TAG:
covid-19 testing
What Comes Next? Predictions on COVID-19 Test Volumes in 2021-22
CEO SUMMARY: Incoming data show that the number of referrals for both COVID-19 tests and routine tests is in a decline that started in October and is continuing. This complicates the strategic planning for hospital/health system labs, independent labs, and pathology groups. They nee…
Might Politics Sway California Lab’s CLIA Compliance?
IS IT A CONFLICT FOR A STATE GOVERNMENT TO BUILD AND OPERATE A CLIA high-complexity clinical laboratory and have the same department that manages this lab facility also conduct the CLIA-mandated inspections and oversight of the lab’s compliance, as required by the federal Clinical Laboratory Improv…
New Year Brings Three New Clinical Lab Trends
CEO SUMMARY: Since the year began, three trends have affected clinical laboratories and anatomic pathology groups. First is a continuing surge in COVID-19 test volume. Second is inconsistent payment from government and commercial insurers for SARS-CoV-2 test claims. Third is growing…
Whistleblowers Disclose Issues in California’s COVID Lab
SUMMARY: Whistleblowers at the State of California’s brand-new COVID-19 Valencia Branch Laboratory are telling reporters about staff sleeping on the job, unlicensed staff handling specimens, and other significant issues. Given the reports of several news outlets, one relevant ques…
Pathology Lab Transforms, Runs 1M COVID-19 Tests
CEO SUMMARY: Last spring, a histopathology lab in Illinois began running molecular COVID-19 tests and decided the clinical side of the lab would focus exclusively on PCR testing for COVID-19. The challenge was how to access a reliable source of test kits, reagents, and supplies to o…
March 1, 2021 Intelligence: Late-Breaking Lab News
Even as the nation’s clinical laboratories work to expand the number of molecular COVID-19 tests they can perform daily, the demand for such tests is plunging. That’s one conclusion in a news story published by the Associated Press in recent days. The AP illustrated this fact with t…
January 19, 2021 Intelligence: Late-Breaking Lab News
Just days ago, the federal Food and Drug Administration (FDA) issued updated information about the COVID-19 tests it has authorized since early in the pandemic. As of Jan. 15, 2021, the agency had authorized a total of 317 tests for the SARS-CoV-2 coronavirus. Included in this total are 236 mo…
UK Postpones Mass COVID Testing Plan Due to Questions of Accuracy
IN THE UNITED KINGDOM, A MASS COVID-19 TESTING PLAN called “Operation Moonshot” is on hold until at least the end of January. Under the plan, health ministers sought to increase daily SARS-CoV-2 testing from 430,000 to 10 million Englanders per day. …
December 28, 2020 Intelligence: Late-Breaking Lab News
Seattle is the latest city to open walk-up kiosks for COVID-19 testing that allow individuals to collect their own saliva, then hand the specimen to a worker in the booth for overnight testing. Three such kiosks are now in operation. Curative, based in San Dimas, Calif., performs the testing u…
NorDx Lab Started COVID Preparation in 2019
This is an excerpt of a 2,995-word article in the December 7, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testin…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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