II

106TH CONGRESS

2D SESSION S. 2378

To amend titles XVIII and XIX of the Social Security Act to improve

the safety of the medicare and medicaid programs, and for other purposes.

IN THE SENATE OF THE UNITED STATES

APRIL 6, 2000

Mr. GRASSLEY (for himself, Mr. LIEBERMAN, Mr. KERREY, and Mr. BRYAN)

introduced the following bill; which was read twice and referred to the

Committee on Finance

A BILL

To amend titles XVIII and XIX of the Social Security Act

to improve the safety of the medicare and medicaid programs, and for other purposes.

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; TABLE OF CONTENTS.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Stop All Frequent Errors (SAFE) in Medicare and Med6 icaid Act of 2000’’.

7 (b) TABLE OF CONTENTS.—The table of contents of

8 this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Purposes.
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Sec. 3. Improvement of patient safety under the medicare program.

‘‘PART D—ADDITIONAL RESPONSIBILITIES FOR THE SECRETARY IN ORDER

TO IMPROVE HEALTH CARE QUALITY

‘‘Sec. 1860A. Definitions.

‘‘Sec. 1860B. Establishment of patient safety programs.

‘‘Sec. 1860C. Patient safety reporting system.

‘‘Sec. 1860D. Confidentiality and privacy protections.

Sec. 4. Improvement of patient safety under the medicaid program.

Sec. 5. Establishment of the Center for Patient Safety.

Sec. 6. Grants to establish patient safety programs.

1 SEC. 2. PURPOSES.

2 The purposes of this Act are as follows:

3 (1) To develop a nonpunitive error reduction

4 system under the medicare and medicaid programs

5 under titles XVIII and XIX of the Social Security

6 Act (42 U.S.C. 1395 et seq.; 1396 et seq.) with

7 pragmatic reporting requirements and adequate legal

8 protections to support the collection of information

9 under such systems.

10 (2) To extend existing confidentiality and peer

11 review protections to the additional required reports

12 of error under such systems that are developed for

13 safety and quality improvement purposes under the

14 medicare and medicaid programs.

15 (3) To create leadership, research, tools, and

16 protocols to enhance the knowledge base concerning

17 patient safety under the medicare and medicaid pro18 grams.
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1 (4) To raise standards and expectations for im2 provements in patient safety under the medicare and

3 medicaid programs.

4 (5) To reduce deaths, serious injuries, and

5 other health care errors under the medicare and

6 medicaid programs through the implementation of

7 safe practices at the delivery level.

8 SEC. 3. IMPROVEMENT OF PATIENT SAFETY UNDER THE

9 MEDICARE PROGRAM.

10 (a) IN GENERAL.—Title XVIII of the Social Security

11 Act (42 U.S.C. 1395 et seq.) is amended by redesignating

12 part D as part E and by inserting after part C the fol13 lowing new part:

14 ‘‘PART D—ADDITIONAL RESPONSIBILITIES FOR THE

15 SECRETARY IN ORDER TO IMPROVE HEALTH CARE

16 QUALITY

17 ‘‘DEFINITIONS

18 ‘‘SEC. 1860A. In this part:

19 ‘‘(1) ADDITIONAL ERROR EVENT.—The term

20 ‘additional error event’ means an event other than a

21 sentinel event that the Secretary, in consultation

22 with the Agency for Healthcare Research and Qual23 ity, national accrediting organizations, provider and

24 consumer organizations, and peer review organiza25 tions, determines is a health care error, such as a
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1 medication error, that has been demonstrated to

2 contribute substantially to morbidity and mortality.

3 ‘‘(2) APPLICABLE EVENT.—The term ‘applica4 ble event’ means—

5 ‘‘(A) a sentinel event; and

6 ‘‘(B) an additional error event.

7 ‘‘(3) MEDICAID PROGRAM.—The term ‘medicaid

8 program’ means the health care program under title

9 XIX.

10 ‘‘(4) MEDICARE PROGRAM.—The term ‘medi11 care program’ means the health care program under

12 this title.

13 ‘‘(5) PROVIDER OF SERVICES.—The term ‘pro14 vider of services’ means a hospital, critical access

15 hospital, skilled nursing facility, comprehensive out16 patient rehabilitation facility, home health agency,

17 renal dialysis facility, ambulatory surgical center, or

18 hospice program.

19 ‘‘(6) SENTINEL EVENT.—

20 ‘‘(A) IN GENERAL.—The term ‘sentinel

21 event’ means any of the following:

22 ‘‘(i) An event that—

23 ‘‘(I) has resulted in an unantici24 pated death or major permanent loss

25 of function; and
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1 ‘‘(II) is not related to the natural

2 course of the illness or underlying

3 condition of the patient.

4 ‘‘(ii) Any of the following events (even

5 if the outcome of the event did not result

6 in death or major permanent loss of func7 tion):

8 ‘‘(I) Surgery on the wrong pa9 tient or wrong body part.

10 ‘‘(II) Hemolytic transfusion reac11 tion involving administration of blood

12 or blood products that have blood

13 group incompatibilities.

14 ‘‘(III) Suicide of a patient in a

15 setting where the patient receives

16 around-the-clock care.

17 ‘‘(IV) Discharge of an infant to

18 the wrong family.

19 ‘‘(B) MAJOR PERMANENT LOSS OF FUNC20 TION.—For purposes of subparagraph (A), the

21 term ‘major permanent loss of function’ means

22 sensory, motor, physiologic, or intellectual im23 pairment that—
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1 ‘‘(i) requires continued treatment or

2 imposes persistent major restrictions in ac3 tivities of daily living; and

4 ‘‘(ii) was not present—

5 ‘‘(I) on admission of the patient;

6 or

7 ‘‘(II) in the case of a patient who

8 was not admitted, at the initiation of

9 the provision of items or services to

10 the patient.

11 ‘‘ESTABLISHMENT OF PATIENT SAFETY PROGRAMS

12 ‘‘SEC. 1860B. (a) ESTABLISHMENT OF REQUIRE13 MENTS.—The Secretary shall establish requirements for

14 the establishment and implementation of patient safety

15 programs for providers of services participating in the

16 medicare program. Such requirements shall ensure that

17 a patient safety program—

18 ‘‘(1) targets applicable events;

19 ‘‘(2) targets at least 1 additional source of

20 health care errors, to be determined by the provider

21 of services, that contributes significantly to mor22 bidity and mortality in the service area of the pro23 vider or in patients receiving care from the provider;

24 ‘‘(3) analyzes the organizational processes,

25 functions, and services that are relevant to applica26 ble events;
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1 ‘‘(4) utilizes active investigation of medical

2 records, medication utilization, laboratory results,

3 and other information to discover health care errors;

4 and

5 ‘‘(5) achieves significant measurable improve6 ment in rates of health care errors.

7 ‘‘(b) ESTABLISHMENT AND IMPLEMENTATION OF A

8 PATIENT SAFETY PROGRAM AS A CONDITION OF PARTICI9 PATION FOR PROVIDERS OF SERVICES.—The Secretary

10 shall ensure that each provider of services participating

11 in the medicare program (as a condition of such participa12 tion) has established and implemented a patient safety

13 program that is in compliance with the requirements es14 tablished under subsection (a).

15 ‘‘PATIENT SAFETY REPORTING SYSTEM

16 ‘‘SEC. 1860C. (a) ESTABLISHMENT.—The Secretary

17 shall establish a patient safety reporting system that pro18 vides for the collection and analysis of standardized infor19 mation concerning applicable events (including any root

20 cause analysis of, or corrective actions taken with respect

21 to, such events) under the medicare program.

22 ‘‘(b) REPORTS BY PROVIDERS OF SERVICES TO

23 AGENCIES AND ENTITIES.—

24 ‘‘(1) IN GENERAL.—Under the system estab25 lished under subsection (a), a provider of services

26 shall report each applicable event that occurs to an
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1 individual while the individual is in the care or cus2 tody of the provider to—

3 ‘‘(A) the State health agency or other ap4 propriate State agency of the State in which the

5 provider of services is furnishing the services in6 volved;

7 ‘‘(B) in the case of a provider of services

8 participating in the medicare program as a re9 sult of accreditation by a national accrediting

10 body, the national accrediting body for the pro11 vider; and

12 ‘‘(C) the appropriate peer review organiza13 tion under part B of title XI.

14 ‘‘(2) STANDARDIZED DATA FOR REPORTS SUB15 MITTED TO AGENCIES AND ENTITIES.—

16 ‘‘(A) REPORTING STANDARDS.—The Sec17 retary, in consultation with the Agency for

18 Healthcare Research and Quality, national ac19 crediting organizations, provider and consumer

20 organizations, and peer review organizations,

21 shall, after consideration of existing reporting

22 systems and standards, establish and maintain

23 a core set of reporting standards to be used by

24 providers of services in submitting the reports
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1 required under paragraph (1) to the agencies

2 and entities described in such paragraph.

3 ‘‘(B) REQUIREMENTS FOR STANDARDS.—

4 The reporting standards developed under sub5 paragraph (A) shall—

6 ‘‘(i) require the inclusion of a descrip7 tion of the applicable events occurring dur8 ing the period covered by the report;

9 ‘‘(ii) except as provided in subpara10 graph (D), require the inclusion of the root

11 cause analysis of each applicable event in12 cluded in the report and a description of

13 any corrective action taken by the provider

14 of services with respect to such event or

15 any other measures necessary to prevent

16 similar applicable events from occurring in

17 the future;

18 ‘‘(iii) require that all provider of serv19 ices provide the data required under this

20 section;

21 ‘‘(iv) require that the privacy of indi22 viduals whose treatment is the subject of a

23 report is protected;
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1 ‘‘(v) include a nomenclature and tax2 onomy for the collection and reporting of

3 such data; and

4 ‘‘(vi) meet such other requirements as

5 the Secretary determines appropriate.

6 ‘‘(C) MEDICATION ERRORS.—In developing

7 the reporting standards under this paragraph,

8 the Secretary shall give immediate priority to

9 the establishment of taxonomies and reporting

10 protocols relating to medication errors.

11 ‘‘(D) WAIVER OF CERTAIN REPORTING RE12 QUIREMENTS.—If determined appropriate by

13 the Secretary, the standards developed under

14 this paragraph may permit a provider of serv15 ices to waive the reporting requirement de16 scribed in subparagraph (B)(ii) with respect to

17 an additional error event.

18 ‘‘(3) PHASE-IN OF REPORTING.—

19 ‘‘(A) IN GENERAL.—The Secretary shall

20 establish a phase-in period with respect to the

21 submission of data by various providers of serv22 ices pursuant to paragraph (1).

23 ‘‘(B) REQUIREMENTS.—The phase-in pe24 riod described in subparagraph (A) shall require

25 that—
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1 ‘‘(i) all hospitals submit the data re2 quired under this section beginning not

3 later than 1 year after the date of enact4 ment of the Stop All Frequent Errors

5 (SAFE) in Medicare and Medicaid Act of

6 2000; and

7 ‘‘(ii) all other providers of services

8 submit such data beginning at a time de9 termined appropriate by the Secretary.

10 ‘‘(c) DESIGNATION OF AGENCY OR ENTITY.—

11 ‘‘(1) IN GENERAL.—Each provider of services

12 shall designate 1 of the agencies or entities described

13 in subsection (b)(1) to determine compliance with

14 the patient safety reporting system established under

15 this section with respect to applicable events for

16 which reports are required under such subsection.

17 ‘‘(2) DISAPPROVAL BY SECRETARY.—

18 ‘‘(A) IN GENERAL.—The Secretary may

19 disapprove the designation made under para20 graph (1) if the Secretary determines such dis21 approval to be appropriate.

22 ‘‘(B) DESIGNATION OF ANOTHER AGENCY

23 OR ENTITY.—In the case of a disapproval under

24 subparagraph (A), the provider of services shall

25 designate another of the agencies or entities de-
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1 scribed in subsection (b)(1) to have designated

2 authority.

3 ‘‘(d) INVESTIGATION OF APPLICABLE EVENTS BY

4 AGENCY OR ENTITY WITH DESIGNATED AUTHORITY.—

5 The agency or entity designated by a provider of services

6 under subsection (c) shall—

7 ‘‘(1) ensure that the provider of services, with

8 respect to any reported applicable event—

9 ‘‘(A) conducts an investigation of the ap10 plicable event;

11 ‘‘(B) determines the root cause or causes

12 of the applicable event; and

13 ‘‘(C) establishes and implements a time14 limited plan or strategy—

15 ‘‘(i) to correct the problem or prob16 lems that resulted in the applicable event;

17 ‘‘(ii) that leads to the reduction of the

18 risk of such event happening in the future;

19 and

20 ‘‘(iii) that allows the agency or entity

21 to determine the appropriateness of the

22 root cause analyses and any corrective ac23 tions proposed or taken by the provider of

24 services; and
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1 ‘‘(2) prepare and submit the reports required

2 under subsection (e).

3 ‘‘(e) REPORTS TO THE SECRETARY BY AGENCY OR

4 ENTITY WITH DESIGNATED AUTHORITY.—

5 ‘‘(1) IN GENERAL.—The agency or entity with

6 designated authority shall submit a report con7 taining the information described in paragraph (3)

8 to the Secretary in such form and manner, and by

9 such date, as the Secretary prescribes.

10 ‘‘(2) FREQUENCY.—The report described in

11 paragraph (1) shall be submitted to the Secretary at

12 regular intervals, but not less frequently than annu13 ally.

14 ‘‘(3) INFORMATION TO BE REPORTED.—

15 ‘‘(A) IN GENERAL.—The report described

16 in paragraph (1) shall include—

17 ‘‘(i) a description of the applicable

18 events occurring during the period covered

19 by the report;

20 ‘‘(ii) a description of any corrective

21 action taken by the providers of services

22 with respect to the applicable events or any

23 other measures necessary to prevent simi24 lar applicable events from occurring in the

25 future;
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1 ‘‘(iii) a description of proposed sys2 tems changes identified as a result of anal3 ysis of events from multiple providers; and

4 ‘‘(iv) such additional information as

5 the Secretary determines to be essential to

6 ensure compliance with the requirements

7 of this section.

8 ‘‘(B) INFORMATION EXCLUDED.—The re9 port submitted under paragraph (1) shall not

10 identify any provider of services, practitioner or

11 other health care worker, or patient.

12 ‘‘(4) ADDITIONAL REPORTING REQUIREMENTS

13 WHEN A PROVIDER HAS BEEN IDENTIFIED AS HAV14 ING A PATTERN OF POOR PERFORMANCE.—

15 ‘‘(A) REPORT TO SECRETARY.—

16 ‘‘(i) IN GENERAL.—Notwithstanding

17 any other provision of law, in addition to

18 the report required under paragraph (1),

19 the agency or entity with designated au20 thority shall report to the Secretary the

21 name and address of any provider of serv22 ices with a pattern of poor performance.

23 ‘‘(ii) INFORMATION TO THE PUBLIC.—

24 The Secretary shall make the information

25 described in clause (i) available to the pub-
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1 lic if the pattern of poor performance con2 tinues for more than 2 years.

3 ‘‘(B) DETERMINATION OF PATTERN.—The

4 agency or entity with designated authority shall

5 determine if a pattern of poor performance ex6 ists with respect to a provider of services in ac7 cordance with the definition of pattern of poor

8 performance developed by the Secretary under

9 subparagraph (C).

10 ‘‘(C) DEVELOPMENT OF DEFINITION.—

11 ‘‘(i) IN GENERAL.—The Secretary, in

12 consultation with the Agency for

13 Healthcare Research and Quality, national

14 accrediting organizations, provider and

15 consumer organizations, and peer review

16 organizations, shall develop a definition to

17 identify a provider of services with a pat18 tern of poor performance. In developing

19 such definition, the Secretary shall ensure

20 that a provider of services described in

21 clause (ii) is deemed to be a provider of

22 services with a pattern of poor perform23 ance.

24 ‘‘(ii) PROVIDER DESCRIBED.—A pro25 vider of services described in this clause is
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1 a provider of services that has a pattern

2 of—

3 ‘‘(I) failing to report applicable

4 events pursuant to this part; or

5 ‘‘(II) except for events described

6 in subsection (b)(2)(D), failing to im7 plement corrective actions with re8 spect to applicable events or signifi9 cantly delaying such implementation.

10 ‘‘(D) EFFECTIVE DATE.—An agency or en11 tity with designated authority shall not submit

12 a report to the Secretary pursuant to this para13 graph until the Secretary has established the

14 definition under paragraph (C).

15 ‘‘(f) ENFORCEMENT OF REQUIREMENTS FOR ENTI16 TIES.—

17 ‘‘(1) PART OF CONTRACT FOR PEER REVIEW

18 ORGANIZATIONS.—Pursuant to section

19 1154(a)(17)(A), the requirements under this part

20 with respect to a peer review organization shall be

21 considered to be requirements under a contract be22 tween the Secretary and the organization under part

23 B of title XI.

24 ‘‘(2) FAILURE OF ACCREDITING BODY TO COM25 PLY WITH REQUIREMENTS.—If an accrediting body
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1 refuses to comply with the requirements under this

2 part, the Secretary, after notice to the accrediting

3 body and opportunity to comply, may revoke the au4 thority of the accrediting body to serve as an agent

5 of the medicare or medicaid program for certifi6 cation purposes.

7 ‘‘(3) FAILURE OF HEALTH DEPARTMENT OF A

8 STATE TO COMPLY WITH REQUIREMENTS.—If a

9 State health agency or other appropriate State agen10 cy refuses to comply with the requirements under

11 this part, the Secretary, after notice to the agency

12 and opportunity to comply, shall revoke the ability

13 of a provider of services to designate such agency as

14 the agency with designated authority with respect to

15 such provider pursuant to subsection (c).

16 ‘‘(g) LIMITATION ON USE OF INFORMATION.—

17 ‘‘(1) STATE.—Any State health agency or other

18 appropriate State agency that receives information

19 regarding applicable events with respect to a pro20 vider of services pursuant to this part (or a con21 gregate care provider pursuant to the application of

22 this part to such a provider under title XIX) shall

23 not permit such information to be utilized in con24 junction with the survey, certification, or enforce-
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1 ment process conducted by, or on behalf of, the

2 agency with respect to such provider.

3 ‘‘(2) SECRETARY.—The Secretary shall not per4 mit any information received by the Secretary re5 garding applicable events with respect to a provider

6 of services pursuant to this part (or a congregate

7 care provider pursuant to the application of this part

8 to such a provider under title XIX) to be utilized in

9 conjunction with the survey, certification, or enforce10 ment process conducted by, or on behalf of, the Sec11 retary with respect to such provider.

12 ‘‘(h) ANALYSIS OF REPORTED INFORMATION BY THE

13 SECRETARY.—The Secretary shall analyze the data re14 ceived under this part with respect to the medicare pro15 gram in a manner that permits the Secretary to identify

16 pertinent patient safety issues that require more intensive

17 analysis.

18 ‘‘(i) PROVISION OF INFORMATION TO CENTER FOR

19 PATIENT SAFETY.—The Secretary shall provide the direc20 tor of the Center for Patient Safety, established under sec21 tion 5 of the Stop All Frequent Errors (SAFE) in Medi22 care and Medicaid Act of 2000, with any information ob23 tained under this part (or under title XIX pursuant to

24 the application of this part to congregate care providers

25 under such title) that the director of the Center deter-
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1 mines is necessary in order to carry out the mission of

2 the Center.

3 ‘‘CONFIDENTIALITY AND PRIVACY PROTECTIONS

4 ‘‘SEC. 1860D. (a) CONFIDENTIALITY.—

5 ‘‘(1) IN GENERAL.—Notwithstanding any other

6 provision of law, any information (including any

7 data, reports, records, memoranda, analyses, state8 ments, and other communications) developed by or

9 on behalf of a provider of services with respect to an

10 applicable event pursuant to this part—

11 ‘‘(A) shall be privileged, strictly confiden12 tial, and may not be disclosed by any other per13 son to which such information is transferred

14 pursuant to this part without the authorization

15 of the provider of services; and

16 ‘‘(B) shall—

17 ‘‘(i) be protected from disclosure by

18 civil or administrative subpoena;

19 ‘‘(ii) not be subject to discovery or

20 otherwise in connection with a civil, crimi21 nal, or administrative proceeding;

22 ‘‘(iii) not be subject to disclosure pur23 suant to the Freedom of Information Act

24 (5 U.S.C. 552) or any other similar Fed25 eral or State statute or regulation; and
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1 ‘‘(iv) not be admissible as evidence in

2 any civil or administrative proceeding;

3 without regard to whether such information is

4 held by the provider of services or by another

5 person to which such information was trans6 ferred pursuant to this part.

7 ‘‘(2) RULES OF CONSTRUCTION.—Nothing in

8 this subsection shall be construed as prohibiting—

9 ‘‘(A) subject to confidentiality laws, disclo10 sure of a patient’s medical record;

11 ‘‘(B) an entity or agency from requiring a

12 provider of services to transfer information to

13 the entity or agency to the extent required by

14 law;

15 ‘‘(C) an agency or entity described in sec16 tion 1860C(b)(1), the Secretary, or the Center

17 for Patient Safety from transferring informa18 tion received pursuant to this part to another

19 such agency or entity, the Secretary, or such

20 Center; or

21 ‘‘(D) the Center for Patient Safety from

22 releasing data received pursuant to this part in

23 a form that does not identify or permit the

24 identification of providers of services, practi-
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1 tioners or other health care workers, or pa2 tients.

3 ‘‘(b) PROTECTION OF PATIENT INFORMATION.—The

4 Secretary shall establish procedures to ensure that the pri5 vacy of individuals whose treatment is the subject of a re6 port submitted under subsections (b) or (e) of section

7 1860C is protected.

8 ‘‘(c) LIABILITY.—Nothing in this section shall be

9 construed as limiting the liability of an individual, provider

10 of services, agency, or entity for damages relating to the

11 occurrence of an applicable event, including an applicable

12 event that results in death.’’.

13 (b) CONTRACT FOR PEER REVIEW ORGANIZATION.—

14 (1) IN GENERAL.—Section 1154(a) of the So15 cial Security Act (42 U.S.C. 1320c–3(a)) is amended

16 by adding at the end the following:

17 ‘‘(17) The organization shall—

18 ‘‘(A) comply with the requirements for

19 peer review organizations under part D of title

20 XVIII; and

21 ‘‘(B) assist providers of services (as de22 fined in section 1860A(5)) and congregate care

23 providers (as defined in section 1905(x)) in

24 identifying health care errors by utilizing the

25 clinical indicators that the Secretary, in con-
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1 sultation with the Agency for Healthcare Re2 search and Quality, national accrediting organi3 zations, provider and consumer organizations,

4 and peer review organizations, determines are

5 most frequently associated with preventable

6 morbidity and mortality.’’.

7 (2) EFFECTIVE DATE.—The amendment made

8 by this subsection shall apply to contracts entered

9 into or renewed on or after the date of enactment

10 of this Act.

11 SEC. 4. IMPROVEMENT OF PATIENT SAFETY UNDER THE

12 MEDICAID PROGRAM.

13 (a) STATE PLANS FOR MEDICAL ASSISTANCE.—Sec14 tion 1902(a) of the Social Security Act (42 U.S.C.

15 1396a(a)) is amended—

16 (1) in paragraph (64), by striking ‘‘and’’ at the

17 end;

18 (2) in paragraph (65), by striking the period

19 and inserting ‘‘; and’’; and

20 (3) by inserting immediately after paragraph

21 (65) the following new paragraph:

22 ‘‘(66) provide that the State will ensure that

23 any congregate care provider (as defined in section

24 1905(x)) that provides services to an individual for

25 which medical assistance is available shall—
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1 ‘‘(A) establish and implement a patient

2 safety program described in subsection (b) of

3 section 1860B in the same manner as a pro4 vider of services under that section is required

5 to establish and implement such a system; and

6 ‘‘(B) submit the reports required under

7 subsection (b) of section 1860C (relating to ap8 plicable events) in the same manner as a pro9 vider of services under that section is required

10 to submit such reports.’’.

11 (b) DEFINITION OF CONGREGATE CARE PRO12 VIDER.—Section 1905 of the Social Security Act (42

13 U.S.C. 1396d) is amended by adding at the end the fol14 lowing new subsection:

15 ‘‘(x) The term ‘congregate care provider’ means an

16 entity that provides hospital services, nursing facility serv17 ices, services of intermediate care facilities for the men18 tally retarded, hospice care, residential treatment centers

19 for children, services in an institution for mental diseases,

20 inpatient psychiatric hospital services for individuals

21 under age 21, or congregate care services under a waiver

22 authorized under section 1915(c).’’.

23 (c) APPLICATION OF MEDICARE PART D RULES AND

24 REQUIREMENTS TO CONGREGATE CARE PROVIDERS.—
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1 Title XIX of the Social Security Act (42 U.S.C. 1396 et

2 seq.) is amended—

3 (1) by redesignating section 1935 as section

4 1936; and

5 (2) by inserting after section 1934 the following

6 new section:

7 ‘‘APPLICATION OF MEDICARE PART D RULES AND

8 REQUIREMENTS TO CONGREGATE CARE PROVIDERS

9 ‘‘SEC. 1935. The Secretary shall promulgate such

10 regulations as are necessary in order to apply the rules

11 and requirements that are applicable to providers of serv12 ices under part D of title XVIII to congregate care pro13 viders (as defined in section 1905(x)) pursuant to section

14 1902(a)(66) and shall provide an analysis described in sec15 tion 1860C(g) with respect to the program under this

16 title.’’.

17 SEC. 5. ESTABLISHMENT OF THE CENTER FOR PATIENT

18 SAFETY.

19 (a) ESTABLISHMENT.—

20 (1) CENTER.—There is established within the

21 Agency for Healthcare Research and Quality, a cen22 ter to be known as the Center for Patient Safety (in

23 this section referred to as the ‘‘Center’’).

24 (2) DIRECTOR.—The Secretary of Health and

25 Human Services shall appoint a director of the Cen26 ter. The director shall administer the Center and
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1 carry out the duties of the director under this sec2 tion subject to the authority, direction, and control

3 of the Secretary.

4 (b) MISSION.—The mission of the Center is to im5 prove patient safety and reduce the incidence of errors in

6 the provision of health care.

7 (c) DUTIES.—In carrying out the mission of the Cen8 ter, the director of the Center shall provide for the fol9 lowing:

10 (1) The establishment of national goals for pa11 tient safety and mechanisms to track the progress of

12 the Nation in meeting such goals.

13 (2) The provision of recommendations to the

14 Secretary of Health and Human Services

15 regarding—

16 (A) the establishment of additional error

17 events under section 1860A(1) of the Social Se18 curity Act (as added by section 3); and

19 (B) the development of a definition of a—

20 (i) provider of services with a pattern

21 of poor performance under section

22 1860C(e)(3)(C) of the Social Security (as

23 so added); and

24 (ii) congregate care provider with a

25 pattern of poor performance (by reason of
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1 the application of such section to such a

2 provider pursuant to section 1902(a)(66)

3 of the Social Security Act (42 U.S.C.

4 1396a(a)(66)) (as added by section 4)).

5 (3) The preparation and submission to the

6 President and Congress of an annual report and rec7 ommendations concerning patient safety.

8 (4) The development of knowledge and under9 standing concerning errors in health care through—

10 (A) the development of a national health

11 care patient safety research agenda;

12 (B) the provision of funding for dissemina13 tion and communication activities to improve

14 patient safety;

15 (C) the evaluation of methods for identi16 fying and preventing health care errors; and

17 (D) the provision of funding for computer18 ized decision support systems to reduce health

19 care errors and to improve care.

20 (5) The dissemination of information con21 cerning existing patient safety reporting programs.

22 (6) The conduct of activities to track the devel23 opment of new, or modification of existing, patient

24 safety reporting programs.
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1 (7) The convening of panels of patient safety

2 reporting program coordinators and users to evalu3 ate reporting practices that are effective in improv4 ing patient safety.

5 (8) The periodic assessment of whether addi6 tional efforts are needed to—

7 (A) address gaps in patient safety informa8 tion; and

9 (B) encourage organizations to voluntarily

10 participate in patient safety reporting pro11 grams.

12 (9) The provision of funding for pilot projects

13 for the establishment or operation of new or innova14 tive patient safety reporting systems.

15 (10) The provision of funding for pilot projects

16 that reduce health care errors.

17 (11) The provision of funding for the review of

18 existing databases of medical errors in order to iden19 tify best practices.

20 (12) The provision of funding for research to

21 identify the attributes of high-risk organizations and

22 processes.

23 (13) The conduct of activities to encourage all

24 entities and health care providers to demonstrate

25 continuous improvements in patient safety to the
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1 public and private purchasers of the health care

2 services provided by such entities or providers.

3 (14) The conduct of other activities determined

4 appropriate by the director of the Center.

5 (d) PROTECTION OF PATIENT INFORMATION.—The

6 director of the Center shall establish procedures to ensure

7 that the privacy of individuals whose treatment is de8 scribed in any information received by the director pursu9 ant to this part is protected.

10 SEC. 6. GRANTS TO ESTABLISH PATIENT SAFETY PRO11 GRAMS.

12 (a) IN GENERAL.—The director of the Center for Pa13 tient Safety (established under section 5) may award

14 grants to providers of services (as defined in section

15 1860A(5) of the Social Security Act (as added by section

16 3)), congregate care providers (as defined in section

17 1905(x) of such Act (42 U.S.C. 1396d(x)) (as added by

18 section 4)), and health professionals affiliated with such

19 providers of services or congregate care providers for the

20 establishment and operation of patient safety programs.

21 (b) APPLICATION.—To be eligible to receive a grant

22 under subsection (a), a provider of services, a congregate

23 care provider, or a health professional affiliated with such

24 a provider of services or congregate care provider shall

25 prepare and submit to the director of the Center an appli-
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1 cation at such time, in such manner, and containing such

2 information as the director may require.

3 (c) AUTHORIZATION OF APPROPRIATIONS.—There

4 are authorized to be appropriated the following amounts

5 to carry out this section:

6 (1) For fiscal year 2001, $30,000,000.

7 (2) For fiscal year 2002, $35,000,000.

8 (3) For fiscal year 2003, $40,000,000.

9 (4) For each fiscal year thereafter, such sums

10 as may be necessary.

Æ