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Clinical Laboratory Improvement Amendments of 1988 (CLIA)

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). These 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.

In total, CLIA covers approximately 251,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification 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. All clinical laboratories must be properly certified to receive Medicare or Medicaid payments.

CLIA regulations require clinical laboratories to be certificated by their state as well as 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.

Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.

FDA

  • Categorizes tests based on complexity
  • Reviews requests for Waiver by Application
  • Develops rules/guidance for CLIA complexity categorization

CMS

  • Issues laboratory certificates
  • Collects user fees
  • Conducts inspections and enforces regulatory compliance
  • Approves private accreditation organizations for performing inspections, and approves state exemptions
  • Monitors laboratory performance on Proficiency Testing (PT) and approves PT programs
  • Publishes CLIA rules and regulations

CDC

  • Provides analysis, research, and technical assistance
  • Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology
  • Conducts laboratory quality improvement studies
  • Monitors proficiency testing practices
  • Develops and distributes professional information and educational resources
  • Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)

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HHS ‘Stands Down’ FDA on Its Oversight of LDTs

CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…

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Theranos Now Scrambling To Save What It Can

CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…

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