Dear Coroner,

Re: Regulation 28 Report to Prevent Future Deaths – Stephen William Cassidy who died on 5 March 2023.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 18 September 2023 concerning the death of Stephen William Cassidy on 5 March 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Stephen’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Stephen’s care have been listened to and reflected upon.

Following several meetings with colleagues at North Bristol Trust (NBT), NHS England offer the following responses to each of the points raised.

1. There was no provision for clinical staff at SMH to access patients’ Summary Care Record routinely or easily.

The Summary Care Record (SCR) have nationally established Pre-requisites for access which are known to organisations. These include:

▪ access to the internet or a Health and Social Care Network (HSCN) connection. ▪ to ensure your organisation has completed a Data Security and Protection Toolkit. (DSPT) self-assessment and or reviewed the latest updates to it. (DSPT - formerly known as the Information Governance Toolkit). ▪ local technical configuration including Identity Agent and NHS Credential Management as per Warranted Environment Specification on all user computers. ▪ an assigned privacy officer for alert and audit purposes when viewing SCR. ▪ agreed local processes to ensure robust governance - when viewing SCR the user is informed of the need to follow the Permission to View guidelines. ▪ to have prepared training for users covering the features the organisation plans to use. The National Care Records Service (NCRS) is the improved successor to the Summary Care Record application that allows health and social care professionals to access and update a range of patient and safeguarding information across regional Integrated Care Services (ICS) boundaries. The service is a web-based application and can be accessed regardless of what IT system an organisation is using, providing a summary of health and care information for care settings where the full patient record is not required to support their direct care. National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

9 November 2023

Access to SCR or NCRS requires a web link which can be bookmarked or added to relevant desktop machines. Alternatively, access can be via a SCR 1-Click/NCRS Integration, which allows local access to the National Care Records Service.

Authentication is required to ensure that only relevant healthcare professionals are able to access special category personal identifiable information / clinical records. Smartcards have been a common method to support authentication and access to Spine services over the last few years for healthcare professionals. Spine allows information to shared securely though national health services such as the Electronic Prescription Services, the Personal Demographics Service, the Summary Care Record and the e-Referral Service.

Staff require a smartcard to authenticate to Spine services, it is however acknowledged that only a limited number of staff at NBT have and carry a smartcard. NHS England are working with NBT to identify suitable alternative solutions to the use of Smartcards.

While NBT staff have access to clinical records for patients who live within the footprint of their local detailed care record, for patients who reside or are registered with a GP outside of this footprint, the National Care Records Service (NCRS) provides a quick, secure way to access national patient information to improve clinical decision making and healthcare outcomes and it is free to use.

2. This was despite provision existing for South West Ambulance clinical staff to do so before a patient arrived at hospital.

It is understood that South West Ambulance Trust have the technical ability to access Spine services including SCR and have embedded organisational procedures to access this information routinely.

A paramedic from South West Ambulance Trust accessed this patient’s SCR and noted that this patient had an allergy to Ceftriaxone in their record. The paramedic included information that this patient had an allergy to Ceftriaxone, in their handover to A&E staff at SMH.

3. There was no provision for the Summary Care Record to be integrated with SMH’s hospital electronic patient record (known as Careflow/Connect) or the primary care electronic patient record (EMIS – Egton Medical Information System) – such that the Ceftriaxone allergy automatically appeared in SMH’s electronic patient record;

NHS England Summary Care Records team and digital safety experts within the National Patient Safety Team have worked collaboratively with North Bristol Trust to discuss and identify suitable options to access SCR.

The implementation of National Care Records Service (NCRS) will address two of these points: ▪ The NCRS Integration ‘Deep Link’ is a quick and easy way of integrating NCRS into local clinical systems.

▪ CIS2 (the authentication mechanism used by NCRS) permits a variety of authentication methods in addition to Smartcards.

SCR is fully integrated with EMIS, a provider GP IT system for 60% of GP Practices in England. EMIS update the data which is displayed in SCR every time the information in the SCR is updated (approximately 1 million updates per day).

In addition, there is the ability to view SCRs within the EMIS system, which multiple practices routinely do to support the care of temporary resident patients and newly registered patients.

The SCR viewing requirements require clinical systems and organisations that consume the SCR to only present the information as human readable and not machine processed i.e., a human must read the information, assimilate this, and transcribe relevant content in the correct way, into their local patient record.

NHS England is committed to other programs of work (e.g., GP Connect / MIG) which are currently delivering solutions that convey allergy information end to end in a machine processable way.

4. As a result none of the emergency department doctors, the trauma and orthopaedics team or the anaesthetist who administered the antibiotic with induction were able to ascertain Mr Cassidy’s Ceftriaxone allergy;

All healthcare providers are required to perform medicines reconciliation during relevant patient contacts. Medicines reconciliation includes obtaining an accurate allergy history for each patient, this requires at least two sources of information e.g., from the patient / carer, and from the SCR.

In the case presented it appears that Mr Cassidy did not self-report the Ceftriaxone allergy or the patient was only able to report vague details about an allergy which could not be matched to a unique drug when they were asked about allergies by NBT staff.

It is recognised that some NBT staff may not have been aware that out of area patients may not have their allergy information recorded on local NBT systems.

5. This led to an avoidable fatal anaphylactic reaction.

NHS England is fully committed to working with provider organisations to improve access to all available sources of critical patient information. I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around preventable deaths are shared across the NHS at both a national and regional level and helps us pay close attention to any emerging trends that may require further review and action.

Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.

Dear Dr Fox, Re: Regulation 28 Prevention of Future Deaths report following Inquest into the death of Stephen Cassidy I write further to the Regulation 28 report, dated 19th September 2023, issued as a result of the inquest into the death of Mr Stephen Cassidy. North Bristol NHS Trust offers the following responses to the points raised: a) There is no provision for clinical staff at SMH to access patients Summary Care Record (SCR) routinely or easily.

North Bristol NHS Trust (NBT) moved to Careflow EPR in July 2022 and changed its authentication method from Smartcard-based to password-based authentication. The routine use of smartcards since then has declined as they are not required for access to NBT local systems, or to the wider primary care interface – Connecting Care. Since the receipt of the Regulation 28 report, the following actions have been taken and planned:

1. Non-smartcard-based access to NCRS (National Care Record Service): Following discussions with NHSE, NBT IT team have explored access to the new NCRS with existing authentication protocols without having to use Smartcards. This has already been trialled successfully for a pilot cohort, and after a planned limited clinical deployment we would be in a position to make access available to all Trust staff in the first quarter of 2024. This would allow staff to access the NCRS from any browser by using the Microsoft authenticator app and without having to use a Smartcard.

2. One-click/in-context access to NCRS: The ability to access the SCR (and its follower NCRS) in context unfortunately could not be deployed in 2022 at the time of the move to Careflow owing to technical incompatibilities. Following discussions, the IT teams of NHSE, NBT, and System C (producers of Careflow) have had a meeting on the 6th of November to agree a way forward on integration, and the Director of IT at NBT has communicated the requirement to System C so

that this at the highest priority for rapid deployment. This is a complex piece of integration work which requires System C, NBT, and NHSE to align digitally, the pathway was agreed in the last meeting and we are aiming for its completion in the first half of 2024.

3. Smartcard use in NBT: The majority of NBT staff have active Smartcards even though they are not required for access to Careflow EPR. Following the issuance of the Trust safety alert in April 2023 which encouraged staff to access the NCRS/SCR we requested NHSE interrogate access requests and they could confirm that the NCRS was accessed 3,810 times and SCR 2,787 times from NBT since 17th April 2023, with 473 access events for NCRS in the week of 23 October
2023. In the same week the SCR (which can only be accessed with a Smartcard) was accessed 356 times. NHSE were further able to confirm that in the 12 months leading up to October 2023 SCR was accessed from NBT using Smartcards on 30,247 occasions. While we are unable to audit the details of such access, the data confirms that Smartcard use in NBT for accessing NCRS and SCR remains frequent, making information visible to clinicians upon request.

b) This is despite provision existing for SWAS clinical staff to do so before a patient arrives at hospital.

SWASFT access the SCR on a regular basis and populate this information in their documentation. NBT have implemented a process by means of which the ambulance handover letter is printed and scanned into the Electronic Database Management System (EDMS) upon arrival of the patient. All information from the ambulance handover is therefore available to clinicians within minutes after arrival of the patient by ambulance. Safety alerts encourage clinical staff to access the information from EDMS and from Connecting Care, in addition to seeking it from the patient or their relatives, and if an allergy is identified they are expected to add it as an alert to Careflow which then remains visible to clinical staff. This process is now reflected in policies published on the NBT Intranet. Since April 2023, the recording of allergy related alerts in Careflow is audited and has seen a 500% increase in recording of such alerts compared to the preceding period prior to the alert and change in process.

c) There was no provision for the Summary Care Record to be integrated with SMH’s hospital electronic patient record (known as Careflow/Connect) or the primary care electronic patient record (EMIS – Egton Medical Information System) – such that the Ceftriaxone allergy automatically appeared in SMH’s electronic patient record.

We have addressed the progress towards integration of SCR/NCRS in-context in a) 2. The ability to populate alerts across systems was discussed in meetings with NHSE in October, however this poses significant logistical challenges in definition of data points and creation a ‘single source of truth’ across systems. NHSE are aware of the challenges faced and will be best placed to address the specific question of ‘seamless integration’ of EPR systems across England spanning primary and secondary care.

d) As a result, none of the emergency department doctors, the trauma and orthopaedics team or the anaesthetist who administered the antibiotic with induction were able to ascertain Mr Cassidy’s Ceftriaxone allergy.

Until we achieve seamless access to the NCRS, we have taken the following actions:

1. Clarified to staff about the requirements to ascertain allergy information from a minimum of two sources and updated the trust guidelines to reflect this.
2. Actions to be taken to record and communicate allergy alerts in Careflow along with simple guidelines on how to do this have been communicated and reinforced with reminders by email, face to face, and in safety bulletins.
3. Face to face teaching on this topic has been provided to junior doctors in their teaching sessions by the Pharmacy team.
4. We have worked closely with the ICB and the Connecting Care team, they have updated their system to provide clear advice if Connecting Care is unable to reflect the information contained in the NCRS/SCR/EMIS to "Connecting Care cannot display information on this patient at this time, PLEASE access this information from the National Summary Care Record (NCRS) by accessing the NHS Spine Portal".

e) This can lead to avoidable patient harm including death.

NBT recognises the cross system digital processes and human factors which contributed to this tragic avoidable death.

In addition to the work set out above to improve accessibility to the NCRS/SCR, NBT are also working on two other projects:

1. Electronic Prescribing and Medicines Administration (EPMA) – EPMA systems have been demonstrated to reduce medication error across healthcare. NBT have commissioned the implementation of this system, with plans for this to be deployed in the third quarter of 2024. In addition to providing safeguards to medical prescribing, this will also serve as a repository for allergy information across the trust.

2. Red Wrist Bands – We have completed a scoping exercise for deployment of ‘Red Wrist Bands’ for patients with allergy alerts. This is designed to be a ‘human factor’ intervention to bring forth an appreciation for recognition of allergy or similar alerts. This is in business planning stage, and we hope to implement this by the third quarter of 2024.

I hope you will take some assurance from this letter setting out our response in relation to the concerning points that you made in your Regulation 28 report.