Prevention of Future Deaths reports · 2014
Regulation 28 report to prevent future deaths, reference 2014-0325, written 11 Jul 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 11 Jul 2014 |
|---|---|
| Reference | 2014-0325 |
| Deceased | Maria Lopes |
| Coroner | Karen Henderson |
| Coroner area | Surrey |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Frimley Park Hospital NHS 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
THIS REPORT IS BEING SENT TO:
1. Chief Executive, Royal Surrey County Hospital
2. Chief Executive, Frimley Park Hospital NHS Trust
3. MHRA
4.
5. Faculty of Intensive care of Royal College of Anaesthetists
Intensive care society
1
CORONER
I am Karen HENDERSON, assistant coroner for the coroner area of Surrey
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 5th December 2013 I commenced an investigation into the death of Maria De Oliveria Alva LOPES, 31
years of. The investigation concluded at the end of the inquest on 26th June 2014. The medical cause of
death given was:
1a. Multiorgan failure
1b. Rhabdomyolysis
1c. Propofol related infusion syndrome
1d. Complications of urosepsis
2.
My narrative conclusion was:
Mrs Lopes has died from a rare reaction to propofol that has been used to support ventilation in
order to aid her recovery from the consequences of septic shock, that has been caused by a delay
in the recognition of urosepsis and a failure to receive timely medical treatment
4
CIRCUMSTANCES OF THE DEATH
Mrs Lopes presented to A&E on the 1st September 2012 with a short history of sudden onset of
pain suggestive of renal colic. She had an IVU and was found to have a stone in her left ureter
with associated hydronephrosis. She was admitted and seen the following day for the first time
on the routine ward round undertaken by the on call urology registrar. Signs of Systemic
Inflammatory Response syndrome (SIRS) were present at the time of the ward round but were
not recognised as such and the management plan put in place was therefore inadequate. Mrs
Lopes developed increasing signs of sepsis and despite documentation in the form of arterial
blood gases and blood results demonstrating sepsis (raised CRP and lactate with hypoxaemia)
and review by the critical outreach nurse and continuously raised Early Warning Scores its
severity was not recognised or appropriately escalated and opportunities were lost to treat the
sepsis in a timely fashion. Referral and transfer to the Intensive care unit was not properly
expedited and resulted in a further delay in treatment. Mrs Lopes required intubation and
ventilation and inotropic support for septic shock and multiorgan failure. Her sepsis was
resolving after treatment with antibiotics and a nephrostomy but recovery was slow requiring
prolonged ventilation using propofol for sedation. Mrs Lopes began to deteriorate on 7th
September, 6 days after admission to ICU, with increasing oxygen requirements and pyrexia
RT4134
which was thought to be septic in origin. Despite intensive investigation no source of sepsis was
found. She continued to deteriorate throughout 8th September developing myoglobinuria, a
rising creatine kinase and hyperkalaemia from rhabdomyolysis. Supportive management of the
hyperkalaemia was not successful and she became too haemodynamically unstable for
haemofiltration and despite other supportive measures, she died on 9th September 2012.
I heard expert evidence from two experts who both agreed the ultimate cause of death was
propofol related infusion syndrome causing rhabdomyolysis and associated sequelae and this
was a consequence of a slow recovery and weaning from ventilation as a result of the severe
sepsis. The amount of propofol given was likely to be in excess of the recommended dose (both
in length of time used and amount given) with control primarily undertaken by the nursing team.
5
CORONER’S CONCERNS
During the course of the inquest the evidence revealed matters giving rise for concern. In my opinion
there is a risk that future death 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:
1. The consultant urologist’s on call arrangements covering three hospitals at the weekend has no
provision for consultant ward rounds, in contravention of suggested national guidelines
2. A general lack of knowledge or implementation of published ‘on call’ national guidelines
3. The overall supervision of out of hours urology trainees within the current system
4. The review of emergency admissions by urology (not on day of admission, once daily)
5. The recognition and treatment of sepsis as per national guidelines
6. The assessment and size of the renal stone and hydronephrosis, and undue reliance on blood
tests taken on admission (18 hours previously) to assess Mrs Lopes’s condition
7. The lack of active management to expedite physician’s review and to facilitate admission to ITU
8. Failure to recognise and therefore escalate concerns of sepsis by critical care outreach team
9. Failure to act on or escalate elevated Early Warning Scores as per hospital protocol
10. Lack of clarity to the length, volume and dose of propofol infusion to be given in ITU
11. Lack of medical supervision and control of the use of propofol in ITU (no protocol in place)
12. Consideration for the use of daily Creatine Kinase levels when propofol infusions are given
13. Lack of understanding and acceptance Propofol related infusion syndrome (PRIS) is an accepted
albeit rare, complication of the use of prolonged propofol for sedation in Intensive Care Units
14. Lack of understanding that PRIS may have an atypical presentation in adults and should always
be a consideration when propofol is used for a protracted period of time
15. Lack of national understanding and acceptance of the amount of propofol that can be given and
the importance of creating and adhering to guidelines or protocols for its use and to implement
continual assessment to look for the complications of PRIS (serial CK levels)
6
ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you and your organisation,
Royal Surrey County Hospital and other organisations: Frimley Park Hospital, Basingstoke General
Hospital, Royal College of Anaesthetists (Intensive care division), Association of Anaesthetists of Great
Britain and Ireland (AAGBI), Intensive care Society and the MHRA 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, I, the coroner, may
extend this 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.
1REGULATION 28 REPORT TO PREVENT FUTURE DEATHS RT4134
8
COPIES and PUBLICATION
I have sent a copy of my report to the Chief Coroner and to the following Interested Persons;
who may find it useful or of interest.
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
DATE: 11-July-2014 SIGNED: K Henderson
2REGULATION 28 REPORT TO PREVENT FUTURE DEATHS RT4134
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.
Frimley Park Hospital [i254 NHS Foundation Trust Direct Line eo meme POT Direct Fax u Cult on GU16 7 24 September 2014 Tel: 01276 604604 Dr Karen Henderson HM Coroner’s Court Station Approach WOKING Surrey GU22 7AP Dear Dr Henderson Re: Maria LOPES (Deceased) Thank you for your letter dated 14 July 2014 and the attached Regulation 28 Prevention of Future Deaths Report relating to the above named. We have reviewed the concerns raised following the Inquest into Mrs Lopes death and have outlined below the Trust’s position is in relation to the urology on-call arrangements across Frimley Park Hospital, Royal Surrey County Hospital and North Hampshire Hospital (Points 1, 2 and 3). 1. The Consultant Urologist’s on-call arrangements covering 3 hospitals at the weekend has no provision for consultant ward rounds, in contravention of suggested national guidelines. There are no current suggested national guidelines concerning the provision of consultant ward rounds but we believe this is a reference to the guidelines produced by Sir Bruce Keogh in a paper presented to NHS England in December 2013, outlining seven days a week service. This has set out standards which would mean that all emergency in patients would be assessed by a suitable consultant within six hours, (during periods of consultant presence on an acute ward) and, at other times, must have a thorough clinical assessment by a suitable consultant within 14 hours of arrival in hospital. Implementation of this guidance is over the next three years, with a submission of action plans in 2014/15, implementation of the greatest impact changes in 2015/16 and compliance by 2016/17. These standards represent a paradigm shift from the usual on-call arrangements concerning urology in the majority of hospitals in this country. The three trusts will need to undertake a review of the on-call services to develop an action plan towards becoming compliant with 7-day working. When the consultant urologists' on-call rota was established covering North Hampshire Hospital, Royal Surrey County Hospital and Frimley Park Hospital, the agreement was that trusts would make their own arrangements for review of in-patients/emergencies at the weekend. | believe that we have robust arrangements at Frimley Park Hospital, with the consultant on-call on Friday night available to see admissions and a Saturday morning ward round by Specialist Registrar or equivalent who reviews all emergency admissions and in-patients. These cases are then discussed with the consultant who had been on-call on the Friday night. A Frimley Park Hospital consultant is available to come to see these patients. The on-call consultant on the rota is then available for advice and we now have Specialist Registrar able to see emergencies. Frimley Park Hospital consultants undertake a ward round of all urology patients on Sunday morning, which means that there is consultant review over the weekend. 2. Ageneral lack of knowledge or implementation of published ‘on-call’ national guidelines As mentioned above, there are no specific on-call guidelines produced nationally for urology and the Keogh recommendations were published within the last year. These have therefore come into force subsequent to Mrs Lopez's tragic death and it is intended that consultants from all three hospitals meet to discuss future arrangements for on-call. The current on-call arrangements at Frimley Park Hospital have operated safely for over ten years and, by discussing cases with the registrar on Saturday and reviewing collaborative decisions made by the registrars the next day, we are able to provide supervision of the registrars. In addition, the on-call consultant for all three hospitals is able to review patients, if requested. 3. The overall supervision of out-of-hours urology trainees within the system The overall supervision of out-of-hours’ urology trainees within the current system is specific to the arrangements within each Trust. Trainees have access to consultant advice and review, if necessary, 24/7 during the on-call weekend. Provision of consultant-delivered emergency service with regular in-patient ward rounds will require additional consultant appointments to allow trusts to become compliant with Keogh. There is wide variety of provision of urology cover across the country, with approximately 50% of urology departments dependent on general surgical middle grade support. We are fortunate to have urology middle grade support for our emergencies. It is recognised by BAUS that this is an issue that will need to be addressed in the next couple of years. The Trust is committed to patient safety and takes cases such as this very seriously and hope this is demonstrated in our response to the concerns raised. However, if | can be of any further assistance, please do not hesitate in contacting me. Yours sincerely Andrew Morris Chief Executive or 2o0f2 ¢ ‘“ INVESTORS Ny_ a IN PEOPLE In partnership with the Ministry of Defence
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