Does a provider who conducts only waived tests need to obtain a CLIA number?

The requirement for a provider to obtain a Clinical Laboratory Improvement Amendments (CLIA) number applies to all laboratories conducting any type of testing, including waived tests. The rationale for this is that even though waived tests have a lower level of complexity and a reduced risk for patient harm, they still need to adhere to certain quality and regulatory standards established by the CLIA provisions. Therefore, all providers engaging in any laboratory testing, regardless of complexity, must obtain a CLIA number to ensure oversight and compliance with federal regulations. This helps maintain the safety and accuracy of laboratory testing and assures that patients receive quality health services.