Regulations/Legal

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April 2019
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Joint Commission seeking comments on proposed EP for office-based surgery practices using fluoroscopy

Editor's Note The Joint Commission on February 20 announced that it is seeking comments on a proposed element of performance (EP) for office-based surgery practices that provide fluoroscopy services. The new requirement−Environment of Care (EC) standard EC.02.02.01−addresses the monitoring of radiation exposure badges. The deadline for comments is March 29.

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By: Judy Mathias
February 21, 2019
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ASCs react to 2019 regulatory changes

Each year, ambulatory surgery centers (ASCs) adapt to numerous federal regulatory policy reforms. As an example, since 2012, when the Centers for Medicare & Medicaid Services (CMS) launched the Ambulatory Surgery Center Quality Reporting (ASCQR) Program ASCs had been asking for, ASCs have reported data for a changing set of…

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By: Judith M. Mathias, MA, RN
February 20, 2019
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FDA: Class I recall of Medtronic’s Dual Chamber Implantable Pulse Generators

Editor's Note The Food & Drug Administration (FDA) on February 15 identified Medtronic, Inc’s (Dublin, Ireland) recall of it’s Dual Chamber Implantable Pulse Generators (IPGs) as Class I, the most serious. The recall was initiated because of the possibility of a software error that can result in a lack of…

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By: Judy Mathias
February 19, 2019
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Joint Commission revises Sentinel Event Alert on diagnostic radiation

Editor's Note The Joint Commission on February 13 announced the revision of its Sentinel Event Alert on diagnostic radiation, which was updated to also address risks associated with fluoroscopy. The original Alert, “Issue 47: Radiation risks of diagnostic imaging and fluoroscopy was published in August 2011.

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By: Judy Mathias
February 14, 2019
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FDA: Class I recall of Edwards Lifesciences Swan-Ganz Thermodilution Catheter

Editor's Note The Food and Drug Administration (FDA) on February 5 identified the recall by Edwards Lifesciences (Irvine, California) of its Swan-Ganz Thermodilution Catheter as Class I, the most serious. The recall was initiated because of incorrect assembly and reversal of catheter lumens that can expose the patient to serious…

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By: Judy Mathias
February 14, 2019
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FDA warns of link between breast implants and anaplastic large cell lymphoma

Editor's Note The Food and Drug Administration (FDA) on February 6 posted a letter that was sent to healthcare providers to increase their awareness of the association between all breast implants, regardless of filling or texture, and breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). As of September 30, 2018, the…

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By: Judy Mathias
February 13, 2019
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Joint Commission announces new Speak Up campaign on infection prevention

Editor's Note The Joint Commission on February 6 announced its new Speak Up campaign that focuses on ways to prevent infection. The Joint Commission offers free educational resources that include: an infographic poster/flyer an animated video a guide with recommendations on how healthcare organizations can use and provide the materials…

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By: Judy Mathias
February 12, 2019
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ECRI Institute launches new web-based clinical practice guidelines repository with open access

Editor's Note ECRI Institute recently launched ECRI Guidelines Trust, a publicly available web-based repository of evidence-based national and international clinical guidelines as well as Guideline Briefs with TRUST Scorecards. The healthcare community has free access to the repository, which was created after funding cuts forced the Agency for Healthcare Research…

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By: Judy Mathias
February 11, 2019
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Joint Commission reinstates volume requirement for stroke center certification programs

Editor's Note The Joint Commission on January 23 announced that it is reinstating the individual mechanical thrombectomy volume eligibility requirement for the Thrombectomy-Capable Stroke Center (TSC) and Comprehensive Stroke Center (CSC) certification programs. The Joint Commission is also implementing a revised volume requirement in 6 months that expands which physicians…

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By: Judy Mathias
January 24, 2019
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CDC provides first estimates of flu season

Editor's Note New data from the Centers for Disease Control and Prevention (CDC) show that so far, during the 2018-2019 season, between 6 and 7 million people have been sick with the flu. Up to half have sought medical care, and between 69,000 and 84,000 have been hospitalized. These estimates…

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By: Judy Mathias
January 17, 2019
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