Frank Medley

Trust Headquarters 
Royal Blackburn Teaching Hospital 
Haslingden Road 
Blackburn 
BB2 3HH 

30 June 2021 

PRIVATE & CONFIDENTIAL 

Dr James Adeley 
HM Senior Coroner 
Lancashire and Blackburn with Darwen 

Sent via email only 

Dear Dr Adeley, 

Re: REGULATION 28 REPORT TO PREVENT FUTURE DEATHS –  
Mr Frank Medley 

Please  find  below  response  detailing  the  action  taken  or  planned  to  address  the 
matters  of  concern  raised  in  relation  to  the  above  case.  A  narrative  overview  is 
provided as summary, followed by our detailed action plan with embedded evidence. 

A core group has been established to oversee the implementation of this action plan 
led by the Associate Director of Quality and Safety, the Deputy Medical Director and 
Director  of  Nursing  to  ensure  senior  oversight  of  the  issues  raised.  Please  be 
assured that this group will continue to meet until all actions have been embedded as 
business as usual into Trust processes with clear reporting and monitoring processes 
in place. 

MATTERS OF CONCERN 

(1) The Trust has an ineffectual system to detect adverse outcomes where 
the  patient  is  transferred  to  a  tertiary  centre  for  treatment  and 
subsequently dies; 

(2) The Trust's review of this case was seriously deficient in the following 

instances: 
a.  At no point were members of the family spoken to for their views or 

concerns regarding the death up to and including the inquest.  

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 b.  The  date  of  death  was  14  July  2019.  The  Report  was  incomplete 
eight months later in March 2020 when it was suspended during the 
first  Covid  wave.  The report  was  not  completed  before  the  inquest 
on 23 February 2021. This is not in accordance with NHS guidance; 

c.  The  case  was  inappropriately  allocated  to  a  structured  judgement 

review; 

d.  The  "Summary  of 

the 

Incident"  contains  substantial 

factual 

inaccuracies to such an extent that it is deeply misleading; 

e.    Mr Medley's death was due to complications of sepsis. The report failed 
to  note  that  due  to  admission  for  query  sepsis  at  the  same  hospital  11 
days before, that: 

i. the EWS score was sufficient to trigger the septic shock pathway; 

ii.  the  nurse  correctly  identified  that  the  septic  shock  pathway  should 
be followed and drew this to the attention of "a doctor"; 

iii.  that  due  to  the  referrals  taking  place  between  specialties  at  this 
time  the  relevant  speciality  responsible  for  dealing  with  this  issue 
cannot  be  identified  and  made  no  entry  in  the  medical  records  (this 
raises  similar  issues  to  those  concerns  raised  in  the  Regulation  28 
report concerning Mrs Gillian McKinley at the same Trust); 

iv. that, despite the patient observations being readily available to the 
treating consultant orthopaedic surgeon the following morning and the 
nurse  having  documented  the  septic  shock  pathway  should  be 
activated  in  the  notes,  the  consultant  orthopaedic  surgeon  failed  to 
note  this  both  at  the  time  and  during  the  preparation  of  his  witness 
statement for the inquest; 

v.  the  error  was  only  detected  by  the  Trust's  Legal  Services 
Department when preparing for the inquest 19 months after the event. 

e.  That 

the  consultant  physician  responsible 

for  Mr  Medley's  care 
appreciated that his symptoms constituted a medical emergency, that the 
MRI scan should be completed on 2 July 2019 but took no action himself 
to  expedite  the  scan.  There  is  no  documented  evidence  in  the  medical 
records regarding junior doctor’s attempts to expedite the scan; 

2 

 
 
 
 
 
 
 
 
 
 
 
 g. The consultant physician responsible for Mr Medley's care after input from 
the neurologists on 3 July 2019 made no attempts to expedite the scan or 
to contact tertiary neurosurgical services; 

h.  On  2  July  2019  the  treating  clinicians  suspected  infective  complications 
high  in  the  cervical  spine  but  only  undertook  a  chest  x-ray  and  blood 
cultures  without  considering  sending  a  urine  sample 
for  analysis, 
considering an echocardiogram or OPG: 

i.   Mr Medley's scan should have been completed within 24 hours of request 
in  accordance  with  NICE  guidance,  which  was  not  cited  anywhere  in  the 
report, and that the priority attached to the scan on 2 July 2019 placed Mr 
Medley  in  the  lowest  priority  category  when  he  should  have  been  in  the 
highest priority category. This mistake was repeated on 3 July 2019 when 
Mr  Medley  was  placed  in  the  middle  priority  category.  There  is  no 
documentation as to any rationale for the priority allocation; 

j.  The  scan  when  it  was  performed  on  5  July  2019  was  not  a  contrast  scan 
necessary  to  accurately  delineate  foci  of  infection  resulting  in  a  further 
scan using contrast to be performed later that day. 

k. That prioritisation of scans within the radiology department depended to a 
considerable  extent  on  a  personal  attendance  by  clinicians  at  the 
department or speaking to radiologists rather than solely on clinical need;   

l. There was insufficient senior clinical oversight of the conclusions drawn. 

(3) The  Department  undertaking  reviews  of  adverse  incidents  appears  to 

operate independently from the Legal Services Department 

(4) The delay in obtaining the scan was partly attributed to a lack of MRI scanner 
capacity. At the inquest the Trust could only provide conjecture as to whether 
or not alterations to scan capacity had made any difference to the time taken 
to obtain urgent scans 

Radiology actions currently underway   

Access to Diagnostic Imaging 

In October 2020, ELHT commissioned two new Magnetic Resonance Imaging (MRI) 
systems  on  the  Burnley  General  Teaching  Hospital  site.  These  scanners  were 
replacement  assets  identified  as  part  of  the  government  initiative  which  aimed  to 
replace  all  MRI  systems  over  10  years  old.  The  initial  intention  was  to  replace  the 
Philips MRI system at Burnley and the Trust owned asset at RBH. However, due to 

3 

 
 
 
 
 
 
 
 
 
 
 
 increasing demand and the escalation of the COVID pandemic, these systems have 
remained operational.  

The  two  new  MRI  systems  at  Burnley  are  now  fully  operational  and  plans  are 
progressing to replace the oldest asset on the Royal Blackburn site. We are  

anticipating  that  this  will  be  finalised  in  the  coming  weeks  with  a  view  to 
commissioning of the new scanner before the 30th September 2021.  

Following this, the second asset on the Blackburn site will also be upgraded; this is 
expected to be completed in late 2021. On the back of these two replacements, the 
service at ELHT will be second to none with state of the art MRI assets across East 
Lancashire.  

The  Radiology  in  patient  dashboard  has  been  developed  using  our  business 
intelligence  system  and  is  currently  used  in  key  areas  of  the  Trust.  Roll  out  of  the 
dashboard  is  progressing.  The  next  steps  are  to  demonstrate  and  share  access  to 
the dashboard at the Nursing & Midwifery Forum, Foundation Teaching and Clinical 
Leadership to accelerate roll out to the wards and clinical services. 

Improving  coordination  and  communication  between  wards  and  Radiology 
department 

Radiology in-patient Co-ordinator/Navigator role was established in November 2019. 
This role has supported improved patient flow and communication between referring 
clinical teams and the radiology team. Cover is provided 52 weeks of the year by the 
Radiology  Administrative  function.  A  Standard  Operating  Procedure  describing  the 
functions  of  this  role  and  the  actions  required  by  referrers  to  improve  access  and 
efficiency  in  radiology  is  being  developed  to  support  this  function.  Communications 
have  been  clarified  to  advise  on  the  most  appropriate  manner  for  teams  to  access 
the In-patient Navigator. This is the route that teams will use to find out when a scan 
is planned and also to expedite imaging which has not yet been planned. 

Clinico-radiological  meetings  were  established  in  November  2020  and  now  occur 
twice  weekly  on  Monday  and  Friday  on  AMU.  It  is  intended  that  when  possible,  a 
third meeting will be provided on a Wednesday to provide better support through the 
working  week.  This  development  allows  a  forum  in  which  difficult  cases  can  be 
discussed  and  advice  and  guidance  provided  on  the  optimum  imaging  technique 
and/or  interpretation  of  unusual  report  findings  and  has  been  a  significant  success; 
building  improved relationships  and  communication  between  clinical  teams  on  AMU 
and  the  radiology  directorate.  This  meeting  explicitly  addresses  the  human  factors 
highlighted in this case; ensuring that patient management is equitable regardless of 
the  staff  on  duty  and  that  clinical  discussions  can  be  held  without  personal 
attendance. 

4 

 
 
 
 
 
 
 
 
   
 Reviewing the use of NICE guidance to inform prioritisation of referrals 

The  Internal  Professional  Standards  (IPS)  have  been  revised  by  the  Radiology 
Directorate  to  support  the  requirements  for  imaging  in  this  cohort  of  patients.  The 
compliance with the standards are monitored weekly at the Radiology Performance  

Meeting. Phase two of the Power BI dashboard development is to include the IPS for 
in-patient turnaround  times. We  are  also  working  on  a  traffic  light  system  which  will 
demonstrate, at a glance, the average waits for radiology diagnostics supporting the 
need to expedite urgent imaging. The first draft of the traffic light system is now "live" 
on  the  radiology  intranet  site  and  is  being  validated  prior  to  display  in  a  more 
prominent area of the Trust intranet. 

We  are  currently  also  reviewing  the  In-patient  priorities  applied  at  vetting  stage  by 
Radiology.  It  is  anticipated  that  these  will  be  time-based  allowing  a  better 
understanding of the priority applied at vetting; aligned to NICE guidance for urgent 
imaging where stated. This will allow pressures within the system to be escalated so 
that clinical decisions can be made on how best to proceed. 

Reviewing the appropriate use of contrast 

Mr Medley’s case was discussed at the Radiology Directorate Meeting on 19th March 
2021 as evidenced by the minutes of this meeting. All decisions were viewed on the 
electronic  system  and  the  team  consider  the  decisions  made  to  have  been 
appropriate based on the clinical evidence available at the time. 

The  MRI  scan  in  question  was  vetted  on  2nd  July  2019  by  a  senior  Consultant 
Radiologist  and  CRIS  (Radiology  Information  System)  records  demonstrate  that  it 
was  felt  that  the  clinical  question  posed  by  the  clinical  team  could  be  adequately 
answered by an MRI scan without the administration of contrast media. The referral 
was re-vetted the next day (3rd July 2019) by a second Consultant Radiologist who 
also agreed that contrast media was not required. 

Following  completion  of  the  scan,  a  3rd  Consultant  Radiologist  provided  the  final 
report  and  it  is  evident  that  the  clinical  question  had  been  suitably  answered  and  a 
scan following administration of contrast media was not considered necessary. It was 
advised  by  the  Consultant  Radiologist  who  reported  the  scan  that  a  CT  Thorax, 
Abdomen and Pelvis was performed and this was requested on 6th July 2019. 

Our  Clinical  Director  has  since  confirmed  that  the  department  does  not  administer 
contrast  media  in  cases  where  discitis  or  para-spinal  abscesses  are  queried.  The 
rationale  for  this  is  that  these  patients  are  commonly  in  significant  pain  and  this 
lowers  the  tolerance  of  the  scan  owing  to  additional  time  taken  to  complete  the 

5 

 
 
 
 
 
  
 
 
  
  
  
 examination.  Instead,  we  undertake  additional  sequences  (STIR)  which  clearly 
demonstrate abscesses or discitis which is much faster. To summarise, it is felt that 
contrast  media  should  generally  only  be  delivered  to  improve  lesion  conspicuity  in 
areas  of  low  inherent  contrast  resolution  or  to  characterise  a  lesion,  which  was  not 
requested in this case. 

Whilst  the  Lancashire  Teaching  Hospitals  Consultant  Neurosurgeon  requested  a 
scan  with  contrast  media,  it  is  presumed  that  this  was  due  to  the  requirement  to 
answer a different or additional clinical question. In such circumstances, we would be 
happy to provide a further scan with contrast media but it is felt that this has limited 
diagnostic utility. 

As such, having reviewed this case again we are happy that the correct decision was 
made in providing a scan without intra-venous contrast media.  

Action taken to strengthen and integrate and support the Trusts Legal Services 

A  weekly  complex  case  coordination  meeting  has  been  introduced  to  enable  early 
coordination with legal services and complaints team, to agree appropriate routes for 
investigation and ensure all families concerns are understood. This has enabled a full 
review  of  case  currently  listed  for  inquest  and  any  potential  delays  or  concerns 
regarding  linked  investigation  processes.  This  complex  case  group  coordinates  all 
cases that cross divisions, are listed for an inquest, have an ongoing investigation of 
any  kind  (eg  complaint/SJR/LeDeR)  and  ensures  families  are  contacted  by  an 
allocated family liaison officer at as early a stage as possible. 

The  Trust’s  Legal  team  are  currently  advertising  2  additional  solicitor  posts  and  an 
inquest  coordinator.  Inquests  attendance  and  statement  writing  training  provided  in 
partnership with Hempsons on 22nd June. Planned dates for a continued programme 
of training is awaited. 

Divisions  have  taken  responsibility  for  coordinating  statements  from  clinicians  in 
support of inquests, through their clinical governance teams. Statement management 
is  now  visible  to  all  teams  within  governance;  using  the  complex  case  meeting  to 
escalate both statements required and outstanding, for action. 

Follow up ME consideration of deteriorating pt transfers 

You  raised  a  concern  re  the  lack  of  systems  to  follow  up  patients  who  once 
transferred go on to deteriorate in other Trusts. It has proved difficult to achieve this 
from  a  systems  perspective.  Achieving  this  is  heavily  reliant  on  the  Trust  being 
informed of a patient having unfortunately died, in a timely manner. Mr Medley’s case 
has clearly demonstrated the impact of the absence of this system, but no Trust we 
have  spoken  to  has  been  able  to  describe  a  standardised  systematic  approach  to 

6 

 
 
  
  
 
 
 
 
 
 
 achieving this when asked. Recognising the focus and role of the Medical Examiners, 
across  all  Trusts;  our  Lead  Medical  Examiner  has  asked  the  Regional  Team  to 
consider whether these roles could support with this issue. We await a response. 

Whilst we recognise that Mr Medley’s care was not reviewed until well after his death. 
The internal processes designed in line with the national guidance, did escalate the 
investigation 
to  Root  Cause  Analysis 
appropriately.  However  this  did  not  facilitate  early  learning,  nor  did  it  provide  the 
family  with  adequate  opportunity  to  discuss  any  concerns  with  our  clinical  team, 
which we regret. 

from  Structured  Judgement  Review 

Action taken to improve the Trust’s Serious Incident Investigation processes 

A  full  review  and  update  of  investigation  process  has  been  completed,  in  line  with 
Patient  Safety  Incident  Response  Framework.  Funding  has  been  agreed  in  support 
of  a  proposal  to  develop  a  cohort  of  investigators  and  family  liaison  officers  with 
allocated  time,  specific  training  and  administrative  resource  to  enable  timely  and 
thorough investigations. This team will report to the Assistant Director of Safety and 
Risk  and  work  in  partnership  with  the  legal  team  to  coordinate  investigations  and 
learning on behalf of the trust. 

A full policy update is underway in line with the above mentioned proposal including 
new audit measures against investigation standards which will be monitored at Trust-
wide Governance meeting. 

A  weekly  Executive  review  of  Divisional  investigations  due  at  SIRI  Panel  has  been 
introduced  from  21  April  to  monitor  the  quality  of  reports  prior  to  submission.  This 
aims to ensure that the quality of the investigation may be identified earlier and at a 
senior enough level to require any further improvements to be made without delaying 
the  process  or  submission  to  your  court.  A  pro  forma  for  Serious  Incident 
investigations,  with  a  front  sheet  for  sign  off  of  each  stage,  has  been  developed  in 
line  with  the  National  Patient  Safety  Strategy  and  PSIRF  requirements;  which 
prompts investigators to clearly link the problems, learning and recommendations to 
individual  actions  that  are  focused  on  preventing  the  same  incident  reoccurring.  I 
understand  a  pilot  version  of  this  proforma  was  received  favourably  by  one  of  your 
team at an inquest last week. 

Future assurance monitoring 

The  action  plan  implementation  will  continue  to  be  monitored  at  Trust  Wide  Quality 
Governance  meeting  and  will  report  to  the  Quality  Committee  until  all  actions  have 
been embedded as business as usual with monitoring processes in place. 

7 

 
 
 
 
 
 
 
 
 
 
 The  CCG  and  NHSE/I  have  been  involved  in  the  creation  of  this  action  plan  and 
assurance on the implementation will continue to report to the Trust’s monthly Quality 
Review meeting with the CCG. 

Please  do  not  hesitate  to  contact  me  with  any  questions  or  concern  regarding  the 
content  of  this  response;  we  are keen to  work  with  the  Coroner to  demonstrate  our 
ongoing commitment to delivering the safest care possible for our patients. 

Yours sincerely 

Executive Medical Director & Consultant Urological Surgeon 
East Lancashire Hospitals NHS Trust

8 

 
 
 
   
 
 Appendix 1  

Regulation 28 Action Plan with embedded documents 

Matter of Concern 

Objective 

Evidence provided 

Assurance process 

The Trust has an ineffectual 
system to detect adverse 
outcomes where the patient is 
transferred to a tertiary centre for 
treatment and subsequently dies; 

To identify opportunities to 
develop a network to 
support communication 
between hospitals following 
transfer of patients. 

To be confirmed 

Lead Medical Examiner from 
ELHT has proposed that the 
Regional Medical Examiner 
group consider how this 
feedback mechanism might be 
established. 
Awaiting decision. 

The Trust's review of this case 
was seriously deficient in the 
following instances 

To improve the timeliness, 
quality and oversight of the 
Incident Investigation 
process. 

Monitoring SIRIs completed 
within 60 day (not relevant 
for this case) 

Complex Case Review (CCR) 
group established, coordinating 
investigations across open 
inquests, RCAs, complaints, 
SJRs and LeDeR reviews. 

Weekly complex care meeting 
monitors and escalates 
outstanding or delayed 
investigations and contact 
/feedback with families 

CCR also monitors application 
of Duty of Candour, contact with 
families and allocation of Family 

Wednesday Exec SIRI review 
meeting will ensure all 
requirement of front sheet are 

9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Development of joined up 
pathway confirming which 
type of investigation should 
be considered and at which 
stage 

To ensure appropriate 
clinical senior oversight of 
SIRI prior to completion 

The Department undertaking 
reviews of adverse incidents 
appears to operate independently 
from the Legal Services 
Department 

To ensure the legal team 
are integrated into decision 
making processes within 
the governance 
department. 

Liaison Officers. 

Front sheet for all RCAs 
introduced ensuring all stages 
of investigation complete prior 
to sign off. 

met and monitored, escalating 
to SIRI panel 

CCG SIRI Dashboard to 
continue to monitor completion 
of Duty of Candour 

Exec sign off meeting in place 
weekly, to oversee the quality of 
investigations and enabling 
SIRI panel to focus on 
coordinating and learning from 
action plans. 

Exec have agreed to fund a 
central team of lead 
investigators to work with 
Expert/Allocated Clinicians. 
Recruitment is due to start in 
July 21. 
Legal team are core members 
of Complex Case Group and 
inform all decisions made re 
management and prioritisation 
of investigations 

Complex Case Group reports 
exceptions through divisional 
governance leads and SIRI 
panel 

10 

 
 
 
 
 
 
 
 
 
 
 
 
 Legal team are currently 
advertising 2 additional solicitor 
posts and an inquest 
coordinator. 

Monthly inquests update 
meeting established with 
Medical Director 

Inquests attendance and 
statement writing training 
provided in partnership with 
Hempsons on 22nd June. 
Planned dates for continued 
programme of training awaited. 

The delay in obtaining the scan 
was partly attributed to a lack of 
MRI scanner capacity. At the 
inquest the Trust could only 
provide conjecture as to whether 
or not alterations to scan capacity 
had made any difference to the 
time taken to obtain urgent scans 

Development of improved 
communication pathway 
between ward and 
Radiology Department.  
(this also links to the 
previously described IP 
dashboard) 

Maintain turnaround time 

Radiology IP Co-ordinator role 
established and operational.  
This Administrative function 
acts as a conduit between 
referring clinical teams and 
radiology Consultants in 
support of appropriate 
escalation. 

Dashboard development 
complete.  Roll out of system 
has commenced but not fully 
implemented." 

All referrals received are 
vetted/justified by a suitably 
trained Practitioner in 

11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Radiology.  Initial clinical 
urgency is based upon the 
clinical information 
documented on the referral/e-
referral. 

Internal Professional 
Standards (IPS) to be 
reviewed to measure 
performance against IP 
turnaround time of less than 48 
hours (currently measure at 12 
and 24 hours for ED, 
Assessment units and 
standard IPs) 

for scanning of MRI IPs at 
or below 48 hours where 
possible 

Capacity & Demand exercise to 
support revised booking 
templates and access to IP 
scanning slots. 

Development of review of 
transfer out of hospital 
pathway which includes 
timeframes and 
responsibilities for follow up 

Implementation and 
embedding of NICE 
guidance into standard 
radiological practices 

Guidance on when and 
how to use contrast to be 
reconsidered.  However, 
the vetting/justification of 
the scan in question did 
take place and it was felt 
that the clinical question 
could be adequately 
answered without contrast 
media. 

Sharing of incident with 
Radiology Directorate team.  
Requirement to adhere to NICE 
guidance reiterated. 

Review of IPS for radiology at 
weekly performance meetings 
by radiology management 
team.  Any actions required to 
improve performance are 
escalated each week. 

Consensus view on 
requirement for contrast media 
in clinical presentations such as 
this to be considered. 

Set up a biweekly 
radiology/AMU clinical meeting 
to discuss difficult cases, build 

12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 interdepartmental relationships 
and knowledge sharing and 
teaching  

13