Prevention of Future Deaths reports · 2020
Regulation 28 report to prevent future deaths, reference 2020-0199, 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 | 2020-0199 |
| Deceased | Marian Day |
| Coroner | Elizabeth Didcock |
| Coroner area | Nottingham and Nottinghamshire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Sherwood Forest Hospitals NHS Foundation Trust |
| 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) NOTE: This from is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: 1. The Chief Executive- Sherwood Forest Hospitals NHS Foundation Trust (The Trust) 2. ………………………………… 3. …………………………………… 1 CORONER I am Dr Elizabeth Didcock, Assistant Coroner, for the coroner area of Nottinghamshire 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 Twelfth December 2019 I commenced an investigation into the death of Marian DAY aged 73. The investigation concluded at the end of the inquest on the 14th August 2020. The conclusion of the Inquest was a Narrative as follows: Marian Day died from a massive intra- abdominal haemorrhage, secondary to a vascular malformation of the spleen. This was not detected in life. Warfarin, an anticoagulant, given to treat her Atrial Fibrillation was continued in hospital when it should have been omitted, as bleeding was suspected. This prescription error has, on a balance of probability, made a contribution to the haemorrhage. 4 CIRCUMSTANCES OF THE DEATH Mrs Marian Day died at Kings Mill Hospital, Nottinghamshire on the 18th November 2019, following an admission on the 13th November 2019. An initial plan was made in the early hours of the 14th November 2019 to withhold the Warfarin as she had low blood pressure and a likely diagnosis of a gastrointestinal bleed. Later on the 14th Mrs Day moved from the assessment unit to the ward, and despite the Warfarin dose being crossed off on the prescription chart, Warfarin was given that evening. Mrs Day did not have a Consultant review on the ward until the morning of the 16th November, and there was no further recorded discussion of the plan for anticoagulant management. A further dose of Warfarin was given on the evening of the 15th November, when it should have been omitted. There was no written ‘Gastro Intestinal haemorrhage protocol’ document placed in the medical records as would be expected, to help prompt review of the anticoagulant management in this situation, as per hospital guidance. Mrs Day had a sudden collapse on the ward in the early hours of the 18th November. She had a massive bleed into her abdomen at this time, from which she did not recover. 5 CORONER’S CONCERNS The MATTERS OF CONCERNS are as follows: Whilst there has been a detailed Serious Incident review of the circumstances of Mrs Day’s death conducted by the Trust, it remains unclear as to how and why these prescription errors occurred. It is my view that a similar prescription error could occur again, as there remains a number of different charts and documents that allow for muddled prescribing of, or omission of, anticoagulants, when there are complex medical conditions and concern re likely bleeding. Whilst the development of an electronic prescribing system may increase the probability of more clarity in prescription of anticoagulants, this is not in place currently. In addition, this alone in my view will not ensure oversight of anticoagulant management, unless other measures are taken to ensure senior review of patients, and a clear prescription plan recorded for all staff to follow. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you (and your organisation) 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 by 20 November 2020. 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: The family 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, the coroner, at the time of your response about the release or the publication of your response by the Chief Coroner. 9 Elizabeth Didcock, Assistant Coroner Nottinghamshire Dated: 25 September 2020
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.
King’s Mill Hospital
Mansfield Road
Sutton in Ashfield
Nottinghamshire
NG17 4JL
Tel:
Join today: www.sfh-tr.nhs.uk
PRIVATE AND CONFIDENTIAL
Dr Elizabeth Didcock, Assistant Coroner
The Council House
Old Market Square
Nottingham
NG1 2DT
By email only – c/o
Dear Madam,
I am responding to your Regulation 28 Report to Prevent Future Deaths, issued
following the inquest touching the death of Mrs Marian Day. You raised concern
about prescription errors that led to Mrs Day receiving two doses of warfarin on
consecutive days despite there being a medical plan that it should be withheld. You
were concerned that a similar error may occur again in part due to the number of
charts involved in the prescribing and dosing of warfarin. In order to address your
concerns we have undertaken a multidisciplinary (MDT) review of our warfarin
process, prescription and supporting documentation to address these concerns.
Members of the MDT are the Clinical Director of Patient Safety, Assistant Chief
Pharmacist and Medication Safety Officer, the Trust venous thromboembolism lead,
Internal Medicine, Chief
Specialty Registrar Geriatric
Registrar/Emergency Medicine Trainee, Head of Sherwood Forest Hospitals
Governance and the Coagulation Clinical Nurse Specialist team. Prior to this MDT
meeting, further investigation was undertaken into the specific circumstances that led
to each of the two doses of warfarin being prescribed. This is further explained
below.
and General
Current warfarin prescribing and dosing practice at SFH NHS FT
The current practice at Sherwood Forest Hospitals NHS Foundation Trust (SFHFT)
is that warfarin dosing is recorded on a yellow warfarin dosing chart, separate from
the paper ‘Medication Prescription and Administration Record’ which also known as
the ‘main chart’. The warfarin chart is separate from the main chart due to the
complexity of dosing for warfarin which changes depending on the most recent blood
Patient Experience Team
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anticoagulation test result; previous experience demonstrates doses are missed
without this separate chart; and the fact that small numbers of patients are on
warfarin, so this large section would be irrelevant for the vast majority of
patients. SFHT’s warfarin prescription chart is yellow in colour and allows co-located
documentation of the latest blood anticoagulation results (Prothrombin Time
International Normalised Ratio - INR) which guides future prescription and dosing.
The chart also acts as an administration recorded and additional key patient related
information e.g. such as dose prior to admission, dosing responsibility on discharge,
target INR etc. This method of prescribing warfarin is in accordance with widespread
national practice when utilising conventional paper-based prescribing systems.
The Medicine Policy at SFHFT states that the existence of the separate warfarin
chart, along with any other additional charts, must be documented on the front of the
main chart as an aide memoire and quick reference for those involved in the care of
the patient to highlight that additional charts are in existence and must be referred
to. The prescriber is also expected to cross reference the warfarin prescription in the
anticoagulation section of the main chart as the warfarin is written up on the main
chart and the variable daily dose is prescribed each day on the yellow warfarin
dosing chart. If warfarin were to be omitted then it is expected that the warfarin would
be crossed off on the yellow warfarin chart and a coded omission reason
documented on the main chart, this is cross referenced to the “Record of actions
taken after medicine non administration” form at the back of the main chart. This is
evident for the omitted dose on the 16/11/2019 for this case.
In addition warfarin administration traditionally occurs at 6pm across the health
service for both inpatients and for those patients taking it at home. For inpatients
within hospitals, dosing decisions are often made or chased around this time of the
day.
Further investigation into the circumstances of Mrs Day’s warfarin dosing
To obtain further understanding of the prescribing process and decision making
, consultant physician, met with the two
specific to this incident, Dr
doctors who dosed and prescribed the warfarin for Mrs Day. The doctor who
prescribed Mrs Day’s warfarin on the 14th November 2019 was an on call doctor and
not part of the team looking after her care and treatment. Unfortunately she was
unable to recall any aspect of Mrs Day’s care, nor why the warfarin was dosed
despite the plan being to withhold it.
The doctor who prescribed Mrs Day’s second dose of warfarin on 15th November
2019 was able to remember Mrs Day and the rationale behind her prescribing. She
recalled that she was aware that Mrs Day was being managed and investigated for a
possible gastrointestinal bleed but on a risk benefit analysis felt that the patient’s on-
going risk of developing a deep vein thrombosis and potential for a ischaemic stroke
or transient ischaemic attack, outweighed the risk of omitting anticoagulation. As
2
part of this clinical risk assessment the doctor was clear that she had considered at
that time she made the decision that Mrs Day had been stable since admission.
There was also no evidence of on-going melaena (passing altered blood) and her
haemoglobin level and vital signs were stable. Based on her assessment of the
clinical picture at the time, the doctor made a conscious decision to prescribe the
warfarin but in an attempt to mitigate the risk of haemorrhage, deliberately
prescribing a lower warfarin dose. Disappointingly this decision making was not
documented within the medical records.
MDT conclusions
First dose
On reflection, considering particularly the views of the two junior doctors who formed
part of the MDT and are closely involved in warfarin dosing, it is concluded that the
most likely reason that the warfarin was dosed against advice was a lack of easily
accessible information about the plan to omit it. Warfarin dosing is often undertaken
by ward doctors, not from the team most familiar with the patient, as it relies on the
availability of recent INR blood test results. It is concluded that the key factor is to
ensure that doctors dosing warfarin have the up-to-date plan easily available to
them. I set out below actions to put this into effect.
Second dose
The ward doctor on this occasion was familiar with Mrs Day. Whilst she made her
own assessment of the risks and benefits of dosing warfarin that day, her conclusion
differed from the current plan, and does not withstand analysis given that the
suspected GI bleed had not been ruled out. Any change to the plan at this stage
should have been made in consultation with a senior doctor, and been fully
documented.
Immediate further actions
1. Decisions on changes to existing warfarin plans to be documented on the
yellow dosing chart at the time they are made, as well as in the clinical record.
This will ensure that all doctors dosing warfarin are aware of the current plan
even if they are not part of the treating team.
2. Changes to existing warfarin plans to be made only following discussion with
senior doctors, and fully documented.
On-going work
3. Steps to facilitate the parent medical team to dose warfarin whenever
possible. Warfarin has traditionally been dosed and administered around
18.00 as it required the results of INR blood tests taken earlier that day.
3
Advancement of laboratory technology including electronic results makes
most results available earlier in the day. Dosing before the parent team finish
their shift is ideal as they will know their patients’ needs. To achieve this we
are working towards:
a. an MDT approach and the role of the nursing staff in prompting parent
team doctors to prescribe/dose, once INR results are available, before
leaving the ward. This has been discussed at the November Trust
Ward Leaders meeting and individuals identified to take this work
forward.
b. We are exploring the use of the electronic Nervecentre clinical
information system used on the wards to inform ward doctors when
INR results are available, so that they can dose the warfarin as early as
possible.
4. Consideration of the benefits of prompts in the warfarin documentation with
regard to the risks for thrombosis versus the risks of bleeding to aide
prescribing decision making. For discussion at Medicine Safety Group
December 2020 [Assistant Chief Pharmacist and Medication Safety Officer to
Present]
5. Further Education and Awareness:
Ensure all staff are aware that both charts must be amended if withholding
warfarin doses: Learning Matters sent out November 2020. [i-care
electronic communication issued]
Communication programme across
the Trust
to raise awareness.
December 2020.
Add this patient story into training for juniors to highlight the potential
outcome of warfarin prescribing errors: Training updated November 2020
for inclusion in August 2021 junior doctor induction and going forwards.
Add this patient story into training for nurses to highlight the potential
outcome of warfarin administration errors.
6. Pharmacy to audit documentation compliance for the immediate further
actions described above. December 2020 Assistant Chief Pharmacist and
Medication Safety Officer to Conduct
Prescribing documentation
Changes to the existing warfarin prescribing documentation have been carefully
considered. The multi-disciplinary panel verbally risk assessed the possibility of
4
changing the entire process by altering the prescription charts. The differing
expertise outlined that if this was conducted then there would be an increased
likelihood in prescribing and dosing errors affecting patients. Therefore it was
concluded by this expert panel that this would be highly unlikely not to help prevent
future deaths. In addition the roll out of EPMA (electronic prescribing) at SFHFT,
which includes warfarin prescribing, is expected to pilot in February 2021 and
realistically any changes to paper documentation would be highly unlikely to
complete Trust governance processes and printing before this time.
I hope I have been able to describe the seriousness that we have taken matter and
demonstrated a real commitment to improving warfarin dosing safety at SFHFT.
Looking at the problem again using an MDT approach has been a valuable exercise
and I hope that the further actions give you the necessary reassurance.
Yours faithfully
Chief Executive
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