Andrew Nichols

PFD Report All Responded Ref: 2023-0416
Date of Report 27 October 2023
Coroner Nicholas Lane
Coroner Area Worcestershire
Response Deadline ✓ from report 22 December 2023
All 1 response received · Deadline: 22 Dec 2023
Response Status
Responses 1 of 1
56-Day Deadline 22 Dec 2023
All responses received
About PFD responses

Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.

Source: Courts and Tribunals Judiciary

Coroner’s Concerns
1) There seems to be a lack of clarity amongst health and care professionals (certainly those who gave evidence at this inquest) as to whether community organisations receiving patients following discharge from hospital (such as neurorehabilitation centres and care homes) should, as a routine part of their responsibilities, be performing VTE risk assessments.

I was referred to NICE Guidance 89 (Venous thromboembolism in Over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism – published March 2018, updated August 2019), which deals with VTE assessment and procedure for hospital patients, but there is no reference in this guidance to assessments in the community. There is reference in the guidance to patients about to be discharged (paragraph 1.2), but this appears to cover the practicalities of situations where a firm decision has already been made by hospital clinicians that anticoagulation will continue.

I am concerned that hospital clinicians may not be routinely performing VTE assessments as part of discharge planning, on the basis that they believe such assessment will occur in the community placement. However, it is unclear whether (and, based on evidence heard at the inquest, unlikely that) many community organisations are performing such assessments, and instead most will be relying on hospitals to do this.

I am concerned that, as a result, as happened to Andrew, some patients will not have their VTE risk considered when they move from being an in-patient to residing in a community setting. Consideration could be given to making the NICE guidance (NG 89) clearer in respect of the respective responsibilities placed on hospital and community organisations, when a patient is to be discharged from one to the other. Consideration could also be given to the desirability of separate guidance covering VTE risk assessment in community settings, and the potential importance of this to certain groups of patients, particularly those who are immobile and requiring long-term community care.

2) Having heard evidence at the inquest, it was unclear what pathways exist to ensure that organisations come to know of relevant NICE guidance that does, or may, apply to them.

Taking a neurorehabilitation community care centre as an example, some NICE guidance will be completely irrelevant to their practice and need not be considered at all (e.g., NG229 – fetal monitoring in labour), some will be of direct relevance and will require careful consideration (e.g., NG211 – Rehabilitation after traumatic injury), and many others might contain relevant and useful information. Most organisations will have professionals employed in positions (such as Medical Directors or Directors of Safety and Learning) where they (as part of their specific employment responsibilities and through undertaking relevant CPD) will often come to know of relevant guidance and will disseminate accordingly, however this may not always be the case or work as one would hope, particularly perhaps in smaller community-based organisations. Consideration could be given to how NICE shares guidance documents and other relevant information with relevant organisations and whether there exists a sufficient chain of accountability in respect of this.
Responses
National Institute for Health and Care Excellence
22 Jan 2024
NICE plans to review its guideline on venous thromboembolism in over 16s to clarify the continuation of VTE prophylaxis on discharge to community settings. Its implementation support team will also consider delivering specific support on VTE risk assessments and discharge planning, and the external communications team will incorporate lessons into future guidance dissemination. AI summary
View full response
Dear Mr Lane,

I write in response to your regulation 28 report of 27 October 2023 regarding the very sad death of Andrew Nichols. I would like to express my sincere condolences to his family.

Having reviewed the report, we agree that our guideline on venous thromboembolism in over 16s [NG89] is relevant to this case.

Regarding your concern that there is a lack of clarity in the guideline regarding continuation or review of anticoagulation therapy on discharge to community-based hospital settings, we note that section 1.2 of the guideline covers giving information and planning for discharge.

We recommend that as part of the discharge plan patients and their family or carers should be given written and verbal information on the signs and symptoms of deep vein thrombosis (DVT) and pulmonary embolism and the importance of seeking help if DVT, pulmonary embolism or other adverse events are suspected. Further information should be provided on the importance of using VTE prophylaxis correctly (including the correct administration and disposal of pharmacological prophylaxis) and to ensure that people are able to use this treatment effectively, or have arrangements made for someone to be available who will be able to help them.

We recommend that the person's GP should be notified if the person has been discharged with pharmacological and/or mechanical VTE prophylaxis to be used at home, however we recognise that there is no specific reference to managing the continuation of anticoagulation therapy in community settings.

To address this we propose to review the guideline to see if it can be updated to cover the issue of continuing VTE prophylaxis on discharge so that inpatient anticoagulation prescriptions for VTE prophylaxis are converted to ongoing anticoagulation where required, ensuring that the intention cannot be misinterpreted.

To further support the implementation of this guideline NICE’s implementation support team will consider the delivery of support on VTE risk assessments and discharge planning with a specific focus on anticoagulation.

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Regarding your suggestion that consideration could be given to how NICE shares guidance documents and local accountability for keeping up to date with new guidance, I have asked our external communications team to reflect on the issues raised by the report, to incorporate any lessons into NICE’s approach to future guidance dissemination.

Of course, there is a responsibility on local commissioners and providers for having systems and processes in place to reviewing NICE guidance at publication and considering relevance to their setting. We encourage health and social care professionals to register to receive our newsletters and alerts to keep abreast of consultations, updates and the publication of new guidance.

Please do let me know if you require any further information and, again, I offer my sincerest condolences to Mr Nichols’ family.
Report Sections
Investigation and Inquest
On 7 July 2022 an investigation was commenced into the death of Andrew Etlered Nichols. The investigation concluded at the end of the inquest hearing on 25 October 2023 at Stourport Coroner’s Court, in the Worcestershire Coroner Area. The conclusion (a ‘narrative’ conclusion in Section 4 of the Record of Inquest) was determined as follows:

‘Andrew Nichols died as a direct result of blood clots forming in the vein of his leg and circulating to block the veins of his lungs. Andrew not receiving anticoagulation medication when discharged from hospital contributed to his death. Andrew’s immobility, which had occurred as a result of a very rare side-effect following vaccination, contributed to his death.’
Circumstances of the Death
Andrew Nichols was in his early fifties (he was 52 when he died in June 2022), with no significant past medical history, when he received a vaccination in April 2021, as part of the national programme in response to the Covid-19 pandemic. Andrew suffered an extremely rare and serious side-effect of vaccination, and within days developed the neurological condition acute disseminated encephalomyelitis (known as ADEM).

In consequence, Andrew spent over a year in hospital, mostly in intensive care, as he required respiratory, nutrition and organ support and was wholly dependent on professionals for daily care. Andrew was immobile and required hoisting when being moved out of bed. Early on in his hospital admission, Andrew suffered bilateral pulmonary emboli, which were thought to have developed owing to him having become acutely unwell and immobile (not vaccine-induced thrombotic thrombocytopaenia (VITT)). Andrew was commenced on anticoagulation medication and this continued during his stay in hospital.

At the inquest, evidence was given by a consultant haematologist, who stated that, owing to Andrew having two specific risk factors for the development of deep vein thrombosis (namely ongoing immobility and previous thrombosis/emboli), anticoagulation medication would remain clinically indicated, whether he remained in hospital or not. In May 2022, Andrew was discharged from hospital to a specialist neuro-rehabilitation community care centre. Upon discharge, the hospital did not include anticoagulation medication in the list of prescribed medication that Andrew should continue to receive in the community. At the inquest, the hospital accepted that to not do so was a failing on their behalf. It was not clear why this failing happened; however, a finding was made that the most likely reason was that clinicians routinely considered anticoagulation medication was prescribed for patients in hospital, but an assessment of whether it would continue to be required in the community would be made by professionals involved there. Andrew attended a different acute hospital on two further occasions (these were short admissions to provide respiratory support and to treat and monitor infection) later in May, and then in June 2022 – once again, Andrew received anticoagulation medication during his stay in hospital, but not upon discharge.

The inquest heard that the neurorehabilitation community care centre did not, at the time of Andrew’s death, perform their own assessments on new patients’ risk of venous thrombosis (VTE risk assessment), but instead were reliant on information being provided by hospitals and would facilitate prescribed medication being given to patients (including anticoagulation medication), in accordance with discharge information. The centre now has a new policy in place, requiring VTE risk and assessment to be considered when patients are discharged from hospital into their care. The inquest heard evidence from the Director of Services at the centre, who stated that she had spoken to colleagues at other similar community care organisations, who also did not routinely carry out VTE risk assessments on patients, as part of their practice.

Andrew suffered a fatal deep vein thrombosis and pulmonary embolism at the neurorehabilitation centre on 27 June 2022.

Following medical evidence heard at the inquest, the cause of death was determined in Section 2 of the Record of Inquest as:

1a – pulmonary embolism 1b – deep vein thrombosis 2 – acute disseminated encephalomyelitis (vaccine-induced)

Section 3 of the Record of Inquest (which answered how, when and where Mr Nichols came by his death) was determined as follows:

‘Andrew Nichols had no significant medical history at the time he received a vaccination in April 2021, as part of the national programme in response to the Covid-19 pandemic. Within a few days, Andrew became very unwell and was diagnosed with acute disseminated encephalomyelitis (ADEM), a severe neurological condition which had developed as a side-effect of vaccination. Andrew received specialist care for over a year, primarily in hospital, but latterly at a neuro-rehabilitation centre. Andrew had been prescribed anticoagulant medication whilst in hospital, owing to his immobility and risk of developing blood clots. Andrew should have continued to receive this medication, however, upon discharge from hospital to the rehabilitation centre, he did not. Andrew became acutely unwell on 27 June 2022, going into cardiac arrest. Despite prolonged attempts at resuscitation by nursing and paramedic professionals, Andrew was pronounced deceased later the same day, upon arrival at the Worcestershire Royal Hospital.’
Copies Sent To
these being University Hospitals Birmingham NHS Trust Inspire Neurocare Worcester Medicines and Healthcare Products Regulation Agency (MHRA)
Inquest Conclusion
‘Andrew Nichols died as a direct result of blood clots forming in the vein of his leg and circulating to block the veins of his lungs. Andrew not receiving anticoagulation medication when discharged from hospital contributed to his death. Andrew’s immobility, which had occurred as a result of a very rare side-effect following vaccination, contributed to his death.’
Related Inquiry Recommendations

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Publish Exercise Reports and Lessons
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Apply best offer principle equally in GLOS
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.