Prevention of Future Deaths reports · 2017
Regulation 28 report to prevent future deaths, reference 2017-0030, written 6 Feb 2017. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 6 Feb 2017 |
|---|---|
| Reference | 2017-0030 |
| Deceased | Natalie Thornton |
| Coroner | Simon Nelson |
| Coroner area | Manchester North |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Secretary of State Department of Health 1 CORONER I am Simon Nelson Senior Coroner for the Coroner area of Manchester North 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroner’s and Justice Act 2009 and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013 3 INVESTIGATION and INQUEST On the 22nd of January 2015 I commenced an investigation into the death of Natalie Ann Thornton then aged 29 years. The investigation concluded at the end of the inquest on 2 February 2017. The conclusion of the inquest was Natural Causes–the medical cause of death being diabetic ketoacidosis 4 CIRCUMSTANCES OF DEATH Natalie Thornton was diagnosed with type 1 diabetes at the age of 3 years. Her long-standing diabetic control was described as ‘brittle’ with history of recurrent diabetic ketoacidosis exacerbated by diabetic nephropathy leading to chronic kidney disease; advanced diabetic eye disease and delayed stomach emptying. Her blood glucose control had always been highly variable. With a view to improving the quality of her life it was decided on the 2 December 2014 to start her on insulin pump therapy for which she was deemed competent and adequately prepared. At some time after 11:00 hours on 18 January 2015 Natalie awoke and complained of feeling unwell. She subsequently collapsed in the bathroom; deteriorated rapidly and by the time of the arrival of the first paramedic at approximately 14:44 hours CPR was being undertaken without there being any electrical activity in the heart. The fact of death was subsequently confirmed at 15:32 hours that day 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. Concern was expressed as to the adequacy of the monitoring and review of blood sugar levels/data generated following the initial use of the pump provided by the Salford Royal Trust which provided Natalie’s equipment and had been caring for her over many years. More particularly trends were not analysed. Whilst noting that the introduction of insulin pump therapy was deemed an evolutionary process no formal Pump Agreement was in place at the time although such Agreements have now been implemented 2. From the evidence given by the expert Consultant it would appear that the level of support for insulin pump users nationally is variable. Whether the need for consistency and minimum standards should be addressed by Regional Centres of Excellence would be a matter for the Department to consider. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe each of you respectively have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely . 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. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons namely:- 1. Insulet Corporation 2. North West Ambulance Service 3. Family of Natalie Ann Thornton 4. Salford Royal Foundation Trust 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 from. He may send a copy of this report to any person who he believes may find it usefulor 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. 9 Date: 6 February 2017 Signed: Simon Nelson HM Senior coroner
1 response 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.
FromNicola BlackwoodMP ParliamentaryUnderSecretaryofState forPublicHealth andInnovation Department RichmondHouse of Health 79 Whitehall London SWIA 2NS Our Ref: PFD-1074069 020 72104850 Simon Nelson HM Senior Coroner HM Coroner’s Court The Phoenix Centre L/Cpl Stephen Shaw MC Way 19 APR 2017 Heywood OL1O 1LR Thank you for your letter of9 February 2017 to the Secretary ofState for Health about the death ofMiss Natalie Thornton. I am responding as the Minister with responsibility for diabetes at the Department ofHealth. I was saddened to read ofthe circumstances surrounding Miss Thornton’s death. Please pass my condolences to her family and loved ones. Your report explained that Miss Thornton, who had type 1 diabetes, had begun insulin pump therapy several weeks before her death. At inquest, concerns were expressed about the adequacy ofthe monitoring and analysis ofthe trends from the data generated following initial use ofthe pump, and the lack of a formal pump agreement. My officials have sought advice from NHS England, NHS Improvement and the National Institute for Health and Care Excellence (NICE) with regard to the level of support for insulin pump users nationally, and whether the need for consistency and minimum standards should be addressed by regional centres ofexcellence. It may be helpful ifI explain what guidance is available on the use and management ofinsulin pumps for people with diabetes. NICE advises that it published clinical guideline, ‘Type 1 diabetes in adults: diagnosis and management’ (NG17) in August 2016. www.nice.org.uk/guidance/ng17. This includes recommendations on insulin pumps that were incorporated from the technology appraisal, ‘C’ontinuous subcutaneous insulin infusionfor the treatment of diabetes mellitus’ (TA151), published in July 2008. www.nice.org.uk/guidance/tal5l. The guidance includes the following: ‘1.3 It is recommended that CSII therapy be initiated only by a trained specialist team, which should normally comprise a physician with a specialist interest in insulin pump therapy, a diabetes specialist nurse and a dietitian. Specialist teams should provide structured education programmes and advice on diet, lifestyle and exercise appropriate for people using CSII. 1.4 Following initiation in adults and children 12 years and older, CSII therapy should only be continued ifit results in a sustained improvement in glycaemic control, evidenced by a fall in HbAlc levels, or a sustained decrease in the rate ofhypoglycaemic episodes. Appropriate targets for such improvements should be set by the responsible physician, in discussion with the person receiving the treatment or their carer.’ The guidance does not make specific recommendations on support for insulin pump users. However, there are general recommendations in the guideline on early care plans, support and individualised care, as well as education and information provision for people with type 1 diabetes, which applies to pump users and non-pump users alike. NICE advises that there are no plans to review the guidance at this time. However, NICE will retain information on the concerns highlighted in your Report for consideration when the guidance is next considered for review. You ask the Department to consider whether the need for consistency and minimum standards for insulin pump users would be addressed by the establishment ofregional centres ofexcellence. NHS England advises that such a move would be a significant undertaking, involving infrastructure and workforce changes and financial investment, and there is need initially to understand better the extent ofvariation. NHS England is currently in discussion with NHS Digital about a possible extension ofthe National Diabetes Audit to include a spotlight audit on accessibility and outcomes oftreatment using an insulin pump and continuous glucose monitoring. If the proposal for a spotlight audit is agreed, NHS England would be in a position to better assess the extent to which there is variation in standards ofcare for insulin pump users. Department of Health You will appreciate this work is at an early stage but I hope you are assured that action is underway to gain a better understanding ofthe extent ofvariation across the country in this specific area ofdiabetes care. In addition, NHS Improvement advises that it is in the process ofappointing a Clinical Lead for diabetes inpatient care for the Getting it Right First Time programme, www.improvernent.nhs.uk/news-alerts/getting-it-right-first-time recruits-new-clinical-leads/. It is expected that the Clinical Lead will be in post within the next four months. The Clinical Lead will undertake a review ofinsulin pumps and the current support for users, which is expected to be completed towards the latter part of2018. NHS Improvement is able to update you on the outcomes ofthis review in due course ifthat would be helpful. Finally, I would like to assure you that we are working hard to improve outcomes and quality oflife for those living with diabetes or those who will develop it in the coming years. Once a patient has been diagnosed with diabetes, it is vital to ensure they can manage their condition as effectively as possible. We have made achieving a measurable reduction in variation in the management and care ofpeople with diabetes by 2020 a mandate objective for the NHS within the lifetime ofthis Parliament. Building on its National Diabetes Prevention Programme, NHS England is developing a diabetes management and care programme aimed at reducing variation and improving outcomes for people with diabetes. NHS England is making an additional £40 million available from 2017/18 to support delivery ofthe programme which will focus on four areas: reducing variation in the achievement ofthe three NICE treatment targets; improving take up of structured education; improving access to multi-disciplinary foot care teams for people with diabetic foot disease; and improving access to specialist inpatient support. Thank you for bringing the circumstances ofMiss Thornton’s death to our attention. I hope this information is useful. NICOLA BLACKWOOD
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