Page:United States Statutes at Large Volume 102 Part 3.djvu/959

 PUBLIC LAW 100-578—OCT. 31, 1988

102 STAT. 2911

operations and pertinent records during the hours the laboratory is in operation, "(F) has violated or aided and abetted in the violation of any provisions of this section or of any regulation promulgated thereunder, or "(G) has not complied with an intermediate sanction imposed under subsection (h). "(2) ACTION BEFORE A HEARING.—If the Secretary determines that— "(A) the failure of a laboratory to comply with the stand- Safety. ards of the Secretary under subsection (f) presents an imminent and serious risk to human health, or "(B) a laboratory has engaged in an action described in subparagraph (D) or (E) of paragraph (1), the Secretary may suspend or limit the certificate of the laboratory before holding a hearing under paragraph (1) regarding such failure or refusal. The opportunity for a hearing shall be provided no later than 60 days from the effective date of the suspension or limitation. A suspension or limitation under this paragraph shall stay in effect until the decision of the Secretary made after the hearing under paragraph (1). "(3) INELIGIBILITY TO OWN OR OPERATE LABORATORIES AFTER

REVOCATION.—No person who has owned or operated a laboratory which has had its certificate revoked may, within 2 years of the revocation of the certificate, own or operate a laboratory for which a certificate has been issued under this section. The certificate of a laboratory which has been excluded from participation under the medicare program under title XVIII of the Social Security Act because of actions relating to the quality of the laboratory shall be suspended for the period the laboratory is so excluded. "(4) IMPROPER REFERRALS.—Any laboratory that the Secretary determines intentionally refers its proficiency testing samples to another laboratory for analysis shall have its certificate revoked for at least one year and shall be subject to appropriate fines and penalties as provided for in subsection (h). "(j) INJUNCTIONS.—Whenever the Secretary has reason to believe that continuation of any activity by a laboratory would constitute a significant hazard to the public health the Secretary may bring suit in the district court of the United States for the district in which such laboratory is situated to enjoin continuation of such activity. Upon proper showing, a temporary injunction or restraining order against continuation of such activity pending issuance of a final order under this subsection shall be granted without bond by such court.

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"(k) JUDICIAL REVIEW.—

"(1) PETITION.—Any laboratory which has had an intermediate sanction imposed under subsection (h) or has had its certificate suspended, revoked, or limited under subsection (i) may, at any time within 60 days after the date the action of the Secretary under subsection (i) or (h) becomes final, file a petition with the United States court of appeals for the circuit wherein the laboratory has its principal place of business for judicial review of such action. As soon as practicable after receipt of the petition, the clerk of the court shall transmit a copy of the petition to the Secretary or other officer designated by the Secretary for that purpose. As soon as practicable after receipt Records.

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