Prevention of Future Deaths reports · 2020
Regulation 28 report to prevent future deaths, reference 2020-0245, written 19 Nov 2020. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 19 Nov 2020 |
|---|---|
| Reference | 2020-0245 |
| Deceased | Yo Li |
| Coroner | Anna Crawford |
| Coroner area | Surrey |
| Category | Child Death (from 2015) · Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
IN THE SURREY CORONER’S COURT IN THE MATTER OF: __________________________________________________________ The Inquest Touching the Death of Master Yo Li A Regulation 28 Report – Action to Prevent Future Deaths __________________________________________________________ 1 THIS REPORT IS BEING SENT TO: Chief Executive Officer NHS Improvement Skipton House 80 London Road London SE1 6LH Chief Executive British Association of Perinatal Medicine (BAPM) 5-11 Theobalds Road London WC1X 8SH WC1X 8S H8SH 2 CORONER Miss Anna Crawford, HM Assistant Coroner for Surrey 3 CORONER’S LEGAL POWERS I make this report under paragraph 7(1) of Schedule 5 to The Coroners and Justice Act 2009. 1 4 INQUEST The inquest into the death of Master Yo Li was opened on 2 April 2019. It was resumed on 24 September 2020 and the conclusion was handed down on 6 October 2020. The medical cause of Master Li’s death was: 1a. Total Parenteral Nutrition (TPN) Peritonitis 1b. Total Parenteral Nutrition (TPN) Extravasation 2. Extreme Prematurity The inquest concluded with a narrative conclusion which is set out below. 5 CIRCUMSTANCES OF THE DEATH Yo Li was born extremely prematurely at 09:46 on 11 January 2019 at St. Peter’s Hospital. Immediately following his birth he did not make any respiratory effort and had to be resuscitated before being transferred to the Neonatal Intensive Care Unit at the hospital where he was supported by way of mechanical ventilation. At 16:00 on 11 January 2019 an Umbilical Venous Catheter (UVC) was inserted in order to provide Yo Li with Total Parenteral Nutrition (TPN), as well as medication. However, the UVC was mal-positioned within Yo Li’s liver tissue, resulting in TPN Extravasation, which is a rare but known complication of the use of UVCs, and Yo Li’s s death on 15 January 2019. The clinical team caring for Yo Li did not appreciate that the UVC had been mal-positioned and therefore omitted to remove it on 11 and 12 January 2019. If it had removed it on either of those dates Yo Li would have survived. 2 6 CORONER’S CONCERNS The Coroner’s concerns are as follows: The court heard evidence that following several deaths due to central venous catheter extravasation the British Association of Perinatal Medicine (BAPM) issued guidance entitled the ‘Use of Central Venous Catheters in Neonates – A Framework for Practice’ in December 2015 and updated in August 2018. The guidance sets out a number of risk factors for mal-positioned UVCs. The court heard, however, that the BAPM guidance does not identify one key risk factor for mal-positioned UVCs – namely that there is a risk that it is mal-positioned when it is pointing towards the left side of the base of the heart, as it was in Master Li’s case, despite this being a recognised risk in the academic literature on this issue. The court heard evidence that the two clinicians involved in the placement of Master Li’s UVC were not familiar with the updated BAPM guidance. The court also heard that the St. Peter’s Hospital internal guidance on the use of UVCs was not fully compliant with the updated BAPM guidance at the time of Master Li’s death, albeit they have since introduced comprehensive internal guidance on this issue. The court heard that there is no NICE guidance on the use of UVCs and - given that BAPM is a voluntary professional organisation - there is no requirement upon NHS Trusts to ensure that their clinicians are familiar with the BAPM guidance or to ensure that their internal policies and procedures are in accordance with it. The MATTER OF CONCERN is: 1. The BAPM guidance on ‘Use of Central Venous Catheters in Neonates – A Framework for Practice’ does not identify a key risk factor for a mal-positioned UVC. Consideration ought to be given by BAPM to updating the guidance to include reference to this risk factor. 2. There is no NICE guidance on the use of UVCs and there is no requirement on NHS Trusts to ensure that their clinicians are familiar with the BAPM guidance or to ensure that their internal policies and procedures are in accordance with it. Consideration ought to be given by NHSI to introducing some NICE guidance to cover this issue. 3 7 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe that the people listed in paragraph one above have the power to take such action. 8 YOUR RESPONSE You are under a duty to respond to this report within 56 days of its date; I may extend that period on request. Your response must contain details of action taken or proposed to be taken, setting out the timetable for such action. Otherwise you must explain why no action is proposed. 9 COPIES I have sent a copy of this report to the following: 1. Chief Coroner 2. Master Li’s family 3. Ashford and St. Peter’s Hospitals NHS Foundation Trust 10 Signed: Anna Crawford H.M Assistant Coroner for Surrey Dated this 19th day of November 2020 4
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.
BAPM c/o RCPCH 5-11 Theobalds Road, London, WC1X 8SH
t:
e: bapm@rcpch.ac.uk
Miss Anna Crawford
HM Assistant Coroner for Surrey
Sent Via Email
7 January 2021
Dear Miss Crawford,
Re: The Inquest Touching the Death of Master Yo Li. A Regulation 28 Report – Action to
Prevent Future Deaths
Many thanks for contacting the British Association of Perinatal Medicine (BAPM) about
the sad death of Master Yo Li. Having read the Regulation 28 report, I wish to offer the
following statement on behalf of BAPM.
BAPM is a voluntary professional organisation whose mission is to improve standards of
perinatal care in the UK. This is undertaken by supporting all those involved in perinatal
care to optimise their skills and knowledge, deliver and share high quality, safe and
innovative practice, undertake research, and promote the needs of babies and their
families.
Among BAPM’s resources are a series of Frameworks for Practice (FfPs) which, following
review of the literature, are written by multi-professional, voluntary working groups and
published on our website after national consultation. Our FfPs are therefore evidence-
based, consensus documents: specifically they are not guidelines, but as you note,
guidance. This makes them highly suitable to inform local guidelines and protocols
appropriate for individual neonatal units and/or networks. BAPM FfPs are reviewed
regularly and updated if new evidence has become available.
The BAPM FfP for the use of Central Venous Catheters in Neonates (last updated August
2018) was written in response to a Coroner’s inquest and concurrent contact from the
local MP following a case of fatal CVC associated extravasation. The Framework aimed to
reduce harm and improve safety as a national survey revealed wide variation in practices
around central venous (including umbilical) catheter insertion and management.
The current FfP notes that “the use of central venous catheters (CVCs) is an essential part
of neonatal care allowing delivery of intravenous fluids and medication. The use of these
catheters is associated with a number of complications. Whilst catheter-associated
President:
Treasurer:
www.bapm.org
Secretary:
Chief Executive:
Charity No: 285357
– 2 –
infection is well recognised and subject to scrutiny, extravasation into a body cavity is less
common but potentially fatal if tamponade ensues.”
The stated aims of the FfP are to provide practice points to:
Improve the uniformity and standard of CVC care nationally
• Address aspects of insertion, on-going use and care of CVCs in the neonatal setting
•
• Reduce the incidence of complications associated with the use of CVCs
• Highlight early recognition of the rare but potentially fatal complication of
extravasation into a body cavity.
Additionally, the Executive Summary makes the following recommendations:
• Any clinical deterioration of a baby in whom a central venous catheter is present
should raise the question of catheter-related complications, particularly infection,
extravasation and tamponade.
• All central catheter tips should be positioned outside the cardiac silhouette.
• An umbilical venous catheter (UVC) tip should ideally be sited at T8-T9 (assuming
this lies outside the cardiac silhouette). A UVC tip sited at or below T10 carries a
significantly higher risk of extravasation. It may be necessary to use these
catheters in the short term, but they should be replaced at the earliest
opportunity.
The key points to be considered are:
a) The risk of extravasation from a UVC and
b) The early recognition of potential extravasation.
The BAPM Framework deals very explicitly with the latter point, and we would respectfully
contend that in the case of Master Yo Li, the likelihood of extravasation was not promptly
recognised by the attending clinical team.
In regard to placement of the UVC, it is very well recognised that the predicted track of a
UVC is directly upwards through the ductus venosus towards the diaphragm. Any
deviation from this should raise concern that the UVC has entered a hepatic or portal
vessel, with consequent increased risk of extravasation. We would expect all senior
neonatal clinicians (and indeed all but the most inexperienced of trainees) to be aware of
this. Importantly, it must be noted that extravasation from a UVC is possible even if the X-
ray findings are entirely acceptable.
I draw your attention particularly to 3 of the 20 good practice points contained within the
BAPM Framework:
– 3 –
3. Units which use central catheters should have a formal training package for
insertion of catheters which should include an assessment of technical
competence and awareness of potential complications.
16. There should be thorough contemporaneous documentation of each
central catheter insertion including indication, description of the catheter
itself, number of attempts, length inserted, position on X-ray, and any
adjustments subsequently made. The accepted position should be verified in
writing within 24 hours of insertion by a consultant
neonatologist/paediatrician or from a radiologist’s report.
19. Any clinical deterioration of a baby in whom a central venous catheter is
present should raise the question of catheter-related complications,
particularly infection, extravasation and tamponade.
While we agree wholeheartedly with your recommendation that there should be a
requirement on NHS Trusts to ensure that their clinicians are familiar with the current
BAPM FfP for the use of Central Venous Catheters in Neonates, with the greatest of
respect we contend that the suggested amendment is unnecessary and could not be
guaranteed to prevent a recurrence of the incident described which led to the sad death
of Master Yo Li.
I would be very happy to discuss this further with you should you wish.
Yours sincerely
President, BAPM
On behalf of BAPM Executive Committee
Cc:
80 London Road London, SE1 6LH
Chief Executive Officer NHS Improvement Skipton House
2nd Floor
2 Redmond Place
London
E20 1JQ
United Kingdom
Miss Anna Crawford,
HM Assistant Coroner for Surrey
Surrey Coroner’s Service,
HM Coroner's Court,
Station Approach,
Woking,
Surrey, GU22 7AP
Sent via email to:
11 May 2021
Our ref:
Dear Miss Crawford,
I write in response to your correspondence, sent to NICE on 11 March 2021,
regarding the very sad death of Master Yo Li. Our thoughts are with his family.
We have considered the circumstances surrounding Master Yo Li’s death, and the
concerns raised in your report. These were:
1. The BAPM guidance on ‘Use of Central Venous Catheters in Neonates – A
Framework for Practice’ does not identify a key risk factor for a mal-positioned
UVC. Consideration ought to be given by BAPM to updating the guidance to
include reference to this risk factor.
2. There is no NICE guidance on the use of UVCs and there is no requirement
on NHS Trusts to ensure that their clinicians are familiar with the BAPM
guidance or to ensure that their internal policies and procedures are in
accordance with it. Consideration ought to be given by NHSI to introducing
some NICE guidance to cover this issue.
We also note the response you have received from NHS England & NHS
Improvement (NHSE&I) directing you to NICE in relation to your second concern;
namely, that there is a lack of NICE guidance on umbilical venous catheters (UVCs).
NICE has a clinical guideline on neonatal parenteral nutrition (NG154). This
guideline covers parenteral nutrition (intravenous feeding) for babies born preterm,
up to 28 days after their due birth date and babies born at term, up to 28 days after
their birth. Although it does not specifically mention UVCs, it does discuss central
lines in section 1.2 and also contains recommendations on talking about risks and
benefits with parents in section 1.10, including concerns about central venous
catheter placement.
We do not consider it appropriate for NICE to produce guideline recommendations
specifically describing how to insert UVC lines.
We consider it appropriate for the British Association of Perinatal Medicine (BAPM)
framework to contain all the relevant information about how to insert UVC lines and
address the possible risks to consider.
In terms of the requirements of clinicians to be familiar with BAPM guidance, we are
aware that the General Medical Council (GMC) state in their Good Medical Practice
guidance that clinicians should be aware of guidance of their specialism. It says in
point 11: “You must be familiar with guidelines and developments that affect your
work”. We understand this expectation refers to NICE guidelines (where they exist)
as well as other authoritative sources of specialty specific clinical guidelines, such as
those published by medical Royal Colleges and other professional associations.
We consider this an issue of training and awareness. The responsibility for the
education and training of healthcare professionals rests with the relevant
professional bodies, such as the Royal Colleges, the GMC and Health Education
England.
We note from the response from NHSE&I that a reminder of the BAPM framework
and clinical practice guidelines has been sent out via the Maternity Transformation
Bulletin and to all neonatal safety champions.
While we do not consider that direct action is required from NICE at this time, the
concerns you have raised have been logged for further consideration when guideline
NG154 is next reviewed for update.
Yours sincerely,
Chief Executive
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