Dear Mr Pemberton, Thank you for your Regulation 28 report dated 4 April 2025 following the inquest into the death of Hailey Anne Thompson. On behalf of SSP Health and Ashton Medical Centre, I wish to express our deepest sympathies to Hailey’s family and our sincere thanks for the opportunity to reflect on this tragic event. We consider safety and quality of care to be of upmost importance and paramount in our ethos and culture. We acknowledge the concerns raised regarding care navigation, governance, and communication processes, and would like to take this opportunity to provide assurances of the processes that are embedded into the practice. We note that you state that you concluded that the concerns you raised did not contribute to the death and would also point out that the structures and operating procedures which are used at the surgery are consistent with those used in the vast majority of doctors surgeries in the UK. As a result, we would ask you to consider if a Regulation 28 Report is appropriate in these circumstances. Below is our response structured around the key issues raised.
1. During the course of evidence, an issue was explored regarding Hailey’s mother attempting to obtain an appointment or advice with the GP surgery following an apparent allergic reaction to prescribed antibiotics. These had been prescribed on 7 December for tonsilitis but stopped after three days due to an apparent allergic reaction.
2. During a call to the GP surgery, Hailey’s mother spoke with an administrative member of staff (who at the inquest was referred to as a care navigator at a call centre). The staff member referred an appointment to a pharmacist working with the practice to call her.

Practice Response:
• Our pharmacists do not prescribe for children. This has been further reinforced within our teams and further formalised in a policy, preventing pharmacists who work with the practice from issuing or altering antibiotics or medications for children, except when stated explicitly in consultant letters.
• Our receptionists, who are also known as care navigators, receive care navigation training during their induction. They take calls across several of our practices for standardisation.
• The nature and skills of our receptionists are consistent with the vast majority of doctors surgeries in the UK and in line with regulation and contract requirements. Action:
• Our centralised competencies register is under review for all clinical staff, including pharmacists, which will be distributed to care navigation teams and reviewed biannually.
• In addition to regular training and updates, pharmacists employed by the practice have further support from our Director of Clinical Operations.

3. The pharmacist to whom this was assigned was not competent to deal with a paediatric medication enquiry and sent a message back advising of this, albeit not on the medical records system where an auditable trail would exist. On the evidence, the pharmacist was not provided with feedback directly on the need to use the medical records system or involved in the lessons learned process as they were not directly employed by the practice.

Practice Response:
• (Pharmacist) was not known to be involved at the first SEA (Significant Event Analysis) but has since participated in reflective supervision discussions with the Lead Pharmacist, where she reaffirmed her position on not prescribing for children.
• Supervision records provided by (Lead Pharmacist) confirm multiple group and individual reviews between 2021 and 2025, which will now explicitly include any involvement in significant events.
• The policy further ensures that administrative staff follow standard processes to reduce error.

• Instant messaging is not permitted for clinical communication by regulation. All communication must be logged through auditable systems, as per our Queries and Task SOP. A clause is visible on the screen message stating this to serve as a reminder. Action Taken:
• We have conducted a review of our Clinical Correspondence Management SOP and Queries and Task SOP (Attachment 1 & Attachment 2).
• We have reinforced the requirement for auditable documentation across all communication channels.
4. A further concern arose during the course of evidence from the primary care practice manager that a care navigator may not have a clear pathway on whom to refer a task or action to, or triage tool to recognise that a reported allergic reaction to a medication may require urgent consideration by a doctor to assess any risk of anaphylactic shock.

Practice Response:
• Ashton Medical Centre have a clear pathway of whom to refer a task to, action and triage tools that would recognise an allergic reaction or ‘red flag’ symptom. These tools are in the form of guidance sheets which are available to all admin staff at their desks, SOPs which are available in paper format and electronic copies held on the practices drive. All staff are trained on these at induction and regularly reminded.
• Clarification: Phenoxymethylpenicillin was prescribed on Wednesday 7th December 2022, and the medication was stopped on Saturday 10th December 2022. Contact was made by telephone with the practice on Monday 12th December 2022, approximately two days after the last dose and five days after initiation. Given that anaphylaxis typically occurs within minutes to hours of exposure, it is extremely unlikely that a reaction requiring emergency escalation could have occurred at this point. Delayed onset anaphylaxis is exceedingly rare and would not typically present more than 24 hours after the last exposure to the allergen.
• All clinical tasks must be completed same day where possible, with oversight from the Practice Manager and Assistant Practice Manager.
5. No evidence to explain:
a. how a patient telephoning the practice and being answered by the call centre would be referred to the urgent triage doctor on duty at the practice.
b. whether a list of clinician competencies and whom to refer tasks to was held
c. Care Navigator training
d. Algorithms or policies that apply to assist care navigator / call handlers at a centre which is not located within the doctor surgery.

Practice Response:
• All staff working in the contact centre receive the same induction and training as those based within our practices. They are very much part of our team. This includes training in care navigation, immediate and emergency procedures, and other key operational protocols.
• The nature and skills of our care navigator is consistent with the vast majority of doctors surgeries in the UK, regulations and contract requirements.
• Contact centre staff have access to real-time information via OneNote, a visible system which contains essential details specific to each practice they support - such as the availability and competencies of clinicians.
• In addition, all call handlers are provided with relevant policies and procedures, including those for care navigation, our children’s access policy, protocols for identifying and managing immediate and emergency conditions, and emergency escalation processes.
• If an urgent call is received and no appointments remain available, the call handler will contact the practice directly to seek a suitable solution.
• Please find attached evidence to support the processes followed including: Care Navigation Training & Information (Attachment 3) Practice crib sheet (Attachment 4) Call Handler Induction (Attachment 5) Conditions & Exclusions for referral to pharmacists (Attachment 6) Chest Pain Protocol (attachment 7) Emergency Handling Flowchart (Attachment 8) Immediate & Life Threatening Conditions Protocol (Attachment 9)

Action Taken:
• We have a quarterly audit, reviewing care navigator decisions and task completion checks.
• SEA reviews will include retrospective involvement for newly identified staff.
6. These issues are important as I had no reassurance that an administrative member of staff who spoke with a patient contacting the practice, had a clear pathway or guidance on whom the required task should be referred to. Practice Response:
• SSP Health has a Clinical Correspondence Management SOP and a Queries and Task SOP (Attachments 1 & 2)
• All staff members have a yearly appraisal with their line managers. The appraisals allow the line managers to identify any areas which the staff member or manager feel additional training may be required and therefore to implement a plan/performance review.

• We have checked the individual’s training record and it was up to date, but we have actioned a further update of the training for them. SSP Health and Ashton Medical Centre are committed to patient safety and will reinforce the following ongoing actions:
• We reviewed the clinicians’ capabilities matrix accessible by all staff, this will be further reviewed by June 2025.
• Audit trail reinforcement: All communication involving clinical requests must use auditable systems (e.g. EMIS tasks) — screen messages have been categorically banned for clinical referrals.
7. Instead, the task could be allocated using judgement (although as above, guidance to apply this was not clear) to a clinician who could not in fact assist, which occurred in this case. The jury who heard the inquest found that there was a missed opportunity to review the antibiotics, which was not causative in this case. In my opinion, there is a risk that an urgent need for appropriate clinical referral may not occur in the above circumstances. Practice Response:
• Our well-embedded organisational policies suggest that the request was likely made to obtain an alternative medication following an adverse reaction to the original antibiotics.
• Based on the notes recorded at the time, it appears that the nature of the patient request was specifically for an alternative antibiotic, rather than for an appointment.
• The pharmacists manage prescription requests changes for adults not children, on this occasion the call-handler sent it through to the pharmacist. All staff have been reminded of the process to follow with training reinforced.
• Our Access for Children Policy is designed to ensure that all appointment requests for children are handled promptly and appropriately. In this case, we don’t believe that there was a request for an appointment.
• All care navigators and call handlers receive thorough training on this policy during their induction and at regular intervals throughout the year to support consistent and safe practice. Conclusion We acknowledge the deeply tragic circumstances of Hailey’s death and note the concerns raised about missed opportunities for earlier review and intervention. We hope that our responses to each concern have provided reassurance — both that systems were in place at the time and that they have since been reviewed and strengthened.

We also note that you concluded that the areas of concern that you highlighted did not contribute to the death in this case. As such, we would ask you to consider whether a Regulation 28 Report is appropriate in these circumstances. We remain committed to ongoing quality improvement and have already implemented a number of actions to strengthen oversight, clarify clinical responsibilities, and ensure clear, safe pathways for all staff involved in patient care. Should further clarification be required or additional documentation be requested, we would be pleased to provide it.

Dear Mr. Pemberton Re: Regulation 28 Report to Prevent Future Deaths - Hailey Anne Thompson Thank you for your Regulation 28 Report dated 7 April 2025 regarding the sad death of Hailey Anne Thompson. On behalf of NHS Greater Manchester Integrated Care (NHS GM), We would like to begin by offering our sincere condolences to Hailey’s family for their loss. Thank you for highlighting your concerns during the inquest which concluded on the 3 April 2025. Please accept my apologies for the delay in this response. We recognise it is very important to ensure we make the necessary improvements to the quality and safety of future services. During the inquest you identified the following cause for concern:
1. During the course of evidence, an issue was explored regarding Hailey’s mother attempting to obtain an appointment or advice with the GP surgery following an apparent allergic reaction to prescribed antibiotics. These had been prescribed on 7 December for tonsilitis but stopped after three days due to an apparent allergic reaction. Regulation 28 - After Inquest Document Template Updated 30/07/2021
2. During a call to the GP surgery, Hailey’s mother spoke with an administrative member of staff (who at the inquest was referred to as a care navigator at a call centre). The staff member referred an appointment to a pharmacist working with the practice to call her.
3. The pharmacist to whom this was assigned was not competent to deal with a paediatric medication enquiry and sent a message back advising of this, albeit not on the medical records system where an auditable trail would exist. On the evidence, the pharmacist was not provided with feedback directly on the need to use the medical records system or involved in the lessons learned process as they were not directly employed by the practice. Part of Greater Manchester Integrated Care Partnership 4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk

NHS Greater Manchester Integrated Care
4. A further concern arose during the course of evidence from the primary care practice manager that a care navigator may not have a clear pathway action to, or triage tool to recognise that a reported allergic reaction to a medication may require urgent consideration by a doctor to assess any risk of anaphylactic shock.
5. No evidence was provided to:
a. explain how a patient telephoning the practice and being answered by the call centre would be referred to the urgent triage doctor on duty at the practice,
b. whether a list of clinician competencies and whom to refer tasks to was held
c. Care Navigator training
d. Algorithms or policies that apply to assist care navigator / call handlers at a centre which is not located within the doctor surgery.
6. These issues are important as I had no reassurance that an administrative member of staff who spoke with a patient contacting the practice, had a clear pathway or guidance on whom the required task should be referred to.
7. Instead, the task could be allocated using judgement (although as above, guidance to apply this was not clear) to a clinician who could not in fact assist, which occurred in this case. The jury who heard the inquest found that there was a missed opportunity to review the antibiotics, which was not causative in this case. In my opinion, there is a risk that an urgent need for appropriate clinical referral may not occur in the above circumstances. I note that SSP Health have provided a response to you, and this directly addresses the issues in your report from the perspective of the provider responsible for the direct care and treatment for Hailey Anne. My response on behalf of NHS GM will refer in parts to the SSP response and outline further action and assurance that NHS GM will take. I have addressed the causes of concern in turn below:
1. During the course of evidence, an issue was explored regarding Hailey’s mother attempting to obtain an appointment or advice with the GP surgery following an apparent allergic reaction to prescribed antibiotics. These had been prescribed on 7 December for tonsilitis but stopped after three days due to an apparent allergic reaction. Regulation 28 - After Inquest Document Template Updated 30/07/2021
2. During a call to the GP surgery, Hailey’s mother spoke with an administrative member of staff (who at the inquest was referred to as a care navigator at a call centre). The staff member referred an appointment to a pharmacist working with the practice to call her. SSP Health have explained how they managed the request for medication at that time. NHS GM does recognise that administrative staff across all our practices in Greater Manchester receive training on care navigation, signposting and advising patients on the best avenues to treatment. This could be with a GP or other allied health professionals. Whilst the nature of the training and roles can be particular to different practices. The aim is consistently to provide the best care, in the best and most efficient way for patients.
3. The pharmacist to whom this was assigned was not competent to deal with a paediatric medication enquiry and sent a message back advising of this, albeit not on the medical records system where an auditable trail would exist. On the evidence, the pharmacist was not provided with feedback directly on the need to use the medical Part of Greater Manchester Integrated Care Partnership 4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk

NHS Greater Manchester Integrated Care records system or involved in the lessons learned process as they were not directly employed by the practice. I have reviewed the response from SSP Health to this part of your report and think there is some learning for primary care providers around ensuring efficient and effective access to the right clinician to treat them and the requirement to ensure accurate, detailed and timely record keeping. To this aim, I will ensure that:
• Working with NHS GM clinical leadership and the NHS GM primary care team, a learning document is developed to cover responsibilities for safe and effective referrals to treating clinicians, be that between practice administrative staff or clinician to clinician.
• Working with the NHS GM Information Governance (IG) team, a reminder is shared through the NHS GM Primary Care Newsletter on the requirements under GDPR of record keeping.
4. A further concern arose during the course of evidence from the primary care practice manager that a care navigator may not have a clear pathway on whom to refer a task or action to, or triage tool to recognise that a reported allergic reaction to a medication may require urgent consideration by a doctor to assess any risk of anaphylactic shock. I note that SSP Health have provided assurance that they do have referral pathways in place. The learning document described above will cover this and be shared with GM practices.
5. No evidence was provided to:
a. explain how a patient telephoning the practice and being answered by the call centre would be referred to the urgent triage doctor on duty at the practice,
b. whether a list of clinician competencies and whom to refer tasks to was held
c. Care Navigator training
d. Algorithms or policies that apply to assist care navigator / call handlers at a centre which is not located within the doctor surgery.
6. These issues are important as I had no reassurance that an administrative member of staff who spoke with a patient contacting the practice, had a clear pathway or guidance on whom the required task should be referred to.
7. Instead, the task could be allocated using judgement (although as above, guidance to apply this was not clear) to a clinician who could not in fact assist, which occurred in this case. The jury who heard the inquest found that there was a missed opportunity to review the antibiotics, which was not causative in this case. In my opinion, there is a risk that an urgent need for appropriate clinical referral may not occur in the above circumstances. I note that SSP Health have addressed this part of your report and explained how calls are managed by them and provided you with evidence to support this. Although your concerns were addressed specifically to SSP Health, there is a wider opportunity for reflection and learning, and this will come through the learning document I have described above. NHS GM recognises the importance of staff training in all our primary care practices to ensure that patients are navigated correctly and in a timely way as appropriate for the symptoms they are presenting with, including providing appropriate and timely treatment. NHS GM will Part of Greater Manchester Integrated Care Partnership 4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk

NHS Greater Manchester Integrated Care ensure that the practice carries out a Significant Event Analysis (SEA) and key learning is implemented, within the provider and SSP Health as a multiple the SEA and any learning with you. On a more general note, we are also working with the GM locality leads where SSP Health has contracts to agree a more collective approach to contract and quality management, including the review of Regulation 28 Reports and the associated learning. I hope that my response, along with the detailed response to you provided by SSP Health, has addressed your concerns. Please do contact me if I can be of further help. Best wishes Interim Deputy Chief Executive Officer and Chief Nursing Officer NHS Greater Manchester Part of Greater Manchester Integrated Care Partnership 4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk