Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0449, written 14 Nov 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 14 Nov 2023 |
|---|---|
| Reference | 2023-0449 |
| Deceased | Maxwell Frame |
| Coroner | Peter Merchant |
| Coroner area | West Yorkshire Western |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 4 |
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 Department of Health and Social Care 39 Victoria Street, London SW1H 0EU 2 National Institute for Health and Care Excellence Redman Place, London E20 3 Royal College of Anaesthetists Churchill House, 35 Red Lion Square, London WC1R 4SG 4 Academy of Medical Royal Colleges 10 Dallington Street, London, EC1V 0BD 5 National Infusion and Vascular Access Society 6 Association of Anaesthetists 21 Portland Place, London, W1B 1PY 1 CORONER I Peter Merchant Assistant Coroner for the coroner area of West Yorkshire ( West) 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. 3 INVESTIGATION and INQUEST On 14 July 2021 the death of Maxwell Frame was reported to the Coroner for West Yorkshire (West). An inquest was opened on 28 July 2021. An inquest was heard between 9 and 11 October 2023. The medical cause of death (accepted from a report in lieu) was 1a) Acute Ischaemic Strokes (Multifocal); 1b) Inadvertent Insertion of a Central Venous Cather in the Common Carotid Artery;2 Perforated Acute Appendicitis Leading to Septic Shock. The conclusion was one of misadventure contributed to by neglect. 4 CIRCUMSTANCES OF THE DEATH Mr Frame had presented to the A&E department at Huddersfield Royal Infirmary (Part of Calderdale and Huddersfield NHS Foundation Trust- the Trust) in the early hours of 24 June 2021. Investigations identified a pelvic abscess and bowel obstruction as the source of sepsis which was not amenable to radiological drainage. He underwent an emergency laparotomy the same day with findings of a pelvic abscess from a perforated gangrenous appendix and non-viable adjacent colonic tissue and small bowel obstruction. This required drainage of the abscess, removal of the gangrenous tissue and bowel and formulation of a stoma. As part of the pre-surgical preparations for post operative care the placement of a central Regulation 28 – After Inquest Document Template Updated 30/07/2021 venous catheter (CVC) was undertaken using the right subclavian vein. A landmark approach was used. There was no use of ultrasound to assist placement of the CVC despite this being available. As part of the checks to ensure correct placement of the CVC a check chest x-ray was undertaken. Other checks in the form of an arterial blood gas and transducing the intra-vessel pressure wave via the CVC were not undertaken even though the necessary equipment to do so was available. The check chest x-ray was incorrectly interpreted as showing correct placement into the vein whereas, in fact, the CVC had been incorrectly placed into the artery. The check chest x-ray was not reviewed by the consultant who had undertaken the procedure until a later point after discovery that the CVC had been incorrectly placed. Whilst the evidence identified incorrect placement of a CVC was a recognised complication, it was accepted that the various steps detailed above that would have reduced this happening were not undertaken. The incorrect placement of the CVC was identified on 27 June 2021. Following this Mr Frame was transferred to the Bradford Royal Infirmary. On 1 July 2021 he underwent a procedure to remove the misplaced CVC. In the course of this procedure some clot adherent to the CVC dislodged and embolised into his brain circulation causing stroke damage, the extent of which was such that, following discussions with Mr Frame’s family, he was commenced on palliative care. He was extubated and died on 13 July 2021. 5 CORONER’S CONCERNS During 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 MATTER OF CONCERN IS as follows: Absence of a national policy on the placement of CVC’s Over the course of the inquest hearing, oral evidence was provided by several anaesthetic/ ICU doctors ranging from experienced consultants, specialty Dr’s and a Core Trainee 2 all of whom had experience to varying degrees of placing CVC’s. These Dr’s had worked in several hospitals predominantly across the Midlands and North of England. The Trust had a policy entitled Central Venous Access Device which identified the steps that I have identified earlier should have taken place but were not. I was advised by the Dr’s who gave evidence that there was no single standard policy that they had encountered nationally for the placement of CVC’s. The Trust in this case following their internal investigation of Mr Frame’s case had felt it necessary to revise their policy. Further, I was advised by some of the Dr’s who gave evidence that they felt a national policy regarding the placement of CVC’s would be beneficial. 6 ACTION SHOULD BE TAKEN Accordingly, considering the matter of concern and the evidence given, consideration should be given to the introduction of a national policy for the placement of CVC’s. 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 January 09, 2024. 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 Regulation 28 – After Inquest Document Template Updated 30/07/2021 The family of Mr Frame Bradford Teaching Hospitals NHS Foundation Trust Weightmans LLP acting for the Trust who may find it useful or of interest. 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. 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: 14 November 2023 Peter Merchant Assistant Coroner West Yorkshire ( West) Regulation 28 – After Inquest Document Template Updated 30/07/2021
4 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.
8th January 2024 Dear Mr Merchant, Re: Regulation 28: Report to Prevent Future Deaths in the matter of Maxwell Frame Thank you for sending us a copy of your report regarding the sad death of Mr Maxwell Frame. We have jointly reviewed the information available to us in the report via our Safe Anaesthesia Liaison Group (SALG). SALG is a collaborative project between the Association of Anaesthetists, NHS England’s Patient Safety team and the Royal College of Anaesthetists. One of its core objectives is to analyse anaesthesia-related serious incidents and to share the learning with the specialty across the UK. We have also consulted with the Faculty of Intensive Care Medicine (FICM) and the Intensive Care Society (ICS). Your prevention of future deaths report highlighted your concern regarding the “absence of a national policy on the placement of Central venous catheters (CVCs).” In 2016, the Association of Anaesthetists published the guidance “Safe Vascular Access”1, which was endorsed by the Royal College of Anaesthetists. Although this guidance does not contain a list of explicit recommendations for placement, information relating to how placement should be checked is included. The guideline does state "All hospitals should have clear, specific policies for insertion and documentation of CVCs (type, insertion site and tip position), and education on complications and their management." The guidance is currently being updated and we will ensure that it has more explicit recommendations for checking placement. Since that guidance was published, the National Safety Standards for Invasive Procedures (NatSSIPs)2 have been rolled out. As CVC insertion is an invasive procedure, NatSSiPs obliges every organisation to have a local standard (known as a LocSSIP), which would naturally include how placement should be checked. FICM and ICS published a Central Venous Catheter Insertion Checklist in 2017 (updated 2023)3, which can be used as the basis of the LocSSIP for individual organisations. Additionally the ICS Standards and Guidelines Committee is currently developing a “Guideline for the management of inadvertent arterial puncture during central venous catheterisation in Critical Care”, in conjunction with experts within the Vascular Surgery specialty. SALG publishes regular Patient Safety Updates, which are distributed to all members of the Association of Anaesthetists and Royal College of Anaesthetists. FICM publishes regular Safety Bulletins, which are distributed to all their members. Both publications have previously highlighted incidents related to CVC insertion and we will continue to do so to promote compliance with the guidance noted above. We would be happy to respond to any questions that you might have. Yours Sincerely President Royal College of Anaesthetists President Association of Anaesthetists President Intensive Care Society References 1. Association of Anaesthetists of Great Britain and Ireland. Safe vascular access 2016. Anaesthesia 2016; 71: 573-585. 2. NHS England. National Safety Standards for Invasive Procedures (NatSSIPs), 2015 and Centre for Perioperative Care. National Safety Standards for Invasive Procedures (NatSSIPs) 2, 2023. 3. Faculty of Intensive Care Medicine and the Intensive Care Society. Central Venous Catheter Insertion Checklist, 2017 (updated 2023).
The Rt Hon. Andrew Stephenson CBE MP Minister of State for Health and Secondary Care 39 Victoria Street London SW1H 0EU Peter Merchant HM Assistant Coroner West Yorkshire Western Coroner Area City Courts The Tyrls Bradford BD1 1LA Dear Mr Merchant, 1st May 2024 Thank you for your Regulation 28 report to prevent future deaths dated 14/11/2023, about the death of Maxwell Frame. I am replying as Minister with responsibility for Health and Secondary Care. Firstly, I would like to say how saddened I was to read of the circumstances of Maxwell Frame’s death, and I offer my sincere condolences to their family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to my attention. Please accept my sincere apologies for the significant delay in responding to this matter. The report raises concerns over the absence of a national policy on the placement of Central Venous Catheter’s (CVC). I understand that although the Trust had in place a local policy for the placement of CVC’s, several doctors who gave evidence at the inquest stated that a national policy would be beneficial. In preparing this response, Departmental officials have made enquiries with the Care Quality Commission (CQC) and the National Institute for Clinical Excellence (NICE). In their published response to your report, NICE cite existing guidance and national safety standards, including; national safety standards for invasive procedures, national CVC Insertion Safety Checklist, as well as guidance on safe vascular access (2016) which recommends the use of ultrasound locating devices for placing CVC’s. The Department understands the guidance on safe vascular access is currently being updated and is due to be published in 2024. These existing standards and guidance should be used to inform local standards developed at the Trust. 1 Your report explains that a landmark approach was taken to the placement of Mr Frames CVC, and that a series of steps were taken which depart from existing guidance and standard practice, including the omission of an ultrasound during placement, despite being available. Your report also describes how standards were in place at the Trust for Central Venous Access Devices, which included steps that should have been taken in this case but were not. I was deeply saddened to read of the circumstances of Mr Frame’s death. The report has prompted careful reflection within my department, and from NICE and other stakeholders involved in the issuing of national clinical guidance as detailed in their responses. However, as you note in your report, the actions taken by the treating clinician departed from already existing national recommendations, NICE guidelines for administering this procedure and the Trusts own policy. I therefore do not consider there is any further action for the Department of Health and Social Care to take at this time. I hope this response is helpful. Thank you for bringing these concerns to my attention. Kind regards, THE RT HON ANDREW STEPHENSON CBE MP MINISTER OF STATE
13th December 2023
NIVAS Response to Regulation 28: Report to Prevent Future Deaths.
To: Mr Peter Merchant, Assistant Coroner for West Yorkshire.
Dear Mr Merchant,
Thank you for your Section 28 letter dated 14th November 2023 relating to the death of a patient
following the accidental placement of a central venous catheter in the common carotid artery.
, are the Chairman and vice-Chairman of NIVAS (National
We,
Infusion and Vascular Access Society) and aim to promote and support best practice in vascular access.
Our membership ranges from vascular access nurses and teams to anaesthetists and operating
department practitioners, interventional radiologists, infusion nurses and teams who all work within
the NHS.
From your description of this case, we identify three failings: failure to use real time ultrasound
guidance during placement of the central venous catheter; failure to identify inadvertent arterial
puncture and cannulation of the common carotid artery; and failure to remove the catheter in a safe
and timely manner.
We are conscious that the placement of central venous catheters is performed by individuals from a
variety of medical backgrounds as well as nurses, which may have implications in delivering guidelines
for the insertion and management of central venous catheters.
NIVAS has not yet published any guidelines specifically concerning the use of real time ultrasound
guidance for central venous catheter insertion or the identification and management of inadvertent
arterial puncture or cannulation although this is planned for 2024. The recognition of arterial puncture
is mentioned in two recent competency documents for tunnelled and totally implanted vascular access
devices which are available for download by our membership.
NIVAS is a strong proponent of real time ultrasound guidance for vascular access devices and has
delivered teaching on this at our annual conference and study days.
We believe that the best current guidance on the subject is “Safe Vascular Access 2016” published by
the Association of Anaesthetists. We are both involved in the revision of this document, the new
edition is scheduled for publication by the Association of Anaesthetists in 2024.
In response to your letter, we will give the subject prominence at our annual conference in June 2024
with a specific lecture dealing with current guidelines, emphasising the importance of real time
ultrasound guidance and the management of accidental arterial cannulation.
Yours sincerely,
NIVAS chairman NIVAS Vice-Chairman
Nurse consultant in IV therapy and Vascular Access
Consultant Anaesthetist
2nd Floor
2 Redman Place
London
E20 1JQ
United Kingdom
10 January 2024
Peter Merchant
HM Assistant Coroner
West Yorkshire Western Coroner Area
Dear Mr Merchant,
Re: Regulation 28 Prevention of Future Deaths Report (Maxwell Grant Frame)
I write in response to your regulation 28 report dated 14 November 2023 regarding the sad
death of Maxwell Grant Frame. I would like to express my sincere condolences to Maxwell’s
family.
We have reflected on the circumstances surrounding Maxwell’s death and the concern
raised in your report, namely the absence of a national policy on the placement of central
venous catheters (CVC).
Senior clinical advisors within the patient safety team here at the National Institute for Health
and Care Excellence (NICE) reviewed this report carefully and took advice from a consultant
in anaesthesia and intensive care medicine.
There are already National safety standards for invasive procedures (NatSSIPs) which
should be used to develop local standards. Based on NatSSIPs, the Intensive Care Society
(ICS) have published an agreed national CVC Insertion Safety Checklist 2023.
Additionally, the Association of Anaesthetists of Great Britain and Ireland (AAGBI) published
guidance in 2016 that makes recommendations on safe vascular access, including on
policies, documentation, training, supervision, the use of ultrasound and of post insertion
checks to improve the recognition of catheter misplacement.
NICE published guidance recommending the use of ultrasound locating devices for placing
central venous catheters [TA49] in 2002. This guidance did not make any recommendation
for placement of CVCs into the subclavian vein as there was a lack of specific evidence for
subclavian placement at the time of publication. Since this guidance was published,
ultrasound use for placement of central lines has become applicable to all sites.
In conclusion, the use of ultrasound in the placement of central lines is standard practice and
has already been recommended in NICE guidance as well as other nationally recognised
publications.
I was saddened to read of the circumstances surrounding Maxwell’s death. However, on this
occasion I do not consider that further NICE guidance in this area would add to existing
national recommendations from relevant professional bodies and standard requirements,
prevent the failure to use ultrasound or to undertake recommended checks in line
placement.
Please do let me know if you require any further information.
Yours sincerely,
Chief Executive
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