Regulations/Legal

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December 2017
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ECRI Institute offers free disaster preparedness, recovery resources

Editor's Note In response to the destruction caused by hurricanes Harvey, Irma, and Maria, the ECRI Institute is providing free access to resources, publications, and tools to help guide healthcare facilities affected by natural disasters. The Disaster Preparedness and Recovery Resource Center, which includes links to material from the ECRI…

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By: Judy Mathias
October 11, 2017
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CMS moving MU attestation to QualityNet Secure Portal

Editor's Note The Centers for Medicare & Medicaid Services (CMS) is moving submission of 2017 meaningful use (MU) data from the Electronic Health Record (EHR) Incentive Program Registration and Attestation System to the QualityNet Secure Portal (QNet), effective January 2, 2018, the October 4 EHR Intelligence reports. QNet is currently…

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By: Judy Mathias
October 9, 2017
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Joint Commission begins Phase 4 revisions of EP Review Project

Editor's Note The Joint Commission on October 4 announced that Phase 4 of the EP [elements of performance] Review Project has begun, with EPs across all accreditation programs being evaluated for streamlining and consolidation. Revisions from the first part of Phase 4 will take effect January 1, 2018. Consolidation is…

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By: Judy Mathias
October 9, 2017
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Joint Commission deletes Medication Management EP

Editor's Note The Joint Commission announced on October 4 that it is deleting element of performance (EP) 3 for Medication Management 09.01.01 for hospitals and critical access hospitals, effective October 1. The standard states: “The [critical access] hospital educates patients, and their families as needed, regarding the appropriate use of…

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By: Judy Mathias
October 5, 2017
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FDA issues Safety Alert for intraocular TMV injections

Editor's Note The Food & Drug Administration (FDA) on October 3 issued a Safety Alert saying the agency had received an adverse event report on a patient who was diagnosed with bilateral hemorrhagic occlusive retinal vasculitis after being administered injections of a compounded triamcinolone, moxifloxacin, vancomycin (TMV) formulation in each…

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By: Judy Mathias
October 5, 2017
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Joint Commission updates business rules for calculating Life Safety Code surveyor days

Editor's Note The Joint Commission on September 27 announced an update to its business rules that determine the number of days the Life Safety Code surveyor will be part of a hospital’s survey. The changes, which will take effect January 1, 2018, include: Only square footage will be used to…

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By: Judy Mathias
September 28, 2017
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FDA alerts healthcare providers about EVAR graft endoleaks

Editor's Note The Food & Drug Administration (FDA) on September 28 sent letters to vascular and cardiothoracic surgeons, radiologists, and cardiologists, alerting them to an increase in Type III endoleaks associated with endovascular graft systems used in endovascular aneurysm repair (EVAR) for abdominal aortic and aorto-iliac aneurysms. The FDA’s letter…

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By: Judy Mathias
September 28, 2017
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California department of Public Health issues penalties to 10 hospitals

Editor's Note The California Department of Public Health (CDPH) on August 31 issued 10 penalties to 10 California hospitals along with fines totaling $618,002. Of these, three applied to the OR: Loma Linda University Medical Center, Murrieta−a patient sustained a full thickness thermal burn injury to the left calf from…

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By: Judy Mathias
September 27, 2017
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Joint Commission posts sentinel event stats for first half of 2017

Editor's Note The Joint Commission on September 20 posted sentinel event statistics from its database through June 30, 2017. Of the top 10 most frequently reported sentinel events during this time period: Falls topped the list with 49 events. Unintended retention of a foreign object was 3rd with 41 events.…

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By: Judy Mathias
September 27, 2017
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FDA: Class I recall of Spectranetics’ Bridge Occlusion Balloon Catheter

Editor's Note The Food and Drug Administration (FDA) on September 25 categorized the recall by Spectranetics (Colorado Springs, Colorado) of its Bridge Occlusion Balloon Catheter (model 590-001) as Class I, the most serious. The Bridge Occlusion Balloon Catheter is used to temporarily block the superior vena cava when emergency control…

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By: Judy Mathias
September 26, 2017
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