Jan 12, 2009 | Laboratory News, Laboratory Pathology
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”
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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”. |
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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.
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Jan 7, 2009 | Laboratory News, Laboratory Pathology
Patient-Centered Medical Home (PCMH) is the latest concept in managed care. Primary care physicians, relegated to gatekeeper status in the HMO model of the 1990s, are elevated to the status of healthcare guru, taking the role of coordinating care, counseling, and educating patients. Launching the first statewide Patient-Centered Medical Home (PCMH), programs are Rhode Island and North Dakota.
The PCMH concept, which has been endorsed by the AMA, is a care delivery model that provides patients continuous access to a personal physician for the majority of their healthcare needs. There are 22 medical home pilots underway throughout the nation, but Rhode Island and North Dakota are first to take the concept statewide.
The leading advocate for the PCMH is the Patient Centered Primary Care Collaborative, a 200-member group that includes major employers, consumer groups, labor unions and healthcare providers and payers. It contends this healthcare model could improve the health of patients, while ensuring viability of the healthcare delivery system through reduced costs associated with shorter hospital stays, fewer hospital readmissions, and emergency department visits.
A statewide pilot of the Rhode Island Chronic Care Sustainability Initiative was launched last October on the heals of a 2004 state law mandating that health plans work to improve accountability in healthcare affordability, accessibility and quality. The pilot includes the state’s three biggest health plans, including the state’s Medicaid plan, Neighborhood Health Plan of Rhode Island’s Rhody Health Partners; Blue Cross and Blue Shield; and United Healthcare. These plans will pay the five participating primary care practices a fee of $3 per member, per month to cover the services of a care-management nurse.
Rhode Island insurers are optimistic about the model’s potential for reducing healthcare costs and improving outcomes. They also suggest that the new care model, which provides compensation for extra time spent caring for patients, will improve physician satisfaction. Not only with this be due to increased reimbursement, but also because the physicians will have the ability to provide consistent care across the board, regardless of the patient’s health plan.
North Dakota has already completed a two-year pilot of its MediQHome Quality Project, a PCMH pilot focused on diabetes care. The pilot demonstrated an estimated $102,000 savings in the care provided to 192 diabetes patients. The state launched its full-fledged, statewide PCMH program on January 1, 2009.
Under the North Dakota program, Blue Cross Blue Shield of North Dakota, the state’s largest health plan, has agreed to pay primary care physicians a semiannual $50 care-management fee for Blues members treated for coronary artery disease, diabetes or hypertension. However, according to a report from Modern Healthcare, Jon Rice, North Dakota Blues CEO/senior vice president, questions the need for a “medical home infrastructure” to achieve better outcomes and cost savings. He points out that the pilot focused on a single health issue, but has yet to prove its mettle as a broad-based quality improvement program.
This mirrors the position of TransforMed, a nonprofit subsidiary of the American Academy of Family Physicians that is concerned with creating a financially sustainable healthcare model through a nationwide medical home system. TransforMed urges that an effective medical home program must address all patients in a primary care practice, not just certain diseases.
If there is a downside to the medical home trend, it is that it adds to the workload for doctors, even as the pool of primary care physicians dwindles. Practicing primary care physicians are leaving the field to enter higher-paying specialties. Fewer medical school students are opting to enter primary care.
Dark Daily expects that one consequence of the medical home movement will be for physicians to shift their lab test utilization patterns toward greater use of predictive testing and risk assessment testing. That’s because a major goal of the medical home arrangement is to encourage early diagnosis and active intervention to help the patient maintain optimal health.
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The Dangers of the Decrease In Primary Care Physicians
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.
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Dec 30, 2008 | Laboratory News, Laboratory Pathology
Retail care clinics-typically a nurse practitioner offering fast patient access to a limited number of clinical services in a pharmacy or other type of retail store-are now an accepted part of the provider mix in the United States. At least two studies published by credible organizations consider retail care clinics, also called convenient care clinics, to be an important source of care.
One study was released by the Center for Studying Health System Change, based in Washington, DC. Using data from the Health Tracking Study funded by the Robert Wood Johnson Foundation which included 18,000 telephone interviews, this study looked at the use of retail care clinics. It stated that 1.2% of American families reported visiting a retail care clinic in the past 12 months. By contrast, 2.3% of American families said that they have used a retail care clinic in recent years.
What Dark Daily found notable about this study is another finding by researchers. Uninsured families represent 27% of the users of retail care clinics, and the slowdown in the number of new convenient care clinics opening may inhibit access to care through this channel. “If the growth of retail clinics falters, underserved groups already facing access pressures may suffer from the loss of alternate sources of care more than the rest of the population,” stated researchers in the study.
This is an interesting turn of affairs. Dark Daily readers may recall that, several years ago, in the early days of the convenient care clinic movement, the business model of a nurse practitioner and a limited menu of clinical services providing care in a retail store came under plenty of criticism. Now, some healthcare researchers are acknowledging that retail care clinics do provide useful clinical services, at an affordable price, that benefit the uninsured.
The second study, released by the Deloitte Center for Health Solutions, conducted an on-line poll of 3,000 adults in a nationally-representative sample and found that 16% reported that they had used a convenient care clinic located in a retail store. Interestingly, 17% of the uninsured and 11% of the Medicare enrollees in this survey had visited a retail care clinic. At a minimum, the survey results demonstrate that a significant portion of the American public is aware of these in-store clinics and is willing to use them.
Optimistic predictions that there would be 10,000 retail care clinics by 2010 will not come true. Starting in 2006, there were 60 retail care clinics in 18 states. The Convenient Care Association says the number of such clinics in the United States now totals approximately 1,150 retail care clinics in 38 states.
However, despite the slowdown in the rate at which new convenient care clinics are opening, this service delivery model seems to have established itself as a permanent fixture in the American healthcare system. Last summer, Dark Daily reported that Wal-Mart was introducing telemedicine access to a physician at the retail care clinics it operates in multiple Wal-Mart locations in Houston, Texas
Dark Daily believes that, as demonstrated by the telemedicine example at Wal-Mart’s convenient care clinics in Houston, there will be a steady expansion in the range of clinical services offered at these sites. It is highly likely that laboratory testing will be needed to support these additional clinical services. As that happens, these retail clinics will become both a threat and an opportunity for the nation’s laboratories.
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