Prevention of Future Deaths reports · 2017

Maxim Karpovich

Regulation 28 report to prevent future deaths, reference 2017-0054, written 22 Feb 2017. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report22 Feb 2017
Reference2017-0054
DeceasedMaxim Karpovich
CoronerDavid Hinchliff
Coroner areaWest Yorkshire (East)
CategoryChild Death (from 2015) · Hospital Death (Clinical Procedures and medical management) related deaths
Sourcejudiciary.uk record · original PDF
Responses published2

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.

ANNEX A

REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)

NOTE: This form is to be used after an inquest.

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:

1. Po — President of the Royal College of Obstetricians and
Gynaecologists at 27 Sussex Place, Regents Park, London, NW1 4RG

2. Professor Cathy Warwick — Chief Executive of the Royal College of Midwives at
15 Mansfield Street, London, W1G 9NH

CORONER

| am David Hinchliff, Senior Coroner, for West Yorkshire (Eastern) area.

2 | 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.

3 | INVESTIGATION and INQUEST
| On 9" March 2015 | commenced an Investigation into the death of Maxim Karpovich,

who was born on 16" March 2015. The Investigation concluded at the end of the Inquest
on 8” February 2017. The conclusion of the Inquest was a Narrative conclusion, a copy
of which is attached. The medical cause of death being:-

1(a) Perinatal Asphyxia
1(b) Small Ischaemic Placenta
2 Obstetric Cholestasis

4 | CIRCUMSTANCES OF THE DEATH

Baby Maxim Karpovich was delivered by an emergency caesarean section at Leeds
General Infirmary at 0240 hours on 16" March 2015. His mother suffered with obstetric
cholestasis. This was her first child. The mother attended the delivery suite at Leeds
General Infirmary on 15" March 2015 when she was 38 plus 2 weeks gestation. At 0200
hours on 16" March 2015, the baby was identified as having an abnormal heart rate. He
was as stated delivered by caesarean section at 0240 hours, with no signs of life.
Immediate resuscitation produced a low heart rate at 0255 hours. He was ultimately
treated in the Neonatal Intensive Care Unit and treatment was withdrawn and his death
was confirmed at 0730 hours on 16" March 2015.

5 | CORONER’S CONCERNS

During the course of the Inquest the evidence revealed matters giving rise to concern. In
my opinion there is a risk that future deaths will occur unless action is taken. In the
circumstances it is my statutory duty to report to you.

The MATTERS OF CONCERN are as follows. —

(1) It was apparent that the Midwives involved with Maxim’s birth and a Junior

Obstetrician, appeared not to understand that the cardiotocograph (CTG) trace
was abnormal on several occasions. The Obstetric Registrar, at 2357 hours,

incorrectly classified the CTG to be normal when it clearly was not. The baby,
Maxim, who was delivered by an emergency caesarean section. Expert
evidence stated that if the caesarean section had been carried out by midnight,
the baby would have survived, although there could have been some
neurological deficit.

(2) This Inquest and many others previously, have caused me to note that Midwives
and Obstetricians lack the core skills to interpret CTG tracings for intrapartum
care.

(3) There is a need for the development of quality controlled training modules. Such
courses should last for at least two days and cover the correct use of the CTG
technology; foetal pathophysiology; understanding of the role of infection fever
and meconium aspiration, trauma and other stresses and their interaction with

asphyxia.

=

(4) There should be mandatory confirmation of competence at CTG interpretation
with pass or fail testing before entering practice to determine the critical issues
around the contents of intrapartum CTG training modules and the validity of

associated tests.

=

(5) This training should address pattern recognition, pathophysiology of foetal heart
rate changes, clinical scenarios with CTG’s and appropriate responses.

6 | ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and | believe you and your
organisation 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 19" April 2017. I, 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.

8 | COPIES and PUBLICATION

| have sent a copy of my report to the Chief Coroner.

| 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.

| 9 | DATE: 22™ February 2017 SIGNED: acd rt eects /.

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 Royal College of Midwives (PDF)
THE ROYAL]
COLLEGE OF |
MIDWIVES

Promoting - Supporting - Influencing

OA5gat ue),

CEO/CW/ME
CGS LOH wees
PlalrF-
06 April 2017
Mr D Hinchiiff KIM Karpovian,

Senior Coroner

West Yorkshire (Eastern)
71 Northgate

Wakefield

WF1 3BS

Dear Mr Hinchliff,
Thank you for your letter of 23 February 2017, and | do apologise for the delay in replying.

The Royal College of Midwives is the professional organisation and trade union dedicated to
serving midwifery and the whole midwifery team. We provide workplace advice and
support, professional and clinical guidance and information, and learning opportunities with
our broad range of events, conferences and online resources.

It is important to note that midwives are specialists in normal pregnancy and birth, and their
role is to look after a pregnant woman and her baby throughout the antenatal period,
during labour and birth, and after the baby has been born. Where anomalies occur,
midwives support their medical colleagues in providing care.

The Nursing and Midwifery Council (NMC) Code Professional Standards of Practice and
Behaviour for Nurses and Midwives requires practitioners to maintain the knowledge and
skills needed for safe and effective practice and to recognise the limits of their competence.

Point 8 of the NMC Code requires that registrants respect the skills, expertise and
contributions of your colleagues, referring matters to them when appropriate and work with
colleagues to preserve the safety of those receiving care.

The NMC Midwives Rules and Standards 2012, Rule 5 Scope of Practice was in place at the

time of Maxim’s birth. The rule stated: ‘In an emergency, or where a deviation from the
norm, which is outside of your current scope of practice, becomes apparent in a woman or

10 APR 2077

baby during childbirth, you must call such health or social care professionals as may
reasonably be expected to have the necessary skills and experience to assist you in the
provision of care’. A midwife was therefore required to refer to an obstetrician when
abnormal findings were detected.

Midwives are expected to work in accordance with their employer’s guidelines and national
best practice, for example National Institute for Health and Care Excellence (NICE) guidance.

Fetal Heart Rate Monitoring

All NHS trusts will have an evidenced-based guideline or policy on fetal monitoring. The
national guidance for fetal heart rate monitoring in labour is NICE guidance Intrapartum
care for healthy women and babies Clinical guideline [CG190] Published date: December
2014 Last updated: November 2016.

NHS Trust’s mandatory training programmes include interpretation of the fetal heart rate.
Trusts also run multidisciplinary practical ‘skills and drills’ where the maternity team work
together to identify and manage obstetric emergencies, which may include CTG
interpretation.

The RCM in partnership with the Royal College of Obstetricians and Gynaecologists and
Health Education England e-Learning for Healthcare developed a comprehensive web-based
resource called eFM: an e-learning resource aimed at improving the interpretation of
electronic fetal monitoring and subsequent management. This is a free resource for all
employees of the National Health Service and contains knowledge-based interactive
tutorials, assessments and case studies.

The RCM also offers multidisciplinary leadership courses for labour ward coordinators and
obstetric clinical leads.

Evidence

What I have, | hope, demonstrated said up to this point is that there is an awful lot of work
going on to improve the ability of midwives to interpret CTGs and to improve CTG
interpretation more generally however it is important to also understand that the evidence
as to how far this will get us is equivocal for example:

© When preparing the electronic programme eFM, clinical experts were asked to
provide sample CTG case studies for interpretation. Agreement was reached on only
60% of interpretations with variability between practitioners and also over time.
Evidence demonstrates that CTG will not, in itself, prevent fetal loss.

© A 2013 meta-analysis of controlled trials of electronic FHR monitoring versus
intermittent auscultation showed that the former yielded no significant
improvement in overall perinatal death or Cerebral Palsy rates but was associated
with a significant increase in caesarean deliveries (RR 1.63, 95% Cl 1.29-2.07, N=
18,861, 11 trials).!

e Inarecent unmasked randomised controlled trial" found that the use of
computerised interpretation of CTS in women who have continuous electronic fetal
monitoring in labour does not improve clinical outcomes for mothers or babies.
Women were randomly assigned to decision support with the INFANT decision-
support software system or no decision support via a computer-generated stratified
block randomisation schedule. Between Jan 6, 2010, and Aug 31, 2013, 47 062
women were randomly assigned (23 515 in the decision-support group and 23 547 in
the no-decision-support group) and 46 042 were analysed (22 987 in the decision-
support group and 23 055 in the no-decision-support group). There was no
difference in the incidence of poor neonatal outcome between the groups—172
(0-7%) babies in the decision-support group compared with 171 (0-7%) babies in the
no-decision-support group (adjusted risk ratio 1-01, 95% Cl 0-82—1-25). At 2 years, no
significant differences were noted in terms of developmental assessment.

| do hope this information is helpful but please do contact me if you require any further
information.

Yours sincerely,
flarty owes

Professor Cathy Warwick, CBE
Chief Executive

The Royal College of Midwives
15 Mansfield Street A,

London W1G 9NH stonewall

T: 0300 303 0444 Open 24 hours a day, 7 days a week.
F: 0207 312 3536
E: info@rcm.org.uk

Chief Executive: Professor Cathy Warwick CBE, DSc (Hon), MSC, PGCEA, ADM, RM, RN.
President: Professor Lesley Page CBE, PhD, MSc, BA, RN, RM, HFRC. Patron: HRH The
Princess Royal

The Royal College of Midwives. A Company limited by guarantee. Registered No. 30157 at
the above address.

' alfirevic Z, Devane D, Gyte GM. Continuous cardiotocography (CTG) as a form of electronic fetal monitoring
(EFM) for fetal assessment during labour. Cochrane Database Syst Rev. 2013;5:CDOQ6066. Review.

"The INFANT Collaborative Group. Computerised interpretation of fetal heart rate during labour (INFANT): a
randomised controlled trial. Lancet 2017; published online March 21. http://dx.doi.org/10.1016/ S0140-
6736(17)30568-8.
Response from Royal College of Obstetricians and Gynaecologists 1 (PDF)
Royal College of
Obstetricians &
Gynaecologists

Direct telephone: +44 (0)207 772 6238
Email: president@rcog.org.uk

Mr David Hinchcliff

Senior Coroner, West Yorkshire (Eastern)
Coroner's Office and Court

71 Northgate

Wakefield WF1 3BS

3 May 2017

Dear Mr Hinchcliff
Your ref: DH/ST/893/15 re Baby Karpovich / DH/KLA/3156/13 re Billy Wilson

Thank you for writing to me on 22 February and 8 March 2017 regarding the inquest of the deaths of
Maxim Karpovich and Billy Wilson. | responded re on 17 March 2017 after meeting
and discussing with the RCOG Officers and seeking input and advice from the new Vice Presidents of
Education and Clinical Quality. | apologised tT for the delay in my response
explaining that ! heeded to consult with the Curriculum Review team in some detail before | could
address his concerns appropriately. The consensus frem the RCOG Officers and the Curriculum
Review team was that a theoretical course in itself — particularly a course taking place over many
weeks as was being suggested — was unrealistic for all trainees, many of whom are struggling to
obtain study leave from their Trusts and are also complaining bitterly about the mandatory training
modules that they are expected to complete. There is also the question of whether a course is the
most appropriate method of training as the problems that can arise in clinical practice are generally
when the whole picture is not considered and the issue is not escalated appropriately.

Cardiotocograph (CTG) training is part of the current RCOG curriculum. In summary it is part of
module 10 ‘Management of labour’ and by the end of Specialist Training year 1 (ST1), all trainees
must produce evidence of having completed a course demonstrating CTG interpretation skills (see
Module 10 attached with relevant sections highlighted) before they can progress to become an ST2.
As you will see this is usually an e-learning course and the resources which most trainees use are
either the K2MS™ PTP (Perinatal Training Program) package or the e-learning for Healthcare
Electronic Fetal Monitoring chapter. You may be aware that the K2 training requires hospitals to
have a site licence and trainees can then be registered. The e-learning for Healthcare requires
doctors to have a NHS email address and then they can register for free, but this precludes those
working out with the NHS. However | should mention here that, as the official host, the RCOG has
put a significant amount of resource into supporting the eFM package, working with the Royal
College of Midwives and Health Education England.

Royal College of Obstetricians and Gynaecologists 27 Sussex Place, Regent's Park, London NW! 4RG
Telephone: +44 (0)20 7772 6200 Facsimile: +44 (0)20 7723 0575 Website: www.rcog.org.uk

Registered chanty no. 213280

Royal College of
Obstetricians &
Gynaecologists

CTG training is additionally included in the basic practical skills course which all trainees have to take
to progress to ST3. One of the 10 practical stations is on interpretation of CTG and fetal blood
sampling. All delegates are expected to complete the on-line tutorials in electronic fetal monitoring
and fetal blood sampling during the pre-course preparation and should have a basic understanding
the fetal monitoring principles.

In terms of the new curriculum, the pressure of completing modules does not allow us to increase
the emphasis on CTG interpretation but it will remain an important that trainees evidence this skill.
The RCOG opinion on CTG interpretation is that the problems arise in clinical practice when the
whole picture is not considered, and this is why trainees are encouraged to demonstrate clinical
competence within teams as part of workplace based assessments. In addition senior trainees who
are likely to be in charge of such teams can register for our Advanced Training Skills Module (ATSM)
in advanced antenatal practice or advanced labour ward practice, both of which contain curricula
that deliver additional training in the teamwork around CTG interpretation which includes the
running of team meetings and reviews of decision making . mee details a our ATSM programme
can be found at https:

Whilst we fully understand the concerns around this case we would like to reassure you that the
College is committed to ensure that safety is at the heart of anything we do. We have discussed
whether one additional course such as that proposed by Professor Steer for all our trainees would
enhance safety. We believe that it would not and that we should therefore concentrate on ensuring
consistency of our curriculum and also fully engaging with NHS England and the ‘Safer Maternity
Care’ programme, launched by Jeremy Hunt at the RCOG in October 2016. This important national
programme has come with a very strong bias towards team work and leadership, supported by a
new funding stream for multi-professional training programmes.

As | am sure you are aware, the Secretary of State announced £8m of funding for maternity safety
training last Autumn 2016, with at least £40k to each NHS Trust in England. This has allowed some
units to fund training in subjects such as team working in intrapartum care and CTG interpretation
via courses that have already been established.

Lastly | should mention that in my reply Ri reminded him that the RCOG currently
offer an “intrapartum fetal surveillance course” which is run over one day at the RCOG and is aimed
at obstetric team working. | suggested to hat he could liaise with our Convenor of
Meetings to help us design a pilot programme along the lines that Professor Steer proposes, that

Royai College of
Obstetricians &
Gynaecologists

could then be trialled at the RCOG. | offered to give this my full support if he wished to pursue the
proposal and | believe that he has already started to do so.

If you would like to discuss this further with me please do not hesitate to contact me.

Yours sincerely

(tobe

President

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v

asdejoid pos

wo

Aaayep pue snoge| uweyaid eBeuey

elweeploe |e}e) ebeuep|

Guljdwes pooj |e}e) wWOLeg

fa pauinbas oN Oo [2A] paoueapy | [ead] ayelpauayzuy L] (ana) 21seq [aaa] a2uajyaduicD

sa[suajaduuo> yJomauels Ayjenbaus yea] Safuayedwos yomawey diysiepeg| jepayy seluajadwoo yromawey Aduszedwes UOWWUGD

Isr) GulujpeureYW iy UIEWog > PoMWee! pue diysieue, ‘UOHeSIUNWWOD :¢ UeWog §=—-Ayenb pue Ayes :z ulewoq ssueUUOLaY puR SINS ‘aBpaymouy 2, wewoq  -sulIeWwog (qi) eonoelg jeaIpayy POCd OWO
Ss

Ujeep |2}9) ou9jn ul ebeuep

Jaysued} o1ayn ul ebeuey

HE}S JOJO YIM 9SIE!]

puem JNoge| uns pue eyeulpscoD

eyenjeaz

swe|qoid piem inoge] asquoug

uoyo9jul uneynewjul eBeueyy

asdel[oo j2ouje}sq0 ebeuey

sjonpoud poojq jo asn aeg

abeyuouwsey wnyedsjue oje}sqo abeueyy

dnoge| ul dT713H ebeuew;
anoge| ul eisdwejoe efeuey

dnoge| ul ejsduuejoa-aud eienes eGeueyy

yOoq30] OT ajnpow a10>

i paujnbas jon [2Aa] paoueapy Ol [aaa] ae;pauazu] im [Aa] 2Iseq Jana] aousjyadui0>

sauajaduio? yromawel Aijenbaul yzjeay sepuajadios ylomalwey diyssapea| |e21pay) sa!suaysdu0> yomewes Asuayeduw03 UoWWOD
sAay

Js) Bulurejurey :y UeWog = POMUUea, PUR diysseuUeY ‘Uo_eoUNWIWOD ‘¢ UEWOg «= Ajyenb pue Ayeyeg :z wwewog =soUBULIOYed pure S|

is ‘eBpayouy <1 ueWog :suIEWO (dW) e2N2eIq IEDIPAWY POOD OWD

JBUIEJ) [IUD Jo aunyzeusis (juid aseayd) Jousesy jeriu1j> 50 awen

(saduresy jerquy> ayy Aq paza|dwio> aq 03) seunjeugis jo uoMesUOYyINY

JOSIAJaGNs jeUCHeINpa jo sinyeUsis

ia pauinba, 30N [aaa] pasueapy C] [aaa] ae/pauazU] C] JPAQ] 2Iseg [PA] sUajadwoD

00q301 OT aInpowy 2103

sajouajadwo> yomawWed Ayjenbau! yzjea} sepuayeduwos yomauiey diysiapea| |etpayy sapuayadwos yomawiey ANUajedwos UOWLUOD
sAay

ysnay Buyujeujey sy Ulewog =“ womulee, pue diysseuyeg ‘uopeojunWWOD :¢ UEWOg —Ayjenb pue Ajyeg :z UIeWog soUeWWOLE, pue sy)ys ‘ABpaymouy :} UleWog :suleEWog (GW) eoNdeIq [EDIPayy PCO QW

Z

JOsIAJadns JeUOeINpa jo aiunyeudis 4OsiAsadns jeuoHeINpa jo awey

:payajdwuos Alinjssazons usaq aAeY ajnpow ay} jo syUaUOdWOD |ye Jey WUD |
OT FINGOW 40 NOILFIWdWOD

49UJEI3 [EI|/UIP Jo aunyeusis (quid aseajd) sauies jesiuy> yo aie

{sadureg jesus ay} Aq payajdiu0> aq 03) sainjeusis yo uoesOYINY

sapuajediuos Jomawed Ajenbeul yyesq salsuayaduios yomawey diyssapea] [EAIpa,) se!quayedwios yomawwiedy Asuayeduios UoWOD
shay

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