42 U.S.C. § 263a–2 — Certification of embryo laboratories

(a) Development and consultation: Within 2 years of October 24, 1992, the Secretary, through the Centers for Disease Control, must develop a model program, carried out by the States, for certifying embryo laboratories (a "certification program"). In developing it, the Secretary must consult with appropriate consumer and professional organizations experienced with assisted reproductive technology programs and embryo laboratories. (b) Distribution: The Secretary must distribute a description of the certification program to each State's governor, the presiding officers of each state legislature, each state's public health official, and the official responsible for the State's contract with the Secretary under section 1395aa of this title — and must encourage these officials to help the State adopt the program. (c) Requirements: The certification program must be administered by the State, with inspection and certification of embryo laboratories done by the State or by approved accreditation organizations, and must let an embryo laboratory apply to the State for certification, in the form the State specifies. The application must include assurances that the laboratory will follow the standards in subsection (d), a report identifying the assisted reproductive technology programs the laboratory works with, and any other information the State finds necessary. A laboratory that already meets the requirements of section 263a of this title is considered, for these assurance purposes, to already meet the same standards. (d) Standards: The certification program must include standards, developed by the Secretary, covering: consistent performance of procedures by each certified laboratory or approved accreditation organization; a quality assurance and quality control program for valid, reliable, reproducible procedures; maintaining, program by program, records on tests and procedures performed, including their scientific basis and methodology, the standards or controls used, criteria for acceptable and unacceptable outcomes, criteria for rejecting samples, and procedures for safely disposing of samples; maintaining written records on personnel and facilities needed for proper operation, preventive maintenance schedules, equipment function checks, and releasing these records to the State on demand; and personnel qualifications the Secretary develops. (e) Certification under State programs: A State may qualify to adopt the certification program by applying to the Secretary for approval. The application must include the State's assurances that its program meets this section's requirements, an agreement to file reports the Secretary requires, and information about any planned use of accreditation organizations. (f) Use of accreditation organizations: A State that has adopted the certification program may use accreditation organizations approved under section 263a–3 of this title to inspect and certify embryo laboratories. (g) Inspections: A State that qualifies to run the certification program must conduct inspections — carried out by the State or by its accreditation organizations — to check whether laboratories meet the program's requirements. These inspections must be periodic and unannounced, or announced only in circumstances the Secretary determines will not reduce the odds of finding deficiencies (before deciding this, the Secretary must publish a proposal and let the public comment). The specific findings, including any deficiencies, from an inspection, and any later corrections, must be announced and made available to the public on request, starting no later than 60 days after the inspection. (h) Validation inspections: The Secretary may enter and inspect, during regular operating hours, any embryo laboratory certified by a State under the certification program or certified by an accreditation organization the Secretary approved, to determine whether it operates according to the standards in subsection (d). During such an inspection the Secretary has access to all relevant facilities, equipment, materials, records, and information, may copy material or require it be submitted, and may inspect only after presenting identification to the laboratory's owner, operator, or agent in charge. If the Secretary finds through inspection that a laboratory does not comply with subsection (d)'s standards, the Secretary must notify the State (and, if applicable, the accreditation organization that certified the laboratory), make the inspection results public, conduct additional inspections of other laboratories to determine whether the State or the accreditation organization is reliably identifying deficiencies, and, if the Secretary determines the State's program or the accreditation organization is not meeting its requirements, may revoke approval of the State's certification program or of the accreditation organization. (i) Limitation: In developing the certification program, the Secretary may not establish any regulation, standard, or requirement that amounts to supervising or controlling the practice of medicine in assisted reproductive technology programs. A State adopting the certification program is subject to the same limit. (j) Term: The term of a certification issued by a State or an accreditation organization is set by the Secretary as part of the certification program, through the public comment process described in subsection (h)(2). The Secretary must provide an application for recertification, to be submitted whenever ownership of a certified laboratory changes or its administration changes.