Editor's Note The Food and Drug Administration (FDA) on November 3 issued a letter alerting clinical laboratory staff and healthcare providers that false positive results can occur with antigen tests, including when users do not follow instructions for use of antigen tests for the rapid detection of COVID-19. Among the…

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Editor's Note Johnson & Johnson (J&J) has announced plans to test their COVID-19 vaccine in young individuals between the ages of 12 and 18, the October 30 Reuters reports. J&J started testing its vaccine in 60,000 volunteer adults in late September. Depending on safety, J&J also plans to test the…

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Editor's Note The Centers for Medicare and Medicaid Services (CMS) will penalize and reduce a year’s worth of payments to nearly half of the nation’s hospitals because of 30-day readmission rates, the November 2 Kaiser Health News reports. The penalties are part of the ninth year of the Hospital Readmissions…

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Editor's Note Suspension of elective surgical procedures in response to the COVID-19 pandemic in New York State had only a minor effect on ICU capacity, this study finds. State authorities suspended all elective surgical procedures in mid-March 2020 to increase hospital and ICU bed capacity. However, the effect of canceling…

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Editor's Note The Centers for Medicare and Medicaid Services (CMS) on October 28 issued an interim final rule that requires CMS to cover any COVID-19 vaccines that receive Food and Drug Administration (FDA) authorization at no cost to beneficiaries. The rule also will increase what Medicare pays hospitals for COVID-19…

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Editor's Note A state’s stay-at-home orders (SAHOs) were associated with reductions in COVID-19 cases and fatality rates between March and May 2020, and a state’s number of African Americans was associated with more COVID-19 cases and fatalities in this study from the University of Alabama at Birmingham. Of 3,023 pooled…

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Editor's Note The Joint Commission on October 28 announced that beginning January 1, 2021, it is eliminating the element of performance (EP) for Infection Control Standard IC.02.04.01, which sets incremental influenza vaccination goals to try and achieve the 90% rate set by national initiatives. The US Department of Health and…

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Editor's Note The Joint Commission announced October 27 that it had been selected to provide Laboratory Accreditation Program services for the US Department of Veterans Affairs (VA). These services will be provided for moderate and high-complexity clinical laboratories at VA Medical Centers and community-based outpatient clinics. Services include education on…

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Editor's Note In the October 26 Morbidity and Mortality Weekly Report, an analysis led by researchers from the Centers for Disease Control and Prevention (CDC) of hospitalization data from 13 states found that 5.9% of adults hospitalized with COVID-19 between March 1 and May 31 were healthcare workers (HCWs). Among…

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Editor's Note The Food and Drug Administration’s (FDA’s) Office of Biostatistics and Epidemiology is currently developing master protocols to be used in monitoring the safety and effectiveness of a COVID-19 vaccine once it is authorized or approved, in addition to postmarket surveillance requirements, the October 22 Regulatory Focus reports. The…

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