LEXINGTON, Ky. — UK HealthCare has identified 26 COVID-19 test results that were incorrectly shown as positive due to a software flaw in one of the testing platforms.
Here is what happened and how UK HealthCare has responded in the best interest of patients:
- On July 16, University of Kentucky laboratory scientists were inspecting and reviewing raw data from the Massachusetts-based Thermo Fisher testing platform which has FDA Emergency Use Authorization.
- The employees became concerned about discrepancies between the raw data and the software interpretation that might result in false positives.
- The laboratory retested the suspect samples using another testing platform and confirmed that the tests initially reported as positive for COVID-19, were in fact negative. UK’s clinical laboratory uses four different testing platforms. The flaw has only been found in one testing platform.
- Since then, UK has reviewed all COVID-19 positive patient specimens tested on the Thermo Fisher testing platform and assessed the accuracy of the results.
- Results with a discrepancy between the raw data and the software interpretation were then retested on a different testing platform. No negative test results changed. However, 26 tests previously identified as positive were confirmed as negative.
- Every patient who received incorrect results is being notified about the issue. UK HealthCare also has notified Thermo Fisher Scientific and the FDA.
- The Thermo Fisher Scientific TaqPath testing platform has been used by UK since June 27. The test results impacted by the defect were processed between June 27 and July 16. Currently, all positive results are being confirmed utilizing a different platform prior to release of results. In total, UK’s clinical laboratory uses four different testing platforms.
“For anyone tested at UK HealthCare, it is important to know that the vast majority of results have not changed,” said UK Executive Vice President for Health Affairs Dr. Mark Newman. “Since these very astute employees discovered this issue, we have taken extensive measures to validate each test in question and worked diligently to contact all parties — the vendor, the FDA — and most importantly, our patients and providers.”
In addition, UK HealthCare is working with local health departments and the Kentucky Department of Public Health to correct all data.
“UK’s clinical laboratory has performed more than 30,000 COVID-19 tests since March and only a very small percentage of tests have been affected by this software defect,” Newman said. “Anyone who has received test results and has not been contacted this week about re-testing, should be assured their result is correct.”