II

106TH CONGRESS

2D SESSION S. 2738

To amend the Public Health Service Act to reduce medical mistakes and

medication-related errors.

IN THE SENATE OF THE UNITED STATES

JUNE 15, 2000

Mr. JEFFORDS (for himself, Mr. FRIST, and Mr. ENZI) 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 reduce medical

mistakes and medication-related errors.

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 ‘‘Patient Safety and

5 Errors Reduction Act’’.

6 SEC. 2. PURPOSES.

7 It is the purpose of this Act to—

8 (1) promote the identification, evaluation, and

9 reporting of medical errors;
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1 (2) raise standards and expectations for im2 provements in patient safety;

3 (3) reduce deaths, serious injuries, and other

4 medical errors through the implementation of safe

5 practices at the delivery level;

6 (4) develop error reduction systems with legal

7 protections to support the collection of information

8 under such systems;

9 (5) extend existing confidentiality and peer re10 view protections to the reports relating to medical

11 errors that are reported under such systems that are

12 developed for safety and quality improvement pur13 poses; and

14 (6) provide for the establishment of systems of

15 information collection, analysis, and dissemination to

16 enhance the knowledge base concerning patient safe17 ty.

18 SEC. 3. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.

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

20 299 et seq.) is amended—

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

22 (2) by redesignating sections 921 through 928,

23 as sections 931 through 938, respectively;

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

25 striking ‘‘921’’ and inserting ‘‘931’’; and
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1 (4) by inserting after part B the following:

2 ‘‘PART C—REDUCING ERRORS IN HEALTH CARE

3 ‘‘SEC. 921. DEFINITIONS.

4 ‘‘In this part:

5 ‘‘(1) ADVERSE EVENT.—The term ‘adverse

6 event’ means, with respect to the patient of a pro7 vider of services, an untoward incident, therapeutic

8 misadventure, or iatrogenic injury directly associated

9 with the provision of health care items and services

10 by a health care provider or provider of services.

11 ‘‘(2) CENTER.—The term ‘Center’ means the

12 Center for Quality Improvement and Patient Safety

13 established under section 922(b).

14 ‘‘(3) CLOSE CALL.—The term ‘close call’

15 means, with respect to the patient of a provider of

16 services, any event or situation that—

17 ‘‘(A) but for chance or a timely interven18 tion, could have resulted in an accident, injury,

19 or illness; and

20 ‘‘(B) is directly associated with the provi21 sion of health care items and services by a pro22 vider of services.

23 ‘‘(4) EXPERT ORGANIZATION.—The term ‘ex24 pert organization’ means a third party acting on be25 half of, or in conjunction with, a provider of services
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1 to collect information about, or evaluate, a medical

2 event.

3 ‘‘(5) HEALTH CARE OVERSIGHT AGENCY.—The

4 term ‘health care oversight agency’ means an agen5 cy, entity, or person, including the employees and

6 agents thereof, that performs or oversees the per7 formance of any activities necessary to ensure the

8 safety of the health care system.

9 ‘‘(6) HEALTH CARE PROVIDER.—The term

10 ‘health care provider’ means—

11 ‘‘(A) any provider of services (as defined in

12 section 1861(u) of the Social Security Act); and

13 ‘‘(B) any person furnishing any medical or

14 other health care services as defined in section

15 1861(s)(1) and (2) of such Act through, or

16 under the authority of, a provider of services

17 described in subparagraph (A).

18 ‘‘(7) PROVIDER OF SERVICES.—The term ‘pro19 vider of services’ means a hospital, skilled nursing

20 facility, comprehensive outpatient rehabilitation fa21 cility, home health agency, renal dialysis facility, am22 bulatory surgical center, or hospice program, and

23 any other entity specified in regulations promulgated

24 by the Secretary.
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1 ‘‘(8) PUBLIC HEALTH AUTHORITY.—The term

2 ‘public health authority’ means an agency or author3 ity of the United States, a State, a territory, a polit4 ical subdivision of a State or territory, and an In5 dian tribe that is responsible for public health mat6 ters as part of its official mandate.

7 ‘‘(9) MEDICAL EVENT.—The term ‘medical

8 event’ means, with respect to the patient of a pro9 vider of services, any sentinel event, adverse event,

10 or close call.

11 ‘‘(10) MEDICAL EVENT ANALYSIS ENTITY.—

12 The term ‘medical event analysis entity’ means an

13 entity certified under section 923(a).

14 ‘‘(11) ROOT CAUSE ANALYSIS.—

15 ‘‘(A) IN GENERAL.—The term ‘root cause

16 analysis’ means a process for identifying the

17 basic or contributing causal factors that under18 lie variation in performance associated with ad19 verse events or close calls that—

20 ‘‘(i) has the characteristics described

21 in subparagraph (B);

22 ‘‘(ii) includes participation by the

23 leadership of the organization and individ24 uals most closely involved in the processes

25 and systems under review;
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1 ‘‘(iii) is internally consistent; and

2 ‘‘(iv) includes the consideration of rel3 evant literature.

4 ‘‘(B) CHARACTERISTICS.—The characteris5 tics described in this subparagraph include the

6 following:

7 ‘‘(i) The analysis is interdisciplinary

8 in nature and involves those individuals

9 who are responsible for administering the

10 reporting systems.

11 ‘‘(ii) The analysis focuses primarily on

12 systems and processes rather than indi13 vidual performance.

14 ‘‘(iii) The analysis involves a thorough

15 review of all aspects of the process and all

16 contributing factors involved.

17 ‘‘(iv) The analysis identifies changes

18 that could be made in systems and proc19 esses, through either redesign or develop20 ment of new processes or systems, that

21 would improve performance and reduce the

22 risk of adverse events or close calls.

23 ‘‘(12) SENTINEL EVENT.—The term ‘sentinel

24 event’ means, with respect to the patient of a pro25 vider of services, an unexpected occurrence that—
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1 ‘‘(A) involves death or serious physical or

2 psychological injury (including loss of a limb);

3 and

4 ‘‘(B) is directly associated with the provi5 sion of health care items and services by a pro6 vider.

7 ‘‘SEC. 922. RESEARCH TO IMPROVE THE QUALITY AND

8 SAFETY OF PATIENT CARE.

9 ‘‘(a) IN GENERAL.—To improve the quality and safe10 ty of patient care, the Director shall—

11 ‘‘(1) conduct and support research, evaluations

12 and training, support demonstration projects, pro13 vide technical assistance, and develop and support

14 partnerships that will identify and determine the

15 causes of medical errors and other threats to the

16 quality and safety of patient care;

17 ‘‘(2) develop or identify and evaluate interven18 tions and strategies for preventing or reducing med19 ical errors and threats to the quality and safety of

20 patient care;

21 ‘‘(3) develop, in conjunction with experts in the

22 field, reporting requirements to provide consistency

23 throughout the errors reporting system;

24 ‘‘(4) develop approaches for the clinical man25 agement of complications from medical errors; and
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1 ‘‘(5) establish mechanisms for the rapid dis2 semination of interventions and strategies developed

3 under this section for which there is scientific evi4 dence of effectiveness.

5 ‘‘(b) CENTER FOR QUALITY IMPROVEMENT AND PA6 TIENT SAFETY.—

7 ‘‘(1) ESTABLISHMENT.—The Director shall es8 tablish a center to be known as the Center for Qual9 ity Improvement and Patient Safety to assist the Di10 rector in carrying out the requirements of subsection

11 (a).

12 ‘‘(2) MISSION.—The Center shall—

13 ‘‘(A) provide national leadership for re14 search and other initiatives to improve the qual15 ity and safety of patient care;

16 ‘‘(B) develop public-private sector partner17 ships to improve the quality and safety of pa18 tient care; and

19 ‘‘(C) serve as a national resource for re20 search and learning from medical errors.

21 ‘‘(3) DUTIES.—

22 ‘‘(A) IN GENERAL.—In carrying out this

23 section, the Director, acting through the Cen24 ter, shall consult and develop partnerships, as

25 appropriate, with all segments of the health
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1 care industry, including health care practi2 tioners and patients, those who manage health

3 care facilities, systems and plans, peer review

4 organizations, health care purchasers and pol5 icymakers, and other users of health care re6 search.

7 ‘‘(B) REQUIRED DUTIES.—In addition to

8 the broad responsibilities that the Director may

9 assign to the Center for research and related

10 activities that are designed to improve the qual11 ity of health care, the Director shall ensure that

12 the Center—

13 ‘‘(i) builds scientific knowledge and

14 understanding of the causes of medical er15 rors in all health care settings and identi16 fies or develops and validates effective

17 interventions and strategies to reduce er18 rors and improve the safety and quality of

19 patient care;

20 ‘‘(ii) promotes public and private sec21 tor research on patient safety by—

22 ‘‘(I) developing a national patient

23 safety research agenda;
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1 ‘‘(II) identifying promising op2 portunities for preventing or reducing

3 medical errors; and

4 ‘‘(III) tracking the progress

5 made in addressing the highest pri6 ority research questions with respect

7 to patient safety;

8 ‘‘(iii) facilitates the development of

9 voluntary national patient safety goals by

10 convening all segments of the health care

11 industry and tracks the progress made in

12 meeting those goals;

13 ‘‘(iv) develops national patient safety

14 data for inclusion in the annual report on

15 the quality of health care required under

16 section 913(b)(2);

17 ‘‘(v) strengthens the ability of the

18 United States to learn from medical errors

19 by—

20 ‘‘(I) developing the necessary

21 tools and advancing the scientific

22 techniques for analysis of errors;

23 ‘‘(II) providing technical assist24 ance as appropriate to reporting sys25 tems; and
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1 ‘‘(III) entering into contracts to

2 receive and analyze aggregate data

3 from public and private sector report4 ing systems;

5 ‘‘(vi) supporting dissemination and

6 communication activities to improve pa7 tient safety, including the development of

8 tools and methods for educating consumers

9 about patient safety; and

10 ‘‘(vii) undertaking other activities that

11 the Director determines are necessary to

12 enable the Center to fulfill its mission.

13 ‘‘(C) LIMITATION.—Aggregate data gath14 ered for the purposes described in this section

15 shall not include specific patient, health care

16 provider, or provider of service identifiers.

17 ‘‘(c) LEARNING FROM MEDICAL ERRORS.—

18 ‘‘(1) IN GENERAL.—To enhance the ability of

19 the health care community in the United States to

20 learn from medical errors and close calls, the Direc21 tor shall—

22 ‘‘(A) carry out activities to increase sci23 entific knowledge and understanding regarding

24 medical error reporting systems;
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1 ‘‘(B) carry out activities to advance the

2 scientific knowledge regarding the tools and

3 techniques for analyzing medical errors and de4 termining their root causes;

5 ‘‘(C) carry out activities in partnership

6 with experts in the field to increase the capacity

7 of the health care community in the United

8 States to analyze patient safety data;

9 ‘‘(D) develop a confidential national safety

10 database of medical errors reports;

11 ‘‘(E) conduct and support research, using

12 the database developed under subparagraph

13 (D), into the causes and potential interventions

14 to decrease the incidence of medical errors and

15 close calls; and

16 ‘‘(F) ensure that information contained in

17 the national database developed under subpara18 graph (D) does not include specific patient,

19 health care provider, or provider of service iden20 tifiers.

21 ‘‘(2) NATIONAL PATIENT SAFETY DATABASE.—

22 The Director shall, in accordance with paragraph

23 (1)(D), establish a confidential national safety data24 base (to be known as the National Patient Safety

25 Database) of reports of medical errors and close
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1 calls that can be used only for research to improve

2 the quality and safety of patient care. In developing

3 and managing the National Patient Safety Data4 base, the Director shall—

5 ‘‘(A) ensure that the database can only be

6 used for its intended purpose;

7 ‘‘(B) ensure that the database is as com8 prehensive as possible by aggregating data from

9 Federal, State, and private sector patient safety

10 reporting systems;

11 ‘‘(C) conduct and support research on the

12 most common medical errors and close calls,

13 their causes, and potential interventions to re14 duce medical errors and improve the quality

15 and safety of patient care;

16 ‘‘(D) report findings made by the Director,

17 based on the data in the database, to clinicians,

18 individuals who manage health care facilities,

19 systems, and plans, patients, and other individ20 uals who can act appropriately to improve pa21 tient safety; and

22 ‘‘(E) develop a rapid response capacity to

23 provide alerts when specific health care prac24 tices pose an imminent threat to patients or

25 health care workers.
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1 ‘‘(3) CONFIDENTIALITY AND PEER REVIEW

2 PROTECTIONS.—Notwithstanding any other provi3 sion of law any information (including any data, re4 ports, records, memoranda, analyses, statements,

5 and other communications) developed by or on be6 half of a health care provider or provider of services

7 with respect to a medical event, that is contained in

8 the National Patient Safety Database shall be con9 fidential in accordance with section 925.

10 ‘‘(4) PATIENT SAFETY REPORTING SYSTEMS.—

11 The Director shall identify public and private sector

12 patient safety reporting systems and build scientific

13 knowledge and understanding regarding the most

14 effective—

15 ‘‘(A) components of patient safety report16 ing systems;

17 ‘‘(B) incentives intended to increase the

18 rate of error reporting;

19 ‘‘(C) approaches for undertaking root

20 cause analyses;

21 ‘‘(D) ways to provide feedback to those fil22 ing error reports;

23 ‘‘(E) techniques and tools for collecting, in24 tegrating, and analyzing patient safety data;

25 and
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1 ‘‘(F) ways to provide meaningful informa2 tion to patients, consumers, and purchasers

3 that will enhance their understanding of patient

4 safety issues.

5 ‘‘(5) TRAINING.—The Director shall support

6 training initiatives to build the capacity of the health

7 care community in the United States to analyze pa8 tient safety data and to act on that data to improve

9 patient safety.

10 ‘‘(d) EVALUATION.—The Director shall recommend

11 strategies for measuring and evaluating the national

12 progress made in implementing safe practices and stand13 ards identified by the Center through the research and

14 analysis required under subsection (b) and through the

15 voluntary reporting system established under subsection

16 (c).

17 ‘‘(e) IMPLEMENTATION.—In implementing strategies

18 to carry out the functions described in subsections (b), (c),

19 and (d), the Director may contract with public or private

20 entities on a national or local level with appropriate exper21 tise.

22 ‘‘SEC. 923. MEDICAL EVENT ANALYSIS ENTITIES.

23 ‘‘(a) IN GENERAL.—The Director, based on informa24 tion collected under section 922(c), shall provide for the

25 certification of entities to collect and analyze information
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1 on medical errors, and to collaborate with health care pro2 viders or providers of services in collecting information

3 about, or evaluating, certain medical events.

4 ‘‘(b) COMPATIBILITY OF COLLECTED DATA.—To en5 sure that data reported to the National Patient Safety

6 Database under section 922(c)(2) concerning medical er7 rors and close calls are comparable and useful on an ana8 lytic basis, the Director shall require that the entities de9 scribed in subsection (c) follow the recommendations re10 garding a common set of core measures for reporting that

11 are developed by the National Forum for Health Care

12 Quality Measurement and Reporting, or other voluntary

13 private standard-setting organization that is designated by

14 the Director taking into account existing measurement

15 systems and in conjunction with experts in the field.

16 ‘‘(c) DUTIES OF CERTIFIED ENTITIES.—

17 ‘‘(1) IN GENERAL.—An entity that is certified

18 under subsection (a) shall collect and analyze infor19 mation, consistent with the requirement of sub20 section (b), provided to the entity under section

21 924(a)(5) to improve patient safety.

22 ‘‘(2) INFORMATION TO BE REPORTED TO THE

23 ENTITY.—A medical event analysis entity shall, on a

24 periodic basis and in a format that is specified by
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1 the Director, submit to the Director a report that

2 contains—

3 ‘‘(A) a description of the medical events

4 that were reported to the entity during the pe5 riod covered under the report;

6 ‘‘(B) a description of any corrective action

7 taken by providers of services with respect to

8 such medical events or any other measures that

9 are necessary to prevent similar events from oc10 curring in the future; and

11 ‘‘(C) a description of the systemic changes

12 that entities have identified, through an anal13 ysis of the medical events included in the re14 port, as being needed to improve patient safety.

15 ‘‘(3) COLLABORATION.—A medical event anal16 ysis entity that is collaborating with a health care

17 provider or provider of services to address close calls

18 and adverse events may, at the request of the health

19 care provider or provider of services—

20 ‘‘(A) provide expertise in the development

21 of root cause analyses and corrective action

22 plan relating to such close calls and adverse

23 events; or
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1 ‘‘(B) collaborate with such provider of

2 services to identify on-going risk reduction ac3 tivities that may enhance patient safety.

4 ‘‘(d) CONFIDENTIALITY AND PEER REVIEW PROTEC5 TIONS.—Notwithstanding any other provision of law, any

6 information (including any data, reports, records, memo7 randa, analyses, statements, and other communications)

8 collected by a medical event analysis entity or developed

9 by or on behalf of such an entity under this part shall

10 be confidential in accordance with section 925.

11 ‘‘(e) TERMINATION AND RENEWAL.—

12 ‘‘(1) IN GENERAL.—The certification of an enti13 ty under this section shall terminate on the date

14 that is 3 years after the date on which such certifi15 cation was provided. Such certification may be re16 newed at the discretion of the Director.

17 ‘‘(2) NONCOMPLIANCE.—The Director may ter18 minate the certification of a medical event analysis

19 entity if the Director determines that such entity

20 has failed to comply with this section.

21 ‘‘(f) IMPLEMENTATION.—In implementing strategies

22 to carry out the functions described in subsection (c), the

23 Director may contract with public or private entities on

24 a national or local level with appropriate expertise.
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1 ‘‘SEC. 924. PROVIDER OF SERVICES SYSTEMS FOR REPORT2 ING MEDICAL EVENTS.

3 ‘‘(a) INTERNAL MEDICAL EVENT REPORTING SYS4 TEMS.—Each provider of services that elects to participate

5 in a medical error reporting system under this part shall—

6 ‘‘(1) establish a system for—

7 ‘‘(A) identifying, collecting information

8 about, and evaluating medical events that occur

9 with respect to a patient in the care of the pro10 vider of services or a practitioner employed by

11 the provider of services, that may include—

12 ‘‘(i) the provision of a medically co13 herent description of each event so identi14 fied;

15 ‘‘(ii) the provision of a clear and thor16 ough accounting of the results of the inves17 tigation of such event under the system;

18 and

19 ‘‘(iii) a description of all corrective

20 measures taken in response to the event;

21 and

22 ‘‘(B) determining appropriate follow-up ac23 tions to be taken with respect to such events;

24 ‘‘(2) establish policies and procedures with re25 spect to when and to whom such events are to be

26 reported;
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1 ‘‘(3) take appropriate follow-up action with re2 spect to such events; and

3 ‘‘(4) submit to the appropriate medical event

4 analysis entity information that contains descrip5 tions of the medical events identified under para6 graph (1)(A).

7 ‘‘(b) PROMOTING IDENTIFICATION, EVALUATION,

8 AND REPORTING OF CERTAIN MEDICAL EVENTS.—

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

10 provision of law any information (including any

11 data, reports, records, memoranda, analyses, state12 ments, and other communications) developed by or

13 on behalf of a provider of services with respect to a

14 medical event pursuant to a system established

15 under subsection (a) shall be privileged in accord16 ance with section 925.

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

18 this subsection shall be construed as prohibiting—

19 ‘‘(A) disclosure of a patient’s medical

20 record to the patient;

21 ‘‘(B) a health care oversight agency or

22 public health authority from requiring a pro23 vider of services to transfer information to the

24 agency or authority to the extent required by

25 law; or
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1 ‘‘(C) such an agency or authority from dis2 closing information transferred by a provider of

3 services to the public in a form that does not

4 identify or permit the identification of the

5 health care provider or provider of services or

6 patient.

7 ‘‘SEC. 925. CONFIDENTIALITY.

8 ‘‘(a) CONFIDENTIALITY AND PEER REVIEW PROTEC9 TIONS.—Notwithstanding any other provision of law—

10 ‘‘(1) any information (including any data, re11 ports, records, memoranda, analyses, statements,

12 and other communications) developed by or on be13 half of a health care provider or provider of services

14 with respect to a medical event, that is contained in

15 the National Patient Safety Database, collected by a

16 medical event analysis entity, or developed by or on

17 behalf of such an entity, or collected by a health

18 care provider or provider or services for use under

19 systems that are developed for safety and quality im20 provement purposes under this part—

21 ‘‘(A) shall be privileged, strictly confiden22 tial, and may not be disclosed by any other per23 son to which such information is transferred

24 without the authorization of the health care

25 provider or provider of services; and
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1 ‘‘(B) shall—

2 ‘‘(i) be protected from disclosure by

3 civil, criminal, or administrative subpoena;

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

5 otherwise discoverable in connection with a

6 civil, criminal, or administrative pro7 ceeding;

8 ‘‘(iii) not be subject to disclosure pur9 suant to section 552 of title 5, United

10 States Code (the Freedom of Information

11 Act) and any other similar Federal or

12 State statute or regulation; and

13 ‘‘(iv) not be admissible as evidence in

14 any civil, criminal, or administrative pro15 ceeding;

16 without regard to whether such information is

17 held by the provider or by another person to

18 which such information was transferred;

19 ‘‘(2) the transfer of any such information by a

20 provider of services to a health care oversight agen21 cy, an expert organization, a medical event analysis

22 entity, or a public health authority, shall not be

23 treated as a waiver of any privilege or protection es24 tablished under paragraph (1) or established under

25 State law.
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1 ‘‘(b) PENALTY.—It shall be unlawful for any person

2 to disclose any information described in subsection (a)

3 other than for the purposes provided in such paragraph,

4 and any person violating the provisions of this section

5 shall, upon conviction, be fined in accordance with title

6 18, United States Code, and imprisoned for not more than

7 6 months, or both.

8 ‘‘(c) APPLICATION OF PROVISIONS.—The protections

9 provided under subsection (a) and the penalty provided for

10 under subsection (b) shall apply to any information (in11 cluding any data, reports, memoranda, analyses, state12 ments, and other communications) collected or developed

13 pursuant to research, including demonstration projects,

14 with respect to medical error reporting supported by the

15 Director under this part.

16 ‘‘SEC. 926. AUTHORIZATION OF APPROPRIATIONS.

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

18 this part, $50,000,000 for fiscal year 2001, and such sums

19 as may be necessary for subsequent fiscal years.’’.

20 SEC. 4. EFFECTIVE DATE.

21 The amendments made by section 3 shall become ef22 fective on January 1 of the calendar year that begins after

23 the date of the enactment of this Act.

Æ