Prevention of Future Deaths reports · 2016
Regulation 28 report to prevent future deaths, reference 2016-0240, written 30 Jun 2016. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 30 Jun 2016 |
|---|---|
| Reference | 2016-0240 |
| Deceased | Dominic Smith |
| Coroner | Lisa Hashmi |
| Coroner area | Manchester North |
| Category | Child Death (from 2015) · Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Pennine Acute Hospitals NHS Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Chief Executive, Pennine Acute Hospitals NHS Trust 2. Department of Health, London 3. Royal College of Obstetricians 4. Royal College of Paediatricians 5. National Institute for Health and Clinical Excellence CORONER I am Ms L Hashmi, Area Coroner for the Coroner area of Manchester North. 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroner’s and Justice Act 2009 and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST On the 2th0 June 2016 I commenced an investigation into the death of baby Dominic Smith. 4 CIRCUMSTANCES OF DEATH The deceased’s mother had been in the latent phase of labour for approximately 4 days. At inquest I found that she had suffered a pre-labour rupture of membranes (hind waters) on or around the 218h May 2015. She was admitted to the birthing centre on the 1st June. Over the course of the night the CTG trace showed that the baby was in distress and the decision was taken to move mother of theatre for a trial of forceps delivery with a view to proceeding to Caesarean section if necessary. Instrumental delivery was successful and baby was born on the 2nd June 2015 at 04:11. He was in good condition with APGARS of 9/9/9. At 09:00 on the 2 June baby had a ‘dusky episode’. Neonatal observations were not commenced and he was not referred to the paediatrician. By early evening baby was sleepy and reluctant to feed. He was settled into his cot and both mother and baby fell asleep. Mother awoke at around 21:00 and noted that baby’s hand was cold. He appeared to be fast asleep at this point. At 21:40 the night HCA attended mother and immediately noticed that baby was cold and blue. She called for help from a more senior HCA who raised the alarm, picked baby up and ran with him towards the resuscitation area. BLS was commenced by the Midwives and a ‘crash call’ put out. The crash team arrived promptly and ALS commenced. Resuscitation was unsuccessful and the fact of baby’s death was confirmed at 22:11 on the 2d June 2105. The cause of death following post mortem was la) Pneumonia. Conclusion at inquest: Narrative with a rider of Neglect: The deceased died at the Royal Oldham Hospital at approximately 18 hours of life (date and time of birth 04:11 on the 2nd June 2015). Staff did not recognise or identify pre-labour rupture of hind water membranes (PROM) in his_mother,_treatment_was_not_instigated_and_protocols/guidance_were_not_followed. Maternal observations were not conducted post-delivery, despite a raise in the mother’s temperature at or round the time of baby’s birth. The evidence demonstrated that infection could pass during the course of delivery from mother to baby. Subsequent tests in the mother showed Enterococcal (urine) infection but were negative to Group B Streptococcus (CBS). When Baby Smith showed notable signs of deterioration at around 09:00 on the 2nd June 2015, neonatal observations were not commenced and he was not escalated to a paediatrician or neonatologist for review. Timely antibiotic therapy was not instigated. Baby Smith was found collapsed in his cot at 21:40 on the 2nd June. Basic and advanced life support were commenced but proved unsuccessful. Treatment was withdrawn and the fact of baby’s death was confirmed at 22:11. Neglect more than minimally contributed to Baby Smith’s death. The Root Cause Analysis (RCA) investigation identified a number of other failings that were not causally linked to baby’s demise. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows:- Department of Health, NIHCE and the Royal Colleges: 1. I previously completed a PFD 13 month ago in relation to a neonatal GBS death. At that time I raised the following concerns: That antenatal screening for GBS was not being routinely offered by the NHS to all pregnant - women during the final weeks of pregnancy, That prophylaxis intrapartum antibiotics were not routinely offered to all women who test positive - for CBS (or have done so in the past) & 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. During the course of the inquest into Baby Smith’s death the evidence suggested that no further action has been taken in this regard, despite the responses received in relation to the last PFD Form. I therefore raise the issues again as a concern. Pennine Acute Hospitals NHS Trust: 1. During the course ofthe inquest into Baby Smith’s death, the following concerns arose: Inadequate communication, handover and record keeping; - Staff did not follow the Trust’s protocols/guidance and did not document their rationale where - they exercised clinical discretion; 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; Early warning scores were i) miscalculated, ii) not acted upon; - 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; Maternal observations were not carried out after delivery, despite a spike in temperature; - Midwives did not escalate to or consult with the Obstetrician/Paediatrician/Neonatologist - & Inadequate preceptorship for newly qualified (and particularly part-time) Midwives. - 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe each of you respectively have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by the 2th4 August 2016. I, the Coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons namely: Baby’s parents - CQC - GBS Support - - I am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary from. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me the coroner at the time of your response, about the release or the publication of your response by the Chief Coroner. Date: 3th0 June 2016
2 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
RCP H Royal College O 5-11 Theobalds Road Paediatrics and Child Health London WC1X 8SH s-. Ms Li Hashmi Area Coroner Greater Manchester North The Phoenix Centre L/Cpl Stephen Shaw MC Way Heywood CL 10 1LR 2 August 2016 Dear Ms Hashmi Re: Baby Smith, deceased Regulation 28 Report 3th0June 2016 — I have read carefullyyour 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 ofthe 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 ofany 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 ofconcern: 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 ofall 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 ofthe 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 ofantenatal care within the UK and that major organisational changes and newfunding 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 ofearly-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 ifthey 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 ofthe illness, in the absence ofa 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 ofage) infection in newborn infants. A Cochrane review in 2014, however, concluded that, while lAP for colonised mothers reduced the incidence ofearly 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 forthe prevention and treatment ofearly-onset neonatal infection (CG 149) sets out how to monitor risk factors for EOGBS during labour. It statesthat a clinical assessment should be carried out without delay ifthere are any clinical indicatorsfor EOGBS including a review ofthe maternal and neonatal history and a physical examination ofthe baby including an assessment ofthe vital signs. The guideline also states that ifclinical concern increases, consideration should be given to performing necessary investigations and starting antibiotic treatment, adding that ifa baby needs antibiotic treatment it should be given as soon as possible and always within one hour ofthe decision to treat. Thank you for raising this important case and reminding us ofthe importance ofthis work. Yours sincerely, /- ProfessorJudith Ellis MBE RCPCH Chief Executive
Priden Tk’J The Pennine Acute Hospitals Pefl fl I fl NHSTrust If calling please ask for: Trust Headquarters Professor North Manchester General Hospital Delaunays Road Crumpsall Direct line I Ext: Manchester M85RB Our reference: HMC1951 Date: 2n2d August 2016 Confidential Mrs L Hashmi H M Area Coroner The Phoenix Centre LJCpI Stephen Shaw Way Heywood OL1O 1LR 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. -- Pride ri The Pennine Acute Hospitals [A!J.’lLl J’efl fl I fle 4HSTrust 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 outwhen 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 7114i The Pennine Acute Hospitals Pennirie NHSTrust 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. •••• P1ride The Pennine Acute Hospitals T111’I Penr’ e ifl NHSTrust 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 oftheir 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. Yours sincerely Executive Medical Director ..;..
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