Thomas Collings

Regulation 28: REPORT TO PREVENT FUTURE DEATHS (1)

NOTE: This from is to be used after an inquest.
REGULATION 28 REPORT TO PREVENT DEATHS

THIS REPORT IS BEING SENT TO:
Mr Joe Harrison, Chief Executive, Milton Keynes University Hospital

1 CORONER

I am Tom OSBORNE, Senior Coroner for the area of Milton Keynes

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 13th June 2019 I commenced an investigation into the death of John SHROSBREE aged
72. The investigation concluded at the end of the inquest on 25th September 2019.

The conclusion of the inquest was a narrative conclusion:

The deceased was admitted to Milton Keynes University Hospital on 4th June 2019
clearly unwell, there was a failure to recognise the serious nature of his condition and
a failure to take the necessary steps to treat it. He went into cardiac arrest and
suffered hypoxicbrain injury and died on 11th June 2019.

4 CIRCUMSTANCES OF THE DEATH
The deceased was admitted by his GP via ambulance to Milton Keynes University Hospital
on the 4th June 2019 very unwell. His observations and tests confirmed he was unwell with
a high potassium level, his observations were not reviewed, his care was not escalated to a
higher level, he was transferred to a non-observable and unmonitored bay in the emergency
department, there was a delay in starting treatment to reverse his condition and he was
transferred for a CT scan when unstable. He suffered hypoxic brain damage following a
hyperkalaemic cardiac arrest and died on 11th June 2019

5 CORONER’S CONCERNS

The MATTERS OF CONCERNS are as follows:
My concern is that during the evidence it became clear that that the problems encountered in
the Emergency Department on 4th June 2019 were mainly brought about by staff shortages.
I was told that staff shortages occur on a daily basis and I believe that as a result lives of this
citizens of Milton Keynes are being put at risk and the problem should be addressed as a
matter of urgency.

6 ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you (and/or your
organisation) 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,
namely by 21st November 2019.

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.

8 COPIES and PUBLICATION

I have sent a copy of my report to the Chief Coroner and to the following Interested Persons
The Family of Mr Shrosbree
The Care Quality Commission

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

Tom OSBORNE
Senior Coroner for
Milton Keynes
Dated: 26 September 2019

Derek Winter DL
Senior Coroner for the City of Sunderland

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:

GE Healthcare and their Solicitors and Counsel

CORONER

I am Derek Winter DL, Senior Coroner for the City of Sunderland

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

INVESTIGATION and INQUEST

Mr Thomas Smith Collings, aged 64 years, died at Sunderland Royal Hospital on 2"4
August 2018 at 2am from a naturally occurring illness contributed to by a combination
of unexpected factors with regard to his life support. The Inquest, as part of my
Investigation, concluded on 4" April 2019, when I recorded a conclusion ‘Natural
Causes’.

The Cause of Death was: -

Ia Acute Myocardial Infarction

Ib Coronary Artery Disease

II Type 2 Diabetes, High Blood Pressure

CIRCUMSTANCES OF THE DEATH

Mr Collings suffered unheralded ventricular fibrillation (a lethal heart rhythm) at
01.20:41 on 2 August 2018, for which there was no warning — he was stable, symptom-
free and all his observations had been good in the time leading up to the collapse. The
ventricular fibrillation (VF) rhythm was very clear from the ECG traces and will have
resulted in the cessation of effective cardiac output.

The ECG monitor showed a clear artefact after 01.21:00, which hid the true underlying
rhythm, and after this time, it would have been impossible to determine that Mr Collings
was in VF by looking at the monitor. He was undoubtedly in VF throughout this time
however, until he was discovered 6-7 minutes later at around 1.27. VF does not
terminate itself, and it was present when the crash team attached the monitor after
commencement of resuscitation, so it was present throughout this time, and he would
have remained without any cardiac output.

Civic Centre, Burdon Road,Sunderland, SR2 7DN
Tel 0191 5617843 | Fax 01915537803 | DX 60729 Sunderland
www.sunderlandcoroner.co.uk

Lead disconnection is relatively common in sleeping patients (as well as those who are
awake), for example when they roll over in their sleep, and so this pattern of artefact due
to lead connection does not normally lead to urgent concern among nursing staff. This
explained the pausing of the alarm before attending to Mr Collings.

Normally, abnormal rhythms such as VF are spotted quickly on a cardiac care unit when
a nurse notices a patient collapse and checks their heart rhythm, or a nurse notices the
abnormal rhythm on the ECG monitor, or the ECG monitor detects the VF rhythm
automatically (the systems have algorithms to do this) and an urgent alarm is sounded. In
Mr Collings’ case, these usual processes did not occur.

There was an unfortunate combination of factors in Mr Collings' case that led to his
death. It is likely that, if any one of these had not occurred, his death would have been
averted on the balance of probabilities: -

e The occurrence of VF while the nurses were attending to other duties and not close
to the central monitoring console.

e The ECG monitoring system did not detect the VF, and the red crisis alarm did not
sound.

e Genuine artefact occurring 18 seconds later (likely as Mr Collings collapsed and
detached an electrode), resulting in artefact on the ECG trace, when the nurses
viewed the monitor.

e Aconfused patient being present on the unit at the same time, which diverted a
nurse from attending to Mr Collings more quickly.

CORONER’S CONCERNS

I should be glad to be told about any additional learning arising from the evidence heard
at the Inquest especially with regard to the evidence of your engineer PS
a In particular, are there any improvements to the algorithm for earlier
alerts, especially those that may differentiate sooner between any artefact, such as a

detached lead, and a life-threatening event, such as a ventricular defibrillation,
recognisable by the human eye?

ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and I believe you 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 11'" May 2019. 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: -

e Family

e CQC

e South Tyneside and Sunderland NHS Foundation Trust and their Solicitors

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.

Dated this 15" day of April 2019
<

Signature L
Senior Coroner for the City of Sunderland

GE Healthcare 

Date: 

June 26, 2019 

Private and Confidential 

Derek Winter DL 
Senior Coroner for the City of Sunderland 
Civic Centre 
Burdon Road 
Sunderland  
SR2 7DN 

Dear Mr. Winter 

RE:  Regulation 28 Report to Prevent Future Deaths – Mr. Thomas Smith Collings 

GE Healthcare writes further to your correspondence dated April 15, 2019 regarding your concerns 
identified during the Inquest into Mr. Thomas Smith Collings’ death. 

As a medical device manufacturer, GE Healthcare takes patient safety and patient death reports very 
seriously. All death and serious injury reports received are thoroughly reviewed by GE Healthcare Medical 
Directors, product specialists and clinicians to determine whether the relevant patient monitoring system 
performed within specifications or if any further root cause investigation is required. 

In the case involving Mr. Thomas Collings, following an investigation, GE Healthcare concluded that the 
automated ECG arrhythmia detection algorithm (EK-Pro), being used to monitor Mr Collings performed 
within specifications and ECG monitoring industry standards based on the available information and Full 
Disclosure data captured. The signal acquisition conditions combined with the extremely rare “Torsades 
de Pointes” ECG rhythm Mr. Collings presented with on the morning of August 2, 2018 prevented the 
algorithm from asserting a Ventricular Fibrillation (“VF”) or Ventricular Tachycardia (“VT”) arrhythmia 
alarm. Unfortunately, ECG tracings for leads I, II and V were not available for review to further the 
assessment. 

The TRAM and Solar 8000M patient monitoring system used in the Sunderland Coronary Care Unit was 
state-of-the-art technology in 2004 when it was manufactured. If used in accordance with the operator’s 
manual, the TRAM and Solar 8000M patient monitoring system is still an effective physiological patient 
monitoring device today. 

Nevertheless, during the period since this equipment’s manufacture date, there have been technology 
advances in digital signal processing hardware and software and medical industry standards, such as IEC 
60601-1-81, which have improved the performance of patient monitoring equipment. In addition, GE 
Healthcare has a dedicated team of hardware and software engineers whose focus is improving the 

1 General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance 
for alarm systems in medical electrical equipment and medical electrical systems. 

Page 1 of 2 

 
 
 
 
 
 
 
 
 
 
 
 
 
        
 
 
 
 
 
 
 
 
 
 
                                                 
 
 sensitivity and specificity of the EK-Pro automated ECG arrhythmia algorithm based on clinical 
performance, customer feedback and ECG Full Disclosure data. 

GE Healthcare has implemented ECG Technical Alarm notification improvements when the automated 
ECG algorithm detects noise and/or artifact. The current GE Healthcare CARESCAPE B850/B650/B450 
Patient Monitoring platform provides escalating ECG Technical Alarms for “Arrhythmia Paused” and 
“Leads Off” states. These improvements allow clinicians to configure “Arrhythmia Paused” and “Leads 
Off“ Technical Alarms to escalate to a high “red” alarm rather than a warning or advisory alarm. This 
functionality was introduced in the CARESCAPE product line in 2009.  In Mr. Collings’ case, based on the 
ECG tracings and log file information, the “Arrhythmia Paused” Technical Alarm would have escalated to a 
high “red” alarm at approximately 01:21:53, alerting caregivers to the loss of ECG monitoring and 
arrhythmia alarm detection capability. 

GE Healthcare has also implemented improvements in the signal processing specific to the detection of 
Ventricular Fibrillation.  The current GE Healthcare CARESCAPE B850/B650/B450 Patient Monitoring 
platform uses a spectral analysis technique within the EK-Pro algorithm that was not possible in the 
previous generation platforms due to the computational demands.  The primary performance benefits of 
the newer technology include a shorter average time to alarm and the capability to utilize the data in all 
available leads (e.g., I, II, III, V) when the analysis is updated each second.  Testing of the algorithm 
improvements via the requirements of AAMI/ANSI EC-57 confirm the reduced alarm delay relative to the 
older technology.  Furthermore, while the available EC-57 databases do not directly address Torsades de 
Pointes arrhythmias, the use of spectral analysis techniques would be expected to mitigate the primary 
challenge of the rapidly changing amplitude characteristics associated with these events.  GE Healthcare 
expects to continue to invest in improvements in its algorithm detection capabilities in future versions of 
its software. 

Following the incident involving Mr Collings where it became apparent that data for all leads had not been 
captured by the Trust at the time, GE Healthcare has also re-iterated to its complaint handling team to 
request data from all available monitoring leads when initiating an investigation, in an effort to ensure 
that as much data as possible is provided when reviewing a complaint or report requiring investigation. 

Please be assured that maintaining a high level of safety and quality in our patient monitoring systems is 
GE Healthcare’s highest priority. 

We would like to take this opportunity to again offer our condolences to Mr Collings’ family.  

Sincerely,  

GE Healthcare 

Page 2 of 2

Our ref: 20191107JH 
Date: 07 November 2019 

Mr Tom R Osborne 
HM Senior Coroner  
HM Coroner’s Office 
Civic Offices 
1 Saxon Gate East 
Central Milton Keynes 
MK9 3EJ 

Dear Mr Osborne 

Standing Way
Eaglestone
Milton Keynes
MK6 5LD
01908 660033
www.mkhospital.nhs.uk

REGULATION 28 REPORT TO PREVENT DEATHS – Mr John Shrosbree 

I  am  writing  in  response  to  your  Regulation  28  report  following  the  Inquest  held  on  25 
September  2019  into  the  death  of  Mr  Shrosbree.  I  did  not  receive  a  copy  of  the  report 
directly for almost two weeks but accessed it via www.judiciary.uk. The report was covered 
widely in the local press.  

I want to be clear at the outset of my response that I recognise the independent statutory 
nature of coronial inquests, and the role of Regulation 28 reports. We genuinely value the 
part that the coronial process plays in ‘holding a mirror up’ to our services and the care that 
we  provide  here  in  the  hospital.  Inquests  can  help  us  to  reflect  upon  deficiencies  in  care 
which we may not otherwise have appreciated, affording us a valuable opportunity to make 
improvements for the people of Milton Keynes as our future patients.  

Whilst  I  am  aware  that  there  were  shortcomings  in  the  care  that  we  provided  to  Mr 
Shrosbree and that opportunities to potentially alter the course of his illness were missed, I 
must  admit  that  I  was  somewhat  surprised  by  the  content  of  your  Regulation  28  report, 
which read as follows: 

My concern is that during the evidence it became clear that that the problems encountered 
in  the  Emergency  Department  on  4th  June  2019  were  mainly  brought  about  by  staff 
shortages.  I  was  told  that  staff  shortages  occur  on  a  daily  basis  and  I  believe  that  as  a 
result lives of this citizens of Milton Keynes are being put at risk and the problem should be 
addressed as a matter of urgency. 

Whilst  recognising  shortcomings  in  Mr  Shrosbree’s  care,  we  had  not  felt  at  the  Trust  that 

	
	
 
 
 
 
 
 
 
 
 
 staff shortages per se were a significant factor.  

I  will  go  on  to  outline  to  you  how  we  ensure  that  staffing  levels  in  the  Emergency 
Department  are  safe  –  both  in  general  terms  and  shift-by-shift.  We  have  a  good 
understanding of our staffing levels in the Emergency Department, and data that evidence 
the position. I think it is unfortunate that the Trust was not given an opportunity – either prior 
to  the  Inquest  or  between  Inquest  and  issue  of  the  Regulation  28  report  –  to  provide  that 
evidence which offers a significant degree of assurance.  

We  have  invested  heavily  in  clinical  staffing  levels  over  the  past  six  years  and  have 
measures  in  place  day-to-day  in  order  to  ensure  that  the  risk  associated  with  any  sub-
optimal  staffing  numbers  is  spread  appropriately  across  the  organisation  such  that  ‘sub-
optimal’ does not equate to ‘unsafe’.  

I  now  move  on  to  describe  the  objective  position  as  it  stands  (with  further  qualification 
around the June 2019 position where appropriate). The staffing establishment (funded and 
agreed posts) in the Emergency Department is described in the table below: 

Role 
Band 8A (Matron) 
Band  7  (Senior  Sister  / 
Charge Nurse) 
Band  6  (Sister  /  Charge 
Nurse) 
Band 5 (Staff Nurse) 
Band 
2 
Assistant) 
Consultant 
Middle Grade / Registrar 
ENP 
Practitioner)   
Senior House Officer 

(Emergency  Nurse 

(Healthcare 

Establishment / Funded Posts
2.0 
9.54 

Vacancy Rate 
0%
10% 

16.51 

47.39 
24.8 

10 
16 
4.89 

15 

3% 

27% (17% in June 2019)
21% 

0%
6%
0% 

13%  (establishment  increased 
in August 2019) 

Vacancies  (against  our  agreed  establishment)  occur  for  several  reasons  over  and  above 
the  number  of  leavers  exceeding  those  coming  into  post:  for  example,  parental  leave  and 
secondment. In nursing, vacancy rates tend to peak in the late summer / early autumn and 
reduce  as  new  graduates  are  available  to  start  work  in  band  5  entry  level  posts. 
Recruitment  to  nursing  roles  is  ongoing  with  active  and  engaging  open  days  in  place,  in 

	
	
 
 
 
 
 
 
 
 
 
 addition to more passive advertising.   

The establishment described in the table above is calculated in order to ensure appropriate 
ratios for the number and acuity of patients passing through the department. In addition, we 
can benchmark our staffing levels with other hospitals through use of NHS Improvement’s 
Model Hospital dataset.  

The Model Hospital data allow us to compare our local Emergency Department with other 
organisations nationally, and a sub-set of peer Emergency Departments (selected by Model 
Hospital on the basis of similarities in organisational size and complexity). The most recent 
benchmarking  data  demonstrate  that  our  department  is  slightly  less  busy  than  our  peer 
median  but  is  in  all  other  ways  representative.  The  expenditure  on  the  Emergency 
Department  at  Milton  Keynes  (both  crudely  and  as  a  proportion  of  overall  expenditure)  is 
greater than the peer median. Our staffing, in terms of whole time equivalent staff, is at the 
peer median. In terms of breakdown by staff group, more doctors are employed than at our 
peer  organisations  (37%  over  the  peer  median)  and  less  nurses  (13%  below  the  peer 
median).  This  variation  from  peer  median  represents  a  relatively  small  emergency  nurse 
practitioner  (ENP)  workforce  in  Milton  Keynes.  ENPs  typically  work  in  the  ‘ED  minors’ 
environment,  and  in many  departments  ENPs  have  replaced  a  significant  part  of  the  non-
consultant  medical  workforce.  We  do  not  consider  that  there  is  any  material  difference  in 
nurse  staff  numbers  attending  to  the  needs  of  patients  in  the  majors  and  resuscitation 
environments (where Mr Shrosbree was looked after). The Trust continues to develop the 
non-medical workforce in the Emergency Department and has recently confirmed plans to 
train  and  employ  eight  advanced  nurse  practitioners  focusing  on  the  emergency  care 
pathway (ED and Acute Medicine).    

Where  there  is  a  gap  on  a  given  shift  between  staffing  establishment  and  staff  on  duty, 
several things are put in place to mitigate risk. These include:  

1.  identification  of  additional  staff  via  re-deployment  from  other  areas  in  the  hospital 
(facilitated  via  the  daily  safety  huddle  attended  by  all  Ward  Managers  and  senior 
managers, or ad hoc during the day by the site team); and, 

2.  identification  of  additional  staff  to  be  engaged  via  staff  bank  or  staffing  agencies.  The 
staff  bank  includes  a  financial  supplement  for  staff  working  in  ED  in  recognition  of  the 
particular need to ensure good staffing levels there.   

Each day, the Emergency Department rota is designed to operate with 15 registered nurses 
and  5  healthcare  assistants.    These  numbers  include  a  streaming  nurse  but  exclude  the 
Emergency  Nurse  Practitioners  (ENPs)  who  –  as  described  above  –  operate  semi-
autonomously in the management of minor injuries. 

	
	
 
 
 
 
 
 During the shift on 04 June when Mr Shrosbree attended, there were 14 registered nurses 
and 3 healthcare assistants available (1 RN and 2 HCAs below establishment). In addition 
to this, there was a Band 7 working on a supernumerary basis within the Children's ED and 
there were 2 ENPs on shift. On the same day, there was a gap of 14 registered nurses and 
1 healthcare assistant across the wider hospital in medical and surgical wards.  

In terms of general fill rates, ED has had periods over the summer where the rota has had 
up to 4 RN gaps on a shift. Unless there was a period of significantly reduced activity, the 
establishment would be supported by other clinical areas, leaving a maximum gap of 2RNs, 
and only then with Matron’s awareness and approval. When the staffing is reduced in this 
way,  the  Band  7  Nurse  in  Charge,  with  the  duty  Matron,  will  determine  the  most  effective 
and safest use of resources within the geography of the department, based on the acuity at 
the time. 

Having  reviewed  the  data  for  the  day  in  question  (04  June),  the  Emergency  Department 
was  not  particularly  busy.  We  have,  at  our  busiest  periods,  had  up  to  100  patients  in  the 
department.  Numbers  that  day  peaked  at  61.  The  waiting  times  (to  be  seen  by  a  doctor, 
following rapid assessment and triage) were not excessive. There were no specific staffing 
difficulties noted in our site reports.  

Time 
Total patients in ED at time 
Total patients in ED since midnight
Waiting time (ED Majors) 
Number of ambulances since midnight 18

12:00
47
73
1:23

15:00
58
121
2:40
29

19:00 
56 
187 
2:05 
42 

22:00
61
221
2:45
48

Finally I do believe it is important to note that our most recent inspection by our professional 
regulator,  the  Care  Quality  Commission,  did  not  flag  any  concerns  regarding  staffing 
numbers in the ED.  

I hope that this comprehensive response provides assurance to you following the concerns 
which  came  to  light  during  the  Inquest.  We  do  of  course  acknowledge  that  at  times 
workload can place significant pressures upon staff: at such times, we are used to making 
carefully  balanced  judgements  to  ensure  that  our  services  remain  safe  for  patients  at  all 
times.  

Given the potential relationship between Regulation 28 reports and public confidence in our 
hospital  and  the  services  we  provide,  I  wonder  whether  there  is  a  better  mechanism 

	
	
 
 
 
 
  
 
 
 
 through which the Trust could be alerted to concerns as they emerge such that additional 
data can be provided in a timely fashion at the Inquest. I would welcome a discussion on 
this matter.    

With kind regards 

Yours sincerely 

Professor Joe Harrison 
Chief Executive  

Copy 

, Medical Director 

, Director of Operations

NHS)

South Tyneside and Sunderland
NHS Foundation Trust

Ref: KWB/DC/TSC Sunderland Royal Hospital
Kayll Road

22 May 2019 Sunderland
Tyne & Wear

SR4 7TP

Private & Confidential
Derek Winter DL
- . WWW. SISIL.NNS.U

Senior Coroner for the City of Sunderland
Civic Centre

Burdon Road

Sunderland

SR2 7DN

Dear M, binky |

Regulation 28 Report to Prevent Future Deaths — Mr Thomas Smith Collings

| write further to your correspondence dated 15" April 2019 regarding your concerns identified
during the Inquest into Mr Thomas Smith Collings’ death.

As you are aware, the Trust takes all patient deaths extremely seriously and we undertake
mortality reviews to establish if lessons can be learned and services improved. In this case,
we also completed a comprehensive investigation/Root Cause Analysis with regard to the
functioning of Mr Collings’ cardiac monitor when he suffered a fatal heart arrhythmia in the
coronary care unit (CCU) on 2™ August 2018. As part of the learning from this internal
investigation, the clinical team identified the need for increasing staff awareness in respect of
cardiac monitor alarms sounding for artefact purposes and this was immediately addressed at
the time by the department manager. The incident has been discussed at the Directorate
Clinical Governance meeting and nursing team meetings, with an emphasis on the
requirement for staff to review alarms immediately and attend to the patient in order to
undertake a visual check. Additionally, there is now augmented observation of the central
monitor console on CCU by nursing staff, aided by an increase in the staffing levels.

The Directorate developed a business case for a new monitoring system for CCU from an
alternative supplier. | am pleased to inform you that the Trust approved this business case,
the equipment has been purchased and the enabling work for the installation has now
commenced. Staff training on the new monitoring equipment has been procured as part of the
process and there will be a full and comprehensive training package delivered as part of this
changeover. Our estates department is currently installing additional network cabling
throughout the unit, so we do not yet have a completion date for the installation of the
monitoring system, but we estimate that this will be in the Autumn. Unfortunately, until we
have confirmation of when these enabling works will be completed, | am unable to provide you
with the definitive timescales for the commencement of this training, as it needs to be
organised around the installation date. However, | have provided a copy of the training
programme (please see attached).

The path to
excellence

To summarise the training plan, the company’s Clinical Application Specialist (CAS) will be on-
site for a total of 4 weeks to provide on-site training and support. The training will commence
on the department approximately 2 weeks before the roll out, to allow a high percentage of
staff to be trained prior to the go live date. There will be a further 2 weeks support during the
implementation and post go live stage. The training programme will incorporate the alarm
classifications and the importance of maintenance of the lead attachments to ensure optimal
performance of the monitors. The company will also deliver “Train the Trainer” with key
individuals to ensure future new starters can be fully trained following this initial period. The
CAS will then return to the Trust 3-4 weeks post go live to discuss and amend any requested
configuration changes on the monitors. Following this, further visits and training may be
requested if required. | trust this provides you with the assurance regarding the provision of
refresher training to our staff.

With respect to additional learning arising from the evidence heard at inquest, | can assure you
that the cardiology team are vigilant in reviewing both “advisory”, “warning” and “crisis” alarms
and attending to the patient immediately to check for any artefact/lead detachment, to ensure
optimal monitoring conditions to detect arrhythmias. This will be reinforced in the training for
the new monitoring system. There was additional learning arising from the evidence provided
by GE Healthcare and medical expert. The cardiac monitor in
question has multi lead ECG analysis, meaning that it collects data from all four leads to
analyse the rhythm utilising the automated inbuilt detection algorithms. When malfunction of
Mr. Collings’ cardiac monitor was suspected by the clinical team, our electronics department
isolated the monitor for inspection and testing and retrieved the electrocardiogram (ECG)
waveform data from the device log file. However, in this instance, the data was only printed off
from one of the four monitoring leads, which was insufficient for a full review by the
manufacturer. In future, our Hospital Biomedical Engineering Manager will clarify with
manufacturers exactly what data needs to be obtained from the device log file to allow a full
and thorough inspection.

As you will note, the Trust is addressing the shortfalls highlighted during our investigation and
the Inquest, in order to prevent future deaths in similar circumstances. Progress of the
actions detailed in this letter will be overseen by i our Executive Director of
Nursing, Midwifery and Allied Health Professionals, who will also keep me briefed and report
to the Trust’s Clinical Governance Steering Group.

| trust this information provides assurance to you that the Trust has taken appropriate action
to mitigate any future patient safety issues with regard to the monitoring and observation of
patients within cardiology.

| would also like to take this opportunity to offer my sincere condolences to Mr Collings’ family
on behalf of myself and the Trust.

Yours sincerely
KOR >
Ken Bremner MBE

Chief Executive

Enc