This week the California state response to whistleblower allegations at the billion-dollar COVID lab at Valencia established with PerkinElmer. The allegations included employees sleeping at work, swab samples found inside restrooms, lack of training/competency, thousands of inconclusive COVID results (7.5 times higher than other state labs). Testing personnel/supervisors does not meet CLIA and State regulations.
While the investigation is on-going, it’s definitely a wakeup call to other labs doing COVID testing. During the COVID pandemic, a lot of labs quickly ramp up testing through rapid hiring, purchasing and validation now as we are one year into the pandemic many labs are overdue for inspection. Labs should review it’s procedures, processes, training and quality assessment to ensure compliance with CLIA and other applicable regulations before the CLIA office sends it’s inspection notice. By the time, the lab received the inspection notice, there might not be adequate time to review and verify everything needed. Bringing in a consultant can be helpful with a fresh set of eyes and perspective and also add extra help to the lab that’s already stretched thin by the surge of testing volume.
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Michael Yu, MS, MBA, MLS(ASCP)
Michael is the founder and owner of CLIA Lab Consultant where he provides consultation to laboratories and companies world-wide for startup and lab regulations, reimbursement, and testing strategies.