Dear Ms Alison Mutch Re: Regulation 28 Report to Prevent Future Deaths – Maurice Leech, 30th April 2020 Thank you for your Regulation 28 Report dated 23rd August 2021 concerning the death of Maurice Leech on 30th April 2020. Firstly, I would like to express my deep condolences to Maurice Leech’s family. The regulation 28 report concludes Mr Leech’s death was a result of 1a Frailty 1b Peri-prosthetic fracture of right femur 1c Fall II Chronic obstructive pulmonary disease, Type 2 diabetes, Heart Failure Following the inquest you raised concerns in your Regulation 28 Report to NHS England regarding:
1.The inquest heard evidence that pre Covid, Mr Leech would have been examined face to face by the GP rather than a telephone consultation without an examination. The evidence indicated that a physical examination would probably have resulted in Mr Leech being referred back to hospital at an earlier stage. Telephone consultations have been in use in general practice for many decades to help patients access medical advice and care quickly and conveniently. Where studies have been conducted, telephone triage has been shown to be safe. Telephone consultations are part of general practice training schemes. The coronavirus (COVID-19) pandemic has brought about an unprecedented acceleration in the adoption of delivering NHS services remotely, and standard operating procedures have been produced to ensure general practice is able to operate safely in this context. The relevant published version of the Standard Operating Procedure is here for reference which was iterated throughout the pandemic to meet changing needs and requirements since it was first published National Medical Director NHS England & NHS Improvement Skipton House 80 London Road London SE1 6LH 15 February 2022

in March 2020. These procedures make it clear that general practices and Primary Care Networks should triage patients remotely (to determine the right person and timeframe for managing the problem) in advance wherever possible to help prioritise patient care based on needs; and that clinicians should determine the most appropriate consultation method with the patient - telephone, video, online, face to face. This should be determined by taking into consideration the patient’s preferences, needs (including accessibility, privacy, capacity and communication requirements), clinical circumstances and currently, local risks of COVID-19.

In determining the most appropriate consultation method, considerations regarding patient safety, ability to make a satisfactory assessment, gain a sufficient understanding of the problem and whether information can be provided in a way the patient understands including assessing a patient’s understanding of the advice provided should be factors in determining the most appropriate consultation method. If a particular concern did arise following a remote assessment or remote advice being given, then a decision could be made to move to an alternative approach, for example, face to face consultation or for remote advice to be followed up in writing or with the patient’s permission with their carer.

Professional guidance published by the General Medical Council sets out high level principles of good practice expected of everyone when consulting and or prescribing remotely for the patient https://www.gmc-uk.org/ethical-guidance/learning- materials/remote-prescribing-high-level-principles and guidance to support shared decision making https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for- doctors/decision-making-and-consent.

Additionally, guidance has been developed jointly between NHS England and the Royal College of General Practitioners (RCGP) on Remote vs Face to Face: which to use and when? and RCGP publish a range of guidance and learning materials on their Covid-19 Resource Hub .These resources underline the importance of ensuring patient safety, shared decision making and that an individual’s needs are paramount.

Whilst we do not have all the clinical details regarding the circumstances of Mr Leech’s discharge, we would ordinarily expect there to have been communication to the GP, via a discharge summary from the hospital providing details of their assessment including examination and investigations, and for advice to be given to the patient about safety netting.

Safety netting is a routine part of general practice consultations and explicitly sets out next steps to take for the patient in the event of a deterioration in their condition. The joint NHS England and RCGP guidance (linked above), which is now in place, refers to the importance of ‘safety netting’. Every GP practice must continue to provide face to face consultations alongside telephone, video and online consultations as part of making general practice as accessible as possible.

2.Mr Leech was very vulnerable and a poor historian. Due to Covid he was sent alone to hospital and seen alone there. The evidence before the inquest was that if support had been available a more accurate picture of his baseline and needs would have assisted staff in treating him and potentially identifying that he should not be discharged back to the care home and that a fracture would not have been missed.

At the time of Mr Leech’s death, the national guidance around attendance at hospital settings “Visiting healthcare settings during COVID-19 pandemic.” The guidance restricted patients from attending appointments with a person to support them. In March 2021 this guidance was updated to advise that patients attending outpatients, diagnostic service and Emergency Departments are now allowed to be accompanied by one person to support them with making complex/difficult decisions. A link to the full guidance is included for information: Coronavirus » Visiting healthcare inpatient settings during the COVID-19 pandemic (england.nhs.uk)

The following has been shared with NHSEI from Tameside and Glossop CCG.

At the time of Mr Leech’s transfer to hospital at the height of the pandemic, North West Ambulance Service guidance aimed at minimising the number of individuals within the patient compartment of an ambulance. Only essential escorts and the minimum number of clinicians to provide a safe level of care to the patient could remain in the patient compartment. This was to help to minimise the dispersal of respiratory secretions, reduce environmental contamination, and reduce virus particles in the air. Similar policies were in place for hospital A&E’s to reduce risk of transmission of Covid.

Notwithstanding policies around escorting patients, ensuring that clear and accurate information travels with the resident is a crucial factor. There are two initiatives in place in Greater Manchester to this end. The ‘red bag scheme’ (described below) was already in place at the time of the incident, and an information sharing scheme referred to as the ‘GM Care Record’ (described further below) is currently at an advanced implementation stage.

Tameside and Glossop CCG have implemented the red bag scheme for care homes with key information pertinent to the individual’s care. The bags are handed to ambulance crews and travel with patients to hospital where they are then handed to the doctor. Tameside and Glossop CCG had the red bag scheme in place across the patch at the time of the incident. Care home staff also hand over relevant information to ambulance staff to ensure they are aware of the individual’s needs to be passed on to the Emergency department.

Greater Manchester has accelerated use of the GM Care Record (GMCR) to support data sharing between health and care professionals across the city region.  It means that all professionals involved in a patient’s care can share vital information across different organisations, settings and localities.  As well as informing clinical decision making at the point of care, the GMCR is also being further enhanced to support joined up care planning and coordination through a range of clinical use cases. Greater Manchester Health and Social Care Partnership are also continuing to develop the GMCR to include more data feeds between providers and supporting care planning and coordination through enhanced functions.  Social care information from across all 10 localities will also be added to the GMCR in Autumn/Winter 2021. Access to the GMCR can be made available to all relevant organisations that would have a requirement to access data, i.e. GP’s, acute trusts, council and private organisations. Access for private care organisations would be via a Data Protection Impact Assessment process, providing access to information in the GM Care Record

is based on a legitimate relationship to the patient and their care then, access can be discussed/provided via correct routes.

3.The inquest heard that he was in significant pain from the fracture to the femur. Unlike the position relating to a fracture to the neck of femur there is no NICE guidance for treatment of such fractures to ensure a consistent approach to management of them in the elderly across the NHS. This included in Mr Leech’s case how to effectively manage his pain and the impact of that on his overall health.

NICE has provided some guidance, Osteoporosis: assessing the risk of fragility fracture on the management of fragility fractures of the femur. In addition there is best practice guidance on fragility fractures in line with tariff management and patient pathways, available from the National Hip Fracture Database (NHFD), overseen by the Royal College of Physicians. This can be found in Guidance on the Operational Aspects of Best Practice Tariff for Fragility Hip Fracture Care. . NHFD are also due to recommend further best practice criteria including secondary prevention of such fractures. The ‘Best MSK Collaborative’ has a workstream on fragility fractures and the work steam is developing a recommended clinical and operational pathway for this group of patients (non-ambulatory fragility fractures) such that the approach of all the integrated systems will be consistent and reduce unwarranted variation. This includes pain management and we are expecting that the pathway will be shared with all Integrated Care Systems by the end of the year. The pathways are being co- produced with the relevant specialist professional societies.

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 Ms Mutch, Thank you for your letter of 23 August 2021 to Sajid Javid about the death of Maurice Leech. I am replying as Minister with portfolio responsibility for primary care and patient safety and I am grateful for the additional time in which to do so. I wish to begin by saying how saddened I was to read of the circumstances of Mr Leech’s death. I can appreciate how upsetting losing a loved one during the emergency period of the COVID-19 pandemic must be and I offer my heartfelt condolences to Mr Leech’s family and loved ones. In preparing this response, my officials have made enquiries with NHS England and NHS Improvement (NHSEI), and the National Institute for Health and Care Excellence (NICE), and I will comment on each of the three matters of concern in your report. General practice I would like to acknowledge that general practice teams have worked tirelessly during the COVID-19 pandemic response, remaining open throughout and providing both face to face and remote consultations. In response to the pandemic, general practice teams rapidly changed how they provided support and delivered services to their populations, with a focus on triage and remote (telephone and online) consultations, so that they can see as many patients as possible, while minimising risk of infection from COVID-19 for patients and staff. This approach was necessary to enable practices to manage demand and prioritise the most urgent cases and helped to navigate patients to the right services or healthcare professional at the right time. The quality of care must remain the same high standard regardless of whether the appointment is in person or remote.

Throughout the pandemic, NHSEI provided guidance to general practice and continually updated standard operating procedures to ensure that changing services could operate safely. NHSEI set out clear expectations that general practices offer face to face appointments alongside remote appointments (telephone and online), and that clinical appropriateness and patient preference should be taken into account to determine the most appropriate consultation method. NHSEI has also supported general practices in how best to communicate with their population on how to access services. Further details on guidance and standard operating procedures can be found on the NHSEI website1.

General practices have been providing remote consultations to patients by telephone for many years to help patients access care and clinical advice quickly and conveniently. There are existing skills in the workforce when it comes to telephone consultations and telephone consultations are part of general practice training schemes. NHSEI has worked with professional and regulatory bodies, voluntary, community and social enterprise sector (VCSE) and patient organisations to support the safe and effective use of remote consultations guided by the principle of the interests and preferences of the patient.

A number of resources have been developed2 to support general practices with good practice principles in maintaining professional vigilance and identifying concerns around safety and safeguarding when using remote consultations. The resources highlight the importance of ensuring patient safety, shared decision making, and patients’ needs are paramount.

The Department and NHSEI continue to support general practice, as we emerge from the pandemic, to maintain and improve access to care for patients. On 14 October 2021, the Government and NHSEI published Our plan for improving access for patients and supporting general practice3. The plan includes investment of £250million in a Winter Access Fund to improve access to GP practice services.

Hospital visiting

I have noted your concern about the evidence given at the inquest into Mr Leech’s death that suggested his treatment and outcome could have been impacted because he was unaccompanied during his transfer and treatment at hospital.

I would like to assure you that we recognise the importance of being able to accompany family, friends and loved ones in hospital. A compassionate approach to facilitating hospital visiting is essential, balanced with the need to manage the risk of infection.

Throughout the COVID-19 pandemic, national NHS England guidance on how NHS hospitals may choose to facilitate visiting was followed. This was reviewed and updated regularly and outlined a set of principles on which local guidance should be based.

1 Coronavirus » General practice (england.nhs.uk)

2 See Annex

3 Coronavirus » Our plan for improving access for patients and supporting general practice (england.nhs.uk)

The guidance advised that hospital visiting was suspended on 4 April 2020 to manage the risk of infection of COVID-19. Visiting at that time was only permitted if a visitor was supporting someone with specific conditions such as dementia, a learning disability or autism, and where not being present would cause the patient to be distressed.

From 5 June 2020, the number of visitors increased to a limit of one close family contact or somebody important to the patient. However, where it was possible to maintain social distancing throughout a visit, a second additional visitor was permitted in certain circumstances; including a family member for individuals receiving end-of-life care.

This guidance was most recently revised on 16 March 2021, which included guidance that in an emergency department the patient may be accompanied by one close family contact, or somebody important to the patient, to support the patient with complex/difficult decision making.

Since the end of the national lockdown in England, visiting in hospitals is now subject to the discretion of local NHS Trusts, based on the national principles, which will make their own assessment as to the visiting arrangements that can safely be put in place. Careful hospital visiting policies remain appropriate while COVID-19 continues to be in general circulation and organisations can exercise discretion where COVID-19 rates are higher. The health, safety and wellbeing of patients, communities and staff remains the priority.

Fracture of the femur and pain management

In relation to your concern about guidance for the treatment of fractures to the femur, you may wish to note that while NICE Clinical Guideline 124: Hip fracture: management4, does not make specific recommendations on the management of this type of fracture (periprosthetic), it does cover the use of analgesia (see section 1.4) and multidisciplinary management (section 1.8) of people with hip fracture. I am advised by NICE that it is reasonable to expect that Clinical Guideline 124 could be applied to people with periprosthetic femoral fracture, such as Mr Leech.

I am further advised by NICE that pain management of fractures is covered in NICE guidelines such as complex and non-complex fractures (NICE guidelines 375 and 386), and major trauma (NICE guideline 397), and that there is considerable professional and local guidance on the management of acute pain.

Your report explains that Mr Leech was provided with palliative care on his return to the Thorncliffe Grange Nursing Home, and there is NICE guidance on palliative care for adults: strong opioids for pain relief (Clinical Guideline 1408), and for the care of dying

4 Overview | Hip fracture: management | Guidance | NICE

5 Overview | Fractures (complex): assessment and management | Guidance | NICE

6 Overview | Fractures (non-complex): assessment and management | Guidance | NICE

7 Overview | Major trauma: assessment and initial management | Guidance | NICE

8 Overview | Palliative care for adults: strong opioids for pain relief | Guidance | NICE

adults in the last days of life (NICE Guideline 319). NICE does not therefore agree that there is a lack of guidance in this area.

I hope this response is helpful. Thank you for bringing your concerns to my attention.

MARIA CAULFIELD Minister for Primary Care & Patient Safety

9 Overview | Care of dying adults in the last days of life | Guidance | NICE

Annex Resources to support general practice remote consultations

• Remote versus face-to-face: which to use and when? (Royal College of General Practitioners)
• Principles for supporting high quality consultations by video in general practice during COVID-19 (Royal College of General Practitioners and NHSEI)
• How to conduct written online consultations with patients in primary care (British Medical Journal)
• Key principles for intimate clinical assessments undertaken remotely in response to COVID-19 (NHSEI)
• Clinical safety risk templates to support general practice in mitigating risks associated with the implementation of digitally supported triage, online and video consultations
• Advice on how to establish a remote ‘total triage’ model in general practice using online consultations and e-resource on remote total triage model in general practice (NHSEI)
• Supporting practice staff with a Total Digital Triage model for online consultations and Admin Crib Sheet
• Top 10 tips for COVID-19 telephone consultations (Royal College of General Practitioners)
• Guidance for general practice on confidential enquiry questions for domestic abuse during a remote consultation (NHSEI and IRISI)