Prevention of Future Deaths reports · 2023

Raniya Khan

Regulation 28 report to prevent future deaths, reference 2023-0059, written 15 Feb 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report15 Feb 2023
Reference2023-0059
DeceasedRaniya Khan
CoronerHeidi Connor
Coroner areaBerkshire
CategoryChild Death (from 2015) · Hospital Death (Clinical Procedures and medical management) related deaths
Organisation namedRoyal Berkshire NHS Foundation Trust
Sourcejudiciary.uk record · original PDF
Responses published2

The report

Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

THIS REPORT IS BEING SENT TO: 

 Acting Chief Executive, Royal Berkshire NHS Foundation Trust   

1 

CORONER 

I am Mrs Heidi J. Connor, senior coroner for the coroner area of Berkshire. 

2 

CORONER’S LEGAL POWERS 

I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 
and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 

3 

INVESTIGATION and INQUEST 

I conducted an inquest into death of Raniya Rizwan Khan at Reading Town Hall, which 
concluded on 9th February 2023. 

I recorded a conclusion of natural causes. Her cause of death was : 

1a Multi-organ failure 

1b Severe arterial pulmonary hypertension of unknown cause 

4 

CIRCUMSTANCES OF THE DEATH 

Raniya was born at 07:52 hours on 9th May 2020. Although I heard evidence about her 
attendance  at the  day assessment unit (‘DAU’) the day before the birth, and about her 
neonatal management, the focus of the inquest was on her labour management from the 
time of her admission to the labour ward at 03:45 on 9th May. Her care by a band 6 agency 
midwife from that time until shift change at around 7am was the focus of the investigation. 

I found in evidence that this midwife: 

1. Failed to recognise a pathological trace. Both the trust’s internal investigation and
the report of an independent expert concluded that it should have been classified
as pathological from 06:40 hours. This was largely because of reduced variability.

2. Conducted  so  called  ‘fresh  eyes’  reviews  herself  for  this  patient,  rather  than
asking a colleague to do so. The reasons she gave for this significant, repeated
and undocumented deviation from policy were inconsistent with the rest of the
evidence, and I found them unlikely to be true.

3. Recorded  the  maternal  rather  than  fetal  heart  rate  for  part  of  the  trace.  My
understanding is that this can happen (briefly) even in experienced hands, but
this was not recognised at the time by the midwife.

4. Did nothing to escalate or investigate the mother’s high pulse rate.

5. Did  not  take  regular  temperature  readings,  despite  spontaneous  rupture  of
membranes happening some hours before, when Mrs Rizwan was admitted to
the DAU and was given paracetamol for a raised temperature.

 Raniya  was  transferred  to  Great  Ormond  Street  Hospital  on  15th  May  2020,  when  her 
condition  deteriorated.  Despite  extensive  consideration  and  re-consideration  of  all 
relevant  treatment  options,  Raniya  died  at  Great  Ormond  Street  Hospital  on  28th  May 
2020. 

I  concluded  that  earlier  delivery  was  unlikely  to  have  changed  the  outcome.  Despite 
extensive investigation (including genetic investigations) at a very senior level, it has not 
been possible to identify the cause of Raniya’s pulmonary hypertension.  

5 

CORONER’S CONCERNS 

I sent a regulation 28 report to this trust on 20th June 2022, in relation to the death of a 
6-day old baby born at Royal Berkshire Hospital on 26th June 2020. The circumstances 
of that case are different from these, but midwifery training and placenta retention are 
issues common to both cases. 

Placenta retention 

In their response to my previous Regulation 28 report, the trust said : 

Previously, placentas in uncomplicated cases were being disposed of on a daily basis 
but  I  can  confirm  that  the  trust  have  implemented  processes  to  ensure  that  all 
placentas  are  stored  for  48  hours  from  the  time  of  birth.  We  are  advised  by  the 
pathology team that retaining placentas beyond this time would not provide reliable 
histology findings. 

In practical terms, placenta fridges have now been placed in the delivery suite and 
birth  centre,  and  homebirth  placentas  will  be  placed  in  the  birth  centre  fridge  (the 
homebirth operating procedures have been updated to reflect this). Tutela monitors 
are  operating  in  the  fridges,  which  provide  connected  automated  monitoring  and 
alerts the clinical areas if there are any concerns with the temperature of the fridge. 

The Standard Operating Procedure (SOP) for placenta retention will be ratified at the 
Maternity  Clinical  Governance  Meeting  in  October  2022  and  will  go  live  on  10th 
October 2022; it provides guidance on which placentas need to be sent to histology 
for  pathological  examination,  as  well  as  storing  and  retaining  all  placentas  for  48 
hours  before  disposal  in  uncomplicated  cases.  In  order  to  disseminate  this 
information, all of the trust’s band 7 midwives and unit coordinators will be trained on 
the  new  SOP  to  ensure  compliance  throughout  maternity,  and  in  particular  the 
midwives  and  community  support  workers.  We  are  also  working  with  waste 
management to ensure that their team are fully aware of the new processes, as they 
now need to request that a member of the midwifery team attends with them to ensure 
the correct procedures are followed. 

As  an  additional  assurance,  the  safety  huddle  templates  on  our  electronic  patient 
system  will  be  updated  to  prompt  the  team  to  ask  whether  any  babies  have 
deteriorated or been admitted from other areas in the last 24 hours to the pediatric 
wards, who are less than 48 hours of age and require ventilation, cooling or neonatal 
death. This measure will be introduced to ensure that placentas are not erroneously 
disposed of due to lack of communication between the maternity unit and pediatric 
ward. 

 
 
 It was surprising in the extreme to be made aware in open court on the final day of this 
inquest that these undertakings have not in fact been completed – the system referred to 
above  is  not  in  place,  there  is  no  SOP,  nor  has  there  been  any  staff  training.  It  was 
particularly disappointing to hear this in front of a family who had themselves lost a baby 
and who were being reassured of how committed the trust is to improvement. 

Midwifery training and management 

I was also advised that there has been no approach made to NHS Professionals about 
concerns with the midwife in question. Similarly, no approach to the NMC has been made. 

It is fair to recognise that this trust is focused on improving obstetric and midwifery care, 
and they have increased their training and staffing –  to include  appointing a director of 
midwifery. Changes have been made regarding induction of agency staff. It seems likely 
that individual people in these new posts have a clear desire to improve the service and 
are themselves somewhat frustrated that these changes have not yet been made.  

I would ask therefore that the trust respond within the requisite 56 days (at the latest) in 
relation to the following issues: 

1.  The current position with regard to : 

a.  Storage of all placentas for 48 hours, and SoP around this 
b.  Review of policies and staff awareness regarding mandatory sending of 

placentas for pathological examination. 

2.  Training  and  awareness  regarding  these  new  policies  –  to  include  practical 
arrangements  around  ensuring  a  placenta  is  retrieved  and  sent  to  histology 
subsequently if needed. 

3.  The trust should refer concerns about this individual agency midwife as a matter 
of urgency both NHS  Professionals, and to the Nursing and Midwifery Council. 
This is in addition to raising of the possibility of an individual ‘passport’ to prevent 
a midwife moving between agencies to work elsewhere after significant concerns 
have been raised.  

6 

ACTION SHOULD BE TAKEN 

 In my opinion, action should be taken to prevent future deaths and I believe you (and/or 
your organization) have the power to take such action. 

7 

YOUR RESPONSE 

You are under a duty to respond to this report within 56 days of the date of this report, 
namely by 14th April 2023. I, the coroner, may extend the period, however I have already 
indicated that an extension is unlikely to be granted in this case, given that these are not 
new issues.  

Your response must contain details of action taken or proposed to be taken, setting out 
the timetable for action. Otherwise, you must explain why no action is proposed 

8 

COPIES and PUBLICATION 

I have sent a copy of my report to the Chief Coroner and Raniya’s family.  

I have also sent a copy of this to : 

, Chief Executive, NHS Professionals 

 
 , Chief Executive, Nursing and Midwifery Council 

Although NHS P and NMC are not required to submit a formal response, I am mindful of 
their roles in training, assessment (for NHS P) and registration of midwives (for NMC)  It 
is likely that, should a similar case arise, I will include them as Interested Persons. 

I  am  also  under  a  duty  to  send  a  copy  of  your  response  to  the  Chief  Coroner  and  all 
Interested Persons who in my opinion should receive it. I may also send a copy of your 
response to any person who I believe may find it useful or of interest. The Chief Coroner 
may publish either or both in a complete or redacted or summary form. He may send a 
copy of this report to any person who he believes may find it useful or of interest. You may 
make representations to me, the coroner, at the time of your response about the release 
or the publication of your response by the Chief Coroner.  

9 

15th February 2023 

Mrs Heidi J. Connor 

Senior Coroner for Berkshire

Responses

2 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.

Response from Essex Partnership University NHS Foundation Trust (PDF)
t.!1:k1 

Essex  Partnership University 
NHS Foundation Trust 

Patient Safety Incident Management Team 
The Lodge 
Lodge Approach 
Wickford 
Essex 
SS11  ?XX 

27  May 2022 

Private and Confidential 
Mr Sean  Horstead 
HM Area Coroner 
Coroner's Office 
Seax House 
Victoria  Road  South 
Chelmsford 
CM11QH 

Dear Mr Horstead, 

I  am  writing  to  set  out  the  Trust's  formal  response  to  the  report  made  under  paragraph  7, 
Schedule  5,  of the  Coroners  and  Justice  Act  2009  and  regulations  28  and  29  of the  Coroners 
(Investigations)  Regulations  2013,  dated  25th  February  2022,  which  was  issued  following  the 
inquest into the death of Stephanie Moyce. 

I would  like  to  begin  by  extending  my deepest  condolences  to  Stephanie's family  and  friends. 
This  has  been  an  extremely  difficult  time  for  them  and  I  hope  that  my  response  provides  her 
family,  and  you,  with  assurance that the Trust takes their loss seriously and  has taken  action to 
address the issue of concern raised  in your report. 

You  raised  four  matters  of concern  for  EPUT,  and  I have  provided  a response  for  each  of the 
points: 

1.  Evidence  confirmed a conspicuous lack of clarity as to  who,  amongst EPUT clinicians/staff, 
is  responsible  for ensuring that a clear and comprehensive discharge plan is  formulated for 
those  coming  to  the  end  of a  course  of psychotherapy  where  a  Care  Coordinator  is  no 
longer in  place/has not been replaced. 

for 

the  need 

improvements  related 

The  Clinical  Review  under  the  Patient  Safety  Incident  Response  Framework  (PSIRF)  also 
to  patients  who  are  discharged  from 
highlighted 
psychotherapy to ensure their care pathway is clear.  The  Clinical  Review recommended  for the 
psychotherapy  discharge  letter  to  be  updated  to  include  prompts  for  the  psychotherapist  to 
consider  discharge  planning.  Following  completion  of the  Clinical  Review  and  of  Stephanie's 
inquest,  psychotherapy  departments  have  updated  their  discharge  letters.  The  letter  now 
includes  a free-text  box for the  psychotherapist to  consider whether a patient  is  on  the  Section 
117  register,  and  what  the  patient's  discharge  plan  is  after psychotherapy  has  concluded.  This 
includes  those  who  have  an  allocated  care  coordinator,  and  for  those  who  do  not.  The 
discharge letter is sent to the patient's GP and there is a free-text box for the  psychotherapist to 
include specific follow-up  actions for the  GP,  where  required.  The discharge letter is  to be  used 
across the Trust. 
2.  Evidence  confirmed a conspicuous  lack of clarity as  to  who,  amongst EPUT clinicians/staff 
including 
has 
responsibility for ensuring adequate and appropriate safety-netting is  in  place in  the event of 
relapse,  where a Care Coordinator is no longer in place/has not been replaced. 

for  oversight  of  patient  care 

following  discharge, 

the  responsibility 

 
 
 
 Patients  who  are  subject  to  Section  117  reviews  or  who  have  a  care  package,  all  require  a 
review of their needs yearly.  If such  patients had  a therapeutic intervention  and  a decision  had 
been  made  that their risk  is  low and  they do not require  an  allocated  clinician,  the  patients  will 
be  'banked'  under the  team's  Service  Manager. The  details  of the  patient  are  presented  in  a 
spreadsheet  and  are  monitored  by  the  community  team's  administrators  and  the  Section  117 
review team. The teams receive notification of reviews on  a three monthly basis indicating when 
their yearly review is  due.  In  addition, two identified staff members make telephone contact with 
all  of the patients on  the 'banked'  list. They update the  patient's risk  assessment and  determine 
whether the patient may require increased  intervention. This is across Colchester and Tendring, 
where Stephanie was in  receipt of services. 

3.  Evidence  confirmed that patients under psychotherapy are not presently routinely discussed 
in  the  locality multi-disciplinary team  meetings  prior to  their  discharge  leading  to  a  missed 
opportunity:  (a)  to  share  information  about the  specific progress,  vulnerabilities and risks  of 
relapse  of the  patient (and  measures  to  mitigate  or deal  with  the  same);  as  well  as  (b)  to 
organise and follow up  the overall discharge planning. 

Where  patients  are  on  Section  117  aftercare  plans  and  under  psychotherapy,  there  will  be 
written communication with the locality MDT team prior to their discharge to share their progress 
and  highlight concerns  around  risk  and  further  needs,  including  the  need  for follow-up  and  the 
arrangements of this. 

4.  The  evidence  in  this  case  indicated  that,  contrary  to  EPUT's  own  established  Protocol,  a 
patient's  carer  (in  this  case  her  long-term  partner  where  no  confidentiality  issues  were 
identified)  are not in practice always "seen  as equal partners in  the  development and review 
of Section  117 after-care plans" and involved directly in  such reviews. 

The Trust acknowledge and  agree with  the  concern  in  which  you  raise.  In  order to  enhance the 
system  which  is  already in  place,  and  ensure the  policy  is  incorporated  into  daily  practices the 
Care  Programme  Approach  review  (CPA)  documentation  across  Mobius  and  Paris  will  be 
updated.  The  CPA  review  document  will  include  a  'yes/no'  answer  to  whether  a  patient's 
family/partner/carer  have  been  involved  in  the  review  process  and  meetings.  If  the  clinician 
selects  'no',  this  will  generate a free-text  box to  provide  reasons  as  to why they have  not been 
involved.  Prompts  will  be  included  within  the  template  around  the  limitations  to  confidentiality 
discussed with the patient. 

I hope that I have provided you  with  robust assurance that the Trust has taken steps to address 
the issues of concern in  your report,  that we are continuing to take action to strengthen the care 
provided to our patients, and that patient safety is the Trust's top priority. 

Yours sincerely, 

Chief Executive 

2
Response from Royal Berkshire NHS Foundation Trust (PDF)
Private & Confidential 

Mrs Heidi Connor 
Senior Coroner for Berkshire 
Berkshire Coroners' Office 
Reading Town  Hall 
Blagrave Street 
Reading,  RG1  1 QH 

r.•1:bj 

Royal  Berkshire 
NHS  Foundation Trust 

Executive's Office 
Royal  Berkshire Hospital 
Level 4,  Main Entrance 
London Road 
Reading 
Berkshire 
RG1  SAN 

Tel:  0118 322 7230 
www. royalberksh ire . nhs. uk 

04 April  2023 

Response to Regulation  28  Report to Prevent Future Deaths 

Dear Mrs Connor 

I am writing in response to the Regulation 28 Report issued following the Inquest into the death of Raniya 
Rizwan  Khan .  We hope that this response  provides  reassurance that the Trust has acknowledged the 
concerns raised and responded appropdately and timeously to them . 

1. 

a. 

The current position with  regard to : 

Storage of all  placentas for 48  hours, and SoP around this 

Following  the  regulation  28  report  sent to  the  tr.ust  on  20th  June  2022  actions  were  taken  to  enable  a 
robust process for sending placentas for histological examination. This included a process to ensure the 
storage  of  all  placentas  for  48  hours  from  the  time  of  birth.  The  Standard  Operating  Procedure 
(MATSOP064) detailing these changes was ratified  at the maternity clinical governance meeting  on 7th 
October 2022. 

· 

The  placenta  fridges  were  procured  in  August  2022  however they  were  both  found  to  be  faulty  and 
replacements  had to  be  requested.  These  arrived  on  31 st  October. These were  placed  in  the Delivery 
Suite and Birth· Centre and fitted with appropriate alarms to allow automated monitoring and alerts to be 
received  in  the  clinical  areas  should  there  be  any  concerns  with  the  temperature  of.  the  fridge. 
Unfortunately these alarms were subject to interference from another automated system used within the 
Trust. This was identified at the end of December 2022. We would like to apologise for not updating the 
Coroner of this  unexpected issue which prevented the implementation of the new process. 

The issue was  resolved  by  1st  February 2023 and the new process was fully  implemented  on  Monday 
13th  February. 

In  practical terms  all  placentas  are  now stored for 48 hours. The midwife  coordinating  the  intrapartum 
areas  is  responsible for releasing  these to  the waste disposal team  having  identified  all  placentas that 
need  to  be  sent for examination  during this  time. The Daily  Safety  Huddle  is  held  in  the  middle  of the 
·day by the midwife coordinating the delivery suite ..  The huddle identifies and discusses any babies that 

 r~1:bj 

Royal  Berkshire 
NHS  Foundation Trust 

' 

have died,  or have been admitted to the neonatal unit requiring  ventilation  or cooling,  and are  under 48 
hours  of age.  The  placentas  of these  babies  are  then  retrieved  and  sent for histology by  a member of 
midwifery staff.  All  other placentas beyond 48  hours from the  birth,  are  highlighted with  a green sticker 
and  moved to the  bottom  of the fridge.  Only placentas stored on the  bottom two  shelves displaying the 
green  stickers are released to the waste management team . 

b. 

Review  of  policies  and  staff  awareness  regarding  mandatory  sending  of  placentas  for 
pathological exanJination. 

The Placenta  Examination Guideline (GL886)  has  been  amended to signpost to the  new SOP and  this 
was  ratified on  7th  October 2022. 

" 

1st

From 
February  2023  various  communication  strategies  have  been  used  to  highlight  the  new 
processes with all  midwifery and support staff. This focusses on  highlighting the circumstances in which 
placentas  must  be  sent  for  examination,  the  need ·for  all  placentas  to  be  stored  for  48  hours  and 
processes  for  disposal.  Posters  are  displayed  on  the  comhluf"!ication  boards  and  fridges  and  verbal 
communication  has  been  undertaken  at  each  handover. A series  of training  videos  were  made  which 
show how to store the placentas following a home or hospital birth,  how to send a placenta for histology 
and  how to  retrieve  a placenta within  48  hours for sending  for histology  or safe  disposal.  The training 
videos  also  signpost the  member of staff to  the  new SOP. Initially these  videos  were  sent to  staff via 
social  media  however from · 13th  February 2023 they have  been  included on  the Trust Learning  Matters 
platform  and  all  midwives  have  been  made aware through  multiple  communication  channels that they 
are  required  to  undertake this training ..  This will  be  evidenced through  reports  pulled from  the  platform 
by the  practice development team  each week and forwarded to the Director of Midwifery. To  date 98% 
of midwives have received this training  and individual reminders have been sent to those who  still  need 
to  do so. 

2. 

Training and awareness regarding these new policies - to include practical arrangements 
around ensuring a placenta is  retrieved and sent to histology subsequently if needed. 

These points are addressed above in  response to  1 (a)  and  1 (b). 

3. 

The  Trust  should  refer  concerns  about  this  individual  agency  midwife  as  a  matter  of 
urgency  both  NHS  Professionals,  and  to  the  Nursing  and  Midwifery  Council.  This  is  in 
addition  to  raising  of  the  possibility  of  an  individual  'passport'  to  prevent  a  midwife 
moving between agencies to work elsewhere after significant c~ncerns have been  raised. 

The Trust raised  the  concerns  about the  individual  agency  midwife  on  Friday  10th  February 2023  and 
have received confirmation that the agency are meeting with the .midwife to  investigate these concerns. 
The Trust have taken  advice from  the NMC employer link service and  a referral was submitted  on  22nd 
February 2023. 

The  Trust  accepts  that  it  should  have  made  every  effort  to  feedback  the  findings  of  the  internal 
investigation to the agency irrespective of whether the midwife was continuing to work for the Trust. The 
Trust  have  processes  in  place  for  providing  feedback  to  agencies  and  we  are  now  doing  this  in  all 
situations. We are  also strengthening the _policy around  reporting  concerns  in  situations where staff no 
longer work at the Trust, and  ensuring that the  Policy is  explicit in  its requirement to  do so.  The Trust'.s 
learning .culture  and  transparency was  recognised  by an  Ockenden Assurance  and  Insight visit led  by 

 r.•1:bj 

Royal  Berkshire 
NHS  Foundation Trust 

the  Regional Chief Midwife in  September 2022. This was fed back verbally to members of the maternity 
senior leadership team  and Trust exec at the time of the visit. 

The  issue of how, and where,  to feedback on temporary staff when they have left a specific Trust after 
a  period  of employment was  raised  at  a regional  Buckinghamshire,  Oxfordshire  and  Berkshire  Local 
Maternity  and  Neonatal  System  (BOB  LMNS)  Serious  Incident  Review  meeting  soon  after  this 
investigation was concluded .  It was deliberated if a joint set of standards and/or processes for Agency 
staff should  be  drafted  on  a .regional  or national  level  in  collaboration  with  the  Nursing  and  Midwifery 
Council (NMC).  This was  an  action that the regional  LMNS team were cdnsidering . 

Upon further deliberation and reflection, the Trust considers that this is a matter for the regulator because 
a national solution is  required  and this is beyond the means of a single Trust. The Director of Midwifery 
,  who  has  discussed  this  with  the  Chief 
has  raised  this  with  the  Regional  Chief Midwife, 
- Midwife for England and the NMC. As a result recomf"!lendations will be sent to organisations reminding 
them that serious concerns over practice of an agency member of staff should be referred to the agency 
and ·NMC.  In  addition  there  are  plans  in  place  to  convene  a group  including  providers,  LMNS,  region 
and  Health  Edu.cation  England  to  ensure  there  is  a  standardised  approach  to  the  orientation  and 
immediate support provided to  agency staff. 

The Trust are committed to continually improving our midwifery and obstetric care, and believe the points 
outlined  above  demonstrate  our  dedication  to  doing  so.  In  summary,  the  Trust  have  implemented ·a 
robust  process  for  sending  placentas  for  histological  examination,  including  the  Standard  Operating 
Procedure  (MATSOP064)  ensuring  storage of all  placentas for 48 hours from  the time  of birth,  ratified 
at the  maternity  clinical  governance  meeting  on  7th  October 2022. As  of 13th  February 2023,  the  new 
process is now fully operational. A variety of strategies have been used to communicate these processes 
to  relevant  staff.  The  Trust  are  also  strengthening  the  Policy  for  feedback  of  concerns  raised  about 
temporary agency staff. The wider issue was raised with the BOB LMNS and  Regional Chief Midwife to 
take forward. 

We hope this response allays the concerns you  have raised,  and  provides you  and the family of Raniya 
with  assurances  that  the  Trust  have  taken  your  concerns  for  future  patients'  safety  seriously  by 
implementing actions surrounding the storage of placentas, training and awareness of new policies and 
procedures,  and the feedback  of concerns  raised  about  agency staff. We  hope this  demonstrates the 
Trust's commitment to the continuous improvement of our services. If you require any further information 
or evidence,  plea.se do not hesitate to contact us. 

Yours Sincerely, 

Acting  Chief Executive Officer

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