SAFETY & LEARNING

Terms of reference published for the Thirlwall (Letby) inquiry

The DHSC (Department of Health and Social Care) has published the terms of reference for the inquiry. It has been set up to examine events at the Countess of Chester Hospital and their implications, following the murder and attempted murder convictions of nurse Lucy Letby. The terms of reference cover three broad areas:

• the experiences of the parents of the babies named in the indictment
• the conduct of clinical and non-clinical staff and management, as well as governance and escalation processes in relation to concerns being raised about Letby and whether these structures contributed to the failure to protect babies from her
• the effectiveness of governance, external scrutiny and professional regulation in keeping babies in hospital safe, including consideration of NHS culture.

What this means for you

The convictions have thrown the issue of ‘whistleblowing’ and governance into focus again. Pending the outcome of the inquiry, it seems that the key to prevention of anything similar happening in future (and crucial to patient safety generally) is what gets done with the information obtained from whistle blowers. NHS organisations should review their processes for the management, use and escalation of such information and their policies and procedures around freedom to ‘speak up’ as required by NHS England’s (NHSE) letter of 18 August 2023.

There have been calls for regulation of NHS executives. As yet, there appears to be no consensus on whether such a regime would add anything to current professional regulation (e.g. of a medical director by the General Medical Council) or prevent a recurrence. The NHSE letter references the strengthening of the Fit and Proper Person Framework - in particular additional background checks, board member reference template and the fact that the assessment will be refreshed annually and recorded on the Electronic Staff Record. (see, ‘Advisory’ below).

Maternity care - delays to induction and patient safety

Recent Care Quality Commission (CQC) reports, produced as part of the national Maternity Inspection Programme, have highlighted induction of labour delays due to staff shortages, as have some Trust boards in their published minutes. The issues are reported as including long waits to be induced; long waits for transfer to the labour ward once induction has begun; and some instances of lack of effective monitoring during the delay period. Longer term, resource issues may improve with the NHS long-term workforce plan, but in the meantime the risk needs to be managed. The Ockenden review into maternity services at Shrewsbury and Telford Hospitals NHS Trust highlighted the need for safe pathways for induction if delays occur due to staff shortages or periods of high activity. Further information on the Ockenden recommendations can be found in our insight here.

What this means for you

The Healthcare Safety Investigation Branch (now Health Service Safety Investigations Body where maternity investigations are hosted by the CQC) identified individual risk assessment at the time a date for induction was set and clinical oversight during the induction process, as being key for patient safety. The Royal College of Midwives consider that labour should only be induced when there is a midwife to support the patient and a bed available on the labour ward. Effective monitoring is crucial given the possibility of delay.

Government response to East Kent maternity investigation (the Kirkup report)

The Kirkup report considered maternity services at East Kent University Hospitals NHSFT (EKUHT), between 2009 and 2020. A ‘clear pattern’ was found:

• suboptimal clinical care leading to significant harm
• failure to listen to families
•  acting in ways which made families’ experiences ‘unacceptably and distressingly poor’.

Read more on the Kirkup recommendations in our insight here.

Key points in the government response include:

• implementation of the report’s recommendations relating to staff culture, compassionate care, professional behaviour and team-working will be overseen by Dr Kirkup
• a new national oversight group will be formed to review maternity and neonatal improvement programmes, chaired by Health Minister, Maria Caulfield.

In addition to recommendations specifically directed at EKUHT the government has stated that the following issues are being addressed:

• data – better monitoring of patient safety in maternity and neonatology will be provided by a special NHSE data task force
• teamwork – potential improvements will be examined by DHSC and other relevant bodies and will extent to doctors’ training
• maternity representation will be required on Trust boards
• NHSE will continue its work on its approach to poorly performing Trusts.

What this means for you

Trusts should have maternity representation on their boards. The report’s action points cover a number of themes which have featured in previous investigations and inquiries into NHS service failures. Healthcare organisations should keep under close review:

• the efficacy of their training programmes
• policies and procedures for ensuring the duty of candour is understood fully and complied with
• the appropriateness of patient safety investigations - that they are both timely and thorough and that action plans are monitored to ensure that they deliver on the prevention of future harm.

LIABILITY

What must a doctor tell patients about reasonable alternative treatments?

In McCulloch and others (Appellants) v Forth Valley Health Board (Respondents) [2023] UKSC 26, the Supreme Court considered what is a reasonable alternative.  The Appellant’s late husband was admitted to hospital complaining of chest pains, nausea and vomiting. Whilst in hospital his condition improved. When seen by Dr Labinjoh (consultant cardiologist) he looked much better and denied having any chest pain. Dr Labinjoh saw no reason to prescribe any additional medical treatment. In particular she did not regard it as appropriate to prescribe NSAIDs because Mr McCulloch was not in pain at the time and there was no clear diagnosis of pericarditis. Three days later he was discharged home, but on the next day he suffered a fatal cardiac arrest.

It was alleged that Dr Labinjoh was in breach of her duty of care by failing to inform the deceased that NSAIDs were a possible treatment option for him. If he had been given that advice, he would have taken the NSAIDs and would not have died.

The Supreme Court determined that Dr Labinjoh was not obliged to inform the deceased that NSAIDs were a treatment option as her view was supported by a responsible body of medical opinion (the Bolam test).

What this means for you

The decision confirms that in practice there is still a role for clinical judgment in the assessment of treatment options. However, a doctor cannot simply inform a patient about the treatment option(s) the doctor prefers. The information given (or not) must be ‘Bolam compliant’ i.e. supported by a responsible body of medical opinion.

For the consent process to be ‘Montgomery compliant’ the doctor must also consider the material risks of any proposed treatment and that assessment should be based on risks that are material to the patient. This was confirmed in the Court of Appeal decision in Bilal (2023). It remains essential that the discussion of risk issues and alternative treatments is fully documented.

Further information on Bilal can be found in Clinical Law Insight: Summer 2023.

QUANTUM

Personal Injury Discount Rate (PIDR) review update

The Ministry of Justice has published its response to the call for evidence to inform the decision-making process for its next PIDR review. It will not be recommending a policy position on deciding whether a dual/ multiple rate should be introduced at this time – a central question in the ‘call’. All submissions and additional evidence will be provided to the PIDR expert panel and used to inform the options available to the Lord Chancellor. The review is due to be commenced by 15 July 2024.

Further information on the PIDR review can be found in Medical Malpractice and Casualty Forward View 2023.

INQUESTS

Article 2 inquest not required simply because an individual is placed in a care or nursing home or a hospital

In R (Maguire) v HM Senior Coroner for Blackpool and Fylde [2023] UKSC 20, the Supreme Court upheld the coroner’s decision that an expanded conclusion as required by article 2 of the European Convention on Human Rights was not required in the case of Jacqueline Maguire, a care home resident who sadly died in hospital in 2017. Jacqueline had been under a deprivation of liberty safeguards standard authorisation. The Court determined that neither the systems duty nor the operational duty on the state mandating an article 2 inquest had been engaged. Key findings included:

Systems duty

• This operates at a high level in the context of healthcare services, is relatively easily satisfied, and only in rare cases will it be found to have been breached.
• Individual lapses (even those which are negligent) do not generally constitute a failure of that duty.

Operational duty

• Placing an individual in a care or nursing home or hospital does not mean that the state assumes responsibility for all aspects of their physical health nor does it guarantee the adequacy of healthcare.
• It applies in a graduated way depending on the level of risk.

Comment

This decision is helpful confirmation of the high threshold adopted by the courts for there to have been an arguable breach of article 2 in a healthcare setting. For further information read our insight on the case.

COSTS

Two important changes to the fixed recoverable costs regime:

Personal injury claims valued at over £25,000 up to £100,000

From 1 October 2023, fixed recoverable costs (FRCs) were introduced for money claims valued at over £25,000 up to £100,000. The new regime applies 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’ has been 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. A further consultation (which closed on 8 September 2023) proposed that in clinical negligence cases the admission of liability must be made in the Letter of Response.

What this means for you

The new provisions for claims valued at over £25,000 up to £100,000 will make early investigation, assessment of evidence and decisions on the viability of defending ever more crucial. The case of Somoye (reported in Clinical Law Insight: Spring 2023) emphasises the care that needs to be taken before an admission is made, as this may be irreversible.

Following the October rule changes we may see more arguments at CMCs around the exceptions to intermediate track allocation. For all personal injury cases, the changes will address the often disproportionate costs to damages ratio in claims of modest value.

Clinical negligence claims valued at up to £25,000

The government has announced that fixed recoverable costs will be introduced for clinical negligence claims valued at up to £25,000 (excluding stillbirth and neonatal claims).

The new regime is expected to come into force in April 2024. Its focus is early exchange of evidence followed by a mandatory ‘stock take’ by the parties. If the matter is not resolved following the ‘stocktake’ phase it will proceed to neutral evaluation (by an experienced legal professional). Defendants will be responsible for paying the costs of neutral evaluation.

Claims that cannot be resolved without litigation will be governed by a new Low Value Clinical Disputes protocol. They will be allocated to a ‘standard track’ unless suitable for the ‘light track’ (where the circumstances of the incident are such that it is anticipated that liability will not be disputed or that it can be resolved quickly, e.g. a ‘never event’).

A further consultation addressed whether disbursements such as court fees should be included within the fixed costs. Closing date was 27 October 2023.

Comment

The regime for clinical negligence claims up to £25,000 is designed to achieve better proportionality of legal costs to the value of the damages claimed. Once in force it will be interesting to see the stage at which cases settle and the extent to which the government’s dual aim of “speedier justice” is achieved.

According to the consultation response, the government thinks there will be few claims that will need neutral evaluation as the majority will have been resolved by that stage.

ADVISORY

New Fit and Proper Person Test framework for NHS boards

Following the 2019 Kark review, NHSE has reviewed and updated the Fit and Proper Person Test (FPPT). The new framework should have been implemented by Trusts, ICBs and arm’s length bodies from 30 September 2023, but is not retrospective. It covers executive and non-executive directors, interim and permanent director appointments of over six weeks and any individuals called “directors” within regulation 5 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Chairs have responsibility for compliance. Detailed requirements include:

• the core elements of FPPT to be considered on annual evaluation of board members
• the definition of a breach of the core elements
• when a full FPPT assessment is required plus annual self-attestation
• considerations for new appointments
• board member reference checks, including a standardised reference template
• maintaining electronic information on board members.

A new NHS Leadership Competency Framework for board level directors is due to be published in spring 2024.

What this means for you

The framework not only provides a means for directors to demonstrate that they are fit for their roles, but should also provide assurance to NHS bodies and the public that unfit directors will not be able to move between them. It is also a reminder of the individual accountability of Board members and the requisite core competencies.

NHS organisations should review their policies, procedure and employment contracts to ensure that they are framework-compliant.

Record fine for mental health provider over patient death

Cygnet Healthcare has been fined £1.5m after pleading guilty to a CQC prosecution for failing to provide safe care at Cygnet Hospital, Ealing in July 2019. A young female patient committed suicide on the ward, having tried to harm herself in an almost identical way four months earlier. The charges included failure to:

• provide a safe ward environment to reduce the risk of patients using a ligature
• ensure patient observations were carried out in line with company procedures
• train staff on emergency resuscitation techniques.

Comment

In an MH setting, the importance of ensuring risk assessments are carried out and regularly reviewed/updated together with regular observations being carried out, cannot be overstated. Staff training on safety policies and techniques such as emergency resuscitation is an essential element of demonstrating and delivering a safe system of care.