[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9377 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 9377

            To establish the National Patient Safety Board.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            December 1, 2022

 Ms. Barragan introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
    Veterans' Affairs, and Education and Labor, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
            To establish the National Patient Safety Board.

    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 ``National Patient Safety Board Act of 
2022''.

SEC. 2. NATIONAL PATIENT SAFETY BOARD.

    (a) Establishment.--There is hereby established an independent 
agency to be known at the National Patient Safety Board (in this 
section referred to as the ``Board'') for the purpose of preventing and 
reducing patient safety events.
    (b) Duties.--
            (1) In general.--For the purpose stated in subsection (a), 
        the Board shall--
                    (A) support Federal departments and agencies in 
                monitoring and anticipating patient safety events with 
                patient safety data surveillance technologies;
                    (B) provide expertise to study the context and 
                causes of patient safety events and solutions; and
                    (C) formulate recommendations and solutions to 
                prevent patient safety events from occurring.
            (2) Annual audit.--The Board shall undergo an annual audit.
            (3) Annual reports to congress.--
                    (A) Submission.--The Chair of the Board shall 
                submit annual reports to the Congress on the progress 
                of the Board in achieving the purpose stated in 
                subsection (a).
                    (B) Contents.--Each annual report under 
                subparagraph (A) shall include--
                            (i) input from the director of each 
                        division of the Board;
                            (ii) detailed solutions;
                            (iii) unaddressed needs; and
                            (iv) any other information determined by 
                        the Chair of the Board to be relevant to 
                        achieving the purpose stated in subsection (a).
    (c) Hearings; Reports.--
            (1) In general.--The Board may, for the purpose of carrying 
        out this Act, hold hearings, sit and act at times and places, 
        take testimony, receive evidence, and issue such reports as the 
        Board considers appropriate.
            (2) No individually identifiable information in 
        publications.--The Board (including any division, subdivision, 
        or other component thereof) shall not include in any report or 
        other publication information that can be used to identify any 
        patient, health care provider, or health care setting.
    (d) Membership.--
            (1) In general.--The Board shall be composed of 5 members, 
        each nominated--
                    (A) by the President, by and with the advice and 
                consent to the Senate; and
                    (B) for a term of 6 years.
            (2) Chair; vice chair.--The Board shall have a Chair and 
        Vice Chair who shall each--
                    (A) be designated by the President from among the 
                members of the Board appointed under paragraph (1); and
                    (B) serve for a 3-year term.
    (e) Staffing.--The Chair of the Board may appoint such personnel as 
the Chair considers appropriate to carry out this section.
    (f) Organization.--The Board shall have--
            (1) an Office of the Chair of the Board;
            (2) a Patient Safety Event Monitoring Division, to be 
        headed by a director appointed by the Board;
            (3) a Study Division, to be headed by a director appointed 
        by the Board;
            (4) a Patient Safety Solutions Division, to be headed by a 
        director appointed by the Board;
            (5) an Administrative Division, to be headed by a director 
        appointed by the Board; and
            (6) regional offices.
    (g) Patient Safety Event Monitoring Division.--
            (1) Health care safety team.--
                    (A) In general.--For the purpose stated in 
                subsection (a), the Director of the Patient Safety 
                Event Monitoring Division shall establish and maintain 
                a public-private team, to be known as a Health Care 
                Safety Team, to review, update, and prioritize patient 
                safety event measures and data sources related to 
                patient and provider safety in health care settings, 
                including survey data, electronic health records data, 
                claims data, health information exchange data, and 
                reports of patient safety events.
                    (B) Recommendations.--The Health Care Safety Team 
                shall recommend to public and private entities patient 
                safety data surveillance technologies and 
                specifications with the ability to identify and 
                anticipate the patient safety measures.
                    (C) Membership.--The membership of the Health Care 
                Safety Team under subparagraph (A) shall include--
                            (i) representatives with patient safety 
                        expertise from the following Federal agencies: 
                        the Agency for Healthcare Research and Quality, 
                        the Centers for Disease Control and Prevention, 
                        the Centers for Medicare & Medicaid, the 
                        Department of Veterans Affairs, the Office of 
                        the National Coordinator for Health Information 
                        Technology, the Indian Health Service, the 
                        Office of Minority Health of the Department of 
                        Health and Human Services, the Health Resources 
                        and Services Administration, the Substance 
                        Abuse and Mental Health Services 
                        Administration, the Food and Drug 
                        Administration, the National Institutes of 
                        Health, and the United States Preventive 
                        Services Task Force; and
                            (ii) representatives of the private sector 
                        with patient safety expertise, representing 
                        providers, organized labor, health care 
                        organizations, patients, payors, suppliers, 
                        vendors, manufacturers, measurement developers, 
                        and data technology experts.
            (2) Obtaining official data.--To carry out this subsection, 
        the Director of the Patient Safety Event Monitoring Division 
        may secure directly from any office or agency of the Department 
        of Health and Human Services or the Department of Veterans 
        Affairs longitudinal, real-time, de-identified patient data, 
        disaggregated by race, ethnicity, gender, facility, and 
        location, relating to patient safety event measures. Upon 
        request of the Director of the Patient Safety Event Monitoring 
        Division, the head of the respective office or agency shall 
        furnish that data to the Director. The Director shall maintain 
        and use such data consistent with applicable privacy and 
        confidentiality law.
            (3) Website or system.--The Director of the Patient Safety 
        Event Monitoring Division shall create and maintain a website 
        or system, to be known as the Patient Safety Reporting System, 
        that can be used by patients, health care providers, non-
        clinical staff, or any other person to report patient safety 
        events to the Division.
            (4) Data access portal.--The Director of the Patient Safety 
        Event Monitoring Division shall--
                    (A) enter into agreements with public and private 
                entities, including at the State and local levels, to 
                opt into allowing the Division to access the entity's 
                longitudinal, real-time, de-identified patient data, 
                disaggregated by race, ethnicity, gender, facility, and 
                location, relating to patient safety event measures;
                    (B) maintain a data access portal to enable such 
                entities to submit such data to the Division; and
                    (C) maintain and use such data consistent with 
                applicable privacy and confidentiality law.
            (5) Reporting.--The Director of the Patient Safety Event 
        Monitoring Division shall--
                    (A) submit to the Health Care Safety Team 
                maintained under paragraph (1) regular reports on 
                patient safety event surveillance; and
                    (B) prompt the Study Division when any of the 
                following types of findings are identified in a 
                geographic area or health care organization:
                            (i) The most frequently occurring major 
                        sources of patient safety events.
                            (ii) Abnormal patterns of patient safety 
                        events.
                            (iii) Unexpectedly low numbers of patient 
                        safety events.
                            (iv) Racial, ethnic, social, gender, or 
                        geographic disparities.
                            (v) Unaddressed reoccurring patient safety 
                        events.
    (h) Study Division.--
            (1) In general.--The Director of the Study Division may 
        conduct or support studies with respect to patient safety 
        events, including to understand the--
                    (A) circumstances, context, and conditions that 
                enable patient safety events; and
                    (B) causes or probable causes of the high or low 
                number of patient safety events.
            (2) Data sharing.--
                    (A) Request.--In conducting or supporting a study 
                under paragraph (1), the Director of the Study Division 
                may request from the Director of the Patient Safety 
                Event Monitoring Division such information as may be 
                collected by the Patient Safety Event Monitoring 
                Division and relevant to the study.
                    (B) Sharing.--Upon receipt of such a request, the 
                Director of the Patient Safety Event Monitoring 
                Division shall share such information with the Director 
                of the Study Division.
            (3) Study requirements.--In conducting or supporting a 
        study under paragraph (1):
                    (A) Study lead.--The Director of the Study Division 
                shall--
                            (i) appoint an individual to serve as the 
                        person in charge of the study (in this 
                        paragraph referred to as the ``Study Lead''); 
                        and
                            (ii) vest such person with authority to 
                        determine the appropriate type of study, 
                        assemble a study team of experts, identify the 
                        study site or sites, and ask any health care 
                        organization that experienced the unexpectedly 
                        high or low numbers of patient safety events 
                        for permission to conduct the study based on 
                        prompts from the Patient Safety Event 
                        Monitoring Division.
                    (B) Study team.--The Study Lead shall--
                            (i) assemble a team of multidisciplinary 
                        experts to improve the understanding of high or 
                        low numbers of patient safety events in the 
                        context of the study, including by gathering 
                        qualitative and quantitative information to 
                        understand--
                                    (I) the circumstances, context, and 
                                conditions that enable the patient 
                                safety events; and
                                    (II) the causes or probable causes 
                                of the high or low number patient 
                                safety events;
                            (ii) include in such team individuals with 
                        the ability to study and understand the 
                        interaction of human abilities, expectations, 
                        and limitations with work environments, 
                        technologies, and system design and other 
                        appropriate experts from the public and private 
                        sectors;
                            (iii) prohibit such team from releasing 
                        information obtained during the study prior to 
                        the public release of such information by the 
                        National Patient Safety Board; and
                            (iv) ensure that such team receives 
                        permission from each health care organization 
                        involved to--
                                    (I) enter health care facilities 
                                participating in the study; and
                                    (II) communicate with staff, health 
                                care providers, patients, vendors, 
                                suppliers, contractors, equipment 
                                manufacturers, and members of the 
                                Board.
                    (C) Appropriate type of study.--The Director of the 
                Study Division shall--
                            (i) create guidelines and criteria to 
                        determine the appropriate type of study to be 
                        conducted or supported, including whether the 
                        study should be virtual, in-person, or a 
                        special board of inquiry; and
                            (ii) in creating such guidelines and 
                        criteria, take into account the impact of the 
                        patient safety events to be studied, whether 
                        such patient safety events may indicate a 
                        systemic risk, and what may potentially be 
                        learned from the study.
                    (D) Novel infection and emergency pandemic.--In the 
                case of a novel infection and emerging pandemic, the 
                Director of the Study Division may establish a special 
                board of inquiry--
                            (i) to provide independent recommendations 
                        on a coordinated national preparedness and 
                        response plan;
                            (ii) to independently monitor the 
                        implementation of the preparedness and response 
                        plan; and
                            (iii) to recommend technologies to support 
                        logistics and autonomous real-time research to 
                        inform evidence-based treatment options and 
                        decisions.
            (4) Reporting.--The Director of the Study Division shall--
                    (A) provide for the submission to the Board and the 
                Patient Safety Solutions Division of--
                            (i) at least one progress report on each 
                        study under this subsection over the course of 
                        the study; and
                            (ii) a final report upon the conclusion of 
                        the study;
                    (B) include in a final report under subparagraph 
                (A)(ii) factual information and analysis regarding the 
                probable causes of the high or low numbers of patient 
                safety events being studied and the recommendations of 
                the Patient Safety Solutions Division; and
                    (C) make such final report publicly available.
            (5) Response by board.--Upon receipt of a final report 
        under paragraph (4)(A)(ii), the Board may elect to--
                    (A) adopt the report;
                    (B) work with the Study Division to make changes to 
                the report prior to adoption; or
                    (C) require the Study Division to conduct or 
                support further studies or revisions.
            (6) Timing.--The Director of the Study Division shall 
        ensure that, not later than 1 year after the commencement of a 
        study under this section--
                    (A) the study is completed; and
                    (B) the final report is made publicly available 
                pursuant to paragraph (4)(C).
            (7) Limitation on authority.--The Study Division and any 
        study team established under this subsection shall not have 
        authority to determine the rights or liabilities of any person 
        with respect to adverse patient safety events.
    (i) Patient Safety Solutions Division.--
            (1) Analysis.--Whenever the Director of the Study Division 
        provides a final report on a study pursuant to subsection 
        (h)(4), the Director of the Patient Safety Solutions Division 
        shall--
                    (A) analyze such report; and
                    (B) formulate recommendations (including solutions) 
                to prevent the patient safety events that were studied 
                from occurring.
            (2) Working with health care safety team.--In formulating 
        recommendations (including solutions) under paragraph (1), the 
        Director of the Patient Safety Event Monitoring Division 
        shall--
                    (A) in consultation with the Health Care Safety 
                Team under subsection (g)(1), identify or develop 
                solutions based on the causes of the patient safety 
                events that were studied; and
                    (B) include such solutions in the recommendations.
            (3) Response by secretary.--Not later than 90 days after 
        the submission of the final report under subsection 
        (h)(4)(A)(ii), the Secretary of Health and Human Services and 
        the Secretary of Veterans Affairs shall publish a response to 
        the recommendations.
    (j) Administrative Division.--
            (1) In general.--The Director of the Administrative 
        Division shall support the day-to-day activities of the Board, 
        including with respect to communications, facility 
        coordination, shipping and receiving, supply inventory, labor 
        relations, and human resource management.
            (2) Subdivision.--The Administrative Division shall have a 
        Safety and Equity Subdivision which shall--
                    (A) advise on, analyze, and publish proper safety 
                guidelines to ensure safe working conditions at the 
                Federal, State, and local levels;
                    (B) create an equity plan to ensure that the 
                Board's programs and operations take into consideration 
                the implications of, and remedies to address, 
                discrimination and disparities; and
                    (C) provide training to enhance employee safety 
                competence.
    (k) Prohibition Against Admissibility as Evidence.--Any report or 
other publication of the Board (including any division, subdivision, or 
other component thereof) shall not be admissible as evidence, or used 
for any purpose, in any Federal or State action, suit, or other 
judicial, legislative, or administrative proceeding.
    (l) Protections for Employees.--
            (1) Prohibition.--No employer shall discharge or in any 
        manner discriminate against any employee with respect to 
        compensation, terms, conditions, or other privileges of 
        employment because the employee (or an individual acting at the 
        request of the employee)--
                    (A) has cooperated, or is perceived as being about 
                to cooperate, with a study of the Board; or
                    (B) has submitted a report to the Patient Safety 
                Reporting System of the Patient Safety Event Monitoring 
                Division.
            (2) Complaint procedure.--
                    (A) In general.--An employee who believes that he 
                or she has been discharged or otherwise discriminated 
                against by any employer in violation of this subsection 
                may seek relief in accordance with the procedures, 
                notifications, burdens of proof, remedies, and statutes 
                of limitation set forth in section 2087(b) of title 15, 
                United States Code.
                    (B) No limitation on rights.--Nothing in this 
                subsection shall be deemed to diminish the rights, 
                privileges, or remedies of any employee under any 
                Federal or State law or under any collective bargaining 
                agreement. The rights and remedies in this subsection 
                may not be waived by any agreement, policy, form, or 
                condition of employment.
            (3) Definition.--In this subsection, the term ``employer'' 
        has the meaning given to such term in section 3 of the Fair 
        Labor Standards Act of 1938 (29 U.S.C. 203).
    (m) Definitions.--In this section:
            (1) The term ``health care setting'' means a hospital, 
        nursing facility, comprehensive outpatient rehabilitation 
        facility, home health agency, hospice program, renal dialysis 
        facility, ambulatory surgical center, pharmacy, physician or 
        other health care practitioner's office, long-term care 
        facility, mental health treatment facility, substance use 
        disorder treatment facility, clinical laboratory, or health 
        center.
            (2) The term ``patient safety event'' means an action or 
        inaction that--
                    (A) led to patient injury or harm in a health care 
                setting;
                    (B) could lead to patient injury or harm as a 
                precursor to injury or harm in a health care setting; 
                or
                    (C) could have caused injury or harm to the patient 
                but did not cause injury or harm in a health care 
                setting as a result of chance, prevention, or 
                mitigation.
    (n) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $110,000,000 for each of fiscal 
years 2023 and 2024.
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