Prevention of Future Deaths reports · 2016

Hayley Clark

Regulation 28 report to prevent future deaths, reference 2016-0143, written 12 Apr 2016. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report12 Apr 2016
Reference2016-0143
DeceasedHayley Clark
CoronerMark Beresford
Coroner areaYorkshire South (East District)
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Sourcejudiciary.uk record · original PDF
Responses published1

The report

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.

Mark Andrew Beresford
Assistant Coroner for South Yorkshire (East District)

TT eee

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS

THIS REPORT IS BEING SENT TO: Ms Louise Barnett, Chief Executive,
Rotherham Hospital NHS Foundation Trust Moorgate Road Rotherham $60 2UD
1 CORONER

| am Mark Andrew Beresford, Assistant Coroner for South Yorkshire (East District)

2 CORONER’S LEGAL POWERS

| 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.

http:/Awww. legislation.gov.uk/ukpga/2009/25/schedule/5/paragraph/7
http:/Avww.legislation.gov.uk/uksi/2013/1629/part/7/made

3 INVESTIGATION and INQUEST

On 27/05/2015 | commenced an investigation into the death of Hayley Christine Clark, 36. The
investigation concluded at the end of the inquest on 12 April 2016. The conclusion of the inquest
was a Narrative conclusion as follows: Hayley Christine Clark died, at Rotherham Hospital, on
24th May 2015, from the effects of severe malnutrition. Her malnutrition arose from a
combination of factors, which did not include anorexia, but which did include poor eating
discipline due, in part, to longstanding abdominal discomfort. The cause of death was

1a. Respiratory failure, 1b Pulmonary oedema, 1c Severe multi-factorial malnutrition,

2. Acute pyelonephritis, electrolyte imbalance, anaemia and immune deficiency

4 CIRCUMSTANCES OF THE DEATH

1. Hayley Christine Clark was a 36 years old female with a medical background which
included long term malnutrition, hypogammaglobulinemia, irritable bowel syndrome,
anaemia and depression.

2. She was admitted to Rotherham General Hospital on 12'" May 2015 with electrolyte
imbalance.

3. As part of a standard package of pain management, Ms Clark received Paracetamol.
However the dose administered was the standard adult one and had not been adjusted
to reflect Ms Clark’s extremely low (less than 50kg) body weight. This overdose of
Paracetamol caused derangement of Ms Clark’s liver function. The problem was
identified, the Paracetamol was withdrawn and Parvolex was administered.

4. Ms Clark’s condition deteriorated. She was transferred to the High Dependency Unit on
22™ May 2015 and she died on 24" May 2015. The cause of her death was as set out
above.

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.

Coroner's Court and Office, Doncaster Crown Court, College Road, Doncaster, DN1 3HS
Tel 01302 737135 | Fax 01302 736365

The MATTERS OF CONCERN are as follows:

(1) There was a failure, on the part of the staff who prescribed and administered the
Paracetamol to Ms Clark, to recognise the need to adjust the dosage (in evidence the required
reduction was said to be 50%) to reflect Ms Clark’s extremely low body weight.

ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and | believe you Ms Louise
Barnett, Chief Executive, 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
Tuesday 7th June 2016. |, 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

| have sent a copy of my report to the Chief Coroner and to the following Interested Persons:

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.

Dated 12 April 2016

Signature_—<C-—

Assistant Coroner for South Yorkshire (East District)

Coroner's Court and Office, Doncaster Crown Court, College Road, Doncaster, DN1 3HS
Tel 01302 737135 | Fax 01302 736365

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 The Rotherham NHS Trust (PDF)
Rotherham Hospital 
Moorgate Road 
Oakwood 
Rotherham 
S60 2UD 

Telephone 01709 820000 
www.therotherhamft.nhs.uk 

Our reference 

Your reference 

Date 

6th June  

Address  

Strictly Private and Confidential 
Mr M A Beresford 
Assistant Coroner 
South Yorkshire (East District) 
Coroner’s Court and Office 
Doncaster Crown Court 
College Road 
Doncaster DN1 3HS 

Via Email 

Dear Mr Beresford 

RE: Ms Hayley Clark – Regulation 28 

Firstly, I wish to state on behalf of The Rotherham NHS Foundation Trust, how sorry we are for the 
shortcomings in practice relating to Ms Clark’s care. We have taken the learning from our investigation and 
your concerns seriously in order to improve practice and take action to ensure that other patients do not 
have the same experience in future.  

Turning to the specific issues that you identified in your conclusion at the inquest on the 12th of April 2016: 

“There was a failure, on the part of the staff who prescribed and administered the paracetamol to Ms Clark, 
to recognise the  need to  adjust the  dosage (in  evidence  the  reduction was said to  be  50%) to reflect  Ms 
Clark’s extremely low body weight” 

I  attach  a  copy  of  our  additional  action  plan  and  can  confirm  that  I  am  assured  that  the  Patient  Safety 
Group will oversee completion of the action plan. In the meantime please do not hesitate to contact me if 
you require any further information 

Yours sincerely 

Louise Barnett  
Chief Executive  

Enc 

Louise Barnett 
Chief Executive, The Rotherham NHS Foundation Trust 

Direct Line 01709 424576 
Executive Assistant Sharree Johnstone 
Direct Line  01709 424001  Fax 01709 304200  Email sharree.johnstone@rothgen.nhs.uk 

  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 ACTION PLAN - REGULATION 28 

Action Plan:  
Regulation 28 – Prevention of 
future deaths  
Management of oral 
paracetamol for adult patients 
of extremely low body weight. 

Date Issued: 
30th May 2016 (Version 1) 

Action Plan Lead:  
Chief Pharmacist and Assistant 
Director of Patient Safety 

Action Plan Review Dates: 
Monthly by Medication Safety Group 
To be signed off by the Patient Safety 
Group by September 2016 provided 
evidence of all actions is available. 

This action plan is dated the 30th May 2016 and relates to concerns identified at the inquest into the death of Ms Hayley Clark who was admitted to The 
Rotherham NHS Foundation Trust (TRFT) with electrolyte imbalance. She had a medical background which included malnutrition, 
hypogammaglobulinemia, irritable bowel syndrome, anaemia and depression. As part of her pain management Ms Clark received paracetamol. However 
the dose administered was the standard adult dose and did not reflect Ms Clarks extremely low body weight. The overdose caused derangement of her 
liver function. The issue was identified and the paracetamol withdrawn and Parvolex administered. The cause of death which was recorded by HM Coroner 
as: 

1a) Respiratory Failure    
1b) Pulmonary oedema 
1c) Severe multifactorial malnutrition 
2) Acute Pyelonephritis, electrolyte imbalance, anaemia and immune deficiency. 

Following the inquest HM Coroner identified: 

  There was a failure on the part of the staff who prescribed and administered the paracetamol to recognise the need to adjust the dosage (in 

evidence the required reduction was said to be 50%) to reflect Mrs Clark’s extremely low body weight.  

 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Objective 
1. Ensure the Trust’s Medicines 
Management Policy includes the 
safe prescribing and 
administration of medication for 
patients with extremely low body 
weight. 

ACTION PLAN – REGULATION 28 
Who will take the action? 
Chief Pharmacist and the Trust’s 
Pharmacist designated as the 
Medication Safety Officer / 
Assistant Director of Patient 
Safety and the Chair of the 
Medication Safety Group 

Action Required 
See notes in far right column 
regarding research undertaken to 
inform this action plan 

1.1 Review of the Trust’s 
Medicines Management Policy 
and/or the development of further 
local guidelines/Standard 
Operating Procedure or a Patient 
Group Directive which must 
include information for all 
prescribers of the need to be 
aware of possible dose reduction 
of drugs for patients with 
extremely low body weight. 

What timescale has been set and agreed? 
As the British National Formulary (BNF) does 
not currently provide dosage reduction 
recommendations the Trust’s Chief 
Pharmacist has sought advice from the  
Medicines and Healthcare products 
Regulatory Agency (MHRA) who have 
recently reviewed the publication of a paper 
from Birmingham Trust; whilst body weight 
alone is not considered a marker for an 
increased risk of oral paracetamol toxicity, an 
adult weighing less than 50kgs is more likely 
to have conditions that predispose them to 
liver damage from the paracetamol. A dose 
reduction to 2-3g total daily dose may be 
warranted. 
The MHRA are not currently recommending 
a change to the licences of oral paracetamol 
products, or a change to the packaging of the 
paracetamol products for the public to buy. 

Local guidelines /Standard Operating 
Procedure or a Patient Group Directive  to be 
completed by September 2016 

1.2 A pharmacy medications 
information leaflet to be produced 
on reducing the dose of oral 
paracetamol for patients who 
weigh less than 50kgs and/or with 
medical conditions which may 
require  consideration of dose 
reduction – malnutrition/anorexia 
or high alcohol consumption all of 
which are known indications for 
considering a dose reduction of 
oral paracetamol 

Chief Pharmacist and the Trust’s 
Pharmacist designated as the 
Medication Safety Officer 

The Trust information leaflet must be 
approved by the Trusts Medication Safety 
Group by July 2016 and available on the 
Trust’s intranet by August 2016. 

Information added to the Trust electronic 
information for junior medical staff by August 
2016. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 2. Ensure all nursing and medical 
colleagues identify adult patients 
with extremely low body weight 
who may need adjustment in the 
dosage of oral paracetamol   

ACTION PLAN – REGULATION 28 

1.3 Development of stickers to be 
used on the Trust’s prescription 
charts to raise awareness and 
compliance with the dose 
reduction guidance of oral (and 
IV) paracetamol 

2.1 All nursing and medical staff  
who prescribe and administer 
medication to be provided with 
information on how to adjust the 
dosage of paracetamol for adult 
patients with extremely low body 
weight 

2.2 A record of all staff who 
require and have received 
appropriate training - on dosage 
reduction; will be collated to 
ensure all appropriate nursing 
and medical colleagues have 
received this in the required 
timescale 

2.3 Review of documentation to 
ensure accurate recording of 
patients weight in the clinical 
records, nursing records and 
prescription charts 

2.4 Audit to be undertaken to 
assess the equipment available 
across the Trust for weighing 
patients.  

Chief Pharmacist and the Trust’s 
Pharmacist designated as the 
Medication Safety Officer. 

The stickers must be approved by  the 
Trust’s Medication Safety Group by July 
2016 and available by August 2016 or any 
delay in the production and compliance with 
this completion date escalated to the Trust’s 
Medication Safety Group 

Chief Pharmacist and the Trust’s 
Pharmacist designated as the 
Medication Safety Officer 

This information for staff will be developed by 
31 August 2016.  

Chief Pharmacist and the Trust’s 
Pharmacist designated as the 
Medication Safety Officer 

All staff requiring additional training will have 
received this by October 2016. Attendance 
will be collated at the time of attendance  

Heads of Nursing/Matrons/Ward 
Managers/Ward pharmacists 

Patient Safety Team with the 
Critical Care - outreach team 

Training will also be on-going and provided 
on induction to appropriate colleagues (from 
September 2016) 

An audit of documentation of weights 
recorded in relevant nursing records and 
charts and on prescription charts will be 
undertaken by August 2016 and the results 
presented to the Patient Safety Group by 
September 2016 

Audit to be completed by July 2016 and a 
business case for any additional equipment 
will be presented to the Trust’s Medical 
Device Management Group (MDMG) by 
August 2016. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 ACTION PLAN – REGULATION 28 

2.5 A learning event to be held to 
discuss the details of this specific 
case 

The Pharmacy Department and 
Patient Safety team will deliver 
the learning event session 

A learning event session will have been 
delivered by 30th September 2016 as part of 
the SAFETEMBER safety work to be 
undertaken in September 2016.  

The changes in practice will be 
communicated in the Quarter 2 Patient 
Safety ‘lessons learnt’ newsletter due to be 
published September 2016. 

Action Plan developed by: Osman Chohan Chief Pharmacist and Fiona Middleton Assistant Director of Patient Safety 

Version Control: Version 1  

Date: 30th May 2016 

Circulation List: Divisional Clinical Directors,  All Consultant colleagues, Clinical Pharmacists, Heads of Nursing, Matrons, Ward Managers  
Medical Education and Practice Development teams.

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