Who is Responsible for Your Lab's Compliance?
Ensuring a lab’s compliance is a duty that falls solely to the CLIA Laboratory Director of record. Although many lab director responsibilities can be delegated to appropriately trained on-site staff, especially in the case of a part-time lab director, one responsibility that cannot be delegated is regulatory compliance. For the overall health of the lab and its business, it is important to have a lab director who understands compliance and is dedicated to ensuring that the lab is compliant and inspection-ready at all times.
Many lab directors utilize a checklist for on-site visits to evaluate the lab’s compliance on at least a quarterly basis. This ensures there are no surprises when it is time for inspection. Being inspection-ready should be a mindset adopted by every clinical lab, as well as its lab director.
High-quality lab directors with good attention to compliance-specific details are especially important for new labs looking to get started on the right foot. As many new labs discover during the start-up phase, it can be difficult to cover the overhead costs of a lab director prior to initiating testing given that the lab is not generating revenue during this time; to counteract this issue, our lab director program members in the start-up phase typically only pay half the normal rate for lab director services until the lab reaches live testing status.
