David Smith

Joint Group Medical Directors’ Office 
Trust Headquarters 
Room 215, Cobbett House 
Oxford Road 
M13 9WL 

Tel:  0161 701 0205 

Email:  t

09 October 2019 

Mr Z Golombeck 
HM Acting Area Coroner 
HM Coroner’s Office – Manchester City Area 
PO Box 532 
Manchester Town Hall 
Albert Square 
Manchester M60 2LA 

Sent via email to:  p.crosby@manchester.gov.uk 

Dear Mr Golombeck 

Re:  David John SMITH – Regulation 28: Prevention of Future Deaths 

I  have  now  had  the  opportunity  to  look  into  the  concerns  you  raise  in  respect  of  this  case.    Manchester  Royal  Infirmary 
acknowledge that the care received by Mr Smith fell below standard and have taken a number of actions following this case 
to ensure that care provided to our patients is always of the appropriate standard.  The response required from Manchester 
University NHS Foundation Trust related to the following: 

1. 
2. 

the consent process 
recording of the CMV status 

I have provided information on both points below as they are intrinsically linked. 

Concerns were noted at Inquest regarding the lack of communication to Mr Smith regarding the donor’s positive CMV status.  
There  were  also  errors  in  correctly  documenting  the  donor  and  recipient  CMV  status  on  the  operation  note  leading  to  a 
failure to provide the recipient with the relevant medication.  This was identified within the Trust’s internal investigation and a 
number of actions were put in place to address this.  I have provided the detail of these below. 

It was acknowledged that the consent process regarding the communication of donor risks, particularly CMV status, needed 
to be more robust and comprehensive so that all recipients are fully informed before transplantation. 

The  consent  process  for  transplantation  has  been  strengthened  all  along  the  listing  pathway,  and  all  recipients  are 
specifically informed during the assessment about CMV infection and its effects, morbidity and mortality.  If they are being 
offered  transplantation  with  a  CMV  positive  kidney  when  they  are  CMV  negative,  they  are  considered  high  risk  for 
developing  CMV  infection.    This  is  discussed  prior  to  transplantation  with  the  recipient  during  the  consent  process  and 
specifically documented. 

Mr Smith’s operation note had inaccuracies recorded with regard to donor kidney details as noted at Inquest.  At the time of 
the transplant, some of the donor organ details were not available.  In order to address this, a formal check process within 
48  hours  of  transplantation  and  independent  to  the  ward  based  team  was  implemented.    This  process  is  led  by  the 
Transplant Coordinators and includes a check of all donor and recipient documentation including the CMV status.  This  is 
then documented on the transplant flow chart.  This process was reviewed after implementation, to ensure that it delivered 
the required assurance.  Following this review, it was further amended in order to include the ward pharmacist providing a 
further independent check of the documentation as part of the established medication review process.  This was considered 
to be a more seamless approach and provide a level of independence to the team reviewing the documentation.  In order to 
support this, Pharmacists have been trained to confirm the CMV status from the original source i.e. the recipient status from 
ICE (electronic test results system) and the donor status from  the National Electronic Offering System (EOS) form.   I can 
confirm that this process remains in place. 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 The renal transplant patient discharge summary letter was also redesigned to incorporate relevant donor details including 
the donor and recipient CMV status.  This was to provide a further level of assurance and robustness in the communication 
processes.  It was also identified that operation notes are completed at the end of complex surgery and that could often be 
undertaken  by  on-call  staff,  therefore  there  was  a  requirement  to  review  the  electronic  process  for  the  completion  of 
operation  notes  in  order  to  reduce  the  risk  of  errors.    I  am  able  to  confirm  that  following  a  review  of  the  processes  and 
systems in place, all transplant  operation notes are commenced on a new operation template, so that there is no risk of 
transcription error.  All operation notes are also reviewed by the responsible consultant after surgery for accuracy. 

We  acknowledge  that  the  care  of  CMV  patients  can  be  complex  and  there  is  a  requirement  for  expert  overview  and 
monitoring  over  an  extended  period  of  time  for  this  cohort  of  patients.    As  a  result  of  this,  we  undertook  a  review  of  the 
outpatient team and clinical follow up processes to look at creating continuity of care, and ensuring that there was overview 
of care at Transplant Nephrology Consultant level for patients  with complex medical needs.   In order to provide this in a 
robust and consistent way, a substantive post for a nephrologist with an interest in transplantation has been appointed to the 
Trust.  A fourth nephrologist post for transplantation is planned and awaits business case and funding review. 

As  a  further  mechanism  for  the  review  and  monitoring  of  the  care  of  this  complex  cohort  of  patients,  a  weekly  multi-
disciplinary team meeting was established.  This takes place on a Thursday afternoon and on review is working effectively 
and efficiently.  Core attendees to the meeting include a Consultant Nephrologist, Consultant Virologist, Renal pharmacist 
and a senior nursing representative from the Transplant outpatients. 

At the meeting, all virology results from the previous week are identified on reports from the virology lab and patients with 
positive results are presented and taking into account their clinical background, suggested management plans are drawn up. 

Ever since this clinic was introduced there has been a demonstrable reduction in the number of CMV cases with the number 
of inpatient days of patients with CMV reducing from 162 to 38 after the introduction of the MDT.  An audit of the impact of 
the clinic was presented at the Transplant Audit and Clinical Effectiveness day on 19 September 2019.  A copy of the audit 
can be provided if required. 

In order to support the appropriate provision of medication intervention, there is a process in place to identify for screening 
all patients due to stop prophylaxis; and the Pharmacy team generate a weekly report of those patients on CMV antiviral 
prophylaxis  to  confirm  the  appropriate  dosing  regime.    This  is  further  supported  through  the  Virology  team  sending  daily 
alerts to the Renal team listing all new CMV positive samples from renal patients. 

These processes also ensure that all relevant information is provided for the discussions with recipient patients, in order for 
them to make an informed and educated decision regarding the consent process for the procedure.  We acknowledge that 
the incomplete form in Mr Smith’s case led to him not being aware of the CMV status of the donor, therefore he was unable 
to provide fully informed consent. 

It is also  worth noting that there is a virology and renal  collaborative clinical research study on  cellular immunity to  CMV 
taking place, with the aim of improving patient management. 

The Trust remains wholly committed to full implementation of  the learning from this case, a case which is still raised and 
discussed at improvement meetings, and will continue to implement improvements based on the learning. 

Please  accept  my  assurances  that  lessons  have  been  learned  from  this  case  and  appropriate  actions  have  been  put  in 
place to address the issues raised.  If you require anything further then please do not hesitate to contact me. 

Yours sincerely 

Joint Group Medical Director / Responsible Officer 

www.mft.nhs.uk 

Incorporating: 
Altrincham Hospital • Manchester Royal Eye Hospital • Manchester Royal Infirmary • Royal Manchester Children’s Hospital •  
Saint Mary’s Hospital • Trafford General Hospital • University Dental Hospital of Manchester • Wythenshawe Hospital •  
Withington Community Hospital • Community Services