If a facility only performs blood draws and no testing, does it require a CLIA number?

In the context of the Clinical Laboratory Improvement Amendments (CLIA), a facility that only performs blood draws and does not conduct any laboratory testing does not require a CLIA number. CLIA regulations primarily apply to facilities that perform laboratory tests, as these tests require specific standards to ensure quality and accuracy.

Since blood draws are considered a part of the specimen collection process rather than testing, a facility that is solely engaged in this practice would not fall under the purview of CLIA regulations. These regulations are designed to ensure that laboratories that analyze specimens adhere to strict quality controls, but simply drawing blood does not meet the criteria necessitating a CLIA certification.

Other factors, such as operating in multiple states or processing specimens, do not change the fundamental requirement regarding the need for a CLIA number for a facility that only performs blood draws. The key distinction lies in the fact that testing, which involves analyzing samples and generating results, is what invokes the necessity for compliance with CLIA regulations.