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No Sanctions Will Be Imposed On Valencia Branch Laboratory After Operator Addresses Record-Keeping 'Deficiencies'

VALENCIA (CBSLA) — No sanctions will be imposed on a Valencia laboratory that processes thousands of the state's COVID-19 tests after an investigation into allegations its workers were not trained adequately, and specimens were being mishandled.

COVID-19 Lab Valencia
The $25 million lab, announced in August as part of a deal with scientific diagnostics firm PerkinElmer, will ultimately be able to process 150,000 tests per day when it reaches full capacity in March — employing 700. (CBSLA)

The Valencia Branch Laboratory, which has performed millions of COVID tests on samples from a network of more than 4,700 specimen collection sites, was determined to have corrected all previously identified deficiencies, according to a letter sent Monday by the California Department of Public Health. The laboratory is operated by PerkinElmer, which also received full accreditation from the College of American Pathologists.

"The regulatory process worked as designed, addressing the identified deficiencies and holding the laboratory operator accountable – ensuring that the integrity of tests processed at this laboratory were not impacted and high standards were maintained," Dr. Tomas Aragon, director of the California Department of Health and the state's Public Health officer, said in a statement.

Several inspections conducted by state public health officials between December of 2020 and February of this year found multiple deficiencies related to documentation record keeping, process, and training. State officials issued Valencia Branch Laboratory a "notice of intent to impose sanctions" in October, but the threat of sanctions was withdrawn following an onsite visit of the lab on Nov. 10, and the College of American Pathologists confirmed accreditation of the facility.

"…in each instance, PerkinElmer (operator of the Valencia Branch Laboratory) immediately worked to clarify where needed and implement improved process and documentation as necessary. All deficiencies were addressed and there was no impact to the integrity of the tests processed at the laboratory," the report's findings said.

In addition to those identified deficiencies, there were media reports that the laboratory's staff were not properly trained or qualified, specimens were being mishandled, and evidence was being destroyed. On the same day those reports were published, state public health officials say they conducted an unannounced inspection to investigate and ensure the quality of the tests processed by the lab, and ultimately determined that there was no evidence to support these allegations.

The state was able to significantly expand testing last year with the building of the Valencia Branch Laboratory. Since it opened, the average turnaround time from collection to result is 36 hours, and the lab accounts for more than 10% of all testing for the past several weeks, according to state officials.

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