Clinical Law Insight: Autumn 202222/11/22
Author: Cheryl Blundell, Consultant at Capsticks
Latest on the Covid-19 Public Inquiry
Module 3 which spans the impact on health systems of Covid-19 and of government and societal responses to it (patients, hospitals and other healthcare workers and staff), opened on 8 November 2022. There are twelve key areas for investigation including:
- core decision-making and leadership
- staffing levels and critical care capacity (including the establishment and use of Nightingale hospitals)
- the prevention of the spread of Covid-19 within healthcare settings (including infection control and the adequacy of PPE)
- communication with patients with Covid-19 and their loved ones about treatment – including discussions about Do not attempt cardiopulmonary resuscitation (DNACPRs)
- shielding and its impact on the clinically vulnerable
- the long-term effects of Covid-19, including Long Covid.
The application process to become a Core Participant for Module 3 has opened and will close on 5 December at 5pm.
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. Most healthcare organisations will have started their preparations already, but for those who haven’t there is still some time as no dates have been set for the module 3 preliminary hearings.
We suggest preparation 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 on what you can expect from module 3.
SAFETY AND LEARNING
NHS Resolution publishes second report on the Early Notification scheme
The Early Notification (EN) scheme has been running since 1 April 2017 and requires NHS Trusts in England to report all births which meet the qualifying criteria to be considered for clinical and, where necessary, legal investigation. The scheme has evolved such that only birth outcomes resulting in brain injury are investigated. As of March 2022, 439 birth incidents over the past five years were identified as having met the criteria.
The report analyses 20 Early Notification (EN) matters reported between 2017 and 2020, where liability was admitted in full.
- 50% of infants in the cohort have either a diagnosis of cerebral palsy or evidence of the condition emerging.
- 40% of infants sadly died within the first two years from injuries related to severe hypoxic brain injury.
- 70% of babies were born by category 1 caesarean section. 14% involved impacted fetal head (IFH).
- 90% of incidents involved problems with fetal heart rate (FHR) monitoring.
The report identifies 11 factors affecting neonatal outcome, the most frequent being problems with fetal monitoring (62 cases), delay in birth (60), infection in labour (13) and reduced fetal movements (11). Two themes are analysed in detail: delayed delivery and uterine rupture in women opting for vaginal birth after caesarean section (VBAC).
Three recommendations are made, all with a systems level focus. They all involve NHS Resolution supporting the work of stakeholders to improve:
- antenatal counselling before trial of VBAC
- awareness in relation to response to harm for families and staff
- working relationships by encouraging a joined up approach between trust legal services and maternity and risk teams.
What this means for you
The EN scheme is clearly demonstrating the value of early investigation to reduce the potential for future harm. It is a key part of NHS Resolution’s strategic shift to move ‘closer to the incident’ and is a contributor to the National Maternity Safety Ambition to achieve a 50% reduction in stillbirth, maternal and neonatal mortality and serious brain injury from the 2010 rate by 2025.
While the recommendations span a number of stakeholders, including royal colleges, NHS Trusts should review their policies, guidelines and training on recognition and management of IFH, FHR monitoring, ante-natal counselling before trial of VBAC, and response to harm (see NHS Resolution’s 'Duty of candour', 'Saying sorry' and 'Being fair'). Joint working by trust legal services, maternity and risk teams and the triangulation of incidents complaints and claims is key to patient safety and learning to prevent future harm.
For further information read our insight on the report.
The report of the independent investigation into maternity and neonatal services in East Kent – a new approach to safety and learning
The investigation involved maternity services at two East Kent Hospitals University NHS Foundation Trust: Queen Elizabeth, The Queen Mother Hospital, Margate and William Harvey Hospital, Ashford, between 2009 and 2020. A ‘clear pattern’ was found: suboptimal clinical care leading to significant harm; failure to listen to families; and acting in ways which made families’ experiences ‘unacceptably and distressingly poor’.
Had care been given to the nationally recognised standards, the outcome could have been different in 48% of cases assessed and in 69% of cases involving the sad death of a baby. In c.75% of all cases considered there was some degree of suboptimal care.
The report identifies four areas for action:
- Flawed team working – pulling in different directions
There needs to be a stronger basis for team working in maternity and neonatal services.
- Monitoring safe performance – finding signals among noise
In essence, this involves better identification of poorly performing units.
- Standards of clinical behavior – technical care is not enough
More needs to be done to ensure that care is given with compassion and kindness.
- Organisational behaviour – looking good while doing badly
Challenges should be responded to with honesty, rather than thinking first of managing the organisation’s reputation. Previous attempts to encourage organisations to change behaviour have not worked.
- the introduction of valid, mandatory national maternity and neonatal outcome measures
- embedding compassionate care into lifelong learning
- introduction of nationally agreed standards of professional behaviour (with sanctions)
- improvements in team working
- a new duty on public bodies not to deny, deflect or conceal information from families and other bodies
- consideration of how trusts manage reputation; and how NHSE deals with poorly performing trusts particularly regarding leadership.
What this means for you
The 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 by all staff
- the appropriateness of serious incident 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.
Further information can be found in our insight on the report.
Roll-out of the new Patient Safety Incident Response Framework (PSRIF)
It has been reported that the implementation date for the new system has been put back by NHSE from March to September 2023. It is understood that providers have been advised that they will still be required to adopt a ‘test system’ by the original deadline and to go live within six months.
The PSIRF replaces the 2015 Serious Incident Framework (SIF) and governs the investigation of patient safety incidents in NHS-funded healthcare. It represents a ‘sea change’ in how the NHS responds to patient safety incidents (PSIs), to achieve learning and improvement.
What this means for you
The PSIRF requires organisations to use a planning exercise to inform what their proportionate response to PSIs should be. As the PSIRF approach is flexible it will adapt as organisations learn and improve. There is plenty of guidance accompanying the PSIRF, including a helpful preparation guide which sets out suggested tasks and timeframes.
Healthcare organisations will need to review their current PSI profile plus their policies, procedures and plans. In addition, they will need to commence the PSI response planning exercise and plan recruitment, training and skills development.
Further information on the PSIRF and suggestions on how to prepare can be found in our insight.
Prison sentence following a finding of fundamental dishonesty in public liability claim
Rita Twist-Wilson received a four month immediate custodial sentence for attempting to defraud the NHS of over £500,000 and was ordered to pay £44,000 in costs. She was found to have exaggerated the effect of injuries to her leg after she fell down a manhole at the Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust in 2014. It transpired that the Claimant had been severely limited in her abilities prior to the accident, for example she had had a stair-lift fitted at home, but subsequently claimed for it.
The courts continue to take a robust approach to attempts to defraud, supporting the NHS to protect funds which could and should be used for NHS services. Read NHS Resolution’s statement on the case.
Supreme Court hearing in Paul secondary victim’s case
The Claimants’ appeal in Paul & Paul v Royal Wolverhampton NHS Trust (2022) has been listed for hearing on 16 May 2023. In January 2022, the Court of Appeal determined that there was insufficient proximity between the late Mr Paul’s negligent cardiac treatment and his death from a heart attack witnessed by his daughters 14 months later, for their claims to succeed.
Given Underhill LJ’s obiter comment that “if the point were free from authority I would be minded to hold that, on the pleaded facts, the Claimants…should be entitled to recover”, it will be interesting to see how the Supreme Court approaches the appeal.
GIRFT and NHS Resolution: new range of guidance for best practice documentation
The guides have been produced in conjunction with the Royal College of Surgeons, the Association of Surgeons of Great Britain and Northern Ireland and the British Association of Endocrine and Thyroid Surgeons. They cover laparoscopic appendicectomy, laparoscopic cholecystectomy, open and laparoscopic inguinal hernia repair, laparotomy and laparoscopic bowel resection surgery and thyroidectomy and include case studies to illustrate the importance and impact of improving documentation.
Clear documentation of procedures helps provide optimum care and crucially supports continuity of care – handover being a time of particular risk in the continuum of care. When things go wrong documentation is a key element of incident investigation and is often crucial to defending a claim.
Remote participation in inquests
Chief Coroner’s guidance note 42 makes it clear that there is no entitlement for a participant or observer to attend an inquest remotely. If remote attendance is required, an application needs to be made to the coroner. The guidance note also confirms the power of a coroner to hold an inquest in writing.
Guidance note 34 (paragraph 24) directs coroners to recognise the clinical commitments of both factual and expert medical witnesses in the provision of statements/ reports and attendance at court.
We are aware that in some cases large numbers of clinicians are being warned to attend inquests and notified late when they are not needed. This has an adverse effect on the delivery of patient care as clinics may need to be cancelled and cannot be reinstated at short notice.
Paragraph 21 of guidance note 42 describes the balancing of the interests of justice and the interests of participants. The former will prevail, but there is a tension between the two guidance notes, which participants should be aware of.
Further information on the impact of guidance note 42 can be found in our insight.
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.
Supreme Court hearing in Maguire article 2 deprivation of liberty case
The Supreme Court will hear the Applicant’s appeal on 22 November 2022.
Jackie Maguire, an adult with Down’s syndrome and moderate learning difficulties lived in a care home under a Mental Capacity Act 2005 Schedule A1 standard authorization. Sadly, she died in hospital as a result of a perforated gastric ulcer, peritonitis and pneumonia, having fallen ill some days before her death. Failures were identified in the response of the care home, GPs, NHS111 and paramedics.
In June 2020 the Court of Appeal determined that obligations under article 2 of the European Convention on Human Rights were not triggered by the mere fact of Ms Maguire’s vulnerability and deprivation of liberty (DoL). There was no systemic or structural failure in the medical services provided to her.
The crucial distinction in determining whether article 2 is engaged is between a breach of duty which is a systemic error and one which is due to ‘ordinary’ clinical negligence. In some cases there will be an element of both and the risk of an article 2 inquiry remains. The position in Maguire where the DoL was pursuant to MCA authorisation, should be contrasted with that where the deceased is under a DoL due to state detention (e.g. under the Mental Health Act 1983). In the latter scenario an article 2 inquest will always be required.
Prosecution for failing to provide safe care in the context of safeguarding
An NHS Trust has been fined £200,000 and over £33,000 costs and victim surcharge for historic failures to provide safe care in the case of four children and other unnamed service users. In each child’s case it was considered that safeguarding concerns should have been raised due to the possibility of non-accidental injury.
Evidence revealed that whilst no actual harm was caused, the Trust did not have effective reporting systems and processes nor up to date policies to keep people safe or make sure staff were fully aware of them. In addition, the Trust failed in ensuring all staff had relevant training.
What this means for you
Care Quality Commission (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/the risk of 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 (safe care) and regulation 20 Health and Social Care Regulations – 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.
Freedom to speak up (FTSU) - work remains to be done
A National Guardian’s Office (NGO) survey has revealed that only 70% of FTSU guardians consider that senior leaders supported workers to speak up. Previously the figure had been 80%. The 2022 results were the first drop since the survey began in 2017.
National Guardian Jayne Chidgey-Clark is reported as saying that the result is an ‘early warning sign’ and that there is ‘still much to do’ to embed speaking up across the NHS.
Once funding is secured the NGO’s remit will extend to adult social care with pilots in 2023.
What this means for you
FTSU is closely connected to the duty of candour in terms of building a culture of openness and transparency. Healthcare organisations need to ensure that FTSU is firmly embedded in their policies, procedures and culture.
Roll-out of virtual wards gathers pace
NHS England (NHSE) has a target of 400 virtual beds per 100,000 population by December 2023.
The original focus was on respiratory teams managing Covid-19 patients, but future roll-out is likely to encompass frailty, palliative medicine and maternity. In respiratory – further roll outs to chronic obstructive pulmonary disease (COPD), asthma, pulmonary rehabilitation and smoking look likely, with the end point being coverage of all acute respiratory chest infection.
A number of other opportunities have been identified for the longer term, for example post-surgical cases and monitoring the use of IV antibiotics.
What this means for you
Any trust rolling-out virtual wards will need to keep in mind a number of risk issues and devise ways to manage them. Patient selection / suitability will be important. The initial patient assessment will be crucial, not only for information gathered but the accuracy of the record created. Issues around the dashboard used to manage patients will need to be considered. Any malfunction is likely to be a product liability issue for the software manufacturer / supplier.
Nevertheless, the indemnity position between the NHS and manufacturers / suppliers will need to be fully understood and managed. Clinical pathways will need review to ensure they are up to date. Training and competency assessment will be important, particularly if there is any element of clinical judgment when the dashboard flags something unexpected. Onward referrals must be appropriate and timely which means that resourcing and skill mix in the wider team should be kept under review.