42 U.S.C. § 274 — Organ procurement and transplantation

Page 508 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274 and Human Services shall submit to the appro- priate committees of Congress a report that de- tails the progress made towards understanding the long-term health effects of living organ do- nation. (Pub. L. 110–144, § 3, Dec. 21, 2007, 121 Stat. 1814.) Editorial Notes CODIFICATION Section was enacted as part of the Charlie W. Nor- wood Living Organ Donation Act, and not as part of the Public Health Service Act which comprises this chap- ter. § 274. Organ procurement and transplantation network (a) In general The Secretary shall provide for the continued operation of an Organ Procurement and Trans- plantation Network which meets the require- ments of subsection (b). The Secretary may award grants, contracts, or cooperative agree- ments, as the Secretary determines appropriate, for purposes of carrying out this section. (b) Composition (1) IN GENERAL.—The Organ Procurement and Transplantation Network shall— (A) be operated through awards to public or private entities made by the Secretary that are distinct from the awards made to support the organization tasked with supporting the board of directors described in subparagraph (B); and (B) have a board of directors— (i) that includes representatives of organ procurement organizations (including orga- nizations that have received grants under section 273 of this title), transplant centers, voluntary health associations, and the gen- eral public; and (ii) that shall establish an executive com- mittee and other committees, whose chair- persons shall be selected to ensure con- tinuity of leadership for the board. (2) The Organ Procurement and Transplan- tation Network shall— (A) establish in one location or through re- gional centers— (i) a national list of individuals who need organs, and (ii) a national system, through the use of computers and in accordance with estab- lished medical criteria, to match organs and individuals included in the list, especially individuals whose immune system makes it difficult for them to receive organs, (B) establish membership criteria and med- ical criteria for allocating organs and provide to members of the public an opportunity to comment with respect to such criteria, (C) maintain a twenty-four-hour telephone service to facilitate matching organs with in- dividuals included in the list, (D) assist organ procurement organizations in the nationwide distribution of organs equi- tably among transplant patients, (E) adopt and use standards of quality for the acquisition and transportation of donated organs, (F) prepare and distribute, on a regionalized basis (and, to the extent practicable, among regions or on a national basis), samples of blood sera from individuals who are included on the list and whose immune system makes it difficult for them to receive organs, in order to facilitate matching the compatibility of such individuals with organ donors, (G) coordinate, as appropriate, the transpor- tation of organs from organ procurement orga- nizations to transplant centers, (H) provide information to physicians and other health professionals regarding organ do- nation, (I) collect, analyze, and publish data con- cerning organ donation and transplants, (J) carry out studies and demonstration projects for the purpose of improving proce- dures for organ procurement and allocation, (K) work actively to increase the supply of donated organs, (L) submit to the Secretary an annual report containing information on the comparative costs and patient outcomes at each transplant center affiliated with the organ procurement and transplantation network, (M) recognize the differences in health and in organ transplantation issues between chil- dren and adults throughout the system and adopt criteria, polices, and procedures that ad- dress the unique health care needs of children, (N) carry out studies and demonstration projects for the purpose of improving proce- dures for organ donation procurement and al- location, including but not limited to projects to examine and attempt to increase transplan- tation among populations with special needs, including children and individuals who are members of racial or ethnic minority groups, and among populations with limited access to transportation, and (O) provide that for purposes of this para- graph, the term ‘‘children’’ refers to individ- uals who are under the age of 18. (3) CLARIFICATION.—In adopting and using standards of quality under paragraph (2)(E), the Organ Procurement and Transplantation Net- work may adopt and use such standards with re- spect to organs infected with human immuno- deficiency virus (in this paragraph referred to as ‘‘HIV’’), provided that any such standards en- sure that organs infected with HIV may be transplanted only into individuals who— (A) are infected with HIV before receiving such organ; and (B)(i) are participating in clinical research approved by an institutional review board under the criteria, standards, and regulations described in subsections (a) and (b) of section 274f–5 of this title; or (ii) if the Secretary has determined under section 274f–5(c) of this title that participation in such clinical research, as a requirement for such transplants, is no longer warranted, are receiving a transplant under the standards and regulations under section 274f–5(c) of this title. (c) Consideration of critical comments The Secretary shall establish procedures for— (1) receiving from interested persons critical comments relating to the manner in which the Page 509 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274 Organ Procurement and Transplantation Net- work is carrying out the duties of the Network under subsection (b); and (2) the consideration by the Secretary of such critical comments. (July 1, 1944, ch. 373, title III, § 372, as added Pub. L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2344; amended Pub. L. 100–607, title IV, § 403, Nov. 4, 1988, 102 Stat. 3115; Pub. L. 101–616, title II, § 202(a)–(c), Nov. 16, 1990, 104 Stat. 3283, 3284; Pub. L. 106–310, div. A, title XXI, § 2101(a), Oct. 17, 2000, 114 Stat. 1156; Pub. L. 110–426, § 2, Oct. 15, 2008, 122 Stat. 4835; Pub. L. 113–51, § 2(a)(1), Nov. 21, 2013, 127 Stat. 579; Pub. L. 118–14, § 2, Sept. 22, 2023, 137 Stat. 69.) Editorial Notes PRIOR PROVISIONS A prior section 274, act July 1, 1944, ch. 373, title III, § 372, as added July 28, 1956, ch. 772, title II, § 201, 70 Stat. 710; amended June 25, 1959, Pub. L. 86–70, § 31(b)(2)–(4), 73 Stat. 148, related to grants to Alaska for a mental health program and payment for construction of hospital facilities, prior to the general revision of this part by section 201 of Pub. L. 98–507. Another section 372 of act July 1, 1944, added by act Aug. 3, 1956, ch. 941, § 1, 70 Stat. 960, which related to functions of National Library of Medicine, was renum- bered section 382 and classified to section 276 of this title, prior to repeal by Pub. L. 99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879. AMENDMENTS 2023—Subsec. (a). Pub. L. 118–14, § 2(1), inserted head- ing, substituted ‘‘The Secretary shall’’ for ‘‘The Sec- retary shall by contract’’, ‘‘continued’’ for ‘‘establish- ment and’’, and ‘‘The Secretary may award grants, con- tracts, or cooperative agreements, as the Secretary de- termines appropriate, for purposes of carrying out this section.’’ for ‘‘The amount provided under such con- tract in any fiscal year may not exceed $7,000,000. Funds for such contracts shall be made available from funds available to the Public Health Service from ap- propriations for fiscal years beginning after fiscal year 1984.’’ Subsec. (b). Pub. L. 118–14, § 2(2), inserted subsec. and par. (1) headings and, in par. (1), substituted ‘‘The Organ Procurement and Transplantation Network shall—’’ and subpar. (A) for ‘‘The Organ Procurement and Transplantation Network shall carry out the func- tions described in paragraph (2) and shall— ‘‘(A) be a private nonprofit entity that has an ex- pertise in organ procurement and transplantation, and’’. 2013—Subsec. (b)(2)(E). Pub. L. 113–51, § 2(a)(1)(A), struck out ‘‘, including standards for preventing the acquisition of organs that are infected with the etio- logic agent for acquired immune deficiency syndrome’’ after ‘‘organs’’. Subsec. (b)(3). Pub. L. 113–51, § 2(a)(1)(B), added par. (3). 2008—Subsec. (a). Pub. L. 110–426 substituted ‘‘$7,000,000’’ for ‘‘$2,000,000’’. 2000—Subsec. (b)(2)(M) to(O). Pub. L. 106–310 added subpars. (M) to (O). 1990—Subsec. (b)(1)(A). Pub. L. 101–616, § 202(a)(1), sub- stituted ‘‘that has an expertise in organ procurement and transplantation’’ for ‘‘which is not engaged in any activity unrelated to organ procurement’’. Subsec. (b)(1)(B). Pub. L. 101–616, § 202(a)(2), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: ‘‘have a board of directors which in- cludes representatives of organ procurement organiza- tions (including organizations which have received grants under section 273 of this title), transplant cen- ters, voluntary health associations, and the general public.’’ Subsec. (b)(2)(D). Pub. L. 101–616, § 202(b)(1), inserted ‘‘nationwide’’ after ‘‘organizations in the’’ and ‘‘equi- tably among transplant patients’’ after ‘‘organs’’. Subsec. (b)(2)(F). Pub. L. 101–616, § 202(c), substituted ‘‘compatibility’’ for ‘‘compatability’’. Subsec. (b)(2)(K), (L). Pub. L. 101–616, § 202(b)(2)–(4), added subpars. (K) and (L). 1988—Subsec. (b)(2)(B), (C). Pub. L. 100–607, § 403(a)(1), added subpar. (B) and redesignated former subpars. (B) and (C) as (C) and (D), respectively. Subsec. (b)(2)(D). Pub. L. 100–607, § 403(a)(1), (2), redes- ignated former subpar. (C) as (D) and substituted ‘‘or- gans’’ for ‘‘organs which cannot be placed within the service areas of the organizations’’. Former subpar. (D) redesignated (E). Subsec. (b)(2)(E). Pub. L. 100–607, § 403(a)(1), (3), redes- ignated former subpar. (D) as (E) and inserted ‘‘includ- ing standards for preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome,’’ after ‘‘organs,’’. Former subpar. (E) redesignated (F). Subsec. (b)(2)(F). Pub. L. 100–607, § 403(a)(1), (4), redes- ignated former subpar. (E) as (F) and inserted ‘‘(and, to the extent practicable, among regions or on a national basis)’’ after ‘‘basis’’. Former subpar. (F) redesignated (G). Subsec. (b)(2)(G) to (I). Pub. L. 100–607, § 403(a)(1), re- designated former subpars. (F) to (H) as (G) to (I), re- spectively. Subsec. (b)(2)(J). Pub. L. 100–607, § 403(a)(5), added sub- par. (J). Subsec. (c). Pub. L. 100–607, § 403(b), added subsec. (c). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1990 AMENDMENT Pub. L. 101–616, title II, § 202(d), Nov. 16, 1990, 104 Stat. 3284, provided that: ‘‘The amendments made by sub- section (a) [amending this section] shall become effec- tive on December 31, 1990.’’ REPORT; LIMITATION ON AMENDMENT BY PUB. L. 110–426 Pub. L. 110–426, § 3, Oct. 15, 2008, 122 Stat. 4835, pro- vided that: ‘‘(a) IN GENERAL.—The Secretary of Health and Human Services shall request that the Executive Direc- tor of the Organ Procurement and Transplantation Network submit to Congress, not later than 1 year after the date of enactment of this Act [Oct. 15, 2008], a re- port that shall include— ‘‘(1) the identity of transplant programs that have become inactive or have closed since the heart alloca- tion policy change of 2006; ‘‘(2) the distance to the next closest operational heart transplant center from such inactivated or closed programs and an evaluation of whether or not access to care has been reduced to the population pre- viously serviced by such inactive or closed program; ‘‘(3) the number of patients with rural zip codes that received transplants after the heart allocation policy change of 2006 as compared with the number of such patients that received such transplants prior to such heart allocation policy change; ‘‘(4) a comparison of the number of transplants per- formed, the mortality rate for individuals on the transplant waiting lists, and the post-transplant sur- vival rate nationally and by region prior to and after the heart allocation policy change of 2006; and ‘‘(5) specifically with respect to allosensitized pa- tients, a comparison of the number of heart trans- plants performed, the mortality rate for individuals on the heart transplant waiting lists, and the post heart transplant survival rate nationally and by re- gion prior to and after the heart allocation policy change of 2006. ‘‘(b) LIMITATION ON FUNDING.—The increase provided for in the amendment made by section 2 [amending this section] shall not apply with respect to contracts en- tered into under section 372(a) of the Public Health Page 510 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274a Service Act (42 U.S.C. 274(a)) after the date that is 1 year after the date of enactment of this Act [Oct. 15, 2008] if the Executive Director of the Organ Procure- ment and Transplantation Network fails to submit the report under subsection (a).’’ § 274a. Scientific registry The Secretary shall, by grant or contract, de- velop and maintain a scientific registry of the recipients of organ transplants. The registry shall include such information respecting pa- tients and transplant procedures as the Sec- retary deems necessary to an ongoing evalua- tion of the scientific and clinical status of organ transplantation. The Secretary shall prepare for inclusion in the report under section 274d of this title an analysis of information derived from the registry. (July 1, 1944, ch. 373, title III, § 373, as added Pub. L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2345; amended Pub. L. 100–607, title IV, § 404, Nov. 4, 1988, 102 Stat. 3116; Pub. L. 101–616, title I, § 101(b), Nov. 16, 1990, 104 Stat. 3282.) Editorial Notes PRIOR PROVISIONS A prior section 373 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, § 1, 70 Stat. 960, which related to a Board of Regents of National Library of Medicine, was renumbered section 383 and classified to section 277 of this title, prior to repeal by Pub. L. 99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879. AMENDMENTS 1990—Pub. L. 101–616 struck out ‘‘and bone marrow registry’’ after ‘‘Scientific registry’’ in section catch- line and struck out subsec. (a) designation and subsec. (b) which directed establishment of bone marrow reg- istry and authorized appropriations for fiscal years 1989 and 1990 for such purpose. 1988—Pub. L. 100–607 inserted ‘‘and bone marrow reg- istry’’ in section catchline, designated existing text as subsec. (a), and added subsec. (b). § 274b. General provisions respecting grants and contracts (a) Application requirement No grant may be made under this part or con- tract entered into under section 274 or 274a of this title unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be submitted in such manner as the Sec- retary shall by regulation prescribe. (b) Special considerations and priority; planning and establishment grants (1) A grant for planning under section 273(a)(1) of this title may be made for one year with re- spect to any organ procurement organization and may not exceed $100,000. (2) Grants under section 273(a)(2) of this title may be made for two years. No such grant may exceed $500,000 for any year and no organ pro- curement organization may receive more than $800,000 for initial operation or expansion. (3) Grants or contracts under section 273(a)(3) of this title may be made for not more than 3 years. (c) Determination of grant amount; terms of pay- ment; recordkeeping; access for purposes of audits and examination of records (1) The Secretary shall determine the amount of a grant or contract made under section 273 or 274a of this title. Payments under such grants and contracts may be made in advance on the basis of estimates or by the way of reimburse- ment, with necessary adjustments on account of underpayments or overpayments, and in such in- stallments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants and contracts. (2)(A) Each recipient of a grant or contract under section 273, 274, or 274a of this title shall keep such records as the Secretary shall pre- scribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant or contract, the total cost of the undertaking in connection with which such grant or contract was made, and the amount of that portion of the cost of the under- taking supplied by other sources, and such other records as will facilitate an effective audit. (B) The Secretary and the Comptroller Gen- eral of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the re- cipient of a grant or contract under section 273, 274, or 274a of this title that are pertinent to such grant or contract. (d) ‘‘Transplant center’’ and ‘‘organ’’ defined For purposes of this part: (1) The term ‘‘transplant center’’ means a health care facility in which transplants of or- gans are performed. (2) The term ‘‘organ’’ means the human kid- ney, liver, heart, lung, pancreas, and any other human organ (other than corneas and eyes) specified by the Secretary by regulation and for purposes of section 274a of this title, such term includes bone marrow. (July 1, 1944, ch. 373, title III, § 374, as added Pub. L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2345; amended Pub. L. 100–607, title IV, § 402(b), Nov. 4, 1988, 102 Stat. 3114; Pub. L. 101–616, title II, § 203, Nov. 16, 1990, 104 Stat. 3284; Pub. L. 118–14, § 3(2), Sept. 22, 2023, 137 Stat. 69.) Editorial Notes PRIOR PROVISIONS A prior section 374 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, § 1, 70 Stat. 961, which related to ac- ceptance and administration of gifts to National Li- brary of Medicine and to establishment of memorials to donors, was renumbered section 384 and classified to section 278 of this title, prior to repeal by Pub. L. 99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879. AMENDMENTS 2023—Subsec. (c)(2). Pub. L. 118–14 substituted ‘‘sec- tion 273, 274, or 274a’’ for ‘‘section 273 or 274a’’ in sub- pars. (A) and (B). 1990—Subsec. (a). Pub. L. 101–616, § 203(1), substituted ‘‘No grant may be made under this part’’ for ‘‘No grant may be made under section 273 or 274a of this title’’. Subsec. (b). Pub. L. 101–616, § 203(2), redesignated par. (2) as (1) and substituted ‘‘section 273(a)(1)’’ for ‘‘section 273’’, struck out former par. (1) which set forth factors