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clinical laboratory improvement amendments

Alert! Changes to CLIA Accreditation, CLIA Revisions

MEDICAL LABORATORIES HAVE LIVED WITH THE REGULATIONS FOR THE CLINICAL LABORATORY IMPROVEMENTS AMENDMENTS (CLIA) since they were first implemented in 1992. Over the past 30 years there has been no major revision or updating of CLIA regulations. Nor has there been much change in the long-standing statu…

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Clinical Laboratories Face 20% Increase in CLIA Fees

CHANGES HAVE BEEN PROPOSED to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that would raise fees by 20% for clinical laboratories and amend certain testing personnel qualifications.  The American Hospital Association (AHA) has obj…

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Might LDT Regulation Bill Support Be Waning in Congress?

This is an excerpt of an 833-word article in the July 18, 2022 issue of  THE DARK REPORT. The full article is available to members of The Dark Intelligence Group.   …

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Might VALID Act Support Be Waning in Congress?

CEO SUMMARY: Just weeks ago, events seemed to indicate that the Verifying Accurate Lea…

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Halfway Through 2022, More Changes Come at Labs

APPROACHING THE MIDWAY MARK OF 2022, some clinical laboratory directors and pathologists might feel like they’ve already experienced enough changes to last the whole year.  For example, since the start of 2022, we’ve seen SARS-CoV-2 testing surges co…

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Passage of FDA Regulation of LDTs Inches Closer in the Senate

CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …

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VALID Act vs. VITAL Act: Day of Reckoning for LDTs

TWO DISTINCTLY DIFFERENT BILLS HAVE SURFACED IN CONGRESS, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. One bill even creates a new acronym for the lab industry: IVCT for in vitro clinical tests….

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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…

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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 …

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CLIA Lab Director Testimony Shows Risks to Pathologists

CEO SUMMARY: Elizabeth Holmes’ criminal trial is a case study for clinical lab directors in how not to run a medical lab, according to an attorney with 30 years of advising labs on CLIA-enforcement issues. During the trial, federal prosecutors cited the Clinical Laboratory Improve…

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