Gov. Newsom’s $100 Million COVID Lab Has Trouble Again with ‘Significant Deficiencies’

In August 2020, Gov. Gavin Newsom announced that a “Twindemic” would be upon us soon with COVID and the flu season in the fall, at the same time he announced a new partnership with PerkinElmer, Inc. a diagnostic company, to build a laboratory within the state, and increase COVID-19 testing into March 2021.

Also in August, the Center for Disease Control announced that it no longer recommended testing people without Coronavirus symptoms, but the governor said California would not be adopting the CDC policy.

Newsom said that because we were headed into the flu season, people would be demanding more flu tests. So in anticipation of increased testing during a “Twindemic,” he and PerkinElmer are collaborating to “disrupt the market” with a California laboratory, “help break supply chain logjams and drive down the costs for tests.”

The only logjam in California has been the rollout of the vaccination.

Here it is February 2021, with no flu season, and Newsom’s Valencia lab has been somewhat of a disaster.

Newsom’s $100 million COVID testing lab in Valencia has been troubled since it opened in October, at first unable to even test 250 lab samples.

In December, we reported that the COVID PCR tests “are being used incorrectly, resulting in the false appearance of widespread transmission,” according to Dr. Joseph Mercola.

Then, as the Globe reported Feb. 8, 2021, a whistleblower exposed thousands of inconclusive test results coming outof the lab.

Now inspectors have found “significant deficiencies” at the coronavirus testing lab, blamed on the rapid ramp-up they required from the lab’s private operator under terms of a $1.4 billion contract, KTLA reported Monday.

But the “significant deficiencies” date back to early December.

“A fraction of 1% of the more than 1.5 million tests processed at the Valencia Branch Laboratory had problems, the state said in a preliminary report.”

Health and Human Services Secretary Dr. Mark Ghaly said “one incorrect test result is one too many.” Yet his own agency knew that this has been going on since the lab was opened.

A November 2020 Newsweek article discussed Gov. Gavin Newsom’s then-new $100 million lab in Los Angeles, and its “bad test results” in the first week: “A brand new $120 million California COVID-19 testing lab has received ‘a higher number than expected’ of bad test results, leaving millions of patients waiting days for results the state vowed to return within 24 to 48 hours.”

NBC Los Angeles reported, “Although the lab was estimated at $25 million, Newsom said the state actually invested $100 million in upfront costs for the facility, including the building and scientific equipment inside. He said the contract with PerkinElmer includes provisions for reimbursement, with $5.51 of every test conducted set aside to pay for the state’s upfront costs.”

This is known as a kickback.

A KCRA segment regarding the contract between the state and PerkinElmer revealed that the lab is expected to net PerkinElmer $270 million. The cost to state: $700 million to $1.6 billion.

The state contract is for 14 months.

The Globe reported in early February 2021 that CBS13 Sacramento reported thousands of inconclusive test results coming out of Gov. Gavin Newsom’s $100 million COVID-19 testing lab with the $1.7 billion contract with PerkinElmer. All of this expense was supposed to ramp up testing and processing, but the high number of false-positives were concerning.

The Globe reported on this lab in December, and spoke to a confidential source who shared concerns with the PCR tests:

“Results from a positive PCR test should be considered as a preliminary result only and doesn’t determine an active infection or  hospitalization rates. Doctors typically order these tests when a patient shows symptoms and the doctor suspects the patient has a high probability of having the disease. Once a result comes back positive, it must be confirmed with another test in order to be considered definitive.

The concern with Covid screening is that none of these steps are taken. A positive PCR has little clinical significance and increases our case numbers without confirming the presence of an active infection. Without the expertise of a physician and a confirmatory assay there is no way to determine if this is a true positive result.”

A report out this week by CHHS found deficiencies at the lab “are focused in five areas, including: facility administration, pre-analytical process, analytical systems, post-analytical process, and laboratory leadership.”

Except the inspection referenced took place December 8-9, 2020. “Since then, LFS has been preparing a written report.” For 73 days, or two-and-a-half months?

The LFS referenced is the Laboratory Field Services Division of the California Department of Public Health (CDPH), which regulates laboratories in the state. LFS found “significant deficiencies” in the Valencia Branch Laboratory “during an initial routine inspection that occurred in early December,” and we are just now, in late February 2021, hearing about it.

“LFS had an exit conference with laboratory leadership on Wednesday, February 17, 2021, and provided them with the written report to respond to on Friday, February 19, 2021.”

The Valencia Laboratory Field Services Division of the California Department of Public Health update continues:

Q: What actions can you take against PerkinElmer?  A: We included strong contractual language to ensure that we protected the state and the taxpayer dollar. The full contract is public and can be found online on the covid19.ca.gov website, here.

Q: Would you terminate this contract if the reported employee allegations are substantiated? A: We need to let the laboratory experts do their work and see if complaints are substantiated — and then the state will take any action that may be merited.

Q: Has PerkinElmer cooperated with the team deployed investigating the complaint? A: Yes.

Q: Do you have confidence in PerkinElmer to deliver on the contract? A: Yes. There is currently nothing to suggest that we do not have confidence in their ability to deliver on the contract. Obviously, we are constantly assessing their performance and are ensuring that they are delivering the best results for the people of California.

The full report on the Valencia Branch Laboratory, with responses from PerkinElmer, will be made available in mid-March, CHHS says.

Nothing to see here folks. Move along please.