Page:United States Statutes at Large Volume 102 Part 3.djvu/958

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PUBLIC LAW 100-000—MMMM. DD, 1988

102 STAT. 2910

PUBLIC LAW 100-578—OCT. 31, 1988 frequency as the Secretary determines to be necessary to assure compliance with such requirements and standards. Inspections of laboratories accredited under subsection (e) shall be conducted on such basis as the Secretary determines is necessary to assure compliance with such requirements and standards.


'(1) IN GENERAL.—If the Secretary determines that a laboratory which has been issued a certificate under this section no longer substantially meets the requirements for the issuance of a certificate, the Secretary may impose intermediate sanctions in lieu of the actions authorized by subsection (i). "(2) TYPES OF SANCTIONS.—The intermediate sanctions which may be imposed under paragraph (1) shall consist of— "(A) directed plans of correction, •'(B) civil money penalties in an amount not to exceed $10,000 for each violation listed in subsection (i)(1) or for each day of substantial noncompliance with the requirements of this section, "(C) payment for the costs of onsite monitoring, or "'(D) any combination of the actions described in subparagraphs (A), (B), and (C). "(3) PROCEDURES.—The Secretary shall develop and implement procedures with respect to when and how each of the intermediate sanctions is to be imposed under paragraph (1). Such procedures shall provide for notice to the laboratory and a reasonable opportunity to respond to the proposed sanction and appropriate procedures for appealing determinations relating to the imposition of intermediate sanctions "(i) SUSPENSION, REVOCATION, AND LIMITATION.—


"(1) IN GENERAL.—Except as provided in paragraph (2), the certificate of a laboratory issued under this section may be suspended, revoked, or limited if the Secretary finds, after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that such owner or operator or any employee of the laboratory— "(A) has been guilty of misrepresentation in obtaining the certificate, "(B) has performed or represented the laboratory as entitled to perform a laboratory examination or other procedure which is not within a category of laboratory examinations or other procedures authorized in the certificate, "(C) has failed to comply with the requirements of subsection (d) or the standards prescribed by the Secretary under subsection (f), "(D) has failed to comply with reasonable requests of the Secretary for— "(i) any information or materials, or "(ii) work on materials, that the Secretary concludes is necessary to determine the laboratory's continued eligibility for its certificate or continued compliance with the Secretary's standards under subsection (f), "(E) has refused a reasonable request of the Secretary, or any Federal officer or employee duly designated by the Secretary, for permission to inspect the laboratory and its