---
kind: "section"
citation: "42 C.F.R. § 493.1810"
title: "42"
number: "493.1810"
heading: "Imposition and lifting of alternative sanctions."
url: "https://uscodex.org/cfr/42/493.1810"
---

# §493.1810. Imposition and lifting of alternative sanctions.

- (a) **Notice of noncompliance and of proposed sanction: Content.** If CMS or its agency identifies condition level noncompliance in a laboratory, CMS or its agent gives the laboratory written notice of the following:
  - (1) **The condition level noncompliance that it has identified.**
  - (2) **The sanction or sanctions that CMS or its agent proposes to impose against the laboratory.**
  - (3) **The rationale for the proposed sanction or sanctions.**
  - (4) **The projected effective date and duration of the proposed sanction or sanctions.**
  - (5) **The authority for the proposed sanction or sanctions.**
  - (6) **The time allowed (at least 10 days) for the laboratory to respond to the notice.**
- (b) **Opportunity to respond.** During the period specified in [paragraph (a)(6)](#a-6) of this section, the laboratory may submit to CMS or its agent written evidence or other information against the imposition of the proposed sanction or sanctions.
- (c) **Notice of imposition of sanction—**
  - (1) **Content.** CMS gives the laboratory written notice that acknowledges any evidence or information received from the laboratory and specifies the following:
    - (i) **The sanction or sanctions to be imposed against the laboratory.**
    - (ii) **The authority and rationale for the imposing sanction or sanctions.**
    - (iii) **The effective date and duration of sanction.**
  - (2) **Timing.**
    - (i) If CMS or its agent determines that the deficiencies pose immediate jeopardy, CMS provides notice at least 5 days before the effective date of sanction.
    - (ii) If CMS or its agent determines that the deficiencies do not pose immediate jeopardy, CMS provides notice at least 15 days before the effective date of the sanction.
- (d) **Duration of alternative sanctions.** An alternative sanction continues until the earlier of the following occurs:
  - (1) **The laboratory corrects all condition level deficiencies.**
  - (2) **CMS's suspension, limitation, or revocation of the laboratory's CLIA certificate becomes effective.**
- (e) **Lifting of alternative sanctions—**
  - (1) **General rule.** Alternative sanctions are not lifted until a laboratory's compliance with all condition level requirements is verified.
  - (2) **Credible allegation of compliance.** When a sanctioned laboratory submits a credible allegation of compliance, CMS's agent determines whether—
    - (i) It can certify compliance on the basis of the evidence presented by the laboratory in its allegation; or
    - (ii) It must revisit to verify whether the laboratory has, in fact, achieved compliance.
  - (3) **Compliance achieved before the date of revisit.** If during a revisit, the laboratory presents credible evidence (as determined by CMS or its agent) that it achieved compliance before the date of revisit, sanctions are lifted as of that earlier date.

## Notes

### 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.