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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Second National Journalism Award Goes to The Dark Report and Robert Michel

Best Investigative Reporting honors earned for story about problems with Vitamin D testing

Top honors in a prestigious national journalism competition were recently awarded to our sister publication, The Dark Report. Editor-In-Chief Robert L. Michel traveled to Washington, DC, to accept the first place award for “Best Investigative Reporting.”

The occasion was the 33rd annual conference of the Specialized Information Publishers Association (SIPA). Handing Editor Robert Michel his first place award was Nora O’Donnell, News Anchor and Political Reporter for NBC News and MSNBC. (more…)

Vitamin D Testing: What the Government Giveth, It Taketh Away

New Study to Research if Supplements of Vitamin D, Fish Oil Reduce Health Risks

With the volume of Vitamin D testing skyrocketing in clinical laboratories across the nation, leave it to government bureaucrats to work at counter purposes to each other. With one hand, the federal Medicare program is proposing to restrict coverage guidelines and reimbursement for Vitamin D testing to Medicare patients. With another hand, the federally-funded National Institutes of Health (NIH) is funding a large, multi-year study to assess the effect Vitamin D supplements and fish oil have in reducing health risks!

Researchers at Harvard Medical School will investigate whether taking daily dietary supplements of Vitamin D or fish oil reduces the risk of developing cancer, heart disease, and stroke in people with no previous history of such illness. Under a $20 million grant from the National Institutes of Health Institutes, researchers from Harvard Medical School and the Brigham and Women’s Hospital in Boston, Massachusetts, will recruit 20,000 participants for the study nationwide. (more…)

Medical Errors Become a Headline News Item

Consumers raise the bar on expectations of error-free healthcare

Multiple cases of medical errors hit the headlines in recent months. Collectively, these headlines raise an interesting point. Patients and the public at large have changed expectations about the quality of healthcare. Consumers increasingly expect medical services to be error-free. When news surfaces that a provider committed a pattern of medical errors over an extended period of time, it becomes a major news story. (more…)

Quest Diagnostics Makes “Five Dumbest Things on Wall Street” List

It may have been adding insult to injury when Quest Diagnostics Incorporated (NYSE:DGX) made the “Five Dumbest Things on Wall Street: Jan. 9” list. After all, this recognition came just hours after the New York Times hit the street with its reporting of Quest’s acknowledgement of inaccurate Vitamin D test results, which itself was based on The Dark Report‘s  coverage of Quest’s problems that had become public the previous week.

“Five Dumbest Things on Wall Street” is a regular feature of TheStreet.com. It is widely-read by professional investors and Wall Street analysts. Joining Quest Diagnostics on that day’s “Dumbest Things” list were Satyam Computer Service, Bernie Madoff, Former Vogue cover girl Liskula Cohen, and Bank of America.

TheStreet.com explained the basic facts about problems with Vitamin D testing at Quest Diagnostics, including Quest’s acknowledgement that it had reported thousands of inaccurate results for as long as a year and a half before initiating a recall/retest program for patients who received erroneous results, TheStreet.com then went on to say:

Quest’s test inaccuracies were first disclosed by The Dark Report, a newsletter for pathologists and lab technicians. Robert Michel, editor of the Dark Report, said it was the largest recall of test results he has heard since he started in the field in 1991.

“It’s an extraordinary event when a fully accredited and licensed laboratory produces such a large number of inaccurate results, and it seems not to have recognized the problem for 18 months,” Michel told TheStreet.com. “That’s a long time to miss something this big”

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This was followed with the irony and satire for which The Street.com is known. Columnist Gregg Greenberg ended his piece by writing, “We here at the Five Dumbest Research Lab aren’t scientists, but checking a patient’s blood for Vitamin D doesn’t seem all that difficult a task. Here’s a test for the brass at Quest Diagnostics: Can you say ‘boneheads’?

Every “Dumbest Thing” company gets a rating. TheStreet.com finished with this comment: “Dumb-o-meter score: 75 -Quest flunked this test. Miserably”.

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News Flash! New York Times Hits Quest Diagnostics for Erroneous Vitamin D Results!

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.

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