Prevention of Future Deaths reports · 2018

Sharon Grierson

Regulation 28 report to prevent future deaths, reference 2018-0034, written 25 Jan 2018. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report25 Jan 2018
Reference2018-0034
DeceasedSharon Grierson
CoronerDavid Roberts
Coroner areaCumbria
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedNorth Cumbria University Hospitals NHS Trust · Cumbria Partnership NHS Foundation Trust
Sourcejudiciary.uk record · original PDF
Responses published2

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

THIS REPORT IS BEING SENT TO: The Chief Executive, North Cumbria University Hospitals NHS Trust
{‘The Trust’)

The Secretary of State for Health, London.

CORONER

lam Mr David Llewelyn Roberts Senior Coroner for County of Cumbria

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.

http://www. legislation.gov.uk/ukpga/2009/25/schedule/S/paragraph/7

http://www. legislation.gov.uk/uksi/2013/1629/part/7/made

INVESTIGATION and INQUEST

On 15/12/2016 | commenced an investigation into the death of Sharon Rose Grierson. The investigation
concluded at the end of the inquest 23rd January 2018. The conclusion of the inquest was On 11th
November 2016 the deceased underwent elective surgery at the Cumberland Infirmary Carlisle to
remove a polyp from her vocal cords under general anaesthetic. The procedure was uneventful. It was
decided to extubate her whilst still under the effect of anaesthetic, in the process of which she went into
laryngospam. Muscle relaxant was administered and she was re-intubated, it was believed, via the
trachea. Shortly afterwards she had a cardiac arrest. Assistance had already arrived. Capnography
readings showed the absence of exhaled carbon dioxide. In the process of introducing an oro-gastric tube
the endotracheal tube, which was found to be in the oesophagus was removed and replaced. The
capnograph continued to show abnormal readings, notwithstanding effective and continuous cardio-
pulmonary resuscitation. The position of the tube was checked by bronchoscope and was, again, found
to be in the oesophagus. It was re-sited. Clinicians had not appreciated that there had, twice, been
oesophageal intubation despite the capnography readings. She died on 14th November 2016 as a
consequence.

Cause of death:

1a) Global Ischaemic/Hypoxic Brain Injury

b) Unrecognised Oesophageal Intubation following Extubation after operation to remove Benign Vocal
Cord Polyp.

Conclusion:

Died following surgery as a result of being deprived of oxygen due to endotracheal tubes being
incorrectly placed on two consecutive occasions.

CIRCUMSTANCES OF THE DEATH

A 44 year old female who attended CIC for short routine elective laryngoscopy for a small lesion on her
larynx.

During the process the patient needed to be intubated. After the procedure she went into laryngospasm
and subsequently endotrachael tubes were inserted into her oesophagus twice instead of her trachea.

This led to hypoxic brain injury.

During the course of the incident which lasted about one hour the deceased was attended by four
consultant anaesthetists, two other doctors and trained theatre staff. By the time the error was rectified
it was too late. This death could have been avoided.

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) There was a lack of appreciation of what the capnography was indicating and some lack of
understanding of the trace one might expect to see during CPR.

(2)There was a lack of co-ordination and situational awareness.

(3)It became apparent that senior staff often have little experience of crisis situations and there is a
danger that they become ‘de-skilled’ to some extent as a result.

ACTION SHOULDBETAKEN. SSCS;7;7;7 }PT Ft!!! ——

In my opinion action should be taken to prevent future deaths and | believe you have the power to take
such action.

The Trust; To ensure that all relevant staff are provided with training in ‘simulation suites’ or other
facilities to drill, refresh and enhance their skills to enable them to deal clearly and logically in crisis
situations. This will inevitably mean ‘protected’ time away from clinical duties with regular refresher
courses.

Nationally: It appears likely that the problems which contributed to this death may well be replicated

elsewhere in the country. There are also likely to be centres of excellence which could provide models,
mentoring and support to other Trusts so that good practice is disseminated.
YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this report, namely by 26"
March 2018. 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:-
-daughter

sister
mother

| have also sent it to Dr J Brown, Dr B Norman and the press who may find it useful or of interest.

tam 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.

25/01/2018

Mr David Llewelyn Roberts Senior Coroner County of Cumbria

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)
we From Caroline Dinenage MP

Minister of State for Care
Department
of Health 30 Victor tan
Your Ref: DLR/LG/30523 SWwiH OEU

020 7210 4850
_ Our Ref: PFD-1118948

Mr David Roberts
HM Senior Coroner — Cumbria
HM Coroner's Office 27 MAR 2018
Station Street
Cockermouth CA13 9PT

Deo Oy Beeld,

Thank you for your letter of 5 February to the Secretary of State about the death of
Mrs Sharon Rose Grierson. I am responding as Minister with responsibility for
hospital care and patient safety.

I was extremely saddened to read of the circumstances surrounding Mrs Grierson’s
death. Please pass my condolences to her family and loved ones. I can only imagine
how difficult a time this must be for them.

Your report raises several areas of concern which I address below. Although not
mentioned in your report, I understand my officials received clarification that you
also wish consideration be given as to whether undetected oesophageal intubation
should be introduced as a ‘Never Event’ given the apparent effectiveness of
capnography. My response will also address this point.

I am aware that similar concerns have featured in a recent Regulation 28 report,
namely that issued by Her Majesty’s Assistant Coroner for Cambridgeshire and
Peterborough following the inquest into the death of Mr Peter Saint, available at
https://www.judiciary.gov.uk/publications/peter-saint/. Mr Saint sadly died in
notably similar circumstances where the significance of capnography readings were
mistaken. Clinicians thought the absence of a proper CO2 end tidal wave was
explained by the patient being in cardiac arrest, while it can be accounted for by
oesophageal intubation and not cardiac arrest, unless there are exceptional
circumstances or technical fault.

That report was issued to the Royal College of Anaesthetists, among others, and my
officials have liaised with the Royal College on this reply.

The use of capnography is widespread in the NHS. The Royal College’s Guidelines
for the Provision of Anaesthetic Services (GPAS) set the national standards for

~ anaesthetic care across the service. The Guidelines recommend the absolute need to

use capnography for any patient with a tube, supraglottic airway device or having
deep sedation, wherever they are (GPAS ref 5.2.39 + 41) and reference the AAGBI’s
Standards of Monitoring 2015 which states that, capnography monitoring is essential
at all times in patients with tracheal tubes, supraglottic airway devices and those who
are deeply sedated.

The Royal College runs an accreditation process, Anaesthesia Clinical Services
Accreditation where accreditation is awarded against the standards derived from the
Guidelines. Further, trainee anaesthetists are taught the essential role of capnography
to recognise and treat immediate complications of induction, including a misplaced
tube.

I am advised that since the introduction of the widespread use of capnography, failure
to recognise tracheal tube misplacement is extremely unusual.

However, a report published by the Royal College of Anaesthetists and the Difficult
Airway Society in 2011 (Major Complications of Airway Management in the UK,
available at www.rcoa.ac.uk/node/4211), commonly known as NAP4, raised the
issue of misinterpretation of capnography in the face of situations such as peri-arrest
or cardiac arrest.

NAP4 is clear that a flat capnograph indicates lack of ventilation of the lungs: the
tube is either not in the trachea or the airway is completely obstructed, and that ...this
applies equally in cardiac arrest as CPR leads to an attenuated but visible expired
carbon dioxide trace. NAP4 recommended the training of all clinical staff include
interpretation of capnography and recognition of the abnormal (but not flat)
capnography trace during low cardiac output states and during CPR.

The Royal College, the Association of Anaesthetists of Great Britain and Ireland
(AAGBI) and the Difficult Airway Society (DAS) have raised the following concern:
Despite the emphasis placed upon the continuing presence of exhaled carbon dioxide
during resuscitation from cardiac arrest in resources such as NAP4 and the Advanced
Life Support programme (run by the Resuscitation Council UK), there are still
clinicians holding senior positions in anaesthesia in the NHS who are unaware of this
important fact.

ey

| Department
of Health

In the response to the Regulation 28 report issued in late 2017 following the Inquest
into the death of Mr Peter Saint, I am advised that the Royal College, the AAGBI and
the DAS agreed to take the following action:

e bringing this to the attention of all trainees in anaesthesia in the UK, to all
Fellows and members of the Royal College, to all members of the AAGBI and
all members of the DAS — and thereby to the overwhelming majority of
practising anaesthetists in the NHS — the publication of an article on this
subject in the Patient Safety Update published quarterly by the Safe
Anaesthesia Liaison Group, highlighting the issue in a Safety Matters article in
Anaesthesia News and in the DAS newsletter;

e bringing this to the attention of the Royal College and DAS Airway Leads that
are present in every NHS trust at a national Airway Leads meeting on 15
March 2018 and inviting feedback on areas for improving training; and

e asking those charged with providing the Royal College’s online educational
programme (e-learning for Anaesthesia) to consider highlighting this issue in
sessions on tracheal intubation, capnography and resuscitation.

Alongside these actions is the proposed new Never Event for undetected oesophageal
intubation. Never Events are defined as Serious Incidents that are wholly preventable
because guidance or safety recommendations that provide strong systemic protective
barriers are available at a national level, and should have been implemented by all
healthcare providers.

It is important to note that undetected oesophageal intubation did not feature as a
Never Event in the framework that was in place at the time of Mrs Grierson’s death.
As you may be aware, the Never Events Framework and list of Never Events were
revised and published on 1 February 2018. A new Never Event proposed as part of
this consultation was ‘undetected oesophageal intubation’.

I am advised by the Royal College that while there is a strong systemic barrier to
failure to use capnography (AAGBI, Standards of monitoring during anaesthesia and
recovery 2015), there is not a strong systemic barrier to prevent misinterpretation of
the capnography waveform.

NHS Improvement is therefore working with relevant national organisations,
including the Royal College, the AAGBI and the British Association of Paediatric
Nephrology (the Renal Association) to develop the national guidance required to
support this proposed Never Event.

NHSI will consider the best routes to share this guidance, once developed, as well as
introducing the Never Event. I hope this clarification is helpful.

Turning to your comments in the report around dissemination of good practice and
the importance of simulation-based education, I would like to reassure you that much
is being done in this area.

The Royal College strongly supports such education, running a regular programme of
training in ‘non-technical skills’ and a working group providing guidance on
simulation of clinical crises. The requirement for human factors training is included
in the Royal College’s exam curricula and its Guidelines for the Provision of
Anaesthesia Services. In addition, Anaesthesia Clinical Services Accreditation
standards include the requirement for regular multidisciplinary team training.

Perioperative emergencies, which should include crisis training, features on the Royal
College’s Continuing Professional Development (CPD) matrix which is used to
assess continuing professional development for revalidation for consultants. For
anaesthetic trainees, in several schools of anaesthesia, simulation training is a
mandatory annual requirement in order to pass the ‘Annual Review of Competence
Progression’. The Royal College’s CPD matrix includes recommendations that all
staff needing revalidation have education on emergency management and
resuscitation as well as education on human factors in anaesthetic practice.

The Royal College has taken the following steps to support the NHS in this area:

e consideration of the creation of guidance on how departments of anaesthesia
can introduce regular crisis simulation for operating theatre teams;

e working with the AAGBI to promote regular multi-disciplinary crisis
simulation through the forthcoming publication of the Quick Reference
Handbook, a series of national guidance documents on the management of
emergency situations in anaesthetic practice; and

e working with the DAS which has set up an expert working group looking
specifically at human factors in airway management to address the non-
technical aspects in the management of tracheal intubation and difficult
airways.

More generally, Health Education England (HEE) advises that simulation-based
education is available nationally, though in varying amounts and to varying degrees
of success on a multi-professional and inter-disciplinary basis. There are pockets of
excellence across the country and HEE is hoping to harness and share these
examples.

aw

Department
of Health

A strategy to enable access and better delivery across the country was initiated by
HEE in September 2017. This aims to encourage the provision of simulation-based
education through the sharing of best practice, consistency of approach and delivery
and promoting equity of access and value for money across the range of learners in
health and social care. Due to the different demographics across the country,
simulation-based education needs to be locally led and delivered (i.e. through the
multi-professional Postgraduate Deans and directors in each local area).

Simulation is used across many professions, and is becoming increasingly utilised as
its strengths in providing safe practice for both patients and learners alike become
more recognised. It is predominantly utilised in postgraduate medical training for
trainee doctors, dentistry and nursing. However, it is becoming increasingly utilised
in multi-disciplinary scenarios - particularly involving simulated patients, which will
include a range of users - from medical to social-care practitioners.

HEE is engaged with the Nursing and Midwifery Council and other healthcare
professionals and learning establishments to see how there could be a unified
approach to simulation-based education in the future and how the implementation of
the HEE strategy might be best utilised.

You may be aware that in the North East region, a Faculty of Patient Safety was
established some three years ago in order to support a region-wide collaborative,
multi-professional approach to simulation, which has been noted to be good practice
by the General Medical Council. The North Cumbria University Hospitals NHS
Trust is a member.

With regard to centres of excellence, all anaesthetic centres that have simulation
centres should be able to provide crisis training. All hospitals with anaesthetic
trainees are connected to ‘schools of anaesthesia’ that help manage trainee rotations,
training, education and pastoral care.

North Cumbria is part of the Northern School of Anaesthesia and Intensive Care
Medicine (www.nsaicm.com/about/) which includes Newcastle, Gateshead, North
Tees and Northumbria Hospital trusts. All four of these trusts have simulation
facilities and form the North East Simulation Network (northeastsimulation.co.uk/).

NHS Improvement views these centres as ‘expert centres’ where knowledge on crisis
situations and human factor training can be disseminated.

Finally, with regard to the regrettable circumstances around Mrs Grierson’s death — I
am advised that the Trust has in place an action plan that includes measures to ensure
there are clear departmental guidelines based on the DAS’s guidance; and ensure that °
all relevant staff will undergo emergency scenario training and simulation, including
human factors training for difficult airway management in emergency situations.

I am further advised the Trust will be developing emergency simulation training more
generally and measures will be taken to strengthen leadership in emergency
situations.

Learning lessons where things have gone wrong is essential to ensuring the NHS
provides safe, high quality care and I am encouraged to see the Trust taking these

steps.

Iam mindful that you issued a Regulation 28 report in January 2017, following the
conclusion of inquests into the deaths of Ms Amanda Coulthard and Mr Michael
Parke involving the misplacement of nasogastric tubes. As you may know, the Care
Quality Commission (CQC) conducted a responsive unannounced inspection into
nasogastric tubing at the Trust in July 2017 to assess the safety of current practices
and progress in delivering the action plan identified in response to the concerns you
raised. I am advised that inspection also included consideration of the incident
involving Mrs Grierson and that CQC was assured that the Trust was taking
appropriate action.

The CQC continues to monitor the Trust, alongside its commissioners.

I hope this reply is helpful. Thank you for bringing the circumstances of Mrs
Grierson’s death to our attention.

of

CAROLINE DINENAGE MP
MINISTER OF STATE FOR CARE
cc: Mr Sean Horstead, HM Assistant Coroner for Cambridgeshire and Peterborough
Response from North Cumbria University Hospitals NHS Trust (PDF)
NHS;

Cumbria Partnership
NHS Foundation Trust

Your Reference: DLR/LG/30523
Our Ref: SE/JLS

Date: 22 March 2018

NHS

North Cumbria
University Hospitals
NHS Trust

Executive Offices:
Voreda House
Portland Place

Private and Confidential Penrith
Mr D.L.I. Roberts CA11 7QQ
H.M Senior Coroner
Fairfield Cumberland Infirmary
Station Road Carlisle
Cockermouth CA2 7HY
Cumbria

Email:
Dear Mr Roberts

Inquest into the death of Sharon Rose Grierson

| am writing in response to your letter dated 5" February 2018, issued under Regulation 28 and
pertaining to the death of Sharon Rose Grierson. The Trust has noted the points you raised during
the inquest and which you subsequently highlight within the Regulation 28 report. In particular those
issues which you raise as matters for concern, namely;

e There was a lack of appreciation of what the capnography was indicating and some lack of
understanding of the trace one might expect to see during CPR.

e There was a lack of co-ordination and situational awareness.

e [tbecame apparent that senior staff often had little experience of crisis situations and there
is a danger that they become ‘de-skilled’ to some extent as a result.

Further, the actions which you require the Trust to take in order to prevent future deaths, are as
follows;

e To ensure that all relevant staff are provided with training in ‘simulation suites’ or other
facilities to drill, refresh and enhance their skills to enable them to deal clearly and logically
in crisis situations. This will inevitably mean protected time away from clinical duties with
regular refresher courses.

Action already taken

As you are aware, the Serious incident investigation into this matter identified that all relevant staff
should undergo emergency scenario training and simulation including human factors training for
difficult ainvay management in emergency situations. The investigation also recommended that
there should be opportunities for multi-disciplinary teams to train together within simulated scenarios
to practice technical and non-technical skills. This was with a view to team training scenarios
reinforcing local clinical guidelines. Work has therefore already been underway prior to the inquest
to implement this recommendation from the action pian.

In particular, the Trust has in place a classroom located within the Education Centre that is used for
simulation. The facilities currently available are primarily for the use of Newcastle University Medical
Students. Teaching sessions are run by qualified medical staff with specific allocated delivery slots
within their agreed job plans. Additionally, a Simulation Trainer assists in the running of the teaching
sessions and also is responsible for upkeep and preparation of the required equipment.

The facilities are also available for use by clinical departments and speciality services to run
simulation sessions identified within their training programme. Following this incident, the suite has
been utilised specifically to provide training in relation to difficult airway management in emergency
situations. This training has been delivered in February 2017 and February 2018. The training
sessions were jointly led by ENT and Anaesthetic Consultants combining airway scenario and
practical emergency front of neck access skills.

There has also been a multidisciplinary paediatric emergency simulation session run in operating
theatres, led by the regional paediatric retrieval team — NECTAR.

Further action to be taken

The Trust recognises that simulation based training is a powerful educational tool that allows the
acquisition of knowledge, skills and attitudes at both individual and team-based levels in a safe and
educational environment. Further, the Trust acknowledges that improved patient care can be
achieved through the promotion of efficient, co-ordinated dissemination of learning across
specialities and professions.

In light of that, a business case has been developed and approved in principle by the Trust to invest
in equipment and a team to deliver simulation training for critical incident scenarios to whole teams
within their clinical areas. The training would be provided by the Trust to full teams, and this training
would complement that provided by Medical Education for undergraduates with the opportunity for
sharing of resources. It is envisaged that further equipment including two manikins would be
procured and a dedicated teaching area and storage developed. In addition, a Simulation Trainer
will be appointed to specifically oversee post-graduate simulation training and will work alongside
the current Simulation Trainer Lead. A Consultant Lead will also be appointed and have time
allocated within their job plan to oversee this.

It is acknowledged that the introduction of this plan will take time and it is proposed that
arrangements are made to enable training to be commenced by December 2018. Training will be
targeted to critical areas such as theatres initially, with a view to early roll-out across the Trust to
follow.

The benefits of this investment have been identified as follows:

Benefits

. Offer critical incident simulation training to full teams in clinical areas.

. Devoted team and equipment prioritised for postgraduate staff.

° Ability to provide above training on both hospital sites.

° Improved resilience of both simulation suite and clinical area simulation training.

. Ability to offer paediatric simulation.

. More realistic simulations and ability to improve ergonomics of clinical areas by
running “real time” scenarios and testing layouts.

. Improved working across departments as simulation/scenarios develop, for
example involving laboratory services in appropriate scenarios.

. As team develops there are many areas with potential to benefit from training, so
scope for rollout is extended to other acute areas

In addition to the internal training, the Trust is already represented on the Patient Safety Faculty of
Health Education England (HEE), and links with the Human Factors and Simulation group that form
part of the work-streams of the faculty. As part of building and promoting a stronger safety culture
within the Trust, there are plans in place to develop a Patient Safety Faculty for the North Cumbrian
health economy mirroring that of the HEE in the North East. This group will be responsible for
enhancing educational opportunities and support initiatives across the North East and North
Cumbria services ensuring that our training for postgraduate simulation remains in line with the rest
of the region, and national best practice guidance. Further, it provides a mechanism through which
the Trust can raise the issues identified during the inquest and ensure they are taken forward
through the national network so that others may benefit from the learning acquired.

I trust this update on the current situation will provide you assurance that ongoing action is being
actively undertaken to explore and implement any lessons that can be learned from this tragic
event. | also want to assure you that we at the Trust take very seriously our responsibilities for
providing safe and effective care in all areas of our services.

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

Yours sincerely

Stephen Eames

CHIEF EXECUTIVE

NORTH CUMBRIA UNIVERSITY HOSPITALS NHS TRUST &

CUMBRIA PARTNERSHIP NHS FOUNDATION TRUST
& IHCS LEAD FOR WEST, NORTH & EAST CUMBRIA

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