Standards/Regulations

Latest Issue of OR Manager
December 2021
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CDC confirms first US case of Omicron COVID-19 variant

Editor's Note The Centers for Disease Control and Prevention, on December 1, issued a statement that the California and San Francisco Departments of Public Health have confirmed that a recent case of COVID-19 in an individual in California was caused by the Omicron variant (B.1.1.529). The individual, who has mild…

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By: Judy Mathias
December 2, 2021
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FDA: Class I recall of Teleflex percutaneous thrombolytic device kit

Editor's Note The Food and Drug Administration (FDA), on November 30, identified the worldwide recall by Teleflex of its Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR as Class I, the most serious. The device, which is used for mechanical declotting of native arteriovenous fistulae and synthetic dialysis grafts, was…

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By: Judy Mathias
December 2, 2021
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Federal judge blocks COVID-19 vaccine mandate for HCWs nationwide

Editor's Note A Louisiana federal judge, on November 30, blocked the COVID-19 vaccine mandate for healthcare workers (HCWs) at facilities participating in Medicare and Medicaid nationwide, the November 30 Axios reports. In his ruling, the judge says the executive branch does not have the authority to bypass Congress in enforcing…

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By: Judy Mathias
December 1, 2021
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COVID-19 vaccine mandate for HCWs blocked in 10 states

Editor's Note A federal judge, on November 29, blocked a Centers for Medicare & Medicaid Services (CMS) mandate requiring COVID-19 vaccinations for healthcare workers (HCWs) in facilities participating in CMS programs in 10 states, the November 29 Bloomberg Law reports. In his ruling, the judge says the CMS mandate requires…

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By: Judy Mathias
November 30, 2021
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CDC: 30% of HCWs remain unvaccinated

Editor's Note This study from the Centers for Disease Control and Prevention (CDC) finds that 30% of healthcare workers (HCWs) in 2,086 US hospitals remained unvaccinated against COVID-19 as of September 15. Analyzing data on more than 3.3 million HCWs, the researchers found that vaccination rates climbed from 36% to…

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By: Judy Mathias
November 18, 2021
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FDA: Nationwide recall of certain SterRx drug products

Editor's Note The Food and Drug Administration (FDA), on November 15, announced the nationwide recall by SterRx, LLC, of 240 lots of its drug products. The recall was initiated because of the lack of sterility assurance due to equipment and process issues. The recalled drugs include: l mg/ml Midazolam in…

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By: Judy Mathias
November 18, 2021
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Lawsuits building to block federal government HCW vaccination mandate

Editor's Note A coalition of 12 states, on November 15, sued the federal government to block a Centers for Medicare and Medicaid Services (CMS) mandate requiring COVID-19 vaccinations for healthcare workers (HCWs) in facilities participating in CMS programs, the November 16 Becker’s Hospital Review reports. This complaint follows a lawsuit…

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By: Judy Mathias
November 17, 2021
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Hospitals, ASCs face tough decisions in wake of vaccine mandates

Health systems across the country are enacting COVID-19 mandates to comply with a broad-sweeping federal requirement. Amid reports of high compliance rates, the mandate has triggered passionate and visceral responses on both sides of the debate. While some healthcare employees are eager to roll up their sleeves, others decry the…

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By: Jennifer Lubell
November 17, 2021
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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…

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By: Judith M. Mathias, MA, RN
November 17, 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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Latest Issue of OR Manager
December 2021
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