Learning from claims related to early onset Group B Streptococcal disease in neonates
Group B Streptococcus (GBS) is the leading cause of serious bacterial infection in the first few weeks of life and is a major global cause of neonatal meningitis, sepsis and pneumonia.
GBS colonisation in adults is usually asymptomatic and does not pose a risk to the carrier. However, in those who are colonised with GBS during pregnancy, there is a risk of vertical transmission in the intrapartum period. Around 1-2% of infants born to GBS colonised mothers will develop septicaemia, pneumonia, meningitis or will sadly die 1-2. Preterm and low birth weight babies are at greatest risk of these GBS related adverse outcomes1. Early onset GBS (EOGBS) disease presents in the first week of life.
Prophylactic intrapartum antibiotics (antibiotics during labour) are currently the most effective way to inhibit vertical transmission in mothers who are carriers of GBS.
An analysis of EOGBS disease claims reported to NHS Resolution between 1 January 2016 and 31 March 2023 identified 19 closed claims. These 19 claims relate to the Clinical Negligence Scheme for Trusts (CNST) dataset only, due to data access and coding protocols in place from 2016 onward.
The total cost of closed claims over this period was £1,430,894. This includes payments for claimant legal costs, NHS legal costs and damages. No PPOs were awarded in this cohort, which is expected given the very small number of cases and the clinical profiles involved.
This time period was chosen due to data usage policies in place from January 2016 onwards. Open claims—those still under investigation—are excluded. Their outcomes may alter aggregate trends once concluded, so figures presented here reflect only closed cases
19 cases is a very small proportion of the total claims managed by NHS Resolution. This small cohort is unlikely to be fully representative of all cases of EOGBS disease in the general population. Whilst claims data is non-representative, it can offer valuable learning opportunities3.
Neonatal mortality in this cohort was 53%. This is significantly higher than the expected population mortality for EOGBS disease in England of 5.2%1. However, as referenced above, claims data is non-representative of mortality data.
95% of babies in this cohort were born at Term (greater than 37 completed weeks of gestation). However, UK surveillance data1 of EOGBS disease in the general population indicates a significantly higher incidence in preterm and low birth weight babies, with the greatest incidence in those weighing less than 1.5kg or those born before 28 weeks gestation.
£59,808
Average (mean) damages
£15,908
Average NHS legal costs, in cases where damages were not paid
£7,994
Average legal costs, when damages were paid
£50,709
Average claimant legal costs
£118,512
Average total cost to the NHS of a claim (damages and NHS legal costs) when damages were paid
61%
Cases resulted in damages awarded
63% of all infants in this cohort required a period of mechanical ventilation as part of their treatment. 47% required inotropic support (medication to support blood pressure, often required in severe sepsis due to the effects of vasodilation, pulmonary hypertension and cardiac dysfunction). This reflects how particularly unwell the babies in this cohort of claims were.
Although some instances were related directly and solely to human factors or documentation, human factors will undoubtedly have played a role in all cases.
Key fact: When all the claims were looked at in detail, there were 81 specific allegations/areas for learning identified. These 81 allegations arose across the 19 claims, reflecting that individual claims often contain multiple issues. Figure 1 shows the themes which emerged.
Figure 1: Themes identified from a total of 19 reported claims and incidents relating to Early-Onset Group B Streptococcus between 1 January 2016 and 31 March 2023
Did you know?
Most babies in this group were symptomatic within the first 24 hours of life.
Most babies in this cohort presented as being unwell at the time of birth or with early jaundice or poor feeding.
79% of infants required a prolonged inpatient admission, with the mean stay being 6.6 days and the maximum being 21 days.
Across all these claims, this included days on neonatal units (NICUs), paediatric intensive care units (PICUs), postnatal wards and paediatric wards.
Did you know?
Only 25% of babies in this group received antibiotics within the nationally recognised 1-hour target.
In this group of babies with EOGBS disease, the proportion of mothers known to be colonised during pregnancy, found to be colonised during or after the delivery, and not known to be carrying GBS at all were almost equal (i.e. around a third in each of these categories).
Detailed findings and our analysis
Each case and theme was explored in more detail by NHS Resolution to consider contributing factors, these themes were then discussed at a clinical advisory group meeting (CAG) with key experts in the field. We have compiled the findings and considered them in the context of other national recommendations on the topic.
Demographics
| Finding | Factors / barriers | Suggested response | Existing related recommendations |
|---|---|---|---|
| 76% of babies in this cohort were symptomatic within the first 24 hours of life. Being born in poor condition, jaundice and feeding difficulties were frequent presenting symptoms. | This is not a new finding. The claims data supports existing knowledge and gives additional weighting to the importance of close observations in the first 12 – 24 hours of life. | Ensure that NEWTT24 is in use and that there is local guidance to assist clinicians to identify those babies that require enhanced observations or septic screen. Staff caring for infants in the first 24 hours to be proficient in the recognition of signs of sepsis. | The three-year delivery plan for maternity and neonatal services (2023)5 recommends the standard use of The Newborn Early Warning Track and Trigger chart (NEWTT2)4 by March 25. This should now be in place in practice. HSSIB (Health Services Safety Investigation Body), in their 2020 GBS learning report6 recommend that reluctance to feed as a sign of sepsis be included in training for all staff caring for women and their babies in the newborn period. |
| In this group of neonates with EOGBS sepsis there was an even split between those mothers with: • No known GBS. • Antenatal diagnosis of GBS carriage. • Peri or post-partum diagnosis of GBS carriage. Only one third of these cases had a pre-labour diagnosis of GBS colonisation. | While antenatal testing for GBS is an important factor, even those who had a pre-labour diagnosis of carriage were represented in this group. Based on current evidence, it is not possible to know which, if any, approach to antenatal testing offers superior clinical benefit. | Royal College of General Practitioners (RCOG) guidance7 regarding antenatal testing for GBS colonisation should be followed whilst updated evidence is awaited. Clinicians should remain aware that colonisation status may change over time and that based on current guidance, testing for GBS carriage, when indicated, should ideally be carried out 3-5 weeks prior to the anticipated delivery date. | Ongoing research into the optimal approach to testing is underway in the UK. The GBS3 Trial hopes to publish its findings later in 2026. This trial is comparing testing in late pregnancy, testing at the onset of labour and no routine testing to establish if one confers greater benefit. |
Antenatal
| Finding | Factors / barriers | Suggested response | Existing related recommendations |
|---|---|---|---|
| Miscommunication and discrepancies in expectation setting have contributed to some poor family experiences, which may influence the decision of a family to bring a claim. | Factors contributing to this situation include: • Circumstances / environment in which information is delivered. • Accessibility and delivery of information to parents. • The need and approach to including wider family members in care. • Access to and availability of translation services. | Parents and maternity services may benefit from information that families can refer to, following the initial conversation, when anticipating birth in the context of GBS colonisation. Trusts may wish to use individualised letters or to access and utilise nationally available resources. Trusts may wish to think about the timing and environment in which information is shared with parents. In addition, it is important for trusts to have an open approach when communicating with families in order to minimise compounded harm. This can arise from problems in the way an initial incident is managed and intensify the negative consequences. | HSSIB, in their 2020 GBS learning report6 stipulate that information given to parents must be both verbal and provided in writing. Information should be available in a range of languages spoken in the local area. Links to parent information regarding GBS can be found in the supplementary document for this leaflet. |
| Claims regarding maternal GBS screening or testing were largely related to the management of results (e.g. chasing results, sharing results with parents, appropriately commencing intrapartum antibiotics when required) rather than the decision to test or not test for GBS colonisation. | Factors include: • Variability of lab processing time and day of reporting for swab results. • Variation in paper-based and paperless medical records systems. • Systems for tracking investigations and their changing status (sent, results available, actioned etc.) • Uncertainties in the responsibility of individual clinicians for chasing and actioning results. • Processes for highlighting GBS positive results. • Failures in established systems, such as physical results books, which remain vulnerable to human error. | Trusts are encouraged to review their paper-based or paperless systems for the management of test results in pregnancy. Trusts are encouraged to have in a place a system that works in their particular setting for chasing and communicating swab results. (It is not possible to stipulate a process that will work universally due to differences between trusts. This should, however, be a key area for review for individual trusts.) Trusts are encouraged to ensure a system is in place to communicate results to the woman / family. | Both the 2020 HSSIB GBS learning report6 and the 2020 MBRRACE-UK Saving Lives, Improving Mothers’ Care report8 call for electronic records that can be accessed in different care settings and can be read and amended by both professionals and service users. The 2019 National Maternity and Perinatal Audit Organisational report9 also called for improved access to electronic records for patients and healthcare professionals. In addition, the 2021 HSSIB learning from Investigations that occurred during the Covid-19 pandemic10 report suggests that alert functionality should be included in electronic notes systems. |
Intrapartum
| Finding | Factors / Barriers | Suggested response | Existing related recommendations |
|---|---|---|---|
| Telephone triage is a point of vulnerability in clinical assessment. One aspect of this is that it can be difficult to gather all the necessary information, including GBS results, in order to make a risk assessment and plan over the telephone. | Factors include: • Availability of guidance. • Staffing of triage areas. • Ability to contact parents easily at home. | Maternity units could benefit from a robust triage system if not already in place. In their review of maternity services in England11, the CQC published a triage improvement resource that trusts may find useful for quality improvement within their own services. | The RCOG guidance12 Maternity Triage (Good Practice Paper No. 17) | RCOG emphasises a standardised approach to face-to-face and telephone triage, advocating the use of BSOTS (Birmingham Symptom-specific Obstetric Triage System) or a similar evaluated system. In 2021 HSSIB10 called for a minimum operating standard for safe and effective telephone triage. Furthermore, the HSSIB GBS report6 highlights the importance of structured and accurate triage in pre-admission assessments. NHS Resolution’s Maternity (and perinatal) Incentive Scheme (MIS), year 713 Safety Action 5 asks services: ‘Can you demonstrate an effective system of midwifery workforce planning to the required standard?’ Which, when achieved, aims to improve the safety of triage services. HSSIB have also recommended that trusts must ensure that the GBS and prevention of early-onset neonatal GBS disease guideline is disseminated to staff6. |
| Misinterpretation of CTGs in the context of a fetus already compromised by sepsis contributed to this cohort of claims. | Related factors include: • Decisions regarding the place and mode of delivery. • Recognition of abnormalities as well as escalation and management of concerns. • The frequency and escalation of monitoring, decisions to expedite delivery and the context in which CTGs were interpreted (taking possible sepsis into account). | Trusts should ensure training and support for those responsible for interpreting CTGs. | Saving Babies’ Lives Version 314 recommends: • Annual fetal monitoring training for staff caring for women in labour. • A structured risk assessment at the onset of labour to determine the approach to fetal monitoring and for the risk assessment to be revisited during labour. • Regular review of maternal and fetal wellbeing, accompanied by a clear guideline for escalation. • A buddy system should be used to help provide an objective holistic review for example ‘Fresh Eyes’. • Maternity care providers should examine their outcomes in relation to their own incidents where fetal monitoring was likely to have been a contributory factor. This is supported by MIS13 Safety Action 6 – Implementing Saving Babies’ Lives v3 |
| There were instances of intrapartum antibiotics being missed. | Factors include: • Variable availability / awareness of antenatal GBS test results. • Lack of recognition of signs of sepsis. • Lack of recognition of risk factors for sepsis. • Difficultly predicting rate of progression of labour. | Maternity services should consider how they display and communicate alerts for women needing intrapartum antibiotics. It is important to have systems that can mitigate for busy units, staffing shortages and other challenges beyond the control of an individual clinician. When a woman is admitted, her medical history should always be reviewed carefully, to identify any risk factors for sepsis that may not be immediately evident. Women should be informed about their own results and empowered to expect early intrapartum antibiotics. | The 2020 HSSIB GBS report6 highlights the importance that where there are identified risk factors for early onset neonatal GBS there is early administration of intrapartum antibiotics prophylaxis. It also recommends that the GBS and prevention of early-onset neonatal GBS disease guideline is disseminated to staff. In addition, the 2021 HSSIB, learning from investigations that occurred during the Covid-19 pandemic10 report suggests that alert functionality should be included in electronic notes systems. The core competency framework version 215 requires (in module 5) for training to include the management of GBS in labour. |
Sepsis management
| Finding | Factors / Barriers | Suggested response | Existing related recommendations |
|---|---|---|---|
| Only 25% of babies in this cohort received antibiotics within an hour of sepsis being suspected. | Factors include: • Staff / team availability for predictably unpredictable (but time-critical) tasks such as neonatal septic screens and antibiotic delivery. • Multiple simultaneous urgent tasks. • Administration tasks required to register a newborn patient and create them a profile on hospital IT systems. | Neonatal services can engage in audits of their management of neonatal sepsis. Delivery of antibiotics within one hour is one important aspect of this audit process. Neonatal services can consider which staff members and teams are best placed to manage antibiotic delivery for babies on maternity wards (i.e. not admitted to neonatal units.) | NICE guidance16 recommends that antibiotics be commenced within an hour of sepsis being suspected. NICE has an audit tool that may be helpful for supporting local audit processes. NHS Resolution’s MIS13 (year 7) safety action 3: ‘Can you demonstrate that you have transitional care (TC) services in place and are undertaking quality improvement to minimise separation of parents and their babies?’ and safety action 4: ‘Can you demonstrate an effective system of clinical workforce planning to the required standard?’ assist trusts to consider the staff and structure required to respond promptly to the need for septic screens in this context. |
| Signs of maternal and neonatal sepsis were sometimes missed, leading to delays in treatment. | Factors include: • Logistics and their impact on likelihood (or ease) of escalation in different environments. • Busy ward environment. • Escalation processes. • Completion of and response to routine observations. | The use of standardised early warning systems has been shown to aid recognition and response to signs of sepsis at the earliest opportunity. Following a successful pilot in Oxfordshire and Buckinghamshire in 2023, a national Maternity Early Warning Score17 (MEWS) tool is now being rolled out across the country for the first time. Trusts can also empower parents to be able to identify signs that something is wrong with their baby, themselves or their partner. | HSSIB6 suggest that trusts use a neonatal warning chart which incorporates more detail in relation to the baby’s behaviour and feeding. The three-year delivery plan for maternity and neonatal services (2023)5 now recommends the standard use of MEWS17 and NEWTT-24. This is also supported by MIS13 safety action 6 –Implementing Saving Babies’ Lives v3. MBRRACE-UK18 suggest that women should be advised, within 24 hours of giving birth, of the symptoms and signs of conditions, including sepsis, that may threaten their lives and require them to access emergency treatment. Links to parent resources can be found in the supplementary documents. |
| There are a small number of claims concerning incomplete neonatal septic screens and delays in escalation of treatment or transfer to the neonatal unit. There are a small number of claims regarding the quality of neonatal resuscitation (as measured against national New-born Life Support – Resuscitation UK guidelines). | Factors include: • New-born life support training provision. • Workload and staffing pressures. • Equipment / facilities available in midwifery led care v obstetric led care unit. • Unfamiliar environments or internal transfer procedures (e.g. birth in the emergency department). | Trusts are invited to consider: • Their processes for completion of neonatal septic screens and administration of antibiotics to neonates. • How to ensure that adequately skilled staff are available to provide transitional care. • Newborn resuscitation training provision and uptake. | The 2019 National Maternity and Perinatal Audit Organisational report9 echoes the need for skilled staff available to provide transitional care. NHS Resolution’s MIS13 (year 7) asks in Safety Action 4: Can you demonstrate an effective system of clinical workforce planning to the required standard? And in in Safety Action 8: ‘Can you evidence the following 3 elements of local training plans: • Obstetric emergencies • Fetal monitoring • Neonatal life support’ |
Links to parent information, healthcare professionals’ tools and resources, online learning materials and reports related to this topic can be found in the supplementary materials document published alongside this leaflet.
For more information on Learning from claims related to early onset Group B Streptococcal disease in neonates, please see our supplementary material.
Published:
