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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. ORGAN PROCUREMENT ORGANIZATION CER2 TIFICATION ACT OF 2000.

3 (a) FINDINGS.—Congress makes the following find4 ings:

5 (1) Organ procurement organizations play an

6 important role in the effort to increase organ dona7 tion in the United States.

8 (2) The current process for the certification and

9 recertification of organ procurement organizations

10 conducted by the Department of Health and Human

11 Services has created a level of uncertainty that is

12 interfering with the effectiveness of organ procure13 ment organizations in raising the level of organ do14 nation.

15 (3) The General Accounting Office, the Insti16 tute of Medicine, and the Harvard School of Public

17 Health have identified substantial limitations in the

18 organ procurement organization certification and re19 certification process and have recommended changes

20 in that process.

21 (4) The limitations in the recertification process

22 include:

23 (A) An exclusive reliance on population24 based measures of performance that do not ac25 count for the potential in the population for

26 organ donation and do not permit consideration
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1 of other outcome and process standards that

2 would more accurately reflect the relative capa3 bility and performance of each organ procure4 ment organization.

5 (B) A lack of due process to appeal to the

6 Secretary of Health and Human Services for

7 recertification on either substantive or proce8 dural grounds.

9 (5) The Secretary of Health and Human Serv10 ices has the authority under section 1138(b)(1)(A)(i)

11 of the Social Security Act (42 U.S.C. 1320b–

12 8(b)(1)(A)(i)) to extend the period for recertification

13 of an organ procurement organization from 2 to 4

14 years on the basis of its past practices in order to

15 avoid the inappropriate disruption of the nation’s

16 organ system.

17 (6) The Secretary of Health and Human Serv18 ices can use the extended period described in para19 graph (5) for recertification of all organ procure20 ment organizations to—

21 (A) develop improved performance meas22 ures that would reflect organ donor potential

23 and interim outcomes, and to test these meas24 ures to ensure that they accurately measure
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1 performance differences among the organ pro2 curement organizations; and

3 (B) improve the overall certification proc4 ess by incorporating process as well as outcome

5 performance measures, and developing equitable

6 processes for appeals.

7 (b) CERTIFICATION AND RECERTIFICATION OF

8 ORGAN PROCUREMENT ORGANIZATIONS.—Section

9 371(b)(1) of the Public Health Service Act (42 U.S.C.

10 273(b)(1)) is amended—

11 (1) by redesignating subparagraphs (D)

12 through (G) as subparagraphs (E) through (H), re13 spectively;

14 (2) by realigning the margin of subparagraph

15 (F) (as so redesignated) so as to align with subpara16 graph (E) (as so redesignated); and

17 (3) by inserting after subparagraph (C) the fol18 lowing:

19 ‘‘(D) notwithstanding any other provision of

20 law, has met the other requirements of this section

21 and has been certified or recertified by the Secretary

22 within the previous 4-year period as meeting the

23 performance standards to be a qualified organ pro24 curement organization through a process that

25 either—
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1 ‘‘(i) granted certification or recertification

2 within such 4-year period with such certification

3 or recertification in effect as of January 1,

4 2000, and remaining in effect through the ear5 lier of—

6 ‘‘(I) January 1, 2002; or

7 ‘‘(II) the completion of recertification

8 under the requirements of clause (ii); or

9 ‘‘(ii) is defined through regulations that

10 are promulgated by the Secretary by not later

11 than January 1, 2002, that—

12 ‘‘(I) require recertifications of quali13 fied organ procurement organizations not

14 more frequently than once every 4 years;

15 ‘‘(II) rely on outcome and process per16 formance measures that are based on em17 pirical evidence, obtained through reason18 able efforts, of organ donor potential and

19 other related factors in each service area of

20 qualified organ procurement organizations;

21 ‘‘(III) use multiple outcome measures

22 as part of the certification process; and

23 ‘‘(IV) provide for a qualified organ

24 procurement organization to appeal a de-
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1 certification to the Secretary on sub2 stantive 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.