TAG:
laboratories
Labs Need to Respond To Inaccurate Results
CEO SUMMARY: What does a lab do when it discovers that it has reported inaccurate test results? In 2004, a turnaround team arrived at the laboratory of Maryland General Hospital in Baltimore to deal with the consequences of a failed infectious disease testing program. For about t…
Vitamin D Test Expert Discusses Mass Spec
CEO SUMMARY: Those labs performing Vitamin 25(OH) D testing by mass spectrometry face an interesting challenge. For more than two decades, physicians, patients, and a majority of credible clinical studies have accepted RIA and IA Vitamin 25(OH) D results as a familiar standard. That is wh…
Patient Retest Effort Is Extraordinary Event
IT IS NOT OFTEN THAT WE DEVOTE AN ENTIRE ISSUE TO A SINGLE TOPIC. The last single-topic special issue of THE DARK REPORT was almost exactly one year ago, when we provided the laboratory industry’s most detailed assessment of the Medicare Part B Competitive Bidding Demonstration Project, the details…
Vitamin D Test Issues Trigger Doctor Discussion
CEO SUMMARY: In recent months, Quest Diagnostics Incorporated quietly launched a campaign to notify certain patients and their physicians that they had received “inaccurate results” for Vitamin D tests it had performed. This notice includes an offer to retest the patient at no charge….
Doctor Notices Different Vitamin D Results over Time
CEO SUMMARY: Psychiatrist John J. Cannell, M.D., was in a unique position to see the noticeable upward shift in the Vitamin D results reported on his patients by Quest Diagnostics Incorporated over the past 24 months, along with the recent decline in test result levels in recent weeks. Hi…
Quest Discusses Use of Mass Spec Methodology
CEO SUMMARY: Having made the decision to perform nearly all Vitamin 25(OH) D testing by liquid chromatography–tandem mass spectrometry (LC–MS/MS), Quest Diagnostics Incorporated found the transition to be challenging. That was particularly true as the volume of Vitamin D specimens tri…
December 22, 2008 “Intelligence: Late Breaking Lab News”
Last Thursday, Sunquest Information Systems, Inc. of Tucson, Arizona, announced that it would purchase the “Outreach Advantage Solution” software system developed by Pathology Associates Medical Laborator ies of Spokane, Washington. PAML has spent most of this de…
Retest Program Offers Useful Lessons for Labs
CEO SUMMARY: Every day in every laboratory, there is the potential for some aspect of the testing process to go wrong and not be immediately detected. In such circumstances, the lab can then unknowingly report inaccurate test results to physicians and patients. That is why lab managers sh…
2008’s Top Ten Lab Stories Lacked Disruptive Impact
CEO SUMMARY: For the first time in recent memory, a year has passed without major tumult or disruptive change in the laboratory industry. Our list of the Top Ten Most Important Stories of 2008 reflects a rather quiet year when compared to most years of this decade. Howeve…
Multi-Modality Diagnosis Heading for Lab Medicine
CEO Summary: At the upcoming Molecular Summit in Philadelphia on February 10-11, 2009, pathologists, molecular imaging experts, and informaticians will share the latest developments on the integration of in vivo (imaging) and in vitro (pathology) diagnost…
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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