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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘National Healthcare 4 Acquired Infection and Medical Error Transparency Act’’. 5 SEC. 2. FINDINGS. 6 (1) The Centers for Disease Control and Pre- 7 vention reported that each day one in thirty-one hos- 8 VerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 9037 IH pital patients has at least one healthcare-associated 1 infection; 2 (2) 32 percent of all healthcare-acquired infec- 3 tions are urinary tract; 4 (3) 22 percent of all infections are surgical site 5 infections; 6 (4) 15 percent are pneumonia (lung infections); 7 (5) 14 percent are bloodstream infections. 8 (6) Patients who acquire infections from sur- 9 gery spend on average an additional 6.5 days hos- 10 pitalized; 11 (7) are five times more likely to be readmitted 12 after discharge; 13 (8) and are twice as likely to die. 14 (9) As recent as 2016, Johns Hopkins Univer- 15 sity patient safety experts calculated that medical 16 error is responsible for at least 250,000 deaths per 17 year (the third leading cause of death in the U.S.). 18 SEC. 3. ESTABLISHMENT OF OFFICE OF PATIENT SAFETY 19 AND HEALTH CARE QUALITY. 20 Title IX of the Public Health Service Act (42 U.S.C. 21 299 et seq.) is amended— 22 (1) by redesignating part E as part F; 23 (2) in part F, as redesignated— 24 VerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 9037 IH (A) by redesignating sections 941 through 1 948 as sections 951 through 958, respectively; 2 and 3 (B) in section 958(1), as redesignated, by 4 striking ‘‘941’’ and inserting ‘‘951’’; and 5 (3) by inserting after part D the following: 6 ‘‘PART E—NATIONAL HEALTHCARE ACQUIRED IN- 7 FECTION AND MEDICAL ERROR REPORTING 8 PROGRAM 9 ‘‘SEC. 941. DEFINITIONS. 10 ‘‘In this part: 11 ‘‘(1) ANTI-RETALIATION.—The term ‘anti-retal- 12 iation’ any patient or legal representative of a pa- 13 tient who engages in Protected Activity will be 14 shielded from retaliation. 15 ‘‘(2) DATABASE.—The term ‘Database’ means 16 the National Patient Safety Database established 17 under section 944. 18 ‘‘(3) HEALTH CARE PROVIDER.—The term 19 ‘health care provider’ means a person or entity li- 20 censed or otherwise authorized under State law to 21 provide health care services, including— 22 ‘‘(A) a hospital, health plan, community 23 clinic, nursing facility, comprehensive rehabili- 24 tation facility, home health agency, hospice pro- 25 VerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 9037 IH gram, renal dialysis facility, ambulatory sur- 1 gical center, pharmacy, doctor’s or health care 2 practitioner’s office, long-term care facility, be- 3 havior health residential treatment facility, clin- 4 ical laboratory, or health center; 5 ‘‘(B) a doctor, nurse, physician assistant, 6 nurse practitioner, clinical nurse specialist, cer- 7 tified nurse anesthetist, certified nurse midwife, 8 psychologist, certified social worker, registered 9 dietitian or nutrition professional, physical or 10 occupational therapists, pharmacist, or other in- 11 dividual healthcare practitioner; and 12 ‘‘(C) any other health care professional 13 specified in regulations promulgated by the Sec- 14 retary. 15 ‘‘(4) HEALTHCARE ACQUIRED INFECTION.— 16 The term ‘Healthcare Acquired Infection(s) (HAI)’ 17 means an infection that is contracted while in a 18 healthcare facility, such as an acute care hospital, 19 skilled nursing care facility, or doctor’s office or clin- 20 ic. 21 ‘‘(6) MEDICAL ERROR.—The term ‘medical 22 error’ means an unexpected occurrence involving 23 death or serious physical or psychological injury, or 24 the risk of such injury, including any process vari- 25 VerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 9037 IH ation of which recurrence may carry significant 1 chance of a serious adverse outcome. 2 ‘‘(7) OFFICE.—The term ‘Office’ means the Of- 3 fice of Patient Safety and Health Care Quality es- 4 tablished under section 943, which shall be a cer- 5 tified patient safety organization as defined under 6 part C. 7 ‘‘(8) OUTCOMES.—The term ‘outcomes’ means 8 any result of healthcare acquired infection and/or 9 medical error on affected patients. 10 ‘‘(9) PATIENT SAFETY DATA.—The term ‘pa- 11 tient safety data’ means information requested by 12 the Director of the Office to be submitted by the pa- 13 tient safety officer of a Program participant as de- 14 scribed in section 945(e). 15 ‘‘(6) PATIENT SAFETY EVENT.—The term ‘pa- 16 tient safety event’ means an occurrence, incident, or 17 process that either contributes to, or has the poten- 18 tial to contribute to, a patient injury or degrades the 19 ability of health care providers to provide the appro- 20 priate standard of care. 21 ‘‘(7) PATIENT SAFETY OFFICER.—The term 22 ‘patient safety officer’ means the individual des- 23 ignated by a Program participant as being respon- 24 VerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 9037 IH sible for ensuring that the conditions for participa- 1 tion in the Program are met. 2 ‘‘(8) PATIENT SAFETY ORGANIZATION.—The 3 term ‘patient safety organization’ has the meaning 4 given such term in section 921. 5 ‘‘(9) PATIENT SAFETY WORK PRODUCT.—The 6 term ‘patient safety work product’ has the meaning 7 given such term in section 921. 8 ‘‘(10) PROGRAM.—The term ‘Program’ means 9 the National Healthcare Acquired Infections and 10 Medical Error Reporting Program established under 11 section 945. 12 ‘‘(11) PROGRAM PARTICIPANT.—The term ‘pro- 13 gram participant’ means any healthcare provider 14 who reports healthcare acquired infections and/or 15 medical errors to the National Healthcare Acquired 16 Infections and Medical Error Reporting Program. 17 ‘‘(12) ROOT CAUSE ANALYSIS.—The term ‘root 18 cause analysis’ means an examination or investiga- 19 tion of an occurrence, event, or incident to determine 20 if a preventable medical error took place or the 21 standard of care was not followed and to identify the 22 causal factors that led to such occurrence, event, or 23 incident. 24 VerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 9037 IH ‘‘(14) WHISTLEBLOWER.—The term ‘whistle- 1 blower’ means any individual or legal representative 2 of an individual, who provides original information 3 relating to a Healthcare Acquired Infection or Med- 4 ical Error outcome. 5 ‘‘SEC. 942. PURPOSE AND GOALS. 6 ‘‘It is the purpose of this legislation to promote a cul- 7 ture of safety and trust within hospitals, health systems, 8 clinics, and other sites of health care, through the estab- 9 lishment of a National Healthcare Acquired Infection and 10 Medical Error Reporting Program. It shall be a goal of 11 the Program to— 12 ‘‘(1) establish standardized procedures for 13 States to provide reports detailing healthcare ac- 14 quired infection and medical error disclosure and re- 15 porting; 16 ‘‘(2) require all State departments of health to 17 use the data provided by hospitals for error report- 18 ing to analyze trends and identify best practices; 19 ‘‘(3) reduce rates of preventable medical errors; 20 and 21 ‘‘(4) ensure patients have access to information 22 for medical injury or illness due to medical error, 23 negligence, or malpractice. 24 VerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 9037 IH ‘‘SEC. 943. OFFICE OF PATIENT SAFETY AND HEALTH CARE 1 QUALITY. 2 ‘‘(a) IN GENERAL.—The Secretary shall establish 3 within the Office of the Secretary, an Office of Patient 4 Safety and Health Care Quality to collaborate with the 5 Director of the Agency for Health Care Research and 6 Quality to improve patient safety and reduce medical error 7 across the health care system. The Office shall be headed 8 by a Director to be appointed by the Secretary. 9 ‘‘(b) ACTIVITIES.—The activities of the Office shall 10 be deemed patient safety activities, as defined in section 11 921. 12 ‘‘(c) DUTIES.—The Director of the Office shall— 13 ‘‘(1) establish and administer the Program; 14 ‘‘(2) determine who is eligible for participation 15 in the Program in accordance with section 945; 16 ‘‘(3) contract with an independent entity for the 17 purpose of evaluating the Program at least once 18 every two years, with the results of such evaluations 19 being disseminated to Program participants, Con- 20 gress, and the public; 21 ‘‘(4) establish and maintain, in consultation 22 with patient safety organizations, health care quality 23 organizations, health care providers, and the health 24 information technology industry, a National Patient 25 Safety Database as provided for in section 944 to 26 VerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037 pamtmann on DSKBC07HB2PROD with BILLS 9 •HR 9037 IH receive nonidentifiable patient safety work product 1 as described in the reporting requirements for Pro- 2 gram participants under section 945(c)(10); 3 ‘‘(5) determine and adopt a standardized pa- 4 tient safety taxonomy, necessary elements, common 5 and consistent definitions, and standardized formats 6 for the electronic reporting of patient safety data to 7 the Database as described in section 944(e); 8 ‘‘(6) survey Federal, State, and local require- 9 ments for the reporting of patient safety data and 10 work to streamline and reduce duplication of such 11 requirements; 12 ‘‘(7) grant patient safety organizations, re- 13 searchers, and other qualified individuals and insti- 14 tutions access to the Database as determined appro- 15 priate through the evaluation of completed applica- 16 tions submitted to the Office for such purpose; 17 ‘‘(8) analyze, directly or through a contract 18 with a patient safety organization, all data entered 19 into the Database and provide Program participants, 20 Congress, and the public with healthcare acquired 21 infection and medical error trend reports and other 22 analyses as determined appropriate by the Director 23 on a quarterly basis; 24 VerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037 pamtmann on DSKBC07HB2PROD with BILLS 10 •HR 9037 IH ‘‘(9) develop, directly or through a contract 1 with a patient safety organization, safety and train- 2 ing recommendations for health care providers that 3 focus on the reduction of medical errors, improved 4 patient safety, and increased quality of care on at 5 least a yearly basis; 6 ‘‘(10) maintain a publicly accessible internet 7 website to provide patients and health care providers 8 with information concerning the Program and the 9 Database; and 10 ‘‘(11) perform any other duties for the adminis- 11 tration of the Program as determined necessary by 12 the Secretary. 13 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 14 are authorized to be appropriated such sums as may be 15 necessary for each fiscal year to carry out the activities 16 of the Office. 17 ‘‘SEC. 944. NATIONAL PATIENT SAFETY DATABASE. 18 ‘‘(a) IN GENERAL.—The Director of the Office shall, 19 in accordance with section 943(c)(6), establish a National 20 Patient Safety Database that shall— 21 ‘‘(1) adopt standardized patient safety tax- 22 onomy in consultation with the Joint Commission on 23 Accreditation of the Healthcare Organizations and 24 other entities with relevant expertise; 25 VerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037 pamtmann on DSKBC07HB2PROD with BILLS 11 •HR 9037 IH ‘‘(2) include necessary elements, common and 1 consistent definitions, and a standardized electronic 2 interface for the entry and processing of the data by 3 Program participants, as developed by the Director 4 in consultation with patient safety organizations, 5 health care providers, and the health information 6 technology industry; 7 ‘‘(3) allow for the comprehensive collection and 8 analysis of the patient safety data required to be 9 submitted by all Program participants under section 10 945; and 11 ‘‘(4) include patient safety data required to be 12 submitted by Program participants under section 13 945 as nonidentifiable patient safety work product 14 and privileged and confidential in accordance with 15 section 922. 16 ‘‘(b) LIMITATION.—Information submitted to the 17 Database shall be confidential and protected from disclo- 18 sure in accordance with the regulations promulgated 19 under section 264(c) of the Health Insurance Portability 20 and Accountability Act of 1996 (42 U.S.C. 1320d–2 note). 21 ‘‘(c) ACCESS.—Access to the patient safety data con- 22 tained within the Database shall only be provided through 23 application to and approval by the Director. 24 VerDate Sep 11 2014 01:07 Jan 28, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H9037.IH H9037 pamtmann on DSKBC07HB2PROD with BILLS 12 •HR 9037 IH ‘‘SEC. 945. NATIONAL HEALTHCARE ACQUIRED INFECTION 1 AND MEDICAL ERROR REPORTING PROGRAM. 2 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 3 through the Director of the Office, shall establish a Na- 4 tional Healthcare Acquired Infection and Medical Error 5 Reporting Program to provide for the confidential disclo- 6 sure of medical errors and patient safety events in order 7 to improve patient safety and health care quality, reduce 8 preventable medical errors, ensure patient access to data 9 and reports for medical injury due to medical error, neg- 10 ligence, or malpractice [Text truncated for display. Full text available on Congress.gov.]