Karen Jane Winn

Nigel Parsley 
H M Coroner 
Coroners Service 
Beacon House 
White House Road 
Ipswich 
Suffolk 
IP1 5PB 

Dear Sir, 

Trust Office - Quince House 
Hardwick Lane 
Bury St Edmunds 
Suffolk 
IP33 2QZ 

Tel: 01284 713000 
Fax: 01284 701993 

Tel: 

www.wsh.nhs.uk 

E-mail: 

11 January 2020 

Karen Winn Deceased – Regulation 28 (Prevention of Future Deaths) 

Thank you for your letter regarding the investigation into the death of Mrs Karen Winn.  

I have asked our Head of Deteriorating Patient, Acting Head of Patient Safety and 
Chief Nursing Information Officer to address the matters of concern that you have 
and the response is as follows; 

Concern 1 
Concern that a differential diagnosis of a rare and serious blood condition (haemolytic 
anaemia),  although  identified  soon  after  admission,  was  not  escalated  to  a 
Haematology Consultant at the time this diagnosis was made. It was a rare condition, 
which by its very nature should be treated with the support of haematology specialists. 
You are concerned that those specialists were unaware that a differential diagnosis of 
serious blood disorder had been made without their specialist input.  

A  meeting  was  convened  with  the  Haematology  Consultants  to  consider  how 
escalation  is  achieved  and  how  we  can  ensure  that  this  is  robust.  Whilst  there  are 
specific  criteria  for  the  treatment  of  Autoimmune  Haemolytic  Anaemia,  it  is 
acknowledged that this is a rare condition. A flow pathway for Autoimmune Haemolytic 
Anaemia  has  been  established,  identifying  investigations  and  treatment  required, 
inclusive  of  referring  to  the  haematology  on  call  consultant.  This  flow  pathway  has 
been published on the Trust’s ‘Pink Book’, a clinical reference point for all clinical staff, 
both internally and within the community (including GPs).  This pathway will also be 
included in the ‘Heads Up book’ (HUB) which is currently being developed. This is a 
quick  reference  guide  intended  to  provide  junior  clinicians  with  flowcharts  and 
algorithms  for  emergent  situations  whilst  waiting  senior  help;  this  book  is  still  in  its 
development stage and we are hoping that it will be available in 2021.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 See  appendix  1:  Management  of  suspected  autoimmune  haemolytic  anaemia  flow 
chart  

Concern 2 
In addition, you are concerned that the automated VTE assessment system does not 
appear to be significantly robust. You are aware that the WSFT have taken steps to 
address  the  problem  and  have  now  placed  the  VTE  assessment  on  the  electronic 
Smart  Zone  ‘to  do  list’  and  introduced  an  automated  14-hour  consultant  review 
function. However, you are concerned that as yet there is still no limit to the amount of 
times the automated ‘pop-up’ can be manually overridden and no automatic escalation 
process when it has been overridden a certain number of times. 

Since  Mrs  Winn’s  death  the  Trust  has  made  a  number  of  changes  designed  to 
encourage the timely and accurate assessment of VTE risk, which includes guidance 
for prophylactic management. These changes were made in close consultation with 
subject matter experts, clinicians responsible for completing assessments at the point 
of care and the clinical informatics team. Some of these changes had already been 
scheduled  for  development  and  were  accelerated  as  part  of  the  critical  incident 
investigation and some have been agreed following a review of the inquest feedback. 

These changes include: 

•  “Smartzone”  alerting  from  point  of  admission  –  the  smart  zone  alerting 
provides  a  constant  reminder  that  VTE  assessment  and  management  is 
required and provides a hyperlink to the document. The alert is deactivated on 
full completion. 

•  Pop-up  alerting  when  closing  the  patient  record  –  an  additional  alert  is 
presented  when  closing  a  patient’s  chart  with  the  ability  to  launch  the 
assessment  document  or  to  return  to  the  patient  record  for  review  before 
completing  the  assessment.  The  pop-up  alert  is  now  triggered  when  the 
clinician closes the chart rather than on opening which means that this person 
is less likely to override as they will have completed the primary purpose for 
opening the patient chart which would not necessarily have been to complete 
VTE. The alert is deactivated upon full completion. 

•  Additional  prompting  displayed  at  point  of  first  consultant  review  –  an 
additional field to confirm completion of the VTE assessment has been added 
to  the  template  used  to  record  the  first  review  by  a  senior  clinical  decision-
maker. Typically, this is recorded within the first 24 hours of admission. 

•  Changes to the presentation of the pop-up alert at 24 hrs from admission 
(in  development)  –  the  text,  display  and  presentation  of  the  pop-up  alert 
indicating  incompletion  will  be  amended  to  indicate  the  urgent  need  to 
complete. The number of overrides to date will be indicated in the body of the 
text. 

 
 
 
 
 
 
 
 
 
 
 •  Appropriate alert presentation - alerts are now presented to the appropriate 
staff  group  that  have  the  ability  (and  responsibility)  for  completion  of  the 
assessment and prescribing of prophylaxis at appropriate times on the patient 
journey. This was identified as one of the factors contributing to high override 
rates.  As  an  example,  the  alert  now  only  appears  for  prescribers,  where 
previously  non-prescribers  were  presented  with  the  alert  and,  in  order  to 
proceed,  were  required  to  record  an  override.  This  will  in  turn  reduce  the 
number of overrides occurring.  

•  Discrete prompting within the body of the assessment – clearer guidance 
has been added to the risk assessment. Haemolytic anaemia has been added 
explicitly  to  the  ‘thrombosis  risk  –  patient  related’  section  of  the  assessment 
document.  The  subsequent  guidance  displayed  following  completion  of  the 
assessment now includes a direct instruction to seek senior clinical guidance if 
needed. 

•  Safety  dashboards  –  the  status  of  VTE  assessment  completion  is  shown 
against  each  patient  on  ward  dashboards  is  displayed  to  clinical  and 
operational teams. These provide “live” status reports and also enable a direct 
documentation  link  from  the  dashboard  if  required;  a  blank  space  identifies 
patients that have not had their VTE assessment completed. 

•  Override  notifications  (in  development)  –  a  notification  will  be  sent  to  the 
Lead  Consultant  responsible  for  the  patient  indicating  incomplete  VTE 
assessments and management plans and the number of times this assessment 
alert has been overridden. These notifications will be issued after every twenty 
overrides  (20/40/60  etc)  and  will  be  sent  to  the  clinicians  “Message  Centre” 
inbox. Message Centre is a secure clinical messaging system embedded within 
the  patient  record  system  which  would  include  clinical  notifications,  referrals 
and critical reminders.   

See appendix 2: screenshots reflect some of the changes listed above 

The Trust have considered the use of a hard stop to prevent continuing overriding of 
the alert once a maximum threshold has been reached. At this point we believe this is 
not in the patient’s best interests as there are many clinical examples where it would 
not be appropriate to complete a VTE assessment especially in emergency situations. 
However, this option will remain under review and the current VTE compliance report 
is  being  amended  to  present the  number of  overrides  and  more  detailed  timings  of 
completions to better inform future monitoring. 

Finally,  clinical  guidelines  have  been  updated  for  VTE  (Prophylaxis  for  Venous 
Thromboembolism  (VTE)  in  Adult  Non-Pregnant  Patients)  which  includes  a  section 
around  risk  factors.  We  have  added  the  following  risk  factor;  “Conditions  such  as 
haemolytic anaemia and sickle cell disease” to the relevant section of these guidelines 
and they are available on the staff intranet and are easily accessible. 

 
 
 
 
 
 
 
 
 
 Concern 3 
You  are  concerned  that  if  a  Consultant,  at  an  early  review,  has  decided  that 
prophylactic  anticoagulation  medication  needs  to  be  administered  (even  in  the 
situation when an INR test is still awaited) that this is not clearly flagged on the patient 
electronic record in the Smart Zone, to act as a prompt for clinicians taking over that 
patient’s care. 

The  narrative  aspect  of  a  clinician’s  plan  cannot  be  ‘pulled  through’  into  the  smart 
zone.  However, the actions described in section 2 will ensure that an in-completed 
VTE assessment is recognised. Furthermore, the addition of the haemolytic anaemia 
prompting within the VTE assessment tool should aid ensuring that the clinicians are 
aware that this condition requires VTE prophylaxis consideration. 

As  part  of  the  discussions  within  the  Trust  concerning  this  case  it  was  agreed  that 
whilst  the  initial  consultant  included  in  his  plan  VTE  prophylaxis,  if  Mrs  Winn’s  INR 
blood test was within normal parameters, it was a conscious decision over a weekend 
to withhold the prophylaxis because haematuria (blood in urine) was present. Over the 
weekend period different clinicians formed the same conclusion.  This is not a thematic 
issue for the Trust, however, it is hoped that by addressing the issues around the VTE 
prophylaxis process described above, as well as a clear referral process and treatment 
required pathway for clinicians to follow would provide further assurance that the risk 
of reoccurrence would be minimalised. Smart zone alerting is restricted to indicating 
an omission, rather than providing a discrete instruction. Although this is often one and 
the same thing, in this case it would not be currently possible to provide the type of 
prompt suggested. 

I hope that the above information and evidence provides you with a level of assurance 
in making your final decision and thank you for your consideration in this sad inquest. 

Yours sincerely 

Chief Executive  

 
 
 
 
 
 
 
 
 
 
 Appendix 1 

 
 
 
 Appendix 2 – e-Care Screenshots 

Screen shot 1: Smartzone alert  

Screenshot 2: Close chart pop-up alert 

Screen shot 3: First consultant review additional prompt 

Screen shot 4: VTE assessment detail 

 
 
 
 
 
 
 
 
 
 
 
 
 
 Screen shot 5: Doctors Safety Dashboard