[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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