Dear Mr Gruffydd,

Re: Regulation 28 Response: Mr. Gareth Wynne Tatchell

Thank you for providing Swansea Bay University Health Board with an opportunity to respond to your concerns raised at the conclusion of the inquest of Mr. Gareth Wynne Tatchell, on 26th June 2025.

Before addressing your specific concerns, I would like to extend my sincere condolences to Mr. Tatchell’s family on behalf of Swansea Bay University Health Board (SBUHB). We understand that bereavement and the inquest process can be profoundly difficult for families. Although there has been a considerable time lapse and Swansea Bay University Health Board was not involved in Mr Tatchell's end of life care, our Care After Death service remains available should his family wish to access it. For further information or support, please contact my office.

In terms of the concerns, you have expressed and the assurance you are seeking:

1. There was a delay in both the diagnostic and staging phase and treatment phase contrary to the timescales in the Suspected Cancer Pathway.

While the Health Board has made significant progress in reducing waiting times for cancer, we, along with many Health Boards, are not delivering the timeliness of care as consistently as we would like. The challenges of delivering cancer waiting times is reflected within the Health Board’s Risk Register.

The following actions are in place to address and mitigate this risk:
• Monitoring at an individual patient level is in place with weekly or fortnightly review meetings depending on the specialty.
• There are explicit targets for each stage of the cancer pathway first appointment (10 working days) and Decision to Treat (DTT) by Day 31, DTT to First Definitive Treatment in 32 days. This information is collected for each specialty and reported monthly.
• Action plans for each specialty are in place targeted at addressing areas of non- compliance. Bwrdd Iechyd Prifysgol Bae Abertawe Swansea Bay University Health Board Un Porthfa Talbot | One Talbot Gateway Parc Ynni, Baglan | Baglan Energy Park Port Talbot SA12 7BR

Rydym yn croesawu gohebiaeth yn y Gymraeg neu'r Saesneg. Atebir gohebiaeth Gymraeg yn y Gymraeg, ac ni fydd hyn yn arwain at oedi. We welcome correspondence in Welsh or English. Welsh language correspondence will be replied to in Welsh, and this will not lead to a delay. Cadeirydd/Chair: Jan Williams Prif Weithredwr/Chief Executive: Abigail Harris Pencadlys BIP Bae Abertawe, Un Porthfa Talbot, Port Talbot, SA12 7BR Bwrdd Iechyd Prifysgol Bae Abertawe yw enw gweithredu Bwrdd Iechyd Lleol Prifysgol Bae Abertawe Swansea Bay UHB Headquarters, One Talbot Gateway, Port Talbot, SA12 7BR Swansea Bay University Health Board is the operational name of Swansea Bay University Local Health Board
• Additional support has been provided to histopathology to facilitate improvement in the turnaround times, but this is still an area of considerable challenge for the Health Board.

In order to monitor the effectiveness of the above actions the following assurance mechanisms have been established:
• Development of digital performance dashboard to provide a “live” performance status.
• Escalation meetings are held chaired by the Deputy Chief Operating Officer, Deputy Medial Director and Cancer Lead Clinician as required.
• Monthly performance reported are provided to the Cancer Performance and Information Group (chaired by the Deputy MD) and the Planned Care and Cancer Board (chaired by the Chief Operating Officer).
• Monthly review meetings are in place with Welsh Government to monitor Health Board performance.

The Health Board’s performance for head and neck cancers treated within the 62 days required by the Single Cancer Pathway, varies month on month with on average 60% of patient meeting the target over the last 12 months.

There are currently 148 patients on the head & neck cancer pathway in SBUHB. This includes 16 patients who have been waiting longer than the 62-day target. However, all 16 of these patients’ waiting times have been prolonged due to patient unavailability
- either the result of patient choice or fitness to undergo treatment. Every effort is being made to ensure that their treatment is delivered at the earliest opportunity, taking into account their personal choices and/or the need to ensure that they are well enough to receive treatment.

2. Part of the delays revolve around the time taken to undertake staging scans for the purpose of the diagnostic and staging phase.

We have processes in place that enable us to track all cancer patients’ progress through the pathway. This includes patients who have been referred to regional specialist services in SBUHB from other Health Boards. While we act as the centre for delivery of the specialist care for these patients, diagnostic testing and staging are conducted within their ‘home’ Health Board, as was the case with Mr. Tatchell, who was a resident of Cwm Taf Morgannwg University Health Board (CTMUHB).

Although we do not directly manage elements of the pathway that occur outside SBUHB, we have oversight and liaise closely with the parent Health Board to expedite tests if needed. For example, if a scan has not been booked by Day 5 after a diagnostic referral has been made, the cancer tracking team in SBUHB will reach out either directly to the radiology department of the referring Health Board or contact the local tracking team to escalate on behalf of the patient.

If there is a failure to respond within an appropriate timescale there are clear routes of escalation via the control measures described above and will include Chief Operating Officer level, should it be required.

Rydym yn croesawu gohebiaeth yn y Gymraeg neu'r Saesneg. Atebir gohebiaeth Gymraeg yn y Gymraeg, ac ni fydd hyn yn arwain at oedi. We welcome correspondence in Welsh or English. Welsh language correspondence will be replied to in Welsh, and this will not lead to a delay. Cadeirydd/Chair: Jan Williams Prif Weithredwr/Chief Executive: Abigail Harris Pencadlys BIP Bae Abertawe, Un Porthfa Talbot, Port Talbot, SA12 7BR Bwrdd Iechyd Prifysgol Bae Abertawe yw enw gweithredu Bwrdd Iechyd Lleol Prifysgol Bae Abertawe Swansea Bay UHB Headquarters, One Talbot Gateway, Port Talbot, SA12 7BR Swansea Bay University Health Board is the operational name of Swansea Bay University Local Health Board Recent review of the head & neck single cancer pathway, for patient seen between May 2034 and May 2025 (sample n=50) has confirmed positive compliance against key indicators:
• Urgent suspected cancer referral to 1st Appointment = 8.9 days
• 1st Appointment to Biopsy = 11.5 days
• Referral to Diagnosis = 36.5 days

3. Two Associate Medical Directors have communicated that delays in undertaking staging scans are ongoing and are having an impact on survivability rates and prognoses by making treatable cancers irresectable.

Radiology is a national shortage specialty that can be a challenge for recruitment, this is further compounded when recruiting sub-specialty interest.

Radiology provision to the Head and Neck service is not as robust as the Health Board would like it to be. We have several highly committed clinicians who deliver this specialist service as part of their roles, including three at consultant level and one at Specialty (SAS) Doctor level. We have worked hard to recruit additional staff and there is a continuous process of advertising and re-advertising in place to actively seek suitable applicants. Locum cover was in place until May 2025. We advertised for a replacement, anticipating the locum’s departure, and interviewed two candidates - but were not able to appoint.

Another round of advertisement has been completed, and we have now secured locum cover for 12 months commencing in October 2025. You can be assured that we are making every effort to recruit in a timely way, recognising that there is a challenge across the UK of recruiting into these highly specialised posts.

While we recognise that the actions and improvements described above cannot alter the outcome for Mr. Tatchell and his family, I trust this demonstrates the Health Board’s commitment to addressing the risks identified by his case.

Dear Mr Morris,

RE: Inquest touching on the death of Sasha Drysdale

I set out below the Trust’s response to your letter to Pennine Care NHS Foundation Trust (PCFT) and the issuing of a Prevention of Future Deaths Notice (Regulation
28), arising from the inquest into the death of Sasha Drysdale and the proceeding Judicial Review. May I take this opportunity to extend my own condolences to the family of Sasha and apologise that you had to raise concerns relating to the services she accessed prior to her sad death. The Trust sets out its response to the points below raised by HMC’s as areas of concern: Whilst it is understood regular blood tests represent an important monitoring requirement for patients taking Clozapine in view of the serious potential side effects of neutropenia and particularly agranulocytosis, I am concerned that the emphasis on these complications raises a risk that the potential significance of other abnormal results may not be readily or promptly appreciated or acted upon, and remain overlooked or possibly incorrectly attributed to Clozapine therapy. Full Blood Count monitoring: Leucocyte (white blood cells) and neutrophil monitoring is a mandatory requirement for all patients treated with Clozapine in the UK. Summary of product characteristics: Clozaril In addition to the mandatory white blood cells (WBC) and neutrophil monitoring other full blood count parameters are currently monitored as standard either via Point of care haematological testing (PoCHi) or local lab analysis includingpocH-100i - Products Detail:

• WBC (white blood cells), RBC (red blood cells), HGB (heamoglobin), HCT (haematocrit), MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Haemoglobin), MCHC (Mean Corpuscular Haemoglobin Concentration), PLT (platelets), LYM (#,%) (lymphocytes), MXD (#,%) (mixed white blood cells), NEUT (#,%) (neutrophils), These full blood count (FBC) parameters would be recommended as standard for assessment of haematological cancers Ref: Haematological cancers - recognition and referral | Health topics A to Z | CKS | NICE. Abnormal results, including neutropenia but also other abnormalities in FBC differentials obtained within a community setting are escalated to medical staff for review. Results for inpatient monitoring conducted via local labourites would be review directly by medical staff and appropriate action taken for abnormalities, neutropenia or otherwise. Medical staff would following NICE guidelines Haematological cancers - recognition and referral regardless of the original indication for Full Blood Count investigation. Pharmacovigilance Risk Assessment Committee (PRAC) recommendations for routine blood count monitoring PRAC has recently endorsed a direct healthcare professional communication (DHPC) about revised recommendations for the monitoring of the blood count to minimise the risk of severe neutropenia and agranulocytosis with Clozapine Ref: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 – 10 July 2025 | European Medicines Agency (EMA) New evidence from the scientific literature suggests that, although Clozapine- induced neutropenia can occur at any time during treatment, it is predominantly observed during the first year, with the incidence peaking in the first 18 weeks of treatment. After this the incidence decreases becoming progressively lower after two years of treatment in patients without previous episode of neutropenia. Therefore, PRAC recommended less frequent blood count monitoring. For example, in patients without neutropenia, the frequency of monitoring is reduced to every 12 weeks after one year, and to once a year after two years of treatment. The product information for all Clozapine-containing medicines will be updated to reflect the monitoring frequency for the risk of Clozapine-related agranulocytosis and the revised ANC thresholds for treatment initiation and continuation. This is anticipated in Autumn 2025. The DHPC for Clozapine will be disseminated to healthcare professionals by the marketing authorisation holders in September 2025, and published on the Direct healthcare professional communications page and in national registers in EU Member States. Currently the monitoring requirements for Clozapine within the UK remain unchanged however the emerging evidence for scientific literature is well known by

clinicians and will be circulated clearly to all PCFT prescribers and pharmacists. This will further increase the scrutiny of any abnormal full blood count results in patients on established treatment due to the known unlikelihood of Clozapine as a causative factor. I hope that the information within this response has provided you with the assurance that you were seeking in relation to learning from these events. Should you require any further information or clarification on the details within this letter, please do not hesitate to get in touch with me again.