What is the primary goal of the CLIA program?

• A. To ensure accuracy, reliability, and timeliness of patient test results regardless of where the test was performed
• B. To regulate medical device manufacturing
• C. To standardize hospital food service
• D. To sponsor physician licensure

Answer: (B)

CLIA is focused on the quality of clinical laboratory testing. Its primary goal is to ensure the accuracy, reliability, and timeliness of patient test results, no matter where the test is performed. Administered by CMS, CLIA applies to laboratories that handle human specimens and classifies tests by complexity, requiring appropriate standards, participation in proficiency testing, and regular inspections to maintain certification. This framework keeps lab results comparable and trustworthy across different laboratories, whether a small facility or a large hospital lab is performing the test. The other options describe activities outside CLIA: regulating medical devices is the FDA’s domain, standardizing hospital food service isn’t related to lab testing, and physician licensure is handled by state medical boards.