Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver. The CLIA Program is funded by user fees collected from approximately 200,000 laboratories, most located in the United States. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services. Test system troubleshooting and equipment maintenanceĬenters for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA Program.Calibration, quality control, and proficiency testing materials.Score 2 is assigned when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3. A score 1 is the lowest level of complexity and a score of 3 indicates the highest level. Per CLIA, each specific laboratory system, assay, examination is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the following seven criteria.

In 2014 the FDA started a public discussion about regulating some LDTs. Most Laboratory Developed Tests have been regulated under this program.

diagnosis, prevention, or treatment of disease or impairmentĪn objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.

CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for: In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing.

What are clia or iata requirements