Dear Ms Hashmi Ref: Baby Olsberg, deceased
— Regulation 28 PFD Thank you for your letter dated 8 May 2015 and for raising your concerns about testing for Group B Strep. We have considered your recommendations in light of the findings from the inquest into the death of baby Olsberg and this is our response. The 2’ edition of the RCOG Green top guideline number 36, Prevention of Early-onset Neonatal Group B Streptococcal Disease was published on 1 st July 2012. It gives guidance based on the recommendations of the National Screening Committee. In response to the specific points in section 5 of your letter:
1. That antenatal screening for GBS is not routinely offered by the NHS, to all pregnant women, during the final weeks of pregnancy. Point 4.1 in the RCOG guidelines states that Routine bacteriological screening of all pregnant women for antenatal GBS carriage is not recommended. Until it is clear that 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 of antenatal care within the UK. Major organisational changes and new funding would be required to ensure an equitable and quality-assured service.
2. That prophylactic intrapartum antibiotics are not routinely offered to all women that have tested positive for GBS (or have done so in the past). Point 5.1 in the RCOG guidelines states that Clinicians should offer lAP to women with GBS bacteriuria identified during the current pregnancy. GBS bacteriuria is associated with a higher risk of chorioamnionitis and neonatal disease. It is not possible to accurately quantify these increased risks. These women should be offered lAP. lAP should be offered if GBS 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. That GBS infection is a very serious illness and in the absence of a national screening programme, babies are potentially being put at risk of harm/death. Group B streptococcus (Streptococcus agalactiae) is recognised as the most frequent cause of severe early- onset (at less than 7 days of age) 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 for the 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 of strategies for the prevention of EOGBS disease and recommended that routine screening using bacteriological culture or near-patient testing 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 of an audit (https://www.rcog.org.uk/globalassets/documents/guidelines/research--a udit/gbs-audit-first report.pdf) which contains the results of a 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 opportunity to comment on this report.

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.

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:

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:

From Ben Gummer MP Parliamentary Under Secretary of State for Care Quality Department of Health Richmond House 79 Whitehall POCS 935173 London SWIA ZNS Tel: 020 7210 4850 Ms L. Hashmi Area Coroner HM Coroner's Court The Phoenix Centre LICpl Stephen Shaw 0 6 JUL 2015 MC Heywood OLIO ILR Lc M Hal Thank you for your letter of &th 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 after his birth: Blood samples confirmed he had been infected with Group B Streptococcus (GBS) You raise the following concerns: that antenatal screening for GBS is not routinely offered by the NHS, to all pregnant women, during the final weeks of pregnancy; that prophylactic intrapartum antibiotics are not routinely offered to all women who test positive for GBS (or have done s0 in the past); and that GBS infection is a very serious illness and in the absence of a national screening and prophylactic treatment programme; babies are potentially 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 Way May' day- being put

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 offered antibiotics that 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 uklgroupbstreptococcus The UK NSC will be reviewing the evidence for antenatal screening for GBS 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 being they . again

[ hope that you find this reply helpful and 1 am grateful to you for bringing the circumstances of baby Ol} s death to my attention: BEN GUMMER Eberg"