Health care providers are helped by diagnostic testing to screen for or monitor particular diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The laboratory testing and require clinical laboratories is regulated by Clinical Laboratory Improvement Amendments (CLIA) 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. Multiple kinds of CLIA certificates can be obtained by laboratories, deployed on the kinds of diagnostic tests they conduct.

There are 3 federal agencies that are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each organization has a distinctive position in assuring quality laboratory testing.

FDA

• Reviews requests for Waiver by Application
• Based on complexity, categorizes tests
• Establishes rules/guidance for CLIA complexity categorization

CMS

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

CDC

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

CLIA Program

The CLIA Program sets standards and releases certificates for clinical laboratory testing in accord with CLIA. Clinical Laboratory Improvement Amendments describes a clinical laboratory as any facility which conducts laboratory testing on specimens derived from humans for the intention of giving data for:

1. Health assessments

1. diagnosis, prevention, or treatment of disease/impairment

CLIA’s aim is to ensure the precision, accuracy, reliability and timeliness of test results regardless of where the test was conducted.

CLIA Waived Tests

Tests and test systems that meet risk, mistakes or errors, and complexity requirements are issued a CLIA certificate of waiver under CLIA. The CLIA waiver provisions were revised and reviewed by the United States Congress in November 2007 to make it clear that tests passed by the FDA for home use automatically qualify for CLIA waiver, however several waived tests are not conducted in accordance to designed protocols — more than 50 percent of such tests are done wrongly — which results in medical flaws, few with fatal outcomes.