Concerns raised 8 Failure to seize and retain relevant scene samples and evidence for later investigation View source Failure to immediately store or freeze stomach contents for triggering-allergen analysis View source Lack of a standard protocol ensuring appropriate samples are taken at the correct time View source Failure to collect and store an early post-mortem blood sample for later analysis View source Failure to retain hospital blood samples for testing View source Failure to raise possible anaphylaxis deaths with the senior coroner at the earliest opportunity View source Failure to collect blood samples for mast cell tryptase and specific IgE serology in suspected anaphylaxis View source Failure to collect and retain tissue samples in suspected anaphylaxis View source See 5 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Benedict BLYTHE · 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
Benedict died at Peterborough City Hospital on 1 December 2021, aged 5, from fatal anaphylaxis following accidental exposure to cow’s milk protein. The report identifies concerns about the retention and testing of samples, including blood and stomach contents, and the police seizure and retention of relevant evidence such as vomitus during investigations of unexplained deaths.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to seize and retain relevant scene samples and evidence for later investigation
Wider context from the report “1) In relation to Pathology
That Kennedy samples collected during a post-mortem examination, should be revised to include the following in cases of suspected anaphylaxis:
a. blood samples for mast cell tryptase and sp IgE serology 2 suspected allergens
b. stomach contents to be immediately stored (and/or frozen) by the pathologist for the analysis of the presence of the triggering allergen
c. blood samples if taken at hospital should not be destroyed but retained for testing
d. that an early blood sample is taken after death and stored for later analysis
e. that the possibility that the death is due to anaphylaxis is raised with the senior coroner for the area where the death occurred at the earliest opportunity
f. tissue samples are taken and retained.
g. Consideration given to the development of a standard protocol to ensure appropriate samples are taken at the correct time to assist later investigation.
2.) The police investigation:
In the circumstances where there is an unexplained death of a child or the person and where that data samples and evidence available at the scene including by way of example vomitus, that the police should include as part of their investigation, the seizure and retention of any such material for the purposes of later investigation either by the Police Pathologist or the Coroner .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to immediately store or freeze stomach contents for triggering-allergen analysis
Wider context from the report “1) In relation to Pathology
That Kennedy samples collected during a post-mortem examination, should be revised to include the following in cases of suspected anaphylaxis:
a. blood samples for mast cell tryptase and sp IgE serology 2 suspected allergens
b. stomach contents to be immediately stored (and/or frozen) by the pathologist for the analysis of the presence of the triggering allergen
c. blood samples if taken at hospital should not be destroyed but retained for testing
d. that an early blood sample is taken after death and stored for later analysis
e. that the possibility that the death is due to anaphylaxis is raised with the senior coroner for the area where the death occurred at the earliest opportunity
f. tissue samples are taken and retained.
g. Consideration given to the development of a standard protocol to ensure appropriate samples are taken at the correct time to assist later investigation.
2.) The police investigation:
In the circumstances where there is an unexplained death of a child or the person and where that data samples and evidence available at the scene including by way of example vomitus, that the police should include as part of their investigation, the seizure and retention of any such material for the purposes of later investigation either by the Police Pathologist or the Coroner.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of a standard protocol ensuring appropriate samples are taken at the correct time
Wider context from the report “1) In relation to Pathology
That Kennedy samples collected during a post-mortem examination, should be revised to include the following in cases of suspected anaphylaxis:
a. blood samples for mast cell tryptase and sp IgE serology 2 suspected allergens
b. stomach contents to be immediately stored (and/or frozen) by the pathologist for the analysis of the presence of the triggering allergen
c. blood samples if taken at hospital should not be destroyed but retained for testing
d. that an early blood sample is taken after death and stored for later analysis
e. that the possibility that the death is due to anaphylaxis is raised with the senior coroner for the area where the death occurred at the earliest opportunity
f. tissue samples are taken and retained.
g. Consideration given to the development of a standard protocol to ensure appropriate samples are taken at the correct time to assist later investigation.
2.) The police investigation:
In the circumstances where there is an unexplained death of a child or the person and where that data samples and evidence available at the scene including by way of example vomitus, that the police should include as part of their investigation, the seizure and retention of any such material for the purposes of later investigation either by the Police Pathologist or the Coroner.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to collect and store an early post-mortem blood sample for later analysis
Wider context from the report “1) In relation to Pathology
That Kennedy samples collected during a post-mortem examination, should be revised to include the following in cases of suspected anaphylaxis:
a. blood samples for mast cell tryptase and sp IgE serology 2 suspected allergens
b. stomach contents to be immediately stored (and/or frozen) by the pathologist for the analysis of the presence of the triggering allergen
c. blood samples if taken at hospital should not be destroyed but retained for testing
d. that an early blood sample is taken after death and stored for later analysis
e. that the possibility that the death is due to anaphylaxis is raised with the senior coroner for the area where the death occurred at the earliest opportunity
f. tissue samples are taken and retained.
g. Consideration given to the development of a standard protocol to ensure appropriate samples are taken at the correct time to assist later investigation.
2.) The police investigation:
In the circumstances where there is an unexplained death of a child or the person and where that data samples and evidence available at the scene including by way of example vomitus, that the police should include as part of their investigation, the seizure and retention of any such material for the purposes of later investigation either by the Police Pathologist or the Coroner.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to retain hospital blood samples for testing
Wider context from the report “1) In relation to Pathology
That Kennedy samples collected during a post-mortem examination, should be revised to include the following in cases of suspected anaphylaxis:
a. blood samples for mast cell tryptase and sp IgE serology 2 suspected allergens
b. stomach contents to be immediately stored (and/or frozen) by the pathologist for the analysis of the presence of the triggering allergen
c. blood samples if taken at hospital should not be destroyed but retained for testing
d. that an early blood sample is taken after death and stored for later analysis
e. that the possibility that the death is due to anaphylaxis is raised with the senior coroner for the area where the death occurred at the earliest opportunity
f. tissue samples are taken and retained.
g. Consideration given to the development of a standard protocol to ensure appropriate samples are taken at the correct time to assist later investigation.
2.) The police investigation:
In the circumstances where there is an unexplained death of a child or the person and where that data samples and evidence available at the scene including by way of example vomitus, that the police should include as part of their investigation, the seizure and retention of any such material for the purposes of later investigation either by the Police Pathologist or the Coroner.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to raise possible anaphylaxis deaths with the senior coroner at the earliest opportunity
Wider context from the report “1) In relation to Pathology
That Kennedy samples collected during a post-mortem examination, should be revised to include the following in cases of suspected anaphylaxis:
a. blood samples for mast cell tryptase and sp IgE serology 2 suspected allergens
b. stomach contents to be immediately stored (and/or frozen) by the pathologist for the analysis of the presence of the triggering allergen
c. blood samples if taken at hospital should not be destroyed but retained for testing
d. that an early blood sample is taken after death and stored for later analysis
e. that the possibility that the death is due to anaphylaxis is raised with the senior coroner for the area where the death occurred at the earliest opportunity
f. tissue samples are taken and retained.
g. Consideration given to the development of a standard protocol to ensure appropriate samples are taken at the correct time to assist later investigation.
2.) The police investigation:
In the circumstances where there is an unexplained death of a child or the person and where that data samples and evidence available at the scene including by way of example vomitus, that the police should include as part of their investigation, the seizure and retention of any such material for the purposes of later investigation either by the Police Pathologist or the Coroner.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to collect blood samples for mast cell tryptase and specific IgE serology in suspected anaphylaxis
Wider context from the report “1) In relation to Pathology
That Kennedy samples collected during a post-mortem examination, should be revised to include the following in cases of suspected anaphylaxis:
a. blood samples for mast cell tryptase and sp IgE serology 2 suspected allergens
b. stomach contents to be immediately stored (and/or frozen) by the pathologist for the analysis of the presence of the triggering allergen
c. blood samples if taken at hospital should not be destroyed but retained for testing
d. that an early blood sample is taken after death and stored for later analysis
e. that the possibility that the death is due to anaphylaxis is raised with the senior coroner for the area where the death occurred at the earliest opportunity
f. tissue samples are taken and retained.
g. Consideration given to the development of a standard protocol to ensure appropriate samples are taken at the correct time to assist later investigation.
2.) The police investigation:
In the circumstances where there is an unexplained death of a child or the person and where that data samples and evidence available at the scene including by way of example vomitus, that the police should include as part of their investigation, the seizure and retention of any such material for the purposes of later investigation either by the Police Pathologist or the Coroner.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to collect and retain tissue samples in suspected anaphylaxis
Wider context from the report “1) In relation to Pathology
That Kennedy samples collected during a post-mortem examination, should be revised to include the following in cases of suspected anaphylaxis:
a. blood samples for mast cell tryptase and sp IgE serology 2 suspected allergens
b. stomach contents to be immediately stored (and/or frozen) by the pathologist for the analysis of the presence of the triggering allergen
c. blood samples if taken at hospital should not be destroyed but retained for testing
d. that an early blood sample is taken after death and stored for later analysis
e. that the possibility that the death is due to anaphylaxis is raised with the senior coroner for the area where the death occurred at the earliest opportunity
f. tissue samples are taken and retained .
g. Consideration given to the development of a standard protocol to ensure appropriate samples are taken at the correct time to assist later investigation.
2.) The police investigation:
In the circumstances where there is an unexplained death of a child or the person and where that data samples and evidence available at the scene including by way of example vomitus, that the police should include as part of their investigation, the seizure and retention of any such material for the purposes of later investigation either by the Police Pathologist or the Coroner.
” Open source report
×
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 Publish autopsy guidelines for suspected acute anaphylaxis, including blood and stomach-content sampling guidance.
Verbatim wording from the response “The Kennedy Protocol has not been formally updated since 2016; it is not known when or if the protocol is to be revised. Since then Autopsy guidelines have been published on sudden unexpected death in infancy and childhood in 2023 under the remit of the Death Investigation Committee at the Royal College of Pathologists and these have superseded the 2016 publication. Neither the 2016 or 2023 guidelines included samples in cases of suspected anaphylaxis. However, the RCPath published autopsy guidelines on autopsies for suspected acute anaphylaxis (includes anaphylactic shock and anaphylactic asthma) in 2018. This document does include very specific guidance of sampling blood and stomach contents in such cases together with caveats for interpreting mast cell tryptase levels.” Source location Response from Royal College of Pathologists
Open published response
×
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 Query the relevant guideline authors about adding IgE testing to an updated autopsy guideline.
Verbatim wording from the response “There are guidelines published by the RCPath for anaphylaxis (referenced below) of note; IgE is not specifically referenced in any of the documents and this will be queried with the authors of the relevant guideline to be included in an updated version. The reference below was published after the guideline was written.” Source location Response from Royal College of Pathologists
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Suspected anaphylaxis should be raised with the Coroner’s officer by the referring medical practitioner or police before the pathologist is contacted.
Verbatim wording from the response “If a death due to anaphylaxis is suspected, this should be raised by the initial referring medical practitioner to the Coroner’s officer or by the police. The case to which the Coroner’s queries are raised should have anaphylaxis or allergic reaction in the potential cause of death or in the deceased’ situational history before the pathologist was contacted. It is usual practice for the autopsy pathologist to communicate a suspected cause of death to the Coroner after the initial examination pending the results of further investigations, however, it is not always possible for a pathologist to be definite at that stage.” Source location Response from Royal College of Pathologists
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Published anaphylaxis autopsy guidance and expected use of relevant guidance are considered sufficient despite paediatric guidelines lacking specific anaphylaxis details.
Verbatim wording from the response “The Kennedy Protocol has not been formally updated since 2016; it is not known when or if the protocol is to be revised. Since then Autopsy guidelines have been published on sudden unexpected death in infancy and childhood in 2023 under the remit of the Death Investigation Committee at the Royal College of Pathologists and these have superseded the 2016 publication. Neither the 2016 or 2023 guidelines included samples in cases of suspected anaphylaxis. However, the RCPath published autopsy guidelines on autopsies for suspected acute anaphylaxis (includes anaphylactic shock and anaphylactic asthma) in 2018. This document does include very specific guidance of sampling blood and stomach contents in such cases together with caveats for interpreting mast cell tryptase levels.” Source location Response from Royal College of Pathologists
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Femoral blood sampling in very young children may be impractical, requiring alternative sites that complicate interpretation of mast cell tryptase levels.
Verbatim wording from the response “Early blood sampling is indicated but timing may be determined by the local post-mortem HTA 2004 arrangements in individual hospitals. In addition, it is extremely difficult to obtain femoral vessel blood samples in very young children purely due to the size of the individual and blood may” Source location Response from Royal College of Pathologists
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Sample retention is determined by the requesting Coroner and subsequently by parental or next-of-kin consent under the Human Tissue Act 2004.
Verbatim wording from the response “In all Coronial post-mortem examinations in children, tissue samples are taken primarily in accordance with the published protocols and also any that are relevant to ascertaining the cause of death. Retention of samples is determined initially by the Coroner requesting the post-mortem examination and thereafter by parental / next-of-kin consent in line with the Human Tissue Act 2004.” Source location Response from Royal College of Pathologists
Open published response
12 Nov 2024 Lisa Gale · Prevention of Future Deaths report Avon
View report summary
Concerns raised 2 Failure of urgent liver function test reporting thresholds to account for pregnancy-specific conditions View source Failure to communicate grossly abnormal liver function test results from laboratory staff to clinical staff View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Lisa Gale · 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
Lisa Gale developed Acute Fatty Liver of Pregnancy (AFLP) and later died despite hospital treatment and intensive care. The report raises concerns that markedly abnormal liver-function results were not urgently communicated because reporting thresholds did not account for pregnancy-specific conditions, resulting in a delay in diagnosing AFLP and starting appropriate treatment.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure of urgent liver function test reporting thresholds to account for pregnancy-specific conditions
Wider context from the report “(1) Blood was taken for liver function tests (LFTs) on admission before her condition was diagnosed;
(2) Lisa’s LFT’s were grossly elevated (normal range in brackets) – ALT 612 (10-50), bilirubin 122 (<21), creatine 168 (45-84);
(3) This was due to a potentially fatal condition – Acute Fatty Liver of Pregnancy – from which she subsequently died;
(3) Despite being grossly elevated, the results once obtained in the laboratory were not phoned through by the laboratory staff to the clinical staff;
(4) This was because the Royal College of Pathologists’ guidelines for urgent reporting only provides for the same with levels above 750 for ALT, 300 for bilirubin and 354 for creatinine – and does not provide for different reporting levels for those taken in pregnant women ;
(5) This is despite pregnancy specific conditions such as AFLP being potentially fatal at much lower levels of abnormal LFTs than those set currently by the Royal College of Pathologists ;
(4) As a result there was a delay in diagnosing her AFLP and starting appropriate treatment.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to communicate grossly abnormal liver function test results from laboratory staff to clinical staff
Wider context from the report “(1) Blood was taken for liver function tests (LFTs) on admission before her condition was diagnosed;
(2) Lisa’s LFT’s were grossly elevated (normal range in brackets) – ALT 612 (10-50), bilirubin 122 (<21), creatine 168 (45-84);
(3) This was due to a potentially fatal condition – Acute Fatty Liver of Pregnancy – from which she subsequently died;
(3) Despite being grossly elevated, the results once obtained in the laboratory were not phoned through by the laboratory staff to the clinical staff ;
(4) This was because the Royal College of Pathologists’ guidelines for urgent reporting only provides for the same with levels above 750 for ALT, 300 for bilirubin and 354 for creatinine – and does not provide for different reporting levels for those taken in pregnant women;
(5) This is despite pregnancy specific conditions such as AFLP being potentially fatal at much lower levels of abnormal LFTs than those set currently by the Royal College of Pathologists;
(4) As a result there was a delay in diagnosing her AFLP and starting appropriate treatment.
” Open source report
×
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 Emphasise the need to agree local critical-result cut-offs with clinicians in the next document revision.
Verbatim wording from the response “With regards to the RCPath document on The Communication of Critical and Unexpected Pathology results, this document is published as ‘advice to pathologists’ and is offered as a basis on which pathologists can construct their own local guidelines after discussion with relevant stakeholders. It is clearly stated that it is vital that this document is seen as guidance for pathology providers to set their own criteria on how, when, and why particular laboratory results are required to be communicated to clinical professionals in an expedited manner. Whilst recommendations are made within the Appendix on cut offs which can be used, it is recommended that individual cut offs are agreed locally with clinicians, and this could be for a variety of clinical conditions with might include pregnancy.” Source location Response from Royal College of Pathologists
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Local pathology providers and clinicians are responsible for agreeing communication cut-offs; the guidance does not prescribe universal thresholds.
Verbatim wording from the response “With regards to the RCPath document on The Communication of Critical and Unexpected Pathology results, this document is published as ‘advice to pathologists’ and is offered as a basis on which pathologists can construct their own local guidelines after discussion with relevant stakeholders. It is clearly stated that it is vital that this document is seen as guidance for pathology providers to set their own criteria on how, when, and why particular laboratory results are required to be communicated to clinical professionals in an expedited manner. Whilst recommendations are made within the Appendix on cut offs which can be used, it is recommended that individual cut offs are agreed locally with clinicians, and this could be for a variety of clinical conditions with might include pregnancy.” Source location Response from Royal College of Pathologists
Open published response
11 Oct 2024 Kingsley Efosa Imafidon · Prevention of Future Deaths report North London
View report summary
Concerns raised 4 Lack of consideration of additional post-operative monitoring and requirements for patients with HbSS View source Failure of the elective liver biopsy SOP to account for patients with other pathologies such as HbSS View source Lack of liaison between care teams about HbSS-relevant matters before liver biopsy View source Failure of liver biopsy clinical guidelines to provide guidance for patients with other pathologies such as HbSS View source See 1 more concern
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Kingsley Efosa Imafidon · 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
Kingsley Efosa Imafidon, who had homozygous sickle cell disease and suspected liver cirrhosis, underwent a liver biopsy on 29 November 2023. He was found unresponsive at home on 2 December 2023, and the post-mortem examination found extensive fresh haemorrhage into the peritoneal cavity following the biopsy. The concerns included lack of apparent liaison about the relevance of his sickle cell disease, insufficient consideration of additional monitoring, and gaps in the biopsy guidance and procedure for patients with conditions such as HbSS.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of consideration of additional post-operative monitoring and requirements for patients with HbSS
Wider context from the report “• There was no apparent liaison between the teams involved in Kingsley's care to consider any matters that may be relevant to his HbSS prior to the biopsy being carried out;
• The Trust’s Standard Operating Procedure (“SOP”) for Elective Liver Biopsy does not appear to give consideration to patients with other pathologies such as HbSS;
• There was no apparent consideration given to potential additional post-operative monitoring or requirements for a patient with HbSS ;
• The Trust’s SOP refers to a document titled “Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology” (Neuberger J, Patel J, Caldwell H et al. Gut 2020) which provides advice on liver biopsy techniques, methods and aftercare etc. These guidelines do not appear to give consideration (and therefore guidance) in relation to the use of liver biopsy for patients with other pathologies such as HbSS.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure of the elective liver biopsy SOP to account for patients with other pathologies such as HbSS
Wider context from the report “• There was no apparent liaison between the teams involved in Kingsley's care to consider any matters that may be relevant to his HbSS prior to the biopsy being carried out;
• The Trust’s Standard Operating Procedure (“SOP”) for Elective Liver Biopsy does not appear to give consideration to patients with other pathologies such as HbSS ;
• There was no apparent consideration given to potential additional post-operative monitoring or requirements for a patient with HbSS;
• The Trust’s SOP refers to a document titled “Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology” (Neuberger J, Patel J, Caldwell H et al. Gut 2020) which provides advice on liver biopsy techniques, methods and aftercare etc. These guidelines do not appear to give consideration (and therefore guidance) in relation to the use of liver biopsy for patients with other pathologies such as HbSS.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of liaison between care teams about HbSS-relevant matters before liver biopsy
Wider context from the report “• There was no apparent liaison between the teams involved in Kingsley's care to consider any matters that may be relevant to his HbSS prior to the biopsy being carried out ;
• The Trust’s Standard Operating Procedure (“SOP”) for Elective Liver Biopsy does not appear to give consideration to patients with other pathologies such as HbSS;
• There was no apparent consideration given to potential additional post-operative monitoring or requirements for a patient with HbSS;
• The Trust’s SOP refers to a document titled “Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology” (Neuberger J, Patel J, Caldwell H et al. Gut 2020) which provides advice on liver biopsy techniques, methods and aftercare etc. These guidelines do not appear to give consideration (and therefore guidance) in relation to the use of liver biopsy for patients with other pathologies such as HbSS.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure of liver biopsy clinical guidelines to provide guidance for patients with other pathologies such as HbSS
Wider context from the report “• There was no apparent liaison between the teams involved in Kingsley's care to consider any matters that may be relevant to his HbSS prior to the biopsy being carried out;
• The Trust’s Standard Operating Procedure (“SOP”) for Elective Liver Biopsy does not appear to give consideration to patients with other pathologies such as HbSS;
• There was no apparent consideration given to potential additional post-operative monitoring or requirements for a patient with HbSS;
• The Trust’s SOP refers to a document titled “Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology” (Neuberger J, Patel J, Caldwell H et al. Gut 2020) which provides advice on liver biopsy techniques, methods and aftercare etc. These guidelines do not appear to give consideration (and therefore guidance) in relation to the use of liver biopsy for patients with other pathologies such as HbSS .
” Open source report
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Further consideration of sickle cell disease in guideline updates is assigned to the group responsible for updating the guidelines.
Verbatim wording from the response “Following these discussions, we understand that the group responsible for updating the guidelines in due course is aware of this very unfortunate case. They will be entering into further discussions and consultations to consider the influence and potential inclusion of underlying conditions, such as sickle cell disease, in any future updates to the guidelines.” Source location Response from Royal College of Pathologists
Open published response
Concerns raised 7 Failure to identify the need for genetic testing before the Pathology report View source Chronic shortage of Paediatric Pathologists View source Limited use of molecular autopsy after sudden death in childhood View source Failure of the SUDIC Protocol to reflect the development of molecular autopsy View source Limited use of molecular autopsy to detect familial genetic variants View source Insufficient time for timely Coronial and Forensic Paediatric Pathology work View source Delays in Paediatric Pathology reports View source See 4 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Tyler Jay Ryan · 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
Tyler Jay Ryan, aged 11, was found collapsed in his bedroom on 12 February 2021 and died after resuscitation attempts. Genetic testing identified two RYR2 variants associated with CPVT, following earlier differing pathological opinions. The report raised concerns about delays in paediatric pathology reporting and the delayed identification of families who may need genetic testing, as well as the need for wider use of molecular autopsy and revision of the SUDIC Protocol.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to identify the need for genetic testing before the Pathology report
Wider context from the report “2. The delay in Paediatric Pathology Reports results in the delayed detection of the need for genetic testing amongst surviving siblings of children who die of Sudden Death in Childhood. Currently, it is not until the Pathologist provides a report that the need for genetic testing is identified . Reports can take up to two years to be filed.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Chronic shortage of Paediatric Pathologists
Wider context from the report “1. ████████ and ████████ each gave evidence that the delay in Paediatric Pathology reports is due to a chronic shortage in recruitment and retention of Paediatric Pathologists in the UK . This shortage is systemic. Currently only 50 out of 80 national vacancies for Paediatric Pathologists are filled . Coronial and Forensic work is undertaken by these Pathologists on a private basis, in addition to their NHS work. This provides insufficient time to carry out this work in a timely fashion. There is an acute shortage of Subspeciality Paediatric Pathologists, with just one Paediatric Orthopedic Pathologist undertaking Forensic and Coronial work in the UK .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Limited use of molecular autopsy after sudden death in childhood
Wider context from the report “3. ████████ and ████████ gave evidence that more widespread use of molecular autopsy would assist in detecting genetic abnormalities in children who have died suddenly , leading to greater opportunities to prevent future deaths within their families and in other families.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure of the SUDIC Protocol to reflect the development of molecular autopsy
Wider context from the report “5. ████████ gave evidence that the development of the use of molecular autopsy calls for a revision of the SUDIC Protocol also known as the Kennedy Protocol .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Limited use of molecular autopsy to detect familial genetic variants
Wider context from the report “4. ████████, Consultant Clinical Geneticist gave evidence that Tyler is, to date, the only human in history to have been found to have these two RYR2 variants which is significant to his family and to the wider scientific community. Greater use of molecular autopsy would save lives within families and in other families . The detection of these variants is directly relevant to others and the prevention of future deaths .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Insufficient time for timely Coronial and Forensic Paediatric Pathology work
Wider context from the report “1. ████████ and ████████ each gave evidence that the delay in Paediatric Pathology reports is due to a chronic shortage in recruitment and retention of Paediatric Pathologists in the UK. This shortage is systemic. Currently only 50 out of 80 national vacancies for Paediatric Pathologists are filled. Coronial and Forensic work is undertaken by these Pathologists on a private basis, in addition to their NHS work . This provides insufficient time to carry out this work in a timely fashion . There is an acute shortage of Subspeciality Paediatric Pathologists, with just one Paediatric Orthopedic Pathologist undertaking Forensic and Coronial work in the UK.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Delays in Paediatric Pathology reports
Wider context from the report “2. The delay in Paediatric Pathology Reports results in the delayed detection of the need for genetic testing amongst surviving siblings of children who die of Sudden Death in Childhood . Currently, it is not until the Pathologist provides a report that the need for genetic testing is identified. Reports can take up to two years to be filed .
” Open source report
21 Nov 2022 Celia Lindsey MARSH · Prevention of Future Deaths report Avon
View report summary
Concerns raised 12 Potentially unsafe exposure to undeclared allergens for people at significantly higher risk of fatal reactions View source Potentially misleading food-labelling wording and public understanding of allergen absence View source Lack of a robust system for capturing and recording anaphylaxis cases View source Failure to obtain and preserve stomach contents and tissue samples at post-mortem examination View source Lack of adequate education for doctors and patients in anaphylaxis risk groups View source Delays in raising suspected anaphylaxis deaths with the Senior Coroner View source Lack of robust confirmation of allergen absence in ingredients and production View source Outdated pathology guidance for suspected anaphylaxis deaths View source Lack of a standard protocol for timely and appropriate sampling in suspected anaphylaxis deaths View source Failure to retain hospital blood samples in suspected anaphylaxis cases View source Failure to prioritise post-mortem examinations in suspected anaphylaxis deaths View source Failure to obtain and store an early post-death blood sample for later analysis View source See 9 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Celia Lindsey MARSH · 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
Celia Lindsey Marsh died on 27 December 2017 after suffering fatal anaphylaxis caused by milk protein in a wrap she believed was safe to eat. The principal concerns included the investigation and retention of evidence in suspected anaphylaxis deaths, education for doctors and patients, systems for reporting anaphylaxis, and potentially misleading “dairy-free” and other allergen-labelling claims.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Potentially unsafe exposure to undeclared allergens for people at significantly higher risk of fatal reactions
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group .
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Potentially misleading food-labelling wording and public understanding of allergen absence
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of a robust system for capturing and recording anaphylaxis cases
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis , to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to obtain and preserve stomach contents and tissue samples at post-mortem examination
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of adequate education for doctors and patients in anaphylaxis risk groups
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Delays in raising suspected anaphylaxis deaths with the Senior Coroner
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of robust confirmation of allergen absence in ingredients and production
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim .
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Outdated pathology guidance for suspected anaphylaxis deaths
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old , the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of a standard protocol for timely and appropriate sampling in suspected anaphylaxis deaths
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to retain hospital blood samples in suspected anaphylaxis cases
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to prioritise post-mortem examinations in suspected anaphylaxis deaths
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to obtain and store an early post-death blood sample for later analysis
Wider context from the report “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this changes are required. This would need changes in the death investigation process and the wider investigation which would need assistance from the Food Standards Agency (FSA).
I was made aware that there needs to be better education both to doctors and to patients in risk groups to prevent future deaths
I was also advised that whereas the FSA would be required to assist with the above areas it could also assist in relation to the current practices of food labelling.
Firstly in relation to Pathology, I am told that the current guidance is 10 years old, the suggestion is for this to be revisited and specifically:
• If bloods are taken at hospital that they are not destroyed in a suspected case but retained for testing
• That an early blood sample is taken after death and stored for late analysis
• That the possibility that a death is due to anaphylaxis is raised with the Senior Coroner for the area where the death occurred at the earliest opportunity
• That an early blood sample is taken after death
• The post mortem examination should be prioritised.
• At the post mortem examination: that stomach contents are taken and frozen to enable testing and that tissue samples are taken
A standard protocol should be available to ensure appropriate samples are taken at the correct time to assist later investigation.
In relation to doctors/patients:
• To highlight, through public awareness and to the medical profession, that while the majority of food-allergic individuals are at very low risk of fatal reactions, a small subset of food-allergic individuals may be at significantly higher risk. These persons must be given appropriate advice as to the dangers of inadvertent exposure, since there may be no detectable safe level of allergen that can be present in a product for this group.
• To be aware that avoidance of foods in adults does not improve eczema and may result in more severe allergy to the food avoided particularly to cow’s milk but tolerance can be maintained by continued regular exposure.
In relation to the FSA, the UK Health Security Agency and the Department of Health and Social Care:
• To establish a robust system of capturing and recording cases of anaphylaxis, and specifically, fatal and near-fatal anaphylaxis, to provide an early warning of the risk posed to allergic individual by products with undeclared allergen content.
• Such a system could involve mandatory reporting of anaphylaxis presenting to hospitals, analogous to the current system used for notifiable diseases (including some food-borne illnesses) whereby registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the state of Victoria in Australia, and also allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate the public health risk.
In relation to the FSA, the British Retail Consortium, Food and Drink Federation and British Hospitality:
• The wording used on food products, and the public’s understanding of these phrases in terms of implying the absence of a particular allergen, can be potentially misleading. Examples include: “free-from” and “vegan”. Foods labelled in this way must be free from that allergen, and there should be a robust system to confirm the absence of the relevant allergen in all ingredients and during production when making such a claim.
• With respect to those with the most severe food allergies, it may be necessary in the interim to clarify that foods labelled “free-from [X allergen]” may not be safe to consume.
In relation to the FSA:
• A hotline to the FSA to provide guidance in fatal cases due to suspected anaphylaxis, although a mandatory reporting system (suggested above) would address this need.
• Nationally recognised best practice and technical advice to assist those investigating such cases;
” Open source report
×
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 Update autopsy guidelines for suspected acute anaphylaxis to include UKFAR contact details and direct pathologists to report fatal cases.
Verbatim wording from the response “The Royal College of Pathologists is currently updating its autopsy practice guidelines for suspected acute anaphylaxis. The updated guidelines will include contact details for the UKFAR and direct pathologists to report fatal anaphylaxis cases to the UKFAR.” Source location Response from Royal College of Pathologists
Open published response
5 Nov 2019 Christopher Byron · Prevention of Future Deaths report Manchester North
View report summary
Concerns raised 11 Failure to ensure pharmacists and clinical teams apply consistent ferritin-checking expectations View source Lack of regular independent peer review of coronial autopsy reports and processes View source Lack of a documented and recorded referral process between District Nurses and Tissue Viability Nurses View source Shortage of staff within the Tissue Viability Nurse team View source Failure to produce accurate and satisfactory coronial post-mortem reports View source Inadequate emergency response arrangements for out-patient iron infusions View source Failure to obtain ferritin levels for anaemia management View source Insufficient access to appropriate dressings for severe pressure sores View source Unclear Royal College of Nursing instructions on continuous observation during iron infusions View source Unclear instructions on continuous observation during iron infusions View source Failure to record pharmacist-clinician discussions and advice View source See 8 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Christopher Byron · 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
Christopher Byron, who had multiple sclerosis and had become bedbound, developed infected pressure sores and was admitted to hospital. He received a second intravenous iron infusion on 9 January 2017 without adequate consideration of the risks and was not observed for 30 minutes afterwards; he suffered cardiac arrest within minutes and died. Concerns included inadequate continuity and documentation of nursing and pharmacy care, shortages of staff and dressings, unclear observation guidance for iron infusions, and inaccurate post-mortem reporting that failed initially to identify anaphylaxis.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to ensure pharmacists and clinical teams apply consistent ferritin-checking expectations
Wider context from the report “2. In addition there was no evidence that on the 30th December or the 9th January 2017 the pharmacist checked Mr Byrons ferritin level . The Court heard from the Clinical lead pharmacist that he would expect this to be done. There was a clear difference between the advice and expectations of the pharmacist and the Clinical team .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of regular independent peer review of coronial autopsy reports and processes
Wider context from the report “3. It is noted there is no regular (independent) peer review of coronial autopsy reports and processes in order to maintain consistency of agreed standards, governance and accountability as was advised within the 2006 National Confidential Enquiry into Patient Death and Outcome (NCEPOD) and reiterated within the Hutton review of forensic pathology of England and Wales in 2015.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of a documented and recorded referral process between District Nurses and Tissue Viability Nurses
Wider context from the report “1. The Court heard evidence that since the death of Mr Byron the District Nursing and Tissue Viability Nurses (TVNs) are now managed as part of the Northern Care Alliance and are jointly located. However there is no documented policy for the referring of patients from the District Nurses to the TVNs . “Unofficial” referrals could occur by way of conversations within the office and there is no policy to ensure these are recorded in writing and recorded in the patients notes . The Court heard evidence that such a referral was thought to have occurred in September 2016 but this was not documented anywhere.
2. Likewise if a referral is sent by email there no instruction to staff that such email must be uploaded into the patients records in order for it to be clearly seen by all workers that the patient has been referred.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Shortage of staff within the Tissue Viability Nurse team
Wider context from the report “3. Shortage of staff. One of the reasons there was a lack of continuity in the care of Mr Byron was the shortage of staff and the increased workload on the remaining staff. The Court was advised there remains a shortage of staff within the Tissue Viability Nurse team .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to produce accurate and satisfactory coronial post-mortem reports
Wider context from the report “1. The quality of the post mortem examination report produced by ████████ was wholly unsatisfactory and proven inaccurate . This meant both the bereaved family and the Trust were initially provided with an inaccurate medical cause of death. As a direct consequence the ability to learn lessons in order to prevent future deaths was not captured in a timely manner. It was not until the Coroner obtained a report from ████████ in 2018 that anaphylaxis was offered as a potential cause of death. Even then, the Court was left having to consider the totality of the evidence and it was not until the inquest that a finding of fact as to the medical cause of death was made.
2. It should be noted the quality of ████████ post mortem practice has been and remains questionable in over 20 Inquests within the North Manchester Coronal area. This is not an isolated case. In this particular case there was clear evidence that the post mortem failings directly impacted on potential lack of clinical learning to prevent future deaths.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Inadequate emergency response arrangements for out-patient iron infusions
Wider context from the report “5. In addition for out-patients who may receive an iron infusion the Court received evidence that they would be handed a buzzer . The Court would question how this would be of use should a patient suffer a cardiac arrest such occurred with Mr Byron. Points 4 and 5 link into the Regulation 28 to the Royal College of Nursing also.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to obtain ferritin levels for anaemia management
Wider context from the report “1. In this case the Trust Guideline ‘Patient Blood Management of Medical Patients’ sets out the Pathway for the Management of Anaemia. In addition to this Trust documents there is NICE guidance for Anaemia – iron deficiency (revised 2018). Both of these documents include as a key factor the obtaining of ferritin levels , albeit the question as to the interpretation of such results will be dependant on the patients presenting condition. On the 30th December 2016 no sample was taken to check the ferritin levels .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Insufficient access to appropriate dressings for severe pressure sores
Wider context from the report “1. The Court heard evidence that at times there was a lack of appropriate dressings in order to treat Mr Byrons infected pressure sores. The Court heard evidence the District Nurses cannot order more than two weeks worth of dressings for any individual patient and cannot hold extra stock . In Mr Byrons case due to the severity and location of the pressure sores there were times when he used more dressings, especially if they came away from the wounds. This could lead to a shortage and meant him having to wait for dressings . In someone with severe pressures sores the requirement to have access to the appropriate dressings is important. The Court heard this instruction regarding the ordering of dressings is governed by the Clinical Commissioning Group.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Unclear Royal College of Nursing instructions on continuous observation during iron infusions
Wider context from the report “1. In the most recent guidance from the Royal College of Nursing dated May 2019, “Iron Deficiency and Anaemia in Adults” the instruction to nurses is for them to “observe the patient for 30 minutes”. The Court heard evidence from the Divisional Director of Nursing for the Northern Care Alliance who told the Court, in his view this instruction to nurses is unclear . This instruction was felt to be open to interpretation as to whether this means nurses should physically remain with the patient constantly for 30 minutes . If this is what is meant then it was suggested the instruction could be made more specific.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Unclear instructions on continuous observation during iron infusions
Wider context from the report “4. The Court heard the Trust Guideline ‘Patient Blood Management of Medical Patients’ indicated the patient was to be observed for 30 minutes during the administration of the iron infusion. Due to a lack of recording the nurse who administered the iron infusion on the 30th December 2017 could not be identified. The nurse on the 9th January 2017 gave evidence to the Court that this was the first time she had administered an iron infusion and she was advised by the Sister to “treat it as a blood transfusion” whereby his observations were taken before and immediately after commencement of the infusion and observations taken every 15 minutes. Hence Mr Byron was left alone during the administration of the iron infusion. The Court heard the policy was unclear as to whether it meant nurses had to remain with the patient constantly for 30 minutes .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to record pharmacist-clinician discussions and advice
Wider context from the report “3. The Court heard of discussions which take place between the Pharmacists and clinicians. These can take place at times when the pharmacist is off the ward. In these circumstances there is no ability for the pharmacist to record such discussions . There was no record anywhere of any discussions on the 30th December 2016 or the 9th January 2017 and any such advice provided, so there was no way of confirming if such conversations had taken place.
” Open source report
20 Jun 2019 Pte Geoff Gray · Prevention of Future Deaths report Surrey
View report summary
Concerns raised 2 Lack of specific guidance on appropriate post-mortem examination in firearms deaths View source Cursory post-mortem investigations following assumptions of suicide View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Pte Geoff Gray · 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
On 17 September 2001, 17-year-old Private Geoff Gray was found shot in the grounds of the Officers’ Mess at Princess Royal Barracks, Deepcut, with two fatal head wounds and a SA80 rifle beside him. The report raises concerns that the death was initially assumed to be suicide and investigated through a routine rather than forensic post-mortem, with photographs, imaging, wound documentation and clothing retention not undertaken, creating a risk that homicides could go undetected.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of specific guidance on appropriate post-mortem examination in firearms deaths
Wider context from the report “2. Both ████████ and ████████, the forensic pathologist who conducted the post-mortem told me that that there is no specific guidance to either pathologists, and as I understand it to coroners, that urges them to give particular consideration to the nature of the post-mortem examination in cases of death by firearms, even when that death is of a child .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Cursory post-mortem investigations following assumptions of suicide
Wider context from the report “3. It is of concern that where assumptions of suicide lead to cursory post-mortem investigations this creates a risk that homicides will go undetected.
” Open source report
25 Jul 2018 Robert Thomas Wrinch · Prevention of Future Deaths report Manchester South
View report summary
Concerns raised 6 Incompatibility of pathology information technology systems between hospital trusts View source Lack of tracking of pathology samples and reports View source Failure of departments to track outstanding pathology reports View source Backlogs delaying pathology sample analysis View source Reliance on delayed paper delivery of pathology reports View source Failure to document conversations with other clinicians View source See 3 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Robert Thomas Wrinch · 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
Robert Thomas Wrinch deteriorated with severe back pain and reduced mobility associated with an undiagnosed metastatic spinal malignancy, and developed bronchopneumonia. The report raised concerns about delays and inadequate tracking in pathology sample processing and reporting, reliance on paper reports, inconsistent departmental tracking systems, incompatible information technology systems between trusts, and pathology backlogs linked to shortages of pathologists.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Incompatibility of pathology information technology systems between hospital trusts
Wider context from the report “4. The I.T systems of the pathology department of the Trust and other hospital Trusts were incompatible with each other . This meant that transfer of information between trusts to obtain a second opinion were more difficult .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of tracking of pathology samples and reports
Wider context from the report “1. The Inquest heard evidence that the pathology department at the Trust had no system for tracking samples . As a result, it was unclear when samples had been received and analysis had taken place . There was no documentation of conversations with other clinicians and so, it was difficult to be clear about the chronology of events. Transmission dates of the sample to another Trust were unclear . It was also difficult to know on what date the report of the pathologists findings had been issued to the treating clinician . It was unclear if these issues are specific to the pathology department of the Trust or more widespread.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure of departments to track outstanding pathology reports
Wider context from the report “3. At the Trust, some departments such as the respiratory department had clear tracking systems to identify outstanding pathology reports. Other departments such as orthopaedics did not . As a result, clinicians could not readily identify where there was delay in receipt of information required to assess and diagnose a patient .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Backlogs delaying pathology sample analysis
Wider context from the report “5. The Inquest heard that the delay in analysis of the sample taken was due to a backlog . The backlog was not unique to the Trust and such backlogs were prevalent across pathology departments nationally due to a local and national shortage of pathologists.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Reliance on delayed paper delivery of pathology reports
Wider context from the report “2. The Trust had a system of issuing reports digitally to clinicians to speed up receipt. In addition the Inquest were told that due to preferences of clinicians paper copies were also produced and sent via internal mail to the treating clinicians . The Inquest heard that the responsible orthopaedic consultant relied on wholly on the paper system although this built in delay .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to document conversations with other clinicians
Wider context from the report “1. The Inquest heard evidence that the pathology department at the Trust had no system for tracking samples. As a result, it was unclear when samples had been received and analysis had taken place. There was no documentation of conversations with other clinicians and so, it was difficult to be clear about the chronology of events . Transmission dates of the sample to another Trust were unclear. It was also difficult to know on what date the report of the pathologists findings had been issued to the treating clinician. It was unclear if these issues are specific to the pathology department of the Trust or more widespread.
” Open source report
25 Jul 2014 Clare Serena Anke COOPER · Prevention of Future Deaths report Surrey
View report summary
Concerns raised 14 Insufficiently detailed EDS referral information about low sodium and blood results View source Failure to consider chemical pathology flagging of particularly concerning results View source Lack of a national protocol for assessing seriously ill eating-disorder patients for an organic basis View source No established GP practice system for recognition, assessment and management of electrolyte abnormalities View source Lack of GP routine vital sign monitoring when weight loss is a concern View source Insufficient reinforcement of excluding an organic basis before psychiatric or psychological labelling View source Lack of a documented list of potential diagnoses for exclusion at eating-disorder triage View source Lack of hospital or GP notes available to the post-mortem pathologist View source Failure to robustly assess presenting signs and symptoms and consider or exclude organic causes View source Lack of understanding of hyponatraemia causes, investigation thresholds and required investigations View source Insufficient communication from referral agents to the eating disorder service View source Poor GP documentation View source Insufficiently robust EDS eating-disorder triage proforma for considering and excluding organic causes View source Insufficiently clear published guidance on the causes, investigation and treatment of low blood sodium View source See 11 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Clare Serena Anke COOPER · 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
Clare Serena Anke Cooper, a young adult, developed weight loss, lassitude, dizziness, nausea, difficulty eating and an intermittently low blood sodium level before dying after a cardiorespiratory arrest and hospital admission. The inquest concluded that she died from the consequences of undiagnosed Addison’s disease and an Addisonian crisis. Principal concerns included inadequate assessment and documentation in primary care, failure to investigate the low sodium and possible physical causes, insufficient eating-disorder service triage processes, and inadequate information available for the post-mortem examination.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Insufficiently detailed EDS referral information about low sodium and blood results
Wider context from the report “6. Insufficiently detailed referral letter to EDS (mentioning ‘low sodium’ but not accompanied with a copy of the blood results ) and an opportunity was lost for its significance to be considered
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to consider chemical pathology flagging of particularly concerning results
Wider context from the report “4. No established system for recognition, assessment and management of electrolyte abnormalities within the GP practice and/or consideration of the chemical pathology service to ‘flag-up’ particularly concerning results .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of a national protocol for assessing seriously ill eating-disorder patients for an organic basis
Wider context from the report “8. The lack of a national protocol for assessing patients seriously ill with an eating disorder with the possibility of detecting individuals with an organic basis for the condition .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation No established GP practice system for recognition, assessment and management of electrolyte abnormalities
Wider context from the report “4. No established system for recognition, assessment and management of electrolyte abnormalities within the GP practice and/or consideration of the chemical pathology service to ‘flag-up’ particularly concerning results.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of GP routine vital sign monitoring when weight loss is a concern
Wider context from the report “3. Lack of GP routine vital sign monitoring e.g. heart rate, blood pressure and weight measurement when weight loss is a concern with a lost opportunity to assess the severity of weight loss.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Insufficient reinforcement of excluding an organic basis before psychiatric or psychological labelling
Wider context from the report “10. The need to highlight this case nationally to clarify published guidance with regard to the causes, investigation and treatment of low blood sodium and to reinforce the importance of excluding an organic basis of an illness before labelling the condition a psychiatric or psychological disorder .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of a documented list of potential diagnoses for exclusion at eating-disorder triage
Wider context from the report “7. Insufficiently robust EDS proforma used to triage patients for an eating disorder: lack of prompts and a need to emphasise and exclude organic causes, however rare. The lack of a documented list of potential diagnoses to be assessed and excluded at triage, including organic causes. A need to facilitate communication from the referral agents to the eating disorder service.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of hospital or GP notes available to the post-mortem pathologist
Wider context from the report “9. Lack of hospital or GP notes available for the pathologist undertaking the post mortem to facilitate a greater opportunity for clinic-pathological correlation in deaths which are unascertained and a higher level of suspicion to explore rare causes of unexpected death, especially in the young.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Failure to robustly assess presenting signs and symptoms and consider or exclude organic causes
Wider context from the report “2. Lack of evidence of a robust assessment of presenting signs and symptoms with a presumption of a psychological/psychiatric problem without considering or excluding an organic cause .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of understanding of hyponatraemia causes, investigation thresholds and required investigations
Wider context from the report “5. Lack of understanding of the underlying causes of hyponatraemia (consistently or intermittently low) and the level below which will require further investigation, and the investigations that should be carried out , particularly in circumstances when there is no obvious cause of the low sodium.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Insufficient communication from referral agents to the eating disorder service
Wider context from the report “7. Insufficiently robust EDS proforma used to triage patients for an eating disorder: lack of prompts and a need to emphasise and exclude organic causes, however rare. The lack of a documented list of potential diagnoses to be assessed and excluded at triage, including organic causes. A need to facilitate communication from the referral agents to the eating disorder service.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Poor GP documentation
Wider context from the report “1. Poor GP documentation
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Insufficiently robust EDS eating-disorder triage proforma for considering and excluding organic causes
Wider context from the report “7. Insufficiently robust EDS proforma used to triage patients for an eating disorder: lack of prompts and a need to emphasise and exclude organic causes, however rare. The lack of a documented list of potential diagnoses to be assessed and excluded at triage, including organic causes. A need to facilitate communication from the referral agents to the eating disorder service.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Insufficiently clear published guidance on the causes, investigation and treatment of low blood sodium
Wider context from the report “10. The need to highlight this case nationally to clarify published guidance with regard to the causes, investigation and treatment of low blood sodium and to reinforce the importance of excluding an organic basis of an illness before labelling the condition a psychiatric or psychological disorder.
” Open source report
14 Jul 2014 Shayla Anne Walmsley · Prevention of Future Deaths report Inner North London
View report summary
Concerns raised 3 Lack of post-mortem analysis of medical devices in unexplained deaths View source Inconsistent issuing of FSNs to appropriate NHS Trust recipients View source Delays in Medtronic providing safety data on request View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Shayla Anne Walmsley · 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
Shayla Anne Walmsley was found deceased at her home on 9 May 2013; she had diabetes and used a Medtronic insulin pump. The cause of death remained unascertained, and the report raised concerns about delays in providing safety data, inconsistent distribution of Field Safety Notices, and failure to analyse the medical device during the post-mortem investigation.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Lack of post-mortem analysis of medical devices in unexplained deaths
Wider context from the report “(3) Non-analysis of medical devices at post mortem - I am concerned that future investigations into the deaths of medical device users could be impaired by the lack of analysis of medical devices at post mortem . It is clear that these devices are increasingly being used by patients and, if death is unexplained in such a patient, appropriate analysis should be considered . As such, I believe that it is necessary to emphasise, to those involved in death investigation, the potential importance of device analysis.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Inconsistent issuing of FSNs to appropriate NHS Trust recipients
Wider context from the report “(2) Inconsistency in issuing FSNs - I am concerned that the apparently ad hoc nature by which FSNs are issued applies inappropriate individuals within NHS Trusts being aware of safety concerns and that this could result in future deaths. It is clear the CAS distributes MDAs to NHS Trust governance departments in a reliable manner. I believe that consideration should be made as to whether CAS could be used also to distribute FSNs.
I heard evidence from the governance department representative that this would not lead to ‘alert fatigue’ (where receipt of numerous alerts results in less attention being paid to them). This is because governance departments should be receiving these FSNs in any case and taking steps to distribute as appropriate. I heard concerns from the MHRA that this view may not be shared by all governance departments but, in my judgement, there should be consideration of the use of CAS for FSN distribution.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Royal College of Pathologists; that does not assign responsibility.
PFD Monitor interpretation Delays in Medtronic providing safety data on request
Wider context from the report “(1) Interval to availability of Medtronic data - I am concerned that the investigatory role of non-US regulators could be hampered by the timescale within which Medtronic can provide data on request . Given the potential consequences of a delay in production of this safety data , I believe that future deaths could result and that this warrants consideration by Medtronic.
” Open source report
Pin
Request correction
Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations