Patient deaths or serious harm due to suspected criminal acts or omissions by healthcare staff - e.g. deliberate harm or care so grossly negligent as to constitute a crime - are thankfully very rare.
When this does happen, however, there will often be multiple agencies involved in parallel investigations - including the coroner, police, CQC and professional regulators - not to mention the relevant healthcare provider needing to ensure that any wider systems issues are addressed. With so many organisations involved, there is ample scope for confusion about who can/should do what and when.
Getting it right from the start, in terms of coordination and communication between all those involved, is therefore vital. This is where a new Memorandum of Understanding (MoU) - designed to ensure a coordinated approach where individuals are suspected of criminal activity in the course of healthcare delivery - comes in.
In this briefing, we look at the key takeaways from the MoU, including specific considerations for healthcare providers.
Context
"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", was published on 17 December 2024.
This new MoU delivers on a recommendation made by the 2018 Williams review into gross negligence manslaughter in healthcare that the 2006 protocol on "Investigating patient safety incidents involving unexpected death or serious untoward harm" needed updating and should be replaced with a new MoU, to be agreed between a wider group than the 2006 protocol had been, including, for example, professional regulators. This recommendation is reflected in the large number of signatories to the new MoU, which include NHS England, the CQC, HSE, CPS, National Police Chiefs' Council and 8 statutory regulators of healthcare professionals, including the General Medical Council, Nursing & Midwifery Council and the Health & Care Professions Council.
The Williams review arose out of concerns that simple errors in the delivery of care could result in prosecution for gross negligence manslaughter, even if they happened in the context of broader organisational/system failings, and a key element of its recommendation about the new MoU was that this should help support a 'just culture' in healthcare, which recognises both systemic factors and individual accountability. This is reflected in the new MoU's emphasis on ensuring that the context of an incident is explored and taken into account, to enable a fair evaluation of the individual's actions.
Practicalities
What is the MoU for?
The MoU's aim is to facilitate early, effective coordination of investigations and patient safety learning responses where criminal activity by individuals delivering healthcare is suspected, whilst not prejudicing criminal or regulatory investigations, including ensuring that relevant information is appropriately shared between organisations, evidence is effectively identified, stored and handled and steps are taken quickly to manage any ongoing risk to patients or the public.
When does the MoU apply?
The MoU applies where one or more of its signatories needs to investigate - in parallel - any incident where there is a reasonable suspicion that a criminal offence has or may have been committed by an individual providing healthcare services in a health or care setting that leads to, or significantly contributes to, the death of, or serious life-changing harm to, a patient or service user.
This is intended to cover only the most serious cases - e.g. acts of deliberate harm or where the acts or omissions of a member of healthcare staff amount to a breach of the duty of care which not only results in death or life-changing harm, but is also so reprehensible and falls so far below the standards to be expected (taking into account relevant qualifications, experience and responsibilities), that it amounts to a crime. This is a high bar, and it is worth emphasising that, as stated in the MoU itself: "The vast majority of patient safety incidents in the NHS can and should be dealt with under the PSIRF without any need for this MoU to be invoked".
It is also important to note that the MoU only applies where the suspected criminal activity has been conducted by an individual rather than, for example, healthcare providers as organisations.
The MoU applies where such incidents are suspected to have occurred in the delivery of NHS funded care or privately funded care that occurs on NHS premises. It is expected, though, that the same principles should also be applied in the context of private healthcare.
How does it work?
As was the case under the 2006 protocol that preceded it, at the heart of this MoU are 'Incident Coordination Groups' (ICGs).
ICGs are made up of appropriately senior representatives from the relevant healthcare organisations, regulatory bodies, investigatory bodies and prosecuting bodies involved.
Where one or more parties to the MoU identifies a reasonable suspicion of a criminal offence of the nature outlined above, an initial meeting of the ICG (either in person or virtually) should take place as soon as is practical and the ICG should agree a lead, who will chair future meetings.
The MoU outlines key tasks for the ICG, including for example:
- Ensuring that any evidence is secured and preserved as soon as possible
- Establishing arrangements for coordinating patient safety learning responses by healthcare organisations alongside any regulatory/criminal investigation
- Coordinating liaison with the patient/service user or family members, ensuring they are involved and supported from the outset
- Agreeing a communications strategy with the media
- Convening at appropriate intervals throughout the regulatory/criminal investigation to share findings, reflect on ways of working and address issues
It also includes a detailed list of suggested items for discussion at ICG meetings (at Appendix D) - for example: Is patient safety at risk and, if so, what is to be done to minimise this risk? What steps need to be taken to ensure the investigation considers the rights of those under potential investigation? What information is available and what may be shared?
Meanwhile, supporting a 'just culture' by looking at the bigger picture is a key theme running throughout the MoU, which states: "Throughout the investigation consideration of the wider systems at play during the incident should be made by all parties, including members of the ICG, expert witnesses and those tasked with securing and gathering evidence".
Key considerations
We have highlighted below some specific points for healthcare providers to note:
- The MoU stipulates that, where an NHS body is conducting a learning response under PSIRF and the MoU has been invoked, they should follow the advice of the ICG in terms of how they manage the learning response to ensure that any other responses - particularly any criminal investigation - are not adversely affected.
- There is a specific obligation on NHS providers to inform their ICB and NHS England regional team that an ICG has been established (albeit this may be usual practice in any event), as well as informing the CQC so it can consider whether to carry out parallel, but separate, monitoring, assessment and/or investigation of the healthcare provider to determine the impact of wider systems at the time of the incident.
- Where the Police refer a case to the CPS, they must inform the CQC of this within 7 days, so the CQC can consider whether to carry out its own investigation of the healthcare provider to determine if it has breached any relevant regulations, such as the Regulation 12 requirement to provide safe care and treatment.
- The ICG will usually include the healthcare provider where the events took place, unless at any point that organisation itself becomes a potential defendant in criminal proceedings (e.g. if there is a suspicion of provider-level failure which may justify a corporate manslaughter investigation and/or CQC Regulation 12 prosecution), in which case representatives of the provider should be removed from the ICG. This does mean that, in reality, there will be limited circumstances in which the healthcare provider will be included in the ICG as it is often the case that both corporate and individual failures are considered as part of a criminal investigation (at least during preliminary stages). In circumstances where an ICG is proceeding without the healthcare provider in attendance, it is still likely to be helpful for that provider to seek updates from the ICG and on progress of the investigation(s) more broadly.
- One of the main objectives of the ICG will be to facilitate disclosure of documents and evidence and as such, it will be important for healthcare providers to ensure any member of staff appointed to attend an ICG on their behalf understands information governance and disclosure obligations to ensure requests are responded to appropriately and given proper consideration, notwithstanding the ongoing criminal process.
- Whilst not a listed objective for ICGs, this forum may assist healthcare providers in navigating operational impacts of lengthy criminal investigations involving clinical staff. Historically, investigations of this kind can take many months, or even years, to complete and this can create situations where staff are unable to work, or are unable to perform their usual clinical duties for this extended period which creates operational and HR pressures. Regular ICG discussions may present an opportunity for healthcare providers to remind other stakeholders of this ongoing impact and encourage prompt progress and review to ensure staff do not remain impacted for any longer than is absolutely necessary.
How we can help
Our national team of regulatory and criminal specialist lawyers have extensive experience of supporting healthcare providers across the NHS and independent sector on a wide range of matters relating to patient safety and incident responses, including:
- Advising in the immediate aftermath of incidents involving patient death or serious harm where criminal activity by an individual healthcare professional is suspected, including in relation to preservation of evidence, liaison with other agencies involved such as the Police and CQC and advice on information sharing
- Attending and advising healthcare organisations in Incident Coordination Groups convened following such incidents in line with the new MoU
- Clinical governance scrutiny to assess the effectiveness of learning responses, including patient safety incident investigations and improvement plans
- Representation and support in relation to further investigations linked to patient safety incidents, including strategic advice to reduce the risk of the healthcare provider being prosecuted as an organisation - e.g. for corporate manslaughter and/or breach of CQC regulations - and defence of criminal prosecutions where charges are brought