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Clinical Laboratory Improvement Amendments of 1988
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…
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 …
Holmes, Balwani Get Lengthy Prison Terms for Theranos Fraud
SENTENCING OF ELIZABETH HOLMES AND RAMESH “SUNNY” BALWANI in federal court caps the strange, yet captivating, saga of Theranos and its flawed blood testing technology. For laboratory professionals, the four years of legal wranglings that surrounded the Theranos fraud case may be remembered …
VALID and SALSA Acts Still Pending in Congress
CEO SUMMARY: Both the pending VALID Act and SALSA Act continue to push ahead as 2022 comes to an end. Meanwhile, a new bill centered on the Physician Fee Schedule may protect pathologist payments. These three different proposals share something in common:…
November 21, 2022, Intelligence: Late-Breaking Lab News
In yet another employment ripple from the pandemic, a group of more than 75 pathologists penned a letter to Congress urging lawmakers to retain the option for remote diagnostic work. In the letter, which appeared in the Oct. 20 issue of Nature, the pathologists wrote, “During the COVID-19 pa…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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