[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3504 Engrossed in House (EH)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
107th CONGRESS
  1st Session
                                H. R. 3504

_______________________________________________________________________

                                 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 Representatives of the 
United States of America in Congress assembled,  That section 371(b)(1) 
of the Public Health Service Act (42 U.S.C. 273(b)(1)) is amended by 
striking subparagraph (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 qualified organ procurement organization 
        through a process 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 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,
            ``(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.''.

            Passed the House of Representatives December 20, 2001.

            Attest:

                                                                 Clerk.
107th CONGRESS

  1st Session

                               H. R. 3504

_______________________________________________________________________

                                 AN ACT

To amend the Public Health Service Act with respect to qualified organ 
                       procurement organizations.