Prevention of Future Deaths reports · 2023

Beryl Ellison

Regulation 28 report to prevent future deaths, reference 2023-0002, written 3 Jan 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report3 Jan 2023
Reference2023-0002
DeceasedBeryl Ellison
CoronerJohanna Thompson
Coroner areaSefton, St Helens and Knowsley
CategoryAlcohol, drug and medication related deaths · Care Home Health 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.

Regulation 28: REPORT TO PREVENT FUTURE DEATHS 

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

REGULATION 28 REPORT TO PREVENT DEATHS 

THIS REPORT IS BEING SENT TO: 

1  Chief Coroner's Office 
2  CQC 
3 
 (Weightman’s Solicitors) 
4  Four Seasons Health Care (HEAD OFFICE) 

1  CORONER 

I am Johanna THOMPSON, Assistant Coroner for the coroner area of Sefton, St. Helens and 
Knowsley 

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 12 July 2022 I commenced an investigation into the death of Beryl ELLISON aged 75. 
The investigation concluded at the end of the inquest on 20 December 2022.  The 
conclusion of the inquest was that: 

Mrs Ellison was in declining health and was receiving end of life care.  She was found 
deceased at Alexandra Care Home, Park Road, Newton-le-Willows, on 28th June 2022 as a 
consequence of her underlying poor health in combination with taking an excessive quantity 
of her prescribed medication. 

4  CIRCUMSTANCES OF THE DEATH 

Mrs Ellison had been in hospital and was discharged to the Alexandra Care Home for 
Palliative Care. A DNAR was in place. She had previously suffered with pneumonia and 
Septicaemia, and had an amputation of her leg and finger due to blood clots. Her family 
had been advised that there was nothing further that could have been done for her 
medically. 
On the 28th of June 2022, at approximately 1000 hours, Mrs ELLISON had been due her 
medication around this time. One of the care workers went into her room to give her her 
medications and check on her, as it was unusual for Mrs ELLISON not to have not pressed 
the call button for her medications before this time. When the care 
worker went in, she noticed that Mrs ELLISON was very drowsy and sleepy. As such, she 
turned the lights on and noticed she was pale. 
With this, the care assistant has took her observations, which were concerning. 
Consequently, she informed the registered staff nurse before calling for an ambulance. As 
the care assistant returned to the office to make her call, the registered staff nurse 
informed her that Mrs Ellison had already passed away and it was therefore too late. 
As such, police and Mrs Ellison's GP were called. The GP attended and pronounced time of 
death at 1352 hours. 
Mrs Ellison's son stated he had raised a concern to the care home 4-6 weeks ago about 
medication being left in his mother's room, as she had been observed hiding it under the 
bed covers. He had been informed that the staff would administer the morphine and 

Regulation 28 – After Inquest 
Document Template Updated 30/07/2021 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 observe her taking it from then on. Mrs Ellison's son was concerned that there had been no 
change in the care home practice since his earlier complaint, which may have led to his 
mother taking an accidental overdose of her medication. 

5  CORONER’S CONCERNS 

During the course of the investigation my inquiries revealed matters giving rise to concern. 
In my opinion there is a risk that future deaths could 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) 

Mrs Ellison was resident at Alexandra Care Home and was found deceased on 28th June 
2022 by staff. Her family expressed concern that she had been left with syringe medication 
unsupervised by staff and raised concerns about this with the care home both historically 
and four days prior to her death. A post mortem examination revealed Mrs Ellison to have 
an excessive concentration of oxycodone in her system which was likely to exceed any 
acquired tolerance level. The evidence heard at inquest revealed no explanation as to why 
Mrs Ellison was found to have taken the excessive quantity of oxycodone which contributed 
to her death. Furthermore, the systems at the care home were stated categorically to be 
the same as those that were in place prior to Mrs Ellison's death. 

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 February 28, 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 

 – Representing Alexander Care Home 
- Family 

Four Seasons Health Care (HEAD OFFICE) 

I am also under a duty to send a copy of your response to the Chief Coroner and all 
interested persons who in my opinion should receive it. 

I may also send a copy of your response to any person who I believe may find it useful or 
of interest. 

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: 03/01/2023 

Regulation 28 – After Inquest 
Document Template Updated 30/07/2021 

 Johanna THOMPSON 
Assistant Coroner for 
Sefton, St. Helens and Knowsley 

Regulation 28 – After Inquest 
Document Template Updated 30/07/2021

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 Four Seasons Health Care Group (PDF)
28th February 2023 

Johanna Thompson 
Assistant Coroner for 
Sefton, St. Helens and Knowsley 

Dear Madam Coroner, 

Inquest touching the death of Beryl Ellison 
Response to the Regulation 28 Report to Prevent Future Deaths 

Thank you for your Regulation 28 Report dated 3 January 2023, following the conclusion of the inquest into 
the very sad death of Mrs Beryl Ellison. This letter sets out the response to your Report. 

I know that you will share a copy of this response with the family of Mrs Ellison and I would like to express 
my condolences for their loss. Please be assured that the safety of those in our care is my absolute priority. 

In your report, you raised the following matters of concern:  

Mrs Ellison was resident at Alexandra Care Home and was found deceased on 28th June 2022 by staff. Her 
family expressed concern that she had been left with syringe medication unsupervised by staff and raised 
concerns about this with the care home both historically and four days prior to her death. A post mortem 
examination revealed Mrs Ellison to have an excessive concentration of oxycodone in her system, which was 
likely to exceed any acquired tolerance level. The evidence heard at inquest revealed no explanation as to 
why Mrs Ellison was found to have taken the excessive quantity of oxycodone, which contributed to her death. 
Furthermore, the systems at the care home were stated categorically to be the same as those that were in 
place prior to Mrs Ellison's death 

The Four Seasons Health Care Group (the Group) comprises a number of Registered Social Care Providers, 
and we recognise the importance of looking after the health needs of our residents, ensuring that our staff 
have the requisite skills, confidence and ability to provide high quality care. 

We  are  also  aware  that it  is  extremely important for  us  to  operate  an effective  medication management 
system  and  that  lessons  are  learned  when  incidents  occur.  This  is  supported  by  ensuring  that  our 
investigations into incidents are progressed in a timely manner and by way of an open, frank and transparent 
process involving all relevant stakeholders from an early stage.  

During the course of the inquest touching the death of Mrs Ellison, Wendy Martindale provided evidence to 
you about the immediate actions taken at a local level at the Alexandra Care Home. These actions were taken 
in response to concerns raised initially by Mrs Ellison’s family, which identified that the policies, due process 
and appropriate escalation of actions as mandated by the Group had not been followed. By way of reminder, 
a summary of action taken at Alexandra Care Home is as follows: 

•  Team  Members  responsible  for  the  administration  of  medicines  completed  medication                             
competencies, irrespective of when these were last conducted. 
•  A Warning Notice is displayed within treatment rooms, advising staff of the correct process to follow 
when administering Controlled Drugs.   
•  Weekly observations of drug rounds are now completed. 
•  Medication issues and areas of learning or development are discussed within daily flash meetings. 

Four Seasons Health Care and brighterkind are part of the Four Seasons Health Care Group. 
Four Seasons Health Care Holdings Limited, Registered Office: Norcliffe House, Station Road, Wilmslow, SK9 1BU. Registered in England. Company number: 03806216 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Following the inquest, we have carefully reviewed the Regulation 28 Report issued by you. We now write to 
give you  assurance that further steps have been taken and actions implemented to address the matters of 
concern. These have been incorporated into the ongoing provision of care services at the Alexandra Care 
Home  and  more  widely  across  our  business  as  part  of  our  approach  to  learning  and  continuous  quality 
improvement. 

Lessons learned and action taken to address the concerns raised by you are as follows: 

Policies; training of staff, and communication 

The Group works to  The Managing Medicines in Care Homes Social Care Guideline [SC1] published by the 
National Institute for Health and Care Excellence (NICE) 

The  Group’s  medication  competency  assessment,  which  applies  to  all  members  of  our  care  team  was 
reviewed  and  refreshed  in  November  2022  and  reissued  to  every  care  home.  Prior  to  commencing  this 
assessment, staff must complete the following: 

  Read  the  Four  Seasons  Health  Care  Group’s  Medicines  Management  Policy  (Document  reference 
number:  CQpol-009)  and  associated  How  to  Guides  which  identify  the  key  requirements  under  the 
Medicines Act 1968 and the Misuse of Drugs Act 1971  

 Complete all Medication Administration and Management eLearning modules  

 Read the Managing Medicines in Care Homes Social Care Guideline [SC1] published by the National 
Institute for Health and Care Excellence (NICE) https://www.nice.org.uk/Guidance/SC1    

The  Group  have  further  reviewed  and  improved  the  competency  assessment  for  Care  Assistants  who  
witness  Controlled  Drugs  (CD)  administration,  stock  counts  and  signing  the  CD  register.  This  assessment                           
now validates staff knowledge on Controlled Drugs and the Misuse of Drugs Act 1971 alongside practical 
assessment on the process of witnessing the correct administration of Controlled Drugs.   

The  How  to  Guide  for  Administration  of  Controlled  Drugs  has  been  reissued  across  the  Group.  Home 
Managers  were  instructed  to  discuss  this  with  all  team  members  who  are  responsible  for  medication 
management during regular meetings held at the home.   

More generally, as part of our efforts on continuous quality improvement for the benefit of our residents, 
the  Group  has  invested  in  a  new  dependency  tool  called  DepenSys,  a  proven,  effective  and  researched 
methodology  for  assessing  the  holistic  care  needs  of  residents,  from  the  point  of  pre-assessment,  while 
supporting  the  professional  judgement  of  the  Home  Manager.  DepenSys  assists  Home  Managers  to 
successfully calculate the care and clinical team requirements, their deployment and required skill mix, to 
meet  the  needs  of  all  residents  in  the  home.  DepenSys,  in  conjunction  with  our  comprehensive  pre-
admission assessment process covering all activities of daily living, ensures a clear record of any area of risk 
that may be associated with medication management or the behaviour of a resident, for the attention of the 
Home Manager and so such risk can be supported by the team working at the home. Alongside the rollout 
of DepenSys, the Group has recently introduced a new behavioural management care plan template, which 
allows team members to create personalised plans for any resident that may experience a behaviour that 
could result in risk and the necessary management of that risk; specifically this would include any known 
issues with hoarding of medication, addiction to medication or suicidal ideation.  

Additional learning and development - Learning and development that is based on a team/team  member’s 
specific  needs,  identified  either  as  knowledge  gaps  (information  that  employees    need  to  know  or  
understand  but  currently  don’t),  or  skills  gaps  (actions  that    employees    need  to be  able  to  carry  out  or 
perform but currently can’t). This is usually identified as part of the processes of supervision, annual appraisal 

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 or compliance (i.e. to meet the requirements of a particular service or local authority contract). It often leads 
to the development of personal improvement plans, which are regularly updated, reviewed and monitored. 

Monitoring of compliance with training takes place regularly across all operational portfolios, reviewed by 
Managing Directors and Operational Managers to identify any corrective action where required. Compliance 
may be further assessed during internal and/or external audit. Group learning platforms continually monitor 
compliance data and alerts are issued to Managing Directors and Operational Managers on a monthly basis 
to ensure line of sight of all care team compliance.     

Further to  the improvements  made  to medication  competency  assessments  detailed  above,  the Group’s 
Heads  of  Care  Quality  and  Care  Support  Managers  have  introduced  medication  management  learning 
surgeries  on  the  last  two  Thursdays  of  each month,  where  support,  direction  and  discussion  takes  place 
under  lessons  learned  following  any  incident  of  concern  or  more  generally  to  ensure  best  practice  in 
compliance with the Group’s policies is followed at all times. These surgeries are available for all staff who 
administer medications and allows for open discussion and lessons learned on a national scale across the 
Group.  

The Care Quality Team have further expanded upon the learning focus for medication management across 
the Group, with the introduction of medication management bulletins which are distributed to every home 
within the Group on a monthly basis. Edition 3: November 2022 Medicines Management Bulletin specifically 
discussed Controlled Drugs.  

Medication issues and areas of learning or development are discussed within daily flash meetings held by 
the  Home  Manager  or  Deputy  Manager,  allowing  for  improved  communication  and  increased  staff 
awareness. This is a change introduced on 23 December 2022.  

Incident Management 

Through  reflection  and  review, it  has  been recognised  that  the Group  Incident  Reporting  System, RADAR  
was not utilised at the Alexandra Care Home in the way for which it was intended. 

The RADAR system was deployed across the Group in 2021 as a fundamental change to the previous system 
DATIX,  an  incident  management  system  commonly  used  in  the  sector.  Whereas  the  DATIX  system  was 
controlled by the external program developers, which restricted our ability to invoke change when this was 
required to meet the needs of our business, the RADAR system allows for full participation and control to 
enable positive change by the Group.   

Every incident reported has a designated workflow to guide and prompt team members as to the information 
required  and  notifications  that may  be required;  these  workflow  steps  are  regularly reviewed  to  support 
improved reporting and investigation. A Root Cause Analysis function aligned to incident reporting has been 
simplified and improved with additional guidance and prompts to support team members.  Furthermore, 
the  Group  has  developed  a  bespoke  training  module  to  guide  team  members  on  how  to  conduct  an 
investigation;  this  is  directly  aligned  to  the  Incident  Management  System,  workflow  steps  and  effective 
completion  of a  Root  Cause  Analysis  and is  delivered nationally across  the Group.  The  training  has  been 
developed  using  a  ‘lessons  learned’  approach  and  guides managers  through  the  process  of completing  a 
timely, thorough and effective investigation. Areas covered include: reasons why we have to investigate an 
incident; the four steps of effective investigation and the correct method; and terminology for completing 
an  investigation.  The  training  also  encompasses  interactive  participation,  where  attendees  review  a case 
study and then discuss methods of investigation, identification of risk, causation, corrective action needed, 
how to write the investigation report and finally how to cascade lessons learned to the wider team.    

The  completion  of  the  incident  management  process  is  reliant  upon  human  elements,  namely  the 
importance of understanding the process, an honest and accurate approach to completion and the ability to 
execute this through comprehensive and open reporting. At Alexandra Care Home, group supervisions have 

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 been held  concerning the  importance  and  requirement  to report  any  concern, incident  or  near  miss  in  a 
timely manner and ensure effective use of the Group RADAR system, to allow management to be notified 
immediately of any incident, allowing for timely action. Across the Group, regular clinical meetings attended 
by Home Managers and team members are reminded of the importance of escalating any concern reported 
or  issue  identified  to  management  within  a  timely  manner.  Monthly  Nurse  and  Care  Home  Assistant 
Practitioner (CHAP) meetings are held at all homes with the purpose to review the previous month’s incident 
management system and medication audit, which provides further assurance that incidents are escalated 
accordingly and appropriate action is taken.    

The DepenSys system provides a continuous process of review and assessment which identifies changes in 
care needs and acts as an early warning indicator for emerging risk, supporting the review and updating of 
care documentation and risk assessments in a timely manner. 

Where  a  risk  to  medication  administration  or  management  is  identified  for  any  resident,  a  specific 
medication risk assessment will be written  and shared with the nursing and care team to ensure awareness 
of the specific risk and control measures in place. For ease of reference and to ensure that this potential risk 
is  highlighted  at  each  drug  round  to  the  member  of  staff  administering  medication,  a  copy  of  this  risk 
assessment will be held alongside the medication administration records for the individual resident.    

Thank you for bringing your concerns to my attention.  I hope that the detailed information provided in this 
response,  offers you  assurance  about  both  our  systems  and  processes  and  the  significant  and continuing 
improvements we have made and will continue to make in order to mitigate risk to our residents. 

We are sincerely sorry for the shortcomings in the care of Mrs Ellison and are committed to ensuring that 
the  improvements  we  have  made  are  sustained  both  at  the  Alexandra  Care  Home  and  across  our  wider 
business.  

Yours sincerely 

Chief Operating Officer  
Four Seasons Health Care Group  

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