CDPH: COVID-19 testing lab had ‘significant deficiencies’ in December

California Connection

SACRAMENTO, Calif. (KTXL) – California public health officials announced Monday that one of the laboratories chosen to expand COVID-19 testing in the state had significant deficiencies back in December.

Inspectors from the California Department of Public Health’s Laboratory Field Services Division found significant deficiencies in the Valencia Branch Laboratory during an initial routine inspection that occurred in early December when the laboratory first opened, according to a news release.

PerkinElmer, the operator of the Valencia Branch Laboratory with CDPH, was provided the deficiencies on February 19, 2021.

CDPH officials said the state opened the Valencia Branch Laboratory in collaboration with PerkinElmer to “expand laboratory testing capacity and ensure access to testing for neighborhoods that were disproportionately affected by the pandemic at a time when testing was relatively scarce and supply chains were strained.”

The Valencia Branch Laboratory has performed more than 1.5 million tests on samples from a network of more than 1,500 specimen collection sites, according to the release.

Out of a total of more than 1.5 million tests performed, the Valencia Branch Laboratory has issued corrected reports for approximately 60 samples and been unable to test approximately 250 samples due to lab errors.

“One incorrect test result is one too many. California takes these findings seriously and has been working hand in hand with PerkinElmer from the beginning to ensure Californians have the accurate, timely, high-quality test results,” Health and Human Services Secretary Dr. Mark Ghaly said in the release.

CDPH officials said PerkinElmer has until March 1 to formally respond with how it has addressed or plans to address the laboratory’s initial challenges.

“PerkinElmer’s partnership with the State of California has enabled us to meaningfully help millions of residents in local communities as we have worked together to battle the pandemic,” said Prahlad Singh, PerkinElmer’s president and chief executive officer in the release.

PerkinElmer believes that the Valencia Branch Laboratory is not in danger of closure as nearly all of the deficiencies have been resolved for some time given the original inspection occurred over 10 weeks ago and the deficiencies that have not been fully resolved are in the process of being resolved and will be sufficiently resolved soon, according to the release.

CDPH officials did not release specific details on the deficiencies found at Valencia Branch Laboratory but they said the full report on the lab, with responses from PerkinElmer, will be made available in mid-March.

This story is developing. Check back for updates.

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