CEO SUMMARY: Most laboratory professionals don’t know it yet, but significant changes occurred to the entire lab industry last week. After Quest Diagnostics Incorporated acknowledged that it was retesting tens of thousands of patients because 7% of the Vitamin D results it reported during an 18-month period were inaccurate, a blitz of newspaper headlines and television news coverage of the story alerted Americans to the problem.
LAST WEEK, Quest Diagnostics Incorporated found itself in the midst of a media firestorm, as the nation and the world heard Quest admit that it had reported inaccurate results for Vitamin 25(OH) D tests to tens of thousands of patients.
It was THE DARK REPORT which scooped the national media and first broke this important story in its issue dated December 22, 2008. Until then, even the laboratory industry was unaware that Quest Diagnostics was conducting a voluntary retest program, notifying what THE DARK REPORT believes is actually hundreds of thousands of patients who were given inaccurate Vitamin D results by Quest during 2007 and 2008.
From the New York Times and USA Today to CNN and ABC’s Good Morning America show, news coverage last week centered around such themes as “nation’s largest lab acknowledges erroneous Vitamin D tests” and “can you trust your lab test result?” Across the country, local newspapers ran stories about the problems with Vitamin D testing at Quest Diagnostics.
The negative publicity put Quest Diagnostics in a damage control mode. In speaking to reporters, it constantly stressed the theme that this was just a small matter and it was not likely that patients had been harmed because of an inaccurate Vitamin D test result.
The Associated Press, in its story published on January 9, interviewed Gary Samuels, Quest Diagnostics’ Vice President of Communications, who said “Last year, we did have an issue in a few of our labs that affected a small minority of tests in those labs. We identified the problem our- selves. We corrected the problem. We notified doctors and other customers and offered free retesting.”
However, Samuel’s characterization of the issue as a “small minority of tests in those labs” needs to be viewed in two dimensions. First, as a percentage of Vitamin D tests performed during that time. Second, in terms of the actual number of patients to whom Quest Diagnostics reported inaccurate results.
When studied in these two dimensions, Samuel’s “small minority of tests” actually represents a major quality control/quality assurance failure by an accredited, licensed laboratory organization. It also becomes a failure which directly affected hundreds of thousands of patients and tens of thousands of physicians. The two dimensions are analyzed below.
7% Of Results Were Wrong!
How many inaccurate Vitamin D tests did Quest perform? In the January 9th Associated Press story, Wael A. Salameh, M.D., Medical Director, Endocrinology at Quest Nichols Institute in San Juan Capistrano, disclosed the number of inaccurate results. The AP reporter wrote “Eventually, the company [Quest] flagged about 7% of vitamin D testing results from 2007-2008 as questionable, although it believes the problem was much smaller. Generally, the readings obtained on the questionable tests were higher than they should have been, Salameh said. In some cases, though, it was hard to discern a pattern.”
This is a remarkable concession. Quest Diagnostics is revealing that, for a period lasting as long as 18 months, 7% of the test results it reported from its high-volume home brew LC-MS/MS assay for Vitamin 25(OH) D were inaccurate!
Pathologist and laboratory scientists must ask themselves this question: Does the American public expect their laboratory provider to report an accurate lab test result 93 out of 100 times?
Most people know the correct answer to that question. The media immediately recognized how Quest Diagnostics had betrayed the trust of the American public. Journalists knew this was a big story and would catch the attention of the American consumer. That is why, on Thursday and Friday last week, so many news outlets issued screaming headlines about “inaccurate lab test results.”
May Have Misled Patients
For the same reason, it is why ABC’s Good Morning America did a 3-minute feature on Friday, January 9, titled “How Accurate Are Blood Tests?” Its opening statement was that “Quest Diagnostics alerted doctors that many Vitamin D tests performed over the past two years were wrong and could have misled patients into thinking they are healthier than they actually are.”
Trust is the theme here. Consumers don’t expect an accredited, licensed medical laboratory of good standing to deliver accurate test results only 93 out of 100 times. Even Samuel’s “small minority of tests” is a big deal with the American public.
Having looked at the percentage of inaccurate tests results as one dimension to this important story, the actual number of patients to whom Quest Diagnostics reported inaccurate Vitamin D results represents a second dimension.
Retesting 490,000 Patients?
THE DARK REPORT estimates that the number of inaccurate Vitamin D test results probably ranges between 350,000 and 490,000. Information on the Web indicates that Quest Diagnostics was performing 500,000 Vitamin D tests per month last summer. Factor in a rate of growth in specimen volume over the previous 18 months and one estimate is that Quest Diagnostics performed a total of between 5 million and 7 million Vitamin D tests during the time in 2007 and 2008 when it admits it was reporting inaccurate results at the 7% rate.
If it is true that Quest Diagnostics is sending notification and retest letters to as many as 490,000 patients across the United States, then that fact is a headline story by itself! Quest Diagnostics was lucky to keep reporters from uncovering the accurate and total number of patients who are involved in this retesting program.
Last week’s news headlines changed the lab industry status quo in two important ways. One, it made a large number of Americans aware that not every laboratory test result can be trusted—nor is the quality of a test result from one laboratory necessarily comparable to the quality of a lab test result from another laboratory. In fact, the ABC Good Morning America segment interviewed a private practice doctor (not a pathologist) who made exactly that point.
Lab executives with a long memory will remember that the last time the lab industry made the news cycle in this way, it was following revelations, in the 1980s, of sink testing by a cytology laboratory in California. That media coverage spurred Congress to pass the Clinical Laboratory Improvement Act (CLIA) to reform lab testing practices and prevent these types of abuses. It is not unreasonable to believe that this current round of news headlines could be used as justification for lawmakers to further regulate laboratory testing activities.
Search Engine Links
Two, at a minimum, Quest Diagnostics is now identified with “inaccurate testing” in the public mind. Put “Quest” and “Vitamin D” together in a search on Google, Yahoo, MSN, and other sites. At the moment, almost all of the entries returned will have Quest—along with such words as inaccurate, erroneous, errors, false, and wrong— in the description line. This Internet record will follow Quest Diagnostics for years into the future. Some companies have changed their names simply to disassociate themselves from this type of bad publicity. Think of National Medical Enterprises (NME), which changed its name to Tenet Healthcare Corporation in 1994 to leave behind all its legal and public relations problems.
In addition to the two changes noted above, both Quest Diagnostics and the lab industry at large may face several broad, relevant questions.
First, will the decision by Quest Diagnostics to drop the use of a popular, FDA-cleared lab test and instead substitute a home brew method—to test specimens from millions of patients in a high-volume setting—now be viewed critically by regulators, legislators, and the press? Armed with hindsight and looking back in time, can it be argued that ethical and legal considerations were outweighed by a laboratory’s goal, among other objectives, of using a home brew to reduce operational costs?
Home Brew vs. FDA-Cleared
Another element may attract regulatory scrutiny. Quest Diagnostics has heavily promoted its tandem mass spectrometry Vitamin D assay to doctors as offering: 1) “gold standard” analytical accuracy; and 2) capable of reporting D2 and D3, along with total Vitamin 25(OH) D. This marketing/sales plan is designed to encourage physicians to cease using the FDA-approved immunoassay in favor of the Quest home brew assay. Again, with hindsight, might regulators view this as one more reason why sanctions should be levied against Quest? Could Congress use this as one more reason to give the FDA increased oversight over laboratory-developed tests (LDTs)?
The key insight here is that much of the short-term news value in this story has to do with the public’s reaction to news that a major laboratory acknowledged issuing inaccurate lab test results to large numbers of patients for a period of almost two years. It is the long-term consequences of this story that will may well end up altering—in unwelcome ways—several industry practices that are common today.
Quest’s Inaccurate Vitamin D Tests Dominate the News Cycle–But Where Are Pathologists?
IT WAS NATIONAL NEWS LAST WEEK that the nation’s biggest laboratory company had admitted to a clinical testing fiasco of immense consequences. But absent from major news reports was any other lab industry voice other than Quest Diagnostics Incorporated.
For the entire laboratory profession, this fact may turn out to be just as important to the future of laboratory medicine as the consequences from the public disclosure by Quest Diagnostics of systemic failures with its Vitamin D testing program, and how it reported inaccurate results to patients for a period lasting as long as one and one half years. At a minimum, that’s because the internal lab testing problems at one high- profile lab company could cause lab regulators to tighten licensing and regulatory requirements in unwelcome ways.
News reporters seemed to have no problem locating experts to discuss how inaccurate Vitamin D test results may have been harmful to patients or to inform consumers about the role Vitamin D plays in maintaining health. But THE DARK REPORT is unaware of a news story or television news segment which included comments by a non-Quest pathologist on different aspects of this headline news story.
Speaking For Lab Medicine
Are pathologists and medical laboratory scientists invisible to the nation’s news media? Is there no professional lab organization that reporters consider to be a credible source of experts on laboratory medicine? Or, was this a story that was “too hot” and too full of professional dynamite for any individual pathologist to volunteer an interview with a major news outlet?
Pathologists complain regularly that the public does not recognize the essential services they provide. Here was an opportunity for the pathology profession to provide objective information to Americans, along with relevant information about why this systemic failure with Quest Diagnostics’ Vitamin D testing program is an exceptional event in modern medicine.
THE DARK REPORT asks these questions because laboratory medicine stands at the threshold to the era of genetic medicine. Already the first elements of personalized medicine—informed and supported by molecular diagnostics—are gaining clinical acceptance. News stories about break-throughs in cancer diagnosis and treatment appear regularly, for example.
Preparing For Genetic Age
However, genetic testing and molecular diagnostics require a much more complex mix of technology, clinical expertise, and laboratory science to properly perform than, say, a test such as Vitamin 25(OH) D. It is time for the pathology profession to establish its “brand” and name recognition with the media, as well as among consumers, health policy-makers, and elected officials. As society makes decisions about how to respond to genetic medicine, pathologists and lab scientists need a voice in that debate.
But to have credibility and authority going forward, laboratory professionals must have a united, public front. The alphabet soup of acronyms from lab specialty associations and societies becomes a barrier for news reporters seeking lab professions to provide expert opinion on specific topics in laboratory medicine, as well as to speak authoritatively for the laboratory medicine establishment.
It appears that the news of Quest’s problems with Vitamin D testing has caught the lab industry flat-footed and unprepared. That is why the voice of the laboratory profession was missing from the rancorous headlines of last week. It is time to act, so that in the next news cycle dealing with a laboratory issue, lab professionals have the opportunity to be part of the discussion in a positive way.