Month: February 2009

Need Rigorous Validation For Home Brew Assays

CEO SUMMARY: National headlines about erroneous Vitamin D results are a reminder to the lab industry of the imprecision and risks associated with home brew testing. According to one laboratory expert, every laboratory-developed test (LDT) must meet two high standards. One, accuracy, reproducibility, and transferability of the test result number. Two, a reference range that …

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Dark Daily

February 23, 2009 “Intelligence: Late Breaking Lab News”

Here’s an interesting development on the road to genetic medicine. In England last month, the press heralded the birth of what it has dubbed the “cancer-free” baby. It turns out the parents had the embryo screened for the BRCA-1 gene before implantation—and this was the first example known in Great Britain of an infant screened …

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Local Labs Have Opportunities To Increase MC Patient Access

CEO SUMMARY: Although the nation’s two largest laboratory companies have achieved a dominant managed care position, opportunities remain for regional labs to do more business with managed care plans. Two experts provide an update of managed care pricing trends for laboratory testing services. For independent labs and hospital lab outreach programs seeking to expand access …

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Ten Years Ago: Quest Diagnostics Agrees to Buy SmithKline Labs

IT WAS 10 YEARS AGO THIS MONTH when a major event changed the competitive landscape for lab testing services. On February 9, 1999, Quest Diagnostics Incorporated signed an agreement to purchase SmithKline Beecham Clinical Laboratories (SBCL). It was the largest laboratory acquisition up to that point. In one masterstroke, Quest Diagnostics would become the largest …

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Medicare Carrier Proposes No Pay for Vitamin D Test

CEO SUMMARY: Medicare contractor NGS wants to end payment to labs and physicians for routine Vitamin D testing. In a proposed local coverage determination (LCD), the Medicare carrier says it would cover Vitamin D testing only for patients with chronic kidney disease, osteomalacia, hypercalcemia, and rickets. All other testing for Vitamin D would be denied. …

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Are Labs To Be Punished for Vitamin D Testing?

HERE’S AN INTERESTING QUESTION: Are labs to be punished because patients want to know if their Vitamin D levels are sufficient? Consider this: THE DARK REPORT predicted last year that labs might suffer a backlash from payers as a result of increased demand for Vitamin D testing. In a briefing titled: “Vitamin D Test Volumes …

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Molecular Advances Soon To Reshape Anatomic Path

CEO SUMMARY: Early this month, the second annual Molecular Summit assembled molecular first movers and early adopters to discuss their efforts to integrate molecular imaging and molecular diagnostics in patient care. One clear message emerged from two days of presentations and discussion: a host of new technologies is ready for clinical introduction and is likely …

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When Does Cost Cutting Affect a Lab’s Quality?

CEO SUMMARY: Many lab professionals note the irony that a laboratory so publicly committed to Six Sigma quality management methods is now identified with the single largest episode of systemic failure in lab test accuracy. Looking in from the outside, some pathologists suggest that a decade of aggressive cost cutting and the current campaign to …

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Laboratory Industry Has “Elephant in the Room”

CEO SUMMARY: In almost every laboratory across the United States and in several countries around the globe, one much-discussed topic in recent weeks has been the Vitamin D testing program deficiencies at Quest Diagnostics Incorporated. Yet, even as rank and file laboratorians actively talked to each other about what this story means, the lab industry’s …

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Got a Lab Test Question? Call an ASCLS Lab Guru!

CEO SUMMARY: Each year since its launch in 2001, the ASCLS Consumer Response Team serves increasing numbers of patients and physicians. Clinical Laboratory Scientist volunteers from the American Society for Clinical Laboratory Science provide answers and help patients understand the meaning of their lab test results. After sending a question by e-mail, these patients get …

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