Source · Prevention of Future Deaths

Arthur Brockett-Deakins

Ref: 2014-0077 Date: 25 Feb 2014 Coroner: Andrew Harris Area: London (Inner South) Responses identified: 4 / 4 View PDF

Midwives failed to timely escalate abnormal CTG results due to misapplication of guidelines and inadequate training. Concerns also arose about CTG machines potentially misinterpreting maternal heart rate as fetal heart rate.

Date 25 Feb 2014
56-day deadline 22 Apr 2014 est.
Responses identified 4 of 4
Hospital Death (Clinical Procedures and medical management) related deaths

Coroner's concerns

AI summary
Midwives failed to timely escalate abnormal CTG results due to misapplication of guidelines and inadequate training. Concerns also arose about CTG machines potentially misinterpreting maternal heart rate as fetal heart rate.
View full coroner's concerns
During the course of the inquest the evidence revealed matters giving rise to concern: _ 1, When to escalate concerns about a CTG: With regard to not escalating an abnormal CTG that ran for about half an hour after augmentation of labour, reliance was placed by midwives on a clause of NICE Clinical Guidelines; Intrapartum Care, 2007 , which advises that a 40 minutes trace shouldbe studied before concluding if it is abnormal. Expert evidence from Dr and Msl suggested that this guidance was appropriate in the first stage of labour; but not in the context in this case, namely a slow second stage. Training of one midwife in CTG interpretation: Both midwives underwent voluntary further training and supervision, including an expert workshop on CTG interpretation. Both accepted that a number of errors had been made by them and applied the learning to their current practice. However even in retrospect; one of the midwives could not accept that the early CTG trace was pathological, as held by both expert obstetrician and midwife. Although she would refer now; there is doubt about the urgency. She said in court it would be within half an hour but also that 40 minutes was needed to see if it was abnormal_ The expert midwife said that she needed further training on CTG interpretation.
3. Display of MHR as FHR on CTGs: Ms_ explained that if the foetus moves of the range of the ultrasound field or the baby has sadly dies, the ultrasound transducer may then pick up the maternal pulse from the aorta, iliac or uterine and it is displayed as the FHR and can show reactivity and variability due to MHR changes and muscle contractions can be difficult to distinguish from the FHR_ It is known that the rate can be doubled or halved the out artery

The only explanation that both expert midwife and expert obstetrician could reach for the unusual CTG trace after Ipm, in the context of the state of the baby at birth, was that the maternal pulse rate was masquerading as the FHR but it had been multiplied by 1.5. The CTG machine was not of the type that is known rarely to multiply by 2 and the phenomenon of a multiplication by a factor other than 2, being unknown to both experts in their long distinguished careers_ Evidence was not heard from the manufacturer or the product's regulatory authority: The inquest heard that new CTG machines incorporate maternal ECG or pulse oximetry, which alerts staff t0 investigate when MHR and FHR appear the same: But it also heard that it will take some time before all old machines are replaced_ It needs to be established if multiplication by 1,5 is a possible functional feature of some machines and if so whether either it can be designed away or whether dissemination or guidance or an action by the regulatory authority is needed to prevent it leading to a fatality or child disability_ Models of private midwifery led services for low risk pregnancy: private midwifery caseload for low risk pregnancies was managed by a pair of midwives who set up the servicer to provide continuity of care midwifery service that was operating when) was pregnant was not adequately documented No job description was seen by the court and the referral and operational arrangements were discussed, but no documentation was brought to the court: There was no evidence of risk assessment: Although NHS employees were required to be self sufficient in terms of annual leave and sickness cover; on call arrangements and use of NHS personnel except in emergencies. They did not at the outset have a link obstetrician_ This led to fear of burn out, a sense of isolation and lack of support and collegiality. When they transferred babies to the Hospital Birthing Centre; they were expected to refer to a duty obstetric consultant; access to whom was described as variable The midwife in charge of the NHS unit agreed that she provided a different threshold of care to private and NHS mothers and was reluctant to intervene or review the care plan for augmentation of labour; which she would have done in an NHS patient: The midwives expected her to be involved but did not ask her. In the event no peer senior midwife or obstetrician sawi which was necessary. The reasons for non referral were complex and were not because the midwives thought they could not refer_ Misjudgements were made which in part were caused by a 15 hour shift with only a 40 minute break This would not occur in contexts where there was normal NKS management of staff;, but this arrangement continued apparently unknown to the NHS Trust management: The service is no longer operational, the Trust reporting that it was discontinued for economic reasons_ Expert advice considered that the model of service created a riskof deaths_ although it was not found to have directly done so in this case_ Dri reported that there were similar units operating elsewhere in the country and that the lessons the difficulties in operating this one should be disseminated to other such units. expert midwfe Ms was particularly concerned about adequate support and cover_ Dr was particularly concerned about the isolation and professional culture and Iack of interdisciplinary peer discussion, in the context of increasingly risks in obstetric and midwifery practice. The Trust head midwife reported that she expected that the matter would now be dealt with robustly by the statutory supervision system_ No evidence was heard about whether this was now effective in this regard, nor how influence and information could be brought to bear on those setting up or managing such midwife led services_ It was further reported that not all midwives are members of the College that runs supervision and that midwives are not necessarily practising within the

Responses

4 respondents
N.I.C.E Other
21 Mar 2014 PDF
Action Planned

NICE is currently updating its clinical guideline on Intrapartum Care (CG55) and the progress of the update can be monitored via their website. They will consult on the draft recommendations with stakeholders between 13th May - 24th June 2014 and the final guideline will be published in October 2014. (AI summary)

View full response
Dear Dr Harris, Re: William Arthur BROCKETT-DEAKINS (Deceased) Coroners Regulation 28 Notice has asked me to respond to your letter: Although cannot comment on individual cases, was sorry to Iearn of William's death, and hope the following information helps to explain our guidance, and our process for reviewing and updating recommendations_ As you are aware; the NICE clinical guideline on Intrapartum Care (CG5S) states that 40 minutes should elapse if the cardiotocography feature of concern is 'lack of baseline variability' _ The guideline also recognises that there are other abnormalities of the cardiotocography which do not require 40 minutes for concerns to be raised, such as, a baseline fetal heat rate that is outside the normal range; or decelerations of the fetal heart rate_ Where there is clear evidence of fetal compromise, for example, prolonged deceleration of the fetal heart rate, greater than 3 minutes, urgent action should be taken and preparations should be made to urgently expedite the birth of the baby: In relation to fetal monitoring, in the presence of oxytocin, the NICE guideline states, if the fetal heart rate trace is normal, oxytocin may be continued until the woman is experiencing 4 or 5 contractions every 10 minutes. However, oxytocin should be reduced if contractions occur more frequently than 5 contractions in 10 minutes If the fetal heart rate trace is classified as suspicious, this should be reviewed by an obstetrician and the oxytocin dose should only continue to increase to achieve 4 or 5 contractions every 10 minutes: If the fetal heart rate trace is classified as

NICE National Institute for 10 Spring Gardens Health and Care Excellence London SWIA 2BU United Kingdom +44 (0)845 003 7780 pathological, oxytocin should be stopped and a full assessment of the fetal condition undertaken by an obstetrician before oxytocin is recommenced_ The definition of suspicious and pathological is set out in the NICE clinical guideline (CG55). The NICE clinical guideline on Intrapartum Care (CG55) also states, that the maternal pulse should be palpated, on initial assessment in labour and during labour; if there is suspected fetal braycardia or any other fetal heart rate anomaly; to differentiate between maternal and fetal heart rate We review all of our guidance at regular intervals and also consider feedback and requests for updates where this is appropriate_ Our clinical guideline on Intrapartum Care (CG55) is currently being updated: The progress of the update can be monitored via our website (http Ilguidance nice org:ukICGWaveR/109): The team working on updating this guideline re-examined the evidence on fetal assessment and monitoring during labour: This specifically includes cardiotocography on admission to the labour ward and during labour and the definition and interpretation of the features of fetal heart rate trace. Whilst | am not able to anticipate the outcome of the final guideline, can report that we have found no evidence to support a significant change in the recommendations but have been further strengthened where appropriate. We will consult on the draft recommendations with stakeholders between 13th May 24th June 2014 and the final guideline will be published in October 2014. We have confidence that our guidance, correctly implemented, will provide the best outcomes for patients but clinicians retain the responsibility for their decisions. NICE Clinical Guidelines are not mandated and clinical staff can depart from them if there are appropriate and documented clinical reasons for doing so. With kind regards, Programme Director, Centre for Clinical Practice have they
Medicines Healthcare Products Regulatory Agency Other
14 Apr 2014 PDF
Noted

The MHRA states that the incident was not reported to them and that the CTG model was placed on the market by Philips Healthcare and sold in the UK between 1992 and 2006. They included a Safety Notice from August 2002, warning of risks associated with the interpretation of CTG traces. (AI summary)

View full response
Dear Dr Harris Regulation 28 Report: William Arthur Brockett-Deakins (deceased) Thank you for your Regulation 28 report of 26 February which we received on 3 March 2014. Here is my reply to your Matters of Concern (3): This incident occurred in 2007 and it was not reported to MHRA by Guy's and St Thomas' NHS Trust or any other organisation: As the make and model of the cardiotocograph (CTG) device was not specified in vour report; we asked your Officer) on 11/3/2014 if this detail was known_ informed uS on 28/3/2014 that the CTG model in use was a M1353A. This was a popular model of CTG machine and was placed on the market by Philips Healthcare and sold in the UK between 1992 and 2006. We contacted Philips Healthcare to establish if they were made aware of this incident at the time and if S0, whether had inspected the device to confirm it was working correctly. Philips Healthcare found no notification of this incident in their records thus they did not inspect the device One of our predecessor Agencies, The Medical Devices Agency (MDA), published and disseminated a Safety Notice to relevant healthcare professionals in August 2002, warning of the risks associated with the interpretation of CTG traces. This Safety Notice, MDA SN2002(23), was extant in 2007 and a copy is appended to this letter: This Safety Notice was an update to earlier advice as adverse incident reports received by the MDA in 2002 indicated that CTGs were still being incorrectly relied upon to monitor foetal heart rate. Five reports were received in 2002 where CTGs had produced an apparently normal trace during labour but the baby was delivered stillborn. In all these cases the baby had been dead for a number of hours. Two cases showed values of twice the maternal heart rate (MHR x
2) and three cases showed values of one and half times the maternal heart rate (MHR x 1.5), although there has been some dispute as to the source of these signals It is however well known that CTGs can display twice the maternal heart rate (MHR x 2) and half the foetal heart rate (FHR +2) CPRD NIBSC MHRA they

However;, MHR multiplied by one and a half is confusing artefact that can be difficult to recognise. It appears that when there is no foetal heart beat the CTG may respond to a weak signal derived from a combination of the maternal aorta, iliac and uterine arteries Our advice on CTG use was revised in 2010 to become MDA 2010/054, and is our current advice_ The reference to the MHR x 1.5 artefact was removed from MDA 2010/054 as there had been no further reports received since SN2O02(23) was published. Modern CTG units now incorporate maternal ECG or pulse oximetry functions and many have prompts to double-check if readings of MHR x 2 occur: It is possible that some older units remain in clinical use but there is insufficient evidence provided by users and manufacturers for MHRA to advise that they should be removed from use. In June 2013, MHRA published a special maternity edition of 'Qne Liners', which again highlighted the issues of interpreting CTG readings. For information; the National Institute for Health and Care Excellence (NICE) guidance on intrapartum care was also updated in 2007 , (CG55, section
1.12) http Ilpublications niceorg_uklintrapartum-care-cg55/quidancett16-normal-labour-first-stage hope this information gives you the assurance that we have appropriate safety advice available to those using CTG medical devices_
NMC Regulator / Inspectorate
16 Apr 2014 PDF
Action Planned

The Nursing and Midwifery Council (NMC) will treat the information about one of the midwives as a new referral and investigate. A local supervisory authority (LSA) would be alerted to serious incidents of this nature via their database system and there is a link to the LSA for every maternity service in London who would provide guidance to a supervisor of midwives when a serious incident occurs. (AI summary)

View full response
Dear Dr Harris Arthur Brockett Deakins (deceased) Thank you again for your letter dated 26 February 2014 concerning the inquest into the death of Arthur Brockett Deakins_ You sought our input on two specific matters. Training of one midwife in CTG interpretation You are concerned that one of the midwives; could not accept the CTG trace was pathological, as was held by the expert evidence. There was also concern about the acknowledged urgency with which she would refer an issue in future_ The expert midwife who gave evidence to the inquest also said that needed further training in CTG interpretation. Where concerns are raised about a registrants fitness to practise, the NMC will take appropriate action in order to fulfil our statutory duty to protect thepublic In this case, can confirm that we will be treating this information about @as a new referral which will be investigated. We are able to do this because this is new inforation which has not previously been considered by us. Please let me know if you would wish to be joined as an 'interested party' to this referral so that my fitness to practise colleagues can you updated regarding the progress of the case The NMC will not; however; be able to consider the actions of either midwife in relation to the death of Arthur: This is because this aspect of the referral was considered and closed, by our investigating committee (IC) in 2009. Since the case was closed over three years ago_ it cannot be reconsidered by the IC under rule 7(1) of the NMC's Fitness to Practise Rules 2004. There is also no evidence of an error which would allow us to remit the case back to the committee in accordance with the case law in this area (R (on the application of B) v NMC [2012] EWHC 1264 (Admin)): 23 Portland Place; London WIB 1PZ T+44207637 7181 F+44207436 2924 wwwnmc-ukorg nursing and midwifery regulator for England, Wales; Scotland, Northern Ireland and the Islands Registered charity in England and' Wales (1091434}and in Scotland (SC038362) keep fully; The

Models of private midwifery care As the regulatory body for nurse and midwives, the NMC is not in a position to offer a View on the models of midwifery care offered in private and NHS settings and | think that references to this particular area of your report would be more addressed by colleagues at the Department of Health. appropriately As regards comments about the system of statutory supervision; the reported comients of the trust head of midwiery at the inquest do reflect that the approach to handling a similar issue has evolved since Arthurs birth in 2007 . Currently the local supervisory authority (LSA) would be alerted to serious incidents of thisnature via their database system and there is a link to the LSA for every maternity service in London who would provide guidance to a supervisor of midwives when a serious incident occurs_ A serious incident of this nature would also trigger a supervisory investigation which would be reported to the local supervisory authority midwifery officer. understand the lead supervisor of midwives for the London area that there were no separate supervisory investigations undertaken at the time of Arthurs birth. Furthermore, there were_no guidelines in place at that time forehe conduct of supervisory investigations There is now policy and training in placeeon supervisory investigations IRiccorrect to state that not all midwives are members of the Royal College of Midwives (RCM However the RCM is a body that represents midwives professionally; it does not oversee the supervisory mechanism and membership of this body is not a pre- requisite to practising as midwife. All midwives wishing to practice must be registered withthei NMC Supervision is a statutory responsibility undertaken by local supervising authorities and, as the regulator, the NMC sets rules and standards for the functions of the LSAs. hopeethat this response is helpful: Please do not to hesitate to contact me again if can provide any additional information,
Department of Health Central Government
9 May 2016 PDF
Noted

The Department of Health acknowledges the coroner's concerns and notes that NICE has responded on CTG interpretation. They explain the role of statutory supervision of midwives and state the NMC is reviewing this. (AI summary)

View full response
From Rt Hon Jeremy Hunt MP Secretary of State for Health Department of Health Richmond House 79 Whitehall London POCI 846082 SWIA 2NS Tel: 020 7210 3000 Mr A Harris Mb-sofs@dhgsigovuk Senior Coroner Southwark Coroners Court 1 Tennis Street Southwark London 9 MAY 2016 SEI 1YD L_ IL/ Thank you for your letter following the inquest into the death of baby William Arthur Brockett-Deakins In your report you conclude that William died from respiratory failure, chest infection and perinatal hypoxic ischaemic encephalopathy (HIE): William died in October 2011 from respiratory problems These problems and his disabilities were a direct result of acute profound perinatal HIE, which was not due to any inherent condition of the baby or mother or any antenatal factors William had been born in a pOOr condition on 16 December 2007. He initially required resuscitation and ventilation. He survived but was brain damaged, severely disabled with seizures, spasms, visual and hearing impairments, feeding and respiratory difficulties requiring constant medical and parental support, His condition was incurable and he received all the treatment that was in his best interests, You describe the management of the mother's labour by the midwives involved and detail failures of care and neglect; including a failure to refer issues relating to cardiotocograph (CTG) tracings to an obstetrician and a consecutive midwife attendance of 15 You also accepted the expert evidence that there was an opportunity to render care, which if taken by a certain time, on the balance of probabilities would have prevented the tragedy from occurring: William would not therefore have died of HIE when he did. Inote that you have sent your letter to several organisations and have asked each to consider specific concerns I am aware that the National Institute of Health and Care Excellence (NICE) has already responded on its clinical guideline on Intrapartum Care (CGSS) and the issues relating to CTG interpretation: The Nursing and the hours _

Midwifery Council (NMC) has also replied, addressing the training of one of the midwives in CTG interpretation and explaining the current system of midwife statutory supervision; You raise the following matter of concern both for my attention and that of the Nursing and Midwifery Council: Models of private midwifery led services for low risk pregnancy. Expert advice considered that the model of service created a risk of deaths It is not clear how the risks are best identified and managed across a mixed health economy, which is why the Secretary of State is an addressee of my report As the NMC has already suggested, this is more appropriately addressed by my department: The model of midwifery provision described in this case was and is unacceptable and, for the reasons cited in the Regulation 28 Report, unsustainable. When this incident occurred in 2007 the Trust had a of two midwives providing care to private patients who requested midwifery-led care. This was discontinued in July 2010 and no longer operates. The model is not known to exist elsewhere in England. The issue of statutory supervision of midwives is, as the Report points out; important but needs some clarification: All midwives arc registered with the Nursing and Midwifery Council (NMC) and are required, by law, to have statutory supervisor: All practising midwives are required to meet their statutory supervisor at least once a year (or more frequently, if either party wishes to discuss issues of concern caseload and practice for example): This annual discussion ensures the midwife is up-to-date in his or her sphere of practice and results in the supervisor of each midwife making a decision about the midwife's continuing fitness to practice. Provided the midwife is fit to continue practising the statutory supervisor enters the annual review on the NMC database and confirms that the registrant has undergone supervision and is fit to practice. The consequence of this is that the midwife $ name has a statement next to it which confirms that the midwife is entitled to provide midwil care until a certain date (limited to one year from the date of statutory supervision most run until 31st March each year) This is not however a performance review O appraisal in the managerial sense Statutory supervisors of midwives are not usually the managers of the midwives are supervising: Your report states that "not all midwives are members of the College that runs supervision" . While it is true that not all midwives are members of the Royal College of Midwives (RCM), the RCM does not regulate the profession. The RCM is a union and there is no requirement for midwives to join. system system fery they

Department of Health This disconnection between statutory supervision and performance management of midwives was of concern to the Parliamentary and Health Service Ombudsman in her report on maternity care in Morecambe She published her report Midwifery supervision and regulation: recommendations for in December 2013 which has initiated a national review of statutory supervision which is led by the NMC. In order to practise midwifery all midwives must; by be registered with the NMC. This applies regardless of where practise, including the NHS, the private sector, in a social enterprise or as an independent self-employed practitioner: midwife registered with the NMC is subject to statutory supervision regardless of where 'practise. As the regulator of the profession, the NMC has the authority to place conditions on or suspend the ability to practise Or remove a midwife from the register: The midwives involved in this case were referred to the NMC in 2009 by the family: The case was reviewed and was not taken to a full hearing by the NMC. I hope that this response is helpful and I am grateful to you bringing the circumstances of William 's death to my attention. Yv 5s JEREMY HUNT Bay. change- being law, they - Every they- for

Report sections

Investigation and inquest
On 21.10.11, opened an inquest into the death of baby Arthur Brockett-Deakins, aged 3 years, who died on 18th October 2011. Proceedings were delayed by legal challenge and delays in securing disclosure. The inquest was concluded on 2Oth January 2014 Arthur died from: 1a Respiratory failure 1b Chest infection 1c Perinatal hypoxic ischaemic encephalopathy
Circumstances of the death
booked for her first pregnancy with the private caseload team shared by two Band midwives at St Thomas Hospital;, the service being designed to promote continuity of care. Baby Arthur Brockett Deakins was born in a poor condition at 14.45 on 16th December 2007 and initially required resuscitation and ventilation. He survived, but was brain damaged, severely disabled with seizures, spasms, visual and hearing impairments, feeding and respiratory difficulties and requiring constant medical parental support until His condition was uncurable and he received all the treatment that was in his best interests. He died on 18th October 201 at home from respiratory problems, these and his disabilities being a direct result of acute profound perinatal hypoxic ischaemic encephalopathy; which was not due to any inherent condition of the baby or_mother_or_any antenatal factors and

Iwas admitted in labour, after an unremarkable pregnancy: She was transterred to the hospital birthing centre at having progressed to 9cm dilation, for augmentation with Syntocinon and her labour was managed both midwives together_ There was no case management discussion (or examination of cardiotocograph (CTG) and records) about starting Syntocinon between the case midwives and midwife in charge of the unit, as required in the Trust guidelines, this being a failure of care which contributed to HIE and amounted to neglect The Syntocinon was started at the same time as the CTG was attached at 11.40 and the dose was progressively increased three times up to 2.4 mls per hour at 12.50 and then again at 1.30. These increases caused hypertonicity and hyperstimulation, which impaired the blood supply to the baby, causing HIE. These increases in Syntocinon and the failure to recognize the hyperstimulation, which was evident considering the records of frequency of contractions reached 6 in 10, amounted to neglect: accepted the expert evidence that there was an opportunity to render care; which if taken even at 12.50 would on balance of probabilities have prevented tragedy from occurring so that Arthur would not have died of HIE when he did. The CTG tracing was not normal from the outset; but there were some features which understandably reassured around 12.10. After pm the trace was at the very least atypical and the midwives had not realized that the machine was no longer displaying the foetal heart rate (FHR) but had picked up and multiplied the maternal heart rate (MHR): This phenomenon was rare and unexpected and the mistake could easily be made: Nevertheless the tracing at this time was sufficiently abnormal to require referral to an obstetrician. The failure to refer to an obstetrician when the CTG required it more than minimally or trivially contributed to the development of acute profound HIE and amounted to neglect Midwifery attendance of labour for 15 consecutive hours, with one 40 minute break, has contributed to some or all of these failures_

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Report details

Reference
2014-0077
Date of report
25 February 2014
Coroner
Andrew Harris
Coroner area
London (Inner South)

Responses identified

Responses identified 4 of 4
All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 22 Apr 2014 (estimated).

Sent to

Department of Health and Social Care
General Midwifery Council
Medicines and Health Regulatory Authority
National Institute for Clinical Excellence

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