The California Department of Public Health closed the investigation for complaints filed against the PerkinElmer COVID-19 laboratory this month without imposing sanctions, following the release of the long-awaited investigative report regarding the Valencia lab, eight months overdue.
PerkinElmer, a Massachusetts-based diagnostics company, was tasked with increasing California’s daily COVID-19 tests by 150,000 via a no-bid contract with the state at the 134,287-square-foot industrial building on Livingston Avenue late last year.
However, a review of the lab conducted by the state Public Health Department’s Laboratory Field Services earlier this year uncovered thousands of inconclusive or erroneous test results, among other issues, ultimately giving the lab an “immediate jeopardy” designation — which is reportedly “the most severe and egregious threat to the health and safety of recipients,” according to the oversight group.
Laboratory inspectors reportedly found significant deficiencies during a routine inspection process in February, with the state calling for the lab to not only address all of the issues but also go through an independent inspection and accreditation process with the College of American Pathologists.
While the lab received its full accreditation in March, the final report, which had been scheduled to be made public by mid-March, was not released.
For the last couple of months, state Sen. Scott Wilk, R-Santa Clarita, has continued to put pressure on the California Health and Human Services Agency to release the report, calling for Gov. Gavin Newsom to be held accountable for its failings.
Then, just 10 days before the lab’s $1.7 billion contract was quietly auto-renewed on Nov. 1, the LFS issued a “Notice of Intent to Impose Sanctions” letter to the Valencia lab, stating that the lab was not in compliance with requirements after it had failed to remove all deficiencies.
But after receiving evidence from the lab indicating they’d corrected the remaining deficiencies, the state withdrew its threat of sanctions before finally closing the complaint investigation and releasing the long-overdue report Monday.
“I think it’s pretty clear when you dig into the details of the report that they’ve known for a long time of the inefficiencies and just honest failings of the program, and I believe that they delayed it because of the recall,” Wilk said during a phone call with The Signal Tuesday. “What’s really disappointing about it is this is a no-bid contract that Gov. Newsom awarded that… wasn’t meeting expectations, and yet, was automatically renewed rather than doing the right thing.”
The newly released documents detail the various interactions between the state and lab over the past few months, when the state’s “examiners determined that the deficient practices of (the) laboratory pose immediate jeopardy to patient health and safety,” according to the original complaint investigation issued in April.
Among the issues discovered during the February inspection were that the lab failed to assess the competency of approximately 55% of its staff prior to allowing them to process, test and report patient samples, and that the lab had no policy on how to issue corrected results following errors.
The lab reportedly responded to these issues and others, contending that employees were trained as required, attributing the error to a delay in documenting the training.
“The regulatory process worked as designed, addressing the identified deficiencies and holding the laboratory operator accountable — ensuring that the integrity of tests processed at this laboratory were not impacted and high standards were maintained,” Dr. Tomás J. Aragón, CDPH director and state public health officer, said in a prepared statement.
The state’s report noted that after multiple visits to the laboratory and numerous correspondences, the lab had “immediately worked to clarify… and implement improved process,” characterizing the deficiencies as those “routinely found in laboratory inspections.”
“All deficiencies were addressed and there was no impact to the integrity of the tests processed at the laboratory,” the LFS report stated.
PerkinElmer released a statement to The Signal following the report, noting that since November 2020, the company has worked closely with the state to provide testing via the Valencia lab, performing tests on samples from a network of more than 2,000 specimen collection sites established in collaboration with churches, schools, clinics, essential workplaces, congregate settings and community-based organizations.
“We have worked with LFS to clarify our practices and, where appropriate, implement improved processes and documentation to address any and all concerns by LFS,” read the PerkinElmer statement. “As a result of these efforts and our work with LFS, we are pleased to say that LFS has recently informed us that the (Valencia lab) is in full compliance with state laws and regulations governing clinical laboratories. 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 state’s report also went on to laud the lab’s work through the pandemic, which reportedly allowed increased testing in communities at high risk for contracting COVID-19, such as essential workers, those in congregate care settings and in communities of color.
Roughly 62% of tests performed at the Valencia lab are among racial minorities, with 32% in the most disadvantaged neighborhoods based on the California Healthy Places Index, per the state report.
The state Public Health Turnaround Time Dashboard, which reports testing turnaround times for all the state’s labs, showed that more than half, or 60%, of the Valencia lab’s tests took two or more days to complete, whereas a majority of other labs were making a 24-hour turnaround, according to data from Oct. 10-16.
Most recent data from Nov 7-13 shows the Valencia lab has improved, processing 66% of the week’s more than 160,000 tests within 24 hours and 30% within 48 hours.
The Valencia lab processed nearly 10% of the state’s 1.6 million tests during that time frame. However, comparatively, commercial labs, which processed more than 1 million tests, or approximately 66% of those tests, had returned 78% of results within 24 hours and 18% within 48 hours.
“Along with widespread vaccination, testing availability remains critical to California as the state looks to regain some sense of normal life again,” the LFS report reads. “Reliable, timely and cost-effective test results are critical to allowing schools and many businesses to reopen and stay open with confidence as we continue to closely monitor the prevalence of COVID-19 in California.”
