Violet Nelson

Peter J Bedford

INHS By, 1)

YEARS
Nt
0

England = v8

Professor Stephen Powis
National Medical Director
Skipton House

Senior Coroner for Berkshire 80 London Road
Reading Town Hall SE1 6LH
Blagrave Street
Reading
RG1 1QH

February 2018
Dear Mr Bedford

Re.: Report to Prevent Future Deaths (Regulation 28) following the death of
Mrs Violet Levine Nelson

Thank you for your letter and Regulation 28 Report (“Report”) issued on 7
December 2017 following the death of Violet Nelson. | would like to offer my
condolences to the family of Mrs Nelson. | would also like to apologise for the
delay in producing this response.

In your report you raised a number of concerns relating to the content of the
ultrasound reports. | thought it may be helpful to explain that aortic aneurysms
can be difficult to diagnose and treat in a timely fashion, as they are largely
asymptomatic. A national screening programme is currently in place for the
detection of abdominal! aortic aneurysms (“AAA”), but it only invites men aged 65
years. As with all national screening programmes, this decision is based on the
best available evidence of clinical and cost-effectiveness. As AAAs are very rare
in women, they are not currently included in this screening programme.

| note that your Report has been sent to The Royal College of General
Practitioners and The Society of Radiographers who may be able to address
your specific concerns as detailed in section 5 of your Report.

It may be helpful to recognise that General Practitioners (“GPs”) are not
specialists in a particular area of medicine, but are trained to practice in general
medicine. Most GPs will therefore be prompted to make referrals when a
recommendation is made in a scan report or if a scan report contains details or
indications of further medical problems that require further investigation. It is
therefore useful to recognise that GPs will have a different skill set compared to a
Consultant Radiologist or an experienced Sonographer who is trained to take
images and give indications about further problems that may require further
investigations.

As explained above, aortic aneurysms can be difficult to diagnose, one route that
could be explored to raise GP awareness would be to try and incorporate specific
training/awareness into their appraisal process. NHS England’s Medical

High quality care for all, now and for future generations

Directorates issue regular newsletters to their appraisers and include “lessons
learned”. This can be fed into an individual GPs’ professional development
plans.

NICE are developing new Clinical Guideline on “Abdominal aortic aneurysm:
diagnosis and management”; the expected publication date is November 2018."
The guideline is intended for a wide audience, including patients and their
families. It will also provide standards and thresholds for clinicians involved in
the diagnosis and management of patients with AAs. This appears to be a timely
opportunity for NHS England to inform the NICE AAA Committee of the concerns
you raised and ask them to consider incorporating appropriate advice to all
relevant clinical professions. Therefore, | will ensure that the NICE lead for this
Guideline, Mr Andrew Bradbury, is aware of your Regulation 28 letter and the
concerns raised by you. | will also ensure that your Report is considered by the
Working group led by the National Clinical Director for Diagnostics, in their
current review of another Coroner's case involving aortic aneurysms, so that any
recommendations take this case into account.

1 hope that the information above addresses the concerns you raised within your

report and provides assurance that NHS England recognises your concerns and
is taking further action to ensure that appropriate steps are taken.

Yours sincerely,

Professor Stephen Powis
National Medical Director
NHS England

* https: //www.nice.org.uk/guidance/indevelopment/gid-cgwave0769
High quality care for all, now and for future generations

| Royal College of
_ General Practitioners

Dr Sue Rendel BA MB BS FRCGP MRCP DRCOG
Assistant to the Honorary Secretary of Council

Peter J Bedford

Senior Coroner for Berkshire
Reading Town Hall

Blagrave Street

Reading, Berkshire

RG1 1QH

DX 40124 Reading Castle Street

19 January 2018

Dear Mr Bedford,

Re: Mrs Violet Levine Nelson, Regulation 28 Report
Reference: PJB/NELSON, VL

Thank you for asking the Royal College of General Practitioners to make a response to your
report about Mrs Violet Levine Nelson, who sadly died suddenly following the Rupture of a
Thoracic Aortic Aneurysm.

The Royal College of General Practitioners (RCGP) is the largest membership organisation in
the United Kingdom solely for GPs. It aims to encourage and maintain the highest standards
of general medical practice and to act as the ‘voice’ of GPs on issues concerned with
education; training; research; and clinical standards. Founded in 1952, the RCGP has just
over 50,000 members who are committed to improving patient care, developing their own
Skills and promoting general practice as a discipline.

You highlight three matters of concern in your report.

| agree with the comment you make in the second, i.e. that GPs are in general, unlikely to be
aware that the presence of a supra-renal aortic aneurysm should raise concerns about the
possibility of a thoracic aortic aneurysm and that further investigation and referral would be
appropriate.

When GPs request investigations such as ultrasounds, they rely upon the report from their
secondary care colleagues to make recommendations about the findings and in particular
suggestions for further investigation and referral. Many GPs do not have access to the related
images and so the accuracy and fullness of the report is their usual guide as to future
management.

Dr Matt Hoghton, Medical Director of the Clinical Innovation and Research Centre in the
RCGP understands that the cut-offs for referrals for the size of a suprarenal aortic abdominal
aneurysm (AAA) after ultrasound is usually determined locally in the hospital between the
local radiology department and the local vascular surgeons. It may be worth asking the Royal
Berkshire Hospital Reading for their protocol during the time period the ultrasound scans took

Royal College of General Practitioners 30 Euston Square London NW1 2FB
Tel 020 3188 7400 Fax 020 3188 7401 Email info@rcgp.org.uk Web www. regp.org.uk
Patron: His Royal Highness the Duke of Edinburgh Registered charity number 223106

place. The national AAA screening programme in England, screens for AAA In men during
the year they tum 65 years but is not offered to women.

hit «://usin_nhg.uk/conditions/abdominal-aortic-aneu sem-screening/

Their local office for Reading is AAA, Admin Office, John Radcliffe Hospital, Headley Way,
Headingion Oxford Tel: 01865 572636

You ask in your covering letter for suggestions about other organisations whe might be able to
influence change in this area anc would suggest that you may wish to consider contacting:

4. Royal College of Radiciogists,
83 Lincoln's Inn Fields, London WC2A 3UW

2. Royal College of Surgeons of England
35-43 Lincoln's Inn Fields, London WC2A 3PE

3 National Institule for Health ane Care Excellence (NICE)
10 Spring Gardens, London SW1A 2BU
NICE have a guideline in development. Abdominal aortic aneurysm: diagnosis and
management IGID-CGWAVE0769] with an expected publication date of 07 November
2016."

Yours Sincerely

Sue Rendel MB BS, MRCP, DRCOG, FRCGP
Assistant to the Honorary Secretary of RCGP Council

Royal College of General Practitioners 30 Euston Square London NW 2FB
Yel 020 3188 7400 Fax 020 3188 7401 Email info@regp.org.uk Web wean roge.org.uk
Patron: His Royal Highness the Duke of Edinburgh Registered charity number 223106

Chief Executive Officer
Richard Evans OBE

THE SOCIETY OF
RADIOGRAPHERS

30 January 2018
Your ref: PIB/NELSON, VL

Peter J Bedford

Senior Coroner for Berkshire
Reading Town Hall
Blagrave Street

Reading

Berkshire

RG1 1QH

Dear Mr Bedford
Re: Regulation 28 Report following the death of Violet Levine Nelson

Thank you for your letter dated 7” December 2017, which we at the Society and College of
Radiographers (SCoR) have now had the opportunity to consider. We should like to offer the
following response:

To comment first on your matters of concer (section 5 of the report), with reference to
matter number 1, there is an implication that sonographer-led examinations are of a lower
standard than those of a consultant radiologist. The performing and reporting of ultrasound
examinations, including of the vascular system, by non-medically qualified sonographers is
extremely well established practice in the UK. There is extensive audit and research evidence
to show that image interpretation and reporting capabilities are equivalent to radiologists and
this has led to widespread local practices where suitably skilled sonographers work
autonomously in scanning and reporting cases such as that in your investigation.

The SCoR has always been clear in its demands that, in each of the fields in which they
report, reporting radiographers must operate at the same standard as their clinical radiologist
colleagues, and must demonstrate this at the point at which they complete their training and
begin to practice.!

The nature of ultrasound scanning is that, as a dynamic examination, the interpretation of
images is best undertaken by the operator in real time as the examination proceeds.
Supervision or second opinions provided by another clinician usually involve static images.

This is not to suggest that a second opinion from another skilled professional might not have
been helpful in identifying the possibility that the findings in this case were suggestive of
thoracic extension of the aortic aneurysm. There is good evidence to suggest that second
opinions or double reporting of examinations can increase reporting accuracy,

Quartz House, 207 Providence Square, Mill Street, London SE] 2EW
T: 0207 740 7200 E: info@sororg W: www.sor.org

The Society of Radiogrophers is a company limited by guarantee registered in England under No. 169483
Registered Office: 207 Providence Square, Mill Street, London SE] 2EW

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To comment now on the more general points of concern; In this case it would appear that the
sonographers involved in the case have reported the abdominal aortic aneurysm {AAA} as
both infra-renal and supra-renal at different examinations.

It can be quite difficult, with ultrasound, to determine the origin of the renal arteries,
particularly in patients with increased body habitus or overlying bowel gas. lbnage quality is
also dependent on the equipment available. Colour Deppler scanning (where available) can

be of value in determining the origin of the renal arteries in relation to AAA in difficult cases,

‘The SCoR and the British Medical Ultrasound Society (BMUS) Guidelines for Professional
Ultrasound Practice * (2017) refer to the Society of Vascular Technologists (SVT) guidelines
for vascular examinations. It might be helpful to include within the SCoR and BMUS
guidelines some information about abdominal aortic ancurysms and a suggested policy for
referral for thoracic CT and review by a radiologist or a vascular surgeon, when a supra-renal
aneurysm is detected or suspected,. This would provide clarity and guidance, which could
then be incorporated into local protocols.

The NHS AAA Screening Pro gramme 4 provides the following protocal:

“Tf the proximal abdominal aorta appears aneurysmal as an extension of a more proximal
thoracic acrtic aneurysm the visible aoria should be measured accurately at its widest point
as per usual protocol. The incidental findings policy should then be followed for further
investigation of any suspected thoracic aortic aneurysm. The {patient} should remain within
the screening programme with appropriate surveillance until informed otherwise via the
clinical director.” (page 12).

This AAA screening programme guidance indicates that further investigation should be
included as part of the screening protocol. Consequently, we feel it would be appropriate for
the same arrangements to be in place for detection during other ultrasound examinations in
secondary care.

The current best practice guidelines produced jointly by SCoR and BMUS in 2017
recommend appropriate guidance on further investigations, where required, to be included
within the ultrasound report. Specifically:

“Local policy should exist clearly stating mechanisms for advising on relevant further
investigations that takes account oj the professional background of the report author, which
may be a non-medical one.” (page 38}

and
“Recommendations for further investigations / management to include any appropriate

recommendations for further investigation (eg CT/MRi/drainage/biopsy etc) dependent upon
local department guidelines and practice.” (page 40).

Quariz House, 257 Providence Square, Mil Street, London SE1 2EW
¥. 0207 740 7200 E: info@sororg We www.sororg

The Society of Radiographers is a company limited by guarantee registered in England under No. 186483
Registered Office: 207 Providence Square, Mill Street London SE1 EW

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it is known that this practice of sono graphers recommending additional investi gations varies
across the UK, dependent on local protocols and schemes of work. In some departments,
policy allows Sonographers only to provide a descriptive report and there would not be
authority to recommend additional imaging. In these cases, a radiologist opinion should be
sought for advising on further imaging or referral.

Suggested actions:

l. We suggest that the Royal College of Radiologists ¢ RCR) is asked to provide an
opinion on this case. The RCR standards for reporting should (along with SCoR /
BMUS) be referenced in local protocols for reporting on AAAs by both radiologists
and sonographers *,

2. We will review the SCoR and BMUS guidelines (2017), specifically to include
guidance on referral of suspected supra-renal abdominal aortic aneurysms for thoracic
CT, review by a radiologist or a vascular surgeon.

3. As we review the SCoR and BMUS guidelines (2017) we will inchude advice on:

i} the use of colour Doppler to determine the origin of the aneurysm in relation
to the renal arteries, in difficult cases or recommend alternative imaging
modalities, if necessary.

ii) using the superior mesenteric artery (SMA) as a landmark te help determine
supra or infra-renal location of an ancurysm, as the renal artery is
approximately lcm inferior to this

4. We will undertake an exercise to communicate to radiology services the need for
sonographers to have clear processes for arranging onward referral or for ensuring this
is handled by a suitable colleague in authority.

i trust that this fulfils the requirements for response from the Society of Radiographers.
Naturally we shail be happy to provide any further detail if this might be of assistance.

Yours sincerely

RICHARD EVANS
Chief Executive Officer

Quariz House, 207 Providence Square, Mill Street, London SE7 JEW
T. G207 740 7200 E info@sor.org W. wwwsororg

The Society of Radiographers is a company limited by guarantee registered in England under No. 188483
Registered Office: 207 Providence Square, Mill Street, Londen SE1 2EW

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References:

1. SCoR (2010) Medical Image Interpretation By Radiographers Definitive Guidance
Page 8; Safety of radiographer reporting
httos://www.sor.or /system/files/document-
bibrary/public/sor Definitive Guidance May 2010.pdf

2, Society and College of Radiographers and British Medical Uleasound Society (2017)
Guidelines for professional ultrasound practice. Available at:
hitosy//wnww_sor.or /sites/default/files/document-

2018.15 scor bmus guidelines final.ndf

3. Public Health England ¢ 2016) NHS Abdominal Aorta Sereening Programme: Clinical
guidance and scope of practice for professionals involved in the provision of the
ultrasound scan within AAA screening. Available at:
hitps://www.gov.uk/government/ uploads/system/u loads/attachment_data/file/$52720
/NAAASP scope _of practice document V2.0 130916.pdf

4. Royal College of Radiologists (2006)

Quartz House, 207 Providence Square, Mil Street, London SE1 DEW
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The Society of Radiographers is a company limited by guarantee registered in England under Ne, 160483
Regisiered Office: 207 Providence Square, Mill Street, London Set sew