Prevention of Future Deaths reports · 2015

Sheila Johnson

Regulation 28 report to prevent future deaths, reference 2015-0238, written 19 May 2015. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report19 May 2015
Reference2015-0238
DeceasedSheila Johnson
CoronerRobert Hunter
Coroner areaDerby and Derbyshire
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedUniversity Hospitals of Morecambe Bay NHS Foundation Trust · Tameside Hospital NHS Foundation Trust
Sourcejudiciary.uk record · original PDF
Responses published2

The report

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

OFFICE OF HER MAJESTY’S CORONER 
DERBY& DERBYSHIRE CORONER’S AREA 

            REGULATION 28:  REPORT TO PREVENT FUTURE DEATHS (1) 

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

THIS REPORT IS BEING SENT TO: 

1.  Karen James Chief Executive, Tameside Hospital 

1 

CORONER 

I am Robert W Hunter, senior coroner, for the coroner area of Derby and Derbyshire. 

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 23rd May 2013 I commenced an investigation into the death of Sheila Johnson aged 
74 years. The investigation concluded at the end of the inquest on 11th March 2015. The 
conclusion of the inquest was that the medical cause of death was: 

1a. Haemorrhage from left femoral artery graft site (operated May 2013). 

The circumstances were that on the 15th May 2013 Sheila Johnson died at 11 John 
Street, Glossop from catastrophic haemorrhage from a femoral graft wound less than 24 
hours after being discharged from Tameside Hospital with an open left groin wound 
being treated with Total Negative Pressure Therapy. 

My Conclusion was: 

Sheila Johnson died as a result of wound dehiscence from a left femoral endarterectomy 
and bovine graft, in part because signs of bleeding from the wound were recognised 
before her discharge from the ward, however a number of failures prevented appropriate 
measures being taken to address the issue and prevent further bleeding. On balance 
these failures were gross failures and Sheila Johnson’s death was contributed to by 
neglect. 

4 

CIRCUMSTANCES OF THE DEATH 

The nurse in charge of Mrs Johnson’s care was informed by two doctors that Mrs 
Johnson was not to be discharged until Mrs Johnson had been reviewed by the 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 consultant later that afternoon. Despite this she carried on and discharged Mrs Johnson 
before that consultant review.  

The consultant when he came to the ward to review Mrs Johnson he was made aware 
that she had already been discharged. Despite appreciating that she was at risk of 
catastrophic haemorrhage he made no effort to recall Mrs Johnson back to the ward that 
afternoon as a matter of urgency. 

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)  The court was provided with a copy of the Trust’s Internal Report of the 

circumstances of Mrs Johnson’s death and heard evidence regarding the 
findings from the author of the report. 

(2)  The court was of the opinion that any such investigation and report must be 
sufficiently robust if it is to have any meaning and lessons learnt to prevent 
future deaths. 

(3)  The court was of the opinion that on this occasion there was insufficiency of 

inquiry and the investigation was perfunctory and slipshod. 

(4)  Statements of 6 members of staff were taken. Two of those members were 

interviewed, the court was of the opinion that other key witnesses including the 
nurse who discharged Mrs Johnson should have been interviewed. 

(5)  An audit of the nursing and medical documentation was undertaken, however 

this confined itself to establishing that the entries were accurately dated and 
timed with a legible signature. No consideration was given to the clinical content 
of those entries and as to whether or not they were appropriate. 

(6)  The report contained serious factual inaccuracies and based on those errors of 

fact erroneous findings and recommendations were made. 

(7)  The court believes that should future reports be conducted in this manner then 
patient’s clinical conditions may be compromised and such errors could lead to 
deaths in the future. 

(8)  The Trust appeared to have no system in place for the urgent recall of patients 

who had been discharged with potentially life threatening conditions. 

6 

ACTION SHOULD BE TAKEN 

In my opinion action should be taken to prevent future deaths and I believe you and your 
organisation  has 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 14th July 2015. 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; the Family of Mrs Johnson. 
 I have also sent it to: 
The Secretary of State for Health. 
The Chief Executive of the Care Quality Commission. 

 
 
 
 
 
 
 
 
 
 
 
 
 
  who may find it useful or of interest. 

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. 

9 

19th May 2015                                            Robert W Hunter

Responses

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.

Response from Department of Health (PDF)
ak»
aS ‘ From the Rt Hon Jeremy Hunt MP
Secretary of State for Health

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| Department
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Your Ref: RWH/DS/906/13 79 Whitehall
London
SWIA 2NS
PO00000936797 rs
Dr Robert W Hunter

Senior Coroner, Derby and Derbyshire Coroner’s Area
Coroner’s Court
5-6 Royal Court

Basil Close
Chesterfield $41 7SL 17 JUN 2015

Dw a. Wk,

Thank you for your letter of 19 May enclosing the Regulation 28 Report on the
inquest into the death of Sheila Johnson.

I share your concern following your comments on the lack of co-operation by the
Tameside Hospital NHS Foundation Trust. Departmental officials have made
enquiries with the Trust, and I have been assured that it will be responding
appropriately to your Regulation 28 Report.

Officials have shared your letter with the Care Quality Commission (CQC). The
CQC advises that it will follow up any actions identified as a result of the Trust’s
response as part of its ongoing engagement with the Trust. The CQC will also
reinforce the duties of the Trust in relation to its duty of candour and being open,
transparent and cooperative with key stakeholders and statutory bodies.

You are right that improving transparency and reinforcing a culture of openness and
honesty is a key focus for the NHS and it is crucial that NHS trusts meet
expectations in this area. The fundamental standards require that providers assess,
monitor and improve the quality and safety of services. The CQC’s guidance about
complying with this regulation, to which all providers must have regard, states that
providers should share relevant information. This would include sharing
information about incidents with relevant bodies, including coroners.

In addition, the CQC has a number of actions in hand that are intended to improve
working between healthcare providers and coroners, including the establishment of a
Memorandum of Understanding with the Coroners Society of England and Wales to

achieve better working relationships and improve the sharing of information, as well
as developing a single protocol for handling information from coroners, which
includes storing and passing on information.

You will also be aware that there is existing legislation in relation to how public
bodies and professionals should behave with respect to coronial processes.

Finally, you may be aware that one of the recommendations made by
in his report into the deaths of mothers and babies at the University Hospitals of
Morecambe Bay NHS Foundation Trust was around the setting out of duties of all
NHS trusts and their staff in relation to inquests. The Government hopes to respond
formally and fully to the Morecambe Bay investigation recommendations shortly,
which may be of interest to you. While I am not able at this point to give an
indication of the Government’s response to the recommendations, I hope you will be
assured that we are giving thought to whether further measures are required to guide
appropriate behaviour in relation to coroner investigations and inquests.

I have also copied your letter to Monitor, as the Foundation Trust sector regulator for
health services in England, so it is aware of your concerns in relation to Tameside.

I hope this reply is helpful.

GA yinonhy

JEREMY HUNT

|
|
|
Response from Tameside Hospital NHS Trust (PDF)
Tameside Hospital
NHS Foundation Trust

Tameside General Hospital

ually one Department Fountain Street
Tameside General Hospital Ashton-Under-Lyne
Ashton-Under-Lyne Tameside
OL6 SRW OL6 SRW

[ee Telephione: 0161 922 6000
Fax:

9" June 2015

Dr Robert W Hunter
HM Senior Coroner
Coroner's Court

5 — 6 Royal Court
Basil Close
Chesterfield
Derbyshire

S41 7SL

Dear Dr Hunter,

Re: Regulation 28: Report to Prevent Future Deaths following Inquest
into the death of Mrs. Sheila Johnson

| am in receipt of your Regulation 28 Report to Prevent Future Deaths dated
19" May 2015. ! am very sorry that you have had cause to identify concerns
regarding the quality of the Trust’s internal investigation process and in
relation to the system for the urgent recall of patients discharged with
potentially life threatening conditions. We accept in full your verdict and
requirements.

It was recognised by the Keogh Review Team who visited the Trust in May
2013 that at the time of Mrs. Johnson’s death the Trust fell below expected
standards in relation to a number of areas associated with the governance of
care and treatment. As a result, the Trust was placed in Special Measures.
The Trust engaged a new Leadership team and accepted all the
recommendations made by the Keogh Review and CQC which resulted in a
Trust-wide review and improvement programme. The improvement plan has
been extensively monitored by the CQC, Monitor, NHS England and
Tameside and Glossop CCG with independent third part scrutiny

Since Mrs. Johnson’s inpatient treatment, her tragic death and the 2013
investigation into the circumstances surrounding her death; considerable
changes have been made both to improve the quality of the Trust's internal
investigations and the process for discharging patients.

As part of the improvement programme across the Trust, a review of senior
nursing staff took place, and medical staffing underwent a review with the
intention of improving Senior Doctor presence within the Trust and their
availability out of hours to improve quality, safety and patient care.

The Trust has implemented a programme of Leadership Development for
Clinical Leaders and Ward and Senior managers to develop leadership
capabilities, abilities and build a more collaborative organisational culture.

In relation to your particular concerns regarding the quality of the internal
investigation undertaken at this time, the Trust's processes have been revised
significantly and beyond all recognition. The current policy for the
management of serious incidents including their investigation has been
rewritten and implemented. The policy provides clear guidance to Trust staff
in relation to incident reporting and the investigation process, with the aim of
improving the quality of the Trust's investigations. We have had this monitored
by the CQC and CCG and reported to external oversight groups.

All serious incidents are reviewed by Directors who assign a level of
investigation and an investigation team to each serious incident, consisting
either of appropriate individuals from the Trust or where relevant external
independent persons. Professional advice relevant to the specialty is now

obtained.

We recognise that staff undertaking incident investigations need to be
appropriately trained. Since the investigation into Mrs. Johnson's death the
Trust has invested significantly in additional training provided by an external
facilitator. This has delivered root cause analysis and investigation training
across all divisions of the Trust, the most recent training taking place in March
of this year. More than 75 senior officers have been trained in RCA. This has
underpinned the revised policy to ensure investigations are more robust and
recommendations are acted upon and patient care and safety is improved.

A sample of serious incident investigations conducted since the training were
audited during the period November 2014 and March 2015 by independent
third party auditors (MIAA) and the audit demonstrated that the individuals
involved in those investigations were appropriately trained.

The auditors concluded in their report dated 10" March 2015 that the serious
incident processes provided significant assurance to the Trust that systems
and processes were in place.

We have also introduced improvements to the process for internal review of
serious incident reports. There is now an Executive led Serious Incident
Review Panel which reviews all serious incident investigation reports and
action plans and scrutinises and challenges them, providing feedback to the
investigation teams when further clarity is required. The panel also require
that responsible nursing and medical leads attend the meeting to feed back
what changes have been made and what lessons have been learnt from
investigations.

As part of the investigation process appropriate recommendations and actions
are identified either within the investigation report or in a separate action plan
to address issues that have been highlighted. The Serious Incident Executive
Review Panel discusses actions arising from serious incidents and how they
will be addressed by the divisions of the Trust.

The Trust has a number of improvement work streams into which the actions
arising from serious incidents have been mapped, including patient safety
programme work streams that are monitored and feed into the Trust's
Governance arrangements which report to Trust Board. The Quality &
Governance Unit has developed processes to work with the Trust’s Clinical
Divisions and follow-up on the implementation of actions identified and further
assurances are gained through the ward accreditation process, Board
leadership walk-rounds to wards and departments, and patient experience
feedback.

The complaints processes, HM Coroner’s Inquest processes and mortality
review processes are now coordinated into one process to oversee the

Statutory Duty of Candour requirement.

! also note your concern that the audit of the nursing and medical
documentation undertaken during the investigation into Mrs. Johnson’s care
confined itself to establishing that the entries were accurately dated and timed
with a legible signature.

The revised investigation process and procedure includes the requirement
that incident and complaint investigations consider relevant best practice and
policies and that the investigation should include whether the recommended
systems and processes were followed, as well as whether record keeping

standards were adhered to. It signposts the user to the Incident Decision Tree
which also includes the requirement to assess decisions made and actions
taken against policies and procedures to identify whether there were failures
in systems and processes or individual failures.

The Trust acknowledges your concerns and accepis them in full. The fact that
there was no formal system for the urgent recall of patients discharged with
potentially life threatening conditions, has been addressed by the Patient Flow

Manager.

Staff will be directed to attempt to contact the patient or relatives in the first
instance and contact the General Practitioner and Community staff should the
patient or relatives not be contactable, if necessary staff will be directed to
contact the Police and ask for a ‘safe and well’ check.

The procedure will be defined in a simple flowchart which signpost will staff to
the correct actions and responsibilities should any staff member identify that a
patient has been discharged and needs to be recalled urgently. We are
closely monitoring the quality of discharges with our CCG. The process will
also be included as an appendix within the Admission and Discharge Policy.

| am writing directly to the family of Mrs. Johnson extending my apologies and
sincere condolences.

! hope that the above clarifies the improvements that we have made and
addresses your concerns and findings in relation to Mrs. Johnsons Inquest.
Piease do noi hesitate to contact me again if any more information is required.

Yours sincerely

Karen James
Chief Executive

cc. Monitor
cQc
Tameside and Glossop CCG

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