Recurring concern

Failure to reliably validate electronic clinical records

First to latest report 20 May 2021 — 18 Apr 2024

Reports that mention this concern: 2
Times this concern has been raised: 2
Stated actions linked to this concern: 4

What this concern includes

Includes failures of electronic clinical-record validation controls, including point-of-entry plausibility checks, challenge or correction of erroneous data, timely post-entry validation, and related audit or system controls where these directly determine whether clinical-record data is reliable for patient-safety decisions.

What is not included

Excludes general electronic-record information-access, display, interoperability or clinical-action failures where record validation is not itself deficient.
Excludes generic documentation, training, staffing or governance deficiencies unless they directly impair validation of electronic clinical records.
Excludes failures to review or act on accurate clinical-record information after validation has been completed.
Excludes non-clinical records and validation processes unrelated to electronic clinical or patient-care records.

Trends

Reports over time

Reports mentioning this concern, over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Reports about this concern sent to each recipient.

Cegedim Healthcare Solutions1

Egton Medical Information Systems Limited1

EMIS Group1

Joint GP IT Committee1

NHS England1

North East London NHS Foundation Trust1

The Phoenix Partnership (Leeds) Ltd1

Reports and published responses 2 reports

See individual reports that have raised this concern, and the actions taken in response

18 Apr2024
West Yorkshire Eastern
Concerns raised1
1. Failure of general practice IT systems to validate or challenge potential data input errors at the point of entry
Linked responses

Cegedim Healthcare Solutions
EMIS Group
NHS England
Royal College of General Practitioners
The Phoenix Partnership (Leeds) Ltd
Stated actions 4
1. The Phoenix Partnership (Leeds) Ltd
  Maintain point-of-entry validation restricting extreme height, weight and calculated BMI values in SystmOne.
2. The Phoenix Partnership (Leeds) Ltd
  Contact NHS England separately about validation of calculated BMI data in GP IT systems.
3. Royal College of General Practitioners
  Ask NHS England to consider coordinating funded clinical-safety workshops to document causes, identify controls and define professional requirements for safer system behaviour.
1. Royal College of General Practitioners
  Ask NHS England to report to the Joint GPIT Committee on addressing the concerns through changes to existing supplier-contract standards and capabilities.
Respondent positions 8
1. EMIS Group
  Existing EMIS Web functionality is sufficient to mitigate the specific data-entry risk, so no further software development is required.
  Existing arrangements considered sufficient
1. NHS England
  GP IT systems are centrally assured against the GP IT Futures Framework and statutory clinical safety standards require consideration of data-entry and transmission hazards.
  Existing arrangements considered sufficient
2. NHS England
  Cross-domain validation of automatically calculated BMI is not currently implementable, and implementation would present substantial challenges and further clinical risks requiring balanced assessment.
  Unable to act
3. The Phoenix Partnership (Leeds) Ltd
  SystmOne already validates height, weight and BMI ranges, and must permit unusually high BMI values when clinically accurate.
  Disputes the concern
4. The Phoenix Partnership (Leeds) Ltd
  Any additional BMI validation requirements should be set nationally by NHS England to ensure consistency across GP systems.
  Redirects responsibility
5. Cegedim Healthcare Solutions
  Age-sensitive BMI functionality has not been developed because it is not currently required under NHS framework agreements.
  Unable to act
6. Royal College of General Practitioners
  Building validation of multiple GP-record data items was not feasible within the Covid-19 programme’s speed, safety and delivery constraints.
  Unable to act
7. Royal College of General Practitioners
  Completely preventing entry of a BMI of 68.97 may not be appropriate, limiting use of exclusion thresholds as a data-entry control.
  Unable to act
AI-generated summary

ALEXANDER LEE REID · 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

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.

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.
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. ”
Source location
ALEXANDER LEE REID · Prevention of Future Deaths report
Page 2 · concerns
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
Maintain point-of-entry validation restricting extreme height, weight and calculated BMI values in SystmOne.

Verbatim wording from the response
“In SystmOne, there is already validation at the point of entry on height and weight measurements to prevent extreme values being entered. For example, a maximum height of 3 metres can be entered, with the maximum weight being 500 kilograms. Similarly, a calculated BMI is constrained to between 0 and 150. It is not impossible, however, for someone to have a BMI as high as the one that was calculated in this instance. Thus the system must allow such a BMI to be accurately recorded if this is the true calculated BMI.”

Source location
Response from TPP
Page 1 · response
Published 29 April 2024
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
Contact NHS England separately about validation of calculated BMI data in GP IT systems.

Verbatim wording from the response
“To return to the specific concern that could be directed to GP system suppliers, should NHS England decide that it would be appropriate to include validation concerning the calculation of BMIs in GP IT systems, the requirements for this would be most appropriately set at a national level to ensure a consistent approach across all GPs. Of course, in the clinical environment there are already a number of alerts, flags, prompts and notifications directed at clinical staff, and consideration would need to be taken to the sensitivity of the validation to ensure this is not triggered so frequently as to cause ‘alert fatigue’.”

Source location
Response from TPP
Page 2 · response
Published 29 April 2024
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
Ask NHS England to consider coordinating funded clinical-safety workshops to document causes, identify controls and define professional requirements for safer system behaviour.

Verbatim wording from the response
“We will ask NHS England to:”

Source location
Response from RCGP
Page 4 · response
Published 29 April 2024
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
Ask NHS England to report to the Joint GPIT Committee on addressing the concerns through changes to existing supplier-contract standards and capabilities.

Verbatim wording from the response
“We will ask NHS England to:”

Source location
Response from RCGP
Page 4 · response
Published 29 April 2024
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
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
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
GP IT systems are centrally assured against the GP IT Futures Framework and statutory clinical safety standards require consideration of data-entry and transmission hazards.

Verbatim wording from the response
“Core GP IT records systems are developed - and centrally assured - against standards set out in the GP IT Futures Framework. More information about this can be found here.”

Source location
Response from NHS England
Page 3 · response
Published 29 April 2024
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
Cross-domain validation of automatically calculated BMI is not currently implementable, and implementation would present substantial challenges and further clinical risks requiring balanced assessment.

Verbatim wording from the response
“Where there is an automated calculation using other data items (such as is the case for BMI), there is no currently implementable means to apply validation – or define normal – across domains. It should also be noted that the ranges of values that may be possible (or probable) for height, weight and BMI vary by age, gender, and may vary by ethnicity.”

Source location
Response from NHS England
Page 3 · response
Published 29 April 2024
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
SystmOne already validates height, weight and BMI ranges, and must permit unusually high BMI values when clinically accurate.

Verbatim wording from the response
“In SystmOne, there is already validation at the point of entry on height and weight measurements to prevent extreme values being entered. For example, a maximum height of 3 metres can be entered, with the maximum weight being 500 kilograms. Similarly, a calculated BMI is constrained to between 0 and 150. It is not impossible, however, for someone to have a BMI as high as the one that was calculated in this instance. Thus the system must allow such a BMI to be accurately recorded if this is the true calculated BMI.”

Source location
Response from TPP
Page 1 · response
Published 29 April 2024
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
Any additional BMI validation requirements should be set nationally by NHS England to ensure consistency across GP systems.

Verbatim wording from the response
“To return to the specific concern that could be directed to GP system suppliers, should NHS England decide that it would be appropriate to include validation concerning the calculation of BMIs in GP IT systems, the requirements for this would be most appropriately set at a national level to ensure a consistent approach across all GPs. Of course, in the clinical environment there are already a number of alerts, flags, prompts and notifications directed at clinical staff, and consideration would need to be taken to the sensitivity of the validation to ensure this is not triggered so frequently as to cause ‘alert fatigue’.”

Source location
Response from TPP
Page 2 · response
Published 29 April 2024
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
Age-sensitive BMI functionality has not been developed because it is not currently required under NHS framework agreements.

Verbatim wording from the response
“It should be noted that, such enhanced functionality (to additionally take into account patient age when recording weight or height for calculation of BMI, including for patients who are under 16 years of age) is not currently among the NHS requirements in the Framework agreements and therefore has not been developed in our clinical solutions.”

Source location
Response from Cegedim
Page 2 · response
Published 29 April 2024
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
Building validation of multiple GP-record data items was not feasible within the Covid-19 programme’s speed, safety and delivery constraints.

Verbatim wording from the response
“Issue 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”

Source location
Response from RCGP
Page 3 · response
Published 29 April 2024
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
Completely preventing entry of a BMI of 68.97 may not be appropriate, limiting use of exclusion thresholds as a data-entry control.

Verbatim wording from the response
“a) A warning at the point of entry would be one example of a control mechanism and we agree that it would have been likely that if such a mechanism were in place, those data would not have been recorded in Alex’s record.”

Source location
Response from RCGP
Page 4 · response
Published 29 April 2024
Open published response
20 May2021
East London
Concerns raised1
1. Delays in validating electronic medical records
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
No linked response statements
No respondent-stated action or position is linked to these concerns in the published data.
AI-generated summary

Neil Challinor-Mooney · 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

Neil Challinor-Mooney was admitted to hospital under the Mental Health Act after an acute relapse in his mental health. After disclosing suicidal thoughts and a plan to hang himself using his shoes, his trainers were not removed, and he was later found suspended by their laces; he died on 18 November 2018. Concerns included failures by nursing staff to follow risk assessment and management policy, and delays and amendments affecting the integrity of electronic medical records.

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.
PFD Monitor interpretation
Delays in validating electronic medical records
Wider context from the report
“Another concern arising during the course of the Inquest related to the integrity of the electronic records. The Inquest heard that medical records should be validated very shortly after being entered into the system. The Court saw evidence of multiple entries where there was a significant delay between original entry and validation. Amendments were made to the records after Neil had passed away, but these were not apparent on the records disclosed to the Court. An audit of the records had to be carried out before the amendments were exposed. ”
Source location
Neil Challinor-Mooney · Prevention of Future Deaths report
Page 2 · concerns
Open source report