II
Calendar No. 310
107TH CONGRESS
2D SESSION
H. R. 3504
IN THE SENATE OF THE UNITED STATES
DECEMBER 20 (legislative day, DECEMBER 18), 2001
Received and read the first time
JANUARY 23, 2002
Read the second time and placed on the calendar
AN ACT
To amend the Public Health Service Act with respect to
qualified organ procurement organizations.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
That section 371(b)(1) of the Public Health Service Act
HR 3504 PCS
(42 U.S.C. 273(b)(1)) is amended by striking subpara-
graph (D) and all that follows and inserting the following:
‘‘(D) notwithstanding any other provision of
law, has met the other requirements of this section
and has been certified or recertified by the Secretary
as meeting the performance standards to be a quali-
fied organ procurement organization through a proc-
ess that granted certification or recertification with
such certification or recertification in effect as of
January 1, 2000, and remaining in effect through
the completion of certification or recertification, no
earlier than July 31, 2004, as is defined through
regulations that are promulgated by the Secretary
that—
‘‘(i) require recertifications of qualified
organ procurement organizations not more fre-
quently than once every 4 years,
‘‘(ii) rely on outcome and process perform-
ance measures that are based on empirical evi-
dence, obtained through reasonable efforts, of
organ donor potential and other related factors
in each service area of qualified organ procure-
ment organizations,
‘‘(iii) use multiple outcome measures as
part of the certification process, and
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‘‘(iv) provide for a qualified organ procure-
ment organization to appeal a decertification to
the Secretary on substantive and procedural
grounds,
‘‘(E) has procedures to obtain payment for non-
renal organs provided to transplant centers,
‘‘(F) has a defined service area that is of suffi-
cient size to assure maximum effectiveness in the
procurement and equitable distribution of organs,
and that either includes an entire metropolitan sta-
tistical area (as specified by the Director of the Of-
fice of Management and Budget) or does not include
any part of the area,
‘‘(G) has a director and such other staff, in-
cluding the organ donation coordinators and organ
procurement specialists necessary to effectively ob-
tain organs from donors in its service area, and
‘‘(H) has a board of directors or an advisory
board which—
‘‘(i) is composed of—
‘‘(I) members who represent hospital
administrators, intensive care or emer-
gency room personnel, tissue banks, and
voluntary health associations in its service
area,
HR 3504 PCS
‘‘(II) members who represent the pub-
lic residing in such area,
‘‘(III) a physician with knowledge, ex-
perience, 
or 
skill 
in 
the 
field 
of
histocompatibility or an individual with a
doctorate degree in a biological science
with knowledge, experience, or skill in the
field of histocompatibility,
‘‘(IV) a physician with knowledge or
skill in the field of neurology, and
‘‘(V) from each transplant center in
its service area which has arrangements
described in paragraph (3)(G) with the or-
ganization, a member who is a surgeon
who has practicing privileges in such cen-
ter and who performs organ transplant
surgery,
‘‘(ii) has the authority to recommend poli-
cies for the procurement of organs and the
other functions described in paragraph (3), and
‘‘(iii) has no authority over any other ac-
tivity of the organization.’’.
Passed the House of Representatives December 20,
2001.
Attest:
JEFF TRANDAHL,
Clerk.
Calendar No. 310
107TH CONGRESS
2D SESSION
H. R. 3504
AN ACT
To amend the Public Health Service Act with re-
spect to qualified organ procurement organiza-
tions.
JANUARY 23, 2002
Read the second time and placed on the calendar