Prevention of Future Deaths reports · 2015
Regulation 28 report to prevent future deaths, reference 2015-0084, written 6 Mar 2015. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 6 Mar 2015 |
|---|---|
| Reference | 2015-0084 |
| Deceased | Mary Marshall |
| Coroner | Alan Walsh |
| Coroner area | Manchester (West) |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Bolton NHS Foundation Trust |
| 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: 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:
1. The Right Honourable Jeremy Hunt, Secretary of State, Department of
Health, Richmond House, 79 Whitehall, London, SW1A 2NS
1 | CORONER
I am Alan Peter Walsh, HM Area Coroner, for the Coroner Area of Manchester
West
—
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 5" September 2014, I commenced an Investigation into the death of Mary
Magdalene Marshall, 87 years, born on the 26" May 1927. The Investigation
concluded at the end of the Inquest on 23 February 2015.
The medical cause of death was:
1a) Pseudomembranous Colitis
1b) Clostridium Difficile Colitis
The conclusion of the Inquest was that Mary Magdalene Marshall died as a
consequence of a recognised complication of antibiotic therapy on a background
of Glutamate Dehydrogenase and naturally occurring disease.
4 | CIRCUMSTANCES OF THE DEATH
1. Mary Magdalene Marshall died at the Royal Bolton Hospital, Minerva
Road, Farnworth, Bolton on the 29" August 2014.
2. In March 2013 Mrs Marshall was an inpatient at the Royal Bolton
Hospital when she was identified as being Glutamate Dehydrogenase
(GDH) positive from a faecal specimen.
3. A GDH positive result indicates vulnerability to the development of
Clostridium Difficile infection.
4. The Royal Bolton Hospital had two systems to report a finding of GDH
positive, namely:-
i. The Ascribe Discharge summary which communicates findings to
a General Practitioner.
it. The Extramed which records the findings on the hospital records
so that appropriate measures may be taken on any subsequent
admission in terms of infection control.
On the 13" August 2014 Mrs Marshall was seen by her General
Practitioner who diagnosed a chest infection and prescribed Amoxicillin
as a recommended antibiotic to treat the chest infection.
On the 19" August 2014 Mrs Marshall was admitted to the Royal Bolton
Hospital with a tender swelling in the left inguinal region and a CT scan
on the 20° August 2014 identified an incarcerated inguinal hernia
causing small bowel obstruction. Mrs Marshall consented to surgery to
repair the hernia but when she was transferred to the operating theatre,
later the same evening, she suffered a cardiac arrest and required
cardiopulmonary resuscitation. She was transferred to the High
Dependency Unit when it was deemed too high a risk to proceed with
the surgery and the small bowel! obstruction was managed with
conservative measures including intravenous fluid administration and
nasogastric drainage.
On the 26" August 2014 Mrs Marshall developed an elevated
temperature and a chest X-ray showed evidence of a right sided
pneumonia. Appropriate antibiotic therapy was commenced along with
chest physiotherapy.
On the 28" August 2014 a stool sample confirmed Clostridium Difficile
infection and, after discussion with the Consultant Microbiologist,
Metronidazole was commenced as an appropriate antibiotic to treat
Clostridium Difficile but Mrs Marshall continued to deteriorate and died
on the 30 August 2013.
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.
During the Inquest evidence was heard that:
i. A GDH positive result indicates vulnerability to the development
of Clostridium Difficile infection.
it. The evidence indicated that there was a lack of awareness, in
general, of the importance of GDH positive results in relation to
the future prescription of antibiotics and the risk of the
J
vi.
development of Clostridium Difficile infection. Furthermore there
is a lack of awareness amongst General Practitioners in relation
to GDH positive results.
The evidence indicated that there were Hospital Trusts in the
North West that did not inform General Practitioners of GDH
positive results and it is believed that a similar problem may exist
Nationwide.
The Bolton NHS Foundation Trust has addressed the problem of
awareness and procedures have been implemented with
instruction to all medical staff to communicate information
regarding the GDH positive results to General Practitioners and
other providers of primary care. Furthermore there has been a
discussion with the Bolton CCG Clinical lead regarding raising
awareness of GDH positive results in primary care and the
implications for future prescription of antibiotics.
The Trust has drafted letters (copies attached hereto) to be sent
to General Practitioners, immediately upon diagnosis of GDH
positive results, to confirm the diagnosis and to confirm that the
patient is an inpatient at the Hospital at the time of the writing of
the letter. The Trust will share the diagnosis with the relevant
CCGT, in real time, if the patient is not an inpatient.
In so far as inpatients at the Hospital are concerned the Bolton
NHS Foundation Trust has established procedures whereby the
Extramed is noted with the GDH positive results and the Hospital
has initiated a ward clerk alert system at the beginning of each
ward round confirming that a patient is GDH positive so that the
prescription of antibiotics may take account of the positive
results.
The evidence raised concerns that future deaths will occur unless
action is taken to review the above issues on a Nationwide basis.
. Trequest you to consider the above concerns and to carry out a review
with regards to the following:
The awareness amongst all Health Practitioners of the
significance of GDH positive results and the training of General
Practitioners in relation to the relevance of GDH positive results,
particularly in relation to the future prescription of antibiotics.
The procedures in Hospitals to advise General Practitioners and
Primary Care Practitioners of a GDH positive result by use of
letters similar to the attached letters prepared by the Bolton NHS
Foundation Trust.
Hospitals to have a log, similar to the Extramed system at the
Royal Bolton Hospital, recording GDH positive results in the
hospital records and procedures for such results to be brought to
the attention of Clinicians at the beginning of every ward round.
I request the above review to increase the awareness in relation to GDH
positive results particularly in relation to the future prescription of
antibiotics and the reduction of the risk and the occurrence of
Clostridium Difficile infection which may lead to Pseudomembranous
Colitis and future deaths.
ACTION SHOULD BE TAKEN
In my opinion urgent action should be taken to prevent future deaths and I
believe you and/or your organisation 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 1% May 2015. I, 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
I have sent a copy of my report to the Chief Coroner and to the following
Interested Persons:
1. ER — usband of Mary Magdalen Marshall
iia
- Son of Mary Magdalen Marshall
— Assistant Director Infection Control, the Royal Bolton
Hospital NHS Foundation Trust.
WN
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.
6" March 2015 Mr Alan P Walsh
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.
ae Department of Health Mr A Walsh Area Coroner HM Coroner’s Court Paderborn House Howell Croft North Bolton BLI 1QY 27 April 2015 Dear Mr Walsh Chief Operating Officer Richmond House 79 Whitehall London SWIA 2NS Thank you for your letter following the inquest into the death of Mary Marshall. As a result of evidence heard at the inquest, you would like to see an increased awareness of the implications of Glutamate Dehydrogenase (GDH) positive results and of the need to prescribe appropriate antibiotics to reduce the risk and the occurrence of Clostridium Difficile infection. You raise several concerns relating to the understanding and handling of GDH positive results: a lack of awareness generally amongst medical staff of the importance of such results, a lack of hospital procedures to inform the patient’s GP of a GDH positive diagnosis and the need for all hospitals to record such diagnosis on patient’s hospital records for the attention of treating clinicians. You request that we review the following issues: e the awareness amongst all Health Practitioners of the significance of GDH positive results and the training of General Practitioners in relation to the relevance of GDH positive results, particularly in relation to the future prescription of antibiotics. e the procedures in Hospitals to advise General Practitioners and Primary Care Practitioners of a GDH positive result by use of letters similar to the attached letters prepared by the Bolton NHS Foundation Trust. (You provide a copy of the letter and GDH awareness sheet that Bolton NHS FT has developed and which they send to the GP of the patient who has been diagnosed GDH positive). e whether hospitals have a log, similar to the Extramed system at the Royal Bolton Hospital, recording GDH positive results in the hospital records and their procedures for such results to be brought to the attention of Clinicians at the beginning of every ward round. Your letter has been shared with leading Clostridium difficile infection (CDI) experts within Public Health England and antimicrobial specialists within NHS England. Whilst they advise that no changes are currently made to existing guidance in this area, there are measures that are currently being taken and considered to improve information exchange and understanding of CDI. The management of CDI can be complex as many factors need to be considered to achieve the best treatment for the patient. Tests to identify Clostridium difficile (C. diff) form a fundamental part of CDI management. This is outlined in the Department of Health’s, Updated guidance on the diagnosis and reporting of Clostridium difficile (2012) which outlines two types of tests, which when used in combination, will deliver the most accurate results for the detection of C. diff infection. This national two test screening protocol comprises a ‘GDH enzyme immunoassays EIA (or NAAT/PCR) followed by a sensitive toxin EIA. If the first test (GDH or NAAT) is negative, the second test (sensitive toxin EIA) does NOT need to be performed. A third test (e.g. NAAT or PCR) may be optionally added to the algorithm to further identify samples from potential C. difficile excretors.’ Whilst a GDH positive result may identify the presence of C. diff, it does not identify whether the strain is toxigenic or non-toxigenic and the additional toxin test outlined above is therefore required. In addition, being colonised by C. diffcan provide some protection against CDI. Therefore, it is not entirely accurate to say that a GDH positive result indicates vulnerability to the development of C. diff infection. In Mrs Marshall’s case, the absence of the information from a toxin test and other clinical information, makes it difficult to determine whether or not amoxicillin was the most appropriate treatment. It is a reasonable choice of antibiotic to treat a chest infection in community care and, as outlined by NICE, Evidence Summary, Clostridium difficile infection: risk with broad-spectrum antibiotics (2015), it presents a lower risk in relation to C. diff compared to other broad spectrum antibiotics. However, it is also possible that the patient could have developed CDI even without the use of amoxicillin due to the multi-factorial nature of CDI and the presence of other risk factors including; age, hospital admission, high dependency unit admission and likely administration of broad spectrum antibiotics. Furthermore, the Department of Health’s guidance is purposely cautious with regards to the treatment of GDH positive, toxin negative patients due to the lack of robust evidence regarding best practice. For this reason our expert advisers have recommended that changes to the national guidance are not required. Nevertheless, appropriate information relating to a patient’s CDI status is essential for informing the most appropriate care and treatment. Nationally work is already being undertaken to ensure that this is recognised. As part of NHS England’s Antimicrobial Resistance (AMR) work programme, work has been undertaken to promote the importance of C. diff testing. This has been achieved in part by the delivery of three national AMR workshops and a national clostridium difficile study day. All materials will be made available on the NHS England Patient Safety Domain webpage http://www.england.nhs.uk/ourwork/patientsafety/associated-infections/. The national workshops included a session on Improving Antibiotic Prescribing in Primary Care and specific content about identifying past C. diff infections. To ensure this work is developed further, and in light of the recommendations made, NHS England will work with partners to continue to explore ways to develop a wider understanding of C. diff testing and the implications of the results, including but not limited to GDH testing. In addition, NHS England’s patient safety team will consider the specific circumstances of this case to determine if any further action, over and above that already planned, is merited. However, all future work must take account of the national algorithm for C. diff testing and mitigate against the risk of unintended consequences, (which may involve patients being treated inappropriately i.e. as though they have CDI) if the implications of GHD positive results are miscommunicated. Methods to support local health communities in the reporting and sharing of information in relation to a patient’s CDI status will also be explored. More widely, NHS England is already working on ideas for improving the provision of information between hospitals and primary care upon patient discharge. This will be informed by examples of best practice implemented locally and by consulting with relevant partners and subject matter experts to determine how information should be disseminated. I would like to say how sorry I was to hear of Mrs Marshall’s death and wish to extend my sincere condolences to her family. I hope that this response is helpful and I am grateful to you for bringing the circumstances of Mrs Marshall’s death to my attention. Yours sincerely TAMARA FINKELSTEIN
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