CEO SUMMARY: In recent months, Quest Diagnostics Incorporated quietly launched a campaign to notify certain patients and their physicians that they had received “inaccurate results” for Vitamin D tests it had performed. This notice includes an offer to retest the patient at no charge. There are several unprecedented dimensions to this story which have the potential to trigger long-lasting ramifications that touch the entire clinical laboratory community.
OFF THE RADAR SCREEN OF THE WIDER LABORATORY INDUSTRY, an interesting tussle over the accuracy of Vitamin D results produced by a home brew assay has been unfolding over the past 18 to 24 months.
Protagonist, or the central character in this important story, is Quest Diagnostics Incorporated. The antagonists, or forces opposing the protagonist, are a cadre of physicians who refer tests to Quest Diagnostics and, as early as two years ago, began questioning the accuracy of Vitamin D test results reported by Quest Diagnostics on their patients.
The overview to this story is simple and goes like this: toward the end of 2006, Quest Diagnostics did a national roll-out of a new home brew assay for Vitamin 25-hydroxy D. This assay is performed by liquid chromatography–tandem mass spectrometry (LC-MS/MS, or mass spectrometry). That fact is notable because it represented a shift in the common practice of most laboratories in recent decades to offer clinicians a Vitamin D test based on radioimmunnoassay (RIA) or immunoassay (IA) methods.
Within months of implementing its national introduction of this home brew Vitamin 25(OH) D assay to its referring clinicians, a growing number of physicians began to contact Quest Diagnostics to express their concern that the results reported by the mass spectrometry method were not consistent with earlier Vitamin D results that had been reported on these same patients. One common theme in these concerns was the higher number reported to the patient by Quest Diagnostics’ home brew Vitamin 25(OH) D assay. Some of these physicians tell THE DARK REPORT that the mass spectrometry results reported by Quest Diagnostics during this time were consistently higher than what they were accustomed to seeing from the RIA/IA Vitamin D test methods.
Apparently, here was merit to some criticisms directed by vocal physicians at Quest Diagnostics and its use of the home brew assay for Vitamin 25(OH) D. Earlier this fall, Quest Diagnostics quietly initiated what it describes as a “voluntary Vitamin D retesting program.” In certain communities, particularly around New York City and the Northeastern States, surprisingly large numbers of physicians have received letters from Quest Diagnostics advising them that “questionable Vitamin D test results” had been reported on certain of their patients. Quest Diagnostics then offered to retest these patients at no charge, upon the direction of the physician receiving the retest letter. (See pages 16-18.)
News that the nation’s largest laboratory company was informing client physicians and patients that it had produced and reported inaccurate test results for some extended period of time is a remarkable event for the laboratory medicine profession. “Old timer” pathologists cannot recall a similar such episode where a respected, financially successful laboratory organization publicly acknowledged that it had discovered that, for specified periods of time, it had deficiencies in some of its internal testing programs and would offer a free retest for the physicians and patients who had received inaccurate test results.
As with any news story, there is a cast of characters. On the pages that follow, THE DARK REPORT presents interviews with individuals involved in some relevant way with this story. Of course, each has a motivation—a vested interest—and readers should understand that each person will spin in support of his or her perspectives on this story.
The views of two antagonists are presented. First, on pages 6-9, is John Jacob Cannell, M.D., who is a psychiatrist who works at Atascadero State Hospital in Atascadero, California. Eight years ago, his professional interest in Vitamin D led him to found the Vitamin D Council as a platform to educate clinicians and the public about the importance of Vitamin D for good health. Cannell was among the first to publicize the news, on the Vitamin D Council Web site, that there was a consistent and notable difference in the Vitamin D results reported by Quest Diagnostics and Laboratory Corporation of America.
Variation in Vitamin D Results
He saw this difference within his own practice at the Atascadero State Hospital, which has used Quest Diagnostics as its reference laboratory during the eight years he has practiced at the institution. Cannell is an advocate for more physician and patient knowledge about Vitamin D, as well as a practicing physician who saw the variation over time in the Vitamin D test results Quest Diagnostics was reporting on his patients. Cannell recently noted that Atascadero State Hospital has received test recall letters from Quest Diagnostics about inaccurate Vitamin D results along with offers of free retesting to the patients at Atascadero who received these results.
An Interesting Individual
The second antagonist is Bruce W. Hollis, Ph.D., of the Medical University of South Carolina in Charleston, South Carolina, where he is Professor of Pediatrics, Biochemistry, and Molecular Biology; and Director of Pediatric Nutritional Sciences. (See pages 10-12.)
Hollis is an interesting figure in this story, for several reasons. First, he is recognized as a leading researcher in the field of Vitamin D metabolism and nutrition for the past 30 years and has 150 published papers to his credit. Second, back in the 1980s, Hollis was among the first in the nation to develop a radioimmunossay for Vitamin 25(OH) D. This led to an RIA kit sold by DiaSorin, Inc. (then called Immunonuclear Corp.). By 1993, this assay had been further developed and gained FDA clearance for the clinical diagnosis of nutritional Vitamin D deficiency. Hollis continues to consult for DiaSorin and thus has a significant motivation to support the clinical accuracy and relevance of DiaSorin’s Vitamin D assays.
Representing the protogonist, Quest Diagnostics Incorporated, are two individuals. First is Wael Antoine Salameh, M.D., Medical Director, Endocrinology at Quest Nichols Institute, based in San Juan Capistrano, California. In response to questions from THE DARK REPORT, Salameh provided written answers about the home brew Vitamin D assay. His comments are found on page 13.
Speaking next for the protagonist is Richard Reitz, M.D., Medical Director, Quest Nichols Institute and Medical Director, Endocrinology/Metabolism, Toxicology at Quest Nichols Institute. He discusses different aspects of the Vitamin D mass spectrometry testing program. (See pages 14-15.)
Readers Free To Decide
Of course, the two experts speaking for the protagonist are motivated to characterize events at their company in the best possible light. That is equally true of the antagonists on their positions. Clients and regular readers of THE DARK REPORT can draw their own conclusions from the remarks of these protagonists and antagonists.
THE DARK REPORT is first in the nation to call attention to this development. It is a story with several implications that may be unfavorable to the entire laboratory industry. A few questions illustrate the land mines that might await, not just Quest Diagnostics, but all clinical laboratories in this country.
First, could this turn into a story that catches the attention of national media? After all, it is a rare event when thousands of doctors have been notified by a nationally prominent laboratory about the reporting of inaccurate lab test results on an unknown number of patients.
Would the media take an adversarial perspective on this problem and cause the American public to lose trust in the integrity of their local laboratories? Past events, such as the cytology testing scandal of the 1980s that led Congress to pass the Clinical Laboratory Improvement Act (CLIA), demonstrate how the media can magnify a lab failure story into a national concern.
Ammunition For The FDA
Second, might the Food and Drug Administration (FDA) decide that this situation gives it an ideal opportunity to attack the issue of home brew assays? The fact that some physicians have contacted the agency to complain about receiving inaccurate Vitamin D results may have given the FDA the right kind of ammunition to justify expanding its oversight of home brew tests. That would be a very unpopular development among laboratory professionals.
One very important dimension to this story as it unfolds is that it provides a contemporary opportunity to learn the “do’s and don’ts” of how a laboratory should execute a lab test recall program. Pathologists and laboratory staff are ever-aware of the potential for a test run to go awry without detection, causing inaccurate results to unknowingly be reported to patients. Thus, having a case study example of a significant campaign to notify physicians and patients and offer free retests will be a valuable learning experience for laboratories across the country.
Finally, for pathologists and laboratory administrators, these developments are reminders that every laboratory can find itself surprised in unwelcome ways. The complexities of operating a modern, high-tech laboratory can be overwhelming, particularly if increased volumes of specimens come flooding in at unexpected times.