TAG:
laboratory regulation
Why Theranos Is a Big Test for CMS and CLIA
OFFICIALS AT THE FEDERAL CENTERS FOR MEDICARE & MEDICAID SERVICES are at what may be the most important crossroads in the history of clinical laboratory regulation since Congress passed the CLIA 1988 legislation. Will CMS pursue the severe sanctions it disclosed to Theranos, Inc.,…
Quality Assurance Regs to Tighten for UK Labs
CEO SUMMARY: In the United Kingdom, a window of opportunity has opened for improving the quality assurance activities of pathology and histopathology laboratories. Last week, at the Frontiers in Laboratory Medicine conference, the newly-published “Pathology Quality Assurance Review” w…
AAB’s Suit Prevails over NY State Following 11 Years of Litigation
SCORE A BIG WIN FOR THE GOOD GUYS! An appeals court in New York state has upheld a lower court ruling that the New York State Department of Health (NYSDOH) intentionally overcharged clinical laboratories for the costs of regulating clinical laboratories and blood banks, possibly goin…
Phlebotomists in Calif. Undergoing Certification
CEO SUMMARY: State certification of phlebotomists is under way in the Golden State. By April 9, 2006, all phlebotomists in California will need to maintain state certification. This development adds complexity to laboratory management in California. However, there are no signs that other …
Specialty Progresses With CA Lab Regulators
CEO SUMMARY: Earlier this month California laboratory regulators found Specialty Laboratories, Inc. to be “in substantial compliance with California clinical laboratory law.” This is an important milestone in restoring the lab company to full compliance with both state and federal labor…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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