1. Spire Norwich Hospital called the ambulance service on 6 August 2022 at 18.16 hours. The call was coded as a Category 3 call, requiring a response within 2 hours. The Spire Hospital were told the response would be 6 hours.
2. The ambulance service was called again at 23.45 hours and the call was again coded as a Category 3 call.
3. The ambulance service was called again on 7 August 2022 at 07.38 hours and the call was now coded as a Category 2 call, requiring a response within 40 minutes and with an average time of 18 minutes.
4. Due to continuing demand on the ambulance service, an ambulance did not become available until 08.16 hours. The ambulance arrived on scene at 08.26 hours.
5. The time between calling the ambulance service and an ambulance arriving was in excess of 14 hours.
6. Evidence was heard as to the very high call demand overnight on 6th August 2022 and with regard to the significant pressure the healthcare system was and remains under.
7. Evidence was also heard as to the steps being taken by EEAST in an attempt to deal with this pressure on the healthcare system.
8. Despite the steps being taken by the EEAST, considerable delays in attending to calls continue.
9. Spire Norwich Hospital does not deal with multi-disciplinary and emergency treatment at its hospital and transfers patients requiring such treatment to local acute Trusts, usually the Norfolk and Norwich University Hospital.
10. Spire Norwich Hospital continues to rely on EEAST to transport such patients to the acute hospital, being fully aware of the demands placed on the EEAST generally and the delays which occur as a result.
11. At the inquest Spire Norwich Hospital placed great reliance on now being part of an lnterfacility Transfer Group led by the Norfolk and Norwich University Hospital working with the EEAST to look at a pathway in respect of inter hospital transfers. The evidence of EEAST was that this pathway was not expected to reduce delays in inter hospital transfers.
12. This concern has been raised at previous inquest.

This Prevention of Future Deaths report raises similar patient safety concerns about delayed transfers from a Spire Norwich Hospital to Norfolk and Norwich University Hospital NHS Foundation Trust to the two reports below. These three patients covered by these reports all died within a nine-month period.

• Prevention of Future Deaths report: Barbara Hollis (3 October 2022)
• Prevention of Future Deaths report: Christina Ruse (3 October 2022)

There was no carefully documented assessment of risk. There was no carefully devised risk management plan. A decision was made to discharge Allison from the mental health team, with no multi-disciplinary review or liaison with the referrer. Allison continued to receive counselling provided at her school, but this concluded at the end of term, on the 15 July 2022. On the 18 July 2022 Allison was found suspended in her bedroom. The failure to provide basic mental healthcare to Allison contributed to her death.

Matters of Concern

• The Inquest identified multiple failings in the care provided to Allison. The failings occurred within a children and adolescent mental health service which was significantly under resourced.
• The Inquest heard evidence that the under resourcing of CAMHS services is not confined to this local Trust but is a matter of National concern.
• The under resourcing of CAMHS services contributed to delays in Allison being assessed by the mental health team. The delay between triage to assessment was 9 months. The Inquest heard evidence that this delay is not unusual within CAMHS teams across the country.
• There was very little evidence of any consultant psychiatrist leadership within the CAMHS team. The Inquest heard of the difficulties in recruiting suitably qualified psychiatrists to CAMHS teams.
• The Inquest heard that funding for CAMHS teams within the allocation of funding for general mental health is poor.
• The Inquest heard that the number of children presenting to CAMHS teams is increasing significantly. The number of referrals of children to the local CAMHS team in the early 2010s was between 10 – 12 per week. The current number of referrals is in the region of 140 patients per week.
• There is a concern that ongoing under resourcing of CAMHS services (whilst demand continues to increase), will result in future similar deaths.

Tees Esk and Wear Valleys NHS Foundation Trust (TEWV) routinely fails, to employ, in a timely way, nationally recognised process and procedure designed to prevent avoidable death. In permitting delay of “serious incident” investigations, TEWV may: (i) permit lethal hazard to persist for longer than necessary; and (ii) compromise the quality of such investigations and hence their value in preventing avoidable deaths.

The above-mentioned inquest has not been heard; there has been no finding that the present death was attributable to acts or omissions in care.

Although arising in the present investigation, the matter of concern is general and has arisen in the context of other investigations. Despite past assurances that the material circumstances have been addressed, the facts of the present case demonstrate that they continue to exist. On 19 July 2023, Assistant Coroner Janine Richards notified TEWV of the same concern arising from matters revealed by another investigation.

TEWV identified Ian Darwin’s death as a serious incident (SI) for the purposes of The Serious Incident Framework (the Framework). The SI investigation (SII) process, defined in the Framework, was the means employed by TEWV to investigate this SI.

The Framework defines SIs as “events where the potential for learning is so great, or the consequences to patients… so significant that they warrant particular attention to ensure these incidents… are investigated thoroughly… and trigger actions that will prevent them from happening again”. SIs “include acts or omissions in care that result in… avoidable death…”. Further, the “occurrence of a serious incident demonstrates weaknesses in a system or process that need to be addressed to prevent future incidents leading to avoidable death or serious harm”. SI investigations are the means “to ensure that weaknesses in a system are identified, to understand what went wrong … and what can be done to prevent similar incidents happening again”.

Discussing one of the seven key principles of the SI Investigation - that they be Timely and Responsive - the Framework requires that SIs “must be reported without delay and no longer than 2 working days after the incident is identified”. One of “two key operational changes” introduced in the 2015 update was a single timeframe of 60 working days (from date of initial report) for completion of investigation reports. At an “early meeting” the investigator must “set out a realistic and achievable timescales and outcomes”.

The present case:

• Death occurred on 06.03.23;
• Coroner informed that an investigator was initially appointed in around mid-June 2023;
•  By late June, TEWV were “unable to say” when the investigation would be complete;
• The investigation is now expected to be complete in the week commencing 21.08.23 and its report to be finalised 18.09.23.

The general situation:

• TEWV SI death investigations, at all levels of seriousness, are routinely (if not invariably) significantly delayed and the coroner understands there is no expectation of immediate, or any timetable for eventual rectification.
• In some other cases delay is significantly longer than in the present.
• Such delays affect cases of all levels of seriousness.

1. The Inquest was held one year after Bethan Naomi Harris's death. During the course of the oral evidence it emerged that several, in my mind important, learning issues had not been addressed.
2. There were issues relating to handover of patients to midwives and at the time of Inquest there had been no further specific training in relation to handover. Indeed it was stated that the process in place at the time of Bethan's delivery still pertained without alteration. This represented a risk to patients.
3. At the time of Inquest a team debrief, which I consider to be a source of learning to reduce the risk of serious incident in future was still outstanding.
4. There was little evidence from the oral evidence given that any effective reflection, reflective discussions or learning had taken place subsequent to Bethan's birth and then death. I consider it important that organisations seek to ensure individual and collective reflection to seek to avoid repetition. The evidence for this, one year on, was lacking. 

St George's University Hospitals response.

During the course of the inquest, the evidence revealed matters giving rise to concern. In the coroner's opinion, there is a risk that future deaths will occur unless action is taken.

Matters of Concern

1. When Ms Findlay ran off, the HCA escorting her was so panicked that she did not even think of following. Ms Findlay had run across a road and so chasing her at speed did present safety considerations. However, the ELFT policy, training, culture and expectation was such, that there the HCA did not at any point consider attempting to walk after her to keep her in sight. Clinical staff must be adequately prepared for such an eventuality. That means more than simply a change in policy wording.

2. By the time the HCA rang the duty senior nurse for advice Ms Findlay was out of sight, and so the HCA was instructed to return to the ward. Evidence heard that an email is to be sent out shortly to explain that a new ELFT absent without leave policy will be in place by the end of June 2023. The new policy will confirm that, if it is safe to do so an escort may follow a patient who has absconded, keeping them in line of sight whilst ringing the duty senior nurse for instructions.

However, there is no ELFT policy for what those instructions should be or even what they could include. No member of ELFT gave evidence of any organisational thought having gone into how then to progress such a situation, other than the ward calling the police to report a missing person. No member of ELFT giving evidence was able to set out what the staff member following should do. This appears to be a significant omission.

3. One of the MPS policy leads in this area gave evidence that in such a situation the police would not necessarily attend, even if called direct by a hospital staff member in the street following a patient about whom they are worried. The impression gave was that a clinician calling the police in what the clinician perceived to be an emergency situation might not be assisted by the police. 

4. Right Care, Right Person is an operational model developed by Humberside Police that changes the way the emergency services respond to calls involving concerns about mental health. It is in the process of being rolled out across the UK as part of ongoing work between police forces, health providers and government. The MPS has already created a similar model under the resource and demand team. The protocol is called Affinity. It attempts to target preventable demand from the mental health trusts.

From the evidence heard, it appears the police / health trust partnership working allows each agency to regard such a situation as the other’s responsibility, whilst nobody is on the ground attempting to retrieve a seriously ill patient who is meant to be inside a locked ward for their own safety. Whether this is a matter of policy or practice, the result is the same. If partner agency working is to be effective in caring for this extremely vulnerable cohort of patients, there needs to be crystal clear understanding by all those involved, from the highest policy maker to the most junior member of a team at the sharp end, of how to tackle these difficult situations and exactly who is meant to be doing what.

5. Evidence was given that the police classify a person at high risk as: the risk is immediate and there are substantial grounds for believing immediate risk of self harm.

At the time of reporting to the MPS, trusts should volunteer their own grading of the patient’s risk. The police said that they will not necessarily follow the trust grading, but they regard it as a significant factor and it should form part of the MPS thinking. ELFT witnesses said that if the police did not ask for the trust’s grading then the trust would not offer it.

Until April 2022, the grab pack prepared by ELFT for the MPS in such a situation was printed out and handed to police if and when the police attended the ward. It is now filled out on a portal as part of the reporting procedure. However, it is not clear ow far the grab pack aligns with local policies, whether all useful information (including the trust’s grading of risk) is recorded as a matter of routine, and how far the police and the trust are using the same terminology with the same definitions. It seems that this would benefit from consideration. 

6. ELFT staff said that after Ms Findlay had run off, they still graded her as medium rather than high risk. She had had long term suicidal thoughts, had made previous attempts on her life and, prior to being admitted to hospital on 20 May 2020 had purchased sodium nitrate and had planned to take this to kill herself. However, she had appeared to improve in hospital, and had been granted 15 minutes’ escorted leave twice a day since 1 June without incident.

At one point in her evidence it appeared that the matron, taking the point that by running away Ms Findlay had acted in a manner that was wholly unexpected by the trust, was of the view that Ms Findlay should then have been re-categorised as high risk. However, following re-examination by counsel for ELFT the matron appeared to retract this and to return to her former position that, even after she had run away Ms Findlay was only of medium risk to herself.

It is of course a matter of clinical opinion what risk grading a patient should be given, and no person can see into the future. However,

• the jury found a failure by ELFT to recognise that, by 11 June 2020, Ms Findlay was at imminent risk of suicide by sodium nitrate; and
• any investigation following a death like Heather Findlay’s presents an opportunity for sober and searching reflection.

So it is concerning that an element of positional bias may have influenced the thinking of ELFT staff. When giving evidence at inquest, the ELFT serious incident investigation author was adamant that it was only appropriate for the HCA who called the police on 11 June 2020 after Ms Findlay had run away, to tell the police of a risk of self harm not of a risk of suicide. Her rationale for this was that the last time Ms Findlay had articulated a plan to kill herself, was when she was found in hospital with a ligature round her neck on 28 May 2020.

1. Inquests – recommendations from Prevention of Future Deaths reports.
2. Public inquiries – statutory inquiries established under the Inquiries Act 2005.
3.  Investigations and official reviews – such as those done by the Prisons and Probation Ombudsman or the Independent Office for Police Conduct.

The report argues that there is an urgent need to create a mechanism to ensure proper oversight and follow-up of these important and potentially life-saving recommendations.

National Oversight Mechanism

It calls for the creation of a new independent public body responsible for collating, analysing and following-up on recommendations arising from inquests, inquiries, official reviews and investigations into state-related deaths. This would be:

• Structurally and operationally independent, accountable to Parliament.
• Accountable to bereaved families, by establishing an advisory panel compose of families and community groups.
• Required to produce an annual report on lack of follow-up to recommendations.
• Given powers to highlight concerns about a lack of follow-up to recommendations.
• Given powers to require information from relevant stakeholders.
• Underpinned by standards on combatting discrimination and racism.

• The Consent Form signed by Mr Wilson was a standard pre-printed form. It did not attempt to provide any statistical rating for the risks identified, which would have enabled Mr Wilson to evaluate the risks.
• No attempt was made to interpret or tailor the risk inherent in the procedure in the light of Mr Wilson's extensive medical history and co-morbidities.
• The Consent Form did not refer to the risk of death. The Coroner states that due to this, Mr Wilson was not in a position to make a truly informed procedure to undergo the sigmoidoscopy.
• The Consent Form did not identify the clinicians involved in discussing the decision with him apart from one individual, the latter having obtained the patients signature when he was under the influence of morphine sedation.

Related Reading

• Julie Smith, Informed Consent: what is it? (21 December 2020)
• NHS Resolution, Nadine’s story: Informed consent (the Montgomery case) (6 August 2020)

Evidence was heard to suggest that the prescribing doctor did not reference this side effect at the time of issuing the prescription to Mr Stevenson, since it was not in accord with current advice.

Evidence suggests that prescribing doctors may not be fully aware of this rare side effect, and that patient’s suffering from depression may be more vulnerable to it.

The coroner is concerned that this potential risk has not been given sufficient emphasis and would ask you to consider the appropriateness of reviewing the current guidelines as to the dispensation of the drug to patients by clinicians and increasing the awareness of the side effect in order to monitor and mitigate the risk.

On the 4 December 2021, Sandra called the West Midlands Ambulance Service and told them she was feeling more sleepy, her glucose was high and she had been vomiting. The categorisation of this call was category 3. This meant she was a medical emergency and required an ambulance. However, before an ambulance could be dispatched a clinical review was required by the CV team.

The team was under staffed and had no time limit attached for an assessment. As such, an attempt for an assessment did not take place until 10 hours later. At 12:47 on the 5 December 2023 the decision was made by the team to categorise the ambulance request as a category 2 and dispatch an ambulance. This arrived at Sandra Diane Finches address at 13:08 and she was found to have passed away as a result of ketoacidosis.

The view of clinicians was that had the ambulance been despatched within the accepted time limit for a category 3 ambulance, Sandra Diane Finch would not have died when she did.

Matters of concern

1. That the pathways used by the service to categorise the level of ambulance and ridged and have no capacity for movement away from the path. This led to a type 1 diabetic patient, who was feeling sleepy and with deranged glucose levels, not being classed as a potentially serious situation requiring rapid intervention. Clinical opinion in agreement that this was, but the rigidly of the pathway meant it was categorised incorrectly. 
2. That the use of an assessment team, to asses a category 3 ambulance call, with no time limit for assessments to take place, and no prioritisation system, will lead to further deaths resulting from delays.

•  Shante Turay-Thomas
• Ruben Bousquet
• Celia Marsh

The Coroner states that it seems clear in all these cases, that the only way to improve understanding and prevent or reduce future deaths is to gather information nationally and fund appropriate research.

Coroner’s Matters of Concern

• There is significant goodwill and desire to improve amongst numerous organisations involved in anaphylaxis work. What is lacking is national leadership and funding. In my view, consideration should be given to creating a leadership role and responsibility within NHS England to coordinate a national approach.
• As considered by other coroners before me, it should be mandatory to refer fatal anaphylaxis cases. UK Fatal Anaphylaxis Registry (UKFAR) has indicated that they would be prepared to take on the role of receiving these reports (to avoid duplication for reporting clinicians), with the responsibility to forward the relevant information to other organisations such as the Medicines and Healthcare products Regulatory Agency (MHRA), where appropriate. Whilst my focus is on fatal anaphylaxis, inclusion of non-fatal cases would be a matter for the lead role to consider.
• Gathering data and using this to research and reduce the risk of future deaths requires funding, and this should be reviewed.
• Information sharing amongst the organisations referred to in this report should be straightforward. Confidentiality constraints are important, but not the same in the case of a deceased person as they are for a living person. I believe that a confidential advisory group has already started to consider this matter.
• Consideration of including contact details for the UKFAR in algorithms used by doctors attempting to resuscitate patients – so that there is a clear requirement for referral to UKFAR in the event of an unsuccessful resuscitation. This is currently being considered by the Resuscitation Council UK.

1. Evidence was heard that there was a delay in Mrs Brind being transferred from the ambulance to the Emergency Department of the Queen Elizabeth Hospital as there was no space in the hospital
2. As delays are a reoccurring problem, checks are made by paramedics and Hospital clinicians on patients while they wait in ambulances for transfer into the hospital to assist in prioritising the need for transfer.
3. In the case of Mrs Brind, physiological observations were not undertaken regularly in accordance with East of England Ambulance Service Trust (EEAST) Guidance and when they were taken, her high NEWS2 score was not escalated to the Hospital Ambulance Navigator who assesses priority for beds in the hospital.
4. Further Mrs Brind was not assessed by a senior doctor from the Hospital within an hour, in accordance with Hospital protocol
5. Coroner was satisfied that steps have been taken by both EEAST and the Hospital in respect of these matters and do not make a report in respect of either of these matters
6. Evidence was heard that there are regularly too many patients in the Emergency Department and so ambulances cannot safely transfer patients into the Emergency Department. The EEAST is working with the Hospital (along with other hospitals in the area) to find ways to deal with this problem and methods are in place to try to alleviate the consequences of these delays.
7. However, it was heard that this is a much wider and more complex problem, in that the Hospital is unable to discharge patients who are medically fit to be discharged and they remain occupying much needed beds. This in turn means patients cannot be moved from the Emergency Department into the hospital wards, and patients remain waiting in ambulances. This in turn causes delays in ambulances being returned to normal duty and being able to attend to emergencies in the community.
8. Evidence was heard that at the time of Mrs Brind’s death, approximately 7 ambulances were waiting to transfer patients into the Emergency Department, Queen Elizabeth Hospital. At the time of the inquest, this had risen to 17 ambulances commonly waiting to transfer patients from the ambulance into the Emergency Department.
9. Further at the time of the inquest there were approximately 140 beds at the Queen Elizabeth Hospital occupied by patients who were medically fit to be discharged, but beds could not be found in the community.

When she was readmitted, despite discharge information from the acute hospital stating that she had been treated with VTE prophylaxis and despite Yvonne fulfilling several trigger criteria, a VTE risk assessment was not undertaken in accordance with the detaining authorities’ policy. There was a failure to monitor her condition and make appropriate records or an action and management plan and she did not have further mental capacity assessments. On 19 February 2020 she was again detained and on the morning of 23 February 2020, she had a cardiorespiratory arrest and was resuscitated for a brief period of time before being taken to the emergency department of North Manchester General Hospital. Further attempts at resuscitation proved unsuccessful and she was pronounced dead due to a pulmonary thromboembolism.

The Greater Manchester Mental Health NHS Foundation Trust (GMMH) serious incident investigation failed to establish:

• whether the responsible clinician, junior doctors or nursing staff were aware of the trusts VTE policy and if not, why not.
• if they were aware of it, why was it not complied with.
• whether there was an awareness and compliance with the policy Trust wide.

It also failed to identify, acknowledge or be aware of the death of a patient in 2016 from a VTE at Park House unit.

In their report, the Coroner raised the following matters of concern:

1. There was a lack of appropriate safeguarding review, Senior clinical oversight as well as necessary MDT meetings and actions to be completed.
2. It did not appear that all permanent or locum clinical and nursing staff Trust-wide were aware of the VTE policy and how it should be implemented including initial assessments and reassessments of the risks as well as consequent medical management.
3. There was no regular audit of compliance with the VTE policy.
4. There was no training programme to ensure familiarity and compliance.

A copy of the report was sent to the Chief Coroner.

1. Evidence given at the inquest revealed that there were seven different organisations involved in Hayley’s care all of whom had different systems for recording their clinical notes.
2. The evidence given at the inquest revealed that each of the organisations were reliant on being copied into correspondence or on specific information being shared by others.
3. The evidence at the inquest revealed that communication between those involved in her short life was inadequate and, as each ran separate clinical records systems, they could not access crucial information which could have made a difference ultimately meaning Hayley may not have died when she did.
4. Evidence was given at the inquest that locally some steps have been taken to try to share key data between acute hospitals but there have been significant hurdles which have impeded the process namely, the different information technology systems used, licensing issues for the software, Data Protection requirements, confidentiality and consent issues as well as training and funding.
5. Hayley died following an out of hospital cardiac arrest on Christmas day 2019. If information been shared between different health care organisations particularly crucial information about Hayley’s CTO it is highly likely she would still be alive today.

Jeesal Cawston Park (JCP)

1. Jeesal Akman Care Corporation was the care provider for JCP and closed in 2021. However, Jeesal Holdings Ltd, Jeesal Residential Care Services Ltd (JRCSL)  and possibly other linked companies with the same directors, continue to provide residential care to persons with mental health illness, learning disabilities, complex needs and physical disability. The concerns raised at the inquest could apply to residential care offered by these companies and unless such concerns are addressed there is a risk that future deaths may occur. It is not known if the directors of these companies are directors of other companies providing care for persons with learning and other disabilities.
2. CCTV was shown at the inquest which revealed Ben King had been assaulted in the hours prior to his death and also that 1 to 1 observation was not carried out in accordance with the Observations Policy. CCTV is a reliable means of ensuring that staff comply with Policies and residents are treated with dignity. CCTV is not available in many if not all of the residential homes owned by JHL and JRCSL.
3. Basic dietary advice and guidance provided was not followed by staff.
4. The use of the Dietician in training of staff was reduced in 2017 from one day’s training to an hour’s power point presentation.
5. Important records were not completed by staff, eg Food intake, Exercise, Weight and vital observations.
6. Evidence was heard that exercise was not regularly offered to Ben King and when the Sports Instructor was absent for lengthy periods of time, there was no replacement
7. Multi-Disciplinary Team (MDT) Meetings were not held every 4 to 6 weeks as required. At MDT meetings which did take place, out of date weight measurements were recorded and relied upon for Ben. His increasing weight gain was not discussed at these meetings and weight loss was not set as a desirable or essential goal.
8. JCP used the Pandora software system, (company Directors for Pandora are the same as for JHL and JRCSL) which is still used at the residential homes owned by JHL and JRCSL. Concerns were raised at the inquest in respect of this software system in that not all policies and documents were available to staff on the IPads provided, some of the documents were unwieldy and difficult to read (for example, Personal Healthcare Plan), the Dietician recommended use of paper records in respect of Food and Fluid intake as these would be more accessible to staff and encourage the documents to be completed or in the alternative providing for the records on Ipads to be more easy to access and complete.
9. The internal investigation carried out following Mr Ben King’s death did not capture the concerns raised at inquest.
10. Evidence was heard that no substantive changes have been made at the residential homes owned by JHL and JRCSL following the death of Ben King and the closure of JCP to deal with these concerns.

Norfolk and Norwich University Hospital (NNUH)

1. Guidance was sought by Emergency Department (ED) when Ben King attended on 10 July 2020 from a Respiratory Consultant, who was not made aware that Ben King had attended some 6 hours earlier with the same symptoms.
2. The Respiratory on call consultant was not contacted when Mr King returned to NNUH two days later on the 12 July 2020 with the same symptoms.
3. At the time of Ben King’s attendance at NNUH, Ben King was under the Respiratory Team and had been seen a few days earlier, on 3 July 2020. The Respiratory Team was not made aware of Ben King’s attendances at ED on 9, 10 or 12 July 2020 with respiratory problems. Advice given on discharge appears to be unclear and contradictory. The expert Respiratory Consultant referred to the advice as being “inadequate, unclear and inaccurate”
4. On the Discharge Form provided on 9 July 2020 it is noted “Plan – home as Ben is back to normal, self, red flags and safety netting covered, to return in the event of any difficulty.” On discharge from ED on 10 July 2020 (second occasion) the hospital record states that Ben King is to return home, encouraged to lose weight, fluids are to be encouraged and “with no need to monitor his sats unless clinically unwell with sats in 60s%”. Not all of this information was included in the Discharge Form on 10 July 2020: The Discharge Form provided under “Other” - “seen by respiratory team, they are happy to send him home, they have clerked their advice on the paper. CPAP and O2” On 12 July 2020 the Discharge Plan provided “Home”. The advice from the Respiratory Consultant seen on 3 July 2020 was for CPAP to stop. Evidence was heard from the Care staff at JCP that they were unclear as to what the plan was with regard to Ben and specifically as to when Ben was to be returned to Hospital. One of the Doctors at JCP contacted the ED, NNUH to try to ascertain what the advice was and was unable to get any substantive response. Email contact was made with the Respiratory Team but no response was received until after Ben King’s death on 28 July 2020.
5. The section headed “Drug History” was not completed on the Discharge Form on Ben King’s attendances on 9 or 12 July 2020. On 10 July, it states “nil significant”. This is despite Ben King being prescribed Promethazine, a sedative medication, affecting the respiratory system. Evidence was heard that not all prescribed medications could be expected to be included in “the small space” provided. That this is a medication where consideration would have been given to a risk/benefit analysis but there was no evidence of any such analysis. Regulation 28 evidence was that not all medication can be listed; only “pertinent” medication. Promethazine would appear to be such a medication.
6. Arterial and venous blood gas samples were taken from Ben King on his attendances on 9 and 10 July 2020, which the Respiratory Consultant said in evidence were incomparable (although this was not the evidence of the Expert Respiratory Consultant). No blood gas samples were taken on the 12 July 2020.

A copy of this report was sent to:

• The Chief Coroner
• Clinical Commissioning Group
• Norfolk Safeguarding Adults Review Group
• Care Quality Commission
• Department of Health
• Healthcare Safety Investigation Branch (HSIB)
• Healthwatch - Norfolk

During the course of the investigation the evidence revealed matters giving rise to concern. If the coroner is inhibited from being in a position to confirm the cause of death of a baby, there is a risk that future deaths will occur unless action is taken.

Matters of Concern

1. The placenta, a key organ required for a full paediatric post mortem in an early neonatal death, has been interfered with such that the Paediatric Pathologist, is limited in his conclusion as to the likely cause of death. In some ways the placenta is akin to an organ for the purposes of a paediatric post mortem- Loss of an organ at any post mortem examination, may well undermine the ability of the pathologist to carry out a full and proper examination. Decisions surrounding interference with, or disposal of, the placenta should be made in a careful and considered manner, with thought given to an early discussion with the coroner as would happen if organ donation is being considered. This did not happen in this case.
2. Unfortunately, there have been a number of cases in Nottingham where the death of a baby shortly after the birth was anticipated, but the placenta was disposed of and/or interfered with prior to the death being reported to the coroner. This undermines the coronial investigation resulting in limited findings and therefore limited conclusions at inquest. This will likely lead to a lack of learning from such deaths, and therefore a risk that similar deaths will occur in the future. It may also deprive the parents of significant information when considering whether future pregnancies may be at greater risk with the consequent need for appropriate management and planning.
3. The Nottinghamshire Coronial service has to date worked collaboratively with all local Trusts, but particularly with NUH NHS Trust, to ensure key staff understand the importance of retaining the placenta in an early neonatal death. This has not led to the actions necessary to achieve a full and proper examination of the placenta in repeated paediatric post mortems in this jurisdiction.

Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA). There needs to be better education both to doctors and to patients in risk groups to prevent future death.

In relation to Pathology:

The current guidance is 10 years old, the suggestion is for this to be revisited and specifically:

• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing.
• That an early blood sample is taken after death and stored for late analysis.
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity.
• That an early blood sample is taken after death.
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken.

A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.

In relation to doctors/patients:

• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.

In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:

• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.

In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:

• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.

In relation to the FSA:

• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases.

1 It is recognised that M. abscessus poses a risk of death to those who are immunosuppressed. That will be so for many patients at specialist hospitals such as Royal Papworth and more generally for hospital patients. To date, 34 patients at Royal Papworth have contracted M. abscessus from the hospital’s water. Cases continue to be reported, albeit at a declining rate.

2 There is an incomplete understanding of how M. abscessus may enter and/or colonise a hospital water system.

3 Health Technical Memorandum 04-01 Safe Water in Healthcare Premises was published by the Department of Health in 2016. It is concerned with the design, installation, commissioning and operation of hospital water systems. This guidance requires urgent review and amendment, whether by way of an Addendum or otherwise because:

• a. It is a key document for hospital estate managers and Water Safety Groups;
• b. It purports to provide comprehensive guidance on waterborne bacteria;
• c. However, it provides no relevant guidance in relation to mycobacteria and none in relation to M. abscessus. It provides no guidance on the identification and control of M. abscessus. It does not require routine testing for mycobacteria, including M. abscessus or provide guidance on acceptable levels (if any). Compliance with the guidance does not identify or guard against the risk from M. abscessus;
• d. It provides no guidance on any additional measures that may be required in respect of “augmented care” patients, including those who are immunosuppressed;
• e. It is not in any event consistent with British Standard BS 8580-2:2022 on Water Safety.

4 There is evidence that the risk from M. abscessus is especially acute for new hospitals. Consideration needs to be given to whether special or additional measures are required in respect of the design, installation, commissioning and operation of hospital water system in new hospitals.