Dear Ms McKenna Re: Ania Sohail (deceased) Regulation 28 Preventing Future Deaths Response On behalf of Greater Manchester Mental Health NHS Trust (GMMH) I would like to offer Ania’s family our sincere condolences at this difficult time. Ms McKenna, thank you for highlighting your concerns during Ania’s Inquest which concluded on 30 January 2023. On behalf of the Trust can I apologise that you have had to bring these matters of concern to the Trust’s attention. Please see the Trust’s response in relation to the concerns you have raised, and the actions taken by the Trust: (1) The Recovery and Discharge plans contained inaccurate information regarding Ania’s consent to share information with her mother. The evidence was that this was an entry made in error in June 2020 and was not picked up by any of the Nurses who updated the Recovery and Discharge Plan over the subsequent eleven months. The Recovery and Discharge Plan that was in place prior to the incident Ania’s death is no longer used by GMMH and has been replaced by the care plan document that is used in all other inpatient areas of the Trust. This document is called the ATAC (Acute Triage and Assessment Care Plan). A local audit of care plans will be undertaken by the ward manager by the end of May to ensure learning is embedded and consent is evidenced in the care plans. Greater Manchester Mental Health NHS Foundation Trust, Trust Headquarters, Bury New Road, Prestwich, Manchester M25 3BL.

The Service has developed training that has been delivered through ‘Lunch and Learn’ events in respect of capacity, consent and the Trust’s ATAC document. There has been a Trust wide learning event how to assess and record decisions around testing a patient’s capacity and formally record the decision made. This was recorded and is available to all Trust employees. (2) The Recovery and Discharge Plans did not address the risks associated with Ania’s procurement of Propranolol from online Pharmacies. The evidence was that an update of the Recovery and Action Plan involved members of Nursing staff simply adding a note that the overdoses had taken place. The plan did not show that any meaningful thought had been given to addressing the particular risk associated with the procurement of online medication. During the Trust review, following Ania’s death, it was unclear whether all staff were aware that Ania was buying medications from online Pharmacies or that this was an easily accessible way to obtain medication. In response, GMMH have created a Safety Briefing regarding the use of online pharmacies and Propranolol, aimed at communicating to staff the risks associated with the procurement of medication via online Pharmacies and the General Medical Councils ‘ten principles’ around online purchasing. This briefing, and the circumstances leading to its development featured in the Trust patient safety Newsletter in February 2023. This Newsletter is developed monthly and is shared with all staff across the Trust. A copy of the Safety Briefing is attached to this response. (3) Mandatory refresher training on basic aspects of Nursing care, such as good record-keeping, searches, care-planning, undertaking pre and post-leave assessments and confidentiality is not provided to staff. The Trust has developed an inpatient ‘Care Bundle – Leave from inpatient units’. The care bundle provides guidance to staff when supporting service users who are inpatients to access leave into the community and return to the ward safely. The care bundle prompts staff to complete pre and post-leave assessments and where to document these. This care bundle has been shared with all inpatient staff through established communication systems and was featured in the Patient safety Newsletter in January 2023. An audit of pre and post leave assessments and related documentation will be carried out by the ward manager by the end of May 2023. The Care Bundle is attached to this response. In respect of searches, a Trust Risk & Safety Advisor has facilitated training sessions regarding how to conduct both room and personal searches effectively. All ward staff have completed this training and the ward manager keeps a record of staff compliance. Confidentiality and when to breach this is included in the Trust Clinical Risk Assessment policy and the training. This was also included in the learning event held in respect of Capacity and Consent, that is available to all staff via the Trust Intranet. All staff on Griffin ward will have access to this training event by the end of April 2023. A9 Greater Manchester Mental Health NHS Foundation Trust, Trust Headquarters, Bury New Road, Prestwich, Manchester M25 3BL.

(4) There is no requirement for the outcome of negative personal searches to be documented in the records and consequently there is no ability to effectively audit whether searches are taking place and the treating team are unable to assess a patient's level of compliance with rules around bringing contraband items onto the ward. As part of the Inpatient Leave Care Bundle, outlined in point 3, pre and post leave assessments should be recorded in the clinical record, including any reason to search a person following leave. The Trust Search Policy includes clear guidance on what should be recorded when a search is undertaken and whether anything was found or not. (5) Searches undertaken of Ania's room following the overdoses on 10 March and 5 June 2021 were ineffective and did not uncover the Propranolol that Ania had been stockpiling. GMMH Trust did carry out room searches on the above dates and did not find any medication. Staff did not conduct intimate searches of her person as there was no indication that this was required at the time. As outlined in point 3 the staff on the ward have received training on how to search a person’s room and carry out a personal search. The Trust policy HS13 Search of service users, visitors and belonging policy was reviewed and updated to include the learning from Ania’s death. This included a review of contraband items and reinforcement of search procedures. (6) Documentation on which 1 :5 observations are recorded does not evidence that a check has taken place every 5 minutes. Instead, the current documentation, simply requires one signature per hour. There is therefore no mechanism by which observations can be effectively audited. The current Trust observation policy does have a 1:5 minute recording sheet that requires a signature every 5 minutes. This has now been adopted by the service and its completion is audited by the ward manager as a minimum weekly. The Trust is currently undertaking a review of our Observation policy and practices through a task and finish working group which to date has reviewed best practice standards and guidance on the management and practice of therapeutic observations & engagement including the review of any digital innovations to support practice. Senior members of this group have attended workshops facilitated by the CQC who acknowledge that carrying out and recording observations is a National issue. A training needs analysis of the requirements for staff training and education is being undertaken and a training package and competency assessment framework is being developed. (7) There is no requirement to make a separate entry evidencing that a post-leave assessment has been undertaking. The post-leave assessments are currently subsumed within Day Notes and do not clearly state whether an assessment was undertaken, what was discussed and the outcome of the assessment. As outlined in point 3 pre and post leave assessments should be undertaken and recorded in the patient’s clinical record. The care bundle that has been developed sets out clear expectations of what assessments staff should be doing and what they should be recording. A10 Greater Manchester Mental Health NHS Foundation Trust, Trust Headquarters, Bury New Road, Prestwich, Manchester M25 3BL.

In addition to the audit being caried out in this service, an audit tool will be developed by the Head of Nursing on the back of this to be rolled out across the Trust. Ms McKenna, on behalf of the Trust can I thank you again for bringing these matters of concern to the Trust’s attention. I hope this response demonstrates to you and Ania’s family that GMMH have taken the concerns you have raised seriously. If you have any further questions in relation to the Trust’s response, please do let me know.

Dear Catherine, Thank you for your Regulation 28 report to prevent future deaths dated 7 February 2023 about the death of Ania Sohail. I am replying as the Minister with responsibility for mental health and patient safety. Firstly, I would like to say how saddened I was to read of the circumstances of Ania’s death and I offer my sincere condolences to his family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to my attention. Please accept my sincere apologies for the significant delay in responding to this matter. Your report raises concerns about online prescribing, information sharing and the provision of care on Griffin Ward at Junction 17 (part of Greater Manchester Mental Health NHS Foundation Trust). I understand that the Trust wrote to you on 4 April 2023 with the Trust’s comprehensive response to the matters of concern that you raised in your report. In preparing this response, Departmental officials have made enquiries with the Care Quality Commission (CQC) and NHS England. The CQC was formally notified of Ania’s death through a statutory notification from the Trust on 21 June 2021. CQC has subsequently carried out a series of inspections of the acute and psychiatric intensive care wards for working age adults (including Griffin Ward) in September 2021 to consider the safety of the wards and the care and treatment being provided to patients. These contributed to the Trust being placed into Segment 4 of the NHS Oversight Framework which meant it entered the national Recovery Support Programme and is now in receipt of mandated intensive support. An NHS England System Improvement Board was set up to support the delivery of the programme, chaired by the Regional Director for Strategy and Transformation for NHS North West, with representatives from the Trust, Greater Manchester Integrated Care Partnership, Care A5

Quality Commission, Health Education England, Bury Local Authority (as safeguarding lead), General Medical Council and the Nursing and Midwifery Council. The Trust has subsequently been the subject of an NHS England-commissioned independent investigation into the failings within the Trust’s services reported at the Edenfield Centre and the failure within the organisation to appropriately manage concerns and mitigate against patient harm. The investigation’s final report was published in January 2024 and notes that Griffin Ward has now been closed. The Trust has developed an improvement plan, which was updated to reflect the findings of the independent review. The report is available at: Independent Review of Greater Manchester Mental Health NHS Foundation Trust From a national perspective, with regard to online prescribing, NHS England has advised that the NHS does everything in its capacity to take into account the plurality of healthcare provision that is available to the public in England. NHS England is supportive of a patient’s rights to choose the providers they wish to use. For vulnerable patients, the right course of action is to advise them on the risks of using services outside of the NHS and the benefits of remaining within the NHS. NHS England has no jurisdiction over private provision. Private providers would need a very good reason to breach a patient’s refusal to share their information as they are legally obliged to safeguard sensitive information under the General Data Protection Regulation. The General Pharmaceutical Council has provided information to online pharmacies on Providing medicines online, which is available at: Online Pharmacy Services (rpharms.com) The Summary Care Record (SCR) was originally designed and communicated as a means to support patients when they receive emergency care. Over time, the significant value of access to SCR to wider healthcare services has been recognised and, as a result, NHS England has worked with an Expert Advisory Committee to extend its use into multiple other care settings through a governance framework into which patients and professionals contribute. NHS England has also done significant work with a number of private sector organisations, including a range of private hospitals and privately funded healthcare services as part of Proof of Concepts (PoCs), into settings where SCRs have previously been unavailable. eg private GP Services. This work will continue throughout 2024. Whilst it is difficult to define precisely what is included within “private hospitals and privately funded healthcare services”, all “private hospitals and independent healthcare services” that have approached NHS England to date seeking access to SCR have either been onboarded into the existing proof of concepts or there have been discussions with the requesters regarding initial setup and their use for access to SCR. Learnings from these PoCs will be reported back to the Expert Advisory Committee to better understand any benefits realised but also any potential unintended consequences. NHS England will work with the Expert Advisory Committee to seek full rollout approval in this sector and consider the scope of this approval and any specific exclusions, constraints, or caveats. You may be interested to note that the General Pharmaceutical Council (GPhC) issued a statement in January 2024 following concerns about the potential risks for patients using A6

online services to get medicines and treatment in a case that was similar to Ania’s. In it the GPhC makes clear that it will take enforcement and regulatory action where appropriate against owners of registered pharmacies, as well as individual pharmacy professionals involved in both the prescribing and supply of medicines where their conduct may have fallen short of professional standards. The GPhC’s statement is available at: BBC News: investigation into safety checks online pharmacies carry out when selling prescription-only medicines | General Pharmaceutical Council (pharmacyregulation.org) I hope this response is helpful. Thank you for bringing these concerns to my attention.