Whistleblowers allege that a range of misconduct — unqualified lab techs conducting COVID-19 tests and being inattentive during the testing procedures, COVID-19 test swabs ending up on the bathroom floor — has transpired at the recently built $25 million California COVID-19 testing lab. One whistleblower said that the lab “should be shut down because they’re jeopardizing people’s lives.” Sacramento-based news outlet CBS13 conducted a series of interviews with whistleblowers at the lab, and testimonies from whistleblowers as well as documents obtained by CBS13 allege that there has been mismanagement and mishandling of COVID test supplies, according to the February 8 article.
Background
CBS13 states that they “interviewed more than half a dozen whistleblowers and obtained dozens of internal records and quality control reports” from the state’s new COVID-19 testing lab, which began functioning in November of 2020. The creation of the lab, along with a contract with “major diagnostics company” PerkinElmer, aimed to speed up the state’s COVID-19 testing capabilities. The lab is located in Valencia, California.
“PerkinElmer is contracted to process up to 150,000 COVID tests daily by March, returning results in 24-48 hours,” the CBS13 article states. However, “[r]ecords indicate they’re currently processing an average of fewer than 20,000 tests a day but, according to the state, are being paid the contracted rate for 100,000 tests per day.”
CBS13 explains that they started having questions about the lab when investigative reporter Julie Watts and her family had their COVID test results processed in November 2020. “Two out of their four results came back inconclusive,” the article states. CBS13 inquired with the California Department of Public Health (CDPH) to no avail, while Placer County revealed that “one out of every 13 Placer County tests processed by the new lab in its first week, came back inconclusive.”
CBS13 also questioned California’s Health and Human Services Secretary Dr. Mark Ghaly about the inconclusive test results, and Dr. Ghaly “did acknowledge that there had been ‘a higher number than expected.’” Dr. Ghaly also noted a possible area of inaction that caused the tests to come back inconclusive and said that the lab has “since corrected it.” Now, CBS13 states that they have “obtained a quality control report from that week confirming Ghaly’s explanation.” CBS13 also reports that when they inquired further with the CDPH about “data related to inconclusive tests, the state changed its explanation.”
According to the article, someone from CDPH said in a January email to CBS13 that the type of test being used at the facility was the reason for the number of inconclusive test results. CDPH told CBS13 that the test used at the facility is “able to detect lower levels of viral load than other tests on the market.” This means, according to CDPH, that “when low levels are detected ‘these are reported as inconclusive,’” the article states. CBS13 points out that many of the inconclusive test results from this lab “came during the peak of the pandemic, between November and the end of the year, as people were traveling and visiting loved ones over the holidays.” CBS13 also states: “The rate of inconclusive results from the CDPH-PerkinElmer lab is seven and a half times higher than the other 22 COVID labs [processing California tests] combined.”
Whistleblower Allegations Emerge
According to CBS13, a whistleblower came forward and told them that the rate of inconclusive test results “was not due to a problem with a chemical reaction or the highly sensitive test.” Since that initial whistleblower reached out to CBS13, the news outlet has been in touch with other whistleblowers, “including several current and former employees at the lab.” These whistleblowers allege that there are “systemic problems inside the state lab and pointed to contamination, constantly changing protocols as well as unlicensed and inadequately trained staff as the reason for the high number of invalid and inconclusive results.”
Some of the whistleblowers with whom CBS13 was in contact were concerned with the wellbeing of the patients and offered “evidence of unlicensed lab techs learning basic skills on the job while processing patient samples.” Some of the whistleblowers provided photos and videos of “unlicensed lab techs watching videos on their phones and literally sleeping while processing the nasal swabs for testing,” the article states. Other whistleblowers notified CBS13 of an email sent to lab staff members “that reported sample swabs were found in the restrooms more than once.”
Some of the whistleblowers’ allegations seem to be supported by “dozens of quality control reports” that CBS13 obtained. According to the article, the reports detail “contamination, swapped samples, and repeated errors that could impact patients’ test results.” Multiple reports “indicated that there was no system in place to immediately notify people that had received someone else’s results.” In response to CBS13’s findings from the quality control reports, CDPH “acknowledged that at least ‘38 samples were reported incorrectly’ due to swapped samples.” The article states that CDPH “insisted that the patients were notified but could not immediately provide evidence or an explanation or how those patients received corrected results.”
Overall, the whistleblowers who talked with CBS13 seemed to pinpoint the misconduct in the lab as a result of unqualified lab techs, “a lack of qualified supervisors and constantly changing testing protocols,” according to the article. CBS13 writes that some of the whistleblowers provided evidence that indicated “lab techs had been processing patient samples before completing required training modules or getting signed-off for competency.” This evidence took the form of “emails from management.” CDPH denied this allegation, stating: “All individuals who are working in the laboratory…handling specimens are credentialed and trained.” But CBS13 writes that one whistleblower insisted that this statement was false. “I was running samples my first day with zero clinical experience. So were the rest of my colleagues,” the whistleblower said. Later on, CDPH “acknowledged they did ‘identify a handful of individuals’ who did not meet state requirements.” The agency stated that “these individuals were moved to roles that align with their credentials or trained to ensure they now have the proper credentials.”
Reactions
CBS13 states that the majority of the whistleblowers they spoke with want to remain anonymous in fear of being retaliated against. However, they note that one of the whistleblowers is part of “a growing number of people quitting due to ethical concerns that, they say, were ignored by management.”
A representative from the California Health and Human Services Agency, the government body that oversees CDPH, responded to the allegations on February 7. “We are troubled by these allegations against our laboratory vendor and its employees and will investigate them immediately and thoroughly,” the response read. “If these claims are substantiated, they would represent a clear violation of our existing agreement with PerkinElmer and we would take swift action to fix these issues, up to and including termination of the contract.”
“This lab was established by the state to provide accurate test results for the people of California as quickly as possible,” the statement concluded.
