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:
Jan 5, 2009 | Laboratory News, Laboratory Pathology
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 rmichel@darkreport.com 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.
Related Information:
Mar 7, 2007 | Compliance, Legal, and Malpractice, Laboratory Operations, Laboratory Pathology
Senators Edward M. Kennedy (D-MA) and Gordon H. Smith (R-OR) yesterday introduced a bill in the Senate that aims squarely to control laboratory-developed tests, also known as ‘home brew” tests. The trigger for this bill is the growing role of genetic technology in laboratory testing. Also, the appearance of Web sites purporting to sell genetic tests directly to consumers has created a concern in some quarters that regulation of laboratory tests can help keep scam artists and bad science out of the marketplace.
First and foremost, the bill, S.736, would require all laboratory-developed tests to be labeled with their intended use, along with a statement if the test has not been approved under this new Laboratory Test Improvement Act [Jude – Publish the PDF of the Bill on DarkDaily.com somewhere and link to it!] for such intended use. Should this bill pass, laboratories would be required to comply within 60 days of the bill becoming law.
Labeling laboratory-developed tests is just one part of this bill. It also mandates creation of a public database of information on validity of laboratory-developed tests. This database will contain explicit details on the intended use of all laboratory-developed tests that are not yet cleared by the Laboratory Test Improvement Act. This database would be maintained by the Secretary of the Food and Drug Administration, and would be available to and searchable by the public on the FDA website. Submission of laboratory-developed test data to the database would be required within one year of the bill passing.
The act also lays out three specific classes of laboratory-developed tests. Class III laboratory-developed tests are tests that are intended for use in the diagnosis of a contagious disease or condition that is highly likely to result in a fatal outcome. It is expected that special provisions will be made to allow these tests to get through the more quickly get through the verification process defined in the Laboratory Test Improvement Act.
How will this bill directly affect labs that produce their own laboratory-developed tests? More red tape…along with more development costs because of the need to properly document all tests and filter the information to federal regulators with appropriate forms. Does this bill amount to better quality of care for patients, as intended by Senators Kennedy and Smith? It certainly aims to make it blatantly obvious as to how each laboratory-developed test is to be used. It also gives the public access to information about which specific tests have or have not passed this Act.
In the long run, enactment of this proposed legislation is likely to impede the ability of legitimate clinical laboratories to develop and offer useful tests to clinicians. After all, many laws do little to deter scamsters and con artists. They continue to rip off consumers by appearing in the nooks and crannies of the system and avoiding law enforcement. It is accredited laboratories, with ongoing compliance programs, that will be forced to endure the burdens of meeting the law’s requirements. Dark Daily also observes that the uncertainty over the consequences of genetic testing is a factor in motivating elected officials to “take action” to protect the public. So the laboratory industry is also likely to see other bills designed to control the genetic genie before it gets out of the lamp.
Related Items:
Analysis of Senator Kennedy’s sponsorship of the Laboratory Test Improvement Act
Senator Kennedy Press Release on Genetic Laboratory Tests
Oct 13, 2006 | Laboratory News, Laboratory Pathology
In September, The New York Times reported that the Food and Drug Administration was taking steps to regulate a new category of complex diagnostic tests expected to play a growing role in tailoring medical treatments to specific patients. The new policy was published only as draft guidelines open for public comment, so the regulation has not yet become law and there is still time to voice any concerns you or your lab may have.
The FDA already requires approval of diagnostic test kits that are sold widely to labs, hospitals, and doctors. But it has yet to regulate “home-brew” tests developed and performed by a single laboratory. The FDA’s September announcement specifically targets one category of home-brew tests, which it refers to as “multivariate index assays.” These tests measure multiple genes, proteins, or other pieces of clinical information taken from a patient and then use an algorithm or software program to analyze the data. Perhaps the most well-known of these tests is the Oncotype DX, offered by Genomic Health, which analyzes the activities of 21 genes in a sample of a breast tumor and then computes a score that is said to be predictive of whether a patient’s cancer will recur and whether she would benefit from chemotherapy.
The FDA says that its primary concern with multivariate index assays is based on the fact that these assays use algorithms in analysis of the test results. Because these algorithms are usually proprietary, it is difficult for doctors to interpret the test results.
The FDA regulation of multivariate index assays will have significant effects on laboratories that create and offer these tests. First, FDA restrictions may serve to inhibit labs from creating such tests because the amount of time that the lab must wait to get approval for the test could make the amount of time it takes to recoup the investment costs from test development exponentially longer. Furthermore, the requirement might inhibit the gradual improvement of new or existing tests because each change in the test might require an additional regulatory submission.
Second, the FDA regulation of multivariate index assays may affect certain tests, such as the Oncotype DX, that are already on the market and gaining in clinical acceptance. Laboratories currently offering multivariate index assays may find themselves unable to continue offering such test until FDA approval has been obtained.
FDA regulation of genetic tests is a hot topic, widely discussed by both those that are pro-and anti-regulation of such tests. Public notice and public debate about the development and use of genetic tests is expanding outside the medical community and the clinical diagnostics industry. Over-regulation by the FDA of diagnostic tests that incorporate genetic technologies would inhibit the development of useful new assays. It would also lengthen the time and increase the costs of developing such tests and introducing them into clinical use. Lab managers and pathologists should stay alert to ongoing developments in this story. The outcome is likely to be more regulation, not less.
