CLIA

Clinical Laboratory Improvement Amendments

In 1998, the U.S. Congress passed the Clinical Laboratory Improvement Amendments to establish quality standards for all laboratories testing to ensure:

• Accuracy;
• Reliability; and
• Timeliness of patient test results regardless of where the test was performed.

As per CLIA, a laboratory is any facility that does laboratory testing on specimens derived from humans to provide information for the diagnosis, prevention, treatment of disease, impairment of or assessment of health. The Centers for Medicare and Medicaid Services (CMS) assume primary responsibility for financial management operations of the CLIA program.

This is only an overview/extract of the standard. Users should not rely on its accuracy, but should refer to the complete standard of the appropriate revision.

Click here for full list of Standards and Regulations.