State Inspections Confirm Whistleblower Allegations At Troubled California COVID Lab

SACRAMENTO (CBS13) - The California Department of Public Health (CDPH) released its long-overdue report on state inspections of California's troubled COVID testing lab, following a CBS13 whistleblower investigation. Inspectors confirmed the whistleblowers' allegations and found the lab "pose(d) immediate jeopardy to patient health and safety."

Along with inspection records released Monday, CDPH issued a summary that downplayed the findings and misconstrued some whistleblower allegations. However, the actual inspection records tell a very different story.

Lab inspectors issued scathing reports following the state's routine initial inspection and the whistleblower complaint investigation. Both inspections found the lab "caused, is causing, or is likely to cause, at any time, serious injury or harm, or death" to Californians.

Instead of pausing testing or warning the public, the state allowed the lab to continue processing patient samples and concealed the risks as problems continued for at least six months and the lab began contracting with schools across the state.

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 properly report delayed results. Their contract mandates a 48hr testing turnaround time.
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.

*Note this is a partial list of deficiencies, failures and patient dangers that may be updated as we continue to review inspection records.

During the Feb 7th surprise inspection, prompted by the whistleblower complaints, inspectors confirmed the allegations and found problems so egregious that they were forced to notify federal regulators, stating in a notice:

"Because of the seriousness of these deficiencies, your laboratory no longer meets the requirements to perform testing under the Health and Safety Code. Based on the finding of immediate jeopardy, this office has contacted the Centers for Medicare & Medicaid Services (CMS), and has notified them of our determination of non-compliance.

Two weeks later, CDPH and PerkinElmer claimed the "serious deficiencies" had "long since been resolved." We now know that simply wasn't true.

Not surprisingly, the agency did not issue sanctions against its own lab Monday. Instead, in its summary of the investigation, CDPH concluded, "(t)his blueprint can serve as a model for other states, and the federal government, in how to scale testing."

If it weren't for brave whistleblowers risking their careers in the name of public health, the public may never have learned of these shocking public health failures at California's COVID testing lab.

UPDATE: WATCH THE CBS NEWS SACRAMENTO
SPECIAL REPORT

THE COVID LAB: State Secrets Exposed

https://youtube.com/playlist?list=PLa9rnaEtSHWXFoG1pAj1CiNilb7n4mdjH

The Whistleblowers

It began with one whistleblower and quickly grew to more than a dozen whistleblowers with allegations and evidence of shocking public health dangers at the state's COVID lab that, they said, the state tried to hide.

Unlicensed lab techs asleep while processing COVID samples, test swabs found in lab restrooms, incidents of contamination, swapped samples, and tens of thousands of inconclusive COVID tests were just the first of many shocking revelations from inside California's $1.7B COVID testing lab, which was built at the taxpayers' expense.

ALSO READ: Questionable COVID Results – More Concerning Whistleblower Allegations From State COVID Lab

In February, the state initially denied the whistleblower allegations and called our reporting "irresponsible journalism." State regulators later changed their response.

We later learned that state inspectors already knew about problems at the lab and previously found "significant deficiencies" during a preliminary licensing inspection, months before our initial reports.

ALSO READ: CA's Billion-Dollar COVID Testing Lab Under Investigation Following CBS13 Whistleblower Report

Immediate Jeopardy to Patient Health and Safety

Records released Monday confirm deficiencies at the lab continued for months and "pose(d) immediate jeopardy to patient health and safety."

According to the February 7th complaint inspection, prompted by the whistleblower allegations, inspectors found that the "laboratory's non-compliance" had "already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public."

Yet public health officials and the Newsom administration continued to downplay problems at the lab and failed to warn the public about the possible risks as COVID cases and deaths peaked.

Problems Continued

It wasn't until weeks later, after our fourth report exposed that the lab's COVID test was no longer FDA authorized, and lawmakers pressed the state for answers, that state health officials finally acknowledged deficiencies at the lab in a February 22nd press release.

In February, both state regulators and PerkinElmer insisted the problems had "long since been resolved".

Monday's report indicates that was not true.

ALSO READ: Regulators Find 'Significant Deficiencies' At CA COVID Testing Lab – Whistleblowers Respond

In fact, inspectors issued a "Notice of Intent to Impose Sanctions" in October, when the lab had still failed to correct the issues, ten days before CDPH renewed its $1.7B COVID lab contract with PerkinElmer.

As we've reported, ongoing deficiencies continued to have significant impacts on the Californians relying on those COVID test results.

A Flawed Test?

The report confirmed the whistleblower allegations that management repeatedly made changes to the lab's COVID test, thereby voiding the FDA Authorization that is outlined in the $1.7B COVID lab contract. Inspection records indicate that the lab was using the test on patients, for months, without properly validating the test to confirm the results were accurate.

ALSO READ: 'Inconclusive' Results Should Be 'Reported as Positive' – State COVID Test Not FDA Authorized

Investigators also confirmed the whistleblower allegations that when the lab made errors, and later had to correct a result, they did not immediately notify the patient of the new result.

As whistleblowers stressed, people who received a negative test result, but were positive for COVID, may have been unknowingly infecting others, and people who were negative, but received a positive test result, may have been unnecessarily quarantined, preventing them from being able to work.

"Destruction of Documents and Data"

In its summary of the report, the CDPH said, "inspectors were not able to substantiate the local media outlets reporting that there was the destruction of documents and data," presumably referring to our reports.

Except, we didn't report that.

ALSO READ: CA's Billion-Dollar COVID Testing Lab Under Investigation Following CBS13 Whistleblower Report

We reported that "employees were told to come in to the lab [on] Super Bowl Sunday, to alter competency records" ahead of our initial report which was scheduled to run after the February 7th Super Bowl on CBS.

PerkinElmer had denied the allegations that hundreds of employees did not have documented competency, which is required by law.

Shortly after we sent additional evidence to CDPH that day, whistleblowers warned us that managers were being called in, during the Super Bowl, to alter competency records ahead of our report.

We later received an email confirming that managers were, in fact, called in during the Super Bowl to address the records "since this became even more urgent," a manager said in the email. However, Whistleblowers said they were unable to alter the records after we warned CDPH.

Inspection records now confirm the competency allegations. Inspectors found roughly half the lab's employees did not have documented competency

Questionable Records

Inspectors also found that lab employees were effectively concealing lab errors by classifying lost or damaged samples as "unsatisfactory samples." Incidentally, state data indicates the lab's "unsatisfactory samples" more than doubled since August.

The state has at least five categories of samples that do not return clear results:

Unsatisfactory - Samples that can't be tested due to the quality of the sample itself
Lost - Samples that can't be tested due to lab accidents or errors
Invalid - Problems with the test itself (Internal control failures)
Canceled- Samples processed by the lab after 96hrs or that arrive without an order.
Inconclusive - The test detects very low levels of virus
(*reported to patients as presumptive positive)

ALSO READ: 'Inconclusive' Results Should Be 'Reported as Positive' – State COVID Test Not FDA Authorized

Back in February, when we reported on tens of thousands of inconclusive covid results, Health Secretary Ghaly downplayed the number of the flawed tests by focusing on other categories. We later learned many of those "inconclusive results" had also been miscategorized and were actually "invalid" meaning there was a problem with the test's internal quality control.

Ghaly said, at the time, that there had only been 60 wrong results, which he referred to as "corrected reports," and 250 lost samples that couldn't be tested due to lab errors. But the Health Secretary failed to acknowledge all the "inconclusive," "invalid" and "canceled" samples, in addition to those reportedly miscategorized as "unsatisfactory samples."

ALSO READ: Regulators Find 'Significant Deficiencies' At CA COVID Testing Lab – Whistleblowers Respond

As of August, there were more than 44,000 invalid, lost or canceled samples combined, according to previous data provided by CDPH.

That's in addition to another 44,000+ inconclusive/presumptive positive results, which is the designation given by the lab when PerkinElmer's highly sensitive test identifies very low levels of virus.

As of August, one out of every 42 tests processed at the lab did not return a clear positive or negative result - and that doesn't include "unsatisfactory samples" that may have been miscategorized.

287 Days - And Problems Continue

The Newsom administration continues to downplay problems at the lab. Despite the blatant public health failures, the state characterized these violations of federal law as deficiencies "which are routinely found in laboratory inspections."

Laboratory experts we've consulted dispute that assertion.

In response to the report, Senate Republican Leader Scott Wilk (R-Santa Clarita) released the following statement:

"It should not have taken 287 days for Californians to receive answers about this taxpayer-funded COVID testing lab. Especially when our vulnerable students are the ones at-risk. Parents and families deserve accountability and transparency from the Newsom Administration. The allegations exposed in February were troubling to say the least – swapped samples, inaccurate results, contamination, and beyond. Not to mention, private labs are producing the same results at a reduced cost. Looks like we can add this to the list of the times Newsom has failed to 'meet the moment.'"

As Wilk notes, according to the state, more than 1,600 schools are using the lab for COVID-19 testing. As we've reported, many students have struggled with false-positive results and unnecessary quarantines due to problems at the lab.

ALSO READ: Are False Positives or Sensitive Tests Responsible For School COVID Spikes?

While the lab's testing turn-around time has improved this month, in September, the lab returned between one-third and two-thirds of COVID results in more than 48 hours and was among the slowest COVID labs in the state.

The CDPH-PerkinElmer lab's turnaround time was nearly twice the state average for much of October.

Accountability Continues

The report, which was supposed to be released eight months ago, was released late Monday afternoon ahead of the Thanksgiving Holiday. CBS13 is still reviewing the documents and will have much more in the coming days as we dig into this report.

ALSO READ: Theranos Trial Reveals Details of Federal Investigation at Troubled CA COVID Lab, No-Bid Contract Renewed

Notably, court records reveal that federal inspectors also found "serious deficiencies" at this lab, ranging from inaccurate test results to quality control failures and test validation problems.

The state's COVID lab director testified last month that his license was in jeopardy due to deficiencies at the state lab. The federal investigation is reportedly ongoing.

**NOTE: This story will be updated with additional information and links as we continue to review the inspection documents.

(Last updated 11/25/21)

THE COVID LAB: State Secrets Exposed

The Whistleblowers

ALSO READ: Questionable COVID Results – More Concerning Whistleblower Allegations From State COVID Lab

ALSO READ: CA's Billion-Dollar COVID Testing Lab Under Investigation Following CBS13 Whistleblower Report

Immediate Jeopardy to Patient Health and Safety

Problems Continued

ALSO READ: Regulators Find 'Significant Deficiencies' At CA COVID Testing Lab – Whistleblowers Respond

A Flawed Test?

ALSO READ: 'Inconclusive' Results Should Be 'Reported as Positive' – State COVID Test Not FDA Authorized

"Destruction of Documents and Data"

ALSO READ: CA's Billion-Dollar COVID Testing Lab Under Investigation Following CBS13 Whistleblower Report

Questionable Records

ALSO READ: 'Inconclusive' Results Should Be 'Reported as Positive' – State COVID Test Not FDA Authorized

ALSO READ: Regulators Find 'Significant Deficiencies' At CA COVID Testing Lab – Whistleblowers Respond

287 Days - And Problems Continue

ALSO READ: Are False Positives or Sensitive Tests Responsible For School COVID Spikes?

Accountability Continues

ALSO READ: Theranos Trial Reveals Details of Federal Investigation at Troubled CA COVID Lab, No-Bid Contract Renewed

The Whistleblower Investigation

The Troubled Test

Continued Accountability

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