Clinical Laboratory Improvement Amendments of 1988
PL 100-578 (H.R.5471), enacted 10/31/1988

PUBLIC LAW 100-578—OCT. 31, 1988 
102 STAT. 2903 
Public Law 100-578 
100th Congress 
An Act 
To amend the Public Health Service Act to revise the authority for the regulation of 
clinical laboratories. 
Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the "Clinical Laboratory Improvement 
Amendments of 1988". 
SEC. 2. REVISION OF AUTHORITY. 
Section 353 of the Public Health Service Act (42 U.S.C. 263a) is 
amended to read as follows: 
Oct. 31, 1988 
[H.R. 5471] 
Clinical 
Laboratory 
Improvement 
Amendments of 
1988 
42 u s e 201 note. 
CERTIFICATION OF LABORATORIES 
"SEC. 353. (a) DEFINITION.—As used in this section, the term 
'laboratory' or 'clinical laboratory' means a facility for the 
biological, microbiological, serological, chemical, immuno-hema-
tological, 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 certifi-
cate for a laboratory only if the laboratory meets the require-
ments of subsection (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 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 accred-
ited under subsection (e), the accreditation body which 
accredited the laboratory submits), an application— 
"(i) in such form and manner as the Secretary shall 
prescribe, 
"(ii) that describes the characteristics of the labora-
tory examinations and other procedures performed by 
the laboratory including— 
102 STAT. 2904 
PUBLIC LAW 100-578—OCT. 31, 1988 
"(I) the number and types of laboratory examina-
tions and other procedures performed, 
"(11) the methodologies for laboratory examina-
tions 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), or 
"(ii) with proof of accreditation under subsection (e), 
"(C) the laboratory agrees to permit inspections by the 
Secretary under subsection (g), 
"(D) the laboratory agrees to make records available and 
submit reports to the Secretary as the Secretary may 
reasonably require, and 
"(E) the laboratory agrees to treat proficiency testing 
samples in the same manner as it treats materials derived 
from the human body referred to it for laboratory examina-
tions 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 para-
graph (3) shall be issued a certificate of waiver or have its 
certificate of waiver renewed i
f
— 
"(i) the laboratory submits an application— 
"(I) in such form and manner as the Secretary 
shall prescribe, 
"(II) that describes the characteristics of the lab-
oratory examinations and other procedures per-
formed by the laboratory, including the number 
and types of laboratory examinations and other 
procedures 
performed, 
the 
methodologies 
for 
laboratory examinations and other procedures em-
ployed, and the qualifications (educational back-
ground, 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. 
Reports. 
"(B) CHANGES.—If a laboratory makes changes in the 
examinations and other procedures performed by it only 
PUBLIC LAW 100-578—OCT. 31, 1988 
102 STAT. 2905 
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 per-
formed 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) 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 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 Adminis-
tration for home use, 
"(B) employ methodologies that are so simple and ac-
curate 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. 
"(4) DEFINITION.—As used in this section, the term 'certifi-
cate' includes a certificate of waiver issued under paragraph (2). 
"(e) ACCREDITATION.— 
"(1) IN GENERAL.—A laboratory may be accredited for pur-
poses 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 des-
ignate) 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 meth-
odologies 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 deter-
mined by Secretary, 
"(ii) the standards applied by the body in determin-
ing whether or not to accredit a laboratory are equal to 
or more stringent than the standards issued by the 
Secretary under subsection (f), 
"(iii) there is adequate provision for assuring that the 
standards of the accreditation body continue to be met 
by the laboratory, 
"(iv) in the case of any laboratory accredited by the 
body which has had its accreditation denied, suspended, 
withdrawn, or revoked or which has had any other 
action taken against it by the accrediting body, the 
accrediting body agrees to submit to the Secretary the 
102 STAT. 2906 
PUBLIC LAW 100-578—OCT. 31, 1988 
name of such laboratory within 30 days of the action 
taken, 
"(v) the accreditation body agrees to notify the Sec-
retary at least 30 days before it changes its standards, 
and 
"(vi) if the accreditation body has its approval with-
drawn 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 Sec-
retary 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). 
"(D) EVALUATIONS.—The Secretary shall evaluate an-
nually the performance of each approved accreditation 
body by— 
"(i) inspecting under subsection (g) a 
sufficient 
number of the laboratories accredited by such body to 
allow a reasonable estimate of the performance of such 
body, and 
"(ii) such other means as the Secretary determines 
appropriate. 
"(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 (2XD). 
"(D STANDARDS.— 
"(1) IN GENERAL.—The Secretary shall issue standards to 
assure consistent performance by laboratories issued a certifi-
cate under this section of valid and reliable laboratory examina-
tions 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 proce-
dures of the laboratory and to meet requirements relating 
to the proper collection, transportation, and storage of 
specimens and the reporting of results. 
PUBLIC LAW 100-578—OCT. 31, 1988 
102 STAT. 2907 
"(B) to maintain records, equipment, and facilities 
Records. 
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 examina-
tions and procedures within the laboratory, which qualifica-
tions 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 per-
formed 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 meet-
ing the standards established by the Secretary under para-
graph (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 in-
struments 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 accept-
able performance under a proficiency testing program. 
102 STAT. 2908 
PUBLIC LAW 100-578—OCT. 31, 1988 
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 in-
clude a system for grading proficiency testing performance 
to determine whether a laboratory has performed accept-
ably 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 pro-
gram 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) ON-SITE 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). The Secretary 
shall perform, on an onsite or other basis, proficiency test-
ing 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), 
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 testing program, 
"(ii) to enroll in a program of enhanced proficiency 
testing, or 
"(iii) to undertake any combination of the training, 
technical assistance, or testing described in clauses (i) 
and (ii). 
Public 
"(F) TESTING RESULTS.—The Secretary shall establish a 
information. 
system to make the results of the proficiency testing pro-
grams 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 CYTOL-
OGY SERVICES.— 
(A) ESTABLISHMENT.—The Secretary shall establish na-
tional standards for quality assurance in cytology services 
PUBLIC LAW 100-578—OCT. 31, 1988 
102 STAT. 2909 
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 C3rtology slides that any 
individual may screen in a 24-hour period, 
"(ii) requirements that a clinical laboratory maintain 
Records. 
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 C3i;ology slides by such individual, 
"(iii) criteria for requiring rescreening of cytological 
preparations, such as (I) random rescreening of cytol-
ogy 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 pro-
ficiency of individuals involved in screening or inter-
preting 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 ren-
dered on such slides, and for notifying referring physi-
cians 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 
C3rtology 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 be submitted to the 
Secretary. An inspection under this paragraph may be made 
only upon presenting identification to the owner, operator, or 
agent in charge of the laboratory being inspected. 
"(2) COMPLIANCE WITH REQUIREMENTS AND STANDARDS.—The 
Secretary shall conduct inspections of laboratories under para-
graph (1) to determine their compliance with the requirements 
of subsection (d) and the standards issued under subsection (f). 
Inspections of laboratories not accredited under subsection (e) 
shall be conducted on a biennial basis or with such other 
102 STAT. 2910 
PUBLIC LAW 100-578—OCT. 31, 1988 
frequency as the Secretary determines to be necessary to assure 
compliance with such requirements and standards. Inspections 
of laboratories accredited under subsection (e) shall be con-
ducted 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 labora-
tory 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). 
"(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 (iXD or for 
each day of substantial noncompliance with the require-
ments of this section, 
"(C) payment for the costs of onsite monitoring, or 
"'(D) any combination of the actions described in subpara-
graphs (A), (B), and (C). 
"(3) PROCEDURES.—The Secretary shall develop and imple-
ment 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 
"(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— 
Fraud. 
"(A) has been guilty of misrepresentation in obtaining the 
certificate, 
"(B) has performed or represented the laboratory as en-
titled to perform a laboratory examination or other 
procedure which is not within a category of labora-
tory examinations or other procedures authorized in the 
certificate, 
"(C) has failed to comply with the requirements of subsec-
tion (d) or the standards prescribed by the Secretary under 
subsection (f), 
"(D) has failed to comply with reasonable requests of the 
Secretary for— 
"(i) any information or materials, or 
"(ii) work on materials, 
that the Secretary concludes is necessary to determine the 
laboratory's continued eligibility for its certificate or 
continued compliance with the Secretary's standards under 
subsection (f), 
"(E) has refused a reasonable request of the Secretary, or 
any Federal officer or employee duly designated by the 
Secretary, for permission to inspect the laboratory and its 
PUBLIC LAW 100-578—OCT. 31, 1988 
102 STAT. 2911 
operations and pertinent records during the hours the lab-
oratory is in operation, 
"(F) has violated or aided and abetted in the violation of 
any provisions of this section or of any regulation promul-
gated thereunder, or 
"(G) has not complied with an intermediate sanction 
imposed under subsection (h). 
"(2) ACTION BEFORE A HEARING.—If the Secretary determines 
that— 
"(A) the failure of a laboratory to comply with the stand- 
Safety. 
ards of the Secretary under subsection (f) presents an 
imminent and serious risk to human health, or 
"(B) a laboratory has engaged in an action described in 
subparagraph (D) or (E) of paragraph (1), 
the Secretary may suspend or limit the certificate of the labora-
tory 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) INEUGIBILITY TO OWN OR OPERATE LABORATORIES AFTER 
REVOCATION.—No person who has owned or operated a labora-
tory 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 partici-
pation under the medicare program under title XVIII of the 
Social Security Act 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). 
"(j) INJUNCTIONS.—Whenever the Secretary has reason to believe 
Safety. 
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 intermedi-
ate sanction imposed under subsection (h) or has had its certifi-
cate suspended, revoked, or limited under subsection (i) may, at 
any time within 60 days after the date the action of the Sec-
retary under subsection (i) or (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 or other officer designated by the 
Secretary for that purpose. As soon as practicable after receipt Records. 
102 STAT. 2912 
PUBLIC LAW 100-578—OCT. 31, 1988 
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, United States Code. 
"(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 mate-
rial 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, tempo-
rarily 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, United States Code. 
"(1) SANCTIONS.—Any person who intentionally violates any 
requirement of this section or any regulation promulgated there-
under shall be imprisoned for not more than one year or fined under 
title 18, United States Code 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, United States Code 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 pay-
ment 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). 
"(3) CRITERIA.— 
"(A) FEES UNDER PARAGRAPH (i).—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) 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). 
PUBLIC LAW 100-578—OCT. 31, 1988 
102 STAT. 2913 
"(C) F E E S IMPOSED UNDER PARAGRAPHS (1) AND (2).—FeCS 
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 
Health care 
Secretary shall compile and make available to physicians and the 
professionals. 
general public information, based on the previous calendar year, 
which the Secretary determines is useful in evaluating the perform-
ance 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, sus-
pended, or limited under subsection (i), or 
"(B) which have been the subject of a sanction under 
subsection (1), 
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) together with a statement of the reasons 
for the sanctions, 
"(4) a list of laboratories whose accreditation has been with-
drawn or revoked together with a statement of the reasons for 
the withdrawal or revocation, 
"(5) a list of laboratories against which the Secretary has 
taken action under subsection (j) together with a statement of 
the reasons for such action, and 
"(6) a list of laboratories which have been excluded from 
participation under title XVIII or XIX of the Social Security 
Act. 
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 appro-
priate 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. 
102 STAT. 2914 
PUBLIC LAW 100-578—OCT. 31, 1988 
"(q) CONSULTATIONS.—In carrying out this section, the Secretary 
shall consult with appropriate private organizations and public 
agencies.". 
42 u s e 263a 
SEC. 3. EFFECTIVE DATE. 
Subsections (g)(1), (h), (i), (j), (k), (1), and (m) of section 353 of the 
Public Health Service Act, as amended by section 101, 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, subsec-
tions (a) through (d) and subsections (i) through (1) 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 (gX2) 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. 
42 u s e 263a 
SEC. 4. STUDIES. 
(a) STUDIES.—The Secretary of Health and Human Services, acting 
through the Public Health Service, shall conduct studies of— 
(1) the validity, reliability, and accuracy of proficiency testing 
of clinical laboratories under section 353 of the Public Health 
Service Act (as amended by section 2 of this Act), 
(2) the correlation between established standards for person-
nel employed in clinical laboratories and the accuracy and 
reliability of the results of the tests performed by the labora-
tories which are subject to such standards, 
(3) the correlation between internal quality assurance and 
quality control programs for clinical laboratories and the 
accuracy and reliability of the results of the tests performed by 
the laboratories, 
(4) the extent and nature of problems in the diagnosis and 
treatment of patients caused by inaccurate laboratory test 
results, and 
(5) the effect on laboratory test accuracy of errors in each of 
the components of the clinical testing process, including the 
communication between the attending physician and the clini-
cal laboratory which is to conduct the tests, the selection of the 
tests to be performed, the limits applicable to the tests selected, 
the acquisition of the material to be tested, the transportation 
of the material to the laboratory, the storage of the material by 
the laboratory, the analysis of the material by the laboratory, 
and the reporting of the results by the laboratory. 
PUBLIC LAW 100-578—OCT. 31, 1988 
102 STAT. 2915 
(b) REPORT.—Not later than May 1, 1990, the Secretary shall 
report to the Congress the results of the studies conducted under 
subsection (a). 
Approved October 31, 1988. 
LEGISLATIVE HISTORY—H.R. 5471: 
CONGRESSIONAL RECORD, Vol. 134 (1988): 
Oct. 6, considered and passed House. 
Oct. 11, considered and passed Senate.