Prevention of Future Deaths reports · 2023

Valerie Simmons

Regulation 28 report to prevent future deaths, reference 2023-0400, written 20 Oct 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report20 Oct 2023
Reference2023-0400
DeceasedValerie Simmons
CoronerAndrew Cox
Coroner areaCornwall and the Isles of Scilly
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Sourcejudiciary.uk record · original PDF
Responses published1

The report

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

Information Classification: CONTROLLED 

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

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

THIS REPORT IS BEING SENT TO: 

1. 
1  CORONER 

, Community Nurse Locality Team Lead 

I am Andrew Cox, the Senior Coroner for the coroner area of Cornwall 
and the Isles of Scilly. 

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 20/10/2023, I concluded an inquest into the death of Valerie Ann 
Simmons who died on 11/01/2023.  
 . 
The medical cause of death was recorded as: 
1a) Hypovolaemic Shock 
1b) Left Thigh Haematoma  
1c Low Molecular Weight Heparin and Warfarin Therapy with high INR for 
Metallic Mitral Valve Replacement.  
II Ischaemic Heart Disease, Congestive Cardiac Failure, Frailty 

I recorded a Narrative Conclusion that Mrs Simmons died from a known 
complication (bleeding) of a necessary medical procedure (anti-
coagulation.) 

4  CIRCUMSTANCES OF THE DEATH 

Mrs Simmons was well known to the community nursing team. She had a 
past medical history that included a mitral valve replacement in 2007 
following which she was prescribed warfarin with a target therapeutic INR 
of 3.5. In December 2022, it was noted her INR levels were sub-
therapeutic and so she was prescribed bridging Fragmin therapy. Her 
NEWS score was recorded as 5. Community nurses attended daily. 
On 7/1/23, she had an injection of Fragmin into her left thigh. On 8/1/23, 
she was found to have developed a large haematoma. In spite of her 
changed presentation, there were no recorded observations that 
objectively demonstrated she was otherwise ‘well.’  
Her INR was tested on 9/1/23 and found to be 4.9. A doctor attended and 
advised admission into hospital which Mrs Simmons initially declined. 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Information Classification: CONTROLLED 

She subsequently changed her mind but an email to advise the doctor did 
not reach him. An ambulance was later called, and Mrs Simmons was 
admitted into Royal Cornwall Hospital. She deteriorated and died in the 
hospital on 11/1/23. 

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.  –  

It was accepted in evidence that: 

-  Where there was a change in a patient’s presentation, it would be 
expected that a set of observations would be undertaken and 
recorded in a patient’s notes; 

-  Further training related to the risks of hypovolaemia in an anti-

coagulated patient would be beneficial. 

6  ACTION SHOULD BE TAKEN 

In my opinion action should be taken to prevent future deaths and I 
believe you [AND/OR 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 16/12/2023. 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: 

. 

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 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Information Classification: CONTROLLED 

the release or the publication of your response by the Chief Coroner. 

9 

[DATE]                                              [SIGNED BY CORONER] 
20/10/2023

3

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 Cornwall Partnership NHS Foundation Trust (PDF)
Mr Andrew J. Cox 
H.M. Senior Coroner 
Cornwall & the Isles of Scilly Coroner’s 
Area 

Director of Nursing and AHPs 
Carew House 
Beacon Technology Park 
Dunmere Road 
Bodmin  
PL31 2QN  

louise.dickinson2@nhs.net  

Date: 30 November 2023 

Dear Mr Cox  

Regulation 28 report to prevent future deaths following the inquest 
into the death of Mrs Valerie Simmons 

I am writing in response to the Regulation 28 report, in my role as Director of Nursing 

and  Allied  Health  Professionals  on  behalf  of  Cornwall Partnership NHS  Foundation 

Trust. 

I  wish  to  begin  by  offering  my  sincere  condolences  to  Mrs  Simmons’  family.    I  am 

deeply sorry for their loss. 

In this letter I will outline the action we will take to address the concerns raised at Mrs 

Simmons’ inquest and to provide assurance that our learning has been identified and 

actioned. I will set out the context of the community nursing roles and responsibilities 

with patients receiving anticoagulant medication, explaining the polices and training 

currently in place.   

Three  meetings  have  been  held  during  November  2023,  with  community  nursing 

clinical, operational, and patient safety leads to understand the specific issues in this 

case to ensure the right response to the concerns you have raised: 

Head office: Carew House, Beacon Technology Park, Dunmere Road, Bodmin, PL31 2QN 
Margaret Schwarz, Chair. Debbie Richards, Chief Executive.  

Call us on 01208 834 600 | Visit our website at cornwallft.nhs.uk 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 1.  The use of observations when there is a change in a patient’s presentation. 

2.  Training related to the risks of hypovolaemia in an anti-coagulated patient. 

The community nursing service aims to deliver high quality nursing services spanning 

care pathways between primary and secondary care. This service provides a pivotal 

role ensuring the co-ordination and seamless provision of care to people in their place 

of residence, with the aim of promoting personalised and anticipatory care to promote 

independent living.  

The  Cornwall  Partnership  NHS  Foundation  Trust,  (CFT)  integrated  community 

standard operating procedure (SOP), which includes community nursing, states that 

an integrated team core assessment is the agreed initial assessment which must be 

completed on a community nurses’ first visit to a patient. Additional assessments will 

be  completed  as  clinically indicated.  The expectation  is  that  basic  observations  are 

taken on initial assessment as a baseline so that if the patient’s clinical presentation 

changes, they are repeated and compared.  

In  this  case,  Mrs  Simmons  was  receiving  regular  visits  by  community  nurses  to 

administer  anticoagulant  injections  and  international  normalised  ratio  (INR)  point  of 

care  testing.  Anticoagulants  are  used  to  reduce  the  risk  of  thrombo-embolic 

complications  in  patients  at  increased  risk.  People  prescribed  anticoagulant 

medication will routinely have a laboratory blood test performed to ensure their INR is 

within therapeutic limits. This ratio is a representation of the pro-thrombin time and is 

measurement of how long it takes the blood to clot. A high ratio INR may indicate an 

increased risk of bleeding, a low ratio may indicate a risk of blood clot development. 

Community  nurses  use  a  portable  INR  monitoring  device  for  point  of  care  testing, 

(POCT) providing an instant measurement of INR to reflect the anticoagulant. POCT 

is an established part of community nursing clinical practice and offers rapid provision 

of tests for people in their own homes. A CFT SOP has been developed to ensure that 

consistent  procedures  are  in  place  throughout  Cornwall.  The  SOP  applies  to  both 

registered  (e.g.,  nurses)  and  unregistered  (e.g.,  health  care  assistants)  community 

nursing  staff  members  responsible  for  INR  point  of  care  testing.  The  procedure 

described in this standard should only be carried out by, registered and unregistered, 

Page 2 

 
 
 
 members  of  the  community  nursing  team  who  have  been  specifically  trained  and 

assessed as competent in the use of the INR POCT device, and who can demonstrate 

an understanding of the role of INR testing including a basic interpretation of the INR 

result.  Practitioners  must  demonstrate  competence  and  be  signed  off  before 

performing this role. However, on review of the SOP and training video, conducted in 

response  to  the  Regulation  28  report,  we  have  identified  that  it  does  not  include 

awareness  on  the  tendency  of  patients  taking  anticoagulants  to  have  bleeding 

complications such as haematomas, or how to manage the side effects/consequences 

for  example  hypovolaemia.  (A  haematoma  is  a  collection  of  blood  which  is  located 

outside the blood vessels. They can be found under the skin within a soft tissue and 

display as a purple-coloured bruise. Sometimes, haematomas may not show up as a 

bruise  and  can  be  deeply located.  Haematomas are  usually  caused  by an  injury to 

blood  vessel  walls  [such  as  veins  or arteries]  which  allow the  blood  to  escape  and 

collect together to form a lump). 

The groups first recommendation for action to take in response to the Regulation 28 

report is for an update of the INR POCT SOP and training video to include awareness 

of symptoms and prompt for basic observations in any change of clinical presentation 

such  as  a  haematoma.  The  recommendation  of  the  group  is  that  POCT  training  is 

essential and mandatory for community nursing staff undertaking POCT as a clinical 

skill. 

On review of training for community nursing,  we have identified that  the community 

assessment of sick patient training, (CASP) is a mandatory training requirement for 

the acute care at home and home first teams only.  As a result of learning  from this 

incident, the group has recommended that CASP would be an advantageous course 

to be added to the registered community nurse’s mandatory training, particularly as 

the acuity of patients in the community is increasing. 

The  CASP  training  will  update  mandatory  skills  for  registered  community  nurses  to 

cover: 

•  Recognition of the deteriorating patient. 

Page 3 

 
 
 
 
 
 •  NEWS2 assessment (National Early Warning Score which is a tool to improve the 

detection and response to clinical deterioration in adult patients). 

•  Communication including the importance of documentation. 

•  Sepsis 

•  Anaphylaxis 

•  Acute kidney injury 

•  Diabetes (including Hypoglycaemia) 

•  Breathing issues 

•  Clinical observations and physical health assessment  

The training will support community nurses to use clinical observations when there is 

a change in patients’ clinical presentation. 

This recommendation will lead to 260 staff needing additional CASP training which will 

require 3-4 further courses to be delivered per year. The decision has been made to 

follow this recommendation. 

We recognise that policy updates and training changes can take time. To reassure the 

family,  as  part  of  our  meetings,  we  have  undertaken  learning  from  experience  to 

develop  a  poster  which  will  be  shared  across  all  community  nursing  teams 

demonstrating the importance of recognising the signs of a deteriorating patient and 

highlighting the importance of taking and recording basic observations when there is 

change in clinical presentation.   

Thank you for highlighting your concerns. I trust that this response provides assurance 

that action is being taken to address the matters that you have raised. 

Page 4 

 
 
 
 
 
 
 
 
 
 
 
 
 Yours sincerely  

Director of Nursing and AHPs 

Enc 

Page 5 

 
 
 
 
 
 
 Recommendations  

Action to be Taken 

Lead 
Responsibility 

Date to be 
completed 

Expected outcome 

1.  Ensure the point of care testing 
SOP and training includes 
guidance on side effects for 
people taking anticoagulant 
medication specifically increased 
tendency of bleeding 
complications such as bruising or 
haematoma. Prompting basic 
observations if any change in 
clinical presentation.  

Amend the current SOP and 
edit the training video for point 
of care testing INR’s to add 
further guidance on side 
effects for people taking 
anticoagulation medication 
including increased tendency 
of bleeding complications such 
as bruising or haematoma 
prompting basic observations if 
any change in clinical 
presentation.  

28 Feb 
2024 

Community 
Nursing Practice 
Educator 

SOP will be updated and 
available for all staff to access 
and information on the updated 
SOP shared widely with the 
community nursing teams. 
Training video will be updated 
to include guidance on the side 
effects of taking 
anticoagulants.  

2.  Strengthen the requirement for 

staff who undertake POCT in the 
community. 

POCT training to become 
mandatory for staff undertaking 
POCT clinical skill.  
All relevant staff to undertake 
the training.  

28 Feb 
2024 

Community 
Nursing Practice 
Educator. 

POCT add to the mandatory 
training matrix for community 
nurses and evidence of 
training compliance. 

Head office: Carew House, Beacon Technology Park, Dunmere Road, Bodmin, PL31 2QN 
Margaret Schwarz, Chair. Debbie Richards, Chief Executive.  

Call us on 01208 834 600 | Visit our website at cornwallft.nhs.uk 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 3.  Registered community nurses to 
undertake the CASP course. 

Seek investment for future 
capacity to training team for 
additional CASP training 
sessions, (3-4 per year) and 
deliver the additional sessions. 

Head of 
Education & 
Training 

30 Jan 2025 

All registered community 
nurses will have completed the 
CASP training by January 
2025 evidenced by training 
records. 

4.  Learning from experience poster 
to be shared across community 
nursing teams highlighting the 
importance of taking basic 
observations when there is any 
change in clinical presentation of 
the patient and importance of 
documentation.  

Development of learning from 
experience poster and sharing 
of this at Clinical Quality 
Assurance Meetings to all 
Community nursing Teams. 

Central 
Business 
Governance 
Partner 

31 Dec 
2023. 

Evidence of poster. 
Minutes of the CQAG 
meetings. 
Signed sheet from each 
community nursing team to 
indicate all staff have read this. 

Page 7

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