Page:United States Statutes at Large Volume 102 Part 3.djvu/953

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PUBLIC LAW 100-000—MMMM. DD, 1988

PUBLIC LAW 100-578—OCT. 31, 1988

102 STAT. 2905

with respect to examinations and procedures which are described in paragraph (3), the laboratory shall report such changes to the Secretary not later than 6 months after the change has been put into effect. If a laboratory proposes to make changes in the examinations and procedures performed by it such that the laboratory will perform an examination or procedure not described in paragraph (3), the laboratory shall report such change to the Secretary before the change takes effect. "(C) EFFECT.—Subsections (f) and (g) shall not apply to a laboratory to which has been issued a certificate of waiver. "(3) EXAMINATIONS AND PROCEDURES.—The examinations and

procedures identified in paragraph (2) are simple laboratory examinations and procedures which, as determined by the Secretary, have an insignificant risk of an erroneous result, including those which— "(A) have been approved by the Food and Drug Administration for home use, "(B) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible, or "(C) the Secretary has determined pose no reasonable risk of harm to the patient if,performed incorrectly. "(4) DEFINITION.—As used in this section, the term 'certificate' includes a certificate of waiver issued under paragraph (2). "(e) ACCREDITATION.—

"(1) IN GENERAL.—A laboratory may be accredited for purposes of obtaining a certificate if the laboratory— "(A) meets the standards of an approved accreditation body, and "(B) authorizes the accreditation body to submit to the Secretary (or such State agency as the Secretary may designate) such records or other information as the Secretary may require. "(2) APPROVAL OF ACCREDITATION BODIES.—

"(A) IN GENERAL.—The Secretary may approve a private nonprofit organization to be an accreditation body for the accreditation of laboratories if^ "(i) using inspectors qualified to evaluate the methodologies used by the laboratories in performing laboratory examinations and other procedures, the accreditation body agrees to inspect a laboratory for purposes of accreditation with such frequency as determined by Secretary, "(ii) the standards applied by the body in determining whether or not to accredit a laboratory are equal to or more stringent than the standards issued by the Secretary under subsection (f), "(iii) there is adequate provision for assuring that the standards of the accreditation body continue to be met by the laboratory, "(iv) in the case of any laboratory accredited by the body which has had its accreditation denied, suspended, withdrawn, or revoked or which has had any other action taken against it by the accrediting body, the accrediting body agrees to submit to the Secretary the