Standards/Regulations

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June 2020
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CDC releases reopening guidelines

Editor's Note The Centers for Disease Control and Prevention (CDC) on May 20 posted two new resources to help states reopen. The first is a 60-page document that includes information on general and healthcare surveillance and continuing guidance on infection control, contact tracing, and testing. It also includes a standardized…

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By: Judy Mathias
May 21, 2020
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AORN, AHA, AdvaMed issue release re-entry guidance

Editor's Note: The Association of periOperative Registered Nurses (AORN), American Hospital Association (AHA), and Advanced Medical Technology Association (AdvaMed) on May 19 released a “Re-entry Guidance for Health Care Facilities and Medical Device Representatives.” The guidance, which builds on the April 17 joint statement by AORN, AHA, American College of…

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By: Judy Mathias
May 20, 2020
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NIH begins clinical trial of hydroxychloroquine, azithromycin for COVID-19 treatment

Editor's Note The National Institutes of Health (NIH) on May 14 announced that it is enrolling adults with mild to moderate COVID-19 in a study of treatment with hydroxychloroquine and azithromycin. The Phase 2b trial is enrolling around 2,000 adults across the US. Participants must have confirmed infection with SARS-CoV-2…

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By: Judy Mathias
May 19, 2020
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CDC posts updated point-of-care testing guidelines for COVID-19

Editor's Note The Centers for Disease Control and Prevention on May 12 posted updated point-of-care (POC) testing biosafety guidelines for COVID-19. The update includes guidance for: use of instruments in a location associated with a current Clinical Laboratory Improvement Amendments certificate site- and activity-specific risk assessment proper staff training adherence…

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By: Judy Mathias
May 14, 2020
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California pharmacists to begin testing patients for COVID-19

Editor's Note On May 12, California's Governor Gavin Newsom announced that California pharmacists will be allowed to collect specimens and order COVID-19 tests. Specimens will be are processed at public health, university, or commercial labs. The move is an effort to increase the state’s testing capacity as it modifies its…

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By: Judy Mathias
May 14, 2020
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FDA accelerates development of COVID-19 prevention, treatment options

Editor's Note The Food & Drug Administration on May 11 took new actions to accelerate the development of novel prevention and treatment options for COVID-19. The agency is providing guidance documents to make the process for submitting applications to initiate studies for new drugs and biological products more efficient. The…

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By: Judy Mathias
May 14, 2020
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CMS releases proposed inpatient payment rule for FY 2021

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on May 11 released a proposed rule that increases Medicare inpatient prospective payment system (IPPS) rates by a net of 3.1% in FY 2021, compared to 2020, for acute care hospitals participating in the Hospital Inpatient Quality Reporting Program that…

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By: Judy Mathias
May 13, 2020
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OR leaders chart new territory for resuming elective surgery

Elective surgical procedures that were temporarily suspended in mid-March are now on the table—or soon will be—at some US facilities. The ban, announced on March 18 by the Centers for Medicare & Medicaid Services (CMS), was enacted to free up resources for facilities overwhelmed by surges of COVID-19 patients. On…

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By: Elizabeth Wood
May 12, 2020
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CDC updates weekly COVID-19 stats

Editor's Note: The Centers for Disease Control and Prevention on May 8 updated it weekly surveillance summary of COVID-19 activity in the US for week 18. Among the updates: The percentage of specimens testing positive for SARS-CoV-2 decreased at public health, commercial, and clinical laboratories. Labs have confirmed 832,238 positive…

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By: Judy Mathias
May 11, 2020
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FDA issues guidance to prevent device shortages during COVID-19 pandemic

Editor's Note The Food & Drug Administration (FDA) on May 6 issued a guidance to implement section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) as it relates to shortages and potential shortages of medical devices occurring during the COVID-19 pandemic. Manufacturers are required to notify…

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By: Judy Mathias
May 7, 2020
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