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Clinical Laboratory Improvement Amendments
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Clinical Laboratory Improvement Amendments
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.
In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for:[citation needed]
An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Most laboratory-developed tests have been regulated under this program. In 2014 the FDA started a public discussion about regulating some LDTs.
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. A score of 1 is the lowest level of complexity, and a score of 3 indicates the highest level. Score 2 is assigned when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3.
Criteria for categorization:
Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services.
List of CLIA test complexity categorizations:
Complementary and alternative medicine tests, such as live blood analysis (LBA), biological terrain assessment (BTA), dental sensitivity testing, and cytotoxic testing have not been categorized by the CDC, and are thus treated as high complexity laboratory developed tests. CAM tests are often ordered by chiropractors, naturopaths, and nutritionists and accompanied by non-validated clinical interpretations which are used to recommend or justify costly, unnecessary, and potentially damaging treatments. A 2001 OIG report found that the majority of laboratories performing CAM tests were not enrolled in CLIA and that CAM laboratory personnel did not meet the high complexity qualifications. For laboratories enrolled in CLIA, they had their certificates revoked or were sent deficiency notices for failing to adhere to CLIA regulations. No CLIA laboratory has been able to validate their LBA CAM tests per standards. CAM tests are not covered by health insurance. The number of CAM laboratories is unknown and the sales of supplemental remedies based on the results of these tests is unknown. Since CLIA does not regulate the clinical validity/usefulness of a test, it is possible for a CLIA laboratory to offer tests that have no clinical utility.
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Clinical Laboratory Improvement Amendments
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.
In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for:[citation needed]
An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Most laboratory-developed tests have been regulated under this program. In 2014 the FDA started a public discussion about regulating some LDTs.
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. A score of 1 is the lowest level of complexity, and a score of 3 indicates the highest level. Score 2 is assigned when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3.
Criteria for categorization:
Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services.
List of CLIA test complexity categorizations:
Complementary and alternative medicine tests, such as live blood analysis (LBA), biological terrain assessment (BTA), dental sensitivity testing, and cytotoxic testing have not been categorized by the CDC, and are thus treated as high complexity laboratory developed tests. CAM tests are often ordered by chiropractors, naturopaths, and nutritionists and accompanied by non-validated clinical interpretations which are used to recommend or justify costly, unnecessary, and potentially damaging treatments. A 2001 OIG report found that the majority of laboratories performing CAM tests were not enrolled in CLIA and that CAM laboratory personnel did not meet the high complexity qualifications. For laboratories enrolled in CLIA, they had their certificates revoked or were sent deficiency notices for failing to adhere to CLIA regulations. No CLIA laboratory has been able to validate their LBA CAM tests per standards. CAM tests are not covered by health insurance. The number of CAM laboratories is unknown and the sales of supplemental remedies based on the results of these tests is unknown. Since CLIA does not regulate the clinical validity/usefulness of a test, it is possible for a CLIA laboratory to offer tests that have no clinical utility.