Prevention of Future Deaths reports · 2014

Maria Lopes

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 report11 Jul 2014
Reference2014-0325
DeceasedMaria Lopes
CoronerKaren Henderson
Coroner areaSurrey
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedFrimley Park Hospital NHS Trust
Sourcejudiciary.uk record · original PDF
Responses published1

The report

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

Responses

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.

Response from Frimley Park Hospital (PDF)
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

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