II 

111TH CONGRESS 

2D SESSION S. 3596 

To establish the Culture of Safety Hospital Accountability Study and 

Demonstration Program. 

IN THE SENATE OF THE UNITED STATES 

JULY 15, 2010 

Mrs. HAGAN introduced the following bill; which was read twice and referred 

to the Committee on Finance 

A BILL 

To establish the Culture of Safety Hospital Accountability 

Study and Demonstration Program. 

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 ‘‘Culture of Safety Hos5 pital Accountability Act of 2010’’. 

6 SEC. 2. CULTURE OF SAFETY HOSPITAL ACCOUNTABILITY 

7 STUDY AND DEMONSTRATION PROGRAM. 

8 (a) STUDY.— 

9 (1) IN GENERAL.—The Secretary shall conduct 

10 a study that— 


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1 (A) examines existing activities and pro2 grams in hospitals for quality assurance, pa3 tient safety, and performance improvement and 

4 provides an analysis regarding best practices 

5 with respect to such activities and programs; 

6 and 

7 (B) identifies best practices that should be 

8 replicated in hospitals to improve patient safety 

9 and quality of care, consistent with the provi10 sions included under the quality assessment and 

11 performance improvement program, as required 

12 under the conditions of participation for hos13 pitals under Medicare. 

14 (2) REPORT.—Not later than 2 years after the 

15 date of enactment of this Act, the Secretary shall 

16 prepare a report containing the results of the study 

17 conducted under paragraph (1). Such report shall be 

18 made available on the Internet website of the Cen19 ters for Medicare & Medicaid Services. 

20 (b) DEMONSTRATION PROGRAM.— 

21 (1) IN GENERAL.—The Secretary shall establish 

22 the Culture of Safety Hospital Accountability dem23 onstration program to provide support for estab24 lishing partnerships and other cooperative ap25 proaches between hospitals, State health care agenVerDate Mar 15 2010 05:10 Jul 16, 2010 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3596.IS S3596

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1 cies, and the Department of Health and Human 

2 Services to promote and implement the best prac3 tices identified under subsection (a), with the goal of 

4 improving the safety and quality of care provided to 

5 Medicare beneficiaries and enhance compliance with 

6 the conditions of participation for hospitals under 

7 Medicare. 

8 (2) DURATION.—The demonstration program 

9 shall operate during a period of 3 years, beginning 

10 not later than 12 months after completion of the re11 port described in subsection (a)(2). 

12 (3) SCOPE.— 

13 (A) STATES.—The Secretary shall select 

14 not less than 4 States, but not more than 6 

15 States, to participate in the demonstration pro16 gram. 

17 (B) HOSPITALS.—The Secretary shall se18 lect not more than 24 hospitals, within the 

19 States selected under subparagraph (A), to par20 ticipate in the demonstration program. The hos21 pitals selected under this subparagraph shall 

22 satisfy criteria, as developed by the Secretary, 

23 relating to compliance with the conditions of 

24 participation for hospitals under Medicare. 


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1 (4) APPLICATION.—A State or hospital that de2 sires to participate in the demonstration program 

3 shall submit to the Secretary an application at such 

4 time, in such manner, and containing such informa5 tion as the Secretary may require. 

6 (5) IMPLEMENTATION.— 

7 (A) TECHNICAL ASSISTANCE.—The Sec8 retary shall provide participating hospitals with 

9 technical assistance in implementation of the 

10 best practices identified through the study 

11 under subsection (a). 

12 (B) HOSPITAL SURVEYORS.—For each 

13 State participating in the demonstration pro14 gram, the Secretary shall provide training to 

15 State surveyors that is designed to— 

16 (i) enhance knowledge of the dis17 ciplines of patient safety, quality assess18 ment, and performance improvement; 

19 (ii) increase skill in evaluating compli20 ance with quality assessment and perform21 ance improvement programs required 

22 under the conditions of participation for 

23 hospitals under Medicare; and 

24 (iii) focus investigations of complaints 

25 regarding hospital care on the hospital’s 


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1 quality assessment and performance im2 provement program. 

3 (6) EVALUATION.—For each State and hospital 

4 participating in the demonstration program, the Sec5 retary shall evaluate the following: 

6 (A) The level of implementation of the best 

7 practices identified under subsection (a) by the 

8 participating hospitals and whether adoption of 

9 such practices— 

10 (i) improved quality and patient safe11 ty (including an analysis of changes in 

12 quality measures and other indicators of 

13 outcome and performance); and 

14 (ii) resulted in a decrease in the seri15 ousness or number of citations for defi16 ciencies under the conditions of participa17 tion for hospitals under Medicare. 

18 (B) The training provided to State sur19 veyors and whether such training resulted in 

20 enhanced proficiency in evaluations of hospital 

21 quality assessment and performance improve22 ment programs. 

23 (7) REPORT.—Not later than 12 months after 

24 completion of the demonstration program, the SecVerDate Mar 15 2010 05:10 Jul 16, 2010 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3596.IS S3596

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1 retary shall submit to Congress a report containing 

2 an evaluation of such program, including— 

3 (A) the findings of the evaluation under 

4 paragraph (6); and 

5 (B) recommendations— 

6 (i) in regard to whether the best prac7 tices identified under the demonstration 

8 program should be adopted by other hos9 pitals, and how the Secretary can best pro10 mote adoption of such best practices; 

11 (ii) in regard to whether the training 

12 for State surveyors developed under the 

13 demonstration program should be provided 

14 to all State surveyors; and 

15 (iii) for such legislation and adminis16 trative action as the Secretary determines 

17 appropriate. 

18 (8) WAIVER AUTHORITY.—The Secretary may 

19 waive such requirements under titles XI and XVIII 

20 of the Social Security Act as may be necessary to 

21 carry out the demonstration program. 

22 (c) FUNDING.—For purposes of carrying out this 

23 Act, the Secretary shall provide for the transfer from the 

24 Federal Hospital Insurance Trust Fund under section 

25 1817 of the Social Security Act (42 U.S.C. 1395i) of 


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1 $25,000,000, to the Centers for Medicare & Medicaid 

2 Services Program Management Account for the period of 

3 fiscal years 2010 through 2017. Amounts transferred 

4 under the preceding sentence shall remain available until 

5 expended. 

6 (d) ALTERNATIVE REMEDIES.—Section 1866(b) of 

7 the Social Security Act (42 U.S.C. 1395cc(b)) is amended 

8 by adding at the end the following new paragraph: 

9 ‘‘(5)(A) The Secretary is authorized to promul10 gate regulations that establish enforcement remedies 

11 that are in addition to, or in lieu of, termination of 

12 an agreement under this section for hospitals or crit13 ical access hospitals for violations of health and safe14 ty requirements under this title. Such remedies may 

15 include directed plans of correction that are designed 

16 to— 

17 ‘‘(i) ensure compliance with require18 ments under this title (including conditions 

19 of participation for hospitals or critical ac20 cess hospitals); 

21 ‘‘(ii) prevent recurrence of non-compli22 ance with such requirements; and 

23 ‘‘(iii) improve the internal structures 

24 and processes within the hospital or critical 


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1 access hospital for provision of continuous 

2 quality and safety enhancement. 

3 ‘‘(B) The regulations described under sub4 paragraph (A) may be promulgated by the Sec5 retary before, during, or after the evaluation 

6 described under section 2(b)(6) of the Culture 

7 of Safety Hospital Accountability Act of 

8 2010.’’. 

9 (e) NON-APPLICATION OF PAPERWORK REDUCTION

10 ACT.—Chapter 35 of title 44, United States Code (com11 monly referred to as the ‘Paperwork Reduction Act of 

12 1995’) shall not apply to this Act. 

13 (f) DEFINITIONS.—In this Act: 

14 (1) DEMONSTRATION PROGRAM.—The term 

15 ‘‘demonstration program’’ means the Culture of 

16 Safety Hospital Accountability demonstration pro17 gram conducted under this Act. 

18 (2) HOSPITAL.—The term ‘‘hospital’’ means— 

19 (A) an institution described under section 

20 1861(e) of the Social Security Act (42 U.S.C. 

21 1395x(e)); or 

22 (B) a critical access hospital (as described 

23 under section 1861(mm)(1) of such Act (42 

24 U.S.C. 1395x(mm)(1)). 


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1 (3) MEDICARE.—The term ‘‘Medicare’’ means 

2 the program established under title XVIII of the So3 cial Security Act (42 U.S.C. 1395 et seq.). 

4 (4) SECRETARY.—The term ‘‘Secretary’’ means 

5 the Secretary of Health and Human Services. 

Æ 


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