‘‘(8) REVIEW
PHYSICIAN.—The term ‘review
physician’ means a physician as prescribed by the
Secretary under subsection (f)(1)(D) who meets
such additional requirements as may be established
by an accreditation body under subsection (e) and
approved by the Secretary to review clinical images
under subsection (e)(1)(B)(i) on behalf of the ac-
creditation body.’’.
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 mam-
mogram—
‘‘(I) except as provided in sub-
clause (II), maintain 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) a summary of the written re-
port 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 sen-
tence—
(1) by striking ‘‘certified’’; and
(2) by inserting ‘‘the certification requirements
under subsection (b) and’’ after ‘‘compliance with’’.
SEC. 8. DEMONSTRATION PROGRAM REGARDING FRE-
QUENCY 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 para-
graph:
‘‘(6) DEMONSTRATION PROGRAM.—
‘‘(A) IN GENERAL.—The Secretary may es-
tablish a demonstration program under which
inspections under paragraph (1) of selected fa-
cilities are conducted less frequently by the Sec-
retary (or as applicable, by State or local agen-
cies acting on behalf of the Secretary) than the
interval specified in subparagraph (E) of such
paragraph.
‘‘(B) REQUIREMENTS.—Any demonstra-
tion program under subparagraph (A) shall be
carried out in accordance with the following:
‘‘(i) The program may not be imple-
mented 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 in-
clusion in the program unless the facility is
substantially free of incidents of non-
compliance with the standards under sub-
section (f). The Secretary may at any time
provide that a facility will no longer be in-
cluded in the program.
‘‘(iii) The number of facilities selected
for inclusion in the program shall be suffi-
cient to provide a statistically 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 deter-
mines will ensure that the facilities are
maintaining compliance with such stand-
ards.’’.
SEC. 9. CLARIFICATION OF AUTHORITY TO DELEGATE IN-
SPECTION RESPONSIBILITY TO LOCAL GOV-
ERNMENT 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 in-
serting ‘‘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 follow-
ing:
‘‘(2) PATIENT INFORMATION.—If the Secretary
determines that the quality of mammography per-
formed by a facility (whether or not certified pursu-
ant 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 re-
quire.’’.