Testing ceases following July 19 inspection by officials from CMS and CAP
Last Friday, The Washington Post broke the news that Georgetown University Hospital (GUH) had closed the pathology laboratory that performed certain breast cancer tests. The action—described as an “unprecedented” suspension by GUH Chief Medical Officer Stephen Evans, M.D.—was taken in response to an investigation of the pathology laboratory by federal officials.
The closure of the laboratory followed an inspection on July 19, 2010 by officials from the Centers for Medicare and Medicaid Services (CMS) and inspectors from the College of American Pathologists (CAP). Hospital officials say the molecular testing laboratory in question will be closed as long as four to eight weeks. During this time, specimens are being referred to outside laboratory testing sources.
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”
|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”.
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 email@example.com or by dialing 512-264-7103.
Starting in October, Quest Diagnostics Incorporated (NYSE:DGX) has quietly notified certain physicians and patients that it had reported “inaccurate” lab test results for Vitamin 25(OH) D. This ongoing campaign appears to be the largest voluntary patient recall/retest program known to have been instituted by a clinical laboratory company.The Dark Report and Dark Daily are first to report this remarkable story. Quest Diagnostics has told The Dark Report that, for a period of time in 2007 and extending into 2008, it reported inaccurate results for Vitamin 25(OH) D to some patients. The problem is related to Quest Diagnostics’ decision, several years ago, to switch away from immunoassay methods for Vitamin 25(OH) D testing and create a home brew assay that utilizes liquid chromatography-tandem mass spectrometry (LC-MS/MS).
To date, Quest Diagnostics’ voluntary program to alert physicians and patients to possibly inaccurate Vitamin 25(OH) D results seems most active in the Northeast. In particular, competing labs in the New York metropolitan area are reporting their belief that thousands of physicians have gotten letters from Quest Diagnostics informing them that certain of their patients had received unreliable results for Vitamin 25(OH) D tests performed during the period in question. Quest Diagnostics is offering a free retest to these patients, subject to the referring physicians’ authorization of the retest.
This rare campaign by Quest Diagnostics to alert physicians and patients and to offer free retesting is significant for a number of reasons. First, it is extraordinarily rare for any licensed, accredited laboratory in this country to acknowledge that, due to internal deficiencies in analytical processes, it reported unreliable test results on a sizeable number of patients over a specified period of time.
Second, Quest Diagnostics’ program to alert physicians and patients about the questionable Vitamin D test results and offer a free retest provides the entire laboratory industry with a management case study on how to respond to a laboratory discovers that significant numbers of patients and their physicians might have received unreliable test results that could negatively affect patient care.
Third, because the source of the unreliable Vitamin 25 (OH) D test results is a home brew assay, this episode could catch the attention of federal and state healthcare regulators. For example, the Food and Drug Administration (FDA) is known to want more authority to regulate laboratory-developed tests (LDTs), commonly called “home brew” tests.
Fourth, this recall/retest campaign has the potential to involve large numbers of physicians and patients. That is because the volume of Vitamin D testing tripled at Quest Diagnostics between May 2006 and May 2008, and Web sources report that Quest Diagnostics is doing as many as 500,000 Vitamin D tests each month. Accordingly, even a tiny percentage of the millions of Vitamin D home brew tests performed at Quest Diagnostics during this time could mean that tens of thousands of patients may be getting recall/retest letters from Quest Diagnostics. The number of patients and physicians affected by this episode may motivate federal and state healthcare regulators to take a closer look at what internal deficiencies created this problem at the nation’s largest lab company.
The current issue of The Dark Report provides detailed coverage of these events. This issue has been distributed to existing subscribing members. To see the individual intelligence briefings, use this link (or paste 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 firstname.lastname@example.org or by dialing 512-264-7103.)
Additionally, Dark Daily would be interested in the opinions, advice, and questions that laboratory professionals have on this voluntary program of Vitamin D retesting. Because it provides a rare opportunity to learn how clinical laboratories and pathology groups should improve their own contingency plans, Dark Daily intends to provide ongoing news and intelligence about the full spectrum of issues triggered when a laboratory discovers it has reported inaccurate results to significant numbers of physicians and their patients.