This article produced by Justin Valentine has been published in the AvMA Lawyers Service Newsletter (November 2023) which you can download here.
A criticism of the NHS generally is that it does not learn from mistakes. Despite the “never event” framework, the number of such incidents remains stubbornly high. In response to the perceived failures to the improvement of patient safety, NHS England are introducing the Patient Safety Incident Response Framework (“PSIRF” pronounced “pea surf”) to replace the Serious Incident Framework. The transition to PSIRF from the Serious Incident Framework should be completed by autumn 2023.
The Serious Incident Framework
Clinical negligence practitioners will be familiar with the Serious Incident Framework and, in particular, the Serious Incident Investigation Report (“SIIR”) prepared pursuant to that framework (sometimes referred to as an RCA, root cause analysis, or SUI, serious untoward incident). The Serious Incident Framework, last updated in 2015, endorses the application of root cause analysis as “a powerful mechanism for driving improvement” and notes “the fundamental purpose of safety investigation, … is to learn from incidents, and not to apportion blame”.
In relation to the threshold for investigation, the Serious Incident Framework provides:
In broad terms, serious incidents are events in health care where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations are so significant, that they warrant using additional resources to mount a comprehensive response.
The Serious Incident Framework provides an indicative list of incidents requiring investigation including:
- Unexpected or avoidable death.
- Unexpected or avoidable injury resulting in serious harm.
- Actual or alleged abuse.
- Never events as defined by the Never Events Policy and Framework which are, in broad terms, patient safety incidents that are wholly preventable and which have the potential to cause serious patient harm or death. There is a list of never events which is periodically updated.
There is no doubt that SIIRs can be helpful in clinical negligence litigation. In many cases, breach of duty, if not causation, can be established from the report. For example, in two recent cases I have dealt with:
- A letter of claim was drafted in relation to the stillbirth of twins based purely on the SIIR and without obtaining breach or causation expert evidence. The allegations focused on failures of cardiotocography monitoring in light of reduced fetal movements and failure to undertake obstetric review to consider mode and timing of delivery. Causation was not expressly dealt with in the SIIR but a full admission was made in the letter of response.
- A letter of claim was drafted, again without commissioning expert evidence, in relation to the death of a patient subsequent to hysteroscopy resulting in perforation of her bowel and the development of peritonitis not immediately recognised. The SIIR was conclusive as to breach and implied causation. A full admission was made in the letter of response.
Despite this, it is not uncommon for a Defendant trust to seek to row back from acknowledgements of “missed opportunities” in SIIRs. To a certain extent, this is a valid observation. SIIRs are not prepared with litigation in mind and will not apply the Bolam test.
Since SIIRs are not prepared with litigation in mind, they are not subject to legal professional privilege and neither is material gathered nor witness statements obtained for the purpose of the SIIR. Witness statements are not generally voluntarily disclosed but in appropriate cases can be requested.
The use of SIIRs in litigation depends on the relevant health provider investigating and preparing a report. In many areas of clinical negligence litigation they are rarely seen, and even when clearly appropriate are not always undertaken. For example, in a recent case where I acted, a claim was advanced against a tertiary neurosurgery centre on the basis of delay to treat timeously degenerative cervical myelopathy at the C4/5 level. It was known, by the claimant’s legal team, that after initial decompression surgery the claimant underwent “revision” surgery a few days later. In the letter of response, it was noted that the initial surgery was carried out at C5/6 rather than C4/5 in error and the “revision” surgery was merely surgery at the right level. Surgery at the wrong level is a “never event”. Subsequent records persisted in identifying the level of first surgery at C4/5 and the second surgery as “revision”. Despite this, no SIIR was prepared and no explanation has been offered for this failure[1].
There were previously funding repercussions for never events (on the basis that commissioners should withhold payment for the cost of the relevant episode of care). However, this was removed in 2018 since financial sanctions “reinforced the perception of a ‘blame culture’”[2].
The Patient Safety Incident Response Framework (“PSIRF”)
NHS England is introducing a new framework for the response to patient safety incidents which all providers must have in place by autumn 2023. The finalised Patient Safety Incident Response Framework 2022 is emphatic that “The PSIRF is not a different way of describing what came before – it fundamentally shifts how the NHS responds to patient safety incidents for learning and improving”.
There is a move away from root cause analysis which is perceived as attempting to identify single causes and apportioning blame (though in fact the Serious Incident Framework was also emphatic that it was about learning and not apportioning blame). Rather, a systems-based approach is to be adopted. North Bristol NHS Trust were early adopters of PSIRF and as noted in their Plan[3], “An incident is the system showing us symptoms that something is wrong”.
An investigation report within PSIRF is entitled “Patient safety incident investigation (PSII) report” a template for which is available online[4]. The PSII template notes that “PSIIs focus on improving healthcare systems; they do not look to blame individuals”. Rather:
The key aim of a PSII is to provide a clear explanation of how an organisation’s systems and processes contributed to a patient safety incident. Recognising that mistakes are human, PSIIs examine ‘system factors’ such as the tools, technologies, environments, tasks and work processes involved. Findings from a PSII are then used to identify actions that will lead to improvements in the safety of the care patients receive.
The aim, in broad terms, is to undertake far fewer investigations but to do them better and it is implicit, whatever the merits of the systems-based approach may be, that a key driver for the change was the burden on providers of producing so many SIIRs (and possibly the litigation that they prompt).
There is no longer a specified list of incidents which must be investigated. Rather, organisations must decide for themselves what to investigate informed by local and national priorities. For example, North Bristol NHS Trust has identified inpatient falls, medication errors, responding well to clinically changing conditions, pressure injuries and discharge issues as their five patient safety priorities in 2021. National guidance recommends that there are 3-6 investigations for each priority area per year and for North Bristol NHS Trust “this will likely result in 20-25 investigations per year” as compared to an average of 59/year for the two previous financial years.
PSIIs must also be completed for never events and for deaths more likely than not due to problems in care.
The concept of “never events” is, perhaps, not in keeping with PSIRF. In this regard, the work of Professor Peter Brennan on the role of “human factors” in improving patient safety is illuminating[5]; everyone makes mistakes particularly when tired, hungry, stressed or when there is significant hierarchy preventing speaking up. It is suggested that for the sake of consistency, the never event framework may be subject to review before too long.
It will no doubt be disappointing for patients and families (and possibly for their lawyers) that serious incidents which would previously meet the criteria for investigation will no longer do so. There are investigations triggered by incidents in particular clinical areas, for example maternal or baby deaths/serious injury should be investigated by the Healthcare Safety Investigation Branch (“HSIB”)[6] who adopt a systems-based approach with an emphasis on human factors consistent with PSIRF.
However, for incidents not fulfilling the PSIRF, HSIB or other criteria (the majority of those where previously there would have been an SIIR), the statutory duty of candour, pursuant to Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, remains in place and should be complied with where there is a “notifiable safety incident”. Regulation 20(8) provides:
In relation to a health service body, “notifiable safety incident” means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in—
- a) the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition, or
- b) severe harm, moderate harm or prolonged psychological harm to the service user.
By Regulation 20(2) and (3) the person involved (patient or family as the case may be) must be notified as soon as reasonably practicable of a safety incident. The notification must “be recorded in a written record” and “provide an account, which to the best of the registered person’s knowledge is true, of all the facts the registered person knows about the incident as at the date of the notification”.
AvMA, amongst others, have been critical of failings in relation to compliance with the statutory duty of candour[7] and national reports have also noted failure to comply with the duty[8]. In that context, whilst it is to be hoped that PSIRF will succeed in its aim to improve patient safety, it may be that there will be little in the way of explanation or investigation in individual cases where the local and national priorities are not engaged. This will likely make the route to compensation more difficult. As noted in North Bristol’s PSIRF Plan:
Patient safety incidents that have resulted in severe harm:
These incidents would have automatically been a serious incident under the Serious Incident Framework. It is crucial that these incidents are not routinely investigated using the PSII process, otherwise we will be recreating the Serious Incident Framework.The routine response to an incident that results in severe harm will be to follow the Statutory Duty of Candour requirements. This will both provide insights to thematic learning and provide information about the events to share with those involved. [emphasis added].
Justin Valentine, Clinical Negligence Barrister.
Justin has been ranked as a Tier 1 Legal 500 clinical negligence specialist for several years. He acts almost exclusively for claimants in cases of significant value. He has particular interest in obstetrics and gynaecology cases where consent issues are often present. He also specialises in cauda equina cases and is credited as a contributor to the GIRFT National Suspected Cauda Equina Syndrome Pathway. He has extensive experience of a range of clinical negligence cases including delayed diagnosis of cancer and diabetic cases and is instructed by many of the leading firms in clinical negligence. Read more here.
[1] No duty of candour notification was made either; the claimant was entirely unaware of the error until receipt of the letter of response.
[2] Never Events policy and framework, revised January 2018.
[3] Available here: https://www.nbt.nhs.uk/about-us/our-standards/patient-safety
[4] https://www.england.nhs.uk/publication/patient-safety-learning-response-toolkit/
[5] For example, here: https://wchh.onlinelibrary.wiley.com/doi/full/10.1002/tre.858
[6] HSIB’s maternity investigations are to be transferred to the CQC from October 2023 and HSIB will become the Health Services Safety Investigations Body (“HSSIB”) with enhanced powers to investigate “high-level” patient safety incidents including statutory legal privilege known as a “safe space”. The concept of “safe space” for such investigations is controversial.
[7] https://www.avma.org.uk/policy-campaigns/duty-of-candour/regulating-the-duty-of-candour-2/
[8] See, for example, the Ockenden Report into maternity services at the Shrewsbury and Telford Hospital NHS Trust, March 2022.