Page:United States Statutes at Large Volume 102 Part 3.djvu/951

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PUBLIC LAW 100-000—MMMM. DD, 1988

PUBLIC LAW 100-578—OCT. 31, 1988

Public Law 100-578 100th Congress

102 STAT. 2903

An Act To amend the Public Health Service Act to revise the authority for the regulation of clinical laboratories.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE.

This Act may be cited as the "Clinical Laboratory Improvement Amendments of 1988". SEC. 2. REVISION OF AUTHORITY.

Section 353 of the Public Health Service Act (42 U.S.C. 263a) is amended to read as follows: CERTIFICATION OF LABORATORIES

"SEC. 353. (a) DEFINITION.—As used in this section, the term 'laboratory' or 'clinical laboratory' means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. "(b) CERTIFICATE REQUIREMENT.—No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure. "(c) ISSUANCE AND RENEWAL OF CERTIFICATES.—

"(1) IN GENERAL.—The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d). "(2) TERM.—A certificate issued under this section shall be valid for a period of 2 years or such shorter period as the Secretary may establish. "(d) REQUIREMENTS FOR CERTIFICATES.—

"(1) IN GENERAL.—A laboratory may be issued a certificate or have its certificate renewed if^ "(A) the laboratory submits (or if the laboratory is accredited under subsection (e), the accreditation body which accredited the laboratory submits), an application— "(i) in such form and manner as the Secretary shall prescribe, "(ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory including—

Oct. 31, 1988 [H.R. 5471] Clinical Laboratory Improvement Amendments of 1988 42 USC 201 note.