Prevention of Future Deaths reports · 2014

Janet Goodacre

Regulation 28 report to prevent future deaths, reference 2014-0408, written 18 Sep 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report18 Sep 2014
Reference2014-0408
DeceasedJanet Goodacre
CoronerLydia Brown
Coroner areaLeicester City & South Leicestershire
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedUniversity Hospitals of Leicester NHS Trust
Sourcejudiciary.uk record · original PDF
Responses published1

The report

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

REGULATION 28:  REPORT TO PREVENT FUTURE DEATHS (1) 

NOTE: This form is to be used after an inquest. 

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

THIS REPORT IS BEING SENT TO: 

1.  Mr John Adler, Chief Executive, University Hospitals of Leicester NHS 

Trust 

1 

CORONER 

I am Lydia Brown assistant coroner, for the coroner area of Leicester (City and South)   

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. 

3 

INVESTIGATION and INQUEST 

On 24 May 2013 I commenced an investigation into the death of Janet Doreen 
Goodacre, age 88. The investigation concluded at the end of the inquest on 10th 
September 2014.  
The cause of death was: 1a Acute Gastrointestinal bleed, 1b. Combination of antiplatelet 
and anticoagulation therapy, 1c. Atrial Fibrillation and acute coronary syndrome, 2. 
Myocardial infarction: Congestive cardiac failure. 
The conclusion of the inquest was a narrative conclusion :  
Mrs Goodacre was admitted to Leicester Royal Infirmary on 1st May 2013 and she 
remained an in-patient until her death on 21st May 2013.  During her stay she 
developed atrial fibrillation and was started on warfarin, and continued on other 
medications including deltaparin and aspirin.  On the balance of probabilities this 
combination of medication provoked and then exacerbated a gastro intestinal bleed 
which led to her death.  This was a recognised complication of her necessary medical 
treatment. 
CIRCUMSTANCES OF THE DEATH 
See Narrative Conclusion  above  

4 

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.  –  

University Hospitals of Leicester NHS Trust (“the Trust”) prepared an Investigation report 
concerning this death, and this was signed off on 15th January 2014.  A copy was duly 
provided to the Coroner’s office in accordance with the local approved information 
sharing agreement.  On the day of the inquest itself, nearly 9 months later, without any 
amendments or further communications from the Trust, Evidence was heard that  

(1)  the Trust acknowledged that the report was factually incorrect  

1

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 (2)  That the only 2 “Root causes” identified in the report were incorrect  
(3)  the Clinical Lead (who signed off the Investigation Report) said it was “flawed” and 
“not helpful” 

I am therefore concerned that the Trust is providing inaccurate and misleading 
investigation reports, and Action Plans based on the erroneous findings that are not only 
of no assistance, but in fact divert attention away from the actual difficulties in service 
provision that should be identified.  This not only fails to achieve the intention of the 
investigation, but also has the potential to miss opportunities to prevent future deaths.  
Furthermore, there was a failure to communicate the Trust knowledge of the 
Investigation Reports shortcomings until the day of the Inquest itself, and it was clear no 
attempts had been made to revisit the report to correct the recognized errors. 

I request to be advised of any actions that have been taken to improve and oversee the 
preparation and conclusions of Investigation Reports, and that consideration be given to  
introduce a system to re-open any reports found to be inadequate or erroneous. 

6 

ACTION SHOULD BE TAKEN 

In my opinion action should be taken to prevent future deaths and I believe you and your 
organisation have the power to take such action.  

7 

YOUR RESPONSE 

You are under a duty to respond to this report within 56 days of the date of this report, 
namely by  6th November 2014. 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: 

 (Daughter Of Mrs Goodacre ) 

I have also sent it to 
it useful or of interest. 

 Medical Director NHS England  who may find 

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 

18 September 2014                                               

2

Responses

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

Response from University Hospitals of Leicester NHS Trust (PDF)
University Hospitals of Leicester  r.!1:bj 

NHS  Trust 

, 
Chief Executive 

Mrs Catherine Mason , 
Her Majesty's Coroner, 
Leicester South, 
Leicester Town  Hall Square, 
Leicester. 
LE1  9BG 

5th  November 2014 

Dear Mrs Mason 

Re: Regulation 28 Report to Prevent Future Deaths 

I  acknowledge  receipt  of the  Regulation  28  - PFD  report  from  your  office , 
dated  18th  September 2014,in  which  you  request to be  advised  of any actions 
that have  been  taken to improve and  oversee  the preparation  and  conclusion 
of  RCA  (Root  Cause  Analysis)  Investigation  reports;  and  suggest  that 
consideration  be  given  to  introducing  a  system  to  re-open  any  such  reports 
found  to be inadequate or erroneous. 

First, I would  like to apologise that, on  this  occasion, the  root  cause  analysis 
investigation  report  was  not  helpful.  I  accept that  information  was  presented 
by clinicians  at  inquest that was  not covered  in  the  RCA  report and  this must 
have  been  frustrating  for  your  assistant  deputy  who  heard  this  inquest. 
However, the purpose of these  internal patient safety investigations is to learn 
lessons  and  implement  solutions  which  prevent  recurrence.  By  their  very 
nature, they  often  contain  differing  clinical  opinion  and  judgements.  We  use 
the  RCA  reports  as  a  tool  for  listening,  learning  and  improving,  as  well  as 
providing  a documented account of the facts for the patient/family. 

The Trust continually works to improve the  quality of the  investigations  of the 
RCA reports and we have recently introduced three further measures to  assist 
with this. 

1.  From  April  2014, the Trust has established  a process whereby each  RCA 
investigation  has  a  named  'Chair'.  This  individual  is  either  the  Medical 
Director  or  Chief  Nurse  or  one  of  their  nominated  deputies  (i.e.  Deputy 

University Hospitals of Leicester NHS Trust includes 
Glenfield  Hospital,  Leicester General Hospital and  Leicester Royal  lnfinnary 
Website:  www. leicestershospitals.nhs.uk  · 

 
 
 
 
 
 
 Medical  Director,  Director  of  Safety  and  Risk,  Deputy  Ch ief Nurse).  The 
RCA  Chair  will  review  the  terms  of  reference  and  scope  of  the 
investigation ;  ensure 
team  has  been 
established  and  ensure  that  an  adequate  ('SMART')  action  plan  is 
produced.  In addition  to  the  Clinical  Management  Group  (CMG)  Director, 
the RCA Chair will also sign off the report. 

the  appropriate 

investigation 

2.  The Trust has recently purchased external expert RCA training :-

Basic RCA training for investigation leads. 
RCA Masterclass training for senior patient safety investigators. 
RCA Oversight training for RCA Chairs. 

3.  The Trust has established a new 'Adverse  Events Committee', reporting to 
the Executive Quality Board, to  review all serious untoward events (SU ls). 

This new Committee will ensure sufficient senior scrutiny is given to the 
events 
that  cause  avoidable  death  and  .  harm.  A  collective 
understanding  of the  root causes, the themes and  the  actions  required 
to  reduce  similar  failings  is  required  to  ensure  appropriate  safety 
workstreams are in  place. 

The  Adverse  Events  Committee  will  provide  a  systematic  review  of 
every action plan, tracking all actions to full  implementation. 

With  respect to  re-opening  investigation  reports,  the  Tr.ust  does  consider  any 
feedback  received  from  Commissioners  and  may make  amendments to  such 
reports  if there is  compelling evidence to do so. 

I  hope  that  this  provides  you  with  assurance  that  we  strive  to  provide 
comprehensive  and  accurate  reports.  Although  these  reports  are  not written 
for any  legal  purposes, either claims  or inquests, we are very willing  to  share 
them externally should they be useful to you. 

We  always  welcome  feedback  from  your  office  and  whilst  I ful ly  understand 
your  concern  regarding  the  RCA  Investigation  in  this  case,  I  was  a  little 
surprised  that  it  has  resu lted  in  a  Regulation  28  Report.  However, we  note 
your  concerns  and  strive  to  continue  to  improve  our  investigation  and 
reporting  processes as detailed  above. 

Yours sincerely, 

Chief Executive 

University Hospitals of Leicester NHS Trust includes 
Glenfield  Hospital, Leicester General Hospital and  Leicester Royal  Infirmary 
Website:  www. leicestershospitals.nhs.uk 

 
 
 
 
 
 Cc: 

,  Director of Corporate and Legal Affairs 

,  Chief Nurse 
, Director of Safety and  Risk 

, Assistant Director (Head of Legal  Services) 

University  Hospitals of Leicester NHS Trust includes 
Glenfield  Hospital, Leicester General Hospital and Leicester Royal  lnfinnary 
Website:  www.leicestershospitals.nhs.uk

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