Healthcare - what are the similarities between public inquiries and patient safety investigations.

Introduction

We explore what the similarities are, if any, between a patient safety incident investigation in an NHS setting and a public inquiry (PI) even though the purpose of each of them may be different and they are bound by different rules.

As a public body, NHS organisations are invariably under some degree of scrutiny from various quarters. This can be at a local level when there is a patient safety incident and harm has been caused to a person in the care of a particular service, to trust-wide investigations involving a number of patients. Investigations can be undertaken internally in an NHS organisation, but can sometimes undergo an external review, as we have seen with maternity services and the Ockenden Report relating to maternity services in East Kent and more recently the ongoing review in Nottingham. There are also statutory ways that a public body organisation can come under wider scrutiny through an investigation process, such as public inquiries. The NHS has come under scrutiny at inquiries such as the Francis Inquiry, the Infected Blood Inquiry and the ongoing Covid-19 Inquiry.

Changes to how the NHS investigates

The NHS is undergoing a significant programme of change when investigating patient safety incidents as it transitions from the serious incident framework (SIF) 2015 to the Patient Safety Incident Response framework(PSIRF) which is being implemented across the health service.

The approach to an investigation has fundamentally changed as the NHS progresses to moving away from looking at the root cause or individual behaviours/actions to adopting a systems-based approach. This is underpinned by a range of tools, guides and frameworks, in understanding and analysing a patient safety incident, reaching conclusions, and making recommendations that will form part of an action plan to bring about change and improvement for patient care. Although some of the ways or 'tool kits' used to understand what happened and learn from patient safety incidents are different, some key principles of an investigation remain.

Regardless of the incident under investigation, there are common themes between all investigations, such as gathering evidence, finding out what happened, who is affected, why or how it happened and what were the contributory factors. An investigation at an NHS trust may take place in close proximity to the events, gathering and forming crucial and significant evidence for use at a later date - whether that be at an inquest, as part of a legal claim, independent review or a public inquiry. Therefore, the same facts and evidence gathered and utilised to inform conclusions in one investigation may well contribute to another investigation, and can be a pre-cursor to a wider or statutory investigation process, albeit they have a different function and purpose. An important consideration for any investigation is to be aware that debrief notes, interviews and accounts of events taken from witnesses, even if that information is considered to have been obtained on an informal basis, can form part of disclosed materials for inquests, and certainly for public inquiry.

Key aspects of an investigation

Investigations can be very complex, multifaceted and require different skills and approaches, particularly in complex socio-technical environments such as the NHS. However, there are common aspects of any investigations, for example:

  1. To be clear about what the investigation is required to achieve
  2. Work appropriately with key stakeholders and agree how meaningful lines of communication will be maintained
  3. Carefully gather the evidence/facts from available sources, information/documentation, observation, and witness evidence
  4. Maintain detailed and organised records throughout the course of the investigatory process and
  5. Draw conclusions and make recommendations as a consequence of the findings of the investigation.

Let's explore the above a little further.

Plan

There must be a clear plan and/or framework to work within from the outset, as this provides a common understanding for everyone of the scope and objectives of an investigation and helps to avoid the risk that the key questions go unanswered. A key component is to identify what the issues are and set out clear aims and outcomes, which are commonly in the form of terms of reference. In fact, setting out the terms of reference is one of the first steps we see in any PI.

Stakeholders

Key stakeholders must be identified and included from the beginning, so anybody who was involved with the incident, such as clinical staff if in a hospital setting, along with the patient/family/carers. There may be different reasons for this, but most stakeholders will be looking for answers as to what happened and why and how it can be prevented in the future. For patients/families/carers this is often to ensure that their experiences are not repeated and the desire to prevent a future recurrence is a common theme expressed by families, whether they have made a complaint, are involved in a more in-depth investigation or a PI. Therefore, it is crucial in any investigation to actively engage with patients/families/carers and enable them to tell their story, otherwise they are unlikely to feel listened to or understood, and this can significantly undermine confidence in any investigation.

In public inquiries, families are placed at the heart of the process, which has been particularly evident since the Hillsborough inquests in 2014 and we have seen more recently in the Grenfell Inquiry, Infected Blood Inquiry and Manchester Arena Inquiry. The families were invited to speak about their loved ones, including what they were like, their importance in the family, their character, hobbies, job, giving a 'pen portrait' of the person. In addition, those who were impacted were able to give evidence in detail about their experiences of what happened.

This is not only to ensure that the voices of the families were heard, but it meant that they meaningfully contribute to the investigation. It is a crucial step in maintaining public confidence in the investigatory process, and that it is thorough and objective in its quest to understand what and how things happened, to learn, and to make recommendations to prevent and/or minimise a recurrence in the future.

Evidence

Preparation is essential and once the purpose of the investigation is clear, relevant documents and materials need to be preserved, such as medical records. The facts need to be established based on the evidence, such as a chronology of events, drawn from various sources, such as stakeholders and both verbal, written and observational information.

Relevant documents need to be obtained including internal and external standards/policies and information that provides context, such as the physical environment. The information gathered must be kept in good order and indexed/numbered so that it can be easily referred to, accessed, or cross-referenced as an investigation progresses and as new information comes to light. The information would also need to be available if an investigation was audited or followed up in any way at a later date, such as being relevant to a PI which invariably take place sometime after a given event/s.

PSIRF provides some flexibility with regard to how some information is gathered, and this is a new approach. For instance, PSIRF does not require that information from staff always needs to be in the form of a formal witness statement, but may be a written record of a meeting between individuals/groups or a recorded discussion about a patient safety incident. However, it is still important to ensure that it is factually correct. This is because the information does not only inform the investigatory process, but equally it may be difficult to remember detailed events some time down the line, say one or more years later, if the information is needed for another type of investigation, such as a PI.

The information that may be more difficult to recall at a later point, if there was no detailed record, would be what it was like at the time, such as the context of a particular ward the nature of the patients admitted, say if there was a higher than usual ratio of sick patients to staff making it more challenging to meet the needs of all patients in comparison to another day when this was not the case. Careful consideration should therefore be given to how witness information is obtained from those involved with a patient safety incident. This is particularly because it is disclosable and in the event of a public inquiry a formal and detailed witness statement would be necessary for that purpose, and therefore the person would have to repeat or 'relive' the index events potentially at a time when their recall may not be as sharp.

Communication

A core aspect of the investigatory process is communication. Clear lines of communication, in what format and how often this will happen with staff and the patient/family/carer, requires agreement from the start of the process. This aids in ensuring that they are and feel involved, including their continued contribution and help to clarify information as new evidence emerges, which often requires cross-checking (with staff and/or patients/families/carers) to help try and establish, as closely as possible, what happened.

Skills and experience

An investigation team must have relevant training, skills and experience to undertake an investigation. This is a key plank of PSIRF, in recognition of the requirement to ensure that an investigation is robust, meaningful and able to make recommendations to facilitate learning. The team will need to be able to take a step back, and utilising relevant methods/tools, be clear on the facts and analyse the information to understand what, why and how something happened as a whole, the aim being to avoid any risk of drawing or reaching the wrong conclusions or failing to comply with the terms of reference and ensuring that any thematic learning or recommendations will be meaningful and contribute to avoiding a recurrence of another patient being harmed in the same or similar circumstances. A good investigation will identify the core learning, so should a PI or inquest follow, the level of recommendations imposed should diminish.

Typically, for a PI, a senior member of the judiciary is appointed. This is not just because of the statutory nature of an inquiry, but also to provide a high degree of confidence in being fearless in looking for the truth about what happened. The recommendations as a consequence of an inquiry will clearly serve a wider public service to prevent what has gone wrong from happening again.

All investigations are required to take place in an open, honest, and transparent way, to comply with the duty of candour obligation for the NHS. The very purpose of a PI is for public accountability and transparency to be at the heart of the process, and the Chair will take all reasonable steps to ensure the public can watch hearings and view the record of evidence. An inquiry Chair can only depart from that with good reason, and this alone is a powerful message in maintaining the confidence of key stakeholders. It is for this reason that almost all public inquiries are broadcast live on media and television outlets.

Conclusion

In summary, although the above is a rather succinct exploration of what is a complex and dynamic process, it is evident that any investigatory process can share some key similarities with inquiries, despite their purpose and impact on each other.

It is important to get an investigative process right and adopt a clear framework of how that will be achieved. The main reasons are to ensure that it identifies learning at the earliest possible stage, provides confidence and assurance to users and stakeholders. The process, from beginning to end when recommendations are made, needs to be robust and carried out in such a way so that any document retention and evidence gathering is as compliant as possible, should further investigative oversight apply.

The overall aim is to aid learning, improvement and diminish the risk of a higher level of investigation. A case in point is Essex Partnership University NHS Trust where patient safety concerns were raised and investigated by the trust, but has since progressed to a non-statutory inquiry and more recently to a full public inquiry, and it will be interesting to see whether there were gaps in the investigatory process when the inquiry concludes their investigation of the evidence.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.