Might Politics Sway California Lab’s CLIA Compliance?

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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 Improvement Amendments (CLIA)? 

That is the situation in California today. Last August, the state government issued a no-bid contract worth as much as $1.7 billion to PerkinElmer, which requires the company—on an accelerated timeline—to find a location, design, and build a lab facility, install and validate instruments and assays, hire and train staff, and have the entire lab operation produce an ambitious 150,000 molecular SARS-CoV-2 tests per day by early March. That level of daily test production would make it one of the nation’s largest genetic testing laboratories. From concept to 150,000 COVID-19 tests per day was planned to take just 180 days! (See TDR, “California Builds COVID-19 Lab: $25 Million or $1.7 Billion?,” Nov. 16, 2020.) 

Since the State of California’s Valencia Branch Laboratory (VBL) became operational last fall, news outlets have reported about various problems, as we describe in this issue. Numerous whistleblowers are talking to different news outlets. One of the senior lab directors—who no longer works for VBL—went public with her concerns. Since she previously worked as a clinical lab inspector for the state, she should have credibility. 

These developments raise a question of great interest to all pathologists and clinical laboratory professionals. Normally, as a regulator, a state wants to protect public health, safety, and welfare. For lab testing, California does this through its Laboratory Field Services (LFS), which is part of the California Department of Public Health (CDPH). But the Valencia Branch Laboratory is owned and operated by the State of California, which has committed to spend as much as $1.7 billion to grow this lab into one of the nation’s largest genetic testing labs. Does this not create a major conflict of interest? How can this lab, operated by a state government agency—the CDPH—be inspected and regulated by its internal department, the LFS? To avoid blame for any problems, will elected officials and government bureaucrats blunt CLIA inspections of this lab and surpress publication of identified deficiencies? 

Events so far do not inspire confidence that the right things will happen.

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