United States Code/Title 42/Chapter 6a/Section 263a
[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.