Page:United States Statutes at Large Volume 106 Part 4.djvu/411

 PUBLIC LAW 102-493—OCT. 24, 1992 106 STAT. 3147 (1) DEVELOPMENT. —Not later than 2 years after the date of the enactment of this Act, the Secretary, through the Centers for Disease Control, shall develop a model program for the certification of embiyo laboratories (referred to in this section as a "certification program**) to be carried out by th$ States. (2) CONSULTATION. —In developing the certification program under paragraph (1), the Secretary shall consult with appropriate consumer and professional organizations with expertise m using, providing, and evaluating professional services and embryo laboratories cuisociated with the assisted reproductive technology programs. (b) DISTRIBUTION.— The Secretary shall distribute a description of the certification program to— (1) the Governor of each State, (2) the presiding officers of each State legislature, (3) the public health official of each State, and (4) the official responsible in each State for the operation of the State's contract with the Secretary under section 1864 of the Social Security Act, and shall encourage such officials to assist in the State adopting such program. (c) IU:QUIREMENTS. —The certification program shall include the following requirements: (1) ADMINISTRATION.— The certification program shall be administered by the State and shall provide for the inspection and certification of embryo laboratories in the State by the State or by approved accreditation organizations. (2) APPLICATION REQUIREMENTS.— The certification program shall provide for the submission of an application to a State by an embryo laboratory for certification, in such form as may be specified by the State. Such an application shall include— (A) assurcuices satisfactory to uie State that the embryo laboratory will he operated in accordance with the standards under subsection (d), (B) a report to the State identifying the assisted reproductive technology programs with which the laboratory is associated, ana (C) such other information as the State finds necessary. An embryo laborato^ which meets the requirements of section 353 of the Public health Service Act shall, for the purposes of subparagraph (A) be considered in compliance with the standards refeiried to in such subparagraph which are the same as the standards in effect under such section 353. (d) STANDARDS. — The certification program shall include the following standards developed by the Secretary: (1) A standard to assure consistent performance of procedures by each embryo laboratory certified under the certification program or by an approved accreditation organization in a State which has not adopted the certification program. (2) A standard for a quaUty assurance and a quality control program to assure valid, reliable, and reproduceable procedures m the laboratory. (3) A standard for the maintenance of records (on a program by program basis) on laboratory tests and procedures performed, including the scientific basis of, and the methodology used for, the tests, procedures, and preparation of any standards or controls, criteria for acceptaSle and imacceptable out-

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