Source: https://casetext.com/statute/united-states-code/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/section-263a-certification-of-laboratories?ref=AsVVwS!_taWwd
Timestamp: 2020-01-23 18:31:17
Document Index: 599448204

Matched Legal Cases: ['§ 263', 'art 2', '§ 263', '§353', '§5', '§2', '§123', '§2', '§1395', '§1396', '§2', '§2', '§2', '§3', '§5', '§30573057', '§4']

Section 263a - Certification of laboratories, 42 U.S.C. § 263a | Casetext
Title 42 - THE PUBLIC HEALTH AND WELFAREChapter 6A - PUBLIC HEALTH SERVICESubchapter II - GENERAL POWERS AND DUTIESPart F - LICENSING OF BIOLOGICAL PRODUCTS AND CLINICAL LABORATORIES
Subpart 2 - CLINICAL LABORATORIES
Section 263a - Certification of laboratories
42 U.S.C. § 263a
No person who has owned or operated a laboratory which has had its certificate revoked may, within 2 years of the revocation of the certificate, own or operate a laboratory for which a certificate has been issued under this section, 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. The certificate of a laboratory which has been excluded from participation under the medicare program under title XVIII of the Social Security Act [ 42 U.S.C. 1395 et seq.] because of actions relating to the quality of the laboratory shall be suspended for the period the laboratory is so excluded.
(6) a list of laboratories which have been excluded from participation under title XVIII or XIX of the Social Security Act [ 42 U.S.C. 1395 et seq., 1396 et seq.].
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 TEXTThe 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 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.
CODIFICATIONSubsec. (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 of Pub. L. 104-66 as amended, set out as a note under section 1113 of Title 31, Money and Finance. See, also, page 96 of House Document No. 103-7.
AMENDMENTS 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 of Pub. L. 105-115 set out as a note under section 321 of Title 21, Food and Drugs.
EFFECTIVE DATE OF 1988 AMENDMENT; EXCEPTIONS; CONTINUING APPLICABILITYPub. L. 100-578, §3, Oct. 31, 1988, 102 Stat. 2914, provided that: "Subsections (g)(1), (h), (i), (j), (k), (l), and (m) of section 353 of the Public Health Service Act [ 42 U.S.C. 263a ], as amended by section 101 [probably means section 2 of Pub. 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) and subsection (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."
EFFECTIVE DATEPub. 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."
CLIA WAIVER IMPROVEMENTS Pub. L. 114-255, div. A, title III, §30573057,, 130 Stat. 1128, provided that:"(a) DRAFT REVISED GUIDANCE.-Not later than 1 year after the date of the enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that-"(1) revises 'Section V. Demonstrating Insignificant Risk of an Erroneous Result - Accuracy' of the guidance entitled 'Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices' and dated January 30, 2008; and"(2) includes the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy. "(b) FINAL REVISED GUIDANCE.-The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance published under subsection (a) not later than 1 year after the comment period for such draft guidance closes."
STUDIESPub. 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.
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