---
kind: "section"
citation: "42 C.F.R. § 493.1806"
title: "42"
number: "493.1806"
heading: "Available sanctions: All laboratories."
url: "https://uscodex.org/cfr/42/493.1806"
---

# §493.1806. Available sanctions: All laboratories.

- (a) **Applicability.** CMS may impose one or more of the sanctions specified in this section on a laboratory that is out of compliance with one or more CLIA conditions.
- (b) **Principal sanction.** CMS may impose any of the three principal CLIA sanctions, which are suspension, limitation, or revocation of any type of CLIA certificate.
- (c) **Alternative sanctions.** CMS may impose one or more of the following alternative sanctions in lieu of or in addition to imposing a principal sanction, except on a laboratory that has a certificate of waiver.
  - (1) Directed plan of correction, as set forth at [§ 493.1832](/cfr/42/493.1832.md).
  - (2) State onsite monitoring as set forth at [§ 493.1836](/cfr/42/493.1836.md).
  - (3) Civil money penalty, as set forth at [§ 493.1834](/cfr/42/493.1834.md).
- (d) **Civil suit.** CMS may bring suit in the appropriate U.S. District Court to enjoin continuation of any activity of any laboratory (including a CLIA-exempt laboratory that has been found with deficiencies during a validation survey), if CMS has reason to believe that continuation of the activity would constitute a significant hazard to the public health.
- (e) **Criminal sanctions.** Under section 353(1) of the PHS Act, an individual who is convicted of intentionally violating any CLIA requirement may be imprisoned or fined.

## Notes

### Amendments

[57 FR 7237, Feb. 28, 1992, as amended at 58 FR 5237, Jan. 19, 1993]

### Source

Source: 57 FR 7237, Feb. 28, 1992, 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.

### Amendments

[57 FR 7237, Feb. 28, 1992, as amended at 58 FR 5237, Jan. 19, 1993]