| Home > 106th Congressional Bills > H.R. 2418 (ih) To amend the Public Health Service Act to revise and extend programs relating to organ procurement and transplantation. [Introduced in House] ...
H.R. 2418 (ih) To amend the Public Health Service Act to revise and extend programs relating to organ procurement and transplantation. [Introduced in House] ...
106th CONGRESS 2d Session H. R. 2418 _______________________________________________________________________ AN ACT To amend the Public Health Service Act to revise and extend programs relating to organ procurement and transplantation. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Organ Procurement and Transplantation Network Amendments of 2000''. SEC. 2. FINDINGS. (a) In General.--The Congress finds as follows: (1) It is in the public interest to maintain and improve a system for promoting and supporting a central network in the private sector to assist organ procurement organizations and transplant centers in the distribution of organs among transplant patients and the provision of organ transplantation services, and to assure quality and facilitate collaboration among network members and individual medical practitioners participating in network activities. (2) The Organ Procurement and Transplantation Network (``Network''), which was established in the private sector pursuant to a contract awarded by the Federal Government, should continue to be operated by a nonprofit private entity pursuant to a contract with the Federal Government. (3) The Federal Government should continue to provide Federal oversight of and financial assistance for the services provided by the Network. (4) The responsibility for developing, establishing, and maintaining medical criteria and standards for organ procurement and transplantation belongs in the private sector and is a function of the Network. (5) The Federal Government should assist the efforts of the Network to serve patient and donor families in procuring and distributing organs. (6) The Federal Government should carry out programs to educate the public with respect to organ donation, including the need to provide for an adequate rate of such donations. (b) Sense of the Congress Regarding Family Discussions of Organ Donations.--The Congress recognizes the importance of families pledging to each other to share their lives as organ and tissue donors and acknowledges the importance of discussing organ and tissue donation as a family. (c) Sense of the Congress Regarding Living Donations of Organs.-- The Congress-- (1) recognizes the generous contribution made by each living individual who has donated an organ to save a life; and (2) acknowledges the advances in medical technology that have enabled organ transplantation with organs donated by living individuals to become a viable treatment option for an increasing number of patients. SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK. (a) In General.--Section 372 of the Public Health Service Act (42 U.S.C. 274) is amended to read as follows: ``organ procurement and transplantation network ``Sec. 372. (a) In General.--The Secretary shall by contract provide for the continuing operation of an Organ Procurement and Transplantation Network (in this section referred to as the `Network'), which contract shall be awarded to a nonprofit private entity that has expertise and experience in organ procurement and transplantation. The Network shall meet the following requirements: ``(1) The Network shall be an independent, nonprofit private entity that is a separate legal entity from the entity to which such contract is awarded. ``(2) The Network shall in accordance with criteria under subsection (b)(3) include as members qualified organ procurement organizations (as described in section 371(b)), transplant centers, and other entities that have a demonstrated interest in the fields of organ donation or transplantation. (such members are in this section referred to as `Network participants'). ``(3) The Network shall have a board of directors (in this section referred to as the `Board'). The Board shall, after consultation with Network participants, establish the policies for carrying out the functions described in this section for the Network. ``(4) The Board shall be in accordance with the following: ``(A) The Board shall include representatives of qualified organ procurement organizations, transplant centers, voluntary health associations, and the general public, including a reasonable proportion of the members of the Board who are patients awaiting a transplant or transplant recipients or individuals who have donated an organ or family members of patients, recipients or donors. ``(B) The Board shall establish membership categories and qualifications with respect to serving on the Board, and shall have exclusive authority to admit individuals to membership on the Board. Transplant surgeons and transplant physicians shall comprise not less than 50 percent of the membership of the Board. The Board shall be limited to a total of 42 members. ``(C) The Board shall have an executive committee, and such other committees as the Board determines to be appropriate. ``(D) The chair of each such committee shall be selected so as to ensure the continuity of leadership for the Board. ``(b) General Functions.--The following applies to the Network: ``(1) The Network shall establish and operate a national system to match organs and individuals who need organ transplants, especially individuals whose immune system makes it difficult for them to receive organs. ``(2) The national system shall maintain one or more lists of individuals who need organ transplants, shall be operated in accordance with established medical criteria, shall be operated through the use of computers, and may function on a regionalized basis. ``(3) The Network shall establish criteria for being a Network participant, shall establish medical criteria for listing patients and for allocating organs, and shall provide to members of the public an opportunity to comment with respect to such criteria. ``(4) The Network shall maintain a twenty-four-hour telephone and computer service to facilitate matching organs with individuals included in the list. ``(5) The Network shall assist organ procurement organizations in the distribution of organs. The distribution of organs shall be based on medical criteria established by the Network, and also shall be based on equity and ethics without regard to economic status of those awaiting organ transplants and without political control or influence. ``(6) The Network shall adopt and use standards of quality for the acquisition and transportation of donated organs, including standards regarding the transmission of infectious diseases. ``(7) The Network shall 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. ``(8) The Network shall coordinate, as appropriate, the transportation of organs from organ procurement organizations to transplant centers. ``(9) The Network shall work actively to increase the supply of donated organs. ``(10) The Network shall recognize the differences in health and in organ transplantation issues between children and adults throughout the system and adopt criteria, policies, and procedures that address the unique health care needs of children. ``(c) Scientific Registry.-- ``(1) In general.--The Network shall maintain a scientific registry of patients awaiting organ transplantation, persons from whom organs are removed for transplantation, and organ transplant recipients for the ongoing evaluation of the scientific and clinical status of organ transplantation. ``(2) Reports.--The Network shall prepare for inclusion in the report under section 375 an analysis of scientifically and clinically valid information derived from the scientific registry under paragraph (1). ``(d) Information and Data.-- ``(1) In general.--The Network shall-- ``(A) provide information to physicians and other health professionals regarding organ donation and transplantation; and ``(B) collect, analyze, and annually publish data concerning organ donation and transplantation. ``(2) Information for patients and general public.--The Network shall make available to patients in need of organ transplants information in accordance with the following: ``(A) The information shall be transplant-related information specific to transplant centers that are Network participants, which information has been determined by the Network to be scientifically and clinically valid. ``(B) The information shall be designed to assist patients and referring physicians in choosing a transplant center, including information on the supply of and demand for organs. ``(C) With respect to the patient involved, the information shall (taking into account patients in similar medical circumstances) include the following as applied to specific transplant centers: ``(i) The probability of receiving an organ transplant. ``(ii) The length of time that similarly situated patients have waited historically to receive a transplant. ``(iii) Medical outcomes for similarly situated patients, which information shall be adjusted to reflect the medical risk factors for such patients. ``(D) With respect to the patient involved, the information shall include the information described in subparagraph (C) as applied to the service areas of specific qualified organ procurement organizations (other than such areas in which there is only one transplant center). ``(E) Information under this paragraph shall be updated not less frequently than once a year. ``(3) Annual public report.--The Network shall annually make available to the public a report on the overall status of organ procurement and transplantation. ``(4) Confidentiality.--Except for the release of information that is authorized under paragraph (2) or (3) by the Network, neither the Network nor the Secretary has authority to release the following information (unless authorized in writing by the patient or other entity with which the data is concerned): ``(A) Information that permits direct or indirect identification of any patient who is waiting for a transplant, or who is an organ transplant patient or recipient of an organ. ``(B) Information that permits direct or indirect identification of any potential or actual organ donors. ``(C) Information that permits direct or indirect identification of participants in Network deliberations or determinations related to practitioner or institutional qualifications, due process proceedings or peer review activities, except for information announcing final decisions of the Network. This paragraph may not be construed as prohibiting the disclosure of information within the Network, including information disclosed in the course of interactive organ sharing operations within the Network. ``(e) Studies.-- ``(1) In general.--The Network shall carry out studies and demonstration projects for the purpose of improving procedures for organ procurement and allocation, including but not limited to projects to examine and attempt to increase transplantation among populations with special needs or limited access to transplantation, and among children. ``(2) Certain technologies.--The Network may study the impact of possible transplantation of animal organs (xenotransplantation) and other technologies to determine the impact upon, and prevent negative effects on, the fair and effective use of human allograft organs. ``(f) Quality Assurance; Monitoring of Network Participants.--The Network shall monitor the operations of Network participants to the extent appropriate for determining whether the participants are maintaining compliance with criteria under subsection (b)(3). In monitoring a Network participant under the preceding sentence, the Network shall inform the participant of any findings indicating noncompliance by the participant. ``(g) Quality Assurance; Peer Review Proceedings.-- ``(1) In general.--The Network shall develop a peer review system for assuring that members of the Network comply with criteria under subsection (b)(3). ``(2) Noncompliance.-- ``(A) Payment of damages.--The Network shall require that, as a condition of being a Network participant, each such participant agree that the Network may, through a peer review proceeding under paragraph (1), require the participant to pay damages for the failure of the participant to comply with criteria under subsection (b)(3). The Network shall establish procedures to ensure that such proceedings are conducted in an impartial manner, with adequate opportunity for the Network participant involved to receive a hearing. The Network shall identify various types of violations of such criteria and specify the
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