Diagnostic testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct. Show Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). Each agency has a unique role in assuring quality laboratory testing. FDA
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Resources
SpotlightProposed RuleCMS and CDC issued a proposed rule to update CLIA fee, histocompatibility and personnel, and alternative sanctions for Certificate of Waiver laboratories. You can download the proposed rule from the Federal Register at: https://www.federalregister.gov/public-inspection. Search for “CMS-3326-P.” For additional information please see the Fact Sheet (PDF).
Get Online Payment Info (PDF)  The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 330,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program. 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. For the following information, refer to the downloads/links listed below:
COMPLAINT REPORTING To report a complaint about a laboratory, contact the appropriate State Agency (PDF) that is found on the State Agency & Regional Office CLIA Contacts page located in the left-hand navigation pane in this section. See the Consumer Complaints FAQ (PDF) on how to file a complaint. Additionally, see the Temporary COVID-19 Testing Sites (PDF) infographic, which advises those receiving laboratory services of things to be aware of to ensure they are receiving quality laboratory testing. QUESTIONS ABOUT the CLIA PROGRAM
Would you like to receive email updates from CLIA? Sign up for our CLIA Communications Email List with the link below: https://public.govdelivery.com/accounts/USCMS/subscriber/new?topic_id=USCMS_12461 Downloads
Which organization is responsible for test categorization and CLIA studies?The Centers for Disease Control and Prevention (CDC) is responsible for the CLIA studies, convening the Clinical Laboratory Improvement Amendments Committee (CLIAC) and providing scientific and technical support/consultation to DHHS/CMS. The Food and Drug Administration (FDA) is responsible for test categorization.
Which of the following organizations is responsible for the standards for laboratory procedures?The correct answer is A) Clinical and Laboratory standards institute. The Clinical and Laboratory Standard Institute is a non-profit organization that adheres to established laboratory standards when performing molecular-based laboratory testing.
What are the three categories of testing under CLIA quizlet?CLIA'88 regulations require that three different procedures be performed in the quality-control protocol for automated hematology instruments. The procedures are calibration, control sampling testing, and proficiency testing.
What does CLIA stand for quizlet?Clinical Laboratory Improvements Amendment of 1988.
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Which of the following organizations is responsible for test categorization and CLIA studies Quizlet
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