What entity must a clinical laboratory director register with to perform CLIA-waved tests?

What entity must a clinical laboratory director register with to perform CLIA-waved tests?

• A. Local health department
• B. State medical board
• C. Clinical Laboratory Improvement Amendments (CLIA)
• D. American Optometric Association (AOA)

Answer: (C)

A clinical laboratory director must register with the Clinical Laboratory Improvement Amendments (CLIA) to perform CLIA-waved tests. CLIA establishes quality standards for laboratory testing to ensure that tests performed in laboratories are accurate, reliable, and timely. This registration is crucial because it signifies that the laboratory meets the federal standards established for laboratory testing, particularly for tests deemed to have a low risk of incorrect results. CLIA-waved tests are those that are simple and have a low likelihood of error, making them suitable for use in a wider range of healthcare settings, including physician offices and clinics. By registering with CLIA, the laboratory ensures compliance with necessary regulations, enabling it to provide safe and legally permissible testing services. The other entities mentioned, such as the local health department, state medical board, and professional associations like the American Optometric Association, do not have the authority to register laboratory directors for CLIA purposes. They may have their roles in regulatory compliance or professional standards, but the specific action of registering for CLIA is solely the responsibility of the laboratory director with CLIA itself.

A clinical laboratory director must register with the Clinical Laboratory Improvement Amendments (CLIA) to perform CLIA-waved tests. CLIA establishes quality standards for laboratory testing to ensure that tests performed in laboratories are accurate, reliable, and timely. This registration is crucial because it signifies that the laboratory meets the federal standards established for laboratory testing, particularly for tests deemed to have a low risk of incorrect results.

CLIA-waved tests are those that are simple and have a low likelihood of error, making them suitable for use in a wider range of healthcare settings, including physician offices and clinics. By registering with CLIA, the laboratory ensures compliance with necessary regulations, enabling it to provide safe and legally permissible testing services.

The other entities mentioned, such as the local health department, state medical board, and professional associations like the American Optometric Association, do not have the authority to register laboratory directors for CLIA purposes. They may have their roles in regulatory compliance or professional standards, but the specific action of registering for CLIA is solely the responsibility of the laboratory director with CLIA itself.