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SEC. 5. CLARIFICATION OF FACILITIES’ RESPONSIBILITY TO RETAIN
MAMMOGRAM RECORDS.
Section 354(f )(1)(G) of the Public Health Service Act (42 U.S.C.
263b(f )(1)(G)) is amended by striking clause (i) and inserting the
following:
‘‘(i) a facility that performs any mammogram—
‘‘(I) except as provided in subclause (II), main-
tain the mammogram in the permanent medical
records of the patient for a period of not less than
5 years, or not less than 10 years if no subsequent
mammograms of such patient are performed at
the facility, or longer if mandated by State law;
and
‘‘(II) upon the request of or on behalf of the
patient, transfer the mammogram to a medical
institution, to a physician of the patient, or to
the patient directly; and’’.
SEC. 6. DIRECT REPORTS TO PATIENTS.
Section 354(f )(1)(G)(ii) of the Public Health Service Act (42
U.S.C. 263b(f )(1)(G)(ii)) is amended by striking subclause (IV) and
inserting the following:
‘‘(IV) whether or not such a physician is available
or there is no such physician, a summary of the written
report shall be sent directly to the patient in terms
easily understood by a lay person; and’’.
SEC. 7. SCOPE OF INSPECTIONS.
Section 354(g)(1)(A) of the Public Health Service Act (42 U.S.C.
263b(g)(1)(A)) is amended in the first sentence—
(1) by striking ‘‘certified’’; and
(2) by inserting ‘‘the certification requirements under sub-
section (b) and’’ after ‘‘compliance with’’.
SEC. 8. DEMONSTRATION PROGRAM REGARDING FREQUENCY OF
INSPECTIONS.
Section 354(g) of the Public Health Service Act (42 U.S.C.
263b(g)) is amended—
(1) in paragraph (1)(E), by inserting ‘‘, subject to paragraph
(6)’’ before the period; and
(2) by adding at the end the following paragraph:
‘‘(6) DEMONSTRATION PROGRAM.—
‘‘(A) IN
GENERAL.—The Secretary may establish a
demonstration program under which inspections under
paragraph (1) of selected facilities are conducted less fre-
quently by the Secretary (or as applicable, by State or
local agencies acting on behalf of the Secretary) than the
interval specified in subparagraph (E) of such paragraph.
‘‘(B) REQUIREMENTS.—Any demonstration program
under subparagraph (A) shall be carried out in accordance
with the following:
‘‘(i) The program may not be implemented before
April 1, 2001. Preparations for the program may be
carried out prior to such date.
‘‘(ii) In carrying out the program, the Secretary
may not select a facility for inclusion in the program
unless the facility is substantially free of incidents
of noncompliance with the standards under subsection
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(f ). The Secretary may at any time provide that a
facility will no longer be included in the program.
‘‘(iii) The number of facilities selected for inclusion
in the program shall be sufficient to provide a statis-
tically significant sample, subject to compliance with
clause (ii).
‘‘(iv) Facilities that are selected for inclusion in
the program shall be inspected at such intervals as
the Secretary determines will reasonably ensure that
the facilities are maintaining compliance with such
standards.’’.
SEC. 9. CLARIFICATION OF AUTHORITY TO DELEGATE INSPECTION
RESPONSIBILITY TO LOCAL GOVERNMENT AGENCIES.
Section 354 of the Public Health Service Act (42 U.S.C. 263b)
is amended—
(1) in subsections (a)(4), (g)(1), (g)(3), and (g)(4), by inserting
‘‘or local’’ after ‘‘State’’ each place such term appears;
(2) in the heading of subsection (g)(3), by inserting ‘‘OR
LOCAL’’ after ‘‘STATE’’; and
(3) in subsection (i)(1)(D)—
(A) by inserting ‘‘or local’’ after ‘‘State’’ the first place
such term appears; and
(B) by inserting ‘‘or local agency’’ after ‘‘State’’ the
second place such term appears.
SEC. 10. PATIENT NOTIFICATION CONCERNING HEALTH RISKS.
(a) REQUIREMENT.—Section 354(h) of the Public Health Service
Act (42 U.S.C. 263b(h)) is amended—
(1) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively; and
(2) by inserting after paragraph (1) the following:
‘‘(2) PATIENT INFORMATION.—If the Secretary determines
that the quality of mammography performed by a facility
(whether or not certified pursuant to subsection (c)) was so
inconsistent with the quality standards established pursuant
to subsection (f ) as to present a significant risk to individual
or public health, the Secretary may require such facility to
notify patients who received mammograms at such facility,
and their referring physicians, of the deficiencies presenting
such risk, the potential harm resulting, appropriate remedial
measures, and such other relevant information as the Secretary
may require.’’.
(b) CIVIL MONEY PENALTY.—Section 354(h)(3) of the Public
Health Service Act (42 U.S.C. 263b(h)(3)), as redesignated by
subsection (a)(1), is amended—
(1) by striking ‘‘and’’ at the end of subparagraph (B);
(2) by redesignating subparagraph (C) as subparagraph
(D); and
(3) by inserting after subparagraph (B) the following:
‘‘(C) each failure to notify a patient of risk as required
by the Secretary pursuant to paragraph (2), and’’.
(c) CONFORMING AMENDMENT.—Section 354(h)(4) of the Public
Health Service Act (42 U.S.C. 263b(h)(4)), as redesignated by
subsection (a)(1), is amended by striking ‘‘paragraphs (1) and (2)’’
and inserting ‘‘paragraphs (1) through (3)’’.
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SEC. 11. REQUIREMENT TO COMPLY WITH INFORMATION REQUESTS.
Section 354(i)(1)(C) of the Public Health Service Act (42 U.S.C.
263b(i)(1)(C)) is amended—
(1) by inserting after ‘‘Secretary’’ the first place such term
appears the following: ‘‘(or of an accreditation body approved
pursuant to subsection (e))’’; and
(2) by inserting after ‘‘Secretary’’ the second place such
term appears the following: ‘‘(or such accreditation body or
State carrying out certification program requirements pursuant
to subsection (q))’’.
SEC. 12. ADJUSTMENT TO SEVERITY OF SANCTIONS.
Section 354(i)(2)(A) of the Public Health Service Act (42 U.S.C.
263b(i)(2)(A)) is amended by striking ‘‘makes the finding ’’ and all
that follows and inserting the following: ‘‘has reason to believe
that the circumstance of the case will support one or more of
the findings described in paragraph (1) and that—
‘‘(i) the failure or violation was intentional; or
‘‘(ii) the failure or violation presents a serious risk
to human health.’’.
SEC. 13. TECHNICAL AMENDMENT.
Section 354(q)(4)(B) of the Public Health Service Act (42 U.S.C.
263b(q)(4)(B)) is amended by striking ‘‘accredited’’ and inserting
‘‘certified’’.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.