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California Department of Public Health
California Cancels COVID-19 Test Contract with PerkinElmer
CALIFORNIA HAS SHED MORE LIGHT ON THE DECISION to terminate PerkinElmer’s valuable contract to run the Valencia Branch Laboratory (VBL). The lab has been embroiled in controversy for much of its existence. The state noted that SARS-CoV-2…
Questions Remain about California COVID-19 Lab
This is an excerpt of a 2,058-word article in the March 14, 2022 issue of THE DARK REPORT. The full article is available to members of The Dark Intelligence Group CEO SUMMARY: Despite multiple investigations citing more than 60 deficiencies, including some that caused immediate j…
Questions Remain about California’s Valencia Lab
CEO SUMMARY: Despite multiple investigations citing more than 60 deficiencies, including some that caused immediate jeopardy to patient safety according to state inspectors, the Valencia Branch Laboratory never closed. The California Department of Public health said the state lab no…
Major CLIA Deficiencies Found at California’s COVID-19 Lab Facility
MIGHT THERE BE DIFFERENT STANDARDS IN HOW government regulators enforce CLIA requirements on privately-owned clinical laboratories compared to a government-owned lab? This question is being asked after the California Department of Public Health (…
Whistleblower Lab Manager Files Response to PerkinElmer Lawsuit
IN A DAVID-VERSUS-GOLIATH-LIKE BATTLE, perhaps the most unusual lawsuit in decades involving clinical laboratory operations and compliance is unfolding in a federal courthouse in California. In this case, a multi-billion-dollar in vitro diagnostics (IVD) company is suing a laboratory manager w…
Might Politics Sway California Lab’s CLIA Compliance?
IS IT A CONFLICT FOR A STATE GOVERNMENT TO BUILD AND OPERATE A CLIA high-complexity clinical laboratory and have the same department that manages this lab facility also conduct the CLIA-mandated inspections and oversight of the lab’s compliance, as required by the federal Clinical Laboratory Improv…
Whistleblowers Disclose Issues in California’s COVID Lab
SUMMARY: Whistleblowers at the State of California’s brand-new COVID-19 Valencia Branch Laboratory are telling reporters about staff sleeping on the job, unlicensed staff handling specimens, and other significant issues. Given the reports of several news outlets, one relevant ques…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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