Cardiology Catheter Laboratory Services

1. Executive Summary Purpose The purpose of this paper is to provide a response to the Regulation 28 Report issued to the Trust by Anna Morris KC, Assistant Coroner for the Coroner Area of Greater Manchester South, on conclusion of the inquest held on 11th September 2025. The response outlines the details of the case, matters of concern raised and the actions to be taken.

Case Summary The inquest relates to a 79-year-old lady who attended Royal Preston Hospital on 20th August 2024, where a reburial of her pacemaker was performed. The procedure was performed without any complications and there was a plan to review her again in two weeks’ time. The Inquest was attended by two cardiology consultants (treating consultant and AAR Clinical Lead). Legal representation was in place for the inquest with pre inquest meetings, preparation and support provided by the Inquest and Mortality Team. In accordance with statutory requirements, the Trust’s response to the Coroner is required to be submitted within 56 days of receipt, by 21st November 2025. Matters of Concern Raised by the Coroner The matters of concern raised by the coroner are as follows:
• International clinical guidance relating to signs of infection were not adhered to;
• There had been a lack of information sharing at LTHTR, with particular reference to there being no evidence that wound swab results were shared with the operating consultant pre procedure, which resulted in a missed opportunity to consider pre-operative planning and wider MDT discussion as to whether the procedure should go ahead. Both issues may have contributed to an extraction process not being undertaken at the earliest opportunity. Action Plan An action plan has been developed by the Division of Medicine which has formed the basis of the response to the coroner and can be found in Appendix 1. Regulation 28 Response A1

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2. Regulation 28

The relevant section from the Regulation 28 report is outlined below with the full Report attached in Appendix 2. Coroner Concerns: taken from Regulation 28
1. Mrs Culshaw attended Wythenshawe Hospital on the 10th July 2024 and presented with an opening of her pacemaker scar. I heard evidence at the inquest from a Consultant Cardiologist at Wythenshawe that International clinical guidance indicates that any opening of an implantation scar should be interpreted as a sign of systemic infection of the wound and that extraction and replacement of the pacemaker should follow in order to remove the infection. This was the advice of the on-call Cardiologist at Wythenshawe on 10th July 2024 to the Emergency Department medical team. I heard evidence that Wythenshawe is one of a limited number of specialist surgical centres for the extraction of pacemakers.
2. Mrs Culshaw was not admitted to Wythenshawe Hospital, but discharged to the care of Royal Preston Hospital, where her pacemaker had been fitted. Royal Preston Hospital is not a specialist surgical centre for pacemaker extraction. I heard that the decision of the Consultant Cardiologist at Royal Preston was to re- position, rather than extract the pacemaker.
3. I heard evidence that on 15th August 2024, a swab from the pacemaker wound tested positive for the Morganella Morganii bacteria, which was also found post-mortem. It is not clear from the evidence who on the surgical team was made aware of this result, and whether it was properly taken into consideration as part of the pre-operative risk assessment. Mrs Culshaw had her pacemaker re-sited on the 20thAugust 2024.
4. I found that Mrs Culshaw’s experience of persistent and prolonged infection depleted her physiological reserve and contributed to her succumbing to a fatal pneumonia on the 25th October 2024.
5. I am concerned that this lack of information sharing of test results, which in this case may have resulted in an extraction process not taking place at the earliest opportunity. Regulation 28 report issued to Manchester At the inquest the Coroner issued a further Regulation 28 report to Manchester University NHS Foundation trust regarding their reliance on the patient to relay clinical information in relation to treatment plans to LTHTR. Whilst this response will primarily focus on the Regulation 28 concerning LTHTR, the Cardiology team are committed to working with Wythenshawe to strengthen communication pathways with tertiary centres.
3. Case Details The case concerns a 79-year-old female patient who was first seen by a cardiology consultant in December 2013, the diagnosis was complete heart block, confirmed on the Electrocardiogram (ECG) as a missed myocardial infarction approximately 5 weeks prior to that consultation. The patient had symptoms of angina, fatigue and dizziness. The patient had a permanent pacemaker implant and diagnostic coronary angiography on 18th December 2013. A dual chamber pacemaker was implanted. The coronary angiography showed a narrowing in the left anterior descending artery, for which arrangements were made for the patient to have coronary intervention at Blackpool A2

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Victoria Hospital (BVH). The pacemaker was implanted locally at Royal Preston Hospital (RPH), and the patient was managed by BVH for recurring intervention for coronary artery disease. The patient was followed up regularly in the pacemaker clinic for the following 10 years until mid-August 2023. In August 2023, the patient’s pacemaker battery was running low, and the patient was admitted for a replacement on 7th November 2023. The procedure was performed by a specialist registrar and was uneventful. In early July 2024, the patient attended Wythenshawe Hospital with signs of infection at the pacemaker site. The patient had a bleeding disorder called idiopathic thrombocytopenic purpura, which contributed to bleeding within the pacemaker pocket and infection. The patient was advised by Wythenshawe Hospital that she should return to RPH, where the procedure had been undertaken. On 16th July 2024, the patient was reviewed by a cardiologist consultant at RPH, who identified there was a 1cm hole in the centre of the wound. The wound was glued, which was deemed to have been appropriate, and the patient was advised to return in one week for a review, possibly a new pacemaker battery or referral to Wythenshawe Hospital for lead explant. The patient was safety netted, and a wound swab taken at the time showed no significant growth and there were no signs of infection. The patient was admitted again to RPH on 23rd July 2024, where her wound around the pacemaker was noted to have appeared much better and there were no signs of infection. The hole was still visible, and the cardiology consultant made the decision to rebury the pacemaker at a deeper level. The patient received antibiotics during and post procedure. The consultant noted everything appeared normal at the site and there was a plan for the patient to return for a follow up appointment in 3 weeks’ time. The patient contacted the catheter laboratory in early August to advise that she could see the pacemaker, and plans were made for her to return. The patient attended RPH on 15th August 2024, where the wound was reviewed and a swab was taken. As the patient did not want to remain in hospital, she went home with a plan for her to return on 20th August 2024. The wound swab result was available on Harris flex from 18th August 2024. On 20th August 2024 a reburial of the pacemaker was performed without any complications and there was a plan to review the patient again in two weeks’ time. The patient was informed that in the case of further breakdowns, a request would be made to Wythenshawe Hospital to explant the entire pacing system for the left pectoral area and to implant a new one on the right side. The patient was discharged home with a two-week prescription of ciprofloxacin in line with the identified sensitivities of the wound swab taken on 15th August 2024. The patient attended an appointment on 3rd September 2024 for a review of her pacemaker, and the review identified that there was no swelling, oozing or breakdown of the scar.

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4. Response to Regulation 28

Initial Actions taken The cardiology team welcome the scrutiny and challenge from HM Coroner. They have reviewed their practices with regard to the reviewing and acting on investigation results and strengthened them where necessary. The inquest proceedings and outcome have been shared with the Cardiac Catheter Laboratory Team to allow for collective reflective practice.

Learning

The Cardiology Catheter Laboratory Team have worked with the Governance Teams to develop a robust result reporting system to ensure the staff are fully informed of any ‘wound swab results’ prior to the commencement of a clinical procedure being undertaken. There is a broader pre-operative assessment process using a standard care pathway booklet that the Catheter laboratory nursing team utilise from the start to the end of the process for procedures. This involves the patient attending for a pre-operative review prior to the day of the procedure including bloods tests and infection control swabs. Any concerns at this appointment are flagged to the consultant who has scheduled the procedure.

An action plan has been developed with a focus on documentation that investigation results are reviewed and shared with the clinical team. The full Action Plan and progress updates are attached as Appendix 1 with summary actions outlined below.

Following the inquest, attempts were made to check access to the patient’s Harris Flex clinical information record to confirm whether or not the Registrar accessed the wound swab result prior to the procedure. Whilst it is evident that there were multiple points of access into the clinical record on the day of the procedure, it is not possible to drill down into whether specific sections of a clinical record (in this case the wound swab result) were accessed.

Summary of actions
• A wound swab tracking document managed by the Cardiology Catheter Laboratory (CCL) team has been strengthened. This includes a daily check, details of results received, and which clinicians have been informed.
• “Wound swab check” has been added to the WHO checklist.1 The WHO checklist is carried out immediately prior to the procedure with the participation of the full team undertaking the procedure.
• The CCL Team will continue to work within the Trust wide Microbiology critical results framework where critical results (such as virulent organisms or those with markers of national concern) are telephoned through to the treating team.

1 The WHO Surgical Safety checklist is a tool developed by the World Health Organization to improve safety during surgical procedures A4

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• The CCL team will continue to follow national guidance that the individual who orders the test is responsible for the result and to communicate this with relevant colleagues caring for the patient as required. The actions are being monitored through Cardiology Governance Meetings, Divisional Safety and Quality meetings and through the PSIRF Oversight Panel. The action plan will also be shared with the wider cardiology consultant body to ensure collective awareness of the learning and confirmation of the agreed processes.

Further Reflection and Continuous Improvement The Regulation 28 has provided an opportunity for further reflection and learning for the Cardiac Catheter Team, who in addition to developing specific actions in response to the coroner concerns raised, have also implemented end of day debriefs to review all cases performed that day. This is a 10-minute reflective session to discuss each case, identify any issues, and discuss continuous learning and on-going quality improvement within the department.

The CCL team are fully committed to embed the actions identified into their everyday clinical practice to prevent a similar incident occurrence.

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Appendix 1 - Action Plan

Note: This action plan combines the actions in response to the Prevention of Future death regulation 28 order and the actions agreed with key stakeholders. Version Updated by Date 1

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Area of Concern Key Actions Action Identified: Evidence Lead Deadline for action Progress Current Status 1 2 3 4

1. The inquest heard evidence that on 15th August 2024, a swab from the pacemaker wound tested positive for the Morganella Morganii bacteria, which was also found post- mortem. It is not clear from the evidence who on the surgical team was made aware of this result, and whether it was properly taken into consideration as part of the pre-operative risk assessment. Review the process of identifying and acknowledging swabs have been taken and results checked.

Regulation 28 Wound Review Checklist

Wound%20Review %20Checklist%20v1.

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Following the incident a ‘wound swab’ document has been updated as part of the pre-operative process. The documentation requires date/times swabs are taken, alongside when results are reviewed. The documentation also requires details of who has been informed of the result. Following results, the clinicians will prescribe the appropriate medications, and this is recorded onto the wound review checklist. The information within the checklists is also recorded onto Harris Flex. The wound review checklists are kept in the Cath Lab in the team’s work list files for the week ahead. Results are looked for daily, until reported, and upon receiving the results, the

Action Plan – Regulation 28 (Cardiology Datix 181528) A6

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2 Local Safety Standards for Invasive Procedures (LocSSIPs) are based on the National Safety Standards for Invasive Procedures (NatSSIPs). Organisations are required to develop LocSSIPs for invasive procedures being undertaken outside of operating theatre environments. 3 NatSSIPs (National Safety Standards for Invasive Procedures) cover all invasive procedures, which can be defined as a procedure that requires piercing the skin to gain access to the inside of a patient’s body, or gaining access to a body cavity without cutting into the body or using electromagnetic radiation. The revised standards (NatSSIPs2) are intended to share the learning and best practice to support multidisciplinary teams and organisations to deliver safer care. consultants/registrars are informed of the results. The updated documentation will be reviewed and approved by the divisional governance committees before being submitted to the Trust Clinical Documentation Group to ensure consistency and standardisation. Add ‘wound swab results’ to the WHO checklist

Regulation 28 WHO checklist

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31.12.25 The WHO checklist is currently in place and audited monthly. (Results on AMAT). ‘Wound swab results’ will be added to the checklist to provide assurance the results are available and alerted to the team prior to a procedure. Awareness of the results will enable the clinician to make an informed decision in regards whether the procedure should continue. Whilst awaiting the form to be re- designed and sent for printing, the team will utilise the use of a ‘sticker’ to enable ‘wound swab results’ to be captured. Going forward the WHO checklist will be incorporated into a wider Trust workstream to standardise LocSSIPs2 across the organisation in line with NATSIPPS23.

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2. There were concerns raised at inquest regarding the lack of information sharing of test results

• Confirm microbiology result reporting protocols. Regulation 28 Bacteriology Authorising Manual Bacteriology authorising manual ve Dr O
20.10.25 Microbiology advise they will telephone through critical results about virulent organisms such as group A streptococcus, or if it is from a normally sterile site, or if the organism has resistant markers of national concern. In this case, it was superficial wound swab with an organism that is known to colonise wet wounds, therefore no Microbiology call to flag the result was required.

• Confirmation of Trust expectations for result access and review via Harris Flex. Regulation 28 Datix Dr C
24.10.25 The Trust follows national guidance that the individual who orders the test is responsible for the result and to communicate this with relevant colleagues caring for the patient as required. The electronic system in place at the Trust does not have a facility to automatically alert the clinician and therefore there is a risk on the risk register (Datix ID 2176) ‘Harris Flex currently does not follow, or support UK medical workflows leading to delay or missed review of Pathology results.’ To mitigate this risk critical inpatient and outpatient results that require immediate attention are communicated directly to clinicians by phone. Pathology results are accessible through the Harris Flex inbox, abnormal or critical findings are flagged

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Appendix 2 Regulation 28 Report LTH Amended Reg 28 - PFD.pdf

based on normal ranges, and interactive care grids highlight trends over time. This risk outlines ongoing IT challenges within Harris Flex, which the IT team is actively addressing. Plans are underway to implement a system that facilitates more obvious and easier result sign-off. Across the ICB a new EPR is being procured. The ‘wound swab’ document implemented as part of this action plan would ensure the results are reviewed and communicated as part of the pre- operative process.

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