November 23, 2021 – SACRAMENTO – The California Department of Public Health (CDPH) on Monday released the results of a routine inspection and a complaint investigation of the Valencia Branch Laboratory. The CDPH Laboratory Field Services Branch, which regulates all laboratories in California, closed its two inspections after multiple visits and detailed assessment of the laboratory with no sanctions imposed and all previously identified deficiencies corrected. Here is an issue brief summarizing the processes and findings.
In the interest of transparency, on February 22, 2021 the California Health and Human Services Agency, which oversees CDPH, made public that laboratory inspectors found significant deficiencies during a routine inspection process. In addition to addressing all of the deficiencies, the state required PerkinElmer (the operator of the Valencia Branch Laboratory) to go through an independent inspection and accreditation process with the College of American Pathologists (CAP). The laboratory was inspected by the CAP accreditation program on March 19, 2021, and received full accreditation. CDPH found that the laboratory satisfactorily addressed all the identified deficiencies in closing the routine inspection. The final letter can be found here (PDF).
In addition to the routine inspection, Laboratory Field Services conducted a complaint investigation on February 7, 2021 following reporting by a local media outlet related to allegations regarding the training and qualifications of staff in the laboratory. Additional allegations were reported regarding the destruction of evidence and mishandling of specimens. As a result, on the same day the allegations were made available to the state, CDPH deployed an unannounced team of state laboratory experts to the Valencia Branch Laboratory to investigate and ensure the quality of the tests processed within the laboratory. CDPH found that the laboratory satisfactorily addressed all the identified deficiencies in closing the complaint investigation. Additionally, Laboratory Field Services was not able to substantiate local media reports that there was destruction of documents and data. There was no evidence to support these allegations. The final letter can be found here (PDF).
“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,” said Dr. Tomás J. Aragón, CDPH Director and State Public Health Officer.
The laboratory has increased testing availability in communities at high risk for contracting COVID-19, such as essential workers, those in congregate care settings, and communities of color. The Laboratory has performed more than 5.5 million tests on samples from a network of more than 4,700 specimen collection sites developed with churches, schools, clinics, essential workplaces and community-based organizations.
This created deeper and wider access to testing. Roughly 62 percent of tests performed are among racial minorities with 32 percent in the most disadvantaged neighborhoods based on the California Health Places Index (HPI) Quartile 1 and 25 percent in Quartile 2.
Since the laboratory opened, the median turnaround time is 36 hours from collection to result. In the most recent Testing Taskforce Turn-Around-Time report (10-31-21 to 11-6-21), the Laboratory had an average turnaround time of 1.3 days, with 96% of all results delivered in less than 2 days. On average across all laboratories, 97% of samples were delivered in less than 2 days in that same period. All this while the Laboratory accounted for more than 10% of all testing for the past several weeks and delivering more results than any other laboratory by a significant amount.
As we approach winter, the state is preparing to respond to a variety of scenarios should we experience another surge in cases. We have learned over the last two years that COVID-19 spreads when we put our guard down. There are three variables that may result in a surge: (1) colder weather keeping people indoors; (2) waning of vaccine and natural immunity; and (3) mixing among multiple households. As a result, the state chose to allow the auto renew provision in the contract with PerkinElmer to take effect to ensure we have the capabilities in place for a potential surge. The contract still includes termination provisions including ending the contract without cause with a 45-day notice. The laboratory continues to play a critical role in meeting the California‘s goal of expanding equitable and affordable access to COVID-19 testing.