Title: Patient Safety Improvement Act of 2020
Policy area: Health

Summary:
Patient Safety Improvement Act of 2020
This bill directs the Department of Health and Human Services (HHS) to undertake actions related to (1) health care-associated infections (HAI), (2) antimicrobial stewardship, and (3) patient safety.
With respect to HAI, HHS must award grants for state and regional infection control programs and must establish a pilot program related to HAI data reporting by long-term care facilities and others. HHS must also award grants to eligible entities for infection control during patient care transitions, and the Centers for Medicare & Medicaid Services (CMS) must develop guidance regarding transfers or discharges of patients with HAI diagnoses. The Government Accountability Office must evaluate the adequacy of oversight and validation of specified HAI data reporting.
With respect to antimicrobial stewardship, the Centers for Disease Control and Prevention must award grants to states to implement antimicrobial stewardship plans and must otherwise take steps to address antibiotic prescribing.
With respect to patient safety, the HHS must incentivize state medical boards to require education on patient safety topics as a condition of licensure, and the CMS must harmonize quality measure reporting requirements through a collaborative that includes representatives from, among other groups, insurers and patient groups. In addition, as a condition of a hospital's participation in Medicare, members of the hospital's board must periodically receive training on relevant patient safety topics.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3380 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  2d Session
                                S. 3380

To improve patient safety by supporting State-based quality improvement 
  efforts and through enhanced data collection and reporting, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 3, 2020

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

_______________________________________________________________________

                                 A BILL


 
To improve patient safety by supporting State-based quality improvement 
  efforts and through enhanced data collection and reporting, 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 
2020''.

SEC. 2. SUPPORTING STATE AND LOCAL COLLABORATIVES TO ADDRESS HEALTH 
              CARE-ASSOCIATED INFECTIONS.

    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 reporting.
            ``(2) Purpose.--Amount 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) Conducting a needs assessment to identify 
                gaps in health care-associated infection prevention and 
                reporting in a State or region.
                    ``(D) 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) a list of the specific goals of the entity 
                for the regional or statewide reduction of health care-
                associated infection rates;
                    ``(C) an assurance that the entity will publicly 
                report performance on a set of quality and outcomes 
                measures in carrying out activities under the grant to 
                reduce health care-associated infections; 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) Prevention Epicenter Program Expansion Grants.--
            ``(1) In general.--The Centers for Disease Control and 
        Prevention shall expand the Prevent Epicenters Program to up to 
        five additional sites. New sites shall work with State or 
        regional prevention collaboratives to develop tools, 
        strategies, and evidence-based interventions to--
                    ``(A) prevent or limit infection rates in health 
                care facilities across the continuum of care and in 
                community settings;
                    ``(B) facilitate public health research on the 
                prevention and control of drug-resistant organisms and 
                emerging microbial threats; and
                    ``(C) assess the feasibility, cost effectiveness, 
                and appropriateness of surveillance and prevention 
                programs in different health care settings.
            ``(2) Authorization of appropriations.--There is authorized 
        to be appropriated such sums as may be necessary to carry out 
        this subsection.''.

SEC. 3. IMPROVING COMMUNICATION DURING CARE TRANSITIONS.

    (a) Improving Provider Communication Regarding Patient Infections 
in Medicare and Medicaid.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this Act as the ``Secretary'') shall award 
        competitive grants to support the development and evaluation of 
        programs aimed at improving inter-facility communication about 
        health care-associated infections, multidrug-resistant 
        organisms, emerging microbial threats, and antimicrobial use 
        during transitions of care.
            (2) Eligibility.--To be eligible for a grant under 
        paragraph (1) an applicant for such grant shall be composed of 
        two or more health care providers or facilities that regularly 
        transfer or refer patients to each other.
            (3) Report to congress.--Not later than 1 year after the 
        end of the grant period under this subsection, the Secretary 
        shall submit a report to Congress on lessons learned by grant 
        awardees, including best practices and recommendations for 
        guidelines, policies, or payment reforms to improve inter-
        facility communication during care transitions.
            (4) Authorization of appropriations.--There is authorized 
        to be appropriated such sums as may be necessary to carry out 
        this subsection.
    (b) Guidance on Inter-Facility Communication.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Administrator of the Centers for 
        Medicare & Medicaid Services, in collaboration with the 
        Director of the Agency for Healthcare Research and Quality, 
        shall convene a working group to develop guidance for 
        standardized communication between health care facilities upon 
        the discharge and transfer of individuals who were diagnosed 
        and treated for health care-associated infections.
            (2) Topics.--The working group convened under paragraph (1) 
        shall identify--
                    (A) types of information related to health care-
                associated infections that should be communicated when 
                an individual is discharged and transferred from one 
                health care facility to another, including--
                            (i) the type of infection or colonization 
                        acquired by an individual, including whether or 
                        not such infection or colonization is caused by 
                        a multidrug-resistant organism; and
                            (ii) the type of antimicrobial drugs, if 
                        any, that the individual received for the 
                        infection from the discharging or transferring 
                        provider and the stop date for those drugs;
                    (B) methods for transmitting information;
                    (C) timeframes for transmitting information; and
                    (D) any other information determined appropriate.
            (3) Working group participants.--The working group under 
        paragraph (1) shall be composed of representatives from--
                    (A) patient groups;
                    (B) hospitals;
                    (C) long-term care facilities;
                    (D) accreditation agencies;
                    (E) State and local health departments; and
                    (F) other stakeholders as determined appropriate by 
                the Secretary.
            (4) Guidance.--Not later than 1 year after the working 
        group has been convened under paragraph (1), the Administrator 
        of the Centers for Medicare & Medicaid Services shall issue 
        guidance on standardized content and structure for transmitting 
        information regarding individuals who were diagnosed and 
        treated for health care-associated infections.

SEC. 4. IMPROVING DATA ACCURACY AND SURVEILLANCE.

    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 ANTIMICROBIAL USE.

    ``(a) Identifying Best Practices.--The Centers for Disease Control 
and Prevention, in collaboration with the Agency for Healthcare 
Research and Quality and the Centers for Medicare & Medicaid Services, 
shall convene stakeholders to identify best practices for the 
collection and electronic reporting of data on health care-associated 
infections to the National Healthcare Safety Network by a subsection 
(d) hospital (as defined in section 1886(d)(1)(B) of the Social 
Security Act (42 U.S.C. 1395ww(d)(1)(B))).
    ``(b) Data Collection Pilot Program.--
            ``(1) In general.--The Director of the Agency for 
        Healthcare Research and Quality, in consultation with the 
        Director of the Centers for Disease Control and Prevention, 
        shall establish and implement a pilot program to identify best 
        practices and innovative approaches for the collection and 
        electronic 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 (c).
            ``(2) Report.--Not later than 6 months after the completion 
        of the pilot program under paragraph (1), the Director shall 
        submit to the Secretary and the appropriate committees of 
        Congress a report on the best practices identified through the 
        pilot program, including the lessons learned and challenges 
        encountered with respect to data collection and electronic 
        reporting in long-term care settings, ambulatory surgical 
        centers, and dialysis facilities as well as any recommended 
        health care-associated infections surveillance methods for 
        those settings.
            ``(3) Authorization of appropriations.--There is authorized 
        to be appropriated such sums as may be necessary to carry out 
        this subsection.
    ``(c) Data Validation Methodology.--The Centers for Disease Control 
and Prevention shall work with State and local health departments to 
develop a standard methodology for validating data reported by long-
term care facilities to the National Healthcare Safety Network.
    ``(d) Study and Report.--
            ``(1) In general.--The Comptroller General of the United 
        States shall conduct a study to evaluate the adequacy of State 
        health departments' and other State oversight agencies' methods 
        for external validation of data reported to the National 
        Healthcare Safety Network by health care facilities.
            ``(2) Contents.--In conducting the study under paragraph 
        (1), the Comptroller General shall--
                    ``(A) assess the types and frequency of external 
                validation strategies conducted by State departments of 
                health;
                    ``(B) identify barriers to adherence with the 
                Centers for Disease Control and Prevention's external 
                validation guidance; and
                    ``(C) recommend strategies to improve the 
                consistency and reliability of data that is reported to 
                the National Healthcare Safety Network.
            ``(3) Report.--Not later than 18 months after the date of 
        enactment of this section, the Comptroller General shall submit 
        to Congress a report containing the results of the study 
        conducted under paragraph (1), together with recommendations, 
        if any, for such legislation and administration action as the 
        Comptroller General determines appropriate.''.

SEC. 5. STRENGTHENING ANTIMICROBIAL STEWARDSHIP.

    (a) In General.--Section 320B of the Public Health Service Act, as 
added by section 2, is amended by adding at the end the following:
    ``(c) Grant Program for State Antimicrobial 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 and 
        implementation of State antimicrobial stewardship action plans.
            ``(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 with experience in antimicrobial 
                stewardship or a pharmacist with expertise in 
                infectious disease and antimicrobial stewardship; and
                    ``(B) an assurance that the plan will focus on 
                collaboration across health 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 1 year after the date of 
enactment of this Act, the Administrator of the Centers for Medicare & 
Medicaid Services shall issue a notice of proposed rulemaking that 
requires acute care hospitals to 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) In General.--Section 320B of the Public Health Service Act, as 
added by section 2 and amended by subsection (a), is further amended by 
adding at the end the following:
    ``(d) Promoting the Appropriate Use of Antibiotics.--
            ``(1) In general.--Beginning on January 1, 2021, and 
        annually thereafter, the Centers for Disease Control and 
        Prevention shall conduct at least one antimicrobial stewardship 
        workshop in a State or region where annual prescriptions for 
        antimicrobial drugs per capita exceed the national average.
            ``(2) Requirements.--The workshop under paragraph (1) shall 
        identify regional strategies to support collaboration across 
        the care continuum to promote the appropriate use of 
        antimicrobials. 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 health care, 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.
    ``(e) Study on Prescription Drug Monitoring Programs.--
            ``(1) In general.--The Centers for Disease Control and 
        Prevention shall conduct a study on the feasibility of 
        requiring ambulatory and outpatient health care providers to 
        report prescriptions for antimicrobial drugs to a State 
        prescription drug monitoring program, if such a program is 
        available in the practitioners' States.
            ``(2) Report.--The Centers for Disease Control and 
        Prevention shall submit a report to Congress on the findings of 
        the study under paragraph (1) and make recommendations for the 
        use, improvement, or expansion of State prescription drug 
        monitoring programs to capture information on prescriptions for 
        antimicrobial drugs.''.

SEC. 6. IMPROVING SAFETY IN PEDIATRIC CARE.

    (a) Pediatric Safety Advisory Council.--The Secretary shall 
establish a Pediatric Safety Advisory Council (referred to in this 
section as the ``Council'') to advise and make recommendations on 
policies to improve pediatric safety and reduce the incidence of health 
care-acquired conditions in children's hospitals and other pediatric 
care settings.
            (1) Membership.--The Council shall include at least one of 
        each of the following providers:
                    (A) Neonatologist.
                    (B) Pediatrician.
                    (C) Pediatric infectious disease specialist.
                    (D) Pediatric intensive care specialist.
                    (E) Pediatric hospitalist.
    (b) Study on the Feasibility of Children's Hospitals Reporting to 
the Nationalhealth Care Safety Network.--
            (1) In general.--The Centers for Disease Control and 
        Prevention shall conduct a study on the appropriateness and 
        feasibility of requiring freestanding children's hospitals to 
        report information on health care-associated infections to the 
        National Healthcare Safety Network.
            (2) Content.--The study under paragraph (1) shall evaluate 
        the applicability of National Healthcare Safety Network 
        modules, risk adjustment methodologies, and case definitions to 
        freestanding children's hospitals.
            (3) Report.--The Centers for Disease Control and Prevention 
        shall submit a report to Congress on the findings of the study 
        under paragraph (1) and make recommendations for--
                    (A) increasing the number of children's hospitals 
                that report to the National Healthcare Safety Network; 
                and
                    (B) an alternative means to collect data on health 
                care-associated infections that occur during a 
                patient's stay at a children's hospital.

SEC. 7. OTHER PATIENT SAFETY IMPROVEMENTS.

    (a) In General.--Section 320B of the Public Health Service Act, as 
added by section 2 and amended by section 5, is further amended by 
adding at the end the following:
    ``(f) 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 or other 
        patient safety topics as a condition of receiving a new or 
        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, and 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)) is amended--
                    (A) in subparagraph (X), by striking ``and'' at the 
                end;
                    (B) in subparagraph (Y), by striking the period and 
                inserting ``; and''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(Z) in the case of hospitals, including critical 
                access hospitals, to require that, not less than once 
                every 5 years, all members of the board of such 
                hospital receive training (which may include coursework 
                at an accredited institution of higher education) on 
                patient safety topics relevant to a hospital (or 
                critical access hospital, as the case may be) 
                setting.''.
            (2) Effective date.--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 enactment of this 
        Act.
    (c) Core Quality Measures Collaborative.--
            (1) In general.--The Administrator for the Centers for 
        Medicare & Medicaid Services shall establish a Core Quality 
        Measures Collaborative to harmonize quality measure reporting 
        requirements across public and commercial quality improvement 
        and reporting programs.
            (2) Stakeholder input.--Administrator for the Centers for 
        Medicare & Medicaid Services shall seek input from a broad 
        array of stakeholders to identify priorities for clinical areas 
        and care settings that could benefit from core quality measure 
        sets and to inform the quality measures that are included in 
        core sets. Stakeholders shall include--
                    (A) commercial health plans;
                    (B) Medicare and Medicaid managed care plans;
                    (C) physician and other provider organizations;
                    (D) patient groups; and
                    (E) quality improvement groups.
            (3) Framework and goals.--Not later than 1 year after the 
        date of enactment of this Act, the Administrator for the 
        Centers for Medicare & Medicaid Services shall publish a 
        framework and goals for the Collaborative under paragraph (1).
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