Authorities said Monday that the new Californian coronavirus testing lab will not face sanctions for what state officials called “significant flaws,” which a whistleblower said threaten the accuracy of its results.
According to the California Department of Public Health (CDPH), the Valencia branch lab had training and record keeping issues, but authorities were unable to substantiate whistleblower reports that the lab destroyed data or documents.
Problems found “are usually found in laboratory tests,” the department said.
“All deficiencies have been eliminated, and this did not affect the integrity of the tests carried out in the laboratory,” so no sanctions will be imposed, the agency said.
The $ 25 million lab opened in October 2020 north of Los Angeles. A preliminary report from the state says that a fraction of 1% of the more than 1.5 million tests processed had problems.
Last month, the Health Department’s Laboratory Services Division issued a notice of its intent to impose sanctions, but just 10 days later, the state renewed a $ 1.7 billion contract without bidding to operate a laboratory with Massachusetts-based PerkinElmer, a diagnostic company.
The threat of sanctions was lifted earlier this month as authorities said PerkinElmer had fixed the problems.
In a statement, PerkinElmer said it worked with the state’s public health department to resolve issues and was pleased that the lab was found to be “in full compliance” with state laws and regulations.
“This is further evidence that PerkinElmer and CDPH remain focused on delivering a best-in-class laboratory for the benefit of California residents,” the statement said.
Automatic contract renewals have been allowed due to concerns that winter could bring a new surge in COVID-19, the health ministry said. He noted that the state still has the right to terminate the contract without giving any reasons, if it so wishes.
The inspectors blamed the laboratory for the problems in part due to the rapid power build-up they were demanding from the operator. The government pushed for this at a time when it was often difficult to obtain COVID-19 tests, which were sometimes delayed until the results became relatively useless because they came too late.
In addition to routine screening, the department investigated whistleblower claims of incompetence and mismanagement, including reports of workers sleeping at work.
The recordings received by CBS13 in Sacramento suggested problems, including sample swapping, inconclusive tests caused by contamination, and inaccurate results sent to patients.
The lab sued the whistleblower for violating the confidentiality agreement.
The laboratory is also under federal investigation.
The Public Health Department also praised the lab, saying it played a “critical role” in increasing the availability of testing for people at high risk of COVID-19, including key workers, those in nursing homes, and disadvantaged neighborhoods and communities. minorities.
“The lab has conducted more than 5.5 million tests on samples from a network of more than 4,700 sample collection points developed with participation of churches, schools, clinics, mainstream jobs and community organizations,” the department said in a statement.