[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7591 Introduced in House (IH)]

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118th CONGRESS
  2d Session
                                H. R. 7591

            To establish the National Patient Safety Board.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 8, 2024

  Ms. Barragan (for herself and Mr. Burgess) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce, and 
 in addition to the Committee on Veterans' Affairs, 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 
2024''.

SEC. 2. NATIONAL PATIENT SAFETY BOARD.

    (a) Establishment.--For the purpose of preventing and reducing 
patient safety events, there is hereby established, within the Office 
of the Secretary of Health and Human Services, an independent board, to 
be known as the National Patient Safety Board (in this section referred 
to as the ``Board'').
    (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;
                    (B) provide expertise to study the context and 
                causes of patient safety events and prevented patient 
                safety events; and
                    (C) formulate recommendations and solutions to 
                prevent patient safety events from occurring.
            (2) Authority.--The Board shall have the sole authority 
        to--
                    (A) request changes to, or approve, the patient 
                safety measures and solutions recommended by the 
                Patient Safety Research and Development Division under 
                subsection (g);
                    (B) review each report transmitted to the Board 
                under subsection (g)(7) and based on such review 
                require the Director of such Division--
                            (i) to conduct further studies; or
                            (ii) to make revisions to the report; and
                    (C) make any such report publicly available.
            (3) Timeline for public availability.--The Board shall 
        ensure that each report transmitted to the Board under 
        subsection (g)(7) is made publicly available not later than one 
        year after commencement of the study that is the subject of the 
        report.
            (4) Annual audit.--The Board shall undergo an annual audit.
            (5) 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, 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--
                    (A) each appointed by the President; and
                    (B) each appointed for a term of 5 years, with the 
                option to remain on the Board until another person is 
                appointed to fill the position.
            (2) Staggered terms.--Notwithstanding paragraph (1)(B), of 
        the initial 5 members of the Board--
                    (A) 2 shall be appointed for a term of 3 years; and
                    (B) 3 shall be appointed for a term of 5 years.
            (3) Qualifications.--Of the 5 members of the Board--
                    (A) at least 3 shall have expertise specifically in 
                patient safety, or have demonstrated experience in 
                increasing the safety of systems in complex, high-risk 
                industries; and
                    (B) at least 2 shall represent individuals who have 
                experienced a patient safety event, or who have a 
                family member who experienced a patient safety event.
            (4) Conflicts of interest.--Each member of the Board shall 
        abide by all relevant conflict of interest policies.
            (5) Chair; vice chair.--The Board shall have a Chair and 
        Vice Chair who shall each--
                    (A) be designated by the President, in consultation 
                with the Senate, from among the members of the Board 
                appointed under paragraph (1);
                    (B) serve for a 3-year term; and
                    (C) have demonstrated complex, high-risk experience 
                in patient safety.
    (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 Research and Development 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; and
            (4) an Administrative Division, to be headed by a director 
        appointed by the Board.
    (g) Patient Safety Research and Development Division.--
            (1) Health care safety team.--
                    (A) In general.--For the purpose stated in 
                subsection (a), the Director of the Patient Safety 
                Research and Development Division shall establish and 
                maintain a public-private team (in this section 
                referred to as the ``Health Care Safety Team'') to 
                identify, develop, review, update, prioritize, and 
                recommend patient safety event measures and solutions, 
                based on the precursors and causes of patient safety 
                events, for the Board's approval.
                    (B) Data sources.--For each patient safety event 
                measure and solution recommended under subparagraph 
                (A), the Health Care Safety Team shall identify the 
                data sources used, including survey data, electronic 
                health records data, claims data, health information 
                exchange data, and reports of patient safety events.
                    (C) Patient safety data technologies.--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 and solutions.
                    (D) Membership.--The membership of the Health Care 
                Safety Team shall include--
                            (i) representatives with demonstrated 
                        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 demonstrated patient safety expertise, 
                        representing providers, including organized 
                        labor, health care organizations, patients, 
                        families, caregivers, payors, suppliers, 
                        vendors, manufacturers, measurement developers, 
                        and data technology experts.
            (2) Obtaining official data.--To carry out the data 
        analysis under paragraph (5), the Director of the Patient 
        Safety Research and Development 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-level data relating to patient 
        safety event measures and solutions. Upon request of the 
        Director of the Patient Research and Development Division, the 
        head of the respective office or agency shall furnish such 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 
        Research and Development 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, 
        nonclinical staff, or any other person--
                    (A) to report patient safety events to the 
                Division, anonymously or not; and
                    (B) to receive a response to any such report from 
                the Board.
            (4) Data access portal.--The Director of the Patient Safety 
        Research and Development Division shall--
                    (A) enter into agreements with public and private 
                entities, including at the State and local levels, to 
                enable such entities to opt into allowing the Division 
                to access their longitudinal, real-time, de-identified 
                patient-level data relating to patient safety event 
                measures and solutions;
                    (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, including--
                            (i) the Federal Information Security 
                        Management Act of 2002 (6 U.S.C. 511 et seq.);
                            (ii) the Risk Management Framework and 
                        Artificial Intelligence Risk Management 
                        Framework of the National Institute of 
                        Standards and Technology;
                            (iii) HIPAA privacy and security law (as 
                        defined in section 3009(a)(2) of the Public 
                        Health Service Act (42 U.S.C. 300jj-19(a)(2))); 
                        and
                            (iv) the Blueprint for an AI Bill of Rights 
                        of the White House Office of Science Technology 
                        Policy.
            (5) Analyzing data.--The Director of the Patient Safety 
        Event Research and Development Division shall--
                    (A) aggregate and analyze the patient-level data 
                collected in accordance with this section to anticipate 
                and identify patient safety events, including the 
                precursors to and outcomes of patient safety events; 
                and
                    (B) analyze such patient-level data by race, 
                ethnicity, gender, facility, age, social factors, and 
                location to identify disparities in patient safety 
                events.
            (6) Monitoring.--The Director of the Patient Safety 
        Research and Development Division shall--
                    (A) submit to the Health Care Safety Team bimonthly 
                briefs on patient safety event surveillance; and
                    (B) prompt the Study Division to conduct a study in 
                accordance with subsection (h)(3) 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) Persistent patterns of injury or harm.
                            (v) Emergent risks of patient safety 
                        events.
                            (vi) Racial, ethnic, social, gender, or 
                        geographic disparities.
                            (vii) Unaddressed reoccurring patient 
                        safety events.
            (7) Recommending solutions.--The Director of the Patient 
        Safety Research and Development Division shall--
                    (A) work with the Health Care Safety Team to 
                identify, develop, review, update, prioritize, and 
                recommend patient safety event measures and solutions, 
                based on the precursors and causes of patient safety 
                events, for the Board's approval;
                    (B) include the resulting recommendations in a 
                report for the Board; and
                    (C) transmit such report to the Board, together 
                with the relevant report of the Study Division under 
                subsection (h)(4) regarding probable precursors, 
                causes, and outcomes.
    (h) Study Division.--
            (1) In general.--The Director of the Study Division may 
        conduct or support studies with respect to 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 
                Research and Development Division such information as 
                may be collected by the Patient Safety Research and 
                Development Division and relevant to the study.
                    (B) Sharing.--Upon receipt of such a request, the 
                Director of the Patient Safety Research and Development 
                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, and identify 
                        the study site or sites.
                    (B) Study team.--The Study Lead shall--
                            (i) assemble a team of multidisciplinary 
                        experts to conduct the study;
                            (ii) include in such team--
                                    (I) individuals with the ability to 
                                study and understand the interaction of 
                                human abilities, expectations, and 
                                limitations with work environments, 
                                technologies, and system design; and
                                    (II) 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 
                        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 emerging pandemics.--In the 
                case of a novel infection and emerging pandemic, the 
                Director of the Study Division, in coordination with 
                the Director of the Centers for Disease Control and 
                Prevention, 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 Research and Development 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 to inform the Patient Safety Research 
                        and Development Division's recommendations and 
                        solutions to prevent patient safety events; and
                    (B) include in a final report under subparagraph 
                (A)(ii) factual information and analysis regarding the 
                probable precursors, causes, and outcomes of the 
                factors that prompted the study of the patient safety 
                events.
            (5) Response by secretary.--Not later than 90 days after 
        the submission of a final report under subsection (g)(7)(C), 
        the Secretary of Health and Human Services and the Secretary of 
        Veterans Affairs shall publish a response to the 
        recommendations in such report.
    (i) Administrative Division.--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.
    (j) Nonpunitive Restrictions.--
            (1) Inadmissibility as evidence.--
                    (A) In general.--Any report or other publication of 
                the Board (including any division, subdivision, or 
                other component thereof) shall not be admissible as 
                evidence of individual or organizational liability in a 
                civil action for damages resulting from the events 
                mentioned in the report.
                    (B) Special rule.--Subparagraph (A) does not apply 
                with respect to data collected or housed outside of the 
                Board.
            (2) Standards of care.--Nothing in this section shall be 
        construed to prohibit the use of reports, recommendations, or 
        publications of the Board to develop or inform standards of 
        care.
            (3) Use of information by hhs.--The Department of Health 
        and Human Services shall not use data, reports, publications, 
        or work product of the Board to impose, implement, or enforce 
        any disciplinary or other punitive measure with respect to a 
        health care provider.
            (4) Limitation on authority.--The Board and any study team 
        of experts assembled under subsection (h)(3)(A)(ii) shall not 
        have authority to determine the rights or liabilities of any 
        person with respect to adverse patient safety events.
    (k) Protections for Employees.--Cooperation by an employee with the 
Board shall be treated as an activity for which the employee may not be 
discharged or discriminated against under section 40 of the Consumer 
Product Safety Act (15 U.S.C. 2087).
    (l) 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, health 
        center, urgent care center, wound clinic, emergency room, or 
        any other setting in which health care is delivered.
            (2) The term ``patient safety event'' means an action, 
        interaction, inaction, condition, or outbreak occurring in a 
        health care setting or as part of health care treatment that--
                    (A) leads to patient injury, harm, or death;
                    (B) could lead to--
                            (i) patient injury, harm, or death; or
                            (ii) a precursor or potential precursor to 
                        patient injury, harm, or death; or
                    (C) could have harmed the patient but did not cause 
                harm as a result of chance, prevention, mitigation, or 
                other factors.
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