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 Iike 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. AAAs are rare in women, 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 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 traininglawareness into their appraisal process: NHS England's Medical High quality care for all, now and for future generations As very they

Directorates issue regular newsletters to their appraisers and include "lessons leamed". 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 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 $ case involving aortic aneurysms, so that any recommendations take this case into account hope that the information above addresses the concerns you raised within your report and provides assurance that NHS England recognises your concems and is taking further action to ensure that appropriate steps are taken.

Dear Mr Bedford, Re: Mrs Violet Levine Nelson, Regulation 28 Report Reference: PJBINELSON, VL Thank you for 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 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 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 agreewith the comment you make in the second, ie 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, rely upon the report from their secondary care colleagues to make recommendations about the findings andon paoticuler suggestions for further investigation and referral 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 the time period the ultrasound scans took Royal College of General Practitioners 30 Euston Square London NWI 2FB Tel 020 3188 7400 Fax 020 3188 7401 Email info@rcgp org.uk Web Www.rcgp orguk Patron: His Royal Highness the Duke of Edinburgh Registered charity number 223106 College asking has they Many during

The national AAA screening programme in England, screens for AAA in men during place_ the year they turn 65 years but is not offered to women: https IWWnhs uklconditionslabdominal-aortic-aneurysm-screeningl Their local office for Reading is AAA, Admin Office, John Radcliffe Hospital; Headley Way. Headington Oxford Tel: 01865 572636 covering letter for suggestions about other organisations who might be able to You ask in your: this and wouid suggest that you may wish to consider contacting: influence change in area Royal College of Radiologists, 63 Lincoln's Inn Fields, London WCZA 3JW 2 Royal College of Surgeons of England 35-43 Lincoln's Inn Fields; London WCZA 3PE National Institute for Health and Care Excellence (NICE) 10 Spring Gardens; London SWIA 2BU NICE have a guideline in development: Abdominal aortic aneurysm: diagnosis ad [GID-CGWAVE0769] with an expected publication date of 07 November management 2018

Dear Mr Bedford Re: Regulation 28 Report following the death of Violet Levine Nelson Thank you for your letter dated 7th December 2017, which we at the and 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 concemn (section $ 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 qualificd 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 report reporting radiographers must operate at the Same standard as their clinical radiologist colleagues, and must demonstrate this at the point at which 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: Contl_ Quartz 207 Providence Square, Mill Streel, London SET 2EW T: 0207 740 7200 E: info@sororg W: wwwsor.org The Society of Radiogrophers company limited by guaranfee registered in England under No. 169483 Registered Olfice: 207 Providencae Square_ Mill Street, London SE 2EW Society College they they House ,

~2- 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 o overlying bowel Image quality is also dependent on the equipment available. Colour Doppler scanning (where available) cgn be of value in determining the origin ofthe renal arteries in relation to AAA in difficult cases. The SCoR and the British Medical Ultrasound (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 aneurysms and a suggested policy for referral for thoracic CT and review by a radiologist Or a vascular surgeon, when & 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 Programme provides the following protocol: "If the proximal abdominal aorta appears aneurysmal as an extension ofa more proximal thoracic aortic aneurysm the visible aorta 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 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 of the professional background of the report author; which may be a non-medical one. (page and 'Recommendations for further investigations management to include any appropriate recommendations for further investigation (eg CT MRIldrainage/biopsy etc) dependent upon local department guidelines and practice. (page 40). Contl Quartz House, 207 Providence Square; Mill Street London SEI 2EW T: 0207 740 7200 E: info@sororg W: wWWsororg The Society of Radiographers company limited by guarantee registered in England under No . 169483 Registered Office: 207 Providence Square, Mill Street London SET ZEW gas. Society during
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~3- It is known that this practice of sonographers recommending additional investigations varies aoross the UK s 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, & radiologist opinion sbould be sought for advising on further imaging Or referral_ Suggested actions; We suggest that the Royal of Radiologists (RCR) is asked to provide an opinion on this case. The RCR standards 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), ifically to include guidance on referral of suspected supra-renal abdominal aortic aneurysms for thoracic CT, review by a radiologist or & vascular surgeon: 3 _ As we review the SCoR and BMUS guidelines (2017) we will include advice on: the use of colour Doppler to determine the origin of the aneurysm in relation to the renal arteries, in difficult cases or recommend altemative imaging modalities, if necessary: the superior mesenteric artery I(SMA) as a landmark to determine supra or infra-renal location of an aneurysm; as the renal artery is approximately lcm inferior to this 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: trust that this fulfils the requirements for response from the Society of Radiographers: Naturally we shall be to provide any further detail ifthis might be of assistance: sincerely 8e_ RICHARD EVANS Chief Executive Officer Contl Quartz House; 207 Providence Square; Mill Street London SEI 2EW T: 0207 740 7200 E: info@sor.org W: wwWsororg The Society of Radiographers is company limited by guarantee registered in England under No, 189483 Registered Office: 207 Providence Square, Mill Street London SET ZEW College for specil using help happy - Yours

References:
1. SCoR (2010) Medical Image Interpretation By Radiographers Definitive Guidance 8; Safety of radiographer reporting https / Lwww SOL_org/system /files/documentz librarylpublic/sor_Definitive_Guidance 2010_pdf Society and of Radiographers and British Medical Ultrasound Society (2017) Guidelines for professional ultrasound practice. Available at: https:LLWWw SOL_org/sites/default/files/document- versions/2018.L5 ScOr_bmus_guidelines_finaLpdf
3. Public Health England (2016) NHS Abdominal Aorta Screening Programme: Clinical guidance and scope of practice for professionals involved in the provision of the ultrasound scan within AAA screening: Available at: https:ILWWW_gov uklgovemmentluploads/system /uploads/attachment_data/file/552720 NAAASP_scope_of_practice_document V20_130916pdf Royal College of Radiologists (2006) https L rcL_ac uklsites/default/filesbbfcrO6l_standardsforreporting pdf Quartz House 207 Providence Square; Mill Street London SE1 2EW T: 0207 740 7200 E: info@sororg W;: wwWsororg The Society of Radiographers is company limited by guarantee registered in England under No, 169483 Registered Office: 207 Providence Square Mill Street; London SEI ZEW Page May College Ilwww