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From the U.S. House of Representatives Downloadable U.S. Code
[uscode.house.gov]
[Laws in effect as of January 5, 1999]

[CITE: 42USC263a]

 
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
    .
 
-HEAD-
    subpart 2 - clinical laboratories
 
-CITE-
    42 USC Sec. 263a                                             01/05/99
 
-EXPCITE-
    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
 
-HEAD-
    Sec. 263a. Certification of laboratories
 
-STATUTE-
    (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.
    (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)
      of this section.
      (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) of this section, 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
        the laboratory agrees to provide to the Secretary (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) not later than 6 months after the
        change was put into effect,
          (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) of this section, or
            (ii) with proof of accreditation under subsection (e) of
          this section,
          (C) the laboratory agrees to permit inspections by the
        Secretary under subsection (g) of this section,
          (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.
      (2) Requirements for certificates of waiver
        (A) In general
          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 -
              (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 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.
        (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), the
        laboratory shall report such changes to the Secretary 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), the laboratory shall report such change to the Secretary
        before the change takes effect.
        (C) Effect
          Subsections (f) and (g) of this section 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) 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).
    (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 (or such State agency as the Secretary may designate)
        such records or other information as the Secretary may require.
      (2) Approval of accreditation bodies
        (A) In general
          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 (FOOTNOTE 1) Secretary,
       (FOOTNOTE 1) So in original.  Probably should be ''by the''.
            (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) of this section,
            (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.
        (B) Criteria and procedures
          The Secretary shall promulgate criteria and procedures for
        approving an accreditation body and for withdrawing such
        approval if the Secretary determines that the accreditation
        body does not meet the requirements of subparagraph (A).
        (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) of this section.
        (D) Evaluations
          The Secretary shall evaluate annually the performance of each
        approved accreditation body by -
            (i) inspecting under subsection (g) of this section 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.
      (3) Report
        The Secretary shall annually prepare and submit, to the
      Committee on Energy and Commerce of the House of Representatives
      and the Committee on Labor and Human Resources of the Senate, a
      report that describes the results of the evaluation conducted
      under paragraph (2)(D).
    (f) Standards
      (1) In general
        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.
      (2) Considerations
        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 -
          (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 considers relevant.
      (3) Proficiency testing program
        (A) In general
          The Secretary shall establish standards for the proficiency
        testing programs for laboratories issued a certificate under
        this section which are conducted by the Secretary, conducted by
        an organization approved under subparagraph (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 has determined that a proficiency test
        cannot reasonably be developed.  The testing shall be conducted
        on a quarterly basis, except where the Secretary 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) shall
        include uniform criteria for acceptable performance under a
        proficiency testing program, based on the available technology
        and the clinical relevance of the laboratory examination or
        other procedure subject to such program.  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
        which meet the standards established under subparagraph (A),
        the Secretary shall approve a proficiency testing program
        offered by a private nonprofit organization or a State if the
        program meets the standards established under subparagraph (A)
        and the organization or State provides technical assistance to
        laboratories seeking to qualify under the program.  The
        Secretary shall evaluate each program approved under this
        subparagraph annually to determine if the program continues to
        meet the standards established under subparagraph (A) and shall
        withdraw the approval of any program that no longer meets such
        standards.
        (D) Onsite testing
          The Secretary shall perform, or shall direct a program
        approved under subparagraph (C) to perform, onsite proficiency
        testing to assure compliance with the requirements of
        subsection (d)(5) of this section.  The Secretary shall
        perform, on an onsite or other basis, proficiency testing to
        evaluate the performance of a proficiency testing program
        approved under subparagraph (C) and to assure quality
        performance by a laboratory.
        (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) of this section,
        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 (FOOTNOTE 2) testing program,
       (FOOTNOTE 2) So in original.  Probably should be
    ''proficiency''.
            (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).
        (F) Testing results
          The Secretary shall establish a system to make the results of
        the proficiency testing programs subject to the standards
        established by the Secretary under subparagraph (A) available,
        on a reasonable basis, upon request of any person.  The
        Secretary 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 shall establish national standards for quality
        assurance in cytology services designed to assure consistent
        performance by laboratories of valid and reliable cytological
        services.
        (B) Standards
          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.
    (g) Inspections
      (1) In general
        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 (FOOTNOTE 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.
       (FOOTNOTE 3) So in original.  Probably should be ''require it
    to''.
      (2) Compliance with requirements and standards
        The Secretary shall conduct inspections of laboratories under
      paragraph (1) to determine their compliance with the requirements
      of subsection (d) of this section and the standards issued under
      subsection (f) of this section.  Inspections of laboratories not
      accredited under subsection (e) of this section shall be
      conducted on a biennial basis or with such other frequency as the
      Secretary determines to be necessary to assure compliance with
      such requirements and standards.  Inspections of laboratories
      accredited under subsection (e) of this section shall be
      conducted on such basis as the Secretary determines is necessary
      to assure compliance with such requirements and standards.
    (h) Intermediate sanctions
      (1) In general
        If the Secretary 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 may impose intermediate sanctions in lieu of the
      actions authorized by subsection (i) of this section.
      (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) of this section
        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).
      (3) Procedures
        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 (FOOTNOTE 4)
       (FOOTNOTE 4) So in original.  Probably should be followed by a
    period.
    (i) Suspension, revocation, and limitation
      (1) In general
        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) of this section or the standards prescribed by the
        Secretary under subsection (f) of this section,
          (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) of this section,
          (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) of this section.
      (2) Action before a hearing
        If the Secretary determines that -
          (A) the failure of a laboratory to comply with the standards
        of the Secretary under subsection (f) of this section 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),
      the Secretary may suspend or limit the certificate of the
      laboratory before holding a hearing under paragraph (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 made after the hearing under paragraph (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.  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.
      (4) Improper referrals
        Any laboratory that the Secretary determines intentionally
      refers its proficiency testing samples to another laboratory for
      analysis shall have its certificate revoked for at least one year
      and shall be subject to appropriate fines and penalties as
      provided for in subsection (h) of this section.
    (j) Injunctions
      Whenever the Secretary has reason to believe that continuation of
    any activity by a laboratory would constitute a significant hazard
    to the public health the Secretary 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) of this section or has had its certificate
      suspended, revoked, or limited under subsection (i) of this
      section may, at any time within 60 days after the date the action
      of the Secretary under subsection (i) or (h) of this section
      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 or other
      officer designated by the Secretary for that purpose.  As soon as
      practicable after receipt of the copy, the Secretary shall file
      in the court the record on which the action of the Secretary is
      based, as provided in section 2112 of title 28.
      (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, the court may order such
      additional evidence (and evidence in rebuttal of such additional
      evidence) to be taken before the Secretary, and to be adduced
      upon the hearing in such manner and upon such terms and
      conditions as the court may deem proper.  The Secretary may
      modify the findings of the Secretary as to the facts, or make new
      findings, by reason of the additional evidence so taken, and the
      Secretary shall file such modified or new findings, and the
      recommendations of the Secretary, 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),
      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 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 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.
    (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, or
    both, except that if the conviction is for a second or subsequent
    violation of such a requirement such person shall be imprisoned for
    not more than 3 years or fined in accordance with title 18, or
    both.
    (m) Fees
      (1) Certificate fees
        The Secretary shall require payment of fees for the issuance
      and renewal of certificates, except that the Secretary shall only
      require a nominal fee for the issuance and renewal of
      certificates of waiver.
      (2) Additional fees
        The Secretary 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 approved under
      subsection (f)(3)(C) of this section.
      (3) Criteria
        (A) Fees under paragraph (1)
          Fees imposed under paragraph (1) shall be sufficient to cover
        the general costs of administering this section, including
        evaluating and monitoring proficiency testing programs approved
        under subsection (f) of this section and accrediting bodies and
        implementing and monitoring compliance with the requirements of
        this section.
        (B) Fees under paragraph (2)
          Fees imposed under paragraph (2) shall be sufficient to cover
        the cost of the Secretary in carrying out the inspections and
        proficiency testing described in paragraph (2).
        (C) Fees imposed under paragraphs (1) and (2)
          Fees imposed under paragraphs (1) and (2) shall vary by group
        or classification of laboratory, based on such considerations
        as the Secretary 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 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) of this section, or
          (B) which have been the subject of a sanction under
        subsection (l) of this section,
      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) of this section 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) of this section 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.).
    The information to be compiled under paragraphs (1) through (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 may, pursuant to
    agreement, use the services or facilities of any Federal or State
    or local public agency or nonprofit private organization, and may
    pay therefor in advance or by way of reimbursement, and in such
    installments, as the Secretary may determine.
    (p) State laws
      (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.
    (q) Consultations
      In carrying out this section, the Secretary shall consult with
    appropriate private organizations and public agencies.
 
-SOURCE-
    (July 1, 1944, ch. 373, title III, Sec. 353, as added Pub. L.
    90-174, Sec. 5(a), Dec. 5, 1967, 81 Stat. 536; amended Pub. L.
    100-578, Sec. 2, Oct. 31, 1988, 102 Stat. 2903; Pub. L. 105-115,
    title I, Sec. 123(h), Nov. 21, 1997, 111 Stat. 2324.)
 
-REFTEXT-
                             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 (Sec. 1395 et seq.) and XIX (Sec.
    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.
 
-MISC2-
                                 AMENDMENTS
      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).
 
-CHANGE-
                               CHANGE OF NAME
      Committee on Energy and Commerce of House of Representatives
    treated as referring to Committee on Commerce of House of
    Representatives by section 1(a) of Pub. L. 104-14, set out as a
    note preceding section 21 of Title 2, The Congress.
 
-MISC4-
                      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
      Section 3 of Pub. L. 100-578 provided that: ''Subsections (g)(1),
    (h), (i), (j), (k), (l), and (m) of section 353 of the Public
    Health Service Act (this section), 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
      Section 5(b) of Pub. L. 90-174 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.''
                                SHORT TITLE
      Section 5(c) of Pub. L. 90-174 provided that: ''This section
    (enacting this section and provisions set out as a note under this
    section) may be cited as the 'Clinical Laboratories Improvement Act
    of 1967.' ''
                                  STUDIES
      Section 4 of Pub. L. 100-578 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.
 
-SECREF-
                   SECTION REFERRED TO IN OTHER SECTIONS
      This section is referred to in sections 263a-2, 300aa-2, 1395x,
    1395aa of this title; title 35 section 287.

 


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