42 CFR § 493.1806 - Available sanctions: All laboratories.

---
identifier: "/us/cfr/t42/s493.1806"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 493.1806 - Available sanctions: All laboratories."
title_number: 42
title_name: "Public Health"
section_number: "493.1806"
section_name: "Available sanctions: All laboratories."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "G"
subchapter_name: "STANDARDS AND CERTIFICATION"
part_number: "493"
part_name: "LABORATORY REQUIREMENTS"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17)."
regulatory_source: "55 FR 9576, Mar. 14, 1990, unless otherwise noted."
cfr_part: "493"
---


# 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.

(2) State onsite monitoring as set forth at § 493.1836.

(3) Civil money penalty, as set forth at § 493.1834.

(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.

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