§263a–7. Definitions — Inbound Citations
42 U.S.C. § 263a–7
Cited by 40 provisions in release 119-102.
Citations to 42 U.S.C. § 263a–7 as a whole
-
(a) Effective 2 years after October 24, 1992, each assisted reproductive technology (as defined in section 263a–71 of this title) program shall annually report to the Secretary through the Centers for Disease Control—(1) pregnancy success rates achieved by such program through each assisted reproductive technology, and(2) the identity of each embryo laboratory (as defined in section 263a–71 of this title) used by such program and whether the laboratory is certified under section 263a–2 of this title or has applied for such certification.
-
(2) the identity of each embryo laboratory (as defined in section 263a–71 of this title) used by such program and whether the laboratory is certified under section 263a–2 of this title or has applied for such certification.
-
The Secretary may require the payment of fees for the purpose of, and in an amount sufficient to cover the cost of, administering sections 263a–1 to 263a–7 of this title. A State operating a program under section 263a–2 of this title may require the payment of fees for the purpose of, and in an amount sufficient to cover the costs of, administering its program.
Citations to §263a–7(1)
-
(a) Effective 2 years after October 24, 1992, each assisted reproductive technology (as defined in section 263a–71 of this title) program shall annually report to the Secretary through the Centers for Disease Control—(1) pregnancy success rates achieved by such program through each assisted reproductive technology, and(2) the identity of each embryo laboratory (as defined in section 263a–71 of this title) used by such program and whether the laboratory is certified under section 263a–2 of this title or has applied for such certification.
-
(1) pregnancy success rates achieved by such program through each assisted reproductive technology, and
-
(A) the basic live birth rate calculated for each assisted reproductive technology performed by an assisted reproductive technology program by dividing the number of pregnancies which result in live births by the number of ovarian stimulation procedures attempted by such program, and
-
(B) the live birth rate per successful oocyte retrieval procedure calculated for each assisted reproductive technology performed by an assisted reproductive technology program by dividing the number of pregnancies which result in live births by the number of successful oocyte retrieval procedures performed by such program.
-
(c) In developing the definition under subsection (b), the Secretary shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional services and embryo laboratories associated with assisted reproductive technologies.
-
(2) In developing the certification program under paragraph (1), the Secretary shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional services and embryo laboratories associated with the assisted reproductive technology programs.
-
(B) a report to the State identifying the assisted reproductive technology programs with which the laboratory is associated, and
-
(1) 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) In adopting the certification program, a State 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.
-
(A) 1 pregnancy success rates reported to the Secretary under section 263a–1(a)(1) of this title and, in the case of an assisted reproductive technology program which failed to report one or more success rates as required under such section, the name of each such program and each pregnancy success rate which the program failed to report, and
-
(2) with respect to an individual or family member utilizing an assisted reproductive technology, include genetic information of any embryo legally held by the individual or family member.
-
(2) with respect to an individual or family member utilizing an assisted reproductive technology, include genetic information of any embryo legally held by the individual or family member.
-
(B) with respect to an individual or family member utilizing an assisted reproductive technology, include genetic information of any embryo legally held by the individual or family member.
-
(2) with respect to an individual or family member utilizing an assisted reproductive technology, include genetic information of any embryo legally held by the individual or family member.
Citations to §263a–7(2)
-
(2) the identity of each embryo laboratory (as defined in section 263a–71 of this title) used by such program and whether the laboratory is certified under section 263a–2 of this title or has applied for such certification.
-
(c) In developing the definition under subsection (b), the Secretary shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional services and embryo laboratories associated with assisted reproductive technologies.
-
(1) Not later than 2 years after October 24, 1992, the Secretary, through the Centers for Disease Control, shall develop a model program for the certification of embryo laboratories (referred to in this section as a “certification program”) to be carried out by the States.
-
(2) In developing the certification program under paragraph (1), the Secretary shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional services and embryo laboratories associated with the assisted reproductive technology programs.
-
(1) 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) 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) assurances satisfactory to the State that the embryo laboratory will be 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, and(C) such other information as the State finds necessary.An embryo laboratory which meets the requirements of section 263a of this title shall, for the purposes of subparagraph (A) be considered in compliance with the standards referred to in such subparagraph which are the same as the standards in effect under section 263a of this title.
-
(A) assurances satisfactory to the State that the embryo laboratory will be operated in accordance with the standards under subsection (d),
-
(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.
-
(f) A State which has adopted the certification program may use accreditation organizations approved under section 263a–3 of this title to inspect and certify embryo laboratories.
-
(1) The Secretary may enter and inspect, during regular hours of operation, embryo laboratories—(B) which have been certified by an accreditation organization approved by the Secretary under section 263a–3 of this title,for the purpose of determining whether the laboratory is being operated in accordance with the standards in subsection (d).
-
(2) 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 necessary 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) 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) notify the State in which the laboratory is located and, if appropriate, the accreditation organization which certified the 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 program is reliably identifying the deficiencies of such laboratory, or(ii) the accreditation organization which certified such laboratories is reliably identifying such deficencies,3 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(ii) the accreditation organization which certified such laboratory has not met the requirements of section 263a–3 of this title,
-
(C) conduct additional inspections of other embryo laboratories under paragraph (1) to determine if—(i) such State in carrying out the certification program is reliably identifying the deficiencies of such laboratory, or(ii) the accreditation organization which certified such laboratories is reliably identifying such deficencies,3 and
-
(a) Not later than 2 years after October 24, 1992, the Secretary, through the Centers for Disease Control, shall promulgate criteria and procedures for the approval of accreditation organizations to inspect and certify embryo laboratories. The procedures shall require an application to the Secretary by an accreditation organization for approval. An accreditation organization which has received such an approval—(1) may be used by States in the certification program under section 263a–2 of this title to inspect and certify embryo laboratories, or(2) may certify embryo laboratories in States which have not adopted such a certification program.
-
(1) may be used by States in the certification program under section 263a–2 of this title to inspect and certify embryo laboratories, or
-
(2) may certify embryo laboratories in States which have not adopted such a certification program.
-
(1) inspecting under section 263a–2(i)2 of this title a sufficient number of embryo laboratories accredited by such an organization to allow a reasonable estimate of the performance of such organization, and
-
(d) If the Secretary revokes approval under section 263a–2(i)(3)(D)3 of this title of an accreditation organization after an evaluation under subsection (c), the certification of any embryo laboratory accredited by the organization shall continue in effect for 60 days after the laboratory is notified by the Secretary of the withdrawal of approval, except that the Secretary may extend the period during which the certification shall remain in effect if the Secretary determines that the laboratory submitted an application to another approved accreditation organization for certification after receipt of such notice in a timely manner.
-
(a) A certification issued by a State or an accreditation organization for an embryo laboratory shall be revoked or suspended if the State or organization finds, on the basis of inspections and after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that the owner or operator or any employee of the laboratory—(1) has been guilty of misrepresentation in obtaining the certification,(2) has failed to comply with any standards under section 263a–2 of this title applicable to the certification, or(3) has refused a request of the State or accreditation organization for permission to inspect the laboratory, its operations, and records.
-
(b) If the certification of an embryo laboratory is revoked or suspended, the certification of the laboratory shall continue in effect for 60 days after the laboratory receives notice of the revocation or suspension. If the certification of an embryo laboratory is revoked or suspended, the laboratory may apply for recertification after one year after the date of the revocation or suspension.
-
(i) the identity of each embryo laboratory in a State which has adopted the certification program under such program and whether such laboratory is certified under section 263a–2 of this title,
-
(ii) the identity of each embryo laboratory in a State which has not adopted such certification program and which has been certified by an accreditation organization approved by the Secretary under section 263a–3 of this title, and
-
(iii) in the case of an embryo laboratory which is not certified under section 263a–2 of this title or certified by an accreditation organization approved by the Secretary under section 263a–3 of this title, whether the laboratory applied for certification.