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Clinical Laboratory Improvement Amendments (42 USC 263a)pdf iconexternal icon
Source: Government Printing Office (GPO) Federal Digital Systemexternal icon.
Source: Government Printing Office (GPO) Federal Digital Systemexternal icon.
What's the easiest way to become an agent and get an IATA (IATAN?). Travel agents must meet certain requirements to be eligible to secure IATA licence. Clinical Laboratory Improvement Amendments (CLIA) In total, CLIA covers approximately 260,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the enter for Clinical Standards and Quality (CCSQ) has.
The Clinical Laboratory Improvement Amendments of 1988 statute is an amendment to the Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing. Two subsequent amendments were made after 1988. The law continues to be cited as CLIA ’88 as named in legislation.
Standards and Certification: Laboratory Requirements (42 CFR 493)external icon
Source: Government Printing Office (GPO) Federal Digital Systemexternal icon.
Source: Government Printing Office (GPO) Federal Digital Systemexternal icon.
The section of the federal regulations titled “Standards and Certification: Laboratory Requirements” is issued by the Centers for Medicare & Medicaid Services (CMS) to enact the CLIA law passed by Congress (see below). In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. The final CLIA regulations were published in 1992, phased in through 1994, and amended in 1993, 1995, and 2003. Visit the CLIA Documents page to search and view the Federal Register Notices and former editions of the Code of Federal Regulations (published annually in October).”
CMS Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Appendix C)external icon
The interpretive guidelines to the CLIA regulations are published in the CMS State Operations Manual (SOM). The SOM is used by state offices to administer various federal programs, such as clinical laboratory certification under the CLIA regulations, and enforced by CMS. It is also a source of guidance to laboratories for interpreting the CLIA regulations.
The interpretive guidelines to the CLIA regulations are published in the CMS State Operations Manual (SOM). The SOM is used by state offices to administer various federal programs, such as clinical laboratory certification under the CLIA regulations, and enforced by CMS. It is also a source of guidance to laboratories for interpreting the CLIA regulations.
- Clinical Laboratory Improvement Act of 1967pdf iconexternal icon (81 Stat. 536, Public Law 90-174, Sec. 5)
- Clinical Laboratory Improvement Amendments of 1988pdf iconexternal icon (102 Stat. 2903, Public Law 100-578)
- Food and Drug Administration Modernization Act of 1997pdf iconexternal icon [111 Stat. 2324, Public Law 105–115, Sec. 123(h)]1
- Taking Essential Steps for Testing Act of 2012pdf iconexternal icon (126 Stat. 1483, Public Law 112-202, Sec. 2)2
1See 1997 changes to CLIA ’88pdf icon
2See 2012 changes to CLIA ’88pdf icon
2See 2012 changes to CLIA ’88pdf icon