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Clinical Laboratory Improvements Amendments (CLIA)
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) are the regulations for clinical laboratory testing. The regulations are established to ensure that all patient test results are accurate and reliable. CLIA is a federal program governed by the Centers for Medicare & Medicaid Services (CMS); however, the CLIA program is administered at the state level by the Louisiana Department of Health, Health Standards Section.
CLIA regulations apply to testing performed in any type of facility with or without a conventional laboratory. CLIA requires all facilities that perform tests on …“materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of human beings” to comply with the federal regulations. If a facility performs tests for these purposes, it is considered to be a laboratory according to the definition by CLIA, and must obtain and maintain CLIA certification.
Regulations
The CLIA regulations can be found in the Code of Federal Regulations in volume 42 part 493. An online version of the most current regulations can be accessed from the Centers for Disease Control and Prevention (CDC) website. The regulations provide all the requirements for laboratories to perform testing.
Resources
- How to Apply for a CLIA Certificate
- How to Make Changes to CLIA Certificate
- How to Complete a Change of Ownership for CLIA
- Types of CLIA Certificates
- CLIA Fees
- Laboratory Director Qualifications
- Proficiency Testing
- Accreditation Organizations
- Survey Information Packet for Certificate of Compliance
Interpretive Guidelines for Laboratories
The interpretive guidelines were established to clarify and/or explain the Federal requirements for laboratories. The interpretive guidelines provide a copy of the specific regulation followed by an interpretation or explanation of the CMS requirement. Additional information is provided at many regulations to facilitate a better understanding of the requirements. The interpretive guidelines are useful as a tool for obtaining and maintaining compliance.
Contact
Alexa Little, MLS (ASCP)cm, MBEC
Email: Alexa.Little@la.gov
Phone: 225-342-9324
Fax: 225-342-5073