CLSI AUTO04-A

This document describes operational requirements, characteristics, and required information elements of clinical laboratory automation systems. This information is used to determine the status of a clinical specimen within the clinical laboratory automation system, as well as the status of the actual components of the clinical laboratory automation system.

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This document is no longer being reviewed as part of our consensus process. However, because of its usefulness to a limited segment of the healthcare community, we are continuing to make the document available for its informational content.