Title 42 Part 493 → Subpart J → §493.1101

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart J → §493.1101

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart J → §493.1101

e-CFR data is current as of January 16, 2020

Title 42Chapter IVSubchapter GPart 493Subpart J → §493.1101

Title 42: Public Health
Subpart J—Facility Administration for Nonwaived Testing

§493.1101   Standard: Facilities.

(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.