(July 1, 1944, ch. 373, title III, § 353, as added Pub. L. 90–174, § 5(a),Dec. 5, 1967, 81 Stat. 536; amended Pub. L. 100–578, § 2,Oct. 31, 1988, 102 Stat. 2903; Pub. L. 105–115, title I, § 123(h),Nov. 21, 1997, 111 Stat. 2324; Pub. L. 112–202, § 2,Dec. 4, 2012, 126 Stat. 1483.)
References in Text
The Social Security Act, referred to in subsecs. (i)(3) and (n)(6), is act Aug. 14, 1935, ch. 531, 49 Stat. 620
, as amended. Titles XVIII and XIX of the Social Security Act are classified generally to subchapters XVIII (§ 1395 et seq.) and XIX (§ 1396 et seq.), respectively, of chapter
of this title. For complete classification of this Act to the Code, see section
of this title and Tables.
Subsec. (e)(3) of this section, which required the Secretary to annually prepare and submit to certain committees of Congress a report describing the results of the evaluation conducted under subsec. (e)(2)(D) of this section, terminated, effective May 15, 2000, pursuant to section 3003 ofPub. L. 104–66
, as amended, set out as a note under section
, Money and Finance. See, also, page 96
of House Document No. 103–7
2012—Subsec. (d)(1)(E). Pub. L. 112–202
, § 2(1), inserted “, except that no proficiency testing sample shall be referred to another laboratory for analysis as prohibited under subsection (i)(4)” before period at end.
Subsec. (i)(3). Pub. L. 112–202
, § 2(2)(A), inserted “, except that if the revocation occurs pursuant to paragraph (4) the Secretary may substitute intermediate sanctions under subsection (h) instead of the 2-year prohibition against ownership or operation which would otherwise apply under this paragraph” after “issued under this section”.
Subsec. (i)(4). Pub. L. 112–202
, § 2(2)(B), substituted “may have its certificate revoked” for “shall have its certificate revoked”.
1997—Subsec. (d)(3). Pub. L. 105–115
amended heading and text of par. (3) generally. Prior to amendment, text read as follows: “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.”
1988—Pub. L. 100–578
substituted “Certification of laboratories” for “Licensing of laboratories” in section catchline, and amended text generally, revising and restating as subsecs. (a) to (q) provisions of former subsecs. (a) to (l).
Effective Date of 1997 Amendment
Amendment by Pub. L. 105–115
effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 ofPub. L. 105–115
, set out as a note under section
, Food and Drugs.
Effective Date of 1988 Amendment; Exceptions; Continuing Applicability
Pub. L. 100–578
, § 3,Oct. 31, 1988, 102 Stat. 2914
, provided that: “Subsections (g)(1), (h), (i), (j), (k), (l), and (m) ofsection
353 of the Public Health Service Act [42
], as amended by section
[probably means section 2 ofPub. L. 100–578
], shall take effect January 1, 1989, except that any reference in such subsections to the standards established under subsection (f) shall be considered a reference to the standards established under subsection (d) of such section
353, as in effect on December 31, 1988. During the period beginning January 1, 1989, and ending December 31, 1989, subsections (a) through (d) andsubsection (i) through (l) of such section
353 as in effect on December 31, 1988, shall continue to apply to clinical laboratories. The remaining subsections of such section
353, as so amended, shall take effect January 1, 1990, except that subsections (f)(1)(C) and (g)(2) shall take effect July 1, 1991, with respect to laboratories which were not subject to the requirements of such section
353 as in effect on December 31, 1988.”
Pub. L. 90–174
, § 5(b),Dec. 5, 1967, 81 Stat. 539
, provided that: “The amendment made by subsection (a) [enacting this section] shall become effective on the first day of the thirteenth month after the month [December 1967] in which it is enacted, except that the Secretary of Health, Education, and Welfare may postpone such effective date for such additional period as he finds necessary, but not beyond the first day of the 19th month after such month [December 1967] in which the amendment is enacted.”
Pub. L. 100–578
, § 4,Oct. 31, 1988, 102 Stat. 2914
, directed Secretary to conduct studies and submit report to Congress, not later than May 1, 1990, relating to the reliability and quality control procedures of clinical laboratory testing programs and the effect of errors in the testing procedures and results on the diagnosis and treatment of patients.