PLEASE NOTE:  This Excel file contains a comparative overview of the following certification regulations and the information provided is not intended as definitive, understanding that there are many factors that may bear on individual circumstances.  The ICLN is providing this overview to inform a way forward in the certification process, but does not endorse, underwrite, or guarantee it in any way.  Please refer to the relevant guidance/regulatory documents of each certification organization, in conjunction with your general counsel, to determine a way forward specific to your circumstances and needs.

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 320,000 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 for human clinical samples. 

In response to an article published in The Wall Street Journal in November 1987 describing the large number of false negative lab tests resulting in a large number of medical claims, the Clinical Laboratory Improvement Act of 1988 (CLIA 88) was passed. The CLIA regulations are constantly being updated so see the link below for the latest version of the regulations.

CLIA provides regulatory standards and certificates for clinical laboratory testing in facilities that test human specimens for diagnostic, preventive, or therapeutic purposes, and for health assessments. Its purpose is to ensure accurate test results for proper medical decisions and follow-up care. The CLIA regulations detail the required knowledge, training, and experience of laboratory staff, preparation of reagents and materials, operational steps and their characteristics, calibration, quality control, multiple proficiency testing requirements, test system troubleshooting, equipment maintenance, and interpretation of test results. CLIA covers the three types of clinical testing, waived, moderately complex and high complexity testing. Waived testing is found in many physicians’ offices with FDA waived instruments. Moderately complex testing is in most “fixed” laboratories and high complexity testing is testing with highly technical clinical analyzers or lab procedures using highly complex instrumentation. Radiobioassay testing is high complexity lab testing.

Many very informative CLIA Brochures can be found at: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures