
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC263a-2]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
                SUBCHAPTER II--GENERAL POWERS AND DUTIES
 
   Part F--Licensing of Biological Products and Clinical Laboratories
 
                    subpart 2--clinical laboratories
 
Sec. 263a-2. Certification of embryo laboratories


(a) In general

                           (1) Development

        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) Consultation

        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) 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

        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) 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) of this section,
            (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\ procedures 
    in the laboratory.
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    \1\ So in original. Probably should be ``reproducible''.
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        (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\ of this section.
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    \2\ So in original. Probably should be subsection ``(f)''.
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(f) Use of accreditation organizations

    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) Inspections

                           (1) In general

        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\ of this section.

                          (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

        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) 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) of this 
    section.

                (2) Access to facilities and records

        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) of this 
    section. 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) 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) of this section, 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
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    \3\ So in original. Probably should be ``deficiencies,''.

            (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

        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) State

        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) Term

    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) \4\ of this section. 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.
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    \4\ So in original. Probably should be subsection ``(g)(2)''.
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(Pub. L. 102-493, Sec. 3, Oct. 24, 1992, 106 Stat. 3146.)

                          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.

                         Change of Name

    Centers for Disease Control changed to Centers for Disease Control 
and Prevention by Pub. L. 102-531, title III, Sec. 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.

                  Section Referred to in Other Sections

    This section is referred to in sections 263a-1, 263a-3, 263a-4, 
263a-5, 263a-6, 263a-7 of this title.
