National Healthcare Acquired Infection and Medical Error Transparency Act
This bill establishes a program to collect confidential reports from health care providers that detail instances of health care-acquired infections and medical errors.
It also establishes the Office of Patient Safety and Health Care Quality within the Department of Health and Human Services to administer the program.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9037 Introduced in House (IH)]
<DOC>
116th CONGRESS
2d Session
H. R. 9037
To amend the Public Health Service Act to ensure transparency within
the health care system through the establishment of a National
Healthcare Acquired Infection and Medical Error Reporting Program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 20, 2020
Ms. Gabbard introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to ensure transparency within
the health care system through the establishment of a National
Healthcare Acquired Infection and Medical Error Reporting Program.
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 Healthcare Acquired
Infection and Medical Error Transparency Act''.
SEC. 2. FINDINGS.
(1) The Centers for Disease Control and Prevention reported
that each day one in thirty-one hospital patients has at least
one healthcare-associated infection;
(2) 32 percent of all healthcare-acquired infections are
urinary tract;
(3) 22 percent of all infections are surgical site
infections;
(4) 15 percent are pneumonia (lung infections);
(5) 14 percent are bloodstream infections.
(6) Patients who acquire infections from surgery spend on
average an additional 6.5 days hospitalized;
(7) are five times more likely to be readmitted after
discharge;
(8) and are twice as likely to die.
(9) As recent as 2016, Johns Hopkins University patient
safety experts calculated that medical error is responsible for
at least 250,000 deaths per year (the third leading cause of
death in the U.S.).
SEC. 3. ESTABLISHMENT OF OFFICE OF PATIENT SAFETY AND HEALTH CARE
QUALITY.
Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.)
is amended--
(1) by redesignating part E as part F;
(2) in part F, as redesignated--
(A) by redesignating sections 941 through 948 as
sections 951 through 958, respectively; and
(B) in section 958(1), as redesignated, by striking
``941'' and inserting ``951''; and
(3) by inserting after part D the following:
``PART E--NATIONAL HEALTHCARE ACQUIRED INFECTION AND MEDICAL ERROR
REPORTING PROGRAM
``SEC. 941. DEFINITIONS.
``In this part:
``(1) Anti-retaliation.--The term `anti-retaliation' any
patient or legal representative of a patient who engages in
Protected Activity will be shielded from retaliation.
``(2) Database.--The term `Database' means the National
Patient Safety Database established under section 944.
``(3) Health care provider.--The term `health care
provider' means a person or entity licensed or otherwise
authorized under State law to provide health care services,
including--
``(A) a hospital, health plan, community clinic,
nursing facility, comprehensive rehabilitation
facility, home health agency, hospice program, renal
dialysis facility, ambulatory surgical center,
pharmacy, doctor's or health care practitioner's
office, long-term care facility, behavior health
residential treatment facility, clinical laboratory, or
health center;
``(B) a doctor, nurse, physician assistant, nurse
practitioner, clinical nurse specialist, certified
nurse anesthetist, certified nurse midwife,
psychologist, certified social worker, registered
dietitian or nutrition professional, physical or
occupational therapists, pharmacist, or other
individual healthcare practitioner; and
``(C) any other health care professional specified
in regulations promulgated by the Secretary.
``(4) Healthcare acquired infection.--The term `Healthcare
Acquired Infection(s) (HAI)' means an infection that is
contracted while in a healthcare facility, such as an acute
care hospital, skilled nursing care facility, or doctor's
office or clinic.
``(6) Medical error.--The term `medical error' means an
unexpected occurrence involving death or serious physical or
psychological injury, or the risk of such injury, including any
process variation of which recurrence may carry significant
chance of a serious adverse outcome.
``(7) Office.--The term `Office' means the Office of
Patient Safety and Health Care Quality established under
section 943, which shall be a certified patient safety
organization as defined under part C.
``(8) Outcomes.--The term `outcomes' means any result of
healthcare acquired infection and/or medical error on affected
patients.
``(9) Patient safety data.--The term `patient safety data'
means information requested by the Director of the Office to be
submitted by the patient safety officer of a Program
participant as described in section 945(e).
``(6) Patient safety event.--The term `patient safety
event' means an occurrence, incident, or process that either
contributes to, or has the potential to contribute to, a
patient injury or degrades the ability of health care providers
to provide the appropriate standard of care.
``(7) Patient safety officer.--The term `patient safety
officer' means the individual designated by a Program
participant as being responsible for ensuring that the
conditions for participation in the Program are met.
``(8) Patient safety organization.--The term `patient
safety organization' has the meaning given such term in section
921.
``(9) Patient safety work product.--The term `patient
safety work product' has the meaning given such term in section
921.
``(10) Program.--The term `Program' means the National
Healthcare Acquired Infections and Medical Error Reporting
Program established under section 945.
``(11) Program participant.--The term `program participant'
means any healthcare provider who reports healthcare acquired
infections and/or medical errors to the National Healthcare
Acquired Infections and Medical Error Reporting Program.
``(12) Root cause analysis.--The term `root cause analysis'
means an examination or investigation of an occurrence, event,
or incident to determine if a preventable medical error took
place or the standard of care was not followed and to identify
the causal factors that led to such occurrence, event, or
incident.
``(14) Whistleblower.--The term `whistleblower' means any
individual or legal representative of an individual, who
provides original information relating to a Healthcare Acquired
Infection or Medical Error outcome.
``SEC. 942. PURPOSE AND GOALS.
``It is the purpose of this legislation to promote a culture of
safety and trust within hospitals, health systems, clinics, and other
sites of health care, through the establishment of a National
Healthcare Acquired Infection and Medical Error Reporting Program. It
shall be a goal of the Program to--
``(1) establish standardized procedures for States to
provide reports detailing healthcare acquired infection and
medical error disclosure and reporting;
``(2) require all State departments of health to use the
data provided by hospitals for error reporting to analyze
trends and identify best practices;
``(3) reduce rates of preventable medical errors; and
``(4) ensure patients have access to information for
medical injury or illness due to medical error, negligence, or
malpractice.
``SEC. 943. OFFICE OF PATIENT SAFETY AND HEALTH CARE QUALITY.
``(a) In General.--The Secretary shall establish within the Office
of the Secretary, an Office of Patient Safety and Health Care Quality
to collaborate with the Director of the Agency for Health Care Research
and Quality to improve patient safety and reduce medical error across
the health care system. The Office shall be headed by a Director to be
appointed by the Secretary.
``(b) Activities.--The activities of the Office shall be deemed
patient safety activities, as defined in section 921.
``(c) Duties.--The Director of the Office shall--
``(1) establish and administer the Program;
``(2) determine who is eligible for participation in the
Program in accordance with section 945;
``(3) contract with an independent entity for the purpose
of evaluating the Program at least once every two years, with
the results of such evaluations being disseminated to Program
participants, Congress, and the public;
``(4) establish and maintain, in consultation with patient
safety organizations, health care quality organizations, health
care providers, and the health information technology industry,
a National Patient Safety Database as provided for in section
944 to receive nonidentifiable patient safety work product as
described in the reporting requirements for Program
participants under section 945(c)(10);
``(5) determine and adopt a standardized patient safety
taxonomy, necessary elements, common and consistent
definitions, and standardized formats for the electronic
reporting of patient safety data to the Database as described
in section 944(e);
``(6) survey Federal, State, and local requirements for the
reporting of patient safety data and work to streamline and
reduce duplication of such requirements;
``(7) grant patient safety organizations, researchers, and
other qualified individuals and institutions access to the
Database as determined appropriate through the evaluation of
completed applications submitted to the Office for such
purpose;
``(8) analyze, directly or through a contract with a
patient safety organization, all data entered into the Database
and provide Program participants, Congress, and the public with
healthcare acquired infection and medical error trend reports
and other analyses as determined appropriate by the Director on
a quarterly basis;
``(9) develop, directly or through a contract with a
patient safety organization, safety and training
recommendations for health care providers that focus on the
reduction of medical errors, improved patient safety, and
increased quality of care on at least a yearly basis;
``(10) maintain a publicly accessible internet website to
provide patients and health care providers with information
concerning the Program and the Database; and
``(11) perform any other duties for the administration of
the Program as determined necessary by the Secretary.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary for each fiscal year to
carry out the activities of the Office.
``SEC. 944. NATIONAL PATIENT SAFETY DATABASE.
``(a) In General.--The Director of the Office shall, in accordance
with section 943(c)(6), establish a National Patient Safety Database
that shall--
``(1) adopt standardized patient safety taxonomy in
consultation with the Joint Commission on Accreditation of the
Healthcare Organizations and other entities with relevant
expertise;
``(2) include necessary elements, common and consistent
definitions, and a standardized electronic interface for the
entry and processing of the data by Program participants, as
developed by the Director in consultation with patient safety
organizations, health care providers, and the health
information technology industry;
``(3) allow for the comprehensive collection and analysis
of the patient safety data required to be submitted by all
Program participants under section 945; and
``(4) include patient safety data required to be submitted
by Program participants under section 945 as nonidentifiable
patient safety work product and privileged and confidential in
accordance with section 922.
``(b) Limitation.--Information submitted to the Database shall be
confidential and protected from disclosure in accordance with the
regulations promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
``(c) Access.--Access to the patient safety data contained within
the Database shall only be provided through application to and approval
by the Director.
``SEC. 945. NATIONAL HEALTHCARE ACQUIRED INFECTION AND MEDICAL ERROR
REPORTING PROGRAM.
``(a) Establishment.--The Secretary, acting through the Director
of the Office, shall establish a National Healthcare Acquired Infection
and Medical Error Reporting Program to provide for the confidential
disclosure of medical errors and patient safety events in order to
improve patient safety and health care quality, reduce preventable
medical errors, ensure patient access to data and reports for medical
injury due to medical error, negligence, or malpractice.
``(b) Eligible Participants.--To be eligible to participate in the
Program an entity shall--
``(1)(A) be a healthcare provider; or
``(B) be any other entity determined to be eligible by the
Director;
``(2) designate a patient safety officer to ensure that the
conditions of participation described in subsection (c) are
met;
``(3) submit a completed application to the Office at such
time, in such manner, and containing such information as the
Director may require; and
``(4) agree to comply with the conditions of participation
under subsection (c).
``(c) Conditions of Participation.--A Program participant shall,
directly or indirectly--
``(1) submit a comprehensive plan, as part of the
application for participation in the Program, to reduce the
incidence of medical errors and improve patient safety in the
case of a Program participant that is a health care provider,
activities that result in the reduction of medical errors or
that otherwise improve patient safety;
``(2) require health care providers included in the Program
by the Program participant and as outlined in the Program
participant application, to submit to the patient safety
officer a report of any incident or occurrence involving a
patient that is thought to either be a medical error or patient
safety event;
``(3) ensure that the reports filed under paragraph (2) are
submitted to the Database in a standardized format as
designated by the Director;
``(4) where appropriate, ensure that a root cause analysis
of any report submitted to the patient safety officer under
paragraph (2) is performed within 90 days of the filing of a
report under such paragraph;
``(5) ensure that if a patient was harmed or injured as the
result of a healthcare acquired infection or medical error, or
as a result of the relevant standard of care not being
followed, an account of the incident or occurrence, as
described in paragraph (2) shall be disclosed to the patient
not later than 5 business days after the completion of root
cause analysis;
``(6) disclose information contained in any report
submitted to the patient safety officer under paragraph (2)
upon the request of the patient with respect to whom the report
has been filed;
``(7) offer, at the time of disclosure of an incident or
occurrence in which it was determined that a patient was harmed
or injured as a result of medical error or as a result of the
relevant standard of care not being followed, to share, where
practicable, any efforts the health care provider will
undertake to prevent reoccurrence; and
``(8) prepare and submit entries to the Database as
required by the Director of the Office and in accordance with
subsection (d).
``(d) Submission of Patient Safety Data.--
``(1) In general.--All entries into the Database shall--
``(A) contain only non-identifiable patient safety
work product;
``(B) be in a standardized electronic format to be
determined by the Director; and
``(C) if related to a single occurrence or
incident, be given a common identifier to link entries
of related data.
``(2) Reporting requirements.--The patient safety officer
of a Program participant shall be required to prepare and enter
into the Database--
``(A) reports, containing only nonidentifiable
patient safety work product, filed by a health care
provider under subsection (c)(4) and a summary of the
findings of the root cause analysis with respect to
such report within 5 business days of the completion of
the root cause analysis;
``(B) any disciplinary actions taken against a
health care provider as a result of involvement in any
incident or occurrence involving a patient that is
thought to be a medical error or patient safety event,
or legal action for which a report under subsection
(c)(4) was filed; or
``(C) other data as determined appropriate by the
Director.
``(3) Privilege and confidentiality.--The provisions of
section 922 shall apply to patient safety data submitted under
this subsection.
``SEC. 946. THE NATIONAL HEALTHCARE ACQUIRED INFECTION AND MEDICAL
ERROR REPORTING ACCOUNTABILITY STUDY.
``(a) In General.--The Director of the Office shall conduct,
directly or through a contract with patient safety organizations or
qualified individuals or institutions, an analysis of the patient
safety data in the Database and other available data to determine
performance and systems standards, tools, and best practices (including
peer review) for doctors and other health care providers necessary to
prevent medical errors, improve patient safety, and increase
accountability within the health care system. Such analysis shall also
consider the value of increasing the transparency of the patient safety
data to include the identity of health care providers and provide
recommendations for improvements to the peer review process.
``(b) Report and Recommendations.--Not later than 2 years after the
date of enactment of this section, the Director of the Office shall
submit to Congress and make available to States, State medical boards,
and the public a report that describes the results of the study carried
out under subsection (a) and contains recommendations for Congress
based on the findings of the report.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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