II

106TH CONGRESS

2D SESSION S. 2743

To amend the Public Health Service Act to develop an infrastructure for

creating a national voluntary reporting system to continually reduce

medical errors and improve patient safety to ensure that individuals

receive high quality health care.

IN THE SENATE OF THE UNITED STATES

JUNE 15, 2000

Mr. KENNEDY (for himself, Mr. DODD, and Mrs. MURRAY) 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 Service Act to develop an infrastructure for creating a national voluntary reporting system to continually reduce medical errors and improve

patient safety to ensure that individuals receive high

quality health care.

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 ‘‘Voluntary Error Re5 duction and Improvement in Patient Safety Act’’.
2

•S 2743 IS

1 SEC. 2. PURPOSE.

2 It is the purpose of this Act to establish a national

3 voluntary system to continually reduce medical errors, and

4 the harm that results from such errors, and improve pa5 tient safety to ensure that individuals receive the highest

6 quality health care.

7 SEC. 3. REDUCING MEDICAL ERRORS AND IMPROVING PA8 TIENT SAFETY.

9 Title IX of the Public Health Service Act (42 U.S.C.

10 299 et seq.) is amended—

11 (1) by redesignating part C as part D;

12 (2) by redesignating sections 921 through 928,

13 as sections 931 through 938, respectively;

14 (3) in section 938(1) (as so redesignated), by

15 striking ‘‘921’’ and inserting ‘‘931’’; and

16 (4) by inserting after part B the following:

17 ‘‘PART C—REDUCING MEDICAL ERRORS AND

18 IMPROVING PATIENT SAFETY

19 ‘‘SEC. 921. DEFINITIONS.

20 ‘‘In this part:

21 ‘‘(1) ACCREDITING ORGANIZATION.—The term

22 ‘accrediting organization’ means a national, non23 profit organization that—

24 ‘‘(A) accredits health care professionals;

25 and
3

•S 2743 IS

1 ‘‘(B) is recognized as an accrediting entity

2 by Federal or State law or by a Federal or

3 State agency that regulates health care profes4 sionals or health care organizations.

5 ‘‘(2) ADVERSE SAFETY EVENT.—The term ‘ad6 verse safety event’ means an occurrence that is di7 rectly associated with medical care or services pro8 vided by a health care organization that results, or

9 could result, in an accident, injury, or illness.

10 ‘‘(3) BEST PRACTICE.—The term ‘best practice’

11 with respect to the provision of health care or serv12 ices, means—

13 ‘‘(A) an excellent or optimal action, con14 duct, or procedure, based on sound science; or

15 ‘‘(B) an excellent or optimal level of per16 formance, based on sound science.

17 ‘‘(4) CENTER.—The term ‘Center’ means the

18 Center for Quality Improvement and Patient Safety

19 established under section 922.

20 ‘‘(5) DIRECTOR.—The term ‘Director’ means

21 the Director of the Agency for Healthcare Research

22 and Quality.

23 ‘‘(6) HEALTH CARE ORGANIZATION.—The term

24 ‘health care organization’ means an entity that pro25 vides health care services in the ordinary course of
4

•S 2743 IS

1 business or practice of a profession, pursuant to a

2 license, certification, accreditation, or other legal au3 thorization. Such term shall include hospitals, phar4 macies, health clinics, long-term care facilities, inter5 mediate care facilities, home health agencies, hospice

6 programs, residential treatment centers, physicians’

7 offices, and the officers, employees, and agents of

8 such entities (such as physicians, nurses, phar9 macists, interns, residents, and other health care

10 professionals).

11 ‘‘(7) HEALTH CARE PROFESSIONAL.—The term

12 ‘health care professional’ means an individual who is

13 licensed or otherwise authorized by State law to pro14 vide health care services in that State.

15 ‘‘(8) HUMAN FACTORS.—The term ‘human fac16 tors’ with respect to health care means human char17 acteristics derived from the study of the interaction

18 of humans with systems, products, and the environ19 ment. Such characteristics may be derived through

20 the development of psychological principles and

21 knowledge in areas such as perception, cognition,

22 and decisionmaking. Such term includes biomedical

23 and psychosocial considerations, human engineering,

24 personnel selection, training, life support, job per25 formance, and human performance evaluation.
5

•S 2743 IS

1 ‘‘(9) MEDICAL ERROR.—The term ‘medical

2 error’ with respect to the provision of health care or

3 services, means—

4 ‘‘(A) the failure of a planned action to be

5 completed as intended; or

6 ‘‘(B) the use of a wrong plan to achieve a

7 desired result.

8 ‘‘(10) SURVEILLANCE SYSTEM.—The term

9 ‘Surveillance System’ means the National Patient

10 Safety Surveillance System established under section

11 925.

12 ‘‘(11) STATE.—The term ‘State’ means each of

13 the 50 States, the District of Columbia, the Com14 monwealth of Puerto Rico, the United States Virgin

15 Islands, Guam, American Samoa, and the Common16 wealth of the Northern Mariana Islands.

17 ‘‘(12) VOLUNTARY REPORTING SYSTEM.—The

18 term ‘Voluntary Reporting System’ means the Na19 tional Patient Safety Reporting System established

20 under section 924.

21 ‘‘SEC. 922. CENTER FOR QUALITY IMPROVEMENT AND PA22 TIENT SAFETY.

23 ‘‘(a) ESTABLISHMENT.—There is established within

24 the Agency for Healthcare Research and Quality an office

25 to be known as the Center for Quality Improvement and
6

•S 2743 IS

1 Patient Safety, which shall be headed by an individual to

2 be appointed by the Director. The Secretary shall carry

3 out this part acting through the Director.

4 ‘‘(b) PURPOSE.—The purpose of the Center is to pro5 mote patient safety through the establishment of an infor6 mation infrastructure and evidence base for patient safety

7 to permit health care professionals and organizations to

8 take a more strategic approach to reducing medical errors

9 and improving patient safety. In carrying out the purpose

10 of this subsection the Director shall—

11 ‘‘(1) direct the efforts of the Center across all

12 types of health care organizations, health care pro13 fessionals, and patients;

14 ‘‘(2) take into consideration differences between

15 types of health care organizations and make rec16 ommendations for best practices in a manner that

17 takes into consideration such differences;

18 ‘‘(3) collect and analyze existing information on

19 the causes of medical errors and evidence-based rec20 ommendations to reduce such errors; and

21 ‘‘(4) obtain input from, and consult with, enti22 ties as provided for in subsection (c).

23 ‘‘(c) INPUT AND CONSULTATION.—To carry out the

24 purpose described in subsection (b), the Director shall—
7

•S 2743 IS

1 ‘‘(1) obtain input from a wide range of public

2 and private sources, including Federal as well as

3 State governmental entities, including the Centers

4 for Disease Control and Prevention, the Food and

5 Drug Administration, the National Institutes of

6 Health, the Health Care Financing Administration,

7 the Department of Veterans Affairs, the Department

8 of Defense, State departments of health, State li9 censing boards, organizations representing health

10 care professionals and health care organizations,

11 purchasers, industry, consumer groups, and other

12 public, private, and public-private organizations and

13 alliances that address quality in health care; and

14 ‘‘(2) consider input from relevant disciplines

15 and industries that have a demonstrated experience

16 with proven safety initiatives, such as the aviation

17 industry, industrial engineering, anesthesiology, and

18 psychology.

19 ‘‘SEC. 923. GENERAL ACTIVITIES.

20 ‘‘(a) IN GENERAL.—The Center, and other compo21 nents of the Agency for Healthcare Research and Quality

22 as the Director determines to be appropriate, shall—

23 ‘‘(1) serve as a central, publicly accessible clear24 inghouse for information concerning patient safety,

25 including data collected through the Voluntary Re-
8

•S 2743 IS

1 porting System and the Surveillance System, and in2 formation about the causes of medical errors and

3 best practices to prevent or minimize medical errors

4 and injuries that may result from such errors;

5 ‘‘(2) administer the National Patient Safety Re6 porting System under section 924;

7 ‘‘(3) administer the National Patient Safety

8 Surveillance System under section 925;

9 ‘‘(4) conduct, support, and coordinate the anal10 ysis of data collected through the Voluntary Report11 ing System in conjunction with multi-disciplinary

12 panels of experts selected from the public and pri13 vate sector;

14 ‘‘(5) conduct and support research on the

15 causes of and best practices to prevent or minimize

16 medical errors;

17 ‘‘(6) support the Patient Safety Centers of Im18 provement established under section 926 to develop

19 effective and fiscally responsible best practices to ad20 dress critical patient safety challenges, including de21 signing management and information systems that

22 optimize patient safety;

23 ‘‘(7) obtain and provide evidence-based informa24 tion to guide in the development and continuous im25 provement of best practices;
9

•S 2743 IS

1 ‘‘(8) educate the public and the health care

2 community concerning the existence and causes of

3 medical errors, the lessons learned, outcomes meas4 ures, and best practices with respect to medical er5 rors;

6 ‘‘(9) promote the universal acknowledgment,

7 adoption, and implementation of best practices to

8 promote more efficient, effective, and safe health

9 care systems throughout the Nation; and

10 ‘‘(10) carry out other functions determined ap11 propriate by the Secretary to fulfill the purpose of

12 the Center.

13 ‘‘(b) 3-YEAR REQUIREMENTS.—Not later than 3

14 years after the date on which the Center is established,

15 the Director shall—

16 ‘‘(1) based on expert opinion and a review of

17 the current evidence relating to medical errors, de18 velop a limited, achievable set of high-priority goals

19 for improving patient safety;

20 ‘‘(2) assess the progress made in achieving the

21 goals developed under paragraph (1) by compiling

22 aggregate information from Federal, State, and

23 other adverse event or error reporting systems,

24 health care organizations, and other sources;
10

•S 2743 IS

1 ‘‘(3) for purposes of making the assessments

2 under paragraph (2), periodically conduct a survey

3 or review of representative health care organizations

4 with respect to the progress of such organizations in

5 meeting the goals established under paragraph (1);

6 ‘‘(4) develop and provide support for a research

7 agenda as described in subsection (c), which may in8 clude the use of existing data sources, such as health

9 claims databases, if appropriate;

10 ‘‘(5) in accordance with subsection (d), evaluate

11 existing, and develop evidence for new best practices

12 and tools for improving and protecting patient safety

13 in key processes, including clinical, managerial, and

14 informational support systems for—

15 ‘‘(A) medication systems (from prescribing

16 to administering);

17 ‘‘(B) operating rooms, surgical procedures,

18 and surgical care (including pre-operative and

19 post-operative care);

20 ‘‘(C) emergency departments;

21 ‘‘(D) the management of diagnostic tests,

22 screening, and information;

23 ‘‘(E) intensive care units, including neo24 natal and pediatric intensive care units;
11

•S 2743 IS

1 ‘‘(F) the care of frail elderly (such as care

2 after falls and for decubitus ulcers);

3 ‘‘(G) the use of simulation and simulators

4 in health care training;

5 ‘‘(H) team training and crew resource

6 management applications in health care; and

7 ‘‘(I) home health care services;

8 ‘‘(6) develop instructional methods, demonstra9 tion projects, and technical support projects to en10 sure the widespread implementation of the best

11 practices and tools developed under this subsection;

12 ‘‘(7) provide technical support to health care or13 ganizations to enable such organizations to provide

14 for internal quality improvement demonstration

15 projects to improve patient safety;

16 ‘‘(8) develop tools and methods for educating

17 consumers and purchasers about patient safety;

18 ‘‘(9) facilitate technology transfer from indus19 tries that have succeeded in reducing errors and im20 proving safety within their industry;

21 ‘‘(10) increase the understanding of health care

22 organizations, health care professionals, and the

23 public concerning the use of information technology

24 to improve patient safety (such as automated drug

25 order entry systems and reminder systems);
12

•S 2743 IS

1 ‘‘(11) increase the understanding of health care

2 organizations, health care professionals, and the

3 public concerning medical errors in different settings

4 (such as in ambulatory or home care settings) and

5 among different populations (including individuals

6 with disabilities and other vulnerable populations

7 such as children and the elderly);

8 ‘‘(12) establish baseline rates of specific types

9 of medical errors and monitor trends in such rates,

10 as appropriate;

11 ‘‘(13) establish Centers of Patient Safety Im12 provement as provided for in section 926;

13 ‘‘(14) develop or support the development of

14 tools to objectively measure the impact of best prac15 tices on patient safety and to measure progress to16 wards implementing best practices;

17 ‘‘(15) establish the National Patient Safety Re18 porting System;

19 ‘‘(16) establish the National Patient Safety

20 Surveillance System;

21 ‘‘(17) research and analyze existing State man22 datory reporting systems;

23 ‘‘(18) disseminate information to health care

24 organizations, health care professionals, and other

25 interested parties concerning the causes of medical
13

•S 2743 IS

1 errors, the lessons learned with respect to such er2 rors, outcomes measures, and best practices;

3 ‘‘(19) develop and disseminate educational ma4 terial to the public concerning the manner in which

5 medical errors may be avoided and the manner in

6 which the public can take a more active role in their

7 health care;

8 ‘‘(20) collaborate with health care professional

9 associations, licensing bodies, and other related or10 ganizations in the provision of training in medical

11 error reduction and prevention, and patient safety;

12 and

13 ‘‘(21) develop an awards or incentive program

14 for health care professionals and health care organi15 zations that develop effective methods to enhance

16 patient safety.

17 ‘‘(c) RESEARCH.—

18 ‘‘(1) PROCESS.—In carrying out subsection

19 (b)(4), the Director shall establish a formal process

20 to gather information on priorities, methodologies

21 and approaches for medical errors and patient safety

22 research. In gathering such information, the Direc23 tor shall ensure that input is obtained from a wide

24 range of individuals and organizations who will use
14

•S 2743 IS

1 and can benefit from the availability of such infor2 mation.

3 ‘‘(2) OTHER INDUSTRIES.—In carrying out this

4 subsection, the Director shall consider the experi5 ences of other industries in reducing errors within

6 such industries and the processes that such indus7 tries employ to reduce errors.

8 ‘‘(3) ISSUES.—The issues to be addressed with

9 respect to the research to be conducted and sup10 ported under this subsection shall include—

11 ‘‘(A) the types and causes of errors in the

12 provision of health care;

13 ‘‘(B) the impact of health care professional

14 fatigue (including working hours and overtime),

15 stress, and other workplace-related factors on

16 patient safety;

17 ‘‘(C) staffing needs for health care organi18 zations to provide quality health care;

19 ‘‘(D) training requirements for health care

20 professionals to ensure that such professionals

21 provide quality health care generally (such as

22 continuous quality improvement training), in

23 specific settings (such as the emergency room),

24 and for specific practices (such as

25 ultrasonography);
15

•S 2743 IS

1 ‘‘(E) the use of intensivists and intensive

2 care unit teams on patient outcomes;

3 ‘‘(F) the development of effective commu4 nication methods and tools between disciplines

5 to improve patient safety;

6 ‘‘(G) the use of interdisciplinary teams to

7 improve patient safety;

8 ‘‘(H) the barriers to medical error reduc9 tion strategies; and

10 ‘‘(I) other areas determined appropriate by

11 the Secretary.

12 ‘‘(d) EVALUATIONS.—

13 ‘‘(1) GENERAL MEDICAL ERROR CONSIDER14 ATIONS.—In carrying out subsection (b)(5) with re15 spect to the evaluation of efforts to reduce medical

16 errors and improve patient safety, the Director shall

17 take into consideration—

18 ‘‘(A) the standardization of processes;

19 ‘‘(B) the reduction in system complexity;

20 ‘‘(C) human factors; and

21 ‘‘(D) the use of demonstration projects.

22 ‘‘(2) MEDICATION ERROR CONSIDERATIONS.—

23 In carrying out subsection (b)(5) with respect to the

24 evaluation of efforts to reduce medication errors and
16

•S 2743 IS

1 improve the safe use of medications, the Director

2 shall take into consideration—

3 ‘‘(A) the computerization of the drug pre4 scribing process;

5 ‘‘(B) effective prescriber and patient edu6 cation;

7 ‘‘(C) the expanded and integrated use of

8 pharmacists;

9 ‘‘(D) the use of bar codes on patient name

10 bracelets and medications;

11 ‘‘(E) the controlled use of, and limited ac12 cessibility to, highly toxic or hazardous drugs,

13 such as potassium chloride, in health care orga14 nizations;

15 ‘‘(F) the development and use of protocols

16 for highly toxic or hazardous drugs and drugs

17 with a narrow therapeutic range, such as writ18 ten guidelines, checklists, pre-printed orders,

19 double-checks, special packaging, special label20 ing;

21 ‘‘(G) the use of pharmacy-based intra22 venous admixture programs;

23 ‘‘(H) the standardization of drug storage

24 locations, internal packaging or labeling;
17

•S 2743 IS

1 ‘‘(I) the use of unit dose drug distribution

2 systems;

3 ‘‘(J) the use of machine-readable labeling,

4 such as a bar-coding system; and

5 ‘‘(K) the standardization of terminology,

6 nomenclature (such as medication names), and

7 abbreviations used in prescribing.

8 ‘‘SEC. 924. NATIONAL PATIENT SAFETY REPORTING SYS9 TEM.

10 ‘‘(a) ESTABLISHMENT.—

11 ‘‘(1) IN GENERAL.—Not later than 1 year after

12 the date of enactment of this part, the Director shall

13 establish a National Patient Safety Reporting Sys14 tem, to be headed by an administrator to be ap15 pointed by the Director. The Director may contract

16 with other organizations to carry out some or all of

17 the components described in subsection (b).

18 ‘‘(2) VOLUNTARY SYSTEM.—The Voluntary Re19 porting System shall be a voluntary medical error

20 reporting system that collects voluntary reports on

21 adverse safety events.

22 ‘‘(3) REPORTS CONCERNING FDA-REGULATED

23 PRODUCTS.—With respect to adverse safety events

24 that relate to products regulated by the Food and

25 Drug Administration, the Director and the Commis-
18

•S 2743 IS

1 sioner of the Food and Drug Administration, in con2 sultation with the entities described in section

3 922(c)(1), shall determine how reports under this

4 section will be treated.

5 ‘‘(b) COMPONENTS.—The Voluntary Reporting Sys6 tem shall—

7 ‘‘(1) encourage the voluntary, confidential re8 porting of adverse safety events by any individual or

9 entity, including health care organizations, health

10 care professionals, and patients;

11 ‘‘(2) provide for the multi-disciplinary expert

12 analysis of all reported adverse safety events;

13 ‘‘(3) provide for the clear identification of

14 causes of medical errors;

15 ‘‘(4) develop effective, high-leverage patient

16 safety solutions;

17 ‘‘(5) establish best practices, based on an anal18 ysis of reports received, through the use of experts

19 from multiple disciplines; and

20 ‘‘(6) provide for the widespread dissemination

21 of information about medical errors and best prac22 tices.

23 ‘‘(c) EXISTING REPORTING SYSTEMS.—In estab24 lishing the Voluntary Reporting System, the Director shall

25 consider—
19

•S 2743 IS

1 ‘‘(1) whether to—

2 ‘‘(A) incorporate existing voluntary medical

3 error reporting systems that are being imple4 mented on the date of enactment of this part

5 into the Voluntary Reporting System; or

6 ‘‘(B) complement the existing systems de7 scribed in paragraph (1).

8 ‘‘(2) how to coordinate with mandatory sys9 tems.

10 ‘‘(d) STANDARDS.—The Director shall develop stand11 ards for the types of information to be reported to the

12 Voluntary Reporting System.

13 ‘‘(e) REPORTING OF ADVERSE SAFETY EVENTS.—

14 ‘‘(1) WHO MAY REPORT.—Any individual or en15 tity may report an adverse safety event to the Vol16 untary Reporting System, including a health care or17 ganization, a health care professional, or a patient.

18 ‘‘(2) REPORTING FORM.—

19 ‘‘(A) IN GENERAL.—The Director, in ac20 cordance with subparagraph (B), shall develop

21 the written and electronic forms to be used for

22 submitting reports under this section.

23 ‘‘(B) REQUIREMENTS.—A form used for

24 the reporting of information under this section

25 shall contain standard minimum data fields—
20

•S 2743 IS

1 ‘‘(i) for the identification of the re2 porting individual, except that nothing in

3 this section shall require a reporting indi4 vidual to provide such information if the

5 individual desires to remain anonymous;

6 ‘‘(ii) that provide for the identification

7 of the causes of the medical error de8 scribed in the report;

9 ‘‘(iii) that identify the relevant char10 acteristics about the health care organiza11 tion involved, including the location of the

12 organization (the city, State and urban or

13 rural nature of the location), the size of

14 the organization, and other characteristics

15 determined appropriate by the Director.

16 Such data may only be used in aggregate anal17 yses and may only be included in the National

18 Patient Safety Database if it cannot be used to

19 identify a specific health care organization,

20 health care professional, or patient.

21 ‘‘(3) SUBMISSION.—A reporting form may be

22 submitted under this section electronically, by mail,

23 by fax, or by telephone. The administrator shall es24 tablish a Post Office box, a toll-free fax number, a
21

•S 2743 IS

1 toll-free telephone number, and an Internet website

2 or e-mail address to receive reporting forms.

3 ‘‘(4) ADDITIONAL INFORMATION.—If the ad4 ministrator of the Voluntary Reporting System de5 termines that additional information is needed with

6 respect to an adverse safety event report so that the

7 report complies with the standards described in sub8 section (d), the administrator may request such data

9 from the reporting individual within 30 calendar

10 days of receiving the report.

11 ‘‘(5) DE-IDENTIFICATION.—Upon a determina12 tion by the administrator of the Voluntary Reporting

13 System that no additional information is needed con14 cerning a report under this section, or the expiration

15 of the 30 calendar day-period beginning on the date

16 on which the last submission of information for the

17 report has occurred, whichever is earlier, the Vol18 untary Reporting System shall remove all informa19 tion that may be used to identify the reporting indi20 vidual and all other persons and entities from the

21 records of the Voluntary Reporting System. The ad22 ministrator may establish a mechanism for notifying

23 the reporting individual of such de-identification (if

24 adequate contact information has been provided in
22

•S 2743 IS

1 the report). Such mechanism shall be applied uni2 formly.

3 ‘‘(6) LIMITATION.—No identifying information

4 with respect to a reporting individual or other per5 sons under this section may be disclosed to any

6 other entity unless the adverse safety event involved

7 in the report was a criminal act or an act related to

8 an impaired health care professional or employee of

9 a health care organization due to alcohol or sub10 stance abuse. If the administrator of the Voluntary

11 Reporting System determines that such an act has

12 occurred, the administrator shall forward such re13 port with the identifying information to the appro14 priate regulatory or law enforcement entity.

15 ‘‘(f) ROOT CAUSE ANALYSIS.—

16 ‘‘(1) TECHNICAL ASSISTANCE.—The Director

17 shall develop and disseminate model instructions and

18 forms for conducting a root cause analysis that in19 volves all relevant personnel and, upon request, pro20 vide technical assistance.

21 ‘‘(2) BY DIRECTOR.—The Director may, upon

22 request and for a fee to be determined by the Direc23 tor to cover costs, conduct a root cause analysis on

24 behalf of a health care organization.

25 ‘‘(g) ANALYSIS OF REPORTS.—
23

•S 2743 IS

1 ‘‘(1) IN GENERAL.—The administrator of the

2 Voluntary Reporting System shall ensure that anal3 yses of data entered into the Voluntary Reporting

4 System are reviewed by independent, multi-discipli5 nary expert panels (as provided for in paragraph

6 (2)) for each category of medical error that has been

7 reported in order to objectively determine the causes

8 of medical errors and develop evidence for best prac9 tices to reduce and prevent such errors.

10 ‘‘(2) SELECTION OF PANELS.—A panel de11 scribed in paragraph (1) shall be composed of ex12 perts to be appointed by the Director in cooperation

13 with the Director of the Centers for Disease Control

14 and Prevention, the Commissioner of the Food and

15 Drug Administration, the Director of the National

16 Institutes of Health, the Secretary of Veterans Af17 fairs, the Secretary of Defense, the Director of the

18 National Academy of Sciences, as well as other in19 terested parties, such as academic institutions, med20 ical specialty societies, nursing and other health pro21 fessional organizations, industry, labor, and con22 sumer groups. Such panels shall be appointed in a

23 manner that prevents conflicts of interests.

24 ‘‘(3) RESULTS.—The administrator of the Vol25 untary Reporting System shall ensure that the re-
24

•S 2743 IS

1 sults of the analyses conducted under this subsection

2 are made available to the general public.

3 ‘‘(h) NATIONAL PATIENT SAFETY DATABASE.—

4 ‘‘(1) IN GENERAL.—The administrator of the

5 Voluntary Reporting System shall ensure that all ad6 verse safety event reports and analyses are cataloged

7 in a database developed under the Voluntary Report8 ing System. The information in the database shall

9 use standard terminology and fields, to be developed

10 by the Director, and be maintained in a manner that

11 permits the information to be aggregated and com12 pared across health care organizations and across

13 States.

14 ‘‘(2) AVAILABILITY.—The database under para15 graph (1) shall be designed in a manner so as to be

16 accessible and easily usable by the general public.

17 ‘‘(i) RULE OF CONSTRUCTION.—Nothing in this sec18 tion shall be construed to preempt or otherwise modify a

19 Federal or State medical error or adverse safety event re20 porting system in effect on, or established after, the date

21 on which the Voluntary Reporting System is established.

22 ‘‘SEC. 925. NATIONAL PATIENT SAFETY SURVEILLANCE SYS23 TEM.

24 ‘‘(a) ESTABLISHMENT.—
25

•S 2743 IS

1 ‘‘(1) IN GENERAL.—Not later than 1 year after

2 the date of enactment of this part, the Director, in

3 collaboration with the Director of the Centers for

4 Disease Control and Prevention, the Commissioner

5 of the Food and Drug Administration, the Adminis6 trator of the Health Care Financing Administration,

7 the Director of the National Institutes of Health,

8 the Secretary of Veterans Affairs, and the Secretary

9 of Defense, shall establish a National Patient Safety

10 Surveillance System under which the Director will

11 enter into voluntary agreements with a geographi12 cally and institutionally diverse group of eligible en13 tities to identify and monitor adverse safety events.

14 The Director may contract with other organizations

15 to carry out this section.

16 ‘‘(2) NUMBER AND TYPES OF ORGANIZA17 TIONS.—In carrying out paragraph (1), the Director

18 shall determine the number and types of health care

19 organizations with whom to enter into agreements,

20 as well as the types of adverse safety events the par21 ticular health care organizations with which the Di22 rector enters into an agreement should identify and

23 the types of analyses that such organizations should

24 perform.
26

•S 2743 IS

1 ‘‘(b) ELIGIBILITY.—To be eligible to enter into an

2 agreement under subsection (a) an entity shall—

3 ‘‘(1) be a health care organization; and

4 ‘‘(2) prepare and submit to the Director an ap5 plication at such time, in such manner, and con6 taining such information as the Director may re7 quire.

8 ‘‘(c) SUBMISSION OF REPORTS.—

9 ‘‘(1) IN GENERAL.—A health care organization

10 that enters into a voluntary agreement under sub11 section (a) shall, with respect to such organization,

12 submit reports of adverse safety events, or reports of

13 specific types of adverse safety events if so pre14 scribed by the agreement, and shall submit, if pre15 scribed by the agreement, root cause analyses con16 cerning such events (using standards developed by

17 the Director), and corrective action plans to the Di18 rector.

19 ‘‘(2) PROCESSING OF INFORMATION.—The Di20 rector shall process the reports submitted under

21 paragraph (1) in the same manner as reports are

22 processed through the Voluntary Reporting System,

23 including making data concerning such reports avail24 able to the general public through the National Pa25 tient Safety Database.
27

•S 2743 IS

1 ‘‘(3) PROVISION OF FEEDBACK TO ORGANIZA2 TION.—The Director shall provide feedback con3 cerning adverse safety event reports directly to the

4 health care organizations that are participating in

5 this Surveillance System.

6 ‘‘(d) TECHNICAL ASSISTANCE.—The Director shall

7 provide participating health care organizations with tech8 nical support and may provide technology support, includ9 ing computer software and hardware.

10 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec11 tion shall be construed to preempt Federal or State sen12 tinel surveillance systems in effect on the date of enact13 ment of this part, or Federal or State sentinel surveillance

14 systems developed after such date of enactment.

15 ‘‘SEC. 926. CENTERS OF PATIENT SAFETY IMPROVEMENT.

16 ‘‘(a) ESTABLISHMENT.—The Director, in accordance

17 with section 923(b)(13), shall provide for the establish18 ment of Centers of Patient Safety Improvement to con19 duct, or facilitate the conduct of, research that focuses

20 on—

21 ‘‘(1) particular types of medical errors (such as

22 medication-related errors);

23 ‘‘(2) medical errors in particular settings or

24 clinical specialties (such as intensive care); and
28

•S 2743 IS

1 ‘‘(3) types of interventions or strategies that

2 may be applied across many areas and settings (in3 cluding multi-disciplinary teams) to reduce medical

4 errors.

5 ‘‘(b) ELIGIBILITY.—To be eligible to be designated

6 as a Center of Patient Safety Improvement under sub7 section (a) an entity shall—

8 ‘‘(1) be a health care organization or an applied

9 research entity; and

10 ‘‘(2) prepare and submit to the Director an ap11 plication at such time, in such manner, and con12 taining such information as the Director may re13 quire including a description of the research to be

14 conducted.

15 ‘‘(c) ACTIVITIES.—A Center of Patient Safety Im16 provement shall—

17 ‘‘(1) conduct state-of-the-art research—

18 ‘‘(A) to increase the awareness of health

19 care organizations, health care professionals,

20 and the general public concerning—

21 ‘‘(i) medical errors;

22 ‘‘(ii) lessons learned; and

23 ‘‘(iii) best practices;

24 ‘‘(B) to better understand the causes of

25 medical errors;
29

•S 2743 IS

1 ‘‘(C) to develop and assess best practices

2 to improve patient safety;

3 ‘‘(D) to evaluate outcomes measures for

4 accuracy and reliability in assessing the impact

5 of best practices on patient safety; and

6 ‘‘(E) to improve patient safety by pre7 venting medical errors and increasing the use of

8 best practices; and

9 ‘‘(2) conduct such other activities as the Sec10 retary determines to be appropriate.

11 ‘‘SEC. 927. CONFIDENTIALITY.

12 ‘‘(a) INFORMATION PRIVILEGED AND CONFIDEN13 TIAL.—Notwithstanding any other provision of law and

14 except as provided in subsection (c), information developed

15 in connection with the Voluntary Reporting System or the

16 Surveillance System (including any root cause analyses of

17 reported adverse safety events and the corrective actions

18 taken in response to such events), as well as the fact that

19 a report was submitted to either System, shall be privi20 leged and confidential and shall not be susceptible to legal

21 process or otherwise disclosed in connection with any civil,

22 criminal, or administrative proceeding under Federal or

23 State law, or subject to disclosure under the Freedom of

24 Information Act under section 552 of title 5, United

25 States Code, or similar State laws.
30

•S 2743 IS

1 ‘‘(b) APPLICATION OF SECTION.—Subsection (a)

2 shall apply to information, but not facts, that is in the

3 custody of a health care professional, a health care organi4 zation, or an employee of a health care organization, or

5 that is transferred to an individual, entity, or agency pur6 suant to this part, that was created for submission to the

7 Voluntary Reporting System or the Surveillance System.

8 ‘‘(c) EXCEPTION.—Subsection (a) shall not apply

9 to—

10 ‘‘(1) information that is false if the individual

11 providing the information to the Voluntary Report12 ing System or the Surveillance System knew that the

13 information was false;

14 ‘‘(2) information that is the custody of a health

15 care professional or health care organization that

16 has been developed or maintained separately from

17 the process by which the professional or organization

18 develops information for submission to the Voluntary

19 Reporting System or the Surveillance System, such

20 as patient medical records, except that this para21 graph shall not be construed to limit other privileges

22 that may be available under Federal or State law;

23 ‘‘(3) nonidentifiable information entered into

24 the National Patient Safety Database;

25 ‘‘(4) a criminal act; and
31

•S 2743 IS

1 ‘‘(5) an act related to an impaired health care

2 professional or employee of a health care organiza3 tion due to alcohol or substance abuse.

4 ‘‘(d) NO WAIVER OF PRIVILEGE.—The submission of

5 information about adverse safety events, root cause anal6 yses, and corrective action plans to the Voluntary Report7 ing System or the Surveillance System under this part

8 shall not be construed to constitute a waiver of any privi9 lege established by Federal or State law or as an affirma10 tive defense, inference, or presumption in a civil, criminal,

11 or administrative proceeding.

12 ‘‘(e) LIABILITY.—Nothing in this section shall be

13 construed as limiting the liability of an individual, entity,

14 or agency for damages relating to the occurrence of an

15 adverse safety event.

16 ‘‘(f) PROTECTION OF PATIENT INFORMATION.—The

17 Director shall establish procedures to ensure that the pri18 vacy of an individual whose care is described in any infor19 mation received by the Voluntary Reporting System or the

20 Surveillance System, with respect to that information or

21 the individual’s identity, is protected.

22 ‘‘SEC. 928. PROTECTIONS FOR PATIENT SAFETY REPORT23 ING.

24 ‘‘(a) PROHIBITION OF RETALIATION.—A health care

25 organization may not discharge, or otherwise discriminate
32

•S 2743 IS

1 against a health care worker with respect to compensation,

2 terms, conditions, or privileges of employment, because the

3 health care worker in good faith—

4 ‘‘(1) provides information relating to a medical

5 error to the Reporting System or the Surveillance

6 System;

7 ‘‘(2) discloses information relating to the care,

8 services, or conditions affecting one or more patients

9 to an appropriate public regulatory agency, an ap10 propriate private accreditation body, or the appro11 priate management personnel of the health care or12 ganization; or

13 ‘‘(3) initiates, cooperates, or otherwise partici14 pates in an investigation or proceeding by such an

15 agency with respect to such care, services, or condi16 tions.

17 ‘‘(b) REQUIREMENT OF GOOD FAITH.—For purposes

18 of subsection (a), a health care worker is considered to

19 be acting in good faith with respect to disclosures de20 scribed in subsection (a) if, with respect to the information

21 disclosed—

22 ‘‘(1) the disclosure is made on the basis of per23 sonal knowledge and is consistent with that degree

24 of learning and skill ordinarily possessed by health
33

•S 2743 IS

1 care workers with the same experience, licensure, or

2 certification;

3 ‘‘(2) the worker reasonably believes the infor4 mation to be true;

5 ‘‘(3) the information evidences a medical error,

6 a violation of a law, rule, or regulation, of an appli7 cable accreditation standard, or of a generally recog8 nized professional or clinical standard, or that a pa9 tient is in imminent hazard of loss of life or serious

10 injury; and

11 ‘‘(4) pursuant to disclosures or reports made in

12 accordance with paragraphs (2) and (3) of sub13 section (a) and subject to paragraphs (2) and (3) of

14 subsection (c), the worker has followed reasonable

15 internal procedures of the health care organization

16 established for the purpose of addressing quality

17 concerns before making the disclosures.

18 ‘‘(c) EXCEPTION AND SPECIAL RULE.—

19 ‘‘(1) GENERAL EXCEPTION.—Subsection (a)

20 shall not be construed to protect disclosures that

21 would violate Federal or State laws or diminish or

22 impair the rights of any person to the continued pro23 tection of confidentiality of communications provided

24 by such laws.
34

•S 2743 IS

1 ‘‘(2) NOTICE OF INTERNAL PROCEDURES.—

2 Paragraph (4) of subsection (b) shall not apply to

3 a disclosure unless the internal procedures involved

4 are reasonably expected to be known to the health

5 care worker involved. For purposes of this para6 graph, a health care worker is reasonably expected

7 to know of internal procedures if those procedures

8 have been made available to the worker through dis9 tribution or posting.

10 ‘‘(3) INTERNAL PROCEDURE EXCEPTION.—

11 Paragraph (4) of subsection (b) also shall not apply

12 to a disclosure if—

13 ‘‘(A) the disclosure relates to an imminent

14 hazard of loss of life or serious injury to a pa15 tient;

16 ‘‘(B) the disclosure is made to an appro17 priate private accreditation body pursuant to

18 disclosure procedures established by the body;

19 or

20 ‘‘(C) the disclosure is in response to an in21 quiry made in an investigation or proceeding of

22 an appropriate public regulatory agency and the

23 information disclosed is limited to the scope of

24 the investigation or proceeding.
35

•S 2743 IS

1 ‘‘(d) NOTICE.—A health care organization shall post

2 a notice, to be provided or approved by the Secretary of

3 Labor, setting forth excerpts from, or summaries of, the

4 pertinent provisions of this section and information per5 taining to enforcement of such provisions.

6 ‘‘(e) HEALTH CARE WORKER DEFINED.—For the

7 purposes of this subsection, the term ‘health care worker’

8 means an employee of the health care organization as well

9 as an employee of a subcontractor or independent con10 tractor who provides health care services, treatment, as11 sistance with daily living activities, or medications to pa12 tients. Such term includes physician, intern, resident,

13 nurse, nurse’s aide, and laboratory technician.’’.

14 ‘‘SEC. 929. ENFORCEMENT BY THE SECRETARY OF LABOR.

15 ‘‘(a) FILING OF COMPLAINT.—A health care profes16 sional who believes that he or she has been discharged or

17 otherwise discriminated against in violation of section

18 928(a) may, within 180 days after the date on which the

19 violation is alleged to have occurred, file a complaint with

20 the Secretary of Labor alleging a violation of such section.

21 ‘‘(b) PROCEDURES.—Upon the filing of a complaint

22 under subsection (a), the Secretary shall—

23 ‘‘(1) notify the health care organization named

24 in the complaint; and
36

•S 2743 IS

1 ‘‘(2) investigate, afford an opportunity for a

2 hearing, and issue findings with respect to the com3 plaint using the same procedures used for com4 plaints filed under section 31105(b) of title 49,

5 United States Code.

6 Appeals from orders issued under this section, as well as

7 civil actions to enforce such orders, shall be brought pur8 suant to the procedures contained in section 31105(b) of

9 title 49, United States Code.

10 ‘‘(c) DETERMINATIONS.—If, in response to a com11 plaint filed under subsection (a), the Secretary of Labor

12 determines that a violation of section 928(a) may have oc13 curred, the Secretary shall order, as appropriate—

14 ‘‘(1) that the health care organization reinstate

15 the health care professional to his or her former po16 sition together with the compensation (including

17 back pay), terms, conditions and privileges of the po18 sition;

19 ‘‘(2) compensatory damages; and

20 ‘‘(3) exemplary damages.

21 ‘‘(d) COSTS AND EXPENSES.—Upon the issuance of

22 an order under subsection (c), the Secretary of Labor may

23 assess against the health care organization involved a sum

24 equal to the costs and expenses (including attorney’s fees

25 and expert witness fees) reasonably incurred by the health
37

•S 2743 IS

1 care professional, as determined by the Secretary, in

2 bringing the complaint, including costs and expenses in3 curred as part of an appeal.

4 ‘‘SEC. 930. REPORTS.

5 ‘‘Not later than 1 year after the establishment of the

6 Center, and annually thereafter, the Director shall pre7 pare, submit to Congress, and make available to health

8 care organizations, health care professionals, and the gen9 eral public, a report on the progress made in improving

10 patient safety. Such report shall include the recommenda11 tions of the Director for modifications—

12 ‘‘(1) in the activities of the Agency for

13 Healthcare Research and Quality; and

14 ‘‘(2) in other Federal or State programs, and in

15 the activities of accrediting organizations, health

16 care professional associations, group health plan

17 purchasers, and health care organizations;

18 to improve patient safety.

19 ‘‘SEC. 930A. AUTHORIZATION OF APPROPRIATIONS.

20 ‘‘There is authorized to be appropriated to carry out

21 this part—

22 ‘‘(1) $50,000,000 for fiscal year 2001, of which

23 $25,000,000 shall be made available to fund the Vol24 untary Reporting System and the Surveillance Sys25 tem;
38

•S 2743 IS

1 ‘‘(2) $100,000,000 for fiscal year 2002, of

2 which $35,000,000 shall be made available to fund

3 the Voluntary Reporting System and the Surveil4 lance System;

5 ‘‘(3) $150,000,000 for fiscal year 2003, of

6 which $50,000,000 shall be made available to fund

7 the Voluntary Reporting System and the Surveil8 lance System;

9 ‘‘(4) $175,000,000 for fiscal year 2004, of

10 which $60,000,000 shall be made available to fund

11 the Voluntary Reporting System and the Surveil12 lance System; and

13 ‘‘(5) $200,000,000 for fiscal year 2005, of

14 which $75,000,000 shall be made available to fund

15 the Voluntary Reporting System and the Surveil16 lance System.’’.

17 SEC. 4. APPLICATION TO DEPARTMENT OF HEALTH AND

18 HUMAN SERVICES PROGRAMS.

19 (a) IN GENERAL.—The Secretary of Health and

20 Human Services shall—

21 (1) develop a process for determining which evi22 dence-based best practices disseminated by the Di23 rector under part C of title IX of the Public Health

24 Service Act (as added by section 3) should be ap25 plied to health care organizations, health care pro-
39

•S 2743 IS

1 fessionals, and any other entity or individual who

2 participates in a Federally funded health care pro3 gram that is under the authority of the Secretary;

4 (2) take reasonable steps (including revising

5 agreements with utilization and quality control peer

6 review organizations) as may be appropriate to bring

7 about the implementation of the best practices se8 lected by the Secretary using the process developed

9 under paragraph (1);

10 (3) enter into agreements with utilization and

11 quality control peer review organizations, accrediting

12 organizations, and State agencies for such organiza13 tions to provide, upon request, technical assistance,

14 expert advice, and education to entities and individ15 uals described in paragraph (1) regarding the best

16 practices made applicable to such entities and indi17 viduals under such paragraph, as well as how to per18 form root cause analyses;

19 (4) take reasonable actions as may be appro20 priate to bring about the implementation of a pa21 tient safety program in each participating health

22 care organization that includes—

23 (A) a process and standards for the inter24 nal identification of adverse safety events;
40

•S 2743 IS

1 (B) a process and standards for per2 forming internal root cause analyses of adverse

3 safety events that caused or could have caused

4 serious injury or death;

5 (C) a process for developing an internal

6 corrective action plan for adverse safety events

7 identified under subparagraph (B);

8 (D) a process for informing health care

9 professionals who are employed by the health

10 care organization of—

11 (i) evidence-based best practices dis12 seminated by the Director;

13 (ii) other methods to improve patient

14 safety; and

15 (iii) other patient safety-related

16 issues; and

17 (E) a process for informing the chief ad18 ministrative officer, other senior management

19 officials, and the health care professional em20 ployees of the health care organization of ad21 verse safety events evaluated under subpara22 graph (B), and the corrective action plans im23 plemented under subparagraph (C); and
41

•S 2743 IS

1 (5) identify increased use of autopsies as one of

2 the quality improvement goals of the Secretary’s

3 quality improvement programs.

4 (b) AVAILABILITY OF DATA.—As a condition of

5 maintaining its deemed status with the Secretary of

6 Health and Human Services relating to any Federally

7 funded health care program that is under the authority

8 of the Secretary, the Joint Commission on Accreditation

9 of Health Care Organizations shall agree to make de-iden10 tified data received by the Joint Commission through its

11 Sentinel Event Program available to the Director.

12 SEC. 5. APPLICATION TO THE FEDERAL EMPLOYEES

13 HEALTH BENEFITS PROGRAM.

14 Chapter 89 of title 5, United States Code is

15 amended—

16 (1) in section 8902—

17 (A) in subsection (e), by striking ‘‘(e) The’’

18 and inserting ‘‘(e)(1) Subject to subsection (p),

19 the’’; and

20 (B) by adding at the end the following:

21 ‘‘(p) The Director of the Office of Personnel Manage22 ment shall—

23 ‘‘(1) develop a process for determining which

24 evidence-based best practices disseminated by the

25 Director of the Agency for Healthcare Research and
42

•S 2743 IS

1 Quality under part C of title IX of the Public Health

2 Service Act should be applied to health benefits

3 plans described in section 8903 or 8903a as pur4 chasing standards;

5 ‘‘(2) develop measures to rate such plans on pa6 tient safety improvement activities identified by the

7 Director of the Office of Personnel Management;

8 and

9 ‘‘(3) rate such plans using the measures devel10 oped under paragraph (2).’’; and

11 (2) in section 8907(a), by adding at the end the

12 following: ‘‘Such information shall include the rating

13 (based on measures developed by the Director of the

14 Office of Personnel Management) for each plan ap15 proved for enrollees under this title.’’.

Æ