42 USC 263a-2 - Certification of embryo laboratories

U.S Code last checked for updates: Nov 22, 2024

§ 263a–2.

Certification of embryo laboratories

(a)

In general

(1)

Development

(2)

Consultation

(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 1395aa of this title,

and shall encourage such officials to assist in the State adopting such program.

(c)

Requirements

The certification program shall include the following requirements:

(1)

Administration

(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)

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.

(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 quality assurance and a quality control program to assure valid, reliable, and reproduceable 1

 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)

Certification under State programs

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).2

 So in original. Probably should be subsection “(f)”.

(f)

Use of accreditation organizations

(g)

Inspections

(1)

In general

(2)

Requirements

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.

Before making a determination under subparagraph (B), the Secretary shall make public, in such manner as to facilitate comment from any person (including any Federal or other public agency), a proposal indicating the circumstances under which announced inspections would be permitted.

(3)

Results

(h)

Validation inspections

(1)

In general

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,

for the purpose of determining whether the laboratory is being operated in accordance with the standards in subsection (d).

(2)

Access to facilities and records

(3)

Failure to comply

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

 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,

the Secretary may revoke the approval of the State certification program or revoke the approval of such accreditation organization.

(i)

Limitation

(1)

Secretary

(2)

State

(j)

Term

(Pub. L. 102–493, § 3, Oct. 24, 1992, 106 Stat. 3146.)

cite as: 42 USC 263a-2