Prevention of Future Deaths reports · 2020
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 report | 9 Mar 2020 |
|---|---|
| Reference | 2020-0060 |
| Deceased | Darren Goddard |
| Coroner | Sarah-Jane Richards |
| Coroner area | South Wales Central |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths · Wales prevention of future deaths reports (2019 onwards) |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
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
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.
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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