Code of Federal Regulations Title 42. Public Health § 42.493.1810 Imposition and lifting of alternative sanctions

(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.

(1) Content. CMS gives the laboratory written notice that acknowledges any evidence or information received from the laboratory and specifies the following:

(2) Timing.

(1) The laboratory corrects all condition level deficiencies.

(2) CMS's suspension, limitation, or revocation of the laboratory's CLIA certificate becomes effective.

(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—

(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.