TAG:
clia
FDA Expected to Publish Proposed LDT Rule in August
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…
Atrium Health’s Advice on Epic Beaker Rollouts
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…
CMS Ends Remote Reading of Pathology Glass Slides
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…
Pathologist Sues Hulu Over Depiction in Theranos TV Series
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. …
Six Important Themes to Help Labs Succeed
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…
Elizabeth Holmes’ Appeal Questions Competence of CLIA Lab Director
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…
CAP, Joint Commission Under Pressure to Add More Inspectors
CEO SUMMARY: Like the clinical laboratories they accredit to the requirements of CLIA, The Joint Commission and College of American Pathologist (CAP) face recruitment and hiring pressures when it comes to their surveyors and inspectors. Labs involved with CAP’s peer inspections ma…
Joint Commission Will Not Accept COLA Accreditation
CEO SUMMARY: This may be a first in the 40-year history of CLIA accreditation of clinical laboratories. The Joint Commission (TJC) announced it will no longer recognize COLA’s laboratory accreditation program within “TJC-accredited facilities,” effective Jan 1, 2023. COLA-accredited labs …
What’s Behind Joint Commission Move to Not Accept COLA Labs?
DURING THE NEXT TWO YEARS, a substantial number of hospitals and healthcare facilities will need to respond to The Joint Commission’s (TJC) decision to no longer recognize CLIA accreditations issued by COLA in “TJC-accredited facilities.” In the 30-year history of the current C…
CLIA on Path to Recognize Lab Data As a Specimen
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 …
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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