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Current as of January 02, 2025 | Updated by Findlaw Staff
(a) The laboratory must be constructed, arranged, and maintained to ensure the following:
(1) The space, ventilation, and utilities necessary for conducting all phases of the testing process.
(2) Contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized.
(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation.
(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs.
(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements.
(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials.
(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation.
Cite this article: FindLaw.com - Code of Federal Regulations Title 42. Public Health § 42.493.1101 Standard: Facilities - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-42-public-health/cfr-sect-42-493-1101/
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.
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