[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2743 Introduced in Senate (IS)]







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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Voluntary Error Reduction and 
Improvement in Patient Safety Act''.

SEC. 2. PURPOSE.

    It is the purpose of this Act to establish a national voluntary 
system to continually reduce medical errors, and the harm that results 
from such errors, and improve patient safety to ensure that individuals 
receive the highest quality health care.

SEC. 3. REDUCING MEDICAL ERRORS AND IMPROVING PATIENT SAFETY.

    Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) 
is amended--
            (1) by redesignating part C as part D;
            (2) by redesignating sections 921 through 928, as sections 
        931 through 938, respectively;
            (3) in section 938(1) (as so redesignated), by striking 
        ``921'' and inserting ``931''; and
            (4) by inserting after part B the following:

     ``PART C--REDUCING MEDICAL ERRORS AND IMPROVING PATIENT SAFETY

``SEC. 921. DEFINITIONS.

    ``In this part:
            ``(1) Accrediting organization.--The term `accrediting 
        organization' means a national, nonprofit organization that--
                    ``(A) accredits health care professionals; and
                    ``(B) is recognized as an accrediting entity by 
                Federal or State law or by a Federal or State agency 
                that regulates health care professionals or health care 
                organizations.
            ``(2) Adverse safety event.--The term `adverse safety 
        event' means an occurrence that is directly associated with 
        medical care or services provided by a health care organization 
        that results, or could result, in an accident, injury, or 
        illness.
            ``(3) Best practice.--The term `best practice' with respect 
        to the provision of health care or services, means--
                    ``(A) an excellent or optimal action, conduct, or 
                procedure, based on sound science; or
                    ``(B) an excellent or optimal level of performance, 
                based on sound science.
            ``(4) Center.--The term `Center' means the Center for 
        Quality Improvement and Patient Safety established under 
        section 922.
            ``(5) Director.--The term `Director' means the Director of 
        the Agency for Healthcare Research and Quality.
            ``(6) Health care organization.--The term `health care 
        organization' means an entity that provides health care 
        services in the ordinary course of business or practice of a 
        profession, pursuant to a license, certification, 
        accreditation, or other legal authorization. Such term shall 
        include hospitals, pharmacies, health clinics, long-term care 
        facilities, intermediate care facilities, home health agencies, 
        hospice programs, residential treatment centers, physicians' 
        offices, and the officers, employees, and agents of such 
        entities (such as physicians, nurses, pharmacists, interns, 
        residents, and other health care professionals).
            ``(7) Health care professional.--The term `health care 
        professional' means an individual who is licensed or otherwise 
        authorized by State law to provide health care services in that 
        State.
            ``(8) Human factors.--The term `human factors' with respect 
        to health care means human characteristics derived from the 
        study of the interaction of humans with systems, products, and 
        the environment. Such characteristics may be derived through 
        the development of psychological principles and knowledge in 
        areas such as perception, cognition, and decisionmaking. Such 
        term includes biomedical and psychosocial considerations, human 
        engineering, personnel selection, training, life support, job 
        performance, and human performance evaluation.
            ``(9) Medical error.--The term `medical error' with respect 
        to the provision of health care or services, means--
                    ``(A) the failure of a planned action to be 
                completed as intended; or
                    ``(B) the use of a wrong plan to achieve a desired 
                result.
            ``(10) Surveillance system.--The term `Surveillance System' 
        means the National Patient Safety Surveillance System 
        established under section 925.
            ``(11) State.--The term `State' means each of the 50 
        States, the District of Columbia, the Commonwealth of Puerto 
        Rico, the United States Virgin Islands, Guam, American Samoa, 
        and the Commonwealth of the Northern Mariana Islands.
            ``(12) Voluntary reporting system.--The term `Voluntary 
        Reporting System' means the National Patient Safety Reporting 
        System established under section 924.

``SEC. 922. CENTER FOR QUALITY IMPROVEMENT AND PATIENT SAFETY.

    ``(a) Establishment.--There is established within the Agency for 
Healthcare Research and Quality an office to be known as the Center for 
Quality Improvement and Patient Safety, which shall be headed by an 
individual to be appointed by the Director. The Secretary shall carry 
out this part acting through the Director.
    ``(b) Purpose.--The purpose of the Center is to promote patient 
safety through the establishment of an information infrastructure and 
evidence base for patient safety to permit health care professionals 
and organizations to take a more strategic approach to reducing medical 
errors and improving patient safety. In carrying out the purpose of 
this subsection the Director shall--
            ``(1) direct the efforts of the Center across all types of 
        health care organizations, health care professionals, and 
        patients;
            ``(2) take into consideration differences between types of 
        health care organizations and make recommendations for best 
        practices in a manner that takes into consideration such 
        differences;
            ``(3) collect and analyze existing information on the 
        causes of medical errors and evidence-based recommendations to 
        reduce such errors; and
            ``(4) obtain input from, and consult with, entities as 
        provided for in subsection (c).
    ``(c) Input and Consultation.--To carry out the purpose described 
in subsection (b), the Director shall--
            ``(1) obtain input from a wide range of public and private 
        sources, including Federal as well as State governmental 
        entities, including the Centers for Disease Control and 
        Prevention, the Food and Drug Administration, the National 
        Institutes of Health, the Health Care Financing Administration, 
        the Department of Veterans Affairs, the Department of Defense, 
        State departments of health, State licensing boards, 
        organizations representing health care professionals and health 
        care organizations, purchasers, industry, consumer groups, and 
        other public, private, and public-private organizations and 
        alliances that address quality in health care; and
            ``(2) consider input from relevant disciplines and 
        industries that have a demonstrated experience with proven 
        safety initiatives, such as the aviation industry, industrial 
        engineering, anesthesiology, and psychology.

``SEC. 923. GENERAL ACTIVITIES.

    ``(a) In General.--The Center, and other components of the Agency 
for Healthcare Research and Quality as the Director determines to be 
appropriate, shall--
            ``(1) serve as a central, publicly accessible clearinghouse 
        for information concerning patient safety, including data 
        collected through the Voluntary Reporting System and the 
        Surveillance System, and information about the causes of 
        medical errors and best practices to prevent or minimize 
        medical errors and injuries that may result from such errors;
            ``(2) administer the National Patient Safety Reporting 
        System under section 924;
            ``(3) administer the National Patient Safety Surveillance 
        System under section 925;
            ``(4) conduct, support, and coordinate the analysis of data 
        collected through the Voluntary Reporting System in conjunction 
        with multi-disciplinary panels of experts selected from the 
        public and private sector;
            ``(5) conduct and support research on the causes of and 
        best practices to prevent or minimize medical errors;
            ``(6) support the Patient Safety Centers of Improvement 
        established under section 926 to develop effective and fiscally 
        responsible best practices to address critical patient safety 
        challenges, including designing management and information 
        systems that optimize patient safety;
            ``(7) obtain and provide evidence-based information to 
        guide in the development and continuous improvement of best 
        practices;
            ``(8) educate the public and the health care community 
        concerning the existence and causes of medical errors, the 
        lessons learned, outcomes measures, and best practices with 
        respect to medical errors;
            ``(9) promote the universal acknowledgment, adoption, and 
        implementation of best practices to promote more efficient, 
        effective, and safe health care systems throughout the Nation; 
        and
            ``(10) carry out other functions determined appropriate by 
        the Secretary to fulfill the purpose of the Center.
    ``(b) 3-Year Requirements.--Not later than 3 years after the date 
on which the Center is established, the Director shall--
            ``(1) based on expert opinion and a review of the current 
        evidence relating to medical errors, develop a limited, 
        achievable set of high-priority goals for improving patient 
        safety;
            ``(2) assess the progress made in achieving the goals 
        developed under paragraph (1) by compiling aggregate 
        information from Federal, State, and other adverse event or 
        error reporting systems, health care organizations, and other 
        sources;
            ``(3) for purposes of making the assessments under 
        paragraph (2), periodically conduct a survey or review of 
        representative health care organizations with respect to the 
        progress of such organizations in meeting the goals established 
        under paragraph (1);
            ``(4) develop and provide support for a research agenda as 
        described in subsection (c), which may include the use of 
        existing data sources, such as health claims databases, if 
        appropriate;
            ``(5) in accordance with subsection (d), evaluate existing, 
        and develop evidence for new best practices and tools for 
        improving and protecting patient safety in key processes, 
        including clinical, managerial, and informational support 
        systems for--
                    ``(A) medication systems (from prescribing to 
                administering);
                    ``(B) operating rooms, surgical procedures, and 
                surgical care (including pre-operative and post-
                operative care);
                    ``(C) emergency departments;
                    ``(D) the management of diagnostic tests, 
                screening, and information;
                    ``(E) intensive care units, including neonatal and 
                pediatric intensive care units;
                    ``(F) the care of frail elderly (such as care after 
                falls and for decubitus ulcers);
                    ``(G) the use of simulation and simulators in 
                health care training;
                    ``(H) team training and crew resource management 
                applications in health care; and
                    ``(I) home health care services;
            ``(6) develop instructional methods, demonstration 
        projects, and technical support projects to ensure the 
        widespread implementation of the best practices and tools 
        developed under this subsection;
            ``(7) provide technical support to health care 
        organizations to enable such organizations to provide for 
        internal quality improvement demonstration projects to improve 
        patient safety;
            ``(8) develop tools and methods for educating consumers and 
        purchasers about patient safety;
            ``(9) facilitate technology transfer from industries that 
        have succeeded in reducing errors and improving safety within 
        their industry;
            ``(10) increase the understanding of health care 
        organizations, health care professionals, and the public 
        concerning the use of information technology to improve patient 
        safety (such as automated drug order entry systems and reminder 
        systems);
            ``(11) increase the understanding of health care 
        organizations, health care professionals, and the public 
        concerning medical errors in different settings (such as in 
        ambulatory or home care settings) and among different 
        populations (including individuals with disabilities and other 
        vulnerable populations such as children and the elderly);
            ``(12) establish baseline rates of specific types of 
        medical errors and monitor trends in such rates, as 
        appropriate;
            ``(13) establish Centers of Patient Safety Improvement as 
        provided for in section 926;
            ``(14) develop or support the development of tools to 
        objectively measure the impact of best practices on patient 
        safety and to measure progress towards implementing best 
        practices;
            ``(15) establish the National Patient Safety Reporting 
        System;
            ``(16) establish the National Patient Safety Surveillance 
        System;
            ``(17) research and analyze existing State mandatory 
        reporting systems;
            ``(18) disseminate information to health care 
        organizations, health care professionals, and other interested 
        parties concerning the causes of medical errors, the lessons 
        learned with respect to such errors, outcomes measures, and 
        best practices;
            ``(19) develop and disseminate educational material to the 
        public concerning the manner in which medical errors may be 
        avoided and the manner in which the public can take a more 
        active role in their health care;
            ``(20) collaborate with health care professional 
        associations, licensing bodies, and other related organizations 
        in the provision of training in medical error reduction and 
        prevention, and patient safety; and
            ``(21) develop an awards or incentive program for health 
        care professionals and health care organizations that develop 
        effective methods to enhance patient safety.
    ``(c) Research.--
            ``(1) Process.--In carrying out subsection (b)(4), the 
        Director shall establish a formal process to gather information 
        on priorities, methodologies and approaches for medical errors 
        and patient safety research. In gathering such information, the 
        Director shall ensure that input is obtained from a wide range 
        of individuals and organizations who will use and can benefit 
        from the availability of such information.
            ``(2) Other industries.--In carrying out this subsection, 
        the Director shall consider the experiences of other industries 
        in reducing errors within such industries and the processes 
        that such industries employ to reduce errors.
            ``(3) Issues.--The issues to be addressed with respect to 
        the research to be conducted and supported under this 
        subsection shall include--
                    ``(A) the types and causes of errors in the 
                provision of health care;
                    ``(B) the impact of health care professional 
                fatigue (including working hours and overtime), stress, 
                and other workplace-related factors on patient safety;
                    ``(C) staffing needs for health care organizations 
                to provide quality health care;
                    ``(D) training requirements for health care 
                professionals to ensure that such professionals provide 
                quality health care generally (such as continuous 
                quality improvement training), in specific settings 
                (such as the emergency room), and for specific 
                practices (such as ultrasonography);
                    ``(E) the use of intensivists and intensive care 
                unit teams on patient outcomes;
                    ``(F) the development of effective communication 
                methods and tools between disciplines to improve 
                patient safety;
                    ``(G) the use of interdisciplinary teams to improve 
                patient safety;
                    ``(H) the barriers to medical error reduction 
                strategies; and
                    ``(I) other areas determined appropriate by the 
                Secretary.
    ``(d) Evaluations.--
            ``(1) General medical error considerations.--In carrying 
        out subsection (b)(5) with respect to the evaluation of efforts 
        to reduce medical errors and improve patient safety, the 
        Director shall take into consideration--
                    ``(A) the standardization of processes;
                    ``(B) the reduction in system complexity;
                    ``(C) human factors; and
                    ``(D) the use of demonstration projects.
            ``(2) Medication error considerations.--In carrying out 
        subsection (b)(5) with respect to the evaluation of efforts to 
        reduce medication errors and improve the safe use of 
medications, the Director shall take into consideration--
                    ``(A) the computerization of the drug prescribing 
                process;
                    ``(B) effective prescriber and patient education;
                    ``(C) the expanded and integrated use of 
                pharmacists;
                    ``(D) the use of bar codes on patient name 
                bracelets and medications;
                    ``(E) the controlled use of, and limited 
                accessibility to, highly toxic or hazardous drugs, such 
                as potassium chloride, in health care organizations;
                    ``(F) the development and use of protocols for 
                highly toxic or hazardous drugs and drugs with a narrow 
                therapeutic range, such as written guidelines, 
                checklists, pre-printed orders, double-checks, special 
                packaging, special labeling;
                    ``(G) the use of pharmacy-based intravenous 
                admixture programs;
                    ``(H) the standardization of drug storage 
                locations, internal packaging or labeling;
                    ``(I) the use of unit dose drug distribution 
                systems;
                    ``(J) the use of machine-readable labeling, such as 
                a bar-coding system; and
                    ``(K) the standardization of terminology, 
                nomenclature (such as medication names), and 
                abbreviations used in prescribing.

``SEC. 924. NATIONAL PATIENT SAFETY REPORTING SYSTEM.

    ``(a) Establishment.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this part, the Director shall establish a National 
        Patient Safety Reporting System, to be headed by an 
        administrator to be appointed by the Director. The Director may 
        contract with other organizations to carry out some or all of 
        the components described in subsection (b).
            ``(2) Voluntary system.--The Voluntary Reporting System 
        shall be a voluntary medical error reporting system that 
        collects voluntary reports on adverse safety events.
            ``(3) Reports concerning fda-regulated products.--With 
        respect to adverse safety events that relate to products 
        regulated by the Food and Drug Administration, the Director and 
        the Commissioner of the Food and Drug Administration, in 
        consultation with the entities described in section 922(c)(1), 
        shall determine how reports under this section will be treated.
    ``(b) Components.--The Voluntary Reporting System shall--
            ``(1) encourage the voluntary, confidential reporting of 
        adverse safety events by any individual or entity, including 
        health care organizations, health care professionals, and 
        patients;
            ``(2) provide for the multi-disciplinary expert analysis of 
        all reported adverse safety events;
            ``(3) provide for the clear identification of causes of 
        medical errors;
            ``(4) develop effective, high-leverage patient safety 
        solutions;
            ``(5) establish best practices, based on an analysis of 
        reports received, through the use of experts from multiple 
        disciplines; and
            ``(6) provide for the widespread dissemination of 
        information about medical errors and best practices.
    ``(c) Existing Reporting Systems.--In establishing the Voluntary 
Reporting System, the Director shall consider--
            ``(1) whether to--
                    ``(A) incorporate existing voluntary medical error 
                reporting systems that are being implemented on the 
                date of enactment of this part into the Voluntary 
                Reporting System; or
                    ``(B) complement the existing systems described in 
                paragraph (1).
            ``(2) how to coordinate with mandatory systems.
    ``(d) Standards.--The Director shall develop standards for the 
types of information to be reported to the Voluntary Reporting System.
    ``(e) Reporting of Adverse Safety Events.--
            ``(1) Who may report.--Any individual or entity may report 
        an adverse safety event to the Voluntary Reporting System, 
        including a health care organization, a health care 
        professional, or a patient.
            ``(2) Reporting form.--
                    ``(A) In general.--The Director, in accordance with 
                subparagraph (B), shall develop the written and 
                electronic forms to be used for submitting reports 
                under this section.
                    ``(B) Requirements.--A form used for the reporting 
                of information under this section shall contain 
                standard minimum data fields--
                            ``(i) for the identification of the 
                        reporting individual, except that nothing in 
                        this section shall require a reporting 
                        individual to provide such information if the 
                        individual desires to remain anonymous;
                            ``(ii) that provide for the identification 
                        of the causes of the medical error described in 
                        the report;
                            ``(iii) that identify the relevant 
                        characteristics about the health care 
                        organization involved, including the location 
                        of the organization (the city, State and urban 
                        or rural nature of the location), the size of 
                        the organization, and other characteristics 
                        determined appropriate by the Director.
                Such data may only be used in aggregate analyses and 
                may only be included in the National Patient Safety 
                Database if it cannot be used to identify a specific 
                health care organization, health care professional, or 
                patient.
            ``(3) Submission.--A reporting form may be submitted under 
        this section electronically, by mail, by fax, or by telephone. 
        The administrator shall establish a Post Office box, a toll-
        free fax number, a toll-free telephone number, and an Internet 
website or e-mail address to receive reporting forms.
            ``(4) Additional information.--If the administrator of the 
        Voluntary Reporting System determines that additional 
        information is needed with respect to an adverse safety event 
        report so that the report complies with the standards described 
        in subsection (d), the administrator may request such data from 
        the reporting individual within 30 calendar days of receiving 
        the report.
            ``(5) De-identification.--Upon a determination by the 
        administrator of the Voluntary Reporting System that no 
        additional information is needed concerning a report under this 
        section, or the expiration of the 30 calendar day-period 
        beginning on the date on which the last submission of 
        information for the report has occurred, whichever is earlier, 
        the Voluntary Reporting System shall remove all information 
        that may be used to identify the reporting individual and all 
        other persons and entities from the records of the Voluntary 
        Reporting System. The administrator may establish a mechanism 
        for notifying the reporting individual of such de-
        identification (if adequate contact information has been 
        provided in the report). Such mechanism shall be applied 
        uniformly.
            ``(6) Limitation.--No identifying information with respect 
        to a reporting individual or other persons under this section 
        may be disclosed to any other entity unless the adverse safety 
        event involved in the report was a criminal act or an act 
        related to an impaired health care professional or employee of 
        a health care organization due to alcohol or substance abuse. 
        If the administrator of the Voluntary Reporting System 
        determines that such an act has occurred, the administrator 
        shall forward such report with the identifying information to 
        the appropriate regulatory or law enforcement entity.
    ``(f) Root Cause Analysis.--
            ``(1) Technical assistance.--The Director shall develop and 
        disseminate model instructions and forms for conducting a root 
        cause analysis that involves all relevant personnel and, upon 
        request, provide technical assistance.
            ``(2) By director.--The Director may, upon request and for 
        a fee to be determined by the Director to cover costs, conduct 
        a root cause analysis on behalf of a health care organization.
    ``(g) Analysis of Reports.--
            ``(1) In general.--The administrator of the Voluntary 
        Reporting System shall ensure that analyses of data entered 
        into the Voluntary Reporting System are reviewed by 
        independent, multi-disciplinary expert panels (as provided for 
        in paragraph (2)) for each category of medical error that has 
        been reported in order to objectively determine the causes of 
        medical errors and develop evidence for best practices to 
        reduce and prevent such errors.
            ``(2) Selection of panels.--A panel described in paragraph 
        (1) shall be composed of experts to be appointed by the 
        Director in cooperation with the Director of the Centers for 
        Disease Control and Prevention, the Commissioner of the Food 
        and Drug Administration, the Director of the National 
        Institutes of Health, the Secretary of Veterans Affairs, the 
        Secretary of Defense, the Director of the National Academy of 
        Sciences, as well as other interested parties, such as academic 
        institutions, medical specialty societies, nursing and other 
        health professional organizations, industry, labor, and 
        consumer groups. Such panels shall be appointed in a manner 
        that prevents conflicts of interests.
            ``(3) Results.--The administrator of the Voluntary 
        Reporting System shall ensure that the results of the analyses 
        conducted under this subsection are made available to the 
        general public.
    ``(h) National Patient Safety Database.--
            ``(1) In general.--The administrator of the Voluntary 
        Reporting System shall ensure that all adverse safety event 
        reports and analyses are cataloged in a database developed 
        under the Voluntary Reporting System. The information in the 
        database shall use standard terminology and fields, to be 
        developed by the Director, and be maintained in a manner that 
        permits the information to be aggregated and compared across 
        health care organizations and across States.
            ``(2) Availability.--The database under paragraph (1) shall 
        be designed in a manner so as to be accessible and easily 
        usable by the general public.
    ``(i) Rule of Construction.--Nothing in this section shall be 
construed to preempt or otherwise modify a Federal or State medical 
error or adverse safety event reporting system in effect on, or 
established after, the date on which the Voluntary Reporting System is 
established.

``SEC. 925. NATIONAL PATIENT SAFETY SURVEILLANCE SYSTEM.

    ``(a) Establishment.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this part, the Director, in collaboration with the 
        Director of the Centers for Disease Control and Prevention, the 
        Commissioner of the Food and Drug Administration, the 
        Administrator of the Health Care Financing Administration, the 
        Director of the National Institutes of Health, the Secretary of 
        Veterans Affairs, and the Secretary of Defense, shall establish 
        a National Patient Safety Surveillance System under which the 
        Director will enter into voluntary agreements with a 
        geographically and institutionally diverse group of eligible 
        entities to identify and monitor adverse safety events. The 
        Director may contract with other organizations to carry out 
        this section.
            ``(2) Number and types of organizations.--In carrying out 
        paragraph (1), the Director shall determine the number and 
        types of health care organizations with whom to enter into 
        agreements, as well as the types of adverse safety events the 
        particular health care organizations with which the Director 
        enters into an agreement should identify and the types of 
        analyses that such organizations should perform.
    ``(b) Eligibility.--To be eligible to enter into an agreement under 
subsection (a) an entity shall--
            ``(1) be a health care organization; and
            ``(2) prepare and submit to the Director an application at 
        such time, in such manner, and containing such information as 
        the Director may require.
    ``(c) Submission of Reports.--
            ``(1) In general.--A health care organization that enters 
        into a voluntary agreement under subsection (a) shall, with 
        respect to such organization, submit reports of adverse safety 
        events, or reports of specific types of adverse safety events 
        if so prescribed by the agreement, and shall submit, if 
        prescribed by the agreement, root cause analyses concerning 
        such events (using standards developed by the Director), and 
        corrective action plans to the Director.
            ``(2) Processing of information.--The Director shall 
        process the reports submitted under paragraph (1) in the same 
        manner as reports are processed through the Voluntary Reporting 
        System, including making data concerning such reports available 
        to the general public through the National Patient Safety 
        Database.
            ``(3) Provision of feedback to organization.--The Director 
        shall provide feedback concerning adverse safety event reports 
        directly to the health care organizations that are 
        participating in this Surveillance System.
    ``(d) Technical Assistance.--The Director shall provide 
participating health care organizations with technical support and may 
provide technology support, including computer software and hardware.
    ``(e) Rule of Construction.--Nothing in this section shall be 
construed to preempt Federal or State sentinel surveillance systems in 
effect on the date of enactment of this part, or Federal or State 
sentinel surveillance systems developed after such date of enactment.

``SEC. 926. CENTERS OF PATIENT SAFETY IMPROVEMENT.

    ``(a) Establishment.--The Director, in accordance with section 
923(b)(13), shall provide for the establishment of Centers of Patient 
Safety Improvement to conduct, or facilitate the conduct of, research 
that focuses on--
            ``(1) particular types of medical errors (such as 
        medication-related errors);
            ``(2) medical errors in particular settings or clinical 
        specialties (such as intensive care); and
            ``(3) types of interventions or strategies that may be 
        applied across many areas and settings (including multi-
        disciplinary teams) to reduce medical errors.
    ``(b) Eligibility.--To be eligible to be designated as a Center of 
Patient Safety Improvement under subsection (a) an entity shall--
            ``(1) be a health care organization or an applied research 
        entity; and
            ``(2) prepare and submit to the Director an application at 
        such time, in such manner, and containing such information as 
        the Director may require including a description of the 
        research to be conducted.
    ``(c) Activities.--A Center of Patient Safety Improvement shall--
            ``(1) conduct state-of-the-art research--
                    ``(A) to increase the awareness of health care 
                organizations, health care professionals, and the 
                general public concerning--
                            ``(i) medical errors;
                            ``(ii) lessons learned; and
                            ``(iii) best practices;
                    ``(B) to better understand the causes of medical 
                errors;
                    ``(C) to develop and assess best practices to 
                improve patient safety;
                    ``(D) to evaluate outcomes measures for accuracy 
                and reliability in assessing the impact of best 
                practices on patient safety; and
                    ``(E) to improve patient safety by preventing 
                medical errors and increasing the use of best 
                practices; and
            ``(2) conduct such other activities as the Secretary 
        determines to be appropriate.

``SEC. 927. CONFIDENTIALITY.

    ``(a) Information Privileged and Confidential.--Notwithstanding any 
other provision of law and except as provided in subsection (c), 
information developed in connection with the Voluntary Reporting System 
or the Surveillance System (including any root cause analyses of 
reported adverse safety events and the corrective actions taken in 
response to such events), as well as the fact that a report was 
submitted to either System, shall be privileged and confidential and 
shall not be susceptible to legal process or otherwise disclosed in 
connection with any civil, criminal, or administrative proceeding under 
Federal or State law, or subject to disclosure under the Freedom of 
Information Act under section 552 of title 5, United States Code, or 
similar State laws.
    ``(b) Application of Section.--Subsection (a) shall apply to 
information, but not facts, that is in the custody of a health care 
professional, a health care organization, or an employee of a health 
care organization, or that is transferred to an individual, entity, or 
agency pursuant to this part, that was created for submission to the 
Voluntary Reporting System or the Surveillance System.
    ``(c) Exception.--Subsection (a) shall not apply to--
            ``(1) information that is false if the individual providing 
        the information to the Voluntary Reporting System or the 
        Surveillance System knew that the information was false;
            ``(2) information that is the custody of a health care 
        professional or health care organization that has been 
        developed or maintained separately from the process by which 
        the professional or organization develops information for 
        submission to the Voluntary Reporting System or the 
        Surveillance System, such as patient medical records, except 
        that this paragraph shall not be construed to limit other 
        privileges that may be available under Federal or State law;
            ``(3) nonidentifiable information entered into the National 
        Patient Safety Database;
            ``(4) a criminal act; and
            ``(5) an act related to an impaired health care 
        professional or employee of a health care organization due to 
        alcohol or substance abuse.
    ``(d) No Waiver of Privilege.--The submission of information about 
adverse safety events, root cause analyses, and corrective action plans 
to the Voluntary Reporting System or the Surveillance System under this 
part shall not be construed to constitute a waiver of any privilege 
established by Federal or State law or as an affirmative defense, 
inference, or presumption in a civil, criminal, or administrative 
proceeding.
    ``(e) Liability.--Nothing in this section shall be construed as 
limiting the liability of an individual, entity, or agency for damages 
relating to the occurrence of an adverse safety event.
    ``(f) Protection of Patient Information.--The Director shall 
establish procedures to ensure that the privacy of an individual whose 
care is described in any information received by the Voluntary 
Reporting System or the Surveillance System, with respect to that 
information or the individual's identity, is protected.

``SEC. 928. PROTECTIONS FOR PATIENT SAFETY REPORTING.

    ``(a) Prohibition of Retaliation.--A health care organization may 
not discharge, or otherwise discriminate against a health care worker 
with respect to compensation, terms, conditions, or privileges of 
employment, because the health care worker in good faith--
            ``(1) provides information relating to a medical error to 
        the Reporting System or the Surveillance System;
            ``(2) discloses information relating to the care, services, 
        or conditions affecting one or more patients to an appropriate 
        public regulatory agency, an appropriate private accreditation 
        body, or the appropriate management personnel of the health 
        care organization; or
            ``(3) initiates, cooperates, or otherwise participates in 
        an investigation or proceeding by such an agency with respect 
        to such care, services, or conditions.
    ``(b) Requirement of Good Faith.--For purposes of subsection (a), a 
health care worker is considered to be acting in good faith with 
respect to disclosures described in subsection (a) if, with respect to 
the information disclosed--
            ``(1) the disclosure is made on the basis of personal 
        knowledge and is consistent with that degree of learning and 
        skill ordinarily possessed by health care workers with the same 
        experience, licensure, or certification;
            ``(2) the worker reasonably believes the information to be 
        true;
            ``(3) the information evidences a medical error, a 
        violation of a law, rule, or regulation, of an applicable 
        accreditation standard, or of a generally recognized 
        professional or clinical standard, or that a patient is in 
        imminent hazard of loss of life or serious injury; and
            ``(4) pursuant to disclosures or reports made in accordance 
        with paragraphs (2) and (3) of subsection (a) and subject to 
        paragraphs (2) and (3) of subsection (c), the worker has 
        followed reasonable internal procedures of the health care 
        organization established for the purpose of addressing quality 
        concerns before making the disclosures.
    ``(c) Exception and Special Rule.--
            ``(1) General exception.--Subsection (a) shall not be 
        construed to protect disclosures that would violate Federal or 
        State laws or diminish or impair the rights of any person to 
        the continued protection of confidentiality of communications 
        provided by such laws.
            ``(2) Notice of internal procedures.--Paragraph (4) of 
        subsection (b) shall not apply to a disclosure unless the 
        internal procedures involved are reasonably expected to be 
        known to the health care worker involved. For purposes of this 
        paragraph, a health care worker is reasonably expected to know 
        of internal procedures if those procedures have been made 
        available to the worker through distribution or posting.
            ``(3) Internal procedure exception.--Paragraph (4) of 
        subsection (b) also shall not apply to a disclosure if--
                    ``(A) the disclosure relates to an imminent hazard 
                of loss of life or serious injury to a patient;
                    ``(B) the disclosure is made to an appropriate 
                private accreditation body pursuant to disclosure 
                procedures established by the body; or
                    ``(C) the disclosure is in response to an inquiry 
                made in an investigation or proceeding of an 
                appropriate public regulatory agency and the 
                information disclosed is limited to the scope of the 
                investigation or proceeding.
    ``(d) Notice.--A health care organization shall post a notice, to 
be provided or approved by the Secretary of Labor, setting forth 
excerpts from, or summaries of, the pertinent provisions of this 
section and information pertaining to enforcement of such provisions.
    ``(e) Health Care Worker Defined.--For the purposes of this 
subsection, the term `health care worker' means an employee of the 
health care organization as well as an employee of a subcontractor or 
independent contractor who provides health care services, treatment, 
assistance with daily living activities, or medications to patients. 
Such term includes physician, intern, resident, nurse, nurse's aide, 
and laboratory technician.''.

``SEC. 929. ENFORCEMENT BY THE SECRETARY OF LABOR.

    ``(a) Filing of Complaint.--A health care professional who believes 
that he or she has been discharged or otherwise discriminated against 
in violation of section 928(a) may, within 180 days after the date on 
which the violation is alleged to have occurred, file a complaint with 
the Secretary of Labor alleging a violation of such section.
    ``(b) Procedures.--Upon the filing of a complaint under subsection 
(a), the Secretary shall--
            ``(1) notify the health care organization named in the 
        complaint; and
            ``(2) investigate, afford an opportunity for a hearing, and 
        issue findings with respect to the complaint using the same 
        procedures used for complaints filed under section 31105(b) of 
        title 49, United States Code.
Appeals from orders issued under this section, as well as civil actions 
to enforce such orders, shall be brought pursuant to the procedures 
contained in section 31105(b) of title 49, United States Code.
    ``(c) Determinations.--If, in response to a complaint filed under 
subsection (a), the Secretary of Labor determines that a violation of 
section 928(a) may have occurred, the Secretary shall order, as 
appropriate--
            ``(1) that the health care organization reinstate the 
        health care professional to his or her former position together 
        with the compensation (including back pay), terms, conditions 
        and privileges of the position;
            ``(2) compensatory damages; and
            ``(3) exemplary damages.
    ``(d) Costs and Expenses.--Upon the issuance of an order under 
subsection (c), the Secretary of Labor may assess against the health 
care organization involved a sum equal to the costs and expenses 
(including attorney's fees and expert witness fees) reasonably incurred 
by the health care professional, as determined by the Secretary, in 
bringing the complaint, including costs and expenses incurred as part 
of an appeal.

``SEC. 930. REPORTS.

    ``Not later than 1 year after the establishment of the Center, and 
annually thereafter, the Director shall prepare, submit to Congress, 
and make available to health care organizations, health care 
professionals, and the general public, a report on the progress made in 
improving patient safety. Such report shall include the recommendations 
of the Director for modifications--
            ``(1) in the activities of the Agency for Healthcare 
        Research and Quality; and
            ``(2) in other Federal or State programs, and in the 
        activities of accrediting organizations, health care 
        professional associations, group health plan purchasers, and 
        health care organizations;
to improve patient safety.

``SEC. 930A. AUTHORIZATION OF APPROPRIATIONS.

    ``There is authorized to be appropriated to carry out this part--
            ``(1) $50,000,000 for fiscal year 2001, of which 
        $25,000,000 shall be made available to fund the Voluntary 
        Reporting System and the Surveillance System;
            ``(2) $100,000,000 for fiscal year 2002, of which 
        $35,000,000 shall be made available to fund the Voluntary 
        Reporting System and the Surveillance System;
            ``(3) $150,000,000 for fiscal year 2003, of which 
        $50,000,000 shall be made available to fund the Voluntary 
        Reporting System and the Surveillance System;
            ``(4) $175,000,000 for fiscal year 2004, of which 
        $60,000,000 shall be made available to fund the Voluntary 
        Reporting System and the Surveillance System; and
            ``(5) $200,000,000 for fiscal year 2005, of which 
        $75,000,000 shall be made available to fund the Voluntary 
        Reporting System and the Surveillance System.''.

SEC. 4. APPLICATION TO DEPARTMENT OF HEALTH AND HUMAN SERVICES 
              PROGRAMS.

    (a) In General.--The Secretary of Health and Human Services shall--
            (1) develop a process for determining which evidence-based 
        best practices disseminated by the Director under part C of 
        title IX of the Public Health Service Act (as added by section 
        3) should be applied to health care organizations, health care 
        professionals, and any other entity or individual who 
        participates in a Federally funded health care program that is 
        under the authority of the Secretary;
            (2) take reasonable steps (including revising agreements 
        with utilization and quality control peer review organizations) 
        as may be appropriate to bring about the implementation of the 
        best practices selected by the Secretary using the process 
        developed under paragraph (1);
            (3) enter into agreements with utilization and quality 
        control peer review organizations, accrediting organizations, 
        and State agencies for such organizations to provide, upon 
        request, technical assistance, expert advice, and education to 
        entities and individuals described in paragraph (1) regarding 
        the best practices made applicable to such entities and 
        individuals under such paragraph, as well as how to perform 
        root cause analyses;
            (4) take reasonable actions as may be appropriate to bring 
        about the implementation of a patient safety program in each 
        participating health care organization that includes--
                    (A) a process and standards for the internal 
                identification of adverse safety events;
                    (B) a process and standards for performing internal 
                root cause analyses of adverse safety events that 
                caused or could have caused serious injury or death;
                    (C) a process for developing an internal corrective 
                action plan for adverse safety events identified under 
                subparagraph (B);
                    (D) a process for informing health care 
                professionals who are employed by the health care 
                organization of--
                            (i) evidence-based best practices 
                        disseminated by the Director;
                            (ii) other methods to improve patient 
                        safety; and
                            (iii) other patient safety-related issues; 
                        and
                    (E) a process for informing the chief 
                administrative officer, other senior management 
                officials, and the health care professional employees 
                of the health care organization of adverse safety 
                events evaluated under subparagraph (B), and the 
                corrective action plans implemented under subparagraph 
                (C); and
            (5) identify increased use of autopsies as one of the 
        quality improvement goals of the Secretary's quality 
        improvement programs.
    (b) Availability of Data.--As a condition of maintaining its deemed 
status with the Secretary of Health and Human Services relating to any 
Federally funded health care program that is under the authority of the 
Secretary, the Joint Commission on Accreditation of Health Care 
Organizations shall agree to make de-identified data received by the 
Joint Commission through its Sentinel Event Program available to the 
Director.

SEC. 5. APPLICATION TO THE FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM.

    Chapter 89 of title 5, United States Code is amended--
            (1) in section 8902--
                    (A) in subsection (e), by striking ``(e) The'' and 
                inserting ``(e)(1) Subject to subsection (p), the''; 
                and
                    (B) by adding at the end the following:
    ``(p) The Director of the Office of Personnel Management shall--
            ``(1) develop a process for determining which evidence-
        based best practices disseminated by the Director of the Agency 
        for Healthcare Research and Quality under part C of title IX of 
        the Public Health Service Act should be applied to health 
        benefits plans described in section 8903 or 8903a as purchasing 
        standards;
            ``(2) develop measures to rate such plans on patient safety 
        improvement activities identified by the Director of the Office 
        of Personnel Management; and
            ``(3) rate such plans using the measures developed under 
        paragraph (2).''; and
            (2) in section 8907(a), by adding at the end the following: 
        ``Such information shall include the rating (based on measures 
        developed by the Director of the Office of Personnel 
        Management) for each plan approved for enrollees under this 
        title.''.
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