[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2038 Introduced in Senate (IS)]







106th CONGRESS
  2d Session
                                S. 2038

To amend the Public Health Service Act to reduce accidental injury and 
death resulting from medical mistakes and to reduce medication-related 
                    errors, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 8, 2000

 Mr. Specter (for himself, Mr. Harkin, and Mr. Inouye) 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 accidental injury and 
death resulting from medical mistakes and to reduce medication-related 
                    errors, and for other purposes.

    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 ``Medical Error Reduction Act of 
2000''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress makes the following findings:
            (1) The United States has the finest health care system in 
        the world. However, there is continuing concern and fear among 
        the public about the safety of the nation's health care system 
        as a result of a high occurrence of medical mistakes--the fifth 
        leading cause of death.
            (2) One national study estimates that more than 100,000,000 
        Americans have experience with medical errors and 1 out 3 cases 
        caused permanent harm, with half of the errors occurring in 
        hospitals.
            (3) Three of the top patient-safety issues were exposure to 
        infection, level of care received, and the credentials of 
        health care professionals.
            (4) A recent large-scale study indicates that at least 
        44,000 Americans may die each year as a result of medical 
        error. Another study suggests that this number may be as high 
        as 98,000 Americans.
            (5) When using the lower estimate in paragraph (4), deaths 
        due to medical errors still exceed the number of deaths 
        attributable to motor vehicle accidents (43,458), breast cancer 
        (42,297), or AIDS (16,516).
            (6) Deaths from adverse drug events total more than 7,000 
        annually--exceeding the number of yearly workplace injuries 
        (6,000).
            (7) The total national cost of preventable medical errors 
        resulting in injury is estimated to be between $17,000,000,000 
        and $29,000,000,000, from direct medical costs, lost 
        productivity, and disability.
            (8) One recent study found that about 2 out of every 100 
        admissions involves a preventable adverse drug event. If these 
        findings are generalized, these adverse drug events affecting 
        inpatients cost $2,000,000,000 nationally.
            (9) Medical errors are costly in terms of repeat tests and 
        medical countermeasures, which also are subject to compounding 
        errors. Purchasers and patients pay for errors when insurance 
        costs and co-payments are inflated by services that would not 
        have been necessary had proper care been provided.
            (10) Errors also erode trust in the health care system by 
        patients who experience longer hospital stays or disabilities 
        and physical and psychological discomfort. Health care 
        professionals pay for errors with loss of morale and 
        frustration at not being able to provide the best care 
        possible.
    (b) Purpose.--It is the purpose of this Act to ensure that 
individuals enjoy the right to be free from accidental injury, 
accidental death, and medication-related errors, including medication-
related errors.

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 an 
        injury resulting from medical management rather than the 
        underlying condition of the patient.
            ``(2) Error.--The term `error' means the failure of a 
        planned action to be completed as intended or the use of a 
        wrong plan to achieve the desired outcome.
            ``(3) Health care provider.--The term `health care 
        provider' means an individual or entity that provides medical 
        services and is a participant in a demonstration program under 
        this part.
            ``(4) Health care-related error.--The term ``health care-
        related error'' means a preventable adverse event related to a 
        health care intervention or a failure to intervene 
        appropriately.
            ``(5) Medication-related error.--The term `medication-
        related error' means a preventable adverse event related to the 
        administration of a medication.
            ``(6) Safety.--The term `safety' with respect to an 
        individual means that such individual has a right to be free 
        from preventable serious injury.
            ``(7) Sentinel event.--The term `sentinel event' means an 
        unexpected occurrence involving an individual that results in 
        death or serious physical injury that is unrelated to the 
        natural course of the individual's illness or underlying 
        condition.

``SEC. 922. ESTABLISHMENT OF STATE-BASED MEDICAL ERROR REPORTING 
              SYSTEMS.

    ``(a) In General.--The Secretary shall make grants available to 
States to enable such States to establish reporting systems designed to 
reduce medical errors and improve health care quality.
    ``(b) Requirement.--
            ``(1) In general.--To be eligible to receive a grant under 
        subsection (a), the State involved shall provide assurances to 
        the Secretary that amounts received under the grant will be 
        used to establish and implement a medical error reporting 
system using guidelines (including guidelines relating to the 
confidentiality of the reporting system) developed by the Agency for 
Healthcare Research and Quality with input from interested, non-
governmental parties including patient, consumer and health care 
provider groups.
            ``(2) Guidelines.--Not later than 90 days after the date of 
        enactment of this part, the Agency for Healthcare Research and 
        Quality shall develop and publish the guidelines described in 
        paragraph (1).
    ``(c) Data.--
            ``(1) Availability.--A State that receives a grant under 
        subsection (a) shall make the data provided to the medical 
        error reporting system involved available only to the Agency 
        for Healthcare Research and Quality and may not otherwise 
        disclose such information.
            ``(2) Confidentiality.--Nothing in this part shall be 
        construed to supersede any State law that is inconsistent with 
        this part.
    ``(d) Application.--To be eligible for a grant under this section, 
a State shall prepare and submit to the Secretary an application at 
such time, in such manner and containing, such information as the 
Secretary shall require.

``SEC. 923. DEMONSTRATION PROJECTS TO REDUCE MEDICAL ERRORS, IMPROVE 
              PATIENT SAFETY, AND EVALUATE REPORTING.

    ``(a) Establishment.--The Secretary, acting through the Director of 
the Agency for Healthcare Research and Quality and in conjunction with 
the Administrator of the Health Care Financing Administration, may 
establish a program under which funding will be provided for not less 
than 15 demonstration projects, to be competitively awarded, in health 
care facilities and organizations in geographically diverse locations, 
including rural and urban areas (as determined by the Secretary), to 
determine the causes of medical errors and to--
            ``(1) use technology, staff training, and other methods to 
        reduce such errors;
            ``(2) develop replicable models that minimize the frequency 
        and severity of medical errors;
            ``(3) develop mechanisms that encourage reporting, prompt 
        review, and corrective action with respect to medical errors; 
        and
            ``(4) develop methods to minimize any additional paperwork 
        burden on health care professionals.
    ``(b) Activities.--
            ``(1) In general.--A health care provider participating in 
        a demonstration project under subsection (a) shall--
                    ``(A) utilize all available and appropriate 
                technologies to reduce the probability of future 
                medical errors; and
                    ``(B) carry out other activities consistent with 
                subsection (a).
            ``(2) Reporting to patients.--In carrying out this section, 
        the Secretary shall ensure that--
                    ``(A) 5 of the demonstration projects permit the 
                voluntary reporting by participating health care 
                providers of any adverse events, sentinel events, 
                health care-related errors, or medication-related 
                errors to the Secretary;
                    ``(B) 5 of the demonstration projects require 
                participating health care providers to report any 
                adverse events, sentinel events, health care-related 
                errors, or medication-related errors to the Secretary; 
                and
                    ``(C) 5 of the demonstration projects require 
                participating health care providers to report any 
                adverse events, sentinel events, health care-related 
                errors, or medication-related errors to the Secretary 
                and to the patient involved and a family member or 
                guardian of the patient.
            ``(3) Confidentiality.--
                    ``(A) In general.--The Secretary and the 
                participating grantee organization shall ensure that 
                information reported under this section remains 
                confidential.
                    ``(B) Use.--The Secretary may use the information 
                reported under this section only for the purpose of 
                evaluating the ability to reduce errors in the delivery 
                of care. Such information shall not be used for 
                enforcement purposes.
                    ``(C) Disclosure.--The Secretary may not disclose 
                the information reported under this section.
                    ``(D) Nonadmissibility.--Information reported under 
                this section shall be privileged, confidential, shall 
                not be admissible as evidence or discoverable in any 
                civil or criminal action or proceeding or subject to 
                disclosure, and shall not be subject to the Freedom of 
                Information Act (5 U.S.C. App). This paragraph shall 
                apply to all information maintained by the reporting 
                entity and the entities who receive such reports.
    ``(c) Use of Technologies.--The Secretary shall encourage, as part 
of the demonstration projects conducted under subsection (a), the use 
of appropriate technologies to reduce medical errors, such as hand-held 
electronic prescription pads, training simulators for medical 
education, and bar-coding of prescription drugs and patient bracelets.
    ``(d) Database.--The Secretary shall provide for the establishment 
and operation of a national database of medical errors to be used as 
provided for by the Secretary. The information provided to the 
Secretary under subsection (b)(2) shall be contained in the database.
    ``(e) Evaluation.--The Secretary shall evaluate the progress of 
each demonstration project established under this section in reducing 
the incidence of medical errors and submit the results of such 
evaluations as part of the reports under section 926(b).
    ``(f) Reporting.--Prior to October 1, of the third fiscal year for 
which funds are made available under this section, the Secretary shall 
prepare and submit to the appropriate committees of Congress an interim 
report concerning the results of such demonstration projects.

``SEC. 924. PATIENT SAFETY IMPROVEMENT.

    ``(a) In General.--The Secretary shall provide information to 
educate patients and family members about their role in reducing 
medical errors. Such information shall be provided to all individuals 
who participate in Federally-funded health care programs.
    ``(b) Development of Programs.--The Secretary shall develop 
programs that encourage patients to take a more active role in their 
medical treatment, including encouraging patients to provide 
information to health care providers concerning pre-existing conditions 
and medications.

``SEC. 925. PRIVATE, NONPROFIT EFFORTS TO REDUCE MEDICAL ERRORS.

    ``(a) In General.--The Secretary shall make grants to health 
professional associations and other organizations to provide training 
in ways to reduce medical errors, including curriculum development, 
technology training, and continuing medical education.
    ``(b) Application.--To be eligible for a grant under this section, 
an entity shall prepare and submit to the Secretary an application at 
such time, in such manner and containing, such information as the 
Secretary shall require.

``SEC. 926. REPORT TO CONGRESS.

    ``(a) Initial Report.--Not later than 180 days after the date of 
enactment of this part, the Secretary shall prepare and submit to the 
appropriate committees of Congress a report concerning the costs 
associated with implementing a program that identifies factors that 
contribute to errors and which includes upgrading the health care 
computer systems and other technologies in the United States in order 
to reduce medical errors, including computerizing hospital systems for 
the coordination of prescription drugs and handling of laboratory 
specimens, and contains recommendation on ways in which to reduce those 
factors.
    ``(b) Other Reports.--Not later than 180 days after the completion 
of all demonstration projects under section 923, the Secretary shall 
prepare and submit to the appropriate committees of Congress a report 
concerning--
            ``(1) how successful each demonstration project was in 
        reducing medical errors;
            ``(2) the data submitted by States under section 922(c);
            ``(3) the best methods for reducing medical errors;
            ``(4) the costs associated with applying such best methods 
        on a nationwide basis; and
            ``(5) the manner in which other Federal agencies can share 
        information on best practices in order to reduce medical errors 
        in all Federal health care programs.

``SEC. 927. AUTHORIZATION OF APPROPRIATIONS.

    ``There is authorized to be appropriated such sums as may be 
necessary to carry out this part.''.
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