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 (CDPH) finally made public the CLIA inspection report by state officials after they visited the state-owned Valencia Branch Laboratory last winter.
‘Scathing Inspection Report’
Last week, CBS13Sacramento wrote, “Lab inspectors issued scathing reports following the state’s routine initial inspection and a whistleblower complaint investigation that found lab practices [at the Valencia lab facility] posed a threat of ‘serious injury or harm, or death to Californians.’”
Arguing that the state needed more COVID-19 testing capacity, last July, California officials awarded a no-bid contract worth as much as $1.7 billion to PerkinElmer. PerkinElmer built the COVID-19 laboratory, uses a SARS-CoV-2 assay it developed, and operates the lab under this contract, which was renewed in recent weeks.
News reports of poor operations, inaccurate COVID-19 test results, and poor staff work habits have plagued the Valencia laboratory since it opened in the fall of 2020. Early in 2021, whistleblowers went public with details about these issues, attracting more news headlines. (See TDR, “Multiple Whistleblowers Disclose Issues in California’s Big New COVID-19 Laboratory,” Mar. 1, 2021.)
Whistleblowers talking to the press provided many details that match the findings of the state inspectors. But the state did not make this report public last winter, as promised. Instead, CBS13Sacramento reported that, “in February, CDPH and PerkinElmer claimed the ‘serious deficiencies’ had ‘long since been resolved.’
“However, inspectors issued a Notice of Intent to Impose Sanctions on October 21st for outstanding deficiencies—just 10 days before the lab’s contract was renewed last month. … not surprisingly, the agency did not issue sanctions against its own lab. Instead, the CDPH concluded, ‘(t)his blueprint can serve as a model for other states, and the federal government, in how to scale testing,’” said CBS13Sacramento.
These statements should catch the full attention of all clinical lab administrators and pathologists. This news report indicates that state officials do not appear to be enforcing federal and state laws with this state-owned clinical laboratory. Will these same regulators act tough with privately-owned labs that are inspected and found to have serious deficiencies, particularly deficiencies that put patients at risk of harm?
Expect more surprising revelations in this unfolding story of how government officials are assessing the compliance of the Valencia Branch Laboratory.