California’s new coronavirus testing laboratory won’t face sanctions for what state officials had called “significant deficiencies” that a whistleblower said threatened the accuracy of its results, authorities said Monday.
The Valencia Branch Laboratory was found to have problems with training and record-keeping but authorities couldn’t substantiate reports stemming from a whistleblower that the lab destroyed data or documents, according to the California Department of Public Health (CDPH).
The problems found were “routinely found in laboratory inspections,” the department said.
“All deficiencies were addressed and there was no impact to the integrity of the tests processed at the laboratory” so sanctions won’t be imposed, the agency said.
The $25 million lab opened in October 2020 north of Los Angeles. In a preliminary report, the state said a fraction of 1% of the more than 1.5 million tests processed had problems.
The health department’s Laboratory Field Services division issued a notice last month of its intent to impose sanctions but just 10 days later the state renewed a $1.7-billion no-bid contract to operate the lab with Massachusetts-based diagnostics company PerkinElmer.
The sanctions threat was withdrawn earlier this month because authorities said PerkinElmer had corrected problems.
In a statement, PerkinElmer said it had worked with the state public health department to address concerns and was pleased that the laboratory had been found in “full compliance” with state laws and regulations.
“This is further evidence that PerkinElmer and CDPH remain steadfastly focused on operating a best-in-class laboratory for the benefit of California residents,” the statement said.
The automatic contract renewal was permitted out of concern that winter may bring another COVID-19 surge, the public health department said. It noted that the state still has the right to end the contract without cause if it chooses.
Inspectors had partly blamed problems at the lab on the rapid ramp-up they required from the operator. The state pushed for it at a time when it was often difficult to get COVID-19 tests, which were sometimes delayed until the results were relatively useless because they came too late.
In addition to a routine inspection, the department looked into whistleblower allegations of incompetence and mismanagement, including reports of workers sleeping on the job.
Records obtained by CBS13 TV in Sacramento alleged problems including swapped samples, inconclusive tests caused by contamination, and inaccurate results sent to patients.
The lab has sued the whistleblower for violating a confidentiality agreement.
The lab also remains under federal investigation.
The public health department also praised the laboratory saying it had played a “critical role” by increasing the availability of testing for people considered at high risk of COVID-19, including essential workers, those in care homes and disadvantaged and minority neighborhoods.
“The laboratory has performed more than 5.5 million tests on samples from a network of more than 4,700 specimen collection sites developed with churches, schools, clinics, essential workplaces and community-based organizations,” a department statement said.