Written evidence submitted by Group B Strep Support (MSE0045)

Health and Social Care Committee: Safety of maternity services in England

Written evidence submitted by Group B Strep Support, 4 September 2020

Executive Summary

Group B Strep Support welcomes the Committee’s inquiry into the safety of maternity services in England. We consider it essential that the NHS ensures the implementation of standards of care known to prevent most group B Strep infections in newborn babies.

Our key recommendations, expanded in the sections below, are that:

1. An audit should be conducted of maternity units comparing current practice for early onset neonatal group B Streptococcal (group B Strep) infection prevention with the latest guidelines from the Royal College of Obstetricians & Gynaecologists (RCOG) and the National Institute for Health & Care Excellence (NICE). These guidelines include recommendations for the clinical care of the mother and her baby and the provision of information which have to date been poorly implemented. Incentives to improve their implementation may need to be offered.
2. The implementation of the RCOG’s current group B Strep guidelines should be improved, thereby reducing the number of successful clinical negligence claims.
3. The Government should improve data collection on group B Strep colonisation and infection, allowing analysis of the effects of racial, ethnic and socio-economic background, which are known to affect colonisation rates and early onset infection rates.
4. All staff involved in maternity and neonatal care should be provided with mandatory high-quality training on group B Strep, with regular audits of group B Strep policies and practices in the units in which they work, compared with national guidelines.
5. HSIB should undertake a full national investigation into group B Strep, including establishing why ‘work as done’ differs from ‘work as prescribed.

Introduction

6. Group B Strep Support is the UK’s leading charity working to eradicate group B Strep infection in babies. The charity provides information and support to families affected by group B Strep. It raises awareness of group B Strep among new and expectant parents, provides education services to health professionals (so they are better able to prevent, or detect and treat group B Strep infection in babies), and provides a voice for all those affected by group B Strep infection.
7. Group B Strep is the UK’s most common cause of severe infection in newborn babies, causing sepsis, pneumonia or meningitis (Cailes et al., 2017). On average, every day in the UK two babies develop group B Strep infection - one of those sick babies dies every week and one survivor is left with long-term disability. Approximately 800 babies a year in the UK develop early onset group B Strep infection (O’Sullivan et al., 2018).
8. Most early onset group B Strep infections can be prevented by giving intravenous (IV) antibiotics (usually penicillin) in labour to women whose babies are at raised risk of developing group B Strep infection (Schrag and Verani, 2013).
9. In the UK, women are offered the IV antibiotics if they have one or more ‘risk-factors’ present. In most developed countries, women are offered testing for group B Strep carriage late in pregnancy and offered the IV antibiotics in labour if the test is positive (Le Doare et al., 2017). In the UK, there has been disagreement about which approach is better.
10. A recently published meta-analysis (Hasperhoven et al., 2020) reported that testing reduces the incidence of early onset group B Strep infection by 57% compared with risk-based protocols and by 69% compared with no policy. Importantly, testing was not associated with significantly higher antibiotic administration rates (31 versus 29%).
11. A large scale prospective randomised controlled clinical trial (GBS3 https://www.gbs3trial.ac.uk/), designed to test the hypothesis that testing is more effective than risk-based strategies for the prevention of group B Strep infection in babies in the UK, is currently underway, supported by the National Institute for Health Research (NIHR). It is expected to report late in 2022. The trial is supported by the Minister for Patient Safety, Suicide Prevention and Mental Health Nadine Dorries MP, who announced group B Strep was her “No. 1 in the key priority areas because this in itself will prevent infant mortality.”[1]

Health & Social Care Committee Safety of Maternity Services in England Call for Evidence Point 1:

What the impact has been of the work which has already taken place aimed at improving maternity safety, and the extent to which the recommendations of past work on maternity safety by Trusts, Government and its arm’s-length bodies, and reviews of previous maternity safety incidents, are being consistently and rigorously implemented across the country.

12. The charity has welcomed recent policy documents such as the NHS Long Term Plan that highlight the need to improve maternity safety and care in England. However, more emphasis on ensuring implementation is needed.
13. We are concerned that despite clear clinical best practice recommendations issued by the RCOG in their Green-Top Guideline No. 36 on preventing group B Strep infection in newborn babies (Hughes et al., 2017), many Trusts are not adhering to these recommendations[2].
14. Our survey of maternity services across the UK started in June 2019 (using Freedom of Information Act requests) reported that only 44% of units reported that they routinely informed pregnant women about group B Strep in line with RCOG guidelines, and only 12% of units reported using the group B Strep-test methodology recommended by the RCOG and Public Health England specifically for detecting group B Strep colonisation (Public Health England, 2018).
15. Failure to adhere to guidelines limits the ability of families to make informed choices about their care – including where to give birth, whether to opt for group B Strep testing in pregnancy, and whether to accept the offer of IV antibiotics in labour if a group B Strep test result is positive.
16. Poor adherence to group B Strep clinical guidelines is a long-standing issue. An audit in 2013/4 of NHS maternity unit policy compared with the 2012 RCOG guidelines led by the RCOG and the London School of Hygiene and Tropical Medicine (LSHTM), supported by the Royal College of Midwives (RCM) and funded by the UK National Screening Committee found variation in group B Strep policies across the UK[3]. The previous audit[4], conducted in 2005-6, had found the same, and reported that the introduction of RCOG guidelines in 2003 had led to only “a slight improvement in the proportion of units offering IAP [intrapartum antimicrobial prophylaxis, or preventative IV antibiotics in labour] to appropriate women since the previous surveys in 1999 and 2001.”
17. We are concerned about the potential for clinical negligence claims against NHS Trusts that do not use the recommended group B Strep-specific test methodology (the ECM or Enriched Culture Medium test) recommended by the RCOG and PHE for detecting group B Strep carriage. A leading clinical negligence Queen’s Counsel5 has stated that, in his opinion, it is very likely that this would establish a breach of duty in a consent claim if either:
1. Scenario 1: A mother is recommended a group B Strep test because she tested positive for group B Strep carriage in a previous pregnancy but, instead of ECM testing, she is offered and given the standard test.
2. Scenario 2: The facts are the same as Scenario 1 save that the mother is offered no testing at all.
18. The opinion concluded that there is “potential exposure to expensive litigation and the financial burden imposed on the State by those injured by the failure to provide the ECM test.”[5]
19. Investigations into Shrewsbury and Telford NHS Foundation Trust have highlighted repeated errors in the care and management of group B Strep.[6],[7],[8]
20. Investigations into East Kent NHS Foundation Trust have highlighted errors in the identification and treatment of a baby with group B Strep infection.[9] [10]
21. We welcome HSIB’s 2020 national learning report into early onset group B Strep infection. It is notable that this report found that “there was inconsistency between local guidelines and local practice”[11] and that the failings around group B Strep cases were similar across England.
22. We recommend that an audit should be conducted of maternity units comparing current practice for early onset group B Strep infection prevention with the latest group B Strep guidelines from the RCOG and NICE. These guidelines include recommendations for the clinical care of the mother and her baby and information provision which have to date been poorly implemented. Incentives to improve their implementation may need to be offered.

Health & Social Care Committee Safety of Maternity Services in England Call for Evidence Point 2:

“the contribution of clinical negligence and litigation processes to maternity safety, and what changes could be made to clinical negligence and litigation processes to improve the safety of maternity services”

23. Our 2018 report, The Cost of group B Strep infection, found that 32 clinical negligence claims relating to group B Strep between 2006-2018 (submitted from six firms of solicitors) totalled admitted liability of nearly £40 million (Group B Strep Support, 2019).
24. The report found three main factors which led to families making a clinical negligence claim:
1. a failure to follow either local or national guidelines,
2. a failure to escalate cases appropriately, and
3. missed signs of infection in hospital or reported by parents.
25. Families reported that they took forward legal cases for a variety of multifactorial reasons, with three main themes emerging:
1. dissatisfaction with investigations or the handling of a complaint,
2. clinical failings around the time of birth or issues emerging later, or
3. the need for financial support for the continuing care of a child.
26. We caution against an over-focus on reducing the number of clinical negligence claims unless care is first improved, as this may have an unintended consequence of penalising families whose babies are injured due to clinical negligence. 31% of claimants in our report stated they were dissatisfied with the way an event or complaint had been investigated. If NHS Trusts improve complaints and internal investigations processes, including by involving parents earlier and throughout the investigation, this may lead to a reduction in claims.
27. It is impossible to say how much group B Strep clinical negligence claims cost the NHS in England on an annual basis, as NHS Resolution has not historically recorded this information. Expert lawyers estimate that group B Strep cases are likely to be costing the NHS at least £10m per annum in compensation and legal fees alone.[12]
28. At our request, NHS Resolution has introduced a new learning code specific to group B Strep to their claims management system, effective from April 2020. This new code will allow group B Strep clinical negligence claims to be analysed for themes and commonalities, enabling NHS Resolution to share learning from claims across England, helping Trusts learn from others’ experiences.
29. We recommend that the implementation of the current RCOG guidelines should be improved, thereby reducing the number of successful clinical negligence claims.

Health & Social Care Committee Safety of Maternity Services in England Call for Evidence Point 3:

“advice, guidance and practice on the choices available to pregnant women about natural births, home births and interventions such as C-sections, and the extent to which medical advice and decision-making is affected by a fear of the “blame culture””

30. Our Helpline frequently hears from expectant parents who are very anxious about group B Strep, and the lack of choices within the NHS. This leads to a feeling of disempowerment, resulting in both fear and reduced birth choices. For example:
1. Many women would prefer to have an antenatal group B Strep test so they and their health team know their likely group B Strep carriage status before labour starts. However, most trusts do not make the group B Strep-specific ECM test available even at the request of health professionals, and women are rarely able to access a group B Strep-specific test within the NHS, despite the recommendations from the RCOG and PHE.
2. Women who know they carry group B Strep and who would prefer to give birth at home or in a freestanding midwifery led unit are often denied that option. IV antibiotics are rarely available in either of these settings, and women carrying group B Strep are made to choose between having the recommended IV antibiotics, or giving birth in their place of choice.
31. The Supreme Court ruling in Montgomery v Lanarkshire Health Board highlighted the duty of health professionals to ensure that patients are aware of the risks of treatment and alternative options so they can make an informed decision about their care. Too often pregnant women are not given information about group B Strep, are not offered the option of a group B Strep-specific test in pregnancy, and are not told that these tests are available privately. These women are then not able to make an informed choice about their care and that of their babies.
32. Research has found that women of black African origin are more likely to carry group B Strep than white British women, and those of south Asian origin are less likely to carry group B Strep (Gopal Rao et al., 2019). Additionally, racial, ethnic and socio-economic backgrounds have been shown to impact early-onset infection rates (Nanduri et al., 2019).
33. A response to a recent WPQ[13] established that the DHSC does not hold data on how many babies from BAME backgrounds developed or died from group B Strep infection. It is worrying that these data are not collected, since it means that the opportunity to provide targeted advice and guidance on care for BAME families is missed.
34. We recommend that the Government should improve data collection on group B Strep colonisation and infection, allowing analysis of the effects of racial, ethnic and socio-economic background, which are known to affect colonisation rates (Gopal Rao et al BJOG 2019;126:1347–1353) and early onset infection rates (Nanduri et al JAMA Pediatr. 2019;173(3):224-233).

Health & Social Care Committee Safety of Maternity Services in England Call for Evidence Point 4:

“how effective the training and support offered to maternity staff is, and what improvements could be made to them to improve the safety of maternity services”

35. Despite group B Strep being the most common cause of serious infection in newborn babies in the UK (Cailes et al., 2017) and the fact that approximately one in every four pregnant women carry group B Strep (Daniels et al., 2011), there is no mandatory training on group B Strep for staff involved in maternity care.
36. Data from a survey Group B Strep Support conducted in 2014 of qualified and student midwives at the RCM conference found that only 16.4% of respondents had read the RCOG’s 2003 group B Strep guidelines, with 46.4% having read their local group B Strep guidelines.
37. In that survey, almost half of respondents 44.5% reported that they felt they did not have adequate information about group B Strep, with 49.4% reporting that they felt they were not sufficiently informed about group B Strep to discuss it with families in their care.
38. We have worked with the RCM to develop an online learning module on group B Strep for their members, which covers clinical best practice and guidelines around group B Strep. Launched during Strep B Awareness Month in July 2020, it has already been completed by approximately 200 midwives, and consistently receives excellent feedback.
39.                    We recommend that all staff involved in maternity and neonatal care should be provided with mandatory high-quality training on group B Strep, with regular audits of group B Strep policies and practices in the units in which they work, compared with national guidelines.

Health & Social Care Committee Safety of Maternity Services in England Call for Evidence Point 5:

“the role and work of the Healthcare Safety Investigation Branch in improving the safety of maternity services, and the adequacy and appropriateness of the collection and analysis of data on maternity safety.”

40. In July 2020, the Healthcare Safety Investigation Branch (HSIB) published their national learning report on Severe brain injury, early neonatal death and intrapartum stillbirth associated with group B streptococcus infection[14]. HSIB reported that group B Strep was identified in 39 reports from their maternity investigation programme, and contributed to “6 neonatal deaths, 6 intrapartum stillbirths and 3 severe brain injuries. In these cases, GBS was either not known about, or antibiotic treatment was delayed or not given”.
41. We welcome the HSIB report, but believe it missed an important opportunity to provide Trusts with clear guidance and direction about improving care around group B Strep. While HSIB’s maternity investigations are individual to a specific family and Trust, the themes are not. It was frustrating to see recommendations positioned as “Examples” rather than as clear calls-to-action.
42. HSIB’s 2020 group B Strep report is the latest in a series of reports and investigations into group B Strep which have reported broadly similar findings, including the 2007, 2015 and 2016 RCOG audit report discussed above, plus before them two surveys of national practice carried out in 1999 and 2001 (Kenyon et al., 2004).
43. It is unclear how the safety recommendations in the HSIB report will be followed up to ensure they are implemented across England. We would encourage national recommendations to be made on best practice, with an audit tool and an appraisal process developed to ensure the safety recommendations and examples move from guidelines, to policy and into practice.
44. The HSIB report completed a relatively superficial analysis of why there is a gap between documented national policy and the implementation or execution of it in practice. This was dismissed as “an international problem and not limited to the health service in England. The contributory factors or solutions to this gap in practice are not well explored”. This overlooks an important issue the report could have addressed – namely why well-established clinical guidelines are not followed. This had the potential for wide-ranging and impactful system-wide learning.
45. We recommend that HSIB should undertake a full national investigation into group B Strep, including establishing why ‘work as done’ differs from ‘work as prescribed’

Jane Plumb MBE

Chief Executive, Group B Strep Support

jane.plumb@gbss.org.uk

0330 120 0794

References:

Cailes, B. et al. (2017) ‘Epidemiology of UK neonatal infections: The neonIN infection surveillance network’, Archives of Disease in Childhood: Fetal and Neonatal Edition, 103, pp. 547–553. doi: 10.1136/archdischild-2017-313203.

Daniels, J. et al. (2011) ‘Intrapartum tests for group B streptococcus: Accuracy and acceptability of screening’, BJOG: An International Journal of Obstetrics and Gynaecology, 118(2), pp. 257–265. doi: 10.1111/j.1471-0528.2010.02725.x.

Le Doare, K. et al. (2017) ‘Intrapartum Antibiotic Chemoprophylaxis Policies for the Prevention of Group B Streptococcal Disease Worldwide: Systematic Review’, Clinical Infectious Diseases, 65(February), pp. S143–S151. doi: 10.1093/cid/cix654.

Gopal Rao, G. et al. (2019) ‘Differential rates of group B streptococcus (GBS) colonisation in pregnant women in a racially diverse area of London, <scp>UK</scp> : a cross‐sectional study’, BJOG: An International Journal of Obstetrics & Gynaecology, 126(11), pp. 1347–1353. doi: 10.1111/1471-0528.15648.

Group B Strep Support (2019) The cost of group B Strep infection. Haywards Heath. Available at: https://gbss.org.uk/wp-content/uploads/2018/10/2018_09-The-cost-of-group-B-Strep-infection-FINAL-WEB.pdf (Accessed: 17 October 2019).

Hasperhoven, G. et al. (2020) ‘Universal screening versus risk‐based protocols for antibiotic prophylaxis during childbirth to prevent early‐onset Group B streptococcal disease: a systematic review and meta‐analysis’, BJOG: An International Journal of Obstetrics & Gynaecology. Blackwell Publishing Ltd, pp. 1471–0528.16085. doi: 10.1111/1471-0528.16085.

Hughes, R. G. et al. (2017) ‘Prevention of Early-onset Neonatal Group B Streptococcal Disease: Green-top Guideline No. 36’, BJOG: An International Journal of Obstetrics and Gynaecology, 124(12), pp. e280–e305. doi: 10.1111/1471-0528.14821.

Kenyon, S. et al. (2004) ‘Antenatal screening and intrapartum management of Group B Streptococcus in the UK.’, BJOG : an international journal of obstetrics and gynaecology, 111(3), pp. 226–30. doi: 10.1111/j.1471-0528.2005.00448.x.

Nanduri, S. A. et al. (2019) ‘Epidemiology of Invasive Early-Onset and Late-Onset Group B Streptococcal Disease in the United States, 2006 to 2015: Multistate Laboratory and Population-Based Surveillance’, JAMA Pediatrics. American Medical Association, 173(3), pp. 224–233. doi: 10.1001/jamapediatrics.2018.4826.

O’Sullivan, C. et al. (2018) ‘Group B streptococcal (GBS) disease in UK and Irish infants younger than 90 days, 2014-2015: results from prospective surveillance’, Lancet Infectious Diseases, In press, pp. 197–199.

Public Health England (2018) SMI B 58: detection of carriage of group B streptococci - GOV.UK, UK Standards for Microbiology Investigations. London: UK Standards for Microbiology Investigations. Available at: https://www.gov.uk/government/publications/smi-b-58-processing-swabs-for-group-b-streptococcal-carriage (Accessed: 6 February 2020).

Schrag, S. J. and Verani, J. R. (2013) ‘Intrapartum antibiotic prophylaxis for the prevention of perinatal group B streptococcal disease: Experience in the United States and implications for a potential group B streptococcal vaccine’, Vaccine. Elsevier Ltd, 31(S4), pp. D20–D26. doi: 10.1016/j.vaccine.2012.11.056.

11 September 2020

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