Dear Ms Hashmi Re: Baby Smith, deceased — Regulation 28 Report 30 th June 2016 I have read carefully your report and discussed this again with senior colleagues at the RCPCH. Given that we do not have all the details of the tragic death of Baby Smith, the RCPCH is unable to comment on the specifics of the case and the Pennine Acute Hospitals NHS Trust has been asked to respond directly on local communication, record keeping and policies and procedures. Following your report from May 2015, you raise again concerns around neonatal Group B Streptococcus (GBS). We are not aware of any new evidence or guidance on GBS and hence the RCPCH’s response remains as in May 2015. I have set this out again below in response to each of your matters of concern:
1. That antenatal screening for GBS was not being routinely offered by the NHS, to all pregnant women, during the final weeks of pregnancy The UK National Screening Committee does not recommend routine screening of all pregnant women for GBS carriage. We note that the National Screening Committee is due to review this recommendation again in 2015/16. The Royal College of Obstetricians and Gynaecologists (RCOG) has produced a guideline (no. 36) for the prevention of early-onset neonatal group B streptococcal disease. The most recent edition was published in July 2012 and is based on the recommendations of the National Screening Committee. Point 4.1 in the guideline states that routine bacteriological screening of all pregnant women for antenatal GBS carriage is not recommended. The RCOG has also stated that initiating national swab based screening for antenatal GBS would have a substantial impact on the provision of antenatal care within the UK and that major organisational changes and new funding would be required to ensure an equitable and quality-assured service.

2. That prophylactic intrapartum antibiotics were not routinely offered to all women who test positive for GBS (or have done so in the past). The RCOG guideline states that clinicians should offer intrapartum antibiotic prophylaxis (lAP) to women with GBS identified during the current pregnancy, if detected on a vaginal swab. The National Institute of Health and Clinical Excellence (NICE) published a guideline on antibiotics for the prevention and treatment of early-onset neonatal infection (CG 149) in 2012. Section 1.3 of the guideline states that women should be offered lAP using intravenous benzylpenicillin to prevent EOGBS if they have:
• had a previous baby with an invasive GBS infection or
• GBS colonisation, bacteriuria or infection in the current pregnancy
3. That given the seriousness of the illness, in the absence of a national screening and prophylactic treatment programme, babies were potentially being put at risk of harm/death. GBS is recognised as the most frequent cause of severe early-onset (at less than 7 days of age) infection in newborn infants. A Cochrane review in 2014, however, concluded that, while lAP for colonised mothers reduced the incidence of early onset neonatal GBS (EOGBS), 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 NICE guideline on antibiotics for the prevention and treatment of early-onset neonatal infection (CG 149) sets out how to monitor risk factors for EOGBS during labour. It states that a clinical assessment should be carried out without delay if there are any clinical indicators for EOGBS including a review of the maternal and neonatal history and a physical examination of the baby including an assessment of the vital signs. The guideline also states that if clinical concern increases, consideration should be given to performing necessary investigations and starting antibiotic treatment, adding that if a baby needs antibiotic treatment it should be given as soon as possible and always within one hour of the decision to treat. Thank you for raising this important case and reminding us of the importance of this work.

Dear Mrs Hashmi, Re: Baby Dominic Christopher Smith (formerly Dominic Fisher)
— Date of birth 0210612015
— Date of death 02106/2015 Please find herewith a response to your concerns as outlined in the Regulation 28 (Prevention of Future Deaths) Report served on the Trust following the Inquest into the death of the above named baby which was held on 20
— 22 June 2016. The matters of concern are listed below with the accompanying response; I have provided a supplementary document with specific evidence for each concern raised. Coroner’s concerns I Inadequate communication, handover and record keeping. Response from the Trust: The Division of Women and Children’s is undertaking a programme of rolling audits on communication and documentation. The purpose is to ensure compliance with policy standards and to identify areas where there are challenges in order to implement remediating measures. The division has commissioned an improvement programme of work focusing on these three areas in order to fully embed effective and reliable processes into clinical practice.
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Pride ri The Pennine Acute Hospitals [A!J.’lLl J’efl fl I fle 4HS Trust 2 Staff did not follow the Trust’s protocolslguidance and did not document their rationale where they exercised clinical discretion. Response from the Trust: The findings from the RCA and in particular the lack of adherence to protocols are part of a process which aims to embed learning from incidents within the division. In this particular case, a lessons learned proforma was sent to all midwives and medical staff within obstetrics to share more widely the key themes around care delivery within the Division. 3 Midwives did not carry out a speculum examination, on two separate occasions, in order to establish whether there had been a rupture of membranes. The time between rupture and delivery was, more likely than not, miscalculated as a result of this. Response from the Trust: There has been guidance issued to all practitioners to reiterate the need to obtain a thorough, probing history from the patients to ensure questioning covers the potential rupture of membranes in line with policy and carry out an appropriate speculum examination. The incident and investigation has been widely discussed with the birthing centre and community midwives, in particular. 4 Early warning scores were i) miscalculated, ii) not acted upon. Response from the Trust: Undertaking correct acute monitoring of patients condition, through using early warning scores is currently a Trust wide project to improve practice. The work will include a suite of improvement measures and is part of the first improvement collaborative for the Trust in response to CQC findings (August 2016). The intended outcomes are to align practice to ensure compliance with best practice standards and sustain improvements. Within the maternity services, a specific Maternity Early Warning Scoring Chart (MEWS) has been revised which has greater sensitivity to the needs of the physical parameters of women during pregnancy. This tool is in the pilot phase currently to enable any necessary alterations to be implemented prior to being fully embedded in practice. 5 Neonatal observations were not carried out when it became apparent that there had been a material change in baby’s condition. Signs and symptoms relating to the deterioration were also missed. Response from the Trust: The neonatal services has developed a module of training entitled Care of the Compromised Infant, which now forms part of each midwife’s mandatory training; the

Pride The Pennine Acute Hospitals 7114i Penn irie NHS Trust aim is to ensure early detection of the deteriorating infant and appropriate response to this. There has been an audit as part of the divisional yearly programme looking at compliance with the Early Onset Sepsis Guidelines. Actions put in place following the audit was to introduce a new observation chart based on the Newborn Early Warning Score recommended by British Association of Paediatric Medicine (BAPM) and this work is in progress. Once completed there will be further audits to monitor compliance. 6 Maternal observations were not carried out after delivery, despite a spike in temperature. Response from the Trust: The Division have developed a programme of training to emphasise recognition of signs and symptoms or deviations from normal physiological observations. The training focuses on the escalation to a medical practitioner and having clear clinical management plans in place, which are monitored. 7 Midwives did not escalate to or consult with the Obstetrician!PaediatricianlNeonatologist. Response from the Trust: The training referred to in points 4 and 5 above involves emphasising the importance of escalation to the appropriate medical teams, where deviations from the normal physiological parameters are recognised. The Critical Care outreach team are also supporting the Division where elevated early warning scores are identified. This involves direct care by the outreach team and subsequent follow up to ensure stabilisation of the patient. 8 Inadequate preceptorship for newly qualified (and particularly part-time) Midwives. Response from the Trust: The Preceptorship programme has been updated in order to provide a competency based framework to support newly qualified midwives to become confident practitioners. This has been adjusted most recently following feedback from recent cohorts, with a view to embedding lessons learned from incidents and complaints into clinical practice. The current framework provides for preceptor staff to rotate every four months with an identified preceptor to meet and formalise objectives within the clinical placement for newly qualified midwives and where support is now offered within a structured supportive environment. A practice development midwife has been recruited to support the preceptorship programme and to act as a reference point for new midwives in practice.
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Pride 1 The Pennine Acute Hospitals T’I 1 Pen r’ i fle NHS Trust The majority of concerns identified by the Coroner were raised as part of the Root Cause Analysis investigation into Baby Dominic’s death, and actions were subsequently put in place to prevent reoccurrence. Therefore, and in order to support the information provided above the Trust would, if required be able to provide a significant amount of evidence against each of the areas of concern. These are listed for your information in Appendix 1. The investigation into Baby Dominic’s death identified a number of system and organisational learning opportunities as well as individuals who needed to reflect on their practice and address shortcomings. These areas have all been addressed and individuals have had the opportunity to reflect on their practice and make improvements as part of their supervisory arrangements. It is hoped that the Trusts response provides you with the assurance that the Trust has, and will, continuously strive to ensure patient safety. May I take this opportunity to again convey our sincere condolences to the family of Baby Dominic for the failings in the care provided.