COVID-19 Update: FDA Provides Promised Transparency for Antibody Tests

Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests (from CDC, updated May 22, 2020) Key points: On May 21, 2020, the U.S. Food and Drug Administration (FDA) announced that it has removed a number of antibody tests from the “notification list” of tests offered under the Policy for Coronavirus Disease-2019 Tests During the…

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Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with COVID-19 (updated May 11, 2020)

Attention: Acute Care Hospital, Critical Access Hospital, Clinical Laboratory, Ambulatory Surgery Center Please share this with: Accreditation Coordinator Quality Director Medical Director – Laboratory services Administrative Director – Laboratory Laboratory Manager Point of Care Coordinator The CDC has updated Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with COVID-19 Key points: This is…

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Update: HFAP to begin onsite surveys in June

In response to the COVID-19 public health emergency, HFAP paused onsite survey activity beginning in mid-March. At that time, we began collecting weekly data from organizations as each entered the six-month period (the “survey window”) prior to the stated expiration of accreditation/certification. At this time, we expect to begin surveying in the month of June.…

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Laboratory News Items: SARS-CoV-2 Laboratory Testing Comparison & CLIA-issued Abbott iStat FAQs

Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Managers, Laboratory Services Memo 20-06-CLIA: CMS SARS-CoV-2 Testing Comparison KEY POINTS CMS is committed to taking critical steps to ensure America’s clinical laboratories can respond to the threat of COVID-19. Laboratories need a CLIA certificate to perform SARS-CoV-2 testing. Guidance on the different…

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