Dear Mr Irvine Re: Regulation 28 Report to Prevent Future Deaths I write regarding your letter of regarding your concerns relating to the death of Christine Nakafeero at Newham University Hospital. I hope this letter will provide assurance to you of the steps that we are taking to address the concerns you have outlined. I will respond to these concerns in turn.
1. Patients lost to follow-up on the Gynaecology pathway We are implementing a fully electronic outpatient outcome system using outpatient organiser on our Cerner millennium system. This provides real time outcoming within clinics, and an electronic audit trail to track the patient along the pathway. Alongside the use of electronic outcome forms, the Trust is rolling out LUNA, a digital monitoring tool for patient tracking lists which will replace our current electronic waiting list tool at the end of September 2023. LUNA has the ability to pick up errors allowing staff to make corrections. It has an AI tool that reviews letters for key text which can indicate where incorrect discharge is matched with a letter stating the patient should be seen again. Therefore, this can be corrected, and a follow up appointment sent to the patient .
2. Limitations of the VTE risk assessment You raised concerns that the use of tranexamic acid and the presence of pelvic fibroids may have have limited the national risk assessment tool for prevention of venous thromboembolism although the national tool was used correctly.

The Trust has discussed this matter at the Venous Thromboembolism Prevention Committee and reviewed the available published evidence regarding the relative risk of these two factors and any other available guidance. Current evidence of relative risk is very limited and subject to debate nationally and there are no specific College or National guidelines available dealing with these specific topics. In addition, the Trust has sought advice from who is Professor of Thrombosis and Haemostasis at Kings College Hospital and Director of the National VTE Exemplar Centres Network in England as well as previously Clinical Lead for the National VTE Prevention Programme. The Trust has been advised that the use of the tool was appropriate and at this time there is not enough evidence to adapt or change this. In addition, in a patient who was experiencing recurrent heavy bleeding the use of enoxaparin was not indicated and there was no indication for anti-embolic stockings. The Trust’s VTE committee will continue to monitor the information received from national bodies as part of the overarching vigilance regarding preventable venous thromboembolism. Thank you for bringing your concerns to my attention. I trust that you are assured that I have taken them seriously and that the hospital has investigated them appropriately and is taking appropriate action. Please let me know if you require clarity on any of the points above.

Dear Mr Irvine,

Thank you for the Regulation 28 (Preventing Future Deaths) report of 24th July 2023 in relation to the death of Christine Nakafeero. I am replying as Minister with responsibility for patient safety.

Please accept my sincere apologies for the delay in responding to this matter. I would like to assure you that the Department is mindful of the statutory responsibilities in relation to PFD reports and we are prioritising responses as a matter of urgency.

I would like to begin by saying how saddened I was to read about the circumstances of Ms Nakafeero’s death and would like to offer my sincere condolences to her family and loved ones. It is vital that we learn from incidents where we can to improve NHS care.

I have noted the concerns raised in your report. The first relates to the Trust’s failure to allocate an appointment for Ms Nakafeero to undergo a hysterectomy, coupled with the absence of a clear explanation as to why she slipped out of this care pathway. You also

expressed concern that Ms Nakafeero’s venous-thrombo-embolism (VTE) risk was assessed by utilising an established algorithm based on national guidance but that despite this being done appropriately, it failed to identify two risk factors which made the formation of a deep vein thrombosis more likely.

I understand that the Care Quality Commission (CQC) engaged with Barts Health NHS Trust following Ms Nakafeero death, to understand what actions it was taking to address your concerns. The Trust explained that it was in the process of improving how it monitors outpatient outcomes and how it tracks patients along the pathway. To facilitate this, the Trust confirmed that it was implementing an improved digital monitoring tool for patient tracking lists to replace its electronic waiting list tool. I understand that CQC is monitoring the impact of this implementation and how the Trust assures itself that it is effectively monitoring all patients across care pathways.

The Trust also explained to CQC that it was seeking expert advice from Professor Roopen Arya, Professor of Thrombosis and Haemostasis at King’s College Hospital and Director of the National VTE Exemplar Centres Network in England. Professor Arya advised the Trust that the use of the tool to assess VTE risk and determine intervention was appropriate and that at that time there was insufficient evidence to adapt or change this. I am aware that the Trust is also continuing to monitor the information it received from national bodies that informed how it implements best practice on prevention of VTE.

I would like to assure you that ensuring patients are safe is a priority for this Government. We have taken significant action over the last decade to advance patient safety and the response to harm in the NHS and, with our system partners, will continue to do all we can to stop harmful events from ever happening.

Thank you again for bringing your concerns to my attention.