Lab Experts Criticize State's Response To Risk Of 'Serious Injury, Harm or Death' At CA COVID Testing Lab
SACRAMENTO (CBS13) — Lab experts are speaking out, shocked that the state allowed its billion-dollar coronavirus testing lab to continue operating for nearly a year while putting public health at risk. This comes after the state finally released its investigation into "significant deficiencies" at California's COVID testing lab, which was prompted by a CBS13 whistleblower investigation.
Experts point out that inspectors did confirm the whistleblower allegations. In two separate reports (here and here), inspectors found that the CDPH-PerkinElmer Valencia Branch (VBL) lab was putting patient health and safety in "immediate jeopardy" and that lab practices were "likely to cause, at any time, serious injury or harm, or death."
However, the California Department of Public Health (CDPH) claimed in its summary of the investigation, that inspectors found deficiencies that "are routinely found in lab inspections" and that they had "no impact to the integrity of the tests processed at the laboratory."
Lab experts say the inspector's reports clearly contradict the CDPH's claims.
The link to the actual inspection records was buried at the bottom of the state's 10-page "issue brief", in which the state did not mention any of the specific risks to public health that are detailed in the inspectors' reports.
Those reports indicate that the lab failed to correct the deficiencies for at least nine months, asking for repeated extensions and meetings with inspectors as they struggled to bring the lab into compliance while continuing to process patient samples. Yet, the state never paused testing or warned the public, which experts say is "unheard of."
Inspection records confirm whistleblower allegations that:
- Lab practices "pose(d) immediate jeopardy to patient health and safety."
- When the lab discovered it reported wrong results, it did not immediately notify patients.
- There were widespread contamination concerns.
- Roughly half the lab's employees did not have documented competency.
- Lab errors were effectively concealed by miscategorizing errors as problems with the sample.
- The lab voided PerkinElmer's FDA Emergency Authorization by repeatedly making unauthorized changes to the test.
- The lab used its version of the test on patients for months before properly validating that the results were accurate.
Records also reveal:
- Inspectors found that lab director, Dr. Adam Rosendorff, was not qualified to run the lab "based on the severity of deficiencies" found. Rosendorff is the former lab director of Elizabeth Holmes' disgraced finger-stick blood-testing company, Theranos.
- "The lab did not always document delayed test results when tracking Testing Turnaround Times (TAT), which are published by the state. The lab's $1.7B contract mandates a 24-48hr TAT.
- Deficiencies had not been corrected months after CDPH and the Newsom Administration claimed that they were "resolved."
- The lab continued to face sanctions in October, ten days before its $1.7B state contract was renewed.
Lab Experts Respond
Tim Hamill, a former chair of the state's Clinical Lab Technology Advisory Committee (CLTAC) was surprised that the state did not, at least, pause testing until the problems were fixed in light of the number and severity of the deficiencies found at the lab.
"I've never inspected a lab that had this many problems," said Hamill, adding that, contrary to the state's claims, deficiencies like these are not "routinely found" to this magnitude.
"Until the lab is ready to turn out a consistently quality test, they shouldn't have started," he said.
"Any other laboratory would have been shut down" added Dora Goto, a voting member of CLTAC and the Governmental Affairs chairperson for the California Association for Medical Laboratory Technology (CAMLT).
They are among many in the licensed laboratory community who are concerned that the state's $1.7B coronavirus testing lab was allowed to continue processing patient samples while failing to correct deficiencies—for nearly a year—without revealing the risk to patients.
"That's not how laboratories are supposed to operate in the United States," Hamill said.
Goto explained, "the deficiencies listed in the Feb 7 (whistleblower) complaint inspection were so egregious that CDPH found the lab posed immediate jeopardy to patient health and safety. As such, the lab should have been ordered to cease and desist until the deficiencies were corrected."
Instead, she noted, the lab continued to operate at the same time it was making changes to correct the deficiencies, that weren't fully corrected for at least 9 months.
"I'm not aware of any other laboratory that received this kind of preferential treatment," Goto said.
In February, inspectors found that roughly half the lab's staff did not have documented competency or training, which confirmed whistleblower allegations that CDPH initially denied.
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Inspectors also confirmed whistleblower allegations of contamination concerns, that the lab reported incorrect results but waited to notify patients, and that the lab was effectively hiding the extent of "lab accident (s) or errors" by misclassifying samples that couldn't be tested.
However, records indicate that inspectors knew about one of the most concerning allegations before whistleblowers reported it.
Fixing A Flawed Test
In February, whistleblowers reported that the lab was repeatedly making changes to its FDA authorized test, in an effort to troubleshoot errors and concerns, while continuing to process patient samples. Whistleblowers warned that the changes voided the FDA's Emergency Use Authorization (EUA) for the PerkinElmer test and compromised patient results.
For weeks the state denied this, claiming its test was "approved by the FDA" and claiming that PerkinElmer did "not need approval from the FDA" to make changes. The FDA disagreed and confirmed to CBS13 that the changes did void the FDA Emergency Use Authorization (EUA) for the PerkinElmer covid test.
Only after we shared that response with the state, did CDPH finally admit the lab was using its own Lab Developed Test (LDT) which was not authorized by the FDA. CDPH claimed it "mistakenly said" its test was FDA approved. Repeatedly. For weeks.
PerkinElmer's $1.7B contract required that they use the FDA Authorized (EUA) test. After our report, the state amended PerkinElmer's contract to allow for, what's called, a lab-developed test (LDT),
But under federal law, an LDT must undergo an extensive validation process to confirm accuracy and reliability before it is used on patients. Whistleblowers said that didn't happen and records reveal that state inspectors knew about it -- months before CDPH's denials.
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In December, inspectors found that the lab failed to follow the FDA's authorized procedures for the test and that they failed to properly validate their testing changes for accuracy, before reporting patient results.
"If a test is not validated, it is considered experimental," Goto explained. "The patient should be aware and needs to agree."
Yet the state claimed to us, and on patient results, that the test was validated while the lab was struggling to properly validate its test for at least 9 months.
"That was appalling," said Goto.
The state never warned the public and didn't pause testing, even as the lab was secretly facing sanctions in October, just days before CDPH renewed the $1.7 billion dollar contract with PerkinElmer to continue running the lab.
"I would say thanks to the whistleblowers," Hamill said, adding that he thinks they did a "great service to the people of California."
"I've got to believe, or hope, that the laboratory is a better laboratory now because of what the whistleblowers did," Hamill noted.
Attempting to Discredit Whistleblowers
The CDPH summary appears to discredit whistleblower allegations stating, "inspectors were not able to substantiate the local media outlets reporting that there was the destruction of documents and data," which presumably refers to our reports.
Except, CBS13 didn't report that.
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We reported that "employees were told to come in to the lab [on] Super Bowl Sunday, to alter competency records" after PerkinElmer denied allegations that day that hundreds of employees did not have documented competency and training.
CDPH and PerkinElmer claimed in an email on Super Bowl Sunday that, "No employee without sign-off competency is running samples."
We had records that contradicted that claim. A short time later, whistleblowers warned us that staff was being called in, during the Super Bowl, to alter those records.
Internal emails later confirmed that managers were called in shortly after they denied the competency issues, "since this became even more urgent," a manager said in the email.
After emailing CDPH on Super Bowl Sunday, we clarified and discussed the alleged plans to alter competency records at length on a phone call with CDPH that afternoon.
Inspectors arrived that evening and ultimately found that roughly half the lab's employees did not have documented competency or training, contrary to CDPH's initial denial.
It's not clear if a different media outlet reported the allegations of "destruction of documents and data" that CDPH refers to in their summary or if they are mischaracterizing our reports. CDPH has not yet responded to our request for clarification.
Contradictions
In its summary, CDPH concluded that the blueprint for its lab "can serve as a model for other states, and the federal government, in how to scale testing that is both accessible and equitable."
However, experts note the potential for severe consequences to public health, due to delayed and wrong results, if others attempt to duplicate this model of a rushed lab with inexperienced staff and an un-validated test -- further exacerbating "long-standing health inequities in low-income, minority, and rural communities," which CDPH said this lab was intended to serve.
Many point out that an inaccurate COVID test result can be a greater threat to public health than no COVID test at all.
When asked about CDPH's claim that "there was no impact to the integrity of the tests processed at the laboratory," Goto replied, "That would be impossible." "You just can't make a statement like that," she said. "It makes no sense."
She points to the clear findings of "immediate jeopardy to patient health and safety," "likely to cause serious injury, harm or death."
Hamill added, "This was not just an, 'Oops, we made a minor mistake that didn't harm any patients.'"
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It appears inspectors agreed. They chastised the lab director in this letter for downplaying the lab's risk to public health, noting, " there is no acceptable error rate for false-negative results for a highly transmissible viral infection."
When we asked the inspectors, during a public meeting, about the discrepancy between the findings in their inspection reports and what the state said in its public summary, their chief, Bob Thomas, said they couldn't comment on the summary that CDPH published.
"I will stand behind my team's report," Thomas said.
CBS13 has asked CDPH to reveal who wrote their public summary of the inspections, that lab experts call misleading.
We've also asked the state if it can provide an example of any other clinical lab that:
- Received an "Immediate Jeopardy" designation
- But was allowed to continue processing patient samples
- While failing to correct the Immediate Jeopardy deficiencies for (more than) 9 months
- And, while using an unvalidated LDT on patients without notifying them that it was experimental and no longer FDA authorized?
We have not received a response.
(This story was last updated on 12/6/21)