Maxwell Frame

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.

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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.

Dear Mr Merchant,

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.

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