Early involvement of the NHS Litigation Authority (NHS LA) and its lawyers in the coronial process, on behalf of the NHS, makes a difference to patient safety. Evidence shows the NHS learns from mistakes and implements changes to improve patient safety.
The Coroners (Inquests) Rules 2013 came into force on 25 July 2013. The NHS LA introduced an inquest funding protocol in April 2013. For the first time the NHS LA’s protocol provides for a financial contribution to a trust’s inquest costs, subject to the inquest satisfying certain criteria.
The protocol provides NHS LA involvement in the conduct of an inquest and, with it, a unified and consistent approach between the management of an inquest and a potential civil claim investigation. The two processes run in tandem and are conducted by NHS LA panel solicitors.
This has, in our view, led to some significant improvements as:
- The same NHS LA claims handler and panel lawyer have conduct of the inquest and management of any civil claim.
- The pre-inquest meetings ensure NHS staff are supported and allow panel lawyers to form an early risk assessment of any potential civil claim.
- Early admissions of liability are made and letters of apology provided, often before the inquest has commenced. This is consistent with the principle of a transparent health service both in service delivery and conduct of incident investigations.
- Early admissions of liability and apologies remove the adversarial nature of the litigation process and take the ‘heat’ out of inquests as families have their questions answered.
- The two processes running in tandem leads to real legal costs savings for both parties.
- The prospect of a Regulation 28 report has led to genuine changes in the delivery of healthcare services which makes a difference to patient safety.
We have set out below three anonymised case studies which we consider reflect genuine improvements in patient safety as a direct consequence of the NHS LA’s involvement in the coronial process.
In case studies A and B changes were made which improved patient care and safety to prevent similar incidents recurring. The trusts in these case studies avoided Regulation 28 reports. In case study C, the changes proposed had not gone far enough, despite the Head of Midwifery giving evidence at the inquest. The trust was, however, forced to address the issues following the Coroner issuing a Regulation 28 report.
Why do we not achieve the same changes in process or systems in civil claims as we do with our involvement in the coronial process? We believe the answer is multifactorial:
- An inquest is investigated directly with the staff involved in the death, who are still employed by the trust and recall the incident. Contrast this with a civil claim, which may not be notified to the trust and the NHS LA until two years after the incident. The investigations may subsequently be taking place three years after the incident. By this stage staff have moved on, memories faded, clinical leaders have changed and medical practice already evolved.
- The coroner calls ‘relevant’ witnesses. This produces staff engagement. They have no option but to attend. Those involved in the death must provide a written witness statement. The coroner will serve a witness summons for those witnesses they wish to attend the inquest. Contrast this to a civil claim investigated three years later where the NHS employee can no longer be traced or, if found, chooses not to cooperate. This is less than ideal.
- The threat of a Regulation 28 report attracts the attention of the trust’s clinical directors and sometimes the chief executive. This allows the NHS LA’s panel lawyers to challenge clinical leaders on current clinical practice which is the subject of the inquest and request they focus their minds on providing solutions to avoid future deaths. Pressing the clinical directors to identify improvements in their areas of clinical practice, improving the teaching/training of staff and redrafting protocols to avoid Regulation 28 reports has led to identifiable and measurable improvements in patient safety.
Working with the NHS LA to represent its members at inquests is extremely satisfying, particularly as we have assisted/supported clinical leaders to improve clinical practice to avoid future deaths and improve patient safety.
The NHS LA should be congratulated for the introduction of its inquest funding protocol. Trust participation at an inquest must be an opportunity to genuinely reflect on the cause of death and ensure any practices that may lead to future deaths are improved. May the NHS LA’s members continue to learn and improve their patient safety as a result of the NHS LA’s involvement in the coronial process.
Case Study A: emergency admission
The deceased attended the Trust’s accident and emergency (A&E) department on 18 June 2012 via an emergency ambulance at 00:32 following assessment by an emergency GP. He was complaining of severe and constant abdominal pain since 08:00 on 17 June 2012. He was assessed by a foundation year 2 doctor at 03:00. An initial differential diagnosis of intestinal obstruction or mesenteric infarction was made. A full blood count and serum amylase analysis was undertaken and found to be normal. X-rays of chest and abdomen were also normal.
The foundation year 2 doctor requested a review by the surgical team. The surgical registrar would not attend in person as the deceased did not require surgical intervention if x-rays and blood tests were normal. Despite repeated requests guidance was given by telephone only, without the benefit of a physical examination.
The locum specialist registrar in A&E elected to keep the deceased in hospital overnight. The deceased was discharged the following morning with a diagnosis of chronic constipation.
The deceased was admitted as an emergency to another hospital. Emergency surgery was undertaken two days later on 21 June 2012 where removal of the deceased’s infected gallbladder took place. The deceased sadly died the following day.
The post-mortem report confirmed the cause of death as:
- a) Sepsis with multi-organ failure.
b) Acute cholecystitis with gangrenous gallbladder (operated).
- Diabetes mellitus.
The pathologist stated in his report that earlier surgical intervention may have resulted in a different outcome, as sepsis and necrosis of the gallbladder progressed over the three days prior to surgery, reflected in the deteriorating clinical condition of the deceased. He considered haemorrhage following the surgery contributed to the shock and subsequent multi-organ failure.
Inquest funding was granted by the NHS LA, pursuant to its inquest funding protocol. We were instructed and independent expert evidence was obtained from a consultant in emergency medicine on breach of duty and consultant surgeon on causation. Both experts were highly critical of the surgical registrar’s failure to attend to assess the deceased in person when called to do so by the A&E doctor. The deceased should not have been discharged.
Evidence was submitted to the coroner from the Divisional Director of Surgery that the Trust’s standard practice whenever a referring doctor requested a surgical opinion is for the specialist doctor to see the patient in person and make a decision on management based on the history and physical examination. He was concerned there may be a perception that clinical decisions can be made over the telephone and the following was implemented with immediate effect:
- A document was sent to all junior doctors and their consultants emphasising their obligation to assess personally each referral. Each doctor was required to sign and return the document to confirm acknowledgment.
- The junior doctors’ handbook was to be rewritten to emphasise obligations of referring doctors and the need to assess the patient personally.
- A new process was introduced that every referral made, whether for assessment or advice, will be discussed with the supervising consultant.
- It was reconfirmed to A&E colleagues that should they request a surgical opinion this will be provided in person by a clinician with suitable training and experience.
It was further agreed that to avoid a Regulation 28 report the Trust would notify the Senior Coroner within 56 days (the same time period as responding to a Regulation 28 report) that the above had been implemented.
The action taken by the Trust shows it took on board the criticism of the experts instructed, pursuant to the inquest funding protocol, and agreed to put in place measures to improve patient safety and remove any potential misconception. This action also persuaded the Coroner and a Regulation 28 report was avoided.
Incidentally, admissions were made to the deceased’s family at the time of the inquest, a letter of apology provided by the Trust’s Chief Executive and the claim settled within six weeks of the inquest.
Case Study B: premature baby
The deceased was delivered by emergency caesarean section on 7 May 2012 at 28 weeks and three days and was the second of twins. She was admitted to the special care baby unit for prematurity, respiratory distress, jaundice, suspected sepsis and intrauterine growth retardation.
Her observations over the next 10 days were within normal limits for her gestational age.
At 03:45 on 16 May 2012 the deceased had a sudden apnoeic episode. She was suctioned with emergency resuscitation, intubated and ventilated but her heart rate dropped to 58 beats per minute at 04:55 and cardiac compression recommenced. She sadly died at 06:00.
The post-mortem confirmed the cause of death as cardiac tamponade due to total parental nutrition (TPN) fluid in the pericardial cavity.
Even though cardiac tamponade is a recognised complication of central venous catheterisation it appears the catheter was placed too far into the deceased’s body. It was placed above the diaphragm and into the right atrium, which is substandard management. In addition the 28 gauge long line was inappropriate for a 905g premature baby.
There was a general failure by junior doctors to appreciate the positioning of the central line tips.
Inquest funding was granted by the NHS LA, pursuant to its inquest funding protocol and we were instructed. Breach of duty and causation were admitted before the inquest and the civil claim settled. The Coroner had to be satisfied during the inquest that there was no risk of future deaths so the Trust could avoid a Regulation 28 report. We worked closely with the Trust to change clinical practice to ensure this did not reoccur. Oral evidence was given, at the inquest, by one of the lead consultant paediatrician neonatologists at the Trust, confirming the following changes to Trust procedure had been made as a consequence of this death:
- Training to all medical staff in identifying optimal positioning of long lines in premature infants.
- Practical guidance published on the desired tip position of the long line.
- Consultant paediatricians to check all x-rays during ward rounds to ensure the long line location and document this in patients’ clinical notes. This now takes place before TPN is commenced.
- Mobile laptops used during ward rounds to facilitate viewing of the x-rays showing the position of the long line.
- Registrars expected to insert all long lines with senior house officers inserting under direct supervision of a registrar or consultant.
- Audit to be undertaken to ensure compliance with new guidelines.
- On ward neonatal care from the same consultant from Monday to Friday to improve the continuity of care and supervision of junior doctors.
- Two week induction introduced to all doctors commencing work in the neonatal unit which will include guidelines on insertion of lines.
The Coroner was provided in advance of the inquest revised guidelines and a pro forma audit form.
Whilst the changes made are little consolation to the grieving family, the extensive changes made in the management of TPN lines reinforces the fact the Trust genuinely learnt lessons and improved patient care and safety. The early admissions of liability and early settlement saved further anguish to the family but also saved significant costs to both parties and the NHS.
Case Study C: antenatal care
An expectant mother had an estimated date of delivery of 2 June 2013. The mother had decided her antenatal care would be managed by Trust 1 but her delivery would take place at Trust 2.
The mother had numerous antenatal appointments with community midwives employed by Trust 1. As she would be delivering at Trust 2, the normal arrangements were for Trust 1 midwives to use the antenatal notes of Trust 2.
On 10 June 2013 the mother attended Trust 2 following spontaneous rupture of membranes. A decision was made to perform an emergency caesarean section following concerns as to the baby’s well-being. The baby was delivered with the cord wrapped around its neck. Despite attempts to resuscitate, the baby was pronounced dead.
Trust 1 was granted inquest funding by the NHS LA pursuant to the inquest funding protocol. We were instructed and it soon became clear that unfortunately Trust 1 midwives were not adequately trained in using Trust 2 antenatal records. Trust 1 midwives failed to:
- Record fundal height during the antenatal period.
- Plot the fundal height on the customised growth chart.
Had this been done it would have been identified that the baby was small for dates and prompted referral to Trust 2, which would have led to a decision to deliver earlier. The evidence before the Coroner was that this would not have altered the outcome.
Trust 1’s Head of Midwifery confirmed to the Coroner at the inquest that Trust 1 community midwives had been retrained to record the fundal height and plot it on a customised growth chart using Trust 2’s antenatal records. Despite our advice no improvements had been made in the way the shared services between the two trusts were delivered. In particular, the two trusts’ heads of midwifery failed to meet to agree a unified approach to shared services. The Coroner issued Trust 1 with a Regulation 28 report as he was concerned the current lack of consistent arrangements with Trust 1 in managing antenatal care could lead to future deaths.
Despite our best efforts a Regulation 28 report could not be avoided. Trust 1 had not taken on board concerns we had highlighted in the provision of shared antenatal/maternity services. Accordingly, the issue came before Trust 1’s Chief Executive following the Coroner issuing a Regulation 28 report and solutions had to be found with the Chief Executive having to respond within a 56 day period. We hope the issuing of a Regulation 28 report has led to improvement in the shared services between the two trusts.
Whilst admissions have been made in respect of breach of duty in the civil claim, the evidence obtained confirms that even with alternative management the outcome would have been the same. Accordingly, causation has been denied.