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 transparency within the health care system through the establishment of a National Healthcare Acquired Infection 

and Medical Error Reporting Program. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘National Healthcare 

5 Acquired Infection and Medical Error Transparency Act’’. 

6 SEC. 2. FINDINGS. 

7 (1) The Centers for Disease Control and Pre8 vention reported that each day one in thirty-one hosVerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037

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1 pital patients has at least one healthcare-associated 

2 infection; 

3 (2) 32 percent of all healthcare-acquired infec4 tions are urinary tract; 

5 (3) 22 percent of all infections are surgical site 

6 infections; 

7 (4) 15 percent are pneumonia (lung infections); 

8 (5) 14 percent are bloodstream infections. 

9 (6) Patients who acquire infections from sur10 gery spend on average an additional 6.5 days hos11 pitalized; 

12 (7) are five times more likely to be readmitted 

13 after discharge; 

14 (8) and are twice as likely to die. 

15 (9) As recent as 2016, Johns Hopkins Univer16 sity patient safety experts calculated that medical 

17 error is responsible for at least 250,000 deaths per 

18 year (the third leading cause of death in the U.S.). 

19 SEC. 3. ESTABLISHMENT OF OFFICE OF PATIENT SAFETY 

20 AND HEALTH CARE QUALITY. 

21 Title IX of the Public Health Service Act (42 U.S.C. 

22 299 et seq.) is amended— 

23 (1) by redesignating part E as part F; 

24 (2) in part F, as redesignated— 


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1 (A) by redesignating sections 941 through 

2 948 as sections 951 through 958, respectively; 

3 and 

4 (B) in section 958(1), as redesignated, by 

5 striking ‘‘941’’ and inserting ‘‘951’’; and 

6 (3) by inserting after part D the following: 

7 ‘‘PART E—NATIONAL HEALTHCARE ACQUIRED IN8 FECTION AND MEDICAL ERROR REPORTING 

9 PROGRAM 

10 ‘‘SEC. 941. DEFINITIONS. 

11 ‘‘In this part: 

12 ‘‘(1) ANTI-RETALIATION.—The term ‘anti-retal13 iation’ any patient or legal representative of a pa14 tient who engages in Protected Activity will be 

15 shielded from retaliation. 

16 ‘‘(2) DATABASE.—The term ‘Database’ means 

17 the National Patient Safety Database established 

18 under section 944. 

19 ‘‘(3) HEALTH CARE PROVIDER.—The term 

20 ‘health care provider’ means a person or entity li21 censed or otherwise authorized under State law to 

22 provide health care services, including— 

23 ‘‘(A) a hospital, health plan, community 

24 clinic, nursing facility, comprehensive rehabili25 tation facility, home health agency, hospice proVerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037

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1 gram, renal dialysis facility, ambulatory sur2 gical center, pharmacy, doctor’s or health care 

3 practitioner’s office, long-term care facility, be4 havior health residential treatment facility, clin5 ical laboratory, or health center; 

6 ‘‘(B) a doctor, nurse, physician assistant, 

7 nurse practitioner, clinical nurse specialist, cer8 tified nurse anesthetist, certified nurse midwife, 

9 psychologist, certified social worker, registered 

10 dietitian or nutrition professional, physical or 

11 occupational therapists, pharmacist, or other in12 dividual healthcare practitioner; and 

13 ‘‘(C) any other health care professional 

14 specified in regulations promulgated by the Sec15 retary. 

16 ‘‘(4) HEALTHCARE ACQUIRED INFECTION.— 

17 The term ‘Healthcare Acquired Infection(s) (HAI)’ 

18 means an infection that is contracted while in a 

19 healthcare facility, such as an acute care hospital, 

20 skilled nursing care facility, or doctor’s office or clin21 ic. 

22 ‘‘(6) MEDICAL ERROR.—The term ‘medical 

23 error’ means an unexpected occurrence involving 

24 death or serious physical or psychological injury, or 

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1 ation of which recurrence may carry significant 

2 chance of a serious adverse outcome. 

3 ‘‘(7) OFFICE.—The term ‘Office’ means the Of4 fice of Patient Safety and Health Care Quality es5 tablished under section 943, which shall be a cer6 tified patient safety organization as defined under 

7 part C. 

8 ‘‘(8) OUTCOMES.—The term ‘outcomes’ means 

9 any result of healthcare acquired infection and/or 

10 medical error on affected patients. 

11 ‘‘(9) PATIENT SAFETY DATA.—The term ‘pa12 tient safety data’ means information requested by 

13 the Director of the Office to be submitted by the pa14 tient safety officer of a Program participant as de15 scribed in section 945(e). 

16 ‘‘(6) PATIENT SAFETY EVENT.—The term ‘pa17 tient safety event’ means an occurrence, incident, or 

18 process that either contributes to, or has the poten19 tial to contribute to, a patient injury or degrades the 

20 ability of health care providers to provide the appro21 priate standard of care. 

22 ‘‘(7) PATIENT SAFETY OFFICER.—The term 

23 ‘patient safety officer’ means the individual des24 ignated by a Program participant as being responVerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037

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1 sible for ensuring that the conditions for participa2 tion in the Program are met. 

3 ‘‘(8) PATIENT SAFETY ORGANIZATION.—The 

4 term ‘patient safety organization’ has the meaning 

5 given such term in section 921. 

6 ‘‘(9) PATIENT SAFETY WORK PRODUCT.—The 

7 term ‘patient safety work product’ has the meaning 

8 given such term in section 921. 

9 ‘‘(10) PROGRAM.—The term ‘Program’ means 

10 the National Healthcare Acquired Infections and 

11 Medical Error Reporting Program established under 

12 section 945. 

13 ‘‘(11) PROGRAM PARTICIPANT.—The term ‘pro14 gram participant’ means any healthcare provider 

15 who reports healthcare acquired infections and/or 

16 medical errors to the National Healthcare Acquired 

17 Infections and Medical Error Reporting Program. 

18 ‘‘(12) ROOT CAUSE ANALYSIS.—The term ‘root 

19 cause analysis’ means an examination or investiga20 tion of an occurrence, event, or incident to determine 

21 if a preventable medical error took place or the 

22 standard of care was not followed and to identify the 

23 causal factors that led to such occurrence, event, or 

24 incident. 


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1 ‘‘(14) WHISTLEBLOWER.—The term ‘whistle2 blower’ means any individual or legal representative 

3 of an individual, who provides original information 

4 relating to a Healthcare Acquired Infection or Med5 ical Error outcome. 

6 ‘‘SEC. 942. PURPOSE AND GOALS. 

7 ‘‘It is the purpose of this legislation to promote a cul8 ture of safety and trust within hospitals, health systems, 

9 clinics, and other sites of health care, through the estab10 lishment of a National Healthcare Acquired Infection and 

11 Medical Error Reporting Program. It shall be a goal of 

12 the Program to— 

13 ‘‘(1) establish standardized procedures for 

14 States to provide reports detailing healthcare ac15 quired infection and medical error disclosure and re16 porting; 

17 ‘‘(2) require all State departments of health to 

18 use the data provided by hospitals for error report19 ing to analyze trends and identify best practices; 

20 ‘‘(3) reduce rates of preventable medical errors; 

21 and 

22 ‘‘(4) ensure patients have access to information 

23 for medical injury or illness due to medical error, 

24 negligence, or malpractice. 


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1 ‘‘SEC. 943. OFFICE OF PATIENT SAFETY AND HEALTH CARE 

2 QUALITY. 

3 ‘‘(a) IN GENERAL.—The Secretary shall establish 

4 within the Office of the Secretary, an Office of Patient 

5 Safety and Health Care Quality to collaborate with the 

6 Director of the Agency for Health Care Research and 

7 Quality to improve patient safety and reduce medical error 

8 across the health care system. The Office shall be headed 

9 by a Director to be appointed by the Secretary. 

10 ‘‘(b) ACTIVITIES.—The activities of the Office shall 

11 be deemed patient safety activities, as defined in section 

12 921. 

13 ‘‘(c) DUTIES.—The Director of the Office shall— 

14 ‘‘(1) establish and administer the Program; 

15 ‘‘(2) determine who is eligible for participation 

16 in the Program in accordance with section 945; 

17 ‘‘(3) contract with an independent entity for the 

18 purpose of evaluating the Program at least once 

19 every two years, with the results of such evaluations 

20 being disseminated to Program participants, Con21 gress, and the public; 

22 ‘‘(4) establish and maintain, in consultation 

23 with patient safety organizations, health care quality 

24 organizations, health care providers, and the health 

25 information technology industry, a National Patient 

26 Safety Database as provided for in section 944 to 


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1 receive nonidentifiable patient safety work product 

2 as described in the reporting requirements for Pro3 gram participants under section 945(c)(10); 

4 ‘‘(5) determine and adopt a standardized pa5 tient safety taxonomy, necessary elements, common 

6 and consistent definitions, and standardized formats 

7 for the electronic reporting of patient safety data to 

8 the Database as described in section 944(e); 

9 ‘‘(6) survey Federal, State, and local require10 ments for the reporting of patient safety data and 

11 work to streamline and reduce duplication of such 

12 requirements; 

13 ‘‘(7) grant patient safety organizations, re14 searchers, and other qualified individuals and insti15 tutions access to the Database as determined appro16 priate through the evaluation of completed applica17 tions submitted to the Office for such purpose; 

18 ‘‘(8) analyze, directly or through a contract 

19 with a patient safety organization, all data entered 

20 into the Database and provide Program participants, 

21 Congress, and the public with healthcare acquired 

22 infection and medical error trend reports and other 

23 analyses as determined appropriate by the Director 

24 on a quarterly basis; 


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1 ‘‘(9) develop, directly or through a contract 

2 with a patient safety organization, safety and train3 ing recommendations for health care providers that 

4 focus on the reduction of medical errors, improved 

5 patient safety, and increased quality of care on at 

6 least a yearly basis; 

7 ‘‘(10) maintain a publicly accessible internet 

8 website to provide patients and health care providers 

9 with information concerning the Program and the 

10 Database; and 

11 ‘‘(11) perform any other duties for the adminis12 tration of the Program as determined necessary by 

13 the Secretary. 

14 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

15 are authorized to be appropriated such sums as may be 

16 necessary for each fiscal year to carry out the activities 

17 of the Office. 

18 ‘‘SEC. 944. NATIONAL PATIENT SAFETY DATABASE. 

19 ‘‘(a) IN GENERAL.—The Director of the Office shall, 

20 in accordance with section 943(c)(6), establish a National 

21 Patient Safety Database that shall— 

22 ‘‘(1) adopt standardized patient safety tax23 onomy in consultation with the Joint Commission on 

24 Accreditation of the Healthcare Organizations and 

25 other entities with relevant expertise; 


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1 ‘‘(2) include necessary elements, common and 

2 consistent definitions, and a standardized electronic 

3 interface for the entry and processing of the data by 

4 Program participants, as developed by the Director 

5 in consultation with patient safety organizations, 

6 health care providers, and the health information 

7 technology industry; 

8 ‘‘(3) allow for the comprehensive collection and 

9 analysis of the patient safety data required to be 

10 submitted by all Program participants under section 

11 945; and 

12 ‘‘(4) include patient safety data required to be 

13 submitted by Program participants under section 

14 945 as nonidentifiable patient safety work product 

15 and privileged and confidential in accordance with 

16 section 922. 

17 ‘‘(b) LIMITATION.—Information submitted to the 

18 Database shall be confidential and protected from disclo19 sure in accordance with the regulations promulgated 

20 under section 264(c) of the Health Insurance Portability 

21 and Accountability Act of 1996 (42 U.S.C. 1320d–2 note). 

22 ‘‘(c) ACCESS.—Access to the patient safety data con23 tained within the Database shall only be provided through 

24 application to and approval by the Director. 


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1 ‘‘SEC. 945. NATIONAL HEALTHCARE ACQUIRED INFECTION 

2 AND MEDICAL ERROR REPORTING PROGRAM. 

3 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 

4 through the Director of the Office, shall establish a Na5 tional Healthcare Acquired Infection and Medical Error 

6 Reporting Program to provide for the confidential disclo7 sure of medical errors and patient safety events in order 

8 to improve patient safety and health care quality, reduce 

9 preventable medical errors, ensure patient access to data 

10 and reports for medical injury due to medical error, neg11 ligence, or malpractice. 

12 ‘‘(b) ELIGIBLE PARTICIPANTS.—To be eligible to 

13 participate in the Program an entity shall— 

14 ‘‘(1)(A) be a healthcare provider; or 

15 ‘‘(B) be any other entity determined to be eligi16 ble by the Director; 

17 ‘‘(2) designate a patient safety officer to ensure 

18 that the conditions of participation described in sub19 section (c) are met; 

20 ‘‘(3) submit a completed application to the Of21 fice at such time, in such manner, and containing 

22 such information as the Director may require; and 

23 ‘‘(4) agree to comply with the conditions of par24 ticipation under subsection (c). 

25 ‘‘(c) CONDITIONS OF PARTICIPATION.—A Program 

26 participant shall, directly or indirectly— 


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1 ‘‘(1) submit a comprehensive plan, as part of 

2 the application for participation in the Program, to 

3 reduce the incidence of medical errors and improve 

4 patient safety in the case of a Program participant 

5 that is a health care provider, activities that result 

6 in the reduction of medical errors or that otherwise 

7 improve patient safety; 

8 ‘‘(2) require health care providers included in 

9 the Program by the Program participant and as out10 lined in the Program participant application, to sub11 mit to the patient safety officer a report of any inci12 dent or occurrence involving a patient that is 

13 thought to either be a medical error or patient safe14 ty event; 

15 ‘‘(3) ensure that the reports filed under para16 graph (2) are submitted to the Database in a stand17 ardized format as designated by the Director; 

18 ‘‘(4) where appropriate, ensure that a root 

19 cause analysis of any report submitted to the patient 

20 safety officer under paragraph (2) is performed 

21 within 90 days of the filing of a report under such 

22 paragraph; 

23 ‘‘(5) ensure that if a patient was harmed or in24 jured as the result of a healthcare acquired infection 

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1 ard of care not being followed, an account of the in2 cident or occurrence, as described in paragraph (2) 

3 shall be disclosed to the patient not later than 5 

4 business days after the completion of root cause 

5 analysis; 

6 ‘‘(6) disclose information contained in any re7 port submitted to the patient safety officer under 

8 paragraph (2) upon the request of the patient with 

9 respect to whom the report has been filed; 

10 ‘‘(7) offer, at the time of disclosure of an inci11 dent or occurrence in which it was determined that 

12 a patient was harmed or injured as a result of med13 ical error or as a result of the relevant standard of 

14 care not being followed, to share, where practicable, 

15 any efforts the health care provider will undertake to 

16 prevent reoccurrence; and 

17 ‘‘(8) prepare and submit entries to the Data18 base as required by the Director of the Office and 

19 in accordance with subsection (d). 

20 ‘‘(d) SUBMISSION OF PATIENT SAFETY DATA.— 

21 ‘‘(1) IN GENERAL.—All entries into the Data22 base shall— 

23 ‘‘(A) contain only non-identifiable patient 

24 safety work product; 


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1 ‘‘(B) be in a standardized electronic format 

2 to be determined by the Director; and 

3 ‘‘(C) if related to a single occurrence or in4 cident, be given a common identifier to link en5 tries of related data. 

6 ‘‘(2) REPORTING REQUIREMENTS.—The patient 

7 safety officer of a Program participant shall be re8 quired to prepare and enter into the Database— 

9 ‘‘(A) reports, containing only nonidentifi10 able patient safety work product, filed by a 

11 health care provider under subsection (c)(4) 

12 and a summary of the findings of the root 

13 cause analysis with respect to such report with14 in 5 business days of the completion of the root 

15 cause analysis; 

16 ‘‘(B) any disciplinary actions taken against 

17 a health care provider as a result of involve18 ment in any incident or occurrence involving a 

19 patient that is thought to be a medical error or 

20 patient safety event, or legal action for which a 

21 report under subsection (c)(4) was filed; or 

22 ‘‘(C) other data as determined appropriate 

23 by the Director. 


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1 ‘‘(3) PRIVILEGE AND CONFIDENTIALITY.—The 

2 provisions of section 922 shall apply to patient safe3 ty data submitted under this subsection. 

4 ‘‘SEC. 946. THE NATIONAL HEALTHCARE ACQUIRED INFEC5 TION AND MEDICAL ERROR REPORTING AC6 COUNTABILITY STUDY. 

7 ‘‘(a) IN GENERAL.—The Director of the Office shall 

8 conduct, directly or through a contract with patient safety 

9 organizations or qualified individuals or institutions, an 

10 analysis of the patient safety data in the Database and 

11 other available data to determine performance and sys12 tems standards, tools, and best practices (including peer 

13 review) for doctors and other health care providers nec14 essary to prevent medical errors, improve patient safety, 

15 and increase accountability within the health care system. 

16 Such analysis shall also consider the value of increasing 

17 the transparency of the patient safety data to include the 

18 identity of health care providers and provide recommenda19 tions for improvements to the peer review process. 

20 ‘‘(b) REPORT AND RECOMMENDATIONS.—Not later 

21 than 2 years after the date of enactment of this section, 

22 the Director of the Office shall submit to Congress and 

23 make available to States, State medical boards, and the 

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1 ried out under subsection (a) and contains recommenda2 tions for Congress based on the findings of the report.’’. 

Æ 


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