Regulations/Legal

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December 2021
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Cleveland Clinic mandates COVID-19 vaccinations for US employees

Editor's Note Cleveland Clinic, on November 12, announced that it is requiring all US employees and those who provide services with Cleveland Clinic to receive the COVID-19 vaccine by January 4, 2022. In accordance with federal mandates from the Centers for Medicare & Medicaid Services, employees who are not fully…

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By: Judy Mathias
November 15, 2021
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FDA: Class I recall of Aligned Medical Solutions custom convenience kits

Editor's Note The Food and Drug Administration (FDA), on November 9, identified the recall by Aligned Medical Solutions of its custom convenience kits as Class I, the most serious. The recall was initiated because of the potential for the plunger in Cardinal Health's Monoject Flush Prefilled Syringe (0.9% sodium chloride),…

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By: Judy Mathias
November 11, 2021
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Participate in survey on effects of COVID-19 on evacuation of surgical smoke

Editor's Note Please participate in an important nationwide perioperative survey on surgical smoke evacuation. The purpose of the research led by Brenda Ulmer MN, RN, CNOR, is to determine evacuation behaviors in hospitals before COVID-19, and then note changes as the virus continued to spread in the US. Ulmer and…

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By: Judy Mathias
November 10, 2021
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The Joint Commission issues new Sentinel Event Alert on healthcare disparities

Editor's Note The Joint Commission, on November 10, released a new Sentinel Event Alert, Issue 64: “Addressing healthcare disparities by improving quality and safety.” The Alert summarizes strategies for healthcare and human services organizations as they begin to address healthcare disparities, and it provides examples of successful initiatives already underway.…

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By: Judy Mathias
November 10, 2021
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CDC recommends Pfizer/BioNTech pediatric COVID-19 vaccine

Editor's Note The Centers for Disease Control and Prevention (CDC), on November 2, recommended broad use of the Pfizer/BioNTech COVID-19 vaccine for children ages 5 to 11. Distribution of the vaccine to clinics, children’s hospitals, and pediatricians’ offices across the country have started, with plans to scale up to full…

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By: Judy Mathias
November 4, 2021
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CMS: COVID-19 vaccine mandates for Medicare providers

Editor's Note The Centers for Medicare and Medicaid Services (CMS), on Novermber 4, released regulations that will require Medicare-participating providers to ensure their staff members are fully vaccinated against COVID-19. CMS says: “Facilities covered by this regulation must establish a policy ensuring all eligible staff have received the first dose…

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By: Judy Mathias
November 4, 2021
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CMS releases final Medicare payment rule for ASCs, HOPDs

Editor's Note The Centers for Medicare and Medicaid Services (CMS), on November 2, released its 2022 final payment rule for ambulatory surgery centers (ASCs) and hospital outpatient departments (HOPDs). The final rule increases Medicare prospective payment system rates by a net 2.0%—a combination of a 2.7% inflation update based on…

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By: Judy Mathias
November 3, 2021
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FDA investigating imported surgical, exam gloves

Editor's Note The Food and Drug Administration (FDA), on September 29, announced that healthcare facilities and providers should not purchase or use imported surgical and patient examination gloves from companies included on Import Alert 80-04. Companies are listed on an import alert when the FDA has enough evidence that they…

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By: Judy Mathias
November 3, 2021
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FDA: Class I recall of Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs

Editor's Note The Food and Drug Administration (FDA), on October 29, identified the recall by Datascope/Getinge/Maquet of its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs as Class I, the most serious. The recall was initiated because of the risk of the battery failing and having a shortened run time, which…

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By: Judy Mathias
November 1, 2021
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CMS penalizes nearly half of all hospitals for high readmission rates

Editor's Note In FY 2022, the Centers for Medicare and Medicaid Services (CMS) will penalize 2,499 (47%) hospitals for excessive patient readmissions, the October 28 Kaiser Health News reports. In its 10th year of the Hospital Readmissions Reduction Program, CMS will cut payments to the penalized hospitals by as much…

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By: Judy Mathias
November 1, 2021
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Latest Issue of OR Manager
December 2021
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