TAG:
clia
May 19, 2014 “Intelligence: Late Breaking Lab News”
How about a hospital that doesn’t have a medical laboratory but issues lab test reports to patients? This unusual development happened in India recently. The Free Press Journal of Mumbai, India, reported earlier this month that government health officials had conducted a surprise inspectio…
April 28, 2014 Intelligence: Late Breaking Lab News”
In recent years, a series of decisions involving molecular diagnostics tests made by Medicare officials and the Medicare Administrative Contractors (MACs) have caused much disruption in the clinical laboratory industry. In response to these developments, on April 16, the California Clinical L…
Congress Raises Stakes in Lab Test Pricing Game
EACH OF YOU READERS KNOW that there is always a story behind the story. This is particularly true in Congress and the federal government, where lobbying and influence can often have their own role in shaping how laws and regulations are written. Keep that in mind as you learn more about the new law …
CMS Gives Deemed Status to A2LA under CLIA Law
CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accredita…
New Mass Spectrometry Toxicology Test Delivers Clinical Benefits
CEO SUMMARY: Researchers at the University of Colorado in Aurora used mass spectrometry technology to create a paradigm-shifting toxicology test. It uses a urine specimen and can identify 112 compounds and more than 500 illicit and brand-name drugs in a single assay. For pain management t…
Caris Life Sciences Achieves Accreditation to ISO 15189
IN DECIDING TO PURSUE ACCREDITATION TO ISO 15189: Medical Laboratories, Caris Life Sciences considered the international benefits of this designation. It was December when Caris Life Sciences of Irving, Texas, announced that it had earned accreditation to ISO 15189 from the …
Claritas Is Example of New Lab Business Model
CEO SUMMARY: One by one, new business models for clinical laboratory testing are popping up. Each is a response to healthcare’s rapid evolution, the ongoing decline in lab test reimbursement, and the growing role for molecular diagnostics and genetic testing. In Cambridge, Massachusetts…
Medicare Price Cuts Drive Labs to Sell or File BK
CEO SUMMARY: Professional investors are smart with their money. Thus, it is no surprise that clinical lab and pathology companies owned by private equity firms are the first to be sold or closed. These investors are acting in response to the cumulative negative financial impact of recent …
Walgreens To Go National with Lab Tests in Stores
CEO SUMMARY: A disruptive innovation is one that shakes up an entire market or industry. By adding clinical lab testing to its health services offerings in more than 8,100 stores nationwide, Walgreens could disrupt the status quo in the clinical lab industry. Walgreens says its lab partne…
Theranos Won’t Discuss Disruptive Lab Technology
CEO SUMMARY: In a partnership with Walgreens pharmacies, Theranos Inc. announced that it will run clinical lab tests on “micro-samples” and collect these blood samples without venipuncture. Even as Theranos touts the patient-friendly benefits of its proprietary diagnostic technology, …
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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