Source · Prevention of Future Deaths

Marian Hoskins

Ref: 2019-0005 Date: 9 Jan 2019 Coroner: Alison Hewitt Area: City of London Responses identified: 1 / 1 View PDF

An unclear system for obtaining full and informed consent, particularly lacking sufficient outpatient discussion prior to admission, led to insufficient patient information on investigatory options.

Date 9 Jan 2019

56-day deadline 18 Jul 2019 est.

Responses identified 1 of 1

Hospital Death (Clinical Procedures and medical management) related deaths

Coroner's concerns

AI summary

An unclear system for obtaining full and informed consent, particularly lacking sufficient outpatient discussion prior to admission, led to insufficient patient information on investigatory options.

View full coroner's concerns

The MATTER OF CONCERN is as follows : As stated above, at the Inquest I found that in October 2016 the Deceased was admitted to St Bartholomew’s Hospital having suffered an acute non-ST elevation myocardial infarction and she was treated by percutaneous stenting of the right coronary artery. Moderate to severe stenosis in the left anterior descending artery was noted and a plan was made for investigative pressure wire testing in order to assess the functional impact of the stenosis and whether stenting of the area was indicated. The evidence suggested that there was insufficient discussion with the Deceased to enable her to consider properly alternative non-invasive investigations (although it was not possible to know whether sufficient discussion would have resulted in a different plan, not least because it was clear from the evidence that the clinical advice to the Deceased was and would have been that the invasive pressure wire testing was preferable to the non-invasive alternatives). From the evidence I heard it was apparent that the insufficient discussion with Mrs Hoskins about the investigatory options resulted, in large part at least, from the absence of a clear system and process designed to ensure that full and informed consent is obtained. In particular, the advice and decision making about the pressure wire testing was made (in principle at least) at about the time of her initial percutaneous stenting in October 2016 and without sufficient subsequent out-patient access to advice and discussion. Prior to the conclusion of the Inquest I received a statement dated 21 November 2018 from , Director of Quality and Safety.

stated that the Trust has started a “major quality improvement project” to improve the process of gaining informed consent and he set out details of steps which have already been taken and those planned. In paragraph 10 of the statement it is noted that informed consent is a process that is undertaken over time and that the Trust’s current process does not include informed consent being obtained prior to the patient being admitted for a specific procedure. I am concerned that the insufficiency of the process in the Deceased’s case resulted largely from the absence /insufficiency of outpatient contact to enable full communication from the clinicians to the patient and family and vice versa, and that this situation persists. Although statement indicates that the Trust “will work towards” informed consent being undertaken as an outpatient, the current absence of a system to facilitate informed consent being taken and to ensure it is obtained prior to the patient’s admission for the procedure in question, is of concern in relation to the prevention of future deaths.

Responses

1 respondent

Barts Health NHS Trust NHS / Health Body

24 Jan 2020 PDF

Action Planned

A new Trust policy on informed consent and supported decision making for elective surgical procedures is being drafted, clarifying that informed consent is a process over time in the outpatient clinic. St Bartholomew’s Hospital has committed to a programme of improvement for consent as one of their Key Objectives for 2019/20. (AI summary)

View full response

Dear Ms Hewitt RE: Regulation 28: Report to Prevent Future Deaths

I write in response to the recent Regulation 28: Report to Prevent Future Deaths notice regarding the consent process that preceded a cardiology intervention procedure being undertaken on Mrs Marian Hoskins. I acknowledge that there are improvements that need to be made in order to ensure that patients are fully briefed and able to provide their informed consent before undergoing elective surgical or interventional procedures and we need to ensure that sufficient time is allocated in outpatient clinics to allow for consent to be fully discussed before the day of a procedure. From a Trust perspective work on this matter has been led by the Surgery Network board who established a task and finish group to review consent processes and pathways for elective procedures across the Trust. The outcome of this group has been a proposed new Trust policy ‘Informed Consent and Supported Decision Making for Elective Surgical Procedures’. The draft policy is currently out for consultation and we anticipate this will be taken for approval at the Trust Policies Committee within the next 2-3 months. The policy clarifies that informed consent is a process that takes place over time in the outpatient clinic via interaction with health professionals and that “Surgeons and health professionals must be satisfied that their patient has received and understood sufficient information about their diagnosis – as well as the proposed treatment and its implications – to allow them to decide what they deem to be in line with their own values and wishes. Different options for treatment, including the option of no treatment, should be presented side by side and the benefits and material risks should be given objectively”. I have included the defined pathway for consent as an appendix.

Following approval of this policy there will be on-going audit of performance, via the trust internal audit schedule, Quality and Safety meetings, hospital boards and via the surgical networks and the surgery board. Training and resource will be given where there are areas for improvement

Trust Executive Office Ground Floor Pathology and Pharmacy Building The Royal London Hospital 80 Newark Street London E1 2ES

Telephone: 020 32460641

Chief Medical Officer

St Bartholomew’s Hospital, where Mrs Hoskins was cared for, has already committed to a programme of improvement for consent. This commitment has been included as one of their Key Objectives for 2019/20 and as such progress against this will be closely monitored by both the Hospital Management Board and by the Trust Executive team as part of our schedule of performance reviews.

We have already discussed the implications of proposed changes to the consent policy at St Bartholomew’s Hospital (extended outpatient clinic times, consent documentation, revised Job Plans etc.). We realise how profound a change the shift in Consent process and policy will be, and are determined to introduce at pace and ensure its rigorous implementation.

Report sections

Investigation and inquest

I commenced an investigation into the death of Marian Hoskins. The investigation concluded at the end of the inquest on 22 November 2018.

My conclusion as to the death was that the Deceased : “Died as a result of a recognised complication of an investigative medical intervention.”

Circumstances of the death

In October 2016 the Deceased was admitted to St Bartholomew’s Hospital having suffered an acute non-ST elevation myocardial infarction and she was treated by percutaneous stenting of the right coronary artery. Moderate to severe stenosis in the left anterior descending artery was noted and a plan was made for investigative pressure wire testing in order to assess the functional impact of the stenosis and whether stenting of the area was indicated. The evidence suggested that there was insufficient discussion with the Deceased to enable her to consider properly alternative non-invasive investigations but it was not possible to know whether sufficient discussion would have resulted in a different plan. On the 14th December 2016 the Deceased underwent electively pressure wire testing in the course of which there was iatrogenic dissection of the artery. This was quickly treated by stenting but the consequential impairment of blood flow to the distal artery caused the Deceased to suffer damage to the heart tissue and another heart attack. Further, the placement of the stent resulted in the loss of septal branches. As a result, over the following days the Deceased developed a ventricular septal defect. Investigative imaging suggested that percutaneous intervention could be used successfully to repair the defect and this was attempted on the 28th December 2016. However, it was not successful because of the extent of the damage which had in fact been caused by the infarction, and surgical repair was therefore attempted later the same day. Post-operative testing showed a small residual defect but further surgical treatment could not safely be undertaken. The Deceased was given maximal support but, after a period of stability, her condition deteriorated. An attempt to repair the residual defect percutaneously was made on the 10th January 2017 and was anatomically successful but on the 11th January 2017 the Deceased suffered multi-organ failure and she died.

Action should be taken

In my opinion action should be taken to prevent future deaths by addressing the concerns set out above and I believe you have the power to take such action.

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Report details

Reference: 2019-0005
Date of report: 9 January 2019
Coroner: Alison Hewitt
Coroner area: City of London

Responses identified

Responses identified 1 of 1

All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 18 Jul 2019 (estimated).

Sent to

Barts Health NHS Trust

Source links

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Data: judiciary.uk under OGL.