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<bill bill-stage="Introduced-in-House" bill-type="olc" dms-id="H2C2761A4B4EE48CBAAC7CEAD3C732EE5" public-private="public">
	<form>
		<distribution-code display="yes">I</distribution-code>
		<congress>112th CONGRESS</congress>
		<session>1st Session</session>
		<legis-num>H. R. 3386</legis-num>
		<current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber>
		<action>
			<action-date date="20111104">November 4, 2011</action-date>
			<action-desc><sponsor name-id="H001032">Mr. Holt</sponsor> (for himself
			 and <cosponsor name-id="C001036">Mrs. Capps</cosponsor>) introduced the
			 following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and
			 Commerce</committee-name></action-desc>
		</action>
		<legis-type>A BILL</legis-type>
		<official-title>To encourage the use of medical checklists through
		  research, and for other purposes.</official-title>
	</form>
	<legis-body id="HC32742AF6D454E2DB2DE507A75CD3A48" style="OLC">
		<section id="H8AC71C92486F4178867D317685FBD6B1" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the
			 <quote><short-title>Medical Checklist Act of
			 2011</short-title></quote>.</text>
		</section><section id="H0891C57091A84086B6F25C36CDB40432"><enum>2.</enum><header>Research into
			 medical checklist development and efficacy</header>
			<subsection id="HD88CB93CBA694BB2BAA00C198426EC10"><enum>(a)</enum><header>Study</header><text>The
			 Director of the Agency for Healthcare Research and Quality, acting through the
			 Center for Quality Improvement and Patient Safety, shall conduct research and a
			 study, in accordance with the requirements of this section, regarding the
			 development and efficacy of medical checklists.</text>
			</subsection><subsection id="H471D906CF51349118D28E99BE0ADB2AF"><enum>(b)</enum><header>Contents</header><text>In
			 carrying out subsection (a), the Director shall conduct research and a study
			 regarding the following:</text>
				<paragraph id="HD6B5CE097C484BA99B8E5970692B0B49"><enum>(1)</enum><text>Testing of
			 different models of medical checklists to measure the effect of checklist
			 format, length, and design for different clinical tasks on—</text>
					<subparagraph id="H4E66D1EDB34C4FCDAA9ABE821A8AB3A7"><enum>(A)</enum><text>adoption of
			 checklists by health care professionals;</text>
					</subparagraph><subparagraph id="H357A1030610140F39C74F48998FE91F5"><enum>(B)</enum><text>time spent by
			 health care professionals on the clinical task of interest; and</text>
					</subparagraph><subparagraph id="H23E3F8A981B54DC0865EF5B1C5AF9557"><enum>(C)</enum><text>reliable
			 completion of health care procedures.</text>
					</subparagraph></paragraph><paragraph id="H00DE2DCE66AB49559D3E320904E92243"><enum>(2)</enum><text>Examination of
			 checklist development and use in other industries, such as commercial aviation
			 and nuclear power, and the feasibility of applying and adapting methodology
			 developed in those industries to the health care industry in a way that would
			 result in health care quality improvement.</text>
				</paragraph><paragraph id="H12A6E29C65734FF9A38D407EC730766D"><enum>(3)</enum><text>Identification of
			 organizational characteristics needed to effectively implement the use of
			 medical checklists in health care settings.</text>
				</paragraph><paragraph id="H4D14A5A92386411E9129FFFC82E37F73"><enum>(4)</enum><text>Measurement of the
			 effects of the use of medical checklists on patient safety and health
			 outcomes.</text>
				</paragraph><paragraph id="HAD4A1497F5B3451CB8B51FF0738752A5"><enum>(5)</enum><text>Identification of
			 health care procedures for which the development and use of medical checklists
			 would be beneficial.</text>
				</paragraph><paragraph id="H945688AFC2BF4CA5A9239F24DA0ACA1B"><enum>(6)</enum><text>Investigation of
			 the development, implementation, and use of available medical checklists,
			 including checklists for safe surgery and central line insertion and
			 maintenance, to inform further medical checklist development.</text>
				</paragraph></subsection><subsection id="HB7226983C78C4F17B08D9EE9251D6307"><enum>(c)</enum><header>Scope</header><text>The
			 Director shall ensure that each aspect of the research and study conducted
			 under subsection (a) is examined across a variety of health care provider
			 characteristics, medical procedures, patient populations, and other factors
			 that could affect the use of medical checklists.</text>
			</subsection><subsection id="H0075C67B4CA14E16BD08DBF36C470D3B"><enum>(d)</enum><header>Dissemination</header><text>The
			 Director shall make available to the public the results of the study conducted
			 under subsection (a) and shall disseminate such results to patient safety
			 organizations listed pursuant to section 924(d) of the Public Health Service
			 Act (42 U.S.C. 299b–24(d)).</text>
			</subsection><subsection id="HA3626A935F654EA799F65613CE55DA8F"><enum>(e)</enum><header>Authorization of
			 appropriations</header><text>There are authorized to be appropriated to carry
			 out this section such sums as may be necessary for each of fiscal years 2012
			 through 2015.</text>
			</subsection></section><section id="H936B43715F85449EA8C324FB503D6734"><enum>3.</enum><header>Coordinating
			 medical checklists and health information technology systems</header>
			<subsection id="H00B09BB133124D52BECE7940FD70FC91"><enum>(a)</enum><header>In
			 general</header><text>The HIT Policy Committee in the Office of the National
			 Coordinator for Health Information Technology (as established in section 3002
			 of the Public Health Service Act (42 U.S.C. 300jj–12)) shall develop policy
			 recommendations regarding—</text>
				<paragraph id="HCF1B3CD0AB804671854E37AC69A07D1E"><enum>(1)</enum><text>the extent to
			 which the use of medical checklists should be incorporated into health
			 information technology systems; and</text>
				</paragraph><paragraph id="H8463C7C343CD417CAEE77B2B358F52DB"><enum>(2)</enum><text>measures to
			 determine the effectiveness of such use.</text>
				</paragraph></subsection><subsection id="HFA03265A73B8447E850559F53BFF0F39"><enum>(b)</enum><header>Areas of
			 consideration</header><text>In making recommendations under subsection (a), the
			 HIT Policy Committee may consider the following areas:</text>
				<paragraph id="H113E16001AB544C0AD8CC973F7DCB859"><enum>(1)</enum><text>The ease with
			 which medical checklists in electronic formats can be used by health care
			 professionals.</text>
				</paragraph><paragraph id="H441DEDDFC2334841A482C307D3535BC3"><enum>(2)</enum><text>The effect of the
			 availability of medical checklists in electronic formats on the adoption and
			 use of medical checklists by health care professionals.</text>
				</paragraph><paragraph id="H205D75D8BE69460586032AC1FBEC7236"><enum>(3)</enum><text>The effect of the
			 use of medical checklists in electronic formats on the time spent by health
			 care professionals on medical procedures.</text>
				</paragraph><paragraph id="H2B18DA41EF21414982534C39D732E49D"><enum>(4)</enum><text>The ability of the
			 health information technology system to collect data on patient safety and
			 health outcomes that could be analyzed to aid in the design and update of
			 medical checklists.</text>
				</paragraph><paragraph id="H4CA391F1722D4FBC8A71BB0DBB37952C"><enum>(5)</enum><text>The ease with
			 which medical checklists in electronic formats can be updated on an ongoing
			 basis based on evidence from medical research and local experience.</text>
				</paragraph><paragraph id="H4BF6A819BA074C8893431851945E421B"><enum>(6)</enum><text>The capability of
			 health information technology systems to collect data, where applicable,
			 regarding the use of medical checklists by health care clinicians and
			 providers, and any relation between that use and patient safety and health
			 outcomes.</text>
				</paragraph></subsection></section><section id="HCC027CF87ACA418BBC105B5C6BBF7F9B"><enum>4.</enum><header>Institute of
			 medicine study on further medical checklist research</header>
			<subsection id="H27FD3E0FE872442097E226F7B596FED7"><enum>(a)</enum><header>In
			 general</header><text>The Secretary of Health and Human Services shall enter
			 into an agreement with the Institute of Medicine and the National Academy of
			 Engineering of the National Academies to conduct a study in accordance with
			 this section.</text>
			</subsection><subsection id="H99968505011E4700A90B011F93C5EAB5"><enum>(b)</enum><header>Study</header><text>The
			 Secretary shall ensure that the study conducted under this section—</text>
				<paragraph id="H293976C4D8E7488FB9D0A19692EE7161"><enum>(1)</enum><text>reviews available
			 medical checklists and similar quality improvement techniques, data on the
			 adoption and use of such techniques by health care professionals, and evidence
			 of the efficacy of such techniques in relation to patient safety and health
			 outcomes;</text>
				</paragraph><paragraph id="HE9A3E8DE48B44FB4910077B97ADAB0FD"><enum>(2)</enum><text>identifies areas
			 of research needed to improve medical checklists in order to increase the
			 adoption and efficacy of medical checklists;</text>
				</paragraph><paragraph id="H3277ADC1C61C4EC68C0A2974592B50B6"><enum>(3)</enum><text>analyzes
			 organizational impediments to the adoption and use of medical
			 checklists;</text>
				</paragraph><paragraph id="H9709791683724C8E8754F4732CD885F5"><enum>(4)</enum><text>reviews the degree
			 to which there is sufficient evidence with which to develop new medical
			 checklists and, if such evidence is insufficient, identifies areas requiring
			 further study in order to develop such evidence; and</text>
				</paragraph><paragraph id="H7B82EB799CCC4320B9B72933BF125F6C"><enum>(5)</enum><text>determines whether
			 the availability of an increased number of medical checklists would improve
			 patient safety and health outcomes and, if so, identifies methods for using
			 recent medical research to develop new medical checklists.</text>
				</paragraph></subsection><subsection id="H4C7953B934B2419A977F8404476C60FB"><enum>(c)</enum><header>Methodology of
			 study</header>
				<paragraph id="HB038A80831B74640BB1584E82D97E592"><enum>(1)</enum><header>Scope</header><text>The
			 Secretary shall ensure that the agreement entered into under subsection (a)
			 provides that the study conducted under such subsection will consider the
			 perspectives of—</text>
					<subparagraph id="HF93612061D0544CCB2FE9BAFBE1224CD"><enum>(A)</enum><text>various types of
			 health care professionals in various types of health care settings;</text>
					</subparagraph><subparagraph id="HB6E2A10E1E50485EB1597BA81951416F"><enum>(B)</enum><text>individuals
			 conducting academic research in health care quality; and</text>
					</subparagraph><subparagraph id="H9CD5A0BA31FA4550AB84D5488244C262"><enum>(C)</enum><text>patients.</text>
					</subparagraph></paragraph><paragraph id="HD6100F0AB233414BB2502B1C96F859C6"><enum>(2)</enum><header>Consultation
			 with relevant organizations</header><text>The Secretary shall ensure that the
			 agreement entered into under subsection (a) provides that relevant agencies and
			 organizations with expertise on medical checklists will be consulted during the
			 study conducted under such subsection, including the following:</text>
					<subparagraph id="H37A23ECC46A449AB895624BB45774AD3"><enum>(A)</enum><text>The Agency for
			 Healthcare Research and Quality.</text>
					</subparagraph><subparagraph id="HFA87517CE4204537AE58FF97E674CCD8"><enum>(B)</enum><text>The American
			 Nurses Association.</text>
					</subparagraph><subparagraph id="HCF1C5CBF7E144CDC8FD509C44566EA2F"><enum>(C)</enum><text>The Institute for
			 Healthcare Improvement.</text>
					</subparagraph><subparagraph id="HB5A5228998024BD5A3B8C444985BA134"><enum>(D)</enum><text>The American
			 Hospital Association.</text>
					</subparagraph><subparagraph id="H9AE0A714771E4D0DA0F82EFFFA74ED5C"><enum>(E)</enum><text>The American
			 Medical Association.</text>
					</subparagraph><subparagraph id="HAADA8FAF951E460FB7DBAC1BA03FB2D6"><enum>(F)</enum><text>The World Health
			 Organization.</text>
					</subparagraph><subparagraph id="H7D6449165EC242AEA5E4F14F5E49C5AA"><enum>(G)</enum><text>The National
			 Committee for Quality Assurance.</text>
					</subparagraph><subparagraph id="H738265E9074740E18A35D8D6EC12B660"><enum>(H)</enum><text>The Joint
			 Commission.</text>
					</subparagraph><subparagraph id="H50E4A39FC5F7478792B07905AAC7ADC9"><enum>(I)</enum><text>The American
			 Academy of Physician Assistants.</text>
					</subparagraph></paragraph></subsection><subsection id="HE761EBE4321949BDBC13F9017302F8E9"><enum>(d)</enum><header>Report</header><text>The
			 Secretary shall ensure that the agreement entered into under subsection (a)
			 provides that not later than 18 months after the date of the enactment of this
			 Act, a report providing the findings and recommendations made in the study
			 conducted under such subsection will be submitted to the Secretary, the
			 Committee on Energy and Commerce of the House of Representatives, and the
			 Committee on Health, Education, Labor, and Pensions of the Senate.</text>
			</subsection></section><section id="H1F10586EFB4F4604B3743695B4055357"><enum>5.</enum><header>Definitions</header><text display-inline="no-display-inline">In this Act, the following definitions
			 apply:</text>
			<paragraph id="HEA9172163425422C964F89D03EE6254A"><enum>(1)</enum><header>Health care
			 professional</header><text>The term <term>health care professional</term> means
			 an individual who provides health care services, including a physician,
			 physician assistant, nurse practitioner, clinical nurse specialist (as those
			 terms are defined in section 1861 of the Social Security Act (42 U.S.C.
			 1395x)), and such other individuals as the Secretary of Health and Human
			 Services determines appropriate.</text>
			</paragraph><paragraph id="HE1238F7521B2454A91AEB75B24120A3E"><enum>(2)</enum><header>Health care
			 setting</header><text>The term <term>health care setting</term> means a
			 facility at which health care services are provided, including a hospital
			 providing inpatient hospital services (as that term is defined in section 1861
			 of the Social Security Act (42 U.S.C. 1395x)), an ambulatory surgical center
			 (meeting the standards specified under section 1832(a)(2)(F)(i) of the Social
			 Security Act (42 U.S.C. 1395k)), and such other settings as the Secretary of
			 Health and Human Services determines appropriate.</text>
			</paragraph><paragraph id="H9774B2D338A64F23B36E5D3F40E5C349"><enum>(3)</enum><header>Health care
			 provider</header><text>The term <term>health care provider</term> means a
			 health care professional or a health care setting.</text>
			</paragraph><paragraph id="HC7B7F707FEBB489299FF3BD43258C950"><enum>(4)</enum><header>Medical
			 checklist</header><text>The term <term>medical checklist</term> means a
			 predetermined, evidence-based, well-defined set of steps that should be
			 completed during a designated medical clinical encounter or medical procedure,
			 as further defined by the Director of the Agency for Healthcare Research and
			 Quality in consultation with the Institute of Medicine and the National Academy
			 of Engineering of the National Academies.</text>
			</paragraph></section></legis-body>
</bill>
