Corporate report

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

Published 29 November 2022

The causes of the failures at the Wolverhampton laboratory run by Immensa Health Clinic Limited are described in the serious untoward incident (SUI) report published alongside this document. This document details the changes that NHS Test and Trace and its successor the UK Health Security Agency (UKHSA) have made to their own systems and processes since the Immensa incident in order to improve organisational performance management processes and to enable earlier detection of any similar laboratory errors wherever possible.

We will firstly set out some initial context to help explain the wider state of the coronavirus (COVID-19) pandemic at the time of the incident, and why we took these corrective actions to improve our core functions.

In March 2020, the public sector laboratory capacity in the UK was not sufficient to meet the testing demand from the general public. NHS Test and Trace (originally part of the Department for Health and Social Care (DHSC) and now subsumed into UKHSA) was tasked with the provision of population COVID-19 testing capacity.

Staff within NHS Test and Trace worked tirelessly to build this capacity, and, due to the scale of the task, the organisation worked across the public and private sectors, as well as with universities, to build a well-staffed network.

Since the start of the pandemic, around 150 million polymerase chain reaction (PCR) tests have been processed. At times of highest demand during the Omicron wave, the laboratory network in the UK was able to process over 580,000 samples a day. Immensa’s role within the overall network was comparatively small, but as the SUI sets out, the impact of the errors within the lab was significant.

While building a service of exceptional quality was of paramount importance, we also knew that scaling up at the required speed meant we would carry greater risk when it came to contracting suppliers and regulating and assuring their services.

The SUI report outlines that the Immensa laboratory operated below the required quality standard and that some further assurance in our contracting process may have reduced the risk of this happening. Further opportunities were missed in our investigatory processes which led to a delay in identifying why a disproportionate number of people, particularly in the South West of England, had tested positive on a lateral flow test but negative on a subsequent PCR test. We now know the root cause of the incident was a failure by Immensa to set the testing thresholds appropriately.

That is why we made the improvements outlined below – these actions incorporate both how the testing operations group now operates, but also how we have strengthened our commercial processes.

It is important to note that all of the decisions taken happened at a different phase of the pandemic to the one we are in now. Demand for testing was incredibly high, and the network was working to maximum capacity. While this does not provide an explanation in its own right for what happened with Immensa, it is important to state that the risk of an incident like this happening again has been diminished not only because of the improvements we have made but because the demands for testing are much reduced, and therefore UKHSA works with fewer providers with whom we can work more closely and proactively on assuring high levels of performance.

Improvements within the testing operations group

Immediately after the Immensa incident, UKHSA undertook its own internal investigation (which concluded on 22 November 2021) to identify which of the testing operations group’s systems and processes needed to be improved to reduce the likelihood of such an incident happening again. Informed by that investigation, we have done the following:

1. We have changed the reporting functions of the Real-World Performance Monitoring and Post-Deployment Performance Evaluation and Monitoring teams. We now produce an all-device summary report that allows us to monitor rates of positivity across the country and spot unexplained discrepancies to identify issues quickly. We also have a regionalised laboratory performance report and additional lab reporting, which are monitored on a daily basis.
2. We have ensured better links between the team overseeing laboratories and the incident response team, so that both teams have a detailed understanding of the other’s operations and processes.
3. We have implemented stronger public health oversight and clearer accountabilities for the investigation of incidents. Performance monitoring is now incorporated into the additional clinical governance processes put in place.
4. We have implemented substantial changes in logging, tracking and record-keeping in relation to incident investigation and response. Previously, while incidents were logged, we did not systematically record the rationale for which incident management decisions had been made or who had been consulted.

Improvements within the commercial function

Since the Immensa incident, UKHSA has launched a ‘commercial reset’ to improve and raise the standard of our commercial practices. A critical component of the reset is our contract management capability programme established to improve contract management across the organisation. The Cabinet Office requires staff managing contracts across government to be trained and accredited at the appropriate level of the Contract Management Capability Programme (CMCP).  To strengthen the capability, we:

• have developed a contract management playbook and toolkit to upskill teams
• have established a working group to support contract managers working on UKHSA’s 25 biggest value and most complex contracts
• will have trained and accredited all relevant commercial staff at CMCP Foundation level by the end of December 2022
• will offer CMCP training at practitioner and expert level to selected staff within the testing operations group

Investigations into the Immensa incident have revealed that there were conflicting terms between our framework agreements and the associated mini-competition documentation which could cause confusion.

While it is not unusual to have potentially conflicting terms across contract documentation, a clear order of precedence should apply to provide clarity as to which terms apply. We will be including training on order of precedence within our contract management playbook going forward.