In response to the COVID−19 pandemic, clinical laboratories have increased their diagnostic testing capabilities and expanded their business by testing COVID−19 specimens from different states and entering into arrangements to conduct COVID−19 screening for employers. Despite waivers designed to make COVID-19 testing available and accessible on a widespread basis, labs must be careful in expanding their business to ensure that they maintain compliance with federal and state laws. Similarly, companies looking to partner with labs for specimen collection should familiarize themselves with applicable federal and state laws.
For an overview of the state and federal regulatory landscape in this context, please read our client alert. For guidance on your company’s situation, please contact us.