PRIA, Government Policy, Made Personal

Summary

Within two years after October 24, 1992, the Secretary, through the Centers for Disease Control, must set up standards and steps to approve groups that inspect and certify embryo laboratories. An approved accreditation group can be used by States that run certification programs, or it can certify labs in States without such programs. The rules must require certain reports, records, and how inspections are done. The Secretary must check each approved accreditation group every year by inspecting enough of the labs they approved to judge how well the group is doing and by other methods the Secretary chooses. If approval of an accreditation group is taken away, labs it certified stay certified for 60 days after notice, unless the Secretary extends that time because the lab quickly applied to another approved group.

Title 42, §263a–3

The Public Health and Welfare, Source: USLM XML via OLRC

(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.

(b)The criteria and procedures promulgated under subsection (a) shall include—

(1)requirements for submission of such reports and the maintenance of such records as the Secretary or a State may require, and

(2)requirements for the conduct of inspections under section 263a–2(h) 11 So in original. Probably should be section “263a–2(g)”. of this title.

(c)The Secretary shall evaluate annually the performance of each accreditation organization approved by the Secretary by—

(1)inspecting under section 263a–2(i) 22 So in original. Probably should be section “263a–2(h)”. 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

(2)such other means as the Secretary determines to be appropriate.

(d)If the Secretary revokes approval under section 263a–2(i)(3)(D) 33 So in original. Probably should be section “263a–2(h)(3)(D)”. 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.

Notes & Related Subsidiaries

Editorial Notes

Codification Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Change of Name

Centers for Disease Control changed to Centers for Disease Control and Prevention by Pub. L. 102–531, title III, § 312, Oct. 27, 1992, 106 Stat. 3504.

Effective Date

Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of Pub. L. 102–493, set out as a note under section 263a–1 of this title.

§263a–3 Accreditation Organizations