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<bill bill-stage="Introduced-in-Senate" public-private="public">
	<form>
		<distribution-code display="yes">II</distribution-code>
		<congress>111th CONGRESS</congress>
		<session>2d Session</session>
		<legis-num>S. 3596</legis-num>
		<current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber>
		<action>
			<action-date date="20100715">July 15, 2010</action-date>
			<action-desc><sponsor name-id="S320">Mrs. Hagan</sponsor> introduced
			 the following bill; which was read twice and referred to the
			 <committee-name committee-id="SSFI00">Committee on
			 Finance</committee-name></action-desc>
		</action>
		<legis-type>A BILL</legis-type>
		<official-title>To establish the Culture of Safety Hospital
		  Accountability Study and Demonstration Program.</official-title>
	</form>
	<legis-body>
		<section id="id25F34B1AE27F434B924BF459306B68AB" 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>Culture of Safety Hospital
			 Accountability Act of 2010</short-title></quote>.</text>
		</section><section id="id2AF447F31EA44994AA2130829518BEF8"><enum>2.</enum><header>Culture of
			 Safety Hospital Accountability Study and Demonstration Program</header>
			<subsection id="idA61AA9E0510642279F41DB627AE44D0B"><enum>(a)</enum><header>Study</header>
				<paragraph id="idD4ED76C8B9A54D948D36E6CD80D7E0AA"><enum>(1)</enum><header>In
			 general</header><text>The Secretary shall conduct a study that—</text>
					<subparagraph id="id7E08C32C66CD42C09EF41A796F28E52A"><enum>(A)</enum><text>examines existing
			 activities and programs in hospitals for quality assurance, patient safety, and
			 performance improvement and provides an analysis regarding best practices with
			 respect to such activities and programs; and</text>
					</subparagraph><subparagraph id="id5FCF0010F9044B3ABD4F24CB10937339"><enum>(B)</enum><text>identifies best
			 practices that should be replicated in hospitals to improve patient safety and
			 quality of care, consistent with the provisions included under the quality
			 assessment and performance improvement program, as required under the
			 conditions of participation for hospitals under Medicare.</text>
					</subparagraph></paragraph><paragraph id="id16E0100CA019488E99605B842E68963C"><enum>(2)</enum><header>Report</header><text>Not
			 later than 2 years after the date of enactment of this Act, the Secretary shall
			 prepare a report containing the results of the study conducted under paragraph
			 (1). Such report shall be made available on the Internet website of the Centers
			 for Medicare &amp; Medicaid Services.</text>
				</paragraph></subsection><subsection id="id8D40728E3E1B47708F2BFD155247F776"><enum>(b)</enum><header>Demonstration
			 program</header>
				<paragraph id="id31C0FF1339F14A40929D5BE1AADA38DB"><enum>(1)</enum><header>In
			 general</header><text>The Secretary shall establish the Culture of Safety
			 Hospital Accountability demonstration program to provide support for
			 establishing partnerships and other cooperative approaches between hospitals,
			 State health care agencies, and the Department of Health and Human Services to
			 promote and implement the best practices identified under subsection (a), with
			 the goal of improving the safety and quality of care provided to Medicare
			 beneficiaries and enhance compliance with the conditions of participation for
			 hospitals under Medicare.</text>
				</paragraph><paragraph id="id43E62CFFDE47441FA2B87D704D0FDBEE"><enum>(2)</enum><header>Duration</header><text>The
			 demonstration program shall operate during a period of 3 years, beginning not
			 later than 12 months after completion of the report described in subsection
			 (a)(2).</text>
				</paragraph><paragraph id="idB84B2223CE344D0397C863CFEE6272D2"><enum>(3)</enum><header>Scope</header>
					<subparagraph id="idAF1B3E6B94274283B78CCBE8CE7FFEE8"><enum>(A)</enum><header>States</header><text>The
			 Secretary shall select not less than 4 States, but not more than 6 States, to
			 participate in the demonstration program.</text>
					</subparagraph><subparagraph id="idD42FF1894E0D461B99AC97A57C392ABE"><enum>(B)</enum><header>Hospitals</header><text>The
			 Secretary shall select not more than 24 hospitals, within the States selected
			 under subparagraph (A), to participate in the demonstration program. The
			 hospitals selected under this subparagraph shall satisfy criteria, as developed
			 by the Secretary, relating to compliance with the conditions of participation
			 for hospitals under Medicare.</text>
					</subparagraph></paragraph><paragraph id="id5D186C4889F4447CA1B61E60003A3402"><enum>(4)</enum><header>Application</header><text>A
			 State or hospital that desires to participate in the demonstration program
			 shall submit to the Secretary an application at such time, in such manner, and
			 containing such information as the Secretary may require.</text>
				</paragraph><paragraph id="idF4E6803984DF45A4BF2A480103593927"><enum>(5)</enum><header>Implementation</header>
					<subparagraph id="idFA23E91630204A8D9D11B71D06ADEB92"><enum>(A)</enum><header>Technical
			 assistance</header><text>The Secretary shall provide participating hospitals
			 with technical assistance in implementation of the best practices identified
			 through the study under subsection (a).</text>
					</subparagraph><subparagraph id="id8C03230175BB4B1AA9CFA95D5D25708F"><enum>(B)</enum><header>Hospital
			 surveyors</header><text>For each State participating in the demonstration
			 program, the Secretary shall provide training to State surveyors that is
			 designed to—</text>
						<clause id="id73D1F0E371474CAAAD8F295DE76BAA89"><enum>(i)</enum><text>enhance knowledge
			 of the disciplines of patient safety, quality assessment, and performance
			 improvement;</text>
						</clause><clause id="idAFA8E75C836049408FD81CF940C3CB65"><enum>(ii)</enum><text>increase skill
			 in evaluating compliance with quality assessment and performance improvement
			 programs required under the conditions of participation for hospitals under
			 Medicare; and</text>
						</clause><clause id="id4CCBF97F3589414EB8361C9B4A4572C8"><enum>(iii)</enum><text>focus
			 investigations of complaints regarding hospital care on the hospital's quality
			 assessment and performance improvement program.</text>
						</clause></subparagraph></paragraph><paragraph id="idC7BA85B715C342588E0CE670924EAF1D"><enum>(6)</enum><header>Evaluation</header><text display-inline="yes-display-inline">For each State and hospital participating
			 in the demonstration program, the Secretary shall evaluate the
			 following:</text>
					<subparagraph id="idAF31BCE8BF7A458286DC66C350EF7969"><enum>(A)</enum><text>The level of
			 implementation of the best practices identified under subsection (a) by the
			 participating hospitals and whether adoption of such practices—</text>
						<clause id="id10BC35D65D654C3C813DBE646A81083D"><enum>(i)</enum><text>improved quality
			 and patient safety (including an analysis of changes in quality measures and
			 other indicators of outcome and performance); and</text>
						</clause><clause id="id763A6ED268B04CBF8A09B00F365DD1C0"><enum>(ii)</enum><text>resulted in a
			 decrease in the seriousness or number of citations for deficiencies under the
			 conditions of participation for hospitals under Medicare.</text>
						</clause></subparagraph><subparagraph id="id00D6505F260E424F82AB66B5BAE1E7DE"><enum>(B)</enum><text>The training
			 provided to State surveyors and whether such training resulted in enhanced
			 proficiency in evaluations of hospital quality assessment and performance
			 improvement programs.</text>
					</subparagraph></paragraph><paragraph id="id1E2A7FB34AC64DB58A289881B19C1AEB"><enum>(7)</enum><header>Report</header><text>Not
			 later than 12 months after completion of the demonstration program, the
			 Secretary shall submit to Congress a report containing an evaluation of such
			 program, including—</text>
					<subparagraph id="idE59A52728AAF4349B0CEEF5D7DD950B0"><enum>(A)</enum><text>the findings of
			 the evaluation under paragraph (6); and</text>
					</subparagraph><subparagraph id="id57A7F37AE0F74640A61BD8BAD0E82177"><enum>(B)</enum><text>recommendations—</text>
						<clause id="idC164A0EDF486410FB384C3B5BDE1D50E"><enum>(i)</enum><text>in
			 regard to whether the best practices identified under the demonstration program
			 should be adopted by other hospitals, and how the Secretary can best promote
			 adoption of such best practices;</text>
						</clause><clause id="id1EA76D465B374179ABEE79A96AB0F59F"><enum>(ii)</enum><text>in
			 regard to whether the training for State surveyors developed under the
			 demonstration program should be provided to all State surveyors; and</text>
						</clause><clause id="id888298C436A54503B43C93BFD49D4165"><enum>(iii)</enum><text>for such
			 legislation and administrative action as the Secretary determines
			 appropriate.</text>
						</clause></subparagraph></paragraph><paragraph id="idE812CD89B1EF4ECDAB65ACA266F88F28"><enum>(8)</enum><header>Waiver
			 authority</header><text display-inline="yes-display-inline">The Secretary may
			 waive such requirements under titles XI and XVIII of the Social Security Act as
			 may be necessary to carry out the demonstration program.</text>
				</paragraph></subsection><subsection id="id7C03D08E5C394155A328FA3E1A9455B3"><enum>(c)</enum><header>Funding</header><text display-inline="yes-display-inline">For purposes of carrying out this Act, the
			 Secretary shall provide for the transfer from the Federal Hospital Insurance
			 Trust Fund under section 1817 of the Social Security Act (42 U.S.C. 1395i) of
			 $25,000,000, to the Centers for Medicare &amp; Medicaid Services Program
			 Management Account for the period of fiscal years 2010 through 2017. Amounts
			 transferred under the preceding sentence shall remain available until
			 expended.</text>
			</subsection><subsection id="id96CB4E65A18B4EE8AC967785161BFC00"><enum>(d)</enum><header>Alternative
			 remedies</header><text>Section 1866(b) of the Social Security Act (42 U.S.C.
			 1395cc(b)) is amended by adding at the end the following new paragraph:</text>
				<quoted-block display-inline="no-display-inline" id="id7E84DEAA62E34BCCA6784D09B9413A9C" style="OLC">
					<paragraph id="id880B12F7836545468FE2DD2514F950FE"><enum>(5)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id773C436CE0344D8E88CECE112E4147BF"><enum>(A)</enum><text>The Secretary is
				authorized to promulgate regulations that establish enforcement remedies that
				are in addition to, or in lieu of, termination of an agreement under this
				section for hospitals or critical access hospitals for violations of health and
				safety requirements under this title. Such remedies may include directed plans
				of correction that are designed to—</text>
							<clause id="id2B9730B7B4F54EC99E199BF60443C7B1"><enum>(i)</enum><text>ensure compliance
				with requirements under this title (including conditions of participation for
				hospitals or critical access hospitals);</text>
							</clause><clause id="idC8A0B8355758413F99BC834C36008070"><enum>(ii)</enum><text>prevent
				recurrence of non-compliance with such requirements; and</text>
							</clause><clause id="id26A260C76DD84C3EB0D7B6EAF323FC8B"><enum>(iii)</enum><text>improve the
				internal structures and processes within the hospital or critical access
				hospital for provision of continuous quality and safety enhancement.</text>
							</clause></subparagraph><subparagraph id="idD010AC7DDACE4DD18BC69E8CA719FD72"><enum>(B)</enum><text>The regulations
				described under subparagraph (A) may be promulgated by the Secretary before,
				during, or after the evaluation described under section 2(b)(6) of the
				<short-title>Culture of Safety Hospital Accountability Act
				of
				2010</short-title>.</text>
						</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
			</subsection><subsection id="idC21F3046703E428DAF7902EF07E6CFAE"><enum>(e)</enum><header>Non-Application
			 of Paperwork Reduction Act</header><text>Chapter 35 of title 44, United States
			 Code (commonly referred to as the ‘Paperwork Reduction Act of 1995’) shall not
			 apply to this Act.</text>
			</subsection><subsection id="id7BF32D77F6B44CAC978450BC870A5E3F"><enum>(f)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this Act:</text>
				<paragraph id="id4A2A6A39C4654D31815713751C84C588"><enum>(1)</enum><header>Demonstration
			 program</header><text display-inline="yes-display-inline">The term
			 <term>demonstration program</term> means the Culture of Safety Hospital
			 Accountability demonstration program conducted under this Act.</text>
				</paragraph><paragraph id="id8ACAAF4D1C2144CF8C59EE863425E5F7"><enum>(2)</enum><header>Hospital</header><text display-inline="yes-display-inline">The term <term>hospital</term>
			 means—</text>
					<subparagraph id="idF94DEEC7A7D04A9FA34505A679E44445"><enum>(A)</enum><text>an institution
			 described under section 1861(e) of the Social Security Act (42 U.S.C.
			 1395x(e)); or</text>
					</subparagraph><subparagraph id="idDA140866318742AB9C5D8C43DCF5C95E"><enum>(B)</enum><text>a critical access
			 hospital (as described under section 1861(mm)(1) of such Act (42 U.S.C.
			 1395x(mm)(1)).</text>
					</subparagraph></paragraph><paragraph id="id4A62B2CD17F14F8DB2BCB9F2C36C5853"><enum>(3)</enum><header>Medicare</header><text>The
			 term <term>Medicare</term> means the program established under title XVIII of
			 the Social Security Act (42 U.S.C. 1395 et seq.).</text>
				</paragraph><paragraph id="id6BE0CEBAA51745529DB23FC6F5F1DC09"><enum>(4)</enum><header>Secretary</header><text>The
			 term <term>Secretary</term> means the Secretary of Health and Human
			 Services.</text>
				</paragraph></subsection></section></legis-body>
</bill>
