Darran Busby

Fulford Grange 
Micklefield Lane 
Rawdon 
Leeds LS19 6BA 
Tel: 0113 380 3000 
emishealth.com 

9th March 2022 

Ref: REGULATION 28 – 13 January 2022 

Dear Mr Cohen, 

With regard to the Regulation 28 report dated 13th January 2022 (the “Report”), we have reviewed 
and considered the circumstances relating to this very unfortunate incident.   

Whilst  we  note that the  failure  to  review  the  MRI  scan  report  was  not  causative or  related to  Mr 
Busby’s death, we treat such matters with the utmost seriousness and an internal review has been 
undertaken, focussing on the issues of:  

1) No flag attached for abnormal radiology results;

2)

Inadvertent ‘multiple clicking’ of the ‘file no comment’ button in EMIS Web will result in the
filing of more than one result if subsequent results are not flagged as abnormal.

We would like to note the collaboration of North Cumbria Integrated Care NHS Foundation Trust (“the 
Trust”) throughout this investigation. 

1) No flag attached for abnormal radiology results

In relation to this issue, we reviewed the functionality available within EMIS Web and confirmed that 
it is working as designed, and as per NHS Digital specification. EMIS Web flags results based on the 
presence of a normal / abnormal clinical code (relevant to the investigation type) within the message 
received from the Trust’s reporting system (in this case ICE). 

In  this  case,  the  message  containing  the  MRI  result  did  not  have  a  code  which  indicated 
‘normality/abnormality’ for the MRI.  The MRI report was tagged with a ReadV2 code  “56D – Other 
diagnostic radiology” terminology code, which is not specific enough to provide any receiving system 
(in  this  case  EMIS  Web)  with  the  relevant  details  to  flag  the  report  as  abnormal  and  present  the 
relevant warnings. 

The Report further notes that the Trust had subsequently, unsuccessfully, attempted to add flags to 
all pathology and radiology results. The above explains why this action was not successful as it requires 
associated coded clinical terminology, rather than custom flags, for results from any source system.

EMIS Health is a trading name used by members of the EMIS Group of companies 
which includes Egton Medical Information Systems Limited. 
Egton Medical Information Systems Limited is registered in England and Wales. 
Registered number: 02117205. Registered office: Fulford Grange, Micklefield Lane, Rawdon, Leeds LS19 6BA 

 
 Investigation by EMIS, in collaboration with the Trust, has determined that a local EMIS Web protocol 
to flag 56D-coded terms would not be possible. EMIS Web does not have the ability to configure rule-
based logic on a particular code or result type to drive the desired protocol alert. 

The understanding of functional limitations of third party systems (ICE & Cris), reviewed as part of this 
investigation, is based upon information provided by the Trust during the investigation process.  

The  UK  messaging  standards  for  laboratory  and  radiology  reports  are  currently  based  on  EDIFACT 
specification  which  are  some  20  years  old.  EMIS  is  aware  that  NHS  Digital  are  currently  building  a 
modern set of FHIR messaging standards which, when implemented, will enable report level flagging 
of normal / abnormal findings which will significantly improve the safety of these messages; EMIS is 
collaborating with NHS Digital on these standards.  There are no current timelines for introduction 
from NHS Digital. 

2)  Inadvertent ‘multiple clicking’ of the ‘file no comment’ button in EMIS Web will result in the 

filing of more than one result if subsequent results are not flagged as abnormal 

The report states that the Trust, during the course of their investigation, determined that “clicking 
more than once on the 'file no comment' button will result in the displayed result being filed, but will 
also result in filing of the next in the list if that result has no flag indicating the result is abnormal.” 

In relation to this issue, we reviewed the functionality available within EMIS Web and confirmed that 
it is working as designed and in accordance with NHS Digital requirements and specification. 

Within EMIS Web, there are two views that a user can select when undertaking results filing activities: 
‘Inbox overview’ and ‘Detailed overview’. 

Inbox overview (dummy data screenshot shown below in fig 1) shows all report tasks in a list view 
including the date the report was received, the patient’s name and the report type. 

 
 
 
 
 
 
 
 
 
 Fig 1 

Within this view, it is not possible to inadvertently file multiple results through ‘multiple clicking’ of 
the ‘file no comment’ button, as the next result in the list is not automatically selected.  The ‘file no 
comment’  button  is  not  available  again  (after  being  pressed  once)  until  the  next  result  is  selected 
manually by the user. 

Detailed overview (dummy data screenshot shown below in fig 2) shows all report tasks in a list, and 
the full report is seen on screen (when one result is selected). 

Fig 2 

Within this view, after clicking the ‘file no comment’ button, the result in context will move down the 
list to the next available result.  As another result is then in context, a user can click ‘file no comment’ 
again, and this may be done without the user reviewing the displayed report in appropriate detail.  

 
 
 
 
 
 The user therefore can click through any number of results in quick succession. If clicking fast enough, 
the  system  will  not  have  time  to  load  the  result  on screen  before the  user  has  clicked  the ‘file  no 
comment’ button again.  The user therefore may not see the full report. 

Irrespective  of  which  method  is  used  for  results  filing  activities,  it  is  important  to  note  that  filing 
actions do not remove the results from the user’s screen.  Results must be manually archived for this 
to occur.  Results remain visible to the user and can be unfiled and re-actioned if needed. The system 
will indicate to the user which results have been filed by a green tick, meaning the user can re-review 
those results prior to archiving (as per dummy data screenshot shown below in fig 3).  

Fig 3 

A user can choose to archive using the ‘archive’ button on the EMIS Web ribbon or, when the user 
gets to the end of the results list, the system will suggest archiving, to which the user must apply a 
manual  acceptance.    Whichever  method  the  user  chooses  to  archive  the  results,  they  must  click 
through  a  screen  alert  to  confirm  intended  action  (as  per  screenshot  shown  below  in  fig  4).  It  is 
important to note that the screen alert is defaulted to ‘No’ to prevent accidental clicking through. 

 
 
 
 
 
 
 
 Fig 4 

In terms of results filing, and against the information provided in the Report, our investigation shows 
that the system is working as expected and as per NHS Digital specification. 

Conclusion 

Based upon the information provided in the Report and the subsequent investigation, EMIS do not 
believe there are any software developments to be undertaken to mitigate risks relating to either of 
the issues raised in this case. 

In  respect of  the  abnormal  flag  for  radiology  results,  EMIS  do  not  believe  that  mitigation  through 
EMIS  Web  development  is  plausible  until  emerging  NHS  Digital  standards  are  implemented,  given 
there  are  no  clear  identifiers  on  these  types  of  results  that  would  allow  a  system  to  differentiate 
between a normal or abnormal result. 

In relation to any inadvertent filing activity, EMIS believe that there are sufficient failsafe measures 
within the system, alongside appropriate diligence from the user, to prevent such occurrence.  It must 
be the responsibility of the clinician to review, file and subsequently archive results at a speed and 
with a level of diligence that fits the clinical nature of the results and the patient involved.  

As a result of this case and your findings, EMIS is undertaking a number of actions to support our users 
in the prevention of future harm: 

1.  EMIS is reviewing and will update the EMIS Web Hazard Log and Safety Case to reflect these 
identified  concerns;  highlighting  established  system  and  training  mitigations  that  can  reduce 
the risk of future patient harm.  

2.  EMIS is reviewing training material relating to the filing of results, to include reference to those 
results that may require a more detailed review, such as radiology results – to prevent users 
becoming inappropriately reliant upon clinical decision support such as ‘abnormal flags’.  

 
 
 
 
 EMIS will continue to review and investigate any cases of a similar nature, and review effectiveness of 
any current and ongoing mitigations.  

EMIS  have  identified,  during  collaboration  with  the  Trust,  a  number  of  operational  improvements 
within their results management practices that the Trust could implement to improve patient safety. 
Additionally,  EMIS  will work  with  the  Trust  to  modify  local  technical  configurations  to  support  the 
workflow.  EMIS will support the Trust to implement these should they wish to. 

We trust that the details outlined above are of help. 

Finally, as a company, we work very hard to support health care services across the UK and patient 
safety  is  of  paramount  importance  to  us.  We  were  saddened  to  read  of  the  issues  relating  to  this 
particular incident and we would like to pass our condolences on to the family. 

If  you  have  any  further  queries  then  please  contact  our  Senior  Clinical  Director, 

  (via 

, in the first instance. 

Kind regards 

Dr 
Chief Medical officer, EMIS Group

6 July 2022 

HM Coroner’s Office 
Fairfield 
Station Road 
Cockermouth 
Cumbria 
CA13 9PT 

Dear Sir, 

Regulation 28: Prevention of Future Deaths Report Response 
Deceased: Mr Darren BUSBY (Case Ref: 2281920) 

As indicated within our communication on 11 March 2022, I would like to provide you with a further update 
as to the Trust’s progress to address the concerns raised within the regulation report: 

  There is no flag attached in the ICE system for abnormal radiology results, and so no failsafe exists 

for defaulting to a 'file and comment' if a significant positive or negative finding is reported.  

  Clicking more than once on the 'file no comment' button will result in the displayed result being filed, 

but will also result in filing of the next in the list if that result has no flag indicating the result is 
abnormal. Therefore making it possible that a clinician may inadvertently click 'file no comment' 
more than once on one result would cause results which require urgent follow up being filed without 
a clinician being involved.  

As previously advised, the Neurology team has increased vigilance when reviewing results, and have 
ceased using the file no comment function and instead continue to use the “File and Comment” button. This 
ensures a direct action is required by clinicians, resulting in a pop up box always appearing and inadvertent 
misfiling being prevented. 

The Trust continues to ensure that the improvement of review and action of abnormal radiology and 
histology results is a priority and as such has established a task and finish group to oversee this area.  A 
new standard operating procedure has been developed and from 18 May 2022 reports containing text 
“significant radiological finding” have been flagged as abnormal in the ICE system with a red exclamation 
mark alongside. 

We previously advised that the Trust was implementing a RAD alert system, which will operate separately, 
though alongside ICE and upon recognising an alert code in a radiology report it will email the referring 
consultant/GP to advise them of a significant radiology finding. Rad-Alerts contain a safeguard so that 
prompts are issued until an alert is acknowledged. If this is not responded to within 72 hours, it will be 
followed up with a phone call. The RAD alert system is currently built and available within the test area of 
the system and is in pilot phase. 

I hope the above information provides assurance to the Chief Coroner that the Trust has put in place 
immediate mitigation of the risk and is continuing to progress with the long term permanent solution. 

Signed:  

Date:  6 July 2022 

Pillars Building, Cumberland Infirmary, Infirmary Street, Carlisle, Cumbria, CA2 7HY 

Safe, high quality care every time

HM Coroners Office 
Fairfield  
Station Road 
Cockermouth  
Cumbria 
CA13 9PT 

11 March 2022 

Dear Sir 

Regulation 28: Prevention of Future Deaths Report Response  
Deceased: Mr Darran BUSBY 

I write following the inquest held on 13 January 2022, before Mr Robert Cohen, into the death of Darran 
Busby who sadly died on 14 August 2021 with a medical cause of death of 1a) Hanging. 

During the inquest Mr Cohen issued a Regulation 28 report to both the Trust and EMIS. The Regulation 28 
report  reflects  that  Mr  Cohen  was  appreciative  of  the  Trust’s  frank  evidence.    The  evidence  however 
identified a failure to review the outcome of a head MRI undertaken in April 2021 as a result of functionality 
issues within the EMIS system.   

Mr  Cohen  recognised  that  the  failure  to  review  the  MRI,  or  any  other  aspect  of  the  Trust’s  care  and 
treatment, was not causative or related to Mr Busby’s death.  However, Mr Cohen raised concern that the 
functionality  of  the  EMIS  system  may,  inadvertently,  lead  to  future  deaths  if  action  is  not  taken,  and  his 
statutory duty to report to the Trust was engaged. 

The specific concerns raised within the Regulation Report were: 

  There is no flag attached in the ICE system for abnormal radiology results, and so no failsafe exists 

for defaulting to a 'file and comment' if a significant positive or negative finding is reported. 

  Clicking more than once on the 'file no comment' button will result in the displayed result being filed, 
but  will  also  result  in  filing  of  the  next  in  the  list  if  that  result  has  no  flag  indicating  the  result  is 
abnormal. Therefore making it possible that a clinician may inadvertently click 'file no comment' more 
than once  on  one  result  would  cause results which require  urgent follow  up  being filed  without  a 
clinician being involved. 

I am grateful to Mr Cohen for raising these concerns as it is imperative to the Trust that prospective safety 
issues are identified and rectified to ensure our services are safe and effective. As a result of the Trust’s 
progress I am now in a position to provide an update in this matter ahead of the timescale of 11 March 2022.   

The Trust’s Digital Services has since engaged with EMIS in support of testing a workable solution, and 
have made available all resources necessary to support the work on this issue.   

In  addition  to  the  Trust’s  engagement  with  EMIS,  the  Trust  ensured  that  services  utilising  the  same 
functionality within EMIS, outlined within the Regulation 28 report, were identified.  The Trust identified two 
services: the community ward at Cockermouth Hospital and the Neurology Service.   

The ward at Cockermouth Hospital reverted back to using the ICE Order Comms system (ICE was outlined 
in the Trust’s evidence to the inquest), following an initial assessment of the functionality.  Whilst this option 

Trust Headquarters | Cumberland Infirmary | Newtown Road | Carlisle | Cumbria | CA2 7HY 

 
 
 
 
 
 
 
 
 
 
 
 
 was  explored  for  the  Neurology  Service  it  not  a  feasible  solution  for  the  service  due  to  the  potential  of 
introducing other risks such as transcription error when transferring data from ICE to EMIS.   

The Trust has looked at ways of using codes to flag results via the ICE system but when the interface is 
linked  to  EMIS,  the  data  comes  directly  from  the  source  system  (in  this  case,  this  would  be  either  the 
Telepath Laboratory Information Management System or the GE (recently replaced by Philips) Radiology 
Information system).  Both these systems bypass the ICE Order Comms system and interface directly with 
EMIS Web.  Therefore, adding codes to ICE would not impact on any functionality for flagging.   

Whilst this information has been shared with EMIS to inform their consideration of solutions to this issue the 
Trust  has  sought  other  appropriate  remedies.  The  Trust  is  implementing  a  Rad  Alert  system,  which  will 
operate separately, though alongside ICE and upon recognising an alert code in a radiology report it will 
email the referring consultant/GP to advise them of a significant radiology finding. In the event the email is 
not acknowledged within a given time period (variable according to the severity of the alert) the system will 
alert the rad alert admin in order that alternate clinicians can be emailed. This should prevent a recurrence 
of this incident regardless of whether the report is being reviewed on EMIS or on ICE as it is a separate way 
of  highlighting  the  significance  of  the  report  to the  referrer.  It  is  anticipated  that  the  RAD  system  will  be 
implemented in April 2022. 

and the Neurology team have increased vigilance when reviewing results, and have 
In the interim Dr 
accepted the key recommendation from the Digital Services to stop using the “file no Comment” button in 
favour of the “File and Comment” button. This approach will introduce a direct action by the clinician that 
means a result cannot be filed inadvertently as a popup box always appears.  This introduces extra mouse 
clicks and is therefore more time consuming but does provide the assurance that the results cannot be filed 
without appropriate review until a more robust system based solution is in place.   

The Trust has notified colleagues in Primary Care as users of EMIS through discussion with the CCG Chief 
Clinical Information Officer, to minimise any similar adverse action within GP provision.  

The Trust will continue to work with EMIS and support their work in identifying a solution to this issue.  In 
addition  the  Trust  has  provided  feedback  to  EMIS  to  support  their  consideration  of  communication  and 
escalation to  system  users  if  such  issues  are  highlighted  to  enable  them  to  better  engage  with  users  to 
understand the risk and develop early solutions.  

I  hope  the  above  information  provides  assurance  to  the  Chief  Coroner  that  the  Trust  has  an  ongoing 
commitment to finding a resolution to this issue and in turn, mitigate the risk of future deaths to the users of 
the Trust’s services.  Whilst it is anticipated that the implementation of the RAD systems will mitigate the 
risk  from  the  Trust  perspective  with  implementation  commencing  in  April  2022,  we  will  have  undertaken 
testing and confirmation of this solution by the 1 July 2022; we will also continue to engage with EMIS and 
would like to propose that we provide a further update on this date. 

Signed:   

Date:  11 March 2022 

Chief Executive