[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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