Quest Says Nearly 10% Of Its Vitamin D Tests Were Inaccurate
Last October, Quest Diagnostics contacted "thousands of doctors" around the country to notify them that one or more of their patients might have received "questionable" results on vitamin D tests performed over the past two years. It's offering free retests to anyone who was affected.
The errors came about when Quest switched from an FDA-approved test to "a new test of its own design," reports the New York Times.
So what does it mean to have an incorrect vitamin D analysis?
An erroneously high result may mean patients will not take vitamin D supplements when perhaps they should, doctors said. And an erroneously low test result might lead in rare instances to a toxic overdose of vitamin D. When the Quest tests have been inaccurate, the reading has typically been too high, although not in all cases.
There's at least one case, reported in the Times article, of a patient who subsequently tested positive for a "toxic level" of vitamin D after his Quest result said he had a deficiency.
Dr. Salameh, a medical director for Quest, says the mass spectrometers Quest uses weren't calibrated properly, and that 4 of the 7 labs didn't always follow proper procedure. He also notes, however, that Quest erred on the side of caution by contacting anyone with even the slightest chance of a mistaken test, and that "We are kind of being penalized for going the extra mile." Actually, we think Quest did the right thing by being overcautious, and Dr. Salameh's whiny complaint is why you use a spokesperson to speak on behalf of your company.
"Lab Acknowledges Problem With Vitamin D Test" [New York Times]
(Photo: R'eyes)
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Comments:
Damn these rickets!!
Two years?! How can it go on for that long? I could understand a week. Maybe a month. But two years is just plain insane.
I can't have a vitamin D deficiency anyways; I always drink my malk!
I prefer Quisp, which is loaded with vitamin D.
If your a pasty faced geek who never goes out in the sun because your always at your computer, you probably have at least some vitamin D deficiency. Winter is worse.
Even if you go out in the sun and drink your milk there's a good chance you are Vitamin D deficient. That's what my test results showed a year ago, and I'm a big dairy consumer and enjoy the outdoors. Of course, perhaps my test was sent to Quest. I'm not surprised about this total lack of quality control. I walked out of one of their facilities a few years back due to their total lack of professionalism.
Anyway, 1000 IU supplement daily will provide much benefits. I noticed a difference in mood, energy, and lack of knee pain since I started taking Vitamin D. So even if my test results were inaccurate, I'm glad I starting taking the D.
There's a much easier way to take Vitamin D, that many people often forget. It's going out for some sun. Our skin naturally produces vitamin D from UVB radiation. This is also how people get tanned. And a healthy tan is never bad.
I would like to point out for anyone who wants to insult quest here...
They admitted their error and are taking the appropriate steps to correct it.
From any company that's awesome.
@TVarmy: That was my first reaction. I'm guessing (I can't read the article because I can't get any of the bugmenot passwords to work) that not following procedure included never checking to make sure the machines were calibrated.
"We are kind of being penalized for going the extra mile."1) Fixing your mistake is not 'going the extra mile'. That's what you're supposed to do.
2) You can't mess up (especially for that long) and not expect to face some kind of penalty.
3) Fixing the mistake is not the penalty. The lawsuits from the people who's health suffered as a result of the incorrect tests are the penalty.
This guy's attitude says he doesn't think they should have to do this. If most of his colleges feel the same way then I think that explains how this happened in the first place.
@Ajh: Sure, they admitted their error. But, let's not forget that this came about because Quest ditched the FDA approved test to use a "a new test of its own design".
I'm guessing (and this is purely speculative) that their test was quite a bit cheaper to perform than the FDA test.
@bohemian: Hehe, too true. Plus, my Fitness magazine I just received in the mail had an article about vitamin deficiency. It said if you live above the 42nd parallel, in winter you won't get vitamin D from the sun. I can believe it. We barely see sun in NW Indiana from November-May.
@neko613: You only get Vitamin in the sun between 10 am and 3 pm. A lot of people are indoors, working during that time. Or they live in places like where I'm at where winter is gray, cloudy, cold and snowy. I'm can't remember the last time I saw sun. :( That's why people are happier in the summer than in the winter here.
@Hank Scorpio: Cheaper is good. Cheaper costs to do tests lowers the overall medical costs. Well, we can all bitch and whine about how evil corporations keep all profits, but in reality that extra margin is far better for everyone involved than sticking to a needlessly overpriced procedure. Could you argue that, all other things being equal, they should have stuck with an expensive test only because it was FDA approved?
Also, is there evidence that the tests were inaccurate because of the new test procedure, or because of mistakes involved in following the new test procedure?
@chrisjames: Mistakes are often made with new procedures (and/or inadequately refined procedures) which is why companies stick with the tried and true [and usually FDA approved] ones. Not to say that Quest shouldn't innovate, but clearly they had some gaps in the procedure or training, and their mass specs. being out of calibration (multiple machines!) is just negligent.
@Hank Scorpio: Got any sugar around here?
@chrisjames:
"Could you argue that, all other things being equal, they should have stuck with an expensive test only because it was FDA approved?"
Clearly, all other things weren't equal.
"Also, is there evidence that the tests were inaccurate because of the new test procedure, or because of mistakes involved in following the new test procedure?"
If implementing the new procedure is the cause of the mistakes, is there really a difference? It's clear from the article that the procedure itself is not to blame, but how it was performed. Maybe all they needed to do was invest a little more in training lab technicians on the new procedure, but they didn't, and they're still at fault.
Also, the article brings up the issue that Quest, and other companies like them, are resistant to any oversight and standardization that would have prevented this in the first place. Sure, it's great that they came up with an new test that was supposed to be more accurate and detailed, but if they can't actually perform the test correctly, what good is it?
I might reiterate that that comment was pure speculation on my part. For all I know, their new test may have been more expensive (although, I sincerely doubt that). Profit and cost-cutting is good, but not at the expense of the well being of their patients.
What our mamas always said ("Drink your milk and go outside and get some sunshine") as right! The big increase in Vit D testing is due to research findings released last October which showed Vit D is even more important than we ever realized. We're woefully low in this sunshine vitamin say researchers -- even nursing babies aren't getting enough from their mother's milk. So, the American Academy of Pediatrics recently DOUBLED its recommendation of Vit D for kids. And, doctors are seeing teen athletes with osteoporosis! Remember, O.J. Simpson suffered from rickets when he was a kid and had to wear leg braces. Doubt that O.J. will get a lot of sunshine in jail. For a good article on Vit D research, go to Ethic Soup blog at:
http://www.ethicsoup.com/2008/10/slather-up-with-sunscreen-or-let-the-sunshine-in.html
Vitamin D is not the only test Quest has been burned on. Para thyroid hormone (PTH) calcium, newborn testing was revoked by the state of Virginia. Quest has bought all but one competitor thats Lab Corp. So with no one left to compete with, why should they care. They hire clinical students for cheap. Their lack of experience are the most common reasons for bad results. Having a test done wrong at procurement will most assuredly give the wrong result. It takes the employee to care how the testing is done. They have to know how and with what to mix blood with to get it right. Having worked for Quest for 9 years and almost being part of their death toll statistics made me a bit cynical. I contracted TB from a patient, my blood test came back negative. As it did every 6 months. Till I went into congestive heart failure due to the TB. Quest failed me, but I lived. Not every one does
I predict "going the extra mile" will be 2009's "taking it seriously". you heard it here first.