42 U.S.C. § 273 : US Code - Section 273: Organ procurement organizations

Search 42 U.S.C. § 273 : US Code - Section 273: Organ procurement organizations

(a) Grant authority of Secretary
(1) The Secretary may make grants for the planning of qualified
organ procurement organizations described in subsection (b) of this
section.
(2) The Secretary may make grants for the establishment, initial
operation, consolidation, and expansion of qualified organ
procurement organizations described in subsection (b) of this
section.
(b) Qualified organizations
(1) A qualified organ procurement organization for which grants
may be made under subsection (a) of this section is an organization
which, as determined by the Secretary, will carry out the functions
described in paragraph (2) (!1) and -
(A) is a nonprofit entity,
(B) has accounting and other fiscal procedures (as specified by
the Secretary) necessary to assure the fiscal stability of the
organization,
(C) has an agreement with the Secretary to be reimbursed under
title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]
for the procurement of kidneys,
(D) notwithstanding any other provision of law, has met the
other requirements of this section and has been certified or
recertified by the Secretary within the previous 4-year period as
meeting the performance standards to be a qualified organ
procurement organization through a process that either -
(i) granted certification or recertification within such 4-
year period with such certification or recertification in
effect as of January 1, 2000, and remaining in effect through
the earlier of -
(I) January 1, 2002; or
(II) the completion of recertification under the
requirements of clause (ii); or
(ii) is defined through regulations that are promulgated by
the Secretary by not later than January 1, 2002, that -
(I) require recertifications of qualified organ procurement
organizations not more frequently than once every 4 years;
(II) rely on outcome and process performance measures that
are based on empirical evidence, obtained through reasonable
efforts, of organ donor potential and other related factors
in each service area of qualified organ procurement
organizations;
(III) use multiple outcome measures as part of the
certification process; and
(IV) provide for a qualified organ procurement organization
to appeal a decertification to the Secretary on substantive
and procedural grounds; (!2)
(E) has procedures to obtain payment for non-renal organs
provided to transplant centers,
(F) has a defined service area that is of sufficient size to
assure maximum effectiveness in the procurement and equitable
distribution of organs, and that either includes an entire
metropolitan statistical area (as specified by the Director of
the Office of Management and Budget) or does not include any part
of the area,
(G) has a director and such other staff, including the organ
donation coordinators and organ procurement specialists necessary
to effectively obtain 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 emergency room personnel, tissue banks, and
voluntary health associations in its service area,
(II) members who represent the public residing in such
area,
(III) a physician with knowledge, experience, or skill in
the field of histocompatability (!3) 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 (2)(G) (!1) with the
organization, a member who is a surgeon who has practicing
privileges in such center and who performs organ transplant
surgery,
(ii) has the authority to recommend policies for the
procurement of organs and the other functions described in
paragraph (2),(!1) and
(iii) has no authority over any other activity of the
organization.
(2)(A) Not later than 90 days after November 16, 1990, the
Secretary shall publish in the Federal Register a notice of
proposed rulemaking to establish criteria for determining whether
an entity meets the requirement established in paragraph
(1)(E).(!1)
(B) Not later than 1 year after November 16, 1990, the Secretary
shall publish in the Federal Register a final rule to establish the
criteria described in subparagraph (A).
(3) An organ procurement organization shall -
(A) have effective agreements, to identify potential organ
donors, with a substantial majority of the hospitals and other
health care entities in its service area which have facilities
for organ donations,
(B) conduct and participate in systematic efforts, including
professional education, to acquire all useable organs from
potential donors,
(C) arrange for the acquisition and preservation of donated
organs and provide quality standards for the acquisition of
organs which are consistent with the standards adopted by the
Organ Procurement and Transplantation Network under section
274(b)(2)(E) of this title, including arranging for testing with
respect to preventing the acquisition of organs that are infected
with the etiologic agent for acquired immune deficiency syndrome,
(D) arrange for the appropriate tissue typing of donated
organs,
(E) have a system to allocate donated organs equitably among
transplant patients according to established medical criteria,
(F) provide or arrange for the transportation of donated organs
to transplant centers,
(G) have arrangements to coordinate its activities with
transplant centers in its service area,
(H) participate in the Organ Procurement Transplantation
Network established under section 274 of this title,
(I) have arrangements to cooperate with tissue banks for the
retrieval, processing, preservation, storage, and distribution of
tissues as may be appropriate to assure that all useable tissues
are obtained from potential donors,
(J) evaluate annually the effectiveness of the organization in
acquiring potentially available organs, and
(K) assist hospitals in establishing and implementing protocols
for making routine inquiries about organ donations by potential
donors.
(c) Pancreata islet cell transplantation or research
Pancreata procured by an organ procurement organization and used
for islet cell transplantation or research shall be counted for
purposes of certification or recertification under subsection (b)
of this section.