Dear Ms Bradford,

Re: Regulation 28 Report to Prevent Future Deaths

I write in response to the Regulation 28 Report to Prevent Future Deaths dated 11 October 2024, which you sent following the inquest touching the death of Kingsley Efosa Imafidon.

In the report, you have raised the following concerns:

1. There was no apparent liaison between the teams involved in Kingsley’s care to consider any matters that may be relevant to his HbSS prior to the biopsy being carried out;

2. The Trust’s Standard Operating Procedure (“SOP”) for Elective Liver Biopsy does not appear to give consideration to patients with other pathologies such as HbSS;

3 There was no apparent consideration given to potential additional post-operative monitoring or requirements for a patient with HbSS;

4 The Trust’s SOP refers to a document titled “Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology” (Neuberger J, Patel J, Caldwell H et al. Gut 2020) which provides advice on liver biopsy techniques, methods and aftercare etc. These guidelines do not appear to give consideration (and therefore guidance) in relation to the use of liver biopsy for patients with other pathologies such as HbSS.

The Trust’s response to these concerns is as follows:

Concern 1

The Trust’s Elective Liver Biopsy Standard Operating procedure (SOP) has been reviewed and updated in light of the concerns raised at the inquest, and the latest version was sent to Emergency Care, Medicine and Rehabilitation Services (EMRS) clinical governance meeting which was held on November 8. Within the updated SOP, Section 3 entitled ‘Vetting of Referrals’ has been amended to read as follows:

In cases where liver biopsy may be considered higher risk, in particular patients with known bleeding disorders or hyperbilirubinaemia of any aetiology, the decision to biopsy should

- 2 - be discussed in the Northeast London network liver MDT, as an alternative route for biopsy may be indicated.

Higher risk patients who are to undergo percutaneous biopsy should attend a pre- assessment clinic for workup prior to biopsy.

Liver biopsy requests must be requested on EPR and discussed by email with radiology or with the GI radiologists, Dr

or Dr

The North East London Network Liver MDT includes clinicians from other Trusts and tertiary centres, and is a forum at which specialist advice can be obtained in respect of any high risk cases. The expectation is that this will identify any need for consultation with other specialties such as haematology.

The need to adopt a MDT approach in complex cases has been disseminated across the gastroenterology department, which is the main department referring patients for biopsies. The Trust has reviewed the process of biopsy referrals, the liver biopsy pre-assessment clinic and the patient information leaflet. This has led to the creation of a template on Electronic Patient Record (EPR) for use in the pre-assessment clinic.

The Elective Liver Biopsy SOP itself is now being highlighted to clinicians at various stages. For example, when a liver biopsy is booked, the radiographic assistants who book the biopsies are now sending out a standard email which draws the referring clinician’s attention to the SOP and includes a link to it. Additionally, when liver biopsy reports are sent to the referring clinician, the email attaching the report also signposts the clinicians to the SOP, with a link.

High risk patients who are due to undergo a liver biopsy will attend a pre-assessment clinic with a specialist nurse or gastroenterologist. This is another opportunity for the Trust’s SOP to be considered, particularly in relation to high risk patients, and to consider whether a discussion with the North East London Network liver MDT or any other specialties may be required if this has not already taken place.

Concerns 2 and 3

As set out above, the Trust’s Elective Liver Biopsy SOP has been updated.

The Trust is confident that the changes made to the SOP will help to ensure that appropriate consideration is given to patients with other relevant pathologies.

Discussion of complex or higher risk cases with the North East London Network Liver MDT, which is now embedded within the SOP, should highlight any particular post-operative monitoring requirements for patients with other relevant pathologies.

Concern 4

The Trust has reviewed the current guidelines entitled Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology” (Neuberger J, Patel J, Caldwell H et al. Gut 2020 and updated the Trust’s SOP to refer to this latest guidance.

The Trust will of course review its SOP in light of any further guidance produced by The British Society of Gastroenterology, The Royal College of Radiologists and The Royal College of Pathology.

I hope that this response addresses the concerns which you have raised and explains why the Trust has chosen to take the steps it has. I thank you for bringing these issues to our attention.

- 3 - Yours sincerely Chief Executive Officer

- 4 -

APPENDIX 1 – Elective Liver Biopsy Standard Operating procedure dated 4 November 2024

TYPE THE DOCUMENT TITLE

Author(s) (Consultant Radiologist & Radiology Clinical lead), (Consultant Gastroenterologist & Associate Medical Director EMRS Division), Version
2.0 Version Date November 2024 Implementation/approval Date TBC Review Date November 2027 Review Body EMRS Governance

1. Aim This document aims to clarify the management of patients requiring liver biopsy. It defines the pre- procedure assessment and post procedure care including the criteria for nurse-led discharge.

2. Background Ultrasound guided percutaneous liver biopsies are performed by Radiology in Homerton University Hospital. Liver biopsies may be targeted at a lesion or non-targeted to obtain a diagnosis in conditions such as autoimmune hepatitis. Complications from elective percutaneous liver biopsies are rare. Studies have shown a 0.6% risk of major bleeding1,2 and a 0.2% risk of death2. The 2020 British Society of Gastroenterology Guidelines on the use of liver biopsy in clinical practice, recommend post biopsy monitoring for at least 3 hours after liver biopsy, with regular clinical observations and measurement of blood pressure and pulse.3

3. Vetting of referrals

The clinical team must discuss requirements for liver biopsy with the patient and determine ability to consent prior to request.

In cases where liver biopsy may be considered higher risk, in particular patients with known bleeding disorders or hyperbilirubinaemia of any aetiology, the decision to biopsy should be discussed in the Northeast London network liver MDT, as an alternative route for biopsy may be indicated.

- 5 -

Higher risk patients who are to undergo percutaneous biopsy should attend a pre- assessment clinic for workup prior to biopsy.

Liver biopsy requests must be requested on EPR and discussed by email with radiology @nhs.net or with the GI radiologists, Dr

or Dr .

4. Pre-procedure assessment a) Blood testing must be performed by the referring clinician prior to or at referral.

Platelet count >60

Hb >90

INR <1.4

APTT 22-41 seconds

If the results are not within these parameters, a discussion with Haematology may be necessary for blood products prior to the biopsy.

b) Anticoagulation/anti-platelets:

Low dose (75mg) aspirin does not need to be stopped

Clopidrogrel should be stopped 7 days prior to the biopsy and restarted after 24 hours

Ticagrelor/Prasugrel (stop 7 days prior, restart after 1 day)

Apixaban/Rivaroxaban/Edoxaban (omit 2 days prior, restart after 3 days)

Fondaparinux, prophylactic (omit 1 day prior, restart after 24hrs)

Fondaparinux, therapeutic (omit 2 days prior, restart after 24hrs)

Warfarin (omit 5 days prior, restart after 1 day)

LMWH, prophylactic (stop 12hrs prior, restart after 1 day)

LMWH, therapeutic (stop 1 day prior, restart after 1-3 days)

Dabigatran (omit 2 or 4 days prior depending on renal function, restart 2-3 days

c) Ascites: It there is ascites, drainage must be performed prior to the liver biopsy.

5. Scheduling

Once a date and time is allocated by the radiographic assistants ( @nhs.net), it is the referring team’s responsibility to request a bed in MDU and inform the patient.

The referring team must give the patient fasting instructions. Patients are to remain nil by mouth for 6 hours (but can have water up to 2 hours) prior to the procedure. Further information regarding stopping and restarting anticoagulation should be provided to the patient as detailed above.

6. Post-procedure care

The patient is transferred within 15 minutes post procedure, from Radiology to the Medical Day Unit (MDU), or other ward where they will be observed. The patient is to be observed for a total of 4 hours, following the protocol as outlined below.

- 6 -

Aftercare protocol: o strict bed rest and lie on the right side for 1 hour o semi recumbent for the remaining 3 hours o NBM for 3 hours and then encourage oral intake

Observation protocol (NEWS 2): o every 15 minutes for 1 hour o every 30 minutes for 1 hours o every hour for the next 2 hours

The clinical team or Gastroenterology Team on bleep 247 or 108 is to be contacted if the NEWS > 2 or more OR if the patient shows any features suggesting complications. This includes:.

Systolic BP <100 or >200 mmHg

HR >100

Respiratory distress

Change in conscious level

Severe persistent abdominal pain

Chest pain

7. Nurse led discharge Once the patient meets the 4-hour observation period, they may be discharged provided they meet the nurse-led discharge criteria below.

8. Discharge checklist

Patient tolerating oral intake

Patient mobilising to previous ability

Pain score < 1 and improving with simple analgesia

NEWS score 0 or back to baseline (provided baseline <NEWS2)

Wound site is clean If they do not meet these criteria, the clinical team or Gastroenterology Team (bleep 247/108) or the on call medical doctor is to be contacted for assessment prior to discharge.

9. Documentation The radiology report will include the needle type and Gauge, number of passes and drugs used during procedure as well as any immediate complications. The observation protocol and nurse led discharge checklist is on EPR as a pre-configured document template under the heading “Liver Biopsy Care Plan”. If the criteria are met, the nurse discharging the patient may then generate a discharge summary and an aftercare leaflet (see below) is to be printed and given to the patient. Verbal safety netting information is also to be provided by the discharging nurse. Follow-up will be arranged by the referring team.

- 7 -
10. Liver biopsy aftercare information:
1) Please avoid vigorous or strenuous activity and heavy lifting including children for at least 1 week.
2) You may have some discomfort at the site of the procedure or in your right shoulder. This is usually described as an ache and can be worse on breathing in. This is normal and should resolve after a few days. Over the counter pain killers such as paracetamol are recommended.
3) You can eat and drink as normal after the period of observation in hospital.
4) Please take all your usual medications unless advised by the doctor. If you are on blood thinning medication, you may restart it the day after unless advised by your doctor.
5) You can go back to work as normal provided there is no heavy lifting involved.
6) You can remove any plasters after 12 hours and bathe as normal.
7) You should ensure that you are not alone at home for 48 hours after the biopsy.
8) Complications from liver biopsy are rare, but if you experience severe abdominal pain, notice a sudden change in the colour of your motions (e.g. a black tar colour), extensive bruising of the abdomen, experience fainting or light-headedness, or develop a high temperature after you return home, you should present directly to the nearest emergency department (ED). These symptoms may be signs of internal bleeding or other significant complication requiring urgent attention.
9) An outpatient appointment will be made with the requesting medical team to discuss the biopsy results when these are available.

- 8 - References
1) Gilmore IT, Burroughs A, Murray-Lyon IM, et al. Indications, methods, and outcomes of percutaneous liver biopsy in England and Wales: an audit by the British Society of Gastroenterology and the Royal College of Physicians of London. Gut 1995;36:437–441.

2) West J and Card TR. Reduced mortality rates following elective percutaneous liver biopsies. Gastroenterology 2020; 139:1230-1237.
3) Neuberger et al. Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology. Gut 2020;0:1-22.

British Society of Gastroenterology: Company No. 8124892 Charity No. 1149074 / VAT No. 347 4214 61

5 December 2024

Coroner’s Office North London Coroner’s Service Barnet Coroner’s Court 29 Wood Street London EN5 4BE By email only:

Regulation 28: Report to Prevent Future Deaths ( , date 11.10.24) The late Kingsley Efosa Imafidon Thank you for bringing to our attention the circumstances leading to the death of Mr Kingsley Efosa Imafidon. I understand that he had a diagnosis of Sickle Cell disease (HbSS) prior to undergoing the liver biopsy. You are correct that this scenario was not specifically covered in the guideline “Guidelines on the use of liver biopsy in clinical practice” from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology Neuberger J, et al GUT 2020. In drafting a response to the Regulation 28 report, we have consulted the Guideline Lead, now retired, Professor and Dr , Consultant Haematologist, a member of the guideline group. Although sickle cell disease is not a bleeding disorder per se and therefore not included in the section on disordered coagulation, there is a concern from historical case reviews that local vascular issues in the sickle affected liver could increase the risk of bleeding. We would therefore agree that it is important to remind health care professionals that particular care must be taken in any patients with a prior history of blood disorders before any biopsy. We would encourage discussion with a consultant haematologist for anyone with any blood disorder that may predispose to extra bleeding such as sickle cell disease. We plan to publish this advice in a peer-reviewed journal within the next three months, prior to a scheduled five-year revision of the whole guideline. It is important to note that the reported scenario also occurred due to complication of the biopsy technique itself, but the principles will apply prior to any therapeutic intervention which requires biopsy in such patients with an enhanced bleeding potential.

We also plan to publish this advice in a BSG newsletter distributed to all members within the next month.

Dear Ms Bradford, RCR Response to Regulation 28: Prevention of Future Deaths report issued on 11 October 2024 in relation to the death of Kingsley Efosa Imafidon. I was very sorry to read about the death of Mr Kingsley Imafidon and I would like to express my deepest condolences to Mr Imafidon’s family. I sincerely apologise for the delay in sending this response. We have reviewed the reasons for this delay, and I can confirm that we have put additional measures in place to refine our process when responding to important correspondence such as your report. We take the matters raised in your report very seriously and I hope this reply will be helpful in outlining how we are committed to learning from them and supporting our members and Fellows to develop and maintain excellent medical care. The hospital at which Mr Imafidon was treated has referenced the Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology and you refer to them in your report. You have asked us to specifically consider that “These guidelines do not appear to give consideration (and therefore guidance) in relation to the use of liver biopsy for patients with other pathologies such as HbSS.” All patients having a liver biopsy will, by definition, have some concern relating to their liver function and many will be at increased risk of bleeding compared to a healthy population. The guidelines note that although techniques have been refined, all invasive procedures have an associated risk of both morbidity and mortality. The guidelines also note that the benefits of a biopsy must be balanced against the risks involved and discuss the need for this to be through a process which incorporates informed consent. 10

Within the guidelines there is detailed consideration of the different possible technical approaches for liver biopsy and also consideration of where the procedure should occur. Management of the inherent risks is not explicitly referenced at each paragraph but is the underpinning reason for these considerations to inform services and operators about the relevant factors when arriving at a decision, which will include many judgement calls and should be a process approached in partnership with their patients. The guidance document does not reference HbSS, and it would not be possible to attempt to exhaustively list every condition which might put a patient at higher risk through risk of bleeding. The guidance does, however, reference many different groups of patients who are at higher risk and some of those groups are likely to include patients in Mr Imafidon’s position. For instance, when discussing the site of the biopsy and post-procedure monitoring the guidance states: Outpatient day case liver biopsy It is recommended that patients undergoing day case percutaneous liver biopsy should have no conditions that might increase the risk of biopsy; these include encephalopathy, ascites, malignancy, hepatic failure with severe jaundice or evidence of significant extrahepatic biliary obstruction, significant coagulopathies or serious diseases involving other organs, such as severe congestive heart failure or advanced age. Pragmatic issues that will affect the decision not to undertake day case biopsy includes the travel time between the hospital and patient’s home (or place of recovery), domestic situation and time of day that the biopsy is done. It then goes on to make a recommendation: ►Liver biopsy may be safely done as a day case procedure if there are no increased risk factors and the patient can be looked after when they have left hospital, can seek appropriate advice and access appropriate medical help if needed. Tragically, it appears that no matter how well-intentioned plans might have been before the procedure, on this occasion Mr Imafidon was not able to be looked after and seek such help when it was required. Particularly in a resource limited environment where continued additional efficiencies are required, many decisions around place of care or exact approach are difficult. The trust has replied to your report that they intend to use a more specialist liver MDT as a decision- making vehicle to improve how decisions around route and location of biopsy are taken in future and this is certainly one mechanism where additional expert input will be possible which would be expected to be better able to balance risk and benefit. This guidance was developed by the British Society of Gastroenterology in collaboration with the Royal College of Radiologists and Royal College of Pathology. At the time in which this guidance is due to be reviewed, we will facilitate expert radiological input, and we will specifically include your report in the material to consider. 11

I am grateful to you for bringing these matters of concern to our attention and for giving us the opportunity to respond. Once again, I do apologise for the delay in our response and express my deepest condolences to Mr Imafidon’s family and loved ones.

Dear , Happy New Year! Thank you for reaching out to us regarding this matter. We would like to acknowledge receipt of your enquiry and confirm that we have discussed this case with the senior author of the original British Society of Gastroenterology guidelines. Following these discussions, we understand that the group responsible for updating the guidelines in due course is aware of this very unfortunate case. They will be entering into further discussions and consultations to consider the influence and potential inclusion of underlying conditions, such as sickle cell disease, in any future updates to the guidelines. Should you require any further information or clarification, please do not hesitate to contact us. Best regards,

Senior Professional Guidelines Officer The Royal College of Pathologists 6 Alie Street, London, E1 8QT Tel:

Email: Website: www.rcpath.org

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