Baby Olsberg

de From Ben Gummer MP
Parliamentary Under Secretary of State for Care Quality

Department
Richmond House
of Health 79 Whitehall
POCS 935173 Serene

Ms L. Hashmi Tel: 020 7210 4850
Area Coroner

HM Coroner's Court
The Phoenix Centre
L/Cpl Stephen Shaw 06 JUL 2015
MC Way Heywood

OL10 1LR

tes Hy Habis

Thank you for your letter of 8th May 2015 following the inquest into the death of baby
Olsberg. I was very sorry to hear of baby Olsberg’s death and wish to extend my
sincere condolences to his family.

Baby Olsberg died the day after his birth. Blood samples confirmed he had been
infected with Group B Streptococcus (GBS).

You raise the following concerns:

e that antenatal screening for GBS is not routinely offered by the NHS, to all
pregnant women, during the final weeks of pregnancy;

e that prophylactic intrapartum antibiotics are not routinely offered to all women
who test positive for GBS (or have done so in the past); and

e that GBS infection is a very serious illness and in the absence of a national
screening and prophylactic treatment programme, babies are potentially being
put at risk of harm or death.

Screening is an important public health tool and whilst it can deliver life-saving
benefits, it also has the potential to do significant harm. For this reason, any decision
to introduce a national screening programme is subject to a rigorous assessment of the
evidence.

The UK National Screening Committee (UK NSC) advises Ministers and the NHS in
all four countries about all aspects of screening policy and supports implementation.
Using research evidence, pilot programmes and economic evaluation, it assesses the

evidence for programmes against a set of internationally recognised criteria. In the
case of GBS carriage in pregnancy, the current evidence does not support universal
screening.

In November 2012 the UK NSC recommended that antenatal screening for GBS
carriage at 35-37 weeks of pregnancy should not be offered because there is
insufficient evidence to demonstrate that the benefits to be gained from screening
would outweigh the harms. The UK NSC highlighted that a screening programme
would lead to large numbers of predominantly low risk women being offered
antibiotics that they did not need. This is because the test cannot distinguish between
the small number of carriers whose babies would be affected by early onset GBS and
the large number which would not.

The UK NSC recommendation on Group B Streptococcus screening in pregnancy is
found at the following web address:

http://www.screening.nhs,uk/groupbstreptococcus

The UK NSC will be reviewing the evidence for antenatal screening for GBS again in
2015/16 as part of its routine evidence review process. It has commissioned a
modelling exercise to estimate the likely impact of screening which will report in late
autumn 2015.

The current advice from the UK NSC is consistent with guidance from the National
Institute for Health and Care Excellence (NICE) and the Royal College of
Obstetricians and Gynaecologists (RCOG). I understand the RCOG has written to you
separately explaining its approach to the prevention of early onset GBS.

A range of work is also being taken forward by Public Health England (PHE) and the
National Institute for Health Research (NIHR). PHE established enhanced surveillance
of infant GBS disease in April 2014, in partnership with St George’s Hospital, the
British Paediatric Surveillance Unit and national public health bodies across the UK
and Ireland, to assess disease incidence, associated mortality and frequency of
established risk factors. Several candidate GBS vaccines are in development and PHE
are monitoring these. PHE are also seeking research funding to identify any genetic
differences in the GBS carriage strains that cause infant disease — this may help in the
development of a more specific screening test.

The NIHR has recently approved funding for a study on accuracy of a rapid test for
use during labour for maternal group B streptococcal colonisation and its potential to
reduce antibiotic usage in mothers with risk factors (GBS2). The study is expected to
begin this summer.

I hope that you find this reply helpful and I am grateful to you for bringing the
circumstances of baby Olfberg’s death to my attention.

Or. |

BEN GUMMER

ki t National Institute for 10 Spring Gardens
I I
Health and Care Excellence London
SW1A 2BU
27 May 2015
United Kingdom
Ms L J Hashmi
Area Coroner
Greater Manchester North
HM Coroner’s Court
The Phoenix Centre
L/CPL Stephen Shaw MC Way
Rochdale
Heywood OL1O 1LR
Our ref: 58085
Dear Ms Hashmi
Thank you for sending me a copy of your Regulation 28 report into the death
of baby Olsberg, dated 8 May 2015, for information and comment. I was very
sorry to learn of the death of baby Olsberg.
I note your concerns that antenatal screening for Group B Streptococcus
(GBS) is not routinely offered to all women during the final weeks of
pregnancy and that prophylactic intrapartum antibiotics are not routinely
offered to all women who test positive for GBS (or have previously done so).
Exposure to group B Streptococcus (GBS) is common in new-born babies and
although most babies do not develop GBS infection, I am aware that GBS is
the leading cause of early-onset bacteraemia in the UK. We know that it
causes serious infection that usually presents in the first 72 hours of life.
I should point out that our role is to provide the evidence for decisions to be
made by local clinicians and organisations on the best approach to care by
providing guidance on treatments and other forms of practice. In developing
the recommendations in our clinical guideline on antenatal care (CG62, 2008),
we referred to the evidence-based recommendations of the UK National
Screening Committee (NSC), which is part of Public Health England.
As you are aware, our guideline does not recommend routine screening for
GBS. This is because there was insufficient evidence to support a positive
recommendation. However, we have encouraged more research to be carried
out in this area and we will keep our recommendations under review, pending
new evidence emerging. Our consideration of the evidence informing this
recommendation is available in the full guideline which is available on our
website: www.nice.orq.uklcq62. Screening for GBS is discussed in section
10.9.
www.nice.org.uk I nice@nice.org.uk
We most recently reviewed the evidence in 2014, and after consulting with
stakeholders, we decided that there was not enough new evidence to justify
updating the guideline.
It is worth noting that the current position of the UK National Screening
Committee is that screening for this condition is not currently supported by the
evidence available which might support the benefits of doing so. I understand
that this policy was reviewed in November 2012 but no changes were made. I
believe it is due to be considered again during 201 5/16. Further information is
available via the UK Screening Portal at:
http://www.screening.nhs.uk/groupbstreptococcus
The Screening Committee has published an FAQ document to explain why
there isn’t a national screening programme which is available via the above
link. However for ease of access I have enclosed a copy with this letter.
You may also be interested in our clinical guideline on Antibiotics for early-
onset neonatal infection (CG149, 2012). The guideline provides a framework
outlining risk factors and clinical indicators that may be used to direct antibiotic
management decisions. Once again, we have encouraged further research
into the clinical and cost effectiveness of intrapartum antibiotic prophylaxis
targeting group B streptococcus and guided by routine antenatal screening.
Further information is available on our website at: www.nice.org.uk/CG149.
Finally, you may wish to refer to national guidance for maternity staff on the
prevention of early-onset neonatal group B streptococcal disease, published
by the Royal College of Obstetricians and Gynaecoiogists (guideline 110. 36)
which is available here from the RCOG website:
www.rcoq.org.uk/en/guidelines-research-services!
Yours sincerely,
Sir Andrew Dillon
Chief Executive

Royal College of
Direct telephone:
Email: Obstetricians &
Gynaecologists
Ms Li Hashmi
Area Coroner
Greater Manchester North
The Phoenix Centre
L/Cpl Stephen Shaw
MC Way Heywood
OL1O 1LR
15 May 2015
Dear Ms Hashmi
Ref: Baby Olsberg, deceased Regulation 28 PFD
—
Thank you foryour letter dated 8 May 2015 and for raising your concerns abouttestingfor Group B
Strep. We have considered your recommendations in light ofthe findingsfrom the inquest into the
death of baby Olsberg and this is our response.
The 2’ edition ofthe RCOG Green top guideline number 36, Prevention of Early-onset Neonatal
Group B Streptococcal Disease was published on 1stJuly 2012. It gives guidance based on the
recommendations ofthe National Screening Committee.
In response to the specific points in section 5 ofyour letter:
1. ThatantenatalscreeningforGBSis notroutinely offeredby the NHS, to allpregnant women,
during thefinal weeks ofpregnancy.
Point 4.1 in the RCOG guidelines states that Routine bacteriological screening of all
pregnantwomen for antenatal GBS carriage is not recommended.
Until it is clearthat antenatal screening for GBS carriage does more good than harm and that
the benefits are cost-effective, the National Screening Committee does not recommend
routine screening in the UK. Initiating national swab-based screening for antenatal GBS
carriage would have a substantial impact on the provision ofantenatal care within the UK.
Major organisational changes and new funding would be required to ensure an equitable and
quality-assured service.
2. Thatprophylacticintrapartum antibiotics are notroutinely offeredto all women thathave
testedpositiveforGBS (orhave done so in the past).
Point 5.1 in the RCOG guidelines states that Clinicians should offer lAP to women with GBS
bacteriuria identified duringthe current pregnancy.
GBS bacteriuria is associated with a higher risk ofchorioamnionitis and neonatal disease. It is
not possible to accurately quantify these increased risks. These women should be offered
lAP.
lAP should be offered ifGBS is detected on a vaginal swab in the current pregnancy.
Royal College of
Obstetricians &
Gynaecologists
Current evidence does not support screening for GBS or the administration of lAP to women
in whom GBS carriage was detected in a previous pregnancy.
3. ThatGBSinfection is a veryserious illnessandin the absence ofa nationalscreening
programme, babies arepotentiallybeingputatrisk ofharm/death.
Group B streptococcus (Streptococcus agalactiae) is recognised as the most frequent cause
ofsevere early- onset (at less than 7 days ofage) infection in newborn infants. However,
there is still controversy about its prevention. A Cochrane review concluded that, while lAP
for colonised mothers reduced the incidence of EOGBS disease, it has not been shown to
reduce all causes of mortality or GBS-related mortality. There have been no studies
addressing whether routine screening has had any impact on all-cause mortality. In addition,
antenatal screening and treatment may carry disadvantages forthe mother and baby. These
include anaphylaxis, increased medicalisation of labour and the neonatal period, and possible
infection with antibiotic-resistant organisms, particularly when broad- spectrum antibiotics
such as amoxicillin are used for prophylaxis. The UK National Screening Committee examined
the issue ofstrategies forthe prevention of EOGBS disease and recommended that routine
screening using bacteriological culture or near-patienttesting techniques should not be
introduced into UK practice, and the RCOG guidance is in line with their recommendation.
The RCOG has recently published a report ofan audit
(https://www.rcog.org.uk/globalassets/documents/guidelines/research--audit/gbs-audit-first
report.pdf) which contains the results ofa survey of NHS obstetric units in the UK and analyses of
routinely collected maternity data, which you may also find useful.
With many thanks for the opportunityto comment on this report.
Yours sincerely
Vice President, Clinical Quality