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		<title>RedLine: January 3, 2012</title>
		<link>http://www.auburnstrat.com/2011/12/redline-january-3-2012/</link>
		<comments>http://www.auburnstrat.com/2011/12/redline-january-3-2012/#comments</comments>
		<pubDate>Fri, 30 Dec 2011 18:44:32 +0000</pubDate>
		<dc:creator>admin</dc:creator>
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		<guid isPermaLink="false">http://www.auburnstrat.com/?p=768</guid>
		<description><![CDATA[











Defense to Demo Lab Developed Test Evaluations



The US Department of Defense (DoD) announced its intention to evaluate laboratory-developed tests for possible coverage under the TRICARE military health system. The demonstration project aims to determine the feasibility for the DoD to review laboratory developed tests approved by the Centers for Medicare and Medicaid Services, but not [...]]]></description>
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		<title>RedLine: November 28, 2011</title>
		<link>http://www.auburnstrat.com/2011/11/redline-november-28-2011/</link>
		<comments>http://www.auburnstrat.com/2011/11/redline-november-28-2011/#comments</comments>
		<pubDate>Mon, 28 Nov 2011 06:14:10 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Newsletter]]></category>

		<guid isPermaLink="false">http://www.auburnstrat.com/?p=752</guid>
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CMS Retracts Physician Signature Policy for Labs




In a painstaking policy review, the Centers for Medicare &#38; Medicaid Services (CMS) rescinds its decision to require the signature of a physician or non-physician provider on a requisition for clinical diagnostic laboratory tests paid under the Medicare Clinical Laboratory Fee Schedule. The decision was explained in a 4,500 [...]]]></description>
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		<title>RedLine: October 11, 2011</title>
		<link>http://www.auburnstrat.com/2011/10/redline-october-11-2011/</link>
		<comments>http://www.auburnstrat.com/2011/10/redline-october-11-2011/#comments</comments>
		<pubDate>Tue, 11 Oct 2011 04:19:18 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Newsletter]]></category>

		<guid isPermaLink="false">http://www.auburnstrat.com/?p=727</guid>
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FDA, CMS Ready to Pilot Parallel Reviews for Medical Devices



Sponsors of innovative device technologies are invited to participate in a pilot program that would permit concurrent review of certain premarket review submissions at the Food and Drug Administration and national coverage determinations at the Centers for Medicare &#38; Medicaid Services. The two agencies released their [...]]]></description>
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		<title>RedLine: September 12, 2011</title>
		<link>http://www.auburnstrat.com/2011/09/redline-september-12-2011/</link>
		<comments>http://www.auburnstrat.com/2011/09/redline-september-12-2011/#comments</comments>
		<pubDate>Mon, 12 Sep 2011 21:15:48 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Newsletter]]></category>

		<guid isPermaLink="false">http://www.auburnstrat.com/?p=717</guid>
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HHS Proposes Direct Patient Access to Lab Test Results



On September 12, 2011, the Secretary of Health and Human Services released a proposed rule that would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) so that laboratories may provide patient access to completed test reports. It would also amend the Health Insurance Portability and Accountability [...]]]></description>
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		<title>RedLine: August 24, 2011</title>
		<link>http://www.auburnstrat.com/2011/08/redline-august-24-2011/</link>
		<comments>http://www.auburnstrat.com/2011/08/redline-august-24-2011/#comments</comments>
		<pubDate>Wed, 24 Aug 2011 15:34:31 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Newsletter]]></category>

		<guid isPermaLink="false">http://www.auburnstrat.com/?p=706</guid>
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IOM Panel Examines Use of Tissue Repository



The Institute of Medicine convened a panel to respond to questions from the U.S. Department of Defense on the appropriate use of the Armed Forces Institute of Pathology&#8217;s Tissue Repository as it is transferred to the Joint Pathology Center. With the mandated disestablishment of the AFIP, responsibility for the [...]]]></description>
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		<title>RedLine: January 3, 2011</title>
		<link>http://www.auburnstrat.com/2011/01/redline-january-3-2011/</link>
		<comments>http://www.auburnstrat.com/2011/01/redline-january-3-2011/#comments</comments>
		<pubDate>Sun, 02 Jan 2011 05:07:40 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Newsletter]]></category>

		<guid isPermaLink="false">http://www.auburnstrat.com/?p=685</guid>
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FDA Signals Intent to Require Quality Systems for Nonclinical Lab Practices



The Food and Drug Administration (FDA) has signaled its intent to modify existing regulations overseeing good laboratory practices for all facilities and laboratories conducting nonclinical studies.  The agency issued an advance notice of proposed rulemaking on December 21, 2010, outlining its deliberations on the matter.
The [...]]]></description>
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		<title>RedLine: October 5, 2010</title>
		<link>http://www.auburnstrat.com/2010/10/redline-october-5-2010/</link>
		<comments>http://www.auburnstrat.com/2010/10/redline-october-5-2010/#comments</comments>
		<pubDate>Tue, 05 Oct 2010 22:17:59 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Newsletter]]></category>

		<guid isPermaLink="false">http://www.auburnstrat.com/?p=660</guid>
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Nurses Should Take the Reins Says IOM



The Institute of Medicine released its consensus report, The Future of Nursing: Leading Change, Advancing Health on October 5, 2010.  Developed over two years, the report assessed the nursing profession and formulated four key messages intended to help transform the profession.  Those messages include urging nurses to practice to [...]]]></description>
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		<title>RedLine: September 4, 2010</title>
		<link>http://www.auburnstrat.com/2010/09/redline-september-4-2010/</link>
		<comments>http://www.auburnstrat.com/2010/09/redline-september-4-2010/#comments</comments>
		<pubDate>Sun, 05 Sep 2010 01:39:48 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Uncategorized]]></category>

		<guid isPermaLink="false">http://www.auburnstrat.com/?p=653</guid>
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CLIAC Focuses on Proficiency Testing


The Clinical Laboratory Improvement Advisory Committee (CLIAC) met on September 1-2, 2010, to discuss laboratory proficiency testing (PT) issues, including: continuation of cytology PT, routes for inclusion and prioritization of analytes, acceptable performance criteria and grading, PT referral mandates and improvements for microbiology PT.
 
The panel reiterated that PT is one of [...]]]></description>
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		<title>RedLine: June 8, 2010</title>
		<link>http://www.auburnstrat.com/2010/06/redline-june-8-2010/</link>
		<comments>http://www.auburnstrat.com/2010/06/redline-june-8-2010/#comments</comments>
		<pubDate>Tue, 08 Jun 2010 19:28:39 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Newsletter]]></category>

		<guid isPermaLink="false">http://www.auburnstrat.com/?p=633</guid>
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Vision for Food Safety Lacking Says IOM



On June 8, 2010, the Institute of Medicine (IOM) released its report, Enhancing Food Safety: The Role of the Food and Drug Administration, finding that the agency&#8217;s &#8220;approach to food safety continues to be reactive and lacking a systematic focus on prevention.&#8221;  To guard properly against the 76 million [...]]]></description>
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		<item>
		<title>RedLine: February 10, 2010</title>
		<link>http://www.auburnstrat.com/2010/02/redline-february-10-2010/</link>
		<comments>http://www.auburnstrat.com/2010/02/redline-february-10-2010/#comments</comments>
		<pubDate>Wed, 10 Feb 2010 07:29:08 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Newsletter]]></category>

		<guid isPermaLink="false">http://www.auburnstrat.com/?p=577</guid>
		<description><![CDATA[



FDA Opens Dialogue on Device Challenges



The federal government closed on February 9, 2010, due to major snow accumulations, but the Food and Drug Administration (FDA) persevered with its scheduled meeting to discuss how new science should be incorporated into regulatory decision-making. 
Jeff Shuren, MD, JD, the new Director of the Center for Devices and Radiological Health [...]]]></description>
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