Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0251, written 17 Jul 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 17 Jul 2023 |
|---|---|
| Reference | 2023-0251 |
| Deceased | Jane Wadsworth |
| Coroner | Alison Mutch |
| Coroner area | Manchester South |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Tameside and Glossop Integrated Care NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO: Tameside and Glossop Integrated Care NHS
Foundation Trust and NHS England
1
CORONER
I am Alison Mutch, Senior Coroner, for the Coroner Area of Greater Manchester 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 3rd January 2023 I commenced an investigation into the death of Jane Elizabeth
Wadsworth .The investigation concluded on the 12th June 2023 and the conclusion was
one of Narrative: Died from the complications of elective surgery where antibiotics were
not always administered in accordance with her prescription and her deteriorating
condition was not assessed by Intensive Care clinicians until 31st December despite her
poor liver function, poor kidney function and worsening condition. The medical cause of
death was 1a) Sepsis; 1b) Cellulitis; II) Elective Hip replacement performed on 13/11/22,
Deep Vein Thrombosis, Adult Polycystic Kidney
Disease with Liver Cyst, Acute Kidney Injury, Ulcer Left Foot
1
4
CIRCUMSTANCES OF THE DEATH
Jane Elizabeth Wadsworth had elective hip surgery. She returned to Tameside General
Hospital with concerns over her wound. She subsequently developed a deep vein
thrombosis and cellulitis. On 22nd November 2022 she became very unwell and was
admitted to Intensive Care Unit with sepsis, acute kidney injury and liver failure. She
was treated on the Intensive Care Unit until 26th November when she returned to the
ward. She continued to be treated for her cellulitis and an ulcer of the left foot that had
developed. She was stepped down to the Stamford Unit on 16th December 2022. On 22nd
December 2022 she returned to Tameside General Hospital due to concerns about her
raised NEWS 2 score, raised probably as a consequence of cellulitis. She was started on
intravenous
antibiotics. Her liver function was deranged and she had acute kidney injury. She had a
catheter but her urine output was difficult to assess due to issues regarding possible
catheter bypass. On 24th December, one dose of antibiotics was missed. On 25th
December, two doses of antibiotics were missed. She continued to be unwell and on 27th
December further antibiotics were prescribed. She was referred to the Critical Care
Outreach Team who assessed and determined that Intensive Care Unit referral was not
necessary. On 29th December the antibiotics were changed. There was a further referral
to Critical Care Outreach that was unsuccessful as there were no staff available. There
was no doctor to doctor assessment and no consultant review and no liver specialist
advice sought or provided. She continued to deteriorate on 30th December with poor
liver function and poor kidney function. On the morning of
31st December she deteriorated rapidly and was accepted by the Intensive Care Unit
where despite aggressive treatment she deteriorated rapidly and died on 31st December
2022.
2
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. –
1. Mrs Wadsworth missed three doses of antibiotics prescribed to treat her infection
according to the evidence given to the inquest. This did not appear to have been
escalated and there was no clear explanation regarding this occurring other than
that her cannula may not have been in place and there was a delay in a doctor
being available to reinsert one;
2. The evidence before the inquest was that on her admission over Christmas/New
Year there was no effective consultant input into her care;
3. The junior doctor involved in her care felt that ICU involvement/input would be
beneficial. The evidence was that there did not seem to be any doctor to doctor
discussion of this. The inquest heard evidence that this was one way a patient
could be transferred to ICU. It was unclear why there had not been such a
discussion and whether in periods such as Christmas/ New Year where there
were fewer consultants available the system worked effectively. This was not a
situation where there had been a ward based ceiling of care put in place and
ultimately Mrs Wadsworth was treated by ICU but was extremely unwell at that
point and did not respond to that intervention at that point;
4. The alternative support available to ward based staff and possible route into ICU
according to the evidence given at inquest was via the Critical Care Outreach
team. That team is staffed primarily by nurses and its key
3
focus is on presentation linked to NEWS2 scores according to the evidence
given to the inquest. Mrs Wadsworth’s case was a complex one involving issues
relating to her liver function and kidney function rather than just her NEWS2
scores and it was unclear if the Critical Care
Outreach Team were best placed to assess her need for ICU support;
5. The inquest heard that on the date of one referral that team was not in any event
available to the ward and the nurse who should have undertaken the role had
been redeployed elsewhere in the trust and there was no capacity to fill that role;
6. Following her first admission to ICU there was a note that Mrs Wadsworth’s
case should be discussed with a specialist Liver team. There was no evidence
available to the inquest that such a discussion had taken place. It was not entirely
clear on the evidence precisely which clinician was to take ownership of the
action.
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.
7 YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this report,
namely by 11th September 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 namely
useful or of interest.
on behalf of the Family, who may find it
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.
4
9 Alison Mutch
HM Senior Coroner
17.07.2023
5
2 responses 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.
Alison Mutch
Senior Coroner
Manchester South Coroner’s Court
1 Mount Tabor Street
Stockport
SK1 3AG
Dear Coroner,
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
10 October 2023
Re: Regulation 28 Report to Prevent Future Deaths – Jane Elizabeth
Wadsworth who died on 31 December 2022.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 17 July
2023 concerning the death of Jane Wadsworth on 31 December 2022. In advance of
responding to the specific concerns raised in your Report, I would like to express my
deep condolences to Jane’s family and loved ones. NHS England are keen to assure
the family and the coroner that the concerns raised about Jane’s care have been
listened to and reflected upon.
I am grateful for the further time granted to respond to your Report, and I apologise for
any anguish this delay may have caused to Jane’s family or friends. I realise that
responses to Coroner Reports can form part of the important process of family and
friends coming to terms with what has happened to their loved ones and appreciate
this will have been an incredibly difficult time for them.
The matters of concern raised in your Report come under the remit of Tameside and
Glossop Integrated Care NHS Foundation Trust (hereafter “the Trust”), who are
therefore the appropriate organisation to respond to the concerns raised. I am however
grateful to you for bringing these important patient safety issues to my attention. The
concerns have been shared with my relevant regional Quality colleagues in the North
West, who are engaging with Greater Manchester Integrated Care Board (the
responsible commissioning body for Greater Manchester) about the issues raised.
NHS England had been waiting to be sighted on the Trust’s response to you, which
we received a copy of on 2nd October 2023. We note that the Trust’s response does
address each of the concerns raised in your Report and that they have been
implementing improvement work to address missed doses of medication, together with
new processes for clinical documentation and review.
Your Report will also be discussed by the Regulation 28 Working Group, comprising
Regional Medical Directors, and other clinical and quality colleagues from across the
regions. This ensures that key learnings and insights around preventable deaths are
shared across the NHS at both a national and regional level and helps us pay close
attention to any emerging trends that may require further review and action.
Thank you again for bringing these issues to my attention and please do not hesitate
to contact me should you need any further information.
Yours sincerely,
National Medical Director
r.!1:b1
Tameside and Glossop
Integrated Care
NHS Foundation Trust
Chief Executive Officer
Tameside and Glossop Integrated Care NHS Foundation Trust
· Silver Springs
Fountain Street
Ashton under Lyne
Lancashire OL6 9RW
7 September 2023
Strictly Private and Confidential
FAO Ms Mutch
HM Coroner
Coroner's Court
1 Mount Tabor Street
Stockport
Cheshire
SK13AG
Private and confidential
To be opened by the addressee only
Dear Ms Mutch,
I am writing further to the inquest touching upon the death of Mrs Jane Wadsworth,
who died on 31 st December 2022 which concluded 12th June 2023 and the subsequent
Regulation 28 Notice issued to the Trust.
You raised 6 questions of concerns which are set out below and I will respond and
answer these questions as succinctly as possible to provide you with additional
information and assurance.
1. Mrs Wadsworth missed three doses of antibiotics prescribed to treat her
infection according to the ev~dence given to the inquest. This did not
appear to have been escalated and there was no clear explanation
regarding this occurring other than that her cannula may not have been
in place and there was a delay in a doctor being available to reinsert one;
The Trust acknowledge that in Mrs Wadsworth's case she missed a number of doses
of intravenous antibiotics on 26/12/2023 as her cannula had become dislodged. The
medical records document the steps taken by the Registered Nurse to attempt to re-
site the cannula without success. This also included escalation to both the Night Nurse
Practitioner and the doctor. The doctor was eventually successful in gaining
intravenous access.
fi11:b1
Tameside and Glossop
· Integrated Care
NHS Foundation Trust
During Trust induction all registered members of staff undergo clinical induction
training which includes intravenous (IV) cannulation. Registered members of staff is
asked to complete an e-learning package and present evidence of the completion of
training by way of a certificate to the Trust Training team. On receipt of the certificate
the Trust training team support simulated practice on an artificial arm to illustrate and
reinforce practice under direct su·pervision. Once completed the registered member of
staff is provided with a competency document which is taken into clinical practice.
Competency is completed foll.owing assessment in the clinical setting by another
competent colleague. This skill is essential to role for all Registered Nurses working
within Acute Care and the IV therapy Team.
The Trust continue to focus on improvement in relation to missed doses of medication.
There is an established program of medication audits which are reported to the Trust's
Medication Safety Group. The Medication Group meet bi-monthly and has a
multidisciplinary membership. At present the Pharmacy Department perform an
annual snapshot retrospective audit which focusses on omitted/unsigned doses. The
audit covers inpatient areas and looks at any medication doses which are not
administered as prescribed and the documented reasons for this. The most recent
audit was presented to Trust Medicines Safety Group on 28/04/23.
.
The Trust recognise that there is an overall percentage of medication doses which are
omitted for a 'non-valid clinical reason'. This means that unsigned doses would be
recorded under this category (along with any medication doses omitted due to lack of
availability). In the last completed audit the percentage of medication doses omitted
for a 'non-valid clinical reason' averaged 4% of all prescribed doses. This audit is part
of the Trust's standard audit cycle and the results are fed back to the multidisciplinary
Medicines Safety Group. One of the actions from the last audit was to issue a new
poster which highlights to all staff how to avoid missions in medication- this includes
information of how to access medication if unavailable within the clinical area.
In addition to the annual pharmacy led audit, Ward Managers perform their own
documentation audits and complete electronic incident reports as appropriate. An
incident would then evoke further local investigation and individual competency
assessment using the medication management assessment tool. Any learning from
this is shared at the daily huddles within each ward setting to ensure all staff appreciate
the importance of accurate medication management. Medication incident numbers are
monitored through the Trust Medicines Safety Group and the Medicines Safety Officer
also provides a summary document of any emergent themes and trends.
In addition to documentation audits the ward managers also complete a monthly
Quality Assurance audit. This includes an assessment of whether medications have
been administered as prescribed, each audit involves the review of three patient's
medical records which includes the medication kardex.
The Trust has an embedded ward accreditation process, where each ward is
accredited on an at least 32 weekly basis and more regularly if required. The ward
accreditation process includes a review of omitted· doses of medication. The
,.,,:f;j
Tameside and Glossop
Integrated Care
NHS Foundation Trust
accreditation team is led by a Head of Nursing or Midwifery and is supported by four
senior health professionals. The results are shared with the ward managers and
leadership team with Executive oversight. This enables areas for improvement to be
identified and appropriate action to be taken.
The Trust medication kardex has been redesigned to place greater emphasis on time
critical medications. Pharmacy systems for ordering medications to the ward have
been streamlined and the Trust also has an emergency medication cupboard and an
on-call pharmacy for obtaining medications out of hours. I attach a copy of the template
of the updated medicines kardex and the PowerPoint slides to support the new
medicine chart for your consideration and information.
To provide further support for inpatient areas each ward has a Ward based Pharmacy
Team. Each ward area has an allocated ward pharmacist and pharmacy technician
who evaluate individual treatment sheets on a daily basis. They form a key element of
the multidisciplinary team caring for our patients. Pharmacy presence on the wards
supports the accurate prescribing and administration of medication. They also ensure
timely ordering of medications which do not form part of the routine medication stocked
within the ward area.
Out of hours, in the event of a medication being unavailable on the ward, nursing
colleagues have access to an Emergency Drug Cupboard, a list of where medications
are stocked across the site ("Location of Stock on Wards" list available on the Trust's
intranet site). This is further supported with access to an on-call Pharmacist who can
offer further support if necessary.
The issue of omitted doses is covered in the nursing induction training that the
Pharmacist delivers. Every nurse receives this training at the point of joining the Trust.
This training can also be accessed as a refresher course. Every nurse new to the Trust
also receives a medication management assessment undertaken by the Ward
Manager which evidences safer practice in keeping with Trust policy. This is recorded
in the individual's personnel file and a copy sent to the learning and development
department.
2. The evidence before the inquest was that on her admission over
Christmas/New Year there was no effective consultant input into her care;
The Trust operates a Consultant on-call rota which includes all weekends and bank
holidays throughout the year. The on-call Consultant's remit is one of assisting their
Urgent Care consultant colleagues in the review of new patients who have been
admitted to the Acute Medical Unit and also tp perform the review and care planning
of any acutely unwell medical patients located in the medical wards across the Hospital
if required.
This Consultant rota is planned 6 weeks in advance and managed by the Trusts
medical staffing department. The medical staffing department have confirmed that the
Consultant on-call rota identified no deficit for the period of Mrs Wadworth's admission.
,.,,:~j
Tameside and Glossop
. Integrated Care
NHS Foundation Trust
Alongside the Consultant on call rota the Trust operate a Consultant ward round which
includes weekends and bank holidays, which focusses upon patients who are deemed
medically optimised and fit for discharge. This ward round takes place on every
medical ward between the hours of 9am - 1pm and despite the focus being
dischargeable patients, the Consultant would be a point of escalation should any of
the ward team identify that a patient required urgent review.
In terms of staffing areas of the Trust there is a robust mechanism of oversight of
staffing both .medical and nursing which takes place several times per day to ensure
safe staffing across the organisation. This is monitored at least 5 times per day during
the Trust capacity meetings, where operational / clinical /site and senior managers
attend. Any potential shortfalls in medica_l cover are addressed and actioned by
operational and clinical colleagues to mitigate risk. Should any further escalations
relating to staffing shortfalls be required then the onsite team are supported by a first
on call senior manager rota and a Executive on - call rota.
3. The junior doctor involved in her care felt that ICU involvement/input
would be beneficial. The evidence was that there did not seem to be any
doctor to doctor discussion of this. The inquest heard evidence that this
was one way a patient could be transferred to ICU. It was unclear why
there had not been such a discussion and whether in periods such as
Christmas/ New Year where there were fewer consultants available the
system worked effectively. This was not a situation where there had been
a ward based ceiling of care put in place and ultimately Mrs Wadsworth
was treated by ICU but was extremely unwell at that point and did not
respond to that intervention at that point;
From a review of Mrs Wadsworth care and medical records there is evidence that she
was reviewed by the medical team on a daily basis. Mrs Wadworth was also reviewed
by a Renal Consultant (30/12/2022) and a Microbiology Consultant. On 28/12, 29/.12,
30/12 and 31/12/22 Mrs_ Wadsworth was reviewed by a Medical Registrar. On
31/12/22 at 08:S0am Mrs Wadsworth was reviewed by the Medical Registrar following
appropriate escalation by the nursing team, who contacted the Critical Care Team to
request a higher level of care for her. Following this Mrs Wadsworth was admitted to
the Critical Care Unit. ·Further information regarding Critical Care and MERIT team
provision is provided as part of the response to point 4.
4. The alternative support available ,to ward based staff and possible route
into ICU according to the evidence given at inquest was via the Critical
Care Outreach team. That team is staffed primarily by nurses and its key
focus is on presentation linked to NEWS2 scores according to the
evidence given to the inquest. Mrs Wadsworth's case was a complex one
involving issues relating to her liver function and kidney function rather
t.•1:kj
Tameside and Glossop
Integrated Care
NHS Foundation Trust
4. The alternative support available to ward based staff and possible route
into ICU according to the evidence given at inquest was via the Critical
Care Outreach team. That team is staffed primarily by nurses and its key
focus is on presentation linked to NEWS2 scores according to thf:!
evidence given to the inquest. Mrs Wadsworth's case was a complex one
involving issues relating to her liver function and kidney function rather
than just her NEWS2 scores and it was unclear if the Critical Care
Outreach Team were best placed to assess her need for ICU support;
The Trust has an establi§,hed Critical Care Outreach Team which is cpmprised of a
number of highly skilled and experienced critical care nursing colleagues. The service
is available on a 24 hour, seven day a week basis. In addition to this the Trust also
implemented a MERIT (Medical Emergency and Rapid Intubation Team) team as part
of its response to the Covid-19 pandemic. Although the Trust, like others nationally
have stood down many of the supportive measures implemented in response to the
pandemic, the organisation has continued with the MERIT Team. The MERIT Team is
staffed by senior anaesthetic colleagues, including Consultant level from 08:30 to
18:00, and from 18:00 to 08:30 this is staffed by a middle grade anaesthetist. The
MERIT team is available on a 24 hour seven day per week service and this is in
addition to the medical staff who support the Critical Care Unit who would also provide
support ( advice and guidance. At the time of Mrs Wadsworth's admission there were
no deficits within the staffing of the MERIT team or the Critical care Medical team.
The Admission and Discharge Policy for Critical Care clearly sets out referral pathways
for those patients who may require a higher level of care including critical care due to
their current clinical condition. The referral pathway is in line with national guidance
(National Confidential Enquiry into Perioperative Deaths- NCEPOD, The National In-
stitute for Health and Care Excellence- NICE, National Patient Safety Agency-NPSA,
and Royal College Physicians) that the optimal referral pathway is consultant to con-
sultant. However the policy describes that in more critical instances where any delay
may be detrimental to the patient then a referral may come from training grade doctors.
It is expected that this be a medical registrar (i.e. the medical middle grade either on-
call or responsible for the patient). It is not expected that F1/F2 trainees are to refer
directly to Critical Care unless directed to do so whilst the registrar is in attendance.
5. The inquest heard that on the date of one referral that team was not in any
event available to the ward and the nurse who should have undertaken
the role had been redeployed elsewhere in the trust and there was no
capacity to fill that role;
~he outreach team at Tameside Hospital are a team of 7 clinical practitioners, the
service is run on a 24 hour a day, 7 day per week basis and this was first launched
January 2018. On 29/12/2022 when nursing staff contacted the Outreach Practitioner
to review Mrs Wadsworth, she had already been reviewed and been seen by the
medical doctor who had prescribed Albumin to be given intravenously. The Outreach
Practitioner had advised the ward nurse that they could not attend so therefore the
nurse correctly re contacted the ward doctor to review Mrs Wadsworth again and for
r.•1:b1
Tameside and Glossop
Integrated Care
NHS Foundation Trust
the appropriate medical plan to be put in place. At the time of Mrs Wadsworth's
admission the Outreach Practitioner had been allocated to an inpatient area to mitigate
risk following a short notice staff absence. However de.spite this the ward team could
have also considered contacting the MERIT team for advice and guidance for Mrs
Wadsworth.
There is a Standard Operating procedure to manage short notice absence from within
the outreach team which includes a number of proactive steps to cover the shift. In
terms of staffing other areas of the Trust there is a robust mechanism of oversight of
staffing which takes place several times per day to ensure safe staffing across the
organisation. This is monitored at least 5 times per day during the Trust capacity
meetings, where operational/ clinical /site and senior managers attend.
6. Following her first admission to ICU there was a note that Mrs
Wadsworth's case should be discussed with a specialist Liver team.
There was no evidence available to the inquest that such a discussion
had taken place. It was not entirely clear on the evidence precisely which
clinician was to take ownership of the action.
The Critical Care Team have regular team huddles during each day to overview and
discuss patient's in their care. The huddles which take place several times per day
involve Advanced Care Practitioners, Medical Staff, Physiotherapists, Nurses and
support workers. The huddles involve diagnostic tests, results, current condition,
specialist team involvement and can also include resuscitation status of the patient. In
addition to the huddles the medical team also have a formal handover of care between
shifts, these are recorded electronically.
The Trust acknowledge that the clinical documentation recorded within the Critical Unit
was not clear with regards to who and when Mrs Wadsworth was referred to the Liver
Unit. In response to this the Critical Care Unit have amended their daily review chart
to provide additional clarity on this point and that this is documented in a more
comprehensive way.
Medical Director
On behalf of Karen James
Chief Executive Officer
Tameside and Glossop Integrated Care NHS Foundation Trust
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