Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section263a&num=0&edition=prelim
Timestamp: 2020-01-23 22:17:59
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Matched Legal Cases: ['art 2', '§ 263', 'art 2', '§263', '§353', '§5', '§2', '§123', '§2', '§1395', '§1396', '§2', '§2', '§2', '§3', '§5', '§3057', '§4']

[USC02] 42 USC 263a: Certification of laboratories
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42 USC 263a: Certification of laboratories Text contains those laws in effect on January 22, 2020
From Title 42-THE PUBLIC HEALTH AND WELFARECHAPTER 6A-PUBLIC HEALTH SERVICESUBCHAPTER II-GENERAL POWERS AND DUTIESPart F-Licensing of Biological Products and Clinical Laboratoriessubpart 2-clinical laboratories
§263a. Certification of laboratories
(a) "Laboratory" or "clinical laboratory" defined
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.
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-
(I) the number and types of laboratory examinations and other procedures performed,
(II) the methodologies for laboratory examinations and other procedures employed, and
(III) the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and
(iii) that contains such other information as the Secretary may require to determine compliance with this section, and
(B) the laboratory provides the Secretary-
(i) with satisfactory assurances that the laboratory will be operated in accordance with standards issued by the Secretary under subsection (f), or
(ii) with proof of accreditation under subsection (e),
(C) the laboratory agrees to permit inspections by the Secretary under subsection (g),
(D) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may reasonably require, and
(E) the laboratory agrees to treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business, except that no proficiency testing sample shall be referred to another laboratory for analysis as prohibited under subsection (i)(4).
A laboratory which only performs laboratory examinations and procedures described in paragraph (3) shall be issued a certificate of waiver or have its certificate of waiver renewed if-
(i) the laboratory submits an application-
(II) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory, including the number and types of laboratory examinations and other procedures performed, the methodologies for laboratory examinations and other procedures employed, and the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and
(III) that contains such other information as the Secretary may reasonably require to determine compliance with this section, and
(ii) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may require.
(3) Examinations and procedures
The examinations and procedures identified in paragraph (2) are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that-
(A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or
(B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.
(4) "Certificate" defined
As used in this section, the term "certificate" includes a certificate of waiver issued under paragraph (2).
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.
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 1 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 name of such laboratory within 30 days of the action taken,
(v) the accreditation body agrees to notify the Secretary at least 30 days before it changes its standards, and
(vi) if the accreditation body has its approval withdrawn by the Secretary, the body agrees to notify each laboratory accredited by the body of the withdrawal within 10 days of the withdrawal.
(C) Effect of withdrawal of approval
If the Secretary withdraws the approval of an accreditation body under subparagraph (B), the certificate of any laboratory accredited by the body shall continue in effect for 60 days after the laboratory receives notification of the withdrawal of the approval, except that the Secretary may extend such period for a laboratory if it determines that the laboratory submitted an application for accreditation or a certificate in a timely manner after receipt of the notification of the withdrawal of approval. If an accreditation body withdraws or revokes the accreditation of a laboratory, the certificate of the laboratory shall continue in effect-
(i) for 45 days after the laboratory receives notice of the withdrawal or revocation of the accreditation, or
(ii) until the effective date of any action taken by the Secretary under subsection (i).
(i) inspecting under subsection (g) a sufficient number of the laboratories accredited by such body to allow a reasonable estimate of the performance of such body, and
(ii) such other means as the Secretary determines appropriate.
The Secretary shall issue standards to assure consistent performance by laboratories issued a certificate under this section of valid and reliable laboratory examinations and other procedures. Such standards shall require each laboratory issued a certificate under this section-
(A) to maintain a quality assurance and quality control program adequate and appropriate for the validity and reliability of the laboratory examinations and other procedures of the laboratory and to meet requirements relating to the proper collection, transportation, and storage of specimens and the reporting of results,
(B) to maintain records, equipment, and facilities necessary for the proper and effective operation of the laboratory,
(C) in performing and carrying out its laboratory examinations and other procedures, to use only personnel meeting such qualifications as the Secretary may establish for the direction, supervision, and performance of examinations and procedures within the laboratory, which qualifications shall take into consideration competency, training, experience, job performance, and education and which qualifications shall, as appropriate, be different on the basis of the type of examinations and procedures being performed by the laboratory and the risks and consequences of erroneous results associated with such examinations and procedures,
(D) to qualify under a proficiency testing program meeting the standards established by the Secretary under paragraph (3), and
(E) to meet such other requirements as the Secretary determines necessary to assure consistent performance by such laboratories of accurate and reliable laboratory examinations and procedures.
In developing the standards to be issued under paragraph (1), the Secretary shall, within the flexibility provided under subparagraphs (A) through (E) of paragraph (1), take into consideration-
(D) the difficulty of the calculations involved,
(G) such other factors as the Secretary considers relevant.
(E) Training, technical assistance, and enhanced proficiency testing
The Secretary may, in lieu of or in addition to actions authorized under subsection (h), (i), or (j), require any laboratory which fails to perform acceptably on an individual examination and procedure or a category of examination and procedures-
(i) to undertake training and to obtain the necessary technical assistance to meet the requirements of the proficency 2 testing program,
(ii) to enroll in a program of enhanced proficiency testing, or
(iii) to undertake any combination of the training, technical assistance, or testing described in clauses (i) and (ii).
The standards established under subparagraph (A) shall include-
(i) the maximum number of cytology slides that any individual may screen in a 24-hour period,
(ii) requirements that a clinical laboratory maintain a record of (I) the number of cytology slides screened during each 24-hour period by each individual who examines cytology slides for the laboratory, and (II) the number of hours devoted during each 24-hour period to screening cytology slides by such individual,
(iii) criteria for requiring rescreening of cytological preparations, such as (I) random rescreening of cytology specimens determined to be in the benign category, (II) focused rescreening of such preparations in high risk groups, and (III) for each abnormal cytological result, rescreening of all prior cytological specimens for the patient, if available,
(iv) periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced and unannounced on-site proficiency testing of such individuals, with such testing to take place, to the extent practicable, under normal working conditions,
(v) procedures for detecting inadequately prepared slides, for assuring that no cytological diagnosis is rendered on such slides, and for notifying referring physicians of such slides,
(vi) requirements that all cytological screening be done on the premises of a laboratory that is certified under this section,
(vii) requirements for the retention of cytology slides by laboratories for such periods of time as the Secretary considers appropriate, and
(viii) standards requiring periodic inspection of cytology services by persons capable of evaluating the quality of cytology services.
The Secretary may, on an announced or unannounced basis, enter and inspect, during regular hours of operation, laboratories which have been issued a certificate under this section. In conducting such inspections the Secretary shall have access to all facilities, equipment, materials, records, and information that the Secretary determines have a bearing on whether the laboratory is being operated in accordance with this section. As part of such an inspection the Secretary may copy any such material or require to it 3 be submitted to the Secretary. An inspection under this paragraph may be made only upon presenting identification to the owner, operator, or agent in charge of the laboratory being inspected.
(2) Types of sanctions
The intermediate sanctions which may be imposed under paragraph (1) shall consist of-
(A) directed plans of correction,
(B) civil money penalties in an amount not to exceed $10,000 for each violation listed in subsection (i)(1) or for each day of substantial noncompliance with the requirements of this section,
(C) payment for the costs of onsite monitoring, or
(D) any combination of the actions described in subparagraphs (A), (B), and (C).
The Secretary shall develop and implement procedures with respect to when and how each of the intermediate sanctions is to be imposed under paragraph (1). Such procedures shall provide for notice to the laboratory and a reasonable opportunity to respond to the proposed sanction and appropriate procedures for appealing determinations relating to the imposition of intermediate sanctions 4
Except as provided in paragraph (2), the certificate of a laboratory issued under this section may be suspended, revoked, or limited if the Secretary finds, after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that such owner or operator or any employee of the laboratory-
(A) has been guilty of misrepresentation in obtaining the certificate,
(B) has performed or represented the laboratory as entitled to perform a laboratory examination or other procedure which is not within a category of laboratory examinations or other procedures authorized in the certificate,
(C) has failed to comply with the requirements of subsection (d) or the standards prescribed by the Secretary under subsection (f),
(D) has failed to comply with reasonable requests of the Secretary for-
(i) any information or materials, or
(ii) work on materials,
that the Secretary concludes is necessary to determine the laboratory's continued eligibility for its certificate or continued compliance with the Secretary's standards under subsection (f),
(E) has refused a reasonable request of the Secretary, or any Federal officer or employee duly designated by the Secretary, for permission to inspect the laboratory and its operations and pertinent records during the hours the laboratory is in operation,
(F) has violated or aided and abetted in the violation of any provisions of this section or of any regulation promulgated thereunder, or
(G) has not complied with an intermediate sanction imposed under subsection (h).
(A) the failure of a laboratory to comply with the standards of the Secretary under subsection (f) presents an imminent and serious risk to human health, or
(B) a laboratory has engaged in an action described in subparagraph (D) or (E) of paragraph (1),
On April 1, 1990 and annually thereafter, the Secretary shall compile and make available to physicians and the general public information, based on the previous calendar year, which the Secretary determines is useful in evaluating the performance of a laboratory, including-
(1) a list of laboratories which have been convicted under Federal or State laws relating to fraud and abuse, false billings, or kickbacks,
(2) a list of laboratories-
(A) which have had their certificates revoked, suspended, or limited under subsection (i), or
(B) which have been the subject of a sanction under subsection (l),
(3) a list of laboratories subject to intermediate sanctions under subsection (h) together with a statement of the reasons for the sanctions,
(4) a list of laboratories whose accreditation has been withdrawn or revoked together with a statement of the reasons for the withdrawal or revocation,
(5) a list of laboratories against which the Secretary has taken action under subsection (j) together with a statement of the reasons for such action, and
(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.].
(1) Except as provided in paragraph (2), nothing in this section shall be construed as affecting the power of any State to enact and enforce laws relating to the matters covered by this section to the extent that such laws are not inconsistent with this section or with the regulations issued under this section.
(2) If a State enacts laws relating to matters covered by this section which provide for requirements equal to or more stringent than the requirements of this section or than the regulations issued under this section, the Secretary may exempt clinical laboratories in that State from compliance with this section.
(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 .)
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 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.
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).
Pub. 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."
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. 114–255, div. A, title III, §3057, Dec. 13, 2016, 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."
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.
1 So in original. Probably should be "by the".
2 So in original. Probably should be "proficiency".
3 So in original. Probably should be "require it to".