Prevention of Future Deaths reports · 2023
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 report | 3 Jan 2023 |
|---|---|
| Reference | 2023-0002 |
| Deceased | Beryl Ellison |
| Coroner | Johanna Thompson |
| Coroner area | Sefton, St Helens and Knowsley |
| Category | Alcohol, drug and medication related deaths · Care Home Health related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
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
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.
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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