Prevention of Future Deaths reports · 2020

Darren Goddard

Regulation 28 report to prevent future deaths, reference 2020-0060, written 9 Mar 2020. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report9 Mar 2020
Reference2020-0060
DeceasedDarren Goddard
CoronerSarah-Jane Richards
Coroner areaSouth Wales Central
CategoryHospital Death (Clinical Procedures and medical management) related deaths · Wales prevention of future deaths reports (2019 onwards)
Sourcejudiciary.uk record · original PDF
Responses published1

The report

Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.

ANNEX A 

REGULATION 28:  REPORT TO PREVENT FUTURE DEATHS (1) 

NOTE: This form is to be used after an inquest. 

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

THIS REPORT IS BEING SENT TO: 

The Chief Executive Cwm Taf Morgannwg University Health Board  
Dr. N. Lyons Medical Director, Executive Directorate, Cwm Taf Morgannwg  
                                                    University Health Board 

1  CORONER 

I  am  Dr.  Sarah  -  Jane  Richards,  HM  Assistant  Coroner,  for  the  coroner  area  of  South 
Wales Central. 

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  30th  April  2019  I  commenced  an  investigation  into  the  death  of  Darren  John 
GODDARD.  The  investigation  concluded  at  the  end  of  the  inquest  on  22nd  January 
2020.  

The medical cause of death provided by the Royal Glamorgan Hospital was: 

          1(a) Multi-organ Failure; 
and  
          1(b) Sepsis (escherichia coli) following prostatic biopsy 1/4/19. 

The Coroner’s conclusion at the end of the Inquest was a Narrative Conclusion: 

The  deceased  died  from  a  recognised  complication  of  sepsis  following  an  elective 
medical procedure. Medical intervention failed to recognise the urgency required for the 
diagnosis  and  treatment  of  sepsis  although  the  impact  of  this  upon  the  deceased's 
survival is unclear.       

The family’s concerns at inquest were: 

i)  Advice  received  prior  to  consenting  to  the  Trans  Rectal  Ultrasound  biopsy 
(TRUS)  procedure  was  that  sepsis  was  a  rare  post-procedure  occurrence 
i.e. the consent form stated a risk of “rarely sepsis“ (Sepsis is a recognised 
complication  following  TRUS  biopsy  occurring  in  less  than  1%  of  biopsies 
despite  antibiotic  cover).  Conversely,  transient  flu-like  symptoms  were 
stated as more commonly experienced.   This information led Mr. 
Goddard  to  believe  the  shivers  and  symptoms  he  experienced  on  1st  April 
2019  post-operatively  were,  more  likely  than  not,  to  be  the  more  common 
adverse  effects  of  flu-like  symptoms  rather  than  the  more  insidious 
symptoms  of  sepsis.  The  family  consider  emphasising  flu-like  symptoms 
was  misleading  as  they  can  overlap  with  the  grave  symptoms  of  sepsis 
thereby  minimalizing  patient  concern  and  avoiding  seeking  prompt 
intervention. 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 ii)  Subsequent to Mr. Goddard’s death, the family question how this data i.e.1% is 
generated  and  whether  or  not  it  is  a  reliable  reflection  of  the  incidence  of 
sepsis following TRUS. 

iii)  On 29 March  2019,  prior to his TRUS procedure, Mr. Goddard  was provided a 
prescription  of  4  doses  of  the  antibiotic  Ciprofloxacin  750mg.  This  was 
considered  as  being  contraindicated  for  Phenytoin, 
the  anti-epileptic 
medication prescribed long-term to Mr. Goddard.  In the event, and following 
discussion  between  the  Pharmacy,  the  Urology  Consultant  and  Nurse 
Practitioner,  it  was  agreed  that  Ciprofloxacin  was  safe  to  be  taken  with 
Phenytoin.  The  British  National  Formulary  does  not  list  this  antibiotic  as  a 
contra-indicated medication for Phenytoin. 

iv)  Mr. Goddard  received  his  antibiotic  prescription  which he took as prescribed  in 
order  to  be  provided  antibiotic  prophylaxis  for  the  procedure  he  was  to 
undergo.    The  family  now  have  concerns  whether  the  interaction  between 
Phenytoin  and  Ciprofloxacin  750mgs  which  was  subject  of  discussions 
between the pharmacist and Consultant related to any diminished efficacy of 
the antibiotic.   

v)  Mr. Goddard underwent TRUS on 1 April 2019 at 1100 hours. He was advised 
the  procedure  had  been  conducted  without  complication  and  was 
discharged  at  1300  hours  with  the  warning  that  he  may  suffer  flu-like 
symptoms and advised to drink plenty of water. He was discharged from the 
post-op  recovery  unit  after  demonstrating  he  could  tolerate  fluids;  could 
produce  urine;  and  had  no  per  rectal  bleeding.  He  was  observed  for 
recommended 
approximately  1  hour  post-operatively  whereas 
observation period was for longer. Had Mr. Goddard been observed for the 
full recommended period of time his family consider that his early symptoms 
of sepsis would have been noted in the recovery unit with a good chance of 
rapid diagnosis and treatment.  

the 

vi)  The following day, on 2nd April 2019 Mr. Goddard suffered a headache, shaking 

became incoherent, was bleeding per rectum and in a state of collapse. 

  fearing  sepsis  rushed  her  husband  to  A&E  at  Royal  Glamorgan 
Hospital.  A  full  account  of  the  TRUS  procedure  and  risk  of  sepsis  was 
provided  to  the  Nurse  at  Triage  yet  there  was  no  sense  of  urgency  with 
progressing  Mr.  Goddard  for  antibiotic  treatment  and  significant  delays 
occurred with being reviewed by a doctor and being administered antibiotics 
(a  delay  of  1  hour  40  minutes  later  than  required  with  the  current  sepsis  6 
management  bundle).  These  delays  represented  missed  opportunities  for 
successfully treating Mr. Goddard.  

vii)  There was a further significant delay (around 7 hours) in escalating Mr. Goddard 
for  Critical  Care  by  which  time  he  was  at  risk  of  heart  failure,  sepsis  and 
septic shock from a high lactate level (risen to 20).  

viii) Although  colloidal  IV  fluids  were  administered  in  A&E  these  were  not  the 

recommended fluids for treatment of hypovolaemic shock. 

4  CIRCUMSTANCES OF THE DEATH 

These were recorded as :- 

Darren John Goddard 52 years underwent an elective, trans-rectal ultrasound of his 
prostate gland. A risk associated with the procedure is sepsis. The following day he 
became acutely unwell and was admitted to the Royal Glamorgan Hospital where upon 
sepsis was diagnosed but with significant delays with providing intervention. When 
treatment was provided it was not always the recommended treatment. 

Medical intervention failed to improve his condition and he passed away on 18 April 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 2019. 

The Inquest focused upon:- 

a.  The practices & procedures of the elective surgery of TRUS and information 

provided concerning sepsis as an adverse effect. 

b.  Failures within A&E at triage through to critical care to expedite appropriate 
treatment for sepsis even though warnings of the lethality of sepsis was 
advertised through public warning notices displayed in the A&E department.  

5  CORONER’S CONCERNS 

During the course of the inquest the 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.  –  

(1)  TRUS elective surgery ‘consenting’ and information provision (oral and in written 

format) places a misleading emphasis on flu-like symptoms as adverse effects. 

(2)  The accuracy of the 1% risk of sepsis incidence provided. 
(3)  Premature discharge post-operatively from the recovery unit with the missed 
opportunity to recognise the adverse effect of sepsis when they occurred. 
(4)  The failure at triage to escalate this referral to seeing a doctor within 10 mins of 

admission.  

(5)  Subsequent failure to provide timely and appropriate fluids and antibiotics. 
(6)  Delay in admission to Critical Care.  

6  ACTION SHOULD BE TAKEN 

In my opinion action should be taken to prevent future deaths and I believe you and your 
organisation have the power to take such action.  

•  Review and provide definite warnings (oral and written) of sepsis when 

consenting patients to TRUS and upon their discharge. 

•  Avoid patients being discharged prematurely. 
•  Further training of Triage nursing staff and doctors of the Sepsis 6 bundle and 

ensure the training is kept current.  

7 

YOUR RESPONSE 

You are under a duty to respond to this report within 56 days of the date of this report, 
namely by 10 May 2020.  I, the Coroner, may extend the period upon request. 

Your response must contain details of action taken or proposed to be taken, setting out 
the timetable for action. Otherwise you must explain why no action is proposed. 

8  COPIES and PUBLICATION 

I have sent a copy of my report to Mr. Mark Drakeford, First Minister of Wales,  
Mr. Vaughan Gething, Minister for Health and Social Services, and the family 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. 

3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 9 

9 March 2020 

SIGNED: 

Dr. Sarah - Jane Richards, Assistant Coroner for South Wales Central 

4

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 Dr Hopkins (PDF)
Your Ref/Eich cyf: 18424

2&> IG Our Ref/Ein cyf: SH/NL/PCS
Bwrdd techyd Prifysgol Date/Dyddiad: 04 May 2020
oy CYMRU | Cwm Taf Morgannwg A
Hy J H University Health Board Tel/ffén: 01443 744800
0 WALES Fax/Ffacs: 01443 744889
Email/ebost:
Dept/Adran: Chief Executive

Private & Confidential

David Regan

Her Majesty’s Assistant Coroner
South Wales Central Coroner Area
Coroner's Office

The Old Courthouse

Courthouse Street

Pontypridd

CF37 1JW

Dear Mr Regan
Re: Regulation 28 — Mr Darren John Goddard

Thank you for your correspondence in relation to the above Regulation 28 report, which
details your areas of concern following the conclusion of the inquest held on the 22" January
2020into the sad death of Mr Darren John Goddard.

Please be assured that the Health Board has taken this matter extremely seriously and action
is being taken to address the matters highlighted during the inquest and those raised by you
in the Regulation 28 report.

We sincerely apologise to Mr Goddard’s family and would like to assure them that we have
acted as directed by your findings. We accept that our language and procedures for consent
fell short for Mr Goddard, as did the recognition of his septic illness post procedure and we
apologise for our failings regarding this.

Medical, radiology, nursing and pharmacy staff and the patient care and safety team have
been involved in the development and implementation of our action plan which is attached,
including supporting evidence.

You asked us to take action as follows

1. Review and provide definite warnings (oral and written) of sepsis when
consenting patients to TRUS, and upon their discharge.

We have agreed a way forward to use consistent terminology regarding sepsis, and to
exclude reference to the word ‘rarely’ on the TRUS biopsy consent form.

This was agreed at the meeting of the Consent Working Group on the 11" March 2020.
Following this meeting, Consultant Surgeon, wrote to the
Consultant Urologists and the Interventional Radiologists to explain the decision.

We apologise for any lack of clarity regarding this wording during Mr Goddard's pre
procedure consent process.

Cyfeiriad Dychwelyd/ Return Address:
Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg, Pencadlys, Parc Navigation, Abercynon, CF45 4SN
Cwm Taf Morgannwg University Health Board, Headquarters, Navigation Park, Abercynon, CF45 4SN

We apologise that Mr Goddard's family felt that the reference to ‘flu-like’ symptoms
was misleading. This terminology is used by the Sepsis Trust who advise in their
literature that sepsis, in its early stages, is often indistinguishable from flu symptoms.
However, the Sepsis Trust also emphasises that patients with these symptoms should
seek medical advice urgently. We sincerely apologise that we did not make this clear
to Mr Goddard and his family.

All patients who have TRUS biopsies are given a Prostate Biopsy Aftercare advice
sheet which states that “It is very important to see your GP, contact the out of hours
service, or attend A&E if you experience symptoms of infection or SEPSIS (e.g. high
temperature, feeling hot and cold and shaky, flu-like symptoms) following the
procedure.”

. Avoid patients being discharged prematurely

We acknowledge, and apologise for, the conjflicting information in the two discharge
advice documents which were given to Mr Goddard.

The discharge advice leaflet headed Ward 5 stated that patients are expected to be
observed for 2-3 hours post procedure, whilst the leaflet provided by the Radiology
Department stated that patients normally require monitoring for around an hour.

There are no known recommendations from professional organisations as to the time
period for which patients must be observed prior to discharge. Occasionally men feel
light-headed, and bleeding may occur, and patients are generally asked to wait until
staff are sure that neither of these occurrences have taken place. The majority of
patients will leave before one hour has elapsed after their procedure, as long as they
are feeling well, are able to pass urine and can tolerate oral fluids. Patients will also
have their observations taken and these will need to be stable just prior to discharge.
It is unlikely that patients will show any evidence of sepsis within this first hour. The
Sepsis Trust confirms that patients may show signs of sepsis up to 30 days post
procedures. Mr Goddard’s passing has reminded us all that sepsis can develop
rapidly.

We can confirm that a single leaflet, which is produced by the British Association of
Urological Surgeons (BAUS), is now used, which states that patients should expect
to go home on the same day, with no specific time scales given.

3. Further training of Triage nursing staff and doctors of the sepsis 6 bundle and

ont ee

Score (NEWS) documentation, escalation and the implementation of the Sepsis 6
bundle.

ES << appointed Clinical lead for the Accident and Emergency
epartment has reinstated ongoing Sepsis training for medical and nursing staff,
both agency and substantive. This is currently on hold however due to COVID-19
activity.

Locum Doctors are given a Locum doctor’s advice card, embedded within point 12 of
the attached action plan. This highlights the need to ensure that all blood results are
reviewed in a timely fashion.

will also ensure that point of care testing for venous blood gases is
introduced in order to identify abnormal lactate results, which are key to the early
identification of sepsis.

The learning from your report and the University Health Board’s own investigations has
been shared with individual staff, and also across the organisation via the Health
Board's Listening & Learning Feedback Newsletter.
| sincerely hope that this information will reassure you that the Health Board has learnt
important lessons from the investigation and inquest into the care provided to Mr Goddard and
that effective action is being undertaken to prevent further deaths.

| would like to convey once again my deepest sympathy and sincere apologies to Mr
Goddard's family for the failings identified.

Dr Sharon Hopkins

Prif Weithredwr/Chief Executive

Yours sincerely,

Enc

Cyfeiriad Dychwelyd/ Return Address:
Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg, Pencadlys, Parc Navigation, Abercynon, CF45 4SN
Cwm Taf Morgannwg University Health Board, Headquarters, Navigation Park, Abercynon, CF45 4SN

Cadeirvdd (Chair: PO Pele lathe Ime '

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