Thrombectomy

Executive Summary

The purpose of this paper is to provide a response to the Regulation 28 report issued to the Trust by HM Senior Coroner Mr Christopher Long on conclusion of the inquest of Ms Michelle Mason held on 27th & 28th May 2025.

Regulation 28

The Regulation 28 report was issued to: NHS England. Northern Care Alliance NHS Foundation Trust. Lancashire Teaching Hospitals (LTHTR). The Coroner’s matters of concern are as follows:
1. NHS England national service specifications provide for a 24/7 thrombectomy service which is not currently being delivered in Lancashire and there is no clear plan to deliver that service.

2. There is a lack of understanding from non-stroke specialist clinicians in Lancashire as to when and where thrombectomy services are available for patients in Lancashire.

3. There is no mutual aid regionally, even where thrombectomy is available, clinically appropriate, it is known lack the procedure is likely to result in death and it is anticipated resources are available to complete the procedure.

1.Background and context The LTHTR Mechanical Thrombectomy (MT) service has undergone significant development evolving from a 5- day, in-hours service to a 7-day service with extended evening cover. The Trust acknowledges the coroner’s concerns that more could have been done sooner and recognises the importance of delivering a fully compliant 24/7 service in line with national expectations. Initially, the service operated Monday to Friday between 08:00 and 18.00, with expansion constrained by recruitment and job planning challenges. Through focused recruitment and planning, the service achieved reliable 7-day coverage from 3 August 2024 (although not for Bank Holidays), with the majority weekend shifts staffed either by substantive Neurointerventional Radiologists (NIRs) or supported by locum cover however there were some gaps until the 2nd January when all weekends have been covered. This marked a key milestone in improving access and resilience. Recognising the need to further extend hours, the Trust engaged in prolonged discussions with the NIR team and other speciality teams involved in delivering the service to support evening expansion. From 6th May 2025, Regulation 28 Response

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the service began operating into the evening delivering 7 days per week including Bank Holidays with cover until 22:00 with some occasional gaps due to workforce availability, supported by collaborative working across Anaesthetics, Theatres, and Radiology. From 13 June 2025 cover have been consistently achieved from 08.00-
22.00 (referral cut off times are 20.00 for all sites with the exception of Barrow at 19.30). This has been achieved by flexible use of existing staff rotas, interim arrangements with Anaesthetic and Theatre teams, and a shared commitment across departments to maximise available NIR clinical time. As a result of these improvements, NHS England has confirmed that the current 7-day, 08:00–22:00 service at LTHTR enables the Northwest region to meet approximately 97% of clinical demand for thrombectomy. However, a gap remains in overnight provision (22:00–08:00). While there is currently no formal mutual aid agreement in place with neighbouring centres, and no confirmed rota agreement yet from the NIR team for overnight cover, the Trust is actively addressing this through:
• Ongoing negotiations with the NIR team to agree a sustainable 24/7 rota.
• Finalisation of a business case to be agreed with NHSE to support the required infrastructure and workforce;
• Continued recruitment across Anaesthetics, Radiology, and Radiography;
• Development of operational readiness for overnight theatre and recovery services. These actions form part of a clear and accountable plan to implement a fully operational 24/7 thrombectomy service by 28 February 2026, ensuring equitable access for all patients across Lancashire and South Cumbria. There is a commitment to starting this sooner if staff can be recruited to enable this.

2.Response to Regulation 28

Coroner’s concern 1. NHS England national service specifications provide for a 24/7 thrombectomy service which is not currently being delivered in Lancashire and there is no clear plan to deliver that service. Response This response will include details of service provision prior to 27th May 2025 when the inquest took place, progress from 28th May 2025 to the current date, and proposed actions going forwards. Weekend service development Initially a weekend service from 08.00-18.00 was in place from July 2023 to April 2024, when the service was suspended due to concerns regarding the sustainability of the rota. Consistent weekend service was provided from 3rd August 2024, delivered by four substantive NIRs on a 1 in 6 rota, with two weekends requiring locum cover. Following the recruitment of a 5th and 6th NIR, the service has maintained full weekend coverage since January 2025, with bank holiday cover consistently in place since the 6th May 2025 with the hours extending until 22.00. Current job planning supports a 1 in 8 weekend rota, with two weekends out of eight not formally job planned. These gaps have been mitigated through a combination of internal flexibility and locum support, ensuring full weekend coverage throughout the published rota, which currently extends to the end of October 2025. Evening service expansion Prior to May 2025 the service concluded at 18:00. Following extended discussions with the NIR team, agreement was reached in April 2025 to extend the service to 22:00, with implementation beginning on 6th May 2025. Initial

3

cover was limited to 21:00 due to theatre workforce constraints, but since 13 June 2025, the service has consistently operated until 22:00. This was made possible through collaborative working across Anaesthetics, Theatres, and Radiology, and interim arrangements to support later finish times.

Progress since 28th May 2025 to 18th July 2025 and forward planning While progress has been made with evening and weekend expansion, a 24/7 service is not yet in place. The barriers are multi-factorial and include:
• Ongoing negotiations with the NIR team, who have concerns around workload and sustainability with a high on-call frequency.
• Without confirmation of the NIR rota the 24/7 business case cannot be fully completed and approved.
• Incomplete recruitment and rota changes for Anaesthetic and Theatre staff.
• Radiographer shift planning still in progress.
• Operational readiness of overnight theatre and recovery services. Recent work has focused on the following issues:
• Negotiation with NIRs to facilitate progression to a 24/7 service
• Business case considerations
• Collaborative working across specialties within our own trust (flexible anaesthetic working and theatre scheduling)
• Development of staffing and recruitment plan for anaesthetic cover
• Radiographer shift planning.
• Development of operational readiness of overnight theatre and recovery services.

Collaborative working across LTHTR specialties The agreement to extend service hours to 22:00 came earlier than anticipated. As a result, Anaesthetic and Theatre teams were required to adapt at short notice. On 13th June 2025, it was agreed that any mechanical thrombectomy cases presenting outside scheduled hours or expected to run beyond 22:00 would be booked as Category 1 in emergency theatres, ensuring optimal use of NIR clinical time. NIR engagement and Business Case Development A meeting held on the 27th June with national stakeholders, including the Chair of the United Kingdom Neuro- Interventional Group (UKNG), explored national models for 24/7 service delivery and shared sample rota structures. The NIR team were asked to provide feedback on preferred rota models and job plan implications, with a response received in the week commencing 21st July 2025. In the response the NIRs have suggested a rota model which would allow for a 24/7 service on a 1 in 8 basis. As the proposal involves modifications to their other duties, this requires evaluation by the Radiology Management Team and further negotiation with the NIRs to ensure the safe and sustainable delivery of all radiology services involving the NIRs. This is expected to be completed by 31st August 2025. There are currently 6 NIR Consultants in post and a Vascular Interventional Radiologist in upskill training, which will bring the compliment to 7 in 12- 18 months. The Trust will aim to have the 24/7 service in place by 28th February 2026, with gaps supported with internal and external locum cover until a full complement of staff is achieved.

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The Trust acknowledges that any solution must be sustainable and safe and is committed to working with the NIR team to address the impact on other clinical duties. The business case for 24/7 expansion is being finalised and will include: NIR job planning As described above Radiographer shift planning Radiographer shift planning is underway with a planned go live date of 28th February 2026. A formal consultation process is in progress and is expected to be completed by 31st October 2025. Recruitment Recruitment to both Radiology and Anaesthetic posts is ongoing and is expected to be completed by December
2025. Progress against these actions will be monitored on a monthly basis by the executive management team and an earlier start date will be considered if possible. Coroner’s concern 2. There is a lack of understanding from non-stroke specialist clinicians in Lancashire as to when and where thrombectomy services are available for patients in Lancashire. Response The Trust acknowledges this concern and has taken steps to improve awareness and clarity across the system. The stakeholder communications policy has been updated to reflect the current operational hours of the mechanical thrombectomy service. This update has been broadened to include non-stroke clinical teams across the region, ensuring that all relevant clinicians are informed of when and where thrombectomy is available. The updated document was issued on 13th June 2025 and disseminated through formal communications channels, including via Chief Operating Officers in July 2025. The Trust will continue to reinforce the communication and monitor understanding and awareness through feedback mechanisms and will refresh communications as the service evolves.

Coroner’s Concern 3.

There is no mutual aid regionally, even where thrombectomy is available, clinically appropriate, it is known lack the procedure is likely to result in death and it is anticipated resources are available to complete the procedure. Response The Trust fully recognises the critical importance of regional aid to ensure timely access to thrombectomy for patients in Lancashire and South Cumbria, particularly during the overnight period (22:00–08:00) when local provision is not yet available. Following receipt of the Regulation 28 notice, the Trust has escalated efforts to establish regional aid arrangements with neighbouring centres. Actions taken include Direct contact by the LTHTR Chief Operating Officer with Salford Royal Hospital, and CEO-to-CEO correspondence issued to both Salford Royal Hospital and The Walton Centre, formally requesting regional support.

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Progress to Date: Salford Royal Hospital responded positively, and a meeting was held on 15th July 2025, with participation from the Northwest Medical Director for Commissioning. This was a constructive discussion that outlined the key requirements and challenges for regional aid. Key areas discussed included:
• Risk assessment of the impact on Salford’s existing services, particularly anaesthetics (who also support major trauma), equipment availability, and the effect of additional out-of-hours activity on daytime elective capacity. LTHTR has provided modelled thrombectomy activity data, estimating an average of 2 cases per week, to support this assessment.
• Assurance that LTHTR is actively progressing toward its own 24/7 service, with a clear implementation plan.
• Referral pathway to be managed via the Stroke team, not directly through the NIR team.
• Access to imaging – discussions are ongoing to ensure timely and secure image sharing.
• Repatriation – LTHTR anticipates no issues with timely repatriation of patient’s post-procedure. The Walton Centre also responded positively on 15th July 2025, and a regional meeting involving all three organisations has been scheduled by 22 August 2025 to progress a coordinated regional aid approach. The Trust is committed to working collaboratively with regional partners to ensure that no patient is denied access to lifesaving thrombectomy due to geography or time of day. These discussions are being supported at the highest levels and will continue to be prioritised until a formal agreement is in place. Progress against this will be monitored by the Trust Chief Executive on a monthly basis.

Action Plan Actions outlined above are summarised in Table 1 at Appendix 1.

3.Governance and Risk Management

LTHTR has worked with Governance Teams and Medical Examiners from neighbouring trusts to develop a robust reporting system to ensure that all cases which would have been referred to LTHTR for consideration of thrombectomy out of hours if the service was available, are entered onto incident management systems and communicated across organisations. This allows such cases to be subject to a specialist LTHTR panel review supported by stroke specialists and NIRs to establish the level of harm for each patient and allows for monitoring and reporting to relevant Trust committees.

The absence of a 24/7 thrombectomy service is formally recorded on the Trust Risk Register and is subject to regular review and oversight by the Trust Risk Management Group which is chaired by the Trust Chief Executive Officer.

4.Summary

A target date of 28th February 2026 has been set for the provision of a 24/7 mechanical thrombectomy service at LTHTR. Once rota and job plans are confirmed with the NIR team, supporting actions across Anaesthetics, Radiography, and Theatres are in place to enable a smooth transition. The Trust has issued updated communications regarding current mechanical thrombectomy service hours to all referring organisations across Lancashire and South Cumbria.

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Some progress has recently been made regarding regional agreements to provide regional aid during the interim period with no foreseeable difficulties in LTHTR complying with the requirements set by Salford Royal Hospital. A regional meeting is scheduled for the 22nd August to consider this further. Lancashire Teaching Hospitals (LTH) remain the provider of the mechanical thrombectomy service for Lancashire and South Cumbria (L&SC) and remain wholly committed to providing a 24/7 service, by working with all relevant specialties within the Trust and collaborative working with colleagues across the NW region.

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 Diagnostics and Clinical Support (DCS) 17/07/2025 2 Director DCS 21/07/2025 3 manager DCS 21/07/2025 Ref Area of Concern Key Actions Lead Deadline for action Progress Update

Current Status 1 2 3 4

1.
1) NHS England national service specifications provide for a 24/7 thrombectomy service which is not currently being delivered in Lancashire and there is no clear plan to deliver that service Confirm 24/7 Mechanical Thrombectomy Service Start Date within LTHTr Divisional Management Team (DMT) DCS 31st August 2025 Target date for implementation confirmed as 28th Feb 2026

NIR rota and job plan to be developed and agreed Clinical Director (CD) for radiology 31st August 2025 Rota model to be finalised to support the planned 28th Feb 2026 date of 24/7 service provision with NIR’s,

Consultation process with Radiography Team to progress to 24/7 service provision Professional lead for radiology 31st October 2025 The radiographer shift planning process, along with the corresponding consultation activities, is currently in progress in preparation for the scheduled go-live date on 28th February 2025

Action Plan – Regulation 28 (Thrombectomy service)

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Ref Area of Concern Key Actions Lead Deadline for action Progress Update

Current Status 1 2 3 4

Agree Consultant Rota and proposed job plans CD for radiology / DMT DCS 31st August 2025 Agreement to be reached with the consultant workforce to implement 1:8 rota is currently being negotiated

Recruit to vacant Radiology posts DMT for DCS 31st December 2025 Recruitment ongoing

Recruit to Anaesthetic posts DMT for Surgery 31st December 2025 Recruitment ongoing

2. There is a lack of understanding from non-stroke specialist clinicians in Lancashire as to when and where thrombectomy services are available for patients in Lancashire Issue clear procedural communications to key clinical stakeholders Trust communicati ons team 13th June 2025 The stakeholder communications policy has been updated to reflect the current operational hours of the Mechanical Thrombectomy (MT) service.

Issue follow up communication for assurance through Chief Operating Officers network Chief Operating Officers (COO) communicati ons 21st July 2025 Communication issued on 13th June 2025 and disseminated through formal communications channels via Chief Operating Officers in July 2025.

3. There is no mutual aid regionally, even where thrombectomy is available, clinically appropriate, it is known Initiate COO level contact to seek potential regional support options from Salford. LTHTR COO 20th June 2025 Direct contact by the LTHTR Chief Operating Officer with Salford Royal Hospital.

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Ref Area of Concern Key Actions Lead Deadline for action Progress Update

Current Status 1 2 3 4

lack the procedure is likely to result in death and it is anticipated resources are available to complete the procedure. Initiate regional Chief Executive level contact to seek potential regional support options from Salford Royal Hospital and The Walton Centre. Trust CEO contact 10th July 2025 CEO-to-CEO. Correspondence issued to both Salford Royal Hospital and The Walton Centre, formally requesting regional support

Mobilise initial conversation with Salford Royal Hospital to scope regional aid options DMT for DCS 15th July 2025 Meeting held on 15th July 2025 with Salford Royal and participation from the North West Medical Director for Commissioning. Impact assessment for Salford service undertaken.

Convene regional stakeholder scoping meeting with Salford Royal Hospital and The Walton Centre DMT for DCS By 22nd August 2025 Agreement for engagement gained – meeting to be convened

Thrombectomy

Executive Summary

The purpose of this paper is to provide a response to the Regulation 28 report issued to the Trust by HM Senior Coroner Mr Christopher Long on conclusion of the inquest of Ms Michelle Mason held on 2nd June 2025.

Regulation 28

The Regulation 28 report was issued to: NHS England. Northern Care Alliance NHS Foundation Trust. Lancashire Teaching Hospitals (LTHTR). The Coroner’s matters of concern are as follows:
1. NHS England national service specifications provide for a 24/7 thrombectomy service which is not currently being delivered in Lancashire and there is no clear plan to deliver that service.

2. There is a lack of understanding from non-stroke specialist clinicians in Lancashire as to when and where thrombectomy services are available for patients in Lancashire.

3. There is no mutual aid regionally, even where thrombectomy is available, clinically appropriate, it is known lack the procedure is likely to result in death and it is anticipated resources are available to complete the procedure.

1.Background and context The LTHTR Mechanical Thrombectomy (MT) service has undergone significant development evolving from a 5- day, in-hours service to a 7-day service with extended evening cover. The Trust acknowledges the coroner’s concerns that more could have been done sooner and recognises the importance of delivering a fully compliant 24/7 service in line with national expectations. Initially, the service operated Monday to Friday between 08:00 and 18.00, with expansion constrained by recruitment and job planning challenges. Through focused recruitment and planning, the service achieved reliable 7-day coverage from 3 August 2024 (although not for Bank Holidays), with the majority weekend shifts staffed either by substantive Neurointerventional Radiologists (NIRs) or supported by locum cover however there were some gaps until the 2nd January when all weekends have been covered. This marked a key milestone in improving access and resilience. Recognising the need to further extend hours, the Trust engaged in prolonged discussions with the NIR team and other speciality teams involved in delivering the service to support evening expansion. From 6th May 2025, Regulation 28 Response

2

the service began operating into the evening delivering 7 days per week including Bank Holidays with cover until 22:00 with some occasional gaps due to workforce availability, supported by collaborative working across Anaesthetics, Theatres, and Radiology. From 13 June 2025 cover have been consistently achieved from 08.00-
22.00 (referral cut off times are 20.00 for all sites with the exception of Barrow at 19.30). This has been achieved by flexible use of existing staff rotas, interim arrangements with Anaesthetic and Theatre teams, and a shared commitment across departments to maximise available NIR clinical time. As a result of these improvements, NHS England has confirmed that the current 7-day, 08:00–22:00 service at LTHTR enables the Northwest region to meet approximately 97% of clinical demand for thrombectomy. However, a gap remains in overnight provision (22:00–08:00). While there is currently no formal mutual aid agreement in place with neighbouring centres, and no confirmed rota agreement yet from the NIR team for overnight cover, the Trust is actively addressing this through:
• Ongoing negotiations with the NIR team to agree a sustainable 24/7 rota.
• Finalisation of a business case to be agreed with NHSE to support the required infrastructure and workforce;
• Continued recruitment across Anaesthetics, Radiology, and Radiography;
• Development of operational readiness for overnight theatre and recovery services. These actions form part of a clear and accountable plan to implement a fully operational 24/7 thrombectomy service by 28 February 2026, ensuring equitable access for all patients across Lancashire and South Cumbria. There is a commitment to starting this sooner if staff can be recruited to enable this.

2.Response to Regulation 28

Coroner’s concern 1. NHS England national service specifications provide for a 24/7 thrombectomy service which is not currently being delivered in Lancashire and there is no clear plan to deliver that service. Response This response will include details of service provision prior to 2nd June 2025 when the inquest took place, progress from 2nd June to the current date, and proposed actions going forwards. Weekend service development Initially a weekend service from 08.00-18.00 was in place from July 2023 to April 2024, when the service was suspended due to concerns regarding the sustainability of the rota. Consistent weekend service was provided from 3rd August 2024, delivered by four substantive NIRs on a 1 in 6 rota, with two weekends requiring locum cover. Following the recruitment of a 5th and 6th NIR, the service has maintained full weekend coverage since January 2025, with bank holiday cover consistently in place since the 6th May 2025 with the hours extending until 22.00. Current job planning supports a 1 in 8 weekend rota, with two weekends out of eight not formally job planned. These gaps have been mitigated through a combination of internal flexibility and locum support, ensuring full weekend coverage throughout the published rota, which currently extends to the end of October 2025. Evening service expansion Prior to May 2025 the service concluded at 18:00. Following extended discussions with the NIR team, agreement was reached in April 2025 to extend the service to 22:00, with implementation beginning on 6th May 2025. Initial

3

cover was limited to 21:00 due to theatre workforce constraints, but since 13 June 2025, the service has consistently operated until 22:00. This was made possible through collaborative working across Anaesthetics, Theatres, and Radiology, and interim arrangements to support later finish times.

Progress since 2nd June to 18th July 2025 and forward planning While progress has been made with evening and weekend expansion, a 24/7 service is not yet in place. The barriers are multi-factorial and include:
• Ongoing negotiations with the NIR team, who have concerns around workload and sustainability with a high on-call frequency.
• Without confirmation of the NIR rota the 24/7 business case cannot be fully completed and approved.
• Incomplete recruitment and rota changes for Anaesthetic and Theatre staff.
• Radiographer shift planning still in progress.
• Operational readiness of overnight theatre and recovery services. Recent work has focused on the following issues:
• Negotiation with NIRs to facilitate progression to a 24/7 service
• Business case considerations
• Collaborative working across specialties within our own trust (flexible anaesthetic working and theatre scheduling)
• Development of staffing and recruitment plan for anaesthetic cover
• Radiographer shift planning.
• Development of operational readiness of overnight theatre and recovery services.

Collaborative working across LTHTR specialties The agreement to extend service hours to 22:00 came earlier than anticipated. As a result, Anaesthetic and Theatre teams were required to adapt at short notice. On 13th June 2025, it was agreed that any mechanical thrombectomy cases presenting outside scheduled hours or expected to run beyond 22:00 would be booked as Category 1 in emergency theatres, ensuring optimal use of NIR clinical time. NIR engagement and Business Case Development A meeting held on the 27th June with national stakeholders, including the Chair of the United Kingdom Neuro- Interventional Group (UKNG), explored national models for 24/7 service delivery and shared sample rota structures. The NIR team were asked to provide feedback on preferred rota models and job plan implications, with a response received in the week commencing 21st July 2025. In the response the NIRs have suggested a rota model which would allow for a 24/7 service on a 1 in 8 basis. As the proposal involves modifications to their other duties, this requires evaluation by the Radiology Management Team and further negotiation with the NIRs to ensure the safe and sustainable delivery of all radiology services involving the NIRs. This is expected to be completed by 31st August 2025. There are currently 6 NIR Consultants in post and a Vascular Interventional Radiologist in upskill training, which will bring the compliment to 7 in 12- 18 months. The Trust will aim to have the 24/7 service in place by 28th February 2026, with gaps supported with internal and external locum cover until a full complement of staff is achieved.

4

The Trust acknowledges that any solution must be sustainable and safe and is committed to working with the NIR team to address the impact on other clinical duties. The business case for 24/7 expansion is being finalised and will include: NIR job planning As described above Radiographer shift planning Radiographer shift planning is underway with a planned go live date of 28th February 2026. A formal consultation process is in progress and is expected to be completed by 31st October 2025. Recruitment Recruitment to both Radiology and Anaesthetic posts is ongoing and is expected to be completed by December
2025. Progress against these actions will be monitored on a monthly basis by the executive management team and an earlier start date will be considered if possible. Coroner’s concern 2. There is a lack of understanding from non-stroke specialist clinicians in Lancashire as to when and where thrombectomy services are available for patients in Lancashire. Response The Trust acknowledges this concern and has taken steps to improve awareness and clarity across the system. The stakeholder communications policy has been updated to reflect the current operational hours of the mechanical thrombectomy service. This update has been broadened to include non-stroke clinical teams across the region, ensuring that all relevant clinicians are informed of when and where thrombectomy is available. The updated document was issued on 13th June 2025 and disseminated through formal communications channels, including via Chief Operating Officers in July 2025. The Trust will continue to reinforce the communication and monitor understanding and awareness through feedback mechanisms and will refresh communications as the service evolves.

Coroner’s Concern 3.

There is no mutual aid regionally, even where thrombectomy is available, clinically appropriate, it is known lack the procedure is likely to result in death and it is anticipated resources are available to complete the procedure. Response The Trust fully recognises the critical importance of regional aid to ensure timely access to thrombectomy for patients in Lancashire and South Cumbria, particularly during the overnight period (22:00–08:00) when local provision is not yet available. Following receipt of the Regulation 28 notice, the Trust has escalated efforts to establish regional aid arrangements with neighbouring centres. Actions taken include Direct contact by the LTHTR Chief Operating Officer with Salford Royal Hospital, and CEO-to-CEO correspondence issued to both Salford Royal Hospital and The Walton Centre, formally requesting regional support.

5

Progress to Date: Salford Royal Hospital responded positively, and a meeting was held on 15th July 2025, with participation from the Northwest Medical Director for Commissioning. This was a constructive discussion that outlined the key requirements and challenges for regional aid. Key areas discussed included:
• Risk assessment of the impact on Salford’s existing services, particularly anaesthetics (who also support major trauma), equipment availability, and the effect of additional out-of-hours activity on daytime elective capacity. LTHTR has provided modelled thrombectomy activity data, estimating an average of 2 cases per week, to support this assessment.
• Assurance that LTHTR is actively progressing toward its own 24/7 service, with a clear implementation plan.
• Referral pathway to be managed via the Stroke team, not directly through the NIR team.
• Access to imaging – discussions are ongoing to ensure timely and secure image sharing.
• Repatriation – LTHTR anticipates no issues with timely repatriation of patient’s post-procedure. The Walton Centre also responded positively on 15th July 2025, and a regional meeting involving all three organisations has been scheduled by 22 August 2025 to progress a coordinated regional aid approach. The Trust is committed to working collaboratively with regional partners to ensure that no patient is denied access to lifesaving thrombectomy due to geography or time of day. These discussions are being supported at the highest levels and will continue to be prioritised until a formal agreement is in place. Progress against this will be monitored by the Trust Chief Executive on a monthly basis.

Action Plan Actions outlined above are summarised in Table 1 at Appendix 1.

3.Governance and Risk Management

LTHTR has worked with Governance Teams and Medical Examiners from neighbouring trusts to develop a robust reporting system to ensure that all cases which would have been referred to LTHTR for consideration of thrombectomy out of hours if the service was available, are entered onto incident management systems and communicated across organisations. This allows such cases to be subject to a specialist LTHTR panel review supported by stroke specialists and NIRs to establish the level of harm for each patient and allows for monitoring and reporting to relevant Trust committees.

The absence of a 24/7 thrombectomy service is formally recorded on the Trust Risk Register and is subject to regular review and oversight by the Trust Risk Management Group which is chaired by the Trust Chief Executive Officer.

4.Summary

The current arrangements at LTHTR provide mechanical thrombectomy services to the population of Lancashire and South Cumbria between the hours of 08:00 – 22:00 seven days per week. NHS England has confirmed that the current 7-day, 08:00–22:00 service at LTHTR enables the Northwest region to meet approximately 97% of clinical demand for thrombectomy.

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Outside of these hours, owing to the fragility of services and logistical challenges across the North West, there is currently no agreement to provide mutual aid from Manchester or Liverpool. There has been an initial meeting chaired by the Medical Director for North West specialised commissioning at NHS England and a further date has been agreed to discuss progressing this further on 22nd August 2025. The Trust has issued updated communications regarding current mechanical thrombectomy service hours to all referring organisations across Lancashire and South Cumbria. A target date of 28th February 2026 has been set for the provision of a 24/7 mechanical thrombectomy service at LTHTR. Once rota and job plans are confirmed with the NIR team, supporting actions across Anaesthetics, Radiography, and Theatres are in place to enable a smooth transition. This date will be brought forward if we are able to recruit suitably trained staff earlier than plan. The plan outlined will continue to be monitored by the Chief Executive on a monthly basis through the Executive Management Team meeting.

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 Diagnostics and Clinical Support (DCS) 17/07/2025 2 Divisional Nurse Director DCS 21/07/2025 3 Clinical Business manager DCS 21/07/2025 Ref Area of Concern Key Actions Lead Deadline for action Progress Update

Current Status 1 2 3 4

1.
1) NHS England national service specifications provide for a 24/7 thrombectomy service which is not currently being delivered in Lancashire and there is no clear plan to deliver that service Confirm 24/7 Mechanical Thrombectomy Service Start Date within LTHTr Divisional Management Team (DMT) DCS 31st August 2025 Target date for implementation confirmed as 28th Feb 2026

NIR rota and job plan to be developed and agreed Clinical Director (CD) for radiology 31st August 2025 Rota model to be finalised to support the planned 28th Feb 2026 date of 24/7 service provision with NIR’s,

Consultation process with Radiography Team to progress to 24/7 service provision Professional lead for radiology 31st October 2025 The radiographer shift planning process, along with the corresponding consultation activities, is currently in progress in preparation for the scheduled go-live date on 28th February 2025

Action Plan – Regulation 28 (Thrombectomy service)

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Ref Area of Concern Key Actions Lead Deadline for action Progress Update

Current Status 1 2 3 4

Agree Consultant Rota and proposed job plans CD for radiology / DMT DCS 31st August 2025 Agreement to be reached with the consultant workforce to implement 1:8 rota is currently being negotiated

Recruit to vacant Radiology posts DMT for DCS 31st December 2025 Recruitment ongoing

Recruit to Anaesthetic posts DMT for Surgery 31st December 2025 Recruitment ongoing

2. There is a lack of understanding from non-stroke specialist clinicians in Lancashire as to when and where thrombectomy services are available for patients in Lancashire Issue clear procedural communications to key clinical stakeholders Trust communicati ons team 13th June 2025 The stakeholder communications policy has been updated to reflect the current operational hours of the Mechanical Thrombectomy (MT) service.

Issue follow up communication for assurance through Chief Operating Officers network Chief Operating Officers (COO) communicati ons 21st July 2025 Communication issued on 13th June 2025 and disseminated through formal communications channels via Chief Operating Officers in July 2025.

3. There is no mutual aid regionally, even where thrombectomy is available, clinically appropriate, it is known Initiate COO level contact to seek potential regional support options from Salford. LTHTR COO 20th June 2025 Direct contact by the LTHTR Chief Operating Officer with Salford Royal Hospital.

9

Ref Area of Concern Key Actions Lead Deadline for action Progress Update

Current Status 1 2 3 4

lack the procedure is likely to result in death and it is anticipated resources are available to complete the procedure. Initiate regional Chief Executive level contact to seek potential regional support options from Salford Royal Hospital and The Walton Centre. Trust CEO contact 10th July 2025 CEO-to-CEO. Correspondence issued to both Salford Royal Hospital and The Walton Centre, formally requesting regional support

Mobilise initial conversation with Salford Royal Hospital to scope regional aid options DMT for DCS 15th July 2025 Meeting held on 15th July 2025 with Salford Royal and participation from the North West Medical Director for Commissioning. Impact assessment for Salford service undertaken.

Convene regional stakeholder scoping meeting with Salford Royal Hospital and The Walton Centre DMT for DCS By 22nd August 2025 Agreement for engagement gained – meeting to be convened

Dear Mr Long, Re: Regulation 28 Report to Prevent Future Deaths – Michelle Julie Marie Michaela Mason who died on 1 June 2024

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 2 June 2025 concerning the death of Michelle Julie Marie Michaela Mason on 1 June 2024. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Michelle’s family and loved ones. NHS England is keen to assure the family and yourself that the concerns raised about Michelle’s care, both during the inquest and as set out within your Report, have been listened to and reflected upon.

Your Report raised concerns that there is no 24/7 thrombectomy service currently available in Lancashire, that there is a lack of understanding from non-stroke specialist clinicians in Lancashire as to when and where thrombectomy services are available, and that there are no regional mutual aid arrangements.

NHS England has liaised with Lancashire & South Cumbria Integrated Care Board (ICB) regarding your Report. Stroke thrombectomy services are now a delegated specialised service and, since 1 April 2024, Lancashire & South Cumbria ICB has been the responsible commissioner for the region rather than NHS England. Whilst NHS England was previously responsible for commissioning (funding) stroke thrombectomy services, the responsibility for providing this service rests with the Trusts in each region.

It remains a priority, both nationally and regionally, for all commissioned Comprehensive Stroke Centres (CSCs) to provide a 24/7 thrombectomy service, regardless of a patient’s location. This has proved challenging in certain areas for a variety of reasons. In particular, the ability of services to expand and operate 24/7 is heavily reliant on recruiting the necessary specialist workforce with appropriate competencies.

Before responding to each of the concerns in your Report, it is relevant to note that not all ischaemic stroke patients are suitable for thrombectomy. The NHS Long Term National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

4 August 2025

Plan, published in January 2019, previously set an ambition for 10% of stroke patients to receive thrombectomy treatment (based on there being approximately 80,000 stroke admissions per year, and up to 8,000 of these patients potentially being eligible for thrombectomy). For those eligible patients with a large vessel occlusion to the anterior circulation, there is generally a 6 hour time interval from the onset of stroke symptoms to perform thrombectomy. Delivering treatment successfully depends on a number of factors, including timely diagnosis, conveyance to a CSC within the 6 hour timeframe, and the CSC’s operating hours and available workforce to perform the procedure.

Availability of a 24/7 thrombectomy service in Lancashire

As your Report references, the national service specification for mechanical thrombectomy recognises a requirement for sufficient clinical staff with appropriate competencies to be in place to achieve a 24/7 service at centre level. It also acknowledges that an extended 7 day service is acceptable as a developmental step towards full 24/7 coverage, recognising that most eligible stroke patients present for treatment between 8am and midnight.

The key challenge from a workforce perspective is having a sufficient number of Interventional Neuroradiologists (INRs) in place to deliver the service, alongside Specialist Radiographers and Stroke Consultants. The role of an INR previously involved working from 9am to 5pm on weekdays only, and therefore the workforce was initially much smaller than that required to achieve a fully operational 24/7 service nationally.

Stroke care in England is delivered via 20 Integrated Stroke Delivery Networks (ISDNs), of which Lancashire & South Cumbria is one, which have been in place since 2021/21. The work of the ISDNs is primarily focused on quality improvement and monitoring performance across the whole of the stroke management pathway. ISDNs report into their regional Stroke Board and work closely with the Stroke Association and colleagues across the health system. ISDNs are hosted in provider Trusts.

Currently, 12 of the 24 CSCs across the 20 ISDNs have a 24/7 thrombectomy service in place. In the North West, NHS England’s Regional Specialised Commissioning Team have been focused on work with Lancashire Teaching Hospitals NHS Foundation Trust (LTH) on the sustainable delivery of a 7 day service. LTH had previously been delivering a 7 day service until April 2024 when, due to staffing issues, they regressed to a Monday to Friday weekday service, moving back to 7 days in August 2024 on a six weekend in eight basis. The Regional Specialised Commissioning Team have, through dialogue and formal contractual levers, been following this up with LTH to improve this position and, as a result, the service has gradually expanded. From May 2025, the service has operated consistently on a 7 day basis (between the hours of 8am and 10pm) and NHS England continues to work with LTH in sustaining this service. Work is also ongoing to achieve 24/7 coverage for the region and two alternative delivery options are being pursued to achieve this. These approaches are:

(i) LTH extends their service operating hours to cover the 10pm-8am gap; (ii) Delivery of a 10pm-8am thrombectomy ‘out of hours’ service is undertaken in one centre, covering the three ISDN footprints in the North West region.

Awareness of non-stroke clinicians

LTH implemented a Standard Operating Procedure (SOP) for communication about the availability of thrombectomy services with stakeholders in September 2024, and this was a clinician-led communication.

Upon reflection, it appears that the cascade mechanism for this communication is not as effective as it needs to be. NHS England’s North West Regional Specialised Commissioning Team have suggested that LTH should engage their internal communications to ensure the robustness of this communication, and to link with the Regional Communications Team for support as needed.

Mechanical Thrombectomy as a treatment for Ischaemic Stroke formed part of the portfolio of specialised services which were delegated to ICBs in the North West Region on 1 April 2024. Under delegation arrangements, ICBs are responsible but not directly accountable for the planning and commissioning of specialised services. They exercise their delegated functions through a single specialised commissioning team for the region, which at present is still hosted by NHS England. Assurance that the above has been actioned will be gained through regional assurance meetings.

Mutual aid

In order to ensure equal access for the population across the North West region, the North West’s Medical Director for Commissioning is supporting an options appraisal to consider the best model that supports outcomes for patients, whilst making the most effective use of resources. As set out above, the options currently being considered are for LTH to move to a 24/7 service or for the population of Lancashire & South Cumbria to have access to the service elsewhere in the region during nighttime hours (10pm to 8am).

National service development and improvements

Since January 2021, the national stroke programme has been engaging with the General Medical Council (GMC) and Royal College of Radiologists to support the development of a thrombectomy credentialing programme, including enabling non- INRs, such as Neurosurgeons, Stroke Physicians and Cardiologists, to be trained and supported to perform thrombectomy and address the workforce gap. The GMC credential was published in June 2023. A substantial amount of revenue funding has since been made available to deliver the credentialing programme and the first cohort of trainees have already been enrolled and started the credential. The trainees are completing the credential alongside their full-time NHS employment in their main speciality, but it is hoped that some will be signed off within the next year. There have also been non-INRs, such as Interventional Radiologists, who have developed the skill of delivering mechanical thrombectomy and have joined the workforce in some units outside of this new route / credential.

I would also like to advise you that, alongside the national quality improvement programme, further work to ensure the ongoing service development of mechanical thrombectomy services has been supported by a programme of NHS England site

visits, led personally by my predecessor and our National Clinical Director for Stroke Medicine, . During 2024, they visited every CSC in England to understand the local barriers and successes, support quality improvement, bring together the wider thrombectomy stakeholders to discuss collaborative opportunities and provide specific, jointly agreed, measurable actions for each centre. Each CSC was given a list of recommended actions in order to improve access to thrombectomy, focusing on pre-hospital video triage, ensuring timely diagnostic pathways, encouraging training for non-INRs and optimising all training opportunities generally to increase the workforce, developing repatriation policies to ensure that centres always have free beds, collaborating between units, and data accuracy. 12 CSCs have received second visits during 2025, to reflect on the uptake of actions.

Following their visit to the CSCs at Royal Preston Hospital, Salford Royal and the Walton Centre in April 2025, and issued a letter in June 2025 to LTH, the Northern Care Alliance NHS Foundation Trust, and the Walton Centre NHS Foundation Trust. This outlined their recommendation that an urgent review of mechanical thrombectomy provision within the North West is undertaken by commissioners, and set out their expectation that a fully operational 24/7 service is achievable at the Preston site by October 2025.

I would also like to provide further assurances on the 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 events, such as the sad death of Michelle, are shared across the NHS at both a national and regional level and helps us to 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 Mr Long

Inquest into the death of Michelle Mason

Thank you for bringing your concerns about the availability of thrombectomy services across Lancashire and Cumbria to my attention in your Preventing Future Deaths Report, dated 2 June 2025.

I was saddened to read the circumstances of Ms Mason‘s death and would like to start by offering my condolences to her family. I would also like to emphasise our commitment to working collaboratively with partners across the Northwest (NW) to ensure 24/7 provision is available for all patients across the region.

Matters of Concern

The matters of concern that you raised are: “(1) NHS England national service specifications provide for a 24/7 thrombectomy service which is not currently being delivered in Lancashire and there is no clear plan to deliver that service (2) There is a lack of understanding from non-stroke specialist clinicians in Lancashire as to when and where thrombectomy services are available for patients in Lancashire (3) There is no mutual aid regionally, even where thrombectomy is available, clinically appropriate, it is known lack the procedure is likely to result in death and it is anticipated resources are available to complete the procedure. ”

Response

Matters of Concern 1 and 2:

The Northern Care Alliance NHS Foundation Trust (“the Trust”) is commissioned to provide mechanical thrombectomy services across Greater Manchester. The Trust is not in a position to respond to the first and second areas of concern.

Matter of Concern 3:

I understand that evidence was given to the Inquest that a transfer to Salford Royal Hospital for a thrombectomy was not an option for Ms Mason, as she was unfortunately outside of the time critical clinical window for the procedure.

Geography and transfer times are a critical consideration for thrombectomy services. Every hour of delay from stroke onset to treatment equates to a 10% loss of function and the geographical catchment for services takes this into consideration. Transfer times from Lancashire and Cumbria make the provision of thrombectomy at Salford Royal Hospital within the clinically required timeframes for this population challenging to achieve, with potential impact on patient outcomes. Access to imaging is critical to facilitating the rapid clinical decision-making required for safe, timely care. For patients in the Lancashire and South Cumbria catchment, this is not currently available to our clinicians. I believe this also applies to provision by the Walton Centre for Neurology and Neurosurgery NHS Foundation Trust in Liverpool.

These challenges are recognised by NHS England (“NHSE”) and are the subject of ongoing discussions. It is our understanding that the service provided from Royal Preston Hospital now covers 7 days per week, 8am – 10pm. The team here at Northern Care Alliance will continue to work with NHSE, Lancashire Teaching Hospitals and the Walton Centre to explore options to provide the Lancashire and South Cumbria catchment with access to this service overnight. A meeting between the Trust, NHSE and Lancashire Teaching Hospitals took place on 15 July 2025 to discuss this, where possible options for providing aid overnight were explored. Follow-up meetings will include representation from all NW thrombectomy providers to ensure all possibilities are thoroughly explored and will aim to progress plans and clarify timelines. We will work with our clinicians to support this process.

Our thrombectomy service is based at Salford Royal Hospital and is an integral part of stroke services for the population of Greater Manchester. It has developed over many years to ensure quality and resilience; and is the largest service in the country outside London. We are working closely with Professor Stephen Powis (National Medical Director of NHSE England) and Dr David Hargroves (National Clinical Director for Stroke) to further expand capacity and to improve the resilience of equipment infrastructure.

As Chief Executive of the Northern Care Alliance NHS Foundation Trust, I commit to continuing to support the discussions with other key stakeholders to help improve access to thrombectomy services for all patients across the North-West, while maintaining quality and long-term sustainability.

Dear Mr Long

Thank you for granting the Trust a short extension to respond to your request for confirmation as to the steps being taken to ensure that staff clearly understand what thrombectomy services are available. Please accept this message as the further information requested.

The Clinical Lead for Emergency Medicine at Royal Lancaster Infirmary (RLI) has advised that learning from Michelle’s case and feedback from the inquest have been shared with the team by email and on the WhatsApp group. The RLI Emergency Department (ED) Service Manager has confirmed that the case was also discussed at the ED monthly clinical governance meeting.

Royal Preston Hospital (RPH) provides details of thrombectomy service hours via a weekly email. For UHMB, this has previously been sent to the Stroke Service Manager and the Matron for the Emergency Department at RLI but the RLI ED Service Manager has spoken with RPH to request a wider distribution to ensure everyone is sighted. The operational hours are shared with the WhatsApp group. It is also printed and added to the doctors’ huddle folder and the daily ED huddle sheet for sharing with the team every morning. The huddles are short meetings held for communication purposes. The handover sheets are a structured record of the key issues in relation to patient care and staffing. Copies are attached above for reference. The RLI ED Service Manager, or deputy, also sends the thrombectomy service hours along with the weekend staffing lists, which are emailed out to the team every Friday.

From a nursing perspective, the service times have been shared with all staff and each individual member of the team is being spoken to and a record kept of the date and time when this is done. It has also been added to the nursing handover. Since the inquest, a "Thrombectomy hours" wipe clean board in the ED has been implemented, which the stroke nurses have agreed to update daily.

The UHMB Stroke team is available from 08:00 to 20:00 to facilitate access to thrombectomy and UHMB stroke nurses are on duty when the service is operational and are familiar with the arrangements.

I hope this information provides the reassurance required but if you would like anything further, please do not hesitate to contact me.

Yours sincerely

From:

Sent: 25 June 2025 18:26 To: ;

Cc: ;

Subject: Re: Your ref: Our ref:

Granted

Mr Christopher Long HM Senior Coroner Lancashire and Blackburn with Darwen

From:

Sent: Wednesday, June 25, 2025 6:14:01 PM To: Cc:

Subject: Your ref: Our ref:

Dear Mr Long I was informed that following the inquest touching the death of MM, you had some outstanding concerns about how clearly staff at University Hospitals of Morecambe Bay NHS Trust (UHMB) understood what thrombectomy services are available. I understand that witnesses gave evidence that the Trust was taking steps to address this and you asked that the Trust confirm what steps were being taken, within 28 days.

I have been provided with some relevant information to share with you but am waiting for clarification on a couple of points that weren’t entirely clear to me as a non-clinician, so I write to ask if you would be kind enough to agree to the extension of the 28 day deadline until the end of this week please?