Lab Risk & Compliance

CLIA Lab Accreditors Reveal Most Frequent Deficiencies

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

CEO SUMMARY: CAP, The Joint Commission, COLA, and A2LA took the stage at the recent Executive War College to detail their respective lists of the 10 most often-cited standards during…

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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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Elizabeth Holmes Still Wants ‘To Contribute’ in Healthcare

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

CLINICL LABORATORY AND ANATOMIC PATHOLOGY PROFESSIONALS have another reason to shake …

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Lab Execs Allegedly Lied to FDA about Faulty Tests

By Scott Wallask | From the Volume XXX, No. 7 – May 8, 2023 Issue

CEO SUMMARY: Three former executives of a lab testing company face criminal charges. Federal prosecutors claim that the three plaintiffs who previously worked at Magellan Diagnostics flagrantly hid…

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Draft Rule Standardizes Electronic Signatures

By Robert Michel | From the Volume XXX, No. 6 – April 17, 2023 Issue

CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in…

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OIG’s Issues New Opinion on Use of Gift Cards for Lab Specimens

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

CEO SUMMARY: This new Advisory Opinion from the Office of Inspector General (OIG) outlines a narrow situation in which it may be allowable for clinical laboratories to use gift cards to encourage pa…

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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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Labcorp to Pay $19m to Settle Whistleblower Allegations

By Robert Michel | From the Volume XXX No. 3 – February 13, 2023 Issue

LABCORP AGREED TO SETTLE WHISTLEBLOWER ALLEGATIONS that it violated the False Claims Act by allowing its phlebotomists to draw blood from patients when the company allegedly knew kickbacks were behind the test orders for other lab firms. As part of the settlement, Labcorp in Burli…

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CLIA on Path to Recognize Lab Data As a Specimen

By Scott Wallask | From the Volume XXX No. 2 – January 23, 2023 Issue

CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to …

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