Dear Ms Lake Re: Regulation 28 Report to Prevent Future Deaths following the inquest into the death of Kobi David Wright. T~ank you for your letter dated 16 July 2020 following your inquest into the death of Kobi David Wright. Firstly, I would like to reiterate my condolences on behalf of the Trust to Kobi's family for his sad passing. Following the evidence heard at your inquest, the medical cause of death was given as: 1a) Pre term Stillbirth 1 b) Complicated Instrumental and Caesarean Delivery 1c) ­
2) Prematurity
1.understand that you have made 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. The Trust has carefully considered the issues set out in your letter ih order to respond to your concerns. The Trust 'is continuing to take steps to recruit substantive doctors as first preference. Unfortunately, it is not always possible to employ only substantive staff, and to ensure safe staffing levels are maintained across the services, it is at times necessary to employ locum doctors. The Trust's Executive Lead for Workforce is currently reviewing the recruitment process fo ensure that suitably trained -and experienced doctors are comprehensively inducted at the hospital. This review will be concluded and the changes implemented by the end of September 2020.

At present, the i;nedical staffing team request information from framework agencies to ensure the Trust has all compliant information before employment of any doctor is agreed. This information includes a copy of the CV, two current references, GMC and DBS checks, and Occupational Health (OH) records which are also r~viewed with the Trust's OH provider. A copy of the individual's mandatory training log is provided by the agency: the agency's Responsible Officer will e·nsure that training is up to date. The CVs, training certificates and references are approved by the speciality's consultant body before employment to ensure they are safe to fulfil the vacancy. Following your inquest, the reviewing consultant will, in writing, respond to the staffing team confirming they are satisfied that the clinician meets their requirements. This confirmation will include the date and time the documentation was verified. Additionally, the Trust has started to work with the clinical leads to devise c;1 detailed person specification of all essential and desirable qualities for each speciality. This specification will be shared with the agency, with the expectation that only clinicians that meet these criteria will be nominated for employment. In a situation where a locum doctor is required at short notice, and they do not meet all essential criteria, the staffing team will carry out a risk assessment, with the clinical team, to decide whether the clinician can be employed. This risk assessment will consider any mitigating factors, for example if they are named on the specialist register. If it is appropriate for the clinician to work at the Trust, the risk assessment will be signed by the clinical lead or th_eir deputy and shared with the supervising clinician. On day one at the Trust, locum doctors attend mandatory training and engage in a supervisory period in their department to ensure they are orientated. During this period, the clinician will work alongside a substantive staff member to familiarise themselves with local practice and ensure they have the appropriate skills required for their employed position. This staff member will be responsible for observing experience and skills during this period, and will raise any concerns to the appropriate clinical lead for action. If a locum doctor is unable to participate in a supervisory period, this will also be risk assessed by the staffing team before working. After a period of frequent employment, the Trust's current practice is to offer a substantive contract to the clinici.an. The Trust supports its permanent staff to continue with their professional development and offer training courses and study leave to aid this. This helps increase the pool of substantive doctors at the Trust providing consistency within the services. The Trust works hard to maintain an open culture and encourages staff to raise concerns to appropriate manag·ement; this includes any capability issues. The hospital is focussed on patient safety and promptly investigates any concerns regarding a clinician's competence. The Trust's Medical Director actively considers whether steps outside of the hospital's local · policy is required and if referrals to the GMC are required. I would like to thank you for bringing your concerns to my attention. If you require anything further, then ·please do not hesitate to contact me.

I understand that this letter may be shared witt, Kobi's family and I would like to take this ·opportunity to again personally extend my sincere condolences for their loss.

Dear Madam MDDUS: Dr

Regulation 28 Report to Prevent Future Deaths Inquest touching on the death of Baby KW

We write further to receipt of the Regulation 28 report addressed and for the attention of Dr

following the inquest heard before you between 7 – 9 July 2020 touching on the death of Kobi David Wright. From the outset we confirm that very shortly after the inquest (and before the Regulation 28 report was received) Dr referred himself to the General Medical Council in view of the inquest outcome. The Council have opened an investigation which Dr is engaging with. Nevertheless, we enclose for your consideration a document from Dr in response to the concerns that are highlighted in your report. Dr has spoken with his colleagues at the North Devon District Hospital and has been proactive in his efforts to improve his knowledge and partake in training for obstetric emergencies. In particular, we would highlight that Dr , in addition to having completed the K2 Training Program, which includes a competency assessment tool, has made preparations to attend PROMPT training (Practical Obstetric Multi-Professional Training) when it resumes. This has included him purchasing a copy of the PROMPT training manual which he is reviewing ahead of the course. However, while awaiting that training, Dr is also re-reviewing the K2 courses that he completed prior to the inquest, but this time with the inquest findings in mind. Dr s reflections confirm that he has two simulator sessions outstanding to be undertaken in relation to the assessment of CTGs before he will again have completed this training. The simulator sessions will challenge Dr in simulated ‘live atmosphere’ scenarios to make decisions in respect of CTG management. Dr anticipates completing these simulator sessions in the next few weeks. Unfortunately, the availability of training courses to attend in person are limited as a result of the global Covid-19 pandemic. However, Dr has attended two sessions with Mrs , the Labour Ward Lead at the North Devon District Hospital. We enclose a letter from Mrs which confirms that she holds a number of positions, including Risk Management Lead, College Tutor and Training Programme Director South West Peninsula. We therefore suggest she is very well placed to assess Dr and comment upon his practice, having been approach by him proactively seeking obstetric emergency training.

Jacqueline Lake 09 September 2020 Page 2 

The first session Dr attended with Mrs was a presentation which covered the obstetric emergency topics. It will be noted from Dr s reflection document that he was tested on his understanding of how he would manage the various emergency situations by Mrs asking him questions about the presentation and that he found this exercise useful. This was a joint session with other junior doctors. The second teaching session was a one to one simulation training session which focussed on instrumental deliveries, deeply impacted head and risks of prematurity, being areas pertinent to the matters highlighted in the Regulation 28 report. Dr reflection confirms that he was asked to demonstrate the correct application of forceps in breach deliveries with the head in different positions. Mrs confirms that Dr is booked to attend the PROMPT course, and that having observed him perform a forceps delivery she is satisfied he is competent. She also provides an example of Dr

calling for assistance, appropriately, even though that assistance was not later required. In addition to the training with Mrs it has been arranged at Dr s request that he attend at Exeter Hospital, a busier unit than at North Devon Hospital, because it is likely to expose him to obstetric emergencies. This has been arranged in order for Dr to gather greater exposure to emergency care, albeit he will be an observer. This training is scheduled to occur in the next few weeks in accordance with the consultant’s availability. In the meantime, Dr continues to keep himself updated with the guidance from the Royal College of Obstetrics and Gynaecology. Lastly, we enclose a letter from Mr , a Consultant Obstetrician and Gynaecologist at the North Devon District Hospital. Mr ’s letter confirms that he has observed Dr having worked alongside him during the on-call cover of Obstetrics and Gynaecology and also in various clinics and theatres. Importantly, he too notes that Dr knows the limitations of his practice and will ask for assistance if required. He reports Dr to have run labour ward emergencies with confidence. Mr Eskandar is aware that Dr is making every effort to update himself in all aspects of obstetric emergencies following the inquest. Please note that both Mr and Mrs received a copy of the Regulation 28 report before providing a letter on behalf of Dr . They were therefore both aware of the concerns raised at the inquest but were both content to provide a letter in support of Dr s wider practice and remedial actions. We trust that in providing this information about Dr response to the inquest findings, you will be reassured that Dr has taken this matter very seriously indeed and has committed to improving his knowledge and practice so as to ensure that the tragic circumstances of this case are never again repeated. Yours faithfully RadcliffesLeBrasseur LLP RadcliffesLeBrasseur LLP Encl.

Dr.

Reflection on HM Senior Coroner Report

1. I have carefully considered the report of the Coroner and the evidence presented during the inquest. I was troubled to understand that the Coroner had concerns about my evidence, practice and emergency training. I have as a consequence taken steps to address what I can and undertaken further training in obstetric emergencies. I also self-referred to the General Medical Council and will engage with any subsequent investigation by the Council.

2. On reflection of this case, I accept that it was an option to adopt a ‘wait and see’ approach to manage the patient rather than to proceed to a trial of instrumental delivery. I recognise that instead of allowing an hour for the patient to be prepared for theatre, where there is no clinical urgency, it would be better practice to leave the patient in the room and examine her an hour later and again consider the options at that time. Where I am in any doubt about the best way to proceed I have learnt to involve more the consultant on call.

3. My concern about the CTG was from the previous ones and the part I have seen after I have spoken to the consultant (shortly before 2 pm), but I agree that the CTG was normal as I have documented in the notes before speaking with the consultant. I must accept that from my explanation, regardless of what I had intended and told to Dr , she understood that I was raising a concern about the CTG being abnormal at that time and that informed her agreement to proceed to a trial instrumental delivery. This was not correct. I have learnt as a result of this process to discuss more details about the patient with the consultant on call and ask him/her for the advice and document this conversation separately in the notes where the consultant is not able to also review the underlying information e.g. the CTG, for themselves.

4. In this case Dr , asked me if I am happy to proceed with the procedure, as all the consultants do when I ring them. I did not expect any problem doing the forceps or the CS as I have performed 1000’s of each during my career and I always tell the consultant to come and join me if I am expecting problems and will definitely call him/her if I am facing any. So in this case I had no reason to ask Dr to attend at the time of examination in theatre. I would not hesitate to ask for assistance or supervision if I have any concern about possible complications.

5. I instructed the senior midwife to replace gently the head into the vagina while I was changing my gloves and gown to start the C.S. I accept I should have done this myself but I was running against time to start the C.S before the baby started to breath as in this case we would have been in a more difficult situation. I learnt that in the future in any similar situation I will replace the head myself inside the vagina using Zavanelli manoeuvre.

6. Regarding my training, I have always kept myself with up to date knowledge and completed my CPD hours requested by the Royal College. Before the incident, I have attended many CTG and departmental meetings to discuss emergency obstetrics and how to avoid mistakes. I recognise that as a professional and particularly as a locum it is my responsibility to ensure my training is up to date. After the incident and before the hearing, I have continued to be up to date with my CPD points. I have set out below some of the relevant courses/ training that I have attended:

Post March 2019 (pre-inquest)

a. I have attended the Annual International Royal College Conference in June 2019 where all the updates in our speciality are discussed.

b. K2 training courses: As Prompt courses were not available in 2020 because of the Covid 19 pandemic, I did the alternative K2 courses in March and April 2020. I have passed all the 14 courses covering all the Obstetric emergencies. Each one lasts from 30 minutes to 4 hours. Having videos, diagrams and texts and then 10-20 questions which one has to get 80% marks to pass in each course. These cover 14 subjects of obstetric emergencies such as antenatal and intrapartum CTG, errors and limitation of fetal monitoring, shoulder dystocia, Maternal haemorrhage and collapse, cord presentation and cord prolapse.

c. In perinatal and audit meetings we discuss any problems that led to adverse effects on the mother and the fetus and how to avoid them in the future.

d. The CTG meetings, I attended over the years, help me to identify abnormal CTG’s and the proper action as discussed with the group of doctors in the department. Also courses are useful for me to update my knowledges in the management of all obstetric emergencies. Many of these meetings are now done online as the number attending is very limited due to Covid 19 pandemic. Some Trusts now using a type of software to allow the consultant to see the CTG when he is away from the hospital but this is not available to all hospitals.

Post July 2020
a. After the inquest, I have asked my consultants at North Devon District Hospital about arranging extra training in Emergency Obstetrics. I have attended a session with Mrs , the Clinical Lead for Labour Ward covering all obstetric emergencies such as Sepsis, Pre-eclampsia, eclampsia, Thromboembolism, Obstetric Haemorrhage, Cord prolapse and shoulder dystocia on 6 August 2020. This session was showing online statements and diagrams and she asked me many questions on each subject as what to do in these emergencies and about how to manage these

cases and I have passed them all. This was quite useful to update myself on all these subjects.

b. On 13 August 2020 I attended a simulator course covering Breech delivery and forceps delivery for different positions as OP, OA and for the after coming head in vaginal breech delivery. I was given a model of fetus, pelvis and pair of forceps to demonstrate how to deliver the breech in different positions and to apply the forceps and deliver the head in different positions as OA or OP or the aftercoming head of the breech.

c. I will be attending the PROMPT (PRactical Obstetric Multi-Professional Training) course when it is again available. This is practical training that has to date been postponed as a result of Covid. However, I have in anticipation of completing such training purchased a copy of the PROMPT training manual which I am working my way through. I was told that Prompt is not going to be offered in its classical way this year, but as I have completed the K2 courses in March / April this year, I was told that I can complete the course on line to get the certificate. I did last week the same 14 K2 subjects mentioned before but as assessments which I need to get over 80% to pass. I passed all of them at high marks. I am left only with 2 CTG simulators which I will do next in the next few weeks and then I will complete what Prompt needs and will get the certificate. The simulator puts me in what is called live atmosphere with conditions that I have to assess and decide on the management which is very useful.

d. I requested to go to a busy unit for a day to learn more about emergency obstetrics and they will kindly arrange for me to go to Exeter in the next few weeks when it is convenient for the Consultant. This will allow me to see more obstetric emergencies in one day and share in the management decision.

e. In the next year I will attend the live prompt course which helps me to improve in the management of obstetric emergencies and to improve communication skills.

Royal College Guidance and GMC Good Medical Practice I always endeavour to comply with the Royal College guidance and the GMC Good Medical Practice guidance which includes:
1. Make the care and the safety of the patient my first concern.
2. To be competent and keep my professional knowledge and skills up to date by attending regular clinical meetings and courses.
3. Take prompt action if I think the patient safety is being compromised and ask for help if required.
4. Establish and maintain good relationship with the patients, the nursing staff and my colleagues.
5. Being open, honest and acting with integrity as a doctor.

Regarding the Royal College Guidelines:
a. I have read all their green-top guidelines which are emailed to me frequently and mainly in obstetric emergencies as shoulder dystocia, Antepartum and postpartum haemorrhage, shoulder dystocia, umbilical cord prolapse and maternal collapse.
b. I do regularly the Tog questions which are sent to me by the Royal College. It consists of a subject followed by a series of multiple choice questions and you have to get 80% to pass and get your CPD points. They cover many subjects in Obstetrics & Gynaecology.
c. I attend the annual international meeting of the Royal College when held in the UK as I did in June 2019 in London. It is an excellent chance to attend many lectures and discussions with small group meetings about the updates in our speciality. I will continue to keep my practice under review as I never want a repeat of this sad case. I wish to again send my condolences to the family of Kobi Wright.

I can confirm that I am writing the following statement following a request from Mr

and I am happy for my letter to be provided to HM Senior Coroner for Norfolk and the General Medical Council. I have been provided with a copy of the Regulation 28 Report to Prevent Future Deaths concerning Dr but I have not seen the patient’s notes or the investigation report by the hospital. My name is Miss , I qualified as a doctor in 2003, and I became an Obstetrics and Gynaecology Consultant in 2016 in North Devon District Hospital. I am the Labour Ward Lead in North Devon District Hospital and the Training Programme Director on the South West training programme. Dr has worked in North Devon District Hospital on and off since the 25th of November 2019 in a middle grade locum capacity. He has been very proactive at requesting Obstetric emergency training and has attended two sessions with me. The first session of Obstetric emergencies he attended included a presentation for Obstetric emergencies such as sepsis, shoulder dystocia, APH, PPH, cord prolapse. The session was also attended by new junior doctors in the department and it is part of the induction for new junior doctors. The second teaching session was a one to one “hands on” simulation training session with myself on instrumental deliveries, deeply impacted head and risks of prematurity. Unfortunately our PROMPT course has been cancelled due to Covid however we are looking into restarting this and respecting social distancing rules. I have booked Dr on our next PROMPT course in the NDDH. I am also aware that Dr has completed his K2 training for CTG and Obstetric emergencies. I have observed Mr perform a forceps delivery in theatre of a term baby and he did that in a competent manner. I am aware of an incident where he performed a second stage Caerarean section following a Consultant’s decision in north Devon District Hospital and he had difficulty in delivering the head at Caesarean section. He called the Consultant and he dis-impacted the baby’s head himself and delivered the baby before the Consultant arrived. Mr has been very proactive to attend Obstetric emergency training with myself and is keen to keep up to date.

Mrs

Consultant Obstetrician & Gynaecologist

Labour Ward Lead

Risk Management Lead

College Tutor

Training Programme Director South West Peninsula

Tel :

email:

web: www.northdevonhealth.nhs.uk

1

Department of Obstetrics & Gynaecology North Devon District Hospital Mr

Raleigh Park Consultant Obstetrician & Gynaecologist Barnstaple, Devon Tel: (01271) 322786 Fax: (01271) 311653 EX31 4JB

Tel: 01271 322577 Fax: 01271 311541

Minicom: 01271 322746

OE/KM

28th August 2020

Re: Dr

I am writing this statement following a request from Radcliffe SLE Brasseur LLP to provide a statement for Mr which can be provided to the HM Senior Coroner for Norfolk and General Medical Council.

I have been made aware that Dr was criticised at an inquest in July 2020 and I have been provided with a copy of the regulation 28 report.

I am a Consultant Obstetrician and Gynaecologist at Northern Devon Healthcare Trust. I am the Lead Clinician for the Obs & Gynae Department. I have FRCOG and MFSRH. I have 33 years of experience in obstetrics and gynaecology.

Dr joined our Obs & Gynae Department as a Locum SAS Doctor from November 2019. He has been involved in the Middle Grade Rota and he worked with me during the on-call cover of Obstetrics & Gynaecology and also in various clinics and theatres. I am aware that Dr has completed the K2 Training Programme of Obstetric Emergencies which is a substitution of the PROMPT Training during the Covid-19 pandemic. Also, I am aware that Dr had a simulator training session with the Labour Ward Lead including the obstetrics emergencies and instrumental deliveries. He is up to date with his RCOG CPD. He is intending to go to Royal Devon & Exeter Hospital to have further training in this busy hospital.

During his stay in our Department, I found Dr a competent, experienced Obstetrician and Gynaecologist. He ran labour ward emergencies with confidence and I am not aware of any major incidents during his time with us. He is aware of his limitations and he asks for help when indicated. He is aware of his current circumstances and he is making every effort to make himself updated with all aspects of obstetric emergencies which I feel he is competent in doing so.