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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. [1]
CFR Title 42 - Public Health is one of fifty titles comprising the United States Code of Federal Regulations (CFR). Title 42 is the principal set of rules and regulations issued by federal agencies of the United States regarding public health, including respirator rules and regulations moved from CFR Title 30 (including MSHA), to the Public Health Service (including NIOSH and the CDC).
Tests that are already cleared or approved for home use or are waived by 42 CRF 293.15(c), are classified as waived. [ 36 ] [ 37 ] Otherwise, the tests are either classified as moderate or high complexity based on seven categorization criteria listed in 42 CFR 493.17. [ 38 ]
Download as PDF; Printable version; In other projects Wikidata item; Appearance. move to sidebar hide. CLIA may refer to: Chemiluminescent immunoassay ...
This image is a work of the United States Department of Health and Human Services, taken or made as part of that person's official duties. As a work of the U.S. federal government , the image is in the public domain .
10 years [15] Cytology, apart from fine needle aspiration: 5 years [16] Paraffin-embedded blocks Non-forensic: 2 [16] or 10 years [15] Forensic: Indefinite [16] Requisition form and test report Pathology reports: 10 years [16] Other: 2 years [16] Blood bank records Quality control records: 5 years [15] Donor and recipient records: 10 years [15]
VII part C, established a system of patient safety organizations and a national patient safety database. To encourage reporting and broad discussion of adverse events, near misses , and dangerous conditions, it also established privilege and confidentiality protections for Patient Safety Work Product (as defined in the act).
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]