Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0277, written 26 Jul 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 26 Jul 2023 |
|---|---|
| Reference | 2023-0277 |
| Deceased | Finley May |
| Coroner | Paul Marks |
| Coroner area | East Riding and Hull |
| Category | Child Death (from 2015) · Hospital Death (Clinical Procedures and medical management) related deaths |
| 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) NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. 2. , President, Royal College of Obstetricians & Gynaecologists , Chief Executive of NHS England 1 CORONER I am Professor Paul Marks, Senior Coroner, for the Coroner Area of City of Kingston Upon Hull and the County of the East Riding of Yorkshire. 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST On 24th May 2021 I commenced an investigation into the death of Finley Austin May, aged 28 days. The investigation concluded at the end of the inquest on 30th June 2023. The narrative conclusion of the inquest was: Finley Austin May was born the 16th of February 2021 having been delivered by use of Keilland's rotational forceps. He was floppy, bradycardic, and blue at the time of delivery, and underwent resuscitation according to the neonatal life support algorithm. He was treated as a case of hypoxic ischaemic encephalopathy, but his clinical picture was at variance with this condition and he was investigated for other disorders. A MRI scan showed the presence of a high cervical spinal cord injury, which was caused by the use of Keilland's obstetric forceps. He died at Hull Royal Infirmary, Anlaby Road, Kingston Upon Hull, on the 16th of March 2021 as a result of his spinal cord injury. The medical cause of death was determined as follows: 1(a): High Spinal Cord Injury due to Keilland's Forceps Delivery 1(b): Malposition and Prolonged Labour II: Hypoxic Ischaemic Encephalopathy 4 CIRCUMSTANCES OF THE DEATH These are set out in my summary and findings of facts which are attached. 1 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. – (1) The Hull and East Yorkshire NHS Trust has abandoned the use of Keilland’s forceps since Finley’s death and evidence was heard that other NHS trusts have also done so, Nevertheless, some have retained them. (2) Evidence was heard that the use of these obstetric forceps can facilitate delivery from the mid-pelvis in cases of malrotation, asynclitism and where the lie is occipito- transverse or occipito-posterior, and this is a well-accepted practice. (3) Evidence was heard that such malpositions can be corrected manually, or by the use of the Ventouse suction apparatus, but the evidence adduced was that these alternative techniques may be inferior to the use of Keilland’s forceps in skilled and practiced hands; this might mean increased risk to both mother and baby. (4) Continued use of Keilland’s forceps may be the most appropriate way to manage this obstetric problem but there should be increased awareness of complications associated with its use and guidance issued about the minimum number of cases per annum needed to maintain skill levels coupled with guidance for training. (5) If NHS trusts have abandoned the use of Keilland’s forceps, clear guidance should exist about alternative methods of managing malrotation and asynclitism. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you and your organisation has 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 Thursday, the 21st day of September 2023. 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 following Interested Persons: • • , Capsticks, Counsel for Humber NHS Trust , Family Counsel I have also sent it to the local child safeguarding officer, . 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 form. 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. 9 26th July 2023 2
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.
Professor Paul Marks
East Riding and Hull Coroner’s Service
The Guildhall
Alfred Gelder Street
Hull
HU1 2AA
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
20 September 2023
Dear Coroner,
Re: Regulation 28 Report to Prevent Future Deaths – Finley Austin May who
died on 16th March 2021.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 26 July
2023 concerning the death of Finley Austin May on 16th March 2021. In advance of
responding to the specific concerns raised in your Report, I would like to express my
deep condolences to Finley’s parents and family. NHS England are keen to assure the
family and the coroner that the concerns raised in your Report been listened to and
reflected upon.
Your Report raised that the use of Kielland’s rotational forceps resulted in high spinal
cord injury leading to the death of Finley. During the course of the inquest, evidence
was heard that the use of these obstetric forceps can facilitate delivery from the mid-
pelvis in cases of malrotation, asynclitism and where the lie is occipito-transverse or
occipito-posterior, and that this is a well-accepted practice.
The Royal College of Obstetricians and Gynaecologists (RCOG), who I note you have
also addressed your Report to, published clinical guidance to support obstetricians
and gynaecologists to deliver high quality care. Their guidance on evidence-based
recommendations for assisted vaginal birth can be found here: Assisted Vaginal Birth
(Green-top Guideline No.26). Following several adverse incidents, in June 2023,
RCOG posted an update to this guidance, encouraging clinicians to review and
consider their obligations around the use of Kielland’s rotational forceps. The update
states that rotational births using Kielland’s forceps should only be performed by
experienced operators or under the direct supervision of an experienced operator. An
ultrasound assessment of the foetal head position prior to the application of the forceps
is also advised.
NHS England accepts RCOG’s advice that delivery using Kielland’s forceps may be
appropriate in certain clinical situations. As part of their safety governance standard
operating practices, NHS Trusts providing maternity care should ensure that:
• Any clinician leading a delivery using Keilland’s forceps should be trained and
competent in their use and be aware of all the risks associated with the
technique.
• Any clinician conducting an operative vaginal delivery should assess the
advantages and disadvantages of the available delivery techniques.
• Any clinician conducting an operative vaginal delivery should ensure that the
pregnant woman has been made aware of the delivery options available to her
and the material facts as part of the consent process.
NHS England’s regional members of the Regulation 28 Working Group (please see
penultimate paragraph) will be asked to communicate with their Integrated Care
Boards to ensure that all Trusts are fully aware of the updated guidance.
Birmingham University are also in the process of recruiting to the ROTATE trial. The
randomised trial will look at manual versus instrumental rotation of the foetal head in
malposition at birth. The trial will evaluate the differences between the two rotational
techniques and the clinical outcomes for mothers and babies, and whether manual
rotation reduces the risk of severe maternal perineal trauma. The results of this trial
will be carefully reviewed.
I would like to provide further assurances on national NHS England work taking place
around the Reports to Prevent Future Deaths. All reports received are discussed by
the Regulation 28 Working Group, comprising Regional Medical Directors, and other
clinical and quality colleagues from across the regions. This ensures that key learnings
and insights around preventable deaths are shared across the NHS at both a national
and regional level and helps us pay close attention to any emerging trends that may
require further review and action.
Thank you for bringing these important patient safety issues to my attention and please
do not hesitate to contact me should you need any further information.
Yours sincerely,
National Medical Director
Professor Paul Marks Her Majesty’s Senior Coroner for Kingston Upon Hull The Guildhall Alfred Gelder Street Kingston Upon Hull HU1 2AA 21 September 2023 Dear Sir, Re: Finley Austin May – deceased Thank you for your Regulation 28 Report to Prevent Future deaths following the inquest into the death of Finley Austin May dated 27 July 2023. The loss of a baby is a devastating tragedy for parents, the wider family, and healthcare professionals involved. We would like to begin by extending our deepest and heartfelt condolences to Finley’s family for their deep loss. This response has been developed following input from members of the RCOG Patient Safety Committee and Senior Officers of the College. We recognise and respect the narrative conclusion from the inquest that Finley Austin May died as a result of a spinal cord injury caused by the use of Kielland’s forceps during delivery with malposition and prolonged labour. We also recognise the matters of concern, in particular 4 and 5: (4) Continued use of Kielland’s forceps may be the most appropriate way to manage this obstetric problem but there should be increased awareness of complications associated with its use and guidance issued about the minimum number of cases per annum needed to maintain skill levels coupled with guidance for training. The O&G training curricula follow the GMC’s ‘Excellence by Design’ principles and have been mapped to the Generic Professional Capabilities. The curricula are competency based, rather than ‘number’s’ based, as such the College does not recommend a minimum number of cases per annum. Trainees attaining Certificate of Completion of Training (CCT) will be skilled in managing the labour ward independently and managing the acute gynaecological on-call service. They will have expertise in practical procedures related to the clinical care of women and will be expert communicators with strong interpersonal skills, strong emotional intelligence and adept at the management of sensitive situations. Page 1 of 3 These areas ensure that doctors in training and beyond CCT can provide safe care whilst working in a range of challenging and diverse work environments, balancing acute and non-emergency service provision. The College’s programme of assessment encompasses the integrated framework of exams, assessments in the workplace and judgements made about a learner during their approved programme of training. The emphasis is on the importance of professional judgment in making sure learners have met the learning outcomes and expected levels of performance set out in the approved curricula. It also focuses on the learner as a reflective practitioner with emphasis on acting within one’s own expertise to seek support in less familiar circumstances. Assessors will make accountable, professional judgements on whether progress has been made to support decisions on progression and satisfactory completion of training. As stated above, with regards to training, The College takes a competency versus number per year approach to continuous professional development requirements. The College supports the GMC’s Good Medical Practice guideline (points 7-10) which state that for doctors (supported by the organisations employing them): 7. You must be competent in all aspects of your work, including management, research and teaching. 8. You must keep your professional knowledge and skills up to date. 9. You must regularly take part in activities that maintain and develop your competence and performance. 10. You should be willing to find and take part in structured support opportunities offered by your employer or contracting body (for example, mentoring). You should do this when you join an organisation and whenever your role changes significantly throughout your career. For consultant practitioners and specialists these would be assessed at annual appraisal. For doctors in training they would be assessed annually during their training assessment by the Deanery. In both instances any serious incidents need to be documented to enable review against the GMC Good Medical Practice guidance and the RCOG training matrix. The RCOG training matrix presents a progression from supervised practice to independence, as doctors in training accumulate technical skills and experience. To support our membership in being compliant with the regulators and fulfil these requirements the College hosts a range of training opportunities including an annual training course RCOG Operative Birth Simulation Training (ROBuST). The aim of ROBuST is to provide hands-on practice in all methods of operative vaginal birth (both non-rotational and rotational) to facilitate the achievement of the OSATS (objective structured assessment of technical skills) competencies on the RCOG Training matrix. These promote an evidence base to demonstrate, develop and maintain safe clinical practice and the means to record and validate experience. (5) If NHS trusts have abandoned the use of Kielland’s forceps, clear guidance should exist about alternative methods of managing malrotation and asynclitism. Kielland’s forceps are currently recognised as an option to assist rotational vaginal birth in our current guidance on Assisted Vaginal Birth. The risk of cervical spine injury using Kielland’s is extremely low, but Page 2 of 3 any such serious injury is taken very seriously by the RCOG. We added a safety statement in relation to use of Kielland’s forceps to our guidance on the webpage in June 2023, which states the following: Following several recent adverse incidents, the College wishes to remind clinicians of their key obligations to promote the safe use of Kielland's rotational forceps. Assisted vaginal birth promotes benefits to both mother and the baby when used appropriately and safely. We have no doubt that clinicians use Kielland’s forceps with a high degree of caution, and respect the skill and expertise required to facilitate a safe birth. Misuse or incorrect application of Kielland’s forceps can, however, result in serious complications for both mother and baby. Rotational births using Kielland’s forceps should only be performed by experienced operators or under the direct supervision of an experienced operator. The operator is required to define fetal head position and identify the position of the occiput correctly, in order to safely undertake a rotational birth. In this regard, an ultrasound assessment of the fetal head position prior to application of forceps is more reliable than clinical examination and is advisable. While ultrasound scan is not directly mandated prior to all assisted births, it should be noted that recent concerns arose following inaccurate assessment of the fetal head position by clinicians prior to starting the procedure. Procedure should also be discontinued where rotation is not easily achieved with gentle pressure, after confirming correct application. RCOG Green-top Guideline No. 26 on Assisted Vaginal Birth, published in 2020, provides the evidence-based recommendations to support practitioners around use of instruments for assisted vaginal births, and promotes support for the availability of intrapartum ultrasonography for clinicians in their daily practice. This area of enquiry is active with nationally funded research ongoing (ROTATE Project https://fundingawards.nihr.ac.uk/award/NIHR127818). The RCOG guidance on Assisted Vaginal Birth will be updated once this project has concluded. The RCOG is committed to improving the standard of care provided for women by working collaboratively with all stakeholders, including Coroners. Yours sincerely, CEO Royal College of Obstetricians and Gynaecologists Page 3 of 3
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