- CLIA Contacts and Newsletters: State Agency and CLIA Operations Branch Contacts
- Contact the CLIA program directly regarding specific questions: [email protected]
- Sign up for CLIA update alerts
CLIA Resources
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) establish quality standards for laboratory testing performed on human clinical specimens. To perform such testing, laboratories must maintain a CLIA certification. APHL provides resources, including checklists and bench aids, to help laboratories achieve and maintain CLIA certification.
Questions?
Contact the Quality Systems and Analytics team: [email protected]
About CLIA Regulations
CLIA is the federal program for certification and oversight of clinical laboratory testing to ensure accurate, reliable and timely diagnostic test results, no matter where testing is performed. All laboratories testing human clinical specimens for the purpose of diagnosis, prevention or treatment of disease, or assessment of health, must maintain a CLIA-certification—achieved by meeting specific requirements and maintained through regular audits. There are different types of CLIA certificates, as well as different regulatory requirements, based on the types and complexity of clinical laboratory tests a laboratory conducts.
See the ‘Federal Support and Oversight for CLIA’ section of this page for more information on how CLIA is managed.
CLIA Laboratory Staffing Support
A current trend creates a tough challenge for public health: more laboratory directors retiring and leaving. When a vacancy cannot be managed internally, APHL can help connect you with qualified individuals for interim positions (including CLIA directors), resources for your director search and services to keep transition smooth.
APHL Technical Resources
- APHL Guide for CLIA Internal Audits Related to High Complexity Testing
- Crosswalk of Regulations and Guidance Affecting Laboratories
Federal Support and Oversight of CLIA
The US Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS) and Food and Drug Administration (FDA) all contribute to CLIA oversight and provide support for clinical laboratory quality.
CDC
CDC supports the CLIA program by providing analysis, research, and technical assistance; developing technical standards and laboratory practice guidelines; conducting laboratory quality improvement studies; monitoring proficiency testing practices; developing and distributing professional information and educational resources; and managing the Clinical Laboratory Improvement Advisory Committee (CLIA).
- Quality Management System (QMS) Tools and Resources
- Waived Tests
- Introduction to CLIA Training
- Individualized Quality Control Plan (IQCP)
CMS
CMS supports the CLIA program by issuing laboratory certificates and collecting user fees; conducting inspections and enforcing regulatory compliance; approving private accreditation organizations and state exemptions; monitoring laboratory performance and approving proficiency testing programs; and publishing CLIA rules and regulations.
FDA
FDA supports the CLIA program by categorizing tests based on complexity, reviewing requests for CLIA Waiver by Application, and developing rules/guidance for CLIA complexity categorization.
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CLIA Test Categorization Database
Lists all commercially marketed laboratory tests that have been categorized under CLIA.
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CLIA Currently Waived Analytes
List of all tests currently categorized as waived for any reason (i.e., by regulation, by marketing clearance/approval for over-the-counter use, or following an approved waiver by application).