Prevention of Future Deaths reports · 2024

Nuliyati Businje

Regulation 28 report to prevent future deaths, reference 2024-0441, written 23 Apr 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report23 Apr 2024
Reference2024-0441
DeceasedNuliyati Businje
CoronerVictoria Davies
Coroner areaCheshire
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Sourcejudiciary.uk record · original PDF
Responses published2

The report

Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.

Regulation 28: REPORT TO PREVENT FUTURE DEATHS

NOTE: This form is to be used after an inquest.

REGULATION 28 REPORT TO PREVENT DEATHS
THIS REPORT IS BEING SENT TO:

1 National institute for health and care excellence NICE
2 Department of Health Regulation 28

1 | CORONER

Iam Victoria DAVIES, Area Coroner for the coroner area of Cheshire

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 21 April 2017 I commenced an investigation into the death of Nuliyati BUSINJE aged 52.
The investigation concluded at the end of the inquest on 18 April 2024. The conclusion of
the inquest was that:

Narrative Conclusion - Nuliyati Businje died as a result of a massive pulmonary
thromboembolism (clot) for which there were a number of factors:

- Fluid monitoring was inadequate and the lack of a plan to address this probably caused or
contributed to death.

- Nuliyati's lack of compliance for diabetes treatment and absence of a plan to address this
possibly caused or contributed to her death.

- The plan and management from 7 April onwards when Nuliyati's blood sugars were high
and uncontrolled with the use of insulin, and when significant changes in her vital signs
were seen, and a lack of referral, probably caused or contributed to her death.

4 | CIRCUMSTANCES OF THE DEATH

Ms Businje was an inpatient on a psychiatric unit, sectioned under the Mental Health Act.
On admission, her VTE risk was assessed and, on the basis that her mobility was not
significantly reduced from her baseline, she was deemed to be not at risk and no VTE
prophylaxis was given. During her admission she was accepting only limited diet and fluids,
and was refusing medication for her diabetes. 8 days into her admission, her physical
observations became abnormal (NEWS 7 which included a blood pressure which could not
be obtained) and her blood sugar levels were high (20+mmols). The on call doctor was
called, who repeated her observations and found these to be normal (NEWS 0). Insulin
was given but that evening her blood sugar continued to rise, resulting in an increased dose
in insulin. On day 10 of her admission, her blood sugar reading was over 33.1mmols and
she subsequently suffered a cardiac arrest. The post mortem examination found a massive
pulmonary embolus, due to deep venous thrombosis.

Expert evidence was obtained from a consultant physician and he gave oral evidence in
court. He explained that Ms Businje had a number of risk factors for DVT, including
dehydration, her age and obesity. In his view, the risk assessment should not have
stopped once significantly reduced mobility was ruled out, as her other risk factors would
necessitate the need for VTE prophylaxis. He was surprised when it was pointed out to him
that the Department of Health VTE risk assessment tool in place then (2017) and still in
place now suggests there is no need for further assessment. A consultant psychiatrist on

Regulation 28 — After Inquest
Document Template Updated 30/07/2021

behalf of the Trust gave evidence that there is a growing body of research which indicates
that psychiatric patients on a ward are also at higher risk of DVT and as such they have
amended their local assessment tool to consider other factors over and above mobility.

CORONER’S CONCERNS

During the course of the investigation my inquiries revealed matters giving 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 are as follows:
(brief summary of matters of concern)

1. Despite evidence to suggest that mobility is not the ultimate deciding factor of risk of
DVT, the risk assessment tool as currently drafted and relied upon by clinicians would
suggest that there is no further need for assessment. This raises a risk of future deaths for
those patients such as Ms Businje who were at risk of VTE, or those with cancer for
example, but who do not have significnstly reduced mobility and would therefore fall
outside of the risk assessment.

2. Based on the evidence I heard, patients on a psychiatric unit are at increased risk of DVT
but this is not factored into the risk assessment, nor the NICE guidance. The latter
guidance has a specific section for psychiatric patients but does not provide any specific
information as to risk and directs the reader to the same Department of Health risk
assessment tool.

3. Based on the evidence of the expert physician, a common presentation of a clot can be
a derangement in observations such as respiratory rate and heart rate, but these can
normalise as the clot passes further on and the blockage eases. I am concerned that this
does not appear to be widely known, is not part of training at least in the Trust in this case
due to the lack of awareness, and I am told is not something which is taught nationally.
There is a risk that a clinician without this knowledge would, as in this case, be reassured
by the improving observations and the clot, and risk of a further more serious clot, would
be overlooked.

ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and I believe you (and/or
your organisation) have the power to take such action.

YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this report,
namely by June 18, 2024. 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.

COPIES and PUBLICATION

I have sent a copy of my report to the Chief Coroner and to the following Interested
Persons

Solicitor for the family-
Solicitor for
Solicitor for

Solicitor for Cheshire and Wirral Partnership NHS T-

I have also sent it to

Regulation 28 — After Inquest
Document Template Updated 30/07/2021

who may find it useful or of interest.

I am also under a duty to send a copy of your response to the Chief Coroner and all
interested persons who in my opinion should receive it.

I may also send a copy of your response to any person who I believe may find it useful or
of interest.

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.

Dated: 23/04/2024

Dawes

Victoria DAVIES
Area Coroner for
Cheshire

Regulation 28 — After Inquest
Document Template Updated 30/07/2021

Responses

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.

Response from Dhsc (PDF)
Parliamentary Under-Secretary of State for 
Patient Safety, Women’s Health and Mental Health

39 Victoria Street 
London 
SW1H 0EU 

 22 July 2024 

Our Ref: 

Victoria Davies 
Area Coroner 
Cheshire's Coroner's Service
Museum Street
Warrington
Cheshire WA1 1JX

By email: 

Dear Victoria,

Thank you for your Regulation 28 report to prevent future deaths dated 23 April 2024 about 
the death of Nuliyati Businje, and I’d like to thank you for agreeing an extension. I am replying 
as the newly appointed Minister with responsibility for mental health and patient safety.     

Firstly, I would like to say how saddened I was to read of the circumstances of  Nuliyati’s 
death and I offer my sincere condolences to her family and loved ones. The circumstances 
your  report  describes  are  deeply  concerning  and  I  am  grateful  to  you  for  bringing  these 
matters to my attention.  

Your report raises concerns over the assessment of the risk of deep vein thrombosis (DVT) 
amongst psychiatric inpatients and the guidance on this provided by the National Institute 
for Health and Care Excellence (NICE). 

It is essential that mental health settings meet inpatients' physical as well as mental 
healthcare needs either through their own appropriately qualified and experienced staff or 
in partnership with other providers. This requires mental health inpatient staff to be 
provided with adequate training and guidance on monitoring physical health, and 
importantly how to escalate and respond to concerns as needed. 

It  is  recognised  that  inpatients  on  psychiatric  wards  may  be  at  higher  risk  of  venous 
thromboembolism due to reduced mobility, poor fluid intake, restraint, catatonia, sedation 
and antipsychotic use. NICE’s guidance on Venous thromboembolism in over 16s: reducing 
the risk of hospital-acquired deep vein thrombosis or pulmonary embolism (NG89) makes 
clear that all acute psychiatric patients should be assessed to identify VTE and bleeding risk 
on admission, using a risk assessment tool. The Department will work with NHS England to 
consider the VTE risk assessment tool, in light of the concerns you have raised. 

I note that you have also written directly to NICE.  As NICE is an independent body, it will 
be for NICE to review its current guidance to see if any updates are needed and I would 
expect that NICE will want to take your concerns into account as part of this process. 

 I  hope  this  response  is  helpful  and  demonstrates  my  sincere  desire  to  improve  care  for 
patients  so  we  can  avoid  such  tragedies  from  occurring.  Thank  you  for  bringing  these 
important concerns to my attention.   

Yours sincerely,
Response from Nice (PDF)
NIC National Institute for 24 Floor
Health and Care Excellence 2 Redman Place
London

E20 1JQ

United Kingdom

+44 (0)300 323 0140

18 June 2024

Ms Victoria Davies

Area Coroner for the coroner area of Cheshire
Cheshire Coroner’s Service

Museum Street

Warrington

Cheshire

WA1 1JX

Your ref:
Our ref:
Dear Ms Davies,

| write in response to your regulation 28 report of 23 April 2024 regarding the very sad death of Ms
Nuliyati Busunje. | would like to express my sincere condolences to Ms Busunje’s family.

We have reflected on the circumstances surrounding to Ms Busunje’s death and the concerns raised
in your report.

With regard to the assessment of VTE risk in people with psychiatric disorders admitted to hospital, in
the NICE guideline on venous thromboembolism in over 16s: reducing the risk of hospital-acquired
deep vein thrombosis or pulmonary embolism we recommend that clinicians should use ‘a tool
published by a national UK body, professional network or peer-reviewed journal’ to assess VTE risk,
however we do not recommend a particular risk assessment tool as there is not enough evidence to
support the use of one over another and during development of the guideline, the committee made a
research recommendation in this area, reflecting the uncertainty in the evidence for one risk tool over
another.

The Department of Health’s national risk assessment for VTE, highlighted in recommendation 1.9.1,
has been widely used in the NHS to assess a person’s risk of VTE since 2010, however it has not
been validated or tested against other tools to evaluate its diagnostic accuracy or effectiveness at
correctly identifying people at risk of VTE.

As such, we explain that the tool is commonly used to develop a treatment plan for psychiatric
patients. However, clinicians can and should choose a different tool if it better fits the clinical
circumstances of the patient.

Concerns regarding the risk assessment tool referenced in NG89 would need to be directed to the
Department of Health and Social Care.

We agree that people with psychiatric disorders may be at risk of developing venous
thromboembolism, particularly when acutely unwell and admitted to hospital, and that that risk
assessment should not stop once significantly reduced mobility has been ruled out as other risk
factors may be present.

The committee recognised that the risk of VTE in these patients may be due to the presence of
several risk factors including reduced mobility due to psychiatric illness or sedation, but also
dehydration due to poor oral intake, or comorbid physical illness, and this should be included in the
risk assessment. The committee also noted that as with other populations, prophylaxis decisions for

NICE www.nice.org.uk | nice@nice.org.uk

psychiatric inpatients should be clearly documented and they should be reassessed throughout their
stay as it likely that their clinical condition could change unexpectedly.

We believe that our recommendations for assessment and review cover the clinical circumstances
outlined in your report. In NG89 we recommend that all people admitted to an acute psychiatric ward
should be assessed for risk of VTE at consultant review or if their clinical condition changes
(recommendation 1.9.2). Further, we recommend that clinicians should consider pharmacological
VTE prophylaxis for people admitted to an acute psychiatric ward whose risk of VTE outweighs their
risk of bleeding and that this should be continued until the person is no longer at risk
(recommendations 1.9.3 and 1.9.5).

We note the observations of the consultant physician regarding a growing body of research which
indicates that psychiatric patients on a ward are at higher risk of DVT. As discussed above, the risks
pertaining to this population were discussed by the committee and is reflected in our
recommendations. We are aware of a recent retrospective study which showed no difference in the
VTE rates following psychiatric inpatient admission compared to unselected acute medical admission.

The signs and symptoms of a pulmonary embolus (PE) are discussed in the Clinical Knowledge
Summary on Pulmonary Embolus. This notes that the signs and symptoms of pulmonary embolism
are non-specific, but symptoms typically have a sudden onset, and that PE may be completely
asymptomatic and be discovered incidentally when assessing for another condition. The
recommendations on when to suspect PE is based on clinical features of PE described in the NICE
and European Society of Cardiology (ESC) guidelines [NICE, 2023; Konstantinides, 2020] and the
BMJ Best Practice guide [BMJ Best Practice, 2022].

NICE recommends considering using the Pulmonary embolism rule-out criteria (PERC) rule if clinical
suspicion of PE is low, based on the overall clinical impression, and if other diagnoses are feasible.
However, given the non-specific nature of presenting symptoms, clinicians need to have a high level
of suspicion in people with risk factors for PE.

Again, | offer my sincerest condolences to Ms Busunje’s family.

Yours sincerely,

Chief Executive

Page | 2

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