Corporate report

Immensa Health Clinic Limited: serious untoward incident investigation

Report on serious untoward incident (SUI) wherein Immensa laboratory Wolverhampton was found to have issued incorrect test results for coronavirus (COVID-19).

From:
UK Health Security Agency
Published
29 November 2022

Documents

Final report of the serious untoward incident investigation into the misreporting of PCR test results by the Immensa Health Clinic Limited

PDF, 1000 KB, 89 pages

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Improvements to UKHSA’s systems and processes implemented since the Immensa incident

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Details

This report has been prepared by senior UK Health Security Agency (UKHSA) staff who were unconnected to the incident or the COVID-19 testing programme.

The serious untoward incident (SUI) investigation has looked at the role of NHS Test and Trace (NHSTT) and UKHSA in:

  • the procuring and awarding of the first and second contracts by the UK government with Immensa (in 2020 and 2021 respectively), their mobilisation and monitoring of Immensa’s activity
  • NHSTT’s reviews into concerns that were raised relating to individuals who had positive lateral flow device (LFD) results followed by negative polymerase chain reaction (PCR) results in September and October 2021 and assessments of the potential public health impact associated with these concerns

Further information

For further information, please see the following documents:

Epidemiological impact of a large number of incorrect negative SARS-CoV-2 test results in South West England during September and October 2021

Epidemiological impact of a large number of false-negative SARS-CoV-2 test results in South West England during September and October 2021: supplemental material

Published 29 November 2022