A clinical laboratory improvement amendment (CLIA) was established in 1998 which was passed by congress. CLIA lab possesses all the quality standards for testing and moreover ensures the accuracy, reliability and appropriateness of the test results.
A laboratory generally denotes where the testing of specimens/samples which are obtained from patients are diagnosed to identify the disease and to proceed further with treatment or impairment or evaluation of health.
CLIA waiver is funded by many public and private agencies. Hence it is user free and covers almost all costs of governing the program with regulated facilities. Financial management operation of CLIA is managed by the centers for Medicare and Medicaid services. FDA takes over the responsibility of the commercially marketed test which is grouped under in vitro diagnostic tests. CLIA regulation test are waived tests, tests of moderate complexity and tests of high complexity.
CLIA groups will be publicized in Federal Register Notices, which will make available chance for remark on the result. FDA may reconsider and rearrange these tests based in the lead of the explanation received in response to the Federal Register Notices.
CLIA laboratory requirements are based on the complexity of the test executed and provisions for grouping of the test.
Tests may be waived from narrow supervision if they get together sure necessities recognized by the law The part of the law identifying the criterion for classifying a test as waived was excerpted devoid of explanation in the set of laws at 42 CFR 493.15(b) and 493.15(c) controlled in a catalog of these waived tests. In CLIA test, dipstick and tablet reagent urinalysis are conducted for the following: bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity and urobilinogen. Tests are conducted as per the list and suitable procedures are applied and the valid test results are discussed.