C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER G—STANDARDS AND CERTIFICATION › PART 493—LABORATORY REQUIREMENTS › Subpart R—Enforcement Procedures

42 C.F.R. § 493.1806

Available sanctions: All laboratories

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(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]
Notes of Decisions
Cited in 3 cases, 2007–2020 · leading case: Ali v. United States Dep't of Health & Human Servs., 235 F. App'x 676 (9th Cir. 2007).
Sort: Relevance Newest Treatment
Ali v. United States Dep't of Health & Human Servs., 235 F. App'x 676 (9th Cir. 2007). · cites it 2× “See 42 C.F.R. § 493.1806 (b) (enumerating revocation of CLIA certification as an appropriate sanction for condition-level violations); 42 C.”
Gamma Healthcare, Inc. v. United States Dep't of Health & Human Servs. (W.D. Mo. 2020). “42 C.F.R. § 493.1806 . The two categories of sanctions get meted out against varying levels and patterns of noncompliance, and federal regulations generally guide the considerations in determining appropriate sanctions.”
Ali v. United States Dep't of Health & Human Servs., 240 F. App'x 211 (9th Cir. 2007). “See 42 C.F.R. § 493.1806 (c) (allowing for intermediate sanctions “in addition to” principal sanctions).”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.