Prevention of Future Deaths reports · 2021

Elsie Woodfield

Regulation 28 report to prevent future deaths, reference 2021-0211, written 21 Jun 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report21 Jun 2021
Reference2021-0211
DeceasedElsie Woodfield
CoronerIan Arrow
Coroner areaPlymouth, Torbay and South Devon
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedUniversity Hospitals Plymouth NHS Trust
Sourcejudiciary.uk record · original PDF
Responses publishednone published

The report

Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.

University Hospitals 
Plymouth 
NHS Trust 

, Chief Nurse & Director of Integrated Clinical Professions 
University Hospitals Plymouth NHS Trust 
Derriford  Road 
Crownhill 
Plymouth 
PL6 8DH 

t. 

· 

16!h June 2021 

Mr I Arrow 
HM Coroner 
1 Derriford Business Park 
Breast Road 
Plymouth 
PL6  5QZ 

Dear Mr Arrow 

Re:  Elsie Woodfield 

I write further to the inquest inbMrs Woodfield's death, which concluded on 8 June 2021. This 
letter deals  with  concerns  raised  by  the  family  in  submissions· to  the Coroner with  regard  to 
his duty to write a Prevention of Future  Deaths report to the Trust. 
In  an  ema·u  dated 10th  June 2021  from 

 family concerns were  summarised: 

. 

. 

•  The  divergence  in  terms  of  consenting  process/content  for  endoscopy  processes  . 

between 
  and 
complications and the other s_aying  they always do. 

  with  one  saying  they  never  advise  of  fatal 
· 

•  The sip test intervention was indicated according to the evidence of 

  but was 

not done. 

•  An  unidentified  doctor saw  the  endoscopy  report  on  the  ward  and  took  no  action.  It 
was  never  established  who  -that  docto·r  was  and  so  it  has. not  been  explored  as  to 
whether steps need to be taken to prevent a recurrence. 

/M!lfDFUL 
VEMPLOYER 

Working in  partnership with  the Peninsula  Medical School 

 
 
 
 "  Record  keeping  concerns.  A number of clinicians had failed to  maintain  proper record 

keeping  and  it seems these  issues were  not explored further once recognised. 

Divergence in  terms  of consenting·process  · 

· The  issue of consent regards .death  as· a possible  outcome  df this  endoscopy procedure  has 
evolved  over the  last few years.  As explained by 
 in  his evidence,  death is  not an 
expected outcome and is rare.  Therefore, many clinicians would not have included death when 
obtc~ining  patient  consent.  The  law following  the  case  of
  now suggests that  all 
'material risks' should be discussed with a patient i.e.  ~mything they feel would be important to 
know as  a possibl~ outcome.  Previously,  what was  considered  appropriate to  discuss with  a 
patient when  obtaining  consent. wa~  interpreted  as  being  on  the  basis  of what  a significant 
body of opinion might say:  · 

· 

1 

·currently the plan of the organisation is to move to  procedure specific consent where possible 
and appropriate. We are looking to engage ·with external providers who produce consent and 
procedural  information  that  are  specific  to  particular  procedures.  In  that  way,  rather  than 
individual  clinicians  using  their  clinical  discretion  as  to  what  to  discuss  with  patients, 
standardised  information  is  given · each  time· a  patient  consents,  ensuring  all  material 
information  is  given.  For  those  undergoing  elective  surgery,  it  also  allows  more  time  for 
patients  to  read  at  their  leisure  the  information  provided,  so  they  have  time  to  digest  and 
absorb the relevant information before signing to. say they would wish to  proceed. 

The current consent guideline at UHP is  in  line with the British Society of Gastroenterologists 
(BSG)  2016  a,nd  does  not  expressly  the  mention  mortality1.  However after consultation  with 
the Endoscopy stakeholders and learnfng from  other incidents,  University Hospitals Plymouth 
has  amended the procedure specific consent forms to include: 

Although  very  rare,  complications  arising  from  endoscopy procedures  can  result  in 
death particularly if there are other significant health related problems. 

In  endoscopy  there  have  been  procedure  specific  consent  forms  since  2008,  which  have 
pertinent  information.  The  updating  of  the  procedure  specific,  consent  form  has  been 
particularly. important  as  this  is  provided  tp  patients  in  advance  of their· procedure  and  in 
advance of talking to the endoscopist on the day.  Inpatients (patients that have. come through 
the  emergency  care,pathway)  are  provided  with  this  information  on .the ward. and  it  is  also 
reinforced by endoscopy nurses prior to  entering the procedure·room. 

The ward  consultants  looking  after upper gastro-intestinal  bleed  patients  like  Mrs·Woodfield 
are  senior gastroenterologists  and  endoscopists.  One  of the  main  reasons  the  Trust  has  a. 
gastroenterologist  specialty  medical  take  is  that  .these  individuals  are  experienced  in 
assessing  risk  of  the  procedure  versus  the  risk  of  not  undergoing  the  procedure,  e.g. 
assessing urgency and appropriateness.  In the vast majority of cases there is  good eviqence 
that  early endoscopy  improves  outcome  and  is  instrumental  to  the  management of. patients 
with  upper GI  bleeding in  particular those with  s,ignificant comorbidities  (High Rockall  scores) 
and  those  on  anticoagulants.  This  is  discussed with  patients  prior to  referrimg  for endoscopy 
(and as such is part of the consenting process) and  is usually a straightforward discussion but  . 
may  be  i:nore  detailed  where  there  are  patient  specific concerns,  The documentation  of this 
discussion  in  the  notes  should  certainly  be  improved.  Occasionally  a decision  will  be  made 
not to  proceed  to  endoscopy  after  discussion  with  patients  and  next  of kin  where  the  risks· 
outweigh  the  benefits.  The  documentation  of this  'not treating'  is  largely  on  the whole  better 

. than when the decision is 'for treatment' and is one ofthe learning points. 

1  BSG  (2016) - Guideline for obtaining consent for Gastrointestinal endoscopy proced.ures 

/MIHDFUL 
yeMPLOVffl 

Working in  parlnership with  the  Peninsula  Medical School 

 
 
 The mo$t pertinent passage from the 2016 national  guidance is this: 

The  test of materiality is procedure,  circumstance  and patient-specific.  The  test must 
be patient-centred,  since _the  ris~ that can influence a patient's decision  can  vary from 
one patient to the next and requires careful Judgement and individual discussion.  Thus, 
it is beyond the  scope of this document to  describe in  detail the  information in  relation 
to  risks,  benefits  or  alternatives  that  should  be  provided  for  specific  endoscopic 
procedures.  Similarly,  it is not possible to  state in  this guideline whether specific risks 
should be mentioned or in numerical terms  what level of risk should be  described.  In 
. general,  however,  you  must  tell patients  if the  procedure  might  result  in  a  se.rious 
adverse  outcome,  even  if the  likelihood is  very small,  and mention less  serious  side , 
effects or complications if frequent.  Any·risk that is likely to influence the  decision of a' 
·  patient  should  be  included.  It  is  important  that  in  meeting  these  req1,1irements,  the 
patient is  not overwhelmed with  excessive  information,  such  that they are  unable  to 
evaluate the material risks and benefits. 

The sip test Intervention 

The  use  of  'sip'  checking,  i.e.  'drinking  a  small  amount  of  water  post  oesophago-gastro 
duodenoscopy (OGD) is to indicate that patients are able to. swallow and do not aspirate liquid 
into the  lungs  before  being  allowed  to  eat.  This  is  part of basic care  and  doesn't constitute a 
diagnostic procedure,  merely an  aid  to support post recovery after an  OGD.  The  sip check is 
not a test to  exclude perforation and the small volume of fluid would not result in  mediastinitis. 

An  unidentified doctor saw the endoscopy report on the ward 

,  and  two  junior doctors, 

The only  medical  professionals  involved with  Mrs Woodfield's  care  on  the ward  included the 
consultant, 
. 
did produce a recollection of evehts when the organisation received the complaint letter, 
which  did  not  refer  to  him  having  reviewed  the  endoscopy  report.  As  I  said  when  giving 
evidence at the inquest, if the incident had been addressed as a SIRI at the outset, the relevant 
staff would have been interviewed at the time,  when memories were fresh,  and the poctor who 
reviewed  the endoscopy report would  have been  identified. 

  and 

Record  keeping concerns 

The Trust accepts that elements of the record  keeping were poor in this case. All professional 
bodies have an  expectation that individual practitioners will document in  the  clinical records to 
1  an accepted standard. The Trust also has a policy that reflects this expectation: This highlights 
that  responsibility  lies  with  the  individual  professional  and  the  Trust  expects  that  each 
indMdual  documents  in  the  health  records  in  accordance  with  the  Trust's  policy  and  in  line 
with  codes of practice set by professional standards.  Nevertheless, the Trust recognises that 
documentation  may suffer during  intense wo~king  periods  and  therefore Wf!  regularly  remind 
staff at  induction and  through mandatory training the importance of proper documentation. 

Clear and regular documentation is  part of the induction pack given to juniors working within 
Gastroenterology (see extract below). 

Clinical notes (Gastroenterology Junior doctor induction pack) 

• 

Ideally, ·each notes entry should start with a diagnosis or a short list of 
differential diagnoses/problems,  followed by a man~gement plan for 

/MINDFUL 
VEMPLOYER 

Working in  partnership with  the  Peninsula  Medical School 

 
 
 
 investigation,  monitoring and treatment.  Record all observations numerically 
- it shows you have actually looked at them,  including respiratory rate  as this 
is often the first thing to  "go  off" if patients get sick. 
•  Write in  the notes daily when the patient is reviewed. 
•  Documentthe reasons behind decision making on  ward.rounds . 
.,  Record DNR decisions and ifralevant, how intensively to treat a patient ~g 

patient tor non-invasive ventilation but not fo(ventilation or ICU. 
•  Document discussions with relatives ideally recording their names & 

relationship  to  the patient 

•  Write the results of blood tests in the -notes or update the.  flow charts tor 

· selected patients daily. 

. 

• 

Indicate whether investigations have been requested or are planned,  but are 
not yet reported in the notes. 

•  Take results of current in-patients which you sign to the  appropriate wwds 
during ward round (otherwise results often don't get into the notes during· 
patient's stay and subsequent transfers of care). 

•  Noles can be used as legal documents.  Make entries appropriately and do 

, not back-date clinical entries. 

•  Stick in  a week-end plan for all patients every Friday.  This is  essential and is 

regularly audited. 

•  Ensure patients have an  estimated date of discharge documented. 

The Trust accepts that poor record  keeping  should  have been  discussed with the  individuals 
at the time of the event to ensure reflective learning. The revised SIR!  process will ensure that 
any similar issues that may arise in  the future would  be addressed immediately. 

Yours sincerely 

' 

. 

,  Chief Nurse & Director of Integrated Clinical  Professions 

University Hospital  Plymouth  NHS Trust 

1 5 JUL  2021  . 

/MIUDFUL 
yeuPt.OYER 

Working in partnership with  the Peninsula Medical School
Also filed under 2021-0211: Elsie-Woodfield-2021-0211.pdf
OFFICIAL 

##DW<<ALLTRIM(cSignedBy)>> 
##DW<<ALLTRIM(cSignedByTitle)>> for 
##DW<<ALLTRIM(cJurisdiction)>> 

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

THIS REPORT IS BEING SENT TO:   
University Hospitals Plymouth NHS Trust 
CORONER 

1 

I am Ian Arrow, Senior Coroner for Plymouth Torbay and South Devon                    

2 

CORONER’S LEGAL POWERS 

I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and 
regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 
http://www.legislation.gov.uk/ukpga/2009/25/schedule/5/paragraph/7 
http://www.legislation.gov.uk/uksi/2013/1629/part/7/made 

3 

INVESTIGATION and INQUEST 

Following an Inquest opened on the 19 December 2017 and an inquest hearing at HM Coroner's 
Court, Plymouth on the 7 June 2021 heard before Ian Michael Arrow, in the coroner's area for 
Plymouth, Torbay and South Devon. 

4 

CIRCUMSTANCES OF THE DEATH 
The deceased suffered from significant comorbidities in particular ischaemic heart disease. She 
was determined by her GP to be suffering from Anaemia. She was admitted to hospital for a 
blood transfusion whilst in hospital, hospital clinicians determined an endoscopy was an 
appropriate procedure to investigate blood loss. This endoscopy investigation was carried out on 
11th of December 2017. The endoscopy investigation was abandoned. On the balance of 
probability there was a perforation of the oesophagus during the procedure. The deceased 
developed symptoms of surgical emphysema. She deteriorated and died on 11th of December 
2017 at Derriford Hospital, Plymouth. 

NARRATIVE 

5 

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.  –  

[BRIEF SUMMARY OF MATTERS OF CONCERN] 
(1) There appears to be a significant discrepancy between clinicians on the consenting 
procedure for the identical treatment of endoscopy. 
 (2) A ‘sip test’ to exclude aspiration was not performed, and there has been no evidence that 
this had been noted or remedied at the Trust. 
(3) A doctor did not take action when viewing an endoscopy report which contained an indication 
of a possible dangerous complication. 
(4) Appropriate records were not kept, or were not properly transferred, by senior staff. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 OFFICIAL 

6 

ACTION SHOULD BE TAKEN 

In my opinion action should be taken to prevent future deaths and I believe you have the power 
to take such action.  
Please review the matters of concern in para 5 above.  
YOUR RESPONSE 

You are under a duty to respond to this report within 56 days of the date of this report, namely by 
Monday 16 August 2021. 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 

I have sent a copy of my report to the Chief Coroner and to the following Interested Persons Ms 
Woodfield’s family. I have also sent it to  Derriford Hospital who may find it useful or of interest. 

I am 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. 

9 

Dated 21.06.2021 

Signature_________________________

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