Michael Parke

Date of report	18 Jan 2017
Reference	2017-0025
Deceased	Michael Parke
Coroner	David Roberts
Coroner area	Cumbria
Category	Hospital Death (Clinical Procedures and medical management) related deaths
Organisation named	North Cumbria University Hospitals NHS Trust
Source	judiciary.uk record · original PDF
Responses published	2

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)

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

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
RE: Michael Parke Deceased
THIS REPORT IS BEING SENT TO:

1. The Chief Executive of North Cumbria University Hospitals NHS Trust

2. The Chief Executive of NHS England

3. The Secretary of State for Health
CORONER

{am David LI. Roberts, Senior Coroner, for the coroner area of Cumbria.
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.
[HYPERLINKS]

—— +
3. | INVESTIGATION and INQUEST

| On 13" December 2012 | commenced an investigation into the death of Michael Parke |
aged 40 years. The investigation concluded at the end of the inquest on 16” January
2017. The conclusion of the inquest was:

1. Medical Cause of Death:
1a) Aspiration Pneumonia following a misplaced nasogastric tube for treatment
of gastrointestinal haemorrhage due to underlying alcoholic liver disease.

2. How, when and where, and for investigations where section 5(2) of the Coroners
and Justices Act 2009 applies, in what circumstances the deceased came by
her death.

Michael Parke died at 13.10 on 6 December 2012 at the West Cumberland |
Hospital, Whitehaven, following the insertion of a nasogastric tube into his left
lung resulting in Mr Parke developing aspiration pneumonia from which he died.

3. The deceased died from aspiration pneumonia. The pneumonia developed
because a Nasogastric Tube was placed in such a way as to enter the left lung
instead of the stomach. In the course of the insertion resistance was felt. Trust
policy required that where resistance was felt the nasogastric tube should be
removed and reinserted. However the nasogastric tube was left in situ. An x-
ray was taken in order to confirm the correct placement of the nasogastric tube.
The x-ray clearly showed that the end of the nasogastric tube was situated in
the left lung. The x-ray was mis-interpreted and feeding via the nasogastric tube
was authorised. The failure to note this incorrect placement amounts to neglect.
The Trust policy was inadequate and incorrectly assumed that doctors across
the Trust were competent to interpret chest x-rays and failed to require doctors
to either undertake training or to evidence their competence. The policy failed to
require the completion of a sticker that included the anatomical 4 point checklist
recommended in the 2011 NPSA alert. These failures amount to systemic.
neglect. 140 mis of medication and food was administered via the tube and

4 | CIRCUMSTANCES OF THE DEATH ”

In my view the following action should be taken:

entered the deceased's tung resulting in the development of the pneumonia as a
result of which he died.

Michael Parke suffered from chronic liver disease and was on 2” November 2012
admitted to West Cumberland Hospital intensive therapy unit. On 5" November it was
decided that a nasogastric tube should be fitted as part of his care. This was inserted
the same day. An x-ray was taken to confirm the position of the tube. This image was |
later reviewed by a doctor who confirmed the tube was in the stomach and that feed
could be administered. He subsequently deteriorated and when examined by a
consultant the following morning the tube was found to be in the lung and was removed.
His health did not improve and he died on 6" December 2012.

CORONER’S CONCERNS. 7

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. —

| have now held inquests into 3 deaths as a result of misplaced nasogastric tubes at
North Cumbria Hospitals which occurred over a period of a little over 7 years. These
types of death are described as ‘Never Events’. On the facts of these three cases the
deaths were avoidable. Common themes in all were:

(a) Staff not being aware of the policy.

(b) Staff not reading the policy.

(d) _ Staff not following good practice.

(e) The Trust not ensuring compliance nor rolling out training to all
who needed it.

(6 Lack of checks and audits to establish competence and adherence to policy.

(g) Failure of the Trust to learn from the first death.

(h) Lack of Corporate Memory (the issue of NGTs was not on the Risk Register).

(i) The Trust not fully implementing the 2011 NPSA Alert for over two years and
only as a result of the second death.

(j) Even after the second death not having systems in place to ensure compliance
on the ward which contributed to the third death.

(k} — The Trust Policy growing in size from 20 to 36 pages in 7 years, making it difficult
for busy practitioners to absorb (there are some 200 Policies in the Trust).

(1) The current Policy has cross-references to paragraphs which do not exist. These
errors have been carried through three versions, and raise the risk of
misinterpretation by staff and undermining their confidence in such an important
document.

ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and | believe you
{AND/OR your organisation] have the power to take such action.

()

|
(it)
(iv)
| fo)
(b)
(i)
(ii)

(ttt)

(a)

The Trust should take steps,

To consider an amplified “summary and aim” at the beginning of the policy to
drive home the main points.

To identify areas where statutory or mandatory training is required.

To consider the implementation of an online system of statutory mandatory
training with a central recording system.

To take steps to ensure that good and compliant practice is actually taking place
on the wards.

To correct cross referencing errors in the Policy.

The Secretary of State and NHS England should take steps to ensure that,
Research is undertaken to identify a superior method of ensuring

correct nasogastric tube placement.

The issues identified above are addressed nationally -there is
evidence set out in the NHS Improvement Resource Set ‘tnitiat Placement of
NGTs' July 2016 that demonstrates that the themes set out above are being
replicated across other Trusts.

The 2011 Alert is properly implemented nationally — the evidence before me was
that it has not been.

7 | YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this report,
namely by 15" March 2017. 1, 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
| have sent a copy of my report to the Chief Coroner and to the following Interested
Persons:

{ have also sent it to the persons named below who may find it useful or of interest.

2) ES 2710 Solicitors
b) EE and Solicitors

c) HR and RCN

6) EE anc Solicitors

e) and Solicitors

f)
9)
h)
i)
i)
k)
I)

a)
b)
c)
d) GM

e) NMC
f)
9)
h)
i)

1am 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.

18° January 2017

D. LI. Roberts Cz,

HM Senior Coroner

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 Respondent Not Named (PDF)

RG Philip Dunne MP-
Minister of State for Health

Department
of Health Richmond House
79 Whitehalf
London
SWIA 2NS

Tel: 020 7210 4850
David LI. Roberts

HM Senior Coroner County of Cumbria

Fairfield

Station Road 21 APR 2017

Cockermouth

Cumbria

CA13 9PT

Dear Coroner Roberts,

Thank you for your letter of 18 January 2017 to the Secretary of State for Health
about the deaths of Mrs Amanda Coulthard and Mr Michael Parke. I am
responding as the Minister with responsibility for patient safety at the Department
of Health.

I was saddened to read of the circumstances surrounding both Mrs Coulthard’s and
Mr Parke’s death. Please pass my condolences to their families and loved ones.

My officials have worked closely with NHS England, NHS Improvement and the
Care Quality Commission to ensure thorough examination of the concerns you
have identified. I am grateful for the extra time you allowed to enable this work to
take place.

Your Report asks that action be taken to ensure the failures identified at Inquest are
addressed nationally, and that the 2011 Patient safety Alert is properly
implemented.

We recognise your concerns that patient safety requirements around nasogastric
tubes are not being consistently implemented by all NHS providers.

While the incidence of death resulting from the insertion of liquid into the
respiratory tract as a result of nasogastric tube misplacement is rare, it should be
wholly preventable with national guidance and safety recommendations available
that, if correctly applied, provide a strong systemic protective barrier. Between
September 2011 and March 2016, 95 ‘Never Event’ incidents were reported

nationally where fluids were introduced into the respiratory tract via a misplaced
nasogastric tube. While this should be considered in the context that over 3 million
nasogastric or orogastric tubes were used by the NHS within that period, it is clear
that a risk to patient safety persists.

Your Report refers to the 2011 Patient Safety Alert issued by the National Patient
Safety Agency (NPSA). In addition to this, further communications were issued in
2012 and 2103 by the NPSA and NHS England respectively addressing relatively
rare types of error in nasogastric tube confirmation,

However, the most recent major initiative to address continued concerns on
implementation of safe practice for confirming initial nasogastric tube placement is
the Patient Safety Alert and accompanying resource set issued by NHS

Improvement in July 2016 (https://improvement.nhs.uk/news-alerts/nasogastric-
tube-misplacement-continuing-risk-of-death-severe-harm/),

I am advised that the actions set out in the Alert are very relevant to the concerns
identified at Inquest, and that the circumstances of Mrs Coulthard’s and Mr
Parke’s deaths indicate that future deaths could be prevented if trusts take the
systematic actions required by the 2016 Alert.

The focus of the Alert is on ensuring that the importance of a systematic approach
to implementation of competency-based training, safe equipment, appropriate
policy, bedside documentation and audit are recognised at Board level. To achieve
compliance with the Alert, Boards were asked to assess and address compliance
issues by 21 April 2017.

The Alert is informed by an analysis of the common findings of reported incidents
relating to the misplacement of nasogastric tubes and NHS Improvement is
confident that conscientious implementation of the actions required will have a
substantial impact on preventing future deaths.

Alert compliance is an important area of assurance. Already, NHS Improvement
collects and publishes data on Never Event occurrence and Alert compliance. This
data provides a key tool in alerting commissioners and regulators to fundamental
failings in quality, care and safety processes within an NHS provider.

The current system is based on self-declaration, and so regulatory oversight that
declared compliance represents true compliance is also key. I am advised that the
Care Quality Commission is looking to develop a tool that will assist inspectors to
assess how well a service responds to safety alerts as part of formal inspections.

Department
of Health

This work is at an early stage. However, it is an important development that has
obvious benefits to strengthening patient safety.

The 2016 Patient Safety Alert is the key response to addressing the concerns
around misplaced nasogastric tubes. I am advised that NHS Improvement is taking
additional actions to ensure its effectiveness. For example, NHS Improvement is
working with ‘Sign up to Safety’ to provide a series of webinars to support sharing
of local nasogastric resources and training materials. A video is also being
developed for promotion on social media designed to empower frontline staff who
have not been provided with relevant training by April 2017 to challenge their
managers and ask why this has not occurred.

You also addressed your recommendations to NHS England and my officials have
worked with them to understand what more can be done across the health system. I
am aware that Sir Bruce Keogh, NHS England Medical Director, has written to
you to outline the actions they are taking forward following discussion at Regional
Medical Director and Chief Nurse level. I hope this offers further assurance that
the concerns you have raised are taken very seriously and efforts are being made to
strengthen patient safety in this area. Particularly important is maintaining
awareness of the patient safety dangers at a high level and I am encouraged to see
that consideration is being given to highlighting this issue through professional and
commissioning routes via medical and nursing directors.

Further work with Health Education England and the Medicines and Healthcare
Products Regulation Authority will also be undertaken to explore if training and
product messaging can be strengthened.

Turning to your recommendation that we take steps to ensure research is
undertaken to identify a superior method of ensuring correct nasogastric tube
placement. The National Institute for Health Research (NIHR), funded by the
Department of Health, funds health and care research and translates discoveries
into practical products, treatments, devices and procedures, involving patients and
the public at every step. The NIHR ensures that the NHS is able to support
research funded by all public, charity and industry research funders, which in turn
encourages economic growth. The NIHR has, and continues to fund research into
methods of ensuring correct nasogastric tube placement.

For example, in November 2016, NIHR published the conclusion of a cost analysis
study into placement checks for nasogastric tubes:

https://discover.dc.nihr.ac.uk/portal/article/400049 1 /simple-bedside-check-for-

nasogastric-tube-positioning-is-cost-effective-and-prevents-deaths. The study
confirmed current guidance on nasogastric placement checks. However, the study

did conclude that while pH testing may be the most cost effective and comparable
to chest x-ray in terms of patient outcome, there remain some questions
surrounding the correct interpretation of test results. The study emphasised the
need to ensure that healthcare professionals have adequate support and training to
help minimise the risk of error regardless of the method of checking employed.

Further detail on this and other recent projects is enclosed with this letter which I
hope you will find helpful.

You will appreciate that there are challenges around demonstrating that any new
method is superior given the relative rarity in which there is a failure with current
methods. There are agreed routes through which NHS England can request further
research from the Department of Health and the NIHR in areas of identified
priorities.

In conclusion, I am advised that the challenge around improving patient safety in
this area is not the availability or appropriateness of national guidance, or the
effectiveness of current placement checks but rather their implementation. By
ensuring medical and nursing staff have the right competencies to undertake
procedures relating to nasogastric tube placement, NHS Trusts can ensure that
patient harm and deaths are avoided.

More broadly, it is essential that providers learn from all deaths due to problems in
care. In response to the CQC report, Learning, Candour and Accountability: A
review of the way NHS trusts review and investigate the deaths of patients in
England, the NHS National Quality Board has published the first edition of
National Guidance on Learning from Deaths. This provides guidance for
healthcare providers on reviewing and learning from the care provided to people
who die and introduces a requirement for Trusts to publish on a quarterly basis
from 2017-18 specified information on deaths, including estimates of how many
could have been prevented. We are also amending regulations to require Trusts to
summarise the published information in Quality Accounts from June 2018,
including evidence of learning and action as a result of that information and an
assessment of the impact of actions that a Trust has taken.

Finally, with regard to the North Cumbria University Hospitals NHS Trust, I am
advised that the Trust, under the leadership of the Medical Director, has developed

Department
of Health

an action plan to respond to your specific recommendations, as well as the
requirements for wider organisational learning it has identified as a result of its
review of the general matters of concern.

The Trust’s response and the actions it puts in place will be monitored by NHS
Improvement.

You will know the Trust came out of Special Measures on 29 March as a result of
the findings of a CQC inspection conducted in December 2016. This found that the
Trust had made a number of improvements, including to the Safe care domain.

The challenges facing the Trust in recent years are well known, including around
patient safety and care. However, the removal from Special Measures demonstrates
the progress the Trust has made to improve services and the quality of care. There
is more to do and improvements need to be embedded but there is some confidence
that the Trust is moving in the right direction.

Thank you for bringing the circumstances of Mrs Coulthard’s and Mr Parke’s
death to our attention. I hope this information is useful.

fy D—

PHILIP DUNNE

ae

Department
of Health

RESEARCH — METHODS FOR CONFIRMING NASOGASTRIC TUBE
PLACEMENT

Simple bedside check for nasogastric tube positioning is cost effective and
prevents deaths - A study on bedside checks for tube placement covered
recently by the NIHR Dissemination Centre — November 2016.

The study reviewed evidence on the effectiveness and cost effectiveness of
methods of tube placement. This cost utility analysis utilised three sources of
evidence to populate a decision tree model. Effectiveness data was gathered
from a systematic review and meta-analysis. Three studies were included on
chest X-rays, three on pH testing and three on the probability of obtaining a
sample for the pH test.

Quality of life patient outcomes were not covered in the literature, so were
calculated by asking 23 adult surgical patients to rate the imagined impact of
different nasogastric tube scenarios. These ranged from no complications to
serious complications. Cost information was obtained from current NHS prices
and staff costs.

The study was conducted with reference to healthcare in Scotland, but should be
applicable to the rest of the UK.

The study found that in adults who need a nasogastric tube for a short time, pH
testing was the best initial approach followed by X-ray confirmation if pH
testing wasn’t successful. pH testing was four times less expensive than X-ray
confirmation and when used in sequence both were cost effective uses of NHS
resources.

For further reading access the link below:
https://discover.dc.nihr.ac.uk/portal/article/400049 1/simple-bedside-check-for-
nasogastric-tube-positioning-is-cost-effective-and-prevents-deaths

A NIHR Horizon Scanning Centre report on a technology to help prevent
incorrect placement of tubes

The NIHR Horizon Scanning Centre examined the potential impact for a new
technology. The Kangaroo™ feeding tube with IRIS technology was being

developed by Covidien Commercial Ltd, to help with nasogastric tube
placement. The tube is a small-opening single use, disposable feeding tube
which has an integrated real-time imaging system (IRIS) in the form of a 3mm
camera to visually aid its placement. It was launched in the UK for research use
in 2014, followed by a full NHS clinical launch in 2015.

For further reading access the link below:

aid-in-nasogastric-tube-placement/

NIHR Diagnostic Evidence Cooperative London (DEC) - a new test for tube
placement (in conjunction with a Biomedical Catalyst Award)

The NIHR DEC based at Imperial College, London and Scottish SME Ingenza
are collaborating to study and design a novel enzyme-based test for the accurate
positioning of nasogastric tubes. The evidence generation and assessment of the
new enzymatic test is being carried out using diagnostic toolkit methodology
developed at the DEC. Multi-modality and systemic approach will guide
evidence generation. The DEC London is providing the infrastructure for the
study with NIHR health economists performing the required economic analysis.

For further reading (p.70) access the link below:
https://www.google.co.uk/url?sa=t&rct=|&q=&Kesrc=s&source=web&cd=5&ve
d=QahUKEwiX296xgqnSAhXLIsAKHd7_C_80FggIMAQ&url=https%3A%2
F%2Foxford.dec.nihr.ac.uk%2Freports-and-resources%2Fdec-workshop-2015-
presentations%2Fravi-chana-funding-for-diagnostic-test-
development.pdf&usg=AFQ)|CNFGTOS4wt0fKRPd5Ohg7Ozyj6hyjA.

NIHR Invention for Innovation Grant funding for Location-Indicating
Naso-gastric Tube (NGT) University of Hull (£667,542 Contract ended 2016)

Feeding through a tube passed through the nose into the stomach is very widely
used. Most doctors and nurses think it is the best method of feeding patients of
all ages who cannot feed normally and the procedure may be taught to patients
and carers. Tubes currently used cannot indicate the position in which they have
been placed and up to | in 5 of are incorrectly placed. Tubes wrongly placed in
the gullet can cause irritation and prevent absorption and if placed in the
windpipe or lungs there can be serious complications. The University of Hull
are developing a new tube which is reliable, sensitive and effective in ‘telling’
the doctor, nurse or carer where they placed the tube ensuring greater safety and
reduced distress to patients and carers.

ae

Department
of Health

Currently, finding where a tube has been placed involves sampling stomach
contents to make a measurement. The new Hull tube can give a measurement at
any time without doing this and is quicker, easier, safer and cheaper than
present methods.

Prototypes have shown that the new tube works. It has a ‘stripe’ on the tip
which is chemically sensitive to stomach contents. The ‘stripe’, sends a signal to
an indicator outside the body which tells the carer that the tube is or is not in the
stomach. If approved by the regulators, the Hull tube will be sold to the NHS
and worldwide. It will take away the distress and harm of wrongly placed

tubes.

Response from North Cumbria University Hospitals Trust (PDF)

Executive Office  
North Cumbria University Hospitals NHS 
Trust  
Cumberland Infirmary 
Carlisle 
CA2 7HY 

Direct Tel:  (01228) 814010 

Email: 

Our Ref: RD/SE/REG28NGT 

15 March 2017 

Mr David Roberts 
Her Majesty’s Senior Coroner 
Fairfield  
Station Road 
Cockermouth  
CA13 9PT 

Email: hmcoroner@cumbria.gov.uk  

Dear Mr Roberts 

RE:  REGULATION  28  REPORT  –  MICHAEL PARKE AND AMANDA COULTHARD 
(DECEASED) 

Further to the Regulation 28 Notice issued to the Trust on 18 January 2017, I am writing 
with our response to the actions you have requested.   

It  is  important  to  outline  that  the  preparation  and  review  of  our  response  has  been 
discussed in detail at a dedicated development session with the Trust Board.  Whilst 
there  is  very  specific  learning  for  us  in  relation  to  caring  for  patients  who  require 
Nasogastric tubes to be inserted safely, equally there is significant learning for us as an 
organisation in general terms, which both the Executive and Non Executive Directors of 
the Trust have collectively reflected on.  

Attached to this letter is a report summarising the action we have taken against the five 
specifc  actions  in  your  Regulation  28  Notice.    We  have  also  summarised  additional 
actions that we have identified and will implement over the next 12 months. Progress 
against  the  delivery  of  this  plan  and  compliance  with  the  updated  Nasogastric  Tube 
Policy will be included in the Trust’s Internal Audit Plan for 2017/18.  This is to ensure that 
independent assurance on the delivery of the plan and implementation of the policy can 
be provided to the Trust Board.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 2 

I will be reporting this action plan to the public Board meeting in March 2017, please do 
let me know if you have any concerns regarding this. In addition to this, we are in the 
process of contacting the families of Michale Parke and Amanda Coulthard in order to 
include  a  personal  comment  from  them  in  the  organisational  breifings  which  will  be 
holding in April 2017 to share the learning from these tragic Never Events.  

If you require any further information please do not hesitate to contact me.  

Yours sincerely  

Stephen Eames 
CHIEF EXECUTIVE & STP LEAD FOR  
WEST, NORTH & EAST CUMBRIA 

Enc  

CC: Trust Inspection Manager – Care Quality Commission

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