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. § 493.1812

Action when deficiencies pose immediate jeopardy

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If a laboratory's deficiencies pose immediate jeopardy, the following rules apply:

(a) CMS requires the laboratory to take immediate action to remove the jeopardy and may impose one or more alternative sanctions to help bring the laboratory into compliance.

(b) If the findings of a revisit indicate that a laboratory has not eliminated the jeopardy, CMS suspends or limits the laboratory's CLIA certificate no earlier than 5 days after the date of notice of suspension or limitation. CMS may later revoke the certificate.

(c) In addition, if CMS has reason to believe that the continuation of any activity by any laboratory (either the entire laboratory operation or any specialty or subspecialty of testing) would constitute a significant hazard to the public health, CMS may bring suit and seek a temporary injunction or restraining order against continuation of that activity by the laboratory, regardless of the type of CLIA certificate the laboratory has and of whether it is State-exempt.

Notes of Decisions
Cited in 1 case, 2020–2020 · leading case: Gamma Healthcare, Inc. v. United States Dep't of Health & Human Servs. (W.D. Mo. 2020).
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Gamma Healthcare, Inc. v. United States Dep't of Health & Human Servs. (W.D. Mo. 2020). · cites it 2× “42 C.F.R. § 493.1812 (a). If the findings of a revisit to the lab indicate that the lab has not eliminated the imminent and serious risk to human health, the Centers for Medicare & Medicaid Services (CMS) suspends or limits the lab’s federal certification.”
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