News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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There Ain’t No Such Thing as a Free Lunch (TANSTAAFL): Quality Costs Money

Wall Street has yet to grasp this essential truth of laboratory medicine-lab test quality comes with its own price tag

At this moment in time, Quest Diagnostics Incorporated‘s  (NYSE:DGX) advertised value proposition to other labs—”industry-leading quality and technical proficiency”—has diminished credibility with pathologists and lab industry executives. They are questioning how the nation’s largest lab company could allow systemic errors that caused it to report inaccurate Vitamin 25(OH) D test results to tens of thousands of patients for 18 months during 2007 and 2008.

These same pathologists represent an important source of reference and esoteric testing referrals to the nation’s largest lab company. Thus, the disclosure of systemic failures in its Vitamin D testing program may have implications for Quest Diagnostics over the long term. Many health systems, hospitals, and laboratories across the United States refer reference and esoteric tests to Quest Diagnostics. Quality and test result integrity are a primary buying motive for the pathologists and lab directors in these organizations. As scientists, they want confidence in the analytical integrity of the test results they provide to their own clinicians.

Two national reference laboratories with solid reputations for quality and lab test result integrity are ARUP Laboratories and Mayo Medical Laboratories. These reputations for quality and integrity are key assets at ARUP and Mayo. Both firms compete successfully against the two blood brothers because many referring laboratories believe the scientific integrity at ARUP and Mayo is not compromised in ways that may occur in publicly-traded lab companies. Of interest, both these laboratories earn adequate profit margins while competing effectively on price, service, and quality against the national lab companies.

Quest Diagnostics now finds itself facing a tough challenge in the reference/esoteric testing marketplace. Among its peers in the scientific and laboratory medicine communities, the quality and integrity of its lab test results will be seriously questioned. And because pathologists have long memories, this can be an issue for years into the future.

That has been the experience of Specialty Laboratories, Inc. During the 1990s, this was a go-go reference and esoteric testing laboratory. Fast-growing, it had a reputation for first-rank science and regularly introduced new proprietary assays to the medical community. But, in April, 2002, federal and state laboratory regulators yanked Specialty’s license to do business with Medicare. The story centered around internal whistleblowers and regulatory directives that were not fully addressed by Specialty’s executive team. There were questions about the integrity of test results for some lines of lab tests performed at Specialty. (“State, Federal Regulators Target Specialty Labs,” The Dark Report, April 22, 2002.)

Within a few months, Specialty Labs was able to reclaim its Medicare license after fixing deficiencies and passing its inspections. However, loss of its Medicare license was a body blow to Specialty Laboratories. Across the nation, pathologists and laboratory directors stopped sending specimens to Specialty Labs. Overnight, the company experienced a precipitous decline in specimen volume and revenue. Facing grim financial prospects, in January 2006 it was sold to AmeriPath. Ironically, Quest Diagnostics found itself the owner of Specialty Laboratories when it acquired AmeriPath last year.

The example of Specialty Labs illustrates why quality, integrity, and trust matter-a great deal! Pathologists and lab directors face personal liability if their laboratory delivers inaccurate results to patients and physicians. Their personal reputations ride on the performance of their laboratory. As physicians, they understand the consequences to patient care when a laboratory fails to report accurate test results. Their own laboratory must maintain its reputation for integrity and quality if it is to retain the trust of the clinicians and patients it serves.

Further, these same pathologists and lab directors regularly interview and hire scientists and medical technologists from both of the national laboratory companies. They hear lots of stories about the internal operations of these two billion-dollar lab companies. There are few secrets about events that unfold inside the two blood brothers. For example, lab scientists directing Vitamin D testing at their own labs quickly recognized, early in 2007, that Quest Diagnostics was struggling with its home brew mass spectrometry Vitamin D assay.

The lab community has watched both national labs continually cut costs over the past ten years. Competing labs conduct hiring interviews with the wave after wave of terminated employees hunting for jobs after each RIF (reduction in force) trims back staff to save money. Pathologists and lab directors understand the consequences of sustained cost cutting. Eventually, a laboratory’s cost cutting reaches a point where the resources, staff time, and operational capability required to sustain a high level of analytical accuracy and integrity can be compromised.

That is why many laboratory professionals are asking if the inaccurate Vitamin 25(OH) D results performed over an 18-month period on tens of thousands of patients is a sign that should not be ignored. Has Quest Diagnostics reached the threshold where further cost-cutting to satisfy Wall Street will undermine the quality and integrity of its lab test results?

Of all the customers of the two national laboratories, pathologists are the best informed about how constant budget reductions can undermine the quality and integrity of laboratory test results. They know that lab test quality is an expensive proposition.

Thus, no one should be surprised if, going forward, both national laboratories find it more difficult to expand the reference and esoteric business which comes to them from other laboratories across the nation. Should either firm experience even modest declines in the year-over-growth in this business segment, it will be a significant sign. Questions associated with test integrity may be motivating an important source of reference and esoteric testing to steer their specimens to other laboratory providers.

Should this happen, no one should be surprised. If a decade of sustained cost-cutting has finally reached the point where laboratory customers question the quality of the test results produced by major lab companies, it will only be the market imposing its discipline. The market will be reminding Wall Street investors that spending to sustain quality protects market share and profits. After all, as the libertarians say, “There ain’t no such thing as a free lunch (TANSTAAFL)”!

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Invivo and In Vitro Integration Unfolding at UCLA Laboratories

California is often a national leader for innovations in managed care contracting, as well as new approaches for delivering healthcare. So when your Dark Daily editor visited the laboratory at the UCLA Medical Center this week, he was quite curious about the ways in which clinical laboratory testing and anatomic pathology services are being used at this respected national academic center.

For one thing, UCLA has recently moved into a brand new hospital building. The Ronald Reagan Medical Center is a 525 bed facility (all single patient rooms) and is designed to be state-of-the-art. The UCLA Medical Center is also a world-class institution. It is proudly flying banners throughout the campus which recognize its selection by U.S. News and World Report as the nation’s number 3 best hospital. (Are you interested in which hospitals are ranked 1 and 2? We provide a list of U.S. News & World Report’s Top Ten Best Hospitals at the end of this e-briefing.)

Exciting things are unfolding at the Department of Pathology and Laboratory Medicine. In a briefing session with Scott W. Binder, M.D., Senior Vice Chair, Pathology Clinical Services and Chief, Dermatopathology, your Dark Daily editor learned about a collaborative effort with the Department of Radiology and the Department of Molecular and Medical Pharmacology to develop integrated patient care pathways in several different types of cancers. The particular focus is on lung cancer, melanoma, and breast cancer. The goal is to develop an integrated report which incorporates the radiology components with the pathology report. Molecular assays will be used so that the report emphasizes information about prognostic genes and the most appropriate therapeutic options for the patient. This is an effort to integrate in vivo and in vitro diagnostics to advance patient care.

Over in the clinical laboratory, there were several interesting things that are unique to the UCLA Medical Center. At the 10-story Ronald Reagan Medical Center building, there is a new core laboratory. However, competition for space within the facility meant that the clinical laboratory did not get all the square footage it required to centralize all laboratory testing activities across the campus into one site. Consequently, there are at least four different locations where significant laboratory testing activity takes place.

For example, a medical building next to the new hospital holds a large patient drawing center (serving an average of 500 patients per day). This space also has the accessioning center for routine specimens, along with a fully automated pre-analytical line supplied by Beckman Coulter that includes specimen sorting, de-capping, centerfuging, aliquotting, and re-capping. Prepped specimens are then sent next door to the new core laboratory in the Reagan Medical Center for testing. At the core laboratory, different academic experts supported their “best of breed” choices for analyzers. Thus, the automated line is by Beckman Coulter, while Roche and Olympus supplied chemistry and immunoassay analyzers. PT/PTT testing is done on a system by Siemens (Dade Bering), and hematology is performed on a Sysmex automated line. The clinical laboratory performs tests for inpatients, outpatients, and outreach patients.

Dark Daily summarizes this day of site visits and learning with two observations. First, UCLA’s Department of Pathology and Laboratory Medicine is proactively crossing traditional medical specialty silos to support collaboration with a goal to advancing personalized medicine. For that reason, expect to see some interesting research breakthroughs, particularly in the areas of molecular and genetic testing, from the UCLA pathology department.

Second, the competition for limited resources in healthcare was visible at the new Ronald Reagan Medical Center. Even in a new, state-of-the-art facility, demand for space by all the clinical services was so intense that the clinical laboratory had to settle for a space allotment that made it impossible for them to consolidate all major laboratory testing facilities into a single location.

Related Information:

U.S. Hospitals Honor Roll

Top Ten Hospitals as Ranked by U.S. World & News Report in 2008:

1. Johns Hopkins Hospital, Baltimore
30 points in 15 specialties

2. Mayo Clinic, Rochester, Minn.
28 points in 15 specialties

3. Ronald Reagan UCLA Medical Center, Los Angeles
25 points in 14 specialties

4. Cleveland Clinic
25 points in 13 specialties

5. Massachusetts General Hospital, Boston
24 points in 12 specialties

6. New York-Presbyterian Univ. Hosp. of Columbia and Cornell
22 points in 12 specialties

7. University of California, San Francisco Medical Center
21 points in 11 specialties

8. Brigham and Women’s Hospital, Boston
18 points in 11 specialties

9. Duke University Medical Center, Durham, N.C.
18 points in 11 specialties

10. Hospital of the University of Pennsylvania, Philadelphia
18 points in 10 specialties

15-Minute Diagnostic Biomarkers for Cancer, Other Conditions Unveiled in UK

Use of antibodies that detect biomarkers in as little as 15 minutes now allows researchers at the University of Leeds in the United Kingdom to identify such diseases as prostate and ovarian cancer, stroke, multiple sclerosis (MS), heart disease, and fungal infections. Using biosensors to identify the molecular markers for disease, the technology is much faster than current testing methods.

One goal of this research is to provide a way for hospitals to use this technology for rapid diagnosis. Another goal is to allow surgeons to use the technology to improve the speed and accuracy of referral to specialty physicians. Along with the ability to identify cancer, MS, heart disease, and infections, researchers say these biosensors may also be able to detect a wide range of analytes, including biomarkers in tuberculosis and HIV.
“We believe this to be the next generation diagnostic testing. We can now detect almost any analyte faster, cheaper, and more easily than the current accepted testing methodology,” said Paul Millner, M.D, a member of the faculty of Biological Sciences at the University of Leeds.

Researchers say that this technology could be developed into a device the size of a mobile phone, where different sensor chips could be inserted, depending on the disease being sought. “We’ve designed simple instrumentation to make the biosensors easy to use and understand,” Millner explained. “They’ll work in a format similar to the glucose biosensor testing kits that diabetics use.”

Currently blood and urine are tested for disease markers using test technologies such as ELISA (enzyme-linked immunosorbant assay). Developed in the 1970s, ELISA takes an average of two hours to complete, can be expensive, and can be performed only by highly trained staff.

The new biomarker technology was developed through a European collaboration of researchers and commercial partners in a 2.7 million Euro ($3.6 million) project called ELISHA (Electronic Immuno-Interfaces and Surface Nanobiotechnology: A Heterodoxical Approach).

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