News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups
Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups
Hosted by Robert Michel
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News Flash! New York Times Hits Quest Diagnostics for Erroneous Vitamin D Results!

Jan 8, 2009 | Laboratory News, Laboratory Pathology

Just days after The Dark Report and Dark Daily alerted the laboratory industry to systemic problems with “home brew” mass spectrometry Vitamin D testing at Quest Diagnostics Incorporated (NYSE:DGX) during a period starting in early 2007 and lasting into mid-2008, the New York Times has confirmed the essential details of this extraordinary story.

In the Thursday, January 8, 2009, edition of the New York Times, reporter Andrew Pollack wrote a story titled “Lab Acknowledges Problem with Vitamin D Test.” In balanced coverage, Pollack provided information about Quest Diagnostics’ acknowledgement that it had reported inaccurate results for what appears to be about a year and a half. He also quoted physicians on the various clinical issues associated with Vitamin D testing, Vitamin D therapy, and the role Vitamin D plays in various diseases.

The exact magnitude of the problem remains unknown, because Quest Diagnostics has neither disclosed the number of physicians who received letters about erroneous Vitamin D results reported on their patients, nor the number of patients for whom inaccurate Vitamin 25(OH) D test results were reported by Quest Diagnostics during the 2007-2008 time period.

However, competing laboratories in the New York metropolitan area have told The Dark Report and Dark Daily that thousands of physicians in this region received Vitamin D recall/retest letters from Quest Diagnostics. Most of these letters were sent in October 2008. Each physician may have had as few as a handful of patients to retest, or as many as several hundred. Thus, just in the New York region, it would not be unreasonable to estimate that tens of thousands of patients are involved in this Vitamin D retest program.

One clue to the total number of inaccurate results was provided in The New York Times story, which wrote that “Dr. Salameh [Wael A. Salameh, M.D., Medical Director, Endocrinology at Quest Nichols Institute in San Juan Capistrano, California] said the inaccurate results represented fewer than 10% of all the vitamin D tests done by the Quest from early 2007 to mid 2008. And even many of the possibly inaccurate results were probably accurate, he said, because Quest sent letters even if there was only a remote chance that the test was erroneous.”

Take Salameh’s statement that “fewer than 10% of all the Vitamin D tests” were inaccurate, and assume a 9% rate of inaccurate tests. Next, combine that with a rough estimate that Quest Diagnostics performed between 5 million and 7 million Vitamin D results during 2007-2008, and one comes up a possible range of between 450,000 to 630,000 inaccurate Vitamin D test results.

That’s a lot of patients-and a lot of doctors! Assume 10 patients per doctor, and that means Quest Diagnostics may have reported inaccurate Vitamin D results to between 45,000 and 63,000 doctors! If the real numbers approach these estimates of affected patients and referring physicians, then this is a laboratory failure without precedent.

How could something this troubling happen at the nation’s largest laboratory company? According to the New York Times, Salameh stated that “some materials used to calibrate test results were faulty.” Salameh also admitted that “four of Quest’s seven testing laboratories around the country did not follow proper procedures for some period of time.”

The January 12 issue of The Dark Report will have additional intelligence briefings on this unfolding story. Dark Daily readers interested in becoming a subscribing member to The Dark Report can act immediately with this link (or copy this URL and paste in your browser: http://www.darkreport.com/dark/subscribe.htm).

The current issue of The Dark Report (dated December 22, 2008) was the first public news reporting on Quest Diagnostics’ problems with Vitamin D testing. This issue has been distributed to existing subscribing members. Dark Daily readers can see the individual intelligence briefings by using this link (or pasting this URL in your browser: http://www.darkreport.com/dark/past.htm) For more information on Charter Memberships go here.

Dark Daily asks that anyone with knowledge of this remarkable story about inaccurate Vitamin D results and willing to share insights can contact editor Robert L. Michel in complete confidence at rmichel@darkreport.com or by dialing 512-264-7103.

Related Information:

Top Ten Lab Industry Stories for 2008 Announced by The Dark Report

Dec 9, 2008 | Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations

It’s no surprise that topping The Dark Report’s list of Top Ten Most Important Stories of 2008 for the laboratory industry is the successful repeal of the Medicare Part B Laboratory Services Competitive Bidding Demonstration Project. Across the nation, labs feared the consequences were federal health officials to have implemented the flawed scheme that was scheduled to commence in the San Diego-Carlsbad-San Marcos SMA (statistical metropolitan area) by July 1, 2008.

Our list of the Top Ten Most Important Lab Industry Stories of 2008 leads off the latest issue of The Dark Report, published last week and arriving at client’s locations here and abroad. This annual listing is closely-watched because it provides a clear assessment of major trends unfolding in laboratory medicine.

Editor-In-Chief Robert Michel, after explaining why repeal of Medicare Competitive Bidding was the single most important development during 2008, characterized the balance of 2008 as otherwise a quiet and relatively uneventful year. He wrote “No other story on the Top Ten list approaches the magnitude of importance and implications of Medicare competitive bidding repeal. However, that is a good thing because it means that, over the course of 2008, there were few events that represented disruptive or unwelcome change to the majority of laboratories and pathology group practices.”

In fact, Editor Michel picked the huge increase in the volume of Vitamin D testing as the second most important lab industry story for 2008. “This phenomenon is directly related to widespread media stories about: 1) the alarming increase in the number of people with Vitamin D deficiency; and, 2) the negative health consequences for individuals who are deficient in Vitamin D,” noted Michel in The Dark Report. “Attention to Vitamin D deficiency during the past two years shows how speedily a new clinical guideline can become accepted, particularly when it is something that is easy for consumers to understand.”

Top story number ten was described as “2008-Not a Year for Big Lab Deals as Relative Calm Rules Lab Market.” Michel observed that no major or disruptive laboratory acquisitions took place during the year. He noted how this was unusual for a trend that reaches back to the mid-1980s. However, it remains true that Wall Street is keenly interested in molecular diagnostics. That was reflected in the willingness of Roche Holdings (NYSE: RHHBY) to pay the premium price of $3.4 billion last April to acquire then $290 million Ventana Medical Systems. (See Dark Daily, “Roche Purchases Ventana by Offering Higher Price”, February 22, 2007).

Subscribers and readers of Dark Daily are invited to send in their picks for the most important medical laboratory stories for 2008, along with their reasons why the story is significant. We will publish the best of these submissions. E-mail to: rmichel@darkreport.com.

Related Information:

2008’s Top Ten Lab Stories Lacked Disruptive Impact

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