Prevention of Future Deaths reports · 2019
Regulation 28 report to prevent future deaths, reference 2019-0343, written 30 Sep 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 30 Sep 2019 |
|---|---|
| Reference | 2019-0343 |
| Deceased | Amy Allan |
| Coroner | Edwin Buckett |
| Coroner area | Inner North London |
| Category | Child Death (from 2015) · Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
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: Prevention of Future Deaths report Amy Allan (died 28.9.2018) THIS REPORT IS BEING SENT TO: Mr Matthew Shaw Chief Executive Great Ormond Street Hospital for Children NHS Foundation Trust Great Ormond Street London WC1N 3JH CORONER lam: Edwin Buckett Assistant Coroner Inner North London St Pancras Coroner's Court Camley Street London N1C 4PP CORONER’S LEGAL POWERS | make this report under the Coroners and Justice Act 2009, paragraph 7, Schedule 5, and The Coroners (Investigations) Regulations 2013, Regulations 28 and 29. INVESTIGATION and INQUEST On the 11" October, 2018 an investigation was opened into the death of Amy Allan who died aged 14, on the 28" September, 2018 at Great Ormond Street Hospital, London. The investigation progressed to an inquest which | conducted between the 2 and 5" September, 2019. | made a determination at the conclusion of the inquest that Amy had died as a result of multi-organ failure and that an elective operation on the 4h September, 2018 set in train a sequence of events which led to her death. | reached a narrative conclusion which | have set out in Box 4 below. CIRCUMSTANCES OF THE DEATH 1. Amy was born on the 14" January, 2004 with a ventral septal defect which required heart surgery a few weeks after her birth. She was subsequently diagnosed with Noonan Syndrome, Hypertrophic Cardiomyopathy, Pulmonary Arterial Hypertension, Chronic Thrombocytopenia, borderline Factor 7 deficiency and Kyphoscoliosis. 2. Notwithstanding these conditions, she was able to participate in mainstream school, sport and leisure activities leading a full and active life. 3. As she grew older, she did suffer from increasing back pain and compromised posture caused by the scoliosis. 4. As a result, she was referred to Great Ormond Street Hospital for consideration of elective corrective spinal surgery in early 2018. 5. A mortality risk was originally given of 20% for the operation but this was improved after clinicians considered that the operation could be carried out in a less invasive manner. 6. The operation took place on the 4" September, 2018 and was successful. 7. After the operation, Amy was transferred to the Intensive Care Unit at Great Ormond Street Hospital. 8. Thereafter, the process of extubation occurred at about 11.20pm on the 4" September, 2018. 9. Shortly thereafter, Amy's condition deteriorated and on the 5h September, 2018 she was started on Extra Corporeal Membrane Oxygenation (“ECMO”) support at about 8.30am. This was administered on two occasions ending on the 17 September, 2018. 10. Following this, Amy’s cardiac function plateaued and she became critically ill. 11. On the 27" September, 2018 Amy became acutely unstable with increasing heart dysfunction which led to her death at 5.50am on the 2s September, 2018. 12. The operation of the 4" September, 2018 set in train a sequence of events which caused her death on the 28" September, 2018. 13. She was not able to withstand the effects of surgery and its aftermath upon her. 14. Amy would not have died on the 28" September 2018 had the operation of the 4" September, 2018 not taken place. CORONER’S CONCERNS During the course of the inquest, the following 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 MATTERS OF CONCERN are as follows. Evidence was given by medical staff from Great Ormond Street Hospital that: 1. At Multi-Disciplinary Team meetings convened on the 3” July, 2018 and the 7" August, 2018 to discuss Amy’s case pre-operation, it was identified that: (i) Amy should have ECMO support in the event of a cardiovascular collapse, and (ii) Extubation following the operation was to be regarded as a “critical time” from a pulmonary hypertension point of view. 2. Notwithstanding those concerns: (i) No pre-operative ECMO assessment was made of Amy, and (ii) No plans were put in place for EMCO to be available following the operation of the 4"° September, 2018, and (ii) No members of the Intensive Care Unit were invited to any Multi- Disciplinary Team meeting concerning Amy’s case, nor were any minutes of those meetings circulated to them, prior to her operation. 3. The handover of Amy post operation on the 4" September, 2018 between anaesthetists (who were involved in her operation) and members of the Paediatric Intensive Care Unit (“PICU”) (who took over her care) involved conflicting advice and instruction as to how and when Amy should be extubated. The former considered that Amy should only be extubated when completely stable and the latter considered that there should be an early extubation. 4. No cardiology review or echocardiogram was carried out on Amy post operation but prior to extubation. Both had been requested or suggested by clinical staff involved in her operation. 5. Amy was extubated at about 11.20pm on the 4" September, 2018, when her physiological signs were deteriorating. No clinician at consultant level was present at the time of extubation and staffing levels were low. Shortly after extubation, Amy suffered a severe physiological deterioration with profound hypotension and tachycardia. She was intubated as an emergency at about 4am on the 5 September, 2018. 6. There was a delay in administering ECMO therapy because no pre- warning had been given to the ECMO team. EMCO was not started until about 8.30am on the 5" September, 2018. | am concerned that: (a) It appears there was a lack of awareness and sharing of information between departments at Great Ormond Street Hospital. In particular, the PICU had not been given any advance warming of Amy’s complex medical background and needs before she was admitted there post operation. As PICU staff were not invited to the Multi-Disciplinary Team meetings prior to the operation, they were not aware of the “critical time” which lay ahead for her; (b) There was no clear plan or instruction for the management of Amy post operation in relation to extubation and ECMO support on the PICU; (c) The handover between clinicians involved in Amy's operation and those taking over her care in the PICU, was poorly executed with vital information either not properly conveyed or recorded or simply missed; (d) There was a delay in commencing ECMO support, and (e) No single properly informed clinician appeared to be co-ordinating Amy's post-operative care in such a complex and high risk case. ACTION SHOULD BE TAKEN In my opinion, action should be taken to prevent future deaths and | believe that you 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 27" November, 2019. |, 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 | have sent a copy of my report to the following. e HHJ Mark Lucraft QC, the Chief Coroner of England and Wales; ee tam 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. DATE _ 30" September, 2019 .. SIGNED BY ASSISTANT CORONER EDWIN BUCKETT
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.
Medical Director’s Office
medicaldirectorpa@gosh.nhs.uk
Tel: 020 7405 9200 x 5257
27/11/2019
Wednesday, 27 November 2019
Private & Confidential
Mr Edwin Buckett
Assistant Coroner
Inner North London
St Pancras Coroner’s Court
Dear Sir
Following receipt of your regulation 28 Prevention of Future Death Report, Great Ormond Street
Hospital NHS Foundation Trust (the Trust) convened a working group of senior clinical staff to identify
and implement the necessary actions to ensure that patients like Amy are cared for in the safest
possible way in future.
The actions of the Trust are primarily focussed on improving the pathway that Amy experienced at
GOSH, specifically the spinal surgery pathway with intensive care and ECMO support. The Trust has
also evaluated how the lessons learned from Amy’s care are shared throughout the hospital
particularly in terms of improvements to the surgical pathways for other complex and high risk
patients. The Trust recognises that these actions will not change what happened to Amy, but it hopes
that these actions will give her family some comfort and reassurance that the Trust has learnt from
Amy’s case and continues to do so to ensure that that all patients at the Trust receive the highest
standard of care.
These actions which the Trust has taken, and those actions which are currently in progress have been
summarised below in response to the specific concerns which have been raised.
(a) It appears that there is a lack of awareness and sharing of information between departments at
Great Ormond Street Hospital. In particular, the PICU had not been given any advance warning of
Amy's complex medical background and needs before she was admitted there post operation. As
PICU staff were not invited to the MDT meetings prior to the operation, they were not aware of the
'critical time' which lay ahead for her
The Trust recognises that it is crucial to have processes in place to ensure that all relevant members
of the multi-disciplinary team (MDT) are part of the decision making processes for complex patients.
There are many different MDT meetings which take place in the Trust to enable this to happen,
including a spinal MDT meeting. This monthly spinal MDT meeting is designed to ensure that all
elective spinal admissions are managed safely and that information is shared accordingly with all
relevant teams. It was clear from Amy’s case that the spinal MDT meetings had not achieved this for
her. The spinal MDT meetings took place without the involvement of all necessary participants, and
the outcomes of that MDT were not effectively disseminated to all the necessary personnel following
the meeting.
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The PICU Consultant is an important member of the spinal MDT meeting as many of the spinal patients
are initially cared for on PICU post operatively. When Amy’s case was discussed at the spinal MDT
meetings, the PICU consultant was not present. Although routinely invited to the monthly spinal MDT
meeting, and were specifically invited to both of the spinal MDTs at which Amy was discussed, the
PICU consultant was unable to attend. The Terms of Reference (TOR) for the MDT have now been
amended to mandate the need for the attendance of the identified PICU consultant who acts as liaison
with the Spinal Team. The TOR also now reflects the responsibility of the PICU consultant to arrange
appropriate PICU consultant level cover for the spinal MDT meeting in the event that they are unable
to attend. The same requirement has been applied to all of the additional specialties who are required
to attend the spinal MDT meeting. The TOR also specifies that it is the responsibility of the MDT Chair
to ensure that all relevant specialties are present for the discussion of each case. If there is no
representative present then the patient will not be discussed. If there is a pressing clinical need then
a further meeting involving all required clinicians before the next monthly spinal MDT meeting will be
convened by the Chair of the spinal MDT. A copy of the TOR is enclosed with this response.
The minutes of the spinal MDT meetings which discussed Amy’s care were not circulated to the PICU
team. The attendance of the relevant individual (in this case, the PICU Consultant) at the MDT
meeting is best practice to facilitate appropriate conversation, and the circulation of the minutes
provides additional opportunities for other members of the broader clinical teams to understand the
needs of patients who may be admitted under their care. At the time Amy’s care was discussed at
the spinal MDT meetings, the notes of the meeting were typed up and generally circulated via email.
However, the notes of the MDT meetings at which Amy was discussed were not circulated to the PICU
Consultants.
In April 2019 the Trust launched a new electronic patient record system (Epic) that replaces the
previous paper records and combines numerous existing electronic systems. Epic now enables the
notes of MDT meetings to be recorded directly within the individual patient’s records. It is therefore
much easier for all teams involved in caring for a patient to access the outcome of the MDT
discussions. Epic also includes a messaging system (similar to email) within the patient’s records to
support clinicians discussing the patient’s care and to ensure that those messages are directly linked
to the patient’s records. This provides a much better awareness and sharing of information between
departments.
In addition to the safety improvements which Epic brings, the Trust has made a number of changes to
ensure that the outcome of the spinal MDT meeting are effectively communicated. This includes:
Flagging high risk patients on the electronic PICU booking form;
Requiring the PICU consultant who attended the spinal MDT to brief the PICU team on any elective
spinal admissions to PICU as part of their weekly consultant meeting;
Requiring the spinal CNS to send an email reminder to the PICU consultants regarding high risk
spinal patients a week before admission and on the day of admission to ensure that the consultant
who is in charge of the unit on the day of admission is aware of the known risks;
Requiring the PICU consultant in charge of the unit on the day of admission to discuss the planned
admissions for the day after the morning ward round to update themselves and the team about
any known risks.
The Trust believes that these requirements ensure the PICU consultant in charge, on any given day, is
appropriately aware of high risk patients admitted to the intensive care unit. Further work is also
underway to develop enhanced electronic Patient Status Boards within Epic. The boards will include
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an overview of all patients on the unit (or those due to be admitted imminently). It will provide key
clinical information, including high risk status, on one screen. This work is being supported by the
Electronic Patient Record team and is already underway. It is anticipated that these boards will be in
use from January 2020.
In addition to strengthening the pathways for spinal patients with complex co-morbidities, the Trust
has also reviewed how it can apply the learning from Amy’s case to other surgical pathways. As a
result two significant projects are now underway:
Expanding the provision of Anaesthetic Pre-Operative Assessment (APOA) to all GOSH patients
undergoing an elective intervention under general anaesthetic
o This service triages patients according to their level of risk into an appropriate pre-operative
appointment with the anaesthetic team (i.e. telephone appointment, face to face with nurse or
face to face with anaesthetist). Risk is determined based on a number of factors including;
comorbidity, complexity of intervention and assessment of risk at triage;
o This triage will identify those particularly high risk patients for whom a Complex Patient MDT
meeting should be organised. This would include the need for cardiac and PICU Consultant, and
other relevant specialties, to attend. This Complex Patient MDT would determine the peri-
operative plan and post-operative location for the patient.
o The APOA service is not currently used by all specialities within the Trust, as much of the pre-
operative assessment process is managed at specialty level by the Clinical Nurse Specialist (CNS)
who supports the surgical teams;
o Referrals will be made to the Joint Cardiac Conference (JCC) as required by the cardiac
representative at this Complex Patient MDT. In cases where ECMO is identified as a possibility,
there will be cardiac intensive care team involvement in the consent process.
o The expansion of this service will be phased to allow necessary recruitment into the APOA
service. The first phase of expansion is planned to take place in January 2020. The Trust expects
to be in a position to mandate the requirement for all patients undergoing an intervention
under GA to be triaged by APOA within 9-12 months, namely by November 2020. The
implementation progress will be tracked through the Patient Safety and Outcomes Committee.
Improving the governance of MDT meetings
o Amy’s journey demonstrated how important it is that the Trust has good governance
arrangements in place for all MDT meetings to ensure that all relevant clinicians are in
attendance; that meetings are appropriately documented and the information disseminated
effectively to the right staff; and that all actions arising from MDTs are completed;
o A consultant surgeon has been identified by the Medical Director to lead a project to guide best
practice in conducting MDTs across the Trust. This began in October 2019;
o Trust wide requirements for MDT attendance and documentation have now been agreed. The
requirements will shared with the Operational Board on the 11th December 2019 for
dissemination to operational clinical teams to action.
o A baseline audit of current MDT performance began in November 2019 and the results will be
reviewed at our Patient Safety and Outcomes Committee to support Trust -wide improvement.
The results of this audit are due to be discussed at the December 2019 meeting.
o An annual audit has been agreed to ensure that the Trust has assurance that the MDTs are
working effectively to provide the safest care to our patients. The frequency of the audits may
increase depending on the results of the audit
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The learning from Amy’s case, and the Trust-wide changes we have made as a result will be discussed
at the Surgical Forum on the 13th December 2019. This forum brings together all of the Consultant
Surgeons at the Trust to facilitate discussion and cross-specialty learning. The Trust thinks that sharing
Amy’s story in this way will ensure that the surgical teams understand the importance of the changes
to our systems and processes.
(b) There was no clear plan or instruction for the management of Amy post operation in relation to
extubation and ECMO support on the PICU
The Spinal MDT TOR have been amended to include the specific responsibilities for clinicians attending
the meeting in regards to ECMO. This is reiterated in the PICU guidance for managing spinal patients.
A copy of this guidance is enclosed [Spinal Surgery Pathway PICU FINAL].
The new agreed process is as follows:
If a patient discussed at the spinal MDT is identified as potentially requiring ECMO support post-
operatively, their case will be referred to the Joint Cardiac Conference (JCC) by the Cardiologist
present at the Spinal MDT (or by another appropriately briefed cardiology consultant);
The JCC will review the case and determine whether ECMO support post- operatively is
appropriate;
If the JCC consider that pulmonary hypertension, or another cardiorespiratory condition, is a
significant issue and ECMO is being considered, then the JCC will identify the safest environment
for the patient’s post-operative care (Cardiac Intensive Care Unit or Paediatric Intensive Care Unit)
in light of the patient’s overall condition.
The JCC will also confirm who will participate in the joint consent process with spinal surgeon to
ensure that the patient and family receive appropriate patient information and counselling during
the consent process;
The cardiologist linked to the spinal MDT will share the outcome of the JCC with the spinal team
(either via the next spinal MDT or through the Spinal Consultant or the spinal CNS team if the case
is more clinically urgent). This information will also be recorded as the outcome of the JCC MDT
discussion in the patient record on Epic so that the post-operative management plan for ECMO is
available to all staff caring for the patient;
On the day of the operation, the consultant anaesthetist will contact the ECMO team to confirm
that there is ECMO capacity as well as ICU bed capacity.
Following the post-operative evening ward round on PICU/CICU, there will be a formal discussion
between the PICU Consultant, CICU Consultant and the Perfusionist-on-call regarding the high risk
patients on both units, so that all relevant team members are briefed on the patient’s condition
ahead of the night shift.
The plans and instructions for management of extubation are guided by the patient’s consultant
anaesthetist on the basis of the patient’s response to the general anaesthetic on the day of the
procedure. This means that the handover between the anaesthetic and PICU team is a crucial safety
mechanism. The changes which the Trust has made in relation to the anaesthetic-PICU handover are
outlined in paragraph (c).
The plans for extubation may evolve over the course of the patient’s post-operative course for several
different reasons and the PICU Consultant is responsible for making decisions based on the patient’s
4
clinical condition once the patient is on PICU. The PICU Consultant is also responsible for ensuring
that the plan is clearly articulated, documented and understood by the clinical team supporting
delivery of care in PICU. We undertake twice yearly documentation audits on PICU in line with the
NHS 7 day service reporting requirements. This
includes evaluation of consultant review
documentation at least twice daily. The audit was most recently completed in October 2019 and the
outcome was presented to the Patient Safety Outcomes Committee in November 2019. The results
identified the need for additional computers on the unit to ensure that all documentation can be
completed in a timely way. Additional computers were received on the unit in November 2019.
(c) The handover between clinicians involved in Amy's operation and those taking over her care in
the PICU, was poorly executed with vital information either not properly conveyed or recorded or
simply missed.
The Electronic Patient Record department is currently supporting the Anaesthetic and ICU teams to
develop a standardised electronic handover document which mirrors the paper form which has been
developed for this purpose. The electronic handover document will ensure that all the relevant fields
are together in one section so that they can be clearly and easily discussed as part of a structure verbal
handover, and act as an ongoing plan to support the ICU team.
The electronic handover is currently being tested by the Electronic Patient Record team to ensure that
it provides a secure platform for the anaesthetic and intensive care teams. This is expected to be
completed by February 2020. This will be accompanied by an appropriate training programme to
standardise handover between the two specialties to ensure that both the correct information
required is available and the personnel who need to be present to receive it are in attendance. The
lessons we have learned from Amy’s care will be incorporated in this training. The Trust expects to
launch the new electronic handover in February 2020. In the interim, the anaesthetic and ICU teams
will continue to use the paper form (which will then be scanned onto the Epic system).
The Trust expects this handover to take place between the Anaesthetic Consultant and the PICU
Consultant whenever possible. The Clinical Lead for PICU and the Clinical Lead for Anaesthetics have
reminded all Consultants of this requirement again in November 2019. When it is not possible (e.g.
PICU Consultant is busy with another patient), handover should be given to the most senior doctor on
the unit, who will then share that information, alongside the handover document, with the PICU
Consultant. Where further discussions about the patient between the Anaesthetic Consultant and the
PICU Consultant are required, these are now recorded in Epic. It is the responsibility of the PICU
Consultant to record this information.
(d) There was a delay in commencing ECMO support
ECMO is an invasive therapy that may sustain life where the natural history of the underlying
condition is understood or modifiable. The Trust is commissioned to provide ECMO support for post-
operative cardiac patients and respiratory patients in the South East of England. These children are
generally either:
(i)
(ii)
known to the cardiac team; or
referred with circulatory and/ or respiratory failure that is refractory to conventional
intensive care therapy
5
Patients being considered for ECMO commonly have life threatening physiological signs and metabolic
disturbance consistent with failure to respond to conventional intensive care therapy. Once a patient
is receiving ECMO, the underlying conditions may improve with supportive measures (eg resting the
heart after heart surgery or cessation of aggressive ventilation with influenza) or specific treatments
(e.g. further surgery or antibiotics). With increased complexity, including chronic multi-system or life
limiting conditions, the balance of risk and benefit becomes less clear, and the clinical outcomes
become uncertain.
The Trust does not standardly provide rescue extra corporeal life support (ECLS) for all other patients
who may collapse within the Trust. However, the Trust aims to provide ECLS wherever possible to
patients who are likely to gain benefit. The decision to deploy ECLS routinely includes:
1. an assessment of response to escalation of medical therapy coupled with;
2. discussions with the treating team and family regarding anticipated outcomes, whilst;
3. assembling the team and planning for a surgical cannulation procedure.
There are inherent delays in this approach and there are no local, national or international timescales
for ECMO cannulation. Whilst the ECMO team always works hard to avoid unnecessary delays, it is
recognised that it is not always possible to get this judgement right and they err on the side of safety.
Often transferring a critically ill patient to Great Ormond Street for ECMO or assembling the ECMO
team does not culminate in cannulation for ECMO because it has been possible to stabilise the patient
with conventional ICU therapy. In that situation the ECMO team is retained ‘on standby’ in case of
deterioration.
When Amy was on PICU the clinical need for ECMO was identified at approximately 3am on 5th
September 2018. The Cardiac Intensive Care Consultant was contacted by the PICU Consultant and
they confirmed at approximately 3.30am that the ECMO team was being assembled and this would
take approximately 45 minutes. The PICU Consultant wanted the ECMO team for support in the event
of a cardiac arrest during intubation. Amy’s clinical condition deteriorated significantly (with systolic
blood pressure below 60mmHg accompanied with a drop in her level of consciousness) and this
necessitated re-intubation ahead of the ECMO team arrival. The ECMO team were onsite just after
4am as Amy was being intubated. Amy tolerated re-intubation and showed some initial signs of
improvement with an echocardiogram showing improvement in the function of the right side of her
heart. While the ECMO circuits were being prepared by the ECMO team, the PICU team tried various
conventional management strategies (including vasopressin, sodium bicarbonate, magnesium and a
blood transfusion) to see if ECMO could be avoided. Initially there were some improvements in Amy’s
condition, so the decision to cannulate was delayed. However, there was no significant clinical
improvement overall and therefore the clinical decision to put Amy on ECMO was taken at
approximately 7.15am and ECMO cannulation began. She was cannulated and started on ECMO at
8.30am.
In order to put patients on ECMO, a team of experienced professionals is required. The majority of
staff groups required as part of the ECMO team are part of other 24/7 rotas. However, we do not have
a resident on-call perfusion service 24/7, as the need for unanticipated rescue ECLS out of hours is
rare. The Perfusion team (specialists that routinely manage patients on heart-lung bypass circuits)
have an important role in decisions regarding the mode of ECMO, size of cannula and physical site of
cannulation in addition to an active involvement during the cannulation process. However, outside
their contracted hours, the on-call perfusionists may not be on site unless a patient at risk of
decompensation has been highlighted or an emergency bypass surgery (such as a transplant) is being
6
undertaken. If the perfusionists are required to stay on site, they are provided with appropriate rest
facilities. If there is an emergency involving a patient not known to the ECMO team (including patients
who may be transferred in from other hospitals), but one for whom it is agreed that ECLS would be in
their best interests, then the team are called in from home. This is similar to arrangements for out of
hours theatre cases.
The new agreed process for the identification of patients like Amy (articulated above) ensures that:
there is a more robust pathway for involving the members of the cardiac and ECMO team in pre-
operative preparation via the JCC meeting;
that patients and families have a better understanding of what ECMO entails and how the process
will work;
that the PICU consultant on the day of admission has a clear understanding of any patient who has
been identified as potentially requiring ECMO;
there is a pre-operative check by the anaesthetist to confirm ECLS capacity on the morning of the
procedure; and
it ensures that the perfusion team are able to identify when they need to stay on site as part of
their on-call.
(e) No single properly informed clinician appeared to be coordinating Amy's post-operative care in
such a complex and high risk case.
The nature of caring for complex surgical patients means that there will be several clinicians involved
in their care. This also means there will be different individual clinicians responsible for and
coordinating care at different points in their surgical pathway according to their clinical expertise. In
Amy’s case the individuals were: the Consultant Spinal Surgeon, Consultant Anaesthetist and the
Consultant Intensivist. Effective communication and handover between the teams are crucial in
providing safe care. Below is a table of showing the surgical pathway that details the responsibilities
of a particular clinical speciality at each stage of the pathway:
Surgical Pathway Stage
Pre-operative assessment
Person responsible for care
Spinal Consultant
-
Including arranging quorate MDT
decision making
Bed booking
Spinal Consultant
-
-
Including flagging of high risk patients on
the booking forms
to PICU
Including email
Consultants one week before admission
and on the day of admission
reminder
Pre-operative admission management
Intra-operative management
Handover to PICU
Immediate post-operative care
Ongoing post-operative care following discharge
from PICU
- Undertaken by the Spinal CNS on their
behalf.
Spinal Consultant
Jointly managed by Spinal Consultant and
Anaesthetic Consultant
Anaesthetic Consultant to PICU Consultant
PICU Consultant
Spinal Consultant
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To ensure that all staff members involved in the care are clear about the pathway, and their roles and
responsibilities within that pathway, the PICU Consultant Team have now also developed a guideline
on the spinal surgery pathway for complex cardiac patients admitted to PICU. A copy of this guideline
is enclosed [Spinal Surgery Pathway PICU FINAL].
The PICU Consultant had responsibility for Amy’s post-operative care following transfer to the unit.
The Trust operates a closed intensive care model. A closed intensive care model is when the
responsibility for decision making is taken by the intensive care unit consultants. This is done in
collaboration with other specialists, including the surgeons and anaesthetists, but the intensivists are
the decision makers and they direct care for the patients whilst they remain on ICU. The ICU is staffed
with intensivists directly responsible for care.
An open unit model is when each specialist (e.g. a surgical consultant) is responsible for directing the
care of their patients whilst on ICU; these specialists are not intensivists.
The PICU at Great Ormond Street Hospital is a closed unit so responsibility for care of patients whilst
they are on the ICU is that of the intensive care consultants.
Research has demonstrated the evidence of better outcomes for patients on a closed versus an open
ICU.
Provonost, JAMA 2002: High intensity versus low intensity ICU physician staffing is associated with
reduced hospital and ICU mortality and ICU length of stay.
Treggiani, AJRCCM 2007: In a cohort study of patients with acute lung injury, admission to a closed
model of intensive care unit was associated with reduced mortality independently of patients’
characteristics. These findings support recommendations to implement closed model intensive
care units.
El-Kersh, Am J Infect Control 2016: Infectious complications in the intensive care unit (ICU) are
associated with higher morbidity, mortality, and increased health care use. Reported results of
implementing 2 different models (open vs closed) on infectious complications in the ICU. The
closed ICU model was associated with 52% reduction in ventilator-associated pneumonia rate
(P = .038) and 25% reduction in central line-associated bloodstream infection rate (P = .631). We
speculate that a closed ICU model allows clinical leadership centralization that further facilitates
standardized care delivery that translates into fewer infectious complications.
Wilcox E, CCM 2013: Meta-analysis of 52 studies demonstrating that high intensity intensivist
staffing reduces ICU and hospital mortality in critically ill patients.
Core Standards for Intensive Care Units 2013, Faculty of Intensive Care Medicine, UK
The closed unit structure clearly defines which single clinician is responsible for care. In Amy’s case,
our systems and processes failed to provide that PICU Consultant with all of the information they
needed, and at the time they needed it, to deliver the care that Amy required. The changes that the
Trust has outlined in the preceding paragraphs (MDT meeting management; MDT documentation on
Epic; PICU high risk patient booking forms; PICU consultant meetings; weekly and on admission email
reminders to PICU consultants; PICU patient summary review on the morning of admission; and
anaesthetic consultant to PICU consultant handover) set out the way in which the PICU Consultant
now receives that information, as well as the work the Trust undertaking to improve and refine this
further.
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Monitoring of ongoing actions
The Trust, and all of those staff involved in Amy’s care, are very sorry for what has happened. The
Trust recognises that there were failings in our systems and processes to protect Amy, and the Trust
is committed to ensuring that there is lasting organisational change as a result. These changes will
impact the spinal surgical pathway, and will also impact the pathways of all complex patients
undergoing general anaesthetic at the hospital. There is a diagram enclosed with this response
[Pathway Comparison] which aims to show how the pathway for high risk spinal patients like Amy is
different now, as a result of the lessons we have learned from her care.
The actions outlined in this document will be scrutinised through our internal governance processes
including:
Monthly detailed review of ongoing actions through Closing the Loop meeting (Chair: Medical
Director);
Update on overall progress, and results of associated audits will be completed by the Patient Safety
and Outcomes Committee (Chair: Medical Director);
Assurance on the completion and impact of the actions taken will be provided quarterly to the
Quality Safety and Experience Committee (Chair: Non-Executive Director);
External scrutiny will be undertaken by NHS England and the Care Quality Commission.
NHS England will be updated on progress with the action plan through monthly Clinical Quality Review
Group meetings. The Care Quality Commission will be updated regularly as part of relationship
management meetings.
The Trust would also be willing to provide Amy’s family with regular updates (either directly or through
their solicitors) on the progress that has been made, if they would find that beneficial.
Yours Sincerely
Dr Sanjiv Sharma
Dr Sanjiv Sharma
Executive Medical Director
Consultant Paediatric Intensive Care
Executive Offices
Level 2 Barclay House
Great Ormond Street Hospital NHS Foundation Trust
London WC1N 3BH
9
Terms of Reference
Spinal Service Multidisciplinary Team Meeting
1 Purpose
The Spinal MDT meeting (SMDT) is responsible for co-ordinating a cross speciality approach to agreeing each
complex patient’s continuation to a Spinal Surgical intervention. Its scope includes all patients on the waiting
list for spinal surgery identified as complex and requiring review and individualised plan of care.
From September 2019 the SMDT will include a spinal M+M and present results of audits undertaken by the
spinal team. This meeting will be held from 08:00 – 12:00.
2. Objectives
The objective of SMDT is;
To ensure multi-speciality agreement on patients who should proceed to surgical intervention.
To ensure complex patient have a full systems review prior to surgical intervention.
To ensure patients identified as complex have an individualised plan of care for the duration of their
patient journey up to and including a safe discharge.
To ensure all departments involved in the patient’s journey have access to the individualised plan of
care.
To ensure that patients receive all levels of inpatient care in designated areas which have the
resources required to provide the level of care needed.
To continue to reduce length of stay within the division.
To improve the safety and standards of patient care within the division.
To improve the patient and family experience within the division.
3 Core Membership and Responsibilities
The SMDT core membership is multi-disciplinary with representation from professionals across the care
pathway. All core members are required to regularly attend the SMDT meetings and activity engage and
support the delivery of the SMDTs purpose and objectives.
For a quorum, the following core members must attend:
1. Two consultant surgeons (where one consultant is on annual leave, they must provide comments prior to
the meeting. Comments must be received by the Clinical Nurse Specialist (CNS) Team/Advanced Nurse
Practitioner (ANP) by 2pm on the Friday preceding the meeting)
2. Cardiology Consultant
3. Respiratory Consultant
4. Anaesthetic Consultant
1
5. General Paediatrician (Consultant)
6. Paediatric Intensive Care Consultant
7. Spinal Clinical Nurse Specialist (CNS)
8. Spinal Fellow (if not available a second CNS to present the x-rays and MRI’s)
9. Physiotherapist
10. Occupational Therapist
11. Administrator (taking list of attendees)
Others:
(a) Where there are combined neurosurgery spine cases to be discussed then Dominic Thompson,
Consultant Neurosurgeon, to attend.
(b) Where there are neuromuscular cases to be discussed then Adnan Manzur, Neuromuscular
Consultant, to attend.
(c) Where there are neuro-disability cases Catherine DeVile +/- Belinda Crowe will be invited
(d) Where additional radiological (including neuro radiological) experience is required then an
appropriate consultant radiologist will be invited.
(e) In the event of complex cardiac patients, including patients needing ECMO backup, the Consultant
Cardiologist must be in attendance at the MDT
For patients with known pulmonary hypertension, a specialist pulmonary hypertension consultant
must be in attendance for the discussion of the patient.
The cardiologist/ pulmonary hypertension consultant will then decide if it necessary for the patient to
be discussed further at the cardiac joint case conference (JCC) and will make this referral directly.
All patients identified as potential candidates for ECMO backup must be discussed at the cardiac JCC.
The outcome of the JCC discussion must be fed back at the subsequent Spinal MDT meeting by the
Consultant Cardiologist. In the event of clinical urgency, the Consultant cardiologist should feedback
to the Spinal CNS team and arrangements will be made for an ad hoc MDT.
(f) Other clinicians may be invited to the meeting on an adhoc basis depending on the clinical needs of
the patient due to be discussed.
The group membership is agreed and detailed below:
Spinal MDT Attendance List
Name
Title
Attended
Arrival Time
Adnan Manzur
Aimi McEwan
Caroline Haynes
Claire Cook
Neuromuscular Consultant
Physiotherapist
Occupational Therapist
Spinal Theatre Sister
2
Dominic Thompson
Edel Broomfield
Elaine Chan
Evangelia Papathanasiou
Francois Abel
Grant Stuart
Hiromi Kawai
Imke Meyer-Parsonson
Ioannis Ioannou
Jonathan Smith
Joy Dawes
Sophie Tamiam
Liz Jackson
Loren Wailes
Lucy Howlett
Marina George
Mark Harris
Pascale Du Pre
Pratheeban Nambyiah
Ramesh Nadarajah
Sarah Harmar
Sian Pincott
Stacey Lambourne
Saadiyah Dana
Stewart Tucker
Sophie Tamiam
Suzanne Close
Tom Ember
4 Operational Processes
Consultant Neurosurgeon
Advanced Nurse Practitioner
Respiratory Consultant
Cardiology Consultant
Respiratory Consultant
Consultant Anaesthetist
Administrator
General Paediatrician
Consultant Anaesthetist
Consultant Anaesthetist
Consultant Anaesthetist
Medical Secretary
Consultant Anaesthetist
Clinical Nurse Specialist
Clinical Nurse Specialist
Consultant Anaesthetist
Consultant Spinal Surgeon
PICU consultant
Consultant Anaesthetist
Consultant Spinal Surgeon
Physiotherapist
General Paediatrician
Clinical Nurse Specialist
Medical Secretary
Consultant Spinal Surgeon
Spinal secretary
Physiotherapist
Consultant Spinal Surgeon
From September 2019: One meeting per month, on a Tuesday for 4 hours (i.e. one PA DCC time per month or
0.25 per week).
MDT Schedule:
Theatre 14
Start time
Theatre 15
Start times
26/11/2019
17/12/2019
21/01/2020
18/02/2020
17/03/2020
14/04/2020
12/05/2020
19/06/2020
07/07/2020
04/08/2020
01/09/2020
29/09/2020
12:00
08:15
08.15
08.15
08.15
08.15
08.15
08.15
08.15
08.15
08.15
08.15
08:15
12:00
11.00
11.00
11.00
11.00
11.00
11.00
11.00
11.00
11.00
11.00
3
27/10/2020
24/11/2020
22/12/2020
08.15
08.15
08.15
11.00
11.00
11.00
5 Chair
The meeting is alternately chaired by Mark Harris, Spinal Surgeon and Imke Meyer Parsons, Consultant
Paediatrician. The name of the chair will be confirmed in the minutes of the MDT meeting.
The chair is responsible for ensuring that the TOR are followed. This includes ensuring that the meeting is
appropriately quorate for the discussion of each patient.
If the named consultants (or appropriate deputies) required to discuss a case are absent, the patient case
discussion will be deferred until the next meeting. In the event of clinical urgency, then an ad hoc MDT
meeting with the relevant professionals must be arranged.
If feedback and advice is sought from another MDT or professional before confirming a spinal MDT decision,
the chair must ensure that the case is re-listed at the next spinal MDT or make arrangements for and ad hoc
MDT meeting with the relevant professionals must be arranged.
6 Administration
6.1 Meeting Notifications
Group core members will be notified of meeting dates and changes to meeting data in advance with a
minimum of three weeks’ notice.
6.2 Documentation
Minutes should either be typed directly into Epic at the meeting (or using voice recognition software) by the
Advanced Nurse Practitioner. The notes taken at the meeting will be reviewed with the meeting chair for sign
off. The minutes must be signed off by the chair within 2 working days.
6.3 Attendance
All core members of the MDT are required to attend the meeting.
In exceptional cases where core member attendance is not possible, a suitable deputy, who is briefed and at
an appropriate level to make decisions in a members absence, should be arranged by the named specialty
consultant. Apologies, together with the deputy’s details must be sent to the SMDT administration support by
the named specialty consultant.
7 Monitoring
The service manager for the spinal service, together with the core SMDT members shall review its
effectiveness through audit on an annual basis. This will involve monitoring and reporting on:
Frequency of meetings
Attendance at meetings; and
Compliance with the requirements outlined in the terms of reference
The spinal MDT terms of reference will be reviewed by the service manager, in conjunction with members of
the MDT, on an annual basis or more frequently if needed.
Changes in the TOR must be approved at the MDT meeting.
Next review due: November 2020
4
Spinal Surgery Pathway for Patients Admitted to PICU
Surgical pathway applicable for combined, anterior and posterior approach spinal fusion,
and insertion of growth rods. (Full integrated care pathways available on EPIC)
Appendix 1- spinal MDT decision flow chart for complex cardiac patients
Appendix 2- pulmonary hypertension pathway
Pre-operative assessment
Each spinal patient is discussed in the spinal MDT and assessed for risk by; respiratory, cardiology,
anaesthetic and spinal surgery. Other specialties attend as indicated e.g. pulmonary hypertension
and neuromuscular team. All patients with complex cardiac conditions, significant pulmonary
hypertension or cardiac failure discussed in the JCC and discussion fed back to Spinal MDT (see
appendix 1). Indication for surgery and appropriateness of surgery given risk is discussed. PICU
representative must be present at each meeting, provisionally accepts if appropriate and flags high
risk patients to spinal CNS. Any specific post-operative recommendations are documented in MDT
notes.
Certain high-risk patients discussed at PICU consultant meeting at PICU links discretion for
disseminating information and plan refinement (will include but not exclusive to patients with
complex cardiac co-morbidities). Disagreement to be fed back to spinal MDT by PICU link.
PICU bed to be requested by spinal CNS on EPIC stating; high risk spinal patient, surgery planned and
indication for PICU.
PICU link and PICU clinical lead informed of scheduled admission of high-risk patients by spinal CNS
by e-mail the week before surgery. PICU link updates admitting Consultant team (1st, 2nd and
support PICU Consultant on call) with high risk status and any specific post-op recommendations.
PICU link to include relevant specialties as required.
Admission
Admission as requested by spinal team. Patients with pulmonary hypertension being stabilised on IV
sildenafil pre-op admitted to PICU for cardiology and pulmonary hypertension team review (see
appendix 2)
High risk patients to be prioritised on theatre list aiming to return from theatres before 1900.
Intra-operative management
Intra-op management as per spinal anaesthetic team. Patients with pulmonary hypertension to
continue IV sildenafil if already established on it and inhaled nitric oxide to be available.
PICU November 2019
Spinal Surgery Pathway for Patients Admitted to PICU
Post-operative management- High risk patients
Transferred to PICU ventilated with IABP monitoring.
Anaesthetic Consultant to PICU Consultant handover on PICU. Handover to include high risk status,
post-op recommendations and discussion on timing of extubation. PICU Consultant to co-ordinate
post-op management.
Patients with Pulmonary Hypertension (see appendix 2): start CVP monitoring, continue IV
sildenafil with inhaled nitric oxide available. Optimise analgesia, avoid acidosis, avoid hypoxia
(physiotherapy and optimising lung volumes), and avoid hypotension (whilst avoiding fluid
overload). Oral sildenafil to be reintroduced once tolerating feeds.
Cardiology and pulmonary hypertension team assessment pre-extubation and pre-discharge to
HDU as indicated. Extubation once stable after first night post op during day shift.
Patients with known pulmonary hypertension with signs of pulmonary hypertensive crisis or low
cardiac output at any stage: Medical management optimisation as above, achieve alkalosis, high
FiO2, inhaled nitric oxide, inotropes to achieve systemic blood pressures above pulmonary pressures
and consider milrinone if systemic pressure allows. Urgent cardiology review and ECLS/CICU
referral if evidence of ongoing low cardiac output or hypoxia.
Patients with difficult airway or high risk of tracheostomy also to be extubated in working hours
with appropriate teams informed as indicated by intraoperative assessment or pre-op plan. If known
to be difficult to bag mask ventilate theatre availability for extubation should be confirmed pre-op.
Handover to ward teams and involved specialties with CSP review prior to discharge as per usual
care.
Spinal surgery- low risk and usual post-operative care
PICU post-operative care-day of admission
Sky bed to be sent when patient ready for collection
Anaesthetic team hand over including any specific post-operative recommendations
Post-op plan and timing of extubation if ventilated discussed with PICU Consultant
Commence ABP monitoring as indicated. Routine post-operative observations ¼ hourly
Chest X-Ray
Keep NBM, commence IV fluids, and place NG tube on free drainage
Administer analgesia IV / PR as required. Monitor pain scores hourly
Monitor and record neurovascular observations ½ hourly for the first 4 hours then hourly
Monitor wound site for oozing – apply pressure dressing if required
Monitor urine output- medical review if urine output below 1ml/kg/hour
PICU November 2019
Spinal Surgery Pathway for Patients Admitted to PICU
Administer IV antibiotics as per microbiology policy and ensure prescribed at the correct time post
dose in theatres.
Post combined or anterior spinal fusion; monitor and record chest drain loses hourly
Nurse supine for 12 hours then log roll 2 hourly, attending to pressure area care at least 2hourly
Obtain post-operative blood samples for FBC, U+E and clotting
Low risk patients highlighted for early discharge discussed at evening bed meeting and night CSP
to review before handing over (including patient’s extubated at 0600). Day team to review if still
ventilated
Post-procedure day 1 – Transfer from PICU to post-operative ward
Ensure arterial line removed after doing post op bloods if no longer required and transfer to Sky bed
if not already done.
Catheter to remain in situ
Central line to remain in situ
Pain team review and PCA/NCA converted to ward settings prior to discharge
Review on post-operative ward round by spinal team
Handover from intensive care team to spinal team
CSP review prior to discharge if not already done
Post-procedure day 1 usual ward care if still on PICU is as follows;
Continue to monitor neurovascular observations hourly
NBM, continue IV fluids, NG tube on free drainage
Check for bowel sounds – consider commencing oral fluids if present and spigot NG tube
If IV fluids continue – obtain blood sample for U&E
Convert NCA to PCA after pain team review, monitor pain scores hourly
Monitor wound site for oozing and administer IV antibiotics as per policy
Monitor urine output-medical review if urine output below 1ml/kg/hour
Monitor and record chest drain loses
Assist to turn 2hourly and attend to pressure area care at least 2hourly
Review by physiotherapist and OT daily as indicated; Sit or mobilise as directed by operation note
Contact orthotics were appropriate to arrange timing of cast for brace if required
PICU November 2019
Spinal Surgery Pathway for Patients Admitted to PICU
Post-procedure day 2, Instructions as per day 1 except;
Listen for bowel sounds and commence oral fluid if present
If IV fluids continued obtain blood sample for U&E
Spigot NG tube and remove once tolerating oral fluid and diet
Pain team review and convert PCA to oral medication when tolerating enteral diet
Remove catheter if appropriate once off opiates– ensure urine passed within 12 hours
Attend to pressure area care as a minimum 2 hourly
If no brace required sit to angle as directed by operation note
Post-procedure day 3, Instructions as per day 2 except;
Monitor and record chest drain loses – remove when less than 150ml in 24 hours and chest x-ray
review. Obtain chest x-ray pre and post removal
Commence laxatives if bowels not open
Assist with turns and attend to pressure area care 2 to 4 hourly
Discharge process as above
PICU November 2019
Spinal Surgery Pathway for Patients Admitted to PICU
Appendix 1- spinal MDT decision flow chart for high risk cardiac patients
Patients referred to Spinal MDT with
complex cardiac conditions, significant heart
failure, pulmonary hypertension or referred
for ECLS back up. Discussed in JCC if not
already done.
Joint Cardiac Conference (JCC)- to discuss risk, need for
specific cardiac management, suitability for ECLS and
post op destination
Re-discussed in Spinal MDT for final decision on
suitability for surgery and peri-operative planning-
flagged as high risk to Spinal CNS by PICU link
Decision to admit to CICU
Decision to admit to PICU
CICU bed requested, ECLS team to
counsel family if back up ECLS bed
required. Spinal CNS to liase CICU
the week prior to surgery.
Anaesthetic team to check bed
availability the morning of surgery.
PICU November 2019
PICU bed requested and PICU link to
discuss in PICU consultant meeting for
dissemination of information, post op plan
refinement. Disagreement brought back to
spinal MDT by PICU link. If ECLS back up
appropriate PICU link to liase with ECLS
lead the week prior to surgery and
anaesthetic team to check bed availability
and ECLS capacity the morning of surgery.
Spinal Surgery Pathway for Patients Admitted to PICU
Appendix 2- perioperative management of spinal patients with Pulmonary Hypertension (pHTN)
Pragmatic definition of pHTN: Any patient with the label of pHTN or on treatment for pHTN.
Cardiology to refer to pHTN team if concerned and not previously known to pHTN team.
Cardiology/pHTN team to decide if further vascular studies to assess pulmonary hypertension
required
Risk assessment and risk for surgery to be discussed in spinal MDT. Patients with pHTN not
controlled by medication not suitable for surgery until stable.
Cardiology/pHTN team to discuss complex patients or those referred for ECLS back up in JCC.
Pre-op admission to PICU to stabilise on IV sildenafil 24-48hrs prior to surgery to mitigate poor
enteral absorption post operatively.
Echo assessment on admission pre first dose of IV sildenafil and 4-6 hours post 2nd or 3rd dose.
Cardiology and/or pulmonary hypertension team to review pre op to check estimation of pulmonary
pressures.
IV sildenafil to continue day of surgery and post op until tolerating enteral feeds and medications.
Other enteral medications for pulmonary hypertension such as Bosentan to continue throughout.
Patients with Pulmonary Hypertension: start CVP monitoring, continue IV sildenafil with inhaled
nitric oxide available. Optimise analgesia, avoid acidosis, avoid hypoxia (physiotherapy and
optimising lung volumes), and avoid hypotension (whilst avoiding fluid overload). Oral sildenafil to
be reintroduced once tolerating feeds.
Cardiology and/or pulmonary hypertension team assessment pre-extubation to ensure estimated
pulmonary pressures stable compared to pre-operative assessment and pre-discharge to HDU.
Extubation once stable after first night post op during day shift.
Patients with known pulmonary hypertension with signs of pulmonary hypertensive crisis or low
cardiac output at any stage: Medical management optimisation as above, achieve alkalosis, high
FiO2, inhaled nitric oxide, inotropes to achieve systemic blood pressures above pulmonary pressures
and consider milrinone if systemic pressure allows. Urgent cardiology review and early ECLS referral
if evidence of ongoing low cardiac output or hypoxia.
PICU November 2019
Amy’s journey in 2018
Case reviewed at non-quorate
Spinal MDT, ECMO potential
noted – decision to proceed to
surgery
Spinal pre-assessment process
and consent
Admission to Ward
Anaesthetist confirms PICU
bed availability
Operation in Theatre
Handover from Anaesthetics to
ICU
PICU for post operative care
Extubation out of hours
Patient deterioration and
clinical need for ECMO support
identified
ECMO team called in from
home
ECMO commenced following
assessment
What happens now
Case reviewed at quorate
Spinal MDT and ECMO
potential noted
Patient referred to JCC by
Cardiology Consultant who
attended spinal MDT
JCC assess risks and benefits
of ECMO & confirm post
operative location
Cardiologist feedback to Spinal
MDT. Spinal MDT decision to
proceed to surgery
MDT documented
in patient record
on Epic
Patient and family provided
with ECMO information and
counselling
Pre-assessment process and
consent
Patient discussed at the PICU
Consultants meeting
Spinal CNS high risk patient
reminders one week before
and on day of admission
PICU link consultant will liaise
with ECMO team 1 week prior
to admission regarding capacity
Admission to ward
Anaesthetist confirms PICU
bed and ECMO availability
Operation in Theatres
Consultant level handover
from Anaesthetics to ICU using
structured form
PICU/CICU for post op care
PICU & CICU to notify
perfusion of high risk patient,
so perfusionist stays on site
Extubation in line with
guidance/clinical need
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