QSO 20-10-CLIA: Authorization for Emergency use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel assay and guidance for Use in CDC Qualified Laboratories

On February 6, 2020, CMS published QSO 20-10-CLIA. Key Points: The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel assay and the corresponding protocols have been developed by the CDC for use by CDC qualified laboratories and the assay has been issued an Emergency Use Authorization (EUA) from the FDA. Upon receipt of the CDC 2019-nCoV Real-Time…

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CDC – Lab Update: Specimen Submission Information for the 2019 Novel Coronavirus (2019-nCoV)

At this time, diagnostic testing for 2019-nCoV can only be conducted at CDC. Healthcare providers should contact their local/state health department immediately to notify them about PUIs for 2019-nCoV. State health departments that have identified a PUI should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a 2019-nCoV PUI case investigation form…

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CDC Laboratory Update: Information about Emergency Use Authorization for RT-PCR Assay

On February 6, 2020, the CDC released a Laboratory Update. Key Points: In response to the novel coronavirus (2019-nCoV) outbreak, the Secretary of Health and Human Services declared a public health emergency on January 31, 2020. The CDC has developed a new laboratory test kit called the CDC’s 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic…

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HFAP Approved for Accreditation of Outpatient Surgical Settings in California

Outpatient surgery settings can continue to choose HFAP or state licensing inspections

(Chicago) January 21, 2020 – HFAP, America’s original healthcare accreditation program founded in 1945, has received renewed approval from the Medical Board of California to survey and accredit outpatient surgery settings in the Golden State. California defines “outpatient surgery setting” broadly to include those organizations that provide anesthesia that may place a patient at risk for loss of life-preserving reflexes. Any outpatient surgery setting in the state must be accredited if it is not a Medicare certified ambulatory surgery center (ASC). Organizations can choose HFAP accreditation to meet the requirements of California Health and Safety Code section 1248.

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