| Home > 106th Congressional Bills > S. 2625 (is) To amend the Public Health Service Act to revise the performance standards and certification process for organ procurement organizations. [Introduced in Senate] ...
S. 2625 (is) To amend the Public Health Service Act to revise the performance standards and certification process for organ procurement organizations. [Introduced in Senate] ...
106th CONGRESS 2d Session S. 2625 _______________________________________________________________________ AN ACT To amend the Public Health Service Act to revise the performance standards and certification process for organ procurement organizations. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. ORGAN PROCUREMENT ORGANIZATION CERTIFICATION ACT OF 2000. (a) Findings.--Congress makes the following findings: (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, 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 (42 U.S.C. 1320b-8(b)(1)(A)(i)) to extend the period for recertification of an organ procurement organization from 2 to 4 years on the basis of its past practices in order to avoid the inappropriate disruption of the nation's organ system. (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. (b) Certification and Recertification of Organ Procurement Organizations.--Section 371(b)(1) of the Public Health Service Act (42 U.S.C. 273(b)(1)) is amended-- (1) by redesignating subparagraphs (D) through (G) as subparagraphs (E) through (H), respectively; (2) by realigning the margin of subparagraph (F) (as so redesignated) so as to align with subparagraph (E) (as so redesignated); and (3) by inserting after subparagraph (C) 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 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;''. Passed the Senate July 7 (legislative day, July 6), 2000. Attest: Secretary. 106th CONGRESS 2d Session S. 2625 _______________________________________________________________________ AN ACT To amend the Public Health Service Act to revise the performance standards and certification process for organ procurement organizations.
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