Clinical Law Insight: Summer 202212/07/22
Covid-19 Public Inquiry: terms of reference published
The Government has published the Inquiry terms of reference (ToRs) following a consultation led by the Inquiry Chair, Baroness Hallett. The ToRs consider the response of the health and care sector across the UK and include:
- preparedness, capacity and resilience
- initial contact with 111 and 999
- the role of primary care
- management of the pandemic in hospitals (infection prevention/control, critical care, discharge, use of ‘Do not attempt cardiopulmonary resuscitation’ decisions)
- palliative care
- workforce testing
- changes to inspections
- the impact of the pandemic on staff and staffing levels;
- transfer of care home residents to and from homes;
- ante and post-natal care;
- therapeutics and vaccines;
- the impact of the pandemic on provision for non-Covid care.
The Inquiry is unlikely to begin before 2023.
What this means for you: In a public inquiry process, individuals and organisations can be compelled to provide documentation, a witness statement and oral evidence under oath. In our experience, early preparation is crucial. We suggest this spans the collation of contractual information and, where applicable, construction of an accurate timeline of events to give certainty as to information available at the time decisions were made. Read our insight to find out more on how to prepare for the Inquiry.
Courts continue to take a robust approach to fundamental dishonesty
In North Bristol NHS Trust v White  EWHC 1313, the Respondent received a six-month immediate custodial sentence for attempting to defraud the NHS of over £4 million. The claim, which arose from a delay in diagnosing cauda equina syndrome, was struck out as fundamentally dishonest. Surveillance evidence showed the Respondent walking normally despite claiming to have mobility issues which required her to use a crutch.
In Hull University Teaching Hospitals NHS Trust v Colley  EWHC 854, the Respondent’s litigation friend was given a six-month prison sentence suspended for two years for giving false evidence to support her daughter’s £5.4 million claim based on negligent treatment of hip dysplasia.
Comment: The White case sends a clear message to potential Claimants that fraudulent claims will not be tolerated. The judge described Ms White as presenting a “risk to the public purse and public institutions”’. He stated that “defrauding the NHS …is utterly unacceptable” and that “suspending her sentence would (not) send out the right message”. In Colley, the claim was discontinued before the issue of fundamental dishonesty could be considered by the court. In the circumstances, proceedings for contempt of court were brought based on falsehoods in the mother’s witness statement. Read NHS Resolution’s statement on the White case.
Safety and Learning
NHS Resolution’s thematic review of emergency medicine claims
In a series of reports, NHS Resolution has carried out a detailed analysis of claims relating to Emergency Medicine (EM), sharing common themes and learning points to prevent future harm. The analysis considered high value claims and fatalities, missed fractures and hospital-acquired pressure ulcers and falls. Key conclusions include: themes around diagnostic error, failures in investigation process, failure to recognise significance of re-attendance, delay in accessing senior / specialist review, communications issues, absence of standardised risk assessments and radiology issues.
What this means for you: One of the main findings across all reports is that timely diagnosis and treatment planning is central to patient safety. Healthcare providers can deliver safe systems of care by taking actions should the patient deteriorate (including escalation), good record-keeping, appropriate/ effective handover and ‘safety netting’ for patients. Clinical pathways can ensure consistency of approach and should be kept under regular review. Sharing good practice can be as insightful as learning from what went wrong and will be required by the new Patient Safety Incident Response Framework. Use of all data sources such as scorecards and GIRFT litigation packs can provide valuable insight especially where multiple specialties need to work together as in fracture care.
The Ockenden Report: safety in maternity services
Donna Ockenden’s review of maternity services at Shrewsbury and Telford Hospitals NHS Trust (SaTH) found repeated failures in the quality of care and governance at the Trust as well as failures of monitoring by external bodies. Failures to either undertake serious incident investigations (SIIs) at all or to an appropriate standard, the latter leading to lost opportunities for learning, were central to the inquiry’s conclusions and recommendations. Reasons for the failures included: insufficient staff; lack of ongoing training; lack of investigation and governance; a culture of not listening to families and a tendency to blame mothers for poor outcomes. The review concluded that systemic change is needed both locally and nationally and that awareness of and accountability for values and standards should stretch from ‘ward to board’. In addition to the 60 ‘Local Actions for Learning’ for SaTH, 15 ‘Immediate and Essential Actions’ (IEAs) were directed to all maternity services in England. The IEAs cover a range of issues in ten key areas including workforce, training, governance, engagement with families and staff, the nature of investigations and timely implementation of practice changes.
Subsequently, Donna Ockenden was appointed to lead an independent inquiry into maternity services at Nottingham University Hospitals NHS Trust.
What this means for you: The ‘golden thread’ of good governance runs through many of the IEAs. Transparency and candour when things go wrong, with ‘ward to board’ quality assurance based on a ‘no blame culture’, will be key to ensuring what happened at SaTH is never repeated. Trusts should review their governance procedures and policies, particularly around candour, serious incident (SI) investigation, escalation and mitigation (when agreed staffing levels are not met), to ensure that they are robust and fully fit for purpose. Ensuring post-SI changes in clinical practice are not only implemented but reviewed and evidenced within six months, is particularly crucial. Training should be multi-disciplinary with lessons from clinical incidents forming the basis of the training plan. It seems clear that training with those you work with is not only logical but safety critical. Read our insight on the Ockenden report to learn more about the practical recommendations.
New guidance on the duty of candour
The Nursing and Midwifery Council and General Medical Council have produced joint guidance on the responsibility of healthcare professionals to be open and honest when things go wrong in health and care. 'Openness and honesty when things go wrong' updates earlier guidance to include practical advice on when and to whom an apology should be given, whose responsibility it is to give and record the apology, what should be included and how to say sorry. There is also a section on the duty of healthcare professionals to be open and honest with their organisation by reporting adverse incidents which lead to harm as well as near misses.
What this means for you: Creating a blame-free culture of openness and transparency is the key to good governance and patient safety. Remember that there is a general duty of candour which applies at all times in addition to the statutory duty which is triggered by a ‘notifiable safety incident’ and which requires a specific response. In law, an apology is not an admission of liability. NHS Resolution’s 'Saying sorry' gives guidance on how to apologise and its animation explains the differences between the general and statutory duties.
NHS Resolution’s thematic review of clinical negligence claims involving diabetes and lower limb complications
The review comprises a thematic analysis of 92 compensation claims (settled since 2018/19 with an incident date on or after 2012/13, but before the Covid-19 pandemic), involving patients with progressive diabetes-related lower-limb complications. In 55 cases the claimant underwent a major lower-limb amputation. The report identifies key time points during the patient journey and makes recommendations around improved system oversight, clearer national guidance and improved education. It reveals that “standardised care and better education could prevent diabetic patients from undergoing amputations, preserve wellbeing and save the NHS money”.
What this means for you: The report makes seven recommendations to improve patient care nationally and locally. They span education and training, pathways, biomechanics, commissioning, public health, leadership and workforce and participation in audits. The report and its recommendations warrant closer examination from a clinical and medico-legal perspective. NHS Resolution will continue to work with stakeholders to help implement the suggested recommendations. Read our insight on the thematic review.
Analysis of anaesthesia claims shows low likelihood of claims, but potential for significant harm
A joint review by NHS Resolution and the Association of Anaesthetists of 1230 anaesthetic claims for the period 2008-2018, categorised them by incident type, severity and cost and compared them with a similar published analysis spanning 1995-2007. While the annual number of claims increased by 62%, anaesthesia now accounts for a smaller proportion of all claims submitted to NHS Resolution and a smaller proportion of the total cost than in the previous period. The overall risk of litigation was found to be low. The most common clinical categories were: regional anaesthesia (24%), inadequate anaesthesia (20%) and drug administration (20%). Factors in claims with the highest mean cost included delayed care, planning, monitoring and consent. The review recommends that a structure for national review and learning from all litigation cases is established.
Comment: Although the risk of an anaesthetic claim is low, there is potential for significant harm, for example spinal cord damage from regional anaesthesia. Consent should be fully informed not only for the procedure but for the anaesthetic, including not only the benefits but the material risks of the particular type of anaesthesia. The test of materiality is patient-centric i.e. the consent needs to be tailored to the individual, as what might be material to one patient will not necessarily be material to another.
Remote participation in inquests
A new Chief Coroner guidance note 34 draws together and updates all previous guidance on Covid-19 issues. Arrangements for remote participation in inquests will be of particular interest to clinicians given the pressure of their post-pandemic clinical commitments. The guidance directs coroners to recognise the clinical commitments of both factual and expert medical witnesses in the provision of statements/ reports and attendance at court. Any participant can apply to take part in an inquest remotely. Before deciding whether to hold a partially remote hearing, coroners should give those affected an opportunity to make representations and should consider them alongside the interests of justice. Remote attendance will not normally be permitted purely because a participant would prefer it.
What this means for you: Healthcare organisations faced with a coroner’s witness list which is unmanageable, a short notice request for evidence or who need to request remote participation, should raise the matter with the coroner urgently.
More prosecutions for unsafe care
Two recent fines for failing to provide safe care show that the CQC’s appetite for prosecutions under regulation 12 of the Health and Social Care Regulations 2014 (H&SCR), has not diminished. Following guilty pleas, United Lincolnshire Hospitals NHS Trust (ULHT) was fined £100,000 plus costs for historic breaches of duty and Shrewsbury and Telford Hospital NHS Trust (SaTH) over £1.3 million plus costs. In 2019 an elderly patient sustained spinal injuries and a cut to her head after a fall at ULHT while unsupervised. During assessment she was placed against exposed radiator pipes and suffered burns. She contracted pneumonia and died shortly afterwards. The SaTH prosecution involved two patients: one bled to death during dialysis treatment in 2019 and the other died in 2020 when he became trapped in a bariatric bed.
What this means for you: CQC prosecutions are increasing and so are the financial penalties. A CQC investigation may be prompted by inspections, inquests, complaints or notifications to the CQC. The best outcome is where harm can be avoided in the first place by having effective systems in place to deliver safe care, including the use of appropriate care pathways, staffing levels and skill mix on units. It is also important to appreciate the inter-relationship between regulation 12 and regulation 20 H&SCR – the duty of candour. Investigation of serious incidents and being candid are integral to the provision of safe care and learning to prevent future harm. In the event of investigation by the CQC, providers have the opportunity of influencing the decision to prosecute by demonstrating a positive track record on safety and strong leadership and governance arrangements.
Draft Mental Capacity Act code of practice and implementation of the Liberty Protection Safeguards
A consultation has been launched, seeking views on a new code to be introduced as part of the implementation of the Liberty Protection Safeguards (LPS) which will replace the current Deprivation of Liberty Safeguards (DoLS). The LPS (which will apply to 16 and 17 year olds) retain the core purpose of DoLS and reflect learning from them in real life and environment. There are changes to process and a re-focus on the patient with more emphasis on their wishes and feelings throughout. Executive functioning and difficulties assessing capacity are addressed specifically. There is new guidance around recording best interests’ decisions and the role of advance statements in best interests’ analysis. The consultation closed on 7 July 2022. It seems unlikely that the code and LPS will come into force before Spring 2023 at the earliest.
What this means for you: Healthcare organisations need to be clear as to the decision-making framework they are using when looking after 16 and 17 year olds - the Children Act 1989, Mental Health Act 1983 or Mental Capacity Act 2005. Difficulties in assessing capacity, particularly in the context of impairment of executive functioning, have been a concern for treating clinicians, as has the role of advance statements in best interests’ analysis. The guidance on these issues should provide welcome reassurance for clinicians, while guidance around recording best interests’ decisions will hopefully ensure that all considerations are included.
Trust succeeds in defending data protection claim arising from unauthorised acts of third party
In Underwood and another v Bounty UK Ltd and Hampshire Hospitals NHS Foundation Trust  EWHC 888 (QB), the High Court dismissed a claim for breach of the Data Protection Act 1998 and misuse of private information brought against the Trust arising from a Bounty worker accessing records in the Trust’s hospital without authorisation.
Bounty’s business model was to invite new parents to agree to supply their personal information in exchange for sample packs of baby supplies or photographs. Bounty then supplied the information its representatives had gathered to other businesses for marketing.
To gain access to patients, Bounty entered into contracts with NHS hospitals. When going about their business, Bounty were not permitted to access Trust systems and were required to comply with data protection law. Mrs Underwood gave birth at the Trust in October 2017. Whilst she was in hospital, a Bounty representative appeared at her bedside and seemed to be looking at some records stored in a holder at the end of her bed. The representative was asked to leave, and Mrs Underwood did not agree to share any information with Bounty in that interaction. Subsequently she discovered that Bounty held data about her family, including her child’s name, gender and date of birth.
Mrs Underwood brought a claim against Bounty and the Trust concerning the unauthorised access to her family’s personal data at her bedside. She alleged that this was a misuse of private information and that the Trust had failed to take appropriate technical and organisational measures to prevent unauthorised access, in breach of data protection requirements. The claim against the Trust went to trial. The court found the Trust not liable for the acts of the Bounty representative. The Trust making documents accessible at the bedside to its staff for patient care was not the same as it making those documents freely available to the Bounty representative working in the hospital.
What this means for you: The case illustrates the importance of putting in place appropriate access arrangements with third parties who work on NHS premises, and being able to justify how, why, and where patient information is stored and made available. Read our insight on the case for more detail.
Litigation reform might target NHS clinical negligence and lower value claims
Two separate reforms of the current system have been proposed. Firstly, the Health & Social Care Committee (HSCC) has called for radical reform of NHS clinical negligence litigation. Key proposals from the Committee’s report include:
- An independent administrative body to investigate cases and determine compensation.
- Access to compensation is to be based on agreement that correct procedures were not being followed/ system failure, rather than the current Bolam test.
- All compensation to be based on the costs necessary to top up NHS care.
- Future earnings link to parental earnings for under 18s to be replaced with the national average wage.
- Patients will not be prevented from litigating, but they would have to go through the new administrative body as a mandatory first step.
- Prevention of future harm will be at the core of the new system.
Secondly, the government has consulted on a proposed scheme of fixed recoverable costs for clinical negligence claims of up to £25,000. The aim is to achieve faster resolution of these ‘lower value’ claims, at a more proportionate and lower cost than under the current system. The proposals include a new streamlined process for claims – a ‘light track’ where breach of duty is admitted or there have been other adverse findings (e.g. in a serious incident investigation or an inquest) and a standard track.
Comment: The government has not yet responded to the HSCC report. The likely cost of such a system and how to deal with the thorny issue of causation will be a significant hurdle to cross. The FRC proposals have been subject to a consultation. The suggestion regarding serious incident and inquest findings will have caused concern for healthcare organisations as both are fact finding investigations rather than designed to attribute blame. The government’s response to the consultation is awaited.