Honoria Culshaw (2)

Regulation 28 Response 

Cardiology Catheter Laboratory Services  

1.  Executive Summary 

Purpose  

The purpose of this paper is to  provide a response to the Regulation 28 Report issued to the Trust by  Anna 

Morris KC, Assistant Coroner for the Coroner Area of Greater Manchester South, on conclusion of the inquest 

held on 11th September 2025. The response outlines the details of the case, matters of concern raised and the 

actions to be taken.  

Case Summary 

The inquest relates to a 79-year-old lady who attended Royal Preston Hospital on 20th August 2024, where a 

reburial of her pacemaker was performed. The procedure was performed without any complications and there 

was a plan to review her again in two weeks’ time.  

The  Inquest  was  attended  by  two  cardiology  consultants  (treating  consultant  and  AAR  Clinical  Lead).  Legal 

representation was in place for the inquest with pre inquest meetings, preparation and support provided by the 

Inquest and Mortality Team. In accordance with statutory requirements, the Trust’s response to the Coroner is 

required to be submitted within 56 days of receipt, by 21st November 2025. 

Matters of Concern Raised by the Coroner 

The matters of concern raised by the coroner are as follows:  

• 

International clinical guidance relating to signs of infection were not adhered to; 

•  There had been a lack of information sharing at LTHTR, with particular reference to there being no evidence 

that  wound  swab  results  were  shared  with  the  operating  consultant  pre procedure,  which  resulted  in      a 

missed  opportunity  to  consider  pre-operative  planning  and  wider  MDT  discussion  as  to  whether  the 

procedure should go ahead.  

Both issues may have contributed to an extraction process not being undertaken at the earliest opportunity. 

Action Plan 

An action plan has been developed by the Division of Medicine which has formed the basis of the response to 

the coroner and can be found in Appendix 1.   

A1 
 
  
 
 
 
 
 
 2.  Regulation 28  

The relevant section from the Regulation 28 report is outlined below with the full Report attached in Appendix 2.  

Coroner Concerns: taken from Regulation 28  

1.  Mrs Culshaw attended Wythenshawe Hospital on the 10th July 2024 and presented with an opening of her 

pacemaker  scar.  I  heard  evidence  at  the  inquest  from  a  Consultant  Cardiologist  at  Wythenshawe  that 

International clinical guidance indicates that any opening of an implantation scar should be interpreted as a 

sign of systemic infection of the wound and that extraction and replacement of the pacemaker should follow 

in order to remove the infection. This was the advice of the on-call Cardiologist at Wythenshawe on 10th July 

2024 to the Emergency Department medical team. I heard evidence that Wythenshawe is one of a limited 

number of specialist surgical centres for the extraction of pacemakers.   

2.  Mrs  Culshaw  was  not  admitted  to  Wythenshawe  Hospital,  but  discharged  to  the  care  of  Royal  Preston 

Hospital, where her pacemaker had been fitted. Royal Preston Hospital is not a specialist surgical centre for 

pacemaker extraction. I heard that the decision of the Consultant Cardiologist at Royal Preston was to re-

position, rather than extract the pacemaker.   

3.  I  heard  evidence  that  on  15th  August  2024,  a  swab  from  the  pacemaker  wound  tested  positive  for  the 

Morganella Morganii bacteria, which was also found post-mortem. It is not clear from the evidence who on 

the surgical team was made aware of this result, and whether it was properly taken into consideration as 

part of the pre-operative risk assessment. Mrs Culshaw had her pacemaker re-sited on the 20thAugust 2024. 

4.  I  found  that  Mrs  Culshaw’s  experience  of  persistent  and  prolonged  infection  depleted  her  physiological 

reserve and contributed to her succumbing to a fatal pneumonia on the 25th October 2024.  

5.  I am concerned that this lack of information sharing of test results, which in this case may have resulted in 

an extraction process not taking place at the earliest opportunity.  

Regulation 28 report issued to Manchester 

At the inquest the Coroner issued a further Regulation 28 report to Manchester University NHS Foundation trust 

regarding their reliance on the patient to relay clinical information in relation to treatment plans to LTHTR. Whilst 

this response will primarily focus on the Regulation 28 concerning LTHTR, the Cardiology team are committed 

to working with Wythenshawe to strengthen communication pathways with tertiary centres. 

3.  Case Details 

The case  concerns  a  79-year-old female  patient who  was  first  seen  by  a  cardiology  consultant  in  December 

2013,  the  diagnosis  was  complete  heart  block,  confirmed  on  the  Electrocardiogram  (ECG)  as  a  missed 

myocardial  infarction  approximately  5 weeks  prior  to that  consultation.  The  patient  had symptoms  of  angina, 

fatigue and dizziness.  

The patient had a permanent pacemaker implant and diagnostic coronary angiography on 18th December 2013. 

A dual chamber pacemaker was implanted. The coronary angiography showed a narrowing in the left anterior 

descending artery, for which arrangements were made for the patient to have coronary intervention at Blackpool 

2 

A2 
 
 Victoria Hospital (BVH). The pacemaker was implanted locally at Royal Preston Hospital (RPH), and the patient 

was  managed  by  BVH  for  recurring  intervention  for  coronary  artery  disease.  The  patient  was  followed  up 

regularly in the pacemaker clinic for the following 10 years until mid-August 2023. 

In August 2023, the patient’s pacemaker battery was running low, and the patient was admitted for a replacement 

on 7th November 2023. The procedure was performed by a specialist registrar and was uneventful. 

In early July 2024, the patient attended Wythenshawe Hospital with signs of infection at the pacemaker site. The 

patient had a bleeding disorder called idiopathic thrombocytopenic purpura, which contributed to bleeding within 

the pacemaker pocket and infection.  The patient was advised by Wythenshawe Hospital that she should return 

to RPH, where the procedure had been undertaken.  

On 16th July 2024, the patient was reviewed by a cardiologist consultant at RPH, who identified there was a 1cm 

hole in the centre of the wound. The wound was glued, which was deemed to have been appropriate, and the 

patient  was  advised  to  return  in  one  week  for  a  review,  possibly  a  new  pacemaker  battery  or  referral  to 

Wythenshawe Hospital for lead explant. The patient was safety netted, and a wound swab taken at the time 

showed no significant growth and there were no signs of infection.  

The patient was admitted again to RPH on 23rd July 2024, where her wound around the pacemaker was noted 

to have appeared much better and there were no signs of infection. The hole was still visible, and the cardiology 

consultant made the decision to rebury the pacemaker at a deeper level. The patient received antibiotics during 

and post procedure. The consultant noted everything appeared normal at the site and there was a plan for the 

patient to return for a follow up appointment in 3 weeks’ time.  

The patient contacted the catheter laboratory in early August to advise that she could see the pacemaker, and 

plans  were  made  for  her  to  return.  The  patient  attended  RPH  on  15th  August  2024,  where  the  wound  was 

reviewed and a swab was taken. As the patient did not want to remain in hospital, she went home with a plan 

for her to return on 20th August 2024. 

The wound swab result was available on Harris flex from 18th August 2024. 

On 20th August 2024 a reburial of the pacemaker was performed without any complications and there was a 

plan  to  review  the  patient  again  in  two  weeks’  time.  The  patient  was  informed  that  in  the  case  of  further 

breakdowns, a request would be made to Wythenshawe Hospital to explant the entire pacing system for the left 

pectoral area and to implant a new one on the right side. The patient was discharged home with a two-week 

prescription of ciprofloxacin in line with the identified sensitivities of the wound swab taken on 15th August 2024.  

The patient  attended  an  appointment  on  3rd  September  2024  for  a  review  of  her  pacemaker,  and the review 

identified that there was no swelling, oozing or breakdown of the scar.  

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A3 
 
 
 
 
 
 
 4. Response to Regulation 28 

Initial Actions taken 

The cardiology team welcome the scrutiny and challenge from HM Coroner. They have reviewed their practices 

with regard to the reviewing and acting on investigation results and strengthened them where necessary. 

The inquest proceedings and outcome have been shared with the Cardiac Catheter Laboratory Team to allow 

for collective reflective practice. 

Learning 

The Cardiology Catheter Laboratory Team have worked with the Governance Teams to develop a robust result 

reporting system to ensure the staff are fully informed of any ‘wound swab results’ prior to the commencement 

of a clinical procedure being undertaken. There is a broader pre-operative assessment process using a standard 

care pathway booklet that the Catheter laboratory nursing team utilise from the start to the end of the process 

for procedures. This involves the patient attending for a pre-operative review prior to the day of the procedure 

including  bloods  tests  and  infection  control  swabs.  Any  concerns  at  this  appointment  are  flagged  to  the 

consultant who has scheduled the procedure. 

An action plan has been developed with a focus on documentation that investigation results are reviewed and 

shared  with  the  clinical  team.  The  full  Action  Plan  and  progress  updates  are  attached  as  Appendix  1  with 

summary actions outlined below.  

Following the inquest, attempts were made to check access to the patient’s Harris Flex clinical information record 

to  confirm  whether  or  not  the  Registrar  accessed  the  wound  swab  result  prior  to  the  procedure.  Whilst  it  is 

evident that there were multiple points of access into the clinical record on the day of the procedure, it is not 

possible to drill down into whether specific sections of a clinical record (in this case the wound swab result) were 

accessed. 

Summary of actions 

•  A wound swab tracking document managed by the Cardiology Catheter Laboratory (CCL) team has been 

strengthened.  This  includes  a  daily  check,  details  of  results  received,  and  which  clinicians  have  been 

informed. 

• 

“Wound swab check” has been added to the WHO checklist.1 The WHO checklist is carried out immediately 

prior to the procedure with the participation of the full team undertaking the procedure. 

•  The  CCL  Team  will  continue  to  work  within  the  Trust  wide  Microbiology  critical  results  framework  where 

critical results (such as virulent organisms or those with markers of national concern) are telephoned through 

to the treating team. 

1 The WHO Surgical Safety checklist is a tool developed by the World Health Organization to improve safety during surgical 
procedures 

4 

A4 
 
 
 
 
 
 
 
 
 •  The CCL team will continue to follow national guidance that the individual who orders the test is responsible 

for the result and to communicate this with relevant colleagues caring for the patient as required. 

The  actions  are  being  monitored  through  Cardiology  Governance  Meetings,  Divisional  Safety  and  Quality 

meetings and through the PSIRF Oversight Panel. The action plan will also be shared with the wider cardiology 

consultant body to ensure collective awareness of the learning and confirmation of the agreed processes.  

Further Reflection and Continuous Improvement 

The Regulation 28 has provided an opportunity for further reflection and learning for the Cardiac Catheter Team, 

who in addition to developing specific actions in response to the coroner concerns raised, have also implemented 

end of day debriefs to review all cases performed that day. This is a 10-minute reflective session to discuss each 

case,  identify  any  issues,  and  discuss  continuous  learning  and  on-going  quality  improvement  within  the 

department. 

The CCL team are fully committed to embed the actions identified into their everyday clinical practice to prevent 

a similar incident occurrence.   

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A5 
 
 
 
 
 Appendix 1 - Action Plan  

Action Plan – Regulation 28 (Cardiology Datix 181528)    

Version 

Updated by 

Date 

1 

3 

Note: This action plan combines the actions in response to the Prevention of Future death regulation 28 order and the actions agreed with key stakeholders. 

  Area of Concern 

Key Actions 

Action 
Identified: 

Evidence 

Lead 

Progress 

Deadline 
for 
action 

Current Status 

1  2 

3  4 

Regulation 
28 

Wound Review 
Checklist 

JA/SC 

31.12.25 

Review the 
process of 
identifying and 
acknowledging 
swabs have been 
taken and results 
checked. 

1. 

The inquest heard evidence 
that on 15th August 2024, a 
swab from the pacemaker 
wound tested positive for the 
Morganella Morganii bacteria, 
which was also found post-
mortem. It is not clear from 
the evidence who on the 
surgical team was made 
aware of this result, and 
whether it was properly taken 
into consideration as part of 
the pre-operative risk 
assessment. 

Following the incident a ‘wound swab’ 
document has been updated as part of 
the pre-operative process. The 
documentation requires date/times 
swabs are taken, alongside when results 
are reviewed. The documentation also 
requires details of who has been 
informed of the result. Following results, 
the clinicians will prescribe the 
appropriate medications, and this is 
recorded onto the wound review 
checklist.   

The information within the checklists is 
also recorded onto Harris Flex. 

The wound review checklists are kept in 
the Cath Lab in the team’s work list files 
for the week ahead. Results are looked 
for daily, until reported, and upon 
receiving the results, the 

Wound%20Review%20Checklist%20v1.docxA6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Add ‘wound swab 
results’ to the 
WHO checklist 

Regulation 
28 

consultants/registrars are informed of the 
results. 

The updated documentation will be 
reviewed and approved by the divisional 
governance committees before being 
submitted to the Trust Clinical 
Documentation Group to ensure 
consistency and standardisation. 

WHO checklist 

JA/SC 

31.12.25  The WHO checklist is currently in place 

and audited monthly. (Results on AMAT). 

‘Wound swab results’ will be added to the 
checklist to provide assurance the results 
are available and alerted to the team 
prior to a procedure. 

Awareness of the results will enable the 
clinician to make an informed decision in 
regards whether the procedure should 
continue.  

Whilst awaiting the form to be re-
designed and sent for printing, the team 
will utilise the use of a ‘sticker’ to enable 
‘wound swab results’ to be captured. 

Going forward the WHO checklist will be 
incorporated into a wider Trust 
workstream to standardise LocSSIPs2 
across the organisation in line with 
NATSIPPS23. 

2 Local Safety Standards for Invasive Procedures (LocSSIPs) are based on the National Safety Standards for Invasive Procedures (NatSSIPs). Organisations are required to develop LocSSIPs for 
invasive procedures being undertaken outside of operating theatre environments.  
3 NatSSIPs (National Safety Standards for Invasive Procedures) cover all invasive procedures, which can be defined as a procedure that requires piercing the skin to gain access to the inside of a 
patient’s body, or gaining access to a body cavity without cutting into the body or using electromagnetic radiation. The revised standards (NatSSIPs2) are intended to share the learning and best 
practice to support multidisciplinary teams and organisations to deliver safer care. 

7 

A7 
 
 
 
 
 
 
 
 2.  There were concerns raised at 
inquest regarding the lack of 
information sharing of test 
results 

•  Confirm 

microbiology 
result reporting 
protocols. 

Regulation 
28 

Bacteriology 
Authorising 
Manual 

Regulation 
28 

Datix  

•  Confirmation of 

Trust 
expectations for 
result access 
and review via 
Harris Flex. 

8 

Dr O 

20.10.25  Microbiology advise they will telephone 

through critical results about virulent 
organisms such as group A 
streptococcus, or if it is from a normally 
sterile site, or if the organism has 
resistant markers of national concern. 

In this case, it was superficial wound 
swab with an organism that is known to 
colonise wet wounds, therefore no 
Microbiology call to flag the result was 
required. 

Dr C 

24.10.25  The Trust follows national guidance that 

the individual who orders the test is 
responsible for the result and to 
communicate this with relevant 
colleagues caring for the patient as 
required.  

The electronic system in place at the 
Trust does not have a facility to 
automatically alert the clinician and 
therefore there is a risk on the risk 
register  (Datix ID 2176) ‘Harris Flex 
currently does not follow, or support UK 
medical workflows leading to delay or 
missed review of Pathology results.’ 

To mitigate this risk critical inpatient and 
outpatient results that require immediate 
attention are communicated directly to 
clinicians by phone. Pathology results are 
accessible through the Harris Flex inbox, 
abnormal or critical findings are flagged 

Bacteriology authorising manual version 24.1.docA8 
 
 
 
 
 
 
 based on normal ranges, and interactive 
care grids highlight trends over time.  

This risk outlines ongoing IT challenges 
within Harris Flex, which the IT team is 
actively addressing. Plans are underway 
to implement a system that facilitates 
more obvious and easier result sign-off. 
Across the ICB a new EPR is being 
procured. 

The ‘wound swab’ document 
implemented as part of this action plan 
would ensure the results are reviewed 
and communicated as part of the pre-
operative process. 

Appendix 2 

Regulation 28 Report 

9 

LTH Amended Reg 28 - PFD.pdfA9