TAG:
lab industry
UCLA Pathologists, Radiologists Produce Combined Reports
CEO SUMMARY: To simplify diagnostic reporting, the pathology and radiology departments at the David Geffen School of Medicine/UCLA Medical Center are working together to deliver integrated diagnostic information to treating oncologists. This innovative strategy is designed to im…
Did Theranos Turn Over its CLIA Lab Director?
PROBABLY NO SINGLE LAB INDUSTRY STORY OF THE PAST 24 MONTHS has generated a higher level of curiosity among pathologists and lab administrators than that of Theranos, the Palo Alto, California-based company that regularly claims it has the technology, the business model, and the low price strategy ne…
Phlebotomist Describes Questionable Lab Practices
CEO SUMMARY: While working in the office of a physician who was a client of Health Diagnostic Laboratory, a phlebotomist says he was instructed to write the same 10 diagnoses on every test requisition a doctor sent to HDL, a lab company in Richmond, Virginia. HDL is…
Why ‘Bad Actors’ Continue to Operate in Lab Industry
OVER THE PAST TWO DECADES, pathologists and lab managers have regularly watched certain new lab companies burst on the scene and generate startling growth in revenue and profits by offering proprietary tests–often unsupported by published clinical studies that …
Why You Want the Insider’s Perspective of Lab News
TODAY I WOULD LIKE TO SHARE A QUOTE WITH YOU and offer some thoughts about how it relates to the profession of laboratory medicine that you practice every day. News is what someone wants suppressed. Everything …
PAMA, LDTs and Theranos Top 2014 Biggest News
CEO SUMMARY: Not in recent memory has a single calendar year brought such a cascade of news stories that have the potential to affect nearly every clinical lab and pathology group in the United States. Blame it on the lack of money to fund healthcare and how it is motivating government an…
Top 10 2014 Biggest News Stories
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
Medicare Special Stain LCD May Hinder Pathology Workflow
CEO SUMMARY: Under a proposed rule for Medicare region J-11, a pathologist will no longer be able to use “reflex templates or pre-orders for special stains and/or IHC stains prior to review of the routine H&E.” While the proposed LCD is designed to target a relatively small number…
Attorneys Outline Issues in FDA’s LDT Guidance
CEO SUMMARY: Officials at the FDA believe that CLIA does not go far enough because it does not address the issues of whether laboratory-developed tests (LDTs) have been designed correctly or have been manufactured in accordance with sound standards. Also, CLIA does not include a process to verify…
Level Two of Value Pyramid Defines Internal Benchmarks
CEO SUMMARY: In this second installment of our series on the laboratory value pyramid, we introduce “Level Two: Establish and Meet Standards of Value.” This second level continues the lab’s focus on its internal operations and activities. The goal is for the lab to develop the working cultu…
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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