TAG:
clinical laboratories
Understanding Differences Between 2 CLIA Accreditors
MAJOR CHANGES ARE HAPPENING IN THE COMPETITIVE MARKET for CLIA accreditation of hospital laboratories. Some health systems representing hundreds of hospitals have shifted from using the College of American Pathologists (CAP) to using The Joint Commission (TJC) to meet the accreditation …
Two-Drop ‘Digital CBC’ Enters U.S. Market with FDA Clearance
“We believe the ability to work with just two drops of blood, plus the…
Digital Pathology Launched in the ‘Era of COVID-19’
CEO SUMMARY: Is it smart to initiate digital pathology (DP) systems and whole-slide imaging just as a novel coronavirus upends healthcare and society at large? That was the question asked at Poplar Healthcare, a pathology lab in Memphis. Senior management proceeded with the implemen…
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…
Top 10 2020 Lab Stories Are about More than Just COVID-19
This is an excerpt of a 3,689-word article in the December 28, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There are several surprises in The Dark R…
2020’s Top 10 Lab Stories Are Without Precedent!
CEO SUMMARY: There are several surprises in The Dark Report’s list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social…
OIG Says Medicare Spending On Testing Increased in 2019
CEO SUMMARY: Newly-released data indicates that Medicare officials are falling far short of their goal to decrease the total amount of money spent annually on Part B clinical laboratory tests. That is one finding by the federal Office of the Inspector General in its report of Medica…
THE DARK REPORT’s Ranking of 2019’s Top 10 IVD Companies
One trend continues to reshape the in vitro diagnostics (IVD) industry year after year: acquisitions. Since the 1990s, the biggest IVD companies have frequently used acquisitions to boost their revenue and keep shareholders happy. But acquisition…
Congress Passes Bill to Ban Surprise Medical Bills
Starting Jan. 1, 2022, out-of-network clinical laboratories may no longer be allowed to bill patients for lab tests performed in certain settings under a law both houses of Congress passed on Dec. 21. The COVID relief bill includes a ban on unexpected m…
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 XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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