II

106TH CONGRESS

2D SESSION S. 2235

To amend the Public Health Act to revise the performance standards and

certification process for organ procurement organizations.

IN THE SENATE OF THE UNITED STATES

MARCH 9, 2000

Ms. COLLINS (for herself, Mr. MURKOWSKI, Mr. DODD, Mr. TORRICELLI, and

Mr. HUTCHINSON) introduced the following bill; which was read twice

and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Public Health 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,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Organ Procurement

5 Organization Certification Act of 2000’’.

6 SEC. 2. FINDINGS.

7 Congress makes the following findings:
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1 (1) Organ procurement organizations play an

2 important role in the effort to increase organ dona3 tion in the United States.

4 (2) The current process for the certification and

5 recertification of organ procurement organizations

6 conducted by the Department of Health and Human

7 Services has created a level of uncertainty that is

8 interfering with the effectiveness of organ procure9 ment organizations in raising the level of organ do10 nation.

11 (3) The General Accounting Office, the Insti12 tute of Medicine, and the Harvard School of Public

13 Health have identified substantial limitations in the

14 organ procurement organization certification and re15 certification process and have recommended changes

16 in that process.

17 (4) The limitations in the recertification process

18 include:

19 (A) An exclusive reliance on population20 based measures of performance that do not ac21 count for the potential in the population for

22 organ donation and do not permit consideration

23 of other outcome and process standards that

24 would more accurately reflect the relative capa-
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1 bility and performance of each organ procure2 ment organization.

3 (B) An immediate decertification of organ

4 procurement organizations solely on the basis of

5 the performance measures, without an appro6 priate opportunity to file and a grace period to

7 pursue a corrective action plan.

8 (C) A lack of due process to appeal to the

9 Secretary of Health and Human Services for

10 recertification on either substantive or proce11 dural grounds.

12 (5) The Secretary of Health and Human Serv13 ices has the authority under section 1138(b)(1)(A)(i)

14 of the Social Security Act (42 U.S.C. 1320b15 8(b)(1)(A)(i)) to extend the period for recertification

16 of an organ procurement organization from 2 to 4

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

18 avoid the inappropriate disruption of the nation’s

19 organ system.

20 (6) The Secretary of Health and Human Serv21 ices can use the extended period described in para22 graph (5) for recertification of all organ procure23 ment organizations to—

24 (A) develop improved performance meas25 ures that would reflect organ donor potential
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1 and interim outcomes, and to test these meas2 ures to ensure that they accurately measure

3 performance differences among the organ pro4 curement organizations; and

5 (B) improve the overall certification proc6 ess by incorporating process as well as outcome

7 performance measures, and developing equitable

8 processes for corrective action plans and ap9 peals.

10 SEC. 3. CERTIFICATION AND RECERTIFICATION OF ORGAN

11 PROCUREMENT ORGANIZATIONS.

12 Section 371(b)(1) of the Public Health Service Act

13 (42 U.S.C. 273(b)(1)) is amended:

14 (1) by redesignating subparagraphs (D)

15 through (G) as subparagraphs (E) through (H), re16 spectively;

17 (2) by realigning the margin of subparagraph

18 (F) (as so redesignated) so as to align with subpara19 graph (E) (as so redesignated); and

20 (3) by inserting after subparagraph (C) the fol21 lowing:

22 ‘‘(D) notwithstanding any other provision of

23 law, has met the other requirements of this section

24 and has been certified or recertified by the Secretary

25 within the previous 4-year period as meeting the
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1 performance standards to be a qualified organ pro2 curement organization through a process that

3 either—

4 ‘‘(i) granted certification or recertification

5 within such 4-year period with such certification

6 or recertification in effect as of January 1,

7 2000, and remaining in effect through the ear8 lier of—

9 ‘‘(I) January 1, 2002; or

10 ‘‘(II) the completion of recertification

11 under the requirements of clause (ii); or

12 ‘‘(ii) is defined through regulations that

13 are promulgated by the Secretary by not later

14 than January 1, 2002, that—

15 ‘‘(I) require recertifications of quali16 fied organ procurement organizations not

17 more frequently than once every 4 years;

18 ‘‘(II) rely on outcome and process per19 formance measures that are based on em20 pirical evidence of organ donor potential

21 and other related factors in each service

22 area of qualified organ procurement orga23 nizations;

24 ‘‘(III) use multiple outcome measures

25 as part of the certification process;
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1 ‘‘(IV) provide for the filing and ap2 proval of a corrective action plan by a

3 qualified organ procurement organization

4 that fails to meet the performance stand5 ards and a grace period of not less than 3

6 years during which such organization can

7 implement the corrective action plan with8 out risk of decertification; and

9 ‘‘(V) provide for a qualified organ

10 procurement organization to appeal a de11 certification to the Secretary on sub12 stantive and procedural grounds;’’.

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