§263a–2 — Title 42 The Public Health and Welfare | U.S. Code

§263a–2 Certification of embryo laboratories

Title 42 › Chapter CHAPTER 6A— - PUBLIC HEALTH SERVICE › Subchapter SUBCHAPTER II— - GENERAL POWERS AND DUTIES › Part Part F— - Licensing of Biological Products and Clinical Laboratories › Subpart subpart 2— - clinical laboratories › § 263a–2

Last updated Apr 6, 2026|Official source

Summary

Requires the Secretary, through the Centers for Disease Control, to create a model program for certifying embryo laboratories within 2 years after October 24, 1992. The Secretary must talk with consumer and professional groups while making the program, and must send a description of it to each State’s Governor, legislative leaders, public health official, and the official who handles the State’s contract under section 1395aa. The program is meant to be run by each State and lets States either inspect and certify labs themselves or use approved accreditation organizations. A lab’s application for certification must promise to follow the standards, list the assisted reproductive technology programs it works with, and give any other information the State asks for. The Secretary must set standards that include consistent lab procedures; quality assurance and quality control; record keeping about tests, methods, outcomes, and safe disposal; written records on staff, facilities, and equipment maintenance; and staff qualifications. A State must apply and be approved by the Secretary to use the model program and may use accreditation organizations approved under section 263a–3. Inspections must be periodic and either unannounced or only announced when doing so won’t hide problems. Inspection findings and fixes must be made public on request no later than 60 days after the inspection. The Secretary can also inspect certified labs during regular hours, review and copy records, and must show ID. If a lab fails to meet standards, the Secretary must tell the State and the accreditor, make the results public, and do extra inspections to see if the State or accreditor are catching problems. Neither the Secretary nor a State may use the program to regulate the practice of medicine in assisted reproductive technology. The Secretary sets how long a certification lasts and must provide a recertification application when lab ownership or administration changes.

Title 42, §263a–2

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

(a)(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.

(b)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 1395aa of this title,

(c)The certification program shall include the following requirements:

(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.

(d)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 quality assurance and a quality control program to assure valid, reliable, and reproduceable 11 So in original. Probably should be “reproducible”. procedures in 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 acceptable and unacceptable outcomes, 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 for equipment, and the release of such records to the State upon demand.

(5)A standard for the use of such personnel who meet such qualifications as the Secretary may develop.

(e)A State may qualify 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).22 So in original. Probably should be subsection “(f)”.

(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.

(g)(1)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

(2)Inspections carried out under paragraph (1) shall—

(A)be periodic and unannounced, 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.

(3)The specific findings, 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)(1)The Secretary may enter and inspect, during regular hours of operation, embryo laboratories—

(A)which have been certified by a State under the certification program, or

(B)which have been certified by an accreditation organization approved by the Secretary under section 263a–3 of this title,

(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,33 So in original. Probably should be “deficiencies,”. 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,

(i)(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.

(j)The term of a certification issued by a State or an accreditation organization in a State shall be prescribed by the Secretary in the certification program and shall be valid for a period of time to be defined by the Secretary through the public comment process described in subsection (h)(2).44 So in original. Probably should be subsection “(g)(2)”. The Secretary shall provide an application for recertification to be submitted at the time of changes in the ownership of a certified laboratory or changes in the administration of such a laboratory.

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.