The U.S. Department of Health and Human Services (HHS) on Aug. 13 announced combined investments of $6.5 million in Aegis Sciences Corporation and Sonic Healthcare USA to increase SARS-CoV-2 testing capacity.
This investment will increase staffing and infrastructure and provide equipment from Beckman Coulter Life Sciences and Thermo Fisher, with the hopes of conducting an additional 1 million tests nationwide each week by October.
CDC Releases Antigen Testing Guidance
The Centers for Disease Control and Prevention on Aug. 16 released guidance for antigen testing for SARS-CoV-2. Antigen tests detect the virus that causes COVID-19 more rapidly than reverse transcription polymerase chain reaction (RT-PCR) tests but are not as sensitive as molecular PCR tests. Thus, it might be necessary to confirm antigen test results with an RT-PCR test within two days, with no new opportunities for exposure.
Laboratory and testing professionals who perform rapid antigen testing should determine infection prevalence based on a rolling average of the positivity rate of their own SARS-CoV-2 testing over the previous 7–10 days. The two rapid antigen tests that have received emergency use authorizations from the Food and Drug Administration are limited to diagnostic testing on symptomatic persons within the first five days of symptom onset. When antigen tests are used for screening testing in congregate settings, test results for SARS-CoV-2 should be considered presumptive.
Resumption of CMS Survey Activities
In an Aug. 17 memo to state survey directors, the Centers for Medicare & Medicaid Services (CMS) encouraged states to resume normal survey activities, while also addressing the backlog of surveys that were postponed in March in response to the public health emergency.
Once a state has entered Phase 3 of reopening, or earlier at the state’s discretion, normal survey activities should resume, while prioritizing survey backlog as follows (descending in priority):
- revisit surveys for past noncompliance that do not otherwise qualify for a desk review;
- complaint surveys triaged as non-immediate jeopardy level or higher that have not been completed;
- special purpose renal dialysis facilities;
- initial surveys of new providers;
- past-due recertification surveys with a statutorily required survey interval; and
- past-due recertification surveys without a statutorily required survey interval.
CMS noted that during the public health emergency, surveyors should continue to use the COVID-19 Focused Infection Control Survey: Acute and Continuing Care, specified in the March survey prioritization memo, as part of any survey that is conducted.
HHS and Department of Defense on Aug. 11 announced a collaboration with Moderna to manufacture and deliver 100 million doses of a vaccine candidate. Under Operation Warp Speed, a government initiative to manufacture vaccines simultaneously with clinical trials, the federal government will own these vaccine doses. The Phase 3 clinical trial, which began July 27, is the first government-funded Phase 3 clinical trial for a COVID-19 vaccine in the United States
CDC will host a webinar on flu vaccination planning and guidance during the COVID-19 pandemic on Aug. 20 at 2 pm ET. The webinar will include updates to the Advisory Committee on Immunization Practices recommendations for the 2020–2021 flu season.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the outbreak.
Contact Senior Director of Policy Erin O’Malley at firstname.lastname@example.org or 202.585.0127 with questions.