Clinical laboratory Improvement Amendments - wikipedia Clinical laboratory Improvement Amendments `` CLIA '' redirects here. For trade association, see Cruise Lines International Association. 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. Contents 1 CLIA Program 2 CLIA Waived Tests 3 See also 4 References CLIA Program 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 : diagnosis, prevention, or treatment of disease or impairment Health assessments An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. 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 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 : Knowledge Training and experience Reagents and materials preparation Characteristics of operational steps Calibration, quality control, and proficiency testing materials Test system troubleshooting and equipment maintenance Interpretation and judgment 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. The CLIA Program is funded by user fees collected from approximately 200,000 laboratories, most located in the United States. CLIA waived tests Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver. In November 2007, the CLIA waiver provisions were revised by the United States Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver, although many waived tests are not done according to designed protocols -- more than 50 % of such tests are done incorrectly -- and result in medical errors, some with fatal consequences. See also Medical technologist References Jump up ^ CLIA related Federal Register and Code of Federal Regulation Announcements, and the FDA 's Clinical Laboratory Improvement Amendments ( CLIA ). Accessed Nov. 14, 2015. Jump up ^ CLIA Program homepage Jump up ^ CLIA Categorization Criteria ( December 2012 ) Jump up ^ CLIA Overview ( March 2007 ) Jump up ^ CLIA Waived Testing booklet ( December 2012 ) Jump up ^ CLIA Waived IVD Regulatory Assistance ( November 2007 ) Jump up ^ Gabler, Ellen, Hidden Errors - A Watchdog Report - Common medical tests escape scrutiny but often fall short, Milwaukee Journal Sentinel, Oct 31, 2015. Accessed Nov 15, 2015. Retrieved from `` https://en.wikipedia.org/w/index.php?title=Clinical_Laboratory_Improvement_Amendments&oldid=768612896 '' Categories : Health standards Standards organizations Safety Health in the United States Medicare and Medicaid ( United States ) Organizations established in 1988 Hidden categories : All articles with dead external links Articles with dead external links from January 2017 Talk Contents About Wikipedia Add links This page was last edited on 4 March 2017, at 21 : 00. Text is available under the Creative Commons Attribution - ShareAlike License ; additional terms may apply. By using this site, you agree to the Terms of Use and Privacy Policy. Wikipedia ® is a registered trademark of the Wikimedia Foundation, Inc., a non-profit organization. About Wikipedia

Question: the objective of the clinical laboratory improvement amendments (clia) is
Answer: sets standards and issues certificates for clinical laboratory testing