Skip to content
California officials release report on troubled state lab

After investigating its own COVID-19 testing lab for much of the year, the California Department of Public Health closed its case without issuing sanctions as the state released a long-awaited report on Monday that minimized the generalized problems identified during inspections at the Valencia branch laboratory.

The lab, which was opened in partnership with Massachusetts-based diagnostics company PerkinElmer, has been plagued by problems since the $ 25 million facility opened late last year. The Newsom administration promised a full report in March on “significant deficiencies” found during inspections, but it was not released until Monday – weeks after the state renewed its contract without an offer of $ 1.7 billion. dollars with PerkinElmer to keep the test site running.

Newly released documents show California inspectors sounded the alarm earlier this year about whether staff were properly trained, how the lab reported its own processing errors, and whether protocols that reduce the likelihood of contamination were being followed. which questioned the accuracy of the tests. at one of the largest testing facilities in the state.

“It shouldn’t have taken Californians 287 days to receive responses on this taxpayer-funded COVID testing lab,” said Senator Scott Wilk (R-Santa Clarita). “Especially when our vulnerable students are those at risk, parents and families deserve the accountability and transparency of the Newsom administration.”

The field laboratory services division of the state’s public health department issued a “notice of intent to impose sanctions” letter on October 21 after finding that the Valencia laboratory had failed. corrected all the problems identified during its inspections, despite several extensions during the year. Ten days later, the state authorized the automatic renewal of the contract with PerkinElmer, which a public health spokesperson said was done to protect California from a possible winter outbreak of COVID-19.

“The state was confident in the contract language and its ability to terminate the contract, and therefore felt confident to proceed without the final report,” said Corey Egel, spokesperson for the public health department, of the renewal.

The state withdrew its threat of sanctions on November 10 “on the basis of the demonstrated correction” of the problems.

The existence of the investigation in February was made public after a CBS 13 article in Sacramento shed light on problems in the lab, with whistleblowers telling the station earlier this year that they had seen Laboratory technicians sleep or watch videos while nasal swab processing and unsupervised staff have processed samples before taking required training.

The state has opened a separate investigation into the allegations made in the CBS report. A federal investigation of the lab by the Centers for Medicare and Medicaid Services is underway, Egel said.

Documents released on Monday show the state released a report to the lab in April highlighting major and widespread issues that state investigators say threaten the accuracy of tests performed at the Valencia lab. Among the findings of the February inspections, the lab failed to assess the skills of more than half of its staff before allowing them to independently process, test and report patient samples. The lab responded that all employees had received the required training, but there had been a delay in documenting this training.

State investigators also said the Valencia lab did not have a policy in place outlining how to release corrected results, and state investigators found the lab changed test results days after patients were initially informed without informing them of the changes, based on the month of April. report. When the lab lost or damaged a sample, it blamed the situation on an “unsatisfactory sample,” state investigators wrote in April.

The state’s public health department issued letters in February and April asking lab director Adam Rosendorff to correct the flaws, writing that state investigators “determined that your lab’s flawed practices immediately put at risk. patient health and safety ”.

The state has threatened to sanction the lab and Rosendorff, who is the former lab director of failed blood testing startup Theranos. Rosendorff is a key prosecution witness in the criminal trial of the former CEO of that company, Elizabeth Holmes.

State officials have vowed to release a full report in mid-March on the problems the Valencia lab is facing, with lawmakers criticizing the Newsom administration for the blockage as the state’s contract with PerkinElmer was due be renewed.

Some critics questioned whether the investigation could remain impartial since the state was primarily investigating its own laboratory. The public health department’s field laboratory services operate independently, said Engel, the spokesperson for the department.

The Newsom administration released its report on Monday, which largely downplayed the problems the lab faces, calling the shortcomings those “found routinely during lab inspections,” and said every problem had been corrected. The report says the California public-private lab is a model other states should emulate.

“The regulatory process worked as intended, addressing the identified deficiencies and holding the laboratory operator accountable – ensuring that the integrity of the tests processed in that laboratory is not affected and that high standards are maintained.” Dr Tomás Aragón, director of the state health ministry, said in a statement.

The report touted the lab’s accomplishments, saying it has helped increase testing in high-risk communities and to date has processed more than 5.5 million samples from churches, schools, clinics, essential workplaces and other sites.

The lab has processed 10% of all tests done in the state in the past few weeks.

The state’s contract with PerkinElmer states that California pays for tests based on the number processed. The report says the cost is $ 55 per test for community and employer programs and $ 21 for school-based testing.

To date, the state has paid PerkinElmer $ 716 million, of which $ 684 million has been reimbursed to the state by the Federal Emergency Management Agency.

In October 2020, Newsom visited the newly built facility in Valencia which he said would create 700 new jobs in Southern California when it reaches full capacity. State officials said the lab was built to ensure adequate testing in schools, for healthcare providers and in hard-to-reach communities using diagnostic polymerase chain reaction tests, or PCR.

“Earlier in this pandemic, our ability to test Californians for COVID-19 and get results quickly was hampered by supply chain challenges and overwhelmed labs – so we built our own supply chain. and our own lab with PerkinElmer, ”Newsom said in a statement that October.

The state’s contract with PerkinElmer requires the lab to have a 24- to -48-hour test turnaround, which public health officials say is critical to limiting the spread of COVID-19 allowing for timely tracing and quarantining of contacts.

State data shows that the Valencia lab processed nearly 161,000 tests during the week of November 7 to 13, of which 66% got results in one day and 30% in two days. By comparison, commercial labs have processed over a million tests, with 78% of those results being returned within one day and 18% within two days.

But the Valencia laboratory has fallen behind in the face of higher demand. Between Sept. 26 and Oct. 2, when the lab processed nearly 233,000 samples, a third of the results took more than three days to process, according to state data.

State officials said building laboratory capacity is essential and will help prepare for future infectious disease outbreaks.

“California seized the opportunity to leverage its people, innovation and diversity to not only expand laboratory testing capacity, but also the availability of sample collection sites in neighborhoods that have been disproportionately affected by the COVID-19 pandemic, ”the state report says.

Not all news on the site expresses the point of view of the site, but we transmit this news automatically and translate it through programmatic technology on the site and not from a human editor.