---
kind: "section"
citation: "42 U.S.C. § 263a"
title: "42"
title_heading: "The Public Health and Welfare"
number: "263a"
heading: "Certification of laboratories"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/263a"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter II — General Powers and Duties"
  - "Part F — Licensing of Biological Products and Clinical Laboratories"
  - "Subpart 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](/usc/42/11851.md?p=11) 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](/usc/42/201.md?p=c) 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](/usc/42/201.md?p=c) may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of [subsection (d)](#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](/usc/42/201.md?p=c) 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)](#e), the accreditation body which accredited the laboratory submits), an application—
      - (i) in such form and manner as the [Secretary](/usc/42/201.md?p=c) 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](/usc/42/201.md?p=c) may require to determine compliance with this section, and

      the laboratory agrees to provide to the [Secretary](/usc/42/201.md?p=c) (or if the laboratory is accredited, to the accreditation body which accredited it) a description of any change in the information submitted under [clause (ii)](#d-1-A-ii) not later than 6 months after the change was put into effect,

    - (B) the laboratory provides the [Secretary](/usc/42/201.md?p=c)—
      - (i) with satisfactory assurances that the laboratory will be operated in accordance with standards issued by the [Secretary](/usc/42/201.md?p=c) under [subsection (f)](#f), or
      - (ii) with proof of accreditation under [subsection (e)](#e),
    - (C) the laboratory agrees to permit inspections by the [Secretary](/usc/42/201.md?p=c) under [subsection (g)](#g),
    - (D) the laboratory agrees to make records available and submit reports to the [Secretary](/usc/42/201.md?p=c) as the [Secretary](/usc/42/201.md?p=c) 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)](#i-4).
  - (2) **Requirements for certificates of waiver—**
    - (A) **In general—** A laboratory which only performs laboratory examinations and procedures described in [paragraph (3)](#d-3) shall be issued a certificate of waiver or have its certificate of waiver renewed if—
      - (i) the laboratory submits an application—
        - (I) in such form and manner as the [Secretary](/usc/42/201.md?p=c) shall prescribe,
        - (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](/usc/42/201.md?p=c) may reasonably require to determine compliance with this section, and
      - (ii) the laboratory agrees to make records available and submit reports to the [Secretary](/usc/42/201.md?p=c) as the [Secretary](/usc/42/201.md?p=c) may require.
    - (B) **Changes—** If a laboratory makes changes in the examinations and other procedures performed by it only with respect to examinations and procedures which are described in [paragraph (3)](#d-3), the laboratory shall report such changes to the [Secretary](/usc/42/201.md?p=c) 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)](#d-3), the laboratory shall report such change to the [Secretary](/usc/42/201.md?p=c) before the change takes effect.
    - (C) **Effect—** Subsections [(f)](#f) and [(g)](#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)](#d-2) are laboratory examinations and procedures that have been approved by the Food and [Drug](/usc/42/11851.md?p=4) Administration for home use or that, as determined by the [Secretary](/usc/42/201.md?p=c), 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](/usc/42/201.md?p=c) 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)](#d-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](/usc/42/201.md?p=c) (or such [State agency](/usc/42/300s–3.md?p=12) as the [Secretary](/usc/42/201.md?p=c) may designate) such records or other information as the [Secretary](/usc/42/201.md?p=c) may require.
  - (2) **Approval of accreditation bodies—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) may approve a private [nonprofit](/usc/42/300s–3.md?p=3) 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](/usc/42/201.md?p=c),
      - (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](/usc/42/201.md?p=c) under [subsection (f)](#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](/usc/42/201.md?p=c) the name of such laboratory within 30 days of the action taken,
      - (v) the accreditation body agrees to notify the [Secretary](/usc/42/201.md?p=c) at least 30 days before it changes its standards, and
      - (vi) if the accreditation body has its approval withdrawn by the [Secretary](/usc/42/201.md?p=c), the body agrees to notify each laboratory accredited by the body of the withdrawal within 10 days of the withdrawal.
    - (B) **Criteria and procedures—** The [Secretary](/usc/42/201.md?p=c) shall promulgate criteria and procedures for approving an accreditation body and for withdrawing such approval if the [Secretary](/usc/42/201.md?p=c) determines that the accreditation body does not meet the requirements of [subparagraph (A)](#e-2-A).
    - (C) **Effect of withdrawal of approval—** If the [Secretary](/usc/42/201.md?p=c) withdraws the approval of an accreditation body under [subparagraph (B)](#e-2-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](/usc/42/201.md?p=c) 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](/usc/42/201.md?p=c) under [subsection (i)](#i).
    - (D) **Evaluations—** The [Secretary](/usc/42/201.md?p=c) shall evaluate annually the performance of each approved accreditation body by—
      - (i) inspecting under [subsection (g)](#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](/usc/42/201.md?p=c) determines appropriate.
  - (3) **Omitted—**
- (f) **Standards—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) 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](/usc/42/274l–1.md?p=4) 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](/usc/42/201.md?p=c) 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](/usc/42/274l–1.md?p=4) meeting the standards established by the [Secretary](/usc/42/201.md?p=c) under [paragraph (3)](#f-3), and
    - (E) to meet such other requirements as the [Secretary](/usc/42/201.md?p=c) determines necessary to assure consistent performance by such laboratories of accurate and reliable laboratory examinations and procedures.
  - (2) **Considerations—** In developing the standards to be issued under [paragraph (1)](#f-1), the [Secretary](/usc/42/201.md?p=c) shall, within the flexibility provided under subparagraphs [(A)](#f-1-A) through [(E)](#f-1-E) of paragraph (1), take into consideration—
    - (A) the examinations and procedures performed and the methodologies employed,
    - (B) the degree of independent judgment involved,
    - (C) the amount of interpretation involved,
    - (D) the difficulty of the calculations involved,
    - (E) the calibration and quality control requirements of the instruments used,
    - (F) the type of training required to operate the instruments used in the methodology, and
    - (G) such other factors as the [Secretary](/usc/42/201.md?p=c) considers relevant.
  - (3) **Proficiency testing program—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) shall establish standards for the proficiency testing [programs](/usc/42/274l–1.md?p=4) for laboratories issued a certificate under this section which are conducted by the [Secretary](/usc/42/201.md?p=c), conducted by an organization approved under [subparagraph (C)](#f-3-C), or conducted by an approved accrediting body. The standards shall require that a laboratory issued a certificate under this section be tested for each examination and procedure conducted within a category of examinations or procedures for which it has received a certificate, except for examinations and procedures for which the [Secretary](/usc/42/201.md?p=c) has determined that a proficiency test cannot reasonably be developed. The testing shall be conducted on a quarterly basis, except where the [Secretary](/usc/42/201.md?p=c) determines for technical and scientific reasons that a particular examination or procedure may be tested less frequently (but not less often than twice per year).
    - (B) **Criteria—** The standards established under [subparagraph (A)](#f-3-A) shall include uniform criteria for acceptable performance under a proficiency testing [program](/usc/42/274l–1.md?p=4), based on the available technology and the clinical relevance of the laboratory examination or other procedure subject to such [program](/usc/42/274l–1.md?p=4). The criteria shall be established for all examinations and procedures and shall be uniform for each examination and procedure. The standards shall also include a system for grading proficiency testing performance to determine whether a laboratory has performed acceptably for a particular quarter and acceptably for a particular examination or procedure or category of examination or procedure over a period of successive quarters.
    - (C) **Approved proficiency testing programs—** For the purpose of administering proficiency testing [programs](/usc/42/274l–1.md?p=4) which meet the standards established under [subparagraph (A)](#f-3-A), the [Secretary](/usc/42/201.md?p=c) shall approve a proficiency testing [program](/usc/42/274l–1.md?p=4) offered by a private [nonprofit](/usc/42/300s–3.md?p=3) organization or a [State](/usc/42/201.md?p=f) if the [program](/usc/42/274l–1.md?p=4) meets the standards established under [subparagraph (A)](#f-3-A) and the organization or [State](/usc/42/201.md?p=f) provides technical assistance to laboratories seeking to qualify under the [program](/usc/42/274l–1.md?p=4). The [Secretary](/usc/42/201.md?p=c) shall evaluate each [program](/usc/42/274l–1.md?p=4) approved under this subparagraph annually to determine if the [program](/usc/42/274l–1.md?p=4) continues to meet the standards established under [subparagraph (A)](#f-3-A) and shall withdraw the approval of any [program](/usc/42/274l–1.md?p=4) that no longer meets such standards.
    - (D) **Onsite testing—** The [Secretary](/usc/42/201.md?p=c) shall perform, or shall direct a [program](/usc/42/274l–1.md?p=4) approved under [subparagraph (C)](#f-3-C) to perform, onsite proficiency testing to assure compliance with the requirements of subsection (d)(5). The [Secretary](/usc/42/201.md?p=c) shall perform, on an onsite or other basis, proficiency testing to evaluate the performance of a proficiency testing [program](/usc/42/274l–1.md?p=4) approved under [subparagraph (C)](#f-3-C) and to assure quality performance by a laboratory.
    - (E) **Training, technical assistance, and enhanced proficiency testing—** The [Secretary](/usc/42/201.md?p=c) may, in lieu of or in addition to actions authorized under subsection [(h)](#h), [(i)](#i), or [(j)](#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](/usc/42/274l–1.md?p=4),
      - (ii) to enroll in a [program](/usc/42/274l–1.md?p=4) of enhanced proficiency testing, or
      - (iii) to undertake any combination of the training, technical assistance, or testing described in clauses [(i)](#f-3-E-i) and [(ii)](#f-3-E-ii).
    - (F) **Testing results—** The [Secretary](/usc/42/201.md?p=c) shall establish a system to make the results of the proficiency testing [programs](/usc/42/274l–1.md?p=4) subject to the standards established by the [Secretary](/usc/42/201.md?p=c) under [subparagraph (A)](#f-3-A) available, on a reasonable basis, upon request of any person. The [Secretary](/usc/42/201.md?p=c) shall include with results made available under this subparagraph such explanatory information as may be appropriate to assist in the interpretation of such results.
  - (4) **National standards for quality assurance in cytology services—**
    - (A) **Establishment—** The [Secretary](/usc/42/201.md?p=c) shall establish national standards for quality assurance in cytology [services](/usc/42/201.md?p=a) designed to assure consistent performance by laboratories of valid and reliable cytological [services](/usc/42/201.md?p=a).
    - (B) **Standards—** The standards established under [subparagraph (A)](#f-4-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](/usc/42/201.md?p=c) considers appropriate, and
      - (viii) standards requiring periodic inspection of cytology [services](/usc/42/201.md?p=a) by persons capable of evaluating the quality of cytology [services](/usc/42/201.md?p=a).
- (g) **Inspections—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) 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](/usc/42/201.md?p=c) shall have access to all facilities, equipment, materials, records, and information that the [Secretary](/usc/42/201.md?p=c) determines have a bearing on whether the laboratory is being operated in accordance with this section. As part of such an inspection the [Secretary](/usc/42/201.md?p=c) may copy any such material or require to it[^3] be submitted to the [Secretary](/usc/42/201.md?p=c). An inspection under this paragraph may be made only upon presenting identification to the [owner](/usc/42/13641.md?p=4), operator, or agent in charge of the laboratory being inspected.
  - (2) **Compliance with requirements and standards—** The [Secretary](/usc/42/201.md?p=c) shall conduct inspections of laboratories under [paragraph (1)](#g-1) to determine their compliance with the requirements of [subsection (d)](#d) and the standards issued under [subsection (f)](#f). Inspections of laboratories not accredited under [subsection (e)](#e) shall be conducted on a biennial basis or with such other frequency as the [Secretary](/usc/42/201.md?p=c) determines to be necessary to assure compliance with such requirements and standards. Inspections of laboratories accredited under [subsection (e)](#e) shall be conducted on such basis as the [Secretary](/usc/42/201.md?p=c) determines is necessary to assure compliance with such requirements and standards.
- (h) **Intermediate sanctions—**
  - (1) **In general—** If the [Secretary](/usc/42/201.md?p=c) determines that a laboratory which has been issued a certificate under this section no longer substantially meets the requirements for the issuance of a certificate, the [Secretary](/usc/42/201.md?p=c) may impose intermediate sanctions in lieu of the actions authorized by [subsection (i)](#i).
  - (2) **Types of sanctions—** The intermediate sanctions which may be imposed under [paragraph (1)](#h-1) shall consist of—
    - (A) directed plans of correction,
    - (B) civil money penalties in an amount not to exceed $10,000 for each [violation](/usc/42/2000e–16a.md?p=c) listed in [subsection (i)(1)](#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)](#h-2-A), [(B)](#h-2-B), and [(C)](#h-2-C).
  - (3) **Procedures—** The [Secretary](/usc/42/201.md?p=c) shall develop and implement procedures with respect to when and how each of the intermediate sanctions is to be imposed under [paragraph (1)](#h-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]
- (i) **Suspension, revocation, and limitation—**
  - (1) **In general—** Except as provided in [paragraph (2)](#i-2), the certificate of a laboratory issued under this section may be suspended, revoked, or limited if the [Secretary](/usc/42/201.md?p=c) finds, after reasonable notice and opportunity for hearing to the [owner](/usc/42/13641.md?p=4) or operator of the laboratory, that such [owner](/usc/42/13641.md?p=4) or operator or any [employee](/usc/42/300gg–91.md?p=d-5) 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)](#d) or the standards prescribed by the [Secretary](/usc/42/201.md?p=c) under [subsection (f)](#f),
    - (D) has failed to comply with reasonable requests of the [Secretary](/usc/42/201.md?p=c) for—
      - (i) any information or materials, or
      - (ii) work on materials,

      that the [Secretary](/usc/42/201.md?p=c) concludes is necessary to determine the laboratory’s continued eligibility for its certificate or continued compliance with the [Secretary](/usc/42/201.md?p=c)’s standards under [subsection (f)](#f),

    - (E) has refused a reasonable request of the [Secretary](/usc/42/201.md?p=c), or any Federal officer or [employee](/usc/42/300gg–91.md?p=d-5) duly designated by the [Secretary](/usc/42/201.md?p=c), 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](/usc/42/2000e–16a.md?p=c) 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)](#h).
  - (2) **Action before a hearing—** If the [Secretary](/usc/42/201.md?p=c) determines that—
    - (A) the failure of a laboratory to comply with the standards of the [Secretary](/usc/42/201.md?p=c) under [subsection (f)](#f) presents an imminent and serious risk to human health, or
    - (B) a laboratory has engaged in an action described in subparagraph [(D)](#i-1-D) or [(E)](#i-1-E) of paragraph (1),

    the [Secretary](/usc/42/201.md?p=c) may suspend or limit the certificate of the laboratory before holding a hearing under [paragraph (1)](#i-1) regarding such failure or refusal. The opportunity for a hearing shall be provided no later than 60 days from the effective date of the suspension or limitation. A suspension or limitation under this paragraph shall stay in effect until the decision of the [Secretary](/usc/42/201.md?p=c) made after the hearing under [paragraph (1)](#i-1).

  - (3) **Ineligibility to own or operate laboratories after revocation—** 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)](#i-4) the [Secretary](/usc/42/201.md?p=c) may substitute intermediate sanctions under [subsection (h)](#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](/usc/42/274l–1.md?p=4) under title XVIII of the Social Security Act [[42 U.S.C. 1395](/usc/42/1395.md) et seq.] because of actions relating to the quality of the laboratory shall be suspended for the period the laboratory is so excluded.
  - (4) **Improper referrals—** Any laboratory that the [Secretary](/usc/42/201.md?p=c) determines intentionally refers its proficiency testing samples to another laboratory for analysis may have its certificate revoked for at least one year and shall be subject to appropriate fines and penalties as provided for in [subsection (h)](#h).
- (j) **Injunctions—** Whenever the [Secretary](/usc/42/201.md?p=c) has reason to believe that continuation of any activity by a laboratory would constitute a significant hazard to the public health the [Secretary](/usc/42/201.md?p=c) may bring suit in the district court of the United States for the district in which such laboratory is situated to enjoin continuation of such activity. Upon proper showing, a temporary injunction or restraining order against continuation of such activity pending issuance of a final order under this subsection shall be granted without bond by such court.
- (k) **Judicial review—**
  - (1) **Petition—** Any laboratory which has had an intermediate sanction imposed under [subsection (h)](#h) or has had its certificate suspended, revoked, or limited under [subsection (i)](#i) may, at any time within 60 days after the date the action of the [Secretary](/usc/42/201.md?p=c) under subsection [(i)](#i) or [(h)](#h) becomes final, file a petition with the United States court of appeals for the circuit wherein the laboratory has its principal place of business for judicial review of such action. As soon as practicable after receipt of the petition, the clerk of the court shall transmit a copy of the petition to the [Secretary](/usc/42/201.md?p=c) or other officer designated by the [Secretary](/usc/42/201.md?p=c) for that purpose. As soon as practicable after receipt of the copy, the [Secretary](/usc/42/201.md?p=c) shall file in the court the record on which the action of the [Secretary](/usc/42/201.md?p=c) is based, as provided in [section 2112 of title 28](/usc/28/2112.md).
  - (2) **Additional evidence—** If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the [Secretary](/usc/42/201.md?p=c), the court may order such additional evidence (and evidence in rebuttal of such additional evidence) to be taken before the [Secretary](/usc/42/201.md?p=c), and to be adduced upon the hearing in such manner and upon such terms and conditions as the court may deem proper. The [Secretary](/usc/42/201.md?p=c) may modify the findings of the [Secretary](/usc/42/201.md?p=c) as to the facts, or make new findings, by reason of the additional evidence so taken, and the [Secretary](/usc/42/201.md?p=c) shall file such modified or new findings, and the recommendations of the [Secretary](/usc/42/201.md?p=c), if any, for the modification or setting aside of his original action, with the return of such additional evidence.
  - (3) **Judgment of court—** Upon the filing of the petition referred to in [paragraph (1)](#k-1), the court shall have jurisdiction to affirm the action, or to set it aside in whole or in part, temporarily or permanently. The findings of the [Secretary](/usc/42/201.md?p=c) as to the facts, if supported by substantial evidence, shall be conclusive.
  - (4) **Finality of judgment—** The judgment of the court affirming or setting aside, in whole or in part, any such action of the [Secretary](/usc/42/201.md?p=c) shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in [section 1254 of title 28](/usc/28/1254.md).
- (l) **Sanctions—** Any person who intentionally violates any requirement of this section or any regulation promulgated thereunder shall be imprisoned for not more than one year or fined under [title 18](/usc/18.md), or both, except that if the conviction is for a second or subsequent [violation](/usc/42/2000e–16a.md?p=c) of such a requirement such person shall be imprisoned for not more than 3 years or fined in accordance with [title 18](/usc/18.md), or both.
- (m) **Fees—**
  - (1) **Certificate fees—** The [Secretary](/usc/42/201.md?p=c) shall require payment of fees for the issuance and renewal of certificates, except that the [Secretary](/usc/42/201.md?p=c) shall only require a nominal fee for the issuance and renewal of certificates of waiver.
  - (2) **Additional fees—** The [Secretary](/usc/42/201.md?p=c) shall require the payment of fees for inspections of laboratories which are not accredited and for the cost of performing proficiency testing on laboratories which do not participate in proficiency testing [programs](/usc/42/274l–1.md?p=4) approved under [subsection (f)(3)(C)](#f-3-C).
  - (3) **Criteria—**
    - (A) **Fees under paragraph (1)—** Fees imposed under [paragraph (1)](#m-1) shall be sufficient to cover the general costs of administering this section, including evaluating and monitoring proficiency testing [programs](/usc/42/274l–1.md?p=4) approved under [subsection (f)](#f) and accrediting bodies and implementing and monitoring compliance with the requirements of this section.
    - (B) **Fees under paragraph (2)—** Fees imposed under [paragraph (2)](#m-2) shall be sufficient to cover the cost of the [Secretary](/usc/42/201.md?p=c) in carrying out the inspections and proficiency testing described in [paragraph (2)](#m-2).
    - (C) **Fees imposed under paragraphs (1) and (2)—** Fees imposed under paragraphs [(1)](#m-1) and [(2)](#m-2) shall vary by group or classification of laboratory, based on such considerations as the [Secretary](/usc/42/201.md?p=c) determines are relevant, which may include the dollar volume and scope of the testing being performed by the laboratories.
- (n) **Information—** On April 1, 1990 and annually thereafter, the [Secretary](/usc/42/201.md?p=c) shall compile and make available to physicians and the general public information, based on the previous calendar year, which the [Secretary](/usc/42/201.md?p=c) determines is useful in evaluating the performance of a laboratory, including—
  - (1) a list of laboratories which have been convicted under Federal or [State](/usc/42/201.md?p=f) 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)](#i), or
    - (B) which have been the subject of a sanction under [subsection (l)](#l),

    together with a statement of the reasons for the revocation, suspension, limitation, or sanction,

  - (3) a list of laboratories subject to intermediate sanctions under [subsection (h)](#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](/usc/42/201.md?p=c) has taken action under [subsection (j)](#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](/usc/42/1395.md) et seq., 1396 et seq.].

  The information to be compiled under paragraphs [(1)](#n-1) through [(6)](#n-6) shall be information for the calendar year preceding the date the information is to be made available to the public and shall be accompanied by such explanatory information as may be appropriate to assist in the interpretation of the information compiled under such paragraphs.

- (o) **Delegation—** In carrying out this section, the [Secretary](/usc/42/201.md?p=c) may, pursuant to agreement, use the [services](/usc/42/201.md?p=a) or facilities of any Federal or [State](/usc/42/201.md?p=f) or local [public agency](/usc/42/11851.md?p=8) or [nonprofit](/usc/42/300s–3.md?p=3) private organization, and may pay therefor in advance or by way of reimbursement, and in such installments, as the [Secretary](/usc/42/201.md?p=c) may determine.
- (p) **State laws—**
  - (1) Except as provided in [paragraph (2)](#p-2), nothing in this section shall be construed as affecting the power of any [State](/usc/42/201.md?p=f) 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](/usc/42/201.md?p=d) issued under this section.
  - (2) If a [State](/usc/42/201.md?p=f) 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](/usc/42/201.md?p=d) issued under this section, the [Secretary](/usc/42/201.md?p=c) may exempt clinical laboratories in that [State](/usc/42/201.md?p=f) from compliance with this section.
- (q) **Consultations—** In carrying out this section, the [Secretary](/usc/42/201.md?p=c) shall consult with appropriate private organizations and [public agencies](/usc/42/11851.md?p=8).

## Footnotes

[^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”.
[^4]: So in original. Probably should be followed by a period.

## Source credit

(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.)

## Notes

### Editorial Notes

### 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. 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.

### Codification

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 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).

### Statutory Notes and Related Subsidiaries

### 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 Applicability

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.”

### Effective Date

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.”

### CLIA Waiver Improvements

Pub. L. 114–255, div. A, title III, § 3057, Dec. 13, 2016, 130 Stat. 1128, provided that: 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— 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 includes the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy. 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.”

### Studies

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.