---
kind: "section"
citation: "42 C.F.R. § 493.1101"
title: "42"
number: "493.1101"
heading: "Standard: Facilities."
url: "https://uscodex.org/cfr/42/493.1101"
---

# §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.

## Notes

### Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

### Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.