What must any laboratory performing testing on human specimens do?

Laboratories that perform testing on human specimens must enroll in the CLIA program, which stands for the Clinical Laboratory Improvement Amendments. This program is essential because it establishes quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results. CLIA regulations require that any laboratory conducting tests on human samples be certified under specific criteria depending on the complexity of the tests performed.

Enrolling in the CLIA program is critical as it helps in minimizing errors in laboratory testing, which can have significant implications for patient care and health outcomes. Compliance with CLIA standards also aids in fostering trust in the laboratory's testing processes among patients and healthcare providers.

While having a certificate of compliance may sound relevant, it is specifically tied to the requirements set forth by CLIA. Membership in a professional association or attending compliance training sessions may be beneficial for laboratory staff's professional development, but these are not mandatory for the laboratory's operational compliance. Thus, enrollment in the CLIA program stands out as the fundamental requirement for any laboratory engaged in human specimen testing.