TAG:
lab compliance
Ampersand Buys Calloway Labs, Enters Pain Management Market
By Robert Michel | From the Volume XIX No. – October 8, 2012 Issue
URINE DRUG TESTING for pain management may be a challenging business for clinical labs given that compliance officers in the states and in the federal government have successfully pursued lab compliance abuses in this line of business in recent years. Now comes news that private equity firm …
CMS Proposes Sanctions Against OSU Laboratory
By Joseph Burns | From the Volume XIX No. 11 – August 6, 2012 Issue
CEO SUMMARY: As its reward for self-reporting the referral of six proficiency testing (PT) specimens in three years, the laboratory at Ohio State University Wexner Medical Center (OSUWMC) has been told by the Centers for Medicare & Medicaid Services (CMS) that its CLIA license could b…
November 7, 2011 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XVIII No. 15 – November 7, 2011 Issue
Many experts were impressed when General Electric Co. ponied up $587 million to acquire pathology testing company Clarient, Inc., in October 2010. Now comes further insight behind this transaction. At an investment conference in Boston on November 3, John Dineen, CEO…
Will Lawsuits Re-shape Current Lab Practices?
By Robert Michel | From the Volume XVIII No. 9 – July 5, 2011 Issue
CEO SUMMARY: Recent events in California, triggered by a lab whistleblower lawsuit filed in 2005 and unsealed in 2009, provide the latest example of how these lawsuits and related government enforcement actions can cause fundamental changes in the pricing and marketing p…
AP Test Over-Utilization Will Be One Achilles’ Heel
By Robert Michel | From the Volume XI No. 11 – August 9, 2004 Issue
CEO SUMMARY: Over-utilization is likely to be a prime concern when federal healthcare enforcers eventually investigate in-house anatomic pathology laboratories owned by specialist physicians. Some in-house pathology lab condo promoters are basing financial performance on 100% utilization …
“Waiver of Charges”: What Makes It Work
By Robert Michel | From the Volume X No. 16 – December 1, 2003 Issue
CEO SUMMARY: Little-used in the 1990s, when laboratory test ordering and billing practices were under intense scrutiny by federal regulators, the strategy of “free testing” is popping up in more regions around the country. To comply with compliance guidelines, labs using this strategy g…
Year’s Ten Biggest Stories Reveal Modest Changes
By Robert Michel | From the Volume VII No. 17 – December 4, 2000 Issue
CEO SUMMARY: In many ways, 2000 was a relatively quiet year for laboratory organizations. This list of the ten biggest stories in the lab industry for 2000 demonstrates that the most innovative laboratory organizations in the United States are “raising the bar” for service and quality…
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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