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

SACRAMENTO (CBS13) — One day after a CBS13 investigation revealed shocking whistleblower allegations from inside California's billion-dollar COVID testing lab, state regulators launched an investigation of their own.

Investigators are now inside the California Department of Public Health-PerkinElmer COVID testing lab following allegations from more than a half dozen whistleblowers. However, the state's initial response to the allegations is raising more questions.

Whistleblower Allegations 

In our initial investigation, which aired on Super Bowl Sunday, whistleblowers provided evidence of systemic problems inside the state lab.

The evidence ranged from photos of unlicensed lab techs watching videos and literally sleeping while processing nasal swabs for testing, to emails indicating unsupervised staff were processing patient samples before completing required training modules or getting signed-off for competency, which is required by law.

"When they don't have enough training, they don't know that what they're doing is wrong," a whistleblower told CBS13.

New Evidence

Then, this weekend, ahead of the scheduled report, CBS13 obtained dozens of additional quality control reports describing incidents of contamination, swapped samples, and repeated errors that, whistleblowers say, could impact patients' test results.

We also received new evidence related to staff competency requirements including a copy of the lab's "competency tracker" database. It indicated there were hundreds of lab employees that had still not been signed off for competency, in one or more areas, as of the end of January.

These are internal records that CDPH, as the state regulator and the lab partner, should have been aware of and reviewing.

CBS13 had been asking CDPH for responses and explanations regarding various lab concerns for months.

A Warning - And An Updated Response

Two hours after we asked the state about the new evidence on Sunday, we received shocking new allegations from whistleblowers.

They alleged that employees were told to come into the lab that day, Super Bowl Sunday, to alter competency records, citing the "CBS report."

We immediately notified CDPH again and copied the Governor's office in hopes that the agency would step in and prevent potential wrongdoing.

In response, CDPH called the allegations outrageous and unsubstantiated, accusing CBS13 of irresponsible journalism.

Then, less than four hours later, we received a very different response from Kate Folmar, a spokeswoman for the California Health and Human Services Agency (CHHS), which oversees CDPH.

It read:

"We are troubled by these allegations against our laboratory vendor and its employees and will investigate them immediately and thoroughly. If these claims are substantiated, they would represent a clear violation of our existing agreement with PerkinElmer and we would take swift action to fix these issues, up to and including termination of the contract.

"This lab was established by the state to provide accurate test results for the people of California as quickly as possible."

We included the new response in our story Sunday night but we wanted to understand what prompted it.

CONTINUING COVERAGE: CBS13 Investigates Public Health Failures at California's COVID Testing Lab

The Long-Awaited Interview 

After three months and dozens of requests for an interview with someone from the lab or CDPH, Folmar agreed to speak with CBS13 on Monday, on behalf of the state.

"Obviously, we take these allegations of wrongdoing at the lab we run with our vendor, PerkinElmer, very seriously," Folmar said.

She said the state had deployed a team of state laboratory experts to investigate the allegations and she pointed to "strong language" in the state's contract with PerkinElmer that protects "both the state and the taxpayers."

We wanted to know what action the state took on Sunday, after our warning, to ensure lab documents were not altered ahead of that investigation.

"Did the state send someone there to make sure that didn't happen?" Investigative Reporter Julie Watts asked.

"Julie, I'm not going to speculate on things," Folmar said.

"Are you concerned documents might have been altered yesterday?" Watts pressed.

"Julie, I'm not going to speculate on documents that you say you have that I haven't seen," Folmar said.

Again, as the state regulator and lab partner, CDPH should have already seen all of the documents we have seen. Throughout the five-minute interview, Folmar declined to answer most of our questions.

"Are there currently CDPH employees working inside the lab?" Watts Asked.

"You know, I'm not privy to all of the details of the lab, so I'm going to let our investigators do their work and then I'll get back to you," she responded.

"My understanding is that there was a CDPH Director there who recently resigned," Watts clarified.

"Julie, I'm not privy to all of those details. What I can tell you is that we're taking these allegations very seriously and making sure that we have laboratory experts there to investigate," Folmar responded.

CDPH sent an email shortly after the interview stating the lab initially had two part-time CDPH laboratory co-directors, but for "improved efficiency" they now have one full-time PerkinElmer lab director.

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

We also wanted to know what happened in the four hours on Sunday between the CDPH email that accused CBS13 of irresponsible journalism and Folmar's emailed statement that said they would investigate the allegations "immediately and thoroughly."

"What changed in the four hours between the CDPH email and your response. Did you confirm the allegations?" Watts asked.

Folmar declined to answer and ended the interview.

"I think we're going to leave it there, Julie," Folmar said.

PerkinElmer Responds

We reached out to PerkinElmer early in the investigation, but a spokesperson pointed us to CDPH for responses.

However, after receiving the state's updated statement Sunday, we provided the company another opportunity to respond to the new allegations Sunday night.

On Monday February 8th, 2021, PerkinElmer issued the following statement:

"PerkinElmer and the California Department of Public Health (CDPH) have worked closely together on serving the citizens of California with the COVID-19 testing laboratory in Valencia. PerkinElmer seeks to operate at the highest of standards at all of our laboratories while ensuring the utmost safety and quality.

At the Valencia laboratory, dedicated individuals at both PerkinElmer and CDPH have worked extremely hard to open the facility and ramp up testing over the past several months in order to meet the State's testing demands. We take any complaints or allegations of wrongdoing seriously and are fully cooperating with California to investigate the issues raised on your segment last night and will continue to be fully transparent with CDPH on any concerns they have."

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

Update: February 15, 2021:

After the story aired in which we reported that whistleblowers alleged that some staff were asked to come in on Super Bowl Sunday to "alter documents" at the lab, Joel Goldberg, PerkinElmer's General Counsel, emailed the station and strongly denied these allegations.

According to Mr. Goldberg:

"[u]nder no circumstances is this practice allowed in any PerkinElmer laboratory, and we are unaware of any attempt or direction to do so here. To the contrary, as previously communicated, we are fully cooperating with California to investigate any issues of concern and will continue to be fully transparent with CDPH."

Mr. Goldberg continued:

"We believe this "evidence" amounts to overhearing one side of a phone conversation and text or other subsequent misconstrued interpretations of that conversation. While CBS reported this as indicating PerkinElmer was attempting to destroy evidence, the truth is the opposite – a staff person was asked to go into the laboratory on Sunday in order to facilitate the verification of information for your reporter's inquiries."



WATCH THE CBS NEWS SACRAMENTO SPECIAL REPORT
THE COVID LAB: State Secrets Exposed

CONTINUING COVERAGE - THE COVID LAB: A Year-Long Investigation by Julie Watts TV Investigates on YouTube

This 30-Minute Special Report is the culmination of 14 months of reporting that prompted state and federal investigations, resulted in two new pieces of legislation, and shined a spotlight on shocking public health failures that it appeared regulators tried to hide.

Following these reports, lawmakers introduced legislation that is intended to protect whistleblowers and ensure accountability and transparency long after the pandemic is over. The state ultimately terminated its $1.7B COVID contract with PerkinElmer.


FOLLOW OUR CONTINUING COVERAGE:

STATE SECRETS: The Whistleblower Investigation

Asleep At the Lab: Whistleblower Allegations From Inside CA's Billion-Dollar COVID Lab

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

Questionable COVID Results – More Concerning Whistleblower Allegations From State COVID Lab

PerkinElmer Sues Whistleblower After Allegations About Troubled CA COVID Testing Lab

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


STATE SECRETS: The Troubled Test

State COVID Test Not FDA Authorized

Same COVID Test, Different Results: FDA Looking Into State Lab 'Test Result Concerns'

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

Delayed School COVID Results, Canceled Games and Contamination Concerns

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

CA COVID LAB Returns Fewer Than 1 Out Of 5 Results Within Required 48hrs During Omicron Surge


STATE SECRETS: Continued Accountability

Continued Accountability: Delayed Investigation Report, Denied Interview Requests

Lawmakers Demand Answers –What's CDPH Hiding At The $1.7B COVID Testing Lab?

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

State Inspections Confirm Whistleblower Allegations At Troubled California COVID Lab

Lab Experts Criticize State's Response To Risk Of 'Serious Injury, Harm or Death' At CA COVID Testing Lab

CBS13 COVID Lab Investigation Prompts New Legislation to Protect Whistleblowers & Taxpayers

California Department of Public Health Terminates $1.7B COVID Testing Lab Contract

Whistleblower Protection Legislation Moves Forward - Following Investigations Into Troubled COVID Testing Lab



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