Regulations/Legal
New value-based models allow for surgeon buy-in, cost savings
The growth of value-based healthcare models is changing the way physicians and hospitals provide care. In value-based models, providers are paid based on patient outcomes. The “value” is derived from measuring health outcomes against the cost of delivering the outcomes. This balancing act has now become more achievable with new…
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…
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),…
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…
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.…
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…
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…
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…
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…
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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