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dark report
Georgia Micro Lab Slashes TAT by Almost Two Days
CEO SUMMARY: Two projects to boost the performance of the microbiology laboratory at University Health Services in Augusta, Ga., significantly reduced test turnaround times in ways that contributed to improved patient outcomes. The first project was in 2016, when the lab introduced mass s…
Response to FDA’s Gottlieb on Reducing Regulatory Burden
IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He …
D.C. Circuit Court Reverses Medical Necessity Ruling
MANY LAB EXECUTIVES were concerned last year after a judge in the District of Columbia Circuit Court ruled that clinical laboratories need to determine that all lab test services physicians order are medically necessary. The court also ruled that ordering physicians do not need to determine medical …
Powerful Forces Are Reshaping Lab, Pathology
THERE IS NO BETTER WAY TO UNDERSTAND HOW THINGS ARE CHANGING within the house of laboratory medicine than to survey current news. Understanding why and how breaking news stories are indicators of deeply-rooted and forceful trends is essential for lab administrators and pathologists who want to keep t…
A coming transformation: Control over important diagnostic technologies is about to change hands
This is an excerpt from a 2,920-word article in the March 26, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: He…
Anthem accuses tiny hospital of pass-through billing scheme
This is an excerpt from a 1,300-word article in the March 5, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: THE…
ACLA Sues HHS, Claims Flaws In How CMS Set 2018 Rates
CEO SUMMARY: When the American Clinical Laboratory Association filed its lawsuit Dec. 11 against the Secretary of Health and Human Services, one of its main claims is that HHS collected payment data on the clinical laboratory testing business in a manner that was deeply flawed. HHS then u…
Sale of Tox Lab Company Attracted Multiple Buyers
CEO SUMMARY: In the midst of expanding their toxicology testing services nationally, DrugScan and DSI Medical Services (collectively Toxicology Holdings Inc.) hired a brokerage firm last year to pursue a sale of the two toxicology companies. Multiple potential buyers responded with intere…
NEWSMAKER INTERVIEW: Ralph Taylor, CEO of Sysmex America
“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures. Core laboratories have something unique and irreplacea…
Health insurance fraud cases take new turn with HDL-BlueWave outcome
This is an excerpt from a 2,700-word article in the February 12, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY:…
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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