Prevention of Future Deaths reports · 2020
Regulation 28 report to prevent future deaths, reference 2020-0188, written 25 Sep 2020. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 25 Sep 2020 |
|---|---|
| Reference | 2020-0188 |
| Deceased | Susan Warby |
| Coroner | Nigel Parsley |
| Coroner area | Suffolk |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | West Suffolk NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
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: Rt Hon Matt Hancock MP Secretary of State Department of Health and Social Care 39 Victoria Street London SW1H 0EU D r - Interim Chief Executive Medicines and Healthcare products Regulatory Agency 1 0 South Colonnade London E14 4PU 1 CORONER I am Nigel Parsley, Senior Coroner, for the coroner area of Suffolk. 2 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. 3 INVESTIGATION and INQUEST On 4th October 2018 I commenced an investigation rnto the death of Susan Warby The investigation concluded at the end of the inquest on 7th September 2020. The conclusion of the rnquest was that the death was the result of:- The progression of a naturally occurring illness, contributed to by unnecessary insulin treatment caused by erroneous blood test results. This, in combination with her other coHmorbidities, reduced her physiological reserves to fight her naturally occurring illness. The medlcal cause of death was confirmed as: 1 a MultiNorgan failure 1 b Septicaemia 1c Disseminated aspergillus pneumonia 2 Perforated diverticular disease (operated 27th and 29 th August 2018) with faecal peritonitis, insulin induced hypoglycaemia, pneumothorax, hypertension and hypothyroidism. 4 Susan Warby was a 57-year-old lady admitted to the West Suffolk Hospital on the 26th July 2018. Sue had been unwell from the 18th July 2018 and on the morning of 26th July 2018 suffered a collapse at home. She was admitted into hospital and was found to be suffering from a perforated bowel (diverticular perforation with faecal peritonitis). Sue undeiwent emergency surgery and was transferred onto the Intensive Treatment Unit on the 27th July 2018. Whilst in the operating theatre, Sue had an arterial line fitted that required an intravenous fluid infusion to keep the line flushed. The incorrect intravenous fluid (500mls of Dextrose at 4% with Sodium Chloride at 0.18%) was attached to this line and a number of checks that were required to be conducted failed to identify this. The incorrect intravenous fluid remained in place for approximately 36 hours before it was changed. As a direct result, blood tests on samples drawn from the arterial line gave incorrect results. The incorrect results were exacerbated by the poor technique being used by staff to draw blood from the arterial line transducer set when they failed to fully account for the 'dead space', which needed to be fully removed to obtain an accurate result. These erroneous blood results led to Sue being given doses of insulin medication over a two-day period that she did not need. The incorrect insulin doses caused Sue to suffer from bouts of extremely low blood sugar (hypoglycaemia) which caused her to develop a brain injury of uncertain severity. Sue never fully regained consciousness, so the extent of that brain injury could not be meaningfully assessed. Sue undeiwent a further surgery on the 291h July 2018 and returned to the ITU. Sue remained on the ITU where her abdominal surgery and condition settled but she developed a serious fungal chest infection. Evidence heard that due to Sue's poor physiological reserve, caused by her bowel perforation, chest infection and sepsis, the additional insult of a degree of brain injury would have been a contributing factor leading up to her death. Sue remained on the ITU at the West Suffolk Hospital until her tragic death on the 30th August 2018. 5 CORONER'S CONCERNS During the course of the inquest the evidence revealed matters given rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you; the MATTERS OF CONCERN as follows. - 1. During the evidence it was clear that packaging and visual identification aids available for intravenous fluids to be used in arterial line transducer sets were not sufficiently distinctive. It was heard that following Mrs Warby's death that as far as possible the West Suffolk Hospital has asked its suppliers to change the labelling on the intravenous fluids it purchases. These were exhibited in court and even with the changes the manufacture was prepared to make, the packaging cannot be considered at all distinctive for fluids to be used in an arterial line. In direct contrast, we saw that the tubing used on an arterial line transducer set has a solid red line running its length. This is to clearly indicate to staff that ii is an arterial line and therefore must not be used for the administration of drugs or medicinal fluids. I am therefore concerned that the packaging of the 0.9% Sodium Chloride intravenous fluid to be used with an arterial line is not also so clearly distinguished. II was heard in evidence that there is currently no 0.9% Sodium Chloride intravenous fluid available which is specifically and clearly labelled for arterial line use only. It is important to note that the issue identified in this inquest regarding the use of incorrect intravenous fluid in an arterial line is not a new one. In 2008 the UK National Patient Safety Agency issued a Rapid Response report highlighting problems with infusions and sampling from arterial lines. In that 2008 report the UK National Patient Safety Agency had already identified 84 incidents where the wrong infusion was attached to an arterial line with two of those cases proving fatal. II is understood that the 0.9% Sodium Chloride intravenous fluid has a number of medicinal uses other than just as a flushing fluid in an arterial line. However, the number of cases identified where the incorrect fluid is being used in arterial lines, clearly demonstrates the confusion and errors which occur when using generically labelled intravenous fluids with an arterial line transfusion set. 2. The court was told that the medical staff taking blood samples from the arterial line transducer sets were not using the correct technique to ensure erroneous blood samples were not taken. The court heard that even if the incorrect intravenous fluid is fitted to an arterial line, a good technique used by staff (ensuring to fully account for the 'dead space' when drawing the blood sample) would prevent false readings being obtained. As such, in Mrs Warby's case the error of the incorrect intravenous fluid being fitted to her arterial line was exacerbated by medical staff using an incorrect technique when drawing her blood samples. The court was told that training in drawing blood from an arterial line is given as part of standard training for staff caring for patients with an arterial line in place. However, there were a number of erroneous samples taken in Mrs Warby's case, these samples being taken by a number of different staff. As such, the West Suffolk Hospital has already implemented new training and operational regimes for its staff. However, given the apparent prevalence of errors regarding the incorrect use of intravenous fluids and incorrect blood sampling techniques involving arterial lines, a review of training and operational regimes may be considered necessary on a wider basis. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken in order to prevent future deaths, and I believe you or your organisation have the power to take any such action you identify. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 201h November 2020 I, the Senior Coroner, may extend the period if I consider it reasonable to do so. 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;- 1. Mrs Warby's family. 2. The West Suffolk Hospital, Bury St Edmunds. I am 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 Senior Coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. 9 251h September 2020 Nigel Parsley ~- rJ
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.
From Nadine Dorries MP Minister of State for Patient Safety, Suicide Prevention and Mental Health 39 Victoria Street London SW1H 0EU 1 February 2021 Our Ref: Mr Nigel Parsley HM Senior Coroner, Suffolk HM Coroner's Office Beacon House 53-65 Whitehouse Road Ipswich IP1 5PB Dear Mr Parsley Thank you for your letter of 25 September 2020 to Matt Hancock about the death of Susan Warby. I have been asked to respond as Minister with responsibility for hospital care quality and patient safety and as your letter was delayed in coming to the Department’s attention, I am grateful for the additional time in which to do so. First, I would like to say how deeply saddened I was to read of the circumstances of Mrs Warby’s death and I extend my heartfelt sympathies to her family and loved ones. I can appreciate how distressing her death must be, particularly as there are serious concerns about the standard of care provided. We must learn from clearly regrettable incidents such as these and look to make improvements where we can to ensure the safety of healthcare and prevent future deaths. I am advised that the West Suffolk NHS Foundation Trust acknowledges that aspects of Mrs Warby’s care could and should have been better and has apologised to the family of Mrs Warby. I am further advised that since Mrs Warby’s death, the Trust has put in place enhanced procedures and safeguards to improve the quality of care and has seen a reduction in intensive care medication errors as a result. Improvements include: • More robust processes for prescribing and checking fluid bags; • • Alterations to the way medication bags are supported and displayed when in use to Introduction of completely clear medication bags; make them easier for staff to read; • Changes to fluid checking processes in the Intensive Care Unit; • Improvements to processes so that all bags of fluid are routinely changed every 24- hours; and, Implementation of new training on the use of arterial lines. • I am assured that the Trust has reviewed the findings of your investigation to ensure any further learning is captured. Turning to the matters of concern, in relation to the visual identification of IV fluids that are compatible with use in arterial lines, as you will know from the response by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance has been published for the pharmaceutical industry on how to optimise the presentation of information on labelling so that medicines can be safely supplied and selected to reduce the risk of harm1. You will also know that the MHRA has explained that the way in which the containers of the IV fluids described in your report are manufactured (bags composed of polyolefin/polyamide co-extruded plastic), means that judicious use of colour cannot be used within the labelling to aid differentiation and reduce the likelihood of error at the point of selection. The MHRA states that other risk minimisation measures should be employed locally within clinical areas to assist correct identification. However, the MHRA has undertaken to consider further with the marketing authorisation holder whether improvements can be made to the labelling to help ensure the medicine is used appropriately and reduce the likelihood of such errors in future. In relation to the second matter of concern about training in the correct use of IV fluids and blood sampling techniques, Departmental officials have made enquiries with Health Education England (HEE). I am advised that the insertion and management of arterial lines is a highly specialised skill that is undertaken in a small number of critical care areas in hospitals. For nurses, this is a post-registration competency for which the employer has a responsibility to provide training. It is not an expected competency for undergraduate nursing. I am further advised that medical students would not be expected to have this competency and it is not contained in the curriculum for medical undergraduate training. The insertion of arterial cannula is contained in a small number of postgraduate medical curricula and the competencies are assessed and monitored through standard educational procedures. Training in blood sampling from arterial lines is the responsibility of the employer in the first instance and NHS trusts are able to access learning materials already prepared and available through their own local training resources and/or from their relationship with local Higher Education Institutions providing post-registration nurse training. I hope this clarification is helpful. Education and training are also matters for the relevant professional bodies and my officials have brought the matters of concern in your report to the attention of the Nursing and Midwifery Council and the General Medical Council for their information and consideration. With your permission, my officials also brought your report to the attention of NHS England and NHS Improvement (NHSEI, the lead body for patient safety in the NHS); the Care 1 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/946705/B est_practice_guidance_labelling_and_packaging_of_medicines.pdf Quality Commission (the independent regulator for quality), and the Healthcare Safety Investigations Branch (HSIB). You may wish to note that the HSIB has reviewed the circumstances outlined in your report, together with another incident that occurred in 2020 in another NHS organisation, against its criteria for investigation and has decided that a preliminary investigation into the use of an appropriate infusion fluid when flushing arterial lines will be conducted. Finally, you may be aware that in January 2020, the Government instructed NHSEI to commission a rapid independent review into a whistleblowing incident related to Mrs Warby’s death. The terms of reference for the review are published online2. NHSEI has advised that the review is now expected to be completed by the Spring of this year. Yours sincerely, MINISTER OF STATE FOR PATIENT SAFETY, SUICIDE PREVENTION AND MENTAL HEALTH NADINE DORRIES 2 https://www.england.nhs.uk/east-of-england/2020/02/07/independent-investigation-to-review-nhs-west- suffolk-whistleblowing/
Mr N. Parsley Senior Coroner West Suffolk 16 December 2020 Medicines and Healthcare products Regulatory Agency 10 South Colonnade Canary Wharf London E14 4PU United Kingdom +44 (0) 20 3080 6000 gov.uk/mhra Dear Mr Parsley, Regulation 28 Report concerning SUSAN WARBY Thank you for your letter of 25th September 2020 in which you asked the Medicines and Healthcare products Regulatory Agency (MHRA) to provide a response to the Regulation 28 Report to Prevent Future Deaths following the inquest into the death of Susan Warby. Your report listed a number of matters of concern. In relation to the responsibilities of the MHRA one of your concerns was in the context of the labelling of the intravenous fluids which were implicated in Susan Warby’s death and the potential for these to be confused at the point of selection and administration. You have asked that MHRA review the labelling and product design of the fluids in question. Although the medicines regulations do not address issues of pack design and the presentation of the statutory information on the labelling, the MHRA has, nonetheless, published guidance for the pharmaceutical industry on how to optimise the presentation of the information on the labelling so that medicines may be selected and supplied safely and reduce the likelihood of error. This has been well received and many companies have embraced the principles contained therein. Intravenous fluids as described in your report are supplied in bags known as ‘Viaflo’ which are composed of polyolefin/polyamide co-extruded plastic. The way that these containers are manufactured means that ‘judicious use of colour’ (as recommended in our best practice guidance) cannot be used within the labelling, to aid differentiation and reduce the likelihood of error at the point of selection. As a result, other risk minimisation measures must be employed locally within clinical areas to assist in the correct identification of intravenous fluids one from another. Nonetheless, we will consider further with the marketing authorisation holder whether improvements could be made to assist clinical staff to more easily assimilate the statutory information to reduce the likelihood of errors of this nature in future. 1 Yours sincerely Chief Executive, MHRA T E 2
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