8 Apr 2021 Raphael Maximilian Kolbe · Prevention of Future Deaths report West London
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Concerns raised 1
Failure of hospital policy and practice to clarify attending personnel roles during epidural siting View source
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
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Raphael Maximilian Kolbe · Prevention of Future Deaths report
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Report summary
Raphael Maximilian Kolbe was delivered at term after an uneventful pregnancy, but a cord prolapse during delivery was not recognised until fetal compromise had occurred. He died six weeks later in Kingston Hospital after transfer for palliative care. The concerns identified included inadequate monitoring during induction labour and epidural re-siting, unclear staff roles, and differences between hospital policy and practice.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of hospital policy and practice to clarify attending personnel roles during epidural siting
Wider context from the report “It became apparent during the inquest that although a great deal of positive work, reflection and retraining has taken place and amendments to the Hospital policies and guidelines, the policy does still not reflect practise . This is particularly so in respect of the roles of the primary midwife, the second midwife in support and the anaesthetist when an epidural is being sited .
In order for greater clarification and protection of the fetal well being, further consideration should be given to ensure all attending personnel are aware of their role . The requirements for fetal monitoring during this particular procedure should be highlighted and practise should reflect hospital policy.
The requirement for “fresh eyes” remains under ongoing consideration to encourage and support regular review from another midwife or obstetrician and the hospital are continuing to work on an Action plan to implement best practise. While this is always an area that remains under review, clear guidance from the hospital would best support the staff and facilitate better outcomes.
” Source location Raphael Maximilian Kolbe · Prevention of Future Deaths report Page 2 · concerns
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Implement clarified midwifery and anaesthetic responsibilities, including maintaining fetal monitoring and providing backup support during epidural insertion.
Verbatim wording from the response “As a result of the SI investigation, a number of changes were put in place. In relation to the matters referred to above, it was reiterated to all staff that the primary responsibility of the midwife was in relation to the baby’s fetal monitoring, and that if this could not be maintained whilst assisting the anaesthetist, then another midwife must support the anaesthetist so that the fetal monitoring is not compromised.”
Source location 2021-0029-Response-from-The-Portland-Hospital-Redacted Page 1 · response Published 9 February 2021
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Update the Fetal Monitoring and Epidural Analgesia in Labour policies to clarify staff responsibilities during epidural insertion.
Verbatim wording from the response “Whilst the learning from the SI was properly embedded within the Hospital, we acknowledge that in relation to the ‘budding’ system and the role of the anaesthetist, these changes were not properly reflected in the Portland’s written policy. We apologise for this, and can confirm that this has now been addressed within the following updated policies, attached for your consideration:”
Source location 2021-0029-Response-from-The-Portland-Hospital-Redacted Page 1 · response Published 9 February 2021
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Disseminate the clarified responsibilities through team meetings, multidisciplinary circulation and skills-and-drills training.
Verbatim wording from the response “These clarifications have also been discussed in team meetings, circulated amongst the midwifery multi-disciplinary team (which includes the anaesthetists) and used in the training programme ‘skills and drills’.”
Source location 2021-0029-Response-from-The-Portland-Hospital-Redacted Page 2 · response Published 9 February 2021
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31 Mar 2021 Nicholas Hugh Winterton · Prevention of Future Deaths report City of London
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Concerns raised 1
Failure to keep national Mycobacterium Chimaera risk guidance and web information updated View source
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
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Nicholas Hugh Winterton · Prevention of Future Deaths report
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Report summary
Nicholas Hugh Winterton developed Mycobacterium chimaera infection after aortic valve replacement surgery involving a heater-cooler unit in May 2016. The infection led to endocarditis, sepsis and multi-organ failure, and he died on 29 September 2018. The principal concerns were that the nationally reported infection risk was based on outdated and incomplete data, and that equipment use was not recorded and cleaning was performed less frequently than recommended by the manufacturer.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to keep national Mycobacterium Chimaera risk guidance and web information updated
Wider context from the report “1. It is apparent that it is important that the nationally recognised level of the risk of developing Mycobacterium Chimaera from exposure to a heater cooler unit is accurate, in that it accurately reflects the most current statistical data, and is based on the best gathering of statistical data as to the true incidence of such infection as can practically be achieved. This is because the nationally recognised level of risk is the proper basis upon which –
(i) The informed consent of a patient for a relevant surgery is obtained, and
(ii) Post-operatively, the patient and the clinician(s) caring for him (including his General Practitioner) will base their “threshold for suspicion” for Mycobacterium Chimaera if the patient develops an infection which cannot quickly be identified and treated.
2. Public Health England, together with the National Institute for Cardiovascular Outcomes Research, the Society for Cardiothoracic Surgery, and the College of Clinical Perfusion Scientists, are the national bodies which are able to co-ordinate collation of relevant statistical evidence and then formulate and disseminate accurate information about the level of risk. It is inappropriate for individual hospitals, cardiac centres, or Trusts to formulate risk level on the basis of their own data as this would result, nationally, in the dissemination of inconsistent information.
3. Public Health England’s “Clinical guidance for secondary care” and “Information for general practice” are based on January 2017 data. Further, on its website, under the heading “Who could be at risk of Mycobacterium chimaera infection”, Public Health England currently states,
“People most at risk are those who’ve had heart valve surgery since January 2013. About 1 person in every 5,000 who has this type of surgery will develop the infection.”
This assessment is also based on data collated to January 2017.
4. The evidence at the inquest showed that the figure of “1 person in every 5,000” is inaccurate, in that :
(i) It is based on data from 2017 and not updated data , and
(ii) It is based on data which reflects only those patients who are reported to Public Health England as having died of Mycobacterium Chimaera infection, whereas the true incidence of the infection is very likely to be higher; the likelihood is that there is a potentially significant number of deaths from undiagnosed Mycobacterium Chimaera, given the patient cohort’s usual level of co-morbidities and clinicians’ low threshold of suspicion for this infection.
5. A more accurate assessment of the risk, and more accurate guidance, would therefore result from –
(i) An immediate review by Public Health England of all data held to date with a re-calculation of the incidence of Mycobacterium Chimaera infection and consequential risk being reflected in updated guidance and web-site information, and
(ii) Consideration being given by all the bodies to whom this Report is sent of whether there is a better investigative basis which could be used for obtaining relevant data and statistics as to the true incidence of Mycobacterium Chimaera infection, whether by means of a research study or otherwise.
” Source location Nicholas Hugh Winterton · Prevention of Future Deaths report Page 3 · concerns
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Further update the risk estimates and publish them by September 2021.
Verbatim wording from the response “9) PHE will further update the risk estimates and ensure that these are published by September 2021. The respondent bodies will thereafter cascade these updated risk estimates to healthcare professionals involved in informing and consenting patients or investigating and diagnosing these infections, namely consultant microbiologists and cardiothoracic surgeons. This will be achieved through our respective clinical networks.”
Source location 2021-0204-Response-from-Public-Health-England-Redacted Page 4 · response Published 28 June 2021
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Cascade updated risk estimates through clinical networks to professionals informing or consenting patients and investigating or diagnosing infections.
Verbatim wording from the response “9) PHE will further update the risk estimates and ensure that these are published by September 2021. The respondent bodies will thereafter cascade these updated risk estimates to healthcare professionals involved in informing and consenting patients or investigating and diagnosing these infections, namely consultant microbiologists and cardiothoracic surgeons. This will be achieved through our respective clinical networks.”
Source location 2021-0204-Response-from-Public-Health-England-Redacted Page 4 · response Published 28 June 2021
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Forward requests to NHS England to agree responsibility and a timetable for updating healthcare guidance and NHS website information.
Verbatim wording from the response “12) Given the transfer of responsibility for management for the incident, we will forward this request for the further updating of guidance and to the need to update the NHS website to NHS England to agree responsibilities and a timetable for updating.”
Source location 2021-0204-Response-from-Public-Health-England-Redacted Page 5 · response Published 28 June 2021
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The risk estimate was not inaccurate because it measured infection risk using data on all reported cases, not only deaths.
Verbatim wording from the response “3) With regard to the concern in paragraph (1)(ii) above, we would like to clarify to the Coroner that these risk calculations were not based solely on risk of death but in fact based on risk of infection associated with this type of surgery, namely heart-valve surgery performed on bypass. As such, data collection was not restricted to patients reported to PHE as having died of Mycobacterium chimaera (M. chimaera) infection.”
Source location 2021-0204-Response-from-Public-Health-England-Redacted Page 2 · response Published 28 June 2021
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation NHS England is responsible for updating guidance and the NHS website, so the requests will be forwarded to it.
Verbatim wording from the response “10) In relation to the updating of the guidance for healthcare providers, we would like to make the Coroner aware that NHS England assumed responsibility for management of the M. chimaera incident in October 2016. PHE and SCTS worked with NHS England to support the patient notification exercise launched in February 2017, including the development of guidance for healthcare providers.”
Source location 2021-0204-Response-from-Public-Health-England-Redacted Page 4 · response Published 28 June 2021
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Concerns raised 3
Failure to maintain awareness of revised National Institute for Health and Care Excellence guidance on head-injury scanning View source
Failure of the head-injury policy to include patients receiving low-dose anticoagulants within the 8-hour computerised tomography scan criterion View source
Failure of the head-injury policy to reflect revised National Institute for Health and Care Excellence guidance View source
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Robert James GOODMAN · Prevention of Future Deaths report
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Report summary
Robert James GOODMAN died at Southampton General Hospital on 30 March 2020 after an unwitnessed fall the previous day caused a head injury and subdural haematoma. The principal concern was that his CT scan occurred 30 hours after the injury because the Trust policy did not reflect revised guidance for patients receiving any anticoagulant treatment.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to maintain awareness of revised National Institute for Health and Care Excellence guidance on head-injury scanning
Wider context from the report “When found on the floor the deceased stated that he had a head injury. The Trust has a policy for the assessment and early management of head injuries. The policy was, on the evidence, drafted in 2016. The Trust policy is said to reflect the National Institute for Health and Care Excellence guidance on the assessment and early management of head injuries.
The deceased was receiving the anticoagulant enoxaparine whilst in hospital.
The present Trust policy states that a computerised tomography scan of the head should be undertaken within 8 hours of the injury if a patient is receiving anticoagulant treatment.
The evidence suggests that enoxaparine is a “low dose anticoagulant” which did not place the deceased within the Trust policy where a computerised tomography scan should be provided within 8 hours of a head injury.
The Trust were not aware of the September 2019 variation in National Institute for Health and Care Excellence guidance which now advises that patients who are on any anticoagulant should have a computerised tomography scan within 8 hours of a head injury.
The Trust’s policy does not presently reflect the National Institute for Health and Care Excellence revised guidance, in place since September 2019.
It was accepted in evidence that the deceased would have had a computerised tomography scan within 8 hours of a head injury if the revised National Institute for Health and Care Excellence guidance had been applied and reflected in the Trust policy.
The deceased’s computerised tomography scan was undertaken 30 hours after the deceased had suffered a head injury.
” Source location Robert James GOODMAN · Prevention of Future Deaths report Page 1 · concerns
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of the head-injury policy to include patients receiving low-dose anticoagulants within the 8-hour computerised tomography scan criterion
Wider context from the report “When found on the floor the deceased stated that he had a head injury. The Trust has a policy for the assessment and early management of head injuries. The policy was, on the evidence, drafted in 2016. The Trust policy is said to reflect the National Institute for Health and Care Excellence guidance on the assessment and early management of head injuries.
The deceased was receiving the anticoagulant enoxaparine whilst in hospital.
The present Trust policy states that a computerised tomography scan of the head should be undertaken within 8 hours of the injury if a patient is receiving anticoagulant treatment.
The evidence suggests that enoxaparine is a “low dose anticoagulant” which did not place the deceased within the Trust policy where a computerised tomography scan should be provided within 8 hours of a head injury .
The Trust were not aware of the September 2019 variation in National Institute for Health and Care Excellence guidance which now advises that patients who are on any anticoagulant should have a computerised tomography scan within 8 hours of a head injury.
The Trust’s policy does not presently reflect the National Institute for Health and Care Excellence revised guidance, in place since September 2019.
It was accepted in evidence that the deceased would have had a computerised tomography scan within 8 hours of a head injury if the revised National Institute for Health and Care Excellence guidance had been applied and reflected in the Trust policy.
The deceased’s computerised tomography scan was undertaken 30 hours after the deceased had suffered a head injury.
” Source location Robert James GOODMAN · Prevention of Future Deaths report Page 1 · concerns
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of the head-injury policy to reflect revised National Institute for Health and Care Excellence guidance
Wider context from the report “When found on the floor the deceased stated that he had a head injury. The Trust has a policy for the assessment and early management of head injuries. The policy was, on the evidence, drafted in 2016. The Trust policy is said to reflect the National Institute for Health and Care Excellence guidance on the assessment and early management of head injuries.
The deceased was receiving the anticoagulant enoxaparine whilst in hospital.
The present Trust policy states that a computerised tomography scan of the head should be undertaken within 8 hours of the injury if a patient is receiving anticoagulant treatment.
The evidence suggests that enoxaparine is a “low dose anticoagulant” which did not place the deceased within the Trust policy where a computerised tomography scan should be provided within 8 hours of a head injury.
The Trust were not aware of the September 2019 variation in National Institute for Health and Care Excellence guidance which now advises that patients who are on any anticoagulant should have a computerised tomography scan within 8 hours of a head injury.
The Trust’s policy does not presently reflect the National Institute for Health and Care Excellence revised guidance, in place since September 2019 .
It was accepted in evidence that the deceased would have had a computerised tomography scan within 8 hours of a head injury if the revised National Institute for Health and Care Excellence guidance had been applied and reflected in the Trust policy.
The deceased’s computerised tomography scan was undertaken 30 hours after the deceased had suffered a head injury.
” Source location Robert James GOODMAN · Prevention of Future Deaths report Page 1 · concerns
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Amend and launch the head-injury policy to require CT scanning within eight hours for patients receiving therapeutic anticoagulants, including DOACs.
Verbatim wording from the response “In respect of NICE Clinical Guideline [CG176], I can confirm that the Trust’s policy has now been amended so that it is clear that patients receiving therapeutic anticoagulant treatment including Direct Oral Anticoagulants (DOACs) should undergo a CT scan within 8 hours of a suspected head injury.”
Source location 2020-0285-Response-from-Southampton-General-Hospital-Redacted Page 1 · response Published 7 January 2021
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Disseminate the updated head-injury policy and key NICE changes to clinical teams and publish it on the staff intranet.
Verbatim wording from the response “The Trust launched the updated policy on the 26th January 2021, our head of patient safety emailed out to the clinical teams (including consultants, nursing, pharmacy and therapy staff) to notify them of the updated policy and highlight the key changes including the NICE guidance. We also included the updated policy on the clinical updates section on our staff intranet.”
Source location 2020-0285-Response-from-Southampton-General-Hospital-Redacted Page 2 · response Published 7 January 2021
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Continue ensuring CT scanning within eight hours for patients receiving prophylactic enoxaparin who develop clinical signs or symptoms after a fall, and for patients receiving therapeutic anticoagulants.
Verbatim wording from the response “Finally, I would like to assure you that, whilst further guidance from NICE is awaited, the Trust will continue to ensure that all patients receiving a prophylactic dose of Enoxaparin, who develop clinical signs and symptoms following a fall, will undergo a CT scan within 8 hours of a suspected head injury in addition to all those patients who have received a therapeutic dose of DOAC’s, Warfarin etc.”
Source location 2020-0285-Response-from-Southampton-General-Hospital-Redacted Page 3 · response Published 7 January 2021
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation NICE is expected to clarify whether prophylactic anticoagulants should trigger the same scanning requirements as therapeutic anticoagulants.
Verbatim wording from the response “Unfortunately, NICE’s Clinical Guideline [CG176] fails to provide specific guidance on this point. We, therefore, contacted the National Falls Lead at NHSE/I who confirmed that “we are aware that concordance with the guidelines by acute providers is problematic”. We understand that there is to be a full review of the evidence, undertaken by NICE, in order to clarify whether prophylactic anticoagulants should trigger the same requirements as therapeutic doses of DOACs and Warfarin.”
Source location 2020-0285-Response-from-Southampton-General-Hospital-Redacted Page 2 · response Published 7 January 2021
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Patients receiving prophylactic enoxaparin are not routinely scanned after falls without clinical signs suggesting bleeding.
Verbatim wording from the response “On the basis of the current medical literature on the subject, patients who are receiving a prophylactic dose of Enoxaparin are not routinely given a CT scan following a fall unless they are exhibiting clinical signs that are suggestive of a bleed.”
Source location 2020-0285-Response-from-Southampton-General-Hospital-Redacted Page 2 · response Published 7 January 2021
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Universal CT scanning for patients receiving prophylactic enoxaparin could overwhelm scanning capacity and delay scans for patients who require them.
Verbatim wording from the response “The consensus opinion among Medicine for Older People colleagues is that providing a CT scan for all patients on a prophylactic dose of enoxaparin, without other clinical signs and symptoms being evident, would not influence the outcomes for those patients. However, it could overwhelm a hospital’s scanning capacity, meaning that there is a risk that other patients, who do require a CT scan, may face a delay in obtaining this to the potential detriment of their health.”
Source location 2020-0285-Response-from-Southampton-General-Hospital-Redacted Page 2 · response Published 7 January 2021
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19 Nov 2020 Master Yo Li · Prevention of Future Deaths report Surrey
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Concerns raised 1
Lack of NHS Trust requirements for internal UVC policies and procedures to comply with BAPM guidance View source
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked response
National Institute for Health and Care Excellence
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Master Yo Li · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Yo Li was born extremely prematurely on 11 January 2019 and died on 15 January 2019 after an umbilical venous catheter was mal-positioned, resulting in total parenteral nutrition extravasation. Concerns included gaps in professional guidance about a risk factor for mal-positioned catheters, clinicians’ lack of familiarity with updated guidance, and the absence of NICE guidance or a requirement for NHS Trusts to follow the relevant guidance.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Lack of NHS Trust requirements for internal UVC policies and procedures to comply with BAPM guidance
Wider context from the report “2. There is no NICE guidance on the use of UVCs and there is no requirement on NHS Trusts to ensure that their clinicians are familiar with the BAPM guidance or to ensure that their internal policies and procedures are in accordance with it . Consideration ought to be given by NHSI to introducing some NICE guidance to cover this issue.
” Source location Master Yo Li · Prevention of Future Deaths report Page 3 · concerns
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation NICE considers no direct action necessary at present, while logging the concerns for consideration during the next NG154 update.
Verbatim wording from the response “While we do not consider that direct action is required from NICE at this time, the concerns you have raised have been logged for further consideration when guideline NG154 is next reviewed for update.”
Source location 2020-0245-Response-from-NICE-Redacted.pdf Page 2 · response Published 24 December 2020
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15 Jun 2017 Mr Kevin George Mann · Prevention of Future Deaths report East London
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Concerns raised 1
Visipaque procedure policy failing to require contrast documentation and preliminary checks View source
This report raised 5 other concerns. They are not shown here because they do not form part of this recurring concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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Mr Kevin George Mann · Prevention of Future Deaths report
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Report summary
Mr Kevin George Mann underwent an Ivor Lewis procedure for oesophageal cancer and subsequently developed a pneumothorax. A Visipaque contrast study was performed despite the pneumothorax, and contrast entered his left main bronchus; his respiratory condition deteriorated and he later died. Concerns included failures to check available imaging and an outstanding chest x-ray request, to stop the procedure when contrast entered the bronchus, and to document the amount of contrast used.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Visipaque procedure policy failing to require contrast documentation and preliminary checks
Wider context from the report “5. The policy in place regarding the Visipaque procedure does not require documentation of the amount of contrast material used, or for preliminary checks to be undertaken . The incident occurred over a year ago. Despite clear concerns being raised by the Consultant surgeon on 27 May 2016, there had been no adequate review of the Visipaque procedure policy, by the date of the Inquest hearing.
” Source location Mr Kevin George Mann · Prevention of Future Deaths report Page 2 · concerns
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7 Sep 2016 Dildar Shariff · Prevention of Future Deaths report Manchester North
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Concerns raised 1
Failure to incorporate the significance of head injury in patients undergoing haemodialysis or with significant uraemia due to renal failure into relevant NICE guidelines View source
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
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Dildar Shariff · Prevention of Future Deaths report
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Report summary
Dildar Shariff died at Fairfield General Hospital on 10 May 2016 after a cardiac arrest, following a fall, head pain and vomiting. An intracerebral haemorrhage was confirmed, and the report states that his haemodialysis placed him at increased risk of haemorrhage. The principal concern was that this risk was not widely recognised or referred to in the relevant NICE guidelines, potentially creating a risk to other patients.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to incorporate the significance of head injury in patients undergoing haemodialysis or with significant uraemia due to renal failure into relevant NICE guidelines
Wider context from the report “Evidence was given that patients who are undergoing haemodialysis or with significant uraemia due to renal failure, such as Mr Shariff, are at increased risk of a haemorrhage and that this is not commonly known within the medical profession or referred to in the relevant NICE guidelines. This lack of awareness could create a risk that other deaths will continue to exist or occur in the future and whilst I am satisfied that the Trust have taken this matter very seriously, in that they have implemented appropriate measures to reduce the risk of this occurring in the future, I am concerned with the National procedures as I am mindful that it may take some time for the significance of a head injury within patients with undergoing haemodialysis or with significant uraemia due to renal failure to be incorporated into the NICE guidelines .
” Source location Dildar Shariff · Prevention of Future Deaths report Page 1 · concerns
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Log the concerns with the guideline surveillance team for consideration when the head injury guidance is next reviewed.
Verbatim wording from the response “While we believe that our guideline does not need to be amended as a result of your report, your concerns have been logged with our guideline surveillance team, for their information when the guidance is next considered for update in 2017.”
Source location 2016-0321-Response-by-N.I.C.E Page 2 · response Published 7 September 2016
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The existing head injury guideline does not need amendment because its bleeding-disorder risk factor and CT assessment recommendations already address the concern.
Verbatim wording from the response “We have noted the circumstances around Mr Shariff’s death and the concerns you have raised, in relation to our existing guideline on the assessment and early management of head injury (accessible from our website: www.nice.org.uk/cg176).”
Source location 2016-0321-Response-by-N.I.C.E Page 1 · response Published 7 September 2016
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24 Feb 2016 Wilfrid Pearson · Prevention of Future Deaths report Manchester South
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Concerns raised 1
Failure to maintain an up-to-date Status Epilepticus protocol View source
This report raised 7 other concerns. They are not shown here because they do not form part of this recurring concern.
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Wilfrid Pearson · Prevention of Future Deaths report
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Report summary
Wilfrid Pearson was admitted to Tameside Hospital on 22 April 2015 with epilepsy, developed status epilepticus, and died at a local hospice about a month later. Concerns included possible failures in updating and communicating the status epilepticus protocol, unclear and incomplete records, inadequate escalation of care, staffing pressures, and the legal basis for detaining him after he left the ward.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to maintain an up-to-date Status Epilepticus protocol
Wider context from the report “1. The protocol for the observation, diagnosis and treatment of Status Epilepticus was written by the Consultant Neurologist who gave evidence to me. There was some doubt as to whether the document had been properly updated and whether and how it was promulgated to all relevant medical staff including locum doctors.
” Source location Wilfrid Pearson · Prevention of Future Deaths report Page 1 · concerns
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Revise the Trust’s Status Epilepticus Policy using current clinical guidance.
Verbatim wording from the response “I am informed that since Mr Pearson’s admission in April 2014 nearly two years ago, Dr Douglass has revised the Trust’s Status Epilepticus Policy on two occasions, firstly in direct response to the admission of Mr Pearson and additionally at the time of review in 2015. The policy has been revised to assist clinicians in being able to more easily review and understand the appropriate steps to take when a patient presents with Status Epilepticus. The revisions were made by direct reference to recent guidance on Status Epilepticus published in the Lancet Medical Journal. Please find enclosed a copy of our current policy.”
Source location W-Pearson-Response Page 1 · response Published 24 February 2016
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31 Mar 2015 Thomas Beaty · Prevention of Future Deaths report Manchester North
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Concerns raised 1
Difficulty for Trusts to change guidance without external guidance improvement View source
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked responses
Department of Health and Social Care The Pennine Acute Hospitals
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 4
The Pennine Acute Hospitals
Revise and ratify the assisted vaginal delivery guideline with clarified consultant presence, abandonment criteria, terminology and traction requirements.
View source
The Pennine Acute Hospitals
Issue the consultant-presence requirement for all instrumental delivery trials and audit compliance across both inpatient sites.
View source
The Pennine Acute Hospitals
Review the Trust guideline again after receiving the RCOG recommendations.
View source
Department of Health and Social Care
Send the coroner’s report to the RCOG to communicate the concerns about ambiguity in its maternity guidance.
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Thomas Beaty · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Thomas Beaty was born by emergency caesarean section after an abandoned instrumental delivery on 11 April 2014. At 26 hours of age, he suffered a catastrophic head injury, hypovolaemic shock and hypoxic brain ischaemia, and died. The report raised concerns that guidance on instrumental delivery was ambiguous and potentially open to misinterpretation, including unclear terminology and misleading guidance about traction.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Difficulty for Trusts to change guidance without external guidance improvement
Wider context from the report “1. Instrumental Delivery – the Court heard how local/national protocols and
training programmes are routinely based on guidance issued by the Royal College of
Obstetricians and NICE. The guidance in use at the time of Thomas’ birth was found to be
ambiguous, misleading and potentially open to misinterpretation.
A key example was:
‘…When to abandon the procedure:
• No evidence of progressive descent with each pull
• No evidence of imminent birth following 3 pulls of a correctly placed instrument by
an experienced operator…’
The first point by implication must mean that where there is no descent with the first pull, then the
procedure ought to be abandoned, yet the second point suggests abandonment after a 3rd traction.
2. Terminology - The RCOG Guidance did not provide operational definitions for words such
as ‘imminent’ (vis a vis birth) or ‘crowning’. This was particularly important in Thomas’
case, as it had a bearing on the decision making processes applied during the course of the
forceps delivery.
3. Traction - The term ‘gentle’ (traction) forming the ‘G’ of the algorithm within the Trust’s
protocol was misleading and not in line with the RCOG Guidance. The clinical evidence
suggested that in most (if not all) cases mild to moderate traction is routinely applied by
clinicians in order to ensure safe and successful instrumental delivery. Whilst it was
accepted that this was often subjective, the term ‘gentle’ was clinically out with.
4. Development of Trust Guidance – it is difficult for Trusts to change their guidance until
and unless there is a change/material improvement in the Guidance issued by the RCOG.
” Source location Thomas Beaty · Prevention of Future Deaths report Page 2 · concerns
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Revise and ratify the assisted vaginal delivery guideline with clarified consultant presence, abandonment criteria, terminology and traction requirements.
Verbatim wording from the response “Instrumental Delivery Guidance
Since the sad death of Thomas Beaty, the Trust reviewed and revised the Guideline for Assisted Vaginal Delivery in order to provide staff with greater clarity and guidance regarding the requirement for Consultant presence for trial in theatre if the operator is less than 5ft 6. Additional guidance was also added with regards to the flexion point, complications of instrumental deliveries, and disimpaction of the head. This guideline was ratified in December 2014.”
Source location 2015-0130-Response-by-Pennine-Acute-Hospitals Page 1 · response Published 31 March 2015
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Issue the consultant-presence requirement for all instrumental delivery trials and audit compliance across both inpatient sites.
Verbatim wording from the response “Immediately following the inquest a directive was issued to the obstetric medical team highlighting the requirement for a Consultant Obstetrician to be present in theatre for all trials of instrumental deliveries regardless of the level of experience of the Middle Grade operator. The guideline was amended to reflect this requirement and an audit undertaken on both inpatient sites in April to provide assurance that this requirement was being met consistently.
Upon receipt of the concerns you raised in the Regulation 28 Report to Prevent Future Deaths the guideline has been reviewed and revised further in order to address the areas that were considered ambiguous, misleading and potentially open to misinterpretation.”
Source location 2015-0130-Response-by-Pennine-Acute-Hospitals Page 1 · response Published 31 March 2015
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review the Trust guideline again after receiving the RCOG recommendations.
Verbatim wording from the response “4. Development of Trust Guidance
We have made the interim changes to the Trust guideline whilst waiting for the RCOG to respond to the recommendations. However we will review again once the RCOG recommendations have been received.”
Source location 2015-0130-Response-by-Pennine-Acute-Hospitals Page 2 · response Published 31 March 2015
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Send the coroner’s report to the RCOG to communicate the concerns about ambiguity in its maternity guidance.
Verbatim wording from the response “You had a number of concerns about the guidance issued by the Royal College of Obstetricians and Gynaecologists (RCOG), which the inquest found to be ambiguous, misleading and potentially open to misinterpretation, giving as the example that the RCOG guidance did not provide operational definitions for words such as ‘imminent’ (vis a vis birth) or ‘crowning’.”
Source location 2015-0130-Response-by-Department-of-Health Page 1 · response Published 31 March 2015
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation RCOG is responsible for addressing concerns about its professional guidance.
Verbatim wording from the response “While local maternity and neonatal care providers must determine how best to deliver services in their area, in doing so we would expect them to give due regard to RCOG and other professional guidance. To this end, a copy of your report has been sent to the RCOG to make them aware of the concerns you have raised and I understand that they have responded to you directly.”
Source location 2015-0130-Response-by-Department-of-Health Page 1 · response Published 31 March 2015
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Local maternity and neonatal providers are responsible for determining how services should be delivered in their areas.
Verbatim wording from the response “While local maternity and neonatal care providers must determine how best to deliver services in their area, in doing so we would expect them to give due regard to RCOG and other professional guidance. To this end, a copy of your report has been sent to the RCOG to make them aware of the concerns you have raised and I understand that they have responded to you directly.”
Source location 2015-0130-Response-by-Department-of-Health Page 1 · response Published 31 March 2015
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12 Nov 2014 Patricia Ann Mellor · Prevention of Future Deaths report Nottinghamshire
View report summary
Concerns raised 3
Failure to update guidance to require specific examination of the QTc interval in all pre-operative ECGs View source
Failure to update pre-operative assessment guidance to require consideration of drug-induced LQTS before omitting a 12 lead ECG View source
Failure to update guidance to require 12 lead ECG recording and QTc examination for patients receiving drugs at high or intermediate risk of inducing cardiac arrest in LQTS View source
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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AI-generated summary
Patricia Ann Mellor · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Patricia Ann Mellor suffered a cardiac arrest during general anaesthesia in 2004, resulting in a hypoxic brain injury and severe disability. She died from aspiration pneumonia on 24 January 2014. The investigation identified acquired Long QT Syndrome associated with a combination of citalopram, nortriptyline and ranitidine, and concerns were raised about the need to identify and manage this risk before anaesthesia.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to update guidance to require specific examination of the QTc interval in all pre-operative ECGs
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Source location Patricia Ann Mellor · Prevention of Future Deaths report Page 3 · concerns
Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to update pre-operative assessment guidance to require consideration of drug-induced LQTS before omitting a 12 lead ECG
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Source location Patricia Ann Mellor · Prevention of Future Deaths report Page 3 · concerns
Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to update guidance to require 12 lead ECG recording and QTc examination for patients receiving drugs at high or intermediate risk of inducing cardiac arrest in LQTS
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Source location Patricia Ann Mellor · Prevention of Future Deaths report Page 3 · concerns
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24 Sep 2014 Caroling Carter Crowther · Prevention of Future Deaths report Worcestershire
View report summary
Concerns raised 1
Failure to provide clear and consistent policy on compelling psychiatric patients to attend hospital View source
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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AI-generated summary
Caroling Carter Crowther · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Mrs Crowther, a patient detained under Section 3 of the Mental Health Act, became physically unwell and died after paramedics declined to take her to hospital despite differing views about her capacity and need for treatment. The concerns included conflicting accounts of whether Trust policy prevented paramedics from compelling a psychiatric patient to attend hospital, including without police presence.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to provide clear and consistent policy on compelling psychiatric patients to attend hospital
Wider context from the report “(1) The Paramedic who gave evidence expressed a view that it was "Trust Policy" that a
psychiatric patient whether or not they had capacity should not be compelled to go to
hospital even when it was universally agreed that she was grievously ill.
(2) The Paramedic concerned indicated that without the presence of the police to
physically coerce the patient, Paramedics within the Trust had been told that they should
not become involved in physical coercion.
(3) The Area Support Officer who gave evidence flatly contradicted the Paramedic and
said that it was NOT Trust policy to act in this way and that Paramedics could and
should (in appropriate cases) compel a patient in need to attend hospital
” Source location Caroling Carter Crowther · Prevention of Future Deaths report Page 1 · concerns
Open source report