Prevention of Future Deaths reports · 2016
Regulation 28 report to prevent future deaths, reference 2016-0253, written 15 Jul 2016. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 15 Jul 2016 |
|---|---|
| Reference | 2016-0253 |
| Deceased | James Kane |
| Coroner | Andrew Tweddle |
| Coroner area | County Durham and Darlington |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
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REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. County Durham and Darlington NHS Trust 2. Department of Health CORONER lam Andrew Tweddle Senior Coroner for the coroner area of County Durham and Darlington. 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. (see attached sheet) INVESTIGATION and INQUEST On 12" January 2016 | commenced an investigation into the death of James Kane, 52 years. The investigation concluded at the end of the inquest on 14" July 2016. The conclusion of the inquest was Recognised Complication of Necessary Medical Intervention with a cause of death of 1a) Peritonitis, 1b) Bowel Injury following Paracentesis for Ascites, 1c) Alcoholic Liver Disease including Cirrhosis. CIRCUMSTANCES OF THE DEATH The deceased was admitted to hospital with gross ascites secondary to advanced liver cirrhosis. There had been some occasions where drains had been inserted following an ultrasound scan but some occasions where drains had been inserted without an ultrasound scan. On 2% January 2016 a drain was inserted without a scan and some 7 and a half litres of fluid were drained prior to the drain being removed in the early hours of 3% January. Within an hour of the drain being removed the deceased's condition had deteriorated markedly and he died later that day. It was accepted that the deceased had died of a well-known but rare medical complication. It is likely that at the time the drain was inserted an injury was sustained by the bowel. A consultant gave evidence to say that there was nothing in hospital guidelines to mandate an ultrasound scan prior to the insertion of a drain; that this was a very common procedure and that intuitively it would seem to be beneficial to have a scan prior to a drain being inserted. The matter had been referred to hospital authorities at a regional level and there was no support for a proposition that there should be a scan prior to the insertion of a drain. The family clearly took the view that their loved one would not have died at the time that he did but for the insertion of the drain and that, if a scan had been undertaken, this might have reduced the risk. They feel their loved one could have been that “1 in a million" and in their view therefore further consideration should be given to the risk. 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. — Notwithstanding that a local discussion of the circumstances of this case has taken place and there having been no local support for a change in policy or guidance, given the evidence that the deceased would not have died when he did but for the drain and that it is possible that a scan may have reduced the risk of death | believe this is a matter that requires further thought and consideration. SS eee | 8 | COPIES and PUBLICATION | In my opinion action should be taken to prevent future deaths and | believe you and your organisation] have the power to take such action. ACTION SHOULD BE TAKEN YOUR RESPONSE You are under a duty to respond fo this report within 56 days of the date of this report, namely by 9"" September 2016. 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. | |have sent a copy of my report to the Chief Coroner and to the following Interested | Persons; Care Quality Commission and lam 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. Signed...\wd so. wre Se \o HM SENIOR CORONER COUNTY DURHAM AND DARLINGTON Dated. Vso \\ \ \o
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.
County Durham and Darlington NHS) NHS Foundation Trust Executive Corridor Darlington Memorial Hospital Hollyhurst Road Darlington, DL3 GHX c- Your Ref: Our Ref: 5" September 2016 H.M Coroners Office PO Box 282 Bishop Auckland Co. Durham DL14 4FY Dear Mr Tweddle | am writing in response to the Regulation 28 issued on the 15th July 2016. The content of the Regulation 28 has been given due consideration and an action plan put in place to reduce any risk of future harm of a similar incident occurring to patients in our care. Mr Kane was a gentleman with a history of severe alcoholic liver cirrhosis (Child’s C). Prior to his death, he had multiple episodes of complication from the liver cirrhosis requiring admission to the hospital for treatment. One of the main issues was development of fluid in the abdomen (ascites) which required regular drainage via insertion of an abdominal drain (paracentesis). Mr Kane unfortunately passed away on the 3rd of January 2016 at 12:40pm. An inquest was held on the 14th of July 2016. The events were recognised as complications of necessary medical intervention with the cause of death as 1a) Peritonitis 1b) Bowel injury following paracentesis for ascites 1c) Alcoholic tiver disease including cirrhosis. Prior to this Mr Kane had undergone 5 large volume paracentesis of which the first two were done with ultrasound marking. The subsequent procedures were done without any ultrasound marking and there had been no complications. www.cddft.nhs.uk Chief Executive. Darlington Memorial Hospital, Hollyhurst Road, Darlington, County Durham DL3 6HX Aem au} je ¢ noA uM County Durham and Darlington INHS| NHS Foundation Trust The complication from this procedure was reported on the hospital’s safeguard system and a root cause analysis (RCA) was undertaken. The procedure was performed by the appropriate level of doctor who has previously been assessed and had achieved documented competency for the procedure. A written consent was obtained from Mr Kane, the procedure was appropriately documented and no immediate complication was noted. A post-procedural plan was left in place and the patient had his observations monitored appropriately. Unfortunately a perforation did occur which subsequently led to generalised peritonitis. The national guidance on management of ascites from the British Society of Gastroenterologist was reviewed (Moore et al, Guidelines on the management of ascites in cirrhosis, 2006) and the followings were noted from its recommendations - Therapeutic paracentesis is the first line treatment for patients with large or refractory ascites. - Large volume paracentesis with colloid replacement is rapid, safe and effective There is no mention of the role of ultrasound guidance in the placement of ascitic drain. The regional guidelines from the Gastroenterology Specialist Training Committee do not recommend the routine use of ultrasound for therapeutic paracentesis in liver cirrhosis. The European guidance on the management of ascites from the European Association for the Study of the Liver was also reviewed (Gines et al, EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis, 2010) and the followings were noted from its recommendations - Large volume paracentesis is the treatment of choice for the management of patients with grade 3 ascites. - Large volume paracentesis is a safe procedure and the risk of local complications, such as haemorrhage or bowel perforation is extremely low. There is no mention of ultrasound guidance in the management of the ascitic drain in this document. The most recent guidance was published by the American Association for the Study of Liver Disease (B Runyon, Management of Adult Patients with Ascites Due to Cirrhosis: Update 2012). The followings were noted from its recommendations - Serial paracenteses are a treatment option for patients with refractory ascites (Class 1, Level C) - Although more serious complications (hemoperitoneum or bowel entry by the paracentesis needle) occur, they are sufficiently unusual (<1/1,000 paracenteses) that they should not deter performance of this procedure. www.cddft.nhs.uk Chief Executive. Darlington Memorial Hospital, Hollyhurst Road, Darlington, County Durham DL3 6HX Aem au} |je 4 NoA Uy County Durham and Darlington INHS| NHS Foundation Trust - In recent years, new paracentesis equipment (eg. multihole, large-bore needle and a pump) have become available that may improve the ease and speed of therapeutic paracentesis. With regards to the use of abdominal ultrasound, the guideline states “If the fluid is difficult to localise by examination because of obesity, ultrasonography can be a useful adjunct in locating fluid and visualising the spleen and other structures to be avoided.” The current departmental practice is in keeping with published guidance in that paracentesis is normally done at the bedside with ultrasound guidance only being undertaken when there are concerns such as the presence of previous surgical scars or uncertainty on the presence of ascitic fluid. Ultrasound is not used routinely in large volume paracentesis in patients with liver cirrhosis who have well documented ascites and have previously undergone paracentesis. As NHS professionals the gastroenterology team have discussed the serious incident with their colleagues’ at the British Society of Gastroenterology and clarified that their current practice does meet the standard of our professional body. They appreciate that the field is continually evolving and that the hepatology section of the British Society of Gastroenterology is reviewing the paracentesis service as a whole. The current guidance does not recommend the routine use of abdominal ultrasound in managing large volume paracentesis. It describes the procedure as effective and safe with a very low risk of local complications. The decision on whether abdominal ultrasound may reduce the risk of complication is not supported by current evidence at the present time, and any change fo the guidance in the future will be appropriately incorporated in the Trust's practice. Notwithstanding this, the Trust has recognised actions that need to be taken both in the short term and longer term. Recommendations 1. To continue to provide a timely and safe service to all liver patients who require paracentesis in adherence to national guidelines. All trainees will be provided with a copy of the guidance. 2. Ensure that there is a clear audit trail of patients having undergone paracentesis within CDDFT. This will include the development of a proforma and database which will include i.Patient demographics ii. Date procedure performed ii. Clinician performing the procedure iv.Any complications during or post procedure www.cddft.nhs.uk Chief Executive. Darlington Memorial Hospital, Hollyhurst Road, Darlington, County Durham DL3 6HX uM < Aem au} jje ¢ no County Durham and Darlington NHS; NHS Foundation Trust A lead person will be identified on the Acute Medical Units and Gastroenterology wards across CDDFT and a meeting will be held 3 monthly to reflect on the management of this patient cohort. 3. All procedures will be performed between the hours of 8am and 8pm so that any complications can be identified and escalated to a senior decision maker. 4. A patient information leaflet will be available to all patients at the time of giving informed consent which outlines the procedure and possible complications. This will aim to be in place by 1°' September 2016. Should you have any outstanding queries please do not hesitate to contact us again. Yours Sincerely SS Ss SD Sue Jacques CHIEF EXECUTIVE www.cddft.nhs.uk Chief Executive. Darlington Memorial Hospital, Hollyhurst Road, Darlington, County Durham DL3 6HX Aen au} [je ¢ noA yum
4 * os Philip Dunne MP’ Minister of State for Health Department of Health | Richmond House 79 Whitehalf te Lond § SEP 2016 SWIA2NS Mr Tweddle Tel: 020 7210 4850 Senior Coroner Fourth Floor, Civic Centre North Terrace Crook Co Durham DL15 9ES a Thank you for your letter of 15 July 2016, following the inquest into the death of James Kane. I am responding as the Minister with responsibility for hospital care at the Department of Health. 3 f AUG 2016 I was sorry to hear of Mr Kane’s death. Please extend my condolences to his family and loved ones. Your report explained that Mr Kane was admitted to hospital with gross ascites (build- up of fluid) which was secondary to his advanced liver disease. On the 2 January 2016 he had a drain inserted to remove the fluid. This procedure (paracentesis) was carried out without a prior ultrasound scan. You explained that Mr Kane suffered an injury to the bowel, which is a recognised but rare medical complication associated with paracentesis. You asked that we consider whether insertion of a drain should always be preceded by an ultrasound scan. I have consulted the National Institute for Health and Care Clinical Excellence (NICE) on this matter and have been advised that their recently published guidance - Cirrhosis in over 16s: assessment and management (NGS50) - does not make any recommendations as to whether or not a scan should be taken prior to the insertion of a drain for ascites. This guidance can be found at https://www.nice.org.uk/guidance/ng50. The issue was not raised by stakeholders during the NICE consultation on the guideline scope, nor by the scoping team, and it was therefore not addressed during the development of the guideline. NICE do not believe the guideline needs to be amended at this time. However, your concerns have been highlighted to the guideline surveillance team, for their information when the guideline is next considered for an update. In addition, the Department of Health also consulted the Royal College of Radiologists on the general issue as to whether ultrasound scanning should always be performed immediately prior to drainage of abdominal ascitic fluid. They, in turn, sought advice from the following: * British Society of Gastrointestinal and Abdominal Radiology, * British Society of Gastroenterology, and * — British Society of Interventional Radiology. The Royal College of Radiologists does not consider there is a case for the routine use of ultrasound prior to or during paracentesis. It is the College's view that paracentesis is a safe procedure when performed by trained, competent operators following established guidelines on the appropriate use of the procedure. I note that you report states that there is no support locally for a change in hospital policy or guidance and this view appears to be supported by the advice I have been given. I hope that this reply is helpful and I am grateful to you for bringing the circumstances of Mr Kane’s death to my attention. PHILIP DUNNE
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