TAG:
the laboratory
NorDx CEO Shares Five Rules Critical to every Lab’s Success
CEO SUMMARY: To meet the financial challenges of healthcare today, clinical labs and pathology groups can follow the five classic lab rules of success. However, as noted by Stan Schofield, CEO of NorDx Laboratories in Scarborough, Maine, the “old school” methods need …
FDA Notifies Congress that It Will Regulate LDTs
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
My Visit to Walgreens for Theranos Lab Tests
CEO SUMMARY: One of the biggest unknowns in the lab testing industry today is Theranos, the lab testing company based in Palo Alto, California. It says its proprietary technology is poised to transform the lab testing experience for patients and physicians. It says it can perform hundreds…
Dealing with Realities of Changing Market
CEO SUMMARY: Swift transformation of the American healthcare system is causing financial challenges for those clinical labs and pathology groups that have been slow to react to these developments. At NorDx Laboratories in Scarborough, Maine, the team is following the classic five rules fo…
New Threat to Community-based Anatomic Pathology
THERE IS A NEW DEVELOPMENT that may be off the radar screens of CAP, ASCP, and the various subspecialty pathology associations. It is the requirement for second reviews and subspecialty reviews of certain complex pathology tests as part of the laboratory benefit mana…
Labs Wary of BeaconLBS, Express Major Concerns
CEO SUMMARY: Lab executives asked to join UnitedHealth’s new BeaconLBS lab benefit management system soon to launch in Florida have multiple and serious concerns. The primary issue is that BeaconLBS is a subsidiary of LabCorp—their major competitor. These executives understand why a p…
Test Utilization Targeted by UnitedHealth, LabCorp
CEO SUMMARY: Many independent laboratories serving patients in Florida are unhappy about the decision by UnitedHealth (UNH) to initiate a pilot program that calls for LabCorp’s BeaconLBS subsidiary to handle prior authorization for certain lab tests. UNH’s laboratory benefit managemen…
UCLA, Centre to Open Lab in China to Offer High Quality Testing
CEO SUMMARY: To fill the unmet demand for quality clinical laboratory testing in China, a partnership between pathologists at UCLA and Centre Testing International Corp. of Shenzen have built and will operate a lab facility in Shanghai. The new lab will open by late September and…
One Key to Lab Success Is Daily Performance Metrics
CEO SUMMARY: Every clinical lab today must deal with the twin challenges of performing an increased volume of tests while being paid less money. That’s why a handful of innovative lab organizations now use management information systems with analytics that provide detailed, real-time me…
New Pricing Formula for Advanced Diagnostic Tests
CEO SUMMARY: One section of the federal H.R. 4302: Protecting Access to Medicare Act of 2014 is getting positive reviews from many lab experts. The law defines advanced diagnostic tests (ADTs) and directs CMS to assign a temporary HCPCS code and use list prices to pay labs for such tests …
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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