Arthur Brockett-Deakins

Date of report	25 Feb 2014
Reference	2014-0077
Deceased	Arthur Brockett-Deakins
Coroner	Andrew Harris
Coroner area	London Inner (South)
Category	Hospital Death (Clinical Procedures and medical management) related deaths
Source	judiciary.uk record · original PDF
Responses published	4

The report

Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.

Senior Coroner, London Inner South, UK
Re: Arthur Brockett-Deakins, case ref 2648-11
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
1. Sir Andrew Dillon, Chief Executive
National Institute for Clinical Excellence
10 Spring Gardens, London SW1A 2BU
2. Ms Jackie Smith, Chief Executive and Registrar
General Midwifery Council (practice referrals)
Standards and Guidance Department
23 Portland Place, London W1B IP2
3. Dr lan Hudon, Chief Executive
Medicines and Health Regulatory Authority
151 Buckingham Palace Road
Victoria, London, SW1W 9SZ
4. Rt. Hon Jeremy Hunt, The Secretary of State for Health
Richmond House, 79 Whitehall, London, SW1A 2NS
CORONER
| am Andrew Harris, senior coroner for the jurisdiction of London Inner South
CORONER’S LEGAL POWERS

| 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.

INVESTIGATION and INQUEST

On 21.10.11, | opened an inquest into the death of baby Arthur Brockett-Deakins, aged
3 years, who died on 18" October 2011. Proceedings were delayed by legal challenge
and delays in securing disclosure. The inquest was concluded on 20th January 2014.

Arthur died from:

1a Respiratory failure

1b Chest infection

1c Perinatal hypoxic ischaemic encephalopathy

CIRCUMSTANCES OF THE DEATH

PF booked for her first pregnancy with the private caseload team shared
by two Band 7 midwives at St Thomas Hospital, the service being designed to promote

continuity of care. Baby Arthur Brockett Deakins was born in a poor condition at 14.45
on 16th December 2007 and initially required resuscitation and ventilation. He survived,
but was brain damaged, severely disabled with seizures, spasms, visual and hearing
impairments, feeding and respiratory difficulties and requiring constant medical and
parental support until. His condition was uncurable and he received all the treatment that
was in his best interests. He died on 18th October 2011 at home from respiratory
problems, these and his disabilities being a direct result of acute profound perinatal
hypoxic ischaemic encephalopathy, which was not due to any inherent condition of the
baby or mother or any antenatal factors.

e..: admitted in labour, after an unremarkable pregnancy. She was
transferred to the hospital birthing centre at having progressed to 9cm dilation, for
augmentation with Syntocinon and her labour was managed both midwives together.
There was no case management discussion (or examination of cardiotocograph (CTG)
and records) about starting Syntocinon between the case midwives and midwife in
charge of the unit, as required in the Trust guidelines, this being a failure of care which
contributed to HIE and amounted to neglect. The Syntocinon was started at the same
time as the CTG was attached at 11.40 and the dose was progressively increased three
times up to 2.4 mls per hour at 12.50 and then again at 1.30. These increases caused
hypertonicity and hyperstimulation, which impaired the blood supply to the baby, causing
HIE. These increases in Syntocinon and the failure to recognize the hyperstimulation,
which was evident considering the records of frequency of contractions reached 6 in 10,
amounted to neglect. | accepted the expert evidence that there was an opportunity to
render care, which if taken even at 12.50 would on balance of probabilities have
prevented the tragedy from occurring so that Arthur would not have died of HIE when he
did.

The CTG tracing was not normal from the outset, but there were some features which
understandably reassured around 12.10. After 1pm the trace was at the very least
atypical and the midwives had not realized that the machine was no longer displaying
the foetal heart rate (FHR) but had picked up and multiplied the maternal heart rate
(MHR). This phenomenon was rare and unexpected and the mistake could easily be
made. Nevertheless the tracing at this time was sufficiently abnormal to require referral
to an obstetrician. The failure to refer to an obstetrician when the CTG required it more
than minimally or trivially contributed to the development of acute profound HIE and
amounted to neglect. Midwifery attendance of labour for 15 consecutive hours, with one
40 minute break, has contributed to some or all of these failures.

CORONER’S CONCERNS

During the course of the inquest the evidence revealed matters giving rise to concern.
MATTERS OF CONCERN are as follows.

1. When to escalate concerns about a CTG: With regard to not escalating an
abnormal CTG that ran for about half an hour after augmentation of labour, reliance was
placed by midwives on a clause of NICE Clinical Guidelines, Intrapartum Care, 2007,
which advises that a 40 minutes oo ae before concluding if it is
abnormal. Expert evidence from Dr and a
suggested that this guidance was appropriate in the first stage of labour, but not in the
context in this case, namely a slow second stage.

2. Training of one midwife in CTG interpretation: Both midwives underwent voluntary
further training and supervision, including an expert workshop on CTG interpretation.
Both accepted that a number of errors had been made by them and applied the learning
to their current practice. However even in retrospect, one of the midwives could not
accept that the early CTG trace was pathological, as held by both expert obstetrician
and midwife. Although she would refer now, there is doubt about the urgency. She said
in court it would be within half an hour but also that 40 minutes was needed to see if it
was abnormal. The expert midwife said that she needed further training on CTG
interpretation.

3. Display of MHR as FHR on CTGs: vs explained that if the foetus moves
out of the range of the ultrasound field or the baby has sadly dies, the ultrasound
transducer may then pick up the maternal pulse from the aorta, iliac or uterine artery and
it is displayed as the FHR and can show reactivity and variability due to MHR changes
and muscle contractions can be difficult to distinguish from the FHR. It is known that the
rate can be doubled or halved.

The only explanation that both expert midwife and expert obstetrician could reach for
the unusual CTG trace after 1pm, in the context of the state of the baby at birth, was
that the maternal puise rate was masquerading as the FHR but it had been multiplied
by 1.5. The CTG machine was not of the type that is known rarely to multiply by 2 and
the phenomenon of a multiplication by a factor other than 2, being unknown to both
experts in their long distinguished careers. Evidence was not heard from the
manufacturer or the product's regulatory authority. The inquest heard that new CTG
machines incorporate maternal ECG or pulse oximetry, which alerts staff to investigate
when MHR and FHR appear the same. But it also heard that it will take some time
before all old machines are replaced. It needs to be established if multiplication by 1.5
is a possible functional feature of some machines and if so whether either it can be
designed away or whether dissemination or guidance or an action by the regulatory
authority is needed to prevent it leading to a fatality or child disability.

4. Models of private midwifery led services for low risk pregnancy: The private
midwifery caseload for low risk pregnancies was managed by a pair of midwives who
set up the servicer to provide continuity of care. The midwifery service that was
operating wher I vas pregnant was not adequately documented. No job
description was seen by the court and the referral and operational arrangements were
discussed, but no documentation was brought to the court. There was no evidence of
tisk assessment. Although NHS employees were required to be self sufficient in
terms of annual leave and sickness cover, on call arrangements and use of NHS
personnel except in emergencies. They did not at the outset have a link obstetrician.
This led to fear of burn out, a sense of isolation and lack of support and collegiality.

When they transferred babies to the Hospital Birthing Centre, they were expected to
refer to a duty obstetric consultant, access to whom was described as variable. The
midwife in charge of the NHS unit agreed that she provided a different threshold
of care to private and NHS mothers and was reluctant to intervene or review the care
plan for augmentation of labour, which she would have done in an NHS patient. The
midwives expected her to be involved but did not ask her. in the event no peer senior
midwife or obstetrician saw which was necessary. The reasons for non
referral were complex and were not because the midwives thought they could not refer.
Misjudgements were made which in part were caused by a 15 hour shift with only a
40 minute break. This would not occur in contexts where there was normal NHS
management of staff, but this arrangement continued apparently unknown to the NHS
Trust management. The service is no longer operational, the Trust reporting that it was
discontinued for economic reasons.

Expert advice considered that the model of service created a ri aths,
although it was not found to have directly done so in this case. ri cportec that
there were similar units operating elsewhere in the country and that the lessons
from the difficulties in operating this one should be disseminated to other such
units. The expert midwife, Ms — was particularly concerned about adequate
support and cover. Dr a was particularly concerned about the isolation and
professional culture and lack of interdisciplinary peer discussion, in the context of
increasingly risks in obstetric and midwifery practice.

The Trust head midwife reported that she expected that the matter would now be dealt
with robustly by the statutory supervision system. No evidence was heard about
whether this was now effective in this regard, nor how influence and information
could be brought to bear on those setting up or managing such midwife led
services. It was further reported that not all midwives are members of the College
that runs supervision and that midwives are not necessarily practising within the
NHS. Thus is it was not clear how the risks are best identified and managed across a
complex mixed health economy, which is why the Secretary of State is an addressee of
my report.

ACTION SHOULD BE TAKEN

The following organizations are asked to consider the concerns arising from this case
and whether any action is needed to reduce the risk of perinatal deaths.

(1) National Institute for Clinical Excellence with regard to concern (1) — and
when and if appropriate, (3) above

(2) Nursing and Midwifery Council (practice referrals) with regard to concern (2)
above (name and details of midwife attached separately)

(3) Medicines and Health Regulatory Authority with regard to concern (3) above

(4) Secretary of State for Health and Nursing and Midwifery Council, with
regard to concern (4) above

YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this report,
namely by Monday, April 21 2014. |, the coroner, may extend the period.

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.

COPIES and PUBLICATION
| have sent a copy of my report to the Chief Coroner and to the following Interested

Persons:

Field Fisher Waterhouse for the family

Mr Ron Kerr CBE, CEO of St Thomas Hospital

AC Beachcroft LLP for the NHS Trust

, Thompson Solicitors for Midwife 1.
RCN Legal Services for Midwife 2.

| have also sent it to Dr Nicholas Morris and Mrs Charlene Francois expert witnesses in
this case and The Royal College of Obstetricians

| am also under a duty to send the Chief Coroner a copy of your response. 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.

If you would like further information about the case, please contact my officer

[DATE] ; [SIGNED BY CORONER

Responses

4 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 Department of Health (PDF)

aye
Department
of Health

POC1_ 846082

Mr A Harris

From the Rt Hon Jeremy Hunt MP
Secretary of State for Health

Richmond House
79 Whitehall
London

SIVIA 2NS

Tel: 020 7210 3000
Mb-sofs@dh.gsi.gov.uk

Senior Coroner

Southwark Coroners Court

1 Tennis Street

Southwark

London - QO MAY 2nts
SEI 1YD

Der he thers

Thank you for your letter following the inquest into the death of baby William
Arthur Brockett-Deakins. In your report you conclude that William died from
respiratory failure, chest infection and perinatal hypoxic ischaemic encephalopathy
(HIE).

William died in October 2011 from respiratory problems. These problems and his
disabilities were a direct result of acute profound perinatal HIE, which was not due
to any inherent condition of the baby or mother or any antenatal factors.

William had been born in a poor condition on 16 December 2007. He initially
required resuscitation and ventilation. He survived but was brain damaged, severely
disabled with seizures, spasms, visual and hearing impairments, feeding and
respiratory difficulties requiring constant medical and parental support. His
condition was incurable and he received all the treatment that was in his best
interests.

You describe the management of the mother’s labour by the midwives involved and
detail failures of care and neglect, including a failure to refer issues relating to
cardiotocograph (CTG) tracings to an obstetrician and a consecutive midwife
attendance of 15 hours. You also accepted the expert evidence that there was an
opportunity to render care, which if taken by a certain time, on the balance of
probabilities would have prevented the tragedy from occurring. William would not
therefore have died of HIE when he did.

I note that you have sent your letter to several organisations and have asked each to
consider specific concerns. I am aware that the National Institute of Health and Care
Excellence (NICE) has already responded on its clinical guideline on Intrapartum
Care (CGS55) and the issues relating to CTG interpretation. The Nursing and

Midwifery Council (NMC) has also replied, addressing the training of one of the
midwives in CTG interpretation and explaining the current system of midwife
statutory supervision.

You raise the following matter of concern both for my attention and that of the
Nursing and Midwifery Council:

© Models of private midwifery led services for low risk pregnancy. Expert
advice considered that the model of service created a risk of deaths. It is not
clear how the risks are best identified and managed across a mixed health
economy, which is why the Secretary of State is an addressee of my report.

As the NMC has already suggested, this is more appropriately addressed by my
department. The model of midwifery provision described in this case was and is
unacceptable and, for the reasons cited in the Regulation 28 Report, unsustainable.
When this incident occurred in 2007 the Trust had a system of two midwives
providing care to private patients who requested midwifery-led care. This system
was discontinued in July 2010 and no longer operates. The model is not known to
exist elsewhere in England.

The issue of statutory supervision of midwives is, as the Report points out,
important but needs some clarification. All midwives are registered with the
Nursing and Midwifery Council (NMC) and are required, by law, to have a
statutory supervisor, All practising midwives are required to meet their statutory
supervisor at least once a year (or more frequently, if either party wishes to discuss
issues of concern - caseload and practice for example). This annual discussion
ensures the midwife is up-to-date in his or her sphere of practice and results in the
supervisor of each midwife making a decision about the midwife’s continuing
fitness to practice.

Provided the midwife is fit to continue practising the statutory supervisor enters the
annual review on the NMC database and confirms that the registrant has undergone
supervision and is fit to practice. The consequence of this is that the midwife’s
name has a statement next to it which confirms that the midwife is entitled to
provide midwifery care until a certain date (limited to one year from the date of
statutory supervision — most run until 31% March each year). This is not however a
performance review or appraisal in the managerial sense. Statutory supervisors of
midwives are not usually the managers of the midwives they are supervising.

Your report states that “not all midwives are members of the College that runs
supervision”. While it is true that not all midwives are members of the Royal
College of Midwives (RCM), the RCM does not regulate the profession. The RCM
is a union and there is no requirement for midwives to join.

dee

Department
of Health

This disconnection between statutory supervision and performance management of
midwives was of concern to the Parliamentary and Health Service Ombudsman in
her report on maternity care in Morecambe Bay. She published her report -
Midwifery supervision and regulation: recommendations for change - in December
2013 which has initiated a national review of statutory supervision which is being
led by the NMC.

In order to practise midwifery all midwives must, by law, be registered with the
NMC. This applies regardless of where they practise, including the NHS, the
private sector, in a social enterprise or as an independent self-employed practitioner.
Every midwife registered with the NMC is subject to statutory supervision
regardless of where they practise.

As the regulator of the profession, the NMC has the authority to place conditions on
or suspend the ability to practise or remove a midwife from the register. The
midwives involved in this case were referred to the NMC in 2009 by the family.
The case was reviewed and was not taken to a full hearing by the NMC.

I hope that this response is helpful and I am grateful to you for bringing the
circumstances of William’s death to my attention.

“ns ut weedy

a

JEREMY HUNT

Response from Medicines Healthcare Products Regulatory Agency (PDF)

Medicines and Healthcare
Products Regulatory Agency
68e

Dr Andrew Harris Dr lan Hudson
Coroner for Inner South District Greater London 151 Buckingham Palace Road
Victoria
Southwark Coroner’s Court London SW1W 9SZ
1 Tennis Street United Kingdom
Southwark Teleoh
elephone
London SE1 1YD +44 (0)20 3080 6100
Your ref: 2648-11
My ref: 13445 mhra.gov.uk

14 April 2014
Dear Dr Harris
Regulation 28 Report: William Arthur Brockett-Deakins (deceased)

Thank you for your Regulation 28 report of 26 February which we received on 3 March 2014.
Here is my reply to your Matters of Concern (3):

This incident occurred in 2007 and it was not reported to MHRA by Guy's and St Thomas’ NHS
Trust or any other organisation.

As the make and model of the cardiotocograph (CTG) device was not specified in your report,
we asked your Officer J on 11/3/2014 if this detail was known. informed
us on 28/3/2014 that the CTG model in use was a M1353A. This was a popular model of CTG
machine and was placed on the market by Philips Healthcare and sold in the UK between
1992 and 2006.

We contacted Philips Healthcare to establish if they were made aware of this incident at the
time and if so, whether they had inspected the device to confirm it was working correctly.
Philips Healthcare found no notification of this incident in their records thus they did not inspect
the device.

One of our predecessor Agencies, The Medical Devices Agency (MDA), published and
disseminated a Safety Notice to relevant healthcare professionals in August 2002, warning of
the risks associated with the interpretation of CTG traces. This Safety Notice, MDA
$N2002(23), was extant in 2007 and a copy is appended to this letter.

This Safety Notice was an update to earlier advice as adverse incident reports received by the
MDA in 2002 indicated that CTGs were still being incorrectly relied upon to monitor foetal heart
rate. Five reports were received in 2002 where CTGs had produced an apparently normal
trace during labour but the baby was delivered stillborn. In all these cases the baby had been
dead for a number of hours. Two cases showed values of twice the maternal heart rate (MHR x
2) and three cases showed values of one and half times the maternal heart rate (MHR x 1.5),
although there has been some dispute as to the source of these signals. It is however well
known that CTGs can display twice the maternal heart rate (MHR x 2) and half the foetal heart
rate (FHR +2).

“48 CPRD iff NIBSC

However, MHR multiplied by one and a half is a confusing artefact that can be difficult to
recognise. It appears that when there is no foetal heart beat the CTG may respond to a weak
signal derived from a combination of the maternal aorta, iliac and uterine arteries.

Our advice on CTG use was revised in 2010 to become MDA 2010/054, and is our current
advice.

The reference to the MHR x 1.5 artefact was removed from MDA 2010/054 as there had been
no further reports received since SN2002(23) was published.

Modern CTG units now incorporate maternal ECG or pulse oximetry functions and many have
prompts to double-check if readings of MHR x 2 occur. It is possible that some older units
remain in clinical use but there is insufficient evidence provided by users and manufacturers
for MHRA to advise that they should be removed from use.

In June 2013, MHRA published a special maternity edition of ‘One Liners’, which again
highlighted the issues of interpreting CTG readings.

For information, the National Institute for Health and Care Excellence (NICE) guidance on
intrapartum care was also updated in 2007, (CG55, - section 1.12)

http://publications.nice.org.uk/intrapartum-care-cg55/quidance#16-normal-labour-first-stage

| hope this information gives you the assurance that we have appropriate safety advice
available to those using CTG medical devices.

Yours sincerely,

Dr lan Hudson
Chief Executive

MEDICAL
by DEVICES
AGENCY

2
a

MDA SN2002(23)
August 2002

Cardiotocograph (CTG) monitoring of fetus
during labour — update
MANUFACTURER / SUPPLIER

Various

PROBLEM

A number of stillbirths have occurred in the prese, TG traces interpreted
as being normal. This caused distress for the m d clinical staff involved.

For the attention of:

NHS Trusts (Eggland) — Chief Executives

National Car: ndards Co — Headquarters

Primary C Ss (naan — Chief Executives
ACTIQ

Va that in

Users show ence of a dead fetus the CTG may still

dications of a problem (mother reports no fetal movements,
vi scultation), ultrasound imaging should be used to establish
0p of the fetus.

ingwse
rd maternal pulse rate regularly and check that it is different from the fetal

‘ Compare the actual maternal pulse with the sound from the loudspeaker.

rate (FHR).
WY Compare the recorded maternal pulse rate with the CTG display and chart.

e |f the maternal pulse is synchronised with the sound from the loudspeaker,
the CTG is monitoring maternal heart rate (MHR).

e Be aware that the CTG may be displaying a “doubled” MHR (80 x 2 = 160
bpm), or “half? FHR (150+2 = 75 bpm).

e Fetal scalp electrodes are considered to be more reliable than ultrasonic
transducers, although there is still a need to confirm that FHR is being
correctly displayed.

e Categorise FHR trace as a whole, with reference to individual features and
the clinical picture. (For further information see ‘Clinical Practice Algorithm’
within NICE Clinical Guideline).

e If there are any problems establishing or confirming a fetal heartbeat then
treat CTG displays with caution.

e [fin doubt, consult clinical colleagues.

Page 1 of 4 [MDA SN2002(23)]

/ SAFETY

DISTRIBUTION REQUIRED

Please bring this notice to the attention of all who need to know or be aware of it.
This will include distribution by:

TRUSTS to:

« Liaison Officers (for onward distribution)
* Consultant Obstetricians

¢ Directors of Midwifery

« Midwifery Managers and Supervisors

¢ Medical and Midwifery staff

¢ Community Midwives

* Clinical Risk Managers

* Biomedical Engineering staff

NATIONAL CARE STANDARDS commssion

« Headquarters (for onward distribution)

* Hospitals in the Independent Sector

PRIMARY CARE TRUSTS to: \N)
¢ Liaison Officers (for onward distribution)

* Community Midwives

* General Practitioners e

BACKGROUND, «

eart rate in relation to maternal contractions.
labour, but should not be relied upon to

as to the source of these signals.
s can display double the maternal heart rate (MHR x 2) and

there is some
It is known Cc

half the fe rt rate (FHR +2). However, MHR multiplied by one and a half is a
confusi fagt that is difficult to recognise.
CT w power ultrasound Doppler signal to detect movement within the

mother’s abdomen. The fetal heartbeat is a weak signal in a noisy environment.
al processing techniques are used to extract a periodic/repetitive signal. In
ajority of cases the FHR is correctly displayed and accelerations and

\ erations are faithfully reproduced.

lowever, it would appear that when there is no fetal heart beat the CTG may
respond to a weak signal derived from a combination of the maternal aorta, iliac
and uterine arteries. The resulting trace shows reactivity and variability due to
maternal heart rate changes and muscle contractions. This condition only occurs
in a small number of stillbirths but causes distress for all those involved.

FURTHER GUIDANCE
National Institute for Clinical Excellence — The Use of Electronic Fetal Monitoring,
Clinical Guideline: NICE May 2001. Web: www.nice.org.uk

Royal College of Obstetricians and Gynaecologists — The Use of Electronic Fetal
Monitoring: RCOG May 2001. Web: www.rcog.org.uk

Medical Devices Agency — Cardiotocograph (CTG) monitoring of foetus during
labour, Safety Notice: MDA SN 9813 March 1998.

Medical Devices Agency — Poster Cardiotocographs CTGs April 2002: A4 size
copies can be downloaded from our website at www.medical-devices.gov.uk and
A3 size posters are available by request. Please email
Caroline.Ainsworth@doh.gsi.gov.uk or telephone 020 7972 8127.

Page 2 of 4 [MDA SN2002(23)]

ENQUIRIES
Enquires to the MDA should quote reference number 20020523.005-3 and be
addressed to:

Technical aspects

Mr G R Smith or Mr R A Glover
Medical Devices Agency
Hannibal House

Elephant and Castle

London SE1 6TQ

Tel: 020 7972 8198 or 020 7972 8245 respectiv
Fax: 020 7972 8106

Email: Geoff.Smith@doh.gsi.gov.uk
Richard.Glover@doh.gsi.gov.uk .\)

Clinical aspects:
Dr S Ludgate NS $ \N)

Medical Devices

SAFETY

NOTICE

matively, further information and printed incident report forms are available from:
MDA Adverse Incident Centre
Medical Devices Agency, Hannibal House, Elephant & Castle, London SEl 6TQ
Telephone 020 7972 8080 or Fax 020 7972 8109
or e-mail: mb-mda-aic@doh.gsi.gov.uk
(Ananswerphone service operates outside normal office hours)

From January 2000, MDA Safety Warnings have been available in full text on the MDA
Internet site: http://www.medical-devices.gov.uk/

Page 3 of 4 [MDA SN2002(23)}

APPENDIX

Establish the presence of a fetal hearthe;
auscultation before starting CTG moni;

by using olther a Pinard stethoscop:
held Doppler ultrasound device, yy

e Ifthere are any indications of 4
{mother reports no fetal culty

with auscultation}, ulte
be used toestablishgh

t Clinical Excellence ~
lie Fetal Mumtaring,
AUCE VAzy 2001

Cardiocograph (C7G) mooitering of foetys duting labour,
Safety Nore: ADA SN 9813 Marth 1998.

Published try the Medical Gevices Agerny ~

8 executive agenty of the Gepartment of Health

Fee technical or safety tested information on any inedical
devite, see Ournebste: wawmedical devices qonuk

L MEDICAL
ty DEVICES
‘ AGEN

Safeguarding Public Health

Cardiotocographs (CTGs) monitor the fetal heart rate in
maternal contractions. Some CTGs have the potential for
and maternal heart rates and this may lead to fetal proble

pulse rate regularly and
different from the fetal heart

Compare the recorded maternal pulse
rate with the C1G display and chart.

Compare the actual maternal pulse
with the sound from the loudspeaker.

ifthe maternal pulse is synchronised with
the sound from the loudspeaker, the CTG
is monitoring maternal heart rate (MHR).

Be aware that the CIG may be displaying
4 ‘doubled’ MHR (80 x 2 = 160 bpm),
or half’ FHR (15022 = 75 bpm),

Fetal scalp electrodes are consideted to be
more reliable than ultrasonic transducers,
although there is still a need to confirm
that FHR is being correctly displayed.

Categorse FHR trace 35 a whole with
reference to individual features and the
clinical picture (For further information
see Clinical Practice Algorithm’ within
NICE Clinica! Guideline).

if there are any problems establishing or
confirming a fetal heartbeat then treat
CIG displays with caution.

fin dowbt, consult clinical colleagues

Page 4 of 4 MDA SN2002(23)]

Response from N.i.c.e (PDF)

N j C National Institute for 10 Spring Gardens

Health and Care Excellence London
SW1A 2BU

United Kingdom

+44 (0)845 003 7780

Dr Andrew Harris

Senior Coroner for Inner South District
Southwark Coroners Court

1 Tennis Street

Southwark

London, SE1 1YD

21% March 2014
Your ref: 2648-11
Dear Dr Harris,

Re: William Arthur BROCKETT-DEAKINS (Deceased)
Coroners Regulation 28 Notice

Pe :: asked me to respond to your letter.

Although | cannot comment on individual cases, i was sorry to learn of William's
death, and | hope the following information helps to explain our guidance, and our
process for reviewing and updating recommendations.

As you are aware, the NICE clinical guideline on Intrapartum Care (CG55) states
that 40 minutes should elapse if the cardiotocography feature of concern is ‘lack of
baseline variability’. The guideline also recognises that there are other abnormalities
of the cardiotocography which do not require 40 minutes for concerns to be raised,
such as, a baseline fetal heat rate that is outside the normal range, or decelerations
of the fetal heart rate.

Where there is clear evidence of fetal compromise, for example, prolonged
deceleration of the fetal heart rate, greater than 3 minutes, urgent action should be
taken and preparations should be made to urgently expedite the birth of the baby.

In relation to fetal monitoring, in the presence of oxytocin, the NICE guideline states,
if the fetal heart rate trace is normal, oxytocin may be continued until the woman is
experiencing 4 or 5 contractions every 10 minutes. However, oxytocin should be
reduced if contractions occur more frequently than 5 contractions in 10 minutes.

If the fetal heart rate trace is classified as suspicious, this should be reviewed by an
obstetrician and the oxytocin dose should only continue to increase to achieve 4 or 5
contractions every 10 minutes. If the fetal heart rate trace is classified as

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pathological, oxytocin should be stopped and a full assessment of the fetal condition
undertaken by an obstetrician before oxytocin is recommenced. The definition of
suspicious and pathological is set out in the NICE clinical guideline (CG55).

The NICE clinical guideline on Intrapartum Care (CG55) also states, that the
maternal pulse should be palpated, on initial assessment in labour and during labour,
if there is suspected fetal braycardia or any other fetal heart rate anomaly, to
differentiate between maternal and fetal heart rate.

We review all of our guidance at regular intervals and also consider feedback and
requests for updates where this is appropriate. Our clinical guideline on Intrapartum
Care (CG55) is currently being updated. The progress of the update can be
monitored via our website (http://guidance.nice.org.uk/CG/WaveR/109).

The team working on updating this guideline have re-examined the evidence on fetal
assessment and monitoring during labour. This specifically includes
cardiotocography on admission to the labour ward and during labour and the
definition and interpretation of the features of fetal heart rate trace. Whilst 1 am not
able to anticipate the outcome of the final guideline, | can report that we have found
no evidence to support a significant change in the recommendations but they have
been further strengthened where appropriate.

We will consult on the draft recommendations with stakeholders between 13th May —
24th June 2014 and the final guideline will be published in October 2014.

We have confidence that our guidance, correctly implemented, will provide the best
outcomes for patients but clinicians retain the responsibility for their decisions. NICE
Clinical Guidelines are not mandated and clinical staff can depart from them if there
are appropriate and documented clinical reasons for doing so.

With kind regards,
Programme Director,
Centre for Clinical Practice

Response from Nursing Midwifery Council (PDF)

From the Chief Executive and Registrar Nursing &

Midwifery
Council

Dr Andrew Harris MRCP MSc FFPHM LLB LLM
H M Senior Coroner, London Inner South
Southwark Coroner’s Court

1 Tennis Street

Southwark

SE11YD

16 April 2014

Dear Dr Harris
Arthur Brockett Deakins (deceased)

Thank you again for your letter dated 26 February 2014 concerning the inquest into the
death of Arthur Brockett Deakins. You sought our input on two specific matters.

Training of one midwife in CTG interpretation

You are concerned that one of the midwives, TD cou not accept the
CTG trace was pathological, as was held by the expert evidence. There was also
concern about the acknowledged urgency with which she would refer an issue in future.
The expert midwife who gave evidence to the inquest also said that

needed further training in CTG interpretation.

Where concerns are raised about a registrant's fitness to practise, the NMC will take
appropriate action in order to fulfil our statutory duty to protect the ic. In this case,

I can confirm that we will be treating this information -bout fall anew
referral which will be investigated. We are able to do this because this is new
information which has not previously been considered by us. Please let me know if you
would wish to be joined as an ‘interested party’ to this referral so that my fitness to
practise colleagues can keep you updated regarding the progress of the case.

The NMC will not, however, be able to consider the actions of either midwife in relation
to the death of Arthur. This is because this aspect of the referral was considered fully,
and closed, by our investigating committee (IC) in 2009. Since the case was closed over
three years ago, it cannot be reconsidered by the IC under rule 7(1) of the NMC’s
Fitness to Practise Rules 2004. There is also no evidence of an error which would allow
us to remit the case back to the committee in accordance with the case law in this area
(R (on the application of B) v NMC [2012] EWHC 1264 (Admin)).

23 Portland Place, London WiB 1PZ
T +44 20 76377181 F +44 207436 2924

www.nmc-uk.org

The nursing and midwifery regulator for England,
Wales, Scotland, Northern Ireland and the Islands

Registered charity in England and Wales (1091434) and in Scotland (sco38362)

Models of private midwifery care

As the regulatory body for nurse and midwives, the NMC is not ina position to offer a
view on the models of midwifery care offered in private and NHS settings and I think
that references to this particular area of your report would be more appropriately
addressed by colleagues at the Department of Health.

As regards comments about the system of statutory supervision, the reported
comments of the trust head of midwifery at the inquest do reflect that the approach to
handling a similar issue has evolved since Arthur's birth in 2007.

Currently, the local supervisory authority (LSA) would be alerted to serious incidents of
this nature via their database system and there is a link to the LSA for every maternity
service in London who would provide guidance to a supervisor of midwives when a
serious incident occurs. A serious incident of this nature would also trigger a
supervisory investigation which would be reported to the local supervisory authority
midwifery officer. | understand from the lead supervisor of midwives for the London area
that there were no separate supervisory investigations undertaken at the time of
Arthur's birth. Furthermore, there were no guidelines in place at that time for the
conduct of supervisory investigations. There is now policy and training in place on
supervisory investigations.

It is correct to state that not all midwives are members of the Royal College of Midwives
(RCM). However, the RCM is a body that represents midwives professionally; it does
not oversee the supervisory mechanism and membership of this body is not a pre-
requisite to practising as a midwife. All midwives wishing to practice must be registered
with the NMC. Supervision is a Statutory responsibility undertaken by local supervising
authorities and, as the regulator, the NMC sets the rules and standards for the functions
of the LSAs.

| hope that this response is helpful. Please do not to hesitate to contact me again if | can
provide any additional information.

Yours sincerely

Jackie Smith
Chief Executive and Registrar

The report

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