18 Apr 2024 ALEXANDER LEE REID · Prevention of Future Deaths report West Yorkshire Eastern
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Concerns raised 1 Failure of general practice IT systems to validate or challenge potential data input errors at the point of entry View source
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ALEXANDER LEE REID · Prevention of Future Deaths report
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Report summary
Alexander Lee Reid received the Oxford AstraZeneca Covid-19 vaccine after being invited early because an erroneous BMI in his GP records led him to be identified as vulnerable. He died on 29 June 2021, and the inquest concluded that his death was linked to the vaccination, with the medical cause recorded as cerebral venous sinus thrombosis and Covid-19 vaccine-induced immune thrombotic thrombocytopenia. The principal concern was whether general practice IT systems should validate or challenge potentially erroneous data at the point of entry to improve data reliability and patient safety.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to EMIS Group; that does not assign responsibility.
PFD Monitor interpretation Failure of general practice IT systems to validate or challenge potential data input errors at the point of entry
Wider context from the report “(2) The inquest heard expert evidence that the combined vaccination monitoring and recall specification designed to identify vulnerable people for the purposes of inviting them to receive their Covid vaccinations early had identified Alex as vulnerable from an incorrect BMI of 68.97 recorded in his GP records on 06/02/2004. The mistake was due to the relevant clinician recording Alex's height as 145cm and his weight as 145kg, giving a BMI of 68.97 for an 11 year old boy whose previously recorded BMI aged 9 had been 14.88.
(3) The inquest heard expert evidence that to have built a system that would validate multiple data items in an individual's GP records for the purposes of ensuring that individuals were not incorrectly identified as vulnerable would not have been feasible within the constraints and context of the Covid-19 programme.
(4) The inquest heard expert evidence that an easier and more appropriate option would be to embed validation rules in general practice IT systems that would check such information at the time of data entry .
(5) If the obviously erroneous BMI had not been recorded or had been challenged at the point of entry by the relevant IT system, Alex would not have been classed as vulnerable, would not have been offered a vaccine before guidance was published that the under 30’s should not receive the Oxford Astra Zeneca vaccine, and would not have died when he did.
(6) The consequences of the data input error in this case give rise to a concern that more might be done by way of specification design to allow for the correction of or challenge to potential data input errors at the point of entry , with consequential improvements in the reliability of such data and the safety of patients and reducing the risk of other deaths occurring in similar circumstances in the future.
” Open source report
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Existing EMIS Web functionality is sufficient to mitigate the specific data-entry risk, so no further software development is required.
Verbatim wording from the response “As detailed above, the System has inbuilt safety principles and is compliant with NHS specifications. Nevertheless, we will continue to review our solutions to determine whether there are changes to be made which would improve their performance.”
Source location Response from EMIS Page 3 · response Published 29 April 2024
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13 Jan 2022 Darran Busby · Prevention of Future Deaths report Cumbria
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Concerns raised 2 Failure of the result-filing function to prevent multiple-click filing of subsequent results without clinician review View source Lack of a failsafe for abnormal radiology results to prompt clinician review View source
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Darran Busby · Prevention of Future Deaths report
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Report summary
Darran Busby was at home with his family on 14 August 2021 and ended his life. Before his death, he had undergone an MRI scan after complaining of headaches, but the result was never reviewed by a clinician. The report raised concerns that weaknesses in the electronic systems could allow radiology results requiring urgent follow-up to be filed without clinical review, potentially creating a risk of future deaths.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to EMIS Group; that does not assign responsibility.
PFD Monitor interpretation Failure of the result-filing function to prevent multiple-click filing of subsequent results without clinician review
Wider context from the report “After it became apparent that the result of Mr Busby's MRI scan had not been reviewed by a clinician, a consultant employed by North Cumbria Integrated Care NHS Foundation Trust ('the Trust') undertook an investigation. He noted that the Trust use EMIS as an electronic patient record. He explained that the Trust used a separate system called ICE to gather the results of tests or scans. ICE is capable of linking to EMIS to input results into the EMIS system. Once a test result has been linked to a patient in EMIS the result enters the EMIS record as a provisional result pending review, and is placed on a work list. The consultant or a deputy then reviews the result, files it with or without comment and records any actions taken. EMIS provides two options: 'file no comment' and 'file and comment'. Results of blood tests which are undertaken to monitor treatment and which are normal may be filed without comment. If there is an abnormality flagged, however, EMIS will default to the file with comment dialogue box even if file no comment is selected. This acts as a safeguard against missing a significant finding. Unfortunately, there is no flag attached in the ICE system for abnormal radiology results, and so no failsafe exists for defaulting to a 'file and comment' if a significant positive or negative finding is reported.
In the course of investigating what occurred in relation to Mr Busby's MRI scan, it was determined that clicking more than once on the 'file no comment' button will result in the displayed result being filed, but will also result in filing of the next in the list if that result has no flag indicating the result is abnormal. Thus if a radiology result lies below a normal blood result and a clinician inadvertently double clicks to file the first result, the radiology result is also filed without comment and without the result being displayed. Furthermore, multiple clicks up to 6 (and perhaps even beyond) will lead to multiple filings. In the result it is possible that a clinician inadvertently clicking 'file no comment' more than once on one result would cause results which require urgent follow up being filed without a clinician being involved.
I am concerned that this might lead to lost opportunities to treat patients whose scans reveal, for instance, early malignancies. It might also mean that scans which reveal the need for urgent action will be overlooked. I am therefore concerned that future deaths will occur.
I was impressed by the candour of the report provided to me and the efforts that the Trust have already taken to resolve this issue. However I noted that the evidence I received was that "In order to fix this issue it is likely it will require action by the publishers of EMIS to prevent accidental filing of results. To attempt to mitigate this issue whilst a permanent fix is sought I have worked with colleagues from Pathology and Radiology to attempt to have all radiology results (where the greatest risk lies) flagged within the ICE system as abnormal, so that any attempt to file the result prompts via the file and comment dialogue box. Unfortunately at the time of writing this letter the flag, which is triggered in ICE for any radiology report originating within Cumbria Neuroscience, does not carry through to EMIS
and we continue to seek a local solution to mitigate this newly identified risk."
In the circumstances I have concluded that it is necessary for action to be taken 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 EMIS Group; that does not assign responsibility.
PFD Monitor interpretation Lack of a failsafe for abnormal radiology results to prompt clinician review
Wider context from the report “After it became apparent that the result of Mr Busby's MRI scan had not been reviewed by a clinician, a consultant employed by North Cumbria Integrated Care NHS Foundation Trust ('the Trust') undertook an investigation. He noted that the Trust use EMIS as an electronic patient record. He explained that the Trust used a separate system called ICE to gather the results of tests or scans. ICE is capable of linking to EMIS to input results into the EMIS system. Once a test result has been linked to a patient in EMIS the result enters the EMIS record as a provisional result pending review, and is placed on a work list. The consultant or a deputy then reviews the result, files it with or without comment and records any actions taken. EMIS provides two options: 'file no comment' and 'file and comment'. Results of blood tests which are undertaken to monitor treatment and which are normal may be filed without comment. If there is an abnormality flagged, however, EMIS will default to the file with comment dialogue box even if file no comment is selected. This acts as a safeguard against missing a significant finding. Unfortunately, there is no flag attached in the ICE system for abnormal radiology results, and so no failsafe exists for defaulting to a 'file and comment' if a significant positive or negative finding is reported.
In the course of investigating what occurred in relation to Mr Busby's MRI scan, it was determined that clicking more than once on the 'file no comment' button will result in the displayed result being filed, but will also result in filing of the next in the list if that result has no flag indicating the result is abnormal. Thus if a radiology result lies below a normal blood result and a clinician inadvertently double clicks to file the first result, the radiology result is also filed without comment and without the result being displayed. Furthermore, multiple clicks up to 6 (and perhaps even beyond) will lead to multiple filings. In the result it is possible that a clinician inadvertently clicking 'file no comment' more than once on one result would cause results which require urgent follow up being filed without a clinician being involved.
I am concerned that this might lead to lost opportunities to treat patients whose scans reveal, for instance, early malignancies. It might also mean that scans which reveal the need for urgent action will be overlooked. I am therefore concerned that future deaths will occur.
I was impressed by the candour of the report provided to me and the efforts that the Trust have already taken to resolve this issue. However I noted that the evidence I received was that "In order to fix this issue it is likely it will require action by the publishers of EMIS to prevent accidental filing of results. To attempt to mitigate this issue whilst a permanent fix is sought I have worked with colleagues from Pathology and Radiology to attempt to have all radiology results (where the greatest risk lies) flagged within the ICE system as abnormal, so that any attempt to file the result prompts via the file and comment dialogue box. Unfortunately at the time of writing this letter the flag, which is triggered in ICE for any radiology report originating within Cumbria Neuroscience, does not carry through to EMIS
and we continue to seek a local solution to mitigate this newly identified risk."
In the circumstances I have concluded that it is necessary for action to be taken to prevent future deaths.
” Open source report
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Continue collaborating with NHS Digital on modern messaging standards to improve normal and abnormal result flagging.
Verbatim wording from the response “The UK messaging standards for laboratory and radiology reports are currently based on EDIFACT specification which are some 20 years old. EMIS is aware that NHS Digital are currently building a modern set of FHIR messaging standards which, when implemented, will enable proper level flagging of normal / abnormal findings which will significantly improve the safety of these messages; EMIS is collaborating with NHS Digital on these standards. There are no current timelines for introduction from NHS Digital.”
Source location 2022-0011-Response-from-EMIS_Published Page 2 · response Published 20 January 2022
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review results-filing training materials to emphasise detailed review of radiology and other results that may lack abnormal flags.
Verbatim wording from the response “As a result of this case and your findings, EMIS is undertaking a number of actions to support our users in the prevention of future harm:”
Source location 2022-0011-Response-from-EMIS_Published Page 5 · response Published 20 January 2022
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation EMIS cannot develop abnormal radiology flagging until NHS Digital standards provide identifiers distinguishing normal from abnormal results.
Verbatim wording from the response “The UK messaging standards for laboratory and radiology reports are currently based on EDIFACT specification which are some 20 years old. EMIS is aware that NHS Digital are currently building a modern set of FHIR messaging standards which, when implemented, will enable proper level flagging of normal / abnormal findings which will significantly improve the safety of these messages; EMIS is collaborating with NHS Digital on these standards. There are no current timelines for introduction from NHS Digital.”
Source location 2022-0011-Response-from-EMIS_Published Page 2 · response Published 20 January 2022
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Clinicians are responsible for reviewing, filing and archiving results at a speed and diligence appropriate to their clinical nature and patient context.
Verbatim wording from the response “In relation to any inadvertent filing activity, EMIS believe that there are sufficient failsafe measures within the system, alongside appropriate diligence from the user, to prevent such occurrence. It must be the responsibility of the clinician to review, file and subsequently archive results at a speed and with a level of diligence that fits the clinical nature of the results and the patient involved.”
Source location 2022-0011-Response-from-EMIS_Published Page 5 · response Published 20 January 2022
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Existing EMIS Web failsafes, combined with appropriate user diligence, are considered sufficient to prevent inadvertent filing of multiple results.
Verbatim wording from the response “In relation to any inadvertent filing activity, EMIS believe that there are sufficient failsafe measures within the system, alongside appropriate diligence from the user, to prevent such occurrence. It must be the responsibility of the clinician to review, file and subsequently archive results at a speed and with a level of diligence that fits the clinical nature of the results and the patient involved.”
Source location 2022-0011-Response-from-EMIS_Published Page 5 · response Published 20 January 2022
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17 Oct 2014 Yaser Saleh · Prevention of Future Deaths report Inner South London
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Concerns raised 1 Failure of computerised recall systems to identify chronic disease patients requiring review beyond current prescribing 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.
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Yaser Saleh · 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
Yaser Saleh, aged 15, died on 13 September 2012 after collapsing with cardio-respiratory arrest from acute asthma. The report raised concerns that electronic systems did not identify asthma patients needing review when they were no longer receiving regular prescriptions, creating a risk of preventable deaths in people with chronic diseases.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to EMIS Group; that does not assign responsibility.
PFD Monitor interpretation Failure of computerised recall systems to identify chronic disease patients requiring review beyond current prescribing
Wider context from the report “The GP reported that she believes that her EMIS computer system only called up people for review who were receiving regular prescriptions and thus a patient who had been on regular treatment but no longer was asking for inhalers was not identified as requiring call up for review. Whilst the court heard it was possible to customize the QOF system to call up patients, there was, according to the GP, no computerised system of calling up asthmatics who needed review unless they were currently on regular medication . She and the consultant in emergency medicine considered this created a risk of preventable deaths, that merited my making this report. The consultant in emergency medicine also said that this risk applied to other chronic diseases, such as epilepsy.
This risk of not identifying those at risk of death because they no longer comply or have not been prescribed treatment taken in the past brought to the attention of EMIS and the Secretary of State, to consider whether EMIS has the potential or another electronic system should be commissioned to ensure that those with chronic disease requiring review and monitoring, are triggered for the attention of the GP, on wider criteria than current prescribing , or if such a system is available that the Department considers using it and other GPs are made aware of its use.
” Open source report