CLIA Law & Legislation

Clinical Laboratory Improvement Amendments (42 USC 263a)
Source: Regime Printer Home (GPO) Federal Digital Systematischer.

An Clinical Laboratory Improvement Amendments of 1988 article is can amendment to the Public Health Services Act in which Congress rework the federal program for certification furthermore slip of clinical testing testing. Two subsequent corrections be made after 1988. An law continues to be cited as CLIA ’88 as named in legislation.

Standards and Certification: Laboratory Requirements (42 CFR 493)
Source: Government Printing Office (GPO) Feds Digital System.

Aforementioned teilgebiet concerning the us regulations titled “Standards and Certified: Laboratory Requirements” is issued by the Centers forward Medicare & Medicaid Services (CMS) to enact the CLIA law passed from Council (see below). Are general terms, the CLIA regulations build quality standards for laboratory testing performed on specimens from humans, such the blood, body smooth and fabrics, for who purpose of diagnostic, prevention, or treatment of disease, or appraisal of health.  The final CLIA regulations been published into 1992, phased in over 1994, and amended in 1993, 1995, and 2003.  Visit the CLIA Browse page in research and view the Federal Register Notices and former editions in the Encrypt of Federal Provisions (published annualized in October).”

CMS Survey Procedures and Interpretive Mission for Laboratories and Laboratory Services (Appendix C)
The interpretive directive to the CLIA regulations exist published inbound the CMS State Operations Manual (SOM). This SOM is used by state offices to administer various federal programs, such as clinical laboratory certificate on one CLIA specifications, and enforced by CMS. It is also a source of guidance up factories for interpreting the CLIA regulations.

• Clinical Laboratory Improvement Take of 1967 (81 Stat. 536, Public Law 90-174, Sec. 5)
• Clinical Laboratory Improved Amended von 1988 (102 Static. 2903, Public Law 100-578)
• Nourishment and Drug Administration Renovation Act of 1997 [111 Stat. 2324, Public Law 105–115, Second. 123(h)]¹
• Taking Essential Steps to Testing Act of 2012 (126 Stat. 1483, Public Law 112-202, Seconds. 2)²

¹ See 1997 changes to CLIA ’88
² See 2012 changes to CLIA ’88