Prevention of Future Deaths reports · 2016
Regulation 28 report to prevent future deaths, reference 2016-0368, written 18 Oct 2016. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 18 Oct 2016 |
|---|---|
| Reference | 2016-0368 |
| Deceased | Captain James Bedforth |
| Coroner | Christopher Dorries |
| Coroner area | South Yorkshire (West) |
| 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 REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: The Chief Executive, Barnsley Hospital NHS Foundation Trust 1 CORONER Christopher Dorries, senior coroner for South Yorkshire (West) 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. (1) Where – (a) A senior coroner has been conducting an investigation under this Part into a person’s death and (b) Anything revealed by the investigation gives rise to a concern that circumstances creating a risk of other deaths will occur, or will continue to exist, in the future, and (c) In the coroner’s opinion, action should be taken to prevent the occurrence or continuation of such circumstances, or to eliminate or reduce the risk of death created by such circumstances, the coroner must report the matter to a person who the coroner believes may have power to take such action. (2) (3) A person to whom a senior coroner makes a report under this paragraph must give the senior coroner a written response to it. A copy of a report under this paragraph, and of the response to it, must be sent to the Chief Coroner INVESTIGATION and INQUEST On 30th June 2015 I commenced an investigation into the death of Captain James Michael Bedforth. The investigation concluded at the end of the inquest on 7th September 2016. The conclusion of the inquest was that Captain Bedforth died from 1(a) Cerebral haemorrhage 1(b) Significant pulmonary embolus and paradoxical embolus to the brain (treated) 1(c) Deep vein thrombosis (left) A narrative conclusion was recorded as follows: Captain James Michael Bedforth died at the Barnsley Hospital on 30th June 2015 in consequence of treatment given to him, in accordance with the hospital protocol, for a pulmonary embolus including a paradoxical embolus to the brain. 1 4 CIRCUMSTANCES OF THE DEATH Captain Bedforth was a senior long haul airline pilot. Such an occupation obviously involves prolonged seated immobility although there is some opportunity for movement. On the 18th April 2015 he attended the hospital at Barnsley with pains in his left leg around the knee. Appropriate investigations were made (in accordance with NICE guidelines) which included scanning of the upper but not lower leg. Nothing was found and Captain Bedforth was discharged. On 29th June 2015 Captain Bedforth collapsed at his home some hours after a flight from China. He was admitted to the hospital with classical symptoms of a DVT and much was said at the inquest about the promptness or otherwise of initial examination and diagnosis. The Trust were represented at the inquest and a full reasoned conclusion was subsequently given so those matters are not covered in detail here but will be mentioned in section 5 of this report below. The captain further collapsed at approximately 1445 and was treated with Alteplase. A CT scan showed pulmonary embolus and an early left sided cerebral infarction due to a paradoxical embolism. Heparin treatment was subsequently given (and stopped at 2235). The Captain deteriorated markedly after a seizure at 2345,. A further CT showed an unsurvivable left sided acute cerebral haemorrhage. The inquest found a strong inference that this had arisen from over-anticoagulation with Heparin (again see section 5 below). Death occurred at 1145 the following morning 30th June 2015. 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 MATTER OF CONCERN are as follows: 1. The inquest heard that the scanning practice followed after the first attendance was in accordance with NICE guidelines (indeed possibly a little in excess of the guidance) which did not include scanning of the lower leg. This was said to be on the basis that not all lower leg DVTs will be visible. Yet it became apparent that that there is mixed practice on this point, some hospitals clearly consider that lower leg scanning is worthwhile. Hindsight strongly suggested that Captain Bedforth was developing clots in the left lower leg at the time of the first visit. The inquest found that a full leg scan might have provided the hospital with an opportunity to treat Captain Bedforth although it was accepted that no-one could be certain of this. Whilst a separate Regulation 28 report is being sent to the Secretary of State for Health seeking further consideration of the NICE guidelines on lower leg scanning, the Trust may wish to consider their own practice on this point in the meantime. The Trust may also wish to consider whether discharge after a negative scan may be more closely supervised by a doctor in certain circumstances 2. The evidence of 'safety-netting' after the first attendance (and/or subsequent attendance for scans) was poor and of considerable concern. As made clear in my written findings this was possibly of relevant as to Captain Bedforth's subsequent decision on seeking medical attention in or upon return from China. 3. Whilst it is accepted that Emergency Departments are often busy, and sometimes exceptionally so, there was criticism at the inquest of the priority given to Captain Bedforth on his second admission when he was displaying classical symptoms of a DVT/PE. It appears that he was not medically assessed for at least two and a half hours after admission by ambulance. Dalteparin was not prescribed until 2 three hours post-admission and there was no evidence as to exactly when it was given (although likely shortly thereafter). 4. An expert witness (an ED physician) was critical of the placement in AMU and clerking in by a medical student although it is not suggested this of itself made a difference as to survival. 5. There was no criticism of the use of 50mg Alteplase but there was a lack of clarity as to whether this was followed by an infusion. A further expert witness (a haematologist) criticised the subsequent use of unfractionated Heparin and a test of Heparin level seems to have taken a long time from sampling to delivery to the laboratory and later result. The evidence was strongly suggestive of over- anticoagulation by Heparin. 6. A number of issues were raised as to note-keeping or clarity of note-keeping, most particularly as regards delivery of medications. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe the Trust has 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 by 4th January 2017. I may extend this period, if asked, particularly given the Christmas break. 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: The family of Captain Bedforth The Care Quality Commission The Civil Aviation Authority British Airways 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 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 at the time of your response, about the release or publication of your response by the Chief Coroner. 9 18th October 2016 Christopher P. Dorries OBE HM Senior Coroner South Yorkshire (West) 3
Gawber Road
Barnsley
S75 2EP
Tel: 01226 730000
Fax: 01226 202859
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4 January 2017
Mr C P Dorries
Senior Coroner
South Yorkshire West Area
Medico Legal Centre
Watery Street
Sheffield
S3 7ES
Our Reference: RJ/KAD - Captain Bedforth
Your Reference: CPD – Regulation 28 – Captain Bedforth
Dear Mr Dorries
Captain James Bedforth Inquest - Regulation 28 Prevention of Future Death Response
I am writing in response to your Regulation 28 Report to Prevent Future Deaths received at
the Trust on Tuesday 25 October 2016 relating to the inquest of Captain James Bedforth.
Regarding our response I will follow the same numbering as set out in your report, I will not set
out each of your concerns but respond to them below.
1. The current NICE guidance for Venous Thromboembolism advises proximal leg USS
investigation for those patients who are high risk based on Wells scoring and those who are
low risk with a positive D-dimer. If negative, the patient should undergo a second proximal leg
USS in 6-8 days time to exclude proximal propagation of a clot from a distal DVT. The
rationale behind the NICE guidance is evidence-based following multiple studies.
The hospital has decided it will not change its processes on the basis that in Captain
Bedforth’s case it would be more likely than not that the distal leg USS would not have had
any impact as distal leg USS does not detect all DVTs that are present. No combination of
tests can rule out disease in 100% of cases and a lower leg scan may also have been falsely
reassuring. It is evident from this particular case that consideration could have been given for
treating Captain Bedforth despite the normal USS given that this case may be one of that
small minority of cases where USS is falsely negative. However, treating patients without
confirmatory evidence of a DVT creates a separate set of risks as this would expose
significant numbers of patients to unnecessary anticoagulation.
In relation to your concern regarding the discharge of a patient like Captain Bedforth following
a negative scan and whether he requires close supervision by a doctor, this practice is already
in place and is triggered by the Thrombosis nurse. The process is that if the Thrombosis
Service Sister has concerns regarding a patient they are referred to the consultant for review
in the DVT clinic. The Thrombosis Sister has stated that Captain Bedforth’s case is the first
case of its kind she has been aware of in the last 15 years. We will be interested to see
whether national guidance changes following your letter and would adapt our local guidelines
accordingly, if so.
2. There is a Patient Information Sheet for patients who have attended hospital for
investigation for deep vein thrombosis or pulmonary embolism. (Attached) This sheet is
handed to all such patients at discharge, along with verbal advice provided by our specialist
nurses. The Thrombosis nurses now record in their notes that an information sheet has been
given to the patient. This will be audited to assess compliance.
3. In the Emergency Department (ED) there is now a consultant in the new assessment hub
area, which should speed up the diagnosis and management of someone presenting in this
way. The Short-Term Assessment of Risk and Treatability Hub (START) runs between the
hours of 09:00 and 16:00 hours and is consultant led. The START consultant will provide a
senior ‘front of house’ service to assist with the initial assessment and ensure the appropriate
diagnostic testing is undertaken at the earliest opportunity. The Consultant will work alongside
the assessment hub staff in ensuring a safe and rapid assessment process. The consultant
predominantly receives patients arriving by ambulance, however patients that also ‘self
present’ can be seen on START, if they are unwell, have an elevated NEWS score or require
treatment within one hour.
4. We have and continue to ensure there are sound processes in all clinical areas regarding
prompt escalation of unwell patients. This is covered on the induction programme for all
medical students who are very familiar with the need to escalate if they see someone who is
acutely unwell. We have also recently introduced an Acute Response Team of Advanced
Nurse Practitioners who rapidly attend to support wards with patients who deteriorate. We
have also invested in the VitalPac electronic observation system that has been demonstrated
in other Trusts to improve the recognition and response for sick patients.
5. The Trust has altered the Thrombolysis PE guideline – amongst the changes we have
addressed the concerns about checking whether heparin had been administered previously
and to carefully check and monitor the APTT ratio. A copy of the revised guidance is attached
for your information
In relation to your query surrounding the time taken for sampling to be delivered to the
laboratory and provision of the result, this query was covered in the Serious Incident (SI)
investigation report and I quote that part of the SI Report for your assistance.
“The sample for APTT testing was timed as being collected from ICU at 19.58hrs, but
the sample was not taken until 21.15hrs and not received by pathology until 21.24. The
results were reported to ICU at 22.35hrs, so an apparent delay of 2 hours and 37
minutes seemed to have occurred.
However, when the Lead Nurse on ICU was asked about this as part of the SI
investigation, she explained that ICU staff pre-prepare for testing of bloods, which was
why the test indicated the time 19.58hrs.”
Page 2 of 3
This means that the form was completed in advance at 19:58 hours and the time taken from
collection to report was actually 1 hour 20 minutes not 2 hours 37 minutes.
6. The new Thrombolysis protocol (see point 5) prompts the doctor to ensure that heparin hasn’t
already been given, for example in the ED. We aim to introduce an electronic prescribing system in
2017 that would allow doctors to more easily identify what drugs have already been given.
I hope the above is of assistance, if you wish to discuss this matter please do not hesitate to contact
me.
Yours sincerely
Medical Director
Enc
Page 3 of 3
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: The Secretary of State for Health 1 CORONER Christopher Dorries, senior coroner for South Yorkshire (West) 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. (1) Where – (a) A senior coroner has been conducting an investigation under this Part into a person’s death and (b) Anything revealed by the investigation gives rise to a concern that circumstances creating a risk of other deaths will occur, or will continue to exist, in the future, and (c) In the coroner’s opinion, action should be taken to prevent the occurrence or continuation of such circumstances, or to eliminate or reduce the risk of death created by such circumstances, the coroner must report the matter to a person who the coroner believes may have power to take such action. (2) (3) A person to whom a senior coroner makes a report under this paragraph must give the senior coroner a written response to it. A copy of a report under this paragraph, and of the response to it, must be sent to the Chief Coroner INVESTIGATION and INQUEST On 30th June 2015 I commenced an investigation into the death of Captain James Michael Bedforth. The investigation concluded at the end of the inquest on 7th September 2016. The conclusion of the inquest was that Captain Bedforth died from 1(a) Cerebral haemorrhage 1(b) Significant pulmonary embolus and paradoxical embolus to the brain (treated) 1(c) Deep vein thrombosis (left) A narrative conclusion was recorded as follows: Captain James Michael Bedforth died at the Barnsley Hospital on 30th June 2015 in consequence of treatment given to him, in accordance with the hospital protocol, for a pulmonary embolus including a paradoxical embolus to the brain. 1 4 CIRCUMSTANCES OF THE DEATH Captain Bedforth was a senior long haul airline pilot. Such an occupation obviously involves prolonged seated immobility although there is some opportunity for movement. On the 18th April 2015 he attended the hospital at Barnsley with pains in his left leg around the knee. Appropriate investigations were made (in accordance with NICE guidelines) which included scanning of the upper but not lower leg. Nothing was found and Captain Bedforth was discharged. On 29th June 2015 Captain Bedforth collapsed at his home some hours after a flight from China. He was admitted to the hospital with classical symptoms of a DVT but further collapsed a few hours later and was treated with Alteplase. A CT scan showed pulmonary embolus and an early left sided cerebral infarction due to a paradoxical embolism. Heparin treatment was subsequently given (and stopped at 2235). The Captain deteriorated markedly after a seizure at 2345. A further CT showed an unsurvivable left sided acute cerebral haemorrhage. The inquest found a strong inference that this had arisen from over-anticoagulation with Heparin. Death occurred at 1145 the following morning 30th June 2015. 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 MATTER OF CONCERN for the Secretary of State to consider is as follows: The inquest heard that the scanning practice followed after the first attendance was in accordance with NICE guidelines (indeed possibly a little in excess of the guidance) which did not include scanning of the lower leg. This was said to be on the basis that not all lower leg DVTs will be visible. Yet it became apparent that that there is mixed practice on this point, some hospitals clearly consider that lower leg scanning is worthwhile. Hindsight strongly suggested that Captain Bedforth was developing clots in the left lower leg at the time of the first visit. The inquest found that a full leg scan might have provided the hospital with an opportunity to treat Captain Bedforth although it was accepted that no-one could be certain of this. The Secretary of State for Health is asked to consider whether it is appropriate for further research to be conducted as to the question of lower leg scanning. Note that a separate Regulation 28 report is being sent to The Chief Executive at the Hospital in Barnsley relating to 'safety netting' on the first visit, possible delay following the second admission and anti-coagulation practice. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you have the power to take such action. 2 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 4th January 2017. I may extend this period, if asked, particularly given the Christmas break. 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: The family of Captain Bedforth The Chief Executive, Barnsley NHS Foundation Trust The Civil Aviation Authority British Airways The Care Quality Commission 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 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 at the time of your response, about the release or publication of your response by the Chief Coroner. 9 18th October 2016 Christopher P. Dorries OBE HM Senior Coroner South Yorkshire (West) 3
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.
RR Philip Dunne MP Minister of State for Health Department of Health Richmond House Our ref: 1055768 79 Whitehall Your ref: swin one Mr Christopher Dorries Tel 020 7210 4890 HM Senior Coroner South Yorkshire (West) The Medico-Legal Centre Watery Street Sheffield S3 7ET 22 February 2017 Thank you for your letter of 18 October 2016 following the inquest into the death of Captain James Michael Bedforth. I am responding as the Minister with responsibility for hospital care at the Department of Health. I was sorry to hear of Captain Bedforth’s death. Please extend my condolences to his family and loved ones. Your report explained that Captain Bedforth attended hospital in Barnsley on 18 April 2015 with pains in his left leg around the knee. Appropriate investigations were made (in accordance with NICE guidelines) which included scanning of the upper but not lower leg. Nothing was found and the patient was discharged. On 29 June 2015 Captain Bedforth collapsed at his home following a long flight. He was admitted to hospital with symptoms of Deep Vein Thrombosis (DVT) where his condition worsened. Following a CT scan Captain Bedforth was treated with Heparin, but his condition deteriorated markedly after a seizure late that evening. A further CT scan showed an unsurvivable left sided acute cerebral haemorrhage. The inquest found a strong inference that this had arisen from over-anticoagulation with Heparin. Captain Bedforth died the following morning, 30 June 2015. You asked that the Department of Health considers whether it is appropriate for further research to be conducted as to the question of lower leg scanning. The inquest heard that the scanning practice followed after Captain Bedforth’s first attendance in April 2015, was in accordance with NICE guidelines which do not include scanning the lower leg. As it became apparent there is mixed clinical practice on this point, your view is that some hospitals consider that lower leg scanning is worthwhile. As most hospitals are, or should be, working to NICE guidelines, I therefore advised that you should consider inviting NICE to respond to this case directly. My officials provided you with contact details and I understand that NICE are looking into this and will respond directly to you and copy me into their reply. I have also consulted the Royal Society of Medicine Venous Forum (RSMVF) and asked for their comments on this case. RSMVY advises that it is not possible, without full clinical details on Captain Bedforth’s case, for them to comment on the specifics or ascertain whether the detailed recommendations of NICE clinical guidelines (CG144) were followed. However, RSMVF also points out that the evidence for treating distal DVT alone is weak and cites a recent CACTUS trial (lancet haematology 2016) which showed no benefit in treating symptomatic below knee DVT. RSMVF is of the opinion that that even if Captain Bedforth had had a full leg scan, and had been found to have a below knee DVT in April 2015, the evidence is not clear on whether he should have been immediately anticoagulated at that time. As such RSMVF also recommend that these issues be referred to NICE for comment as the type of scanning used for these investigations originated with the NICE guideline (CG144). I hope this reply is helpful and I am grateful to you for bringing the circumstances of Captain Bedforth’s death to my attention. I am copying this letter to Sir Andrew Dillon, Chief Executive of NICE. PHILIP D
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