The California Department of Public Health is investigating whistleblower allegations of mismanagement and incompetence, including reports of workers sleeping on the job, at the state’s new billion-dollar COVID-19 testing laboratory.
Internal documents from the PerkinElmer-run lab north of Los Angeles detail alleged problems like contamination causing inconclusive tests, swapped samples and inaccurate results sent to patients, according to records obtained by CBS13 TV in Sacramento.
Documents also reveal that some employees handling patient specimens were unlicensed and inadequately trained, the report said.
The news station interviewed current and former lab employees who claim to have found COVID-19 test swabs found in restrooms and witnessed technicians dozing off while processing samples for testing.
Republican state Senator Melissa Melendez said the whistleblower allegations are “concerning and downright shameful” in a statement calling for an investigation.
“Millions of Californians rely on the accuracy of these tests. The mistreatment of COVID test samples jeopardizes the health and safety of over 40 million Californians,” said Melendez, vice-chair of the Senate Health Committee.
“The state is taking this very seriously and we’re looking into the allegations,” Tomas Aragon, director of California’s health department, told lawmakers on Monday. He didn’t respond to any specific allegations or offer a timeline for the investigation.
PerkinElmer is contracted by the state to process up to 150,000 coronavirus tests daily by March at the lab in Santa Clarita, north of Los Angeles. But records indicate the facility is currently processing an average of fewer than 20,000 daily tests while being paid a contracted rate for 100,000 tests per day, CBS13 reported.
The news station reported in November that the rate of inconclusive tests from the PerkinElmer facility was more than seven times higher than the other 22 state COVID-19 labs combined.
After those reports aired, a whistleblower contacted CBS13 to allege that the continued high number of inconclusive results was not due to a chemical reaction or a particularly sensitive test, but worker incompetence.
At least one person came forward out of concern for patients’ health, the news station said.
Several internal documents indicate errors, including swapped specimen samples, that led to dozens of inaccurate results that were sent out to patients before the lab learned of the mistakes.
Other reports showed that there was no system in place to immediately notify people that they received someone else’s results. One report in mid-November stated: “A process for … retracting a report … needs to be established.”
In response, the health department acknowledged that at least “38 samples were reported incorrectly” due to swapped samples. The agency insisted that the patients were notified but could not immediately provide evidence or an explanation of how those patients received corrected results.
Emails from management indicate that some lab techs had been processing patient samples before completing training modules or getting signed-off for competency.
This was due, in part, to a lack of supervisors on some shifts, whistleblowers said. State and federal law require documented competency assessments that are performed by licensed supervisors.
In a written response, the health department said, “All individuals who are working in the laboratory … handling specimens are credentialed and trained.”
But the agency acknowledged they did “identify a handful of individuals” who did not meet state requirements adding, “these individuals were moved to roles that align with their credentials or trained to ensure they now have the proper credentials.”