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 nationís 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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