```

[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2738 Introduced in Senate (IS)]

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.

    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 ``Patient Safety and Errors Reduction 
Act''.

SEC. 2. PURPOSES.

    It is the purpose of this Act to--
            (1) promote the identification, evaluation, and reporting 
        of medical errors;
            (2) raise standards and expectations for improvements in 
        patient safety;
            (3) reduce deaths, serious injuries, and other medical 
        errors through the implementation of safe practices at the 
        delivery level;
            (4) develop error reduction systems with legal protections 
        to support the collection of information under such systems;
            (5) extend existing confidentiality and peer review 
        protections to the reports relating to medical errors that are 
        reported under such systems that are developed for safety and 
        quality improvement purposes; and
            (6) provide for the establishment of systems of information 
        collection, analysis, and dissemination to enhance the 
        knowledge base concerning patient safety.

SEC. 3. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.

    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 ERRORS IN HEALTH CARE

``SEC. 921. DEFINITIONS.

    ``In this part:
            ``(1) Adverse event.--The term `adverse event' means, with 
        respect to the patient of a provider of services, an untoward 
        incident, therapeutic misadventure, or iatrogenic injury 
        directly associated with the provision of health care items and 
        services by a health care provider or provider of services.
            ``(2) Center.--The term `Center' means the Center for 
        Quality Improvement and Patient Safety established under 
        section 922(b).
            ``(3) Close call.--The term `close call' means, with 
        respect to the patient of a provider of services, any event or 
        situation that--
                    ``(A) but for chance or a timely intervention, 
                could have resulted in an accident, injury, or illness; 
                and
                    ``(B) is directly associated with the provision of 
                health care items and services by a provider of 
                services.
            ``(4) Expert organization.--The term `expert organization' 
        means a third party acting on behalf of, or in conjunction 
        with, a provider of services to collect information about, or 
        evaluate, a medical event.
            ``(5) Health care oversight agency.--The term `health care 
        oversight agency' means an agency, entity, or person, including 
        the employees and agents thereof, that performs or oversees the 
        performance of any activities necessary to ensure the safety of 
        the health care system.
            ``(6) Health care provider.--The term `health care 
        provider' means--
                    ``(A) any provider of services (as defined in 
                section 1861(u) of the Social Security Act); and
                    ``(B) any person furnishing any medical or other 
                health care services as defined in section 1861(s)(1) 
                and (2) of such Act through, or under the authority of, 
                a provider of services described in subparagraph (A).
            ``(7) Provider of services.--The term `provider of 
        services' means a hospital, skilled nursing facility, 
        comprehensive outpatient rehabilitation facility, home health 
        agency, renal dialysis facility, ambulatory surgical center, or 
        hospice program, and any other entity specified in regulations 
        promulgated by the Secretary.
            ``(8) Public health authority.--The term `public health 
        authority' means an agency or authority of the United States, a 
        State, a territory, a political subdivision of a State or 
        territory, and an Indian tribe that is responsible for public 
        health matters as part of its official mandate.
            ``(9) Medical event.--The term `medical event' means, with 
        respect to the patient of a provider of services, any sentinel 
        event, adverse event, or close call.
            ``(10) Medical event analysis entity.--The term `medical 
        event analysis entity' means an entity certified under section 
        923(a).
            ``(11) Root cause analysis.--
                    ``(A) In general.--The term `root cause analysis' 
                means a process for identifying the basic or 
                contributing causal factors that underlie variation in 
                performance associated with adverse events or close 
                calls that--
                            ``(i) has the characteristics described in 
                        subparagraph (B);
                            ``(ii) includes participation by the 
                        leadership of the organization and individuals 
                        most closely involved in the processes and 
                        systems under review;
                            ``(iii) is internally consistent; and
                            ``(iv) includes the consideration of 
                        relevant literature.
                    ``(B) Characteristics.--The characteristics 
                described in this subparagraph include the following:
                            ``(i) The analysis is interdisciplinary in 
                        nature and involves those individuals who are 
                        responsible for administering the reporting 
                        systems.
                            ``(ii) The analysis focuses primarily on 
                        systems and processes rather than individual 
                        performance.
                            ``(iii) The analysis involves a thorough 
                        review of all aspects of the process and all 
                        contributing factors involved.
                            ``(iv) The analysis identifies changes that 
                        could be made in systems and processes, through 
                        either redesign or development of new processes 
                        or systems, that would improve performance and 
                        reduce the risk of adverse events or close 
                        calls.
            ``(12) Sentinel event.--The term `sentinel event' means, 
        with respect to the patient of a provider of services, an 
        unexpected occurrence that--
                    ``(A) involves death or serious physical or 
                psychological injury (including loss of a limb); and
                    ``(B) is directly associated with the provision of 
                health care items and services by a provider.

``SEC. 922. RESEARCH TO IMPROVE THE QUALITY AND SAFETY OF PATIENT CARE.

    ``(a) In General.--To improve the quality and safety of patient 
care, the Director shall--
            ``(1) conduct and support research, evaluations and 
        training, support demonstration projects, provide technical 
        assistance, and develop and support partnerships that will 
        identify and determine the causes of medical errors and other 
        threats to the quality and safety of patient care;
            ``(2) develop or identify and evaluate interventions and 
        strategies for preventing or reducing medical errors and 
        threats to the quality and safety of patient care;
            ``(3) develop, in conjunction with experts in the field, 
        reporting requirements to provide consistency throughout the 
        errors reporting system;
            ``(4) develop approaches for the clinical management of 
        complications from medical errors; and
            ``(5) establish mechanisms for the rapid dissemination of 
        interventions and strategies developed under this section for 
        which there is scientific evidence of effectiveness.
    ``(b) Center for Quality Improvement and Patient Safety.--
            ``(1) Establishment.--The Director shall establish a center 
        to be known as the Center for Quality Improvement and Patient 
        Safety to assist the Director in carrying out the requirements 
        of subsection (a).
            ``(2) Mission.--The Center shall--
                    ``(A) provide national leadership for research and 
                other initiatives to improve the quality and safety of 
                patient care;
                    ``(B) develop public-private sector partnerships to 
                improve the quality and safety of patient care; and
                    ``(C) serve as a national resource for research and 
                learning from medical errors.
            ``(3) Duties.--
                    ``(A) In general.--In carrying out this section, 
                the Director, acting through the Center, shall consult 
                and develop partnerships, as appropriate, with all 
                segments of the health care industry, including health 
                care practitioners and patients, those who manage 
                health care facilities, systems and plans, peer review 
                organizations, health care purchasers and policymakers, 
                and other users of health care research.
                    ``(B) Required duties.--In addition to the broad 
                responsibilities that the Director may assign to the 
                Center for research and related activities that are 
                designed to improve the quality of health care, the 
                Director shall ensure that the Center--
                            ``(i) builds scientific knowledge and 
                        understanding of the causes of medical errors 
                        in all health care settings and identifies or 
                        develops and validates effective interventions 
                        and strategies to reduce errors and improve the 
                        safety and quality of patient care;
                            ``(ii) promotes public and private sector 
                        research on patient safety by--
                                    ``(I) developing a national patient 
                                safety research agenda;
                                    ``(II) identifying promising 
                                opportunities for preventing or 
                                reducing medical errors; and
                                    ``(III) tracking the progress made 
                                in addressing the highest priority 
                                research questions with respect to 
                                patient safety;
                            ``(iii) facilitates the development of 
                        voluntary national patient safety goals by 
                        convening all segments of the health care 
                        industry and tracks the progress made in 
                        meeting those goals;
                            ``(iv) develops national patient safety 
                        data for inclusion in the annual report on the 
                        quality of health care required under section 
                        913(b)(2);
                            ``(v) strengthens the ability of the United 
                        States to learn from medical errors by--
                                    ``(I) developing the necessary 
                                tools and advancing the scientific 
                                techniques for analysis of errors;
                                    ``(II) providing technical 
                                assistance as appropriate to reporting 
                                systems; and
                                    ``(III) entering into contracts to 
                                receive and analyze aggregate data from 
public and private sector reporting systems;
                            ``(vi) supporting dissemination and 
                        communication activities to improve patient 
                        safety, including the development of tools and 
                        methods for educating consumers about patient 
                        safety; and
                            ``(vii) undertaking other activities that 
                        the Director determines are necessary to enable 
                        the Center to fulfill its mission.
                    ``(C) Limitation.--Aggregate data gathered for the 
                purposes described in this section shall not include 
                specific patient, health care provider, or provider of 
                service identifiers.
    ``(c) Learning From Medical Errors.--
            ``(1) In general.--To enhance the ability of the health 
        care community in the United States to learn from medical 
        errors and close calls, the Director shall--
                    ``(A) carry out activities to increase scientific 
                knowledge and understanding regarding medical error 
                reporting systems;
                    ``(B) carry out activities to advance the 
                scientific knowledge regarding the tools and techniques 
                for analyzing medical errors and determining their root 
                causes;
                    ``(C) carry out activities in partnership with 
                experts in the field to increase the capacity of the 
                health care community in the United States to analyze 
                patient safety data;
                    ``(D) develop a confidential national safety 
                database of medical errors reports;
                    ``(E) conduct and support research, using the 
                database developed under subparagraph (D), into the 
                causes and potential interventions to decrease the 
                incidence of medical errors and close calls; and
                    ``(F) ensure that information contained in the 
                national database developed under subparagraph (D) does 
                not include specific patient, health care provider, or 
                provider of service identifiers.
            ``(2) National patient safety database.--The Director 
        shall, in accordance with paragraph (1)(D), establish a 
        confidential national safety database (to be known as the 
        National Patient Safety Database) of reports of medical errors 
        and close calls that can be used only for research to improve 
        the quality and safety of patient care. In developing and 
        managing the National Patient Safety Database, the Director 
        shall--
                    ``(A) ensure that the database can only be used for 
                its intended purpose;
                    ``(B) ensure that the database is as comprehensive 
                as possible by aggregating data from Federal, State, 
                and private sector patient safety reporting systems;
                    ``(C) conduct and support research on the most 
                common medical errors and close calls, their causes, 
                and potential interventions to reduce medical errors 
                and improve the quality and safety of patient care;
                    ``(D) report findings made by the Director, based 
                on the data in the database, to clinicians, individuals 
                who manage health care facilities, systems, and plans, 
                patients, and other individuals who can act 
                appropriately to improve patient safety; and
                    ``(E) develop a rapid response capacity to provide 
                alerts when specific health care practices pose an 
                imminent threat to patients or health care workers.
            ``(3) Confidentiality and peer review protections.--
        Notwithstanding any other provision of law any information 
        (including any data, reports, records, memoranda, analyses, 
        statements, and other communications) developed by or on behalf 
        of a health care provider or provider of services with respect 
        to a medical event, that is contained in the National Patient 
        Safety Database shall be confidential in accordance with 
        section 925.
            ``(4) Patient safety reporting systems.--The Director shall 
        identify public and private sector patient safety reporting 
        systems and build scientific knowledge and understanding 
        regarding the most effective--
                    ``(A) components of patient safety reporting 
                systems;
                    ``(B) incentives intended to increase the rate of 
                error reporting;
                    ``(C) approaches for undertaking root cause 
                analyses;
                    ``(D) ways to provide feedback to those filing 
                error reports;
                    ``(E) techniques and tools for collecting, 
                integrating, and analyzing patient safety data; and
                    ``(F) ways to provide meaningful information to 
                patients, consumers, and purchasers that will enhance 
their understanding of patient safety issues.
            ``(5) Training.--The Director shall support training 
        initiatives to build the capacity of the health care community 
        in the United States to analyze patient safety data and to act 
        on that data to improve patient safety.
    ``(d) Evaluation.--The Director shall recommend strategies for 
measuring and evaluating the national progress made in implementing 
safe practices and standards identified by the Center through the 
research and analysis required under subsection (b) and through the 
voluntary reporting system established under subsection (c).
    ``(e) Implementation.--In implementing strategies to carry out the 
functions described in subsections (b), (c), and (d), the Director may 
contract with public or private entities on a national or local level 
with appropriate expertise.

``SEC. 923. MEDICAL EVENT ANALYSIS ENTITIES.

    ``(a) In General.--The Director, based on information collected 
under section 922(c), shall provide for the certification of entities 
to collect and analyze information on medical errors, and to 
collaborate with health care providers or providers of services in 
collecting information about, or evaluating, certain medical events.
    ``(b) Compatibility of Collected Data.--To ensure that data 
reported to the National Patient Safety Database under section 
922(c)(2) concerning medical errors and close calls are comparable and 
useful on an analytic basis, the Director shall require that the 
entities described in subsection (c) follow the recommendations 
regarding a common set of core measures for reporting that are 
developed by the National Forum for Health Care Quality Measurement and 
Reporting, or other voluntary private standard-setting organization 
that is designated by the Director taking into account existing 
measurement systems and in conjunction with experts in the field.
    ``(c) Duties of Certified Entities.--
            ``(1) In general.--An entity that is certified under 
        subsection (a) shall collect and analyze information, 
        consistent with the requirement of subsection (b), provided to 
        the entity under section 924(a)(5) to improve patient safety.
            ``(2) Information to be reported to the entity.--A medical 
        event analysis entity shall, on a periodic basis and in a 
        format that is specified by the Director, submit to the 
        Director a report that contains--
                    ``(A) a description of the medical events that were 
                reported to the entity during the period covered under 
                the report;
                    ``(B) a description of any corrective action taken 
                by providers of services with respect to such medical 
                events or any other measures that are necessary to 
                prevent similar events from occurring in the future; 
                and
                    ``(C) a description of the systemic changes that 
                entities have identified, through an analysis of the 
                medical events included in the report, as being needed 
                to improve patient safety.
            ``(3) Collaboration.--A medical event analysis entity that 
        is collaborating with a health care provider or provider of 
        services to address close calls and adverse events may, at the 
        request of the health care provider or provider of services--
                    ``(A) provide expertise in the development of root 
                cause analyses and corrective action plan relating to 
                such close calls and adverse events; or
                    ``(B) collaborate with such provider of services to 
                identify on-going risk reduction activities that may 
                enhance patient safety.
    ``(d) Confidentiality and Peer Review Protections.--Notwithstanding 
any other provision of law, any information (including any data, 
reports, records, memoranda, analyses, statements, and other 
communications) collected by a medical event analysis entity or 
developed by or on behalf of such an entity under this part shall be 
confidential in accordance with section 925.
    ``(e) Termination and Renewal.--
            ``(1) In general.--The certification of an entity under 
        this section shall terminate on the date that is 3 years after 
        the date on which such certification was provided. Such 
        certification may be renewed at the discretion of the Director.
            ``(2) Noncompliance.--The Director may terminate the 
        certification of a medical event analysis entity if the 
        Director determines that such entity has failed to comply with 
        this section.
    ``(f) Implementation.--In implementing strategies to carry out the 
functions described in subsection (c), the Director may contract with 
public or private entities on a national or local level with 
appropriate expertise.

``SEC. 924. PROVIDER OF SERVICES SYSTEMS FOR REPORTING MEDICAL EVENTS.

    ``(a) Internal Medical Event Reporting Systems.--Each provider of 
services that elects to participate in a medical error reporting system 
under this part shall--
            ``(1) establish a system for--
                    ``(A) identifying, collecting information about, 
                and evaluating medical events that occur with respect 
                to a patient in the care of the provider of services or 
                a practitioner employed by the provider of services, 
                that may include--
                            ``(i) the provision of a medically coherent 
                        description of each event so identified;
                            ``(ii) the provision of a clear and 
                        thorough accounting of the results of the 
                        investigation of such event under the system; 
                        and
                            ``(iii) a description of all corrective 
                        measures taken in response to the event; and
                    ``(B) determining appropriate follow-up actions to 
                be taken with respect to such events;
            ``(2) establish policies and procedures with respect to 
        when and to whom such events are to be reported;
            ``(3) take appropriate follow-up action with respect to 
        such events; and
            ``(4) submit to the appropriate medical event analysis 
        entity information that contains descriptions of the medical 
        events identified under paragraph (1)(A).
    ``(b) Promoting Identification, Evaluation, and Reporting of 
Certain Medical Events.--
            ``(1) In general.--Notwithstanding any other provision of 
        law any information (including any data, reports, records, 
        memoranda, analyses, statements, and other communications) 
        developed by or on behalf of a provider of services with 
        respect to a medical event pursuant to a system established 
        under subsection (a) shall be privileged in accordance with 
        section 925.
            ``(2) Rules of construction.--Nothing in this subsection 
        shall be construed as prohibiting--
                    ``(A) disclosure of a patient's medical record to 
                the patient;
                    ``(B) a health care oversight agency or public 
                health authority from requiring a provider of services 
                to transfer information to the agency or authority to 
                the extent required by law; or
                    ``(C) such an agency or authority from disclosing 
                information transferred by a provider of services to 
                the public in a form that does not identify or permit 
                the identification of the health care provider or 
                provider of services or patient.

``SEC. 925. CONFIDENTIALITY.

    ``(a) Confidentiality and Peer Review Protections.--Notwithstanding 
any other provision of law--
            ``(1) any information (including any data, reports, 
        records, memoranda, analyses, statements, and other 
        communications) developed by or on behalf of a health care 
        provider or provider of services with respect to a medical 
        event, that is contained in the National Patient Safety 
        Database, collected by a medical event analysis entity, or 
        developed by or on behalf of such an entity, or collected by a 
        health care provider or provider or services for use under 
        systems that are developed for safety and quality improvement 
        purposes under this part--
                    ``(A) shall be privileged, strictly confidential, 
                and may not be disclosed by any other person to which 
                such information is transferred without the 
                authorization of the health care provider or provider 
                of services; and
                    ``(B) shall--
                            ``(i) be protected from disclosure by 
                        civil, criminal, or administrative subpoena;
                            ``(ii) not be subject to discovery or 
                        otherwise discoverable in connection with a 
                        civil, criminal, or administrative proceeding;
                            ``(iii) not be subject to disclosure 
                        pursuant to section 552 of title 5, United 
                        States Code (the Freedom of Information Act) 
                        and any other similar Federal or State statute 
                        or regulation; and
                            ``(iv) not be admissible as evidence in any 
                        civil, criminal, or administrative proceeding;
                without regard to whether such information is held by 
                the provider or by another person to which such 
                information was transferred;
            ``(2) the transfer of any such information by a provider of 
        services to a health care oversight agency, an expert 
        organization, a medical event analysis entity, or a public 
        health authority, shall not be treated as a waiver of any 
        privilege or protection established under paragraph (1) or 
        established under State law.
    ``(b) Penalty.--It shall be unlawful for any person to disclose any 
information described in subsection (a) other than for the purposes 
provided in such paragraph, and any person violating the provisions of 
this section shall, upon conviction, be fined in accordance with title 
18, United States Code, and imprisoned for not more than 6 months, or 
both.
    ``(c) Application of provisions.--The protections provided under 
subsection (a) and the penalty provided for under subsection (b) shall 
apply to any information (including any data, reports, memoranda, 
analyses, statements, and other communications) collected or developed 
pursuant to research, including demonstration projects, with respect to 
medical error reporting supported by the Director under this part.

``SEC. 926. AUTHORIZATION OF APPROPRIATIONS.

    ``There is authorized to be appropriated to carry out this part, 
$50,000,000 for fiscal year 2001, and such sums as may be necessary for 
subsequent fiscal years.''.

SEC. 4. EFFECTIVE DATE.

    The amendments made by section 3 shall become effective on January 
1 of the calendar year that begins after the date of the enactment of 
this Act.
                                 <all>
```