Dear Ms Topping,

Re: Regulation 28 Report to Prevent Future Deaths – Peter James Michael Unsworth, date of death 29th July 2018.

Thank you for your Prevention of Future Deaths Report issued under Regulation 28 of the Coroners’ (Investigations) Act 2013 (the “report”) dated 1 December 2020 concerning the death of Peter James Michael Unsworth on 29th July 2018. Firstly, I would like to express my deep condolences to Mr Unsworth’s family.

The regulation 28 report concludes Mr Unsworth’s death was a result of 1a Pulmonary Thrombo-Embolism and 1b Deep Vein Thrombosis.

Following the inquest, you raised concerns in your report to NHS England and NHS Improvement regarding:

1. The advice provided by the Consultant Haematologist related to a very complex medical situation. It was not recorded in writing. The Consultant Orthopaedic surgeon did not record it in the patient’s records nor email his understanding of the advice to the Consultant Haematologist for confirmation of what he understood the advice to be.
2. The Consultant Haematologist did not confirm her advice in writing or make any record of the advice given.
3. As a consequence, there may have been a misunderstanding of the basis on which the advice was sought and/or given, and of the import of the advice.

The Trust carried out an internal investigation and recommended adopting a ‘read back’ approach to the provision of verbal clinical advice or information to check understanding of any advice. The Trust takes the Situation, Background, Assessment, Recommendation (SBAR) approach to communication which is a structured framework for communication that enables information to be transferred accurately between individuals. In addition, Human Factors training events are held NHS England & NHS Improvement Skipton House 80 London Road London SE1 6LH

16th March 2021

regularly as part of the postgraduate education programme. These events focus on improving documentation and communication between team members.

For your second concern, the Trust has reiterated to all staff and clinicians the need to document verbal advice or information contemporaneously within the patient’s notes in line with GMC Good Medical Practice 19, 21 and continues to audit medical records to monitor this and other aspects of record keeping to reinforce good practice. As an organisation, the documentation of specialist advice had been embedded in the curriculum for Junior Doctors and is emphasised at regular Trust events.

Going forward the documenting of specialist advice will be further strengthened by the introduction of Electronic Patient Records which will allow clinicians to input information into health records in real time. It is anticipated that this system will go live within the Trust in December 2021.

Thank you for bringing this important patient safety issue to my attention and please do not hesitate to contact me should you need any further information.

Dear Ms Topping

Re: Mr Peter James Michael Unsworth Regulation 28 Report to Prevent Future Deaths

Please find below my responses to your concerns raised following the inquest into the death of Mr Peter Unsworth. The Regulation 28 report sets out the matters giving rise to concern numbered 1- 2 below.

1. The advice provided by the Consultant Haematologist related to a very complex medical situation. It was not recorded in writing. The consultant Orthopaedic surgeon did not record it in the patient’s records nor email his understanding of the advice to the Consultant Haematologist for confirmation of what he understood the advice to be.
2. The Consultant Haematologist did not confirm her advice in writing or make any record of the advice given. As a consequence, there may have been a misunderstanding of the basis on which the advice was sought and/or given, and of the import of the advice.

It has been understood and agreed practice nationally that the clinician requesting specialist advice should document the advice in the patient’s health record. The Trust notes that the report has been sent to the national bodies and will embrace any changes recommended by them.

As an organisation, the documentation of specialist advice had been embedded in the curriculum for Junior Doctors and is emphasised at regular Trust events. The Trust takes the Situation, Background, Assessment, Recommendation (SBAR) approach to communication which is a structured framework for communication that enables information to be transferred accurately between individuals. In addition, Human Factors training events are held regularly as part of the postgraduate education programme. These events focus on improving documentation and communication between team members.

Going forward the documenting of specialist advice will be further strengthened by the introduction of Electronic Patient Records which will allow clinicians to input information into health records in real time. It is anticipated that this system will go live in December 2021.

I hope the details of the changes the Trust has made to our practices are sufficient to allay the concerns you have raised in your report.

Patients first Personal responsibility Passion for excellence Pride in our team

Please do not hesitate to contact me should you require further details or documentation.

Dear ,

I am writing to confirm the action that the General Medical Council has taken in response to HM Assistant Coroner Caroline Topping’s Regulation 28 report into the death of Mr Peter James Michael Unsworth.

Upon receipt of the report the GMC’s Triage team has worked with our local Employer Liaison Service to obtain further information in relation to the incident and doctor’s involved. This resulted in obtaining the local investigation report into the incident from Ashford and St Peter’s Hospital.

We have now reviewed the local report and have taken the following actions in relation to the two doctors involved:

1. Dr
– GMC Reference

We note that Dr requested specialist advice from a Consultant Haematologist which was provided over the telephone. As a result of Dr interpretation of the advice provided to him he reduced the patient’s dose of clexane. The conversation with the Haematologist was not added to the clinical notes and a letter confirming the decision to reduce the dose was not sent for a month after the conversation happened.

Sadly after this reduction the patient went on to suffer pulmonary emboli which occluded his pulmonary arteries causing him to pass away on 29 July 2018.

After review the GMC’s Triage team have decided that further enquiries are required into the allegations against Dr . As a result a provisional enquiry has now been opened which will allow the GMC to obtain copies of Mr Unsworth’s clinical records and an independent clinical opinion. The clinical opinion will address whether there are any fitness to practise concerns about the actions of Dr .

We will attempt to complete our initial review into the actions of Dr in around three months. This may be impacted by the current pandemic but where possible we are progressing our investigations whilst at the same time being mindful of the local environment and challenges.

2. Dr
– GMC Reference

In addition to the actions of Dr the GMC’s Triage team has also review Dr involvement in the care provided. Our decision maker has decided that no further action or investigation should be carried out into Dr actions.

In making their decision they made the following comments:

“We have carefully considered all of the information you provided within your Regulation 28 notification. We have also sought further information from the Responsible Officer (RO) at St Peter’s Hospital.

We have reviewed a copy of the hospital’s Significant Incident report which explains that it is unlikely that Dr would have advised that a reduction in dose was appropriate, as it would not be her normal practice in this scenario as it would be contrary to established management principles.

Furthermore, the information we received indicated that it would normally be for the recipient of the advice to record it in the medical notes, and where a doctor is giving advice over the phone, the person giving the advice would not always be expected to record it.

Taking this information into consider, it appears that the responsibility of ensuring a written record was made, did not lie with Dr . We can see that there has been a full SI investigation which has addressed these issues, as such we don’t consider any further action is required by the GMC regarding Dr .”

I hope that this email has confirmed the actions and decisions taken in relation to the Regulation 28 report. If you would like to discuss this matter please do not hesitate to contact me on my direct telephone number.

Kind Regards,

Investigation Manager

3 Hardman Street Manchester M3 3AW

Web: www.gmc-uk.org

Dear Ms Topping,

Thank you for sending a copy of your Regulation 28 Report – Action to Prevent Future Deaths dated 1st December 2020 following the conclusion of the Inquest touching on the death of Peter James Michael Unsworth, addressed to as President of the Royal College of Surgeons of England. I am responding on behalf of as Chief Executive of the RCS (England).

I was saddened to read the circumstances described in your report, and wanted to record my sympathy to Mr Unsworth’s family.

We are grateful to you for bringing these circumstances to our attention and we have considered the matters of concern that you highlight in your report carefully.

The Royal College of Surgeons (England) is clear that information sharing is an essential part of the provision of safe and effective care. The need for effective and appropriate information sharing is a key part of our core guidance document for surgeons, Good Surgical Practice, and underpins our series of associated resources, and specifically our Good Practice Guides.

For example, section 1.3 of Good Surgical Practice provides clear and detailed guidance to surgeons on the way that they can meet the standards of the GMC’s Good Medical Practice. This section specifically sets out that Surgeons must ensure that accurate, comprehensive, legible and contemporaneous records are maintained of all their interactions with patients, as well as ensuring that sufficiently detailed follow-up notes and discharge summaries are completed to allow another doctor to assess the care of the patient at any time. Section 1.2 of Good Surgical Practice describes the requirement for surgeons to ensure that patients

receive satisfactory postoperative care and that relevant information is promptly recorded and shared with the relevant teams, the patient and their supporters.

The RCS also has engaged with the development of – and endorses - the detailed advice published by the Professional Record Standards Body and specifically their Standards for the Structure and Content of Health and Care Records.

More widely in the area of supported decision making with patients we provide detailed advice and guidance to surgeons and patients through our Consent: Supported Decision Making Good Practice Guide, and in the area of working with colleagues we provide extensive good practice guidance through The High Performing Surgical Team and Surgical Leadership: a guide to best practice.

As we hope the above demonstrates, we are committed to ensuring that all surgeons and those involved in the care of surgical patients are supported to deliver the highest standards of surgical care to patients.

We would also nevertheless reassure you that we will continue to consider the circumstances you describe in your report, and specifically the matters of concern you identify in your desire that actions are taken to prevent future deaths. Specifically, we will ensure that we consider this in detail within our programme of standards and good practice guidance review and development for 2021, and throughout our supporting wider communication and awareness raising around this activity as part of our continuing efforts to ensure all patients receive the highest standards of surgical care.

We have also shared your correspondence with our colleagues within the British Orthopaedic Association to enable them to do the same.

Dear Ms Topping,

Re: Regulation 28 Report – Action to Prevent Future Deaths dated 1st December 2020 following the conclusion of The Inquest Touching the Death of Peter James Michael Unsworth

I understand that the Royal College of Surgeons of England have already responded to you but they did invite our association to comment as your report related specifically to the field of orthopaedic surgery. We agree with the RCS letter and its sentiments.

Your report was discussed at length in Committee this week and we were all saddened to read the difficult circumstances that were described in your report and our sympathies go to the Unsworth family and friends.

Members of our Orthopaedic Committee recognise that this was always a complex case and one that was likely to fall outside existing Trust protocols for the prevention of thromboembolism in the perioperative period. Hence appropriate discussion, explanation, consent and documentation were essential prior to any surgery. Overall, we recognise with some sadness that this situation may not be as unusual as we would wish it to be in busy arthroplasty units with a need to titrate carefully the risks vs benefits of anticoagulant therapy. We appreciate that although the literature on VTE (venous thromboembolic) prophylaxis does consist of high quality randomised trials, in many studies, patients such as Mr Unsworth with a known history of VTE events are excluded. Thus the evidence to support shared decision making in complex cases is relatively sparse.

We are concerned that the relative risks of bleeding and increased infection vs thromboembolic problems are not well appreciated by physician colleagues and that existing hospital policies may not give advice on scenarios such as this.

The BOA will be taking this further. We produce BOAST documents (British Orthopaedic Association Standards) and will be setting up a short life working group involving haematology colleagues to see if it would be possible to produce relevant guidance on the management of such cases in the future.

Dear Ms Topping

Re: Regulation 28 Report - Mr Peter James Michael UNSWORTH

The Royal College of Physicians (RCP) plays a leading role in the delivery of high quality patient care by setting standards of medical practice and promoting clinical excellence. We provide physicians in the United Kingdom and overseas with education, training and support throughout their careers. As an independent body representing over 39,000 Fellows and Members worldwide, we advise and work with government, the public, patients and other professions to improve health and healthcare.

Thank you for sending your Section 28 notice to the President of the Royal College of Physicians. This reply is on behalf of the organisation following consultation with appropriate officers and partners.

The matter of concern in your notice is of the recording and verifying of clinical advice given between clinicians. Whilst the Royal College of Physicians does not give specific advice to Physicians on this matter this is covered under GMC Good Medical Practice Duties of a Doctor which states Clinical records should include: the decisions made and actions agreed, and who is making the decisions and agreeing the actions.

As members of the Professional Record Standards Board (PRSB) we advise on elements of record standards. Following a review with PRSB the recording of advice is covered by GMC guidance, however standards to confirm the accuracy of that advice if it is given verbally is not currently covered in any standard. We have highlighted this as a member of PRSB. In response to learning from the CoViD 19 pandemic and the increase in the use of remote advice have proposed that standards are developed with respect to what elements of remote advice should be documented to ensure effectiveness and prevent harm. Where electronic records exist then this becomes much easier to implement as it is visible to both parties. We continue to advocate for the introduction of integrated electronic record systems within the NHS to enable this.

Dear Ms Topping

Regulation 28 Report re: Death of Mr Peter James Michael Unsworth

Thank you for the ‘Regulation 28 Report – Action to Prevent Future Deaths’, addressed to our Chair of Council. I am responding as the Officer responsible for the Council’s fitness to practise work.

I am grateful to you for bringing this matter to my attention. We consider that information sharing is an essential part of the provision of safe and effective care. Keeping patients’ medical records up to date is an important part of patient care, informing what happens in the future. It also helps doctors to explain and justify their decisions and actions (see paragraph 50 in our Decision making and consent guidance). Patients may be put at risk if those who provide their care do not have access to relevant, accurate and up to date information about them.

We provide more information about medical records in our core piece of guidance, Good medical practice. We state that the documents doctors make (including clinical records) to formally record their work must be clear, accurate and legible. Records should be made at the same time as the events the doctor is recording or as soon as possible afterwards (see paragraph 19 Good medical practice).

We also give a clear indication of what should be included in clinical records. This includes, the drugs prescribed or other investigation or treatment, who is making the record and when, the decisions made and actions agreed, who is making the decisions and agreeing the actions, relevant clinical findings and the information given to patients, (see paragraph 21 of Good medical practice).

We will consider the information you have provided and determine whether any further action is required either through our Outreach or fitness to practise process.

21 December 2020 Sent via email to: Private: Addressee Only Ms Caroline Topping

2 I hope this is helpful.