John Tompkins

PFD  Response  using  a  systems-
based review  

Name: John Tompkins    

MRN: 

Date of Birth: 11 September 1950   

Date of Death: 25 July 2024 (73 years old) 

Inquest heard on 6 December 2024 

PFD report issued on 11 February 2025 

PFD response due on 8 April 2025 

Page 1 of 69 

 
 
 
 
 
 
 
                     
 
 
 
 
 A note of acknowledgement 

We acknowledge and appreciate the diligent efforts of the staff who supported this patient safety 
investigation. Their commitment to patient safety and willingness to improve to prevent future safety 
events, are highly commendable.  

The  staff's  participation  in  the  multidisciplinary  team  meetings  and  their  extended  support  in 
conducting observational studies in busy lists, have been invaluable to the investigation process. 
The collaborative approach taken by the learning response team, has been pivotal in identifying 
the factors that contributed to the event. 

Led  by  a  Learning  Response Lead  trained  to  conduct  investigations  for  learning,  the  team has 
adhered  to  the  highest  standards.  Their  dedication  to  identifying  actionable  insights  and 
implementing  safety  improvement  plans,  based  on  the  findings,  demonstrates  a  strong 
commitment to enhancing the quality of care provided to patients. 

In conclusion, the collective efforts of all involved, have significantly contributed to the success of 
this PFD Response, paving the way for meaningful improvements. 

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 Executive summary 

Incident overview 
A  73  year  old  patient  with  liver  cirrhosis,  who  developed  hepatocellular  carcinoma  (HCC)  was 
admitted  to  the  Royal  Free  Hospital  on  10th  July  2024  for  elective  Trans  Arterial  Embolisation 
(TAE) and Portal Vein Embolisation (PVE) in preparation for surgical liver resection. The Cancer 
Multi-Disciplinary Team (MDT) recommended sequential TAE and PVE, but combined TAE and 
PVE  were  performed  at  the  same  time  on  11/07/2024.  The  letter  written  by  the  referring 
hepatobiliary (HPB) consultant to the GP indicated the intention for the procedures to be staged 
sequentially. However, the term "sequentially" was not documented in any of the clinical notes after 
the  HPB  consultant  made  the  documentation  on  the  electronic  patient  record  (Cerner)  on 
28/05/2024. As such, the patient had the procedures both booked for and performed on the same 
day/same sitting. Consent was obtained for both procedures, but the material risks of combining 
them  were  not  discussed  with  the  patient,  nor  was  it  articulated  that  the  combination  being 
performed together was new. 

Post-operatively, on 13 July, the patient developed acute liver failure  related to to liver ischemia 
and inadequate function of the non-embolised liver. The patient was admitted to ITU on 14 July. 
Despite  maximal  medical  care,  he  developed  respiratory  failure  and  hepatic  encephalopathy 
secondary  to  acute  liver  failure,  leading  to  multi-organ  failure.  The  HPB  MDT  determined  that 
recovery was not possible. With the family's consent, life-sustaining therapies were withdrawn, and 
the patient passed away on 25 July 2024. 

Summary of key findings 

• 

Individual  requests  were  made  for  TAE  and  PVE  using  the  electronic  patient  record 
(Cerner). It neither specified the sequence of the procedure nor the interval between them, 
despite the referring  HPB consultant mentioning sequential TAE and PVE. The requests 
appeared  on  the  digital  radiology  information  system  (CRIS)  as  a  single  event  with  two 
procedures because both involved the liver. 

•  The patient was booked for both procedures as combined under general anaesthetic (GA).   
•  There is a note on CRIS  - discussed with  the interventional radiology (IR) consultant on 

24/6/2024 and agreed. Vetting was done informally in passing with the radiologist. 

•  Vetting  is  done  by  the  radiologists  and  is  a  thorough  and  personalised  review  of  the 
booking. Radiologists meticulously review patient documentation, including previous notes, 
images, and clinical presentations, to determine the appropriateness and urgency of the 
procedure. 

•  There were communications from the hepatobiliary (HPB, referring team) specialist nurse 
and  radiology  manager  as  to  whether both  procedures  would  be  done  together.  Neither 
were aware that the procedures needed to be performed and booked sequentially. 

•  There was an assumption that it is widely known that both procedures need to be done 
sequentially with a period in between the two bookings. This was not  known to all staff as 
some  staff  were  new,  did  not  have  the  organisational  memory  and  there  was  no  SOP 
relating to the booking. As a confounder, it is relatively common for a different combined 
procedure, that of portal vein embolisation (PVE) and hepatic vein (HE) embolisation to be 
performed either during the same sitting or more usually the next day.  It is quite rare for 
both procedures to be done together even sequentially.  

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 •  The investigation noted that a concern was raised on the day of the briefing, when the IR 
consultant encountered the patient booked for both TAE and PVE in one sitting, in contrary 
to the expected PVE only under GA. Attempts to reach the referring HPB consultant failed 
as he was on annual leave. Other HPB surgical consultants were not contacted as it was 
felt they would be unaware of the details of the case, so unlikely to be prepared to make / 
change management decision 

•  Although notes were again reviewed, the more recent entries did not refer to the procedure 

as a sequential. 

•  The  very  experienced  IR  consultant  was  aware  of  a  small  study  that  provided  limited 
evidence that the procedures could be safely performed together and decided to proceed. 
He  did  not  register  that  the  combination  was  considered  “novel”  and  required  specific 

granting  through  the  Trusts  novel  procedure  process,  nor  was  there an attempt  to  seek 
advice from the clinical or medical director. The decision was influenced by awareness of 
the pressures of admission, other patients waiting for procedures and potential delays that 
could ensue to this patient’s surgery.  

•  The workflow and processes in IRCU are fluid and dynamic on the day to accommodate 
both emergency and  scheduled cases in order of priority. This would have added to the 
complexity,  cognition and  sensemaking on  the  day  that  may have  led  to  the decision  to 
undertake the TAE and PVE as a combined procedure.  

•  The specialist registrar (ST4) did not  appreciate or  discuss that this particular combined 
procedure was being performed for the the first time at RFH. The specialist registrar was 
new to interventional radiology at the time, and this was not flagged as a novel procedure. 
The IR consultant discussed the procedure with the patient after consenting. As far as the 
IR consultant could recollect, the additional risk of a combined procedure was not discussed 
with the patient.   

•  The nursing  team  and  radiographers  who  were  in  the procedure room  were unaware  of 
these discussions  at  the  briefing  and  proceeded  with  additional  safety  checks using  the 
already  obtained  consent  for  TAE  and  PVE.  The  finalised  list  is  available  on  the  digital 
record on the shared drive.  

•  Following  the  death  of  the  patient,  the  team  did  not  report  the  safety  event  as  they 
considered it was a complication of the procedure, not recognising it as a complication of 
the increased risk of the simultaneous procedure. 

Summary of areas for improvement and safety actions  

• 

Issues  in  vetting  and  scheduling  process:  vetting  was  performed  but  without  clear 
documentation or consultation with the relevant parties. 

•  The  dynamic  nature  of  operations  and  processes  in  IRCU  added  to  the  complexity  and 
sensemaking on the day leading to a decision to proceed with a combined procedure. 
•  Two individual procedure requests on Cerner appeared as a single event on CRIS, creating 

ambiguity.  

•  The ambiguity between sequential and simultaneous was not articulated as it was assumed 
this was a norm and would be understood by all stakeholders including the radiologist.  The 
Cerner  system  currently  does  not  aid  booking  of  sequential  procedures.  Additionally,  to 
request a HVE the HPB team had to use the TAE request process on Cerner as a specific 
option for HV, as it is not available is the current build of the system. To mitigate, the HPB 

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 team specify within the clinical information that a HVE is the procedure required. This could 
add further ambiguity.  

•  There were no cues or triggers to prompt staff to consider this an unusual event that would 

require further exploration from booking. 

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 Contents 

A note of acknowledgement ............................................................................................................. 2 
Executive summary........................................................................................................................... 3 
1.  Background and context ............................................................................................................ 7 
2. PFD response approach ............................................................................................................... 9 
3.  PFD Investigation response process ...................................................................................... 10 
4.  SEIPS ...................................................................................................................................... 28 
5.  Findings ................................................................................................................................... 30 
6.  Discussion ............................................................................................................................... 33 
7.  Summary and Recommendations ........................................................................................... 36 
8.  PFD Discussion ....................................................................................................................... 38 
9.  Family questions ...................................................................................................................... 42 
Development of action plans .............................................................................................. 49 
10. 
Safety action summary table .............................................................................................. 51 
11. 
References .......................................................................................................................... 54 
12. 
Appendix ............................................................................................................................. 55 
13. 

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 1.  Background and context 

To gain a comprehensive understanding to enable a PFD response, it was essential to consider 
the broader context within which it occurred. This includes examining relevant medical conditions 
and procedures, as well as the national and local policies in place at the time. By providing detailed 
background information, this section aims to set the stage for the subsequent analysis and findings. 

1.1 Diagnosis and Treatments: 

Hepatocellular carcinoma (HCC) is a type of liver cancer that starts in the cells of the liver. It is 
very serious and can be life-threatening. The main causes of HCC include infection with hepatitis 
B or hepatitis C and having liver cirrhosis, which is a condition where the liver beco mes scarred 
and damaged over time. 

For individuals diagnosed HCC, there are several treatment options available that can help manage 
the disease and improve quality of life. Before considering liver resection, it is essential to explore 
other  therapeutic  procedures  such  as  Trans-Arterial  Embolisation  (TAE)  and  Portal  Vein 
Embolisation (PVE). 

Trans-Arterial Embolisation (TAE) is a minimally invasive procedure used to treat liver tumours 
by cutting off their blood supply. During TAE, an interventional radiologist inserts a catheter into 
the hepatic artery under local anaesthesia and injects embolic agents to block the blood flow to 
the tumour. This deprivation of nutrients and oxygen can cause the tumour to shrink or die. TAE is 
particularly  useful  for  patients  who  are  not  candidates  for  surgery  or  those  with  multiple  liver 
tumours. 

TAE can be beneficial before Portal Vein Embolisation (PVE) and liver resection in several ways. 
Firstly,  it  can  reduce  tumour  size  and  make  subsequent  procedures,  such  as  PVE  and  liver 
resection, more effective and safer. Secondly, by decreasing the tumour burden, TAE can help 
improve  liver  function  and  overall  patient  health,  thereby  enhancing  their  suitability  for  further 
treatments.  The  combined  approach  of  TAE  followed  by  PVE  can  stimulate  liver  regeneration, 
ensuring adequate liver volume for safe resection and improving postoperative outcomes. 

Portal Vein Embolisation (PVE) is another innovative procedure that can be considered before 
liver  resection.  PVE  involves  the  embolisation  of  branches  of  the  portal  vein  under  general 
anaesthesia to redirect blood flow. By selectively blocking parts of the portal vein, PVE stimulates 
the  growth  and  regeneration  of  the  liver  tissue  in  the  remaining  sections.  This  technique  is 
beneficial  for  patients  who  have  insufficient  liver  volume  for  safe  resection.  By  enhancing  liver 
growth, PVE can increase the chances of a successful liver resection and improve postoperative 
liver function. 

Sequential TAE followed by PVE procedures are in clinical practice infrequent and when performed 
the interval between the procedures is typically few weeks to allow sufficient time for the liver to 
adapt and recover, optimising the effectiveness of the subsequent PVE. 

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 1.2 Interventional Radiology and Cardiology Unit (IRCU) 

The  IRCU  at  Royal  Free  London  NHS  Foundation  Trust  (RFL)  carries  out  a  wide  range  of 
procedures receiving patients form all clinical/medical specialities throughout the  Trust. Working 
closely with hepato-biliary and liver transplant teams the suite performs several procedures relating 
to  these  specialities.  The  procedures  include  hepatic  angiogram,  trans-jugular  liver  biopsy, 
cholangiography, Trans-Arterial Embolisation (TAE), Portal Vein Embolisation (PVE), and biliary 
drainage. 

The  interventional  radiology  (IR)  department  at  Royal  Free  London  NHS  Foundation  Trust 
conducts a variety of minimally invasive image-guided diagnostic and therapeutic procedures for 
patients throughout the Trust. The interventional suite covers 2800 procedures per year and covers 
inpatients, outpatients, private patients, A&E patients, emergency out of hours patients and day-
case patients. The suite comprises three interventional rooms equipped with three vascular single-
plane Siemens angiography units as well as an Ultrasound Interventional room.  

Figure 1 IRCU at RFL 

1.3 Guidance  

The  PFD  response  considered  a  number  of  procedures  that  were  related  to  the  investigation 
(Appendix 2):  

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 •  National Safety Standards for Invasive Procedures (NatSSIPs) 
•  Royal Free Consent Policy   
•  Royal Free New Interventional Procedures (NIPs) policy  

1.4 Definitions of “MDT” Use in the report 

The terms "MDT" is referred to in various places in the document. There are three occasions where 
an MDT is used. There was cancer multidisciplinary team meeting (MDT). This happened prior to 
the referral that was made. As  part of the investigation, an MDT learning was facilitated. This is 
referred to as “investigation MDT” in the report. The investigation MDT was attended by the team 
that was involved in the procedure. An earlier MDT learning response was also undertaken as part 
of the response to the prevention of prevention of future death in January 2025.  

2. PFD response approach  

2.1 Investigation team 

Role 

Job title 

Dept/directorate and 
organisation 

Investigation 
commissioner/convenor 

Interim Medical Director 

Interim Director of Nursing 

Investigation lead: 

Head of Quality Governance and 
patient Experience 
Patient Safety Specialist 
Interim Quality governance managers 
Quality governance manager 

Chase  Farm  Hospital 
Unit 

Investigation Team  

Consultant Interventional Radiologist, 
Radiology Clinical Governance Lead 

Interim Matron Radiology 

2.2 Investigation Commissioning and Terms of Reference  

Following  the  death  of  the  patient,  immediate  review  at  the  HPB  and  Radiology  Mortality  & 
Morbidity (M&M) were carried out. The inquest was heard on 6 December 2024. Clinical staff gave 
evidence at the inquest and were supported by the Counsel. The Trust submitted further evidence 
in writing about what actions the Trust would take to improve safety and made submission against 
a Prevention of future death (PFD) on 14 January 2025. An MDT was undertaken to inform the 
response. The coroner has informed that there remain areas of concern giving rise to the risk of 

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 future deaths, hence a PFD was issued on the Trust on 12 February 2025. The safety event was 
reported via Trust’s safety events reporting system (DCIQ) on 24/02/2025.  

The risks that need to be addressed set out in the PFD report are: 

•  Limited  internal  review  of  the  incident  following  the  inquest  on  performing  the  two 

procedures at the same time 

•  The Trust seemingly did not consider the NatSSIPS2 standards either when undertaking 

the procedures, nor in detail as part of its review following the inquest.  

The team discussed the patient safety event at the PSERP meeting on 25 February 2025, which 
is held every Tuesday. The panel includes the Interim Medical Director (Group Clinical Services  
and Chase Farm Hospital, GCS & CFH), Interim Directo of Nursing (Group Clinical Services and 
chase Farm Hospital), Radiology Governance Clinical Lead, Deputy Director of Safety and Risk 
(RFL), Head of Quality Governance and Patient experience (GCS & CFH), Head of Patient Safety 
and Risk (Royal Free London, RFL), and other panel members of the unit, where this was declared 
to be investigated as Patient Safety Incident investigation (PSII) under the Patient Safety Incident 
Response Framework (PSIRF).  

This  PFD  response  covers  the  delivery  of  care  and  any  deviation  from  the  standard  of  care 
provided during the radiology procedure encounter, focusing on the processes around information 
provision, consent-seeking, and adherence to NatSSIPs2. It aims to address the concerns raised 
by the coroner and the family, as mentioned in the PFD report. The investigation will thoroughly 
examine the decision-making process surrounding the elective IRCU procedures (TAE and PVE) 
and scrutinise the internal reviews conducted post-inquest. 

It will also involve identifying any systemic issues that may have contributed to the  safety event 
and  proposing  actionable  recommendations  to  prevent  future  occurrences.  The  scope  will  not 
include any investigation around the post-operative care provided at the ITU, as this falls outside 
the agreed boundaries of this inquiry. 

2.3 Family Concerns  

The  family  raised  a  number  of  concerns  that  were  shared  by  the  coroner  in  the  PFD  report 
(Appendix 1). 

Attempts have been made to answer the family’s questions through the thorough investigation and 
can be found in Section 9 of the report. 

3.  PFD Investigation response process 

3.1 Documentation Reviews 

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 Relevant  documents,  such  as  Electronic  Patient  Records  (EPR  –  Cerner),  CRIS  and  PACS 
(Radiology departmental specific electronic records), staff rosters, Trust Policies and guidelines, 
IRCU  Standard  Operating  Procedures  (SOPs),  IR  LocSSIPs,  IR  Care  pathways  and  email 
communication  between  the  staff  were  reviewed  as  part  of  the  investigation  process  to  gather 
information.  These  documents  offered  objective  record  of  the  events  and  vital  aspects  of 
developing  insightful  improvement  recommendations  to  make  the  care  evidence  based.  The 
documentation timeline was produced (Appendix 1) 

3.2 Interviews 

Recollection  of  event  meetings  were  conducted  with  key  participants  such  as  nurses, 
radiographers, interventional radiologists, referring HPB consultant and Clinical Nurse Specialist, 
nurse managers and admin staff to obtain firsthand accounts of the safety event. These meetings 
provided valuable insights into the perceptions and experiences of those directly affected. 

Staff said that they were confident in speaking up and raising any safety concerns they experience 
in their day-to-day operations. Furthermore, participants were encouraged to share their thoughts 
on systemic issues and potential improvements within the IRCU. 

In addition to recollection of event meetings, the investigation team also observed the actual work 
processes  as  done.  This  included  shadowing  the  staff  during  their  routines  and  identifying  any 
discrepancies between documented procedures and  actual  practices. These observations  were 
crucial in understanding the complexities of the work environment and the real-world challenges 
faced by the team. 

3.3 Post Safety Event MDT Learning Response  

An in-depth review of the processes and input from different disciplines were carried out during the 
MDT  learning  response  on  20/03/2025  with  the  presence  of  three  of  the  IRCU  nurses,  two 
radiographers, two radiologists, and the HPB CNS. The team involvement and participation were 
remarkable and throughout the session psychological safety and well-being of staff were ensured.  

The meeting was supported by review of timelines, observations and observations undertaken in 
advance of meeting. The facilitator reviewed the patient pathway and individual contributions to 
care  delivery,  identifying  areas  for  improvement  and  ensuring  a  thorough  understanding  of  the 
events.  

Investigatory  MDT  discussion  added  more  information  about  the  patient  pathway  in  IRCU 
reinforcing the complexity and dynamic processes within the department, working environment and 
suggestions and recommendations for improvement.  

Although the individual patient flow and processes discussed have a defined pathway, the workflow 
within the IRCU is flexible and complex. The vetting of procedures includes reviews to ensure that 
what  is  requested  includes  the  right  information,  some  following  discussions  are  changed  to 

Page 11 of 69 

 
 
 
 
 
 
 another procedure, some are rejected. There is no specific protocol for vetting, but some cases will 
have their own procedural protocol which will be taken into consideration.  Despite the team brief 
done in the morning the list is subject to changes as requests are being received throughout the 
day with some being emergency. 

The team's workload and the pressure of utilising the right resources are challenging mostly due 
to flexibility in scheduling on the day. The interventional suite covers 2800 procedures per year 
and covers inpatients, outpatients, private patients, A&E patients, emergency out of hours patients 
and day-case patients.  

The  IRCU  team  typically  performs  0-5  elective  procedures  planned  that  are  scheduled  and 
admitted in the ward expressly for IR procedures in each day. In addition, there are 5–15 inpatients 
and emergencies.  A total of fifteen procedures per day, five in each room. All patients are reviewed 
together during the morning team brief and allocated based on the availability. No individual room 
list is printed however a local SOP guides states that a list should be printed and displayed in each 
procedure room. There is an electronic live list. 

As the patient was admitted, the ward staff followed their routine process of preparing the patient 
for a PVE, which was confirmed by the documentation by the anaesthetic team. It was not known 
that the patient was scheduled for a combined procedure. 

The IR consultant stated in the Investigatory MDT that he discovered an uncertainty to the booking 
of the case a combined TAE and PVE, under PVE general anaesthesia list. The decision was either 
cancelling the procedure, to send the patient home and reschedule to the next available slot which 
would have likely incurred a delay that may have been significant or to do TAE under local which 
would mean cancelling the anaesthetic or to do both. It was known to the IR consultant that limited 
evidence  did  exist  to  the  use  of  a  combined  procedure  as  per  the  study  mentioned  during  the 
inquest. 

The  impression  from  the  Investigatory  MDT  discussions  were  that  there  was  pressure  to  begin 
procedures  promptly  leaving  the  team  with  limited  time  to  review  past  notes  thoroughly.  In  this 
case, the term "sequentially" was not documented in any notes after the HPB consultant made the 
documentation on Cerner on 28/05/2024. Reviewing notes from two months prior would be time -
consuming for the team and delay a start of any procedures.  This level of retrospective review is 
unlikely to be practically applicable in practice. The notes were reviewed as part of the confirmation 
of the procedure at the team brief, but the more recent entries in the electronic notes, did not refer 
to a sequential procedure.  

The  referring  HPB  consultant  was  contacted  but  was  on  annual  leave.    Considerations  on 
contacting other members of the team or the on-call registrar was not pursued at that point. It was 
felt that other members of the team may or may not be aware of the case , especially as it is not 
common to undertake both TAE and PVE albeit sequentially. The IR consultant felt that other HPB 
consultants may have been unaware of the details of the case so unlikely to be prepared to make 
or change management decision. 

There  was pressure  on  the  decision  making  and  the  impact  of  sending  the  patient  back  would 
mean a delay in his treatment. The patient was already waiting in the IRCU recovery room as he 
was scheduled as the first patient on the list.  

Page 12 of 69 

 
 
 
 Staff  felt  safe  to  raise  concerns,  unfortunately  this  procedure  did  not  trigger  major  concerns. 
Undertaking a combined TAE and PVE procedure was not as obvious to all staff as a deviation to 
normal  practice.  Some  staff  recognised  that  TAE  and  PVE  were  only  performed  as  individual 
procedures, which may be due to both procedures done for the same patient even sequentially 
was very rare.  They did not feel there was a need to challenge as they trusted the knowledge and 
skills of the IR consultant and assumed any issues were resolved at the team brief.  

The briefing does not include the entire nursing and radiographer team as the rest of the members 
need to prepare the rooms while the full list is being discussed. Not all staff were aware of the 
conversations  and  decisions  made  at  the  briefing.  Despite  a  list  being  used  to  go  through 
procedures, this list is subject to change following discussions. The record of the briefing is made 
on the electronic whiteboard in the radiology office, which is a live document.  

Figure 2 Recovery Bay in IRCU 

From  the  discussions,  it  appears  that  the  recovery  bay  is  a  hub  of  activity  as  day  patients  are 
admitted,  patients  are  consented,  and  patients  are  received  following  the  procedure.  IRCU 
workflow is more fluid and dynamic. 

 3. 4 Observational Study at IRCU 
This section details the existing workflow and patient care process under investigation, referencing 
the Interventional Radiology Standard Operating Procedures, LocSSIPs/NatSSIPs, Image -Guided 
Surgery Care Pathway, and the LocSSIPs Checklist. An observational study was carried out on 

Page 13 of 69 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 14/03/2025  as  part  of  the  investigation  process.  The  study  was  undertaken  by  the  quality 
governance manager and Interim matron for radiology. 

LocSSIPs  for  interventional  radiology  was  developed  by  a  multidisciplinary  group  of  clinical 
practitioners.  The document lays out  the  minimum standards  of  safety  and  care  that  should be 
applied  to  all  interventional  radiology  invasive  procedures  performed  within  the  radiology 
departments of the RFL Trust group of hospitals. The scope of this document sets out the minimum 
standards  of  safety  and  care  to  prevent  never  events  during  the  invasive  procedure  by  good 
practice in various aspects such as scheduling, workforce, handover, team briefing, consent and 
site  marking,  equipment  check,  sign-in  and  time  out,  sign-out,  prevention  of  retained  foreign 
objects,  debrief and  documentation.  This  is audited  monthly and  presented at  Divisional  Safety 
Board Meeting.  

Page 14 of 69 

 
 
 
 Figure 3 NatSSIPs2 process map 

Page 15 of 69 

 
 
 
 
 
 IRCU procedure rooms does not have anaesthetic room attached or holding bays for patients to 
wait for their procedures. Day patients and inpatients who are awaiting consenting are brought to 
the recovery bay. 

Figure 4 Mapping safety checks with location 

Once the patient is verified with the consent and site/side marking by the recovery/receiving nurse 
the patient is taken directly to the procedure room, where the consent and full patient identification 
is carried out again by the full procedural team. This satisfies the statutory requirement of sign-in 
and timeout, which were performed together as a proportionate safety check for the procedure. 
This happens before transferring the patient on to the table. Figure 4 shows the locations of various 
mandated safety checks. 

The IRCU receives interventional Radiological procedures requests from multiple specialities. This 
must  go  through  the  vetting  process  before  scheduling  and  listing  as  emergency  or  elective 
procedures  according  to  the  clinical  presentations  and  urgency.  Figure  5  -  Hierarchical  Task 
Analysis, shows the pathway of IRCU procedures from referral to discharge/escalation process. 
For all tasks outlined in the HTA, NatSSIPs and LocSSIPs protocols are adhered to ensure safer 
procedures and prevent never events. 

Page 16 of 69 

 
 
 
 
 Figure 5 IRCU procedures pathway

Page 17 of 69 

 
 
 
 3.4.1  Referral, Vetting and Scheduling (Work as prescribed versus Work as Observed) 

The IRCU team receives referrals only from within the Trust. Direct access for GPs is not available 
at this facility. All requests for IRCU procedures must be entered on Cerner/CRIS prior to treatment 
within the IRCU facility. Once the referral is made, the referring team contacts the IRCU to inform 
the  referral.  This  is  scheduled  for  the  next  team  brief  for  discussion  unless  the  case  is  an 
emergency.  Elective cases are booked onto the next available session. Emergency and out of 
hours  requests  are  consulted  with  the on-call  radiologist  and decision  is  made.  This  process  is 
referred to vetting. Vetting  for all interventional radiology procedures must be performed by the 
radiologists,  however,  this  case  was  discussed  by  the  radiographer  with  the  IR  consultant 
informally.  

Standard or no protocol required vetting is a process typically handled by admin and clerical staff, 
who schedule patients for interventional radiology procedures based on predefined criteria that do 
not  necessitate  a  detailed  review  of  patient-specific  clinical  information.  This  method  relies  on 
general guidelines and does not involve a comprehensive assessment of each individual case. 

Vetting  by  radiologists,  on  the  other  hand,  is  a  more  thorough  and  personalised  approach. 
Radiologists  meticulously  review  patient  documentation,  including  previous  notes,  images,  and 
clinical  presentations,  to  determine  the  appropriateness  and  urgency  of  the  procedure.  This 
ensures  that  each  case  is  evaluated  based  on  its  unique  clinical  context,  allowing  for  tailored 
decisions that prioritise patient safety and the optimal timing of interventions. Listing only happens 
if the radiologist and radiographer manger approve. A further discussion with the referring team 
may take place to clarify issues otherwise the request is cancelled.  

Figure  6    details  the  vetting  and  scheduling  process  as  prescribed  before  booking  IRCU 
procedures.  The  level  of  review  depends  on  each  case,  the  complexity  and  the  amount  of 
information provided by the referring team.  

Work-as-prescribed is the formalisation, specification and design of work. It is the work that people 
‘should do’, especially according to policies, procedures, rules. Work-as-prescribed is intended to 
define and direct how work ought to be done to achieve its objectives, and often why it ought to be 
done  this  way.  Work-as-prescribed  takes  a number  of  forms,  including  laws,  regulations,  rules, 
procedures, checklists, standards, job descriptions, management systems. 

No matter what the level of granularity, procedures, standards and regulations  lack the detail, 
richness and subtlety of actual work, including the many interdependencies and conditions. The 
Catch-22 of work-as-prescribed is that the more specified the work is, the more incorrect is it 
likely to become in messy work situations. 

Page 18 of 69 

 
 
 
 
 Figure 6 Vetting and scheduling as Prescribed 

The vetting and scheduling were done for the procedure under investigation (Figure 7). Work-as-
observed involves attending to, monitoring and perceiving the work of others, formally or 
informally, and the interpretation and direct description of what is observed by the observer. Not 
all aspects of work-as-done can be observed and so work-as-observed will never be complete. 

On the day of the procedure, the list was printed by admin staff and handed over to the procedural 
team. The list includes elective procedures for review, new referrals for vetting, and emergency 
procedures under patients for discussion. A digital copy is shown on the board and accessible via 
MS Teams as a live, shared document. Any late changes including order of the list and further 
queries and concerns are documented and communicated to the entire team. The scheduling of 
the list depends on the expected workload and taking into consideration of other factors that include 

•  Team briefing and debriefing, and other key safety steps in LocSSIPs 

Page 19 of 69 

 
 
 
 
 
 •  Reviewing previous notes and images 
•  Patient positioning and preparation 
•  Preparation of all necessary equipment and instrumentation 

Any complications from procedure 

Figure 7 Vetting and Scheduling of the procedure 

On 18/06/2024, the Cancer MDT discussion and outcome agreed to proceed with TAE and PVE 
sequentially. The Cancer MDT outcome was to proceed with TAE and right portal vein embolisation 
and not to consider SIRT (Selective Internal Radiation Therapy). 

Page 20 of 69 

 
 
 
 
 Two separate electronic request forms for TAE and PVE were submitted via Cerner by the referring 
team. Both requests were recorded on CRIS (Treating department patient record) as a single event 
involving two procedures. The individual requests did not specify the order in which the procedures 
should be performed or the interval between them. 

On the 20/06/2024, patient was called and information leaflets sent by the HPB CNS. The specialist 
nurses routinely contact patients to update them of the cancer MDT outcomes and treatment plans.  

The  HPB  CNS  enquired  if  the  procedure  should  be  done  on  the  same  day  or  if  to  be  booked 
separately  on  20/06/2024.  On  24/06/2024,  there  was  an  email  confirmation  sent  that  both 
procedures were booked for 11/07/2024. As the HPB Specialist nurse is the link to all parties like 
the  patient,  the  interventional  radiology  team  and  the  HPB  team,  it  would  be  expected  that  a 
challenge or guidance of the intention for both procedures to be communicated and a challenge to 
the booking for both procedures. It may have been that the discussion at cancer MDT on whether 
to proceed with TAE and PVE or SIRT caused the attention to be drawn away for the sequential 
procedure which would have been considered as a norm.  

Few screenshots from CRIS for visualisation are shown in Figure 8 and Figure 9. 

Figure 8 Visualising procedure requests from CRIS 

Figure 9Vetting steps from CRIS 

Upon  reviewing  the  vetting  process,  it  appears  to be  conducted  informally  within  the  context  of 
discussing the day’s procedures, typically during the morning senior team briefing. This focus on 

immediate procedures may detract from effectively vetting upcoming procedures. 

Page 21 of 69 

 
 
 
 
 
 
 
 
 
 Subsequent to these discussions, the Radiographer Manager registered the procedure as vetted 
and  scheduled  in  the  next  available  slot  on  CRIS.  However,  as  illustrated  below  figure, 
documentation  remains  unclear,  impeding  understanding  by  others.  For  instance,  “ok  w/  ND” 
signifies  a  discussion  with  the  IR  consultant’s  initial  ND.  Those  discussions  were  an  informal 
confirmation.  

It is essential to develop and implement a more robust vetting process with clear documentation 
standards to improve clarity and efficacy for future procedures. 

Fig 10 Evidence of the Informal vetting  

During  our review in  IR, we observed  that  the  Cerner  system  currently does  not  support linked 
procedure requests. Additionally, the HPB team requires an option for HVE requests, which is not 
available. To request HVE, they are using TAE (Hepatic Artery Embolisation) request and adding 
a  clinical  note  indicating  hepatic  vein,  which  may  introduce  unnecessary  complexity  to  the 
procedure requesting process. There are limitations with the current system which includes use of 
the national codes for procedures.   

3.4.2 Listing / Vetting Process on the day in IRCU 
A full list of elective patients for IRCU procedures is listed in the digital copy by the radiographer 
in-charge of the day, for which the entire IRCU team has access to. Along with the elective list, the 
list  of  patients  who  were  added  since  the  last brief  for  vetting,  and  also  to be performed as  an 
emergency were all included. This group of patients are classified under the heading ‘patients for 
discussion’. The compiled list is shared on Teams as a live document for the IRCU team to view. 

Once  the  radiographer  prepared  the  list,  this  is  verified  by  the  registrar  to  be  discussed  in  the 
presence of the IR consultant during the morning brief. The consensus decision is made either to 

Page 22 of 69 

 
 
 
 
 
 
 
 
 be done as an emergency or as part of vetting to accept the requests received to be booked for 
procedures in the future days. 

As  such,  on  the  day  of  the  observational  study,  there  were  5  elective  patients,  followed  by  6 
emergency patients  were discussed  during  the brief.  The  team had  access  to  both  Cerner  and 
CRIS during the briefing. Registrar presented individual patients looking at both CRIS and Cerner 
for discussion and decision making. 

During the post incident investigation MDT, the team stated that they feel this is considered as an 
exhaustive list to include the full team in discussion during the morning brief. Also, for the fact that 
the nursing team needs to prepare the rooms and equipment for the start of the list on-time. Hence, 
only senior members of the day are included in the morning brief. Ideally, the nurse manager or a 
representative for the nursing manager, the interventional radiology manager (radiographer) or a 
representative radiographer of the day, and all radiologists discuss the full list. 

However,  on  the  day  of  the  observational  study,  while  doing  the  morning  brief,  there  was  an 
emergency call that needed the radiographer to attend to the emergency. The morning brief was 
carried  out  without  the  radiographer  representative.  The  radiologist  and  the  nurse  manager 
proceeded with the brief upon the team agreement to proceed without the radiographer. 

3.4.3 Consent  
According to the local SOP, all patients must have a valid consent form completed prior to entering 
the  procedure  room.  The  patient  is  consented  in  the  IRCU  recovery  area  prior  to  entering  the 
procedure room. Consent form 1 must be completed for all responsive adults. In IRCU multiple 
safety checks are made at different LocSSIPs steps to check consent form is duly  completed by 
the patient or their care giver before the procedure is started. The checks in various stages must 
comprise  the  validity  of  the  consent  form.  The  checks  were  performed  during  the  sign  in  and 
timeout  using  the  ‘Interventional  Radiology/  Image  Guided  surgery  care  pathway  &  LocSSIPs’ 

checklist at the time of the patient had procedure. These checks are made during: 

✓  Team brief 
✓  Handover to procedure team 
✓  Sign-in/time-out. 
✓  Sign-out 

In  this  instance,  treatment  plan  was  initially  discussed  by  the  HPB  consultant  at  the  time  of 
consultation  on  28/5/2024.  Following  the  HPB  -  MDT  outcome  on  20/6/2024,  CNS  mailed 
information leaflet  to  patient  address  (TAE  &  PVE)  and  discussed  the outcome  with patient  via 
telephone. The final written confirmation was obtained in the IRCU recovery. Following the team 
brief  the  IR  registrar  consented  the  patient  using  consent.  The  registrar  confirmed  that  the 
increased risk combining the procedures done together was not discussed. The IR consultant, as 
far that he could recall, the increased risk of performing both TAE and PVE simultaneously was 
not discussed with the patient. 

See Appendix 3: LocSSIPs for completed LocSSIPs for this patient journey and see Appendix 4 
Consent form Signed for the patient under the investigation.  

Page 23 of 69 

 
 
 
 
 Figure 11 Consent process review 

The patient received patient information leaflets for individual procedures. The ST4 Registrar joined 
trust  in  August  2022  and  started  working  in  imaging  radiology  around  November  2023.  When 
consenting the patient, the registrar did so on the basis of the discussion in the team brief. 

3.5 AcciMap  

The  Accimap  models  the  socio-technical  context  to  identify  the  combination  of  events  and 
decisions.  It  is  useful  tool  to  use  to  highlight  the  complexity  and  interlinked  processes..  It 
emphasises  the  involvement  of  each  level  in  safety  management  through  laws,  rules,  and 
instructions. For systems to function safely, decisions made at high levels should  cascade down 
and be reflected in the decisions and actions occurring at lower levels of the system. Conversely, 
information at  the  lower  levels  (e.g.  staff,  work,  equipment)  regarding  the  system’s  status  must 
travel up the hierarchy to inform the decisions and actions occurring at the higher levels. Without 
this so-called ‘vertical integration stems’, there can be a loss of communication and connection of 
the processes risking failure in the system. 

Page 24 of 69 

 
 
 
 
 
 
 Figure 12 AcciMap

Page 25 of 69 

 
 
 
 
 In the context of a patient safety event, this approach can be illustrated by examining the different 
levels of influence and how they interact.  

At  the  organisational  level,  there  is  a  need  for  more  comprehensive  Standard  Operating 
Procedures (SOPs) for Interventional Radiology and Cardiology Units (IRCU). Current SOP does 
not  reflect  the  complex  operations  within  IRCU.  There  is  a  need  to  balance  adaptability  with 
guidance to bridge the gap  in organisational memory for less frequently performed procedures. 
This case may have not have triggered any warning that this is the first time that both procedures 
were being done together and that it would require it to be treated as a novel or new interventional 
procedure  therefore  requiring  formal  committee  ratification  as  a  new  interventional  procedure 
(NIP). Empowering staff of required processes may have allowed a safe challenge. Any concerns 
or deviations from the process needs to be escalated using the Trust's Datix system. The hospital 
unit has regular conversations of all categories of cases at the PSERP.   

The lack of involvement of the entire clinical team in the briefing may mean important discussions 
and clarifications may be missed. In this instance there were discussions, and the outcome was to 
proceed to doing both cases at the same time. The team confirmed in the MDT that they were 
unaware of concerns discussed at the team brief.  

The team in attendance of the team brief included the IR manager and the registrar, both of whom 
were  between  4-8  months  into  their  role  and  new  in  Interventional  Radiology  (IR)  department 
respectively. Additionally, the nurse manager was on leave and an acting nurse manager attended 
the briefing.  

The IR Manager began working for the Trust in January 2023 as a rotating radiographer, and in 
March 2024 took on the position of IR manager. The IR manager had only been in this position for 
three months before the event and was not familiar with sequential TAE and PVE requests.  

 There is an expectation that all LocSSIPS will be reviewed and developed into a proportionate 
NatSSIPs2 eight steps. Most specialties are expected to continue to use their LocSSIPs during this 
transition. The auditing tool has been built to the standards set out in NatSSIPs2 and focuses on 
the qualitative aspects. This auditing tool went live with testing in December 2024. 

The NatSSIPs2 has evolved to there being less emphasis on tick boxes or rare ‘Never Events’ and 
now include cautions, priorities and a clear concept of proportionate check based on risk.   

Key Enhancements in the updated NatSSIPs2: 

• 

• 

Improved clarity on the roles and responsibilities of healthcare professionals during invasive 
procedures. 
Integration of 'systems thinking' and 'human factors' knowledge to address the complexity 
of invasive procedure work. 

•  Updated checklists and tools to support the effective implementation of safety standards. 
•  Emphasis on developing a team culture that promotes safety and mutual support. 
•  Proportionate checks to ensure that safety measures are appropriate to the risks involved 

in each invasive procedure. 

Page 26 of 69 

 
 
 
 
 The Trust's NatSSIPs steering group  

The group is responsible for ensuring the effective implementation of these guidelines. Their role 
includes: 

•  Provision  of  assurance  to  the  Trust  Executive  Board  on  effective  safety  standards  for 

invasive procedures. 

•  Oversight and reporting on robust safety standards across the Trust. 
•  Development  of  trust-wide  guidance  and  embedded  practice  of  NatSSIPs2  safety 

standards. 

•  Creation of template checklists, tools, and supporting documentation for Local standards 

(LocSSIPs). 

•  Updating existing WHO Five steps to safer surgery with the 'NatSSIPs2 Eight' for relevant 

patients. 

•  Organisational ratification of policies and procedures proportionate to risk, recognising the 

difference between major and minor procedures. 

•  Ensuring appropriate checks to reduce risks, provide clarity, and set expectations. 
• 

Identifying and ensuring adequately resourced leadership for sustained implementation of 
NatSSIPs2. 

Page 27 of 69 

 
 
 
 4.  SEIPS 

The Systems Engineering Initiative for  Patient Safety (SEIPS) model is an innovative approach 
that  integrates human  factors  and  socio-technical  context analysis  to enhance patient  safety.  It 
recognises  that  healthcare  systems  are  complex  and  interconnected,  requiring  a  thorough 
examination of both human and organisational elements. By focusing on the interactions between 
people,  technology,  tasks,  and  the  environment,  the  SEIPS  model  provides  a  comprehensive 
framework for identifying potential safety risks and implementing effective interventions. This model 
aligns well with the principles of human factors engineering, which emphasise designing systems 
that  support  human  performance  and  minimise  errors.  Through  its  holistic  perspective,  SEIPS 
facilitates  a  deeper  understanding  of  the  underlying  causes  of  adverse  events  and  promotes  a 
culture  of  continuous  improvement  within  healthcare  organisations.  Patient  safety  events  result 
from multiple interactions between work system factors.  

Integrating the SEIPS model into safety investigations allows healthcare organisations to foster a 
blame-free  culture,  where  staff  feel  supported  and  empowered  to  report  errors  without  fear  of 
retribution. This culture of openness and transparency is crucial for the continuous enhancement 

Page 28 of 69 

 
 
 
 
 
 Figure 13 2 SEIPS model in patient safety event 

Page 29 of 69 

 
 
 
 5.  Findings 

This section summarises the findings from the investigation of the patient's journey during the IR 
procedure  at  RFL  by  referencing  SOPs,  patient  data,  observational  studies,  and  recollection  of 
event meetings with healthcare professionals directly or indirectly involved in care delivery. The 
goal is to understand the factors influencing decision-making and actions in a healthcare setting 
and identify areas for improvement to prevent future safety events. 

The analysis conducted using SEIPS and AcciMap tools identified some areas requiring further 
attention  for  improvement.  These  findings  are  organised  into  three  sections  for  clarity:  before, 
during, and after the IRCU procedure. 

Before Procedure: 

Vetting, Scheduling, and Listing: 

➢  Two separate electronic request forms for TAE and PVE were submitted via Cerner by the 
referring team. Both requests were recorded on CRIS (Treating department patient record) 
as a single event involving two procedures. 

➢  The  individual  requests  did  not  specify  the  order  in  which  the  procedures  should  be 

performed or the interval between them. 

➢  One day after the requests were made on Cerner, an enquiry was raised via email  by the 
specialist  nurse  regarding  whether  these  procedures  should  be  performed  together  or 
separately. This was with the IR team not the referring HPB consultant. Had the question 
been addressed to the referring HPB consultant, the intention to undertake the procedure 
as a sequential would have been clear. 

➢  The  IR  manager  confirmed  with  the  referring  team  and  more  specifically  with  the  HPB 

specialist nurse, that both procedures were scheduled for the same time.  

➢  Documentation shows vetting was done informally before booking the patient for the next 

available GA slot on CRIS. 

➢  There is no track record of briefing documents discussed during  the morning team brief, 
which raised the concern again whether to proceed with both the procedures, given the use 
and update of digital records. 

➢  The IRCU team performs both schedule and more urgent inpatient cases which makes up 
a greater proportion of the case load. The impact being that the team brief in the morning 
can be lengthy with vetting new cases.  

➢  During  our review in  IR,  we  observed  that  the  Cerner  system  currently does not  support 
linked procedure requests. Additionally, the HPB team requires an option for HVE requests, 
which is not available. To request HVE, they are using TAE (Hepatic Artery Emb olisation) 
request  and  adding  a  clinical  more  indication  hepatic  vein,  which  may  introduce 
unnecessary  complexity  to  the  procedure requesting  process.  This  adjustment  highlights 
areas  for  improvement  process.  Also,  given  the  fact  that  inefficient  vetting  procedure  in 
IRCU pose significant risk to patient safety. 

Page 30 of 69 

 
 
 
 
 
 Information provision/1st stage of consent process:  

➢  On 20 June 2024 at 13:45, the CNS contacted the patient to review the MDT outcome regarding 
the  proposed  TAE  and  PVE  procedures.  It  was  discussed  and  noted  that  the  patient  was 
informed. However, at 13:53 on the same day, the CNS emailed the IRCU manager to inquire 
if these procedures should be performed in one sitting or sequentially. There is no evidence 
that this has been communicated to the patient regarding whether the two procedures would 
be combined or sequential and the associated material risks. 

➢  The Cancer MDT outcome did not include the term "sequential," leading the nurse to request 

TAE and PVE without specifying the order as per the cancer MDT outcome. 

➢  The CNS did not consult the HPB consultant about the sequence of the procedures.   
➢  Patient information leaflets for TAE and PVE were sent on 20/06/2024, intended for individual 

procedures to be performed sequentially as TAE and PVE at the Trust. 

➢  The information leaflets are outdated; TAE (review date April 2017) and PVE (review date June 

2018). 

➢  Ward admission a day prior to the elective IRCU procedure on  10/07/2024 was documented 
as  an  elective  admission  for  right  TAE  and  PVE.  This  followed  the  organisational  memory 
pathway of PVE only admission flow.  

On the day of the procedure 

 Briefing/Confirmatory consent:  

➢  On the day of briefing, the IR consultant was under the impression that this patient required 
a PVE as would have been expected as this was a general anaesthetic list (GA). In the team 
brief and review of the notes it was found that the first procedure of TAE, was not done and 
that a combined TAE and PVE was scheduled under GA session. The question of whether 
to perform these procedures simultaneously or sequentially arose during the briefing. 
➢  The IR consultant attempted to contact the referring HPB consultant but was unable to reach 
them as the referring HPB consultant was on AL. Other HPB surgical consultants were not 
contacted as it was felt they would be unaware of the details of the case so unlikely to be 
prepared to make or change management decision.  

➢  Upon  reviewing  the  patient  notes  the  sequential  procedure  was  requested  by  the  HPB 
consultant  on  28/05/2024  on  Cerner,  but  none  of  the  following  documents  denotes  the 
sequential procedure leading to ambiguity. 

➢  Whilst the team did review the notes, they did not go back to the initial discussions around 
the sequential procedure being documented. It was expected that the decisions from the 
cancer MDT would be communicated by the team and therefore discussion was on how to 
balance the request of the combined procedure with the norms. 

➢  The registrar (ST4), who was relatively new to Interventional Radiology at that time, obtained 
written consent in IRCU recovery following the senior  IR consultant's decision to perform 
both procedures together. The registrar was not familiar with the combined procedure and 
did not recognise that the combined procedure was not the normal process, therefore this 
was not discussed with the patient as a novel procedure and the material risk involved with 

Page 31 of 69 

 
 
 
 
 
 the combined procedure. As far as the IR consultant can recollect, the additional risk of a 
combined procedure was not discussed with the patient.  

➢  According  to  the  registrar,  the  IR  consultant  spoke  to  the  patient  following  the  consent 
obtained  by  the  registrar.  However,  it  cannot  be  confirmed  whether  the  material  risks 
associated with this dual procedure were discussed, as this was not  documented on the 
consent  form.  The  IR  consultant,  as  far  as  can  be  recollected,  the  additional  risk  of  a 
combined procedure was not discussed with the patient.  

➢  The nurse manager was on leave, and the morning briefing was attended by the covering 
senior nurse at that time. Additionally, the radiographer (Interventional Radiology Manager) 
was relatively new to the role.  

➢  None of the team recognised that the combination of these two procedures had not been 
performed at the Trust or in the UK and should follow the new interventional procedures 
(NIPs) policy as it is considered as novel procedure. Staff were familiar with both procedures 
performed  individually.  In  addition,  it  is  relatively  common  for  a  combined  portal  vein 
embolisation (PVE) and hepatic vein (HVE) embolisation to be performed either during the 
same sitting or more usually the next day. 

Procedure Room: 

➢  The team brief did not include all staff there was no subsequent pre-procedural brief with 
the  team  that  was  not  present  at  the  morning  brief  like  the  nurses  and  radiographers 
regarding  individual  case.  It  is  of  note  that  proportionate  checks  are  done,  a  team  brief 
separate to the morning brief is undertaken before the patient is brought into the procedure 
room.  

➢  The list updates are available in the digital record and can be accessed through the shared 

drive. 

➢  During the safety event MDT learning response review, the procedure team indicated that 
they trusted the decisions made by the IR consultant who is very experienced. There were 
no  triggers  to  raise  concerns,  therefore  subsequent  checks  were  done  for  a  combined 
procedure as the patient was consented as such.  

➢  Although  the  procedural  team  possessed  the  expertise  to  perform  both  procedures 
individually, they did not recognise that combining them would constitute a novel procedure, 
necessitating adherence to the NIPs policy. The pressures on the day prompted the decision 
making and there were no further escalations once the decision was made.   

➢  The procedure team confirmed the expected procedure and the actual procedure during the 
combined sign-in and time-out safety check, with prior consent obtained for both TAE and 
PVE at the time of briefing. 

➢  Upon sign-out, the team considered the procedure successful, documented the standard 

post-operative care plan, and did not flag it as a novel procedure subsequently. 

Handover/Debrief: 

➢ 

 Discussions from the team brief were not communicated to the team that were absent from 
the team brief senior brief. Therefore, the discussion around the combination vs sequential 
of TAE and PVE was not flagged to the post-operative care team. 

Page 32 of 69 

 
 
 
 
 ➢  LocSSIPs post-procedure handover process was based on the procedure performed and 

was not significant. Hence, followed standard post-operative care plan.  

Post-operative care/Escalation process 

➢  The complications followed by the procedure was considered as normal complication of the 

procedure, hence it was not reported as a safety event. 

➢  After the patient's death, the IRCU mortality and morbidity review  decided not to perform 
TAE and PVE simultaneously. This decision is undocumented with no follow up minutes or 
actions. 

➢  The IR consultant presented the case study for shared learning in the HPB review meeting. 

6.  Discussion 

Research on sensemaking processes identified action-meaning creation processes in which actors 
respond  to  change  in  their  environment  to  give  meaning  to  what  has  happened,  thus  reducing 
uncertainty  and  enabling  action  (e.g.  Weick,  1988,  1993).  Through  these  diagnostic  processes 
actors  construct  plausible  interpretations  of  uncertain  situations,  so  that  these  plausible 
interpretations are sufficient to sustain action (Weick, 2005). This process involves enactment in 
which  actors  take  notice  of  a  change  in  their  environment,  and  bracket  elements  from  their 
environment that relate to the change. These action-meaning creation cycles occur dynamically 
and  repeatedly  as  actors  construct  plausible  interpretations  that  they  continuously  enact  and 
modify (Maitlis and Christianson, 2013). 

Through  the  use  of  existing  shared  meaning  structures  that  have  been  created  and  modified 
through past experience, knowledge or sensemaking, actors can retrospectively create plausible 
meaning for what has happened in their environment to enable them to ta ke action based on this 
plausible meaning. 

Fig 14 Model of anticipatory and retrospective sensemaking processes (Runswick, 2017) 

Page 33 of 69 

 
 
 
 
 
 
 Conditions  that  allow  for  sensemaking  or  attention  to  these  cues  are  varied.  Ambiguity  and 
uncertainty prompt attention and triggers sensemaking. Ambiguity calls for more information, more 
careful scanning ad discovery.  

 For people within the organisation to take note of the environment is dependent on the information 
load, complexity and turbulence. As information load increases people take measures to manage 
by: 

•  omissions 
•  greater tolerance of  
•  queuing filtering and abstraction 
•  chunking 

Large portions of information are neglected in the efforts to manage information load. The similar 
is true of complexity.  Perrow (1984) warns that the warnings of unimaginable events cannot be 
seen, because it cannot be believed.  

To  enable  actions  staff  need  to  identify  cues  to  prompt  sensemaking.  Not  all  staff  had  the 
organisational memory or awareness that the booking of both procedures was novel.  In addition, 
it  is  relatively  common  for  a  combined  portal  vein  embolisation  (PVE)  and  hepatic  vein  (HE) 
embolisation to be performed either during the same sitting or more usually the next day.  During 
the  review  in  IR,  it  was  observed  that  the  Cerner  system  currently  does  not  support  linked 
procedure requests. Additionally, the HPB team requires an option for HVE requests, which is not 
available. To request HVE, they are using TAE (Hepatic Artery Embolisation) request and adding 
a  clinical  more  indication  hepatic  vein.  There  are  more  nuanced  adaptations  that  makes  the 
combined procedure less novel and seen as a result of multiple scenarios.  

Social context is important for sensemaking. there were several staff who were new and did not 
recognise the norm for undertaking these procedures and hence it did not create a situation that 
need  further  enquiry,  additional  information  and  a  challenge.  for  staff  who  were  aware  of  the 
practice  to  undertake  the  procedures  separately,  there  were  unaware  of  the  background 
conversations  that  took  place  in  the  morning  team  brief  and  would  have  expected  this  to  be 
resolved and would have trusted the decision made by the consultant who was experienced and 
knowledgeable in this area.  

There was incomplete information and the sensemaking could have been extended to look at the 
source of the decision. On the observational study, there were 5 cases scheduled in advance as 
elective cases with an additional 6 cases added as emergency for discussion. The information load 
and complexity lead to a premature end to the sensemaking and resolution by coming up with a 
plausible solution to undertake the two procedures together. 

When dealing with multiple levels of arousal like trying to vet the additional 6 cases on the day 
would mean that staff may narrow and focus their attention on aspects of the situation that is judged 
most important. Attention is drawn away from the periphery which decreases the understanding of 
context which is the core in sensemaking.  

 An  emergent  finding  was  that  the  staff  sensed  a  ‘need  to  do  something’  with  this  need  being 
perceived as a sense of responsibility to protect people, property or the organisation, and/or an 

Page 34 of 69 

 
 
 
 obligation to provide a key business service or product. This sense of a ‘need to do something’ 

was an underlying generative mechanism for the sensemaking processes.  

The adaptability and flexibility within the IRCU using available rooms and resources play crucial in 
preventing delays and cancelations. The morning team brief is conducted within the senior team 
including radiologists, nurse manager and interventional radiology manager. The team discusses 
the complete elective list scheduled for the day as well as any emergencies that arose since the 
previous briefing that need to be addressed under the emergency list. For instance, on the day of 
the observational study, they discussed a total of 12 patients, highlighting the scope and scale of 
their daily operations. 

During these briefings, they have access to both the Cerner and CRIS systems. However, the  IR 
MDT suggested that going back to old notes for every single patient is not feasible. Therefore, once 
the list is confirmed, if any queries arise, they directly contact the referring team if necessary. 

It was noted that involving the whole team in the briefing hinders team performance as they also 
need to prepare their rooms during this process. After the briefing, the communication board is 
updated, which everyone has access to, ensuring that the information is disseminated. 

The  incomplete  documentation  on  procedural  requests  based  on  the  referrer's  notes,  and  the 
continued omission of the word "sequential" in following documentation, led to ambiguity for the 
entire  team.  The  process of  confirming  with  the  treating  team  rather  than  the  referring  team  or 
referring back to the referrer notes caused additional confusion.  

The  limited  availability  of  GA  slots  and  the  patient  awaiting  the  procedure  in  IRCU  recovery 
pressures the entire team to make a quick decision.  

The  investigation  process  involved  thorough  vetting  and  analysis,  ensuring  every  detail  was 
scrutinised  without  placing  undue  blame  on  any  individual.  The  review  highlighted  lapses  in 
communication and procedural clarity among the team. The compassionate element was evident 
as  the  healthcare  professionals  involved  were  treated  with  dignity  and  respect,  their  concerns 
acknowledged, and their insights valued. 

. There are various ways that one may arrive to a decision and the interpretation of the cues: 

•  Staff  distort  and  filter  the  signal  from  the  noise.  Sensemaking  would  be  about  the 

pragmatics, coherence, reasonableness, invention  

•  Most organisational actions are time sensitive and there is speed-accuracy trade off. The 
list needs to get started; patient would have their treatment delay if they were rescheduled.   
•  Efforts to link the present cue with similar interpreted cues from the past.  The connection 
with the study gave support that the procedure could be done together. Fo r other staff the 
links  with  this  set  of  procedure  familiar  to  them  as  they  have  done  them  on  numerous 
occasions previously albeit as individual procedures.  

•  Stimuli  that  are  filtered  out  are  often  those  that  detract  from  an  energetic  motivated 
response. Even though there was an option to send the patient back to be rebooked this 
would not have been an adaptive response requiring something that needs to be done  to 
rectify the situation.  
It was impossible to know if this would be an accurate decision  

• 

Page 35 of 69 

 
 
 
 Accuracy  is  not  essential  in  plausible  reasoning,  it  is  more  about  plausibility,  coherence  and 
reasonableness. Large portions of information are neglected in the efforts to manage information 
load.

7.  Summary and Recommendations  

This  document  lists  the  key  findings,  areas  for  improvement,  and  recommended  safety  actions 
from  the  recent  investigation.  Through  a  detailed  analysis,  several  issues  were  identified  that 
require attention  to ensure  enhanced  patient  safety  and  streamlined  procedural  workflows.  The 
proposed  safety  actions  aim  to  address  these  challenges  effectively,  promoting  a  culture  of 
accountability, communication, and continuous improvement within the healthcare system.

Page 36 of 69 

 
 
 
 
 
 •  Proportionality considered and pre- procedure team 

brief follows the morning brief 

•  Minute and actions of MM and feeding into the 

overall governance structure   

•  Reporting discrepancies and escalation to PSERP for 
wider discussions, support for learning responses  

Procedure

HPB MDT

The initial intention for a sequential procedure seemed to have 
been dropped off in the more recent entries. The last MDT was 
discussions around TAE/PVE or SIRT. Reliance on the specialist 
nurse to be point of communication between patients and IRCU. 
Information sent to patient about separate procedures.   

•  Two stages consenting, first stage 
undertaken by the referral team. 
•  Second stage consent done in the 
recovery area where patients are 
received prior the procedures  
•  Vetting and review on the day may 
mean changes to the consent – will 
patients have enough time to reflect, 
ask questions  

Consent

Referral to 
IRCU

Communications happened between radiology manager 
and specialist nurse. Confirmation of booking sent back to 
the team  
Limitations on how CRIS manage the referrals, vetting was 
not completed before booking the patient for the next 
available GA slot on CRIS. The changes on CRIS can be 
confusing. 

Confirmation of 
procedure/Team 
brief

Vetting 

•  Multiple requests with the same specialty/same organ 

and those requiring single reporting from Cerner are listed 
as a single event on CRIS. 

•  Team brief discusses both scheduled and 
emergency cases 

•  Assumption that vetting has occurred for the 

scheduled cases as would have been expected, 
confirmation of these cases 

•  Not all staff present at these meetings to qualify as a 
team brief meeting -NatSSIPs, more vetting may take 
place that may take more time of the team preparing 
for the procedures 

•  Final list following discussions not shared but available 
on the shared folder- unable to audit or go back as it is 
a live document that is continually being updated.   
Issues or concerns need to be addressed to the 
referring clinician, if not available then the on call- 
follow an escalation process 

• 

•  Notes and clinical review may be lengthy and may 

Listing

•  Combined versus sequential 

procedures and intervals of waiting 
between procedures, not so 
common – procedure protocol for 
these 

•  No “Golden Patient” first patient 

ready to go identified.  

•  Emergencies take precedence over 

other bookings   

•  To request HVE, they are using TAE (Hepatic Artery 
Embolisation) request and adding a clinical more 
indication hepatic vein. 

•  Vetting is quite ambiguous and can be used 

interchangeably for confirming the procedure and 
reviewing the clinical merits 

•  Vetting for emergency for on the day bookings is 

incorporated with the team brief. May provide false 
assurance of team brief meeting NatSSIPs 2 requirements 
vetting is performed by IRCU team members on CRIS on 
behalf of the radiologist 

• 

•  Can be quite an informal process with no blocked time to 

review and agree the running list   

Page 37 of 69 

 
 
 
                
  
 
 
 
 Recommendations  

•  Ensuring  robust  communication  from  the  HPB  and  cancer  MDT  on  specific  procedural 
requirements  and  recommendations  such  as  sequential  procedures  and  referral  -  what 
information is required on referral to limit the look back and correctly inform as to procedure 
required & why.  

•  Escalation  process  from  IR  to  referring  teams  to  clarify  procedural  details  in  cases  of 

uncertainty.  

•  Protocols for rare or specific requirements for cases to be booked.  
•  Review booking process and options on CRIS and Cerner. 
•  Formal process of Vetting and Listing. 
•  List briefing versus team briefing, possible safety huddle before a case.  
•  Development of approved NatSSIPs 2 template document. 
• 
•  Procedure lists for procedure rooms to allow conversations and planning. 
•  First patient ready to go.  
•  Consenting: to consider validity for any changes on the day.  
•  Develop MM review process & discussion outcome documentation. 

Induction for new staff. 

8.  PFD Discussion   

The risks that need to be addressed are set out in the PFD report are: 

•  Limited  internal  review  of  the  incident  following  the  inquest  on  performing  the  two 

procedures at the same time 

•  Trust seemingly did not consider the NatSSIPS2 standards either when undertaking the 

procedures, nor in detail as part of its review following the inquest. 

8.1 Limited internal review of the incident following the inquest on performing the 
two procedures at the same time 

As  the  acute  liver  failure  was  a  rare  but  known  complication,  this  did  not  serve  as  a  trigger  to 
complete a datix that would have a prompted further review.  The first CT scan was to evaluate the 
cause  of  severe  pain  and  specifically  to  rule  out  bleeding,  bile  leak,  visceral  perforation  and 
contralateral  vascular  thrombosis  etc.  No  such  complications  were  identified  on  the  scan.  The 
second CT scan was to evaluate any technical complications to explain the deranged liver function. 
There were no technical issues identified on CT scan. However, the progressive worsening of liver 
function and other clinical features supported the diagnosis of acute liver failure, which is a known, 
but rare complication of the procedure. 

The novel procedure may not have been highlighted for the people involved for various reasons:  

Page 38 of 69 

 
 
 
 
 
 
 
 •  Both TAE and PVE procedures are done separately and seeing them together would not 

• 

have been a trigger. 
it  was  observed  that  the  Cerner  system  currently  does  not  support  linked  procedure 
requests.  

•  Additionally, the HPB team requires an option for HVE requests, which is not available  as 
a distinct category on the electronic patient record. To request HVE, they are using TAE 
(Hepatic Artery Embolisation) request and adding a clinical note indicating hepatic vein.  

There are more nuanced adaptations that makes the combined procedures appear as less novel 
and therefore limiting escalations. This system wide investigation has made these more apparent 
with the accompanying increased awareness, procedure protocols and system changes to mitigate 
the consequences.   

The  safety  event  was  discussed  at  two  Mortality  and  Morbidity  (MM)  reviews.  The  patient  was 
discussed on 26 September 2024 at the HPB Thursday morning M&M meeting. All the Intensivists 
are on the invite for that meeting and includes all staff working in the perioperative pathways. There 
were some important points about how procedures are requested and consent for by HPB and in 
IR. The main liver critical care outcome was to continue to develop the PHLF pathway to manage 
liver failure post-surgery/intervention.  

Discussions at the radiology MM included discussions around the evidence for doing the TAE and 
PVE  as  a  combined  procedure.  The  conclusion  was  not  to  undertake  both  procedures 
simultaneously.  

Following the inquest and request from the coroner to respond to a prevention of prevention of 
future  deaths,  the  learning  responses  available  in  the  time  scale  require  were  explored.  The 
learning response that was undertaken was a multidisciplinary team meeting MDT with the scope 
of  the  MDT  and  the  learning  response  scope  and  the  terms  of  reference  were  limited  to  the 
questions raised by the coroner:  

1. 

2. 
3. 

What  constitutes  a  novel  intervention  that  needs  to  go  to  the  committee  to  be 
considered 
Consent - JT was consented for a procedure he did not have.   
Procedure  requesting  process  and  how  that  can  avoid  confusion  around  sequential 
procedures.  

The health unit was able to undertake this extensive investigation in a very tight timeline due to 
additional  capacity,  with  an  additional  interim  band  7  quality  manager  and  interim  matron  for 
radiology who were able to set up the investigatory MDT, interviews and observational studies.  

Following the learning from this safety event, all inquest will be brought to the patient safety Incident 
response panel (PSERP). There needs to be consideration as a trust if wider investigations are 
required and if PFD’s would be part of the PSIRF policy and plan.   

Page 39 of 69 

 
 
 
 
 
 8.2 Trust  seemingly  did  not  consider  the  NatSSIPS2  standards  either  when 
undertaking  the  procedures,  nor  in  detail  as  part  of  its  review  following  the 
inquest. 

8.2.1 Organisational Standards  

The organisational standards are clear expectations of what Trusts and external bodies should do 
to support teams to deliver safe invasive care. 

a.  Communication 

The communication from the cancer MDT was based on the presumption that everyone would be 
aware that the norm of the standard approach for treating HCC when augmenting the liver prior to 
resection, is sequential embolization of tumour and ipsilateral (same side) portal vein. The term 
"sequentially" was not documented in any notes after the consultant made the documentation on 
Cerner  on  28/05/2024  Consent  was  obtained  for  both  the  procedures,  but  the  material  risks  of 
combining them were not discussed with the patient.  

Communication between the IR manager and the CNS confirmed the combined procedure.  

b.  Knowledge and Understanding 

It was presumed that all staff would be aware that both TAE and PVE were not performed together 
as a norm and that the combined procedures of TAE and PVE was not done together at the same 
time at the trust. It is rare for both procedures to be done together even sequentially. Some of the 
staff  were  new,  did  not  have  the  organisational  memory  and  there  was  no  SOP  relating  to  the 
booking of these procedures.  As a confounder, it is relatively common for a different combined 
procedure,  that  of  portal  vein  embolisation  (PVE) and  hepatic  vein  (HE)  embolisation  to  be 
performed either during the same sitting or more usually the next day. 

c.  Systems  

Individual requests were made for TAE and PVE using the electronic patient record (Cerner). The 
requests appeared on the digital radiology information system (CRIS) as a single event with two 
procedures because both involved the liver. 

Additionally, the HPB team requires an option for HVE requests, which is not available. To request 
HVE  (Hepatic  Artery  Embolisation),  they  are  using  TAE  request  and  adding  a  clinical  more 
indication hepatic vein. 

d.  Vetting and Scheduling 

There is a note on CRIS - discussed with a consultant on 24/6 and agreed. (Figure 10).  Vetting 
was done informall