John Slope
PFD Report
All Responded
Ref: 2021-0144
All 1 response received
· Deadline: 5 Jul 2021
Coroner's Concerns (AI summary)
Critical medical device information was missing from patient records, consent forms, and anaesthetic checklists, alongside generally poor documentation quality and specialist nurses failing to act on patient concerns.
View full coroner's concerns
During 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. That there is no method of noting in the medical records that a salivary bypass tube is in the patient’s body. That this death happened nearly nine months ago and still there is no method of showing staff in the notes that a patient has this prosthesis and that no thought had been given to this simple measure e.g. a rubber stamp stating patient has a bypass tube in situ to be ticked and signed. The hospital already uses this method for when an intravenous cannulae is inserted and hip prosthesis. This is immediately noticeable and would alert staff. That the quality of the documentation pre and post operatively is of poor quality and would not assist other staff to find out what treatment had been given. That there is nowhere on the consent form or the anaesthetic checklist for the presence of a tube to be asked about and documented. These are basic common-sense measures which should have been in place. Had the absence of the tube been noted when it was only in the stomach it is likely that Mr Slope would not have died months later from a perforated small bowel. That the clinical specialist nurses did not contact anyone or document the concerns raised by Mr Slope in March 2020. That the hospital did not request a summary of Mr Slope’s treatment at a different hospital before commencing the procedures, this could easily be requested via e mail.
Responses
Action Planned
The Trust has revised its SI action plan to include checking the bypass tube at dressing changes, making the reasons for using such tubes prominent on the patient record, and informing nursing staff of the risks associated with such tubes. Longer term, a single patient record system is planned for the region, with interim measures to scan patient records onto an electronic document management system. (AI summary)
The Trust has revised its SI action plan to include checking the bypass tube at dressing changes, making the reasons for using such tubes prominent on the patient record, and informing nursing staff of the risks associated with such tubes. Longer term, a single patient record system is planned for the region, with interim measures to scan patient records onto an electronic document management system. (AI summary)
View full response
Dear Ms Blake Re: John Slope (deceased) - Regulation 28 response I am writing in response to the above Regulation 28 report (Report) that I received on 10 May 2021. I hope that this letter and the accompanying documents will satisfy you and Mr Slope's family that the matters of concern raised in the Report have been carefully considered by the Trust and appropriate action has been or is being taken. In reviewing the Regulation 28 report, the fol lowing members of staff have been involved.
• (Consultant Otolaryngologist, Head & Neck/Thyroid Surgeon)
• (Consultant ENT Surgeon and Clinical Governance Lead)
• Dr (Consultant Obstetrician and Gynaecologist, Associate Medical Director and Chief Clinical Information Officer).
• (Governance Manager - Acute Service Integration)
• (Divisional Nurse Director, Surgical)
•
(Associate Director Quality and Safety - Patient Safety Specialist)
• (Matron for Theatres Governance, Risk and Education)
• (Divisional Governance Manager - Surgical Division) SI reports and action plan At the outset, I acknowledge that the Actions in the original Serious Incident (SI) Action Plan annexed to the SI report were insufficiently robust. This has been revisited and revised and is attached to this letter. I will address the key changes made in light of your Regulation 28 Report further in this letter. You also highlighted
your concern that several months after Mr Slope's death, measures had not been put in place to prevent a similar occurrence. has circulated further advice and supporting information to the Corporate Governance teams to ensure that when they are reviewing draft S! reports, the recommendations made should address the care and service delivery problems identified through the analysis of the information gathered; and, the actions should address the recommendations. She has referred to the Action Hierarchy toolkit published by the Institute of Healthcare Improvement which gives some clear examples of what strong, medium and weaker actions look like. There is a hierarchy of actions in relation to their ability to bring about change. This is now covered in the RCA training that we deliver. With this is mind, the Action Plan in Mr Slope's case has been updated. In terms of ensuring that Action Plans are completed, the Division adds new SI Action Plans to Datix within 10 working days of the SI being signed off by the Executive. With regards to robust follow up of SI action plans, within the last two months, the Surgical Division has implemented a process to enter individual actions into the 'actions module' within the Datix System (the Trust's Incident Reporting System). This allows for automated emails to be sent out to the individual action owners for update and advising the action owner if an action becomes overdue. This also allows for an audit trail of any updates made to the action. When SI actions are marked by the action owner as completed on Datix, a notification is sent to the person who has entered the action (the divisional governance team) to review the action update prior to its final closure, thus ensuring that it meets the necessary standard. The Corporate Risk & Patient Safety Team is also able to monitor this on the SI dashboard on Datix. Monthly Datix generated reports of all overdue actions from all serious incidents which now being reviewed quarterly by Safety and Clinical Effectiveness Sub Board and monthly at the Divisional and Directorate boards. Documentation of salivary tubes Your Regulation 28 report highlights that there is no method of noting in the medical records that a salivary bypass tube is in place. Further, that specific mention of it was not on the consent form or anaesthetic checklist. Your suggestion of a rubber stamp on the printed operation note has been given careful consideration. However, on a practical level, it is felt that this may not entirely address this issue given the practices and procedures in place within the hospital. It is common for more than one operation note to be printed for the notes. Also, if a surgeon, anaesthetist or member of theatre staff, is viewing the electronic copy of the note as part of the pre-operative planning or in a MDT, the rubber stamp would not be visible. Therefore, to address this, has adapted ORSOS (Theatres documentation system) to include in the 'surgeon's notes' area of the template a section for documenting retained/implanted items and another for their planned management. This in effect creates a 'digital rubber stamp' and means that the information is visible on every printed copy of the operation note and also on the IT systems. This is also in keeping with the Trust's move towards electronic patient records. It will also be used for all surgical specialities, not just ENT. A copy of the revised template is attached. 2
Further work to highlight that a patient has a surgical device/implant is also ongoing. In terms of the salivary bypass tube, has been in touch with the manufacturers to see if they have a card or leaflet that can be provided to a patient. They do not currently have one but this will be a legislative requirement for manufacturers from May 2024 when the transition period from the Medical Device Directive to the Medical Device Regulation is complete. We have adopted an interim measure with the view to refining this once further information is available from the manufacturers of surgical implants and also advice sought from other NHS Trusts. To better inform our plan for the future , we are also auditing the revised documentation of patients with salivary bypass tubes to include the date of insertion; the point of discussion with the patient regarding the tube being inserted; at follow up whether there is clear evidence of it being in situ; and, a procedural note of it being inserted. In addition to documenting tubes (and other surgical implants) in the operation records in a more robust fashion, we are also ensuring that patients are given more information about the tube and what to do if they have any symptoms which could give cause for concern. They will also have a visible reminder on a wristband that they have a tube in situ, which will alert other care providers, who do not have access to the patient's medical records at this Trust. As an interim measure, handwritten information will be provided to patients regarding salivary bypass tubes and this is going to be documented as part of the discharge checklist for this group of patients. Longer term, a leaflet is being drafted by the ENT team. This will be reviewed by the Neck Breathers Association (a patient support group) for comment, prior to finalising it. This 'foreign body leaflet' will identify potential symptoms and when to seek medical review. This will also be supported with a patient 'card' for temporary surgical devices in situ. It will include contact numbers for the Head and Neck Department, size of salivary tube, date inserted and names of key contacts. A medical alert bracelet is also being devised. This will state that a device it is situ and will not be removed until the device is. Again, this is intended to be a visible alert to other caregivers. Communication between clinical teams Mr Slope's surgical care was under the Norfolk and Waveney ENT Service, which comprises the ENT services of the Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH) but treats patients throughout the region. Therefore, although his local hospital was the Queen Elizabeth Hospital, King's Lynn, Mr Slope's specialist head and neck cancer care was the responsibility of NNUH. Concerns about the lack of inter-connectivity of IT systems between the Trusts has been discussed at the ENT governance meetings; a risk assessment was completed , added to the NNUH (lead provider) risk register and approved in December 2020. At present, the clinicians do not have access to the relevant IT systems across the region to obtain full information for all patients for which they have clinical responsibilities, whether working from any site or remotely. A system wide approach is required to align the different IT systems, for example e-mail accounts, risk and incident management systems, dictation programmes, 3
ICE/SystmOne access and versions, imaging packages and Electronic Prescribing and Medicines Administration (EPMA). Currently workarounds are being devised at an operational level allowing information sharing and transfer where appropriate of governance responsibilities. Longer term, our three hospital (JPUH, QEH , NNUH) electronic records system is now at the strategic outline case stage, which has been approved by all three hospital Trusts and is now with the national regulatory team to approve. This will see, upon implementation, a single patient record known as Electronic Patient Record (EPR), accessible electronically at all sites. The timeline for implementation depends on the pace of regulatory approvals and the governance cycle. The earliest implementation is likely to begin is 2022. In the meantime, a shared care record programme across the region will provide patient data to each Trust. In essence, active patient records are being scanned onto Electronic Document Management System (EDMS) each time a patient is admitted to hospital or attends a clinic. This will improve the visibility of patient records to all providers in a read-only format and will improve communication about patients such as Mr Slope as it will amalgamate records which previously may have been held in paper format by different teams and avoid messages such as those made by the nurse specialists not being within the records viewed by the Consultant. The target for full implementation is September 2021. I hope that this information provides you with the assurances you require that the Trust has implemented changes in practice to ensure that the risk of future deaths from similar circumstances will not occur again. Learning does not end at this point but will also continue following audit of the use of salivary bypass tubes and the effectiveness of the measures now put in place.
• (Consultant Otolaryngologist, Head & Neck/Thyroid Surgeon)
• (Consultant ENT Surgeon and Clinical Governance Lead)
• Dr (Consultant Obstetrician and Gynaecologist, Associate Medical Director and Chief Clinical Information Officer).
• (Governance Manager - Acute Service Integration)
• (Divisional Nurse Director, Surgical)
•
(Associate Director Quality and Safety - Patient Safety Specialist)
• (Matron for Theatres Governance, Risk and Education)
• (Divisional Governance Manager - Surgical Division) SI reports and action plan At the outset, I acknowledge that the Actions in the original Serious Incident (SI) Action Plan annexed to the SI report were insufficiently robust. This has been revisited and revised and is attached to this letter. I will address the key changes made in light of your Regulation 28 Report further in this letter. You also highlighted
your concern that several months after Mr Slope's death, measures had not been put in place to prevent a similar occurrence. has circulated further advice and supporting information to the Corporate Governance teams to ensure that when they are reviewing draft S! reports, the recommendations made should address the care and service delivery problems identified through the analysis of the information gathered; and, the actions should address the recommendations. She has referred to the Action Hierarchy toolkit published by the Institute of Healthcare Improvement which gives some clear examples of what strong, medium and weaker actions look like. There is a hierarchy of actions in relation to their ability to bring about change. This is now covered in the RCA training that we deliver. With this is mind, the Action Plan in Mr Slope's case has been updated. In terms of ensuring that Action Plans are completed, the Division adds new SI Action Plans to Datix within 10 working days of the SI being signed off by the Executive. With regards to robust follow up of SI action plans, within the last two months, the Surgical Division has implemented a process to enter individual actions into the 'actions module' within the Datix System (the Trust's Incident Reporting System). This allows for automated emails to be sent out to the individual action owners for update and advising the action owner if an action becomes overdue. This also allows for an audit trail of any updates made to the action. When SI actions are marked by the action owner as completed on Datix, a notification is sent to the person who has entered the action (the divisional governance team) to review the action update prior to its final closure, thus ensuring that it meets the necessary standard. The Corporate Risk & Patient Safety Team is also able to monitor this on the SI dashboard on Datix. Monthly Datix generated reports of all overdue actions from all serious incidents which now being reviewed quarterly by Safety and Clinical Effectiveness Sub Board and monthly at the Divisional and Directorate boards. Documentation of salivary tubes Your Regulation 28 report highlights that there is no method of noting in the medical records that a salivary bypass tube is in place. Further, that specific mention of it was not on the consent form or anaesthetic checklist. Your suggestion of a rubber stamp on the printed operation note has been given careful consideration. However, on a practical level, it is felt that this may not entirely address this issue given the practices and procedures in place within the hospital. It is common for more than one operation note to be printed for the notes. Also, if a surgeon, anaesthetist or member of theatre staff, is viewing the electronic copy of the note as part of the pre-operative planning or in a MDT, the rubber stamp would not be visible. Therefore, to address this, has adapted ORSOS (Theatres documentation system) to include in the 'surgeon's notes' area of the template a section for documenting retained/implanted items and another for their planned management. This in effect creates a 'digital rubber stamp' and means that the information is visible on every printed copy of the operation note and also on the IT systems. This is also in keeping with the Trust's move towards electronic patient records. It will also be used for all surgical specialities, not just ENT. A copy of the revised template is attached. 2
Further work to highlight that a patient has a surgical device/implant is also ongoing. In terms of the salivary bypass tube, has been in touch with the manufacturers to see if they have a card or leaflet that can be provided to a patient. They do not currently have one but this will be a legislative requirement for manufacturers from May 2024 when the transition period from the Medical Device Directive to the Medical Device Regulation is complete. We have adopted an interim measure with the view to refining this once further information is available from the manufacturers of surgical implants and also advice sought from other NHS Trusts. To better inform our plan for the future , we are also auditing the revised documentation of patients with salivary bypass tubes to include the date of insertion; the point of discussion with the patient regarding the tube being inserted; at follow up whether there is clear evidence of it being in situ; and, a procedural note of it being inserted. In addition to documenting tubes (and other surgical implants) in the operation records in a more robust fashion, we are also ensuring that patients are given more information about the tube and what to do if they have any symptoms which could give cause for concern. They will also have a visible reminder on a wristband that they have a tube in situ, which will alert other care providers, who do not have access to the patient's medical records at this Trust. As an interim measure, handwritten information will be provided to patients regarding salivary bypass tubes and this is going to be documented as part of the discharge checklist for this group of patients. Longer term, a leaflet is being drafted by the ENT team. This will be reviewed by the Neck Breathers Association (a patient support group) for comment, prior to finalising it. This 'foreign body leaflet' will identify potential symptoms and when to seek medical review. This will also be supported with a patient 'card' for temporary surgical devices in situ. It will include contact numbers for the Head and Neck Department, size of salivary tube, date inserted and names of key contacts. A medical alert bracelet is also being devised. This will state that a device it is situ and will not be removed until the device is. Again, this is intended to be a visible alert to other caregivers. Communication between clinical teams Mr Slope's surgical care was under the Norfolk and Waveney ENT Service, which comprises the ENT services of the Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH) but treats patients throughout the region. Therefore, although his local hospital was the Queen Elizabeth Hospital, King's Lynn, Mr Slope's specialist head and neck cancer care was the responsibility of NNUH. Concerns about the lack of inter-connectivity of IT systems between the Trusts has been discussed at the ENT governance meetings; a risk assessment was completed , added to the NNUH (lead provider) risk register and approved in December 2020. At present, the clinicians do not have access to the relevant IT systems across the region to obtain full information for all patients for which they have clinical responsibilities, whether working from any site or remotely. A system wide approach is required to align the different IT systems, for example e-mail accounts, risk and incident management systems, dictation programmes, 3
ICE/SystmOne access and versions, imaging packages and Electronic Prescribing and Medicines Administration (EPMA). Currently workarounds are being devised at an operational level allowing information sharing and transfer where appropriate of governance responsibilities. Longer term, our three hospital (JPUH, QEH , NNUH) electronic records system is now at the strategic outline case stage, which has been approved by all three hospital Trusts and is now with the national regulatory team to approve. This will see, upon implementation, a single patient record known as Electronic Patient Record (EPR), accessible electronically at all sites. The timeline for implementation depends on the pace of regulatory approvals and the governance cycle. The earliest implementation is likely to begin is 2022. In the meantime, a shared care record programme across the region will provide patient data to each Trust. In essence, active patient records are being scanned onto Electronic Document Management System (EDMS) each time a patient is admitted to hospital or attends a clinic. This will improve the visibility of patient records to all providers in a read-only format and will improve communication about patients such as Mr Slope as it will amalgamate records which previously may have been held in paper format by different teams and avoid messages such as those made by the nurse specialists not being within the records viewed by the Consultant. The target for full implementation is September 2021. I hope that this information provides you with the assurances you require that the Trust has implemented changes in practice to ensure that the risk of future deaths from similar circumstances will not occur again. Learning does not end at this point but will also continue following audit of the use of salivary bypass tubes and the effectiveness of the measures now put in place.
Sent To
- Norfolk and Norwich University Hospital NHS Foundation Trust
Response Status
Linked responses
1 of 1
56-Day Deadline
5 Jul 2021
All responses received
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 11 August 2020 I commenced an investigation into the death John Graham Slope. The investigation concluded at the end of the inquest on 28 April 2021. The conclusion of the inquest was a narrative conclusion: “Mr John Slope underwent a total laryngectomy in 2019 with a tracheostomy and insertion of a voice box prosthesis. He developed a leak and a fistula and a salivary bypass tube was inserted at a later date. He had quite a long hospital stay developing pneumonia and difficulties with nutrition. He was discharged from hospital on 17 July 2019. He then asked to be investigated in March 2020, but no-one has documented the exact nature of his concerns. Overall the quality of the documentation was poor. He was being reviewed by another hospital's SALT team. Due to covid-19 and its restrictions, his voice box prosthesis could not be changed as it was a high risk procedure and he was a high risk patient. In August 2020 he became unwell with a painful guarded abdomen with reduced bowel sounds and nausea. CT scan showed small bowel perforation and a foreign body in the small bowel. Mr Slope was deemed too unwell for surgery and died.” The medical cause of death was given as: 1a) Small Bowel Obstruction and Perforation 1b) Ingestion of Foreign Body
Circumstances of the Death
Mr Slope underwent a total laryngectomy for pharyngeal cancer, he had a prosthetic voice box fitted, shortly after he had a salivary bypass tube fitted. It is not recorded whether this first tube was secured by sutures. He developed a fistula, a common complication of this type of operation which is the reason for the bypass tubes insertion. When the bypass tube was to be changed in November 2019, there was no tube present but a new one was inserted. The surgeon was unable to recall why there was no tube, if it had been removed previously and or by whom. The documentation of the operation was poor, but he thought he had been told by somebody, he couldn’t remember whom, that the patient had coughed the tube out. However, he was unsure and otherwise could not account for its absence. An abdominal x ray was taken on that day which was later looked at and does show a foreign body in the fundus of the stomach. However, this was not noticed at the time because they were checking placement of the new tube. In March of 2020 Mr Slope asked to have a scope passed to see what was going on, no one has documented anywhere what his concerns were. He was unable to be investigated or have his voice box changed due to covid restrictions as this procedure was deemed to be high risk. In August 2020 Mr slope was admitted as an emergency, extremely unwell with a tense guarded abdomen pain and nausea. A scan showed he had a perforated small bowel and demonstrated the presence of a foreign body. He was too unwell to undergo surgery and died shortly afterwards.
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.