[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2467 Introduced in Senate (IS)]

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114th CONGRESS
  2d Session
                                S. 2467

  To reduce health care-associated infections and improve antibiotic 
    stewardship through enhanced data collection and reporting, the 
    implementation of State-based quality improvement efforts, and 
  improvements in provider education in patient safety, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 27, 2016

Mr. Whitehouse introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To reduce health care-associated infections and improve antibiotic 
    stewardship through enhanced data collection and reporting, the 
    implementation of State-based quality improvement efforts, and 
  improvements in provider education in patient safety, 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 ``Patient Safety Improvement Act of 
2016''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) A 2014 prevalence survey published in the New England 
        Journal of Medicine found that approximately 1 in 25 hospital 
        patients in the United States has at least one health care-
        associated infection, adding up to an estimated 722,000 health 
        care-associated infections in acute care hospitals in 2011. 
        About 75,000 hospital patients with health care-associated 
        infections died during their hospitalizations.
            (2) Antibiotics are among the most commonly prescribed 
        drugs used in human medicine. Studies indicate that up to 30 to 
        50 percent of antibiotics prescribed for patients are not 
        needed or not optimally prescribed. This is contributing to the 
        growth in the prevalence of dangerous antibiotic-resistant 
        bacteria.
            (3) A 2013 threat report by the Centers for Disease Control 
        and Prevention estimated that each year at least 2,000,000 
        people in the United States are infected by antibiotic-
        resistant bacteria, and approximately 23,000 die as a result.
            (4) Estimates of the annual impact of antibiotic-resistant 
        infections on the United States economy vary but range from 
        $20,000,000,000 to $35,000,000,000 in excess health care costs, 
        and as much as $35,000,000,000 in lost productivity from 
        hospitalizations and sick days.
            (5) The prevalence of health care-associated infections and 
        the rise of antibiotic resistance are serious threats to human 
        health and contribute to escalating health care costs. 
        Strategies to reduce patient harm and preserve the 
        effectiveness of existing antibiotics are needed to combat the 
        rise of antibiotic resistance that is threatening the health of 
        Americans and people around the world.

SEC. 3. IMPROVING DATA RELIABILITY AND SURVEILLANCE.

    (a) Reducing the Incidence of Health Care-Associated Infections and 
Improving Antibiotic Stewardship.--
            (1) In general.--Subpart II of part D of title IX of the 
        Public Health Service Act (42 U.S.C. 299b-33 et seq.) is 
        amended by adding at the end the following:

``SEC. 938. HEALTH CARE-ASSOCIATED INFECTIONS AND ANTIBIOTIC USE.

    ``(a) GAO Study on Data Validation Strategies.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Comptroller General of the 
        United States shall conduct an independent evaluation, and 
        submit to the appropriate committees of Congress a report, 
        concerning the action that the Centers for Disease Control and 
        Prevention and State and local departments of health have taken 
        to improve the completeness and accuracy of hospital-reported 
        National Healthcare Safety Network surveillance data.
            ``(2) Content.--The report submitted under paragraph (1) 
        shall review and assess--
                    ``(A) the types of external and internal data 
                validation strategies that are conducted by the Centers 
                for Disease Control and Prevention, State and local 
                departments of health, and hospitals;
                    ``(B) the frequency with which the Centers for 
                Disease Control and Prevention, State and local 
                departments of health, and hospitals audit data 
                submitted to the National Healthcare Safety Network; 
                and
                    ``(C) identify additional actions that the Federal 
                Government can take to support State and local 
                departments of health and hospitals with such 
                validation efforts and improvements to the quality of 
                data submitted to the National Healthcare Safety 
                Network.
    ``(b) Data Reliability Framework.--
            ``(1) In general.--Following the submission of the report 
        under subsection (a), the Director of the Centers for Disease 
        Control and Prevention, in collaboration with the Administrator 
        of the Agency for Healthcare Research and Quality and relevant 
        stakeholders, shall develop a framework to improve the 
        consistency and reliability of hospital data on health care-
        associated infections that is submitted to the National 
        Healthcare Safety Network.
            ``(2) Requirements.--The framework developed under 
        paragraph (1) shall--
                    ``(A) address issues identified in the findings of 
                the study conducted under subsection (a);
                    ``(B) propose data validation and reliability 
                methodologies; and
                    ``(C) assess the effectiveness and the cost to 
                implement proposed methodologies.
    ``(c) Data Collection Pilot Program.--
            ``(1) In general.--The Administrator of the Agency for 
        Healthcare Research and Quality, in collaboration with the 
        Director of the Centers for Disease Control and Prevention, 
        shall convene a meeting with relevant stakeholders to identify 
        best practices and approaches for the collection and reporting 
        of data on the incidence of health care-associated infections 
        to the National Healthcare Safety Network by long-term care 
        facilities, ambulatory surgical centers, and dialysis 
        facilities.
            ``(2) Pilot program.--After conducting the meeting under 
        paragraph (1), the Administrator of the Agency shall establish 
        and implement a pilot program to test best practices and 
        approaches for the collection and reporting of data on the 
        incidence of health care-associated infections by long-term 
        care facilities, ambulatory surgical centers, and dialysis 
        facilities. Such pilot program should incorporate applicable 
        data validation methodologies and other recommendations 
        described in the framework developed under subsection (b).
            ``(3) Report.--Not later than 1 year after the completion 
        of the pilot program under paragraph (2), the Administrator 
        shall submit to the Secretary and the appropriate committees of 
        Congress a report on the best practices identified through the 
        pilot program under paragraph (1), including the lessons 
        learned and challenges encountered with respect to data 
        collection and reporting in long-term care settings, ambulatory 
        surgical centers, and dialysis facilities as well as 
        recommended data validation methods for those settings.
            ``(4) Authorization of appropriations.--There is authorized 
        to be appropriated, such sums as may be necessary to carry out 
        this subsection. Amounts appropriated under the preceding 
        sentence may be used for the purchase of software and 
        technology that supports data collection and reporting.''.

SEC. 4. ALIGNING QUALITY MEASURES.

    Not later than 1 year after the date of enactment of this Act, the 
Secretary of Health and Human Services shall solicit input from the 
Administrator of the Centers for Medicare & Medicaid Services, the 
Director of the Centers for Disease Control and Prevention, an entity 
with the contract under section 1890(a) of the Social Security Act (42 
U.S.C. 1395aaa), and relevant stakeholders (including accreditation 
bodies) concerning which definitions for health care-associated 
infections measures used in Federal and State quality reporting and 
payment programs for hospitals, long-term care facilities, ambulatory 
surgical centers, and dialysis centers should be aligned. Using such 
input, the Secretary shall submit a report to Congress that identifies 
the following:
            (1) Priorities for measure alignment.
            (2) Programs in which the priority measures identified 
        under paragraph (1) are utilized.
            (3) Recommendations on how to implement the alignment of 
        such measures.

SEC. 5. REDUCING THE INCIDENCE OF HEALTH CARE-ASSOCIATED INFECTIONS.

    (a) In General.--Part B of title III of the Public Health Service 
Act (42 U.S.C. 243 et seq.) is amended by adding at the end the 
following:

``SEC. 320B. EFFORTS TO REDUCE HEALTH CARE-ASSOCIATED INFECTIONS.

    ``(a) Grant Program To Reduce Health Care-Associated Infections.--
            ``(1) In general.--The Secretary shall award competitive 
        grants to eligible entities to support State-based 
        collaboratives in implementing evidence-based, regional 
        approaches to infection prevention, control, and surveillance.
            ``(2) Purpose.--Amounts awarded under grants under 
        paragraph (1) may be used to support the following activities:
                    ``(A) Inter-professional and inter-facility 
                learning activities.
                    ``(B) Building Statewide learning collaboratives.
                    ``(C) Assisting with the implementation of the 
                transition-of-care documentation required in section 5 
                of the Patient Safety Improvement Act of 2016.
                    ``(D) Conducting a needs assessment to identify 
                gaps in health care-associated infection prevention and 
                reporting in a State or region.
                    ``(E) Other activities determined appropriate by 
                the Secretary.
            ``(3) Eligibility.--To be eligible to receive a grant under 
        this subsection, an entity shall be a public or private 
        nonprofit entity that submits to the Secretary an application 
        at such time, in such manner, and containing such information 
        as the Secretary may require, including--
                    ``(A) a description of the activities to be carried 
                out under the grant, including the participants in any 
                collaborative established to carry out such activities;
                    ``(B) goals for the reduction in regional or 
                Statewide rates of health care-associated infections;
                    ``(C) an assurance that the entity will publicly 
                report performance on a set of quality and outcomes 
                measures determined by the Secretary; and
                    ``(D) any other information determined appropriate 
                by the Secretary.
            ``(4) Priority.--In awarding grants under this subsection, 
        the Secretary shall prioritize applicants that collaborate with 
        multiple stakeholders across a region or State.
            ``(5) Authorization of appropriations.--There is authorized 
        to be appropriated, such sums as may be necessary to carry out 
        this subsection.''.
    (b) Improving Communication of Patient Infections in Medicare and 
Medicaid.--
            (1) Medicare.--Section 1866(a) of the Social Security Act 
        (42 U.S.C. 1395cc(a)) is amended--
                    (A) in paragraph (1)--
                            (i) in subparagraph (X), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (Y), by striking the 
                        period at the end and inserting ``, and''; and
                            (iii) by inserting after subparagraph (Y) 
                        the following new subparagraph:
                    ``(Z) to comply with the requirement of paragraph 
                (4) (relating to the transmission of information 
                regarding infections).''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(4)(A) For purposes of paragraph (1)(Z), the requirement 
        of this paragraph is that a hospital transmit information about 
        infections or colonizations that present in an individual 
        receiving treatment not later than 24 hours upon receipt of the 
        culture to--
                    ``(i) the individual;
                    ``(ii) in the case of an individual who is being 
                transferred to another provider, the receiving 
                provider; and
                    ``(iii) the individual's primary care provider, if 
                identified.
            ``(B) The information described in subparagraph (A) shall 
        contain the information fields included in the Centers for 
        Disease Control and Prevention's Inter-facility Infection 
        Control Transfer Form and any other information the Secretary 
        determines appropriate.
            ``(C) When transmitting information to a receiving provider 
        under subparagraph (A)(ii), a provider shall, where practical, 
        transmit such information electronically.''.
            (2) Medicaid.--Section 1902(a) of the Social Security Act 
        (42 U.S.C. 1396a(a)) is amended--
                    (A) in paragraph (80), by striking ``and'' at the 
                end;
                    (B) in paragraph (81), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by inserting after paragraph (81) the following 
                new paragraph:
            ``(82) in the case of any hospital (as defined in section 
        1861(e)) that is a participating provider under the State plan, 
        provide that such hospital meet the requirements of 
        subparagraph (Z) of section 1866(a)(1).''.
    (c) Standardized Form.--Not later than 6 months after the date of 
the enactment of this Act, the Secretary of Health and Human Services, 
acting through the Director of the Centers for Disease Control and 
Prevention, shall issue a standardized electronic version of the form 
for use by providers in transmitting information as required by the 
amendments made by subsection (b).
    (d) Effective Date.--
            (1) Medicare.--In the case of the requirements imposed by 
        the amendments made by subsection (b)(1), such requirements 
        shall apply to agreements entered into or renewed on or after 
        the date that is 180 days after the date of the issuance of the 
        guidance described in subsection (c).
            (2) Medicaid.--
                    (A) In general.--Except as provided in subparagraph 
                (B), the requirements imposed by the amendments made by 
                subsection (b)(2) shall take effect on the date that is 
                180 days after the date of the issuance of the guidance 
                described in subsection (c).
                    (B) Delay permitted if state legislation 
                required.--In the case of a State plan for medical 
                assistance under title XIX of the Social Security Act 
                which the Secretary of Health and Human Services 
                determines requires State legislation (other than 
                legislation appropriating funds) in order for the plan 
                to meet the additional requirements imposed by 
                subsection (b)(2), the State plan shall not be regarded 
                as failing to comply with the requirements of such 
                title solely on the basis of its failure to meet these 
                additional requirements before the first day of the 
                first calendar quarter beginning after the close of the 
                first regular session of the State legislature that 
                begins after the date described in clause (i). For 
                purposes of the previous sentence, in the case of a 
                State that has a 2-year legislative session, each year 
                of such session shall be deemed to be a separate 
                regular session of the State legislature.

SEC. 6. STRENGTHENING ANTIBIOTIC STEWARDSHIP.

    (a) In General.--Section 320B of the Public Health Service Act, as 
added by section 5(a), is amended by adding at the end the following:
    ``(b) Grant Program for State Antibiotic Stewardship Action 
Plans.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 
        shall award grants to States for the development of State plans 
        to promote antibiotic stewardship and prevent the spread of 
        antimicrobial-resistant bacteria across health care settings.
            ``(2) Eligibility.--To be eligible to receive a grant under 
        this subsection, a State shall submit to the Secretary an 
        application at such time, in such manner, and containing such 
        information as the Secretary may require, including--
                    ``(A) an assurance that development of the plan 
                under the grant will be led by an infectious-disease 
                trained physician or a pharmacist with expertise in 
                infectious disease; and
                    ``(B) an assurance that the plan will focus on 
                collaboration across acute and ambulatory care settings 
                and include a summary of resource gaps and challenges.
            ``(3) Authorization of appropriations.--There is authorized 
        to be appropriated, such sums as may be necessary to carry out 
        this subsection.''.
    (b) Advancing Hospital Reporting on Antibiotic Use and 
Antimicrobial Resistance.--Not later than January 1, 2018, the 
Administrator of the Centers for Medicare & Medicaid Services shall 
require that acute care hospitals report antibiotic use and 
antimicrobial resistance using the National Healthcare Safety Network's 
Antimicrobial Use and Resistance Module as part of the Hospital 
Inpatient Quality Reporting Program.
    (c) Information Related to Antibiotic Use and Antimicrobial 
Resistance.--Section 320B of the Public Health Service Act, as added by 
section 5(a) and amended by subsection (a), is further amended by 
adding at the end the following:
    ``(c) Information Related to Antibiotic Use and Antimicrobial 
Resistance.--
            ``(1) In general.--The Director of the Centers for Disease 
        Control and Prevention shall annually prepare and issue a 
        report concerning the aggregate national and regional trends of 
        antibiotic use and bacterial resistance in humans to 
        antibacterial drugs, including the identity of the 10 States 
        with the highest number of prescriptions for antibiotics.
            ``(2) Stewardship workshops.--
                    ``(A) In general.--Beginning on January 1, 2019, 
                and annually thereafter, the Director of the Centers 
                for Disease Control and Prevention shall conduct at 
                least one antibiotic stewardship workshop in a State 
                identified in the report under paragraph (1).
                    ``(B) Requirements.--The workshop under 
                subparagraph (A) shall identify regional strategies to 
                support collaboration across the care continuum to 
                promote antibiotic stewardship. In implementing such 
                workshop, the Director of the Centers for Disease 
                Control and Prevention should seek participation from 
                relevant public and private stakeholders with expertise 
                in infection control, quality improvement, and consumer 
                engagement.
            ``(3) Authorization of appropriations.--There is authorized 
        to be appropriated, such sums as may be necessary to carry out 
        this subsection.''.

SEC. 7. OTHER IMPROVEMENTS.

    (a) In General.--Section 320B of the Public Health Service Act, as 
added by section 5(a) and amended by section 6(c), is further amended 
by adding at the end the following:
    ``(d) Continuing Education on Infection Control and Patient 
Safety.--
            ``(1) In general.--The Secretary shall establish a program 
        to provide incentives (in the form of grants or other 
        assistance) to State medical boards that require health care 
        professionals (as defined by the medical board) to complete 
        accredited coursework or training in infection control, 
        antibiotic stewardship, or other patient safety topics as a 
        condition of receiving a renewed license to practice in the 
        State.
            ``(2) Exemption.--A State medical board that receives 
        assistance under paragraph (1) may provide an exemption from 
        the coursework or training requirement under such paragraph for 
        those health care professionals who have specialized training 
        in infection control (such as an infectious disease specialist 
        or certified infection control practitioner), who are not 
        actively practicing in the State, or who do not provide direct 
        patient care.
            ``(3) Authorization of appropriations.--There is authorized 
        to be appropriated, such sums as may be necessary to carry out 
        this subsection.''.
    (b) Engaging Hospital Leadership in Patient Safety in Medicare and 
Medicaid.--
            (1) Medicare.--Section 1866(a)(1) of the Social Security 
        Act (42 U.S.C. 1395cc(a)(1)), as amended by section 4(a)(1), is 
        amended--
                    (A) in subparagraph (Y), by striking ``and'' at the 
                end;
                    (B) in subparagraph (Z), by striking the period and 
                inserting ``, and''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(AA) in the case of hospitals, including critical 
                access hospitals, to require that new members of the 
                board of such hospital, not later than 6 months after 
                joining the board, receive training (in accordance with 
                criteria established by the Secretary) on patient 
                safety topics that are relevant to a hospital (or 
                critical access hospital, as the case may be) setting, 
                such as infection prevention, care transitions, patient 
                safety and quality of care measurement, and staff 
                communication.''.
            (2) Medicaid.--Section 1902(a)(82) of the Social Security 
        Act, as added by section (5)(a)(2)(C), is amended by striking 
        ``subparagraph (Z)'' and inserting ``subparagraphs (Z) and 
        (AA)'' before the period.
            (3) Criteria.--Not later than 6 months after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services shall propose and finalize criteria, through notice 
        and comment rulemaking, specifying the number of hours and type 
        of training that shall satisfy the training requirements 
        imposed by the amendments made by paragraphs (1) and (2). Such 
        criteria shall be published on the Internet website of the 
        Centers for Medicare & Medicaid Services.
            (4) Effective date.--
                    (A) Medicare.--In the case of the requirement 
                imposed by the amendments made by paragraph (1), such 
                requirement shall apply to agreements entered into or 
                renewed on or after the date that is 30 days after the 
                date of the publication of the criteria described in 
                paragraph (3).
                    (B) Medicaid.--
                            (i) In general.--Except as provided in 
                        clause (ii), the requirement imposed by the 
                        amendment made by paragraph (2) shall take 
                        effect on the date that is 30 days after the 
                        date of the publication of the criteria 
                        described in paragraph (3).
                            (ii) Delay permitted if state legislation 
                        required.--In the case of a State plan for 
                        medical assistance under title XIX of the 
                        Social Security Act which the Secretary of 
                        Health and Human Services determines requires 
                        State legislation (other than legislation 
                        appropriating funds) in order for the plan to 
                        meet the additional requirement imposed by 
                        paragraph (2), the State plan shall not be 
                        regarded as failing to comply with the 
                        requirements of such title solely on the basis 
                        of its failure to meet this additional 
                        requirement before the first day of the first 
                        calendar quarter beginning after the close of 
                        the first regular session of the State 
                        legislature that begins after the date 
                        described in clause (i). For purposes of the 
                        previous sentence, in the case of a State that 
                        has a 2-year legislative session, each year of 
                        such session shall be deemed to be a separate 
                        regular session of the State legislature.
    (c) Improvements to the Patient Safety and Quality Improvement Act 
of 2005.--Section 923 of the Public Health Service Act (42 U.S.C. 299b-
23) is amended by adding at the end the following:
    ``(d) Authority for Direct Reporting by Patients.--
            ``(1) In general.--A patient safety organization may 
        collect information reported directly by patients on patient 
        safety incidents and unsafe conditions. Such information shall 
        not be deemed to be `identifiable patient safety work product'.
            ``(2) Requirements.--In collecting patient safety 
        information (including information submitted by patients under 
        this subsection), a patient safety organization shall--
                    ``(A) ensure that all such information (including 
                any other patient safety work product received by the 
                organization) is submitted to the network of patient 
                safety databases; and
                    ``(B) ensure that such information is de-identified 
                prior to submitting the information to the network of 
                patient safety databases.
            ``(3) Development of best practices.--The Director of the 
        Agency shall conduct research on best practices for enabling 
        patient safety organizations to engage patients in reporting on 
        patient safety incidents and for the collection by such 
        organizations of such patient-reported information, including a 
        standardized format for the submission of such data by 
        patients. The Director shall disseminate such best practices 
        for use by patient safety organizations.
            ``(4) Accessibility.--The Director of the Agency shall 
        establish a single access point on the Internet website of the 
        Agency that may be accessed by the public to obtain patient 
        safety data from the data that has been aggregated by the 
        network of patient safety databases.
            ``(5) Authorization of appropriations.--There is authorized 
        to be appropriated, such sums as may be necessary to carry out 
        this subsection.''.
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