Prevention of Future Deaths reports · 2016
Regulation 28 report to prevent future deaths, reference 2016-0439, written 9 Dec 2016. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 9 Dec 2016 |
|---|---|
| Reference | 2016-0439 |
| Deceased | Shelia Stokes |
| Coroner | Heidi Connor |
| Coroner area | Nottinghamshire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Sherwood Forest Hospitals NHS Foundation 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 REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: Mr Peter Herring, Chief Executive, Sherwood Forest Hospitals NHS Foundation Trust 1 CORONER I am (Mrs) Heidi Connor, assistant coroner for the coroner area of Nottinghamshire. 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 18 July 2016 I commenced an investigation into the death of Sheila Stokes, aged 83. The investigation concluded at the end of the inquest on 21 November 2016. The medical cause of death was : 1a Retroperitoneal haemorrhage 1b Ruptured abdominal aortic aneurysm I recorded a narrative conclusion as follows : Sheila Stokes was diagnosed with a large abdominal aortic aneurysm by ultrasound. Vascular surgeons knew about this on 16 July 2015. There was delay in arranging appointments, CT scanning, discussion at MDT meeting, and in sending key information to the manufacturers of a proposed custom-made graft. These delays contributed directly to her death at home on 26 January 2016, following rupture of her aneurysm. If a finalised plan for her graft had been agreed with the manufacturer any time up to 2 November 2015, then she is likely to have undergone life-saving surgery. 4 CIRCUMSTANCES OF THE DEATH Mrs Stokes was referred to vascular surgeons at Kings Mill Hospital with a clear diagnosis of a 7.3 cm abdominal aortic aneurysm on 16 July 2015. She was given an urgent appointment to see a vascular surgeon. The appointment was on 27 July 2015. She did not attend, but the family have said that no appointment letter was sent. The trust could not show evidence that it was sent. No letter was sent to the patient or GP following the non-attendance in July 2015. She was given a further appointment on 14 September. It was accepted by the witness, Stokes saw his colleague, urgently because Mrs Stokes was a smoker, she had hypertension and the aneurysm was large. He told us that 15% of aneurysms rupture per annum. This view was reached even before a CT was performed. There were clearly risk factors present for rupture of this aneurysm from the start. on 14 September, that a CT was requested (consultant vascular surgeon) that when Mrs The CT scan was carried out on 22 September. A RAD alert appears to have been sent by the radiologists, but there was no evidence that this was received or acted upon by the vascular surgery team. 1 We heard that the radiology report was available on 28 September. All aneurysms are discussed at MDT meetings at QMC. Mrs Stokes’ scan findings were discussed at an MDT meeting on 16 October 2015. It was noted that this was a complex aneurysm, and it was decided that Mrs Stokes would need a custom-made graft. The plan was that this would be made by Cook (UK) Ltd. I find the following to be the key dates in this matter : 16 July 2015 27 July Referral received by vascular surgeons. Large aneurysm had been seen on ultrasound – for urgent appt. Pt did not attend. No evidence that appointment letter was sent, or of chaser letter to patient or GP thereafter. Patient attended – for urgent CT. 14 September 22 September CT ; RAD alert sent by radiologist. No evidence of this being 28 September 16 October 20 October 27 November received or acted upon. CT report available Case discussed at MDT. For custom-made graft. telephoned Cook to notify them of this patient. Cook representative attended QMC (after a further MDT meeting) and waited while CDs of the scans were produced so that they could start to consider the graft. 3 December 30 December Cook sent a preliminary plan to Family raised concerns about delay. An email was sent from to , stating “now she is becoming symptomatic and due to caring for her elderly husband (which includes picking him up when he tumbles to the floor), this lady is convinced that she is putting her 7.6cm [sic] aneurysm under strain”. Chaser email from Cook to forwarded the email from (30 Dec) 30 December 2 January 2016 10.41 (amongst others). to 12.11 graft Cook produced final plan emailed Cook to ask them to proceed with the signed off the final plan Mrs Stokes died. 8 January 11 January 26 January 11 January 2016 was the date on which Cook was effectively given the ‘green light’ to produce the graft. There was some some initial confusion about how the scans would be sent to Cook, resulting in a delay of 5 weeks between initial contact and the scans being received by Cook. I note with some concern the wording of letters and emails sent around the time of these events. email of 2 January 2016 (referred to above ) states : “I have spoken to [Mrs Stokes] and explained that her graft needs to be tailor made for her aneurysm and that’s the delay.” By that date, her large aneurysm had been diagnosed 5 and a half months earlier, and a decision had been made (at the MDT) that a custom-made graft would be needed 2 and a half months earlier. No response had been given to Cook’s first proposed plan for the graft, sent a month earlier. No mention has been made of delay by the trust, even after Mrs Stokes’ death – in morbidity and mortality meeting minutes, or in statements and documents produced for this investigation. The tenor of statements clearly cites manufacturer delay 2 as the central issue. On its kindest interpretation, there has been a complete failure to recognise key areas of delay and administrative errors. On a less kind interpretation, there has been an attempt to disguise the real reasons for this delay. This concerns me greatly, taking into account the trust’s duty of candour and the responsibility of clinicians to assist coroners in their enquiries. Applying the longest time estimates suggested in evidence, ie 8 weeks to manufacture the graft and a further 4 weeks to arrange the surgery, I have calculated that, if Cook had been given the ‘green light’ to manufacture the graft at any time up to 2 November 2015, then Mrs Stokes would, on the balance of probabilities, have undergone surgery and survived. In reaching my conclusions, I have taken account of the fact that the aneurysm was a complex one, and that not every aneurysm is immediately life-threatening / requires emergency surgery. There were however clear risk factors in Mrs Stokes’ case which made delay more significant. The extent of delay by the hospital in this case is stark, and it is clear that this has played a clear and direct part in Mrs Stokes’ death. I find that there was no delay on the part of Cook in these matters. It would appear that they were proactive both in planning and in chasing for and obtaining the scans they needed to plan the graft. 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. There has been delay at almost every stage of these events. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. – 1. Review of administrative systems for contacting and following up patients who DNA appointments – with such correspondence to becopied to their GPs. 2. System for ensuring RAD alerts are received and acted on timeously. 3. Vascular surgeons based at both KMH and NUH should consider having a clear agreed protocol for obtaining custom-made grafts – to include such matters as : a. A clear pathway for contacting and sending scan results to manufacturers. b. Limited no of consultants dealing with these cases. c. Clear timetable between first contact with manufacturer and final sign off – with responsibility of a named consultant to ensure there is no delay. d. Advising and updating patients on these timescales. 4. Adequacy of the trust’s investigation of these events – in particular the morbidity and mortality meeting discussion, which was incomplete, and does not refer to delay by the trust at all. 5. Nature and content of the witness statements provided to the coroner, which again refer only to delay by the manufacturer, which is clearly not the central issue in this case. 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. 3 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 3 February 2017. 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 : 1. Family of Mrs Stokes 2. 3. NUH vascular surgery team 4. Head of legal services at KMH and NUH 5. Cook (UK) Ltd, via their legal representative. , Medical Director, KMH I am also under a duty to send the Chief Coroner a copy of your response. For the avoidance of doubt, only Mr Herring is required to respond to this report. 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 9 December 2016 4
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.
Radiology Department XXXX POLICY The XXXX policy in current use within the imaging department at Sherwood Forest Hospitals NHS Trust and is intended to alert clinicians to findings that are unexpected and/or require early intervention by the referrer. The Royal College of Radiologists 2008 document “standards for the communication of critical, urgent unexpected radiological findings” defined, Critical findings: those where emergency action is required as soon as possible e.g. a pneumothorax or free gas on a chest x-ray; an intracranial bleed on a CT scan; large volume pulmonary embolism disease (expected or unexpected). Urgent findings: where medical evaluation is required within 24 hours Significant unexpected findings: cases where the reporting radiologist is concerned of the findings that is significant to the patient and will be unexpected e.g. pulmonary embolism on a staging CT scan; evidence of new metastatic disease in a follow-up routine staging scan that previously showed no secondary spread. In the case of a critical finding the radiologist or reporting radiographer/sonographer will contact the referrer or a member his or her team directly (using telephone). Cases in the other two categories may also be communicated directly but in most cases the report will be typed and verified without delay and the XXXX code added, the radiologist’s secretaries/typists then having the responsibility of telephoning the result to the referrer or his or her secretary emphasising that the report should be read without delay. A record of the communication will be made on the radiology information system. If the secretary/typist is unable to contact the referrer, the reporting radiologist should be informed immediately. The radiologist or reporting radiographer/sonographer will use their judgement as to which cases require urgent communication and in cases of doubt non medical reporters should consult a radiologist. Cases of new or suspected malignancy will be communicated using the UUUU system (for which there is a separate policy). In cases where follow-up films are recommended for patients attending the Emergency department who are not admitted to hospital a copy of the report will be sent to the patient’s GP and a note made of this in the formal report. The reporting radiologist will indicate to the typist that a copy report is required. The XXXX system will also be used to alert clinicians to cases where the final report differs significantly from the verbal or handwritten interim report i.e. in such a way as to alter patient management. In a similar way it will be used where a significant addendum is made to a pre existing report. It will remain the responsibility of the referrer to ensure that there is robust system for monitoring outstanding referrals and reading and acting upon received imaging reports. The policy will be reviewed and modified to take account of electronic reporting and a referrer acknowledgement system. Written by: Version: Reviewed: Review Date: 2 August 2016 August 2018 Radiology Service Director
King’s Mill Hospital Mansfield Road Sutton in Ashfield Nottinghamshire NG17 4JL 13 February 2017 Mrs H Connor Assistant Coroner for Nottingham and Nottinghamshire By Email Dear Mrs Connor I am writing in response to your Regulation 28 Report dated 09 February following your investigation into the death of Mrs SS. For simplicity’s sake, I have in bold highlighted each of the concerns you raised therein and addressed them in turn in the narrative below. Review of administrative systems for contacting and following up patients who DNA appointments – with such correspondence to be copied to their GPs. At the hearing, the Trust was unable to provide evidence of an appointment letter for the appointment in July 2015. Since the inquest we have interrogated the appointment system, and it appears that where patients have deceased their administrative letters are no longer visible on the main screen unless certain boxes are checked; administrative staff unaware of this feature would assume no letters were created/sent. We have now been able to determine that following referral of Mrs S to the vascular team, a letter was sent to Mrs Stokes (see appendix 1) on 15 July 2015; this was for an appointment on 27th July. Our Medway computer system indicates that this letter was printed on 21st July and we assume it was posted to her (see appendix 2). Mrs S did not attend this appointment and this was inputted onto our system as a ‘DNA’ and she was to have a new appointment made (see appendix 3). We believe that our staff telephoned Mrs S the following day (28th July) to make another appointment for her which was for the 14th September and from the comment made, it was noted that she would like to be seen earlier if there was opportunity by reason of a cancellation (see appendix 4). We believe that it is likely that this date of 14 September was the next available appointment. We have looked back at the vascular clinics for the period July 2015 - September 2015, there was indeed limited capacity for patients to be seen any sooner. A letter again appears to have been sent to Mrs S on the 28th July 2015 (see appendix 5). An Outpatient Improvement programme was commenced in March 2015 to address a number of issues relating to patient experience and waiting times for Outpatient appointments. Some of this work is relevant to this case. The DNA process was re-launched in June 2016 (see the flow chart attached) as it was clear that there was not a consistent approach to dealing with DNAs across the Trust. This process ensures that DNAs are dealt with on the day. Clinic staff will place a DNA sticker into the patient’s notes and ensure this is completed by the clinician who indicates the action to be taken e.g. further appointment within given timescale or discharge. The clinician can also highlight if there are any safeguarding concerns and request the notes to be returned to their Patient Pathway Co-ordinator (PPC) for further action to be taken. The receptionist will input an outcome for the appointment and makes any further appointments as requested by the clinician before sending the notes to the PPC. If the patient is discharged at the clinician’s request a DNA letter will be sent to both the patient and their GP to indicate the discharge has taken place. However, prior to discharging the patient a check is made to ensure that the patient was sent an appointment letter and also that the address for the patient recorded on Medway, matches that on the Summary Care Record. The reconciliation slips which indicate the actions requested by the clinician are destroyed after completion of the task. However, the DNA sticker remains within the case notes permanently and is a record of the request. The Trust is planning to commence a pilot of scanning reconciliation slips into Medway, providing a permanent record. A number of managers involved in the Outpatient service carry out DNA audits on a regular basis to ensure that the process is being adhered to. We are happy to provide audits of this process should you require. Another improvement initiated by the Outpatient Board is a weekly monitoring meeting with all Business Managers to review any clinic capacity issues, for patients awaiting appointments. Any capacity constraints are raised with business managers and escalated to Divisional General Managers and the Chief Operating Officer if not resolved. System for ensuring RAD alerts are received and acted on timeously. Mrs S underwent an ultrasound on 13 July 2015 in which the incidental finding of abdominal aortic aneurysm was noted. This ultrasound was sent urgently (using this Trust’s XXXX system, please see appendix 6) to the referring clinician who then made an urgent referral to the Vascular team at NUH, he also alerted the GP to the finding, and an appointment was made on 21 July 2015 for the patient to be seen on 27 July 2015, as above. Mrs S then underwent a CT scan on 22 September 2015, by which time the aneurysm was no longer a new finding of the 2 nature that a ‘RAD alert’ was required, but a timely response was of course necessary, and this is addressed in the next section of this response. The CT report was sent to the NUH Vascular team for consideration at their MDT. A series of upgrades to the EMRAD systems are underway, which will include a facility to electronically alert clinicians via text message to mobile devices and emails simultaneously which should further enhance the alert system. This should be available to alert not just staff at this Trust but also referring clinicians from NUH and other local trusts that are part of the East Midlands EMRAD/PACs consortium. It also allows specialised reporting radiologists at one of the consortium trusts to report directly on images taken at other Trusts. Vascular surgeons based at both KMH and NUH should consider having a clear agreed protocol for obtaining custom-made grafts – to include such matters as: a. b. c. A clear pathway for contacting and sending scan results to manufacturers. Limited no of consultants dealing with these cases. Clear timetable between first contact with manufacturer and final sign off – with responsibility of a named consultant to ensure there is no delay. The Vascular team at NUH are in the process of developing a FEVAR database. This is a database system for the recording and tracking progress of patients with abdominal aortic aneurysm who are referred to the department of Vascular Surgery, Nottingham University Hospitals NHS Trust (NUH), who will be treated with for standard fenestrated endovascular repair (FEVAR). Unlike grafts used endovascular repair (EVAR), FEVAR graft systems are complex and are custom built for each patient. Consequently, there is a significant lead-time (typically 12 weeks) before they are available for implantation. Planning, ordering, and deploying a FEVAR system involves multiple stages, independent companies that manufacture the grafts and multiple clinical teams. There is a need for an information system to help manage this process, to ensure that treatment timescales are met. The plan is for an intranet interface (using standard desktop web browser software, such as Internet Explorer or Google Chrome) to a Microsoft Access database. The interface will be similar in form to applications currently in use in NUH for the vascular surgery MDT administration, Interventional Radiology (IR) consultant diaries and for NUH IRMER documentation The FEVAR interface is intended to sit alongside that for the vascular MDT administration system. The system will be visible across the NUH intranet, thus providing entry from any NUH networked PC (including remote laptops logged in via VPN). The system will not be visible on the open internet outside NUH. The pathway is considered in four phases: 1) Initial MDT, initial FEVAR MDT decision, FEVAR graft planning, FEVAR MDT sign-off 3 2) 3) 4) Placement of purchase order, graft manufacture and delivery, logistics Final preoperative assessment and checks, the FEVAR procedure Initiation of follow-up FEVAR MDT is intended to occur on a weekly basis. Some patients may leave the pathway for various reasons (e.g. manufacturers determine that anatomy is unsuitable for FEVAR despite initial MDT optimism). An exit protocol will be included for these patients. In the case of those patients that are referred on to other centres, the exit protocol will record details of the onward referral and reply received, with the facility to note any follow-up that NUH is required to carry out. Each phase will have a number of tasks and relevant data (such as expected delivery dates) associated with it. Each task should have a due-by or expiry date and the person signing it as complete should be recorded. Some tasks will always occur (such as placing an order for a graft), and will appear as default. There will be the facility to enter additional tasks relevant to particular patients. Each phase will have a due by date. When all listed tasks are done, the phase can be flagged as complete. In cases where a patient exits the protocol, subsequent phases will be shown as excluded (see below). The person signing-off each stage will be recorded. FEVAR timescales Timescales are set in order that the system can indicate to users when particular tasks, or phases, are overdue. Setting timescales to short (everything becomes overdue) or too long (nothing ever becomes overdue) would serve no purpose. Timescales are not intended to be binding and actual timescales may vary in individual cases. Additionally, timescales may be adjusted, once the system has embedded, to try to achieve a practical balance. The following proposed timescales have been discussed with, and agreed by, Ms Khan, Ms Dabee and Dr O’Neill. Phase 1 (Entry – FEVAR MDT) Initial FEVAR MDT Request copy of CD(s) following entry Print CDs Collect/send CDs by/to manufacturer Reply from manufacturer Second FEVAR MDT (Confirm sizes and manufacturer plan, sign order form, send to manufacturer) Phase overdue VR & IR VS Radiology VS Manufacturer VR & IR 1 week 1 day 2 days 1 days 1 week 1 week 3 weeks Note: It is hoped that direct, electronic transmission of CT data to manufacturers will become available later this year, which will obviate the need to produce CDs. 4 Note: If the manufacturer’s plan is changed at the second FEVAR MDT, it will be returned to the manufacturer for revision and considered at again the following FEVAR MDT. Each cycle will therefore add a further week. Phase 2 (Purchase order – FEVAR graft delivery) Sign order form and send to manufacturer VS Manufacturer to obtain purchase order Acknowledge receipt of purchase order. Manufacture starts Model delivery date (when required) Bench deployment Graft delivery date Phase overdue Finance Manufacturer Manufacturer VS and IR Phase 3 (FEVAR Procedure) Preoperative checks Confirmation anaesthetic assessment Procedure date Phase overdue Phase 4 (Follow-up) Follow-up CT and OPD appointments Phase overdue VS and IR 1 week 2 weeks 1 week 6 weeks 7 weeks 2 weeks 2 weeks 6 weeks 6 weeks The total time from entry to the FEVAR protocol and the FEVAR operation date is approximately 12 weeks. Adequacy of the trust’s investigation of these events – in particular the morbidity and mortality meeting discussion, which was incomplete, and does not refer to delay by the trust at all. Further to the investigations referred to above, Mrs S’ case is to be discussed at the next vascular Morbidity and Mortality meeting at NUH. Nature and content of the witness statements provided to the coroner, which again refer only to delay by the manufacturer, which is clearly not the central issue in this case. The legal team at Sherwood Forest Hospitals NHS FT is soon to be made part of the Governance Directorate, with offices adjacent. This will enable a greater working relationship between the legal team and the Clinical Governance Unit which it is expected will make matters requiring investigation clearer from the outset. Any insufficiency in witness evidence can be addressed at an earlier stage. 5 I hope this provides you with assurance that we have reviewed our systems and will continue to look for further opportunities to improve processes and the experience of patients. Should you require any further information please do not hesitate to contact me. Yours sincerely Chief Executive 6
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