42 CFR § 493.1806 - Available sanctions: All laboratories.
(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.
(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.