Prevention of Future Deaths reports · 2024

Kingsley Imafidon

Regulation 28 report to prevent future deaths, reference 2024-0554, written 11 Oct 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report11 Oct 2024
Reference2024-0554
DeceasedKingsley Imafidon
CoronerLaura Bradford
Coroner areaLondon (North)
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Sourcejudiciary.uk record · original PDF
Responses published4

The report

Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.

"9 North London Coroner's Service,
be Barnet, Brent, Enfield, Haringey and Harrow,
Barnet Coroner's Court,
The
Coroner's
Service

E-mail

Date: 11 October 2024

Annex A
REGULATION 28: REPORT To PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO: -

1. Homerton Healthcare NHS Foundation Trust
2. The British Society of Gastroenterology

3. The Royal College of Radiologists .

4. The Royal College of Pathology

CORONER

| am Laura Bradford, Assistant Coroner for the North London Coroner Service.

CORONER’S LEGAL POWERS

I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and
Ip |regulations 28 and 29 of the Coroner's (Investigations) Regulations 2013.

http://www.legislation.gov. uk/ukpga/2009/25/sched ule/5/paragraph/7
http://www. legislation.gov.uk/uksi/201 3/1629/part/7/made .

INVESTIGATION and INQUEST

On 17th January 2024 an investigation was commenced into the death of Kingsley Efosa
IMAFIDON. The investigation concluded at the end of the inquest on 4 October 2024. The
Conclusion of the inquest was:

ta Intra -abdominal haemorrhage

1b Post liver biopsy for jaundice

1c Liver cirrhosis

1d --

Il Sickle cell disease

| recorded the following narrative conclusion:

Kingsley Efosa Imafidon had a medical history of homozygous sickle cell disease. On 29
November 2023, Mr Imafidon underwent a scheduled fiver biopsy in order to investigate
potential liver disease. Part of the device during the biopsy was deployed outside of the liver:

which later led to the procedural complication of bleeding into the peritoneal cavity, which led
to Mr Imafidon's death. :

CIRCUMSTANCES OF THE DEATH

Kingsley was born with Homozygous Sickle Cell Disease (HbSS). In May 2023 his liver'
function tests were noted to be significantly deranged with worsening jaundice and he was
referred to the gastroenterology team at Homerton Hospital. He underwent non-invasive
imaging (ultrasound elastography) on 22 November 2023 which was suggestive of underlying
cirrhosis. Blood tests also identified that his bilirubin was high and his elastography was high,
Consistent with cirrhosis. It was confirmed that a liver biopsy was required to understand the
likely cause of the liver disease. .

Kingsley underwent a clotting screen on 27 November 2023 prior to the biopsy to check that
his INR was below 1.4 so the procedure could take place, in accordance with Homerton
Healthcare NHS Foundation Trust’s (‘the Trust”) policy. Kingsley’s INR on this date was 1.3.

The liver biopsy took place on 29 November 2023 and the circumstances of this are outlined
in the narrative conclusion in the box above, although these findings were not known until
after the procedure had taken place.

Following the procedure Kingsley was transferred to the Medical Day Unit where he remained
for four hours before being discharged at 16:30. This was the standard period of observation
for all patients,

On 2 December 2023, Kingsley’s family visited him at his home address and found him lying
unresponsive in his bed. The post mortem examination found evidence of extensive fresh
haemorrhage into the free peritoneal cavity following the biopsy, which the post mortem report
indicates was the immediate cause of death.

CORONER'S CONCERNS

During the course of the inquest the evidence revealed matters giving rise to concern. In my
Opinion there is a risk that future deaths will occur unless action is taken. In the circumstances
it is my statutory duty to report to you.

The MATTERS OF CONCERN are as follows. —

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; . ;
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;

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

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 ef
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.

e

ACTION SHOULD BE TAKEN

Sin my opinion action should be taken to prevent future deaths and | believe you [and/or your

organisation] have the power to take such action.

YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this report, namely
by 07 December 2024. I, the coroner, may extend the period.

Your response must contain details of action taken or proposed to be taken, setting out the
timetable for action. Otherwise you must explain why no action is proposed.

8

COPIES and PUBLICATION

| have sent a copy of my report to the Chief Coroner and to the following Interested Persons:

* Kingsley’s family
¢ | have also sent it oS -: the Liver Unit, University Hospitals
Birmingham NHS Foundation Trust who | believe may find it useful or of interest.
lam also under a duty to send the Chief Coroner a copy of your response.

The Chief Coroner may publish either or both in a complete or redacted or summary form. He
may send a copy of this report to any person who he believes may find it useful or of interest.
You may make representations to me, the coroner, at the time of your response, about the
release or the publication of your response by the Chief Coroner.

(<<)

11 October 2024 L w/
Signature Prac

for Laura Bradford Assistant Coroner for North London

Responses

4 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.

Response from Bsg (PDF)
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 (
The late Kingsley Efosa Imafidon 

, date 11.10.24) 

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 
, 
Consultant Haematologist, a member of the guideline group. 

 and Dr 

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. 

Yours sincerely 

BSG VP Hepatology 

Consultant Hepatologist, Retired 

Consultant Haematologist 

British Society of Gastroenterology: Company No. 8124892 
Charity No. 1149074 / VAT No. 347 4214 61
Response from Homerton Hospital (PDF)
Homerton University Hospital 
Homerton Row 
London 
E9 6SR 

www.homerton.nhs.uk 

North London Coroner’s Service 
Barnet Coroner’s Court  
29 Wood Street 
London 
EN5 4BE 

28 November 2024 

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 

Incorporating hospital and community health services, teaching and research 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 be discussed in the Northeast London network liver MDT, as an alternative route for biopsy 

- 2 - 

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. 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Yours sincerely 

- 3 -

Chief Executive Officer

 - 4 - 

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

TYPE THE DOCUMENT TITLE  

Author(s)  

Version  
Version Date  
Implementation/approval Date  
Review Date  
Review Body  

1.  Aim  

  (Consultant  Radiologist  & 

Radiology Clinical lead),  

 (Consultant Gastroenterologist 
&  Associate  Medical  Director  EMRS 
Division),  
2.0 
November 2024 
TBC 
November 2027 
EMRS Governance 

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.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   Higher  risk  patients  who  are  to  undergo  percutaneous  biopsy  should  attend  a  pre-

- 5 - 

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.

 References 

- 8 - 

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. 

Yours faithfully 

Dr 
Medical Director
Response from Royal College of Pathologists (PDF)
From: 
To: 
CC: 
Sent: Mon Jan 06 2025 13:14:28 GMT 
Subject: RE: The Late Kingsley Efosa Imafidon 

(Attachments:) Prevention of future deaths Reg 28 (Signed).pdf 

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 
Follow us on Facebook, X and Instagram 

EXTERNAL EMAIL 

CAUTION: This email originated from outside of the organization. Do not click links or open 
attachments unless you recognize the sender and know the content is safe. 

13
Response from Royal College of Radiologists (PDF)
Assistant Coroner Ms L Bradford 
North London Coroner’s Service 
28 Wood Street 
London 
EN5 4BE 

12 December 2024 

Sent by email: 

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. 

Yours sincerely, 

RCR President 

12

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