Hints and tips on lesson learning, Regulation 28 reports and the new Coroner’s Bench Book
Prevention of Future Deaths/Regulation 28 Reports
As discussed in our Insight on 19 January 2023 — Prevention of Future Deaths (PFD) reports — Coroners have a statutory duty under paragraph 7 (1) of Schedule 5 of the Coroners and Justice Act 2009 to report to a person, local authority or government department when the Coroner believes action should be taken to prevent future deaths.
These reports are commonly known as “Prevention of Future Deaths” or “PFD” or “Regulation 28 Reports” (under Regulations 28 and 29 of the Coroners (Investigations) Regulations 2009 providing detail of the process to be followed).
The obligation on a Coroner to issue a PFD report arises where a Coroner investigates a person’s death and:
- ‘anything* revealed by that investigation gives rise to a concern that circumstances creating a risk of other deaths will occur or continue to exist; and
- the Coroner is of the opinion that action should be taken to prevent those circumstances.
*There is no requirement for the matter of concern to have been causative of the death.
A Coroner may choose to hear and give weight to representations by Interested Persons about whether a PFD report should be issued but, there is no legal obligation for a Coroner to do so before deciding whether to issue a PFD report. Once a concern has arisen on the part of the Coroner, then issuing a PFD report is considered mandatory.
New Bench Book Guidance
In inquests being heard before a jury the practice has been to hear Regulation 28 evidence by the Coroner alone, once the jury has retired. However, Chapter 6 of the new Bench Book Guidance confirms that, going forward, all evidence, including PFD evidence, should be heard before the jury.
Paragraph 16 of Chapter 6 states that as the duty to issue a PFD duty is triggered by “anything revealed by the investigation”, it would be inappropriate to convene a separate hearing to consider evidence about PFD matters after the inquest (and hence the investigation) has ended, and a conclusion has been returned.
“At a jury inquest all evidence that might touch on the circumstances of the death in any way should be heard in the presence of the jury.”
Impact of Regulation 28 Reports
- The recipient of a PFD report has 56 days to respond to the Coroner setting out the action that has been taken, is proposed to be taken, or why no action is proposed. The work entailed in reviewing the PFD, considering the concerns raised, and putting together a response can take up a lot of resource.
- The Coroner must send PFDs to a person who the Coroner believes may have power to take such action”. As well as sending the PFD to the organisation concerned, the PFD report could also be shared with external regulators, such as the CQC and NHSE, as well as commissioning bodies
- On their webpage (How CQC interacts with Coroners) the CQC, for example, notes that PFDs “can yield extremely valuable evidence and information [so] we can … monitor, inspect and undertake civil and criminal enforcement.” Therefore, it is something to be taken seriously by the receiving organisations.
- The issue of a PFD report, or a failure to respond to a PFD report, by individual clinicians could result in formal regulatory investigation and sanction by the GMC or other professional regulators.
- PFDs and their responses are published on the Chief Coroner’s public website so, whilst PFDs are not intended to be a punitive measure, a report can have far reaching effects reputationally.
Monitoring of organisational compliance with PFDs
- Once a PFD report is served, a Coroner has no power to demand a response, nor comment on its adequacy if a reply is received.
- There has been increasing concern about there being no formal body as such that follows up on organisations’ implementation of Coroners’ recommendations in PFDs.
- On 1 January 2025, for the first time, the Chief Coroner published a list of organisations who have not responded to a PFD report in 2024 which she referred to as a “badge of dishonour” (Non-responses to Prevention of Future Death (PFD) reports).
- Of the 26 organisations listed, 16 were part of the health and care sector.
- This naming and shaming has led to many questioning if this could be the start of the PFD report process having ‘more bite’.
The importance of “lesson learning” statements in inquests
- As well as covering an individual’s involvement with the deceased, providing an overview of their care and addressing any family concerns, witness statements should also make the most of this important opportunity to detail any organisational “lesson learning” that has taken place following the individual’s death, in terms of any issues having been identified and procedures etc put in place to reduce or prevent future deaths occurring in similar circumstances.
- Such evidence serves an important public health, welfare and safety function.
- Lesson learning statements can also provide healthcare providers and commissioners with insight and improvements from their counterparts as well as internal learning.
- Lesson learning statements can also reduce the risk of a PFD report being issued if the Coroner is satisfied that improvements have been made and previous concerns resolved, so that future deaths do not pose a risk.
- Often it is more appropriate for a lesson learning statement to be provided by individuals in senior management roles who can provide assurance to the family. and the Coroner, that changes have been implemented across the organisation. That person should be prepared to attend to give their evidence at the inquest.
Serious Untoward Incidents reports (SUIs) and Patient Safety Incident Response Framework (PSIRF)
A good evidence base for a lesson learning statement used to be SUIs that included an analysis of the cause of the incident or death. These are disclosable at inquests (and any later claim) as they are not privileged because they are not produced in contemplation of litigation.
SUIs were replaced by PSIRF in Autumn 2023. These are also disclosable at inquest (and any later claim).
PSIRF changed the way in which investigations are undertaken within the NHS, and consequently the types of investigation reports that are disclosed to the Coroner’s Court are not the same as the previous SUI. PSIRFs are centred more around thematic learning rather than as part of a framework of accountability. Witness statements do not form part of the PSIRF process, and therefore these need to be provided separately for the inquest process.
PSIRF investigations do not tend to make judgments about cause of death. Their focus is more on learning, which often means that additional evidence needs to be adduced on PFD issues and complex causation points.
Key Lessons
- Ensuring your organisation responds fully and in a timely manner to a PFD report is more important than ever. Being associated with a failure to respond to a PFD report could potentially be perceived as a lack of accountability, potentially undermining public confidence in that organisation and leading to reputational damage.
- Receiving a PFD report can be an opportunity for organisations to demonstrate proactive engagement with safety concerns. and to highlight the ways in which they are committed to improving safety and care.
- Nevertheless, demonstrating learning before and during the inquest process should be at front and centre when collating evidence for inquests. The preparation and submission of evidence is essential to avoid a PFD report being issued.
If you need any advice or assistance with Regulation 28 reports and the new Bench Book Guidance, our experienced inquests lawyers can provide invaluable insights and ongoing support.