Dear Andrew,

Thank you for the Regulation 28 report of 31 May 2024 sent to the Department of Health and Social Care about the death of Ms. Glennis Connolly. I am replying as the Minister with responsibility for data in the NHS, on behalf of the Secretary of State for Health and Social Care.

Firstly, I would like to say how saddened I was to read of the circumstances of Ms. Connolly’s death. I offer my sincere condolences to her family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to the attention of myself and the Department.

The report raises concerns over the fact that the Queens Hospital Burton Upon Trent and the Royal Derby Hospital have different electronic patient record systems, although governed by the same hospital trust. Entries made by the renal team at the Royal Derby Hospital were not automatically visible to medical staff at the Queens Hospital, and information on allergies did not automatically cross populate despite entries being made on the Lorenzo system and the GP records being updated.

In preparing this response, Departmental officials have made enquiries with NHS England and the Care Quality Commission (CQC).

As you may be aware, NHS England has been supporting NHS Trusts and Foundation Trusts in acquiring and developing the effectiveness of their electronic patient records, with funding and support available to bring trusts to an optimum level of digital maturity.

The Queens Hospital Burton Upon Trent and the Royal Derby Hospital had secured their own electronic patient records independently when they were governed by separate trusts. Following their organisational merger, University Hospitals of Derby and Burton NHS Foundation Trust undertook to connect data to ensure patients could be identified across the two systems and information appropriately shared to support effective care. The failure of information sharing in respect to Ms. Connelly’s treatment was clearly in part due to the challenge of still having two systems. The action needed to address this, which I am assured is underway, is for the hospitals to move to convergence and the Trust to have a single

electronic patient record system within the next two years. A provider has already been identified. This is a clinically assured process, with NHS England clinicians scrutinising the plans and support provided, to ensure safe implementation, as required by the Information Standard DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems (DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems - NHS England Digital).

More widely within the NHS the One Digital Estate programme will deliver increasing electronic patient record convergence and connection between hospital provider systems, and its implementation will be subject to clinical quality assurance, both centrally, and in the local trusts which are required to have the appropriate leadership, governance and capacity to safely deliver.

Where there is any death or serious injury at a provider or service registered by the CQC, the CQC will consider this in line with their specific incident guidance to identify if a patient has suffered avoidable harm or they were placed at significant risk of avoidable harm. This includes when there are issues relating to digital systems, and a specific incident review would consider the role of the system, as well as the registered providers involved.

Since receiving this Regulation 28 Report, the CQC has followed its usual processes and has reached out to the Trust requesting information on this death, alongside any response the Trust issued to yourself as HM Coroner. This information will be used in the decision making when considering the matter as a specific incident and if any further actions need to be taken by the CQC. The CQC continue to monitor this Trust through its usual regulatory powers.

I understand that the University Hospitals of Derby and Burton NHS Foundation Trust will be separately responding to the report and commenting on specific local action in their response.

I hope this response is helpful. Thank you for bringing these concerns to my attention.

Dear Sir

Glennis Connelly: Regulation 28 Report Response

I am writing in response to the Regulation 28 Report dated 31 May 2024, following the Inquest into Glennis Connelly's sad death.

At the outset, and in the knowledge that her family will read this report, I want to first begin by reiterating the Trust's condolences and offering my own. I am deeply sorry for the errors made in the care we delivered.

Scope

Within your report, you identified the following concern:

"Although the Queens Hospital Burton Upon Trent and the Royal Derby Hospital are governed by the same hospital trust, they have different electronic patient records. Entries made by the renal team at the Royal Derby Hospital are not automatically visible to medical staff at the Queens Hospital, "allergies" do not automatically cross populate despite entries being made on the Lorenzo system and the GP records being updated on 6th & 12th February 2020."

Event Summary

The broad circumstances summarised were:

• In October 2016 Ms Connelly had Tazocin without noted issue.
• In October 2019 Ms Connelly during an admission for pneumonia it was noted that she suffered a deterioration in kidney function with an impression of interstitial nephritis, but of uncertain cause. Tazocin was not identified as PRIVATE & CONFIDENTIAL Mr Andrew R Barkley HM Senior Coroner for Staffordshire & Stoke-on-Trent Stoke Town Hall Kingsway Staffordshire ST4 1HH Our Ref:

Your Ref:

the definitive cause at this stage and further investigations were initiated and her clinical condition improved.
• In January 2020 Ms Connelly was admitted with respiratory problems, amongst other treatments, received Tazocin. Due to her renal function deterioration she was escalated to the Trust's Derby site and with the benefit of this admission and the repeat association with Tazocin, the diagnosis of Tubulo-Interstitial Nephritis (TIN) due to an underlying Tazocin allergy was arrived at. The GP was updated, as standard, upon discharge. The Derby site's electronic record system was also updated.
• In September 2022 Ms Connelly was admitted to the Trust's Burton site and, as heard at inquest, was changed to a prescription of Tazocin. The Burton system did not have the recorded Tazocin allergy and the Summary Care Record (GP summary information) was not effectively interrogated.

Trust Response

At the time of the incident we immediately investigated the circumstances surrounding the death of Ms Connelly, culminating in a full patient safety review. This acknowledged that the Trust operates two electronic patient systems arising from the merger of the two organisations. Our actions arising from this and our wider considerations have included:

1. Electronic Patient Record systems ("EPR")

Whilst the incident was multifactorial, the unification of the EPR systems is something the Trust is working hard to remedy. As noted, the Trust currently has two enterprise wide systems which include all patient administrative and clinical functionality, appointments, waiting lists, test results, medications, emergency care, maternity and clinical noting.

Implementing an entirely new system is not a small undertaking. It is important to get this right for the five hospital sites now and into the future. These EPR systems are not created by the Trust, but rather bought under contracting arrangements with their associated contractual periods, support and shelf life. As was heard at inquest, it has not been possible to extend one of the existing systems to the whole site as they need to function effectively across all specialisms. In the case of one system it is reaching the end of its support life. Any system has to be then integrated into the wider Trust in a safe way, operating alongside our other systems.

Pending implementation of a unified system, the Trust has created a Master Patient Index, enabling us to create a patient context link from each EPR to the other, meaning that staff would be able to click a link to be taken to a mobile version of the other EPR/ eCasenote systems without needing to log in or search for the patient again. Similarly, access was created to link to the GP surgery held Summary Care Record (SCR). Patients have to agree to share their information on SCR in order for the information to be accessible.

However, acknowledging the need for a unified system, we initiated the process of identifying what the needs of the wider Trust would be now and into the future. This is an incredibly large and complex piece of work, requiring engagement of clinical

colleagues from across the Trust. Following initial work the identify needs, the plan was approved by the Trust Board and we went out to market.

For such a large project, this required significant capital investment and NHS England were also at the time embarking on a programme of work to fund EPR replacement systems nationally. Our competitive tender was published in April 2023, followed by supplier demonstrations, briefing sessions, engagement sessions and culminating in a decision in October 2023.

This whole process involved 130 clinicians and operational staff within the procurement process and then also required secured capital investment from NHS England for £65million, granted on 27 March 2024. We signed the contract with our preferred provider on 16 April 2024 and now have a staged implementation across the Trust over the next 18 to 24 months, which has already commenced. We have also liaised with other Trusts within the region as to their systems and the needs for the future. There is a potential additional benefit of aligned systems aiding information sharing.

Our first phase of the rollout is planned to include the allergies, sensitivities and adverse reactions function.

This therefore represents a Trust wide and fundamental change in the way our systems operate. It requires careful implementation to ensure the safety of the immediate changes being made, allowing people to learn and work with the new system, but also provides us with an effective system for the future. It will enable us to link in to a greater extent with regional health sector organisations and will drive forward wider system improvements for the future.

2. Pharmacy Reconciliation

Acknowledging that a wholesale EPR change takes time to tender for, develop and implement, we have sought to improve our interim solutions. We already have a medicines reconciliation process, but arising directly from Ms Connelly's case, we implemented a specific pharmacy prompt to staff to compare allergies, sensitivities and adverse reactions with the GP SCR. Alongside our wider awareness raising, we hope this prompt will deliver real impact arising from the circumstances of this incident.

We also plan to audit against the wider medicines reconciliation process starting in the next quarter and will be conducted every six months until such time that our new EPR system is fully implemented. This will include an assessment of whether the patient's allergy status has been recorded correctly. The medicines reconciliation process includes checking both systems.

3. Trust wide shared learning

The Trust is large, employing over 14,000 people through a variety of very busy clinical services. However, appreciating that incidents can occur in a variety of different settings, we have sought to drive forward wider learning across the organisation. These steps included:

• An article specific to Ms Connelly's case was written and posted on the Trust's intranet page. This is available across all sites, all divisions and all specialities.
• We published the learning article through the all-staff bulletin sent out Trust wide.
• Our Medical Director sent out a bulletin to the whole medical workforce.
• We developed a screen saver, shown on every computer screen in the Trust.
• We developed a desktop banner highlighting the importance of the Summary Care Record and confirming allergy status. This is shown on every computer screen in the Trust.
• Discussed the incident at the Trust's leadership meeting, highlighting the importance of obtaining information directly from the GP systems.
• Case discussion at the Divisional Day agenda with a presentation on "discordant allergy recording on two electronic patient records"

4. Setting up an allergy working group

An allergy working group was set up which is made up of clinical and non-clinical digital staff, alongside the Chief Nursing Informatics Officer, Pharmacy, and the Trust Improvement Team. Their objective is to ensure robust systems are in place to manage allergies and alerts.

5. Medical clerking changes

Medical clerking is an important initial step on a patient journey through the hospital and represents a key opportunity to capture relevant clinical history. We would always ask a patient about relevant history, including allergy information but analysing Ms Connelly's case we felt that this is a better opportunity to check allergy information, rather than expecting a doctor to read all available information on the system or external systems during a busy ward round. As such we added a prompt to both EPRs to each clerking forms to prompt the user to check the patient's SCR. All assessing clinicians are expected to check this regardless of the patient provided information.

To support in the delivery of this we have reviewed and amended the training scripts for both EPRs, specifically referencing that the two systems do not automatically talk to one another.

We have also implemented a new quick reference guide covering how the SCR can be accessed and includes a link to NHSE information and eLearning/Assessment via the new NCRS section on the Digital Services Hub.

6. Allergy card for TIN The Renal team have already developed alert cards to be given to patients who have Tubulointerstitial Nephritis (TIN) because of a known allergy to a medication. The patient can carry this alert card to alert clinicians involved in their care of the adverse reaction they have experienced to certain medications.

We acknowledge that working on two different EPRs is not how we wish to deliver our services. We have worked hard to deliver on an entirely new system, including a £65million investment covering all sites. This will take time to implement safely but in the meantime we have sought to mitigate the risk with the efforts above. We hope that this provides assurance that we are doing all we can pending implementation of the new EPR.