Standards/Regulations

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February 2018
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SHEA issues new guidance on contact precautions

Editor's Note The Society for Healthcare Epidemiology of America (SHEA) on January 11 released new expert guidance on contact precautions for patients with multidrug-resistant bacterial infections. The guidance advises hospitals on when they can safely discontinue contact precautions, including use of gowns, gloves, and masks. In most cases, this ranges…

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By: Judy Mathias
January 19, 2018
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Joint Commission releases 2018 Hospital Compliance Assessment Checklist

Editor's Note Joint Commission Resources on January 17 released the 2018 Hospital Compliance Assessment Checklist, a self-assessment workbook designed to help organizations with standards compliance and survey readiness. In addition to hospital standards and elements of performance (EP), this year’s Checklist includes: High-level prompts to promote staff discussion and cultivate…

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By: Judy Mathias
January 19, 2018
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Editorial

Uncertainty was the defining characteristic of the healthcare industry in 2017 as regulatory changes were proposed, rejected, revised, or tabled for now. The individual insurance mandate was repealed as part of a year-end tax reform bill—a victory for an administration that favors deregulation, but also a change that is projected…

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By: Elizabeth Wood
January 19, 2018
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FDA issues Safety Alert for Zoll LifeVest 4000 Wearable Cardioverter Defibrillator

Editor's Note The Food & Drug Administration (FDA) on January 17 issued a Safety Alert for the Zoll LifeVest 4000 Wearable Cardioverter Defibrillator because of concerns that the device may fail to deliver treatment to patients if the device is not replaced soon after displaying “Call for service: Device has…

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By: Judy Mathias
January 17, 2018
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FDA updates Safety Alert for Cortrak 2 Enteral Access System

Editor's Note The Food & Drug Administration (FDA) on January 12 updated a Safety Alert about pneumothorax events associated with feeding tube placement procedures using the Cortrak 2 Enteral Access System (EAS) by Corpak Medsystems (Buffalo Grove, Illinois). Several of the events were associated with cardiopulmonary arrest, and there were…

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By: Judy Mathias
January 17, 2018
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CMS proposes coverage change for MRI with implanted cardiac devices

Editor's Note The Centers for Medicare & Medicaid Services on January 11 issued a proposal to modify its national coverage determination for magnetic resonance imaging (MRI) to include patients who have implanted cardiac devices. Proposed changes include the expansion of coverage for patients with cardiac devices that are approved or…

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By: Judy Mathias
January 16, 2018
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FDA delays UDI compliance dates for class I, unclassified devices

Editor's Note The Food and Drug Administration (FDA) on January 12 announced a delay in enforcement of unique device identification (UDI) requirements for class I and unclassified devices until September 24, 2020. The FDA also will not enforce direct mark requirements for these devices until September 24, 2022. The guidance…

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By: Judy Mathias
January 16, 2018
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CDC updates data on HAIs

Editor's Note The Centers for Disease Control and Prevention (CDC) on January 5 updated its data on healthcare-associated infections (HAIs). Central line-associated bloodstream infections (CLABSIs) have dropped 50% since 2008. Catheter-associated urinary tract infections (CAUTIs) have had consistent year-to-year decreases, especially since those caused by yeast were deleted from the…

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By: Judy Mathias
January 12, 2018
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FDA: Class I recall of Certitude Delivery System

Editor's Note The Food and Drug Administration (FDA) on January 11 classified the recall by Edwards LifeSciences (Irvine, California) of its Certitude Delivery System as Class I, the most serious. The system is used for delivery of the Edwards SAPIEN 3 transcatheter aortic heart valve. The recall was issued because…

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By: Judy Mathias
January 12, 2018
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CMS announces new voluntary bundled payment model

Editor's Note The Centers for Medicare and Medicaid Services (CMS) on January 9 announced a new voluntary bundled payment model called, “Bundled Payments for Care Improvement Advanced” (BPCI Advanced). Participants in BPCI Advanced will receive payments for performance on 32 (29 inpatient, 3 outpatient) different clinical episodes. The first cohort…

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By: Judy Mathias
January 10, 2018
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