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       Headlines - December 22, 2008 - Special Issue on Quest Diagnostics Inc.
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R. Lewis Dark: 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 theMedicare Part B Competitive Bidding Demonstration Project, the details of which had finally been made public on December 5, 2007.

Obviously this Medicare competitive bidding demonstration project was a high-profile news story-one that had the potential to negatively affect the finances of every laboratory in the United States and lead to an erosion in the current high standard of lab testing in this country today.

So why devote this full issue to the topic of Vitamin D testing and the acknowledgement by QuestDiagnostics Incorporated that, for certain periods of time, it had reported inaccurate results on certain patients? After all, it is an extremely rare event because well-run clinical laboratories are consistently good at producing accurate, reliable, reproducible results every day, on every shift, and on every instrument.When questionable test results are produced, well-run labs are generally quick to recognize that fact and take timely action so that the physician gets an accurate result and patient care is not adversely affected by that particular laboratory failure.

The uncommon nature of this lab retest/recall program is precisely the reason that Vitamin D testing is the sole theme of this DARK REPORT. The Vitamin D test recall is an extraordinary event. Anecdotal reports from certain communities indicate thatmany thousands of physiciansmay have been sent notices of inaccurate testing on their patients, along with an offer for a retest at no charge. It is also a noteworthy story because it involves the nation's largest laboratory company a company that continually reminds Wall Street investors that it is committed to Six Sigma quality.

Every laboratory in this country that offers Vitamin D testing is experiencing strong increases in test volume. Thus, plenty of important laboratory management lessons can be learned by watching how this company manages its relations with physicians, patients, payers, and the press on the very touchy subject of having reported inaccurate Vitamin D results on some patients. This recall/retest campaign by a prominent laboratory is also a reminder to other lab organizations that anything can happen at anymoment. It is why contingency plans and disaster preparations should always be kept up to date.



Vitamin D Test Issues Trigger Doctor Discussion

Meet two protagonists and two antagonists in this unfolding and important lab industry story

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. There are several unprecedented dimensions to this story which have the potential to trigger long-lasting ramifications that touch the entire clinical laboratory community.




Doctor Notices Different Vitamin D Results Over Time

With an eight-year history of Vitamin D testing for his patients, California doctor noticed the change

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. His Vitamin D Council and his newsletter, with 28,000 readers, became a public clearinghouse where physicians and patients could get information about why the two national labs were reporting different Vitamin D results.

BECAUSE OF A KEEN CLINICAL INTEREST in Vitamin D and its role in various diseases, John Jacob Cannell, M.D., quickly recognized that an upward shift in the results of Vitamin D tests performed on his patients had occurred. He also believed this upward shift, combined with what readers of his newsletter were reporting, made it possible that a major American reference lab was reporting what he described as "falsely elevated" Vitamin D levels to many patients across the United States.

Cannell is a psychiatrist, a Vitamin D researcher, and holds a position at Atascadero State Hospital in Atascadero, California, which is the nation’s largest hospital for the criminally insane. He is the founder of the Vitamin D Council (www.vitamindcouncil.org). His newsletter is read by 28,000 people.




Vitamin D Test Expert Discusses Mass Spectrometry

LC-MS/MS Vitamin 25(OH) D test results can be "analytically accurate" but not "clinically relevant"

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 why, to avoid confusing physicians, some labs using the mass spec method correlate those mass spec results to the IA method and report those correlated results with the immunoassay reference ranges.



Pathologist Perspectives: Quest Diagnostics Explains Confidence in LC-MS/MS Method



Quest Discusses Use of Mass Spec Methodology

Moving Vitamin D testing to mass spectrometry provides analytically precise results of D2 and D3

CEO SUMMARY: Having made the decision to perform nearly all Vitamin 25(OH) D testing by liquid chromatography tandem mass spectrometry (LCMS/MS), Quest Diagnostics Incorporated found the transition to be challenging. That was particularly true as the volume of Vitamin D specimens tripled at the nation's largest lab company during the period May 2006 to May 2008. Medical Direct Richard Reitz, M.D., shares insights about Quest's experience with LCMS/MS.



Retest Program Offers Useful Lessons for Labs

Vitamin D patient retest campaign can help labs develop their own effective contingency plans

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 should have a contingency plan in place that effectively addresses the clinical consequences of such an event, along with the ethical, regulatory, and legal issues that are likely to come into play.


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