Author: Cheryl Blundell, Consultant at Capsticks

FAIR RESOLUTION

NHS Resolution publishes Being fair 2

The report aims to “promote the value of a person-centred workplace that is compassionate, safe and fair when care in the NHS goes wrong”. It spans improving workplace culture, fair recruitment, induction and supervision procedures and fair resolution of concern. Links have been identified between culture, workforce and patient safety. The report builds on the original Being fair (2019) and considers the benefits of adopting a more reflective and fair approach to support staff to learn from incidents of harm.

What this means for you

NHS Resolution asks senior leaders of healthcare organisations to consider/ review/ implement a number of key actions including:

• reviewing plans on providing inclusive and supportive environments and ensuring they are evidence based
• taking a proactive approach
• considering how assurance is given that improvements are made and best practice is disseminated
• signposting practitioners to NHS Resolution to, for example, provide impartial advice, effectively manage and resolve concerns about the practice of individuals
• supporting the development of further training for NEDs is also highlighted.

SAFETY & LEARNING

Sands and Tommy’s report on maternity services

The report warns that the government target to halve stillbirths and neonatal deaths is slipping as rates for both have begun to increase as progress has stalled. The following themes are highlighted:

• nationally agreed standards are often not followed
• failure to effectively hear and act upon voices of bereaved parents
• lack of national targets to reduce inequalities around ethnicity and deprivation
• the impact of under-resourcing on patients’ care experience
• many trusts and boards are not learning from error when things go wrong.

What this means for you

The report echoes many of the findings of the Ockenden review into maternity services at Shrewsbury and Telford Hospitals NHS Trust. Transparency and candour when things go wrong, with ‘ward to board’ quality assurance based on a ‘no blame culture’ which is patient-centred are key to the provision of safe care and learning from incidents to prevent harm. Trusts should review their governance procedures and policies, particularly around candour, patient safety investigations, escalation and mitigation (when agreed staffing levels are not met), to ensure that they are robust and fully fit for purpose.

Ensuring post-incident changes in clinical practice are not only implemented but reviewed and evidenced within six months, is particularly crucial. Training, including on the nationally agreed standards should be reviewed.

Further information on the Ockenden report and its recommendations can be found in our insight here.

Roll-out of mandatory outcomes registry

NHSE’s mandatory medical devices outcomes registry launched in May 2023. Trusts must submit full data on surgery which includes a high-risk medical device (e.g. an implant) into the new national registry by December 2023. The new central registry has been created in response to the Independent Medicines and Medical Devices Safety Review’s (IMMDSR) recommendations. Data submissions will include details about the patient, clinician with responsibility for the operation and the device(s) being implanted (including unique identifier).

What this means for you

The challenge has been described as ensuring the information is scanned at the right point before and during the procedure. Data entry is mandated in contrast to some of the smaller current specialty registries where incomplete data has limited their usefulness. Clinicians may have concerns about the registries being used (as per current specialty registries) to flag up outliers. While outliers clearly warrant consideration, they are not necessarily indicative of a problem, but may simply reflect a more complex patient-mix. For the full IMMDSR recommendations, read our insight on its report ‘First Do No Harm’.

Care Quality Commission and the Healthcare Safety Investigations Branch maternity function

It has been confirmed that the CQC will take over maternity investigations from HSIB in October 2023, when the latter will become the Health Services Safety Investigations Body (HSSIB).

What this means for you

An announcement from the CQC to trusts on the arrangements for transition is due soon. We understand that the current maternity investigation process is unlikely to change. It is important to note that maternity investigations were excluded from the new ‘safe space’ provisions for other HSSIB investigations. Investigations conducted in ‘safe space’ (and associated documents) have legal privilege and the contents can only be disclosed with a High Court order.

Staff involved in CQC maternity investigations will continue to require a high level of support during the process.

LIABILITY

Court of Appeal confirms that Bolam test remains relevant to informed consent

In Bilal and Malik v St George’s University Hospitals NHS Trust (2023) the Court of Appeal was asked to consider the interplay between the decisions in Bolam (1957) and Montgomery (2015).

The late Mr. Malik underwent spinal surgery to relieve compression of his left T10 nerve root. The claim was based solely on the issue of informed consent. Sadly Mr. Malik suffered serious (non-negligent) neurological injury. There was a factual dispute regarding the type and duration of Mr. Malik’s pre-operative pain and whether the surgeon should have discussed alternatives other than surgery, which he recommended. It was further alleged that had the surgeon discussed alternatives, Mr. Malik would have declined surgery.

The trial judge held that the surgeon’s view that there was no other reasonably available treatment to address Mr. Malik’s pain, had not been negligent. As a result he was under no obligation to advise about treatment he did not consider appropriate.

The Court of Appeal confirmed that the Supreme Court in Montgomery draws a distinction between two aspects of a clinician’s role. Bolam is applicable to the assessment of treatment options (i.e. for the doctor to assess). Montgomery is relevant to assessment of what risks should be explained to the patient because they are material to them (and for the court to decide).

What this means for you

The decision is welcome confirmation of how Montgomery should be applied in practice and demonstrates that there is still a role for clinical judgment in the assessment of treatment options. The challenge for a doctor remains consideration of what is material to the patient in terms of risk and ensuring these issues are discussed and the conversation documented. The case of McCulloch v Forth Valley Health Board was heard by the Supreme Court in May 2023, on the issue of interplay between Bolam and Montgomery. More updates on this to follow.

Fundamental Dishonesty – ‘good days and bad days’ defence rejected

In Mantey v MOD (2023), the High Court rejected the claimant’s assertion that the inconsistency between his pleaded case and video evidence obtained by the defendant and his pleaded case was due to the latter being obtained on a ‘good day’. The claimant was a former soldier who claimed c. £1.6 million for Non-Freezing Cold Injury. The judge found him to be fundamentally dishonest with no other reasonable explanation for the inconsistencies highlighted by the video. The difference between his presentation to the defendant’s expert and the video was marked. The claimant’s assertion that the video was taken on a ‘good day’ when his pain was numbed by medication was rejected.

The judge considered a number of factors before finding the claimant fundamentally dishonesty, including the lack of an explanation in either the claimant or his wife’s witness statements and his failure to mention, to the defendant’s expert, the impact of the medication on mobility.

What this means for you

This case demonstrates that the courts’ appetite for making findings of fundamental dishonesty in appropriate cases shows no signs of abating. It also provides a helpful indication of what factors courts will take into account when reaching a decision.

COSTS

Fixed recoverable costs extended

From 1 October 2023, fixed recoverable costs (FRCs) will be introduced for money claims valued at over £25,000 up to £100,000. The new regime will apply to personal injury claims where the cause of action accrues after 1 October 2023 and disease cases only if a letter of claim has not been sent prior to that date. A new ‘intermediate track’ is created. Clinical negligence claims are not excluded if breach and causation have been admitted, provided one of the exceptions in the new CPR 26.9 (7c) does not apply (e.g. no more than two experts per party, trial no longer than three days).

Where a party or witness is considered ‘vulnerable’ the courts have power to determine at the end of the case whether the vulnerability caused sufficient extra costs to take the matter outside the regime.

What this means for you

Following the October rule changes we may see satellite litigation around the exceptions to clinical negligence cases with breach and causation admissions being placed on the intermediate track. The new provisions will make early investigation of claims, assessment of evidence and decisions on the viability of defending become ever more crucial. For all personal injury cases, the changes will address the often disproportionate costs to damages ratio in claims of modest value.

The MoJ’s response to its consultation on FRCs for clinical negligence claims of up to £25,000 is awaited. 

ON THE HORIZON…

Spotlight on two appeals

The appeals in Paul & Paul v Royal Wolverhampton NHS Trust (2021) and Mathieu v Hinds (2022) were heard in May 2023. Paul relates to the proximity test in psychiatric damage/ secondary victims claims and Mathieu to whether dementia risk following head injury should trigger a provisional damages awards. The judgments are awaited.

Personal Injury Discount Rate

The MOJ’s call for evidence to inform the decision-making for the next rate review has closed. The review is due to be completed by July 2024.

Further information about the appeals and the PIDR can be found in Clinical Law Insight: Spring 2023.