With so few authorized testing kits available alongside an incredibly large amount of testing demand, the FDA had to start issuing EUAs (Emergency Use Authorizations) to companies that wanted to produce and distribute their own COVID-19 testing kits. This was game–changing for several reasons. First, an EUA can be issued much faster than full FDA approval. With the virus spreading so quickly and stay-at-home orders in place, surveillance efforts were really stunted by the possibility that it could take months or even years to get full FDA approval for a COVID testing kit. EUAs essentially allowed companies to validate their products in a less restrictive way, demonstrating that their kits worked well enough in their respective areas. This shrunk the timeline for approval down, enabling companies across the United States to start distributing more coronavirus testing kits in efforts to combat virus spread and control.
After the FDA started issuing EUAs, testing volume needs were met within a month. Kits were now being produced in massive quantities, making it almost as easy to get a COVID-19 test as it was to put gas in your car. One of the largest testing sites in the nation existed at Dodger Stadium, providing thousands of open appointments per day. Dodger stadium ended up administering a total of over one million tests during its nine-month operation before it was transitioned into a mass vaccination site2. This huge supply of testing kits also introduced a new demand in pandemic control. Clinical laboratories in California require employees to be licensed by the California Department of Public Health, most notably with those obtaining a Clinical Laboratory License (CLS). With numerous EUA’s being granted to dozens of companies, the next wave of demands revolved around laboratory personnel. To put it simply, there were not enough licensed employees to meet the massive amounts of samples coming in to run a COVID facility. In comes Executive Order N-25-20.
Issued by the Governor of California, this order temporarily suspended laboratory personnel licensing requirements within the sole context of COVID-19 testing. While laboratory directors and supervisors were still required to be licensed, testing personnel positions could now be extended and offered to those with a B.S. degree, opening an entirely new field of experience for non-licensed scientists.
Testing was now completely accessible across one of the most populous states, and a new type of sample collecting method began gaining popularity: pop-up COVID testing facilities. T. Not only was this process incredibly user-friendly, safe, and accessible to everyone, but it allowed for a larger sample volume output, reducing unnecessary wait and collection times previously associated with earlier stages of the pandemic. Additionally, drive-through testing centers vastly decreased probability of SARS-CoV-2 exposures at testing sites by removing lines and creating social distance by design. These facilities could also accommodate thousands of people per day, often out growing on-site labs and requiring samples to be sent out to larger scale COVID-19 testing laboratories just to meet requirements. This introduced yet another tool in the invisible war against the coronavirus.