Part H—Organ Transplants
Editorial Notes
Prior Provisions
A prior part H related to grants to Alaska for mental health, prior to the general revision of part H by
Another prior part H, entitled "National Library of Medicine", as added by act Aug. 3, 1956, ch. 907,
§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).
(2) The Secretary may make grants for the establishment, initial operation, consolidation, and expansion of qualified organ procurement organizations described in subsection (b).
(b) Qualified organizations
(1) A qualified organ procurement organization for which grants may be made under subsection (a) 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 [
(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 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 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 (3), 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
(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
(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).
(July 1, 1944, ch. 373, title III, §371, as added
Editorial Notes
References in Text
Paragraph (2), referred to in subsec. (b)(1), meaning paragraph (2) of subsec. (b) of this section, was redesignated paragraph (3) by section 201(d)(1) of
The Social Security Act, referred to in subsec. (b)(1)(C), is act Aug. 14, 1935, ch. 531,
Paragraph (1)(E), referred to in subsec. (b)(2)(A), meaning par. (1)(E) of subsec. (b) of this section, probably should refer to par. (1)(F) of subsec. (b) after the redesignations by section 701(c)(1) of
Prior Provisions
A prior section 273, act July 1, 1944, ch. 373, title III, §371, as added July 28, 1956, ch. 772, title II, §201,
A prior section 371 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
2023—Subsec. (b)(1)(H)(i)(III).
2013—Subsec. (b)(1)(E), (F).
Subsec. (b)(1)(G).
Subsec. (b)(1)(H)(i)(V).
Subsec. (b)(1)(H)(ii).
Subsec. (b)(3)(C).
2004—Subsec. (a)(3).
Subsec. (c).
2000—Subsec. (b)(1)(D) to (H).
1990—
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (b)(1)(E).
Subsec. (b)(1)(G)(i)(III).
Subsec. (b)(2), (3).
Subsec. (c).
1988—Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (a)(4)(C).
Subsec. (b)(1)(E).
Subsec. (b)(1)(G)(i)(III).
Subsec. (b)(2)(C).
Subsec. (b)(2)(E).
Subsec. (b)(2)(K).
Subsec. (c).
Statutory Notes and Related Subsidiaries
Effective Date of 1990 Amendment
Effective Date of 1988 Amendment
Short Title
For short title of
Severability
Certification of Organ Procurement Organizations
"(1) Organ procurement organizations play an important role in the effort to increase organ donation in the United States.
"(2) The current process for the certification and recertification of organ procurement organizations conducted by the Department of Health and Human Services has created a level of uncertainty that is interfering with the effectiveness of organ procurement organizations in raising the level of organ donation.
"(3) The General Accounting Office [now Government Accountability Office], the Institute of Medicine, and the Harvard School of Public Health have identified substantial limitations in the organ procurement organization certification and recertification process and have recommended changes in that process.
"(4) The limitations in the recertification process include:
"(A) An exclusive reliance on population-based measures of performance that do not account for the potential in the population for organ donation and do not permit consideration of other outcome and process standards that would more accurately reflect the relative capability and performance of each organ procurement organization.
"(B) A lack of due process to appeal to the Secretary of Health and Human Services for recertification on either substantive or procedural grounds.
"(5) The Secretary of Health and Human Services has the authority under section 1138(b)(1)(A)(i) of the Social Security Act (
"(6) The Secretary of Health and Human Services can use the extended period described in paragraph (5) for recertification of all organ procurement organizations to—
"(A) develop improved performance measures that would reflect organ donor potential and interim outcomes, and to test these measures to ensure that they accurately measure performance differences among the organ procurement organizations; and
"(B) improve the overall certification process by incorporating process as well as outcome performance measures, and developing equitable processes for appeals."
Study Regarding Immunosuppressive Drugs
Study on Hospital Agreements With Organ Procurement Agencies
Task Force on Organ Procurement and Transplantation
Bone Marrow Registry Demonstration and Study
1 See References in Text note below.
2 So in original. The semicolon probably should be a comma.
§273a. National living donor mechanisms
The Secretary may establish and maintain mechanisms to evaluate the long-term effects associated with living organ donations by individuals who have served as living donors.
(July 1, 1944, ch. 373, title III, §371A, as added
§273b. Report on the long-term health effects of living organ donation
Not later than 1 year after December 21, 2007, and annually thereafter, the Secretary of Health and Human Services shall submit to the appropriate committees of Congress a report that details the progress made towards understanding the long-term health effects of living organ donation.
(
Editorial Notes
Codification
Section was enacted as part of the Charlie W. Norwood Living Organ Donation Act, and not as part of the Public Health Service Act which comprises this chapter.
§274. Organ procurement and transplantation network
(a) In general
The Secretary shall provide for the continued operation of an Organ Procurement and Transplantation Network which meets the requirements of subsection (b). The Secretary may award grants, contracts, or cooperative agreements, as the Secretary determines appropriate, for purposes of carrying out this section.
(b) Composition
(1)
(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 organizations that have received grants under
(ii) that shall establish an executive committee and other committees, whose chairpersons shall be selected to ensure continuity of leadership for the board.
(2) The Organ Procurement and Transplantation Network shall—
(A) establish in one location or through regional centers—
(i) a national list of individuals who need organs, and
(ii) a national system, through the use of computers and in accordance with established 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 medical 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 individuals included in the list,
(D) assist organ procurement organizations in the nationwide distribution of organs equitably 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 transportation of organs from organ procurement organizations to transplant centers,
(H) provide information to physicians and other health professionals regarding organ donation,
(I) collect, analyze, and publish data concerning organ donation and transplants,
(J) carry out studies and demonstration projects for the purpose of improving procedures 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 children and adults throughout the system and adopt criteria, polices, and procedures that address the unique health care needs of children,
(N) carry out studies and demonstration projects for the purpose of improving procedures for organ donation procurement and allocation, including but not limited to projects to examine and attempt to increase transplantation 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 paragraph, the term "children" refers to individuals who are under the age of 18.
(3)
(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
(ii) if the Secretary has determined under
(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 Organ Procurement and Transplantation Network 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
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,
Another section 372 of act July 1, 1944, added by act Aug. 3, 1956, ch. 941, §1,
Amendments
2023—Subsec. (a).
Subsec. (b).
"(A) be a private nonprofit entity that has an expertise in organ procurement and transplantation, and".
2013—Subsec. (b)(2)(E).
Subsec. (b)(3).
2008—Subsec. (a).
2000—Subsec. (b)(2)(M) to(O).
1990—Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
Subsec. (b)(2)(D).
Subsec. (b)(2)(F).
Subsec. (b)(2)(K), (L).
1988—Subsec. (b)(2)(B), (C).
Subsec. (b)(2)(D).
Subsec. (b)(2)(E).
Subsec. (b)(2)(F).
Subsec. (b)(2)(G) to (I).
Subsec. (b)(2)(J).
Subsec. (c).
Statutory Notes and Related Subsidiaries
Effective Date of 1990 Amendment
Report; Limitation on Amendment by Pub. L. 110–426
"(a)
"(1) the identity of transplant programs that have become inactive or have closed since the heart allocation 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 previously 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 performed, the mortality rate for individuals on the transplant waiting lists, and the post-transplant survival rate nationally and by region prior to and after the heart allocation policy change of 2006; and
"(5) specifically with respect to allosensitized patients, a comparison of the number of heart transplants performed, the mortality rate for individuals on the heart transplant waiting lists, and the post heart transplant survival rate nationally and by region prior to and after the heart allocation policy change of 2006.
"(b)
§274a. Scientific registry
The Secretary shall, by grant or contract, develop and maintain a scientific registry of the recipients of organ transplants. The registry shall include such information respecting patients and transplant procedures as the Secretary deems necessary to an ongoing evaluation of the scientific and clinical status of organ transplantation. The Secretary shall prepare for inclusion in the report under
(July 1, 1944, ch. 373, title III, §373, as added
Editorial Notes
Prior Provisions
A prior section 373 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
1990—
1988—
§274b. General provisions respecting grants and contracts
(a) Application requirement
No grant may be made under this part or contract entered into under
(b) Special considerations and priority; planning and establishment grants
(1) A grant for planning under
(2) Grants under
(3) Grants or contracts under
(c) Determination of grant amount; terms of payment; recordkeeping; access for purposes of audits and examination of records
(1) The Secretary shall determine the amount of a grant or contract made under
(2)(A) Each recipient of a grant or contract under
(B) The Secretary and the Comptroller General 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 recipient of a grant or contract under
(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 organs are performed.
(2) The term "organ" means the human kidney, liver, heart, lung, pancreas, and any other human organ (other than corneas and eyes) specified by the Secretary by regulation and for purposes of
(July 1, 1944, ch. 373, title III, §374, as added
Editorial Notes
Prior Provisions
A prior section 374 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
2023—Subsec. (c)(2).
1990—Subsec. (a).
Subsec. (b).
Subsec. (c).
1988—Subsec. (b)(3).
§274c. Administration
The Secretary shall designate and maintain an identifiable administrative unit in the Public Health Service to—
(1) administer this part and coordinate with the organ procurement activities under title XVIII of the Social Security Act [
(2) conduct a program of public information to inform the public of the need for organ donations;
(3) provide technical assistance to organ procurement organizations, the Organ Procurement and Transplantation Network established under
(4) provide information—
(A) to patients, their families, and their physicians about transplantation; and
(B) to patients and their families about the resources available nationally and in each State, and the comparative costs and patient outcomes at each transplant center affiliated with the organ procurement and transplantation network, in order to assist the patients and families with the costs associated with transplantation.
(July 1, 1944, ch. 373, title III, §375, as added
Editorial Notes
References in Text
The Social Security Act, referred to in par. (1), is act Aug. 14, 1935, ch. 531,
Prior Provisions
A prior section 375 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
2023—Pars. (1), (2).
Par. (3).
Par. (4).
1990—
Par. (3).
Par. (4).
1988—
§274d. Report
Not later than 2 years after September 22, 2023, and every second year thereafter, the Secretary shall publish, and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, a report on the scientific and clinical status of organ transplantation. The Secretary shall consult with the Director of the National Institutes of Health and the Commissioner of the Food and Drug Administration in the preparation of the report.
(July 1, 1944, ch. 373, title III, §376, as added
Editorial Notes
Prior Provisions
A prior section 376 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
2023—
1990—
1988—
Statutory Notes and Related Subsidiaries
Change of Name
Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
§274e. Prohibition of organ purchases
(a) Prohibition
It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce. The preceding sentence does not apply with respect to human organ paired donation.
(b) Penalties
Any person who violates subsection (a) shall be fined not more than $50,000 or imprisoned not more than five years, or both.
(c) Definitions
For purposes of subsection (a):
(1) The term "human organ" means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.
(2) The term "valuable consideration" does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.
(3) The term "interstate commerce" has the meaning prescribed for it by
(4) The term "human organ paired donation" means the donation and receipt of human organs under the following circumstances:
(A) An individual (referred to in this paragraph as the "first donor") desires to make a living donation of a human organ specifically to a particular patient (referred to in this paragraph as the "first patient"), but such donor is biologically incompatible as a donor for such patient.
(B) A second individual (referred to in this paragraph as the "second donor") desires to make a living donation of a human organ specifically to a second particular patient (referred to in this paragraph as the "second patient"), but such donor is biologically incompatible as a donor for such patient.
(C) Subject to subparagraph (D), the first donor is biologically compatible as a donor of a human organ for the second patient, and the second donor is biologically compatible as a donor of a human organ for the first patient.
(D) If there is any additional donor-patient pair as described in subparagraph (A) or (B), each donor in the group of donor-patient pairs is biologically compatible as a donor of a human organ for a patient in such group.
(E) All donors and patients in the group of donor-patient pairs (whether 2 pairs or more than 2 pairs) enter into a single agreement to donate and receive such human organs, respectively, according to such biological compatibility in the group.
(F) Other than as described in subparagraph (E), no valuable consideration is knowingly acquired, received, or otherwise transferred with respect to the human organs referred to in such subparagraph.
(
Editorial Notes
Codification
Section was enacted as part of the National Organ Transplant Act, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
2007—Subsec. (a).
Subsec. (c)(4).
1988—Subsec. (c)(1).
Statutory Notes and Related Subsidiaries
Determination on the Definition of Human Organ
No Impact on Social Security Trust Fund
§274f. Reimbursement of travel and subsistence expenses incurred toward living organ donation
(a) In general
The Secretary may award grants to States, transplant centers, qualified organ procurement organizations under
(1) providing for the reimbursement of travel and subsistence expenses incurred by individuals toward making living donations of their organs (in this section referred to as "donating individuals"); and
(2) providing for the reimbursement of such incidental nonmedical expenses that are so incurred as the Secretary determines by regulation to be appropriate.
(b) Preference
The Secretary shall, in carrying out subsection (a), give preference to those individuals that the Secretary determines are more likely to be otherwise unable to meet such expenses.
(c) Certain circumstances
The Secretary may, in carrying out subsection (a), consider—
(1) the term "donating individuals" as including individuals who in good faith incur qualifying expenses toward the intended donation of an organ but with respect to whom, for such reasons as the Secretary determines to be appropriate, no donation of the organ occurs; and
(2) the term "qualifying expenses" as including the expenses of having relatives or other individuals, not to exceed 2, accompany or assist the donating individual for purposes of subsection (a) (subject to making payment for only those types of expenses that are paid for a donating individual).
(d) Relationship to payments under other programs
An award may be made under subsection (a) only if the applicant involved agrees that the award will not be expended to pay the qualifying expenses of a donating individual to the extent that payment has been made, or can reasonably be expected to be made, with respect to such expenses—
(1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program;
(2) by an entity that provides health services on a prepaid basis; or
(3) by the recipient of the organ.
(e) Definitions
For purposes of this section:
(1) The term "donating individuals" has the meaning indicated for such term in subsection (a)(1), subject to subsection (c)(1).
(2) The term "qualifying expenses" means the expenses authorized for purposes of subsection (a), subject to subsection (c)(2).
(f) Authorization of appropriations
For the purpose of carrying out this section, there is authorized to be appropriated $5,000,000 for each of the fiscal years 2005 through 2009.
(July 1, 1944, ch. 373, title III, §377, as added
Editorial Notes
Amendments
2004—
§274f–1. Public awareness; studies and demonstrations
(a) Organ donation public awareness program
The Secretary shall, directly or through grants or contracts, establish a public education program in cooperation with existing national public awareness campaigns to increase awareness about organ donation and the need to provide for an adequate rate of such donations.
(b) Studies and demonstrations
The Secretary may make peer-reviewed grants to, or enter into peer-reviewed contracts with, public and nonprofit private entities for the purpose of carrying out studies and demonstration projects to increase organ donation and recovery rates, including living donation.
(c) Grants to States
(1) In general
The Secretary may make grants to States for the purpose of assisting States in carrying out organ donor awareness, public education, and outreach activities and programs designed to increase the number of organ donors within the State, including living donors.
(2) Eligibility
To be eligible to receive a grant under this subsection, a State shall—
(A) submit an application to the Department in the form prescribed;
(B) establish yearly benchmarks for improvement in organ donation rates in the State; and
(C) report to the Secretary on an annual basis a description and assessment of the State's use of funds received under this subsection, accompanied by an assessment of initiatives for potential replication in other States.
(3) Use of funds
Funds received under this subsection may be used by the State, or in partnership with other public agencies or private sector institutions, for education and awareness efforts, information dissemination, activities pertaining to the State donor registry, and other innovative donation specific initiatives, including living donation.
(d) Educational activities
The Secretary, in coordination with the Organ Procurement and Transplantation Network and other appropriate organizations, shall support the development and dissemination of educational materials to inform health care professionals and other appropriate professionals in issues surrounding organ, tissue, and eye donation including evidence-based proven methods to approach patients and their families, cultural sensitivities, and other relevant issues.
(e) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $15,000,000 for fiscal year 2005, and such sums as may be necessary for each of the fiscal years 2006 through 2009. Such authorization of appropriations is in addition to any other authorizations of appropriations that are available for such purpose.
(July 1, 1944, ch. 373, title III, §377A, as added
§274f–2. Grants regarding hospital organ donation coordinators
(a) Authority
(1) In general
The Secretary may award grants to qualified organ procurement organizations and hospitals under
(2) Eligible hospital
For purposes of this section, the term "eligible hospital" means a hospital that performs significant trauma care, or a hospital or consortium of hospitals that serves a population base of not fewer than 200,000 individuals.
(b) Administration of coordination program
A condition for the receipt of a grant under subsection (a) is that the applicant involved agree that the program under such subsection will be carried out jointly—
(1) by representatives from the eligible hospital and the qualified organ procurement organization with respect to which the grant is made; and
(2) by such other entities as the representatives referred to in paragraph (1) may designate.
(c) Requirements
Each entity receiving a grant under subsection (a) shall—
(1) establish joint organ procurement organization and hospital designated leadership responsibility and accountability for the project;
(2) develop mutually agreed upon overall project performance goals and outcome measures, including interim outcome targets; and
(3) collaboratively design and implement an appropriate data collection process to provide ongoing feedback to hospital and organ procurement organization leadership on project progress and results.
(d) Rule of construction
Nothing in this section shall be construed to interfere with regulations in force on April 5, 2004.
(e) Evaluations
Within 3 years after the award of grants under this section, the Secretary shall ensure an evaluation of programs carried out pursuant to subsection (a) in order to determine the extent to which the programs have increased the rate of organ donation for the eligible hospitals involved.
(f) Matching requirement
The Secretary may not award a grant to a qualifying organ donation entity under this section unless such entity agrees that, with respect to costs to be incurred by the entity in carrying out activities for which the grant was awarded, the entity shall contribute (directly or through donations from public or private entities) non-Federal contributions in cash or in kind, in an amount equal to not less than 30 percent of the amount of the grant awarded to such entity.
(g) Funding
For the purpose of carrying out this section, there are authorized to be appropriated $3,000,000 for fiscal year 2005, and such sums as may be necessary for each of fiscal years 2006 through 2009.
(July 1, 1944, ch. 373, title III, §377B, as added
§274f–3. Studies relating to organ donation and the recovery, preservation, and transportation of organs
(a) Development of supportive information
The Secretary, acting through the Director of the Agency for Healthcare Research and Quality, shall develop scientific evidence in support of efforts to increase organ donation and improve the recovery, preservation, and transportation of organs.
(b) Activities
In carrying out subsection (a), the Secretary shall—
(1) conduct or support evaluation research to determine whether interventions, technologies, or other activities improve the effectiveness, efficiency, or quality of existing organ donation practice;
(2) undertake or support periodic reviews of the scientific literature to assist efforts of professional societies to ensure that the clinical practice guidelines that they develop reflect the latest scientific findings;
(3) ensure that scientific evidence of the research and other activities undertaken under this section is readily accessible by the organ procurement workforce; and
(4) work in coordination with the appropriate professional societies as well as the Organ Procurement and Transplantation Network and other organ procurement and transplantation organizations to develop evidence and promote the adoption of such proven practices.
(c) Research and dissemination
The Secretary, acting through the Director of the Agency for Healthcare Research and Quality, as appropriate, shall provide support for research and dissemination of findings, to—
(1) develop a uniform clinical vocabulary for organ recovery;
(2) apply information technology and telecommunications to support the clinical operations of organ procurement organizations;
(3) enhance the skill levels of the organ procurement workforce in undertaking quality improvement activities; and
(4) assess specific organ recovery, preservation, and transportation technologies.
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $2,000,000 for fiscal year 2005, and such sums as may be necessary for each of fiscal years 2006 through 2009.
(July 1, 1944, ch. 373, title III, §377C, as added
§274f–4. Report relating to organ donation and the recovery, preservation, and transportation of organs
(a) In general
Not later than December 31, 2005, and every 2 years thereafter, the Secretary shall report to the appropriate committees of Congress on the activities of the Department carried out pursuant to this part, including an evaluation describing the extent to which the activities have affected the rate of organ donation and recovery.
(b) Requirements
To the extent practicable, each report submitted under subsection (a) shall—
(1) evaluate the effectiveness of activities, identify effective activities, and disseminate such findings with respect to organ donation and recovery;
(2) assess organ donation and recovery activities that are recently completed, ongoing, or planned; and
(3) evaluate progress on the implementation of the plan required under subsection (c)(5).
(c) Initial report requirements
The initial report under subsection (a) shall include the following:
(1) An evaluation of the organ donation practices of organ procurement organizations, States, other countries, and other appropriate organizations including an examination across all populations, including those with low organ donation rates, of—
(A) existing barriers to organ donation; and
(B) the most effective donation and recovery practices.
(2) An evaluation of living donation practices and procedures. Such evaluation shall include an assessment of issues relating to informed consent and the health risks associated with living donation (including possible reduction of long-term effects).
(3) An evaluation of—
(A) federally supported or conducted organ donation efforts and policies, as well as federally supported or conducted basic, clinical, and health services research (including research on preservation techniques and organ rejection and compatibility); and
(B) the coordination of such efforts across relevant agencies within the Department and throughout the Federal Government.
(4) An evaluation of the costs and benefits of State donor registries, including the status of existing State donor registries, the effect of State donor registries on organ donation rates, issues relating to consent, and recommendations regarding improving the effectiveness of State donor registries in increasing overall organ donation rates.
(5) A plan to improve federally supported or conducted organ donation and recovery activities, including, when appropriate, the establishment of baselines and benchmarks to measure overall outcomes of these programs. Such plan shall provide for the ongoing coordination of federally supported or conducted organ donation and research activities.
(July 1, 1944, ch. 373, title III, §377D, as added
§274f–5. Criteria, standards, and regulations with respect to organs infected with HIV
(a) In general
Not later than 2 years after November 21, 2013, the Secretary shall develop and publish criteria for the conduct of research relating to transplantation of organs from donors infected with human immunodeficiency virus (in this section referred to as "HIV") into individuals who are infected with HIV before receiving such organ.
(b) Corresponding changes to standards and regulations applicable to research
Not later than 2 years after November 21, 2013, to the extent determined by the Secretary to be necessary to allow the conduct of research in accordance with the criteria developed under subsection (a)—
(1) the Organ Procurement and Transplantation Network shall revise the standards of quality adopted under
(2) the Secretary shall revise section 121.6 of title 42, Code of Federal Regulations (or any successor regulations).
(c) Revision of standards and regulations generally
Not later than 4 years after November 21, 2013, and annually thereafter, the Secretary,1 shall—
(1) review the results of scientific research in conjunction with the Organ Procurement and Transplantation Network to determine whether the results warrant revision of the standards of quality adopted under
(2) if the Secretary determines under paragraph (1) that such results warrant revision of the standards of quality adopted under
(3) in conjunction with any revision of such standards under paragraph (2), revise section 121.6 of title 42, Code of Federal Regulations (or any successor regulations).
(July 1, 1944, ch. 373, title III, §377E, as added
1 So in original. The comma probably should not appear.
§274g. Authorization of appropriations
For the purpose of carrying out this part, there are authorized to be appropriated $8,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 and 1993.
(July 1, 1944, ch. 373, title III, §378, as added
Editorial Notes
Amendments
1998—