Editor's Note According to a June 20 article published by JDSupra from law firm Waller Lansden Dortch & Davis, recent government action out of the Justice Department involving ambulatory surgery centers (ASCs) and anesthesia provider arrangements points "to a need to carefully vet these partnerships,” Becker’s ASC Review June 21…

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Editor's Note The Centers for Medicare & Medicaid Services (CMS) has recently updated its State Operations Manual (SOM) Appendix L—Guidance for Surveyors: Ambulatory Surgical Centers (ASCs), making conforming revisions to the regulatory tags and interpretive guidelines, as well as clarifications and technical corrections to other guidance areas including medical history…

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Editor's Note The US Department of Health and Human Services (HHS) on July 1 announced it ordered an additional 2.5 million doses of the FDA-licensed Bavarian Nordic's JYNNEOS vaccine in response to current or future monkeypox outbreaks and as part of US smallpox preparedness, Healthcare Purchasing News (HPN) July 5…

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Editor's Note On Friday, June 24, the American Hospital Association (AHA) voiced support for the Protecting and Transforming Cyber Health Care Act (PATCH Act)—legislation that would “require medical device manufacturers to meet certain cybersecurity requirements when seeking approval for devices that are internet connected or include software” in order to…

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Editor's Note The Joint Commission on June 29 announced that the application deadline for the "Bernard J. Tyson National Award for Excellence in Pursuit of Healthcare Equity" has been extended through July 14. The Tyson Award was established in partnership with Kaiser Permanente in honor of Bernard J. Tyson, the…

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Editor's Note The Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee on June 28 recommended updating the composition of COVID-19 booster vaccines to target the Omicron variant. The Committee noted that booster doses consisting of an Omicron monovalent or bivalent vaccine could improve neutralizing antibody responses…

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Editor's Note The Joint Commission, on June 28, announced a new Quick Safety advisory on “Managing packaged sterile supplies and devices.” The advisory provides guidance to keep patients safe from infection and harm from expired or compromised supplies and devices and urges healthcare workers (HCWs) to pay close attention to…

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Editor's Note The Food and Drug Administration (FDA) on June 28 identified the recall by GE Healthcare of its CARESCAPE R860 Ventilator as Class I, the most serious. The recall was initiated because the ventilator backup batteries, including replacement backup batteries, may run out before they are expected to do…

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Editor's Note The Food and Drug Administration (FDA) on June 23 identified the recall by Baxter Healthcare Corporation of its Volara system with in-line ventilator adaptor as Class I, the most serious. The Volara system is used to clear mucus out of airways, expand lungs, and treat or prevent pulmonary…

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May 2022 saw a critical shortage of the iodinated contrast medium (ICM) iohexol that extended well into June because of a COVID-19-related shutdown of a GE Healthcare plant in Shanghai, China, that interrupted the manufacture of ICM. According to the American College of Radiology, contrast media were added to the…

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