CLIA FAQs

What is the meaning of CLIA?

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.

What is CLIA and what is its purpose?

The Clinical Laboratory Improvement Amendments (CLIA) Program regulates labs testing human specimens and ensures they provide accurate, reliable, and timely patient test results no matter where the test is done. CMS oversees all lab testing (except some research) done on humans in the U.S. through CLIA.

What does it mean to be CLIA approved?

“CLIA” is the acronym for the Clinical Laboratory Improvement Amendments of 1988. This law requires any facility performing examinations of human specimens (e.g., tissue, blood, urine, etc.) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services.

Why is CLIA certification required for IVF Labs?

CLIA certification is important because it ensures that laboratories are meeting standards for accuracy, precision, and reliability in their testing. This is important for patient care, as accurate laboratory test results are essential for making correct diagnoses and decisions about treatment.

What are the 3 levels of CLIA testing?

The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests.

How do I pass a CLIA inspection?

• Always be ready for inspection with a CLIA inspection checklist.
• Engage in the collaborative process.
• Schedule a mock inspection.
• Avoid common deficiencies & be prepared.
• Prepare personnel for possible interviews.

What is waived vs non waived?

Waived tests are simple tests with a low risk for an incorrect result. Nonwaived tests, also called Moderately Complex tests, are those tests that require a number of criteria to be met prior to the operator running the tests.

What is the difference between CLIA and ISO?

CLIA regulations serve as the sieve for laboratory quality, while the ISO 15189 standard catches quality issues that fall through that sieve—issues that are often responsible for a significant number of clinical laboratory errors.

What happens if you fail a CLIA inspection?

Failure to permit an inspection of any type results in suspension or cancellation of the laboratory’s participation in Medicare and Medicaid for payment and suspension or limitation of or action to revoke the laboratory’s CLIA certificate.