Prevention of Future Deaths reports · 2015

Stanley Oliver

Regulation 28 report to prevent future deaths, reference 2015-0281, written 16 Jul 2015. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report16 Jul 2015
Reference2015-0281
DeceasedStanley Oliver
CoronerAlan Walsh
Coroner areaManchester (West)
CategoryHospital Death (Clinical Procedures and medical management) related deaths
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 (1)

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

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

1. Mr Jeremy Hunt MP, Secretary of State for Health
2. Mr David Dalton, Chief Executive, Salford Royal NHS Foundation Trust.

1 | CORONER

I am Alan Peter Walsh, HM Area Coroner , for the Coroner Area of Manchester
West

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.

INVESTIGATION and INQUEST

On 22™ August 2014 I commenced an Investigation into the death of Stanley
Oliver, 85 years, born 6" October 1928. The Investigation concluded at the end
of the Inquest on 6" July 2015.

The medical cause of death was 1a) Multi Organ Failure 1b) Sepsis
1c) Perforated Gall Bladder 2) Neutropenia due to Tuberculosis of the Bone
Marrow.

The conclusion of the Inquest was Natural Causes.

CIRCUMSTANCES OF THE DEATH

1. Stanley Oliver died at the Salford Royal Hospital, Eccles Old Road,
Salford on 14 August 2014.

2. Mr Oliver was admitted to the Salford Royal Hospital on Saturday 2
August 2014 with abdominal pain and a CT scan revealed a perforated
gall bladder. Mr Oliver was referred to the surgical team and the on call
surgeon felt that surgical intervention represented too high a risk to Mr
Oliver’s life and that the better course of action would be intravenous
fluids, antibiotics and the placement of a radiological drain. The Surgeon
referred Mr Oliver to the on call Radiologist to consider the placement of
a percutaneous cholecystostomy drain to drain the gall bladder over the
weekend and Mr Oliver did not respond to the medical treatment.

3. The percutaneous cholecystostomy is an interventional radiology
procedure to place a drainage tube into the lumen of a gall bladder using |

either ultrasound or CT guidance and a_ conscious sedation/local |
anaesthetic. The indication is usually to drain a distended, severely
inflamed/pus containing gall bladder, which has not perforated. The
Radiologist described the CT findings as indicating an already perforated
gall bladder, which was therefore not very distended and would be
difficult to drain. Furthermore the Radiologist told the Consultant
Surgeon that he was unable to drain the gall bladder as he did not have
the competence to perform the procedure.

4. The evidence at the Inquest was that all the gall bladder drainage was
performed by gastro-intestinal (GI) Radiologists. There are four GI
Radiologists at the Salford Royal Hospital but there is no on call rota in
relation to the Radiologists, although it was accepted practice within the
Radiology Department to request a clinical Consultant to contact one of
the Radiologists direct with a view to performing the procedure out of
hours. No contact was made with any of the GI Radiologists and a drain
was not inserted until Monday 4" August 2014 when one of the GI
Radiologists inserted a drain outside the gall bladder.

5. Mr Oliver continued to be treated with antibiotics and intravenous fluids
and the drain was found to be operating successfully from the 4" August
2014 but Mr Oliver subsequently deteriorated and died on the 14"
August 2014.

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. During the Inquest evidence was heard that:

i. There was no on call rota for a GI Radiologist to perform a
percutaneous cholecystostomy out of hours and particularly over
a weekend. The Hospital Trust indicated that a risk had been
identified in relation to the unavailability of GI Radiologists out of
hours and the Hospital that managed the risk by allowing the GI
Radiologist to be contacted out of hours but the Trust accepted
that there was no provision for the Radiologist to be available out
of hours.

ii. The Consultant Surgeon gave evidence at the Inquest that
availability of a GI Radiologist to perform a percutaneous
cholecystostomy was critical to the management of a patient and
he raised concerns that there would be a risk to life if a
percutaneous cholecystostomy could not be performed out of
hours, either overnight or over a weekend.

I accepted evidence at the Inquest that the Salford Royal NHS
Foundation Trust were considering actions to make GI Radiologist
available out of hours and to establish a system for any
Radiologist to contact a GI Radiologist our of hours for
procedures to be conducted out of hours. However there was no
confirmation that an out of hours on call rota was being
considered for GI Radiologists either within the Salford Royal NHS
Foundation Trust or for a rota to relate to a wider area covering
several other hospitals on the basis that an available Radiologist
could travel to different hospitals to carry out a necessary
procedure out of hours.

Evidence was given at the Inquest that the unavailability of GI
Radiologists was not limited to Salford but was a national
problem in that there were very few out of hours on call rotas for
GI Radiologists in hospitals in the United Kingdom.

It was accepted that a perforated gall bladder was a recognised
condition, which occurred on a regular basis as an emergency
presentation to hospital. In some cases surgical intervention
would not be appropriate and an alternative treatment plan
would involve the insertion of a percutaneous cholecystostomy
drain or a drain to be inserted outside the gall bladder, both of
which would require insertion by a GI Radiologist.

The evidence raised concerns that there is a risk of future deaths
will occur unless action is taken to review the above issues.

2. I request you to consider the above concerns and to carry out a review
with regards to the fact

The availability of GI Radiologists out of hours to perform
procedures crucial to the management of the patient, including
the provision of out of hour’s rotas either within a single Hospital
Trust or a rota as between hospitals in a group of Hospital
Trusts.

The provision of an out of hour's rota as referred to in 2.i, above
within Salford Royal NHS Foundation Trust

The provision of procedures and protocols in relation to the
availability of GI Radiologists out of hours and a definitive line of
communication whether it be as between Radiologists or by
clinical Consultant direct to GI Radiologists to discuss and
arrange a procedure out of hours.

The training of health professionals in relation to the availability
of GI Radiologists out of hours including training in relation to the
procedures and protocols established in support of out of hours
availability.

ACTION SHOULD BE TAKEN

In my opinion urgent action should be taken to prevent future deaths and I
believe you and/or your organisation have 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 10" September 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. |

COPIES and PUBLICATION

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

1) EE Mr Oliver's son
2) EE Mr Oliver's son

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.

Dated Signed

16" July 2015 Alan Peter Walsh

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)
From Ben Gummer MP
Parliamentary Under Secretary of State for Care Quality

De partm ent Richmond House

of Health 79 Whitehall

SW1A 2NS

POCS 948085 Tel: 020 7210 4850
Mr A-gWalsh 03 SEP 2015

Area Coroner

Coroner’s Office

First Floor, Paderborn House
Howell Croft North

LA mae

BLI 1QY

Thank you for your letter of 16" July 2015 following the inquest into the death of
Stanley Oliver. I was very sorry to hear of Mr Oliver’s death and wish to extend my
sincere condolences to his family.

Your concerns in this case focus on the unavailability of gastro-intestinal (GD)
Radiologists out of hours (ooh) at the Salford Royal Hospital (SRH) NHS Foundation
Trust and the lack of any ooh rotas to ensure that crucial procedures can be carried out
on patients ooh and at week-ends.

I note that your letter has been sent to the SRH Trust and I would expect the Trust to
fully address these concerns.

You also reveal that the unavailability of ooh GI Radiologists was identified as a
national problem at the inquest where evidence showed that there were very few ooh
on call rotas for GI Radiologists in UK hospitals.

You have therefore asked that we review and consider the following:-

availability of ooh GI radiologists to perform crucial procedures;

e provision of ooh rotas within a single Hospital Trust or within a group of
Hospital Trusts;

e provision of procedures and protocols to ensure availability of ooh GI
Radiologists ; and,

e related training of health professionals in any such procedures and protocols
that are established.

Firstly, I would like to advise that the setting of curricular and standards of training for
health professionals is the responsibility of the regulatory bodies. In addition, the
actual provision of ooh rotas and procedures to ensure availability of radiologists, and
the training of staff in such protocols, is a matter for each local NHS Trust.

In order to address your remaining concern, about the availability of ooh GI
Radiologists nationally, my officials have liaised with NHS England and Health
Education England (HEE) and can provide the following information.

NHS England has advised that both Interventional Radiology (IR) and Gastrointestinal
(GI) Radiology are available in UK hospitals.

Gastrointestinal Radiology provides examinations for the gastrointestinal tract, plus
advanced examinations for swallowing disorders and incontinence. GI radiologists
also undertake interventional procedures involving the liver and GI tract such as
drainage procedures for abscesses or obstruction of the liver, Interventional Radiology
(IR) refers to a range of techniques which rely on the use radiological image guidance
(X-ray fluoroscopy, ultrasound, computed tomography [CT] or magnetic resonance
imaging [MRI]) to investigate disease and target therapy precisely. Most IR treatments
are minimally invasive alternatives to open and laparoscopic (keyhole) surgery.

The procedure outlined in this case could have been undertaken by either GI or IR
radiologists.

IR is important as it provides an essential and often life-saving service and patients
who need it should be able to access IR safely, seven days a week. Whilst I can
confirm that there are far fewer GI than IR radiologists available, there is no centrally
collected data on the availability of GI radiologists either in or out of hours.

Data that has been collected concerning availability of the service is published in the
latest fourth survey of IR provision in English Trusts, carried out in 2014 by NHS
Improving Quality. The survey shows that, as yet, not all patients have seven day
access to IR in the most effective way and a number of hospitals depend on informal
and ad-hoc arrangements to deal with their out-of-hours emergencies. However, NHS
England has been working with the British Society for Interventional Radiology
(BSIR) to improve access to interventional radiology across England in recent years.

Furthermore, in 2013 ten clinical standards for seven day services were developed by
the NHS Services, Seven Days a Week Forum, based on guidance developed by
Medical Royal colleges and Specialist Societies.

http://www.england.nhs.uk/ourwork/qual-clin-lead/7-day-week/
http://www.england.nhs.uk/wp-content/uploads/20 1 3/12/clinical-standards|.pdf

These standards describe the quality of services that patients admitted through urgent
and emergency routes should expect on every day of the week. One standard requires
that hospital inpatients must have 24 hour access, seven days a week, to consultant-
directed interventions, including interventional radiology, either on-site or through
formally agreed networked arrangements with clear protocols.

In July 2015, NHS England, Monitor and the Trust Development Authority (TDA)
wrote to Trusts asking them to provide information about the extent to which they are
delivering services in line with four of the clinical standards that are expected to have
the most impact on mortality. One of these is Clinical Standard 8, on Consultant-
Directed Interventions. By the end of September 2015 NHS England aim to have a
Trust by Trust picture of whether the requirements of the standard are being met
which will enable them to offer further support for improvement where needed.

HEE was established to help improve the quality of care delivered to patients by
ensuring that our future workforce is available in the right numbers with the right
skills, values and competencies to meet patient needs today and tomorrow.

HEE is currently working with key partners to ensure that the NHS has available the
right number of trained staff to deliver the current and future demand for diagnostic
tests. In particular, HEE will ensure the availability, for example, of sufficient
endoscopists to deliver bowel scope screening, while taking account of the wider
diagnostic service. In support of this, HEE is setting up a diagnostics workforce
steering group, to be chaired by Professor Liz Hughes, Director of Education and
Quality, to provide overarching governance.

In June 2014, the Centre for Workforce Intelligence (CfWI) was commissioned by the
Department of Health (DH) and HEE to gather evidence on possible shortage
occupations within the healthcare sector in England. A review of the Shortage
Occupation List (SOL) was completed by the Migration Advisory Committee (MAC)
and in April 2015, radiologists were added to the SOL.

The number of posts advertised in any specific year is dependent on the number of
trainees successfully completing their training and thereby releasing their National
Training Numbers (NTN) and post for a new trainee to fill. Reductions in recruitment
numbers in a specific year in no way indicate, on their own, a reduction in the volume
of training being commissioned. Over the last two years HEE has increased the
number of training places available in radiology and in 2015, 212 training posts were
advertised across England with a 100 per cent fill rate. Included in this number were
16 new posts that were established as part of HEE’s expansion in the specialty.

At the last validated stocktake there were 952 clinical radiology trainees in England
with a further 61 trainees on a break from training due to maternity leave or ‘Out of
Programme’ learning or research experience. With a 5 year programme, 952 would
indicate an average output / intake of 190, although some delays and extensions to
training will lower this average number.

This level of training has enabled the consultant radiology workforce to grow by over
70 full time equivalent (fte) posts a year between 2009 and 2013 (from 2278 to 2561
fte).

HEE’s proposed education and training commissions for 2015/16 are set out in their
second national workforce plan for England. A copy can be found at:

www. hee.nhs.uk/work-programmes/workforce-plannin

I am grateful to yqu for/oringing the circumstances of Mr Oliver’s death to my
attention and hopg thay you find this reply helpful.

BEN GUMMER
Response from Respondent Not Named (PDF)
Salford Royal

NHS Foundation Trust

University Teaching Trust

safe e clean e personal

CHIEF EXECUTIVE
Sir David Dalton

Telephone: 0161206 5186
Email:

4" September 2015
STRICTLY PRIVATE AND CONFIDENTIAL

Mr. A P Walsh

HM Area Coroner

Coroner Area of Manchester West
Ground Floor

Paderborn House

Howell Croft North

Bolton

BL1 1JW

Dear Mr. Walsh
Re: Mr. Stanley Oliver (Deceased)

Response to Regulation 28: Report to Prevent Future Deaths to Salford Royal
NHS Foundation Trust.

Thank you for your Regulation 28 letter dated 16" July 2015, which you issued to Salford
Royal NHS Foundation Trust (“SRFT”) and Mr Jeremy Hunt MP, Secretary of State for
Health, following an Inquest held on 6" July 2015 into the events surrounding the death of
Mr Stanley Oliver.

Your letter requested a review of:

e The availability of Gastro Intestinal (Gl) Radiologists out of hours to perform
procedures crucial to the management of the patient, including the provision of out of
hours rotas either within a single hospital Trust or a rota as between hospitals in a
group of hospital Trusts.

e The provision of an out of hours rota as referred to above within SRFT.

e The provision of procedures and protocols in relation to the availability of GI
Radiologists out of hours and a definitive line of communication whether it be as
between Radiologists or by clinical Consultants direct to GI Radiologists to discuss
and arrange a procedure out of hours

© The training of health professionals in relation to the availability of GI Radiologists out
of hours including training in relation to the procedures and protocols established in
support of out of hours availability.

Background

Interventional Radiology (IR) is an essential service within modern medicine. Non-vascular
interventional radiology procedures use image guided techniques to access solid or luminal
organs for placement of drains/stents, ablation devices or to obtain biopsy specimens. IR
techniques are applicable in most clinical domains, including gastroenterology, acute surgery
and urology, and can offer significant improvement in patient outcomes.

Achieving an appropriately skilled workforce to deliver 7 day IR is a national challenge. A
recent survey (1) shows that not all patients have seven day access to IR and a number of
hospitals depend on informal and ad-hoc arrangements to deal with their out-of-hours
emergencies. In the survey 93 out of 156 acute trusts responded. Of the 93, 66% of these
were able to provide a formal out of hours rota for nephrostomy cover; the only non-vascular
interventional procedure considered in this survey.

The Royal College of Radiologists (RCR) issued a document in 2008 - entitled Standards for
providing a 24-hour interventional radiology service (2) which recognises the requirement,
for the safety of patients, for acute hospital Trusts to have formal and robust arrangements
to ensure provision of an emergency radiology interventional service (vascular and non-
vascular) 24/7, 365 days a year.

The emphasis of the RCR paper is to encourage Trusts to:

e Put patient safety first, recognising the essential role of interventional radiology in the
provision of modern medical care

e Recognise the resources and manpower required to provide an interventional
radiology service

e Be clear and transparent regarding the local provision of interventional radiology
services

e Decide what is, and what is not possible to provide in and out of hours

e Enter into discussions with strategic healthcare authorities, primary care Trusts and
other Trusts in the region to make arrangements which ensure robust and coherent
regional interventional radiology service provision 24 hours a day, seven days a
week.

As with many NHS acute provider Trusts across the country, the IR service at SRFT is
currently unable to deliver a comprehensive out of hours (OOH) service.

This risk is recognised on both the Trust’s corporate and departmental risk registers
(Appendix 1). This problem is due to a national workforce skills gap recognised by

Government with Consultant Clinical Radiologists being added to the approved tier 2
occupation shortage list in April 2015 (3).

The development of a robust OOH IR service is part of SRFT’s strategy and the formal
investigation instigated following this incident has helped identified agreement on the way
forward within a reasonable time scale as described in detail below.

It is accepted that the vast majority of non-vascular interventional cases presenting OOH can
be, with appropriate surgical support and medical management, safely delayed until the next
daytime/normal working session. In the RCR document entitled Provision of Interventional
Radiology Services (4), it is recommended that access to intervention for non-vascular cases
involving genitourinary or gastrointestinal diseases are provided within 12 hours and 24
hours respectively.

Therefore, the Radiology Directorate at SRFT has agreed that a safe OOH non-vascular
interventional radiology service would require a seven day service with provision of sessions
on Saturdays and Sundays. More emergent treatments would also be available but this need
is rare.

Whilst we acknowledge that your Regulation 28 ietter focussed on GI intervention out of
hours, we feel that the requirement for all non-vascular radiology interventional procedures
must be considered. This response therefore relates to the provision of all non-vascular IR
out of hours.

As a final point, it is important to understand that this incident is uncommon and requirement
for IR OOH has been limited. In the past 12 months we have only performed 12 IR
procedures OOH at SRFT. However we recognise that as this service develops demand will
increase particularly given proposed reconfiguration of acute surgical across the GM
conurbation.

DEVELOPMENT OF INTERVENTIONAL RADIOLOGY SERVICES AT SALFORD ROYAL
NHS FOUNDATION TRUST

Short term plan

The short term plan is to continue to use the SRFT ad hoc service with additional support
from Central Manchester NHS Foundation Trust (CMFT). CMFT plan to have a weekend
non-vascular intervention service from October 2015 and have agreed that they will support
our service and perform cases that we are not able to safely perform at SRFT at weekends.
A Standard Operating Procedure (SOP) has been updated to reflect this change (Appendix
2) and further details can be found in the action plan below.

Medium term plan

The medium term plan is to develop a 1 in 6 non-vascular intervention rota at SRFT to
ensure that there is 7 day cover at Consultant level by April 2016. This will involve a number
of detailed actions which are described further within the action plan below. Whilst this has

been the aim of SRFT radiology for many years, the difficulties of implementation are
highlighted by the risks identified within the action plan.

Long term plan

The issues highlighted by this case reflect a national shortage of Consultant Interventional
Radiologists and are not particular to SRFT with no acute provider Trust in Greater
Manchester being able to provide a comprehensive out of hours IR service. We recognise
our role in making sure that access to IR is equitable across 7 days not just at SRFT but
more widely across GM and we will be working with the other acute provider Trusts across
Greater Manchester to ensure expertise is shared.

The Division of Clinical Support Services & Tertiary Medicine will have operational oversight
of the action plan and this forms part of the Division’s Risk Register.

| hope the described actions will provide you with assurance that the Trust takes patient
safety issues very seriously and as a result have developed robust short and medium term
plans to improve OOH access to IR.

Yours sincerely

Aecitatol

Sir David Dalto

CHIEF EXECUTIVE

cc
Edmund Oliver, Mr Oliver's son.
Geoffrey Oliver Mr Oliver's son

Jeremy Hunt MP, Secretary of State for Health

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