Published Date: 2021-10-23
| Postmortem Analysis | |
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| Timeline | 1. The software failure incident at Immensa Health Clinic's laboratory in Wolverhampton, leading to about 43,000 people being wrongly told they did not have the virus, occurred in September 2021 [119716]. |
| System | 1. Immensa Health Clinic’s laboratory quality control processes and oversight from the UK Health Security Agency (UKHSA) failed to raise the alarm before concerned members of the public complained [119716]. 2. The PCR machines' computer software that interprets the results failed to flag failed tests to the operator immediately, indicating a failure in the software system [119716]. |
| Responsible Organization | 1. Immensa Health Clinic's laboratory in Wolverhampton [119716] 2. UK Health Security Agency (UKHSA) [119716] |
| Impacted Organization | 1. Individuals who received potential false negative results from the Covid testing lab at Immensa Health Clinic's laboratory in Wolverhampton [119716] |
| Software Causes | 1. Lack of proper oversight and quality control processes in Immensa Health Clinic’s laboratory software [119716] 2. Failure of the PCR machine software to flag failed tests to the operator immediately [119716] 3. Potential lack of manual data checking for unusual patterns in the PCR machine software [119716] |
| Non-software Causes | 1. Lack of timely oversight and quality control by Immensa Health Clinic's laboratory and the UK Health Security Agency (UKHSA) [119716]. 2. Rapid expansion of private companies into the Covid testing business without sufficient oversight and quality control measures [119716]. 3. Failure to detect discrepancies in regional Covid test data promptly [119716]. 4. Lack of proper monitoring and analysis of data coming off the PCR machines [119716]. 5. Inaccurate accreditation claims by the Department of Health and Social Care (DHSC) regarding Immensa's lab [119716]. |
| Impacts | 1. Approximately 43,000 people, mostly in south-west England, were believed to have wrongly been told they did not have the virus due to the software failure incident at Immensa Health Clinic’s laboratory in Wolverhampton [Article 119716]. 2. The failure led to serious concerns about potential very serious illnesses, hospitalizations, and worse due to the absolute failure of quality in the lab [Article 119716]. 3. Individuals who received potential false negative results were advised to test again, causing inconvenience and potential anxiety for those affected [Article 119716]. 4. The failure prompted calls for the government to publish its contract with Immensa, transfer testing to more reliable labs, and establish more stringent oversight of private companies in the Covid testing business [Article 119716]. |
| Preventions | 1. Implementing more stringent oversight of private companies entering the Covid testing business to ensure quality control measures are in place [119716]. 2. Transferring as much testing as possible to NHS and university labs where quality control is built-in and lab heads take responsibility for test reliability [119716]. 3. Ensuring that the sensitive PCR tests used to analyze Covid swabs are checked manually for unusual patterns such as prolonged periods with no positives, in addition to being interpreted by computer software [119716]. 4. Having a system in place to rapidly identify any problems in the lab, such as strange results or discrepancies, to prevent major failings from going unnoticed for an extended period [119716]. |
| Fixes | 1. Implement more stringent oversight of private companies entering the Covid testing business to ensure quality control measures are in place [119716]. 2. Transfer as much testing as possible to NHS and university labs where quality control is built-in and lab heads take responsibility for test reliability [119716]. 3. Publish contracts with private testing companies to scrutinize quality control measures written into the documents [119716]. 4. Ensure that laboratories have systems in place to rapidly identify any problems, such as unusual patterns in test data [119716]. 5. Consider shifting from PCR testing to lateral flow tests to potentially make better use of the testing budget and support isolation efforts [119716]. | References | 1. Senior scientists, including Alan McNally, a professor in microbial evolutionary genomics at the University of Birmingham [Article 119716] 2. UK Health Security Agency (UKHSA) [Article 119716] 3. UK researcher familiar with Covid testing [Article 119716] 4. Deenan Pillay, a professor of virology at University College London and a member of the Independent Sage group [Article 119716] 5. Department of Health and Social Care (DHSC) [Article 119716] 6. DHSC spokesperson [Article 119716] 7. Ukas (UK's independent accreditation service) [Article 119716] 8. Dr. Will Welfare, incident director for Covid-19 at the UKHSA [Article 119716] |
| Category | Option | Rationale |
|---|---|---|
| Recurring | one_organization, multiple_organization | (a) The software failure incident having happened again at one_organization: The article mentions that the Immensa Health Clinic's laboratory in Wolverhampton, which was involved in the software failure incident related to Covid testing, had major failings leading to thousands of people being wrongly told they did not have the virus. This incident highlights a significant failure in quality control processes within the lab, indicating a serious issue within the organization [119716]. (b) The software failure incident having happened again at multiple_organization: The article discusses how the rapid expansion of private companies into the Covid testing business, often without proper oversight, has led to potential issues with the reliability of testing. This suggests that similar incidents of unreliable testing due to lack of oversight may have occurred at multiple organizations that entered the Covid testing market hastily [119716]. |
| Phase (Design/Operation) | unknown | The articles do not provide specific information about a software failure incident related to the development phases such as design or operation. Therefore, it is unknown how the failure may have been influenced by system development, system updates, or operational procedures. |
| Boundary (Internal/External) | within_system | (a) within_system: The software failure incident at the Immensa Health Clinic's laboratory in Wolverhampton was primarily due to within-system factors. The failure was attributed to major failings in the lab's quality control processes and oversight mechanisms, as neither Immensa's internal quality control nor oversight from the UK Health Security Agency (UKHSA) raised the alarm about the discrepancies in regional Covid test data [119716]. (b) outside_system: There is no specific mention in the articles about the software failure incident being caused by contributing factors originating from outside the system. |
| Nature (Human/Non-human) | non-human_actions, human_actions | (a) The software failure incident in the Immensa Health Clinic's laboratory in Wolverhampton was primarily due to non-human actions. The affected swabs were processed with discrepancies, and the quality control processes, as well as oversight from the UK Health Security Agency, failed to raise the alarm before public complaints triggered an investigation [119716]. (b) However, human actions also played a role in the failure. The incident was exacerbated by the lack of stringent oversight of private companies entering the Covid testing business, the rapid expansion of commercial testing capacity without adequate supervision, and the failure to detect anomalies in the data coming off the PCR machines [119716]. |
| Dimension (Hardware/Software) | software | (a) The software failure incident reported in the articles does not seem to be directly related to hardware issues. The focus of the incident is on the failure of quality control processes, oversight, and data analysis within the Immensa Health Clinic’s laboratory in Wolverhampton, leading to potentially unreliable Covid test results [119716]. (b) The software failure incident is primarily attributed to failures in quality control processes, oversight, and data analysis within the Immensa Health Clinic’s laboratory in Wolverhampton. The incident highlights the importance of monitoring data coming off the PCR machines and manually checking for unusual patterns in the results, which suggests a software-related issue in data interpretation and analysis [119716]. |
| Objective (Malicious/Non-malicious) | non-malicious | (a) The software failure incident at Immensa Health Clinic's laboratory in Wolverhampton was non-malicious. The failure was attributed to major failings in quality control processes and oversight, leading to potentially unreliable testing results for Covid-19 [119716]. The incident was described as a debacle and one of the worst scandals in the UK's Covid crisis, highlighting the serious consequences of the failure [119716]. (b) The failure was not due to malicious intent but rather a lack of proper quality control measures, oversight, and monitoring of the testing processes. The incident was a result of systemic issues and failures in the laboratory's operations, rather than intentional harm introduced by individuals [119716]. |
| Intent (Poor/Accidental Decisions) | poor_decisions | The software failure incident at Immensa Health Clinic's laboratory in Wolverhampton was primarily attributed to poor decisions rather than accidental decisions. The incident was characterized by major failings in quality control processes and oversight, leading to thousands of people being wrongly informed they did not have the virus [119716]. The failure was exacerbated by the lack of stringent oversight of private companies entering the Covid testing business, the rapid expansion of commercial testing capacity without adequate supervision, and the absence of proper quality control measures [119716]. These factors indicate that the failure was more aligned with poor decisions and lack of oversight rather than accidental mistakes. |
| Capability (Incompetence/Accidental) | unknown | The articles do not specifically mention a software failure incident related to development incompetence or accidental factors. Therefore, the information to determine whether the failure was due to development incompetence or accidental factors is unknown. |
| Duration | permanent, temporary | (a) The software failure incident in the article seems to be more of a permanent nature. The failure at the Immensa Health Clinic's laboratory in processing Covid swabs led to about 43,000 people being wrongly told they did not have the virus [119716]. The failure was described as one of the worst scandals in the UK's Covid crisis, indicating a significant and lasting impact. The failure was not promptly detected by Immensa's quality control processes or oversight from the UK Health Security Agency, leading to serious consequences such as potential hospitalizations and worse [119716]. (b) The temporary aspect of the failure could be attributed to the delay in shutting down operations at the Immensa lab. Health officials took weeks to shut down the site after concerns were raised, indicating that the failure was not immediately rectified but rather persisted for a certain period before action was taken [119716]. |
| Behaviour | crash, omission, timing, value, other | (a) crash: The software failure incident in the article can be associated with a crash behavior as the lab's software system failed to flag failed tests to the operator immediately, indicating a loss of state and failure to perform its intended functions [119716]. (b) omission: The incident can also be linked to omission behavior as the lab's software system failed to detect discrepancies in regional Covid test data promptly, leading to a delay in shutting down operations at the site and potentially providing false negative results to individuals [119716]. (c) timing: The timing behavior is evident in this incident as the software system failed to perform its intended functions at the right time. The lab's quality control processes and oversight did not raise the alarm promptly, causing a delay in addressing the issue [119716]. (d) value: The software failure incident can be associated with the value behavior as the lab's software system provided potentially unreliable testing results, leading to individuals being wrongly informed that they did not have the virus, which could have serious consequences [119716]. (e) byzantine: The byzantine behavior is not explicitly mentioned in the articles. (f) other: The software failure incident can also be categorized under the "other" behavior as the lab's software system failed to properly control and monitor the data coming off the PCR machine, indicating a failure in the overall quality control and oversight mechanisms [119716]. |
| Layer | Option | Rationale |
|---|---|---|
| Perception | None | None |
| Communication | None | None |
| Application | None | None |
| Category | Option | Rationale |
|---|---|---|
| Consequence | property, non-human, theoretical_consequence, other | (a) death: People lost their lives due to the software failure - The article does not mention any direct deaths resulting from the software failure incident at the Immensa Health Clinic's laboratory in Wolverhampton [119716]. (b) harm: People were physically harmed due to the software failure - The article does not mention any direct physical harm to individuals resulting from the software failure incident at the Immensa Health Clinic's laboratory in Wolverhampton [119716]. (c) basic: People's access to food or shelter was impacted because of the software failure - The article does not mention any impact on people's access to food or shelter due to the software failure incident at the Immensa Health Clinic's laboratory in Wolverhampton [119716]. (d) property: People's material goods, money, or data was impacted due to the software failure - The software failure incident at the Immensa Health Clinic's laboratory in Wolverhampton led to about 43,000 people being wrongly told they did not have the virus, potentially impacting their health and well-being [119716]. (e) delay: People had to postpone an activity due to the software failure - The article does not mention any specific activities that people had to postpone due to the software failure incident at the Immensa Health Clinic's laboratory in Wolverhampton [119716]. (f) non-human: Non-human entities were impacted due to the software failure - The software failure incident at the Immensa Health Clinic's laboratory in Wolverhampton affected the processing of Covid swabs, leading to potential false negative results for individuals [119716]. (g) no_consequence: There were no real observed consequences of the software failure - The software failure incident at the Immensa Health Clinic's laboratory in Wolverhampton had significant consequences, including potentially unreliable testing, false negative results, and the need for affected individuals to retest [119716]. (h) theoretical_consequence: There were potential consequences discussed of the software failure that did not occur - The article discusses potential consequences of the software failure incident, such as serious illnesses, hospitalizations, and the need for more stringent oversight of private companies involved in Covid testing [119716]. (i) other: Was there consequence(s) of the software failure not described in the (a to h) options? What is the other consequence(s)? - The article highlights the potential consequences of unreliable testing, the need for better quality control measures, and the impact on public confidence in testing services due to the software failure incident at the Immensa Health Clinic's laboratory in Wolverhampton [119716]. |
| Domain | health | The software failure incident reported in the news article [Article 119716] is related to the **health** industry. The incident occurred at Immensa Health Clinic’s laboratory in Wolverhampton, which was involved in processing Covid swabs for testing. The failure led to approximately 43,000 people being wrongly informed that they did not have the virus, highlighting a significant issue in the healthcare sector. The incident raised concerns about the quality control processes in place at the lab and the oversight from regulatory bodies like the UK Health Security Agency (UKHSA) [Article 119716]. |
Article ID: 119716