Regulations/Legal

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October 2020
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Impact of COVID-19 on HAIs

Editor's Note To provide flexibility to healthcare workers responding to the COVID-19 crisis, the Centers for Medicare & Medicaid Services (CMS) waived reporting requirements for healthcare associated infections (HAIs) through June 2020. Using the experience of hospitals in New York City and St Louis, Missouri, the authors provide commentary on…

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By: Judy Mathias
October 21, 2020
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Faulty bronchoscope reprocessing raises risks of infection transmission

Preventing infection transmission has been a chief concern of healthcare leaders and staff striving to protect their patients and themselves from SARS-CoV-2, the virus that causes COVID-19. The virus poses an insidious threat that includes the possibility of bronchoscopy-associated transmission of COVID-19. Long before the pandemic, epidemiologist and researcher Cori…

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By: Judith M. Mathias, MA, RN
October 21, 2020
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FDA reissues EUA for N95 respirators manufactured in China

Editor's Note The Food and Drug Administration (FDA) on October 15 announced that it reissued the Emergency Use Authorization (EUA) for certain N95 and other filtering face-piece respirators that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety…

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By: Judy Mathias
October 19, 2020
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CDC: 85% of COVID-19 patients report ‘always’ or ‘often’ wearing masks

Editor's Note Recently published data from a study by the Centers for Disease Control and Prevention (CDC) finds that 70.6% of COVID-19-positive patients report “always” wearing a mask, 14.4% report “often” wearing a mask, and 3.9% report “never” wearing a mask (See Table: Reported use of cloth face covering or…

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By: Judy Mathias
October 15, 2020
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Joint Commission: Lab surveyors to evaluate CMS reporting requirements for COVID-19 testing results

Editor's Note The Joint Commission announced October 14 that, effective October 15, surveyors will evaluate the Centers for Medicare and Medicaid Services (CMS) reporting requirements for COVID-19 testing results in the Laboratory Accreditation Program. Surveyors will review documentation of COVID-19 test result reporting during the Regulatory Review session of an…

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By: Judy Mathias
October 15, 2020
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Joint Commission issues new Quick Safety on telehealth

Editor's Note The Joint Commission on October 7 issued a new Quick Safety that focuses on the use of telehealth to deliver patient care while preventing exposure to COVID-19. Other benefits of telehealth in the Quick Safety include: promoting social distancing monitoring the progression of home-quarantined COVID-19 patients enabling providers…

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By: Judy Mathias
October 15, 2020
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CMS halts COVID-19 testing in non-CLIA-certified labs

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on October 9 announced that it is taking action to stop labs that are testing for COVID-19 without proper Clinical Laboratory Improvements Amendments (CLIA) certification. The agency has issued 171 cease-and-desist letters to US facilities that were testing for COVID-19…

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By: Judy Mathias
October 13, 2020
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CMS threatens to withhold payments from hospitals not reporting COVID-19, flu data

Editor's Note The Centers for Medicare and Medicaid Services (CMS) on October 6 released guidance on how it will implement an interim final rule that requires hospitals and critical access hospitals to report data on COVID-19 and flu patients. CMS says failure to report specified data may lead to termination…

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By: Judy Mathias
October 8, 2020
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FDA issues guidance on EUA for COVID-19 vaccines

Editor's Note The Food and Drug Administration (FDA) on October 6 released guidance on the data and information needed to support the issuance of emergency use authorization (EUA) for COVID-19 vaccines. The recommended data and information include: chemistry, manufacturing, and controls information clinical and nonclinical data and information administration and…

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By: Judy Mathias
October 8, 2020
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CDC updates guidance on how COVID-19 spreads

Editor's Note The Centers for Disease Control and Prevention (CDC), on October 5, issued updated guidance to its "How COVID-19 Spreads" website, which includes information on the potential for airborne spread of the virus. The CDC says that, based on current science, it continues to believe people are more likely…

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By: Judy Mathias
October 7, 2020
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