From Jackie Doyle Price MP Department Parliamentary Under Secretary of State for Mental Health and Inequalities of Health 39 Victoria Street London SW1H OEU 020 7210 4850 PFD-1109508 1 8 JAN2OI8 Ms Karen Harrold HM Assistant Coroner Portsmouth and South East Hampshire The Coroner' s Court 1 Guildhall Square Portsmouth POI 2GJ Jea A Aereld Thank you for the Regulation 28 Report to prevent future deaths dated 27 November 2017 following the inquest into the death of baby Rafe Robbie Angelo. Firstly, I would like to say extremely saddened [ was to read of the circumstances surrounding baby Rafe's death Please pass my condolences to his family and loved ones. I appreciate this must be a very difficult time for them: [ would like to say that we are committed to making the NHS the safest place in the world to give birth: In November 2017, we launched Safer Maternity Care: progress and next stepsl which set out progress against the delivery of the national maternity ambition to halve the rates of stillbirths, neonatal and maternal deaths and brain injuries that occur during Or soon after birth by 2025. To make sure progress is made quickly, we also set out an expectation of a 20 percent reduction by 2020. Safer Maternity Care sets out a number of steps to make sure we are all we can to prevent serious incidents in maternity services. This includes developing the role of the Healthcare Safety Investigations Branch? (HSIB) to standardise investigations of cases of severe brain injury, intrapartum stillbirths, early neonatal deaths and WWW gov uklgovemmentluploads/system/uploadslattachment_data/file/662969/Safer_maternity care progress_and next_steps pdf https ILwww hsiborgukl how doing

maternal deaths in England so that the NHS learns as quickly as possible from what went wrong and shares this learning as widely as possible to prevent future tragedies As well as providing comprehensive final reports for each case it investigates, the HSIB will publish themed reports drawing together overarching themes and points of learning from multiple investigations and making appropriate recommendations for system bodies to act on these findings. The new investigative approach will begin in a single region from April and will continue to roll out to all areas of England by April 2019. When fully rolled out; the HSIB will investigate around 1,000 cases a year with the expectation that the learning from investigations will spur system improvements leading to fewer deaths and injuries in the future: hope this offers assurance that we are committed to learning from deaths and taking action to prevent future tragedies in maternity care The Regulation 28 Report details a number of concerns, some of which are for local resolution and some that require consideration at a national level. My officials have made enquiries with a range of bodies including NHS England, the National Institute for Health and Care Excellence (NICE), and the Royal College of Obstetricians and Gynaecologists (RCOG) in the preparation of this reply and I will address each of the national level concerns in turn_ Antenatal checks carried out to detect small-for-gestational-age (SGA) babies You raise a matter of concern around maternal weight checks and the effectiveness of GROW charts in identifying cases of fetal growth restriction: You indicate that in this case, the risk assessment followed NICE guidelines at the time: As you will know, NICE'$ current guideline on Antenatal care for uncomplicated pregnancies (CG62'), published in March 2008 and based on best available evidence; includes recommendations regarding smoking, such as the risk of having baby with low birthweight (section 1.3.10.2), prescribed medicines (section
1.3.4.1), and cannabis (section 1.3.11.1). I am advised the guideline is currently updated and the update is due to be published in July 2020. WWW nice Org uklguidance/cg62 being

Department of Health Iam further advised that NICE is currently in the process of 'undertaking review of all its obstetric-related guidelines, which means that NICE has recently considered (or will be considering) new, relevant evidence and how it might impact on existing recommendations. NICE advises that it believes this review will cover all the relevant areas raised within the Regulation 28 Report. You will be further interested to know that the RCOG published a guideline in March 2013 on The Investigation and Management of the Small-for-Gestational-Age Fetus'. Iam advised that revision of the guideline is currently in the early stages of development; Furthermore, I am advised that NHS England recommends the use of Saving Babies- Lives: A Care Bundle for Reducing Stillbirths , which provides interventions for the risk assessment and surveillance for fetal growth restriction during pregnancy: A number of recommendations are made including: using a supplied algorithm or RCOG algorithm to aid decision-making on classification of risk; and corresponding screening and surveillance of all pregnancies; employing serial ultrasound scans to assess fetal growth for women at high risk of fetal growth restriction and estimating fetal weight derived from ultrasound measurements recorded on a chart; using antenatal symphysis fundal height charts to assess fetal growth for risk women; by clinicians trained in their use. All staff must be competent in measuring symphysis fundal height with a tape measure; plotting measurements on charts, interpreting appropriately and referring when indicated; ongoing audit of SGA birth rates, with reporting of antenatal detection rate, false positive rate and false negative rate on local dashboard (or similar); and ongoing case-note audit of selected cases of SGA not detected antenatally to identify barriers: The Investigation and Management of the Small-for-Gestational-Age Fetus wwwrcogorguklenlguidelines-research-serviceslguidelineslgtg31L Saving Babies' Lives: A Care Bundle for Reducing Stillbirth, W england nhs uklmat transformation/saving_babies _ low-

Guidance needed bradycardic episode in labour NICE guidance on Intrapartum care for healthy women and babies [CG190]6, was published in December 2014 and updated in February 2017. It includes recommendations relating to post bradycardic episode in labour: This is covered in Table 10 and subsequent recommendations including sections 1.10.15
1.10.33. You will wish to note that the fetal monitoring section of the guideline has been extensively updated since baby Rafe's death in 2014. Availability and use of cardiotocograph (CTG) at birthing centres Birth centres are accessed by women assessed to be low risk for complications CTG is not made available in birth centres because NICE guidance clearly states that CTG must not be offered to women at low risk of complications in established labour (Intrapartum care for healthy women and babies NICE Guidance, CG190, section
1.10.1). There is no evidence that the use of CTG in low-risk women improves the fetal/neonatal outcome: Iam further advised that the evidence base shows that CTGs are not recommended in a low-risk population because have a high false positive rate, generating much unnecessary interventions such as an instrumental delivery or a caesarean section. The evidence suggests that intermittent auscultation in a low-risk population appears to be equally effective at identifying problems but does not cause as much intervention: As previously advised, NICE is currently in the process of undertaking a review of all its obstetric-related guidelines, including CG190, which means that NICE has recently considered (or will be considering) new relevant evidence and it might impact on existing recommendations Guidance for midwives about auscultation practice during transfer to hospital Risk assessment is an integral part of a midwife'$ role and identified risk will trigger transfer to an obstetric unit as recommended by NICE guidance (Intrapartum care for healthy women and babies, CG19O, section 1.6). Iam advised by NICE that it has noted the concerns in the Regulation 28 Report about a lack of guidance for midwives about auscultation practice during transfer to hospital and consideration of this concern will be given when next reviewing CG190. https;ILwww nice org uklguidancelcgl90 post they how

Department of Health Saving Babies' Lives: A Care Bundle for Reducing Stillbirth includes recommendations for effective fetal monitoring during labour that aim to ensure competency in CTG interpretation and auscultation These include: all staff who care for women in labour to undertake and pass an annual training and competency assessment on CTG interpretation and use of auscultation. No member of staff should care for women in a birth setting without evidence of competence within the year; and buddy in place for review of CTG interpretation, with protocol for escalation if concerns are raised. All staff to be trained in a review system and escalation protocol. Recording all requests to transfer to hospital in notes and active consideration by midwives NICE guideline CG190 (Intrapartum care for healthy women and babies, section 1.6) recommends general principles for the transfer of care during labour; including how care should be given during the transfer. Iam advised that clinical observations are implied to continue despite no specific reference. As before; NICE is currently in the process of undertaking a review of all its obstetric-related guidelines, including CG19O. [ hope this information is helpful You may also wish to know that NICE is currently developing new guidance on intrapartum care for high-risk women"_ which covers intrapartum care for women with an SGA baby (fetal monitoring), interpretation of CTG traces, and transfer of care (for example, via the ambulance service) NICE expects to publish the guidance in March 2019. In terms of the local response, I am aware that the Portsmouth Hospitals NHS Trust is working to implement an action plan in response to the issues raised by this incident and oversight is being provided by NHS Improvement I will not repeat the Trust' $ response here but trust that it answers the concerns you have raised at a local level. www nice org uklguidance indevelopmentgid-cgwave0613 last system

[ hope this reply is helpful Thank you for bringing the circumstances of baby Rafe Angelo's death to our attention. ad & ga T repo+ Jouue JACKIE DOYLE-PRICE Jey -

Dear Mrs Harold Further to your report dated 27ih November 2017 following the inquest into the sad death of Rafe Robbie Angelo, please now find our response to your concerns below: 'Discretion of SCAS call handlers if time critical factors are mentioned but birthing centre staff do not actually request a time critical transfer is requested:" As you are aware, the Standard Operating Procedure (SOP) in place at the time of the request from Blake Birthing Centre was dependent on the Midwife making the call and requesting a "time critical transfer" (TCT) This request would invoke the TCT SOP and prioritise the call s0 that it will take priority over any other incoming call to the Emergency Operations centre. This priority of call would also mean that a Dispatcher would divert a resource away from another Category call in the community (e.g: paediatric respiratory cardiac arrest) to respond to this event should there be no other suitable resource available_ Following your report; we have reviewed the SOP ad updated it so that any Health Care Professional (HCP) requesting an Inter-facility transfer (i.e. Hospital or Birthing Unit) who asks for an emergency immediate response will now be asked "Do you require a Time Critical Transfer?" Due to the known risks associated with obstetric cases, Midwives will be asked whether the case is time critical when they call from a patient's home as well as a standalone birthing centre. If the HCP answers positively then the Emergency Call Taker (ECT) will prioritise the call the TCT pathway and will process the call as a Category response. This questioning will act as a prompt to the HCP and ensure that where patient is for example in hospital where treatment cannot be given for their condition, such as requiring transfer to Hyper-acute stroke unit (HASU), the resource will be allocated in line with their condition. If the request is being made through a third party, they will be instructed to ask the HCP directly if a TCT is required: The new Standard Operating Procedure and Clinical Directive has been sent to all staff in the Emergency Operations Centre. A mail drop will also be issued to all Emergency Departments and Birthing units across the South Central Area to remind all HCP's of the correct process to request a Time critical transfer. 'Clarification of what would be classified as urgent non-urgent or an emergency in the transfer policy' Itis not possible to provide an exhaustive list of diagnoses and circumstances that would or would not be classified as a time critical transfer due to the complex nature of medical care. However; as above, the ECT who is taking the call will now be speaking to clinician and will ask the Registered Headquarters: and 8 Talisman Business Centre, Talisman Road, Bicester 0X26 6HR using

clinician whether the case is time critical: This is designed to ensure that the appropriate response is provided to the patient. As you will recall, the issue in the index case was that neither party involved in the call was clinically trained; with one party also unfamiliar with the TCT process: The Trust has provided the below list of diagnoses &d circumstances as a guide to EOC staff. ECT's are also instructed that if they do not understand what the medical condition is, assistance must be gained from the Clinical Support Desk Primary or rescue cardiac angioplasty (PCI) Vascular emergencies ruptured abdominal or thoracic aortic aneurysm Or aortic dissection transection Immediate cardiothoracic surgery for stab gunshot wound or emergency cardiac surgery Major trauma management (e.g: transfer of severely injured patient to regional major trauma centre) Paediatric sepsis when retrieval service is not available Neurosurgical transfer for evacuation of inter-cranial haematoma, management of sub- arachnoid haemorrhage or neurosurgical intensive care Transfer from midwifery Led Unit to Obstetric Delivery suite for fetal or neonatal distress anti-partum or post-partum haemorrhage or maternal or neonatal medical emergency Stroke Eligible for thrombolysis or mechanical thrombectomy (if not provided on site) To ensure that TCT requests are made by clinicians and are made in appropriate circumstances, as well as the mail drop described above, requests for inter-hospital TCT's will now be audited by SCAS and feedback will be provided to acute Trusts and commissioners when there is discrepancy between the information provided when the request was made and the clinical condition of the patient when SCAS arrive. This is because it is important to ensure that SCAS resources are used appropriately and are not diverted from medical emergencies in the community unnecessarily: This process will also identify at an early stage occasions where re- education or further engagement with acute Trusts is required 'Consider where the "Use of Standby Points policy needs to be refreshed to make it clearer and more consistent' In response to this point; the Trust has reviewed the said policy and amended section 7.13 which previously read:
7.13 Staff requests for facilities will be accommodated and honoured where reasonable; these will be at the most locally Trust recognised star facility in the area unless specific requirements for welfare create a need to return to another suitable location: for example change of uniform or health requirements. A request for facilities use and welfare is a shared staff and EOC responsibility: to confirm that it will not be considered reasonable to request the use of facilities where a crew has been dispatched to a Time Critical or Category _ call: understand that Miss Saunders has already informed you that making changes to this policy requires review by staff union representatives in addition to senior members of the operational team: The final review will take place on 13th February 2018 and we will of course forward a copy of the amended policy to you once it has been finalised. hope that this letter has addressed your concerns, but please do come back to me if you wish to discuss this matter further.