Page:United States Statutes at Large Volume 102 Part 3.djvu/952

 102 STAT. 2904

PUBLIC LAW 100-578—OCT. 31, 1988 "(I) the number and types of laboratory examinations and other procedures performed, "(11) the methodologies for laboratory examinations and other procedures employed, and "(III) the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and "(iii) that contains such other information as the Secretary may require to determine compliance with this section, and the laboratory agrees to provide to the Secretary (or if the laboratory is accredited, to the accreditation body which accredited it) a description of any change in the information submitted under clause (ii) not later than 6 months after the change was put into effect, "(B) the laboratory provides the Secretary— "(i) with satisfactory assurances that the laboratory will be operated in accordance with standards issued by the Secretary under subsection (f), or "(ii) with proof of accreditation under subsection (e), "(C) the laboratory agrees to permit inspections by the Secretary under subsection (g), "(D) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may reasonably require, and "(E) the laboratory agrees to treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business. "(2) REQUIREMENTS FOR CERTIFICATES OF WAIVER.—

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Reports.

"(A) IN GENERAL.—A laboratory which only performs laboratory examinations and procedures described in paragraph (3) shall be issued a certificate of waiver or have its certificate of waiver renewed if— "(i) the laboratory submits an application— "(I) in such form and manner as the Secretary shall prescribe, "(II) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory, including the number and types of laboratory examinations and other procedures performed, the methodologies for laboratory examinations and other procedures employed, and the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and "(III) that contains such other information as the Secretary may reasonably require to determine compliance with this section, and "(ii) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may require. "(B) CHANGES.—If a laboratory makes changes in the examinations and other procedures performed by it only

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