I 
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 trans-
parency within the health care system through the estab-
lishment of a National Healthcare Acquired Infection 
and Medical Error Reporting Program. 
Be it enacted by the Senate and House of Representa-
tives 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 Pre-
vention reported that each day one in thirty-one hos-
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pital patients has at least one healthcare-associated 
infection; 
(2) 32 percent of all healthcare-acquired infec-
tions 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 sur-
gery spend on average an additional 6.5 days hos-
pitalized; 
(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 Univer-
sity 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— 
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(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 IN-
FECTION AND MEDICAL ERROR REPORTING 
PROGRAM 
‘‘SEC. 941. DEFINITIONS. 
‘‘In this part: 
‘‘(1) ANTI-RETALIATION.—The term ‘anti-retal-
iation’ any patient or legal representative of a pa-
tient 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 li-
censed or otherwise authorized under State law to 
provide health care services, including— 
‘‘(A) a hospital, health plan, community 
clinic, nursing facility, comprehensive rehabili-
tation facility, home health agency, hospice pro-
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gram, renal dialysis facility, ambulatory sur-
gical center, pharmacy, doctor’s or health care 
practitioner’s office, long-term care facility, be-
havior health residential treatment facility, clin-
ical laboratory, or health center; 
‘‘(B) a doctor, nurse, physician assistant, 
nurse practitioner, clinical nurse specialist, cer-
tified nurse anesthetist, certified nurse midwife, 
psychologist, certified social worker, registered 
dietitian or nutrition professional, physical or 
occupational therapists, pharmacist, or other in-
dividual healthcare practitioner; and 
‘‘(C) any other health care professional 
specified in regulations promulgated by the Sec-
retary. 
‘‘(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 clin-
ic. 
‘‘(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 vari-
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ation of which recurrence may carry significant 
chance of a serious adverse outcome. 
‘‘(7) OFFICE.—The term ‘Office’ means the Of-
fice of Patient Safety and Health Care Quality es-
tablished under section 943, which shall be a cer-
tified 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 ‘pa-
tient safety data’ means information requested by 
the Director of the Office to be submitted by the pa-
tient safety officer of a Program participant as de-
scribed in section 945(e). 
‘‘(6) PATIENT SAFETY EVENT.—The term ‘pa-
tient safety event’ means an occurrence, incident, or 
process that either contributes to, or has the poten-
tial to contribute to, a patient injury or degrades the 
ability of health care providers to provide the appro-
priate standard of care. 
‘‘(7) PATIENT
SAFETY
OFFICER.—The term 
‘patient safety officer’ means the individual des-
ignated by a Program participant as being respon-
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sible for ensuring that the conditions for participa-
tion 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 ‘pro-
gram 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 investiga-
tion 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. 
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‘‘(14) WHISTLEBLOWER.—The term ‘whistle-
blower’ means any individual or legal representative 
of an individual, who provides original information 
relating to a Healthcare Acquired Infection or Med-
ical Error outcome. 
‘‘SEC. 942. PURPOSE AND GOALS. 
‘‘It is the purpose of this legislation to promote a cul-
ture of safety and trust within hospitals, health systems, 
clinics, and other sites of health care, through the estab-
lishment 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 ac-
quired infection and medical error disclosure and re-
porting; 
‘‘(2) require all State departments of health to 
use the data provided by hospitals for error report-
ing 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. 
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‘‘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, Con-
gress, 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 
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receive nonidentifiable patient safety work product 
as described in the reporting requirements for Pro-
gram participants under section 945(c)(10); 
‘‘(5) determine and adopt a standardized pa-
tient 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 require-
ments for the reporting of patient safety data and 
work to streamline and reduce duplication of such 
requirements; 
‘‘(7) grant patient safety organizations, re-
searchers, and other qualified individuals and insti-
tutions access to the Database as determined appro-
priate through the evaluation of completed applica-
tions 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; 
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‘‘(9) develop, directly or through a contract 
with a patient safety organization, safety and train-
ing 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 adminis-
tration 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 tax-
onomy in consultation with the Joint Commission on 
Accreditation of the Healthcare Organizations and 
other entities with relevant expertise; 
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‘‘(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 disclo-
sure 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 con-
tained within the Database shall only be provided through 
application to and approval by the Director. 
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‘‘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 Na-
tional Healthcare Acquired Infection and Medical Error 
Reporting Program to provide for the confidential disclo-
sure 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, neg-
ligence, 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 eligi-
ble by the Director; 
‘‘(2) designate a patient safety officer to ensure 
that the conditions of participation described in sub-
section (c) are met; 
‘‘(3) submit a completed application to the Of-
fice at such time, in such manner, and containing 
such information as the Director may require; and 
‘‘(4) agree to comply with the conditions of par-
ticipation under subsection (c). 
‘‘(c) CONDITIONS OF PARTICIPATION.—A Program 
participant shall, directly or indirectly— 
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‘‘(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 out-
lined in the Program participant application, to sub-
mit to the patient safety officer a report of any inci-
dent or occurrence involving a patient that is 
thought to either be a medical error or patient safe-
ty event; 
‘‘(3) ensure that the reports filed under para-
graph (2) are submitted to the Database in a stand-
ardized 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 in-
jured as the result of a healthcare acquired infection 
or medical error, or as a result of the relevant stand-
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ard of care not being followed, an account of the in-
cident 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 re-
port 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 inci-
dent or occurrence in which it was determined that 
a patient was harmed or injured as a result of med-
ical 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 Data-
base 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 Data-
base shall— 
‘‘(A) contain only non-identifiable patient 
safety work product; 
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‘‘(B) be in a standardized electronic format 
to be determined by the Director; and 
‘‘(C) if related to a single occurrence or in-
cident, be given a common identifier to link en-
tries of related data. 
‘‘(2) REPORTING REQUIREMENTS.—The patient 
safety officer of a Program participant shall be re-
quired to prepare and enter into the Database— 
‘‘(A) reports, containing only nonidentifi-
able 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 with-
in 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 involve-
ment 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. 
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‘‘(3) PRIVILEGE AND CONFIDENTIALITY.—The 
provisions of section 922 shall apply to patient safe-
ty data submitted under this subsection. 
‘‘SEC. 946. THE NATIONAL HEALTHCARE ACQUIRED INFEC-
TION AND MEDICAL ERROR REPORTING AC-
COUNTABILITY 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 sys-
tems standards, tools, and best practices (including peer 
review) for doctors and other health care providers nec-
essary 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 recommenda-
tions 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 car-
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ried out under subsection (a) and contains recommenda-
tions for Congress based on the findings of the report.’’. 
Æ 
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