In the past 6 months, CLIA Lab Consultant has helped more than 25 clients with COVID testing needs, services provided included: lab director placement, business strategies, reimbursement, establishing back to work/school program, CLIA audit, startup waived, moderate, high complexity and mobile testing laboratories. We had assisted COVID labs startup with 11 different states (AZ, CA, FL, GA, HI, KS, MD, NY, OH, TX and WI) including states (California, Maryland and New York) with its own lab regulations.
All laboratories are currently generating revenue or have active testing for back to school/work programs. One of key services we provided to our client is on-going update to the industry trend and strategic review, allowing laboratories to make changes to capture the market. Some of the changes that were made included: operating its own collection sites, update license for temporary site testing, add offering of rapid testing and lab developed test, move from cash to insurance billing model.
With COVID-19 there are constant changes to the testing market, in order to stay competitive in a rapidly changing environment, laboratories must continuously update and make changes to offering and operation.
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.
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.