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1. What is CLIA? 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, , etc.)
The mission of the Clinical Laboratory Improvement Amendments (CLIA) section of Laboratory Field Services is to ensure compliance with State and federal clinical laboratory laws and regulations by performing biannual onsite inspections to ensure accuracy and reliability of laboratory test results and conducting review
Purpose: The Clinical Laboratory Improvement Advisory Committee (CLIAC) is charged with providing scientific and technical advice and guidance to the Secretary, Department of Health and Human Services; the Assistant Secretary for Health; the Director, Centers for Disease Control and Prevention (CDC); the Commissioner,
The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.
Results: More than 64% of physicians surveyed cited CLIA 88 as a factor in their decision to reduce or eliminate in-office testing. The most striking effect of CLIA 88 appears to be on pediatric practices and practices in rural areas, of which more than 70% have reduced or eliminated onsite testing.
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As defined by CLIA, waived tests are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result. Examples of waived tests include: dipstick urinalysis, fecal occult blood, pregnancy tests, and blood glucose monitoring.

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