Page:United States Statutes at Large Volume 106 Part 4.djvu/413

 PUBLIC LAW 102-493—OCT. 24, 1992 106 STAT. 3149 (2) ACCESS TO FACiunES AND RECORDS. —In conducting an inspection of an embryo laboratory under paragraph (1), the Secretary shall have access to all facilities, equipment, materials, records, and information which the Secretary determines is necessanr to determine if such laboratory is being operated in accordance with the standards in subsection (d). As part of such an inspection, the Secretary may copy any material, record, or information inspected or require it to be submitted to the Secretary. Such an inspection may be made only upon the presentation of identification to the owner, operator, or agent in charge of the laboratory being inspected. (3) FAILURE TO COMPLY. — If the Secretary determines as a result of an inspection under paragraph (1) that the embryo laboratory is not in compliance with the standards in subsection (d), the Secretary shall— (A) not^ the State in which the laboratory is located and, if appropriate, the accreditation organization which certified uie laboratory, (B) make available to the public the results of the inspection, (C) conduct additional inspections of other embryo laboratories under paragraph (1) to determine if— (i) such State in carrying out the certification pro- Sam is reliably identi^ong the deficiencies of such poratory, or (ii) the accreditation organization which certified such laboratories is reliably identifying such deficencies, and (D) if the Secretary determines— (i) that such State in carrying out the certification program has not met the requirements applicable to such program, or (li) me accreditetion organization which certified such laboratory has not met the requirements of section 4, the Secretary may revoke the approval of the State certification program or revoke the approval of such accreditation organization, (i) LIMITATION. — (1) SECRETARY. —In developing the certification program, the Secretary may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs. (2) STATE.— In adopting the certification program, a State may not esteblish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs. (j) TERM.— The term of a certification issued by a State or an accreditetion organization in a State shall be prescribed by the Secretary in the certification program and shall be valid for a period of time to be defined by the Secretary through the public comment process described in subsection (h)(2). The Secretary shall provide an application for recertification to be submitted at the time of changes in the ovniership of a certified laboratory or changes in the administration of such a laboratory.

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