Prevention of Future Deaths reports · 2018
Regulation 28 report to prevent future deaths, reference 2018-0383, written 5 Dec 2018. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 5 Dec 2018 |
|---|---|
| Reference | 2018-0383 |
| Deceased | Sylvia Mitchell |
| Coroner | Zafar Siddique |
| Coroner area | Black Country |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths · Community health care and emergency services related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Chief Executive, Sandwell and West Birmingham Hospitals NHS Trust. Medical Centre, 199 Shady Lane, Birmingham, B44 9ER 2. 1 CORONER I am Zafar Siddique, Senior Coroner, for the coroner area of the Black Country. 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 the 5 June 2018, I commenced an investigation into the death of Mrs Sylvia Mitchell. The investigation concluded at the end of the inquest on 27 November 2018. The conclusion of the inquest was a narrative conclusion of: Died after developing a rare but recognised complication of urosepsis after failures to adequately monitor and review a patient with a shelf pessary which had become impacted and resulted in a recto-vagino-vesical fistula. These failures to review more than minimally, negligibly or trivially contributed to the death and neglect as rider is added to this narrative conclusion. The cause of death was: 1a Urosepsis b c II Chronic Degenerative Mitral & Aortic Valvar Disease. Nephrolithiasia Recto-Vagino-Vesical Fistula(impacted Gellhorn Pessary) 4 CIRCUMSTANCES OF THE DEATH i) Mrs Mitchell was a 90 year old woman with a previous medical history of osteoarthritis and also bladder prolapse. She was managed conservatively for the latter condition initially with a ring pessary between December 1999 and Aril 2008. During this period the pessary was regularly changed. ii) From April 2008 onwards a new replacement Gelhorn pessary was issued. This was then reviewed in June but she failed to attend her appointment in September and did not then re-attend gynaecology services until 6 March 2013 when her GP referred her back. iii) She then attended the outpatient clinic and an impacted shelf pessary was found. This required a surgical procedure under anaesthetic to be removed. iv) She was then booked in for a pre-operative assessment but developed 1 [IL1: PROTECT] MRSA and the procedure postponed to January 2014. However she didn't attend this appointment due to illness. A further letter was sent by the Trust to her GP and to the patient to advise when she was fit to be seen again. The GP and patient don’t have any record of this. v) It wasn't until 1 August 2016 that a further appointment had been rescheduled. However, the patient cancelled this appointment. vi) She had a number of Hospital admissions in 2017 including an admission on the 29 October 2017 when she was diagnosed with urosepsis. She recovered and was discharged in December. Her condition declined further and she was readmitted to Hospital on the 21 May 2018 and sadly she died on the 23 May 2018 at Good Hope Hospital. 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. Evidence emerged during the inquest that there was inadequate communication between the Trust and GP advising Mrs Mitchell of the risks of not having the pessary removed urgently. 2. Specifically, the Pathologist gave evidence confirming that pessaries are typically used in the non-surgical management of severe pelvic organ prolapse, often in post-menopausal women with poorly oestrogenised, and easily traumatised vaginal mucosa. A pessary is a foreign object in constant contact with the vaginal epithelium, therefore, its use requires adequate follow-up to ensure proper fitting, routine cleansing and monitoring of the integrity of the vagina. Failure to observe these precautions heightens risk of infection, impaction/incarceration and ulceration, potentially with recto-vaginal and/or vesico-vaginal fistulation – the latter are very rare iatrogenic complications of pessary use with only approximately 8 cases reported in the world literature (Gordon GH et al. J Clin Gynecol Obstet. 2015; 4 (1): 193-196), almost exclusively, however, associated with Gellhorn and shelf pattern prostheses, usually in the age range of 70 to 80 years, often allegedly contributed to by lapse of regular maintenance & hygiene procedures. 3. Due to the delays in removal of the pessary she died as a result of developing a fistula and urosepsis. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you have the power to take such action. 1. The Trust may wish to consider urgently reviewing the patients who maybe in a similar position and have failed to have any follow up review of the Gellhorn Pessary. 2. The GP Practice may wish to consider adding all patients to their list of patients with a pessary (either ring or Gellhorn) to ensure that adequate referral to gynaecology services occurs. 2 [IL1: PROTECT] 3. To assist I have attached a similar PFD report and responses/audit performed by another Trust within the Black Country area. the Trust, the 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 1 February 2018. 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; Family. 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 5 December 2018 Mr Zafar Siddique Senior Coroner Black Country Area 3 [IL1: PROTECT]
3 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.
Oaks Medical Centre 199 Shady Lane Great Barr Birmingham B44 9ER 1 19 Chester Road Streetly Sutton Coldfield B74 2HE www.oaksmedical.net Please send all correspondence to Shady Lane address 12 September 2018 Black Country Coroners Court Jack Judge House Oldbury B69 2AJ Dear Sirs Re: D.O.B.: 02 March 1928 I am for the past 28 years and have the following qualifications: , senior partner at the Oaks Medical Practice. I have been a GP Bachelor of Medicine, Bachelor of Surgery (Leicester University 1984) Member of the Royal College of General Practitioners: (Edinburgh 1989) Diploma of the Royal College of Obstetricians and Gynaecologists Diploma of Community Child Health Diploma of Palliative Medicine I am writing on behalf of the practice as left the Practice on 1st May 2017. was a patient of the practice registered with us from 13 th December 1966. She was on the following regular medication: Cavilon Durable barrier cream (3M Health Care Ltd) 2 gram - use as directed Adcal-D3 Dissolve 1500mg/400unit effervescent tablets (Kyowa Kirin Ltd) 28 tablet - take one daily Aendronic acid 70mg tablets 4 tablet - take one weekly Administrative Notes: As per discharge summary 17.11.17 Aspirin 75mg dispersible tablets 28 tablet - take one daily Macrogol compound oral powder sachets NPF sugar free 1 20 sachet - 2 sachets twice a day Administrative Notes: Ad per discharge summary 17.11.17 Paracetamol 500mg tablets 224 tablet - take 2 tablets four times a day Senna 7.5mg tablets 56 tablet - take 2 at night Amoxicillin 250mg capsules 28 capsule - 1 EVERY DAY Splenectomy NEC (78403) Gaviscon Advance Mint chewable tablets (Reckitt Benckiser Healthcare (UK) Ltd) 28 tablet - ASD, Mint Fortisip Compact liquid strawberry (Nutricia Ltd) 15000 ml - 1 twice daily I have known to her unfortunate death. since 12th April 1991. 1 was the last Doctor to have visited prior Over the years she has become increasingly frail and became bedbound by 6th October 2017. When I saw her at home with her son present with a swelling of her left elbow. This was investigated with blood tests which were found to be acceptable and was treated with Naproxen and Omeprazole (this was stopped on 17th October 2017 following a telephone call as her elbow was better). Last contact was with her son on 22 nd March 201 8 in order to continue her nutritional support. On looking at her records 1 . was called by City Hospital for removal of her pessary in December 2013 but this was cancelled by the patient as she was not feeling well. Following this (who also left the Practice on 1st November 2017) carried out a telephone call with her son and noticed that the ring pessary had not been changed since 2013, a referral was carried out on that day and an appointment was made on 1st August 2016. We have had no further correspondence regarding this referral. 2. She was seen on 13 th February 2017 by (currently on leave, returning on 25th September 2018 ) who carried out a home visit with her son present, as carer’s had noticed a pessary coming out. He noted that she has a pessary for vaginal prolapse, on examination the abdomen was soft non-tender and inspection of vulva and introitus - no vaginal prolapse seen, no pessary seen. son and agreed as he cannot see a pessary coming out today or a vaginal prolapse, to wait and see. Advice was given to the son that if carer’s notice the pessary again, to contact us to refer to Gynaecology. had a discussion with 3. Looking through the records her last admission prior to 21 May 2018 was 29 th October 2017 for Urosepsis secondary to “L”ureteric calculus, further investigation was not deemed possible due to patient frailty. 4. There were no further assessments by the GPs at the Practice. 5. There was an assessment for nutritional support on 30th November 2017. I believe the contents of this statement are true and to the best of my knowledge. It is with great sadness that the practice heard of her untimely death and I would like to convey our deepest sympathy at this sad time on behalf of the Oaks Medical Practice. I had dealt closely with strong Patient - G.P. relationship. and her son for many years and developed what I thought was a Yours sincerely Diabetes Care. Practice Code -
Sandwell and West Birmingham Hospitals NHS Trust NHS DEPARTMENT OF OBSTETRICS & GYNAECOLOGY City Hospital Dudley Road Birmingham B18 7QH RECEIVED M M f < 31 December 2013 The Oaks Medical Centre 669 Kings Rd, Great Barr Birmingham B44 9HU Dear Dr Naik Re: Ms Sylvia Mitchell DOB: 02 Mar 1928 NHS Number: 488 827 9446 (01) 129 DUNEDIN ROAD GREAT BARR BIRMINGHAM B44 9DL } ,i il The above named lady has been sent 2 appointments to come in to hospital to have her ring pessary removed. However, she cancelled her last appointment with me as she did not feel well enough to come in I I would be grateful if you could let me know when Sylvia feels ready to come in to hospital for her procedure and I would be more than happy to send her a new date. ,, Consultant in Obstetrics & Gynaecology it Please do not call the medical secretaries for test results as this information can not be given over the telephone ■ - - - ir- — J Private & Confidential Copy to: Ms Sylvia Mitchell 129 DUNEDIN ROAD GREAT BARR B44 9DL A University of Birmingham Teaching Hospital CWZ34601 MITCHELL, Sylvia (Ms), printed 04 Mar 2026 12:54 (page 1 of 1) Oaks Medical Centre 1 99 Shady Lane Great Barr Birmingham B44 9ER 1 1 9 Chester Road Streetly Sutton Coldfield B74 2HE FAX: 0121366 6977 www.oaksmedical.net Please send all correspondence to Shady Lane address 01 Jul 2016 Ms Sylvia Mitchell 129 Dunedin Road Great Barr Birmingham B44 9DL Dear Ms Mitchell Further to your recent consultation with Appointment Details. , please find attached choose and book An appointment has been booked for you as per Section 2 on the form. If you wish to change this appointment please follow the instructions in Section 3. Your password can be found on the back page. Many thanks. Yours sincerely, Dictated but not signed Oaks Medical Centre
Mr Z Siddique H.M.Coroner Black Country Coroner’s Court Jack Judge House Oldbury West Midlands B69 2AJ June 2nd 2019 Dear Mr Siddique RE: Regulation 28 Report – Sylvia Mitchell I am in receipt of your Regulation 28 Report following the Inquest and your ruling on 27 November 2018, in respect of the late Mrs Sylvia Mitchell. It has taken too long to then reply to you, but we have in truth been working on this issue in the intervening time, and debating the implications with clinical colleagues including GP leaders. Your finding clearly has implications for all disciplines. In respect of Mrs Mitchell, I do believe that we attempted to review her at appropriate intervals and listed her for surgery to remove the pessary. Unfortunately she was unwell and unable to attend on the date organised and we requested that both the patient and the GP let us know when she was well enough to undergo surgery. As you know, this did not occur. We apply NHS- standard protocols for the ‘chasing’ of patients in these circumstances. Every person attending for pessary insertion now receives an information leaflet which clearly outlines the need for follow up appointments and the risks of having a pessary, including ulceration, bleeding and discharge. These are being translated into multiple languages. We will share these leaflets with primary care colleagues for provision in consult rooms locally. In addition, we had already amended our processes to tighten further our follow up procedure. Women self-book their 6 monthly appointments via partial booking, but if this does not happen we follow up with a letter. For women who do not attend for a planned appointment, we send a further appointment for 4 weeks’ time. This is repeated should they fail to attend again and then will write to the GP requesting them to review and let us know if a further appointment is required. We have now asked our Planned Care Board to undertake a twice yearly clinical review of any patient who does not reply to all of those efforts. This list, pseudo-anonymised, will also be provided to Primary Care Network colleagues. In other words we will be more overtly curious about the reasons for non-response. As part of this, looking forward patients who we have identified have not had a follow up as planned are being recalled for a review appointment with our Clinical Nurse Specialists. We are also discussing ways to enable us to easily see which women need follow up, and when this need ceases, either because the pessary has fallen out, is no longer required for personal or alternative treatment reasons. You asked us to ensure that any patients who may have missed opportunities to be seen, as Mrs Mitchell was, are safe and this is in progress and will likely continue through this year. I am satisfied that we have a process in place which is recalling women appropriately and that we are developing further ways to identify those women who need following up in our service, rather than with their GP, to give a further safety net. In six months’ time we will review at the Trust’s Board data on non-responders within gynaecology services for the prior 18 months to see if there are any further omissions we might consider. My colleague, advice or further details on our actions, or indeed updates on the progress moving forward. , Deputy Director of Governance, would be best placed to provide Yours sincerely Chief Executive cc. Family of Mrs Mitchell , Clinical Chair, Sandwell and West Birmingham CCG , Group Director, Women and Child Health , Deputy Chief Operating Officer
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