Valerie Ellis

Date of report	16 Jun 2016
Reference	2016-0252
Deceased	Valerie Ellis
Coroner	David Skipp
Coroner area	West Sussex
Category	Hospital Death (Clinical Procedures and medical management) related deaths
Organisation named	Western Sussex PCT · Western Sussex Hospitals NHS Foundation Trust
Source	judiciary.uk record · original PDF
Responses published	3

The report

Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.

REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:

1. Marianne Griffiths, Chief Executive Western Sussex Hospitals NHS Trust

2. SECAMB
3. 1C24
1 CORONER

lam Dr David Skipp, Assistant Coroner, for the Coroner's area of West Sussex.

2 | CORONER’S LEGAL POWERS

| 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 14" September 2015 an investigation into the death of Valerie Margaret Ellis was
commenced. The investigation concluded at the end of the inquest on 21* April 2016.
The conclusion, in narrative form, stated:

Mrs Ellis died on 6” September 2015 at home as a consequence of taking a prescribed
blood thinning agent, Apixaban. Counselling as to the side effects of the drug was not
given by the hospital and this, with non-compliance call handling by 111 and inexplicable
premature closure of the case within 1C24 may have contributed to death.

The pathologist gave cause of death as:

1a Massive Gastrointestinal Bleed

due to

1b Apixaban

2 Ischaemic Heart Disease

4 | CIRCUMSTANCES OF THE DEATH

Mrs Ellis was an 83 year old woman who had been treated in hospital for a fractured hip
and discharged on the 14” August 2015.

On 24" August she was readmitted with a cardiac arrhythmia stabilised by a
combination of drugs along with Apixaban, a blood thinning agent.

She was discharged from hospital on 29" August to her home with medication and a
post hospital District Nurse visit on the 2™ September did not identify any unexpected
problems and no further nursing needs were identified.

One" September Mrs Ellis developed a nose bleed and at 18:31 hours her husband
phoned NHS 111 for advice. He was informed that he would receive a call from a
clinician within 1 hour but, although apparently a call was made, who has an
acknowledged hearing disability, did not either hear or respond.

At 21:07 a further call was made to NHS111 and as a result it was suggested at 21:21

that Mrs Ellis be taken to hospital.

Circumstances meant that it was not possible for Eo undertake this action and he
phoned 999 at approximately 21:34. The initial Category C rated call was change to
Red 2 and an ambulance attended at 22:10 but the patient was deceased.

During the inquest there appeared to be missed opportunities which may have had an
impact on Mrs Ellis’ end of life.

1. On discharge from hospital on 29th August, although EEE was given a list of drugs
that his wife was to take, there was no information or counselling given as to the nature
of Apixaban, a novel anticoagulant. Details of side effects and the identification of
bleeding complications were not given. Mrs Ellis was exhibiting signs of confusion and
Yo loss of high frequency tones but his evidence was unequivocal as to lack of
counselling.

2. The community nurse did not identify any nursing needs.

3. The first call to 111 was difficult as a result of communication problems between the
caller and the health advisor. The algorithm used by the health advisor did not make
clear the appropriate pathway for Mrs Ellis’ symptoms and vital information about the
medication she was taking was not elicited, particularly the blood thinning agent.

4. A referral was made to IC24 for a clinician to speak to This was undertaken
but in view of lack of response a note was made to phone in 5 minutes. The file,
however, was lost from the system in 1C24 and the return call was not made. No
explanation could be given as to the fact that the case was closed prematurely without
further contact i

5. A second call to 111 was made as Mrs Ellis’ condition deteriorated. All the information
had to be repeated and again there were communication problems. In neither call to
111 was advice sought from available clinicians by the health advisors.

a was asked to take his wife to A & E after the second call. He agreed although
with no means to get his wife out of the house due to her bleeding and poor mobility he
eventually resorted to dialling 999.

le gave information to the 999 operator that his wife's problem was a severe
nose bleed .The call was therefore rated as category C and only when phoned
again to say that his wife was not breathing was the category raised to the highest
category.

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) On discharge from the hospital the use of Apixaban in an elderly confused patient
being cared for by a carer with hearing loss should have merited careful counselling by
the clinicians and the use of a warning card.

Whilst the hospital is taking steps to assess this area, my understanding is that no policy
has been adopted and | feel it should be made a matter of urgency.

2) KMSS 111 provides a valuable lifeline for many patients and although health advisors
are trained to follow algorithms they only have 4 weeks training followed by 2 weeks of
sitting in with an experienced advisor. | am concerned about the training schedule,
particularly for those with little or no background medical knowledge. Whilst reliant on
algorithms, advisors must be able to recognise potentially fatal illnesses and

deteriorating conditions as thousands of patients rely on this service for medical help.
Clinical advisors on duty were not consulted in this complex case. The senior manager
for Quality and Clinical Governance at KMSS 111 expressed concern at the algorithm
used in the case of Mrs Ellis .The clinical algorithm called NHS Pathways is owned by
the Department of Health and was felt to be imprecise but despite representations to the
Department of Health by KMSS 111 for changes and improvement there has been no
positive communication since February.

3) A disposition from 111 was made to IC24 for a telephone consultation by an on call
clinician. This was received and logged and a call was made within one hour. There
was no response by the carer and a note was made to call back within 5 minutes.
Apparently the case was closed before this could occur; no explanation could be given
as to why this happened. Training for clinical staff in the use of the computer system
used by IC 24 is essential but did not appear well organised and should be rectified.

4) The results of investigations by both KMSS and IC24 should result in a joint RCA.
This has not occurred as yet and no date has apparently been arranged.

ACTION SHOULD BE TAKEN

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

YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this report,
namely by 14° August 2016. 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.

COPIES and PUBLICATION

| have sent a copy of my report to the Chief Coroner and to the following Interested
Persons

GE @t Brachers representing the Community Nurse

Paula Head Chief Executive of Sussex Community NHS Foundation Trust
ee Chambers representing Mr John Ellis

, Western Sussex Hospitals NHS Trust
GER son of Mrs Ellis

| 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@th . |
DATE : 16" June 2016 SIGNED: Newnes @_.

‘da Dr David Skipp

Responses

3 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.

Response from Integrated Care 24 Limited (PDF)

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10" August 2016

Private & Confidential

Dr David Skipp

Assistant Coroner
Coroner's Office

West Sussex Record Office
Orchard Street

Chichester

West Sussex

PO19 1DD

Dear Dr Skipp

Re: Inquest into the death of Valerie Margaret Ellis — 21 April 2016

Thank you for your letter regarding the concluded inquest into the death of Valerie Ellis. We
write to you in response to the Regulation 28 report and the matters of concern points 3 and
4, being the only matters of concern which relate to IC24.

3) A disposition from 111 was made to 1C24 for a telephone consultation by an on call
clinician. This was received and logged and a call was made within one hour. There was no
response by the carer and a note was made to call back within 5 minutes. Apparently the
case was Glosed before this could occur; no explanation could be given as to why this
happened. Training for clinician staff in the use of the computer system used by 1C24 is
essential but did not appear well organised and should be rectified.

|C24's own internal investigation found that the case was closed due to human error on the
part of the GP concerned. The GP concerned could not explain why she had closed the
case on the system and confirmed that training had been provided.

At the time of this incident the software version in use at the time had one warning box that
appeared before a case could be closed and would leave the active case list. The prompt
was “are you sure that no further action is required on this call, if not press save, if yes press
complete”

As explained in evidence at the inquest in evidence ry since this case
IC24 have introduced a new Failed Contact Guidance and a new software version which

means that it is not possible to close a call before three attempts spread over the timeframes
set out in the Guidance have been made. This change has improved the process and the
software. All new users of the software are trained in this regard, and all established users
have been informed of and reminded about the correct process.

Integrated Care 24 Limited
Kingston House, The Long Barrow,
Orbital Park, Ashford,
Kent TN24 0GP

[i ) Social
| Enterprise

1C24 take the training of those providing its services very seriously.

At the inquest there was concern expressed by you regarding training on accessing
information from the NHS Pathways NHS 111 report. The GP concerned did not appear to
have the level of awareness regarding the accessing of the information from 111 that IC24
would have wished. Whilst there was no evidence that the failure to access the information
from 111 had an impact on the outcome for Mrs Ellis, |C24 have reviewed the induction
training programme and have specifically included the access of this information from NHS
111 pathway as a specific topic. A copy of the induction training programme is attached.
C24 have also sent in alert to existing out of hours GP reminding them about accessing this
information.

4) The results of investigations by both KMSS and IC24 should result in a joint RCA. This
has not occurred as yet and no date has apparently been arranged.

The SUI noted that there would be a joint RCA between KMSS and IC24.

A Joint meeting took place between IC24 and KMSS NHS 111 on 31 December 2015. At
this meeting learning across the organisations was discussed and in particular Mrs Ellis case
was reviewed. The note of that meeting is attached to this letter for your ease of reference.

on have discussed the merits of a further joint SI and RCA
investigation. Given the joint working that has already occurred and that will continue, and
the new processes regarding call closure instituted within IC24 and other actions taken they
have concluded that a further RCA would not produce any new learning or actions.

If you would like any further details regarding these matters please do not hesitate to contact
me.

Yours sincerely

a |

Yvonne Taylor
Chief Executive Medical Director

Integrated Care 24 Limited Tt
Kingston House, The Long Barrow, — F:
Orbital Park, Ashford, W:
Kent TN24 0GP E

Response from South East Coast Ambulance Service NHS Trust (PDF)

South East Coast Ambulance Service INHS|

NHS Foundation Trust

) 2 The Horseshoe
< |
Dr D. Skipp E G 4 i V E Bolters Lane
Assistant Coroner for West Sussex
Centenary House
Durrington Lane,
Worthing, alae www.secamb.nhs.uk

Banstead

West Sussex
BN13 2PQ

25 July 2016

Private & Confidential
Re: Inquest into the death of Valerie Ellis.

Dear Sir,

| write in response to the regulation 28 report issued following the proceedings exploring the events
leading to the sad death of Mrs Valarie Ellis. The points of said report have been duly noted and |
provide our Trust’s response below in relation to section 5(2) and 5(4) respectively.

Firstly and with regards to the NHS Pathways training KMSS 111 deliver, this is in line with
requirements set out by the Department of Health who own the system. As commented during
proceedings if three answers of ‘unknown’ are provided by the caller this would flag to pass the call
to a clinician in the room. This is considered the mechanism to provide a safe service, with call
takers operating within the scope of the algorithm.

Developments in training issued by Pathways are incorporated into KMSS 111 training packages
and we can confirm the following levels of training/developments have taken place;

As of July 2015 (which our KMSS 111 call taker received);
e 2weeks (60 Hours) NHSP Core Module 1
e 1 week (30 hours) Common learning
e 1 week shadow shifts

Developments introduced November 2015;
e 2weeks supervised live support
e The Trust provides Pathways update training normally twice a year in the spring and autumn
but in 2015 Pathways brought out only one update which was a full days training face to face.

Developments being or have been introduced in 2016;
e 3 hours face to face training thus far
e This will become 6 hours face to face training scheduled in October November 2016.
e Further, there are additional coaching modules, DoS modules, mental health modules,
sexual abuse modules, domestic abuse workshop and audit levelling modules.

+
Your ont
call

Interim Chair: Sir Peter Dixon _ Interim Chief Executive: Geraint Davies

South East Coast Ambulance Service NHS

NHS Foundation Trust

| believe this demonstrates that training is incorporated as per NHS Pathways requirements and
that further developments and implementation of training have already occurred post the KMSS 111
call regarding Mrs Ellis.

Any concerns regarding the content and degree of training | would consider be appropriately
directed to the Department of Health as suggested during the proceedings as they own the system,
training and auditing requirements.

Indeed as you note in your report, our Senior Manager for Quality and Clinical Governance had
previously raised concerns to the Pathways team regarding the algorithm and impact regarding not
only Mrs Ellis’ case but anyone in a similar situation regarding anticoagulants. The principle areas of
concern raised regarded the blood loss, clinical shock and anticoagulant questions.

| am therefore confident our Trust has already done all it can in relation to improving this algorithm
by raising and following up on concerns through the appropriate governance channels.
Unfortunately our Trust has not received a conclusion regarding these concerns from NHS
Pathways. With these concerns appearing to directly correlate to the points of the regulation 28
report | likewise consider these directed to the Department of Health.

Turning to the matter of a joint RCA, our Trust is always open to cross-NHS collaboration and
review to strive to ensure safe patient care can be provided. However the regulation 28 report does
not comment on what is expected to be achieved by a joint RCA and therefore it is difficult to
respond. | am aware that both our Trust and IC24 have completed Serious Incident (SI) reports and
are happy to share findings and if not already in place a date can be set. However our organisations
are independent of each other and we do not receive communication from an out of hours provider
following such a disposition being reached and a referral passed. In turn we have no further control
in the matter unless we receive a further call either following up for an out of hours call or due to a
change in condition. In each case KMSS 111 is able to appropriately process the call.

In summary | believe the KMSS 111 service of our Trust has already done all it can in relation to
implementing training in accordance with NHS Pathways requirements and residual concerns on
the algorithm and training should be appropriately addressed to the Department of Health who own
the system. We are willingly open to sharing the findings of our SI report with 1C24 and will seek to
confirm a date to complete this.

| trust this clarifies our response to the regulation 28 report.

Yours Sincerely

—_ oS ... of Strategy and Business Development)

Your oni

Interim Chair: Sir Peter Dixon _ Interim Chief Executive: Geraint Davies ‘your enll

Response from Western Sussex Hospital NHS Trust (PDF)

Western Sussex Hospitals

NHS Foundation Trust

St Richard’s Hospital
Spitalfield Lane
Chichester

West Sussex

PO19 6SE

Tel: 01243 788122
Fax; 01243 531269

Our Ref: MEG/AP/KLG/Ellis www.westernsussexhospitals.nhs.uk
10 August 2016

Dr D Skipp

Assistant Coroner, West Sussex
Coroner's Office

West Sussex Record Office
Orchard Street

Chichester

West Sussex

PO19 1DD

Dear Dr Skipp
RE: Regulation 28 Report — Valerie ELLIS

Thank you for your letter dated 16 June 2016 under cover of which you enclosed a formal copy of
the Regulation 28 report to Prevent Future Deaths.

The Trust has welcomed the opportunity to build upon the work already in place to ensure that
patients prescribed Apixiban receive the very best information about the potential side-effects.
Despite the absence of national guidance, the Trust has continued to strive to develop a system
to ensure that both counselling and a warning card provide patients and their carers with a firm
understanding of the risks, as well as the benefits, of this and other new oral anticoagulants
(NOAC).

As you will be aware, the Trust launched the NOAC alert card in October 2015 and introduced a
Standard Operating Procedure to enable pharmacy staff to be fully appraised of the new system
and to support the distribution of the warning card. In addition, daily reminders generated by the
electronic prescribing software ensure that new patients are identified. It is hoped to strengthen
the system still further by placing a further NOAC card in the medication bag given to patients on
discharge and to ensure that all discussions with relatives and carers regarding the new drug are
documented.

The Trust has been extremely saddened by Mrs Ellis’s death and is keen to ensure that the
potential for both local and national learning can be fully maximized. While the prescription and
risks associated with NOACs will continue to be monitored and discussed at Medical Clinical
Governance and Thrombosis committee meetings, the Trust’s Medication Safety Officer has
initiated discussions with NHS England Medication Safety Division meeting co-ordinator to ensure
that the matter is discussed and debated at both regional and national medication forums. Locally,
the introduction of the generic NOAC information leaflet within Primary care has been submitted
to the Coastal Clinical Commissioning Group for the benefit of all NOAC patients in the local area.

The Patient First initiative sits at the very heart of the Western Sussex NHS Foundation Trust’s
vision of continuous improvement and provides a framework for reviewing each stage of a patient
care process. While the above actions seek to address the former inadequacies of the counselling
process, it is intended to adopt this methodology to review the entire NOAC process. The
standards are being captured in the revised policy for prescribing and administration of anti-
coagulants. The policy includes that newly initiated patients are consented by the medical staff as
treatment is initiated and receive written information and counselling during the stay and at
discharge from nursing and pharmacy staff. Concurrently plans are underway for the
establishment of a multi-disciplinary group to design and introduce mechanisms to ensure the
policy is embedded in practice including actions to formalize electronic recording of counselling
discussions, an initiation checklist for use by prescribers and patient leaflets to support the NOAC
card. Mrs Ellis’s family has been invited to be part of this group and we very much hope that, in
time, they will wish to be involved. The Trust's incident reporting system will provide an invaluable
tool to assist future audits to measure the effectiveness of these new initiatives.

We hope that the above provides sufficient assurance that the Trust continues to strive to ensure
that patients prescribed Apixiban are carefully counselled and have the reassurance of a NOAC
card to ensure timely help and advice can be obtained, as and when necessary.

Yours sincerely

Marianne Griffiths
Chief Executive

The report

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