1.1 This guide covers the capabilities needed for a Clinical Laboratory Information Management System (CLIMS). It was written so that both the vendors or developers of CLIMS and laboratory managers would have a common understanding of the requirements and logical structure of a laboratory data system. This guide will also help answer many of the questions faced by designers of CLIMS and provide more uniformity in the way that requirements are expressed from one laboratory to another. It is therefore applicable to users who are involved with acquiring or operating a CLIMS.