TAG:
clia
Congress May Soon Act on LDT, IVCT Regulation
CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…
In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role
CEO SUMMARY: Most clinical lab directors understand the risks that come with running a CLIA-licensed lab. Such risks are at the forefront of the criminal trial of Elizabeth Holmes, founder of now-defunct Theranos. During the trial, federal prosecutors and defense attorneys question…
Congress May Soon Act on IVCT, LDT Regulation
This is an excerpt of a 2,017-word article in the November 29, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …
September 27, 2021 Intelligence: Late-Breaking Lab News
Following the opening of her criminal trial in a Silicon Valley courtroom in recent weeks, Elizabeth Holmes—the disgraced ex-Founder and CEO of Theranos—continues to be the subject of news headlines. Federal prosecutors are calling witnesses to testify. Much of this testimony includes anec…
CLIA Accreditation Market: More Competitive Now?
CEO SUMMARY: It’s been three decades since compliance with the Clinical Laboratory Improvement Amendments (CLIA) became mandatory. During that time, there has been little competition among the major organizations with deeming status by the Medicare Program to accredit labs to CLIA…
Interesting New Surprises for Lab Leaders
Unexpected and surprising things continue to happen in the clinical laboratory industry. You might consider that to be one unifying theme to the intelligence briefings we present in this issue of The Dark Report. For example, a…
CMS Shuts Missouri Lab Due to ‘Immediate Jeopardy’
CEO SUMMARY: CMS ordered Gamma Healthcare to close its two labs, revoked the owners’ CLIA licenses, prohibited them from operating a lab for two years, and ordered payment of more than $55,000 in civil penalties. The two lab facilities had been running COVID-19 and other tests for…
CAP Loses CLIA Accreditation Clients to Joint Commission
This is an excerpt of a 1,790-word article in the January 19, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA …
2021 Opens with a Major Story … and It’s Not COVID!
On the pages that follow, you will learn about a major story in the clinical laboratory…
CAP Loses Accreditation Clients to Joint Commission
CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hu…
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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