Carol Hatch

Dear Sir 

Regulation 28 Report - Response 

We write in response to your Regulation 28 Report dated 28 June 2023 issued following the inquest into the sad death of Mrs Carol Hatch. Please consider 
this letter as Spire Healthcare Limited’s formal response to the concerns raised in the report.  

We would like to take this opportunity to offer our sincerest condolences to Mrs Hatch’s family. Prior to the inquest, we conducted a thorough and candid 
Root Cause Analysis (“RCA”) investigation into the circumstances surrounding Mrs Hatch’s death and had identified the majority of the issues which were 
recorded in the Regulation 28 report. To that extent, we consider it important that it is acknowledged that that the concerns raised in the Regulation 28 
report are comprised largely of concerns Spire had already highlighted and was taking steps to address prior to the inquest. Notwithstanding this, as an 
organisation we have considered the concerns raised in the Regulation 28 report with the utmost seriousness and have undertaken further work to address 
these concerns.  

We have set out our response to the Regulation 28 concerns in the table below with reference to evidence in support of those actions both in the form of the 
evidence which formed part of Spire’s RCA action plan as presented at the Inquest, as well as evidence of the further work undertaken since the hearing took 
place.  

Coroner’s Concern  

Spire’s Response  

Evidence 

Escalafion to consultant 

1.  Mrs Hatch's condifion deteriorated 
markedly during the night of 31 
August/1September 2022 (some hours 
after surgery). Neither the surgeon nor 
the anaesthefist were alerted to this 
unexpected deteriorafion. The Surgeon 
only became aware of the posifion 
when he contacted the hospital and 
came in around 7 am. 

The  RCA  invesfigafion  completed  prior  to  the  inquest 
clearly idenfified that, wholly regreftably, on this occasion, 
some of the staff involved in the pafients’ care made errors 
in  clinical  judgement  in  failing  to  appreciate  the  signs  of 
the  pafient’s  deteriorafing  condifion  and  sepsis  was  not 
considered during the night and up unfil the pafient was 
reviewed  by  the  consultant  surgeon.  As  soon  as  the 
consultant  contacted  the  hospital  at  07:00  hours  and 
received  an  update  on  the  status  of  the  pafient  he 

ADDITIONAL INFORMATION 

 

 

Integrated Quality Governance Team (”IQG”) 
Review of Learnings from Serious Incidents in 
2022 and Q1 2023 
Leeds Incident Review of Escalafing to 
Consultants 

 
 
 
 
 
 
 
 
 
 
 
 Coroner’s Concern  

Spire’s Response  

Evidence 

responded promptly and aftended the hospital. As a result 
of this incident, Spire conducted a full and thorough RCA 
idenfifying areas of concern pufting in place an acfion to 
address those concerns. As stated above, the majority of 
the  issues  idenfified  in  the  Regulafion  28  report  are 
mafters which had already been idenfified and addressed. 
Notwithstanding  this,  Spire  is  commifted  to  ongoing 
learning  from  this  event  and  improving  its  systems  and 
processes.   

Nursing/RMO care 

2.  Mrs Hatch was cared for during the night 
by an agency nurse who had not worked 
at  the  hospital  previously.  No  records 
were  produced  to  the 
Inquest  to 
demonstrate she was (a) competent (b) 
had  an  inducfion  to  the  hospital  or  (c) 
received  a  handover  at  the  start  of  the 
shift. 

or  misinterpreted 

3.  The  nurse  took  observafions  at  fimes 
during the night but either omifted some 
elements 
the 
informafion  with  the  result  that  the 
inaccurately 
NEWS 
portrayed.  This  resulted 
in  missed 
opportunifies  to  escalate  concerns  to  a 
doctor,  more  senior  colleagues,  or  the 
surgeon. 

scores  were 

These  points  were  addressed  in  the  RCA  with  remedial 
acfion listed in acfion points 9, 10, 12, 13, 14, 17, 18, 19 
and 20 and evidence on these acfions was presented at the 
inquest.   

The  agency  staff  hospital  inducfion  process  includes  a 
documented  local  inducfion  based  on  a  standard  format 
for  inducfion  used  across  the  group.  The  invesfigafion 
idenfified that the agency nurse (who had worked at Spire 
Leeds on a previous occasion) received a verbal inducfion 
when  she  arrived  on  shift  on  31.08.22.    A  documented 
record of this inducfion could not be located but from the 
evidence obtained during the invesfigafion and the events 
that  occurred,  we  are  confident  that  the  agency  staff 
member was orientated to the hospital as she completed 
Spire’s  care  plans  and  pafient  records  during  the  shift, 
accessed the handover, knew where to locate equipment, 

RCA ACTIONS EVIDENCE 

  Acfion No. 9 Refresher Training for NEWS 2  
  Acfion No. 10 Heads Together Clinical Night Staff  
  Acfion No. 12 NEWS 2 Training for Nafional 

Agency Supplier  

  Acfion No. 13 Online Training to Recognise a 

Deteriorafing Pafient  

  Acfion No. 14 Spot Audit of NEWS 2 Scores  
  Acfion No. 17 Departmental On-Call Service  
  Acfion No. 18 Updated Inducfion Checklist – 

Leeds 

  Acfion No. 19 Key Learning Points to Nursing 

Agency 

  Acfion No. 20 Completed Agency Inducfion 

AGENCY NURSE & RMO INFORMATION  
 

Confirmafion from Nursing Agency of Acfion 
Taken  

ADDITIONAL INFORMATION  
  Ward Handover 31.08.22 

 
 
 
 
 
 
 
 
 
 
 Coroner’s Concern  

Spire’s Response  

Evidence 

4.  No observafions whatsoever were taken 
in the period between 3 am and 6.25am, 
the  pafient  having  been 
despite 
recorded  as  "crying  in  pain"  around 
10pm. 

5.  The  records  kept  were  inaccurate;  for 
example, there was no record of oxygen 
being provided around 2 am. 

and escalated her concerns to the Resident Medical Officer 
(“RMO”) via a senior member of nursing staff for advice.  

  Agency Confirmafion Form 31.08.22 

Spire has a series of checks to ensure that agency staff are 
assessed as competent to care for pafients, as follows: 

- 

- 

- 

- 

The  nursing  agency  screens  the  candidates  via 
their  CV  and  ensures  that  they  meet  Spire 
Healthcare’s  statutory  and  mandatory  training 
requirements  of  BLS,  Anaphylaxis,  Safeguarding 
Adults  and  Children,  Infecfion  Prevenfion  and 
Control,  Informafion  Governance  and  Manual 
Handling  and  provides  a  Proforma  Confirmafion 
Form to the hospital.  
The  hospital  will  then  thoroughly  review  the 
informafion  provided  to  them  in  the  Proforma 
Confirmafion  Form  before  they  accept  the  nurse 
for the shift.   
In this case, it was documented that the nurse who 
cared  for  the  pafient  overnight  had  “recent  and 
credible experience in surgical nursing, Immediate 
Life Support (“ILS”)/Advanced Life Support (“ALS”) 
and 
training 
requirements”  and  was  suitable  to  care  for 
pafients  at  Level  1A+  per  our  policy  for  Safe 
Staffing. 
If suitable, the hospital agrees to the placement of 
the candidate, but careful considerafion is given in 
each  case  and  it  is  not  uncommon  to  reject  a 
candidate  based  on 
insufficient  skills  and 
experience to meet the hospital’s requirements.   

the  mandatory 

had  met 

 
 
 
 
 
 Coroner’s Concern  

Spire’s Response  

Evidence 

As part of the learning from this event, the team at Spire 
Leeds have shared and discussed the findings in the RCA 
with  this  nurse’s  agency.  The  core  supplier  competency 
checklist includes requires that agency staff are competent 
in the management of the deteriorafing pafient. The new 
checklist  must be  signed  by  the candidate  as  well as the 
agency  to  ensure  both  are  confirming  the  informafion  is 
correct.  

In addifion to addressing NEWS training with agency staff, 
the hospital have ensured that a NEWS update refresher 
has  been  provided  to  all  relevant  colleagues  and  have 
conducted regular audits to provide assurance in relafion 
to compliance. 

As  heard  in  evidence  during  the  inquest,  this  point  was 
idenfified in the RCA and was addressed in the acfion plan 
at  point  8  and  11.  The  RMOs  for  the  majority  of  Spire 
hospitals are provided by an external agency. The agency 
provides training  before RMOs start  with  us and  provide 
top-up training as required. The training provided includes 
on-line  elements  and  a  residenfial  course.    The  Group 
Medical Director (GMD) has visited the training site to get 
assurance  of  the  extent  of  training.    RMOs’  CVs  are 
provided to a site before they commence.  When RMOs are 
new  to  a  site,  they  have  a  period  of  shadowing  with  a 
previous RMO.  In addifion, there is have a RMO handbook 
with an inducfion checklist. 

RCA ACTIONS EVIDENCE 

  Acfion No. 8 to share the RCA with RMO and 

NES 

  Acfion No. 11 Recognising a gastric perforafion 

complicafion  

AGENCY NURSE & RMO INFORMATION  
 
Confirmafion of RMO Appraisal  
 
Clinical Policy 18 RMO Handbook  
  NES Resident Doctor Pre Checks 

6.  The RMO was called to review Mrs Hatch 
twice  during  the  night  but  failed  to 
appreciate that the deteriorafion in her 
condifion  necessitated  an  escalafion  to 
the surgeon and/or anaesthefist. 

 
 
 
 
 
 
 
 
 
 Coroner’s Concern  

Spire’s Response  

Evidence 

Spire  Leeds  has  the  appraisal  for  the  RMO  covering  the 
period when the incident occurred. The appraisal for that 
year documented mandatory training including sepsis. We 
have the doctor’s full CV which includes an NES Healthcare 
inducfion  which  covers  ECGs,  BNF  Medicafion,  NEWS, 
Medical  Note  Wrifing,  Pharmacology,  and  clinical  self-
declarafion of competencies dated 23rd January 2017. At 
the fime of the incident the RMO was trained in Advanced 
Life  Support  and  EPALS.  Compliance  was  assured  in 
accordance with the contractual Spire requirements. 

This mafter was recognised in the RCA, has been discussed 
with the RMO and there is a plan in place for training to be 
delivered to RMOs on recognising signs of a deteriorafing 
pafient  and  recognising  signs  of  gastric  perforafion.  In 
addifion,  Spire  has  received  confirmafion  that  the  RMO 
has undertaken a recent appraisal. We refer the Coroner 
to  evidence  file  relafing  to  the  RMO  which  includes 
evidence of acfion taken in relafion to this concern.  

Care  provided  in  ECU  is  governed  by  Clinical  Policy  80  – 
Elecfive Adult Surgical Admission – Level 1 Provision and 
Clinical Policy 88 – Crifical Care Standards.  Level 1 Care is 
described  as  “Enhanced  care  provides  care  for  pafients 
requiring  more  detailed  observafions  than  level  0  (ward 
and HOC) or step down from Level 2-3 care”, examples of 
requiring  close  physiological 
which  are,  pafients 
monitoring  after  major  surgery  –  may  have  addifional 
monitoring  devices  in  situ  e.g.  arterial  line,  pafients 

ADDITIONAL INFORMATION  

 

 

Clinical policy 80 Enhanced Care Service 
Provision 
Clinical Policy 88 Crifical Care Standards 

Enhanced monitoring/further invesfigafions  

7.  When Mrs Hatch was observed to be in 
pain there was a delay in moving her to 
an extended care unit ('ECU') bed or 
otherwise escalafing the level of 
monitoring. This did not take place unfil 
9.50 am. 

 
 
 
 
 
 
 
 
 Coroner’s Concern  

Spire’s Response  

Evidence 

requiring  a  single  vasopressor  support  (peripheral  or 
central)  but  otherwise  stable  and  not  deteriorafing.  E.g. 
post-op pafient with a “saggy” blood pressure secondary 
to an epidural, pafients stepping down from level 2 crifical 
care whose needs are greater than those that can be met 
by  ward 
requiring  ongoing 
level  care,  pafients 
intervenfions from crifical care outreach teams. 

All colleagues across the group and at Spire Leeds undergo 
competency assessment, with colleagues working in Level 
1  ECUs  also  undergoing  the  Nafional  Competency 
Framework  for  Registered  Nurses  in  Adult  Crifical  Care 
Step  1.    Of  the  nine  colleagues  who  work  within  Spire 
Leeds ECU two have addifionally completed a Crifical Care 
Degree  and  another  has  completed  a  Crifical  Care 
Cerfificate. 

links  with  Spire 
In  addifion,  Spire  Leeds  has  close 
Manchester,  who  provide  Level  3  (ICU)  care  and  an 
agreement with Leeds NHS Hospital where our colleagues 
can  aftend  to  maintain  ongoing  competence  in  specific 
areas, for example,  arterial lines,  inotropes,  non-invasive 
venfilafion, transfer training. 

8.  When  the  surgeon  sought  an  x  ray  at 
8.35 am there was a delay unfil this took 
place at 10.09 am. There was a failure to 
appreciate  the  urgency  of  the  situafion 
in  a  pafient  who  was  displaying 
symptoms of sepfic shock. 

As heard in evidence during the inquest, this mafter was 
idenfified in the RCA and addressed in the acfion plan at 
points 1, 2, 11, and 21. When Consultants commence their 
pracfice at Spire Leeds, they undergo an inducfion process 
which  includes  out  of  hours  provision.    The  hospital  has 
improved  on  call  service  documentafion  and  has 

RCA ACTIONS EVIDENCE 
  Acfion No. 1 RCA to Consultant  
  Acfion No. 2 RCA to Anaesthefist 
  Acfion No. 11 Consultant Training on Symptoms 

and Signs of Gastric Perforafion 

  Acfion No.17 Departmental On-Call Service 

 
 
 
 
 
 Coroner’s Concern  

Spire’s Response  

Evidence 

communicated  this  to  all  consultants  pracfising  at  the 
hospital.   

  Acfion No. 21 Per-operafive Communicafion of 

Difficult Surgeries 

9. 

It was not readily apparent to some of 
those involved at that fime that an out 
of hours radiographer could have been 
called in. This was a further missed 
opportunity to invesfigate her condifion 
before it deteriorated. 

This mafter was idenfified in the RCA and addressed in the 
acfion plan at point 17. When Consultants commence their 
pracfice at Spire Leeds, they undergo an inducfion process 
which  includes  out  of  hours  provision.    The  hospital  has 
improved  on  call  service  documentafion  and  has 
communicated  this  to  all  consultants  pracfising  at  the 
hospital.   

RCA ACTIONS EVIDENCE 
  Acfion No. 17 Departmental On-Call Service  

10. Blood samples taken at 8.02am were 
not delivered to the laboratory unfil 
9.06 am and then not reported on unfil 
10.21 am as they had not been marked 
as ‘urgent’. This also reflects a failure to 
appreciate the gravity of the situafion.  

11. The RMO was the senior doctor at the 

hospital overnight. The RMO recorded a 
note at 8.45 am "feeling much befter 
now". The Inquest noted a discrepancy 
between this comment and the fact 
that Mrs Hatch was deemed too unwell 
to be moved to the radiology 
department at 9.10am, some 25 
minutes later. 

12. Overall,  the  cluster  of  failings  on  31 
August/1  September  brought 
into 
quesfion  the  competence  of  the  staff 

As heard in evidence during the inquest, this mafter was 
idenfified in the RCA acfion plan at point 22.  

RCA Acfions Evidence 

  Acfion No. 22 Labelling of Urgent Bloods 

As  stated  in  Spire’s  RCA,  learning  has  been  developed 
surrounding the appropriate labelling of bloods in relafion 
to the urgency of a clinical situafion. This learning has been 
shared with staff across the hospital 

This  incident  was  escalated  to  the  RMO’s  agency,  NES 
Healthcare,  at  the  fime  of  the  inifial  event.    The  agency 
reviewed the  incident and  considered it  to  be  a learning 
opportunity rather than requiring referral to the GMC.  At 
the  fime of the  incident,  the  RMO had  an  in-date Sepsis 
training  record  (23/1/22) and  he was  asked  to  reflect  on 
the issue in his appraisal.  In his appraisal, he presented a 
case study about Upper GI surgery and its complicafions. 
He  completed  the  GMC  Medical  Pracfice  in  Acfion  in 
October 2022 to update himself on the GMC guidance for 
doctors. He also completed the EPALS course in December 
2022 where a lecture and a pracfical case included sepsis 
training.    

AGENCY NURSE & RMO INFORMATION  
 
Confirmafion of RMO Appraisal  
 
Clinical Policy 18 RMO Handbook  
  NES Resident Doctor Pre Checks 

RCA ACTIONS EVIDENCE 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Coroner’s Concern  

Spire’s Response  

Evidence 

  Acfion No. 4 RCA to RMO’s 
  Acfion No. 7 RCA Sent to Nursing Agency 
  Acfion No. 8 RCA Sent to  NES Healthcare 
  Acfion No. 11 Recognising a gastric perforafion 

complicafion  

looking  after  Mrs  Hatch  on  duty  at  the 
Spire  Hospital  that  night.  The  Inquest 
was  informed  that  such  concerns  had 
not  been  reported  to  the  regulatory 
bodies  of  those  involved,  The  RMO 
confinues  to  pracfice  at  the  Spire 
Hospital. 

Evidence was heard at the inquest that considerafion was 
given  to  referring  the  RMO  to  the  GMC  following  this 
incident.  The  RMO’s  skill  set,  and  competency  were 
discussed  at  a  Scrufiny  Panel  on  17th  February  2023 
aftended  by  hospital  and  senior  clinical  and  medical 
management at Spire. It was concluded that the findings 
of  the  RCA  and  the  known  pracfice  of  the  RMO  did  not 
meet the threshold for referral to the GMC. It was agreed 
that  the  hospital  team  would  share  the  RCA  with  the 
RMO’s agency, which was completed on 16th March 2023. 
It was agreed that the RMO’s agency were best placed to 
assist  us  in  understanding  whether  this  was  an  isolated 
episode  or  not,  whether 
there  were  any  wider 
performance  concerns  that  needed  to  be  addressed  or 
mafters requiring escalafion to the GMC.  

We  have  a  quarterly  meefing  with  NES  Healthcare  and 
have  strengthened  the  process  to  include  case  by  case 
discussion if we have raised any concerns about an RMO, 
and vice versa if the RMOs have raised any concerns about 
our hospital.  If we have significant or unresolved concerns, 
the RMO is replaced by the agency.  The RMOs undertake 
annual  appraisal  with  their  employing  agency,  and  our 
hospital Directors of Clinical Services meet regularly with 
them. 

13. The Inquest was informed that Spire 
Healthcare Limited rely on agencies 

As  stated  above,  the  agency  staff  hospital  inducfion 
process includes a documented local inducfion based on a 

ADDITIONAL ACTIONS EVIDENCE  
  Mandatory Training Planner 

 
 
 
 
 
 
 
 
 
 Coroner’s Concern  

Spire’s Response  

Evidence 

who supply clinical staff to assess their 
competence (whilst retaining a power 
of veto any individual put forward). 
Given the importance of having 
competent nurses and doctors on duty 
overnight further considerafion should 
be given to the methods by which 
professional competence is assessed 
and staff from agencies are engaged. 

  Oxylog Training  
  Resuscitafion Scenarios 

ADDITIONAL INFORMATION  
 
Spire Educafion TNA 

standard format for inducfion used across the group. The 
RCA idenfified that the agency nurse (who had worked at 
Spire  Leeds  on  a  previous  occasion)  received  a  verbal 
inducfion  when  she  arrived  on  shift  on  31.08.22.    A 
documented record of this inducfion could not be located, 
but 
from  the  evidence  obtained  during  the  RCA 
invesfigafion  and  the  events  that  occurred,  we  are 
confident  that  the  agency  staff  member  was  orientated 
and  completed  Spire’s  care  plans  and  pafient  records 
during the shift, accessed the handover, and escalated her 
concerns to the RMO for advice. 

Current ILS  compliance for registered  colleagues  at Spire 
Leeds is 77%, against the target of 90%.  Colleagues who 
do not currently have ILS training are booked onto training 
in  the  near  future. 
is  part  of  ILS 
competency.  We  have  100%  compliance  in  performing 
quarterly scenarios of which sepsis is included. 

  Sepsis  training 

In this case, the RMO had documented mandatory training 
which included sepsis assessment and management.  

Similarly, the agency nurse in this case was ILS/ALS trained, 
which includes the assessment and management of sepsis. 

Spire has a series of checks to ensure that agency staff are 
assessed as competent to care for pafients.  

The nursing agency screens the candidates via their CV and 
ensures  that  they  meet  Spire  Healthcare’s  statutory  and 
mandatory  training  requirements  of  Basic  Life  Support, 

 
 
 
 
 
 
 
 
 
 Coroner’s Concern  

Spire’s Response  

Evidence 

Anaphylaxis,  Safeguarding  Adults  and  Children,  Infecfion 
Prevenfion  and  Control,  Informafion  Governance  and 
Manual  Handling  and  provides  a  Proforma  Confirmafion 
Form to the hospital. 

The hospital will then thoroughly review the informafion 
provided  to  them  in  the  Proforma  Confirmafion  Form 
before they accepted the nurse for the shift.  In the case, it 
was documented that the nurse who cared for the pafient 
overnight had “recent and credible experience in surgical 
nursing,  ILS/ALS  and  had  met  the  mandatory  training 
requirements”  and  was  suitable  to  care  for  pafients  at 
Level 1A+ per our policy for Safe Staffing.   

As part of the learning from this event, the team at Leeds 
have shared and discussed the findings in the RCA with this 
nurse’s  agency.  The  core  supplier  competency  checklist 
includes  requires that  agency  staff  are  competent  in  the 
management  of  the  deteriorafing  pafient.  The  new 
checklist  must be  signed  by  the candidate  as  well as the 
agency  to  ensure  both  are  confirming  the  informafion  is 
correct.  

This concern is a mafter of evidence before the coroner.  
Based on the thorough and considered invesfigafions 
undertaken by Spire (see file enfitled Incident 
Management), the organisafion formed the view that Mrs 
Hatch’s death was regreftably avoidable. 

14. Evidence taken from a consultant 

surgeon at the Inquest indicated that 
the failings at Spire Hospital contributed 
(more than minimally) to the death of 
Mrs Hatch on 18 October. This view 
dovetails with the medical opinion 
obtained by Spire Healthcare Limited 

INCIDENT MANAGEMENT 
  Dafix Report DW-336489 (Transfer Out) 

 
 

01.09.22  
PSIR DW-336489 01.09.22 
CQC Nofificafion DW-336489 (DPL-1355306) 
12.09.22 

  Dafix Report DW-343997 (Pafient Death) 

19.10.22  

 
 
 
 
 
 
 
 Coroner’s Concern  

Spire’s Response  

Evidence 

themselves to the effect that this death 
was “avoidable”. 

PSIR DW-343997 19.10.22 

 
  Medical Examiner Report (Commenced 26.10.22 

- Returned 04.01.23)  
 
Central Scrufiny Panel 17.02.23 
  RCA Report DW-343997 08.03.23 
  Mortality Review Annual Report 2022 28.03.23  
 
Clinical Governance Leads Nafional Meefing 
28.04.23  
 
Structured Judgement Review 06.05.23 
  Group Mortality Review Commiftee 16.05.23 

ADDITIONAL ACTIONS EVIDENCE  
  Deteriorafing Pafient Sfickers  
 
  Agreement in Principle with Leeds Teaching 

ECU Equipment Stock Check 

Hospitals  
  NEWS 2 Posters  
  Addifional CPAP Masks 
  Addifional Chest Drains  
  Venous Blood Gas Process for Deteriorafing 

Pafients 

ADDITIONAL INFORMATION  
  MAC Q1 2023 Newslefter (legible 

documentafion) 

I hope this letter and evidence attached provides both you and Mrs Hatch’s family with assurance that Spire has taken seriously the matters of concern 
raised in your report and has taken substantial effective steps to address those concerns.  

Yours faithfully