SACRAMENTO (CBS13) – State Senate Republican Leader, Scott Wilk, is demanding answers from the Department of Public Health following an ongoing CBS13 investigation into shocking public health failures at the state’s $1.7 billion COVID testing lab.

Following CBS13’s initial whistleblower investigation, the state said it would make its investigation public by mid-March. Now, seven months later, the state says “the investigation is ongoing” as problems continue at the lab and the  $1.7 billion no-bid lab contract is set to renew at the end of the month. 

The contract with PerkinElmer requires the lab to return COVID results in 24-48 hours and process up to 100,000 tests per day. But now at its peak, the lab is processing about a quarter of that and is ranked among the slowest COVID labs in the state.

According to CDPH, more than 1300 schools and districts are now contracted with the lab, which has a history of school quarantines linked to false positive and delayed results.

State Secrets

After CBS13 exposed tens of thousands of inconclusive COVID tests coming out of the state’s new lab late last year, more than a dozen whistleblowers came forward to expose what, they said, the state was trying to hide at the taxpayers’ expense.

ALSO READ: Asleep At the Lab: Whistleblower Allegations From Inside CA’s Billion-Dollar COVID Lab

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

Unlicensed lab techs watching videos and sleeping while processing COVID samples, test swabs found in lab restrooms, incidents of contamination, swapped samples, and wrong results — those were just the first of many troubling allegations from whistleblowers inside the state’s COVID lab. 

The California Department of Public Health (CDPH) initially denied the allegations, calling our reporting irresponsible. However, they quickly changed their response.

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

The state later acknowledged that their own CDPH inspectors found “significant deficiencies” at the lab months earlier. CDPH said the lab had until March 1st to respond and address the deficiencies.

According to the state, the lab was facing an “immediate jeopardy” designation at the time of the initial whistleblower reports. “Immediate Jeopardy” denotes “the most severe and egregious threat to the health and safety.”

However, CDPH failed to reveal this to lawmakers or the California taxpayers who were paying for the lab and relying on its COVID results.

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

It wasn’t until after CBS13 exposed the problems, months after state inspectors first identified the “significant deficiencies,” that CDPH finally acknowledged issues at the lab.

They still haven’t revealed what those “significant deficiencies” were.

Compromised Samples & Questionable Results 

When the state finally issued this February press release, weeks after the first whistleblower reports, the California Health and Human Services Agency (CHHS), the state’s top health agency which oversees CDPH, downplayed the problems.

CHHS said, at the time, that there had only been 60 wrong results, which they referred to as “corrected reports,” and 250 samples that couldn’t be tested due to lab errors. But the press release failed to acknowledge all the “inconclusive,” “invalid” and “canceled” samples in addition to the 250 samples that were “lost” due to lab errors.

The state has at least three categories of samples that do not return results for reasons ranging from problems with the test itself (invalid) to samples that have been misplaced (canceled). There have now been more than 44,000 invalid, lost or canceled samples combined, according to 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.

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

ALSO READ: Same COVID Test, Different Results: FDA Looking Into State Lab ‘Test Result Concerns’

Infectious disease and lab exerts say those low levels are often due to previous infection or contamination. The CDPH lab has a much higher rate of inconclusive results than other labs in the state.

As of August, the state’s own data reveals roughly one out of every 42 samples fell into one of those categories and did not return a clear positive or negative result. That does not include another 20,000 “unsatisfactory samples.”

Test Result Delays 

The state’s contract with PerkinElmer requires the lab to return COVID results within 48 hours, however the lab currently has one of the slowest COVID testing turnaround times out of more than 120 California COVID testing labs.

According to the state’s COVID Testing Turnaround Time dashboard, the CDPH-ParkinElmer COVID lab, known as the Valencia Branch Lab (VBL), has returned between one-third and two-thirds of its recent COVID results in more than the mandated 48 hours.

CBS13 has heard from viewers from across the state who say they’ve been unable to travel, work, go to school and see loved ones in nursing homes due to delayed results from the lab. Proof of a negative COVID test is becoming an increasingly common requirement, even for people who are vaccinated.

ALSO READ: Delayed School COVID Results, Canceled Games and Contamination Concerns 

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

In addition to processing individual test results for the public, the lab has contracts to process tests for more than 1,300 schools and districts.

As CBS13 first reported in May, schools have struggled with delayed results and false positives from the state lab, which led to healthy kids being unnecessarily quarantined for weeks.

CBS13  obtained internal emails which revealed “a contamination issue” at the lab shortly before a spike in school false positives. 

The Missing March Investigation Report 

Following the initial reports, the state vowed to make it’s investigation public by mid-March. In a May interview with CBS13, the Governor implied it already was. 

However, his public health officials refuse to release it, citing an “ongoing investigation,” a response that they’ve also used to deny CBS13’s related public record requests.

CHHS, did provide CBS13 with one internal email related to our request for an interview with Health Secretary Ghaly. However the agency redacted every single word

Secretary Ghaly has denied every interview request from CBS13 even after the Governor himself stated during a public press conference that Ghaly would answer our questions. 

ALSO READ: Continued Accountability: Delayed Investigation Report, Denied Interview Requests 

In Senator Wilk’s letter to Dr. Ghaly, the Republican leader details how lawmakers have also struggled to get answers from CDPH. Wilk’s district includes Valencia, where the state’s lab is located.

Wilk’s letter asked Dr. Ghaly to provide a concrete date for the final public report.

CDPH tells CBS13, “Unless the $1.7 billion contract is terminated, it will auto-renew under the same terms” at the end of the month.

Meanwhile, whistleblowers are urging lawmakers to commission an independent investigation, noting that CDPH is the regulator and investigator of its own state lab.

FOLLOW OUR CONTINUING COVERAGE:

CBS13 Investigates Problems at California’s COVID Testing Lab

ALSO READ: Asleep At the Lab: Whistleblower Allegations From Inside CA’s Billion-Dollar COVID Lab

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

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

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

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

ALSO READ: Same COVID Test, Different Results: FDA Looking Into State Lab ‘Test Result Concerns’

ALSO READ: CBS13 Investigates: Should Rapid Test Be Used To Test School Athletes?

ALSO READ: Delayed School COVID Results, Canceled Games and Contamination Concerns 

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

ALSO READ: Continued Accountability: Delayed Investigation Report, Denied Interview Requests 

 

Julie Watts