California virus testing laboratory is not sanctioned for deficiencies
California authorities said on Monday that California’s new coronavirus testing laboratory will not face sanctions for what state officials call “significant flaws,” whistleblowers say these flaws threaten the accuracy of its results.
According to the California Department of Public Health (CDPH), the Valencia branch laboratory was found to have problems with training and record keeping, but the authorities could not confirm the whistleblower’s report on the laboratory’s destruction of data or documents.
The department stated that the problems found were “often found in laboratory inspections.”
The agency stated that “all deficiencies have been resolved and the integrity of the tests processed by the laboratory has not been affected” and therefore sanctions will not be imposed.
The $25 million laboratory opened in October 2020 in northern Los Angeles. In a preliminary report, the state stated that only 1% of the more than 1.5 million tests processed had problems.
The Laboratory Field Services Department of the Department of Health issued a notice last month expressing its intention to impose sanctions, but only 10 days later, the state renewed a $1.7 billion no-bid contract with the Massachusetts diagnostic company PerkinElmer. Run the laboratory.
The threat of sanctions was lifted earlier this month because the authorities said PerkinElmer had corrected the problem.
PerkinElmer said in a statement that it has worked with the state public health department to resolve the problem and is pleased to find that the laboratory “fully complies with” state laws and regulations.
The statement said: “This further proves that PerkinElmer and CDPH are still unswervingly focused on operating first-class laboratories for the benefit of California residents.”
The public health department said it allowed automatic contract renewal due to fears that the winter might cause a surge of COVID-19 again. It pointed out that if the country chooses, it still has the right to terminate the contract without reason.
Inspectors blamed part of the laboratory’s problems on their request for operators to start quickly. At a time when COVID-19 testing is usually difficult, the state promotes it, sometimes delaying until the results are relatively useless because they come too late.
In addition to routine inspections, the department also investigated allegations of incompetence and mismanagement from whistleblowers, including reports of workers sleeping at work.
Records obtained by CBS13 TV in Sacramento claim to have problems, including sample exchanges, uncertain tests caused by contamination, and inaccurate results sent to patients.
The laboratory has sued the whistleblower for violating the confidentiality agreement.
The laboratory is still under federal investigation.
The public health department also praised the laboratory’s “key role” in providing more testing services for people deemed to be at high risk of COVID-19 (including basic staff, nursing homes, and people in vulnerable and minority communities) , Thus playing a “key role.”
A departmental statement said: “The laboratory has performed more than 5.5 million tests on samples from a network of more than 4,700 sample collection points developed in collaboration with churches, schools, clinics, basic workplaces, and community organizations.”