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

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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:
• Address aspects of insertion, on-going use and care of CVCs in the neonatal setting
• Improve the uniformity and standard of CVC care nationally
• 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:

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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.

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

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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.