Regulations/Legal

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September 2019
Home Regulations/Legal

FDA: Class I recall of Vyaire Medical enFlow fluid warming disposable cartridge

Editor's Note The Food & Drug Administration (FDA) on August 21 identified Medline Industries’ recall of Centurion Medical Products’ Primary Warmer Pack containing the Vyaire Medical enFlow fluid warming system disposable cartridge as Class I, the most serious. The recall was initiated because the cartridge may elute aluminum into infused…

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By: Judy Mathias
August 26, 2019
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ASC Manager Issue 2

Healthcare providers have seen a steady stream of inpatient-only procedures migrate to ambulatory surgery centers (ASCs) over the past few years. Medicare is reimbursing an increasing number of procedures performed in the outpatient setting, many of them cardiovascular in nature. This issue of ASC Manager explores the development of a…

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By: Judy Mathias
August 23, 2019
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FDA: Class I recall of Edwards Lifesciences SAPIEN 3 Ultra Delivery System

Editor's Note The Food and Drug Administration on August 22 identified the recall by Edwards Lifesciences of all lots of its SAPIEN 3 Ultra Delivery System as Class I, the most serious. The delivery system is part of the Edwards SAPIEN 3 Transcatheter Heart Valve System. The recall was initiated…

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By: Judy Mathias
August 22, 2019
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Joint Commission: Reminder for CY 2019 hospital data submission

Editor's Note The Joint Commission on August 21 posted a reminder for accredited hospitals with electronic clinical quality measure (eCQM) requirements that they must submit CY 2019 eCQM data via the Direct Data Submission (DDS) Platform. The deadline to onboard to the DDS Platform is December 20, 2019, and the…

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By: Judy Mathias
August 22, 2019
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CMS to enhance Overall Hospital Quality Star Ratings

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on August 19 announced that it plans to update the quality measurement methodology of the Overall Hospital Quality Star Ratings in 2021. The Star Ratings are located on CMS’ Hospital Compare website. While the new methodology is being finalized, CMS…

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By: Judy Mathias
August 19, 2019
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You may also be interested in these sessions at the OR Manager Conference this September in Nashville, TN

Ace the Test: Strategies for a Successful Joint Commission Survey

After this session you'll be able to: Summarize 2019 Joint Commission (TJC) standards and Centers for Medicare & Medicaid Services (CMS) regulations pertinent to Surgical Services. Develop strategies to ensure ongoing compliance and survey readiness. Understand methodologies surveyors use to assess compliance. Why this is important: Is your team prepared…

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Joint Commission releases new sentinel event stats

Editor's Note The Joint Commission on August 14 released new sentinel event statistics for the first half of 2019. The latest data also introduce new categories for describing sentinel events, including suicide-related events, surgical or invasive procedure events, anesthesia-related events, and product or device events. The top five most frequently…

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By: Judy Mathias
August 15, 2019
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Statewide initiative reduces postop opioid prescribing without increase in patient pain

Editor's Note Implementation of opioid prescribing guidelines in the state of Michigan reduced opioid prescription size without negatively affecting patient satisfaction or pain, this study finds. In 1 year, teams at 43 hospitals across the state reduced by nearly one-third the number of opioid pills they prescribed to patients (having…

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By: Judy Mathias
August 15, 2019
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Joint Commission refines requirements for practitioner credentialing, privileging, and evaluation

Editor's Note The Joint Commission announced on August 14 that accredited hospitals and critical access hospitals will be able to supplement local data with data acquired from Medicare-certified hospitals and critical access hospitals for the purposes of practitioner credentialing, privileging, and evaluation (focused and ongoing). The supplemental data may not…

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By: Judy Mathias
August 15, 2019
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Hospital revisits have increased since implementation of HRRP

Editor's Note Hospital revisits (ie, treat-and-discharge visits to ED, observation stays, or inpatient readmissions) within 30 days of discharge have increased since implementation of the Hospital Readmission Reduction Program (HRRP), this study finds. Though hospital readmissions have dropped since HRRP was implemented as part of the Affordable Care Act, there…

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By: Judy Mathias
August 14, 2019
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FDA: Class I recall of Volumat MC Agilia Infusion System, Vigilant Drug Library

Editor's Note The Food & Drug Administration on August 12 identified the recall by Fresenius Kabi (Bad Homburg, Germany) of its Volumat MC Agilia Infusion System and Vigilant Drug Library as Class I, the most serious. The recall was initiated because of a “Low Priority,” “Keep Vein Open,” “End of…

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By: Judy Mathias
August 13, 2019
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You may also be interested in these sessions at the OR Manager Conference this September in Nashville, TN

2019 Regulatory and Quality Measure Reporting Update for ASCs

After this session you'll be able to: Discuss the most current updates to federal regulations and what to expect in 2020. Identify quality reporting for ambulatory surgery centers (ASCs) required by the Centers for Medicaid & Medicare Services (CMS). State the recent changes to the ASC quality reporting program. Why…

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