cate of any facility accredited by the body shall
continue in effect until the expiration of a rea-
sonable 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
(1)(B) which the Secretary determines are ap-
plicable to the facility, and
‘‘(B) such other standards which the ac-
creditation 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 ac-
creditation body shall—
‘‘(A) make onsite visits of the facilities ac-
credited by the body of a sufficient number and
of such frequency to allow a reasonable esti-
mate of the performance of the body; and
‘‘(B) take such additional measures as the
Secretary determines to be appropriate.
Visits made under subparagraph (A) shall be made
after providing such notice as the Secretary may re-
quire.
‘‘(5) REVOCATION OF ACCREDITATION.—If an
accreditation body revokes the accreditation of a fa-
cility, 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 the performance of each approved ac-
creditation body by—
‘‘(i) inspecting under subsection (g)(2)
a sufficient number of the facilities accred-
ited by the body to allow a reasonable esti-
mate of the performance of the body; and
‘‘(ii) such additional means as the
Secretary determines to be appropriate.
‘‘(f) QUALITY STANDARDS.—
‘‘(1) IN GENERAL.—The standards referred to
in subsection (d)(1)(B)(i) are standards established
by the Secretary which include—
‘‘(A) standards that require establishment
and maintenance of a quality assurance and
quality control program at each facility that is
adequate and appropriate to ensure the reliabil-
ity and accuracy of interpretation of fetal
ultrasound;
‘‘(B) a requirement that personnel who
perform ultrasound—
‘‘(i)(I) be licensed by a State to per-
form ultrasound procedures; or
‘‘(II) be certified as qualified to per-
form ultrasound procedures by an organi-
zation described in paragraph (2)(A); and
‘‘(ii) during the 2-year period begin-
ning October 1, 1997, meet training stand-
ards 
for 
personnel 
who 
perform
ultrasonography or meet experience re-
quirements which shall at a minimum in-
clude 1 year of experience in the perform-
ance of ultrasonography; and
‘‘(iii) upon the expiration of such 2-
year period meet minimum training stand-
ards for personnel who perform fetal
ultrasound;
‘‘(C) a requirement that ultrasound images
be interpreted by a physician who is certified as
qualified to interpret fetal ultrasound and who
meets training and continuing medical edu-
cation requirements as established by the Sec-
retary;
‘‘(D) 
a 
requirement 
that 
fetal
ultrasonography be performed only when medi-
cally necessary.
‘‘(E) a requirement that—
‘‘(i) a facility that performs any fetal
ultrasound maintain a record of such
ultrasound in the permanent medical
records of the patient—
‘‘(I) for a period of not fewer
than 5 years, or longer if mandated
by State law; or
‘‘(II) until such time as the pa-
tient should request that the patient’s
medical records be forwarded to a
medical institution or a physician of
the patient;
whichever is longer; and
‘‘(ii)(I) a facility must assure the
preparation of a written report of the re-
sults of any fetal ultrasound examination
signed by the interpreting physician;
‘‘(II) such written report shall be pro-
vided to the patient’s physicians (if any);
‘‘(III) if such a physician is not avail-
able or if there is no such physician, the
written report shall be sent directly to the
patient; and
‘‘(IV) if such report is sent to the pa-
tient, the report shall include a summary
written in terms easily understood by a lay
person.
Subparagraph (E) shall not be construed to limit a
patient’s access to the patient’s medical records.
‘‘(2) CERTIFICATION
OF
PERSONNEL.—The
Secretary shall by regulation—
‘‘(A) specify organizations eligible to cer-
tify individuals to perform fetal ultrasound as
required by paragraph (1)(B); and
‘‘(B) establish standards for a program to
certify 
physicians 
described 
in 
paragraph
(1)(C).
‘‘(g) INSPECTIONS.—
‘‘(1) INSPECTIONS.—
‘‘(A) IN
GENERAL.—The Secretary may
enter and inspect certified facilities to deter-
mine compliance with the standards established
under subsection (f). The Secretary shall, if fea-
sible, delegate to a State agency the 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.
‘‘(C) SCOPE OF INSPECTION.—In conduct-
ing inspections, the Secretary or State agency
acting on behalf of the Secretary—
‘‘(i) shall have access to all equip-
ment, materials, records, and information
that the Secretary or State agency consid-
ers necessary to determine whether the fa-
cility is being operated in accordance with
this section; and
‘‘(ii) may copy, or require the facility
to submit to the Secretary or the State
agency, any of the materials, records, or
information.
‘‘(D) QUALIFICATIONS OF INSPECTORS.—
Qualified individuals, as determined by the Sec-
retary, shall conduct all inspections. The Sec-
retary may request that a State agency acting
on behalf of the Secretary designate a qualified
officer or employee to conduct the inspections,
or designate a qualified Federal officer or em-
ployee to conduct inspections. The Secretary
shall establish minimum qualifications and ap-
propriate 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 acting on behalf of the Secretary
shall conduct inspections under this paragraph
of each facility as frequently as needed to as-
sure that facilities are in compliance with this
section, but no more frequently than once every
2 years.
‘‘(F) RECORDS AND ANNUAL REPORTS.—
The Secretary or a State agency acting on be-
half of the Secretary which is responsible for in-
specting ultrasound facilities shall maintain
records of inspections required under this para-
graph for a period as prescribed by the Sec-
retary. Such a State agency shall annually pre-
pare and submit to the Secretary a report con-
cerning the inspections carried out under this
paragraph. Such reports shall include a descrip-
tion of the facilities inspected and the results of
such inspections.
‘‘(2) INSPECTION
OF
ACCREDITED
FACILI-
TIES.—The Secretary shall inspect annually a suffi-
cient number of the facilities accredited by an ac-
creditation body to provide the Secretary with a rea-
sonable estimate of the performance of such body.
‘‘(3) INSPECTION OF FACILITIES INSPECTED BY
STATE AGENCIES.—The Secretary shall inspect an-
nually facilities 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 under paragraphs (1), (2),
and (3), during regular business hours or at a mutu-
ally agreeable time and after providing such notice
as the Secretary may prescribe, except that the Sec-
retary may waive such requirements if the continued
performance of ultrasonography at such facility
threatens the public health.
‘‘(5) LIMITED REINSPECTION.—Nothing in this
section limits the authority of the Secretary to con-
duct limited reinspections of facilities found not to
be in compliance with this section.
‘‘(h) SANCTIONS.—
‘‘(1) IN GENERAL.—In order to promote vol-
untary compliance with this section, the Secretary
may, in lieu of taking the actions authorized by sub-
section (i), impose one or more of the following sanc-
tions:
‘‘(A) Directed plans of correction which af-
ford a facility an opportunity to correct viola-
tions in a timely manner.
‘‘(B) Payment for the cost of onsite mon-
itoring.
‘‘(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 re-
quired by subsection (b),
‘‘(B) each failure by a facility to substan-
tially comply with, or each day on which a facil-
ity fails to substantially comply with, the stand-
ards established under subsection (f) or the re-
quirements described in subclauses (I) through
(III) of subsection (d)(1)(B)(ii), 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 facil-
ity required to have a certificate.
‘‘(3) PROCEDURES.—The Secretary shall de-
velop and implement 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 fa-
cility and a reasonable opportunity for the owner or
operator to respond to the proposed sanctions and
appropriate procedures for appealing determinations
relating to the imposition of sanctions.
‘‘(i) SUSPENSION AND REVOCATION.—
‘‘(1) IN GENERAL.—The certificate of a facility
issued under subsection (c) may be suspended or re-
voked if the Secretary finds, after providing, except
as provided in paragraph (2), reasonable notice and
an opportunity for a hearing to the owner or opera-
tor 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 require-
ments of subsection (d)(1)(B)(ii)(III) or the
standards established by the Secretary under
subsection (f);
‘‘(C) has failed to comply with reasonable
requests of the Secretary for any record, infor-
mation, report, or material that the Secretary
concludes is necessary to determine the contin-
ued eligibility of the facility for a certificate or
continued compliance with the standards estab-
lished under subsection (f);
‘‘(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 of the fa-
cility in accordance with subsection (g);
‘‘(E) has violated or aided and abetted in
the violation of any provision of, or regulation
promulgated under, this section; or
‘‘(F) has failed to comply with a sanction
imposed under subsection (h).
‘‘(2) ACTION BEFORE A HEARING.—
‘‘(A) IN
GENERAL.—The Secretary may
suspend the certificate of the 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 Sec-
retary under subsection (f) presents a seri-
ous risk to human health; or
‘‘(ii) a facility has engaged in an ac-
tion described in subparagraph (D) or (E)
of paragraph (1).
‘‘(B) HEARING.—If the Secretary suspends
a certificate under subparagraph (A), the Sec-
retary shall provide an opportunity for a hear-
ing to the owner or operator of the facility not
later than 60 days from the effective date of the
suspension. The suspension shall remain in ef-
fect until the decision of the Secretary made
after the hearing.
‘‘(3) INELIGIBILITY TO OWN OR OPERATE FA-
CILITIES AFTER REVOCATION.—If the Secretary re-
vokes the certificate of a facility on the basis of an
act described in paragraph (1), no person who
owned or operated the facility at the time of the act
may, within 2 years of the revocation of the certifi-
cate, own or operate a facility that requires a cer-
tificate under this section.
‘‘(j) INJUNCTIONS.—If the Secretary determines
that—
‘‘(1) continuation of any activity related to the
provision of fetal ultrasonography by a facility would
action of the Secretary with the return of the addi-
tional 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 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 action of the Secretary shall be final,
subject to review by the Supreme Court of the Unit-
ed States upon certiorari or certification, as provided
in section 1254 of title 28, United States Code.
‘‘(l) INFORMATION.—
‘‘(1) IN GENERAL.—Not later than October 1,
1999, and annually thereafter, the Secretary shall
compile and make available to physicians and the
general public information that the Secretary deter-
mines is useful in evaluating the performance of fa-
cilities, including a list of facilities—
‘‘(A) that have been convicted under Fed-
eral or State laws
relating
to
fraud
and
abuse, false billings, or kickbacks;
‘‘(B) that have been subject to sanctions
under subsection (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 the reasons for the revocation or
suspension;
‘‘(D) against which the Secretary has
taken action under subsection (j), together with
a statement of the reasons 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 ad-
verse action; and
‘‘(G) that meet such other measures of
performance as the Secretary may develop.
‘‘(2) DATE.—The information to be compiled
under paragraph (1) shall be information for the cal-
endar year preceding the date the information is to
be made available to the public.
‘‘(3) EXPLANATORY INFORMATION.—The infor-
mation to be compiled under paragraph (1) shall be
accompanied by such explanatory information as
may be appropriate to assist in the interpretation of
the information compiled under such paragraph.
‘‘(m) STATE LAWS.—Nothing in this section shall be
construed to limit the authority of any State to enact and
enforce laws relating to the matters covered by this section
that are at least as stringent as this section or the regula-
tions issued under this section.
‘‘(n) CONSULTATIONS.—In carrying out this section,
the Secretary shall consult with appropriate Federal agen-
cies within the Department of Health and Human Services
for the purposes of developing standards, regulations,
evaluations, and procedures for compliance and oversight.
‘‘(o) STATE PROGRAM.—
‘‘(1) IN GENERAL.—The Secretary may, upon
application, authorize a State—
‘‘(A) to carry out, subject to paragraph
(2), the certification program requirements
under subsections (b), (c), (d), (g)(1), (h), (i),
and (j) (including the requirements under regu-
lations promulgated pursuant to such sub-
sections), and
‘‘(B) to implement the standards estab-
lished by the Secretary under subsection (f),
with respect to ultrasound facilities operating within
the State.
‘‘(2) APPROVAL.— The Secretary may approve
an application under paragraph (1) if the Secretary
determines that—
‘‘(A) the State has enacted laws and issued
regulations relating to ultrasound facilities
which are the requirements of this section (in-
cluding the requirements under regulations pro-
mulgated pursuant to such subsections), and
‘‘(B) the State has provided satisfactory
assurances that the State—
‘‘(i) has the legal authority and quali-
fied personnel necessary to enforce the re-
quirements of and the regulations promul-
gated pursuant to this section (including
the requirements under regulations pro-
mulgated pursuant to such subsections),
‘‘(ii) will devote adequate funds to the
administration and enforcement of such re-
quirements, and
‘‘(iii) will provide the Secretary with
such information and reports as the Sec-
retary may require.
‘‘(3) AUTHORITY OF STATE.—In a State with
an approved application—