good faith suspicion’. In reaching this view, I have borne in mind Mr Vineall’s answers, in which he spoke in support of the current formulation, when giving evidence about the language of reasonable suspicion in the MoU.14 Nevertheless, in my view, the current formulation gives rise to a risk that concerns which should be referred to the police are not and change is required.
  7. There are then a number of explicit considerations about the way in which the incident coordination group should exercise its function, including who should convene the first meeting, who should attend subsequent meetings and who should be on notice to those meetings. This includes the need for the ICB and CQC (or other relevant regulator) to be informed,15 for a professional regulator to be informed if the incident raises questions of fitness to practise,16 and for the coroner to be informed and invited to send a representative in circumstances where the death is suspicious.17
  8. Of particular relevance to this Inquiry is the requirement for the Maternity and Newborn Safety Investigations programme to be informed in cases that involve early neonatal deaths, intrapartum stillbirths, and severe brain injury in babies born at term following labour or maternal deaths. This is to allow that programme to discharge its functions.18
  9. The MoU then goes on to consider the role of the police, who must appoint a senior investigating officer, who will be responsible for seeking advice from the Crown Prosecution Service and obtaining the view of an expert witness.19 The expert witness is accountable to the police, and not the incident coordination group.20
  10. The police have an obligation to inform CQC (or other relevant regulator) within seven days of referring a case to the Crown Prosecution Service, so that the regulator can determine whether they have a responsibility to take further action to prevent further harm.21
  11. Representatives of the organisations who attend the incident coordination group must have sufficient authority to make decisions on behalf of their organisation.22
  12. The MoU goes on to give guidance on the roles of the incident coordination group and the decision-making process to be followed, including guidance on minuting meetings and providing legal representation for those who are under suspicion.23
  13. The organisations represented on the incident coordination group are explicitly responsible for their own “patient safety learning responses”24 and the incident coordination group has “no role in directing the patient safety learning responses and investigations of the NHS, CQC, police, regulators and/or HSE”.25
  14. The MoU provides comprehensive guidance but for a limited purpose. It is not directed at, and does not provide useful information to, healthcare professionals who may have suspicions of their colleagues. It is aimed at executives or senior managers who have been made aware of suspicions, assessed them as worth investigating and then considered that there is a need for an investigation by more than one of the signatories.
  15. If an incident falls within the scope of the MoU, the guidance given is thorough, and gives a clear indication of the expectations of the incident coordination group in managing and coordinating a response from multiple organisations to an incident in which there was a suspicion of gross negligence or of deliberate harm.
  16. A further limitation of the document is that it requires internal reporting processes to allow for – for example – the accurate identification of those incidents that are serious enough to trigger the response codified by the guidance. In the case of the Countess, concerns were raised but the executives did not consider they were justified. It took over a year to bring in the police. The MoU is unlikely to have made any difference to the actions of those executives. For the MoU to be effective requires hospital executives to be respectful of clinicians’ views. It is always reasonable to challenge the views of others, but when the concerns were so serious and genuinely held, they were bound to be acted upon. Were that approach to prevail, the MoU would be effective.
  17. Read as a whole and alongside the Williams Report, the reason for and the purpose of this MoU appears to be to reassure healthcare professionals that incidents at work (not occurring as a result of intentional harm) are unlikely to result in any criminal or other sanction. In particular, the importance of the wider context and systematic failure is highlighted. The MoU:
    “has been drafted with a view to supporting the development of a ‘just culture’ in healthcare, which recognises the need to consider the wider context and circumstances in which any incident involving a breach of a duty of care occurs. This includes considering the wider systems in place at the time of the incident, to support a fair and consistent evaluation of the actions of individuals.”26
  18. The guidelines accompanying the original 2006 MoU emphasised that “it is best practice to make early contact with the police and/or HSE to discuss concerns and to take their advice on further action”.27 This good advice is absent from the current MoU. Mr Vineall, on behalf of DHSC, was asked why that advice had been omitted. It was his view that guidance is not needed to make the point that, “[I]f people are in doubt at a local level and they see something serious that they think may be the result of malevolent behaviour that they are able to call the police. I mean, that is a I think it’s fair to say a common sense expectation that we would all have of most institutions.”28 Experience at the Countess does not bear out that expectation.
  19. Whilst a comprehensive document is informative and provides context as well as direction, a shorter document would be more useful to someone faced with one of the situations identified in the document. I acknowledge Mr Vineall’s reasonable resistance when I asked him about the desirability of producing a shorter document. He made the point that the document had only recently been published and it was intended to see how it was going after a year (i.e. by December 2025).29 By the time this Report is published, the document will have been in place for 21 months. That will be time for a shorter guide to be considered and, if appropriate, drafted.

Absence of safeguarding input

  1. The fact that the MoU reflects no input in respect of safeguarding30 rather underlines my view of its purpose. Whatever the reason for the omission – oversight or deliberate – Mr Vineall and Sir Stephen Powis31 agreed to provide further information. Some information was provided in a follow-up statement in February 2025. Mr Vineall stated that there was not “any decision to exclude the subject from the 2024 MOU” and “the 2024 MOU was not intended to replace or duplicate guidance on wider issues” such as Working Together to Safeguard Children 2023.32 I have followed up on this, and the latest information provided by DHSC and NHS England on 20 May 2026 is that a review of the MoU was initiated in December 2024 and is ongoing. DHSC said they have been “cognisant” of my observations to Mr Vineall during his oral evidence and stated: “Safeguarding teams and others in the Department and NHS England have been engaged in the review process, and some proposed amendments have been drafted to enhance the prominence of safeguarding in the MOU and shared for views with the signatories.” I am encouraged by this and hope that the next MoU features safeguarding more prominently, as it should.

Endnotes

  1. 1 Witness statement of Wiliam Vineall INQ0108007/2/para 5

  2. 2 Prof. Sir Norman Williams, Gross Negligence Manslaughter in Healthcare: The report of a rapid policy review, June 2018, page 7, para 2.1 (https://assets.publishing.service.gov.uk/media/5b2a3634ed915d2cc8317662/Williams_Report.pdf#page=7)

  3. 3 Prof. Sir Norman Williams, Gross Negligence Manslaughter in Healthcare: The report of a rapid policy review, June 2018, page 12, para 4.6 (https://assets.publishing.service.gov.uk/media/5b2a3634ed915d2cc8317662/Williams_Report.pdf#page=12)

  4. 4 Prof. Sir Norman Williams, Gross Negligence Manslaughter in Healthcare: The report of a rapid policy review, June 2018, page 16, para 6.3 (https://assets.publishing.service.gov.uk/media/5b2a3634ed915d2cc8317662/Williams_Report.pdf#page=16)

  5. 5 Prof. Sir Norman Williams, Gross Negligence Manslaughter in Healthcare: The report of a rapid policy review, June 2018, page 18, paras 7.1-7.4 (https://assets.publishing.service.gov.uk/media/5b2a3634ed915d2cc8317662/Williams_Report.pdf#page=18)

  6. 6 Prof. Sir Norman Williams, Gross Negligence Manslaughter in Healthcare: The report of a rapid policy review, June 2018, page 26 (https://assets.publishing.service.gov.uk/media/5b2a3634ed915d2cc8317662/Williams_Report.pdf#page=26)

  7. 7 Prof. Sir Norman Williams, Gross Negligence Manslaughter in Healthcare: The report of a rapid policy review, June 2018, page 25, para 9.13 (https://assets.publishing.service.gov.uk/media/5b2a3634ed915d2cc8317662/Williams_Report.pdf#page=25)

  8. 8 Prof. Sir Norman Williams, Gross Negligence Manslaughter in Healthcare: The report of a rapid policy review, June 2018, page 26 (https://assets.publishing.service.gov.uk/media/5b2a3634ed915d2cc8317662/Williams_Report.pdf#page=26)

  9. 9 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024 (https://assets.publishing.service.gov.uk/media/67604bbd239b9237f0915471/investigating-suspected-criminal-activity-in-healthcare-mou.pdf)

  10. 10 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 1.1 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#signatories)

  11. 11 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 4.3 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#when-the-mou-applies)

  12. 12 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 4.1 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#when-the-mou-applies)

  13. 13 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 4.5 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#when-the-mou-applies)

  14. 14 William Vineall 15 January 2025 119/23-131/19 (https://thirlwall.public-inquiry.uk/wp-content/uploads/2025/01/Thirlwall-Inquiry-15-January-2025.pdf#page=30)

  15. 15 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    paras 5.5-5.6 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#mou—incident-co-ordination-group)

  16. 16 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 5.9 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#mou—incident-co-ordination-group)

  17. 17 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 5.11 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#mou—incident-co-ordination-group)

  18. 18 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 5.10 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#mou—incident-co-ordination-group)

  19. 19 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 5.16 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#mou—incident-co-ordination-group)

  20. 20 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 5.18 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#mou—incident-co-ordination-group)

  21. 21 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    paras 5.19-5.23 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#mou—incident-co-ordination-group)

  22. 22 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 5.14 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#mou—incident-co-ordination-group)

  23. 23 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    paras 5.24-5.26 and 5.28 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#mou—incident-co-ordination-group)

  24. 24 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 5.27 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#mou—incident-co-ordination-group)

  25. 25 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 5.30 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#mou—incident-co-ordination-group)

  26. 26 DHSC, Investigating healthcare incidents where suspected criminal activity may have contributed to death or serious life-changing harm: A Memorandum of Understanding between regulatory, investigatory and prosecutorial bodies, 17 December 2024,
    para 2.4 (https://www.gov.uk/government/publications/investigating-suspected-criminal-activity-in-healthcare-mou/investigating-healthcare-incidents-where-suspected-criminal-activity-may-have-contributed-to-death-or-serious-life-changing-harm-accessible-version#introduction-and-background)

  27. 27 Witness statement of William Vineall INQ0107019/3/para 17

  28. 28 William Vineall 15 January 2025 131/11-19

  29. 29 William Vineall 15 January 2025 131/22 to 132/15

  30. 30 William Vineall 15 January 2025 211/25 to 212/20

  31. 31 Prof. Sir Stephen Powis 17 January 2025 87/22 to 91/4

  32. 32 Witness statement of William Vineall INQ0108867/2/paras 6-9

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