Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0167, written 19 May 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 19 May 2023 |
|---|---|
| Reference | 2023-0167 |
| Deceased | Amelia Barbosa |
| Coroner | Samantha Goward |
| Coroner area | Cambridgeshire and Peterborough |
| Category | Child Death (from 2015) |
| Organisation named | North West Anglia NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Regulation 28: REPORT TO PREVENT FUTURE DEATHS
NOTE: This form is to be used after an inquest.
REGULATION 28 REPORT TO PREVENT DEATHS
THIS REPORT IS BEING SENT TO:
1. North West Anglia NHS Foundation Trust
1 CORONER
I am Samantha Goward, Assistant Coroner for the coroner area of Cambridgeshire and Peterborough.
2 CORONER’S LEGAL POWERS
I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and Regulations
28 and 29 of the Coroners (Investigations) Regulations 2013.
Coroners and Justice Act 2009 (legislation.gov.uk)
The Coroners (Investigations) Regulations 2013 (legislation.gov.uk)
3
INVESTIGATION and INQUEST
On 14 October 2021 an investigation in to the death of Amelia Barbosa was commenced. Amelia died on
13 December 2020, aged 7 days. The investigation concluded at the end of the inquest on 17 May 2023.
The conclusion of the inquest was:
Medical Cause of Death –
1a Hypoxic Ischaemic Encepalopathy,
2 Placental pathologies: acute chorioamnionitis and delayed vilious maturation
Conclusion – Died as a result of an acute hypoxic injury in the period immediately before delivery, and
which continued during resuscitation, leading to hypoxic ischaemic encephalopathy.
4 CIRCUMSTANCES OF THE DEATH
1.
In summary, Amelia’s mother had a routine pregnancy and was given a due date of 01 December
2020. She attended Peterborough City Hospital at around 1030 hours on 5 December 2020.
2. From very early on, the CTG trace was classified as suspicious on a number of occasions and on
some occasions as pathological. Evidence and a report from HSIB confirms that assessment and
decision making during this period was appropriate.
3. Due to a failure to progress in the second stage of labour and suspected fetal compromise at
around 0240 hours, a decision was made for a Category 2 Caesarean section delivery.
4. The CTG trace was stopped at 0404 hours to enable the Caesarean to take place.
Regulation 28 – After Inquest
Document Template Updated 30/07/2021
5. As had been anticipated, there was some difficulty due to Amelia’s head being impacted, but the
Obstetrician and senior Midwife worked together and this was resolved within 4 minutes.
6. Due to difficulties siting a spinal anaesthetic, and Amelia’s head being impacted, the time from
decision to delivery was 83 minutes. Expert evidence confirmed that, on the balance of
probabilities, Amelia suffered an acute hypoxic insult commencing around 10 minutes before her
delivery and which was ongoing during resuscitation.
7. At delivery, no APGAR scores were recorded as they should have been. However, based upon
the evidence in the notes, I accepted the hypothesis from HSIB that it is likely that her scores were
0 at 1 minute and 1 at 5 minutes.
8. The Midwife took cord blood gases but, as there was no blood in the clamped section of the cord,
the blood was taken from a different part of the cord. I heard independent expert evidence from
a Consultant Neonatologist that these are not likely to have been reliable as they were taken from
close to the base of the placenta rather than the clamped section of cord.
9. The evidence of the Midwife at the inquest was that she felt, and she had since discussed this
with colleagues who agreed, that if necessary it was fine to take blood from anywhere in the cord.
Both the independent expert and the Trust’s own Head of Midwifery, who gave evidence on
changes made at the Trust in light of HSIB recommendations, agreed that blood should not be
taken from anywhere other than the clamped section of cord. Further, if that was not possible,
it must be clearly communicated to the Neonatal/Paediatric team.
10. There were a number of issues identified with the resuscitation and concerns raised by both HSIB
and the independent expert, some of which were addressed by the Trust who produced evidence to
confirm how these issues had been resolved.
11. However, other issues were identified. One such issue was that the independent expert advised that
resuscitation attempts should not have stopped until all reversible causes had been considered and
treated. Prior to resuscitation stopping, no blood transfusion had been given. Amelia had been
described to be very pale. Her haemoglobin level was later found to be 94. Both the expert and HSIB
felt a transfusion should have been given. The treating Registrar also gave evidence that, had he been
aware of the issue with the cord blood and another issue relating to the condition of the placenta, he
would have given a transfusion. The treating Consultant who gave evidence however disagreed.
12. One of the recommendations from HSIB was for there to be training and feedback to those involved in
this case, and others who were not, to learn lessons.
13. There was also difficulty inserting an umbilical venous catheter, which I accept can be difficult even in
experienced hands, and the delay in intra osseous access, which was contributed to by the lack of
correct equipment on the resus trolley, led to a delay in Amelia receiving adrenaline, fluid volume and
sodium bicarbonate. The expert recommended that staff undergo training to improve their skills for
obtaining UVC and IO access.
14. While in NICU there was also a delay in Amelia being effectively cooled due to the active cooling
machine not working. I was advised that this has now been replaced.
15. Amelia was transferred to Addenbrooke’s Hospital where the extent of her injuries were confirmed
and she sadly died on 13 December 2020.
Regulation 28 – After Inquest
Document Template Updated 30/07/2021
5 CORONER’S CONCERNS
During the course of the investigation my inquiries revealed matters giving rise to concern. In my opinion
there is a risk that future deaths could occur unless action is taken. In the circumstances it is my
statutory duty to report to you.
The MATTERS OF CONCERN ARE:
1. While I heard evidence that there has been training for Midwives on how to take cord blood, and I was
provided with a copy of a poster that was said to have been in use at the Trust for some time, in April
2023, over 2 years after this delivery, the Midwife gave evidence that she and her colleagues were of
the opinion that it was appropriate to take a sample from anywhere in the cord, not just in the clamped
area. The expert and the Trust’s own Head of Midwifery advised that this was not appropriate. It
therefore does not appear that the learning has been passed on to all Trust Midwives and there is a risk
that in future cases those treating the baby will be falsely reassured by normal cord pH results which
may not be accurate.
2. While I read evidence of some training that had been provided in response to HSIB recommendations
for further training on auscultation in addition to saturation monitoring and ECG monitoring during
resuscitation, the independent expert also recommended training on UVC and IO access. I am also
concerned that there does not appear to have been training in relation to the provision of blood
transfusions in such cases to ensure that all potential reversible causes are treated before resuscitation
stops. The Head of Midwifery who attended the inquest to advise on issues relating to the
recommendations was not in a position to provide evidence on the neonatal position and I have been
provided with no evidence by the Trust that these issues have been considered. I am concerned that
they require further action.
6 ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you (and/or your
organisation) have the power to take such action.
7 YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this report,
namely by 15 July 2023. I, the coroner, may extend the period.
Your response must contain details of action taken or proposed to be taken, setting out the timetable for
action. Otherwise you must explain why no action is proposed.
8 COPIES and PUBLICATION
I have sent a copy of my report to the Chief Coroner and to the following Interested Persons
1)
Amelia’s parents
I am also under a duty to send a copy of your response to the Chief Coroner and all interested persons
who in my opinion should receive it.
I may also send a copy of your response to any person who I believe may find it useful or of interest.
The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send
a copy of this report to any person who he believes may find it useful or of interest.
Regulation 28 – After Inquest
Document Template Updated 30/07/2021
You may make representations to me, the coroner, at the time of your response about the release or the
publication of your response by the Chief Coroner.
9
Dated: 19/05/2023
Samantha GOWARD
Assistant Coroner for
Cambridgeshire & Peterborough
Regulation 28 – After Inquest
Document Template Updated 30/07/2021
2 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
Office for Product Safety and Standards 1 Victoria Street Westminster London SW1H 0ET 15/06/2023 Miss Kirsty Gomersal HM Area Coroner County of Cumbria Fairfield Station Rd Cockermouth, CA13 9PT Dear Miss Kirsty Gomersal, Thank you for your Regulation 28 Report (Prevention of Future Deaths) dated 20 April 2023, following your investigation and inquest into the death of Chester Allan Stanley Mossop. First, I would like to say how deeply saddened I was on hearing of the tragic death of baby Chester. I would be grateful if you could pass on my condolences to the family if you have the opportunity to do so. The Office for Product Safety and Standards (OPSS) is the UK’s national product regulator. The UK has a product safety system designed to provide a high level of protection for consumers and all consumer products including baby bath seats, must be safe before they can be sold on the UK market. The safety of baby products is a priority area for OPSS and we have recently taken action to prevent the sale of a number of unsafe baby products including baby self-feeding devices. Baby bath seats are regulated under the General Product Safety Regulation 2005 (GPSR). This places an obligation on manufacturers or importers to ensure their products are safe before they can be placed on the market (Regulation 5 of GPSR). They must also provide safety information to enable consumers to assess risks that are not immediately obvious without adequate warnings and to take precautions against those risks (Regulation 7 of GPSR). Distributors have a separate duty to act with due care to ensure that products they offer for sale comply with the law; are safe; and to pass on the necessary information on the risks posed by the product (Regulation 8 of GPSR). The Office for Product Safety and Standards is part of the Department for Business and Trade. We strive to enhance protections for consumers and the environment and drive increased productivity, growth and business confidence. https://www.gov.uk/government/organisations/office-for-product-safety-and-standards Since receiving your Report, OPSS has been in contact with your office to obtain further details of the product involved in this incident. As a result, OPSS will be assessing the safety and compliance for similar models of baby bath seat to assess their compliance with legal requirements. While we do not currently have any evidence that the product itself is unsafe or non-compliant, should that be identified, we have a range of actions open to us to ensure products are brought into compliance or removed from the market. We will also work with the Baby Products Association (BPA), the relevant trade association for the sector, to ask them to remind their members of the requirements for including appropriate instructions for safe use and to ensure that any safety warnings for baby bath seats are suitably clear and prominent. We have worked closely with the National Health Service (NHS) on our programme of activity on the safety of baby products and will ask them to consider whether there is an opportunity to include safety messages related to baby bath seats through their communications with healthcare professionals and new parents. Thank you again for bringing this tragic case to our attention. Yours Sincerely, Deputy Chief Executive Office for Product Safety and Standards The Office for Product Safety and Standards is part of the Department for Business and Trade. We strive to enhance protections for consumers and the environment and drive increased productivity, growth and business confidence. https://www.gov.uk/government/organisations/office-for-product-safety-and-standards
Chief Nurse/ Director of Infection Prevention and Control 4 July 2023 fA!/:kl North West Anglia NHS Foundation Trust Peterborough City Hospital Edith Gavell Campus Bratton Gate Peterborough PE3 9GZ Ms Samantha Goward HM Assistant Coroner for Cambridgeshire & Peterborough Lawrence Court Princes Street HUNTINGDON PE29 3PA Dear Ms Goward Inquest relating to the death of Amelia BARBOSA I refer to your Regulation 28 Report dated 19th May issued following the inquest. There were two matters of concern which you have asked the Trust to respond to. The first area of concern relates to the taking of cord blood samples by midwifery staff. You heard evidence at the inquest that the midwife in this .case did indeed attempt to take a sample of blood from that part of the umbilical cord which had been clamped. Unfortunately, she was unable to obtain any blood from there and therefore obtained a sample from the unclamped part of the cord. Following the inquest the midwifery department has produced and issued a poster in relation to this. I have enclosed a copy of the poster which makes it clear that cord blood samples must be taken from the clamped area and not from any other part of the cord or placenta. If the midwife is unable to obtain any blood from this part of the cord then they are to inform the Paediatricians in order that they can take a capillary sample. The second area of the concern relates to the attempts to resuscitate after Amelia had been delivered in a very poor condition. An experienced Paediatric Registrar was in charge of the resuscitation until the Consultant Paediatrician arrived. The Registrar was unable to insert an umbilical vein catheter (UVC) in order to administer drugs and fluids. He therefore attempted intraosseous access. However, as only long intraosseous needles were available in theatre there was a delay whilst short intraosseous needles were located. I can confirm that following this incident the neonatal resuscitation trolley is now routinely stocked with short intraosseous needles. As for UVC insertion, this is a technically difficult skill and UVCs are only inserted by Paediatric Registrars and Consultant Paediatricians. Before a Paediatric Registrar can be signed off they must be able to insert UVCs under observation. However, as the independent expert stated during the inquest, there are occasions when it is simply not technically possible to insert a UVC. Hence the decision in this case to try to gain intraosseous access to give drugs and fluids. I can also confirm that there is regular training for undertaking these procedures on the ATLS (Advance Trauma Life Support) course which clinicians attend every four years. In addition, the Trust will be introducing annual updates for these procedures from September of this year for all doctors involved in looking after neonates. Your report also referred to training in relation to the provision of blood transfusions. Whether a blood transfusion is given during a resuscitation is a matter of clinical judgement for the clinician in charge of resuscitation. However, it has been accepted by our Paediatricians that there should be a low threshold for giving a blood transfusion. In particular, it is preferable to give a bolus with blood rather than fluids. This adopts the NLS (Newborn Life Support) Guidelines from 2021 which recommends this. I hope that our response to your report has provided reassurance to both you and the family that the necessary changes to our practice have been made following Amelia's tragic death. I would also like to take this opportunity on behalf of the Trust to reiterate our deep condolences for Amelia's parents. Yours sincerely Chief Nurse/ Director of Infection Prevention and Control
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