TAG:
clinical laboratory improvement amendments
Might Lawsuits Come Next in Theranos Story?
CEO SUMMARY: Recent disclosures in the news indicate that an agreement between Theranos and Safeway has gone sour— after Safeway spent a third of a billion dollars to fulfill its part of the collaboration! Reporting by The Wall Street Journal c…
Achieving CLIA, ISO 15189 at Same Time with A2LA
CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…
Public Comment Started on FDA LDT Regulations
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
Labs Working to Release Test Results to Patients
CEO SUMMARY: A new federal requirement requires labs to make test results available to patients beginning this month. What is unknown is how patients will respond to the opportunity to see their lab test results. The effective date for this new requirement was October 6. It is expected th…
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…
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…
2012’s Top Ten Lab Stories Predict More Challenges
CEO SUMMARY: It’s been a year with more lows than highs, when viewed through the lens of THE DARK REPORT’S “Top Ten Lab Stories of 2012.” The end of the TC grandfather clause, new policies for prostate biopsy billing, and a dramatic 52% cut to 88305- TC fees were widely reported. …
Pathologists Benefit from Hospital Lab Consulting
CEO SUMMARY: Deteriorating finances at many rural hospitals and smaller community hospitals is a growing trend. It is also a new consulting opportunity for local pathologists because financially-strapped hospitals often give their labs inadequate working capital and lack the staff needed …
NY Lab Director Resigns, Cites Lack of Support
CEO SUMMARY: When the lab director resigned from his post at a clinical lab in a hospital in rural New York, the resignation letter was sent to the hospital administration and copy went to the New York State Department of Health. In the letter, the lab director outlined eight reasons for …
Louisiana Pathologists ‘Moonlight’ as Consultants
CEO SUMMARY: Few independent pathology groups have developed robust laboratory consulting businesses. But adopting that strategy has brought important benefits to Delta Pathology Group, LLC, of Shreveport, Louisiana. Not only has providing lab consulting services to cash-strapped hospital…
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.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.