Page:United States Statutes at Large Volume 106 Part 4.djvu/412

 106 STAT. 3148 PUBLIC LAW 102-493—OCT. 24, 1992 Public information. Public information. comes, criteria for sample rejection, and procedures for safe sample disposal. (4) A standard for the maintenance of written records on personnel and facilities necessary for proper and effective operation of the laboratory, schedules of preventive maintenance, function verification lor equipment, and the release of such records to the State ujpon demand. (5) A standard for the use of such personnel who meet such qualifications as the Secretary may develop. (e) CERTIFICATION UNDER STATE PROGRAMS. — A State may qiialify to adopt the certification program if the State has submitted an application to the Secretary to adopt such program and the Secretary has approved the application. Such an application shall include— (1) assurances by the State satisfactory to the Secretary that the certification program within the State meets the requirements of this section, (2) an agreement to make such reports as the Secretary may require, and (3) information about any proposed use of accreditation organizations under subsection (g). (f) USE OF ACCREDITATION ORGANIZATIONS. —A State which has adopted the certification program may use accreditation organizations approved under section 4 to inspect and certify embryo laboratories. (g) INSPECTIONS.— (1) IN GENERAL. —^A State which qualifies to adopt the certification program within the State shall conduct inspections in accordance with paragraph (2) to determine if laboratories in the State meet the requirements of such program. Such inspections shall be carried out by the State or by accreditation organizations used by the State under subsection (g). (2) REQUIREMENTS. —Inspections carried out under paragraph (1) shall— (A) be periodic and imannounced, or (B) be announced in such circumstances as the Secretary determines will not diminish the likelihood of discovering deficiencies in the operations of a laboratory. Before making a determination under subparagraph (B), the Secretary shall make public, in such manner as to facilitate comment from any person (including any Federal or other public agency), a proposal indicating the circumstances under which announced inspections would be permitted. (3) RESULTS.— The specific nndings, including deficiencies, identified in an inspection carried out under paragraph (1) and any subsequent corrections to those deficiencies shall be announced and made available to the public upon request beginning no later than 60 days after the date of the inspection, (h) VALIDATION INSPECTIONS. — (1) IN GENERAL.— The Secretary may enter and inspect, during regular hours of operation, embiyo laboratories— (A) which have been certified by a State under the certification program, or (B) which nave been certified by an accreditation organization approved by the Secretary under section 4, for the purpose of determining whether the laboratory is being operated in accordance with the standards in subsection (d).

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