Mammography Quality Standards Act of 1992
PL 102-539 (H.R.6182), enacted 10/27/1992

PUBLIC LAW 102-539—OCT. 27, 1992 
106 STAT. 3547 
Public Law 102-539 
102d Congress 
An Act 
To amend the Public Health Service Act to establish the authority for the regulation 
Oct. 27,1992 
of manunography services and radiological equipment, and for other purposes. 
[H.R. 6182] 
Be it enacted by the Senate and House of Representatives of 
the United States of 
America in Congress assembled, 
QUSIT"^^^^^ 
SECTION 1. SHORT TITLE. 
Standards Act of 
1992 
This Act may be cited as the ''Mammography Quality Standards 42 use 201 note. 
Act of 1992". 
SEC. 2. CERTIFICATION OF MAMMOGRAPHY FACILITIES. 
Part F of title III of the Public Health Service Act (42 U.S.C. 
262 et seq.) is amended by adding at the end the following new 
subpart: 
"Subpart 3—^Mammography Facilities 
<
n
S
E
C
. 354. CERTIFICATION OF MAMMOGRAPHY FACILITIES. 
42 USC 263b. 
"(a) DEFINITIONS.—As used in this section: 
"(1) ACCREDITATION BODY.—The term 'accreditation body* 
means a body that has been approved by the Secretary under 
subsection (eXl)(A) to accredit mammography facilities. 
"(2) CERTIFICATE.—^The term 'certificate* means the certifi-
cate described in subsection (bXD. 
"(3) FACIUTY.— 
"(A) IN GENERAL.—^The term 'facility means a hospital, 
outpatient department, clinic, radiology practice, or mobile 
unit, an office of a physician, or other facility as determined 
by the Secretary, that conducts breast cancer screening 
or diagnosis through mammography activities. Such term 
does not include a facility of the Department of Veterans 
Affairs. 
"(B) ACTIVITIES.—For the purposes of this section, the 
activities of a facility include the operation of equipment 
to produce the mammogram, the processing of the film, 
the initial interpretation of the mammogram and the view-
ing conditions for that interpretation. Where procedures 
such as the film processing, or the interpretation of the 
mammogram are performed in a location difierent from 
where the mammogram is performed, the facility perform-
ing the mammogram shall be responsible for meeting the 
quality standards described in subsection (f). 
"(4) INSPECTION.—^The term 'inspection' means an onsite 
evaluation of the facility by the Secretary, or State agency 
on behalf of the Secretary. 
"(5) MAMMOGRAM.—The term 'mammogram* means a radio-
graphic image produced through mammography. 
"(6) MAMMOGRAJPHY.—^The term 'mammography* means 
radiography of the breast. 
106 STAT. 3548 
PUBLIC LAW 102-539—OCT. 27, 1992 
Reports. 
"(7) SURVEY.—^The term 'survey* means an onsite physics 
consultation and evaluation performed by a medical physicist 
as described in subsection (f)(1)(E). 
"(b) CERTIFICATE REQUIREMENT.— 
"(1) CERTIFICATE.—^No facility may conduct an examination 
or procedure described in paragraph (2) involving mammog-
raphy after October 1,1994, unless the facility obtains— 
"(A) a certificate— 
"(i) that is issued, and, if applicable, renewed, by 
the Secretary in accordance with subsection (c)(1); 
''(ii) that is applicable to the examination or proce-
dure to be conducted; and 
"(iii) that is displayed prominently in such facility; 
or 
"(B) a provisional certificate— 
"(i) that is issued by the Secretary in accordance 
with subsection (c)(2); 
"(ii) that is applicable to the examination or proce-
dure to be conducted; and 
"(iii) that is displayed prominently in such facility. 
The reference to a certificate in this section includes a provi-
sional certificate. 
"(2) EXAMINATION OR PROCEDURE.—A facility shall obtain 
a certificate in order to— 
"(A) operate radiological equipment that is used to 
image the breast; 
"(B) provide for the interpretation of a mammogram 
produced by such equipment at the facility or imder 
arrangements with a qualified individual at a facility dif-
ferent from where the mammography examination is per-
formed; and 
"(C) provide for the processing of film produced bv 
such equipment at the facility or under arrangements witn 
a qualified individual at a facility different from where 
the mammography examination is performed. 
"(c) ISSUANCE AND RENEWAL OF CERTIFICATES.— 
"(1) IN GENERAL.—^The Secretary may issue or renew a 
certificate for a facility if the person or agent described in 
subsection (dXlXA) meets the applicable requirements of sub-
section (d)(1) with respect to the facility. The Secretary may 
issue or renew a certificate under this paragraph for not more 
than 3 years. 
"(2) PROVISIONAL CERTIFICATE.—The Secretary may issue 
a provisional certificate for an entity to enable the entity to 
qualify as a facility. The applicant for a provisional certificate 
snail meet the requirements of subsection (d)(1), except provid-
ing information required by clauses (iii) and (iv) of subsection 
(d)(lXA). A provisional certificate may be in effect no longer 
than 6 months from the date it is issued, except that it may 
be extended once for a period of not more than 90 days if 
the owner, lessor, or agent of the facility demonstrates to the 
Secretary that without such extension access to mammography 
in the geographic area served by the facility would be signifi-
cantly reduced and if the owner, lessor, or agent of the facility 
will describe in a report to the Secretary steps that will be 
taken to qualify the facility for certification under subsection 
(bXl). 
PUBLIC LAW 102-539—OCT. 27, 1992 
106 STAT. 3549 
"(d) APPLICATION FOR CERTIFICATE.— 
"(1) SUBMISSION.—^The Secretary may issue or renew a 
certificate for a facility if— 
"(A) the person who owns or leases the facility or 
an authorized agent of the person, submits to the Secretary, 
in such form and manner as the Secretary shall prescribe, 
an application that contains at a minimum— 
"(i) a description of the manufacturer, model, and 
type of each x-ray machine, image receptor, and proc-
essor operated in the performance of mammography 
by the facility; 
"(ii) a description of the procedures currently used 
to provide mammography at the facility, including— 
"(I) the t>pes of procedures performed and the 
number of such procedures performed in the prior 
12 months; 
"(ID the methodologies for mammography; and 
"(III) the names and qualifications (edu-
cational background, training, and experience) of 
the personnel performing mammography and the 
physicians reading and interpreting the results 
from the procedures; 
"(iii) proof of on-site survey by a qualified medical 
physicist as described in subsection (fKlXE); and 
"(iv) proof of accreditation in such manner as the 
Secretary shall prescribe; and 
"(B) the person or agent submits to the Secretary— 
"(i) a satisfactory assurance that the facility vdll 
be operated in accordance with standards established 
by tne Secretary under subsection (f) to assure the 
safetv and accuracy of mammography; 
(ii) a satisfactory assurance that the facility will— 
"(I) permit inspections under subsection (g); 
"(II) make such records and information avail- Records, 
able, and submit such reports, to the Secretary Repots. 
as the Secretary may reauire; and 
"(III) update the information submitted under 
subparagraph (A) or assurances submitted under 
this subparagraph on a timely basis as required 
by the Secretary; and 
"(iii) such other information as the Secretary may 
require. 
An applicant shall not be required to provide in an application 
under subparagraph (A) any information which the applicant 
has supplied to the accreditation body which accredited the 
apphcant, except as required by the Secretary. 
"(2) APPEAL.—^If tne Secretary denies an application for 
the certification of a facility submitted under paragraph (IXA), 
the Secretary shall provide the owner or lessor of the facilitv 
or the agent of the owner or lessor who submitted sucn 
application— 
"(A) a statement of the grounds on which the denial 
is based, and 
"(B) an opportunity for an appeal in accordance with 
the procedures set forth in regulations of the Secretary 
pubhshed at 42 C.F.R. 498 and in effect on the date of 
the enactment of this section. 
106 STAT. 3550 
PUBLIC LAW 102-539—CKTT. 27, 1992 
"(3) EFFECT OF DENIAL.—^If the application for the certifi-
cation of a facility is denied, the facility may not operate unless 
the denial of the application is overturned at the conclusion 
of the administrative appeals process provided in the regula-
tions referred to in paragraph (2XB). 
*(e) ACCREDITATION.— 
"(l) APPROVAL OF ACCREDITATION BODIES.— 
*
*
(
A
) IN GENERAL.—^The Secretary may approve a pri-
vate nonprofit organization or State agencv to accredit 
facilities for purposes of subsection (dXlxAXiv) if the 
accreditation body meets the standards for accreditation 
established by the Secretary as described in subparagraph 
(B) and provides the assurances required by subparagraph 
(C). 
''(B) STANDARDS.—The Secretary shall establish stand-
ards for accreditation bodies, including— 
"(i) standards that require an accreditation body 
to perform— 
"(I) a review of clinical images from each facil-
ity accredited by such body not less often than 
every 3 years which review will be made by quali-
fied practicing physicians; and 
(II) a review of a random sample of clinical 
images from such facilities in each 3-year period 
beginning October 1, 1994, which review will be 
made by qualified practicing physicians; 
"(ii) standards that prohibit individuals conducting 
the reviews described in clause (i) from maintaining 
any financial relationship to the facility undergoing 
review which would constitute a conflict of interest; 
''(iii) stondards that limit the imposition of fees 
for accreditetion to reasonable amounte; 
"(iv) stondards that require aa a condition of 
accreditation that each facilitv undergo a survey at 
least annually by a medical physicist as described in 
subsection (f)(lXE) to ensure that the facility meets 
the standards described in subparagraphs (A) and (B) 
of subsection (fXD; 
"(v) stondards that require monitoring and evalua-
tion of such survey, as prescribed by the Secretory; 
"(vi) standards that are equal to stondards estob-
lished under subsection (0 which are relevant to 
accreditotion as determined by the Secretory; and 
"(vii) such additional stondards as the Secretory 
may require. 
*
*
(
C
) ASSURANCES.—^The accrediting body shall provide 
the Secretary satisfactory assurances that the body will— 
"(i) comply with the stondards as described in 
subparagraph (B); 
"(ii) comply with the requirements described in 
paragraph (4); 
^iii) submit to the Secretory the name of any 
facility for which the accreditotion body denies, sus-
pends, or revokes accreditotion; 
"(iv) notify the Secretory in a timely manner before 
the accreditotion body changes the standards of the 
body; 
PUBLIC LAW 102-539—OCT. 27, 1992 
106 STAT. 3551 
"(v) notify each facility accredited by the accredita-
tion body if the Secretary withdraws approval of the 
accreditation body under paragraph (2) in a timely 
manner; and 
"(vi) provide such other additional information as 
the Secretary' may reqxiire. 
"(D) REGULATIONS.—^Not later than 9 months after the 
date of the enactment of this section, the Secretary shall 
promulgate regulations under which the Secretary may 
approve an accreditation body. 
"(2) WITHDRAWAL OF APPROVAL.— 
"(A) IN GENERAL.—The Secretary shall promulgate Regulations. 
regulations under which the Secretary may withdraw the 
approval of an accreditation body if the Secretary deter-
mines that the accreditation body does not meet the stand-
ards imder subparagraph (B) of paragraph (1), the require-
ments of clauses (i) through (vi) of subparagraph (C) of 
paragraph (1), or the requirements of paragraph (4). 
"(B) EFFECT OF WITHDRAWAL.—If the Secretary with-
draws the approval of an accreditation body imder subpara-
graph (A), the certificate of any facility accredited by the 
body shall continue in effect vmtil the expiration of a 
reasonable period, as determined by the Secretary, for such 
facility to obtain another accreditation. 
"(3) ACCREDITATION.—^To be accredited by an approved 
accreditation body a facility shall meet— 
"(A) the standards described in paragraph (IXB) which 
the Secretary determines are applicable to the facility, 
and 
"(B) such other standards which the accreditation body 
may require. 
"(4) COMPLIANCE.—^To ensure that facilities accredited by 
an accreditation body will continue to meet the standards of 
the accreditation body, the accreditation body shall— 
"(A) make onsite visits on an annual basis of a suffi-
cient nimiber of the facilities accredited by the body to 
allow a reasonable estimate of the performance of the body; 
and 
"(B) take such additional measures as the Secretary 
determines to be appropriate. 
Visits made imder subparagraph (A) shall be made after provid-
ing such notice as the Secretary may require. 
"(5) REVOCATION OF ACCREDITATION.—If an accreditation 
body revokes the accreditation of a facility, the certificate of 
the facility shall continue in effect until such time as may 
be determined by the Secretary. 
"(6) EVALUATION AND REPORT.— 
"(A) EVALUATION.—The Secretary shall 
evaluate 
annually the performance of each approved accreditation 
body by— 
"(i) inspecting under subsection (gX2) a sufficient 
number of the facilities accredited by the body to allow 
a reasonable estimate of the performance of the body; 
and 
"(ii) such additional means as the Secretary deter-
mines to be appropriate. 
106 STAT. 3552 
PUBLIC LAW 102-539—OCT. 27, 1992 
"(B) REPORT.—^The Secretary shall annually prepare 
and submit to the Committee on Labor and Human 
Resources of the Senate and the Committee on Energy 
and Commerce of the House of Representatives a report 
that describes the results of the evaluation conducted in 
accordance with subparagraph (A), 
"(f) QUALITY STANDARDS.— 
(1) IN GENERAL.—^The standards referred to in subsection 
(dXlXBXi) are standards established by the Secretary which 
include— 
"(A) standards that require establishment and mainte-
nance of a (quality assurance and qusdity control program 
at each facihty that is adequate ana appropriate to ensure 
the reUability, clarity, and accuracy of interpretation of 
mammograms and standards for appropriate radiation 
dose; 
"(B) standards that require use of radiological equip-
ment specifically designed for mammography, including 
radiologic standards and standards for other equipment 
and materials used in coi\junction with such equipment; 
"(C) a requirement that personnel who perform 
mammography— 
'XixD be licensed by a State to perform radiological 
procedures; or 
"(11) be certified as quaUfied to perform radiological 
procedures by an organization described in paragraph 
(2XA); and 
"(ii) during the 2-year period beginning October 
1, 1994, meet training standards for personnel who 
perform mammography or meet experience require-
ments which shall at a minimum include 1 year of 
experience in the performance of mammography; and 
''(iii) upon Uie expiration of such 2-year period 
meet minimum training standards for personnel who 
periorm mammograms; 
(D) a requirement that mammograms be interpreted 
by a physician who is certified as qualified to interpret 
radiological procedures, including mammography— 
"(iXi) by a board described in paragraph (2XB); 
or 
"XII) by a program that complies with the stand-
ards described m paragraph (2XC); and 
"(ii) who meets training and continuing medical 
education requirements as established by the Sec-
retaiy; 
"(E) a reauirement that individuals who survey 
mammography taciUties be medical physicists— 
"(i) licensed or approved by a State to perform 
such survejrs, reviews, or inspections for mammog-
raplnr facilities; 
%n) certified in diagnostic radiological physics or 
certified as qualified to perform such surveys by a 
board as described in paragraph (2XD); or 
'Xiii) in the first 5 years after the date of the 
enactment of this section, who meet other criteria 
established by the Secretary which are comparable 
to the criteria described in clause (i) or (ii); 
PUBLIC LAW 102-539—OCT. 27, 1992 
106 STAT. 3553 
Records. 
"(F) a requirement that a medical physicist who is 
qualified in mammography as described in subparagraph 
(£) survey mammography equipment and oversee quality 
assurance practices at each facility; 
"(G) a requirement that— 
"(i) a facility that performs any mammogram main-
tain the mammogram in the permanent medical 
records of the patient— 
"(I) for a period of not less than 5 years, or 
not less than 10 years if no additional mammo-
grams of such patient are performed at the facility, 
or longer if mandated by State law; or 
"(il) until such time as the patient should 
request that the patient's medical records be for-
warded to a medical institution or a physician 
of the patient; 
whichever is longer; and 
"(iiXD a faciliUr must assure the preparation of Reports. 
a written report of the resvdts of any mammography 
examination signed by the interpreting physician; 
"(11) such written report shall be provided to the 
patient's physicians (if any); 
"(III) if such a physician is not available or if 
there is no such physician, the written report shall 
be sent directly to tne patient; and 
"(IV) if such report is sent to the patient, the 
report shall include a summary written in terms easily 
understood by a lay person; and 
"(H) standards relating to special techniques for 
mammography of patients with breast implants. 
Subparagraph (G) shall not be construed to " 
-The Secretary shall Regulations. 
limit a patient's 
access to the patient's medical records. 
"(2) CERTIFICATION OF PERSONNEL.-
by regulation— 
"(A) specify organizations eligible to certify individuals 
to perform radiological procedures as required by para-
graph (IXC); 
"(B) specify boards eligible to certify physicians to 
interpret radiological procedures, including mammography, 
as required bv paragraph dXD); 
"(C) establish standards for a program to certify physi-
cians described in paragraph (IXD); and 
"(D) specify^ boards eligible to certify medical physicists 
who are qualified to survey mammography equipment and 
to oversee quality assurance practices at mammography 
facilities, 
"(g) INSPECTIONS.— 
"(1) ANNUAL INSPECTIONS.— 
"(A) IN GENERAL.—The Secretary may enter and 
inspect certified facilities to determine compliance with 
the standards established imder subsection (f). The Sec-
retary shall, if feasible, delegate to a State agency liie 
authority to make such inspections. 
**(B) IDENTIFICATION.—The Secretary, or State agency 
acting on behalf of the Secretary, may conduct inspections 
only on presenting identification to the owner, operator, 
or agent in charge of the facility to be inspected. 
106 STAT. 3554 
PUBLIC LAW 102-539—OCT. 27, 1992 
"(C) SCOPE OF INSPECTION.—In conducting inspections, 
the Secretary or State agency acting on ^half of the 
Secretary— 
"(i) shall have access to all equipment, materials, 
records, and information that the Secretary or State 
agency considers necessary to determine whether the 
facility is being operated m accordance with this sec-
tion; and 
"(ii) may copy, or require the facility to submit 
to the Secretary or the State agency, any of the mate-
rials, records, or information. 
"(D) 
QUALIFICATIONS 
OF 
INSPECTORS.—Qualified 
individuals, as determined by the Secretary, shall conduct 
all inspections. The Secretary may request that a State 
agency acting on behalf of the Secretary designate a quali-
fied officer or employee to conduct the inspections, or des-
ignate a qualified Federal officer or employee to conduct 
inspections. The Secretary shall establish minimum quali-
fications and appropriate training for inspectors and 
criteria for certification of inspectors in order to inspect 
facilities for compliance with subsection (f). 
"(E) FREQUENCY.—The Secretary or State agency act-
ing on behalf of the Secretary shsdl conduct inspections 
under this paragraph of each facility not less often than 
annually. 
"(F) RECORDS AND ANNUAL REPORTS.—The Secretary 
or a State agency acting on behalf of the Secretary which 
is responsible for inspecting mammography facilities shall 
maintain records of annual inspections required under this 
P
aragraph for a period as prescribed by the Secretary, 
uch a State agency shall annually prepare and submit 
to the Secretary a report concerning the inspections carried 
out under this paragraph. Such reports shall include a 
description of the facilities inspected and the results of 
such inspections. 
"(2) INSPECTION OF ACCREDITED FACILITIES.—The Secretary 
shall inspect annually a sufficient number of the facilities 
accredited by an accreditation body to provide the Secretary 
with a reasonable estimate of the performance of such body. 
"(3) INSPECTION OF FACIUTIES INSPECTED BY STATE AGEN-
CIES.—^The Secretary shall inspect annually faciUties inspected 
by State agencies acting on behalf of the Secretary to assure 
a reasonable performance by such State agencies. 
"(4) TIMING.—The Secretary, or State agency, may conduct 
inspections imder paragraphs (1), (2), and (3), during regular 
business hours or at a mutually agreeable time and after 
providing such notice as the Secretary may prescribe, except 
that the Secretary may waive such requirements if the contin-
ued performance of mammography at such facility threatens 
the public health. 
"(5) LIMITED REINSPECTION.—Nothing in this section limits 
the authority of the Secretary to conduct limited reinspections 
of facilities found not to be in compliance with this section. 
"(h) SANCTIONS.— 
"(1) IN GENERAL.—In order to promote voluntary compli-
ance with this section, the Secretary may, in lieu of taking 
PUBLIC LAW 102-539—OCT. 27, 1992 
106 STAT. 3555 
the actions authorized by subsection (i), impose one or more 
of the foUowing^ sanctions: 
"(A) Directed plans of correction which afford a facility 
an opportunity to correct violations in a timely manner. 
'XB) Payment for the cost of onsite monitoring. 
"(2) CIVIL MONEY PENALTIES.—The Secretary may assess 
civil money penalties in an amount not to exceed $10,000 
for— 
"(A) failure to obtain a certificate as required by sub-
section (b), 
"(B) each failure by a facility to substantially comply 
with, or each day on which a facility fails to substanticuly 
comply with, the standards established under subsection 
(f) or the requirements described in subclauses (I) through 
(III) of subsection (dXlXBXii), and 
"(C) each violation, or for each aiding and abetting 
in a violation of, any provision of, or regulation promulgated 
under, this section by an owner, operator, or any employee 
of a facility required to have a certificate. 
"(3) PROCEDURES.—^The Secretary shall develop and imple-
ment procedures with respect to when and how each of the 
sanctions is to be imposed under paragraphs (1) and (2). Such 
procedures shall provide for notice to the owner or operator 
of the facility and a reasonable opportunity for the owner 
or operator to respond to the proposed sanctions and appro-
priate procedures for appealing determinations relating to the 
imposition of sanctions, 
"(i) SUSPENSION AND REVOCATION.— 
**(1) IN GENERAL.—^The certificate of a facility issued imder 
subsection (c) may be suspended or revoked if the Secretary 
finds, after providing, except as provided in paragraph (2), 
reasonable notice and an opportimity for a hearing to the 
owner or operator of the facility, that the owner, operator, 
or any employee of the facility— 
"(A) has been guilty of misrepresentation in obtaining 
the certificate; 
"(B) has failed to comply with the requirements of 
subsection (dXlXBXiiXIII) or the standards established by 
the Secretary under subsection (f); 
"(C) has failed to comply with reasonable requests 
of the Secretary for any record, information, report, or 
material that the Secretaiy concludes is necessary to deter-
mine the continued eligibility of the facility for a certificate 
or continued compliance with the standards established 
under subsection (i); 
"(D) has refused a reasonable request of the Secretary, 
any Federal officer or employee duly designated by the 
Secretary, or any State officer or employee duly designated 
by the state, for permission to inspect the facility or the 
operations and pertinent records oi the facility in accord-
ance with subsection (g); 
"(E) has violated or aided and abetted in the violation 
of any provision of, or regulation promulgated imder, this 
section; or 
"(F) has failed to comply with a sanction imposed imder 
subsection (h). 
"(2) ACTION BEFORE A HEARING.— 
106 STAT. 3556 
PUBLIC LAW 102-539—OCT. 27, 1992 
"(A) IN GENERAL.—^The Secretary may Suspend the cer-
tificate of tiie facility before holding a hearing required 
by paragraph (1) if the Secretary makes the finding 
described in paragraph (1) and determines that— 
"(i) the failure of a facility to comply with the 
standards established by the Secretary under sub-
section (f) presents a serious risk to human health; 
or 
"(ii) a facility has engaged in an action described 
in subparagraph (D) or (E) of paragraph (1). 
'\B) HEARING.—^If tiie Secretary suspends a certificate 
under subparagraph (A), the Secretary shall provide an 
opportunity for a hearing to the owner or raerator of the 
facility not later than 60 days fi>om the effective date of 
the suspension. The suspension shall remain in effect until 
the decision of the Secretary made after the hearing. 
"(3) INEUGIBILITY TO OWN OR OPERATE FACIUTIES AFTER 
REVOCATION.—^If the Secretary revokes the certificate of a facil-
ity on the basis of an act described in paragraph (1), no person 
who owned or operated the facihty at the time of the act 
may, within 2 years of the revocation of the certificate, own 
or operate a facility that requires a certificate under this 
section. 
Courts. 
«(j) INJUNCTIONS.—If the Secretary determines that^ 
'*(1) continuation of any activity related to the provision 
of mammography by a facility would constitute a serious risk 
to human health, the Secretary may brin^ suit in the district 
court of the United States for the district in which the facility 
is situated to ergoin continuation of the activity; and 
"(2) a facility is operating without a certificate as re<)uired 
by subsection (b), the Secretary may bring suit in the district 
court of the United States for the district in which the facility 
is situated to ei\join the operation of the facility. 
Upon a proper showing, the district court shall ^ant a temporary 
ii\junction or restraining order against continuation of the activity 
or against operation of a facility, as the case may be, without 
reqmring the Secretary to post a bond, pending issuance of a 
final order under this subsection, 
"(k) JUDICIAL REVIEW.— 
"(1) PETITION.—If the Secretary imposes a sanction on a 
facility under subsection (h) or suspends or revokes the certifi-
cate of a facility imder subsection (i), the owner or operator 
of the facihty may, not later than 60 days after the date 
the action of the Secretary becomes final, file a petition with 
the United States court of appeals for the circuit in which 
the facility is situated for judicial review of the 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 
Records. 
or other officer designated by the Secretary. As soon as prac-
ticable 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, United States 
Code. 
"(2) ADDITIONAL EVIDENCE.—If the petitioner appUes to 
the court for leave to adduce additional evidence, and shows 
to the satisfaction of the court that the additional evidence 
is material and that there were reasonable grounds for the 
PUBLIC LAW 102-539—OCT. 27, 1992 
106 STAT. 3557 
failure to adduce such evidence in the proceeding before the 
Secretary, the court may order the additional evidence (and 
evidence in rebuttal of the 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 determine to be 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 the modified or new findings, and the 
recommendations of the Secretary, if any, for the modification 
or setting aside of the original action of the Secretary with 
the return of the 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 the action aside in whole or 
in part, temporarily or permanently. The findings of the Sec-
retary 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 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) INFORMATION.— 
"(1) IN GENERAL.—Not later than October 1, 1996, and 
annually thereafter, the Secretary shall compile and make 
available to physicians and the general public information that 
the Secretary determines is useful in evaluating the perform-
ance of facilities, including a list of facilities— 
"(A) that have been convicted under Federal or State 
laws relating to fraud and abuse, false billings, or 
kickbacks; 
"(B) that have been subject to sanctions under sub-
section (h), together with a statement of the reasons for 
the sanctions; 
"(C) that have had certificates revoked or suspended 
under subsection (i), together with a statement of tne rea-
sons for the revocation or suspension; 
"(D) against which the Secretary has taken action 
imder subsection (j), together with a statement of the rea-
sons for the action; 
"(E) whose accreditation has been revoked, together 
with a statement of the reasons of the revocation; 
"(F) against which a State has taken adverse action; 
and 
"(G) that meets such other measures of performance 
as the Secretary may develop. 
"(2) DATE.—^The information to be compiled under para-
graph (1) shall be information for the calendar year preceding 
the date the information is to be made available to the public. 
"(3) EXPLANATORY INFORMATION.—The information to be 
compiled under para^aph (1) shall be accompanied by such 
explanatory information as may be appropriate to assist in 
the interpretation of the information compiled imder such para-
graph. 
"(m) STATE LAWS.—^Nothing in this section shall be construed 
to limit the authority of any State to enact and enforce laws relating 
106 STAT. 3558 
PUBLIC LAW 102-539—OCT. 27, 1992 
to the matters covered by this section that are at least as stringent 
as this section or the regulations issued under this section, 
"(n) NATIONAL ADVISORY COMMITTEE.— 
"(1) ESTABLISHMENT.—In carrying out this section, the Sec-
retary shall establish an advisory committee to be known as 
the National Mammography Quality Assurance Advisory 
Committee (hereafter in this subsection referred to as the 
'Advisory Committee'). 
"(2) COMPOSITION.—The Advisory Committee shall be com-
posed of not fewer than 13, nor more than 19 individuals, 
who are not ofiElcers or employees of the Federal Government. 
The Secretary shall make appointments to the Advisory 
Committee from among— 
"(A) phjrsicians, 
"(B) practitioners, and 
"(C) other health professionals, 
whose clinical practice, research specialization, or professional 
expertise include a significant focus on mammography. The 
Secretary shall appoint at least 4 individuals from among 
national breast cancer or consumer health organizations with 
expertise in mammography and at least 2 practicing physicians 
who provide mammography services. 
"(3) FUNCTIONS AND DUTIES.—The Advisory Committee 
shall— 
"(A) advise the Secretary on appropriate quality stand-
ards and regulations for mammography facilities; 
"(B) advise the Secretary on appropriate standards 
and regulations for accreditation bodies; 
"(C) advise the Secretary in the development of regula-
tions with respect to sanctions; 
"(D) assist in developing procedures for monitoring 
compliance with standards under subsection (f); 
"(E) make recommendations and assist in the establish-
ment of a mechanism to investigate consumer complaints; 
"(F) report on new developments concerning breast 
imaging that should be considered in the oversight of 
mammography facilities; 
"(G) determine whether there exists a shortage of 
mammography facilities in rural and health professional 
shortage areas and determine the effects of personnel or 
other requirements of subsection (f) on access to the serv-
ices of such facilities in such areas; 
"(H) determine whether there will exist a sufficient 
number of medical physicists after October 1, 1999, to 
assure compliance with the requirements of subsection 
(fXlXE); 
"(I) determine the costs and benefits of compliance 
with the requirements of this section (including the require-
ments of regulations promulgated under this section); and 
"(J) perform other activities that the Secretary may 
require, 
^poi^- 
The Advisory Committee shall report the findings made under 
subparagraphs (G) and (I) to the Secretary and the Congress 
no later than October 1,1993. 
"(4) MEETINGS.—^The Advisory Committee shall meet not 
less than quarterly for the first 3 years of tJie program and 
thereafter, at least biannually. 
PUBLIC LAW 102-539—OCT. 27, 1992 
106 STAT. 3559 
"(5) CHAIRPERSON.—The Secretary shall appoint a chair-
person of the Advisory Committee. 
*
*
(
o
) CONSULTATIONS.—In carrying out this section, the Sec-
retary shall consult with appropriate Federal agencies within the 
Department of Health and Human Services for the purposes of 
developing standards, regulations, evaluations, and procedures for 
compliance and oversight. 
"(p) BREAST CANCER SCREENING SURVEILLANCE RESEARCH 
GRANTS.— 
"(1) RESEARCH.— 
"(A) GRANTS.—^The Secretary shall award grants to 
such entities as the Secretary may determine to be appro-
priate to establish surveillance systems in selected 
geographic areas to provide data to evaluate the fimctioning 
and effectiveness of breast cancer screening programs in 
the United States, including assessments of participation 
rates in screening mammography, diagnostic procedures, 
incidence of breast cancer, mode of detection (mammog-
raphy screening or other methods), outcome and follow 
up information, and such related epidemiologic analyses 
that may improve early cancer detection and contribute 
to reduction in breast cancer mortality. Grants may be 
awarded for further research on breast cancer surveillance 
systems upon the Secretary's review of the evaluation of 
the program. 
"(B) USE OF FUNDS.—Grants awarded under subpara-
graph (A) may be used— 
"(i) to study— 
"(I) methods to link mammography and clini-
cal breast examination records with population-
based cancer registry data; 
"(II) methods to provide diagnostic outcome 
data, or facilitate the communication of diagnostic 
outcome data, to radiology facilities for purposes 
of 
evaluating 
patterns 
of 
mammography 
interpretation; and 
"(III) mechanisms for limiting access and 
maintaining confidentiality of all stored data; and 
"(ii) to conduct pilot testing of the methods and 
mechanisms described in subclauses (I), (II), and (III) 
of clause (i) on a limited basis. 
"(C) GRANT -^PLICATION.—TO be eligible to receive 
funds under this paragraph, an entity shall submit an 
application to the Secretory at such time, in such manner, 
and contoining such information as the Secretory may 
require. 
"(D) REPORT.—A recipient of a grant under this para-
graph shall submit a report to the Secretory containing 
the results of the study and testing conducted imder clauses 
(i) and (ii) of subparagraph (B), along with recommenda-
tions for methods of estoblishing a breast cancer screening 
surveillance system. 
"(2) ESTABLISHMENT.—The Secretory shall esteblish a 
breast cancer screening siuveillance system based on the rec-
ommendations contained in the report described in paragraph 
(IXD). 
106 STAT. 3560 
PUBLIC LAW 102-539—OCT. 27, 1992 
"(3) STANDARDS AND PROCEDURES.—The Secretary shall 
establish standards and procedures for the operation of the 
breast cancer screening surveillance system, including proce-
dures to maintain confidentiality of patient records. 
"(4) INFORMATION.—^The Secretary shall recruit facilities 
to provide to the breast cancer screening surveillance system 
relevant data that could help in the research of the causes, 
characteristics, and prevalence of, and potential treatments 
for, breast cancer and benign breast conditions, if the informa-
tion may be disclosed under section 552 of title 5, United 
States Code, 
"(q) STATE PROGRAM.— 
"(1) IN GENERAL.—^The Secretary may, upon application, 
authorize a State— 
"(A) to carry out, subject to paragraph (2), the certifi-
cation program requirements under subsections (b), (c), 
(d), (gXl), (n), (i), and (j) (including the requirements under 
regulations promulgated pursuant to such subsections), and 
"(B) to implement the standards established by the 
Secretary under subsection (f), 
with respect to mammography facilities operating within the 
State. 
"(2) APPROVAL.— The Secretary may approve an application 
under paragraph (1) if the Secretary determmes that— 
"(A) the State has enacted laws and issued regulations 
relating to mammography facilities which are the require-
ments of this section (including the requirements imder 
regulations promulgated pursuant to such subsections), and 
"(B) the State has provided satisfactory assurances 
that the State— 
"(i) has the legal authority and qualified personnel 
necessary to enforce the requirements of and the regu-
lations promulgated pursuant to this section (includmg 
the requirements under regulations promulgated 
pursuant to such subsections), 
"(ii) will devote adequate funds to the administra-
tion and enforcement of such requirements, and 
**(iii) will provide the Secretary with such informa-
tion and reports as the Secretary may require. 
"(3) AUTHORITY OF SECRETARY.—In a State with an 
approved application— 
"(A) the Secretary shall carry out the Secretary's func-
tions under subsections (e) and (f); 
"(B) the Secretary may take action under subsections 
(h), (i), and (j); and 
"(C) the Secretary shall conduct oversight fiuictions 
under subsections (gX2) and (gX3). 
"(4) WITHDRAWAL OF APPROVAL.— 
"(A) IN GENERAL.—^The Secretary may, after providing 
notice and opportunity for corrective action, withdraw the 
approval of a State's authority under paragraph (1) if the 
Secretary determines that the State does not meet the 
Regulations. 
requirements of such paragraph. The Secretary shall 
promulgate regulations for the implementation of this 
subparagraph. 
"(B) EFFECT OF WITHDRAWAL.—If the Secretary with-
draws the approval of a State under subparagraph (A), 
PUBLIC LAW 102-539—OCT. 27, 1992 
106 STAT. 3561 
the certificate of any facility accredited by the State shall 
continue in effect until the expiration of a reasonable 
period, as determined by the Secretary, for such facility 
to obtain certification by uie Secretaiy. 
"(r) FUNDING.— 
"(1) FEES.— 
"(A) IN GENERAL.—^The Secretary shall, in accordance 
with this paragraph assess and collect fees from persons 
described m subsection (dXlXA) (other than persons who 
are governmental entities, as determined by the Secretary) 
to cover the costs of inspections conducted under subsection 
(gXD by the Secretary or a State acting under a delegation 
under subparagraph (A) of such subsection. Fees may be 
assessed and collected under this paragraph only in such 
manner as would result in an aggregate amount of fees 
collected during any fiscal year which equals the agn'egate 
amount of costs for such fiscal year for inspections of facili-
ties of such persons under subsection (gXD- A person's 
liabiUty for fees shall be reasonably based on the proportion 
of the inspection costs which relate to such person. 
"(B) DEPOSIT AND APPROPRIATIONS.— 
"(i) DEPOSIT AND AVAILABIUTY.-Fees collected 
under subparagraph (A) shall be deposited as an offset-
ting collection to tne appropriations for the Department 
of Health and Human Services as provided m appro-
priation Acts and shall remain available without fiscal 
year limitation. 
**(ii) 
APPROPRIATIONS.—^Fees 
collected 
under 
subparagraph (A) shall be collected and available only 
to the extent provided in advance in appropriation 
Acts. 
"(2) 
AUTHORIZATION OF APPROPRIATIONS.—There 
are 
authorized to be appropriated to carry out this section— 
'XA) to award research grante under subsection (q), 
such sums as may be necessary for each of the fiscal 
years 1993 through 1997; and 
'XB) for the Secretary to carry out other activities which 
are not supported by fees authorized and collected under 
paragraph (1), such sums as may be necessary for fiscal 
year 1993 through 1997.". 
SEC. 3. STUDY. 
42 USC 263b 
(a) STUDY.—The Comptroller General of the United Stetes shall 
conduct a study of the certification program authorized by the 
amendment maae by section 2 to determine— 
(1) if the program has resulted in the improvement of 
the quality and accessibiUty of mammography services, and 
(2) if the program has reduced the frequency of poor Quality 
mammography and improved the early detection of oreast 
cancer. 
106 STAT. 3562 
PUBLIC LAW 102-539—OCT. 27, 1992 
(b) REPORTS.—^Not later than 3 years from the date of the 
enactment of this Act, the Comptroller General shall submit to 
the Committee on Labor and Human Resources of the Senate and 
the Committee on Energy and Commerce of the House of Represent-
atives an interim report of the results of the study under subsection 
(a). Not later than 5 years from such date the Comptroller General 
shall submit a final report on such study to such Committees. 
Approved October 27, 1992. 
LEGISLATIVE HISTORY—H.R. 6182: 
CONGRESSIONAL RECORD, Vol. 138 (1992): 
Oct. 5, considered and passed House. 
Oct. 7, considered and passed Senate. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 28 (1992): 
Oct. 27, Presidential statement.