I 

112TH CONGRESS 

1ST SESSION H. R. 3386 

To encourage the use of medical checklists through research, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 4, 2011 

Mr. HOLT (for himself and Mrs. CAPPS) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

A BILL 

To encourage the use of medical checklists through research, 

and for other purposes. 

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 ‘‘Medical Checklist Act 

5 of 2011’’. 

6 SEC. 2. RESEARCH INTO MEDICAL CHECKLIST DEVELOP7 MENT AND EFFICACY. 

8 (a) STUDY.—The Director of the Agency for 

9 Healthcare Research and Quality, acting through the Cen10 ter for Quality Improvement and Patient Safety, shall conVerDate Mar 15 2010 03:17 Nov 10, 2011 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3386.IH H3386

tjames on DSK6SPTVN1PROD with BILLS
2 

•HR 3386 IH

1 duct research and a study, in accordance with the require2 ments of this section, regarding the development and effi3 cacy of medical checklists. 

4 (b) CONTENTS.—In carrying out subsection (a), the 

5 Director shall conduct research and a study regarding the 

6 following: 

7 (1) Testing of different models of medical 

8 checklists to measure the effect of checklist format, 

9 length, and design for different clinical tasks on— 

10 (A) adoption of checklists by health care 

11 professionals; 

12 (B) time spent by health care professionals 

13 on the clinical task of interest; and 

14 (C) reliable completion of health care pro15 cedures. 

16 (2) Examination of checklist development and 

17 use in other industries, such as commercial aviation 

18 and nuclear power, and the feasibility of applying 

19 and adapting methodology developed in those indus20 tries to the health care industry in a way that would 

21 result in health care quality improvement. 

22 (3) Identification of organizational characteris23 tics needed to effectively implement the use of med24 ical checklists in health care settings. 


tjames on DSK6SPTVN1PROD with BILLS
3 

•HR 3386 IH

1 (4) Measurement of the effects of the use of 

2 medical checklists on patient safety and health out3 comes. 

4 (5) Identification of health care procedures for 

5 which the development and use of medical checklists 

6 would be beneficial. 

7 (6) Investigation of the development, implemen8 tation, and use of available medical checklists, in9 cluding checklists for safe surgery and central line 

10 insertion and maintenance, to inform further med11 ical checklist development. 

12 (c) SCOPE.—The Director shall ensure that each as13 pect of the research and study conducted under subsection 

14 (a) is examined across a variety of health care provider 

15 characteristics, medical procedures, patient populations, 

16 and other factors that could affect the use of medical 

17 checklists. 

18 (d) DISSEMINATION.—The Director shall make avail19 able to the public the results of the study conducted under 

20 subsection (a) and shall disseminate such results to pa21 tient safety organizations listed pursuant to section 924(d) 

22 of the Public Health Service Act (42 U.S.C. 299b–24(d)). 

23 (e) AUTHORIZATION OF APPROPRIATIONS.—There 

24 are authorized to be appropriated to carry out this section 


tjames on DSK6SPTVN1PROD with BILLS
4 

•HR 3386 IH

1 such sums as may be necessary for each of fiscal years 

2 2012 through 2015. 

3 SEC. 3. COORDINATING MEDICAL CHECKLISTS AND 

4 HEALTH INFORMATION TECHNOLOGY SYS5 TEMS. 

6 (a) IN GENERAL.—The HIT Policy Committee in the 

7 Office of the National Coordinator for Health Information 

8 Technology (as established in section 3002 of the Public 

9 Health Service Act (42 U.S.C. 300jj–12)) shall develop 

10 policy recommendations regarding— 

11 (1) the extent to which the use of medical 

12 checklists should be incorporated into health infor13 mation technology systems; and 

14 (2) measures to determine the effectiveness of 

15 such use. 

16 (b) AREAS OF CONSIDERATION.—In making rec17 ommendations under subsection (a), the HIT Policy Com18 mittee may consider the following areas: 

19 (1) The ease with which medical checklists in 

20 electronic formats can be used by health care profes21 sionals. 

22 (2) The effect of the availability of medical 

23 checklists in electronic formats on the adoption and 

24 use of medical checklists by health care profes25 sionals. 


tjames on DSK6SPTVN1PROD with BILLS
5 

•HR 3386 IH

1 (3) The effect of the use of medical checklists 

2 in electronic formats on the time spent by health 

3 care professionals on medical procedures. 

4 (4) The ability of the health information tech5 nology system to collect data on patient safety and 

6 health outcomes that could be analyzed to aid in the 

7 design and update of medical checklists. 

8 (5) The ease with which medical checklists in 

9 electronic formats can be updated on an ongoing 

10 basis based on evidence from medical research and 

11 local experience. 

12 (6) The capability of health information tech13 nology systems to collect data, where applicable, re14 garding the use of medical checklists by health care 

15 clinicians and providers, and any relation between 

16 that use and patient safety and health outcomes. 

17 SEC. 4. INSTITUTE OF MEDICINE STUDY ON FURTHER MED18 ICAL CHECKLIST RESEARCH. 

19 (a) IN GENERAL.—The Secretary of Health and 

20 Human Services shall enter into an agreement with the 

21 Institute of Medicine and the National Academy of Engi22 neering of the National Academies to conduct a study in 

23 accordance with this section. 

24 (b) STUDY.—The Secretary shall ensure that the 

25 study conducted under this section— 


tjames on DSK6SPTVN1PROD with BILLS
6 

•HR 3386 IH

1 (1) reviews available medical checklists and 

2 similar quality improvement techniques, data on the 

3 adoption and use of such techniques by health care 

4 professionals, and evidence of the efficacy of such 

5 techniques in relation to patient safety and health 

6 outcomes; 

7 (2) identifies areas of research needed to im8 prove medical checklists in order to increase the 

9 adoption and efficacy of medical checklists; 

10 (3) analyzes organizational impediments to the 

11 adoption and use of medical checklists; 

12 (4) reviews the degree to which there is suffi13 cient evidence with which to develop new medical 

14 checklists and, if such evidence is insufficient, identi15 fies areas requiring further study in order to develop 

16 such evidence; and 

17 (5) determines whether the availability of an in18 creased number of medical checklists would improve 

19 patient safety and health outcomes and, if so, identi20 fies methods for using recent medical research to de21 velop new medical checklists. 

22 (c) METHODOLOGY OF STUDY.— 

23 (1) SCOPE.—The Secretary shall ensure that 

24 the agreement entered into under subsection (a) proVerDate Mar 15 2010 03:17 Nov 10, 2011 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3386.IH H3386

tjames on DSK6SPTVN1PROD with BILLS
7 

•HR 3386 IH

1 vides that the study conducted under such sub2 section will consider the perspectives of— 

3 (A) various types of health care profes4 sionals in various types of health care settings; 

5 (B) individuals conducting academic re6 search in health care quality; and 

7 (C) patients. 

8 (2) CONSULTATION WITH RELEVANT ORGANIZA9 TIONS.—The Secretary shall ensure that the agree10 ment entered into under subsection (a) provides that 

11 relevant agencies and organizations with expertise 

12 on medical checklists will be consulted during the 

13 study conducted under such subsection, including 

14 the following: 

15 (A) The Agency for Healthcare Research 

16 and Quality. 

17 (B) The American Nurses Association. 

18 (C) The Institute for Healthcare Improve19 ment. 

20 (D) The American Hospital Association. 

21 (E) The American Medical Association. 

22 (F) The World Health Organization. 

23 (G) The National Committee for Quality 

24 Assurance. 

25 (H) The Joint Commission. 


tjames on DSK6SPTVN1PROD with BILLS
8 

•HR 3386 IH

1 (I) The American Academy of Physician 

2 Assistants. 

3 (d) REPORT.—The Secretary shall ensure that the 

4 agreement entered into under subsection (a) provides that 

5 not later than 18 months after the date of the enactment 

6 of this Act, a report providing the findings and rec7 ommendations made in the study conducted under such 

8 subsection will be submitted to the Secretary, the Com9 mittee on Energy and Commerce of the House of Rep10 resentatives, and the Committee on Health, Education, 

11 Labor, and Pensions of the Senate. 

12 SEC. 5. DEFINITIONS. 

13 In this Act, the following definitions apply: 

14 (1) HEALTH CARE PROFESSIONAL.—The term 

15 ‘‘health care professional’’ means an individual who 

16 provides health care services, including a physician, 

17 physician assistant, nurse practitioner, clinical nurse 

18 specialist (as those terms are defined in section 

19 1861 of the Social Security Act (42 U.S.C. 1395x)), 

20 and such other individuals as the Secretary of 

21 Health and Human Services determines appropriate. 

22 (2) HEALTH CARE SETTING.—The term ‘‘health 

23 care setting’’ means a facility at which health care 

24 services are provided, including a hospital providing 

25 inpatient hospital services (as that term is defined in 


tjames on DSK6SPTVN1PROD with BILLS
9 

•HR 3386 IH

1 section 1861 of the Social Security Act (42 U.S.C. 

2 1395x)), an ambulatory surgical center (meeting the 

3 standards specified under section 1832(a)(2)(F)(i) 

4 of the Social Security Act (42 U.S.C. 1395k)), and 

5 such other settings as the Secretary of Health and 

6 Human Services determines appropriate. 

7 (3) HEALTH CARE PROVIDER.—The term 

8 ‘‘health care provider’’ means a health care profes9 sional or a health care setting. 

10 (4) MEDICAL CHECKLIST.—The term ‘‘medical 

11 checklist’’ means a predetermined, evidence-based, 

12 well-defined set of steps that should be completed 

13 during a designated medical clinical encounter or 

14 medical procedure, as further defined by the Direc15 tor of the Agency for Healthcare Research and 

16 Quality in consultation with the Institute of Medi17 cine and the National Academy of Engineering of 

18 the National Academies. 

Æ 


tjames on DSK6SPTVN1PROD with BILLS