Jennifer McKoy

Black Country Pathology Services 

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Regulation 28: Response to prevent future deaths - Response 

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Date: 

Coroner: 

Inquest: 

23 April 2020 

Zafar  Siddique,  Senior  Coroner,  for  the  coroner  area  of  the  Black 
Country. 
Death of Ms Jennifer McKoy.  Inquest date 19 February 2020 

Matters of concern: 

Evidence emerged during the inquest that there was an inadequate audit 
process in  place for monitoring non-suspicious samples by way of dip-
sampling. 

Action should be 
taken: 

In consultation with the Black Country Hospital Trusts the Black _Country 
Pathology Services may wish to review their audit/ dip-sampling 
processes for both suspicious and non-suspicious samples. 

1.  Background: 
Black  Country  Pathology  Service  (BCPS)  is  a  partnership,· across  the  four  NHS  providers  within 
the Black Country.  BCPS is hosted by The Royal Wolverhampton NHS Trusts and was established 
in  October  2018.  Since  then,  there  has  been  a  planned  transition  period  in  which  pathology 
services  are  being  migrated  to  the  target  operating  model.  As  part  of the  transition  all  histology 
services currently spread across 4  sites will  be consolidated together and based  at the New Cross 
Hospital  site  in  Wolverhampton;  this  includes  the  clinical  histopathology  team.  The  aim  is  to 
provide a more robust pathology service across the BCPS. 

The  BCPS  inherited  a number of issues  regarding  the  histology services,  mainly associated  with 
the  national shortage of Histopathologist; this was of particular-concern at Walsall Healthcare NHS 
Trust (WHT)  site. Several of the  Consultant Histopathologists  at Walsall  had  retired  and  returned 
and  were working  an  excessive  number of PA's  (15  PA's),  which  was  not sustainable  long  term. 
The Walsall  Histology Clinical  Lead  also left for a new post outside the  BCPS, increasing the risk 
level. 

Reporting  turnaround  times  for  histology  cases  across  the  BCPS  were  not  meeting  the 
recommended  standard  stated  by  the  Royal  College  of  Pathologists,  resulting  in  a  backlog  of 
cases  (backlog  varied  across  the  various  sites).  As  such  there  was  significant  pressure  from  the 
Trusts to improve turnaround times especially for patients on cancer pathways. 

Both  WHT and  BCPS  recorded  the  reporting  pressures  in  histology on  their risk  registers; BCPS 
also  raised  the  risk  regarding  the  issues  around  the  recruitment  and  retention  of  Consultant 
Histopathologists, with particular concern at the Walsall site. 

As  a  result ·of the concerns  around  the service  provision  at WHT the decision was  made to  move 
the service to RWT earlier than planned as part of the BCPS reconfiguration. 

Across the entire Black Country region, all malignant cases are reviewed at the appropriate MDT. 

NHS Pathology Serving the Black Country 

Provided by Sandwell and West Birmingham NHS Trust. The Dudley Group NHS Foundation Trust, 
The Royal Wolverhampton NHS Trust and Walsall Healthcare NHS Trust. 

 Black Country Pathology Services 

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To  support quality assurance  systems  within  histology, a programme  of Southampton  audits  had 
been  in  place  at  RWT.  The  audits  involved  the  review  of  both  malignant  and  benign  cases 
(equivalent  to  2%  of the  workload)  to  assess  the  technical  and  clinical  quality  of  the  individual 
departments.  Due  to  the  pressures  to  meet  cancer  targets,  staffing  shortages  and  increased 
activity, the audit programme was not maintained. To rectify the slippage in the Southampton audit 
programme, the  BCPS  has  revised  the audit programme  and  metho_dology across the  network to 
ensure  the  programme  is  achievable  and  provides  assurances  for  both  malignant  and  benign 
cases. The audit programme incorporates: 

. 

•  A  review  of all  histology  multi-disciplinary  team  meeting  cases,  prior  to  MDT,  to  provide 

quality assurance for all malignant cases . 

•  A  modified Southampton audit programme,  which  audits  2%  of the workload  selected from 
non-malignant  cases  to  cover  benign  cases;  both  the  technical  and  clinical  quality  of the 
laboratories are reviewed. 

NHS Pathology Serving the Black Country 

Provided by Sandwell and West Birmingham NHS Trust, The Dudley Group NHS Foundation Trust, 
The Royal Wolverhampton NHS Trust and Walsall Healthcare NHS Trust. 

 Black Country Pathology Services 

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2.  Actions taken: 

S: 

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1 

2 

3 

4 

5 

6 

7 

8 

9 

Comment 

Action 
Case  review  audit  of the  pathologist  responsible  for the  interpretation  No clinical relevant errors were identified. 
and reporting error of this incident. 
Case review audit of non-cancerous WHT cases reportec;i  over 2 month  No clinical relevant errors were identified. 
period. 
Formal  process  in  place  to  document  any  discrepancies  identified  Final site in process of instigating. 
during 
multidisciplinary  team  meetings 
p~rformance. 
Commenced  audit  (modified  Southampton  audit)  of the  technical  and  Cases  audited  on  monthly  basis.  Audit  Completed 
clinical  quality  of  non-malignant  cases;  accounts  to  2%  of  workload  commenced from January 2020 cases. 
activity at each site across the BCPS. 

in  preparation  of 
individual  pathologists 

review  of  malignant  cases 

Status 
Completed 

to  access 

Completed 

routine 

Partial 

Clinical  audit  lead  from  each  site  collates  modified  Southampton  and 
malignant case audit data and presents findings bi-monthly to the BCPS 
histology clinical meeting. 
Implement audit of cases outsourced to the private sector for reporting,  Historical audit of outsourced cases from  RWT  Completed 
to assess the quality and accuracy of reporting. 

Meeting . schedule  in  place  and  minutes  of 
meetings documented. 

Completed 

completed.  Frequency  of  audit  dependant  on 
outsourcing of cases. 

Recruitment of Consultant Histopathologists to fill  vacancies to  achieve 
full workforce establishment. 
Additional  support  for  clinical  teams  across  BCPS  (including  WHT 
Histology prior to relocation) from  RWT clinical team and UHB. 
•  Laboratory  Information  System  (LIMs)  installed at RWT Histology  lab 

to enable remote reportinQ  across the network. 

7  additional  Consultants  recruited  since  BCPS 
formed. 

Ongoing 

Completed 

Accelerated the relocation  plan of Walsall histology laboratory (including 
clinical  staff)  to  the  Wolverhampton  site  as  part  of  the  national  Walsall, 

Improved  robustness  of  histology  services  at  Completed 

includinq 

qreater 

support 

for  October 2019 

:  t  . 

NHS Pathology Serving the Black Country 

Provided by Sandwell and West Birmingham NHS Trust. The Dudley Group NHS Foundation Trust, 
The Royal Wolverhampton NHS Trust and Walsall Healthcare NHS Trust. 

 Black Country Pathology Services 

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pathology consolidation programme. 

histopathologists  (easier  access  to  second 
supported  MDT 
peers, 
opinions 
attendance, workload manaQement~. 

from 

3.  Actions proposed to be taken : 

Action 

Comment 

1 

2 

3 

4 

5 

Complete implementation of audit at remaining  BCPS site for the 
routine  review  of  malignant  cases  in  preparation  of  MDT 
meetinQs. 
Complete modified Southampton audits roll  out. . 
-

Audit  of cases  outsourced  to the  private  sector for reporting, to 
assess  the  quality  and  accuracy  of  reporting  across  entire 
BCPS. 
Recruitment of Consultant Histopathologists 

Improve pathways to notify BCPS of increasing cancer work due 
to waiting list initiative's etc. which then impact directly on the lab 
and histopathology consultants. 

implementing  on  all  sites; 

this 
Currently 
involves  moving  from  previous  audit  process 
to new audit process. 
Currently 
this 
involves  moving  from  previous  audit  process 
to new audit Process . 
. No cases outsourced for reporting. 

implementing  on  all  sites; 

date 

Target 
completion 
31  May 2020 

of 

31  May 2020 

As required 

Consultant  Histopathologist  post  to  continue 
to  be  advertised  on  a  regular  basis  until  the 
. service is fullv established. 
Raised  at  STP  Cancer  Group  meeting-
contact emails to be shared. 

Continue  until 
established 

fully 

31  May 2020 

a,s NHS Pathology Serving the Black Country 

Provided by Sandwell and West Birmingham NHS Trust. The Dudley Group NHS Foundation Trust, 
The Royal Wolverhampton NHS Trust and Walsall Healthcare NHS Trust.

30th April 2020 

JO/LNR 

Mr Zafar Siddique 
HM Senior Coroner for the Black Country 
Black Country Coroner's Court 
Jack Judge House 
Halesowen Street 

.  Oldbury 

West Midlands 
869 2AJ 

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The Royal Wolverhampton 
NHS Trust 

New  Cross Hospital 
Wolverhampton Road 
Wolverhampton 
West Midlands 
WV100QP 

Tel: 01902 307999

Dear Mr Siddique 

RE:  RESPONSE TO REGULATION 28: REPORT TO PREVENT FUTURE DEATHS 

Please  find  enclosed  information  requested  from  Black  Country  Pathology  Services  and  The  Royal 
Wolverhampton  NHS Trust relating to the prevention of future deaths statement issued on  11 th March 
2020. 

With respect to the actions to be taken relating to the review of audit/dip-sampling  processes for both 
suspicious  and  non-suspicious  samples  by  Black  Country  Pathology  Services  (BCPS),  please  find 
enclosed  a  summary  of the  relevant  information  and  the  action  plan  prepared  by  BCPS,  to  ensure 
this  is  achieved.  You  will  see  that  most  of  the  actions  are  completed  with  the  remainder  to  be 
completed by 31 st May 2020. 

With respect to the hospital Trust reviewing their policy on  anticoagulation/prophylaxis for community 
patients,  please find  enclosed  a summary of actions to be taken  by The Royal Wolverhampton  NHS 
Trust,. with  respect  to  this.  Although  I note that the  patient to whom  the PFD  relates was  under the  · 
active care of Walsall Healthcare NHS Trust. 

If you require any additional information,  please do not hesitate to contact me directly. 

Best wishes. 

Yours sincerely 

Dr Jonathan Odum 
MEDICAL DIRECTOR 

Chairman: Professor Steve Field CBE 
Chief Executive: David loughton CBE 
Preventing Infection - Protecting Patients 

A Teaching Trust of the University of Birmingham 

Safe  & Effective  I  Kind &  Caring  Exceeding  Expectation 

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--

Legal Services Department 
Manor Hospital 
Moat Road 
Walsall 
West Midlands 
WS2 9PS 

Tel: 
Email: 
Website: 

01922 721172 ext 5809 
walsallhealthcare.nhs.uk  
www.walsallhealthcare.nhs.uk  

Our Ref:  
Your Ref:  

JM 21/19 
Regulation 28 REPORT 

Date:  

22 May 2020 

Mr Siddique 
Black Country Coroners Court 
Jack Judge House 
Halesowen Street 
Oldbury 
West Midlands 
B69 3AJ 

Dear Mr Siddique 

Re: Mrs Jennifer McKoy - Deceased 
Date of Death: 17/05/2019  
Date of Inquest: 19th February 2020 

I am writing in response to your report under paragraph 7, Schedule 5, of the Coroners and Justice Act 
2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. I fully accept that the 
inquest conclusion was reached with the potential to identify learning to prevent future deaths. 

I would like to take the opportunity to assure you that as an organisation we have taken this case 
seriously and have and will continue to ensure actions and lessons from this are enacted and shared 
widely with staff across the organisation. 

Circumstances of the death 

Mrs  McKoy  was  was  a  58-year-old  female  patient  who  initially  attended  Walsall  Manor  Hospital  for  a 
laparoscopic  cholecystectomy  on  14  August  2018.    Prior  to  this  she  was  referred  by  her  GP  in  March 
2018 for pain in her right side.  A subsequent ultrasound at hospital confirmed she had a thick-walled gall 
bladder with multiple gall stones. 

The  surgical  procedure  was  described  as  difficult  due  to  a  very  thick-walled  gallbladder  packed  full  of 
stones  and  she  was  discharged  home  the  following  day.  The  gall  bladder  was  sent  for  histology  and 
reported to show 'chronic cholecystitis'.  

Mrs McKoy re-attended the emergency department at Manor Hospital on 14 February 2019 with pain and 
a  growing  mass  at  the  port  site,  this  was  reviewed  and  felt  to  be  a  haematoma  or  scar  tissue  and  the 
patient was discharged home with plans for follow up.  

Mrs McKoy was then seen in the vascular clinic on 20 March 2019 and ultrasound completed of mass at 
port  site  which  was  suggestive  of  haematoma.  A  further  MRI  completed  on  15  March  2019  identified 
adenocarcinoma of gallbladder bed, abdominal wall, multiple hepatic and peritoneal and bony metastases 
with some ascites. 

A retrospective review of the histology from 2018 showed that these slides demonstrated a carcinoma at 
that time which had not been identified.  

Mrs McKoy was referred to oncology for palliative chemotherapy and sadly died on 17 May 2019. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Coroner’s Concerns 

1.  Evidence  emerged  during  the  inquest  that  there  was  an  inadequate  audit  process  in  place  for 

monitoring non-suspicious samples by way of dip-sampling. 

2.  There  was 

limited  evidence  of  any  protocol  or  policy 

the 
anticoagulation/prophylaxis  regime  for  community  patients  who  have  identifiable  risk  factors  for 
developing complications.  

for  managing 

in  place 

Action Required 

1. 

In consultation with the Black Country Hospital Trusts the Black Country Pathology services may 
wish  to  review  their  audit/dip-sampling  processes  for  both  suspicious  and  non-suspicious 
samples. 

The  Hospital  Trust  may  wish  to  consider  reviewing  their  policy  on  anticoagulation/prophylaxis  for 
community patients. 

Action Taken 

1.  The Black Country Pathology Service is responding separately to detail the actions taken 

regarding their audit/dip-sampling processes for samples 

2.  A review of available guidance and local practice has been completed with regard to Venous 
Thromboembolism (VTE) anticoagulation/ prophylaxis for community patients, including those 
discharged from hospital, those with cancer and those residing in care homes.  

2.1  Discharge from Hospital 

NICE Guidance ‘Venous Thromboembolism in adults: reducing the risk in hospital’ Quality 
Standards (https://www.nice.org.uk/guidance/qs3), contains 2 relevant standards: 

Standard 6 - Patients/carers are offered verbal and written information on VTE prevention as part 
of the discharge process. 

Standard 7- Patients are offered extended (post hospital) VTE prophylaxis in accordance with 
NICE Guidance  

TRUST ACTION: 

In order to promote and ensure compliance with Quality Standards 6 & 7, we will be monitoring discharge 
assessments of patients through the Trust’s clinical audit programme  

2.2  Community Services 

1.2.1.  Cancer Patients: There is no formal guidance for patients with cancer diagnoses, other than 

at discharge from Hospital (as above 2.1), though the All-Party Parliamentary Thrombosis 
(APPT) group has recommended that all patients with cancer should be risk assessed 
wherever they are in the system. In addition they recommend that all cancer patients should 
receive information about reducing VTE risk, raising awareness of it happening, and clear 
instruction of when and where to get help if they have symptoms of it 
(http://apptg.org.uk/research/). 

In practice, there is evidence to suggest that VTE prophylaxis for palliative cancer patients, is 
futile and may be burdensome to them, however, the review team feels it is important that 
VTE risk assessments are done nonetheless (in any setting) and a discussion had with the 
patient and families to decide on prophylaxis. Recording that appropriate assessments and 
conversations have happened is also important. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 TRUST ACTION:  

We are establishing a Task & Finish Group, led by one of our Consultant Haematologists, to put 
procedures in the ensure that: 

i) 

ii) 

VTE risk assessments are completed for all cancer patients in hospital, on discharge and in 
community services, and  
all cancer patients are being provided with appropriate information about VTE risk and 
prophylaxis 

1.2.2.  Community Patients (generally). There is no national VTE guidance for community patients, 

however the literature demonstrates that there are community services where VTE risk 
assessments being done for those patients who are inpatients (within Intermediate Care 
Facilities), attend day case surgery or are seen in a Minor Injuries Unit 
(https://www.evidence.nhs.uk/search?q=vte%20risk%20assessment). The Trust’s review 
team has assessed that there is a risk to future patients in the absence of local policy.  

TRUST ACTION:  

i) 

• 

• 
• 

The Task & Finish Group will develop a Community Standard Operating Procedure for VTE 
risk assessment and prophylaxis: 
for all patients admitted to Inpatient Intermediate Care Services (including beds in Care 
Homes) 
for all patients receiving Day Case interventions  
to check the VTE risk assessment on discharge from Hospital, or for those with trauma who 
have attended the Emergency Department of the Urgent Treatment Centre, for all patients 
known to Community Services on contact with them (and so aiding in compliance monitoring); 

1.2.3.  Care Home Residents. The Trusts review team has noted that around 9% of all hospital 

admissions for VTE are for patients who live in Care Homes. The APPT group has 
recommended VTE risk assessments for all Care Home residents, though has suggested 
more research is needed to be clear its of benefit 
(https://www.anticoagulationuk.org/admin/resources/downloads/prevention-and-management-
of-vte-in-care-homes.pdf).  

TRUST ACTION:  

The Trust will be liaising with Walsall Clinical Commissioning Group (CCG) to assess the need for 
procedures to be established in Walsall’s Care Homes.  

We expect to complete all actions by 31 October 2020 and would be happy to provide you with 
confirmation at that time.  

I hope you are satisfied that the Trust has taken the circumstances surrounding Mrs McKoy’s death 
seriously and that the action detailed above is acceptable.  

Finally, may I take this opportunity to offer our unreserved apologies to the family of Mrs McKoy for 
distress caused to them along with our sincere condolences for their loss. 

Yours sincerely 

Chief Executive 
Walsall Healthcare NHS Trust