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Artificial Intelligence and Executive War College
By R. Lewis Dark | From the Volume XXXI, No. 6 – April 29, 2024 Issue
By the time you read this our 29th annual Executive W…
FDA Issues Memo to Reclassify Many High Risk IVD Assays
By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
Labs Should Prepare for Arrival of ‘Perfect Storm’
By Robert Michel | From the Volume XXXI, No. 3 – February 26, 2024 Issue
CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…
CMS Issues AI Guidance for Medicare Advantage
By Mary Van Doren | From the Volume XXXI, No. 3 – February 26, 2024 Issue
CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal governme…
February 26, 2024, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXXI, No. 3 – February 26, 2024 Issue
Following an investment of $1.75 million, officials at University of Maine at Augusta (UMA) opened a new lab facility this month that allows it to double the number of medical laboratory technicians it can train, from eight to 10 to as many as 20. In its coverage of the new training …
FDA & CMS Issue Letter, Agree on LDT Oversight
By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue
CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…
CLIA Lab Directors Must Watch Delegated Duties
By Robert Michel | From the Volume XXX, Number 17 – December 4, 2023 Issue
CEO SUMMARY: Laboratory accredito…
Two Forces Push for More FDA Oversight of LDTs
By R. Lewis Dark | From the Volume XXX, No. 14 – October 2, 2023 Issue
CLINICAL AND GENETIC TESTING LABS MAY SUDDENLY FEEL THEMSELVES STUCK IN THE MIDDLE of a yin-yang situation when it comes to laboratory developed tests (LDTs). One force, the U.S. Food and Drug Administrati…
FDA Issues Proposed Rule to Further Regulate LDTs
By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue
CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…
FDA’s Road to Regulation of Lab Developed Tests
By Robert Michel | From the Volume XXX, No. 14 – October 2, 2023 Issue
CEO SUMMARY: Today’s generation of clinical lab managers and pathologists should understand that the FDA’s efforts to publish a draft rule defining its authority to review laboratory developed tests (LD…
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Volume XXXI, No. 6 – April 29, 2024
Laboratory managers will want to note that The Dark Report itself was targeted by the fraudsters who hit Change Health in a cyberattack. Also, one lab has some innovative methods of combatting the chronic staffing shortage, including hiring college graduates and students.
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