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…

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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…

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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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Competency Assessments Prove To Be a Nagging CLIA Deficiency

By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue

CEO SUMMARY: Competency assessment problems rank high among frequently cited deficiencies during CLIA inspections. Representatives from the CAP, COLA, and The Joint Commission explain what areas to…

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FDA Expected to Publish Proposed LDT Rule in August

By Scott Wallask | From the Volume XXX, No. 10 – July 10, 2023 Issue

CEO SUMMARY: Congressional lawmakers and the federal Food and Drug Administration are again eyeing changes that would bring greater oversight to laboratory-developed tests (LDTs). Leaders at clinical laboratories and pathology groups should monitor these proposals, both of which c…

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Atrium Health’s Advice on Epic Beaker Rollouts

By Scott Wallask | From the Volume XXX, No. 9 – June 19, 2023 Issue

CEO SUMMARY: Starting in 2019, Atrium Health began a years-long process to implement Epic Beaker as its laboratory information system. It was an enormous effort, involving dozens of locations across three s…

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CMS Ends Remote Reading of Pathology Glass Slides

By Scott Wallask | From the Volume XXX, No. 8 – May 30, 2023 Issue

CEO SUMMARY: On the day the federal government ended the public health emergency for SARS-CoV-2, CMS issued an updated FAQ that ended the allowance for remote reviews of glass slides…

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Pathologist Sues Hulu Over Depiction in Theranos TV Series

By Scott Wallask | From the Volume XXX, No. 6 – April 17, 2023 Issue

THERE IS AN INTRUGUING NEW TWIST IN THE LONG-RUNNING SAGA of the now-defunct Theranos. Pathologist and former Theranos CLIA lab director Adam Rosendorff, MD, is taking Hulu to court. …

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Six Important Themes to Help Labs Succeed

By Scott Wallask | From the Volume XXX, No. 5 – March 27, 2023 Issue

CEO SUMMARY: Clinical laboratories face business challenges with day-to-day operations, genetic testing, and evolving care delivery models. The 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management returns on April 25-26 in New Orleans. Participant…

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Elizabeth Holmes’ Appeal Questions Competence of CLIA Lab Director

By Scott Wallask | From the Volume XXX No. 4 – March 6, 2023 Issue

TANTALIZING DETAILS ABOUT FORMER THERANOS CEO ELIZABETH HOLMES’ purchase of a one-way plane ticket to Mexico prior to her conviction grabbed headlines following the filing of a motion to appeal her conviction.  However, for clinical labo…

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