CLIA Regulation Fundamentals and Recent Updates

The Clinical Laboratory Improvement Act (CLIA) is the primary regulation that lays the groundwork and impetus of all laboratory operations. Laboratorians, regardless of the department they are assigned, should understand the history of CLIA as well as its content. The CLIA rule covers all areas of the laboratory, some areas not necessarily applicable to everyone. Being knowledgeable of the regulatory standards that drive decisions and processes within the laboratory gives a more global understanding of the lab as a whole and promotes well-rounded laboratory staff.

While the CLIA regulations have been around for many years, they have only been edited a handful of times. Within the last few months, updates to the CLIA rules have been published. One set of updates was published in a final state and the second set was published in a proposed state. Both of these offering much needed changes to some elements of the rule.

This presentation will take a deep dive into the CLIA rule and explain its history and composition. Additionally, we will cover key elements of the newly published final rule and the rule that is currently in a proposed state.